As filed with the U.S. Securities and Exchange Commission on November 9, 2026.

Registration Statement No. 333-299608

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

 

Amendment No. 2

to

Form F-1

REGISTRATION STATEMENT

UNDER

THE SECURITIES ACT OF 1933

 

 

Windward Bio Group AG

(Exact name of registrant as specified in its charter)

 

 

 

Switzerland		2836		Not applicable
(State or other jurisdiction of incorporation or organization)		(Primary Standard Industrial Classification Code Number)		(I.R.S. Employer Identification Number)

 

 

Aeschenplatz 6

4052 Basel

Switzerland

Tel: +41 61 551 75 75

(Address, including zip code, and telephone number, including area code, of registrant’s principal executive offices)

 

 

Windward Bio, Inc.

800 North State Street, Suite 304

Dover, Delaware, United States of America

Tel: +41 61 551 75 75

(Name, address, including zip code, and telephone number, including area code, of agent for service)

Copies of all communications, including communications sent to agent for service, should be sent to:

 

 

Luca Santarelli

Chief Executive Officer

Aeschenplatz 6

4052 Basel

Switzerland

Tel: +41 61 551 75 75

 

 

 

Brandon Fenn Ryan Sansom Divakar Gupta Susan Choy Cooley LLP 55 Hudson Yards New York, New York 10001 +1 (212) 479 6000		Andreas Müller Margrit Marti Niederer Kraft Frey AG Bahnhofstrasse 53 CH-8001 Zurich Switzerland +41 58 800 8080		Nathan Ajiashvili Kaj Nielsen Latham & Watkins LLP 1271 Avenue of the Americas New York, New York 10020 +1 212 906 1200		Alexander von Jeinsen Advestra AG Uraniastrasse 9 8001 Zürich Switzerland +41 58 510 92 00

 

 

Approximate date of commencement of proposed sale to public: As soon as practicable after this registration statement becomes effective.

If any of the securities being registered on this Form are to be offered on a delayed or continuous basis pursuant to Rule 415 under the Securities Act of 1933, as amended, or the Securities Act, check the following box. ☐

If this Form is filed to register additional securities for an offering pursuant to Rule 462(b) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering. ☐

If this Form is a post-effective amendment filed pursuant to Rule 462(c) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering. ☐

If this Form is a post-effective amendment filed pursuant to Rule 462(d) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering. ☐

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act.

Emerging growth company ☒

If an emerging growth company that prepares its financial statements in accordance with U.S. GAAP, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards† provided pursuant to Section 7(a)(2)(B) of the Securities Act. ☐

 

†	The term “new or revised financial accounting standard” refers to any update issued by the Financial Accounting Standards Board to its Accounting Standards Codification after April 5, 2012.

The registrant hereby amends this registration statement on such date or dates as may be necessary to delay its effective date until the registrant shall file a further amendment which specifically states that this registration statement shall thereafter become effective in accordance with Section 8(a) of the Securities Act of 1933 or until the registration statement shall become effective on such date as the U.S. Securities and Exchange Commission, acting pursuant to said Section 8(a), may determine.

 

 

TABLE OF CONTENTS

 

 

ABOUT THIS PROSPECTUS			iii
PRESENTATION OF FINANCIAL INFORMATION			iii
MARKET, INDUSTRY AND OTHER DATA			iv
PROSPECTUS SUMMARY			1
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS			18
RISK FACTORS			20
USE OF PROCEEDS			92
DIVIDEND POLICY			94
CAPITALIZATION			95
DILUTION			98
MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS			101
BUSINESS			115
MANAGEMENT			174
RELATED PARTY TRANSACTIONS			191
PRINCIPAL SHAREHOLDERS			195
DESCRIPTION OF SHARE CAPITAL AND ARTICLES OF ASSOCIATION			198
COMPARISON OF SHAREHOLDER RIGHTS UNDER SWISS AND DELAWARE CORPORATE LAW			215
LIMITATIONS AFFECTING SHAREHOLDERS OF A SWISS COMPANY			227
SHARES ELIGIBLE FOR FUTURE SALE			229
MATERIAL U.S. FEDERAL INCOME TAX CONSIDERATIONS FOR U.S. HOLDERS			231
SWISS TAX IMPLICATIONS FOR OUR HOLDERS			236
UNDERWRITING			239
LEGAL MATTERS			250
EXPERTS			251
SERVICE OF PROCESS AND ENFORCEMENT OF LIABILITIES			252
EXPENSES OF THE OFFERING			254
WHERE YOU CAN FIND ADDITIONAL INFORMATION			255
INDEX TO CONSOLIDATED FINANCIAL STATEMENTS			F-1
INDEX TO CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS			F-34

 

You should rely only on the information contained in this prospectus and any free writing prospectus prepared by or on behalf of us or to which we have referred you. Neither we nor the underwriters have authorized anyone to provide you with information that is different from that contained in this prospectus or in any free writing prospectus that we may authorize to be delivered or made available to you. Neither we nor the underwriters take any responsibility for, or provide any assurance as to the reliability of, any other information others may give you.

We are not, and the underwriters are not, making an offer to sell and seeking offers to purchase these securities in any jurisdiction where the offer or sale is not permitted. You should not assume that the information contained in this prospectus is accurate as of any date other than the date on the front of this prospectus, regardless of the time of delivery of this prospectus or any sale of securities.

For investors outside the United States: Neither we nor any of the underwriters have done anything that would permit the initial public offering or possession or distribution of this prospectus in any jurisdiction where action for that purpose is required, other than in the United States. Persons outside the United States who come into possession of this prospectus must inform themselves about, and observe any restrictions relating to, the initial public offering of the common shares and the distribution of this prospectus outside of the United States.

We are incorporated under the laws of Switzerland and a majority of our outstanding voting securities are owned by non-U.S. residents. Under applicable rules of the SEC, we are currently eligible for treatment as a “foreign private issuer.” As a foreign private issuer, we will not be required to file periodic reports and financial statements with the SEC as frequently or as promptly as domestic registrants whose securities are registered under the Securities Exchange Act of 1934, as amended, or the Exchange Act.

 

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ABOUT THIS PROSPECTUS

Unless otherwise indicated or the context otherwise requires, all references in this prospectus to “Windward Bio,” “Windward Bio Group,” the “Company,” “we,” “our,” “ours,” “us” or similar terms refer to Windward Bio Group AG and its consolidated subsidiaries.

This prospectus includes trademarks, trade names and service marks, certain of which belong to us and others that are the property of other organizations. Solely for convenience, the trademarks, trade names and service marks may appear in this prospectus without the ^® and TM symbols, but any such references are not intended to indicate, in any way, that we or their respective owners forgo or will not assert, to the fullest extent under applicable law, our or their respective owners’ rights or the rights of the applicable licensors to these trademarks, trade names and service marks. We do not intend to use or display other companies’ trademarks and trade names to imply a relationship with, or endorsement or sponsorship of us by, any other companies.

PRESENTATION OF FINANCIAL INFORMATION

This prospectus includes our audited annual consolidated financial statements as of December 31, 2025 and 2024 and for the year ended December 31, 2025 and for the period from July 5, 2024 (inception) to December 31, 2024, which have been prepared in accordance with IFRS Accounting Standards, or IFRS, as issued by the International Accounting Standards Board, or IASB. This prospectus also includes our unaudited condensed consolidated interim financial statements as of June 30, 2026 and for the six months ended June 30, 2026 and 2025, prepared under the International Accounting Standard 34, or IAS 34. None of our financial statements were prepared in accordance with generally accepted accounting principles in the United States, or U.S. GAAP.

All references in this prospectus to “$” are to U.S. dollars and all references to “CHF” mean Swiss francs. Unless otherwise indicated, for the convenience of the reader, all CHF amounts contained in this prospectus, other than the preliminary estimated unaudited cash, cash equivalents and marketable securities as of September 30, 2026 included under “Prospectus Summary—Recent Developments—Preliminary Estimated Unaudited Cash, Cash Equivalents and Marketable Securities”, have been translated into U.S. dollars at the rate of CHF 1.00 to $1.2372, which was the noon buying rate of the Federal Reserve Bank of New York on June 30, 2026. Solely with respect to such preliminary estimated unaudited cash, cash equivalents and marketable securities, CHF amounts have been translated into U.S. dollars at the rate of CHF 1.00 to $1.1979, which was the noon buying rate of the Federal Reserve Bank of New York on September 30, 2026. These translations should not be considered representations that any such amounts have been, could have been or could be converted into CHF at that or any other exchange rate as of that or any other date.

We have made rounding adjustments to some of the figures included in this prospectus. Accordingly, numerical figures shown as totals in some tables may not be an arithmetic aggregation of the figures that preceded them.

 

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MARKET, INDUSTRY AND OTHER DATA

This prospectus contains estimates, projections and other information concerning our industry, our business, and the markets for our product candidates. Information that is based on estimates, forecasts, projections, market research or similar methodologies is inherently subject to uncertainties, and actual events or circumstances may differ materially from events and circumstances that are assumed in this information. Unless otherwise expressly stated, we obtained this industry, business, market and other data from our own internal estimates and research as well as from reports, research surveys, studies and similar data prepared by market research firms and other third parties, industry, medical and general publications, government data and similar sources. While we believe our internal company research as to such matters is reliable and the market definitions are appropriate, neither such research nor these definitions have been verified by any independent source. Statements regarding our market opportunity (such as our estimate that the diseases our product candidates target represent a $60 billion opportunity for biologic therapies and addressable patient populations) are management’s estimates, which are based, in part, on our analysis of data and other information from third-party sources.

In addition, assumptions and estimates of our and our industry’s future performance are necessarily subject to a high degree of uncertainty and risk due to a variety of factors, including those described in the section titled “Risk Factors.” These and other factors could cause our future performance to differ materially from our assumptions and estimates. See “Special Note Regarding Forward-Looking Statements.”

 

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SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS

This prospectus contains express or implied forward-looking statements that involve substantial risks and uncertainties. In some cases, you can identify forward-looking statements by the words “may,” “might,” “will,” “could,” “would,” “should,” “expect,” “intend,” “plan,” “objective,” “anticipate,” “believe,” “estimate,” “predict,” “potential,” “continue,” “ongoing,” or the negative of these terms, or other comparable terminology intended to identify statements about the future. These statements involve known and unknown risks, uncertainties and other important factors that may cause our actual results, levels of activity, performance or achievements to be materially different from the information expressed or implied by these forward-looking statements. The forward-looking statements and opinions contained in this prospectus are based upon information available to our management as of the date of this prospectus and, while we believe such information forms a reasonable basis for such statements, such information may be limited or incomplete, and our statements should not be read to indicate that we have conducted an exhaustive inquiry into, or review of, all potentially available relevant information. Forward-looking statements contained in this prospectus include, but are not limited to, statements about:

 

∎

the ability of our clinical trials to demonstrate acceptable safety and efficacy of WIN378 and WIN027;

 

∎

the timing, progress and results of clinical trials for WIN378 and WIN027, including statements regarding the timing of initiation and completion of studies or trials and related preparatory work, the period during which the results of the trials will become available, and our research and development programs;

 

∎

the timing, scope and likelihood of regulatory filings and approvals;

 

∎

our ability to obtain marketing approvals of WIN378 and WIN027 and to meet existing or future regulatory standards or comply with post-approval requirements;

 

∎

our expectations regarding our ability to fund our operating expenses and capital expenditure requirements with our cash and cash equivalents and net proceeds of this offering and concurrent private placement;

 

∎

future milestone or royalty payments to our licensing partners or other third parties, and the expected timing of such payments;

 

∎

our expectations regarding the potential market size and the size of the patient populations for WIN378 and WIN027, if approved for commercial use;

 

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our expectations regarding the potential advantages of WIN378 and WIN027 over existing therapies and our expectations regarding potential uses of WIN378 and WIN027 to treat multiple indications;

 

∎

developments and projections relating to our competitors and our industry, including competing therapies;

 

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our expectations with regard to our ability to develop additional product candidates or leverage our current product candidate for other indications, and our ability to identify additional products, product candidates or technologies with significant commercial potential that are consistent with our commercial objectives;

 

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our ability to develop, acquire and advance additional product candidates into, and successfully complete, clinical trials;

 

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the commercialization and market acceptance of WIN378 and WIN027;

 

∎

our marketing and manufacturing capabilities or those of third parties with which we contract;

 

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our ability to operate our business without infringing the intellectual property rights and proprietary technology of third parties;

 

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the scope of protection we are able to establish and maintain for intellectual property rights covering our product candidates;

 

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estimates of our expenses, future revenue, capital requirements, our needs for additional financing and our ability to obtain additional capital;

 

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regulatory developments in the United States, Europe and other jurisdictions;

 

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our exposure to additional scrutiny as a U.S. public company;

 

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our ability to effectively manage our anticipated growth;

 

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our ability to attract and retain qualified employees and key personnel;

 

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our use of proceeds from this offering and concurrent private placement; the terms and completion of the concurrent private placement; and

 

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our expectations regarding the time during which we will be an emerging growth company and smaller reporting company under the JOBS Act and qualify as a foreign private issuer.

You should refer to the section titled “Risk Factors” for a discussion of important factors that may cause our actual results to differ materially from those expressed or implied by our forward-looking statements. As a result of these factors, we cannot assure you that the forward-looking statements in this prospectus will prove to be accurate. Furthermore, if our forward-looking statements prove to be inaccurate, the inaccuracy may be material. In light of the significant uncertainties in these forward-looking statements, you should not regard these statements as a representation or warranty by us or any other person that we will achieve our objectives and plans in any specified time frame, or at all. We undertake no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.

You should read this prospectus and the documents that we reference in this prospectus and have filed as exhibits to the registration statement of which this prospectus is a part completely and with the understanding that our actual future results may be materially different from what we expect. We qualify all of our forward-looking statements by these cautionary statements.

 

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RISK FACTORS

Investing in our common shares involves a high degree of risk. You should consider and read carefully all of the risks and uncertainties described below, as well as the other information in this prospectus, including our consolidated financial statements and the related notes appearing elsewhere in this prospectus and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” before deciding whether to invest in our common shares. The risks described below are not the only ones facing us. The following risks or additional risks and uncertainties not presently known to us or that we currently believe to be immaterial could materially and adversely affect our business, financial condition, results of operations and growth prospects. In such an event, the trading price of our common shares could decline, and you may lose all or part of your investment.

This prospectus also contains forward-looking statements and estimates that involve risks and uncertainties not presently known to us or that we currently deem immaterial which may impair our business operations. See “Special Note Regarding Forward-Looking Statements” in this prospectus. Our actual results could differ materially from those anticipated in our forward-looking statements as a result of specific factors, including the risks and uncertainties described below.

Risks Related to Our Limited Operating History, Financial Condition and Need for Additional Capital

We are a clinical-stage biopharmaceutical company with a limited operating history, which may make it difficult to evaluate our current business and predict our future success and viability.

We are a clinical-stage biopharmaceutical company with a limited operating history. We were formed in July 2024 and began operations in January 2025 and our operations to date have been limited to pre-commercial activities. We have not yet demonstrated an ability to generate revenues, obtain regulatory approvals, manufacture any product on a commercial scale or arrange for a third party to do so on our behalf or conduct sales and marketing activities necessary for successful product commercialization. Our limited operating history as a company makes any assessment of our future success and viability subject to significant uncertainty. We will encounter risks and difficulties frequently experienced by early-stage biopharmaceutical companies in rapidly evolving fields, and we have not yet demonstrated an ability to successfully overcome such risks and difficulties. If we do not address these risks and difficulties successfully, our business will suffer.

We have incurred significant financial losses since our inception and anticipate that we will continue to incur significant financial losses for the foreseeable future.

We have no products approved for commercial sale and have not generated any revenue from product sales to date. We have two clinical-stage antibody product candidates targeting the TSLP signaling pathway: WIN378, our lead product candidate, and WIN027. Beyond WIN378 and WIN027, we are building a discovery pipeline of long-acting bispecific antibodies targeting validated biology in respiratory and dermatological conditions. We will continue to incur significant research and development and other expenses related to our nonclinical and clinical development of WIN378 and WIN027 and ongoing operations. As a result, we are not profitable and have incurred losses in each period since our inception. Net losses and negative cash flows have had, and will continue to have, an adverse effect on our total equity and working capital. Our net losses amounted to $48.3 million for the year ended December 31, 2025 and $1.2 million for the period from our incorporation to December 31, 2024, respectively. As of December 31, 2025, we had accumulated losses of $50.6 million. For the six months ended June 30, 2026, we incurred a net loss of $42.6 million. As of June 30, 2026, we had accumulated losses of $93.2 million. We expect to continue to incur significant losses for the foreseeable future, and we expect these losses to increase as we continue our research and development of, and seek regulatory approvals for, WIN378 and WIN027 in multiple indications.

We anticipate that our expenses will increase substantially if, and as, we:

 

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advance WIN378, WIN027 and our potential future product candidates through clinical development;

 

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seek regulatory approvals for WIN378, WIN027 and our potential future product candidates in indications for which clinical trials are successful;

 

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hire additional clinical, quality control, medical, scientific and other personnel to support the ongoing development of WIN378, WIN027 and our potential future product candidates;

 

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experience an increase in headcount as we expand our research and development organization and market development and pre-commercial planning activities;

 

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undertake any pre-commercial or commercial activities required to establish sales, marketing and distribution capabilities;

 

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seek to identify, acquire and develop additional product candidates, including through business development efforts to invest in or in-license other technologies or product candidates;

 

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maintain, expand and protect our intellectual property portfolio;

 

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make milestone, royalty or other payments due under our license agreements and any potential future in-license or collaboration agreements; and

 

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make milestone, royalty, interest or other payments due under any potential future financing or other arrangements with third parties.

Biopharmaceutical product development entails substantial upfront capital expenditures and significant risk that any potential product candidate will fail to demonstrate adequate efficacy or an acceptable safety profile, gain regulatory approval, secure market access and reimbursement and become commercially viable, and therefore any investment in us is highly speculative. Accordingly, before making an investment in us, you should consider our prospects, factoring in the costs, uncertainties, delays and difficulties frequently encountered by companies in clinical development, especially clinical-stage biopharmaceutical companies such as ours. Any predictions you make about our future success or viability may not be as accurate as they would otherwise be if we had a longer operating history or a history of successfully developing and commercializing pharmaceutical products. We may encounter unforeseen expenses, difficulties, complications, delays and other known or unknown factors in achieving our business objectives.

Additionally, our expenses could increase beyond our expectations if we are required by the FDA, the EMA, the European Commission, or other comparable foreign regulatory authorities to perform clinical trials in addition to those that we currently expect, or if there are any delays in establishing appropriate manufacturing arrangements for or in completing our clinical trials or the development of WIN378, WIN027 and our potential future product candidates.

Even if this offering and the concurrent private placement are successful, we will require additional funding in order to finance operations. If we are unable to raise capital when needed, or on acceptable terms, we could be forced to delay, reduce or eliminate our product development programs or commercialization efforts.

Developing biopharmaceutical products, including conducting nonclinical studies and clinical trials, is a time-consuming, expensive and uncertain process that takes years to complete. We expect our expenses to continue to increase in connection with our ongoing activities, particularly as we conduct clinical trials of, and seek regulatory approval for, WIN378, WIN027 or our potential future product candidates in multiple indications and commence additional clinical trials. Even if WIN378, WIN027 or our potential future product candidates are approved for commercial sale, we anticipate incurring significant costs associated with commercializing any approved product candidate. To date, we have funded our operations solely through private financings.

As of June 30, 2026, we had cash, cash equivalents and marketable securities in the amount of $207.3 million. Based upon our current operating plan, we believe that the net proceeds from this offering and the concurrent private placement together with our existing cash, cash equivalents and marketable securities will enable us to fund the completion of our ongoing POLARIS-1, our ongoing Phase 2/3 trial and our confirmatory POLARIS-2 Phase 3 trial of WIN378 in asthma, fund the completion of our planned global Phase 2b trial of WIN027 in COPD, planned global Phase 2 trial of WIN027 in atopic dermatitis, the advancement of our bispecific programs through IND-enabling studies, and our operating expenses and capital expenditure requirements into the first half of 2029. We have based this estimate on assumptions that may prove to be wrong, and we could expend our available capital resources sooner than we expect. We may also raise additional financing on an opportunistic basis in the future. For example, we may seek additional capital due to favorable market conditions or strategic considerations even if we believe we have sufficient funds for our current or future operating plans.

 

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Attempting to secure additional financing may divert our management from our day-to-day activities, which may adversely affect our ability to develop WIN378, WIN027 or our potential future product candidates. Our future capital requirements will depend on many factors, including but not limited to:

 

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the scope, timing, progress, costs and results of the ongoing development of WIN378 and WIN027 as well as for potential discovery, nonclinical development and clinical trials for other potential future product candidates;

 

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the number of clinical trials required for regulatory approval of WIN378 and WIN027 or our potential future product candidates;

 

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the costs, timing and outcome of regulatory review of WIN378 and WIN027 or our potential future product candidates;

 

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the costs associated with acquiring or licensing additional product candidates, technologies or assets, including the timing and amount of any milestones, royalties or other payments due in connection with our acquisitions and licenses;

 

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the cost of manufacturing clinical and commercial supplies of WIN378 and WIN027 or our potential future product candidates;

 

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the costs and timing of preparing, filing and prosecuting patent applications, maintaining and enforcing our intellectual property rights and defending any intellectual property-related claims, including any claims by third parties that we are infringing upon their intellectual property rights;

 

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the effectiveness of our approach to identifying target patient populations;

 

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our ability to maintain existing, and establish new, strategic collaborations or other arrangements and the financial terms of any such agreements, including the timing and amount of any future milestone, royalty or other payments due under any such agreement;

 

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the costs and timing of future commercialization activities, including manufacturing, marketing, sales and distribution, for WIN378 and WIN027 or any other potential future product candidates for which we receive regulatory approval;

 

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the revenue, if any, received from commercial sales of WIN378 and WIN027 or any other potential future product candidates for which we receive regulatory approval;

 

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expenses to attract, hire and retain skilled personnel;

 

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the costs of operating as a public company;

 

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our ability to establish a commercially viable pricing structure and obtain approval for coverage and adequate reimbursement from third-party and government payors;

 

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the effect of macroeconomic trends including inflation and rising interest rates;

 

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addressing any potential supply chain interruptions or delays;

 

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the effect of competing technological and market developments and any competing product candidates in development; and

 

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the extent to which we acquire or invest in business, products and technologies.

Because of the numerous risks and uncertainties associated with research and development of product candidates, we are unable to predict the timing or amount of our working capital requirements. In addition, if we obtain regulatory approval for WIN378, WIN027 or any other potential future product candidates, we expect to incur significant commercialization expenses related to product manufacturing, marketing, sales and distribution which make it difficult to predict when or if we will be able to achieve or maintain profitability. Furthermore, upon the completion of this offering, we expect to incur additional costs associated with operating as a public company. Accordingly, we will need to obtain substantial additional funding in order to support our continuing operations. Our ability to raise additional funds will depend on financial, economic, political and market conditions and other factors, over which we may have no or limited control. Additional funds may not be available when we need them, on terms that are acceptable to us, or at all. Further, as a Swiss corporation we have less flexibility to raise capital, particularly in a quick and efficient manner, compared to U.S. corporations. See “—Risks Related to This Offering and Ownership of Our Common Shares—Our Status as a Swiss Corporation Means That Our Shareholders Enjoy Certain Rights That May Limit Our Flexibility to Raise Capital, Issue Dividends and Otherwise Manage Ongoing

 

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Capital Needs.” As a result, once we are a listed company in the United States, we may not be able to access the capital markets as frequently as comparable U.S. companies. If we fail to obtain necessary capital when needed on acceptable terms, or at all, it could force us to delay, limit, reduce or terminate our product development programs, future commercialization efforts or other operations.

Risks Related to Our Business

We are dependent on third parties having accurately generated, collected and reported data from certain nonclinical studies that were previously conducted for WIN378 and WIN027.

We currently have two product candidates, WIN378 and WIN027, both of which we licensed from third-party biotechnology companies. Kelun and HBM granted us an exclusive, worldwide (excluding certain Asian countries and territories, such excluded countries including Greater China, which are reserved to Kelun and HBM) license to manufacture, develop, use, promote, sell, offer for sale, import and otherwise commercialize WIN378, pursuant to a License and Collaboration Agreement dated December 31, 2024, or the Kelun-HBM Agreement. Additionally, Qyuns granted us an exclusive, worldwide (excluding Greater China) license to develop, use, promote, sell, offer for sale, import and otherwise commercialize WIN027 pursuant to a License and Collaboration Agreement dated December 19, 2025, or the Qyuns Agreement and, together with the Kelun-HBM Agreement, the License Agreements. Our business presently depends entirely on our ability to successfully develop, obtain regulatory approval for, and commercialize WIN378 and WIN027 for one or more of the indications that we are pursuing in a timely manner. The failure of either WIN378 or WIN027 would impose an adverse effect on our business and adversely affect regulatory confidence in and the clinical development of our product candidates.

In addition, our assumptions about the development potential of WIN378 are substantially based on the data generated from nonclinical and clinical studies, including the Phase 1 clinical data, conducted by Kelun and HBM pursuant to the Kelun-HBM Agreement. In contrast, our assumptions about the development potential of WIN027 are based more substantially on nonclinical and early clinical data generated by Qyuns prior to the Qyuns Agreement, as our own clinical development program for WIN027 remains at an earlier stage. We are dependent on Kelun and Qyuns having conducted their research and development in accordance with the applicable protocols, informed consent, legal and regulatory requirements, and scientific standards; having accurately reported the results of all nonclinical and clinical studies conducted with respect to WIN378 and WIN027 and having correctly collected the data and regulatory materials from these studies. If these activities were not compliant, accurate or correct, the clinical development, regulatory approval or commercialization of WIN378 and WIN027 in the United States and other jurisdictions outside of the licensors’ retained territories will be adversely affected. Furthermore, we may observe materially and adversely different results as we continue to conduct our clinical trials, including with respect to WIN378, our ongoing Phase 2/3 POLARIS study in asthma and the Phase 2 SIRIUS study in COPD, and our ongoing Phase 1 clinical study for WIN027 and planned Phase 2 studies in atopic dermatitis and COPD. If we are unable to develop, receive regulatory approval for and successfully commercialize WIN378 or WIN027, or if we experience delays as a result of any of the above factors or otherwise, our business would be significantly harmed.

If we are unable to advance WIN378 and/or WIN027 in clinical development for one or more of the indications that we are pursuing, or to obtain regulatory approval and ultimately commercialize WIN378 and/or WIN027, or experience significant delays in doing so, our business will be materially harmed.

To date, we have not completed the development of any product candidate, and WIN378 and WIN027 remain in clinical development. Our future success and ability to generate revenue depends primarily on our ability to successfully develop, obtain regulatory approval for and commercialize WIN378 and/or WIN027. WIN378, WIN027 and any other potential future product candidates will require substantial additional investment for clinical development, regulatory review and approval in one or more jurisdictions. In particular, any failure of WIN378 and/or WIN027 to receive regulatory approval or achieve commercial success would have an adverse effect on our business. If WIN378, WIN027 or any other potential future product candidates encounter safety or efficacy problems, development delays or regulatory issues or other problems, our development plans and business would be materially harmed.

 

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We may not have the financial resources to continue development of WIN378, WIN027 or any other potential future product candidates if we experience any issues that delay or prevent regulatory approval of, or our ability to commercialize, WIN378, WIN027 or any potential future product candidates, including:

 

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if we are unable to demonstrate to the satisfaction of the FDA, EMA, the European Commission, or other comparable foreign regulatory authorities, that WIN378 and/or WIN027, or any other of our potential future product candidates are, safe, pure and potent, or effective;

 

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if our financial and other resources are insufficient to complete the necessary clinical trials and nonclinical studies;

 

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negative or inconclusive results from our clinical trials, nonclinical studies or the clinical trials of others for product candidates similar to ours, leading to a decision or requirement to conduct additional clinical trials or nonclinical studies or abandon a program;

 

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product-related adverse events experienced by subjects in our clinical trials, or by individuals using drugs or therapeutic biologics similar to WIN378, WIN027 or any other potential future product candidates;

 

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delays in submitting an Investigational New Drug, or IND, application or other regulatory submission to the FDA, EMA, or other comparable foreign regulatory authorities, or delays or failure in obtaining the necessary approvals from regulators to commence a clinical trial or a suspension, termination, or hold, of a clinical trial once commenced;

 

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conditions imposed by the FDA, the competent authorities of individual European Union, or EU, Member States or other comparable foreign regulatory authorities regarding the scope or design of our clinical trials;

 

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poor performance of WIN378, WIN027 or any other potential future product candidates during clinical trials;

 

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better than expected performance of control arms, which could lead to negative or inconclusive results from our clinical trials;

 

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delays in, or slower than expected, enrollment of subjects in our clinical trials;

 

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patients choosing an alternative product for the indications for which we are developing our product candidates, or participating in competing clinical trials;

 

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high drop-out rates of subjects from our clinical trials;

 

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inadequate supply or quality of WIN378, WIN027 or any other potential future product candidates or other materials necessary for the conduct of our clinical trials;

 

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higher than anticipated clinical trial or manufacturing costs;

 

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unfavorable FDA, EMA, competent authorities of individual EU Member States, or other comparable foreign regulatory authority inspection and review of our clinical trial sites;

 

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failure of our third-party contractors or investigators to comply with regulatory requirements or the clinical trial protocol or otherwise meet their contractual obligations in a timely manner, or at all;

 

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delays and changes in regulatory requirements, policies and guidelines, including the imposition of additional regulatory oversight around clinical testing generally or with respect to our therapies in particular; or

 

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varying interpretations of data by the FDA, EMA, the European Commission, and other comparable foreign regulatory authorities.

We are currently conducting, and may in the future conduct, clinical trials for WIN378, WIN027 or any other potential future product candidates outside the United States, and the FDA and comparable foreign regulatory authorities may not accept data from such trials.

We are currently conducting, and may in the future conduct, clinical trials for WIN378, WIN027 or any other potential future product candidates outside the United States, and the FDA and comparable foreign regulatory authorities may not accept data from such trials. WIN378 and WIN027 are currently in clinical trials outside the United States, including but not limited to the People’s Republic of China, or the PRC, South America, and Europe, and we expect to continue to conduct trials internationally in the future. The acceptance of data from clinical trials conducted outside the United States or another jurisdiction by the FDA or any other comparable foreign regulatory authorities may be subject to certain conditions or may not be accepted at all. For example, the FDA recently

 

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launched Operation TrailBlazer to attempt to reshore early-stage clinical trials and legislative efforts have been initiated to potentially restrict the use of Chinese clinical trial data specifically to open a U.S. IND. In cases where data from foreign clinical trials are intended to serve as the sole basis for regulatory approval in the United States, the FDA will generally not approve the application on the basis of foreign data alone unless the data are applicable to the U.S. population and U.S. medical practice, the trials were performed by clinical investigators of recognized competence and pursuant to Good Clinical Practice, or GCP, regulations, and the FDA can validate the data through on-site inspections or other appropriate means. In addition, even where the foreign study data are not intended to serve as the sole basis for approval, if the study was not otherwise subject to an IND, the FDA will not accept the data as support for an application for regulatory approval unless the study is well-designed and well-conducted in accordance with GCP requirements and the FDA is able to validate the data from the study through an onsite inspection if deemed necessary. Additionally, the FDA’s clinical trial requirements, including sufficient size of patient populations and statistical powering, must be met. Many foreign regulatory authorities have similar approval requirements, including in relation to the use of data from clinical trials conducted in foreign jurisdictions. In addition, such foreign trials are subject to the applicable local laws of the foreign jurisdictions where the trials are conducted. There can be no assurance that the FDA or any comparable foreign regulatory authority will accept data from trials conducted outside of the United States or the applicable jurisdiction. If the FDA or any comparable foreign regulatory authority does not accept such data, it would result in the need for additional trials, which could be costly and time-consuming, and which may result in WIN378, WIN027 or any other potential future product candidates that we may develop being delayed or not receiving approval for commercialization in the applicable jurisdiction.

The successful development of pharmaceutical products involves a lengthy and expensive process and is highly uncertain.

Successful development of pharmaceutical products involves a lengthy and expensive process, is highly uncertain and is dependent on numerous factors, many of which are beyond our control. Failure can occur at any time during the nonclinical study or clinical trial process. A number of companies in the pharmaceutical and biotechnology industries have suffered significant setbacks in clinical development even after achieving promising results in earlier studies, and the historical failure rate for product candidates in our industry is high. The results from nonclinical studies or early clinical trials of a product candidate may not predict the results of later clinical trials of the product candidate, and interim results of a clinical trial are not necessarily indicative of final results. Moreover, nonclinical and clinical data are often susceptible to varying interpretations and analyses. Product candidates that appear promising in the early phases of development may fail to reach the market for several reasons, including:

 

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clinical trial results may show product candidates to be less effective than expected (for example, a clinical trial could fail to meet its primary or key secondary endpoint(s)) or have an unacceptable safety or tolerability profile;

 

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failure to receive the necessary regulatory approvals or a delay in receiving such approvals, which, among other things, may be caused by patients who fail the trial screening process, slow enrollment in clinical trials, patients dropping out of trials, patients lost to follow-up, length of time to achieve trial endpoints, additional time requirements for data analysis or a Biologics License Application, or BLA, or similar foreign application preparation, discussions with the FDA, an FDA request for additional nonclinical or clinical data (such as long-term toxicology studies) or unexpected safety or manufacturing issues;

 

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nonclinical or clinical study results may show WIN378, WIN027 or any other potential future product candidates to have harmful side effects;

 

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post-approval requirements; or

 

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the proprietary rights of others and their competing products and technologies that may prevent WIN378, WIN027 or any other potential future product candidates from being commercialized.

The length of time necessary to complete clinical trials and submit an application for regulatory approval for a final decision by a regulatory authority varies significantly from one product candidate to the next and from one country or jurisdiction to the next and may be difficult to predict.

Furthermore, any product candidate we develop and the activities associated with its development and commercialization, including its design, testing, manufacture, safety, efficacy, recordkeeping, labeling, storage,

 

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approval, advertising, promotion, sale, and distribution, are subject to comprehensive regulation by the FDA and other regulatory authorities in the United States and by comparable authorities in other countries. Failure to obtain regulatory approval for WIN378, WIN027 or any other potential future product candidates will prevent us from commercializing the product candidate in a given jurisdiction. We have not received approval to market any product candidates from regulatory authorities in any jurisdiction, and it is possible that WIN378, WIN027 or any of our other potential future product candidates will not ever obtain regulatory approval.

The Company, as an organization, has no experience submitting and supporting the applications necessary to gain regulatory approvals and expects to rely on third-party contract research organizations, or CROs, or regulatory consultants to assist us in this process. However, our experienced management team has held leadership positions in drug discovery and development, global commercialization, finance, business development, and corporate strategy spanning multiple therapeutic areas including immunology, and has experience submitting and supporting the applications necessary to gain regulatory approvals. See “Management” for further details on their prior experience. Securing regulatory approval requires the submission of extensive nonclinical and clinical data and supporting information to the various regulatory authorities for each therapeutic indication to establish the product candidate’s safety and efficacy. Securing regulatory approval also requires the submission of information about the product manufacturing process to, and inspection of manufacturing facilities by, the relevant regulatory authority. Any product candidates we develop may not be effective, may be only moderately effective, or may prove to have undesirable or unintended side effects, toxicities or other characteristics that may preclude its obtaining regulatory approval or prevent or limit commercial use.

The process of obtaining regulatory approvals, both in the United States and abroad, is expensive, may take many years if additional clinical trials are required, if approval is obtained at all, and can vary substantially based upon a variety of factors, including the type, complexity, and novelty of the product candidates involved. Changes in regulatory approval policies during the development period, changes in or the enactment of additional statutes or regulations, or changes in regulatory review for each submitted product application, may cause delays in the approval or rejection of an application. The FDA and comparable authorities in other countries have discretion in the approval process and may refuse to accept any application or may decide that our data is insufficient for approval and require additional nonclinical, clinical or other studies. In addition, varying interpretations of the data obtained from nonclinical and clinical testing could delay, limit, or prevent regulatory approval of a product candidate. Any regulatory approval that we may ultimately obtain could be limited or subject to restrictions or post-approval commitments that render the approved product not commercially viable.

Even if we complete the necessary nonclinical studies and clinical trials, the regulatory approval process is expensive, time-consuming and uncertain and may prevent us from obtaining approvals for the commercialization of our product candidates.

Even if we are successful in obtaining regulatory approval, commercial success of any approved products will also depend in large part on the availability of coverage and adequate reimbursement from third-party payors, including government payors such as the Medicare and Medicaid programs and comparable foreign programs and managed care organizations in the United States or country-specific governmental organizations in foreign countries, which may be affected by existing and future healthcare reform measures designed to reduce the cost of healthcare. Third-party payors could require us to conduct additional studies, including post-marketing studies related to the cost effectiveness of a product, to qualify for reimbursement, which could be costly and divert our resources. If government and other healthcare payors were not to provide coverage and adequate reimbursement for our products once approved, market acceptance and commercial success would be reduced.

In addition, if WIN378, WIN027 or any other potential future product candidates receive regulatory approval, we will be subject to significant regulatory obligations regarding the submission of safety and other post-marketing information and reports and registration, and will need to continue to comply (or ensure that our third-party providers comply) with current Good Manufacturing Practices, or cGMPs, and GCPs for any clinical trials that we conduct post-approval. In addition, there is always the risk that we, a regulatory authority or a third party might identify previously unknown problems with a product post-approval, such as adverse events of unanticipated severity or frequency. Compliance with these requirements is costly, and any failure to comply or other issues with WIN378, WIN027 or any other potential future product candidates post-approval could adversely affect our business, financial condition, results of operations and growth prospects.

 

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Certain estimates of market opportunity and forecasts included in this prospectus may prove to be smaller than we believe.

The estimates of market opportunity and forecasts of market growth included in this prospectus may prove to be smaller than we believe, and even if the markets in which we compete achieve the forecasted growth, our business, including WIN378 and WIN027, may not grow at similar rates, or at all. Our initial focus is on the development of WIN378 and WIN027 for the treatment of severe respiratory and skin diseases, including asthma, COPD and atopic dermatitis. Our estimates of market opportunity and addressable patient populations within these indications are based on our analysis of independent market research, industry and general publications or other information obtained from third parties. Market opportunity estimates and growth forecasts included in this prospectus are subject to significant uncertainty and are based on assumptions and estimates. These estimates, which have been derived from a variety of sources, including scientific literature, surveys of clinics, patient foundations, market research and other third-party information, may prove to be incorrect. Further, new studies may change the estimated incidence or prevalence of these indications. Additionally, the potentially addressable patient population may not ultimately be amenable to treatment with our product candidate if we cannot achieve our intended dosing interval. Our market opportunity may also be limited by current and future products of our competitors that are already available in the market or may enter the market for such patients. If any of our estimates prove to be inaccurate, the market opportunity for WIN378 and WIN027 could be significantly diminished and have an adverse material impact on our business.

Due to the significant resources required for drug development and depending on our ability to access capital, we must prioritize the development of WIN378 and WIN027. Moreover, we may fail to expend our limited resources on the development of WIN378 and WIN027 for the treatment of additional indications or for the development of other potential future product candidates that may have been more profitable or for which there is a greater likelihood of success.

Our lead product candidate, WIN378, an ultra-long-acting anti-TSLP monoclonal antibody intended to target a broad range of immunological diseases, including asthma and COPD, is currently being evaluated in a POLARIS Phase 2/3 asthma study and a SIRIUS Phase 2 COPD study. Our initial focus is on developing WIN378 through Phase 3 in asthma and through Phase 2 in COPD for both indications. Our earlier-stage product candidate, WIN027, is currently being evaluated in an ongoing Phase 1 clinical study for WIN027 and planned Phase 2 studies across respiratory and dermatology indications, including atopic dermatitis and COPD.

Due to the significant resources required for the development of WIN378 and WIN027, we must decide which indications to pursue and advance and the amount of resources to allocate to each. Our decisions concerning the allocation of research, development, collaboration, management and financial resources toward particular indications may not lead to the development of viable commercial products and may divert resources away from better opportunities. If we make incorrect determinations regarding the viability or market potential of WIN378 and WIN027 or misread trends in the pharmaceutical industry, our business, financial condition, results of operations and growth prospects could be materially and adversely affected. As a result, we may fail to capitalize on viable commercial products or profitable market opportunities, be required to forego or delay pursuit of opportunities with WIN378, WIN027 or any potential future product candidates in other diseases and disease pathways that may later prove to have greater commercial potential than those we choose to pursue, or relinquish valuable rights to WIN378 and WIN027 through collaboration, licensing or royalty arrangements in cases in which it would have been advantageous for us to invest additional resources to retain sole development and commercialization rights.

We are subject to substantial milestone, royalty, and other payment obligations under our License Agreements, which could adversely affect our results of operations and, if not satisfied, could result in the loss of our rights to WIN378 and WIN027.

Under the Kelun-HBM Agreement and the Qyuns Agreement, we are obligated to make significant payments to our licensors across the full development and commercialization lifecycle of WIN378 and WIN027. Under the Kelun-HBM Agreement, we may be required to pay Kelun and HBM aggregate development milestone payments of up to $320.0 million (excluding the $10.0 million milestone payments already paid in 2025 and July 2026 in total) for WIN378, aggregate sales milestone payments of up to $600 million per product upon achievement of specified annual net sales thresholds, and low single-digit to low double-digits tiered royalties (a spread of not more than 5 percentage points) on net sales of WIN378 in our licensed worldwide territory (excluding Greater China and several

 

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Southeast and West Asian countries). In addition, under the Kelun-HBM Agreement, following the completion of this offering, we may elect, subject to certain conditions, to satisfy up to 50% of the remaining of each of our first seven development milestone payments, which is up to $73.75 million, payable under the Kelun-HBM Agreement by issuing our common shares, rather than in cash; provided that each of Kelun and HBM may not hold, in the aggregate, 20% or more of our outstanding share capital on a fully diluted basis as a result of such equity issuance. Any such issuance of common shares in satisfaction of milestone payments would dilute the ownership interests of our existing shareholders. Under the Qyuns Agreement, we may be required to pay Qyuns aggregate development milestone payments of up to $100 million for WIN027, aggregate sales milestone payments of up to $570 million upon achievement of specified annual net sales thresholds, and mid-single digit to high-single digit tiered royalties on net sales of WIN027 in our licensed worldwide territory (excluding Greater China).

The payment of these royalties, milestones, and other amounts under the License Agreements may have a negative effect on our results of operations and our ability to reinvest capital generated from commercialization to advance WIN378 and WIN027 into additional indications or otherwise grow our company. Any failure on our part to make payments due under either License Agreement would constitute a material breach and, if not cured within the applicable cure period, would entitle the relevant licensor to terminate the applicable License Agreement, which would cause us to lose all rights to develop and commercialize the affected compound outside the licensors’ retained territory. For additional information on the Kelun-HBM Agreement and the Qyuns Agreement, see the section titled “Business—License and Collaboration Agreements” included elsewhere in this prospectus.

We may seek to grow our business through acquisitions or investments in new or complementary businesses, products or technologies, through the licensing of products or technologies from third parties or other strategic alliances. The failure to manage acquisitions, investments, licenses or other strategic alliances, or the failure to integrate them with our existing business, could have a material adverse effect on our operating results, dilute our shareholders’ ownership, increase our debt or cause us to incur significant expense.

Our success depends on our ability to continually enhance and broaden our product offerings in response to changing clinician and patients’ needs, competitive technologies and market pressures. Accordingly, from time to time we may consider opportunities to acquire, make investments in or license other technologies, products and businesses that may enhance our capabilities, complement our existing products and technologies or expand the breadth of our markets or customer base. Potential and completed acquisitions, strategic investments, licenses and other alliances involve numerous risks, including:

 

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difficulty assimilating or integrating acquired or licensed technologies, products, employees or business operations;

 

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issues maintaining uniform standards, procedures, controls and policies;

 

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unanticipated costs associated with acquisitions or strategic alliances, including the assumption of unknown or contingent liabilities and the incurrence of debt or future write-offs of intangible assets or goodwill;

 

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diversion of management’s attention from our core business and disruption of ongoing operations;

 

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adverse effects on existing business relationships with suppliers, sales agents, healthcare facilities, surgeons and other healthcare professionals;

 

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risks associated with entering new markets in which we have limited or no experience;

 

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potential losses related to investments in other companies;

 

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potential loss of key employees of acquired businesses; and

 

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increased legal and accounting compliance costs.

We do not know if we will be able to identify acquisitions or strategic relationships we deem suitable, whether we will be able to successfully complete any such transactions on favorable terms, if at all, or whether we will be able to successfully integrate any acquired business, product or technology into our business or retain any key personnel, suppliers, sales agent, healthcare facilities, physicians or other healthcare providers. Our ability to successfully grow through strategic transactions depends upon our ability to identify, negotiate, complete and integrate suitable target businesses, technologies or products and to obtain any necessary financing. These efforts could be expensive and time-consuming and may disrupt our ongoing business and prevent management from focusing on our operations.

 

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To finance any acquisitions, investments or strategic alliances, we may choose to issue common shares as consideration, which could dilute the ownership of our shareholders. If the price of our common shares is low or volatile, we may be unable to consummate any acquisitions, investments or strategic alliances using our common shares as consideration. Additional funds may not be available on terms that are favorable to us, or at all.

We and the third parties with whom we work are subject to a variety of stringent and evolving U.S. and foreign laws, regulations and rules; contractual obligations; industry standards; policies and other obligations related to privacy, data protection and information security. Our (or the third parties with whom we work) actual or perceived failure to comply with such obligations could expose us to regulatory investigations or actions, litigation (including class claims) and mass arbitration demands, fines and penalties, disruptions of our business operations, reputational harm, loss of revenue or profits and other adverse business consequences.

In the ordinary course of our business, we and the third parties with whom we work collect, receive, store, process, generate, use, transfer, disclose, make accessible, protect, secure, dispose of, transmit and share, or collectively, process, personal data and other sensitive information, including proprietary and confidential business data, trade secrets, intellectual property, clinical trial data and sensitive third-party data, or collectively, sensitive data.

The legislative and regulatory framework for the processing of personal data worldwide is rapidly evolving in a manner that is increasingly stringent and, globally, this legal and regulatory framework is likely to remain uncertain for the foreseeable future. In the United States, numerous federal, state and local laws and regulations, including federal health information privacy laws, state information security and data breach notification laws, federal consumer protection laws (e.g., Section 5 of the Federal Trade Commission Act), state consumer protection and privacy laws, and other similar laws (e.g., wiretapping and communications interception laws) govern the processing of sensitive data.

For example, the federal Health Insurance Portability and Accountability Act of 1996, or HIPAA, imposes specific requirements relating to the use and disclosure of individually identifiable health information. We may obtain such information from third parties, such as research institutions with which we collaborate, that are subject to privacy and security requirements under HIPAA. Although we do not believe that we are directly subject to HIPAA, other than potentially with respect to providing certain employee benefits, we could be subject to criminal penalties if, for example, we knowingly disclose individually identifiable health information we obtain from a HIPAA covered entity in a manner that violates HIPAA.

Further, numerous U.S. states have enacted comprehensive consumer and health information privacy laws that impose certain obligations on covered businesses, including providing specific disclosures in privacy notices and affording residents with certain rights concerning their personal data. As applicable, such rights may include the right to access, correct or delete certain personal data and to opt-out of certain data processing activities. The exercise of these rights may impact our business. Certain states also impose stricter requirements for processing certain personal data, including sensitive data, such as conducting data privacy impact assessments. These state laws often allow for statutory fines for noncompliance. For example, the California Consumer Privacy Act of 2018, or CCPA, applies to personal data of consumers, business representatives and employees who are California residents and requires businesses subject to the CCPA to provide specific disclosures in privacy notices and respond to requests of such individuals to exercise certain privacy rights. The CCPA provides for fines and allows private litigants affected by certain data breaches to recover significant statutory damages. The CCPA and other U.S. state privacy laws exempt some data processed in the context of clinical trials, but these developments may further complicate compliance efforts, and increase legal risk and compliance costs for us and the third parties with whom we work. Similar laws are being considered in several other states, as well as at the federal and local levels, and we expect more states to pass similar laws in the future. These various privacy and data security laws may impact our business activities, including our identification of research subjects, relationships with business partners and ultimately the marketing and distribution of our products.

Outside the United States, an increasing number of laws, regulations, and industry standards govern privacy, data security, and the transfer of personal data between jurisdictions. For example, the European Union’s General Data Protection Regulation, or EU GDPR, the United Kingdom’s General Data Protection Regulation, or UK GDPR (together with the EU GDPR, the GDPR), and the Swiss Federal Act on Data Protection impose strict requirements for collecting and processing personal data including relating to collecting and processing of sensitive data (referred to as special category data under GDPR), such as health data, ensuring there is a legal basis or condition to justify the processing of personal data, where required, requirements relating to obtaining consent of individuals, disclosures about how personal data is to be used, limitations on retention of information, limitations on the

 

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cross-border disclosure of personal data, implementing safeguards to protect the security and confidentiality of personal data, where required providing notification of data breaches, maintaining records of processing activities and documenting data protection impact assessments where there is high risk processing and taking certain measures when engaging third-party processors. Under GDPR, companies may face temporary or definitive bans on data processing and other corrective activities, fines of up to €20 million under the EU GDPR (and £17.5 million under the UK GDPR) or 4% of annual global turnover, whichever is greater, and private litigation related to processing of personal data brought by classes of data subjects or consumer protection organizations authorized at law to represent their interests. Additionally, in the European Union, the Network and Information Security Directive, or NIS2, regulates resilience and incident response capabilities of entities operating in a number of sectors, including the health sector. Non-compliance with NIS2 may, similar to non-compliance with other privacy or security laws, lead to adverse consequences, including a material adverse effect on our business, financial position and results of operations.

Additionally, we may receive personal data collected and processed by our business partners in the PRC. The PRC enacted the Personal Information Protection Law, or the PIPL, in 2021. The PIPL establishes a comprehensive data privacy and protection framework that applies to the processing of personal information both within the PRC and outside of the PRC where such processing is conducted for the purpose of providing products or services to, or analyzing or evaluating the behavior of, individuals in the PRC. The PIPL imposes significant fines for serious violations of up to RMB 50 million or 5% of annual revenue from the prior year. Certain industry-specific Chinese laws and regulations also impose requirements for processing of certain specific types of data. The PRC’s Regulations on the Administration of Human Genetic Resources, or the HGR Regulation, prohibit foreign organizations, individuals, and entities established or actually controlled by them from collecting, preserving, or exporting the PRC’s human genetic resources. Foreign parties may access or use the PRC’s human genetic resources upon satisfying applicable regulatory requirements, including through approved international collaboration with qualified Chinese institutions and completing required governmental approval, filing, and information backup procedures. In addition, provision of human genetic resources information to foreign entities requires filing with the PRC’s National Health Commission and submission of information backup, and transfers that may affect public health, national security or social public interest must pass a security review. We may need to provide necessary assistance for our Chinese business partners to comply with their obligations under Chinese privacy and data security laws and regulations, and our data processing activities may be subject to obligations applicable to the recipient of personal data collected or generated in the PRC.

In addition, we may be unable to transfer personal data from the PRC, the European Union / European Economic Area (EU 27 Member States, Norway, Iceland and Liechtenstein), or EEA, the United Kingdom, or UK, and other jurisdictions to the United States or other countries due to data localization requirements or restrictions on cross-border data flows. In particular, the European Union, the United Kingdom and Switzerland have significantly restricted the transfer of personal data to the United States and other countries whose privacy laws the European Commission, UK Secretary of State or Swiss Federal Council (as applicable) generally regard as inadequate. There are also restrictions on personal data exports from the PRC—under the PIPL, entities exporting personal data are required to meet certain conditions, including, to the extent applicable, satisfaction of the security assessments conducted by competent government authorities, signing and filing of standard contracts or obtaining certifications from qualified institutions (unless an exemption applies), and fulfillment of notice and consent requirements. Data qualifying as “important data” must also be localized in the PRC unless a security assessment is passed. Other jurisdictions may equally adopt or have already adopted similarly stringent data localization and cross-border data transfer laws. Although there are currently various mechanisms that may be used to transfer personal data from the EU/EEA, the United Kingdom and Switzerland to the United States in compliance with law, such as the EU standard contractual clauses, which are also recognized by Switzerland, the United Kingdom’s International Data Transfer Agreement / Addendum, the EU-U.S. Data Privacy Framework, the UK extension thereto (which allows for transfers to relevant U.S.-based organizations who self-certify compliance and participate in the EU-U.S. Data Privacy Framework) and the Swiss-U.S. Data Privacy Framework, or Framework, these mechanisms are subject to legal challenges, and there is no assurance that we can satisfy or rely on these measures to lawfully transfer personal data to the United States. If there is no lawful manner for us to transfer personal data from the PRC, the EU/EEA, the United Kingdom, Switzerland, or other jurisdictions to the United States (or other countries), or if the requirements for a legally-compliant transfer are too onerous, we could face significant adverse consequences, including the interruption or degradation of our operations, the need to relocate part of or all of our business or data processing activities to other jurisdictions at

 

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significant expense, increased exposure to regulatory actions, substantial fines and penalties, the inability to transfer data and work with collaborators, vendors and other third parties, and injunctions against our processing or transferring of personal data necessary to operate our business. Additionally, companies that transfer personal data across national borders are subject to increased scrutiny from regulators, individual litigants, and activist groups. For example, some European regulators have ordered certain companies to suspend or permanently cease certain transfers of personal data out of the EU for allegedly violating the GDPR’s cross-border data transfer limitations.

Additionally, the U.S. Department of Justice issued a rule entitled “Access to U.S. Sensitive Personal Data and Government-Related Data by Countries of Concern or Covered Persons,” which places additional restrictions on certain data transactions involving countries of concern (for example, the PRC, Russia and Iran) and covered persons (for example, individuals and entities who are designated as such by the U.S. Attorney General or considered “foreign persons” and are majority owned by, organized under the laws of, a primary resident in, an employee of, or a contractor of, a covered person or country of concern, as applicable) that may impact certain business activities such as vendor engagements, sale or sharing of data, employment of certain individuals and investor agreements. Violations of the rule could lead to significant civil and criminal fines and penalties. The rule applies regardless of whether data is anonymized, key-coded, pseudonymized, de-identified or encrypted, which presents particular challenges for companies like ours that operate in the clinical trial space and may impact our ability to engage in certain transactions or agreements with certain third parties in the future.

In addition to data protection, privacy and information security laws, we are contractually subject to industry standards adopted by industry groups and may become subject to such obligations in the future. We are also bound by other contractual obligations related to privacy and data security, and our efforts to comply with such obligations may not be successful.

We have in the past published and may in the future publish privacy policies, marketing materials and other statements concerning data protection, privacy and information security. Regulators are increasingly scrutinizing these statements, and if these policies, materials or statements are found to be deficient, lacking in transparency, deceptive, unfair, or misrepresentative of our practices, we may be subject to investigation, enforcement actions by regulators, or other adverse consequences.

Obligations related to data protection, privacy and information security (and individuals’ data privacy expectations) are quickly changing, becoming increasingly stringent and creating uncertainty. Additionally, these obligations may be subject to differing applications and interpretations, which may be inconsistent or conflict among jurisdictions. Preparing for and complying with these obligations requires us to devote significant resources, which have in the past and may in the future necessitate changes to our services, information technologies, systems and practices and to those of any third parties that process personal data on our behalf.

We may at times fail (or be perceived to have failed) in our efforts to comply with our data protection, privacy and information security obligations. Moreover, despite our efforts, our personnel or third parties with whom we work may fail to comply with such obligations, which could negatively impact our business operations. If we or the third parties with whom we work fail, or are perceived to have failed, to address or comply with applicable data protection, privacy and information security obligations, we could face significant consequences, including but not limited to: government enforcement actions (e.g., investigations, fines, penalties, audits, inspections and similar), litigation (including class-action claims) and mass arbitration demands, additional reporting requirements or oversight, bans or restrictions on processing personal data, orders to destroy or not use personal data, fines and imprisonment of company officials. In particular, plaintiffs have become increasingly more active in bringing privacy-related claims against companies, including class claims and mass arbitration demands. Some of these claims allow for the recovery of statutory damages on a per violation basis and, if viable, carry the potential for significant statutory damages, depending on the volume of data and the number of violations. Any of these events could have a material adverse effect on our reputation, business or financial condition, including: interruptions or stoppages in our business operations (including, as relevant, clinical trials), inability to process personal data or to operate in certain jurisdictions, limited ability to develop or commercialize our products, expenditure of time and resources to defend any claim or inquiry, adverse publicity or substantial changes to our business model or operations.

 

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Our personnel may use artificial intelligence tools in the ordinary course of business, and we may in the future employ artificial intelligence tools in our clinical development processes. If we deploy artificial intelligence tools in our business, we may be exposed to risks and challenges that could impact our business including by posing security risks to our sensitive information.

Our personnel use artificial intelligence, or AI, technologies in the ordinary course of business. Issues in the development and use of AI, particularly in the clinical development operations when combined with an uncertain regulatory environment, may result in reputational harm, liability, or other adverse consequences to our business operations.

As with many technological innovations, AI presents risks and challenges that could impact our business. The disclosure and use of personal data in AI technologies is subject to various privacy laws and other privacy obligations. Governments have passed and are likely to pass additional laws regulating AI and automated decision-making technologies. Our use of this technology could result in additional compliance costs, regulatory investigations and actions and lawsuits. If we are unable to use AI or automated decision-making technologies, it could make our business less efficient and result in competitive disadvantages.

Any sensitive information (including confidential, competitive, proprietary, or personal data) that we input into a third-party AI technology could be leaked or disclosed to others, including if sensitive information is used to train the third parties’ AI technology. Additionally, where an AI technology ingests personal data and makes connections using such data, those technologies may reveal other personal or sensitive information generated by the model.

Our vendors may also incorporate AI technologies into their offerings without disclosing this use to us, and the providers of these AI tools may not meet existing or rapidly evolving regulatory or industry standards, including with respect to privacy and data protection, and may inhibit our or our vendors’ ability to maintain an adequate level of service and experience necessary to support our business operations.

Any of these outcomes could damage our reputation, result in regulatory investigations or enforcement actions as well as private litigation, and adversely impact our business.

Risks Related to the Discovery and Development of WIN378, WIN027 or Any Other Potential Future Product Candidates

The regulatory approval processes of the FDA, the EMA, and the European Commission and other comparable foreign regulatory authorities are lengthy, time-consuming and inherently unpredictable, and if we are ultimately unable to obtain regulatory approval for WIN378, WIN027 or any other potential future product candidates, our business will be substantially harmed.

We are not permitted to commercialize, market, promote or sell any product candidate in the United States without obtaining regulatory approval from the FDA. Regulatory authorities outside of the United States impose similar requirements. The time required to obtain approval by the FDA, European Commission and other comparable foreign regulatory authorities is inherently unpredictable, but typically takes many years following the commencement of clinical trials and depends upon numerous factors, including substantial discretion of the regulatory authorities. In addition, approval policies, regulations, or the type and amount of clinical data necessary to gain approval may change during the course of a product candidate’s clinical development and may vary among jurisdictions. For instance, jurisdictions outside of the United States, such as the European Union or Japan, may have different requirements for regulatory approval, which may require us to conduct additional clinical, non-clinical or chemistry, manufacturing and control studies. To date, we have not submitted a BLA to the FDA or similar drug approval submissions to comparable foreign regulatory authorities for any product candidate. We must complete additional nonclinical studies or clinical trials to demonstrate the safety and efficacy of WIN378, WIN027 or any other potential future product candidates in humans before we will be able to obtain these approvals.

Clinical testing is expensive, difficult to design and implement, can take many years to complete and is inherently uncertain as to outcome. The general approach for FDA approval of a new drug is dispositive data from two or more adequate and well-controlled clinical trials of the product candidate in the relevant patient population. The FDA, the EMA, the European Commission, or other comparable foreign regulatory authorities may disagree with us about whether a clinical trial is adequate and well-controlled or may request that we conduct additional clinical trials prior

 

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to regulatory approval. We cannot guarantee that any clinical trials will be conducted as planned or completed on schedule, if at all. In addition, there is no assurance that the doses, endpoints and trial designs that we intend to use for our planned clinical trials, including those that we have developed based on feedback from regulatory agencies or those that have been used for the approval of similar drugs, will be acceptable for future approvals. The clinical development of WIN378, WIN027 or any other potential future product candidates is also susceptible to the risk of failure inherent at any stage of development, including failure to demonstrate efficacy in a clinical trial or across a broad population of patients, the occurrence of adverse events that are severe or medically or commercially unacceptable, failure to comply with protocols or applicable regulatory requirements and determination by the FDA or any comparable foreign regulatory authority that a product candidate may not continue development or is not approvable. It is possible that even if WIN378, WIN027 or any other potential future product candidates have a beneficial effect, that effect will not be detected during clinical evaluation as a result of one or more of a variety of factors, including the size, duration, design, measurements, conduct or analysis of our clinical trials. Conversely, as a result of the same factors, our clinical trials may indicate an apparent positive effect of such product candidate that is greater than the actual positive effect, if any. Similarly, in our clinical trials we may fail to detect toxicity of, or intolerability caused by, such product candidate, or mistakenly believe that WIN378, WIN027 or any other potential future product candidates are toxic or not well tolerated when that is not in fact the case. Serious adverse events or other adverse events, as well as tolerability issues, could hinder or prevent market acceptance of the product candidate at issue.

WIN378, WIN027 or any other potential future product candidates could fail to receive regulatory approval, or regulatory approval could be delayed, for many reasons, including the following:

 

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the FDA, the EMA, the competent authorities of individual EU Member States, or other comparable foreign regulatory authorities may disagree with the dosing regimen, design or implementation of our clinical trials;

 

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we may be unable to demonstrate to the satisfaction of the FDA, the EMA and the European Commission, or other comparable foreign regulatory authorities that a product candidate is safe, pure and potent, or effective for any of its proposed indications;

 

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the results of clinical trials may not meet the level of statistical significance required by the FDA, the EMA and the European Commission, or other comparable foreign regulatory authorities for approval;

 

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we may be unable to demonstrate that a product candidate’s clinical and other benefits outweigh its safety risks;

 

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the FDA, the EMA or the European Commission, or other comparable foreign regulatory authorities may disagree with our interpretation of data from clinical trials or nonclinical studies;

 

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the data collected from clinical trials of WIN378, WIN027 or any other potential future product candidates may not be sufficient to support the submission of a BLA to the FDA or other submission or to obtain regulatory approval in the United States, the European Union or elsewhere;

 

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the FDA, the EMA or other comparable foreign regulatory authorities may not file or accept our BLA or marketing application for substantive review;

 

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the FDA, the competent authorities of individual EU Member States or other comparable foreign regulatory authorities may find deficiencies with or fail to approve the manufacturing processes or facilities of third-party manufacturers with which we contract for clinical and commercial supplies; and

 

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the approval policies or regulations of the FDA, the EMA and the European Commission, or other comparable foreign regulatory authorities may significantly change in a manner rendering our clinical data insufficient for approval.

This lengthy approval process as well as the unpredictability of clinical trial results may result in our failing to obtain regulatory approval to market any product candidate we develop, which would substantially harm our business, financial condition, results of operations and growth prospects. The FDA and other comparable foreign authorities have discretion in the approval process and determining when or whether regulatory approval will be granted for WIN378, WIN027 or any other potential future product candidates that we develop. Even if we believe the data collected from future clinical trials of WIN378, WIN027 or any other potential future product candidates are promising, such data may not be sufficient to support approval by the FDA, the European Commission, or any other comparable foreign regulatory authority.

 

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In addition, even if we were to obtain approval, regulatory authorities may approve WIN378, WIN027 or any other potential future product candidates for fewer or more limited indications than we request, may not approve the price we intend to charge for our products, may grant approval contingent on the performance of costly post-marketing clinical trials or may approve WIN378, WIN027 or any other potential future product candidates with a label that does not include the labeling claims necessary or desirable for the successful commercialization. Any of the foregoing scenarios could materially harm the commercial prospects for WIN378, WIN027 or any other potential future product candidates.

The uncertainty inherent in developing our product candidates makes it difficult to predict their respective likelihood of success and the timing and cost of their development and obtaining regulatory approval.

We have concentrated our research and development efforts on WIN378, an ultra-long-acting anti-TSLP therapy that we believe is differentiated from currently approved treatments primarily through its potential for twice-yearly subcutaneous dosing, and WIN027, a long-acting anti-TSLP and anti-IL-13 therapy, which we believe could—if successful—offer meaningful efficacy advantages beyond what approved monospecific therapies have achieved, though this has not yet been demonstrated in pivotal clinical trials. WIN378 is a fully human anti-TSLP monoclonal antibody that targets the TSLP ligand and has been engineered with half-life extension to enable potential twice-yearly subcutaneous dosing—a dosing interval that, if supported by our planned pivotal studies and approved for such use, would be meaningfully less frequent than currently approved TSLP-targeting therapies. WIN027 is a long-acting bispecific antibody that simultaneously targets both TSLP and IL-13, an approach with no currently approved therapy and which has not been validated in pivotal clinical trials. Our future success depends in part on the advantages of WIN378’s extended dosing interval being confirmed in our ongoing POLARIS Phase 2/3 asthma study and SIRIUS Phase 2 COPD study, and on WIN027’s dual-targeting approach demonstrating meaningful clinical benefit beyond what monospecific alternatives have achieved. There can be no assurance that development problems we may experience in the future will not cause significant delays or result in unforeseen issues or unanticipated costs, or that any such development problems can be overcome.

We may also experience delays in developing sustainable, reproducible, and scalable manufacturing processes for WIN378 and WIN027, or in transferring those processes to contract manufacturing organizations outside of the PRC. We are currently in the process of transferring the manufacturing process for WIN378 from Kelun’s facilities in the PRC to contract manufacturing organizations in the United States, which may delay or prevent us from completing our clinical studies or commercializing our product candidates on a timely or profitable basis, if at all. Even following the completion of such a transfer, we may encounter challenges in demonstrating that the manufacturing process produces WIN378 with the same quality, yield, and consistency as in prior clinical studies, and any failure to do so could delay or adversely affect our clinical programs or future commercialization.

In addition, our expectations with regard to the advantages of WIN378’s twice-yearly dosing interval relative to existing approved therapies, or the advantages of WIN027’s simultaneous blockade of TSLP and IL-13 relative to monospecific approaches, may not materialize or may not materialize to the degree we anticipate. Further, our scalability and costs of manufacturing may vary significantly as we advance WIN378 and WIN027 and come to understand these critical factors more fully.

In addition, the clinical study requirements of the FDA, the EMA and the European Commission, and other regulatory authorities, and the criteria these regulators use to determine the safety and efficacy of a product candidate, are determined according to the type, complexity, novelty, and intended use and market of the potential product. While TSLP and IL-13 are clinically validated targets—tezepelumab, an approved anti-TSLP antibody for asthma, and dupilumab, an approved anti-IL-4Ra antibody for asthma and COPD, have established regulatory precedents for biologic therapies in these indications—the regulatory approval pathway for WIN378 with its novel twice-yearly dosing profile and for WIN027 as a first-in-class bispecific simultaneously targeting TSLP and IL-13 may be more complex, more expensive, and take longer than for product candidates with more established dosing regimens or mechanisms of action. Prior approvals by the FDA, the EMA and the European Commission, and other regulatory authorities for existing biologic treatments for asthma and COPD, such as tezepelumab and dupilumab, as well as other pathways to approval, may not be indicative of what these regulators may require for approval of WIN378 or WIN027. More generally, approvals by any regulatory authority may not be indicative of what any other regulatory authority may require for approval or what such regulatory authorities may require for approval in connection with our product candidates.

 

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WIN378 and/or WIN027 may also not perform successfully in clinical trials or may be associated with adverse events that distinguish it from previously approved therapies or those that may be approved in the future. Unexpected clinical outcomes could materially and adversely affect our business, financial condition, results of operations and growth prospects.

If our clinical trials fail to replicate positive results from earlier nonclinical studies or clinical trials conducted by us or third parties, we may be unable to successfully develop, obtain regulatory approval for or commercialize WIN378, WIN027 or any other potential future product candidates.

The results observed from nonclinical studies or early-stage clinical trials of WIN378, WIN027, or any other potential future product candidates may not necessarily be predictive of the results of later-stage clinical trials that we conduct. Similarly, positive results from such nonclinical studies or early-stage clinical trials may not be replicated in our subsequent clinical trials. For instance, results observed in the Phase 1 clinical trial for WIN378—including the extended half-life supporting twice-yearly subcutaneous dosing, a low rate of antidrug antibodies, and no treatment-related serious adverse events were observed—may not translate to similar tolerability results in our ongoing POLARIS Phase 2/3 study in patients with asthma or our SIRIUS Phase 2 study in patients with COPD. Similarly, results observed in our ongoing Phase 1 clinical trial for WIN027 and planned Phase 2 studies in atopic dermatitis and COPD may not be replicated in any subsequent clinical trials for that product candidate. Furthermore, WIN378, WIN027, or any other potential future product candidates may not be able to demonstrate similar activity or adverse event profiles to other product candidates or approved therapies that we believe may have comparable profiles. In addition, in our planned future clinical trials, we may utilize clinical trial designs or dosing regimens that have not been tested in prior clinical trials for these product candidates, including novel trial designs intended to evaluate the twice-yearly dosing interval of WIN378 or the dual blockade of TSLP and IL-13 by WIN027 in pivotal settings.

There can be no assurance that any of our clinical trials will ultimately be successful or support further clinical development of WIN378, WIN027, or any other potential future product candidates. There is a high failure rate for drugs proceeding through clinical trials. Many companies in the pharmaceutical and biotechnology industries have suffered significant setbacks in late-stage clinical trials after achieving positive results in early-stage development, and we cannot be certain that we will not face similar setbacks. These setbacks have been caused by, among other things, adverse safety or efficacy observations made in clinical trials. For example, we expect to report initial readouts from our POLARIS-1 Phase 3 study evaluating WIN378 in patients with asthma in the first half of 2029. These readouts may not be positive, may not meet the trial’s pre-specified endpoints, or may not support the continuation of WIN378’s development in asthma or other indications, any of which would have a material adverse effect on our business.

Moreover, nonclinical and clinical data are often susceptible to varying interpretations and analyses, and many companies that believed their product candidates performed satisfactorily in nonclinical studies and clinical trials nonetheless failed to obtain FDA, European Commission, or comparable foreign regulatory authority approval.

We may incur unexpected costs or experience delays in completing, or ultimately be unable to complete, the development and commercialization of WIN378, WIN027 or any other potential future product candidates, which could prevent us from achieving our projected development and commercialization goals in the timeframes we announce and expect, and harm our business and results of operations. Many of the factors that cause or lead to a delay in the initiation or completion of clinical trials may also lead to the denial of regulatory approval or limit market acceptance of WIN378, WIN027 or any other potential future product candidates.

We may experience delays in completing our clinical trials or nonclinical studies and initiating or completing additional clinical trials or nonclinical studies, including as a result of regulators not allowing or delaying clinical trials to proceed under an IND or similar foreign authorization, or not approving or delaying approval for any clinical trial grant or similar approval we need to initiate a clinical trial. We may also experience numerous unforeseen events during our clinical trials that could delay or prevent our ability to receive regulatory approval or commercialize WIN378, WIN027 or any other potential future product candidates we develop, including:

 

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regulators, institutional review boards, or IRBs, ethics committees, or other reviewing bodies may not authorize us or our investigators to commence a clinical trial, or to conduct or continue a clinical trial at a prospective or specific trial site, or provide a related positive opinion permitting such activities;

 

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we may not reach agreement on acceptable terms with prospective CROs and clinical trial sites, the terms of which can be subject to extensive negotiation and may vary significantly among different CROs and trial sites;

 

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WIN027 is at an earlier stage of clinical development than WIN378, currently in a Phase 1 clinical trial, and faces a longer and more uncertain path to generating clinical proof-of-concept data; the risks of delay, failure, or inability to advance to later-stage clinical trials are correspondingly greater for WIN027 than for WIN378 at this time;

 

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we may experience challenges or delays in recruiting principal investigators or study sites to lead our clinical trials;

 

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the number of subjects or patients required for clinical trials of WIN378, WIN027 or any other potential future product candidates may be larger than we anticipate, enrollment in these clinical trials may be insufficient or slower than we anticipate, and the number of clinical trials being conducted at any given time may be high and result in fewer available patients for any given clinical trial and patients may choose to participate in competing clinical trials, or patients may drop out of these clinical trials at a higher rate than we anticipate;

 

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our third-party contractors, including those manufacturing WIN378, WIN027 or any other potential future product candidates or conducting clinical trials on our behalf, may fail to comply with regulatory requirements or meet their contractual obligations to us in a timely manner, or at all;

 

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we may have to amend clinical trial protocols submitted to regulatory authorities or conduct additional studies to reflect changes in regulatory requirements or guidance, which may be required to resubmit to an IRB, ethics committee and regulatory authorities for re-examination;

 

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regulators or other reviewing bodies may find deficiencies with, fail to approve or subsequently find fault with the manufacturing processes or facilities of third-party manufacturers with which we enter into agreements for clinical and commercial supplies, or the supply or quality of any product candidate or other materials necessary to conduct clinical trials of WIN378, WIN027 or any other potential future product candidates may be insufficient, inadequate or not available at an acceptable cost, or we may experience interruptions in supply; and

 

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the potential for approval policies or regulations of the FDA, the EMA, and the European Commission, or the applicable regulatory authorities to significantly change in a manner rendering our clinical data insufficient for approval.

Regulators, IRBs, or ethics committees of the institutions in which clinical trials are being conducted may suspend, limit or terminate a clinical trial, or data monitoring committees may recommend that we suspend or terminate a clinical trial, due to a number of factors, including failure to conduct the clinical trial in accordance with regulatory requirements or our clinical protocols, inspection of the clinical trial operations or trial site by the FDA, the competent authorities of individual EU Member States, or other comparable foreign regulatory authorities resulting in the imposition of a clinical hold, safety issues or adverse side effects, failure to demonstrate a benefit from using a drug, changes in governmental regulations or administrative actions or lack of adequate funding to continue the clinical trial. Negative or inconclusive results from our clinical trials or nonclinical studies could mandate repeated or additional clinical trials and, to the extent we choose to conduct clinical trials in other indications, could result in changes to or delays in clinical trials of WIN378, WIN027 or any other potential future product candidates in such other indications. We do not know whether any clinical trials that we conduct will demonstrate adequate safety, purity and potency, or efficacy to result in regulatory approval to market WIN378, WIN027 or any other potential future product candidates for the indications that we are pursuing. If favorable results are not observed in later-stage clinical trials, our ability to obtain regulatory approval for WIN378, WIN027 or any other potential future product candidates will be adversely impacted.

Further, conducting clinical trials in foreign countries, as we are doing and may in the future do for our future product candidates, presents additional risks that may delay completion of our clinical trials. These risks include the failure of enrolled subjects in foreign countries to adhere to clinical protocols as a result of differences in healthcare services or cultural customs, managing additional administrative burdens associated with foreign regulatory schemes, and political and economic risks, including war, relevant to such foreign countries.

 

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For planning purposes, we sometimes estimate the timing of the accomplishment of various scientific, clinical, regulatory and other product development objectives. These milestones may include our expectations regarding the commencement or completion of scientific studies and clinical trials, the submission of regulatory filings or commercialization objectives. From time to time, we have announced and may in the future publicly announce the expected timing of some of these milestones, such as the completion of an ongoing clinical trial, the initiation of other clinical programs, receipt of regulatory approval or a commercial launch of a product. The achievement of many of these milestones may be outside of our control. All of these milestones are based on a variety of assumptions which, if not realized as expected, may cause the timing of achievement of the milestones to vary considerably from our estimates, including:

 

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our available capital resources or capital constraints we experience;

 

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the rate of progress, costs and results of our clinical trials and research and development activities, including the extent of scheduling conflicts with participating clinicians and collaborators;

 

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our ability to identify and enroll patients who meet clinical trial eligibility criteria;

 

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our receipt of approvals by the FDA and other comparable foreign regulatory authorities and the timing thereof;

 

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other actions, decisions or rules issued by regulators;

 

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our ability to access sufficient, reliable and affordable supplies of materials used to manufacture WIN378, WIN027 or any other potential future product candidates;

 

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the performance of our third-party contract manufacturing organizations and supply collaborators, including those responsible for manufacturing WIN378 and WIN027 during the clinical development phase and prior to completion of manufacturing technology transfers, with respect to the development and supply of WIN378, WIN027 or any other potential future product candidates; and

 

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the securing of, costs related to, and timing issues associated with, product manufacturing as well as sales and marketing activities.

If we fail to achieve announced milestones in the timeframes we expect, the development and commercialization of WIN378, WIN027 or any other potential future product candidates may be delayed, and our business, financial condition, results of operations and growth prospects may be harmed.

In addition, clinical investigators may serve as scientific advisors or consultants to us from time to time and may receive cash compensation in connection with such services. If these relationships and any related compensation result in perceived or actual conflicts of interest or the FDA concludes that the financial relationship may have affected the interpretation of the nonclinical study or clinical trial, the integrity of the data generated at the applicable nonclinical study or clinical trial site may be questioned and the utility of the nonclinical study or clinical trial itself may be jeopardized, which could result in the delay or rejection by the FDA. Any such delay or rejection could prevent us from commercializing our product candidates, if approved.

Our failure to successfully initiate and complete clinical trials and to demonstrate the efficacy and safety necessary to obtain regulatory approval to market WIN378, WIN027 or any other potential future product candidates would also significantly harm our business. Our development costs will also increase if we experience delays in testing or regulatory approvals and we may be required to obtain additional funds to complete clinical trials. We cannot assure you that our clinical trials will begin as planned or be completed on schedule, if at all, or that we will not need to restructure or otherwise modify our trials after they have begun. Significant clinical trial delays also could shorten any periods during which we may have the exclusive right to commercialize WIN378, WIN027 or any other potential future product candidates or allow our competitors to bring products to market before we do and impair our ability to successfully commercialize WIN378, WIN027 or any other potential future product candidates, which may harm our business, financial condition, results of operations and growth prospects. In addition, many of the factors that cause, or lead to, delays of clinical trials may ultimately lead to the denial of regulatory approval of WIN378, WIN027 or any other potential future product candidates.

If we experience delays in obtaining approval or if we fail to obtain approval of WIN378, WIN027 or any other potential future product candidates we may develop, the commercial prospects for such product candidate may be harmed, and our ability to generate revenues will be materially impaired.

 

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Interim, initial, top-line and preliminary data from our clinical trials that we announce or publish from time to time may change as more patient data becomes available and are subject to audit and verification procedures that could result in material changes in the final data.

Interim, initial, top-line and preliminary data from our clinical trials that we announce or publish from time to time may change as more patient data becomes available and are subject to audit and verification procedures that could result in material changes in the final data. From time to time, we publicly disclose preliminary or top-line data from our nonclinical studies and clinical trials, which are based on preliminary analyses of then-available data, and the results and related findings and conclusions are subject to change following a more comprehensive review of the data related to the particular nonclinical study or clinical trial. We also make assumptions, estimations, calculations and conclusions as part of our analyses of data, and we may not have received or had the opportunity to fully and carefully evaluate all data. As a result, the top-line or preliminary results that we report may differ from future results of the same studies or trials, or different conclusions or considerations may qualify such results, once additional data have been received and fully evaluated. Top-line data also remain subject to audit and verification procedures that may result in the final data being materially different from the preliminary data we previously published. As a result, top-line data should be viewed with caution until the final data are available. From time to time, we may also disclose interim data from our nonclinical studies and clinical trials. Interim data from clinical trials that we may complete are subject to the risk that one or more of the clinical outcomes may materially change as participant enrollment continues and more participants’ data become available or as participants from our clinical trials continue other treatments for their disease. Adverse differences between interim data and final data could significantly harm our business prospects. Further, others, including regulatory agencies, may not accept or agree with our assumptions, estimates, calculations, conclusions or analyses or may interpret or weigh the importance of data differently, which could impact the value of the particular program, the approvability or commercialization of the particular product candidate and could adversely affect the success of our business. In addition, the information we choose to publicly disclose regarding a particular study or clinical trial is based on what is typically extensive information, and you or others may not agree with what we determine is material or otherwise appropriate information to include in our disclosure. If the interim, top-line or preliminary data that we report differ from actual results, or if others, including regulatory authorities, disagree with the conclusions reached, our ability to obtain approval for, and commercialize, WIN378, WIN027 or any other potential future product candidates may be harmed, which could harm our business, financial condition, results of operations and growth prospects. Further, disclosure of interim, top-line or preliminary data by us or by our competitors could result in volatility in the price of our common shares after this offering. Furthermore, if we fail to replicate the positive results from our nonclinical studies or clinical trials in our future clinical trials, we may be unable to successfully develop, obtain regulatory approval for and commercialize WIN378, WIN027 or any other potential future product candidates.

If we encounter difficulties enrolling patients in our clinical trials, our clinical development activities could be delayed or otherwise adversely affected.

We may experience difficulties in patient enrollment in our clinical trials for a variety of reasons. The timely completion of clinical trials in accordance with our protocols depends, among other things, on our ability to enroll a sufficient number of patients who remain in the study until its conclusion. Patient enrollment is affected by many factors, including:

 

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the patient eligibility and exclusion criteria defined in the protocol;

 

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the size of the patient population required for analysis of the trial’s primary endpoints;

 

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the number and location of study sites and proximity of patients to study sites;

 

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the design of the trial;

 

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our ability to recruit clinical trial investigators with the appropriate competencies and experience;

 

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competing clinical trials and clinicians’ and patients’ perceptions as to the potential advantages and risks of the product candidate being studied in relation to other available therapies, including any new drugs that may be approved for the indications that we are investigating;

 

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our ability to obtain and maintain patient consents; and

 

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the risk that patients enrolled in our clinical trials will drop out of the trials before completion.

We may experience challenges in recruiting principal investigators and patients to participate in ongoing and future clinical trials for WIN378, WIN027 or any other potential future product candidates if we are unable to sufficiently

 

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demonstrate the potential of such product candidate. In addition, our clinical trials may compete with other clinical trials for product candidates that are in the same therapeutic areas as WIN378, WIN027 or any other potential future product candidates, and this competition will reduce the number and types of patients available to us, because some patients who might have opted to enroll in our trials may instead opt to enroll in a trial being conducted by one of our competitors. Since the number of qualified clinical investigators is limited, we may conduct some of our clinical trials at the same clinical trial sites that some of our competitors use, which will reduce the number of patients who are available for our clinical trials in such clinical trial site. Furthermore, if significant adverse events or other side effects are observed in any of our clinical trials or in clinical trials of product candidates deemed similar to ours, we may have difficulty recruiting patients to our trials and patients may drop out of our trials.

If we are unable to enroll a sufficient number of patients for our clinical trials, it would result in significant delays or might require us to abandon one or more clinical trials or our development efforts altogether. Delays in patient enrollment may result in increased costs, affect the timing or outcome of the planned clinical trials, product candidate development and approval process and jeopardize our ability to seek and obtain the regulatory approval required to commence product sales and generate revenue, which could prevent completion of these trials, adversely affect our ability to advance the development of WIN378, WIN027 or any other potential future product candidates, cause our value to decline and limit our ability to obtain additional financing if needed.

WIN378, WIN027 or any other potential future product candidates may cause undesirable side effects or have other properties that could delay or prevent regulatory approval, limit the commercial profile of an approved label, or result in significant negative consequences following regulatory approval, if obtained. An important driver of WIN378’s anticipated commercial profile is our target of a twice-yearly dosing regimen; if our clinical trial data does not support twice-yearly dosing or if a more frequent dosing interval is otherwise required in the approved label, WIN378’s differentiation and commercial attractiveness could be reduced relative to what we currently anticipate.

Undesirable side effects caused by WIN378, WIN027 or any other potential future product candidates could cause us or regulatory authorities to interrupt, delay or halt clinical trials and could result in a more restrictive label or the delay or denial of regulatory approval by the FDA, European Commission, or other comparable foreign regulatory authorities. We may also observe additional safety or tolerability issues with WIN378, WIN027 or any other potential future product candidates in ongoing or future clinical trials. Although WIN378 was generally well-tolerated in a Phase 1 single ascending dose study and a pre-planned interim analysis of the Phase 2 portion of POLARIS-2 in healthy volunteers, including no treatment-related serious adverse events, withdrawals or discontinuations observed, and low rates of injection site reactions and antidrug antibodies, this data was generated in a small, healthy volunteer population and may not be predictive of the safety profile in larger patient populations with asthma or COPD. WIN027 is currently being evaluated in a Phase 1 clinical trial in healthy volunteers, and based on blinded interim data, we have observed a 62-day half-life, low immunogenicity and low rate of injection site reactions.

Many compounds that initially showed promise in clinical or earlier-stage testing are later found to cause undesirable or unexpected side effects that prevented further development of the compound. Results of ongoing or future clinical trials of WIN378, WIN027 or any other potential future product candidates could reveal a high and unacceptable severity and prevalence of side effects or unexpected characteristics, despite no treatment-related serious adverse events were observed in earlier-stage testing. In addition, although we believe that WIN378’s mechanism of action and broader epitope binding profile may differentiate it from other anti-TSLP therapies, and WIN027’s simultaneous inhibition of both TSLP and IL-13 may differentiate it from monospecific therapies, adverse events observed in clinical studies or postmarket use of anti-TSLP therapies, anti-IL-13 therapies, or other anti-TSLP x IL-13 bispecific programs in clinical development may also be observed with WIN378 and WIN027, which could impact our ability to recruit patients to our clinical trials and our clinical development strategy.

If unacceptable side effects arise in the development of WIN378, WIN027 or any other potential future product candidates, we, the FDA, competent authorities of individual EU Member States, or other comparable foreign regulatory authorities, the IRBs, or independent ethics committees at the institutions in which our trials are conducted, could suspend, limit or terminate our clinical trials, or the independent safety monitoring committee could recommend that we suspend, limit or terminate our trials, or the FDA, competent authorities of individual EU Member States or other comparable foreign regulatory authorities could order us to cease clinical trials, or the FDA, the European Commission, or other comparable foreign regulatory authorities could deny approval of WIN378,

 

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WIN027 or any other potential future product candidates for any or all targeted indications. Treatment-emergent side effects that are deemed to be drug-related could delay recruitment of clinical trial subjects or may cause subjects that enroll in our clinical trials to discontinue participation in our clinical trials. In addition, these side effects may not be appropriately recognized or managed by the treating medical staff. We may need to train medical personnel using WIN378, WIN027 or any other potential future product candidates to understand the side effect profiles for our clinical trials and upon any commercialization of WIN378, WIN027 or any other potential future product candidates. Inadequate training in recognizing or managing the potential side effects of WIN378, WIN027 or any other potential future product candidates could result in harm to patients that are administered WIN378, WIN027 or any other potential future product candidates. Any of these occurrences may adversely affect our business, financial condition, results of operations and growth prospects significantly.

Moreover, clinical trials are conducted in carefully defined sets of patients who have agreed to enter into clinical trials. Consequently, it is possible that our clinical trials may indicate an apparent positive effect of a product candidate that is greater than the actual positive effect, if any, or alternatively fail to identify undesirable side effects.

Other potentially significant negative consequences associated with adverse events include:

 

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we may be required to suspend marketing of a product, or we may decide to remove such product from the marketplace;

 

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regulatory authorities may withdraw or change their approvals of a product;

 

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regulatory authorities may require additional warnings on the label or limit access of a product to

 

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selective specialized centers with additional safety reporting and with requirements that patients

 

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be geographically close to these centers for all or part of their treatment;

 

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we may be required to create a medication guide outlining the risks of a product for patients, or to

 

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conduct post-marketing studies;

 

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we may be required to change the way a product is administered;

 

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we could be subject to fines, injunctions, or the imposition of criminal or civil penalties, or be sued

 

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and held liable for harm caused to subjects or patients; and

 

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a product may become less competitive, and our reputation may suffer.

Any of these events could diminish the usage or otherwise limit the commercial success of our product candidates and prevent us from achieving or maintaining market acceptance of our product candidates, if approved by the FDA or other regulatory authorities.

If we fail to expand our development of WIN378 and WIN027 into additional indications, or discover or acquire, and subsequently develop and commercialize other product candidates, we may be unable to grow our business and our ability to achieve our strategic objectives would be impaired.

Although the development and commercialization of WIN378 in severe asthma and COPD, and of WIN027 in COPD and atopic dermatitis, represent our current clinical focus, as part of our longer-term growth strategy, we plan to initiate and advance development of WIN378 and WIN027 in additional indications, including, for WIN378, indications such as chronic rhinosinusitis with nasal polyps and eosinophilic esophagitis. Expansion into new indications will require additional, time-consuming development efforts prior to commercial sale, including nonclinical studies, clinical trials and approval by the FDA, the European Commission, and comparable foreign regulatory authorities. All product candidates are prone to the risks of failure that are inherent in pharmaceutical product development, including the possibility that the product candidate will not be shown to be sufficiently safe, pure and potent, or effective for approval by regulatory authorities. In addition, we cannot assure you that any such products that are approved will be manufactured or produced economically, successfully commercialized or widely accepted in the marketplace or be more effective than other commercially available alternatives.

 

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Risks Related to the Commercialization of WIN378, WIN027 or Any Other Potential Future Product Candidates

Even if WIN378, WIN027 or any other potential future product candidates receive regulatory approval, such product candidate may fail to achieve the degree of market acceptance by physicians, patients, third-party payors and others in the medical community necessary for commercial success, in which case we may not generate significant revenues or become profitable.

We have never commercialized a product, and even if WIN378, WIN027 or any other potential future product candidate is approved by the appropriate regulatory authorities for marketing and sale, such product candidate may nonetheless fail to achieve sufficient market acceptance by physicians, patients, third-party payors and others in the medical community. Many of the indications for WIN378 and WIN027 have well-established standards of care that physicians, patients and payors are familiar with. Even if WIN378, WIN027 or any other potential future product candidates are successful in registrational clinical trials, such product candidate may not be successful in displacing these current standards of care if we are unable to demonstrate superior efficacy, safety, ease of administration and/or cost-effectiveness. For example, physicians may be reluctant to start biologic-naïve patients on a new medication or take their patients off their current medications and switch their treatment regimen to WIN378, WIN027 or any other potential future product candidates. Further, patients often acclimate to the treatment regimen that they are currently taking and do not want to switch unless their physicians recommend switching products or they are required to switch due to lack of coverage and adequate reimbursement. Even if we are able to demonstrate WIN378’s, WIN027’s or any other potential future product candidates’ safety, purity and potency, or efficacy to the FDA, the European Commission, and other regulators, safety or efficacy concerns in the medical community may hinder market acceptance.

Efforts to educate the medical community and third-party payors on the benefits of WIN378, WIN027 or any other potential future product candidates may require significant resources, including management time and financial resources, and may not be successful. If WIN378, WIN027 or any other potential future product candidates are approved but do not achieve an adequate level of market acceptance, we may not generate significant revenues and we may not become profitable. The degree of market acceptance of WIN378, WIN027 or any other potential future product candidates, if approved for commercial sale, will depend on a number of factors, including:

 

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the efficacy and safety of the product;

 

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the potential advantages of the product compared to competitive therapies;

 

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the prevalence and severity of any side effects;

 

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whether the product is designated under physician treatment guidelines as a first-, second- or third-line therapy;

 

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our ability, or the ability of any future collaborators, to offer the product for sale at competitive prices;

 

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the product’s convenience and ease of administration compared to alternative treatments;

 

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the willingness of the target patient population to try, and of physicians to prescribe, the product;

 

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limitations or warnings, including distribution or use restrictions contained in the product’s approved labeling;

 

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the strength of sales, marketing and distribution support;

 

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changes in the standard of care for the targeted indications for the product; and

 

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availability and adequacy of coverage and reimbursement from government payors, managed care plans and other third-party payors.

Any failure by WIN378, WIN027 or any other potential future product candidate that obtains regulatory approval to achieve market acceptance or commercial success would adversely affect our business prospects.

Competitive products may reduce or eliminate the commercial opportunity for WIN378, WIN027 or any other potential future product candidates, if approved. If our competitors develop technologies or product candidates more rapidly than we do, or their technologies or product candidates are more effective or safer than ours, our ability to develop and successfully commercialize WIN378, WIN027 or any other potential future product candidates may be adversely affected.

The clinical and commercial landscapes for the treatment of inflammatory diseases are highly competitive and subject to rapid and significant technological change. We face competition with respect to our indications for

 

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WIN378, WIN027 and will face competition with respect to any other drug candidates that we may seek to develop or commercialize in the future, from major pharmaceutical companies, specialty pharmaceutical companies and biotechnology companies worldwide. There are a number of large pharmaceutical and biotechnology companies, such as Amgen Inc., Apogee Therapeutics, Inc. (acquired by AbbVie Inc.), AstraZeneca plc, Belenos Biosciences Inc., Generate Biomedicines, Inc., GSK plc, Johnson & Johnson, KeyMed Biosciences Inc., Eli Lilly and Company, Pfizer Inc., Sanofi S.A., and Upstream Bio, Inc. that currently market and sell drugs or are pursuing the development of drug candidates for the treatment of the indications that we are pursuing. Potential competitors also include academic institutions, government agencies and other public and private research organizations that conduct research, seek patent protection and establish collaborative arrangements for research, development, manufacturing and commercialization.

Our potential competitors include large pharmaceutical and biotechnology companies, specialty pharmaceutical and generic drug companies, academic institutions, government agencies and research institutions. See the section titled “Business—Competition” included elsewhere in this prospectus for examples of the competition that WIN378 or WIN027 faces.

In most cases, we do not currently plan to run head-to-head clinical trials evaluating WIN378, WIN027 or any other potential future product candidates against the current standards of care, which may make it more challenging for WIN378, WIN027 or any other potential future product candidates to compete against the current standards of care due to the lack of head-to-head clinical trial data.

Our competitors may have significantly greater financial resources, established presence in the market, expertise in research and development, manufacturing, nonclinical and clinical testing, obtaining regulatory approvals and reimbursement and marketing approved products than we do. Accordingly, our competitors may be more successful than we may be in obtaining regulatory approval for therapies and achieving widespread market acceptance. Our competitors’ products may be more effective, or more effectively marketed and sold, than WIN378, WIN027 or any other potential future product candidates we may commercialize and may render our therapies obsolete or non-competitive before we can recover development and commercialization expenses. If WIN378, WIN027 or any other potential future product candidates are approved, it could compete with a range of therapeutic treatments that are in development. In addition, our competitors may succeed in developing, acquiring or licensing technologies and drug products that are more effective or less costly than WIN378, WIN027 or any other potential future product candidates, which could render WIN378, WIN027 or any other potential future product candidates obsolete and noncompetitive.

If we obtain approval for WIN378, WIN027 or any other potential future product candidates, we may face competition based on many different factors, including the efficacy, safety and tolerability of our products, the ease with which our products can be administered, the timing and scope of regulatory approvals for these products, the availability and cost of manufacturing, marketing and sales capabilities, price, reimbursement coverage and patent position. Existing and future competing products could present superior treatment alternatives, including being more effective, safer, less expensive or marketed and sold more effectively than any products we may develop. Competitive products may make any products we develop obsolete or noncompetitive before we recover the expense of developing and commercializing WIN378, WIN027 or any other potential future product candidates. Such competitors could also recruit our employees, which could negatively impact our level of expertise and our ability to execute our business plan.

In addition, our competitors may obtain patent protection, regulatory exclusivities or FDA approval and commercialize products more rapidly than we do, which may impact future approvals or sales of WIN378, WIN027 or any other potential future product candidates that receive regulatory approval. If the FDA approves the commercial sale of WIN378, WIN027 or any other potential future product candidates, we will also be competing with respect to marketing capabilities and manufacturing efficiency. We expect competition among products will be based on product efficacy and safety, the timing and scope of regulatory approvals, availability of supply, marketing and sales capabilities, product price, reimbursement coverage by government and private third-party payors, regulatory exclusivities and patent position. Our profitability and financial position will suffer if WIN378, WIN027 or any other potential future product candidates receives regulatory approval but cannot compete effectively in the marketplace.

 

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Mergers and acquisitions in the pharmaceutical and biotechnology industries may result in even more resources being concentrated among a smaller number of our competitors. Smaller and other early-stage companies may also prove to be significant competitors, particularly through collaborative arrangements with large and established companies. These third parties compete with us in recruiting and retaining qualified scientific and management personnel and establishing clinical trial sites, as well as in acquiring technologies complementary to, or necessary for, our programs.

If we are unable to develop our sales, marketing and distribution capability on our own or through collaborations with marketing partners, we will not be successful in commercializing WIN378, WIN027 or any other potential future product candidates.

We currently have no marketing, sales or distribution capabilities. We intend to establish a sales and marketing organization, either on our own or in collaboration with third parties, with technical expertise and supporting distribution capabilities to commercialize WIN378, WIN027 or any other potential future product candidates that may receive regulatory approval in key territories. These efforts will require substantial additional resources, some or all of which may be incurred in advance of any approval of the product candidate. Any failure or delay in the development of our or third parties’ internal sales, marketing and distribution capabilities would adversely impact the commercialization of WIN378, WIN027 or any other potential future product candidates.

Factors that may inhibit our efforts to commercialize WIN378, WIN027 or any other potential future product candidates on our own include:

 

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our inability to recruit and retain an adequate number of effective sales and marketing personnel;

 

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the inability of sales personnel to obtain access to or persuade an adequate number of physicians to prescribe any future products;

 

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the lack of complementary products to be offered by sales personnel, which may put us at a competitive disadvantage relative to companies with more extensive product lines; and

 

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unforeseen costs and expenses associated with creating an independent sales and marketing organization.

With respect to WIN378, WIN027 or any other potential future product candidates, we may choose to collaborate with third parties that have direct sales forces and established distribution systems to serve as an alternative to our own sales force and distribution systems. Our future product revenue may be lower than if we directly marketed or sold WIN378, WIN027 or any other potential future product candidates, if approved. In addition, any revenue we receive will depend in whole or in part upon the efforts of these third parties, which may not be successful and are generally not within our control. If we are not successful in commercializing any approved products, our future product revenue will suffer and we may incur significant additional losses.

If we do not establish sales and marketing capabilities successfully, either on our own or in collaboration with third parties, we will not be successful in commercializing WIN378, WIN027 or any other potential future product candidates.

The increasing use of social media platforms presents new risks and challenges.

Social media is increasingly being used to communicate about our clinical development programs and the diseases our therapeutics are being developed to treat, and we intend to utilize appropriate social media in connection with our commercialization efforts following approval of our product candidates, if any. Social media practices in the biopharmaceutical industry continue to evolve and regulations and regulatory guidance relating to such use are evolving and not always clear. This evolution creates uncertainty and risk of noncompliance with regulations applicable to our business, resulting in potential regulatory actions against us, along with the potential for litigation related to off-label marketing or other prohibited activities. For example, patients may use social media channels to comment on their experience in an ongoing blinded clinical trial or to report an alleged adverse event. When such disclosures occur, there is a risk that trial enrollment may be adversely impacted, that we fail to monitor and comply with applicable adverse event reporting obligations or that we may not be able to defend our business or the public’s legitimate interests in the face of the political and market pressures generated by social media due to restrictions on what we may say about our product candidates. There is also a risk of inappropriate disclosure of sensitive information or negative or inaccurate posts or comments about us on any social networking website. If any of these

 

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events were to occur or we otherwise fail to comply with applicable regulations, we could incur liability, face regulatory actions or incur other harm to our business.

Risks Related to Employee Matters and Managing Growth

We expect to expand our organization, and as a result, we may encounter difficulties in managing our growth, which could disrupt our operations.

We expect to experience significant growth in the number of our employees and the scope of our operations, particularly in the areas of regulatory affairs and sales, marketing and distribution, as well as to support our public company operations. To manage these growth activities, we must continue to implement and improve our managerial, operational, quality and financial systems, expand our facilities and continue to recruit and train additional qualified personnel. Our management may need to devote a significant amount of its attention to managing these growth activities. Due to our limited financial resources and the limited experience of our management team in managing a company with such anticipated growth, we may not be able to effectively manage the expansion or relocation of our operations, retain key employees, or identify, recruit and train additional qualified personnel. Our inability to manage the expansion or relocation of our operations effectively may result in weaknesses in our infrastructure, give rise to operational mistakes, loss of business opportunities, loss of employees and reduced productivity among remaining employees. Our expected growth could also require significant capital expenditures and may divert financial resources from other projects, such as the development of additional product candidates. If we are unable to effectively manage our expected growth, our expenses may increase more than expected, our ability to generate revenues could be reduced and we may not be able to implement our business strategy, including the successful commercialization of WIN378, WIN027 or any other potential future product candidates.

Our success and our future growth depend in part on attracting, hiring and retaining our key personnel and recruiting additional qualified personnel.

Our success depends significantly upon the continued service, leadership and contributions of our key management and scientific personnel, for example, Dr. Luca Santarelli, our Chief Executive Officer and Dr. Omar Khwaja, our Chief Medical Officer, many of whom have been instrumental for us and have substantial experience with developing therapies, identifying potential product candidates and building the technologies related to the clinical development of WIN378, WIN027 or any other potential future product candidates. As we continue developing WIN378, WIN027 or any other potential future product candidates, we will require personnel with medical, scientific, or technical qualifications specific to each program. The loss of Dr. Santarelli, Dr. Khwaja or other key personnel would delay our research and development activities and could impair our ability to execute our strategy, raise capital, pursue business development opportunities and advance our product candidates. Despite our efforts to retain valuable employees, members of our team may terminate their employment with us on relatively short notice. The competition for qualified personnel in the biotechnology and biopharmaceutical industries is intense, and our future success depends upon our ability to attract, retain, and motivate highly skilled scientific, technical and managerial employees. We face competition for personnel from other companies, universities, public and private research institutions, and other organizations. If our recruitment and retention efforts are unsuccessful in the future, it may be difficult for us to implement our business strategy, which would have a material adverse effect on our business.

In addition, our clinical operations and research and development programs depend on our ability to attract and retain highly skilled scientists, data scientists, and engineers. There is powerful competition for skilled personnel in these geographical markets, and we have from time to time experienced, and we expect to continue to experience, difficulty in hiring and retaining employees with appropriate qualifications on acceptable terms, or at all. Many of the companies with which we compete for experienced personnel have greater resources than we do, and any of our employees may terminate their employment with us at any time. If we hire employees from competitors or other companies, their former employers may attempt to assert that these employees or we have breached legal obligations, resulting in a diversion of our time and resources and, potentially, damages. In addition, job candidates and existing employees often consider the value of the equity awards they receive in connection with their employment. If the perceived benefits of our equity awards decline, it may harm our ability to recruit and retain highly skilled employees. If we fail to attract new personnel or fail to retain and motivate our current personnel, our business and future growth prospects would be harmed.

 

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Laws and regulations on executive compensation, including legislation in our home country, Switzerland, may restrict our ability to attract, motivate and retain the required level of qualified personnel for our executive committee. In Switzerland, legislation affecting public companies is in force that, among other things, (1) imposes an annual binding shareholders’ “say on pay” vote with respect to the compensation of our executive committee and board of directors, (2) generally prohibits severance, certain advance payments, transaction premiums and similar payments to members of our executive committee and board of directors, and (3) requires companies to specify certain compensation-related matters in their articles of association, thus requiring them to be approved by a shareholders’ vote. Because the Swiss legislation affecting public companies will apply to operations in the United States and may be more onerous and restrictive than comparable laws and regulations applying to U.S. domiciled companies, recruiting and retaining members of our executive committee and board of directors in the United States may be even more difficult as compared to companies domiciled in the United States.

Risks Related to Our Dependence on Third Parties

We currently rely, and plan to rely in the future, on third parties to conduct and support our clinical trials. If they do not perform satisfactorily, we may not be able to obtain regulatory approval or commercialize WIN378, WIN027 or any other potential future product candidates, or such approval or commercialization may be delayed, and our business could be substantially harmed.

We have relied upon and plan to continue to rely on third parties, such as CROs, clinical data management organizations, medical institutions and clinical investigators, to conduct our clinical trials and expect to rely on these third parties to conduct clinical trials for WIN378, WIN027 or any other potential future product candidates that we develop. Our ability to complete clinical trials in a timely fashion depends on a number of key factors. These factors include protocol design, regulatory and IRB approval, or positive opinions from ethics committees, patient enrollment rates and compliance with GCPs. We have opened clinical trial sites and are enrolling patients in a number of countries where our experience is limited. In most cases, we use the services of third parties, including CROs, to carry out our clinical trial-related activities and rely on such parties to accurately report their results. Our reliance on third parties for clinical development activities may impact or limit our control over the timing, conduct, expense and quality of our clinical trials. Moreover, the FDA requires us to comply with GCPs for conducting, recording and reporting the results of clinical trials to assure that data and reported results are credible and accurate and that the rights, integrity and confidentiality of trial participants are protected. The FDA enforces these GCPs through periodic inspections of clinical trial sponsors, principal investigators, clinical trial sites and IRBs. For certain commercial prescription drug products, manufacturers and other parties involved in the supply chain must also meet chain of distribution requirements and build electronic, interoperable systems for product tracking and tracing and for notifying the FDA of counterfeit, diverted, stolen and intentionally adulterated products or other products that are otherwise unfit for distribution in the United States. Comparable requirements and enforcement actions apply in foreign countries.

We remain responsible for ensuring that each of our trials is conducted in accordance with the applicable protocol, informed consent forms submitted to competent regulatory authorities, legal and regulatory requirements and scientific standards. Our failure or the failure of third parties to comply with the applicable protocol, informed consent forms, legal and regulatory requirements and scientific standards can result in rejection of our clinical trial data or other sanctions. If we or our third-party clinical trial providers or third-party CROs do not successfully carry out these clinical activities, our clinical trials or the potential regulatory approval of a product candidate may be delayed or be unsuccessful. Additionally, if we or our third-party contractors fail to comply with applicable GCPs, the clinical data generated in our clinical trials may be deemed unreliable and the FDA or comparable foreign regulatory authorities may require us to perform additional clinical trials before approving WIN378, WIN027 or any other potential future product candidates, which would delay the regulatory approval process. We cannot be certain that, upon inspection, the FDA or comparable foreign regulatory authorities will determine that any of our clinical trials comply with GCPs. We are also required to register certain clinical trials and post the results of completed clinical trials on a government-sponsored database, ClinicalTrials.gov, within certain timeframes. Failure to do so can result in fines, adverse publicity and civil and criminal sanctions. Comparable transparency and publication requirements apply in foreign countries.

In particular, if the sponsor of a clinical trial is not established within the EU, it must appoint an EU entity to act as its legal representative. Compliance with the CTR requirements by us and our third-party service providers, such as CROs, may impact our development plans.

 

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Our third-party contractors, including CROs, may not devote sufficient time or resources to our programs, may face their own operational challenges, or may terminate their engagements with us, and the loss or replacement of a key third-party provider could delay our clinical trials or increase our costs.

The third parties conducting clinical trials on our behalf are not our employees, and except for remedies available to us under our agreements with such contractors, we cannot control whether or not they devote sufficient time, skill and resources to our ongoing development programs. Moreover, many CROs, including some of those that we have engaged to conduct our clinical trials, are experiencing enrollment challenges as a result of, among other things, high employee turnover driven by the post-COVID macroeconomic environment and the inexperience of new employees. Furthermore, at clinical trial sites, the availability of staff and trial participants has been limited due to a decrease in the number of clinical investigative sites across the globe. These contractors may also have relationships with other commercial entities, including our competitors, for whom they may also be conducting clinical trials or other drug development activities, which could impede their ability to devote appropriate time to our clinical programs. If these third parties, including clinical investigators, do not successfully carry out their contractual duties, meet expected deadlines or conduct our clinical trials in accordance with regulatory requirements or our stated protocols, we may not be able to obtain, or may be delayed in obtaining, regulatory approvals for WIN378, WIN027 or any other potential future product candidates. If that occurs, we will not be able to, or may be delayed in our efforts to, successfully commercialize WIN378, WIN027 or any other potential future product candidates. In such an event, our financial results and the commercial prospects for WIN378, WIN027 or any other potential future product candidates that we seek to develop could be harmed, our costs could increase and our ability to generate revenues could be delayed, impaired or foreclosed.

We rely on third parties to store and distribute drug supplies for our clinical trials, and any performance failure by these distributors could delay our clinical development or regulatory approval efforts.

We rely on other third parties to store and distribute drug supplies for our clinical trials. Any performance failure on the part of our distributors could delay clinical development or regulatory approval of WIN378, WIN027 or any other potential future product candidates or commercialization of any resulting products, producing additional losses and depriving us of potential product revenue.

Any of the third-party organizations we utilize may terminate their engagements with us under certain circumstances. The replacement of an existing CRO or other third party may result in the delay of the affected trials or otherwise adversely affect our efforts to obtain regulatory approvals and commercialize WIN378, WIN027 or any other potential future product candidates. For example, although we believe there are a number of other CROs we could engage, we may not be able to enter into alternative arrangements or do so on commercially reasonable terms. In addition, while we believe there may be suitable replacements for one or more of these service providers, there is a natural transition period when a new service provider begins work. As a result, delays may occur, which could negatively impact our ability to meet our expected clinical development timelines and harm our business, financial condition, results of operations and growth prospects.

Our reliance on license arrangements, manufacturing activities and supply-chain components connected to the PRC may expose us to geopolitical, tariff, trade restriction, licensing and other risks, which could adversely affect our development programs and business.

We in-license WIN378 from Kelun and HBM and WIN027 from Qyuns, each of which is based in the PRC or has substantial operations in the PRC, and we rely on these licensors for certain development, manufacturing, technology transfer, regulatory and other activities relating to our product candidates. Our ability to develop and commercialize WIN378, WIN027 and any other potential future product candidates therefore may be affected by geopolitical tensions involving the PRC, changes in U.S., PRC or other governmental policies toward cross-border biotechnology licensing or collaboration, restrictions on technology transfer, export controls, sanctions, investment screening, data-transfer limitations, changes in PRC laws or regulatory enforcement, or other measures that make it more difficult, costly or time-consuming for us to obtain, maintain or exercise rights under license agreements with PRC-based counterparties. Any such developments could impair our ability to receive necessary information, regulatory support, know-how, technology, clinical or manufacturing data, materials or other assistance from our licensors, could delay or prevent the transfer of manufacturing or other activities outside the PRC, could limit our ability to enter into future in-license or collaboration arrangements with PRC-based biotechnology companies, or could otherwise adversely affect our business, financial condition, results of operations and growth prospects.

 

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If our information technology systems or those of third parties with whom we work (including our CROs or other contractors), or our data, are or were compromised, we could experience adverse consequences resulting from such compromise, including but not limited to regulatory investigations or actions, litigation, fines and penalties, disruptions of our business operations, reputational harm, loss of revenue or profits and other adverse consequences.

In the ordinary course of our business, we and the third parties with whom we work process sensitive data including personal data (such as health and clinical trial-related data). Cyberattacks, malicious internet-based activity, online and offline fraud and other similar activities threaten the confidentiality, integrity and availability of our sensitive data and information technology systems and those of the third parties with whom we work. Such threats are prevalent and continue to rise, are increasingly difficult to detect and come from a variety of sources, including traditional computer “hackers,” threat actors, “hacktivists,” organized criminal threat actors, personnel (such as through theft or misuse), sophisticated nation states and nation-state-supported actors. Some actors now engage and are expected to continue to engage in cyberattacks, including without limitation nation-state actors for geopolitical reasons and in conjunction with military conflicts and defense activities. During times of war and other major conflicts, we and the third parties with whom we work may be vulnerable to a heightened risk of these attacks, including retaliatory cyberattacks, that could materially disrupt our systems and operations, supply chain and ability to operate our business (including our ability to conduct our clinical trials).

We and the third parties with whom we work are also subject to a variety of evolving threats, including social-engineering attacks (including through deep fakes and phishing attacks), malicious code (such as viruses and worms), malware (including as a result of advanced persistent threat intrusions), denial-of-service attacks, credential stuffing attacks, credential harvesting, ransomware attacks, supply-chain attacks, software bugs, server malfunctions, telecommunications failures, electrical failures, loss of data or other information technology assets, adware, natural disasters (including fires and earthquakes), attacks enhanced or facilitated by AI and other similar threats. In particular, severe ransomware attacks are becoming increasingly prevalent and can lead to significant interruptions in our operations, loss of sensitive data and income, reputational harm and diversion of funds. Extortion payments may alleviate the negative impact of a ransomware attack, but we may be unwilling or unable to make such payments due to, for example, applicable laws or regulations prohibiting such payments.

As a result of a hybrid working environment, we also face increased cybersecurity risks due to our reliance on internet technology and the number of our employees who are working remotely, which may create additional opportunities for cybercriminals to exploit vulnerabilities. Furthermore, because the techniques used to obtain unauthorized access to, or to sabotage systems change frequently and often are not recognized until launched against a target, we may be unable to anticipate these techniques and/or implement adequate preventative measures.

Due to the nature of some of the attacks described herein, there is a risk that an attack may remain undetected for a period of time. Even if identified, we may be unable to adequately investigate or remediate incidents or breaches due to attackers increasingly using tools and techniques that are designed to circumvent controls, to avoid detection, and to remove or obfuscate forensic evidence.

Future acquisitions or integrations expose us to additional cybersecurity risks and vulnerabilities, as our systems could be negatively affected by vulnerabilities present in acquired or integrated entities’ systems and technologies, and we may discover security issues that were not found during due diligence of such acquired or integrated entities.

We rely on third parties to operate critical business systems and to process sensitive data in a variety of contexts, including cloud-based infrastructure, data center facilities, encryption and authentication technology, and other functions. Our ability to monitor these third parties’ information security practices is limited, and these third parties may not have adequate information security measures in place. In addition, supply-chain attacks have increased in frequency and severity, and we cannot guarantee that third parties’ infrastructure in our supply chain or that of the third parties with whom we work have not been compromised. Likewise, we rely on our third-party research collaborators for research and development of WIN378 and WIN027 and other third parties to conduct clinical trials, and similar events relating to their information technology systems could also seriously harm our business. While we continue to make investments to improve the protection of data and information technology, there can be no assurance that our efforts will prevent service interruptions or security breaches or effectively mitigate their impacts.

 

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We and certain of our service providers are from time to time subject to cyberattack attempts or incidents and security incidents. Any cybersecurity incident could adversely affect our business, by leading to, for example, the loss of trade secrets or other intellectual property, demands for ransom or other forms of blackmail, or the unauthorized disclosure of sensitive information of our personnel, clinical trial participants, and others. We have in the past and may in the future expend significant resources or modify our business activities (including our clinical trial activities) to try to protect against security incidents. Applicable data privacy and security obligations require us, or we may voluntarily choose, to notify relevant stakeholders, including affected individuals and regulators, of security incidents or to take other actions, such as providing credit monitoring and identity theft protection services. Such disclosures and related actions can be costly, and the disclosure or the failure to comply with such applicable requirements could lead to adverse consequences. We could be subject to breach notification requirements, regulatory actions taken by governmental authorities, litigation (including class claims) under laws that protect the privacy of personal information, indemnification obligations, negative publicity, reputational harm, or other forms of legal proceedings, which could result in significant liabilities or penalties, result in substantial costs and distract management. Further, a cybersecurity incident may disrupt our business or damage our reputation, which could have a material adverse effect on our business, financial condition, results of operations, growth prospects, share price and shareholder value. We could also incur substantial remediation costs, including the costs of investigating the incident, repairing or replacing damaged systems, restoring normal business operations, implementing increased cybersecurity protections, and paying increased insurance premiums.

In particular, the loss of clinical trial data from completed, ongoing or future clinical trials could result in delays in or denials of our regulatory approval efforts and significantly increase our costs to recover or reproduce the data.

Our contracts may not contain relevant limitations of liability, and even where they do, there can be no assurance that such limitations of liability in our contracts are sufficient to protect us from liabilities, damages or claims related to our data privacy and security obligations. We cannot be sure that our insurance coverage will be adequate or sufficient to protect us from or to mitigate liabilities arising out of our privacy and security practices, that such coverage will continue to be available on commercially reasonable terms or at all, or that such coverage will pay future claims.

In addition to experiencing a security incident, third parties may gather, collect or infer sensitive data about us from public sources, data brokers or other means that reveal competitively sensitive details about our organization and could be used to undermine our competitive advantage or market position.

We may seek to establish collaborations and, if we are not able to establish them on commercially reasonable terms, we may have to alter our development and commercialization plans.

The advancement, development programs and potential commercialization of WIN378, WIN027 or any other potential future product candidates will require substantial additional cash to fund expenses. For some of our programs, we may decide to collaborate with other pharmaceutical and biotechnology companies with respect to development and potential commercialization. Likely collaborators may include large and mid-size pharmaceutical companies, regional and national pharmaceutical companies and biotechnology companies. In addition, if we are able to obtain regulatory approval for WIN378, WIN027 or any other potential future product candidates from foreign regulatory authorities, we may enter into collaborations with international biotechnology or pharmaceutical companies for the commercialization of such product candidate.

We face significant competition in seeking appropriate collaborators. Whether we reach a definitive agreement for a collaboration will depend, among other things, upon our assessment of the collaborator’s resources and expertise, the terms and conditions of the proposed collaboration and the proposed collaborator’s evaluation of a number of factors. Those factors may include the potential differentiation of WIN378, WIN027 or any other potential future product candidates from competing product candidates, design or results of clinical trials, the likelihood of approval by the FDA, the European Commission, or other comparable foreign regulatory authorities and the regulatory pathway for any such approval, the potential market for the product candidate, the costs and complexities of manufacturing and delivering the product to patients and the potential of competing products. The collaborator may also consider alternative product candidates or technologies for similar indications that may be available for collaboration and whether such a collaboration could be more attractive than the one with us for WIN378, WIN027 or any other potential future product candidates. If we elect to increase our expenditures to fund development or

 

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commercialization activities on our own, we may need to obtain additional capital, which may not be available to us on acceptable terms or at all. If we do not have sufficient funds, we may not be able to further develop WIN378, WIN027 or any other potential future product candidates or bring them to market and generate product revenue.

Collaborations are complex and time-consuming to negotiate and document. Further, there have been a significant number of recent business combinations among large pharmaceutical companies that have resulted in a reduced number of potential future collaborators. Any collaboration agreements that we enter into in the future may contain restrictions on our ability to enter into potential collaborations or to otherwise develop specified product candidates. We may not be able to negotiate collaborations on a timely basis, on acceptable terms, or at all. If we are unable to do so, we may have to curtail the development of WIN378, WIN027 or any other potential future product candidates for which we are seeking to collaborate, reduce or delay its development program or one or more of our other development programs, delay its potential commercialization or reduce the scope of any sales or marketing activities, or increase our expenditures and undertake development or commercialization activities at our own expense.

Our existing research and development arrangement as well as any future collaborations with third parties for the development and commercialization of WIN378, WIN027 or any other potential future product candidates may not be successful, which could adversely affect our ability to advance WIN378, WIN027 or any other potential future product candidates.

We have entered into the Kelun-HBM Agreement, pursuant to which Kelun and HBM retain rights to develop and commercialize WIN378 in the PRC independently of us, and the Qyuns Agreement, pursuant to which Qyuns retains rights to develop and commercialize WIN027 in the PRC independently of us. We may in the future also enter into sublicense or partnership agreements with third parties for the development or commercialization of WIN378, WIN027 or any other potential future product candidates in parts of our licensed territory. Our ability to generate revenues from these arrangements will depend on any future collaborators’ abilities to successfully perform. Under the Kelun-HBM Agreement, Kelun and HBM may conduct their own clinical development program for WIN378 in the PRC, including clinical trials in the PRC that we do not control or fund. As of the date of this prospectus, Kelun and HBM are not conducting, and have no current plans to conduct, an independent clinical development program for WIN378 in the PRC; however, they could elect to initiate such a program in the future, and any clinical data generated independently in that territory could influence regulatory authorities’ assessment of our marketing authorization applications in the United States and other jurisdictions within our licensed territory. Similarly, under the Qyuns Agreement, Qyuns is conducting its own Phase 1 clinical trial for WIN027 in the PRC, has initiated their Phase 2 studies in atopic dermatitis and CRSwNP and plans to begin a Phase 2 study in asthma by the end of 2026 in the PRC in which we will also participate. The results of these studies being conducted independently in the PRC, and the pace and manner in which they are conducted, may affect the global clinical data package for WIN378 and WIN027 and could influence regulatory authorities’ assessment of our marketing authorization applications in the United States and other jurisdictions in our licensed territory. In addition, we expect that a substantial portion of the cost of the WIN027 Phase 2b COPD study will be funded by Qyuns through its PRC development activities, and any failure by Qyuns to perform or fund its portion of that program could delay or increase the cost of our global COPD development plan for WIN027. Any future sublicensees or commercialization collaborators may also have the right to abandon development or commercialization activities and terminate applicable agreements, including funding obligations, prior to or upon the expiration of the agreed upon terms.

Collaborations involving WIN378, WIN027 or any other potential future product candidates pose a number of risks, including the following:

 

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any future collaborators have significant discretion in determining the efforts and resources that they will apply to these collaborations;

 

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any future collaborators may not perform their obligations as expected;

 

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any future collaborators may not pursue development and commercialization of WIN378, WIN027 or any other potential future product candidates or may elect not to continue or renew development or commercialization programs, based on clinical trial results, changes in the collaborators’ strategic focus or available funding or external factors, such as an acquisition, which divert resources or create competing priorities;

 

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each of Kelun and HBM (with respect to WIN378) and Qyuns (with respect to WIN027) retains independent development and commercialization rights, over which we have no operational control and which we do not

 

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fund; any clinical trials or development activities they conduct in the PRC may produce clinical data that is inconsistent with our own data, may be subject to regulatory findings in the PRC that affect global development, or may be deprioritized, delayed, or abandoned by the respective licensor, each of which could adversely affect our global clinical and regulatory strategy; while we retain certain contractual decision rights that may allow us to object to or limit licensor development activities that could materially and adversely affect our program in certain defined circumstances, these rights may not be sufficient to prevent all potential adverse consequences to our global development program;

 

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if Kelun and HBM (with respect to WIN378) or Qyuns (with respect to WIN027) sublicenses its development and commercialization rights in certain Asian countries and territories, including the PRC to third parties, despite our decision rights with respect to such sublicensees’ development and commercialization activities, any development activities conducted by such sublicensees in such Asian countries and territories would be further removed from our oversight and influence, and clinical data generated by such sublicensees could affect our global clinical data package or regulatory position in ways that we could not anticipate or prevent;

 

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any future collaborators may delay clinical trials, provide insufficient funding for a clinical trial program, stop a clinical trial or abandon WIN378, WIN027 or any other potential future product candidates, repeat or conduct new clinical trials or require a new formulation of a product candidate for clinical testing;

 

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any future collaborators could independently develop, or develop with third parties, products that compete directly or indirectly with WIN378, WIN027 or any other potential future product candidates;

 

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any future collaborator with marketing and distribution rights to one or more products may not commit sufficient resources to the marketing and distribution of such product or products;

 

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disagreements with Kelun, HBM, Qyuns or any future collaborators, including disagreements over proprietary rights, including trade secrets and intellectual property rights, contract interpretation, or the preferred course of development might cause delays or termination of the research, development or commercialization of WIN378, WIN027 or any other potential future product candidates, might lead to additional responsibilities for us with respect to such product candidate, or might result in litigation or arbitration, any of which would be time-consuming and expensive;

 

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any future collaborators may not properly maintain or defend our intellectual property rights or may use our proprietary information in such a way as to invite litigation that could jeopardize or invalidate our intellectual property or proprietary information or expose us to potential litigation;

 

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any future collaborators may infringe the intellectual property rights of third parties, which may expose us to litigation and potential liability; and

 

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any future collaborations may be terminated and, if terminated, may result in a need for additional capital to pursue further development or commercialization of the applicable product candidate.

Collaboration agreements may not lead to development or commercialization of WIN378, WIN027 or any other potential future product candidates in the most efficient manner or at all. If any future collaborator of ours is involved in a business combination, it could decide to delay, diminish or terminate the development or commercialization of WIN378, WIN027 or any other potential future product candidates licensed to it by us.

We are currently in the process of transferring, or may in the future transfer, the manufacturing of our clinical trial material from facilities in the PRC to contract manufacturing organizations in the United States. Our use of third parties to manufacture WIN378, WIN027 or any other potential future product candidates may increase the risk that we will not have sufficient quantities of WIN378, WIN027 or any other potential future product candidates, raw materials, active pharmaceutical ingredients, or APIs, or drug products when needed or at an acceptable cost.

We do not own or operate manufacturing facilities for the production of clinical or commercial quantities of WIN378, WIN027 or any other potential future product candidates, and we lack the resources and the capabilities to do so. Our current strategy is to outsource all manufacturing of WIN378, WIN027 or any other potential future product candidates to third parties.

For WIN378, clinical supply of drug substance and drug product was manufactured by our licensor Kelun at its facilities in the PRC and we are in the process of transferring the manufacturing process to contract manufacturing organizations in the United States, which is expected to complete by the end of 2026. For WIN027, our licensor

 

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Qyuns is currently responsible for manufacturing clinical trial material, including drug product for our ongoing Phase 1 clinical trial, in the PRC. We plan to transfer the manufacturing process for WIN027 to the United States in the future, although this process has not yet begun and there can be no assurance as to the timing or terms on which such a transfer will be completed. We cannot guarantee that we will complete the manufacturing transfer in time or complete the manufacturing transfer successfully at all. We remain reliant on Kelun for WIN378 and Qyuns for WIN027, to the extent our manufacturing transfer process is underway, and any disruption to their operations—including failure to maintain compliance with current Good Manufacturing Practices, or cGMP, capacity constraints, regulatory findings, or early termination of our manufacturing agreement—could delay our clinical trials or, if WIN378 or WIN027 is approved, our ability to supply commercial quantities. We may incur added costs and delays in identifying, qualifying, and transitioning to another manufacturer.

In addition, we typically order raw materials, APIs and drug product and services on a purchase order basis and do not enter into long-term dedicated capacity or minimum supply arrangements with any commercial manufacturer. We may not be able to timely secure needed supply arrangements on satisfactory terms, or at all. Our failure to secure these arrangements as needed could have a material adverse effect on our ability to complete the development of WIN378, WIN027 or any other potential future product candidates or, to commercialize them, if approved. We may be unable to conclude agreements for commercial supply with third-party manufacturers or may be unable to do so on acceptable terms. There may be difficulties in scaling up to commercial quantities and formulation of WIN378, WIN027 or any other potential future product candidates, and the costs of manufacturing could be prohibitive.

If our manufacturers have difficulty or suffer delays in successfully manufacturing material that meets our specifications, it may limit supply of WIN378, WIN027 or any other potential future product candidates and could delay our clinical trials. We cannot assure you that similar or longer delays will not be necessary in the future.

Even if we are able to establish and maintain arrangements with third-party manufacturers, reliance on third-party manufacturers entails additional risks, including:

 

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the failure of the third-party manufacturer to comply with applicable regulatory requirements and reliance on third parties for manufacturing process development, regulatory compliance and quality assurance;

 

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manufacturing delays if our third-party manufacturers give greater priority to the supply of other products over WIN378, WIN027 or any other potential future product candidates or otherwise do not satisfactorily perform according to the terms of the agreement between us;

 

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limitations on supply availability resulting from capacity and scheduling constraints of third parties;

 

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the possible breach of manufacturing agreements by third parties because of factors beyond our control;

 

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the possible termination or non-renewal of the manufacturing agreements by the third party, at a time that is costly or inconvenient to us; and

 

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the possible misappropriation of our proprietary information, including our trade secrets and know-how.

If we are unable to maintain our key manufacturing relationships, we may fail to find replacement manufacturers or develop our own manufacturing capabilities, which could delay or impair our ability to obtain regulatory approval for WIN378, WIN027 or any other potential future product candidates. If we do find replacement manufacturers, we may not be able to enter into agreements with them on terms and conditions favorable to us and there could be a substantial delay before new facilities could be qualified and registered with the FDA and comparable foreign regulatory authorities.

Additionally, if any third-party manufacturer with whom we contract fails to perform its obligations, we may be forced to manufacture the materials ourselves, for which we may not have the capabilities or resources, or enter into an agreement with a different manufacturer. In either scenario, our clinical trials supply could be delayed significantly as we establish alternative supply sources. In some cases, the technical skills required to manufacture WIN378, WIN027 or any other potential future product candidates may be unique or proprietary to the original manufacturer and we may have difficulty, or there may be contractual restrictions prohibiting us from, transferring such skills to a back-up or alternate supplier, or we may be unable to transfer such skills at all. In addition, if we are required to change third-party manufacturers for any reason, we will be required to verify that the new manufacturer maintains

 

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facilities and procedures that comply with quality standards and with all applicable regulations. We will also need to verify, such as through a manufacturing comparability study, that any new manufacturing process will produce WIN378, WIN027 or any other potential future product candidates according to the specifications previously submitted to the FDA, the EMA and the European Commission, or another comparable foreign regulatory authority. We may be unsuccessful in demonstrating the comparability of clinical supplies, which could require the conduct of additional clinical trials. The delays associated with the verification of a new third-party manufacturer could negatively affect our ability to develop or commercialize WIN378, WIN027 or any other potential future product candidates in a timely manner or within budget. Furthermore, a third-party manufacturer may possess technology related to the manufacture of WIN378, WIN027 or any other potential future product candidates that such third party owns independently. This would increase our reliance on such third-party manufacturer or require us to obtain a license from such third-party manufacturer in order to have another third party manufacture WIN378, WIN027 or any other potential future product candidates.

If WIN378 or WIN027 is approved by any regulatory authority, we intend to utilize arrangements with third-party contract manufacturers for the commercial production of that product. This process is difficult and time consuming and we may face competition for access to manufacturing facilities as there are a limited number of contract manufacturers operating under cGMPs that are capable of manufacturing WIN378 and WIN027. Consequently, we may not be able to reach agreement with third-party manufacturers on satisfactory terms, which could delay our commercialization.

Our failure, or the failure of our third-party manufacturers, to comply with applicable regulations could result in sanctions being imposed on us, including shutdown of the third-party vendor or rejection of drug product lots or processes, clinical holds, fines, injunctions, civil penalties, delays, suspension, variation or withdrawal of approvals, license revocation, seizures or voluntary recalls of product candidates or drugs if approved, operating restrictions and criminal prosecutions, any of which could significantly affect supplies of WIN378, WIN027 or any other potential future product candidates. The facilities used by our contract manufacturers to manufacture WIN378, WIN027 or any other potential future product candidates must be evaluated by the FDA and comparable foreign regulatory authorities. We have limited control over the manufacturing process of, and are dependent on, our contract manufacturing partners for compliance with cGMPs. If our contract manufacturers cannot successfully manufacture material that conforms to our specifications and the strict regulatory requirements of the FDA, the European Union, or other comparable foreign regulatory authorities, we may not be able to secure and/or maintain regulatory approval for WIN378, WIN027 or any other potential future product candidates manufactured at these facilities. In addition, we have limited control over the ability of our contract manufacturers to maintain adequate quality control, quality assurance and qualified personnel. If the FDA or a comparable foreign regulatory authority finds deficiencies or does not approve these facilities for the manufacture of WIN378, WIN027 or any other potential future product candidates or if it withdraws any such approval in the future, we may need to find alternative manufacturing facilities, which would significantly impact our ability to develop, obtain regulatory approval for or market WIN378, WIN027 or any other potential future product candidates, if approved. Contract manufacturers may face manufacturing or quality control problems causing drug substance production and shipment delays or a situation where the contractor may not be able to maintain compliance with the applicable cGMP requirements. Any failure to comply with cGMP requirements or other FDA, European Union, and comparable foreign regulatory requirements could adversely affect our clinical research activities and our ability to develop, and if approved, market WIN378, WIN027 or any other potential future product candidates.

The FDA and comparable foreign regulatory authorities require manufacturers to register manufacturing facilities. The FDA and corresponding foreign regulators also inspect these facilities to confirm and monitor compliance with cGMPs.

If any third-party manufacturer of WIN378, WIN027 or any other potential future product candidates is unable to increase the scale of its production or the product yield of its manufacturing, then our manufacturing costs may increase and commercialization may be delayed.

In order to produce sufficient quantities to meet the demand for clinical trials and, if approved, subsequent commercialization of WIN378, WIN027 or any other potential future product candidates, our third-party manufacturers will be required to increase their production and optimize their manufacturing processes while maintaining the quality of WIN378, WIN027 or any other potential future product candidates. The transition to larger scale production could prove difficult. In addition, if our third-party manufacturers are not able to optimize

 

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their manufacturing processes to increase the product yield for WIN378, WIN027 or any other potential future product candidates, or if they are unable to produce increased amounts of WIN378, WIN027 or any other potential future product candidates while maintaining the same quality then we may not be able to meet the demands of clinical trials or market demands, which could decrease our ability to generate profits and have a material adverse impact on our business and results of operations.

Changes in methods of product candidate manufacturing or formulation may result in additional costs or delay.

As WIN378, WIN027 or any other potential future product candidates proceed through nonclinical studies to late-stage clinical trials towards potential approval and commercialization, it is common that various aspects of the development program, such as the vendors used to manufacture drug product or manufacturing methods and formulation, are altered along the way in an effort to optimize processes and results. Such changes carry the risk that they will not achieve these intended objectives. Any of these changes could cause WIN378, WIN027 or any other potential future product candidates to perform differently and affect the results of planned clinical trials or other future clinical trials conducted with the materials manufactured using altered processes. Such changes may also require additional testing, notification or approval by the FDA, or comparable foreign regulatory authorities. This could delay or prevent completion of clinical trials, require conducting bridging clinical trials or the repetition of one or more clinical trials, increase clinical trial costs, delay or prevent approval of WIN378, WIN027 or any other potential future product candidates and jeopardize our ability to commence sales and generate revenue.

Risks Related to Government Regulation

Obtaining and maintaining regulatory approval of WIN378, WIN027 or any other potential future product candidates in one jurisdiction does not mean that we will be successful in obtaining regulatory approval in other jurisdictions.

Obtaining and maintaining regulatory approval of WIN378, WIN027 or any other potential future product candidates in one jurisdiction does not guarantee that we will be able to obtain or maintain regulatory approval in any other jurisdiction, while a failure or delay in obtaining regulatory approval in one jurisdiction may have a negative effect on the regulatory approval process in others. For example, even if the FDA grants regulatory approval of a product candidate, the European Commission, or other comparable foreign regulatory authorities must also approve the manufacturing and marketing of the product candidate in those territories. Approval procedures vary among jurisdictions and can involve requirements and administrative review periods different from, and greater than, those in the United States, including additional nonclinical studies or clinical trials, as clinical trials conducted in one jurisdiction may not be accepted by regulatory authorities in other jurisdictions. In many jurisdictions outside the United States, a product candidate must be approved for reimbursement before it can be approved for sale in that jurisdiction. In some cases, the price that we intend to charge for our products is also subject to approval.

We may also submit marketing applications in other countries. Regulatory authorities in jurisdictions outside of the United States have requirements for approval of product candidates with which we must comply prior to marketing in those jurisdictions. Obtaining foreign regulatory approvals and compliance with foreign regulatory requirements could result in significant delays, difficulties and costs for us and could delay or prevent the introduction of our products in certain countries. If we fail to comply with the regulatory requirements in international markets and/or receive applicable regulatory approvals, our target market will be reduced and our ability to realize the full market potential of WIN378, WIN027 or any other potential future product candidates will be harmed.

Even if we receive regulatory approval of WIN378, WIN027 or any other potential future product candidates, we will be subject to ongoing regulatory obligations and continued regulatory review, which may result in significant additional expense and we may be subject to penalties if we fail to comply with regulatory requirements or experience unanticipated problems with WIN378, WIN027 or any other potential future product candidates.

If WIN378, WIN027 or any other potential future product candidates are approved, they will be subject to ongoing regulatory requirements for manufacturing, labeling, packaging, storage, advertising, promotion, sampling, record-keeping, conduct of post-marketing studies and submission of safety, efficacy and other post-market information, including both federal and state requirements in the United States and requirements of comparable foreign regulatory authorities. In addition, we will be subject to continued compliance with cGMP and GCP requirements for any clinical trials that we conduct post-approval.

Manufacturers and manufacturers’ facilities are required to comply with extensive FDA, European Union, and comparable foreign regulatory requirements, including ensuring that quality control and manufacturing procedures

 

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conform to cGMP regulations and applicable product tracking and tracing requirements. As such, we and our contract manufacturers will be subject to continual review and inspections to assess continuous compliance with cGMP and adherence to commitments made in any BLA, other marketing application and previous responses to inspection observations. Accordingly, we and others with whom we work must continue to expend time, money and effort in all areas of regulatory compliance, including manufacturing, production and quality control.

Any regulatory approvals that we receive for WIN378, WIN027 or any other potential future product candidates may be subject to limitations on the approved indicated uses for which the product may be marketed or to the conditions of approval, or contain requirements for potentially costly post-marketing testing, including Phase 4 clinical trials and surveillance to monitor the safety and efficacy of the product candidate. In addition, if the FDA, the European Commission, or a comparable foreign regulatory authority approves WIN378, WIN027 or any other potential future product candidates, we will have to comply with requirements including submissions of safety and other post-marketing information and reports and registration.

The FDA or comparable foreign regulatory authorities may impose consent decrees or withdraw or vary approval if compliance with regulatory requirements and standards is not maintained or if problems occur after the product reaches the market. Later discovery of previously unknown problems with WIN378, WIN027 or any other potential future product candidates, including adverse events of unanticipated severity or frequency, or with our third-party manufacturers or manufacturing processes, or failure to comply with regulatory requirements, may result in revisions to the approved labeling to add new safety information, imposition of post-market studies or clinical trials to assess new safety risks or imposition of distribution restrictions. Other potential consequences include, among other things:

 

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restrictions on the marketing or manufacturing of our products, withdrawal of the product from the market or voluntary product recalls;

 

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restrictions on product distribution or use, or requirements to conduct post-marketing studies or clinical trials;

 

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fines, warning letters or holds on clinical trials;

 

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refusal by the FDA or comparable foreign regulatory authorities to approve pending applications or supplements to approved applications filed by us or suspension, variation or withdrawal of approvals;

 

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product seizure or detention or refusal to permit the import or export of WIN378, WIN027 or any other potential future product candidates;

 

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total or partial suspension of production, distribution, manufacturing or clinical trials;

 

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operating restrictions;

 

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suspension of licenses; and

 

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injunctions, fines or the imposition of civil or criminal penalties.

Additionally, the FDA and comparable foreign regulatory authorities strictly regulate marketing, labeling, advertising and promotion of products that are placed on the market. Products may be promoted only for the approved indications and in accordance with the provisions of the approved label.

The policies of the FDA, the EMA, and the European Commission, and comparable foreign regulatory authorities may change and additional government regulations may be enacted that could prevent, limit or delay regulatory approval of WIN378, WIN027 or any other potential future product candidates. We cannot predict the likelihood, nature or extent of government regulation that may arise from future legislation or administrative action, either in the United States or abroad. For more information, see the section titled “Business—Government Regulation” included elsewhere in this prospectus.

If we are slow or unable to adapt to changes in existing requirements or the adoption of new requirements or policies, or if we are not able to maintain regulatory compliance, we may lose any regulatory approval that we may have obtained and we may not achieve or sustain profitability.

Additional time may be required to obtain marketing authorizations for any product candidates that we develop as biologic-device combination products.

We expect our current injectable product candidates will be regulated as combination products, as we are developing our products candidates to be administered using a disposable injector device (e.g., a pre-filled syringe or

 

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autoinjector) marketed together with the product candidate, if approved. Development of a product candidate as a combination product candidate requires close coordination within the FDA and within comparable regulatory agencies for review of each of the biologic and device components that comprise the product and would typically be reviewed by different centers within the FDA if offered for use as standalone products. For example, the FDA’s review of a marketing application for a biologic-device combination that has a primary mode of action as a biologic would likely be subject to a BLA with the Center for Biologics Evaluation and Research as the lead center, with coordination with the Center for Devices and Radiological Health for the review of the device component. Although the FDA and comparable foreign agencies have or may have systems in place for the review and approval of such combination products, we may experience additional delays in the development and commercialization of such product candidates due to regulatory timing constraints and uncertainties in the product development and approval process. Furthermore, regulatory bodies like the FDA may require a human factors study, sometimes also known as a usability study, to evaluate how people interact with biologic-device combination products in real-world settings to ensure they can be used safely and effectively, and the requirement to conduct a human factors study may delay or prevent approval of a biologic-device combination product. Moreover, although we anticipate that the device component of any combination product candidates we develop will be reviewed within the usual time frames expected for the marketing authorization application for the underlying product candidate, and that no separate marketing application for the device components of such product candidates will be required in the United States, the FDA or comparable regulatory authorities may delay approval or require us to conduct additional studies with the device, which may delay the approval of the combination product.

WIN378, WIN027 or any other potential future product candidates for which we intend to seek approval as biological products may face competition sooner than anticipated, which may adversely affect our pricing, market share and revenues.

The Biologics Price Competition and Innovation Act of 2009, or the BPCIA, created an abbreviated approval pathway for biological products that are biosimilar to or interchangeable with an FDA-licensed reference biological product. Under the BPCIA, an application for a biosimilar product may not be submitted to the FDA until four years following the date that the reference product was first licensed by the FDA. In addition, the approval of a biosimilar product may not be made effective by the FDA until 12 years from the date on which the reference product was first licensed. During this 12-year period of exclusivity, another company may still market a competing version of the reference product if the FDA approves a full BLA for the competing product containing the sponsor’s own nonclinical data and data from adequate and well-controlled clinical trials to demonstrate the safety, purity and potency of its product.

We believe any of our potential future product candidates approved as a biological product under a BLA should qualify for the 12-year period of exclusivity. However, there is a risk that this exclusivity could be shortened due to Congressional action or otherwise, or that the FDA will not consider WIN378, WIN027 or any other potential future product candidates to be reference products for competing products, potentially creating the opportunity for biosimilar competition sooner than anticipated. Moreover, the extent to which a biosimilar, once approved, could be substituted for any one of our reference products in a way that is similar to traditional generic substitution for non-biological products will depend on a number of marketplace and regulatory factors that are still developing.

In the European Union, there is a special regime for biosimilars, or biological medicinal products that are similar to a reference medicinal product but that do not meet the definition of a generic medicinal product. For such products, the results of appropriate nonclinical or clinical trials must be provided in support of an application. Guidelines from the EMA detail the type and quantity of supplementary data to be provided for different types of biological product. In the European Union, new products authorized for marketing generally receive eight years of data exclusivity and an additional two years of market exclusivity upon marketing authorization. The overall ten-year market exclusivity period can be extended to a maximum of eleven years if, during the first eight years, the marketing authorization holder obtains an authorization for one or more new therapeutic indications which are held to bring a significant clinical benefit in comparison with existing therapies. However, as described below, the EU pharmaceutical reforms reduce these data and market exclusivity periods, potentially enabling biosimilar competition earlier than is currently the case.

In addition to the risk associated with biosimilars of our product candidates, the launch of biosimilars to products that compete with our product candidates may intensify competition in the therapeutic areas we target by lowering the overall price point and expanding access to alternative treatments. As these lower-cost biosimilars gain market share, payors may preferentially encourage their use or impose access restrictions that make it more difficult for our

 

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product candidates to obtain favorable coverage, reimbursement or formulary placement. These dynamics could materially limit our market opportunity and adversely affect our commercial prospects.

Our relationships with healthcare professionals and physicians and third-party payors will be subject to applicable anti-kickback, fraud and abuse and other healthcare laws and regulations, which could expose us to criminal sanctions, civil penalties, contractual damages, reputational harm and diminished profits and future earnings.

It is possible that governmental and enforcement authorities will conclude that our business practices may not comply with current or future statutes, regulations or case law interpreting applicable fraud and abuse or other healthcare laws and regulations. Healthcare professionals, physicians and third-party payors in the United States and elsewhere play a primary role in the recommendation and prescription of pharmaceutical products. Arrangements with third-party payors and customers can expose pharmaceutical manufacturers to broadly applicable fraud and abuse and other healthcare laws and regulations that may constrain the business or financial arrangements and relationships through which we conduct research and would sell, market and distribute our products. As a pharmaceutical company, even though we do not and will not bill directly to Medicare, Medicaid or other third-party payors, supranational, national, federal and state healthcare laws and regulations that may affect our ability to operate may apply. For more information on healthcare laws and regulations that may impact us, see the section titled “Business—Government Regulation—Other Healthcare Laws” included elsewhere in this prospectus.

The scope and enforcement of each of these laws is uncertain and subject to rapid change in the current environment of healthcare reform, especially in light of the lack of applicable precedent and regulations. Federal and state enforcement bodies have recently increased their scrutiny of interactions between healthcare companies and healthcare professionals, which has led to a number of investigations, prosecutions, convictions and settlements in the healthcare industry. Ensuring business arrangements comply with applicable healthcare and privacy laws, as well as responding to possible investigations by government authorities, can be time and resource-consuming and can divert a company’s attention from the business.

Ensuring that our internal operations and future business arrangements with third parties comply with applicable healthcare laws and regulations will involve substantial costs. It is possible that governmental authorities will conclude that our business practices do not comply with current or future statutes, regulations, agency or other competent authority guidance or case law involving applicable fraud and abuse or other healthcare laws and regulations. If our operations are found to be in violation of any of these laws or any other governmental laws and regulations that may apply to us, we may be subject to significant penalties, including administrative, civil and criminal penalties, damages, fines, disgorgement, the exclusion from participation in federal and state healthcare programs, individual imprisonment, reputational harm and the curtailment or restructuring of our operations, as well as additional reporting obligations and oversight if we become subject to a corporate integrity agreement or other agreement to resolve allegations of non-compliance with these laws. Further, defending against any such actions can be costly and time consuming, and may require significant financial and personnel resources. Therefore, even if we are successful in defending against any such actions that may be brought against us, our business may be impaired. If any of the physicians or other professionals or entities with whom we expect to do business is found to not be in compliance with applicable laws, they may be subject to criminal, civil or administrative sanctions, including exclusions from government funded healthcare programs and imprisonment. If any of the above occur, our ability to operate our business and our results of operations could be adversely affected.

Coverage and reimbursement may be limited or unavailable in certain market segments for WIN378, WIN027 or any other potential future product candidates, if approved, which could make it difficult for us to sell them profitably.

The success of WIN378, WIN027 or any other potential future product candidates, if approved, depends on the availability of coverage and adequate reimbursement from third-party payors. Patients who are provided medical treatment for their conditions generally rely on third-party payors to reimburse all or part of the costs associated with their treatment. Coverage and adequate reimbursement from governmental healthcare programs, such as Medicare and Medicaid, and commercial payors is critical to new product acceptance.

Government authorities and other third-party payors, such as private health insurers and health maintenance organizations, decide which drugs and treatments they will cover and the amount of reimbursement. Coverage and

 

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reimbursement by a third-party payor may depend upon a number of factors, including the third-party payor’s determination that use of a product is:

 

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a covered benefit under its health plan;

 

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safe, effective and medically necessary;

 

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appropriate for the specific patient;

 

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cost-effective; and

 

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neither experimental nor investigational.

In the United States, no uniform policy of coverage and reimbursement for products exists among third-party payors, and decisions about reimbursement for new medicines from commercial payors are substantially influenced by the Centers for Medicare & Medicaid Services, or CMS, which decides whether and to what extent a new medicine will be covered and reimbursed under Medicare. Even if we obtain coverage for a given product, the resulting reimbursement payment rates might not be adequate for us to achieve or sustain profitability or may require co-payments that patients find unacceptably high. Additionally, third-party payors may not cover, or provide adequate reimbursement for, long-term follow-up evaluations required following the use of product candidates, once approved. It is difficult to predict at this time what third-party payors will decide with respect to the coverage and reimbursement for WIN378, WIN027 or any other potential future product candidates. Even if we do receive a favorable coverage determination for our products by third-party payors, coverage policies and third-party payor reimbursement rates may change at any time.

Net prices for drugs may be reduced by mandatory discounts or rebates required by government healthcare programs or private payors and by any future relaxation of laws that presently restrict imports of drugs from countries where they may be sold at lower prices than in the United States. Increasingly, third-party payors are requiring that drug companies provide them with predetermined discounts from list prices and are challenging the prices charged for medical products. We cannot be sure that reimbursement will be available for WIN378, WIN027 or any other potential future product candidates that we commercialize and, if reimbursement is available, the level of reimbursement. In addition, many pharmaceutical manufacturers must calculate and report certain price reporting metrics to the government, such as average sales price and best price. Penalties may apply in some cases when such metrics are not submitted accurately and timely. Further, these prices for drugs may be reduced by mandatory discounts or rebates required by government healthcare programs. Payment methodologies may be subject to changes in healthcare legislation and regulatory initiatives.

Moreover, increasing efforts by governmental and other third-party payors in the United States and abroad to cap or reduce healthcare costs may cause such organizations to limit both coverage and the level of reimbursement for newly approved products and, as a result, they may not cover or provide adequate payment for WIN378, WIN027 or any other potential future product candidates. There has been increasing legislative and enforcement interest in the United States with respect to specialty drug pricing practices. Specifically, there have been several recent U.S. Congressional inquiries and proposed and enacted federal and state legislation designed to, among other things, bring more transparency to drug pricing, reduce the cost of prescription drugs under Medicare, review the relationship between pricing and manufacturer patient programs and reform government program reimbursement methodologies for drugs. Further, the U.S. Department of Health and Human Services, or HHS, imposes rebates on many Medicare Part B and Medicare Part D products to penalize price increases that outpace inflation. HHS has also been empowered to negotiate the price of certain single-source biologics that have been on the market for at least 11 years covered under Medicare as part of the Medicare Drug Price Negotiation Program. Each year up to 20 products will be selected by HHS for the Medicare Drug Price Negotiation Program. Products subject to the Medicare Drug Price Negotiation Program are expected to experience a significant reduction in reimbursement from the Medicare program on a per unit basis. At the state level, legislatures have increasingly passed legislation and implemented regulations designed to control pharmaceutical and biological product pricing, including price or patient reimbursement constraints, discounts, restrictions on certain product access and marketing cost disclosure and transparency measures, and, in some cases, designed to encourage importation from other countries and bulk purchasing. For example, on June 15, 2026, the FDA approved Colorado’s Section 804 Importation Program proposal to import certain drugs from Canada for specific state healthcare programs. It is unclear how this and

 

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Florida’s similar program, approved by the FDA in 2024, will be implemented and whether they will overcome potential legal, regulatory, or industry challenges in the United States and/or Canada.

We expect that healthcare reform measures that may be adopted in the future may result in more rigorous coverage criteria and in additional downward pressure on the price that we receive for any approved product. The implementation of cost containment measures or other healthcare reforms may prevent us from being able to generate revenue, attain profitability, or commercialize our products. Legislative and regulatory proposals have been made to expand post-approval requirements and restrict sales and promotional activities for pharmaceutical products. We cannot be sure whether additional legislative changes will be enacted, or whether the FDA regulations, guidance or interpretations will be changed, or what the impact of such changes on the regulatory approvals of WIN378, WIN027 or any other potential future product candidates, if any, may be.

In addition, in some foreign countries, the proposed pricing for a product must be approved before it may be lawfully marketed. The requirements governing product pricing vary widely from country to country. For example, the European Union provides options for its Member States to restrict the range of medicinal products for which their national health insurance systems provide reimbursement and to control the prices of medicinal products for human use. To obtain reimbursement or pricing approval, some of these countries may require the completion of clinical trials that compare the cost effectiveness of a particular product candidate to currently available therapies. A Member State may approve a specific price for the medicinal product or it may instead adopt a system of direct or indirect controls on the profitability of the company placing the medicinal product on the market. There can be no assurance that any country that has price controls or reimbursement limitations for pharmaceutical products will allow favorable reimbursement and pricing arrangements for WIN378, WIN027 or any other potential future product candidates. Historically, products launched in the European Union do not follow price structures of the United States and generally prices tend to be significantly lower.

For more information on the laws and regulations that may impact coverage and reimbursement of WIN378, WIN027 or any other potential future product candidates, see the section titled “Business—Government Regulation—Coverage and Reimbursement” included elsewhere in this prospectus.

Ongoing healthcare legislative and regulatory reform measures may have a material adverse effect on our business and results of operations.

Changes in regulations, statutes or the interpretation of existing regulations could impact our business in the future by requiring, for example, (1) changes to our manufacturing arrangements, (2) additions or modifications to product labeling, (3) the recall or discontinuation of our products or (4) additional record-keeping requirements. If any such changes were to be imposed, they could adversely affect the operation of our business. See the sections titled “Business—Government Regulation—Coverage and Reimbursement” and “—Healthcare Reform” included elsewhere in this prospectus.

The containment of healthcare costs has become a priority of federal, state and foreign governments, and the prices of products have been a focus in this effort. There have been a number of federal and state proposals during the last few years regarding the pricing of pharmaceutical products, limiting coverage and the amount of reimbursement for drugs and other medical products, government control and other changes to the healthcare system in the United States. Governments have shown significant interest in implementing cost-containment programs, including price controls, restrictions on reimbursement and requirements for substitution of generic products. Adoption of price controls and cost-containment measures, and adoption of more restrictive policies in jurisdictions with existing controls and measures, could further limit our revenue generated from the sale of any approved products.

Moreover, payment methodologies may be subject to changes in healthcare legislation and regulatory initiatives. For example, CMS may develop new payment and delivery models, such as bundled payment models. In addition, recently there has been heightened governmental scrutiny over the manner in which manufacturers set prices for their commercial products, which has resulted in several Congressional inquiries and proposed and enacted state and federal legislation designed to, among other things, bring more transparency to product pricing, review the relationship between pricing and manufacturer patient programs, and reform government program reimbursement methodologies for pharmaceutical products. Congress has indicated that it will continue to seek new legislative measures to control drug costs.

 

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The current administration is pursuing policies to reduce regulations and expenditures across government agencies including at HHS, the FDA, CMS and related agencies. These actions, presently directed by executive orders or memoranda from the Office of Management and Budget, may propose policy changes that create additional uncertainty for our business. For example, the current administration has announced agreements with certain pharmaceutical companies that require the drug manufacturers to offer, through a direct to consumer platform, or TrumpRx, U.S. patients and Medicaid programs prescription drug Most-Favored Nation pricing equal to or lower than those paid in other developed nations, with additional mandates for direct-to-patient discounts and repatriation of foreign revenues. Other recent actions, for example, include (1) directing agencies to reduce agency workforce and cut programs; (2) directing HHS and other agencies to lower prescription drug costs through a variety of initiatives; (3) imposing tariffs on certain imported pharmaceutical products; and (4) as part of the Make America Healthy Again, or MAHA, Commission’s Strategy Report released in September 2025, working across government agencies to increase enforcement on direct-to-consumer pharmaceutical advertising. Additionally, the current administration recently called on Congress to enact “The Great Healthcare Plan,” to codify and expand Most-Favored Nation pricing, lower government subsidies to private insurance companies, increase healthcare price transparency, expand pharmaceutical drugs available for over-the-counter purchase, and enact restrictions on pharmacy benefit manager, or PBM, payment methodologies, among other things. These actions and policies may significantly reduce U.S. drug prices, potentially impacting manufacturers’ global pricing strategies and profitability, while increasing their operational costs and compliance risks. In June 2024, the U.S. Supreme Court’s Loper Bright decision greatly reduced judicial deference to regulatory agencies, which could increase successful legal challenges to federal regulations affecting our operations. Congress may introduce and ultimately pass health care related legislation that could impact the drug approval process and make changes to the Medicare Drug Price Negotiation Program.

In December 2021, Regulation No 2021/2282 on Health Technology Assessment, or HTA, amending Directive 2011/24/EU, was adopted in the EU. This Regulation entered into force in January 2022 and has been applicable since January 2025 with phased implementation based on the type of product, i.e. oncology and advanced therapy medicinal products as of 2025, orphan medicinal products as of 2028, and all other medicinal products by 2030. The Regulation intends to boost cooperation among EU Member States in assessing health technologies, including new medicinal products, and provide the basis for cooperation at EU level for joint clinical assessments in these areas. The Regulation foresees a three-year transitional period and will permit EU Member States to use common HTA tools, methodologies, and procedures across the EU, working together in four main areas, including joint clinical assessment of the innovative health technologies with the most potential impact for patients, joint scientific consultations whereby developers can seek advice from HTA authorities, identification of emerging health technologies to identify promising technologies early, and continuing voluntary cooperation in other areas. Individual EU Member States will continue to be responsible for assessing non-clinical (e.g., economic, social, ethical) aspects of health technologies, and making decisions on pricing and reimbursement.

In addition, the EU pharmaceutical legislation has been undergoing a complete review process, in the context of the Pharmaceutical Strategy for Europe initiative, launched by the European Commission in November 2020. The European Commission’s proposal for revision of several legislative instruments related to medicinal products was published on April 26, 2023. The proposed changes were since discussed and negotiated by the European Parliament and the Council of the EU as part of the EU ordinary legislative process. A provisional agreement has been reached by the European Parliament and Council of the EU on the proposed revisions on December 11, 2025. Following endorsement of the compromise texts by the Council’s Committee of Permanent Representatives, or COREPER, and approval by the European Parliament’s Committee on Public Health, or SANT, in March 2026, the proposed revisions (affecting the duration of regulatory data protection and market protection, including for orphan medicinal products, revising the eligibility for expedited pathways, etc.) must now be formally adopted by the Council of the EU and the European Parliament in plenary, currently anticipated by fall 2026. The proposed changes are not expected to become applicable before the fourth quarter of 2028 but may, however, have a significant impact on the pharmaceutical industry and our business in the long term.

These laws, and future supranational, national state and federal healthcare reform measures may be adopted in the future, any of which may result in additional reductions in Medicare and other healthcare funding and otherwise affect the prices we may obtain for WIN378, WIN027 or any other potential future product candidates for which we may obtain regulatory approval or the frequency with which any such product candidate is prescribed or used.

 

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Our employees, independent contractors, consultants, and vendors may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements.

We are exposed to the risk of employee fraud or other illegal activity by our current and any future employees, independent contractors, consultants, contract manufacturing organizations, CROs and vendors. Misconduct by these parties could include intentional, reckless, and/or negligent conduct that fails to comply with FDA or other regulations, provide true, complete and accurate information to the FDA, the national competent authorities of individual EU Member States, and other comparable foreign regulatory authorities, comply with manufacturing standards we may establish, comply with healthcare fraud and abuse laws and regulations, report financial information or data accurately, or disclose unauthorized activities to us. If we obtain FDA approval of WIN378, WIN027 or any other potential future product candidates and begin commercializing those products in the United States, our potential exposure under these laws will increase significantly, and our costs associated with compliance with these laws are likely to increase. Employee misconduct could also involve the improper use of information obtained in the course of clinical trials, which could result in regulatory sanctions and serious harm to our reputation. Additionally, we are subject to the risk that a person could allege such fraud or other misconduct, even if none occurred. It is not always possible to identify and deter employee misconduct, and the precautions we take to detect and prevent this activity may not be effective in controlling unknown or unmanaged risks or losses or in protecting us from governmental investigations or other actions or lawsuits stemming from a failure to comply with such laws or regulations. If any such actions are instituted against us, and we are not successful in defending ourselves or asserting our rights, those actions could have a material and adverse effect on our business, financial condition, results of operations and growth prospects.

Off-label use or misuse of WIN378, WIN027 or any other potential future product candidates may harm our reputation in the marketplace or result in injuries that lead to costly product liability suits.

If WIN378, WIN027 or any other potential future product candidates are approved by the FDA, we may only promote or market them in a manner consistent with their FDA-approved labeling. The FDA strictly regulates marketing, labeling, advertising and promotion of prescription drugs. We will train our marketing and sales force against promoting WIN378, WIN027 or any other potential future product candidates for uses outside of the approved indications for use, known as “off-label uses.” We cannot, however, prevent a physician from engaging in off-label use of WIN378, WIN027 or any other potential future product candidates, when in the physician’s independent professional medical judgment he or she deems it appropriate. Furthermore, the use of WIN378, WIN027 or any other potential future product candidates for indications other than those approved by the FDA may not effectively treat such conditions. Any such off-label use of WIN378, WIN027 or any other potential future product candidates could harm our reputation in the marketplace among physicians and patients. There may also be increased risk of injury to patients if physicians attempt to use WIN378, WIN027 or any other potential future product candidates for these uses for which they are not approved, which could lead to product liability suits that might require significant financial and management resources and that could harm our reputation. Similar requirements and considerations apply abroad.

If we are found to have promoted such off-label uses, we may become subject to significant liability. The U.S. federal government has levied large civil and criminal fines against companies for alleged improper promotion of off-label use and has enjoined several companies from engaging in off-label promotion. The FDA has also requested that companies enter into consent decrees or permanent injunctions under which specified promotional conduct is changed or curtailed. If we cannot successfully manage the promotion any product candidates, if approved, we could become subject to significant liability, which would materially adversely affect our business and financial condition.

If product liability lawsuits are brought against us, we may incur substantial liabilities and may be required to limit, delay or cease commercialization of our products.

We face an inherent risk of product liability as a result of the clinical trials of WIN378, WIN027 or any future product candidates and will face an even greater risk if we commercialize WIN378, WIN027 or any future product candidates, if approved. For example, we may be sued if WIN378, WIN027 or any future product candidates allegedly cause injury or are found to be otherwise unsuitable during product testing, manufacturing, marketing or sale. Any such product liability claims may include allegations of defects in manufacturing, defects in design, a failure to warn of dangers inherent in the product candidate, negligence, strict liability and a breach of warranties. Claims may be brought against us by clinical trial participants, patients or others using, administering or selling products that may be approved in the future. Claims could also be asserted under state consumer protection acts.

 

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If we cannot successfully defend ourselves against product liability claims, we may incur substantial liabilities or be required to limit, delay or cease the commercialization of our products. Even a successful defense would require significant financial and management resources. Regardless of the merits or eventual outcome, liability claims may result in:

 

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decreased demand for our product candidates;

 

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injury to our reputation and significant negative media attention;

 

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withdrawal of clinical trial participants;

 

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costs to defend the related litigation;

 

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a diversion of our management’s time and our resources;

 

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substantial monetary awards to trial participants or product recipients;

 

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product recalls, withdrawals or labeling, marketing or promotional restrictions;

 

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significant negative financial impact;

 

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the inability to commercialize WIN378, WIN027 or any future product candidate; and

 

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a decline in our share price.

We currently hold approximately $10.0 million in product liability insurance coverage in the aggregate. We may need to increase our insurance coverage as we expand our clinical trials or if we commence commercialization of WIN378, WIN027 or any future product candidates. Insurance coverage is increasingly expensive. Our inability to obtain and retain sufficient product liability insurance at an acceptable cost to protect against potential product liability claims could prevent or inhibit the commercialization of WIN378, WIN027 or any future product candidates. Although we will maintain such insurance, any claim that may be brought against us could result in a court judgment or settlement in an amount that is not covered, in whole or in part, by our insurance or that is in excess of the limits of our insurance coverage. Our insurance policies will also have various exclusions, and we may be subject to a product liability claim for which we have no coverage. We may have to pay any amounts awarded by a court or negotiated in a settlement that exceed our coverage limitations or that are not covered by our insurance, and we may not have, or be able to obtain, sufficient capital to pay such amounts.

Inadequate funding for the FDA, other government agencies or comparable foreign regulatory authorities could hinder their ability to hire and retain key leadership and other personnel, prevent new products and services from being developed or commercialized in a timely manner or otherwise prevent those agencies from performing normal business functions on which the operation of our business may rely, which could negatively impact our business.

The ability of the FDA or comparable foreign regulatory authorities to review and approve new products can be affected by a variety of factors, including government budget and funding levels, ability to hire and retain key personnel and accept the payment of user fees, and statutory, regulatory, and policy changes. Average review times at the agency have fluctuated in recent years as a result. In addition, government funding of other government agencies or comparable foreign regulatory authorities on which our operations may rely, including those that fund research and development activities, is subject to the political process, which is inherently fluid and unpredictable.

Disruptions at the FDA, other government agencies or comparable foreign regulatory authorities may also slow the time necessary for new drugs to be reviewed and/or approved by necessary government agencies, which would adversely affect our business. For example, over the last several years, the U.S. government has shut down several times and certain regulatory agencies, such as the FDA, have had to furlough critical employees and stop critical activities. Additionally, the current U.S. presidential administration has issued certain policies and Executive Orders directed towards reducing the employee headcount and costs associated with administrative agencies, including the FDA, which have led to substantial personnel changes, and it remains unclear the degree to which these efforts or the resulting changes in FDA personnel may limit or otherwise adversely affect the FDA’s ability to conduct routine activities. If a prolonged government shutdown occurs, including as a result of reaching the debt ceiling, or if funding shortages or staffing limitations hinder or prevent the FDA or other regulatory authorities from conducting their regular inspections, reviews, or other regulatory activities, it could significantly impact the ability of the FDA to timely review and process our regulatory submissions, which could have a material adverse effect on our business. Further, future government shutdowns could impact our ability to access the public markets and obtain necessary capital in order to properly capitalize and continue our operations.

 

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EU drug marketing and reimbursement regulations may materially affect our ability to market and receive coverage for our products in the EU Member States.

We intend to seek approval to market WIN378, WIN027 or any other potential future product candidates in both the United States and in selected foreign jurisdictions. If we obtain approval in one or more foreign jurisdictions for WIN378, WIN027 or any other potential future product candidates, we will be subject to rules and regulations in those jurisdictions. In some foreign countries, particularly those in the European Union, the pricing of products is subject to governmental control and other market regulations which could put pressure on the pricing and usage of WIN378, WIN027 or any other potential future product candidates. In these countries, pricing negotiations with governmental authorities can take considerable time after obtaining regulatory approval of a product candidate. In addition, market acceptance and sales of WIN378, WIN027 or any other potential future product candidates will depend significantly on the availability of adequate coverage and reimbursement from third-party payors for them and may be affected by existing and future healthcare reform measures.

Much like the federal Anti-Kickback Statute prohibition in the United States, the provision of benefits or advantages to physicians and other healthcare professionals to induce or encourage the prescription, recommendation, endorsement, purchase, supply, order or use of medicinal products is also prohibited in the European Union. Interactions between pharmaceutical companies and healthcare professionals, including the provision of benefits or advantages, are governed by strict laws, such as national anti-bribery laws of individual EU Member States and the Bribery Act 2010 in the United Kingdom, national sunshine rules, regulations, industry self-regulation codes of conduct and physicians’ codes of professional conduct. Failure to comply with these requirements could result in reputational risk, public reprimands, administrative penalties, fines or imprisonment. Infringement of these laws could result in substantial fines and imprisonment.

Payments made to physicians and other healthcare professionals in certain EU Member States must be publicly disclosed. Moreover, agreements with physicians often may require prior notification or approval by the healthcare professional’s employer, his or her competent professional organization and/or the regulatory authorities of the individual EU Member States. Failure to comply with these requirements could result in reputational risk, public reprimands, administrative penalties, fines or imprisonment.

In addition, in some foreign countries, including some countries in the European Union, the proposed pricing for a product must be approved before it may be lawfully marketed. The requirements governing product pricing and reimbursement vary widely from country to country. The European Union provides options for its Member States to restrict the range of medicinal products for which their national health insurance systems provide reimbursement and to control the prices of medicinal products for human use. An EU Member State may approve a specific price for the medicinal product, it may refuse to reimburse a product at the price set by the manufacturer or it may instead adopt a system of direct or indirect controls on the profitability of the company placing the medicinal product on the market. Many EU Member States also periodically review their reimbursement procedures for medicinal products, which could have an adverse impact on reimbursement status. We expect that legislators, policymakers and healthcare insurance funds in the individual EU Member States will continue to propose and implement cost-containing measures, such as lower maximum prices, lower or lack of reimbursement coverage and incentives to use cheaper, usually generic, products as an alternative to branded products, and/or branded products available through parallel import to keep healthcare costs down. Moreover, in order to obtain reimbursement for our products in some European countries, including some EU Member States, we may be required to compile additional data comparing the cost-effectiveness of our products to other available therapies. This HTA of medicinal products is becoming an increasingly common part of the pricing and reimbursement procedures in some EU Member States, including those representing the larger markets. The HTA process is the procedure to assess therapeutic, economic and societal impact of a given medicinal product in the national healthcare systems of the individual country. The outcome of an HTA will often influence the pricing and reimbursement status granted to these medicinal products by the competent authorities of individual EU Member States. The extent to which pricing and reimbursement decisions are influenced by the HTA of the specific medicinal product currently varies between EU Member States. Reference pricing used by various EU Member States and parallel distribution, or arbitrage between low-priced and high-priced EU Member States, can further reduce prices. There can be no assurance that any country that has price controls or reimbursement limitations for biopharmaceutical products will allow favorable reimbursement and pricing arrangements for any of our products. Historically, products launched in the European Union do not follow price

 

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structures of the United States and generally prices tend to be significantly lower. Publication of discounts by third-party payors or authorities may lead to further pressure on the prices or reimbursement levels within the country of publication and other countries. If pricing is set at unsatisfactory levels or if reimbursement of our products is unavailable or limited in scope or amount, our revenues from sales and the potential profitability of WIN378, WIN027 or any other potential future product candidates in those countries would be negatively affected.

We are subject to export and import controls, economic sanctions, and anti-corruption laws and regulations of the United States and other jurisdictions. We can face criminal liability and other serious consequences for violations of these laws and regulations, which can harm our business.

We are subject to export control and import laws and regulations, including the U.S. Export Administration Regulations, U.S. Customs regulations, and various economic and trade sanctions regulations administered by the U.S. Treasury Department’s Office of Foreign Assets Control. Export controls and trade sanctions laws and regulations may restrict or prohibit altogether the provision, sale, or supply of our products to certain governments, persons, entities, countries, and territories, including those that are the target of comprehensive sanctions or an embargo. We are also subject to anti-corruption and anti-bribery laws, including the U.S. Foreign Corrupt Practices Act of 1977, as amended, the U.S. domestic bribery statute contained in 18 U.S.C. § 201, the U.S. Travel Act, and other state and national anti-bribery laws in the countries in which we conduct activities. Anti-corruption laws are interpreted broadly and prohibit companies and their employees, agents, contractors, and other collaborators from authorizing, promising, offering, or providing, directly or indirectly, improper payments or anything else of value to recipients in the public or private sector. The FCPA also requires public companies to make and keep books and records that accurately and fairly reflect the transactions of the corporation and to devise and maintain an adequate system of internal accounting controls. We can be held liable for the corrupt or other illegal activities of our employees, agents, contractors, and other collaborators, even if we do not explicitly authorize or have actual knowledge of such activities. Any violation of the laws and regulations described above may result in substantial civil and criminal fines and penalties, imprisonment, the loss of export or import privileges, debarment, tax reassessments, breach of contract and fraud litigation, reputational harm, and other consequences.

If we or any third-party manufacturer we engage now or in the future fail to comply with environmental, health and safety laws and regulations, we could become subject to fines or penalties or incur costs or liabilities that could have a material adverse effect on our business.

We and third-party manufacturers we engage now are, and any third-party manufacturer we may engage in the future will be, subject to numerous environmental, health and safety laws and regulations, including those governing laboratory procedures and the handling, use, storage, treatment and disposal of hazardous materials and wastes. Our operations involve the use of hazardous and flammable materials, including chemicals and biological materials. Our operations also produce hazardous waste products. We generally contract with third parties for the disposal of these materials and wastes. We cannot eliminate the risk of contamination or injury from these materials. In the event of contamination or injury resulting from our use of hazardous materials, we could be held liable for any resulting damages, and any liability could exceed our resources. We also could incur significant costs associated with civil or criminal fines and penalties.

Although we maintain general liability insurance as well as workers’ compensation insurance to cover us for costs and expenses we may incur due to injuries to our employees resulting from the use of hazardous materials, this insurance may not provide adequate coverage against potential liabilities. We do not maintain insurance for environmental liability or toxic tort claims that may be asserted against us in connection with our storage or disposal of biological, hazardous or radioactive materials.

In addition, we may incur substantial costs in order to comply with current or future environmental, health and safety laws and regulations. These current or future laws and regulations may impair our research, development or commercialization efforts. Failure to comply with these laws and regulations also may result in substantial fines, penalties or other sanctions.

Further, with respect to the operations of our current and any future third-party contract manufacturers, it is possible that if they fail to operate in compliance with applicable environmental, health and safety laws and regulations or properly dispose of wastes associated with our products, we could be held liable for any resulting damages, suffer reputational harm or experience a disruption in the manufacture and supply of WIN378, WIN027 or any other

 

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potential future product candidates. In addition, our supply chain may be adversely impacted if any of our third-party contract manufacturers become subject to injunctions or other sanctions as a result of their non-compliance with environmental, health and safety laws and regulations.

Risks Related to Our Intellectual Property

Our success is largely based upon our intellectual property and proprietary technologies, and we may be unable to protect and/or enforce our intellectual property.

Our success will depend, in large part, on obtaining and maintaining patent protection and trade secret protection for WIN378, WIN027 or any other potential future product candidates and their formulations and uses, as well as successfully enforcing our patents against third-party infringers and/or defending these patents against third-party challenges. If we are unable to obtain and maintain patent protection for WIN378, WIN027 or any future product candidates, our ability to develop, license and/or commercialize our products may be adversely affected and we may not be able to prevent competitors from making, using, selling or importing competing products. Any such failure to prevent competitors from commercial launch could have a material adverse effect on our business, financial condition, results of operations and growth prospects.

The patent application process is subject to numerous risks and uncertainties, and there can be no assurance that we or our collaborators will be successful in protecting WIN378, WIN027 or future product candidates by obtaining, enforcing and defending patents. These risks and uncertainties include the following:

 

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patent applications may not result in any patent being issued;

 

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issued patents may not include claims with a broad enough scope to prevent design around solutions by competitors;

 

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issued patents may be challenged, invalidated, modified, revoked, circumvented, found to be unenforceable, or otherwise may not provide adequate barriers to entry or any competitive advantage;

 

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because of the extensive time required for development, testing and regulatory review of a potential product, it is possible that before a potential product can be commercialized, any related patent may expire, or remain in existence for only a short period following commercialization, reducing, or eliminating any advantage of the patent;

 

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our competitors, many of which have substantially greater resources than us or our collaborators, and many of which have made significant investments in competing technologies, may seek, or may already have sought or obtained, patents that will limit, interfere with, or eliminate our ability to make, use, and sell our potential products;

 

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there may be significant pressure on the U.S. government and other international governmental bodies to limit the scope of patent protection for disease treatments that prove successful as a matter of public policy regarding worldwide health concerns;

 

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countries other than the United States may have patent laws less favorable to patentees than those upheld by United States courts, allowing foreign competitors a better opportunity to create, develop, and market competing products; and

 

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we may be involved in lawsuits to protect or enforce our patents or the patents we have rights to enforce, which could be expensive, time consuming and/or unsuccessful.

We may not be able to protect our intellectual property and proprietary rights throughout the world.

Filing, prosecuting, maintaining, enforcing and defending patents on our product candidates in all countries throughout the world is expensive, and the laws of foreign countries may not protect our intellectual property rights to the same extent as the laws of the United States. Prosecution of foreign patent applications is often a longer process and patents may grant at a later date, and with a shorter term, than in the United States. The requirements for patentability differ in certain jurisdictions and countries. Additionally, the patent laws of some countries do not afford intellectual property protection to the same extent as the laws of the United States. For example, other countries may impose substantial restrictions on the scope of claims, including limiting patent protection to specifically disclosed embodiments. Consequently, we may not be able to prevent third parties from practicing our inventions in all countries outside the United States, or from selling or importing products made using our intellectual property in and into the United States or other jurisdictions. Competitors may use our intellectual

 

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property in jurisdictions where we have not pursued and obtained patent protection to develop their own products and, further, may export otherwise infringing products to territories where we have patent protection, but enforcement is not as strong as that in the United States. These products may compete with our products, and our current or future owned or licensed patents or other intellectual property rights may not be effective or sufficient to prevent them from competing. Many companies have encountered significant problems in protecting and defending intellectual property rights in foreign jurisdictions. The legal systems of certain countries, particularly certain developing countries, do not favor the enforcement of patents, trade secrets and other intellectual property protection, particularly those relating to biopharmaceutical products, which could make it difficult for us to stop the infringement of our owned or licensed patents or marketing of competing products in violation of our intellectual property and proprietary rights generally. In addition, some jurisdictions, such as Europe, Japan and the PRC, may have a heightened standard for patentability than in the United States, including, for example, the requirement of claims having literal support in the original patent filing and the limitation on using supporting data that is not in the original patent filing. Under those heightened patentability requirements, we may not be able to obtain sufficient patent protection in certain jurisdictions even though the same or similar patent protection can be secured in the United States and other jurisdictions.

Many countries have compulsory licensing laws under which a patent owner may be compelled to grant licenses to third parties, including governmental agencies. In addition, many countries limit the enforceability of patents against government agencies or government contractors. In these countries, the patent owner may have limited remedies, which could materially diminish the value of such patent. If we are forced to grant a license to third parties with respect to any patents relevant to our business, our competitive position may be impaired, and our business, financial condition, results of operations and growth prospects may be adversely affected.

We may become subject to claims that we are infringing certain third-party patents or other third-party intellectual property rights, any of which may prevent or delay our development and commercialization efforts and may have a material adverse effect on our business.

Our commercial success depends in part on avoiding infringing, misappropriating and otherwise violating the patents and other intellectual property and proprietary rights of third parties. There is a substantial amount of litigation, both within and outside the United States, involving patent and other intellectual property rights in the biotechnology and pharmaceutical industries, including patent infringement lawsuits, and administrative proceedings such as interferences, inter partes review and post grant review proceedings before the United States Patent and Trademark Office, or the USPTO, and opposition proceedings before foreign patent offices. Numerous U.S. and foreign issued patents and pending patent applications, which are owned or controlled by third parties, including our competitors, exist in the fields in which we are pursuing products and product candidates. As the biotechnology and pharmaceutical industries expand and more patents are issued, the risk increases that our products and product candidates may be subject to claims of infringement of the patent rights of third parties.

Third parties may assert that we or our licensors are employing their proprietary technology without authorization. There may be third-party patents or patent applications with claims to materials, formulations, methods of manufacture or methods for treatment relating to our products and product candidates and, because patent applications can take many years to issue, there may be currently pending third-party patent applications which may later result in issued patents, in each case that our products and product candidates, their manufacture or use may infringe or be alleged to infringe.

Parties making patent infringement claims against us may obtain injunctive or other equitable relief, which could effectively block our ability to further develop and commercialize one or more of our products or product candidates. Defense of these claims, including demonstrating non-infringement, invalidity or unenforceability of the respective patent rights in question, regardless of their merit, is time-consuming, would involve substantial litigation expense and would be a substantial diversion of employee resources from our business. For example, in order to successfully challenge the validity of any U.S. patent in federal court, we would need to overcome a presumption of validity. This is a high burden requiring us to present clear and convincing evidence as to the invalidity of any such U.S. patent claim, and we can provide no assurance that a court of competent jurisdiction would invalidate the claims of any such U.S. patent. We may not have sufficient resources to bring these actions to a successful conclusion. There could also be public announcements of the results of hearings, motions or other interim proceedings or

 

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developments. If securities analysts or investors perceive these results to be negative, it could have a material adverse effect on the price of our common shares.

In the event that a holder of any such patents seeks to enforce its patent rights against us with respect to one or more of our products or product candidates, and our defenses against the infringement of such patent rights are unsuccessful, we may be precluded from commercializing such products and product candidates, even if approved, without first obtaining a license to some or all of these patents, which may not be available on commercially reasonable terms or at all. Moreover, we may be required to pay significant fees and royalties to secure a license to the applicable patents. Such a license may only be non-exclusive, in which case our ability to stop others from using or commercializing technology and products similar or identical to ours may be limited. Furthermore, we could be liable for damages to the holders of these patents, which may be significant and could include treble damages if we are found to have willfully infringed such patents. In the event that a challenge to these patents were to be unsuccessful or we were to become subject to litigation or unable to obtain a license on commercially reasonable terms with respect to these patents, it could harm our business, financial condition, results of operations and growth prospects.

Even in the absence of a finding of infringement, we may need to obtain licenses from third parties to advance our research or allow commercialization of our products and product candidates. We may fail to obtain any of these licenses at a reasonable cost or on reasonable terms, or at all. In that event, we would be unable to further develop and commercialize our products and product candidates. Claims that we have misappropriated the confidential information or trade secrets of third parties could have a similar negative impact on our business. Any of the foregoing could materially adversely affect our business, financial condition, results of operations and growth prospects.

We do not control prosecution and enforcement globally for all in-licensed patents and applications that are relevant to our planned products. There may be negative outcomes during prosecution or patent enforcement in those jurisdictions where such processes are out of our control. A negative outcome in a jurisdiction outside of our control may also have consequences to the patent estate that is within our control, including impacts on the validity and enforceability of those patents. We cannot assure you that our licensors will act during prosecution or enforcement with any consideration to consequences on our patent estate.

Third parties may assert that our employees, consultants, or advisors have wrongfully used or disclosed confidential information or misappropriated trade secrets.

As is common in the biotechnology and pharmaceutical industries, we employ individuals that are currently or were previously employed at universities, research institutions or other biotechnology or pharmaceutical companies, including our competitors or potential competitors. Although we employ measures to ensure that our employees, consultants, and advisors do not use the proprietary information or know-how of others in their work for us, we may be subject to claims that we or these individuals have inadvertently or otherwise used or disclosed intellectual property, including trade secrets or other proprietary information, of any such individual’s current or former employer. We may then be directly or indirectly involved in litigation proceedings to defend against these claims. If we fail in defending against any such claims, in addition to potentially paying monetary damages, we may lose valuable intellectual property rights and/or personnel. Even if we are successful in defending against such claims, litigation could result in substantial costs and distract our technical and management personnel from their normal responsibilities. In addition, there could be public announcements of the results of hearings, motions or other interim proceedings or developments, and, if securities analysts or investors perceive these results to be negative, that perception could have a substantial adverse effect on the price of our common shares. Ultimately, any such litigation could substantially increase our operating losses and reduce our resources available for development activities, and we may not have sufficient financial or other resources to adequately engage in such litigation. For example, some of our competitors may be able to sustain the costs of such litigation more effectively than we can because of their substantially greater financial resources. In any case, uncertainties resulting from the initiation and continuation of intellectual property litigation or other intellectual property related proceedings could adversely affect our ability to compete in the marketplace.

 

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We rely heavily on certain in-licensed patent and other intellectual property rights in connection with our development of our product candidates.

Our ability to develop and commercialize our product candidates is heavily dependent on in-licenses to patent rights and other intellectual property granted to us by third parties. Our license agreements impose, and we expect that any future license agreements, will impose, various development, diligence, commercialization, and other obligations on us. If we fail to meet our obligations under these licenses, or if we have a dispute regarding the terms of the licenses, these third parties could terminate the licenses. If the third parties who license intellectual property to us fail to maintain the intellectual property that we have licensed, or lose rights to that intellectual property, the rights we have licensed may be reduced or eliminated, which could subject us to claims of intellectual property infringement. Termination of these licenses or reduction or elimination of our licensed rights may result in our having to negotiate new or reinstated licenses with less favorable terms. We may also be subject to contract breach in litigation or other administrative proceedings that could result in damage awards against us. If we fail to defeat claims of infringement, injunctions could prohibit us from selling our products. Such an outcome may require us to design around the claimed subject matter, which may be time-consuming, expensive, or not possible. Even if we are able to replace such licenses, it may be time-consuming and expensive.

In addition, intellectual property rights that we have licensed or may in-license in the future may, in turn, be sublicensed to our licensors from third parties, in some cases through multiple tiers. The actions of our licensors may therefore affect our rights to use our sublicensed intellectual property, even if we are in compliance with all of the obligations under our license agreements. Should our licensors or any of the upstream licensors fail to comply with their obligations under the agreements pursuant to which they obtain the rights that are sublicensed to us, or should such agreements be terminated or amended, our ability to develop and commercialize our product candidates may be materially harmed.

In addition, some of our licenses from third parties limit the field in which we can use the licensed technology. Therefore, in order for us to use such licensed technology in potential future applications that are outside the licensed field of use, we may be required to negotiate new licenses with our licensors or expand our rights under our existing licenses. We cannot assure you that we will be able to obtain such licenses or expanded rights on reasonable terms or at all.

We may need to obtain additional licenses from third parties to advance our research or allow commercialization of our product candidates, and we have done so from time to time. We may fail to obtain any of these licenses at a reasonable cost or on reasonable terms, if at all. In that event, we may be required to expend significant time and resources to develop or license replacement technology. If we are unable to do so, we may be unable to develop or commercialize the affected product candidates, which could harm our business significantly. We cannot provide any assurances that third-party patents do not exist which might be enforced against our current product candidates or future products, resulting in either an injunction prohibiting our sales, or, with respect to our sales, an obligation on our part to pay royalties and/or other forms of compensation to third parties.

Our agreements with certain of our third-party research partners provide that improvements developed in the course of our relationship may be owned solely by either us or our third-party research partner, or jointly between us and the third party. If we determine that rights to such improvements owned solely by a research partner or other third party with whom we collaborate are necessary to commercialize our product candidates or maintain our competitive advantage, we may need to obtain a license from such third party in order to use the improvements and continue developing, manufacturing or marketing our product candidates. We may not be able to obtain such a license on an exclusive basis, on commercially reasonable terms, or at all, which could prevent us from commercializing our product candidates or allow our competitors or others the chance to access technology that is important to our business. We also may need the cooperation of any co-owners of our intellectual property in order to enforce such intellectual property against third parties, and such cooperation may not be provided to us.

If we fail to comply with our obligations under our existing and any future intellectual property licenses with third parties or we otherwise experience disruptions to our business relationships with our future licensors, we could lose license rights that are important to our business.

Disputes may arise regarding intellectual property subject to a licensing agreement, including:

 

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the scope of rights granted under the license agreement and other interpretation-related issues;

 

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whether we have breached the license agreement and whether any such breach is subject to a cure period;

 

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the extent to which our product candidates, technology and processes infringe on intellectual property of the licensor that is not subject to the licensing agreement;

 

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the sublicensing of patent and other rights under our collaborative development relationships;

 

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our diligence obligations under the license agreement and what activities satisfy those diligence obligations;

 

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our right to transfer or assign the license;

 

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the inventorship and ownership of inventions and know-how resulting from the joint creation or use of intellectual property by our licensors and us and our collaborators; and

 

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the priority of invention of patented technology.

In addition, the agreements under which we license intellectual property or technology from third parties are complex, and certain provisions in such agreements may be susceptible to multiple interpretations. The resolution of any contract interpretation disagreement that may arise could narrow what we believe to be the scope of our rights to the relevant intellectual property or technology, or increase what we believe to be our financial or other obligations under the relevant agreement, either of which could have a material adverse effect on our business, financial condition, results of operations and growth prospects.

In the event a dispute with our licensors were to occur, our licensors may seek to renegotiate the terms of our licenses, increase the royalty rates that we pay to obtain and maintain those licenses, limit the field or scope of the licenses, or terminate the license agreements. Moreover, if disputes over intellectual property that we license in the future prevent or impair our ability to maintain our licensing arrangements on commercially acceptable terms, we may be unable to successfully develop and commercialize the affected product candidates, which could have a material adverse effect on our business, financial conditions, results of operations, and prospects.

Despite our best efforts, our future licensors might conclude that we materially breached our license agreements and might therefore terminate the license agreements, thereby removing our ability to develop and commercialize products and technology covered by these license agreements. If these in-licenses are terminated, or if the underlying patents fail to provide the intended exclusivity, competitors would have the freedom to seek regulatory approval of, and to market, products identical to ours. This could have a material adverse effect on our competitive position, business, financial conditions, results of operations, and prospects.

The patent protection and patent prosecution for some of our product candidates may be dependent on third parties.

While we normally seek to obtain the right to control prosecution, maintenance and enforcement of the patents relating to our product candidates, there may be times when the filing and prosecution activities for patents and patent applications relating to our product candidates are controlled by our future licensors or collaboration partners. If any of our future licensors or collaboration partners fail to prosecute, maintain and enforce such patents and patent applications in a manner consistent with the best interests of our business, including by payment of all applicable fees for patents covering our product candidates, we could lose our rights to the intellectual property or our exclusivity with respect to those rights, our ability to develop and commercialize those product candidates may be adversely affected and we may not be able to prevent competitors from making, using and selling competing products. In addition, even where we have the right to control patent prosecution of patents and patent applications we have licensed to and from third parties, we may still be adversely affected or prejudiced by actions or inactions of our licensees, our future licensors and their counsel that took place prior to the date upon which we assumed control over patent prosecution.

Obtaining and maintaining our patent protection depends on compliance with various procedural, document submission, fee payment, and other requirements imposed by government patent agencies, and our patent protection could be reduced or eliminated for non-compliance with these requirements.

Periodic maintenance fees, renewal fees, annuity fees, and various other government fees on patents and applications are due to be paid to the USPTO and foreign patent agencies outside of the United States over the lifetime of our patents and applications. If, in the future, we in-license patent rights, in the case of any in-licensed patent rights, we generally rely on our licensors to pay these fees due to U.S. and non-U.S. patent agencies. For patent rights we own, we may rely on our outside patent counsel and/or annuity services in the United States and foreign countries to monitor these deadlines and to pay these fees when so instructed by us.

 

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The USPTO and foreign patent agencies require compliance with procedural, documentary, fee payment, and other similar provisions, such as the requirement to disclose known prior art, during the patent application process. If we or our licensors fail to comply with these requirements, our patent applications may not issue or our granted patents may lapse or be found invalid. While certain inadvertent lapses can be cured by payment of a late fee, by petition, or by other means in accordance with the applicable rules, there are situations in which non-compliance can result in a partial or complete loss of patent rights in the relevant jurisdiction. If our patents irreversibly lapse or their scope or term is limited, our competitors might be able to enter the market with similar or identical products or technology, which could have a material adverse effect on our business, financial condition, results of operations and growth prospects.

It is possible that defects of form in the preparation or filing of patent applications may exist, or may arise in the future, for example with respect to proper priority claims, inventorship, claim scope, or requests for patent term adjustments. If there are material defects in the form, preparation, prosecution or enforcement of our patents or patent applications, such patents may be invalid and/or unenforceable, and such applications may never result in valid, enforceable patents. Any of these outcomes could impair our ability to prevent competition from third parties, which may have an adverse impact on our business.

If we do not obtain patent term extension for our products and product candidates, our business may be materially harmed.

Patents have a limited lifespan. In the United States, if all maintenance fees are timely paid, the natural expiration of a patent is generally 20 years from its earliest U.S. non-provisional filing date. Various extensions may be available, but the life of a patent, and the protection it affords, is limited. Even if patents covering our products and product candidates are obtained, once the patent life has expired for a product or product candidate, we may be open to competition from competitive products. Given the amount of time required for the development, testing and regulatory review of new product candidates, patents protecting such candidates might expire before or shortly after such candidates are commercialized. As a result, our owned and licensed patent portfolio may not provide us with sufficient rights to exclude others from commercializing products and product candidates similar or identical to ours.

Depending upon the circumstances, the term of patent rights we own or in-license that cover our product candidates may be extended in the United States under the Hatch-Waxman Act (Patent Term Extension, or PTE), by Supplementary Protection Certificate, or SPC, in certain European countries, and by similar legislation in other countries, for delays incurred when seeking regulatory approval for a drug candidate. For example, depending upon the timing, duration and specifics of any FDA regulatory approval of such product candidates, such patent may be eligible for limited patent term extension under the Drug Price Competition and Patent Term Restoration Act of 1984, or Hatch-Waxman Amendments. The Hatch-Waxman Amendments permit a patent extension term of up to five years as compensation for patent term lost during the FDA regulatory review process. A patent term extension cannot extend the remaining term of a patent beyond a total of 14 years from the date of product approval, only one patent may be extended and only those claims covering the approved drug, a method for using it or a method for manufacturing it may be extended. A patent may only be extended once and only based on a single approved product. However, we may not be granted an extension because of, for example, failure to obtain a granted patent before approval of a product candidate, failure to exercise due diligence during the testing phase or regulatory review process, failure to apply within applicable deadlines, failure to apply prior to expiration of relevant patents or otherwise our failure to satisfy applicable requirements. Moreover, the applicable time period or the scope of patent protection afforded could be less than we request. If we are unable to obtain patent term extension or the term of any such extension is less than we request, our competitors may obtain approval of competing products following our patent expiration, and our revenue could be reduced, possibly materially. In addition, our ability to control which patent is extended by any patent term extension may be limited, and there can be no assurance that licensors will pursue or obtain extensions for patents that we would choose.

If we are unable to obtain patent term extension or restoration, or the foreign equivalent, or the term of any such extension is less than we request, our competitors or other third parties may obtain approval of competing drugs following our patent expiration, and our revenue could be reduced, possibly materially. Further, if this occurs, our competitors or other third parties may take advantage of our investment in development and trials by referencing our clinical and nonclinical data and launch their drug earlier than might otherwise be the case. Any of the foregoing could materially harm our business, financial condition, results of operations and growth prospects.

 

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Changes in patent law in the European Union, the United States and other jurisdictions could diminish the value of patents in general, thereby impairing our ability to protect our products and product candidates, adversely impacting our business.

Obtaining and enforcing patents in the biopharmaceutical industry involves both technological and legal complexity, and is therefore costly, time consuming and inherently uncertain. Changes in patent laws throughout the world can disturb settled expectations and reduce or eliminate patent protections. Recent rulings from the U.S. Supreme Court and the Court of Appeals for the Federal Circuit have narrowed the scope of patent protection available in specified circumstances and weakened the rights of patent owners in specified situations. In addition to increasing uncertainty with regard to our ability to obtain patents in the future, this combination of events has created uncertainty with respect to the value of patents, once obtained. Depending on decisions by the U.S. Congress, the federal courts, and the USPTO, the laws and regulations governing patents could change in unpredictable ways that would weaken our ability to obtain new patents or to enforce our existing patents and patents that we might obtain in the future.

Patent offices may interpret court rulings in ways that may hamper our ability to obtain patent protection. The USPTO has issued subject matter eligibility guidance instructing USPTO examiners on the ramifications of the Supreme Court rulings in Mayo Collaborative Services v. Prometheus Laboratories, Inc. and Association for Molecular Pathology v. Myriad Genetics, Inc., and applied the Myriad ruling to natural products and principles including all naturally occurring molecules. Currently, our patent portfolio contains claims of various types and scope, including methods of medical treatment. Similarly, in 2023, in Amgen Inc. v. Sanofi, the Supreme Court held broad claims to antibodies invalid as lacking enablement, illustrating the challenge in obtaining claims to biological products. While the presence of varying types of claims in our patent portfolio reduces our exposure to potential validity challenges, we cannot guarantee that our patent estate will prevent third parties from entering markets and competing with us.

On September 16, 2011, the Leahy-Smith America Invents Act, or the Leahy-Smith Act, was signed into law and included several significant changes to U.S. patent law that impacted how patent rights could be prosecuted, enforced and defended. In particular, the Leahy-Smith Act also included provisions that switched the United States from a “first-to-invent” system to a “first-to-file” system, allowed third-party submission of prior art to the USPTO during patent prosecution and set forth additional procedures to attack the validity of a patent by the USPTO are administered post grant proceedings. Under a first-to-file system, assuming the other requirements for patentability are met, the first inventor to file a patent application generally will be entitled to the patent on an invention regardless of whether another inventor had made the invention earlier. The USPTO developed regulations and procedures governing the administration of the Leahy-Smith Act, and many of the substantive changes to patent law associated with the Leahy-Smith Act, and in particular, the first-to-file provisions, became effective on March 16, 2013.

The Leahy-Smith Act also introduced new procedures providing opportunities for third parties to challenge any issued patent in the USPTO. Included in these new procedures is a process known as Inter Partes Review, or IPR, which has been generally used by many third parties since the enactment of the Leahy-Smith Act to invalidate patents. Because of a lower evidentiary standard in USPTO proceedings compared to the evidentiary standard in U.S. federal court necessary to invalidate a patent claim, a third party could potentially provide evidence in a USPTO proceeding sufficient for the USPTO to hold a claim invalid even though the same evidence would be insufficient to invalidate the claim if first presented in a district court action. Accordingly, a third party may attempt to use the USPTO procedures to invalidate our patent claims that would not have been invalidated if first challenged by the third party as a defendant in a district court action.

In addition, the U.S. federal government retains certain rights in inventions produced with its financial assistance under the Patent and Trademark Law Amendments Act (Bayh-Dole Act). The federal government retains a “nonexclusive, nontransferable, irrevocable, paid-up license” for its own benefit. The Bayh-Dole Act also provides federal agencies with “march-in rights.” March-in rights allow the government, in specified circumstances, to require the contractor or successors in title to the patent to grant a “nonexclusive, partially exclusive, or exclusive license” to a “responsible applicant or applicants.” If the patent owner refuses to do so, the government may grant the license itself. If we choose to collaborate with academic institutions to accelerate our nonclinical research or development, we cannot be sure that any co-developed intellectual property will be free from government rights pursuant to the Bayh-Dole Act. If, in the future, we co-own or license in technology which is critical to our business that is developed

 

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in whole or in part with federal funds subject to the Bayh-Dole Act, our ability to enforce or otherwise exploit patents covering such technology may be adversely affected.

If we enter into future arrangements involving government funding, and we make inventions as a result of such funding, our intellectual property rights to such discoveries may be subject to provisions of the Bayh-Dole Act of 1980. If the U.S. government exercises “march-in rights” under the Bayh-Dole Act, our competitive position may be harmed, which could have an adverse effect on our prospects.

Geopolitical actions in the United States and in foreign countries could increase the uncertainties and costs surrounding the prosecution or maintenance of patent applications and the maintenance, enforcement or defense of issued patents. For example, the United States and foreign government actions related to Russia’s invasion of Ukraine may limit or prevent filing, prosecution and maintenance of patent applications in Russia. Government actions may also prevent maintenance of issued patents in Russia. These actions could result in abandonment or lapse of patents or patent applications, resulting in partial or complete loss of patent rights in Russia. If such an event were to occur, it could have a material adverse effect on our business. In addition, a decree was adopted by the Russian government in March 2022, allowing Russian companies and individuals to exploit inventions owned by patentees that have citizenship or nationality in, are registered in, or have predominately primary place of business or profit-making activities in the United States and other countries that Russia has deemed unfriendly without consent or compensation. Consequently, we would not be able to prevent third parties from practicing its inventions in Russia or from selling or importing products made using its inventions in and into Russia. Accordingly, our competitive position may be impaired, and our business, financial condition, results of operations and growth prospects may be adversely affected.

In Europe, a new unitary patent system took effect on June 1, 2023, and may significantly impact European patents, including those granted before the introduction of the new system. Under the new system, Applicants can, upon grant of a patent, opt for that patent to become a Unitary Patent which will be subject to the jurisdiction of a new Unitary Patent Court, or the UPC. Patents granted before the implementation of the new system can be opted out of UPC jurisdiction, remaining as national patents in the UPC countries. Patents that remain under the jurisdiction of the UPC may be challenged in a single UPC-based revocation proceeding that, if successful, could invalidate the patent in all countries who are signatories to the UPC. Further, because the UPC is a new court system and there is little precedent for the court’s laws, there is increased uncertainty regarding the outcome of any patent litigation. We are unable to predict what impact the new patent regime may have on our ability to exclude competitors in the European market.

We cannot assure you that our efforts to seek patent protection for one or more of our products and product candidates will not be negatively impacted by the decisions described above, rulings in other cases or changes in guidance or procedures issued by the USPTO. We cannot fully predict what impact the Supreme Court’s decisions may have on the ability of life science companies to obtain or enforce patents relating to their products in the future. These decisions, the guidance issued by the USPTO and rulings in other cases or changes in USPTO guidance or procedures could have a material adverse effect on our existing patent rights and our ability to protect and enforce our intellectual property in the future.

If we are unable to protect the confidentiality of our trade secrets, our business and competitive position could be harmed.

In addition to seeking patents for our technologies and WIN378, WIN027 or any future product candidates, we also rely on trade secret protection, as well as confidentiality agreements, non-disclosure agreements and assignment agreements with our employees, consultants and third parties, to protect our know-how and other confidential and proprietary information, especially where we do not believe patent protection is appropriate or obtainable.

It is our policy to require our employees, corporate collaborators, outside scientific collaborators, CROs, contract manufacturers, consultants, advisors, and other third parties to execute confidentiality agreements upon the commencement of employment or consulting relationships with us. These agreements generally provide that all confidential information concerning our business or financial affairs developed by or made known to an individual or entity during the course of that party’s relationship with us are to be kept confidential and not disclosed to third parties, except in certain specified circumstances. In the case of employees, the agreements also provide that all

 

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inventions conceived by the individual, and that are related to our current or planned business or research and development or made during normal working hours, on our premises or using our equipment or proprietary information, are our exclusive property. In the case of consultants and other third-party service providers, the agreements provide us with certain rights to all inventions arising from the services provided to us by those individuals or entities. However, we cannot guarantee that we have entered into such agreements with each party that may have or have had access to our trade secrets or proprietary technologies and processes. Additionally, the assignment of intellectual property rights may not be self-executing, or assignment agreements may be breached, and we may be forced to bring claims against third parties, or defend claims that they may bring against us, to determine the ownership of what we regard as our intellectual property. We may not be able to obtain adequate remedies for any breaches of such agreements. Ultimately, enforcing a claim that a party illegally disclosed or misappropriated a trade secret can be difficult, expensive, and time consuming, and the outcome is unpredictable.

In addition to contractual measures, we protect the confidential nature of our proprietary information through other appropriate precautions, such as physical and technological security measures. However, trade secrets and know-how can be difficult to protect despite these precautions. These measures may not, for example, in the case of misappropriation of a trade secret by an employee or third party with authorized access, provide adequate protection for our proprietary information. Our security measures may not prevent an employee or consultant from misappropriating our trade secrets and providing them to a competitor, and any recourse we might take against this type of misconduct may not provide an adequate remedy to protect our interests fully. In addition, our trade secrets may be independently developed by others in a manner that could prevent us from receiving legal recourse. If any of our confidential or proprietary information, such as our trade secrets, were to be disclosed or misappropriated, or if any of that information was independently developed by a competitor, our competitive position could be harmed.

If we choose to go to court to stop a third party from using any of our trade secrets, we may incur substantial costs. In addition, courts inside and outside the United States are sometimes less willing or unwilling to protect trade secrets. Even if we are successful, these types of lawsuits may consume, in addition to substantial costs, significant amounts of our time and other resources. Any of the foregoing could have a material adverse effect on our business, financial condition, results of operations and growth prospects.

Any trademarks we may obtain may be infringed or successfully challenged, resulting in harm to our business.

We expect to rely on trademarks as one means to distinguish WIN378, WIN027 or any future product candidates that are approved for marketing from the products of our competitors. However, our trademarks or trade names may be challenged, infringed, circumvented, or declared generic. We may not be able to protect our rights to these trademarks and trade names, which we benefit from to build name recognition among potential collaborators or customers in our markets of interest. At times, competitors or other third parties may adopt trade names or trademarks similar to ours, thereby impeding our ability to build brand identity and possibly leading to market confusion. In addition, there could be allegations of trade name or trademark infringement claims brought by owners of other registered trademarks or trademarks that incorporate variations of our registered or unregistered trademarks or trade names. Over the long term, if we are unable to establish name recognition based on our trademarks and trade names, then we may not be able to compete effectively, and our business may be adversely affected. Our efforts to enforce or protect our proprietary rights related to trademarks, trade secrets, domain names, copyrights or other intellectual property may be ineffective and could result in substantial costs and diversions of resources and could adversely affect our business, financial condition, results of operations and growth prospects.

In addition, any proprietary name we propose to use with WIN378, WIN027 or any future product candidates in the United States must be approved by the FDA, regardless of whether we have registered it, or applied to register it, as a trademark. The FDA typically conducts a review of proposed product names, including an evaluation of the potential for confusion with other product names. If the FDA objects to any of our proposed proprietary product names, we may be required to expend significant additional resources in an effort to identify a suitable proprietary product name that would qualify under applicable trademark laws, not infringe the existing rights of third parties, and be acceptable to the FDA.

We may be subject to claims challenging the inventorship or ownership of the patents and other intellectual property that we own or license.

We or our licensors may be subject to claims that former employees, collaborators or other third parties have an ownership interest in the patents and intellectual property that we own or license or that we may own or license in

 

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the future. The failure to name the proper inventors on a patent application can result in the patents issuing thereon being unenforceable. Inventorship disputes may arise from conflicting views regarding the contributions of different individuals named as inventors, the effects of foreign laws where foreign nationals are involved in the development of the subject matter of the patent, conflicting obligations of third parties involved in developing our product candidates or as a result of questions regarding co-ownership of potential joint inventions. Litigation may be necessary to resolve these and other claims challenging inventorship and/or ownership. Alternatively, or additionally, we may enter into agreements to clarify the scope of our rights in such intellectual property.

While it is our policy to require our employees and contractors who may be involved in the development of intellectual property to execute agreements assigning such intellectual property to us, we may be unsuccessful in executing such an agreement with each party who in fact develops intellectual property that we regard as our own or such assignments may not be self-executing or may be breached. Our licensors may face similar obstacles. We could be subject to ownership disputes arising, for example, from conflicting obligations of employees, consultants or others who are involved in developing our products or product candidates. Litigation may be necessary to defend against any claims challenging inventorship or ownership. If we or our licensors fail in defending any such claims, we may have to pay monetary damages and may lose valuable intellectual property rights, such as exclusive ownership of, or the right to use or enforce, intellectual property, which could adversely impact our business, financial condition and results of operations. Even if we are successful in defending against such claims, litigation could result in substantial costs and be a distraction to management and other employees.

Intellectual property rights do not necessarily address all potential threats.

The degree of future protection afforded by our intellectual property rights is uncertain because intellectual property rights have limitations and may not adequately protect our business or permit it to maintain our competitive advantage. For example:

 

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WIN378, WIN027 or future product candidates, if approved, may eventually become commercially available in generic or biosimilar product forms;

 

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others may be able to make similar antibodies to WIN378, WIN027 or any other potential future product candidates that are not covered by the claims of the patents that we license or may own in the future;

 

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we, or current or future licensors or collaborators, might not have been the first to make the inventions covered by the issued patent or pending patent application that we license or may own in the future, potentially resulting in the invalidation of such patents or refusal of such applications;

 

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we, or current or future licensors or collaborators, might not have been the first to file patent applications covering certain of our or their inventions;

 

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we, or current or future licensors or collaborators, may fail to meet our obligations to the U.S. government regarding any in-licensed patents and patent applications funded by U.S. government grants, leading to the loss or unenforceability of patent rights;

 

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others may independently develop similar or alternative technologies or duplicate any of our technologies without infringing on our owned or licensed intellectual property rights;

 

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it is possible that our pending patent applications or those that we may own or license in the future will not lead to issued patents;

 

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it is possible that there are prior public disclosures that could invalidate our patents;

 

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it is possible that there are unpublished patent applications that may later issue with claims covering WIN378, WIN027 or any other potential future product candidates or technology similar to ours;

 

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it is possible that our patents or patent applications omit individual(s) that should be listed as inventor(s) or include individual(s) that should not be listed as inventor(s), which may cause these patents or patents issuing from these patent applications to be held invalid or unenforceable or result in a change in ownership;

 

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issued patents to which we hold rights may be held invalid, unenforceable, or narrowed in scope, including as a result of legal challenges by our competitors;

 

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the claims of our issued patents or patent applications, if and when issued, may not cover WIN378, WIN027 or any other potential future product candidates or narrowly cover them in such a way that competitors may be able to design around to avoid infringement allegations;

 

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the laws of foreign countries may not protect our proprietary rights or the proprietary rights of current or future licensors or collaborators to the same extent as the laws of the United States;

 

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the inventors of our patents or patent applications may become involved with competitors, develop products or processes that design around our patents, or become hostile to it or the patents or patent applications on which they are named as inventors;

 

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our competitors might conduct research and development activities in countries where we do not have patent rights and then use the information learned from such activities to develop competitive products for sale in our major commercial markets;

 

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we have engaged in scientific collaborations in the past and we intend to continue to do so in the future, and our collaborators may develop adjacent or competing products that are outside the scope of our patents;

 

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we may not develop additional proprietary technologies that are patentable;

 

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WIN378, WIN027 or any other potential future product candidates we develop may be covered by third-party patents or other exclusive rights;

 

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the patents of others may prohibit or otherwise harm our business; or

 

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we may choose not to file a patent in order to maintain certain trade secrets or know-how, and a third party may subsequently commercialize the technology and/or file a patent covering such intellectual property.

Should any of these events occur, they could have a material adverse effect on our business, financial condition, results of operations and growth prospects.

Risks Related to This Offering and Ownership of Our Common Shares

There has been no prior public market for our common shares, and an active trading market may not develop or be sustained.

There has been no public market for our common shares prior to this offering. The initial public offering price for our common shares was determined through negotiations among the underwriters and us and may vary from the market price of our common shares following this offering and concurrent private placement. An active or liquid market in our common shares may not develop upon the completion of this offering or, if it does develop, it may not be sustainable. The lack of an active market may impair the value of your common shares, your ability to sell your common shares at the time you wish to sell them and the prices that you may obtain for your common shares. An inactive market may also impair our ability to raise capital by selling our common shares and our ability to acquire other companies, products, or technologies by using our common shares as consideration.

The price of our common shares may be volatile, and you could lose all or part of your investment.

The trading price of our common shares following this offering is likely to be highly volatile and could be subject to wide fluctuations in response to various factors, some of which are beyond our control, including limited trading volume. In addition to the factors discussed in this section and elsewhere in this prospectus, these factors include:

 

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the commencement, enrollment, completion or results of our current or future nonclinical and clinical trials for WIN378, WIN027 or any other potential future product candidates;

 

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any delay in identifying and advancing a clinical candidate for our other programs;

 

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any delay in our regulatory filings for WIN378, WIN027 or any other potential future product candidates and any adverse development or perceived adverse development with respect to the applicable regulatory authority’s review of such filings, including without limitation the FDA’s issuance of a “refusal to file” letter or a request for additional information;

 

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adverse results or delays, suspensions or terminations in future nonclinical studies or clinical trials;

 

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our decision to initiate a clinical trial, not to initiate a clinical trial or to terminate an existing clinical trial;

 

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adverse regulatory decisions, including failure to receive regulatory approval of WIN378, WIN027 or any other potential future product candidates or the failure of a regulatory authority to accept data from nonclinical studies or clinical trials conducted in other countries;

 

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changes in laws or regulations applicable to WIN378, WIN027 or any other potential future product candidates, including but not limited to clinical trial requirements for approvals;

 

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adverse developments concerning our manufacturers;

 

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our inability to obtain adequate product supply for any approved product or inability to do so at acceptable prices;

 

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our inability to establish collaborations, if needed;

 

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our failure to commercialize WIN378, WIN027 or any other potential future product candidates, if approved;

 

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additions or departures of key scientific or management personnel;

 

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unanticipated serious safety concerns related to WIN378, WIN027 or any other potential future product candidates;

 

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introduction of new products or services offered by us or our competitors;

 

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announcements of significant acquisitions, strategic partnerships, joint ventures or capital commitments by us or our competitors;

 

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our ability to effectively manage our growth;

 

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actual or anticipated variations in quarterly operating results;

 

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our cash position;

 

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our failure to meet the estimates and projections of the investment community or that we may otherwise provide to the public;

 

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publication of research reports about us or our industry, or WIN378, WIN027 or any other potential future product candidates in particular, or positive or negative recommendations or withdrawal of research coverage by securities analysts;

 

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changes in the market valuations of similar companies;

 

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changes in the structure of the healthcare payment systems;

 

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overall performance of the equity markets;

 

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sales of our common shares by us or our shareholders in the future;

 

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trading volume of our common shares;

 

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changes in accounting practices, such as the adoption of a new accounting standard;

 

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ineffectiveness of our internal controls;

 

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disputes or other developments relating to proprietary rights, including patents, litigation matters and our ability to obtain patent protection for our technologies;

 

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significant lawsuits, including patent or shareholder litigation;

 

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general political and economic conditions; and

 

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other events or factors, many of which are beyond our control.

In addition, the stock market in general, and the market for biopharmaceutical companies in particular, have experienced extreme price and volume fluctuations that have often been unrelated or disproportionate to the operating performance of these companies. Broad market and industry factors may negatively affect the market price of our common shares, regardless of our actual operating performance. If the market price of our common shares after this offering and concurrent private placement does not exceed the initial public offering price, you may not realize any return on your investment in us and may lose some or all of your investment. In the past, securities class action litigation has often been instituted against companies following periods of volatility in the market price of a company’s securities. This type of litigation, if instituted, could result in substantial costs and a diversion of management’s attention and resources.

Our operating results may fluctuate significantly, which makes our future operating results difficult to predict and could cause our operating results to fall below expectations.

Our operating results have fluctuated in the past and may fluctuate significantly, due to a variety of factors, many of which are outside of our control and may be difficult to predict, including:

 

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the timing and cost of, and level of investment in, research, development and, if approved, commercialization activities relating to WIN378, WIN027 or any other potential future product candidates, which may change from time to time;

 

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the timing and status of enrollment for clinical trials;

 

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the cost of manufacturing WIN378, WIN027 or any other potential future product candidates, as well as building out our supply chain, which may vary depending on the quantity of production and the terms of our agreements with manufacturers;

 

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expenditures that we may incur to acquire, develop or commercialize additional product candidates and technologies;

 

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timing and amount of any milestone, royalty or other payments due under any collaboration or license agreement;

 

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future accounting pronouncements or changes in our accounting policies;

 

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the timing and success or failure of nonclinical studies and clinical trials for WIN378, WIN027 or any other potential future product candidates or competing product candidates, or any other change in the competitive landscape of our industry, including consolidation among our competitors or collaborators;

 

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the timing of receipt of approvals for WIN378, WIN027 or any other potential future product candidates from regulatory authorities in the United States and internationally;

 

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our exposure to liquidity risk;

 

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changes in global or local economic conditions, including inflation, hyperinflation, fluctuations in interest rates and other increasing price levels;

 

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fluctuations in interest rates and currency exchange rates, including the relative strength or weakness of the U.S. dollar against foreign currencies that are important to our business;

 

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bank/counterparty credit risk associated with our cash and investments;

 

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coverage and reimbursement policies with respect to WIN378, WIN027 or any other potential future product candidates, if approved, and potential future drugs that compete with our products;

 

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the level of demand for WIN378, WIN027 or any other potential future product candidates, if approved, which may vary significantly over time; and

 

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other events or factors, many of which are beyond our control.

The cumulative effects of these factors could result in large fluctuations and unpredictability in our quarterly and annual operating results. As a result, comparing our operating results on a period-to-period basis may not be meaningful. Investors should not rely on our past results as an indication of our future performance.

This variability and unpredictability could also result in our failing to meet the expectations of industry or financial analysts or investors for any period. If our future revenue or operating results fall below the expectations of analysts or investors or below any forecasts we may provide to the market, or if any forecasts we provide to the market are below the expectations of analysts or investors, the price of our common shares could decline substantially. Such a share price decline could occur even when we have met any previously publicly stated revenue or earnings guidance we may provide.

Raising additional capital will cause dilution to our shareholders, restrict our operations or require us to relinquish rights to WIN378, WIN027 or any other potential future product candidates.

Until such time, if ever, as we can generate substantial product revenue, we expect to finance our operations with our existing cash, cash equivalents and marketable securities, the net proceeds from this offering, any future equity or debt financings and additional funds through collaborations, strategic alliances or marketing, distribution or licensing arrangements with third parties. If we raise additional capital through the sale of equity or convertible debt securities, or issue any equity or convertible debt securities in connection with a collaboration agreement or other contractual arrangement, your ownership interest will be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect your rights as a holder of our common shares. In addition, the possibility of such issuance may cause the market price of our common shares to decline. Debt financing, if available, may result in increased fixed payment obligations and involve agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures, declaring dividends or acquiring, selling or licensing intellectual property rights or assets, which could adversely impact our ability to conduct our business.

If we raise additional funds through collaborations, strategic alliances or marketing, distribution or licensing arrangements with third parties, we may have to relinquish valuable rights to our intellectual property, technologies,

 

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future revenue streams or WIN378 and WIN027 or any other potential future product candidates or grant licenses on terms that may not be favorable to us. We could also be required to seek funds through arrangements with collaborators or others at an earlier stage than otherwise would be desirable. Any of these occurrences may have a material adverse effect on our business, financial condition, results of operations and growth prospects.

If securities or industry analysts do not publish or cease to publish research or publish inaccurate or unfavorable research about our business, our share price and trading volume could decline.

The trading market for our common shares will depend in part on the research and reports that securities or industry analysts publish about us or our business. Securities and industry analysts do not currently, and may never, publish research on us. If no securities or industry analysts commence coverage of us, the trading price for our shares would likely be negatively impacted. In the event securities or industry analysts initiate coverage, if one or more of the analysts who covers us downgrades our shares or publishes inaccurate or unfavorable research about our business, our share price may decline. If one or more of these analysts ceases coverage of us or fails to publish reports on us regularly, demand for our shares could decrease, which might cause our share price and trading volume to decline.

The rights of shareholders in companies subject to Swiss corporate law differ in material respects from the rights of shareholders of corporations incorporated in the United States.

We are a Swiss corporation. Our corporate affairs are governed by our articles of association and by the laws governing companies incorporated in Switzerland. The rights of our shareholders and the responsibilities of our directors are in many ways different from the rights and obligations of shareholders and directors of companies governed by the laws of U.S. jurisdictions. For example, in the performance of its duties, our board of directors is required by Swiss law to consider our interests, and may also have regard to the interest of our shareholders, our employees and other stakeholders, in all cases with due observation of the principles of due care and loyalty. It is possible that some of these parties will have interests that are different from, or in addition to, your interests as a shareholder. See the sections of this prospectus titled “Comparison of Shareholder Rights under Swiss and Delaware Corporate Law,” “Management—Corporate Governance Practices” and “Description of Share Capital and Articles of Association.”

Swiss corporate law limits the ability of our shareholders to challenge resolutions made or other actions taken by our board of directors in court. Our shareholders generally are not permitted to file a suit to reverse a decision or an action taken by our board of directors, but are instead only permitted to seek damages for breaches of fiduciary duty. As a matter of Swiss law, due to the jurisdiction clause contained in our revised articles of association, shareholder claims against a director for breach of fiduciary duty would have to be brought exclusively to the competent courts in Basel, Switzerland. In addition, under Swiss law, due to the jurisdiction clause contained in our revised articles of association, any claims by our shareholders against us must be brought exclusively to the competent courts in Basel, Switzerland. U.S.-style class actions and derivative actions are not available under Swiss law. A further summary of applicable Swiss corporate law is included in this prospectus, see “Description of Share Capital and Articles of Association” and “Comparison of Shareholder Rights under Swiss and Delaware Corporate Law” included elsewhere in this prospectus. There can be no assurance that Swiss law will not change in the future, which could adversely affect the rights of our shareholders, or that Swiss law will protect our shareholders in a similar fashion as under U.S. corporate law principles.

Swiss law imposes mandatory shareholder approval of board and executive compensation and prohibits certain forms of compensation, which may limit our flexibility to attract, retain and incentivize directors and executive officers.

As a Swiss company, we are subject to the Swiss Code of Obligations, including provisions originally introduced by the Ordinance Against Excessive Compensation at Listed Stock Corporations and now codified in the Swiss Code of Obligations. These provisions require us to submit the aggregate amounts of compensation of our board of directors and of our executive committee separately to a binding shareholder vote at each annual general meeting. If our shareholders do not approve a compensation proposal, our board of directors shall determine, taking into account all relevant factors, the respective maximum aggregate amount or partial amounts, and submit the amount(s) so determined for approval by a general meeting of shareholders, which could delay our ability to pay, or create uncertainty regarding, compensation owed to our directors and executive officers.

In addition, Swiss law prohibits us from paying our directors and executive officers certain forms of compensation, including severance payments (other than compensation due during the remaining notice period), advance payments, and transaction premiums, and similar payments to members of our board of directors and executive

 

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committee. Swiss law also requires that employment agreements for a fixed term with members of our executive committee have a maximum duration of one year (renewal being possible) and that employment agreements for an indefinite term have a termination notice period of no more than twelve months.

These restrictions are more stringent than those applicable to many of our competitors organized in the United States or other jurisdictions, and may adversely affect our ability to attract, retain and incentivize qualified directors and executive officers, particularly in competition with companies not subject to comparable restrictions. Non- compliance with these requirements may also expose our directors and executive officers to criminal sanctions under Swiss law.

U.S. investors may have difficulty enforcing civil liabilities against us, our directors and senior management.

We are a corporation organized and incorporated under the laws of Switzerland with registered office and domicile in Basel, Switzerland. Certain members of our board of directors and senior management are non-residents of the United States, and all or a substantial portion of our assets and the assets of such persons are located outside the United States. As a result, it may not be possible to serve process on such persons or us in the United States or to enforce judgments obtained in U.S. courts against them or us based on civil liability provisions of the securities laws of the United States. Additionally, it may be difficult to assert U.S. securities law claims in actions originally instituted outside of the United States. Courts outside the United States may refuse to hear a U.S. securities law claim because non-U.S. courts may not be the most appropriate forums in which to bring such a claim. Even if a court outside the United States agrees to hear a claim, it may determine that the law of the jurisdiction in which the non-U.S. court resides, and not U.S. law, is applicable to the claim. Further, if U.S. law is found to be applicable, the content of applicable U.S. law must be proved as a fact, which can be a time-consuming and costly process, and certain matters of procedure would still be governed by the law of the jurisdiction in which the non-U.S. court resides. In particular, there is some doubt as to whether Swiss courts would recognize and enforce certain civil liabilities under U.S. securities laws in original actions or judgments of U.S. courts based upon these civil liability provisions. In addition, awards of punitive damages in actions brought in the United States or elsewhere may be unenforceable in Switzerland. An award for monetary damages under the U.S. securities laws would be considered punitive if it does not seek to compensate the claimant for loss or damage suffered but is intended to punish the defendant. Swiss law provides that an individual shareholder may, in its own name, for the benefit of the corporation, initiate a legal action to seek compensation for damages caused to the corporation from, amongst others, the directors of a corporation. If so, any damages awarded by the court are paid to the corporation and any legal fees relating to such action may be borne by the relevant shareholder. See “Comparison of Shareholder Rights under Swiss and Delaware Corporate Law” included elsewhere in this prospectus.

Investors may also have difficulties obtaining a favorable judicial forum for claims against us, our executive officers or our directors. Our amended and restated articles of association provide that all corporate law disputes between shareholders, our corporate bodies and members of such corporate bodies shall be resolved by the competent courts in Basel, Switzerland. This jurisdiction clause extends to all claims arising out of corporate law.

These provisions may limit a shareholder’s ability to bring a claim in a judicial forum of its choosing for disputes with us or any of our directors, shareholders, officers, or others, or may increase the cost of doing so, both of which may discourage lawsuits with respect to such claims. In the event a court finds the forum selection provisions contained in our amended and restated articles of association to be unenforceable or inapplicable in an action, we may incur additional costs associated with resolving such action in other jurisdictions, which could harm our results of operations.

The enforceability of any judgment in Switzerland will depend on the particular facts of the case as well as the laws and treaties in effect at the time. The United States and Switzerland do not currently have a treaty providing for recognition and enforcement of judgments, other than arbitration awards, in civil and commercial matters. Consequently, a final judgment for payment given by a court in the United States, whether or not predicated solely upon U.S. securities laws, may not be enforceable in Switzerland. See “Service of Process and Enforcement of Liabilities” included elsewhere in this prospectus.

 

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Our common shares are not listed in Switzerland, our home jurisdiction. As a result, certain Swiss law provisions designed to protect shareholders in the event of a public takeover offer or change of control transaction will not apply, in the same way they protect a Swiss company listed in Switzerland.

The Swiss rules that require investors to disclose their interest in a company if they reach, exceed or fall below certain ownership thresholds only applies to issuers that have a listing for their equity securities in Switzerland. Since our common shares are listed exclusively on Nasdaq, a U.S. market, the disclosure obligations regarding major shareholdings according to art. 120 of the Swiss Financial Markets Infrastructure Act and its implementing provisions do not apply to us. Likewise, the Swiss takeover regime does not apply to us. In particular, the duty to make a mandatory bid offer for all outstanding listed equity securities of a company by any person or group of persons that acquires more than one third of a company’s voting rights does not apply to us. In addition, the Swiss takeover regime imposes certain restrictions and obligations on bidders in a voluntary public takeover offer that are designed to protect shareholders. However, these protections are applicable only to issuers that list their equity securities in Switzerland and, because our common shares will be listed exclusively on Nasdaq, will not be applicable to us.

Furthermore, since Swiss law restricts our ability to implement rights plans or U.S.-style “poison pills,” our ability to resist an unsolicited takeover attempt or to protect minority shareholders in the event of a change of control transaction may be limited. Therefore, our shareholders may not be protected in the same degree in a public takeover offer or a change-of-control transaction as are shareholders in a Swiss company listed in Switzerland.

Anti-takeover provisions in our amended and restated articles of association could make an acquisition of us, which may be beneficial to our shareholders, more difficult.

Our amended and restated articles of association contain provisions that may have the effect of discouraging, delaying or preventing a change in control of us that shareholders may consider favorable, including transactions in which our shareholders may receive a premium for their shares. Our amended articles of association, which will become effective immediately prior to the completion of this offering, include provisions that:

 

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in certain cases, allow our board of directors to place an additional number of common shares corresponding to 50% of the share capital registered in the Commercial Register immediately after completion of this offering to be issued by way of a capital increase within our capital range, and rights to acquire an additional number of common shares corresponding to 30% of the share capital registered in the Commercial Register immediately after completion of this offering to be issued out of our conditional capital for financing, acquisitions and other purposes with affiliates or third parties, without existing shareholders having statutory subscription rights in relation to this share placement;

 

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allow our board of directors not to record any acquirer of common shares, or several acquirers acting in concert, in our share register as a shareholder with voting rights with respect to more than 14% of our share capital registered in the Commercial Register;

 

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restrict shareholders from exercising voting rights with respect to own or represented shares in excess of 14% of our share capital registered in the Commercial Register;

 

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limit the size of our board of directors to nine members; and

 

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require two-thirds of the votes represented at a general meeting of shareholders for amending or repealing the above-mentioned registration and voting restrictions, the provision setting a maximum board size, and the provision for indemnification of the members of our board of directors and our executive committee as set forth in our articles of association, and for dismissing the chairman or any member of our board of directors or any member of our compensation committee before the end of his or her term of office.

These and other provisions, alone or together, could delay or prevent takeovers and changes in control. See “Description of Share Capital and Articles of Association” included elsewhere in this prospectus. These provisions could also limit the price that investors might be willing to pay in the future for our common shares, thereby depressing the market price of our common shares.

Our executive officers, directors, principal shareholders and their respective affiliates own a significant percentage of our share capital and will be able to exert significant control over matters subject to shareholder approval.

Based on the beneficial ownership of our outstanding shares as of September 30, 2026, prior to this offering and concurrent private placement, our executive officers, directors, holders of 5% or more of our outstanding shares

 

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and their respective affiliates beneficially owned approximately 57.2% of our outstanding shares conferring voting rights and, upon the completion of this offering and concurrent private placement, that same group will hold approximately 45.4% of our outstanding common shares conferring voting rights (assuming no exercise of the underwriters’ option to purchase additional shares and no exercise of outstanding options), in each case assuming the conversion of all outstanding preferred shares into common shares and assuming no pre-funded warrants to be sold in the concurrent private placement will be exercised. As a result, these shareholders, if acting together, will continue to have significant influence over the outcome of corporate actions requiring shareholder approval, including the election and removal of directors, amendment of our articles of association, any merger, consolidation or sale of all or substantially all of our assets and certain other significant corporate transaction. In addition, certain of our principal shareholders, including OrbiMed Private Investments IX, LP, SR One Capital Fund II Aggregator, LP, and entities affiliated with Omega Funds, have designated certain members of our board of directors. In addition, our amended and restated articles of association, which will become effective immediately prior to the completion of this offering, will contain provisions stating that if an individual or legal entity acquires common shares and, as a result, directly or indirectly, has voting rights with respect to more than 14% of the share capital registered in the Commercial Register, the common shares exceeding the limit of 14% shall be entered in the share register as shares without voting rights. The interests of these shareholders may not be the same as or may even conflict with your interests. For example, these shareholders could delay or prevent a change of control, even if such a change of control would benefit our other shareholders, which could deprive our shareholders of an opportunity to receive a premium for their common shares as part of a sale of our company or our assets and might affect the prevailing market price of our common shares. In addition, because many of these shareholders purchased their shares at prices substantially below the price at which shares are being sold in this offering and have held their shares for a longer period, they may be more interested in selling our company to an acquirer than other investors, or they may want us to pursue strategies that deviate from the interests of other shareholders. The significant concentration of share ownership may adversely affect the trading price of our common shares due to investors’ perception that conflicts of interest may exist or arise.

Future sales of our common shares in the public market could cause our share price to fall.

Our share price could decline as a result of sales of a large number of common shares after this offering or the perception that these sales could occur. These sales, or the possibility that these sales may occur, might also make it more difficult for us to sell equity securities in the future at a time and price that we deem appropriate.

Upon the completion of this offering and the concurrent private placement, 58,038,748 common shares will be outstanding (or 59,582,865 common shares if the underwriters exercise their option to purchase additional common shares from us in full), based on the number of shares outstanding as of June 30, 2026, assuming the Preferred Share Conversion and the Series B Warrant Settlement, and in each case including 1,532,691 common shares to be sold to Sanofi in the concurrent private placement and assuming no pre-funded warrants sold by us will be exercised.

All common shares expected to be sold in this offering will be freely tradable without restriction or further registration under the Securities Act of 1933, as amended, or Securities Act, unless held by our “affiliates” as defined in Rule 144 under the Securities Act. The resale of the remaining 47,744,631 common shares, or 82% of our outstanding common shares following this offering, is currently prohibited or otherwise restricted, subject to certain limited exceptions, as a result of securities law provisions, market standoff agreements entered into by certain of our shareholders with us or lock-up agreements entered into by our directors, officers and our shareholders with the underwriters in connection with this offering under which they have agreed or will agree, subject to specific exceptions described in the section of this prospectus titled “Underwriting,” not to sell any of our common shares for 180 days following the date of this prospectus. We refer to such period as the lock-up period. We and certain of the underwriters may release certain shareholders from the market standoff agreements or lock-up agreements prior to the end of the lock-up period. However, subject to applicable securities law restrictions, these shares will be able to be sold in the public market beginning on the 181st day after the date of this prospectus. Shares issued upon the exercise of share options or vesting of restricted share units outstanding under our equity incentive plans or pursuant to future awards granted under those plans will become available for sale in the public market to the extent permitted by the provisions of applicable vesting schedules, market stand-off agreements and/or lock-up agreements, as well as Rules 144 and 701 under the Securities Act. For more information, see the section titled “Shares Eligible for Future Sale” included elsewhere in this prospectus.

 

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Upon the completion of this offering and the concurrent private placement, the holders of approximately 33,970,216 common shares, or 59% of our outstanding common shares following this offering, will have rights, subject to some conditions, to require us to file registration statements covering the sale of their shares or to include their shares in registration statements that we may file for ourselves or our other shareholders. We also intend to register the offer and sale of all common shares that we may issue under our equity incentive plans. Once we register the offer and sale of shares for the holders of registration rights and shares that may be issued under our equity incentive plans, these shares will be able to be sold in the public market upon issuance, subject to the lock-up agreements described in the section titled “Underwriting” included elsewhere in this prospectus.

In addition, in the future, we may issue additional common shares, or other equity or debt securities convertible into common shares, in connection with a financing, acquisition, employee arrangement, or otherwise. Any such issuance could result in substantial dilution to our existing shareholders and could cause the price of our common shares to decline.

We will have broad discretion in how we use the proceeds of this offering and the concurrent private placement and may not use these proceeds effectively, which could affect our results of operations and cause our share price to decline.

We will have considerable discretion in the application of the net proceeds of this offering and the concurrent private placement, including for any of the purposes described in the section of this prospectus titled “Use of Proceeds,” and you will not have the opportunity as part of your investment decision to assess whether the net proceeds are being used appropriately. As a result, investors will be relying upon management’s judgment with only limited information about our specific intentions for the use of the net proceeds of this offering. We may use the net proceeds for purposes that do not yield a significant return or any return at all for our shareholders. In addition, pending their use, we may invest the net proceeds from this offering and concurrent private placement in a manner that does not produce income or that loses value.

If you purchase our common shares in this offering and concurrent private placement, you will experience substantial and immediate dilution.

The assumed initial public offering price of $17.00 per share, midpoint of our estimated price range, is substantially higher than the pro forma as adjusted net tangible book value per common share outstanding immediately following the completion of this offering and the concurrent private placement. If you purchase common shares in this offering, you will experience substantial and immediate dilution in the pro forma as adjusted net tangible book value of $10.26 per share as of June 30, 2026. That is because the price that you pay will be substantially greater than the pro forma as adjusted net tangible book value per share of the common shares that you acquire. This dilution is due in large part to the fact that our earlier investors paid substantially less than the initial public offering price when they purchased their shares. You will experience additional dilution if the underwriters exercise their option to purchase additional shares in this offering, when those holding share options exercise their right to purchase common shares under our equity incentive plans, upon the vesting of outstanding restricted share units or when we otherwise issue additional common shares. For additional details see the section titled “Dilution” included elsewhere in this prospectus.

The registration of the share capital increases in the Commercial Register may be blocked and the shareholders’ resolutions regarding the ordinary share capital increases and the creation of a capital range may be challenged.

This offering is subject to, among other things, approval by our shareholders of resolutions regarding the ordinary share capital increase and the creation of a capital range necessary to source the common shares to be sold in this offering, which was obtained on November 5, 2026. The execution of the ordinary share capital increase and the share capital increase within the capital range (if applicable) by our board of directors and the related filings will be made prior to the completion of this offering and, with regard to the common shares to be issued upon any exercise of the underwriters’ option to purchase additional common shares (if any), upon exercise of such option. The issuance of new common shares will become effective upon registration in the Commercial Register. As with all share capital increases in Switzerland, the shareholders’ resolutions regarding such share capital increase may be challenged in court within two months after such shareholders’ meeting and/or the registration of the capital increases in the Commercial Register may be blocked temporarily by a preliminary injunction or permanently by order of a competent court. Either action would prevent or delay the completion of this offering.

 

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Our issuance of additional shares in connection with financings, acquisitions, investments, our equity incentive plans or otherwise will dilute all other shareholders.

We expect to issue additional shares in the future that will result in dilution to all other shareholders. We expect to grant equity awards to employees, directors and consultants under our equity incentive plans. We may also raise capital through equity financings in the future. As part of our business strategy, we may acquire or make investments in complementary companies, products or technologies and issue equity securities to pay for any such acquisition or investment. Any such issuances of additional shares may cause shareholders to experience significant dilution of their ownership interests and the per share value of our common shares to decline.

Our amended and restated articles of association provide for conditional share capital for financing, acquisitions and other purposes, excluding the advance subscription rights and pre-emptive subscription rights of our existing shareholders, which may result in a dilution of our existing shareholders.

Our amended and restated articles of association provide for conditional share capital for financing, acquisitions and other purposes in an amount equal to 30% of our share capital registered in the Commercial Register immediately after completion of this offering. Common shares may be issued out of this conditional capital through the exercise or mandatory exercise of conversion, exchange, option, subscription or other rights to acquire shares or through obligations to acquire common shares, which are granted to or imposed on shareholders or third parties alone or in connection with bonds, notes, options, warrants or other financial instruments issued by us or any of our group companies. Our amended and restated articles of association provide for an exclusion of the advance subscription rights of our shareholders in connection with the issuance of any such financial instruments and the exclusion of the pre-emptive subscription rights of our shareholders in connection with the issuance of common shares upon exercise of any such financial instruments. See “Description of Share Capital and Articles of Association—Certain Important Provisions of our Articles of Association, Organizational Regulations and Swiss Law—Our Conditional Share Capital” included elsewhere in this prospectus. Such shares may be issued at a price below the respective stock exchange price, and such financial instruments may be issued below their intrinsic value. As a result, our existing shareholders may experience significant dilution of their ownership interests if and when such financial instruments are issued and subsequently converted into or exercised for our common shares. This may adversely affect the per share value of our common shares.

We do not currently intend to pay dividends and, consequently, our shareholders’ ability to achieve a return on their investment will depend on appreciation of the value of our common shares.

We have never declared or paid dividends, whether in cash, in kind or otherwise, since our incorporation. Even if future operations lead to significant levels of distributable profits, we currently intend to retain all available funds and any future earnings to support operations and to finance the growth and development of our business. We do not intend to declare or pay any dividends in the foreseeable future, and we may never be able to do so. Any proposal of our board of directors to the general meeting of shareholders to pay future dividends will be at the discretion of our board of directors after taking into account various factors, including our business prospects, cash requirements, financial performance and new product development, and subject to approval by the general meeting of shareholders. In addition, payment of future dividends is subject to certain limitations pursuant to Swiss law. See “Description of Share Capital and Articles of Association—Dividends and Other Distributions” included elsewhere in this prospectus. Also, we are a holding company with no material direct operations. As a result, we would be largely dependent on dividends or other distributions from our subsidiaries in order to pay a dividend. Our subsidiaries are subject to legal requirements of their respective jurisdictions of incorporation that may restrict their paying dividends or making other distributions to us. As a result, investors cannot rely on dividend income from our common shares and any investment return on our common shares will depend upon increases in the value for our common shares, which is not certain.

Our status as a Swiss corporation means that our shareholders enjoy certain rights that may limit our flexibility to raise capital, issue dividends and otherwise manage ongoing capital needs.

Swiss law reserves for approval by shareholders certain corporate actions over which a board of directors would have authority in some other jurisdictions. For example, the payment of dividends and the cancellation of treasury shares must be approved by shareholders (other than a cancellation of treasury shares within a capital range). Swiss law also requires that our shareholders themselves resolve to, or authorize our board of directors to, increase our share capital or cancel treasury shares. While our shareholders may resolve to create a capital range and thereby authorize our board of directors to issue new shares or cancel treasury shares without additional shareholder approval, Swiss law limits this authorization to 50% of the share capital registered in the Commercial Register at the time of the

 

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authorization. The authorization, furthermore, has a limited duration of up to five years and must be renewed by the shareholders from time to time thereafter (or in the event of an earlier lapse of the capital range in accordance with Swiss law) in order to be available for raising capital. Additionally, subject to specified exceptions, including exceptions explicitly described in our articles of association, Swiss law grants subscription rights to existing shareholders to subscribe for new issuances of shares, which may be limited or withdrawn under certain conditions. Swiss law also does not provide as much flexibility in the various rights and regulations that can attach to different classes of shares as do the laws of some other jurisdictions. These Swiss law requirements relating to our capital management may limit our flexibility, and situations may arise where greater flexibility would have provided benefits to our shareholders. See “Description of Share Capital and Articles of Association” included elsewhere in this prospectus.

Shareholders outside of the United States may not be able to exercise subscription rights in future issuances of equity or other securities that are convertible into equity.

Under Swiss corporate law, shareholders may receive certain subscription rights to subscribe on a pro-rata basis for issuances of equity securities or other securities that are convertible into equity securities. Due to the laws and regulations in certain jurisdictions, however, shareholders who are not residents of the United States may not be able to exercise such rights unless we take action to register or otherwise qualify the rights offering, including, for example, by complying with prospectus requirements under the laws of that jurisdiction. There can be no assurance that we will take any action to register or otherwise qualify an offering of subscription rights or shares under the laws of any jurisdiction other than the United States where the offering of such rights is restricted. If shareholders in such jurisdictions were unable to exercise their subscription rights, their ownership interest in us will be diluted.

We may not be able to satisfy listing requirements of Nasdaq or obtain or maintain a listing of our common shares on Nasdaq.

We must meet certain financial and liquidity criteria in order to list our common shares on Nasdaq. If we violate Nasdaq’s listing requirements, our common shares may be delisted. If we fail to meet any of Nasdaq’s listing standards, our common shares may be delisted. In addition, our board of directors may determine that the cost of maintaining our listing on a national securities exchange outweighs the benefits of such listing and may therefore propose to the general meeting of shareholders to approve a delisting of our common shares. A delisting of our common shares from Nasdaq may materially impair our shareholders’ ability to buy and sell our common shares and could have an adverse effect on the market price of, and the efficiency of the trading market for, our common shares. The delisting of our common shares could significantly impair our ability to raise capital and the value of your investment.

Other General Risks and Our Status as a Swiss Company with Foreign Private Issuer Status

Unfavorable global economic and geopolitical conditions could adversely affect our business, financial condition, results of operations and share price.

The global credit and financial markets have experienced extreme volatility and disruptions (including as a result of actual or perceived changes in interest rates, foreign currency, inflation and macroeconomic uncertainties), which has included severely diminished liquidity and credit availability, declines in consumer confidence, declines in economic growth, high inflation, uncertainty about economic stability, global supply chain disruptions, and increases in unemployment rates. The financial markets and the global economy may also be adversely affected by the current or anticipated impact of military conflict, including the ongoing conflicts between Russia and Ukraine, and in the Middle East, terrorism, or other geopolitical events, including threatened or actual trade wars and tariffs. Sanctions imposed by the United States and other countries in response to such conflicts, including the one in Ukraine, may also continue to adversely impact the financial markets and the global economy, and any economic countermeasures by the affected countries or others could exacerbate market and economic instability. There can be no assurance that further deterioration in credit and financial markets and confidence in economic conditions will not occur. A severe or prolonged economic downturn could result in a variety of risks to our business, including a decrease in the demand for WIN378 and WIN027 or any other potential future product candidates and in our ability to raise additional capital when needed on acceptable terms, if at all.

There are also current geopolitical tensions with the PRC that may affect our operations. For example, the U.S. BIOSECURE Act, which was enacted in December 2025 as part of the National Defense Authorization Act for Fiscal Year 2026, prohibits federal agencies from procuring or using any biotechnology equipment or services provided or produced by “biotechnology companies of concern,” or entering, extending, or renewing any contracts with entities

 

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that use such biotechnology equipment or services from “biotechnology companies of concern” to perform those contracts. The Office of Management and Budget, or OMB, will issue a list of “biotechnology companies of concern” no later than mid-December 2026, which will include (i) certain companies that are named in the Department of Defense’s List of Chinese Military Companies, also known as the 1260H List, (ii) companies that OMB designates as a “biotechnology company of concern” pursuant to certain criteria including whether such entities are subject to the administrative governance structure, direction, or control, or operates on behalf of, a foreign adversary (including the PRC) and that pose a risk to U.S. national security based on its research with foreign government militaries or multiomic data collection (e.g., collection of genomic information) without consent, and (iii) certain subsidiaries or parent or successor entities of the foregoing. There is a “safe harbor” provision in the BIOSECURE Act providing that the restrictions do not apply to equipment or services that were formerly but are no longer provided by a “biotechnology company of concern,” as well as a “grandfathering” provision providing that the prohibitions shall not apply for a five-year period to biotechnology equipment or services produced or provided under a contract or agreement entered into before the applicable effective date. While the U.S. BIOSECURE Act contains such safe harbor and grandfathering provisions, and has carveouts that protect drugs paid under Medicaid, subject to the Secretary of Veteran Affairs’ discretion, the impact of the U.S. BIOSECURE Act on the biotechnology industry is uncertain. This and similar laws could have the potential to restrict the ability of companies to work with certain PRC biotechnology companies of concern without losing the ability to contract with, or otherwise receive funding from, the U.S. government.

It is possible that some of our contractual counterparties, including Kelun and Qyuns, could be impacted by such future legislation or government policies. If any of the other third parties that we engage to supply any materials or manufacture products for our nonclinical studies and clinical trials should cease to continue to do so, or if we are prevented or restricted from using their services for any reason, we could experience delays in advancing these studies and trials while we identify and qualify replacement suppliers.

We are currently in the process of transferring the manufacturing of WIN378 clinical trial material from Kelun’s facilities in the PRC to contract manufacturing organizations in the United States. Qyuns continues to manufacture WIN027 clinical trial material at its facilities in the PRC. We plan to transfer the manufacturing of WIN027 clinical trial material to contract manufacturing organizations outside of the PRC. To the extent WIN378 and/or WIN027 clinical trial material continues to be manufactured in the PRC pending such a transfer, and if Kelun or Qyuns were to be designated as a “biotechnology company of concern,” our ability to access federal funding in connection with that manufacturing relationship could be adversely affected. Any additional executive action, legislative action or potential sanctions with the PRC could materially impact our current manufacturing collaborators, Kelun and Qyuns, and our agreement with them. We continue to assess the legislation as it develops to determine the effect, if any, on our contractual relationships. Furthermore, any disruptions to our supply chain as a result of unfavorable global economic conditions, including due to geopolitical conflicts or public health crises, could negatively impact the timely execution of our ongoing and future clinical trials.

In addition, current inflationary trends in the global economy may impact salaries and wages, costs of goods and transportation expenses, among other things, and recent and potential future disruptions in access to bank deposits or lending commitments due to bank failures may create market and economic instability. We cannot anticipate all of the ways in which the foregoing, and the current economic climate and financial market conditions generally, could adversely impact our business.

We maintain the majority of our cash and cash equivalents in accounts with major U.S. and multi-national financial institutions, and our deposits at certain of these institutions may exceed insured limits. Market conditions and changes in financial regulations and policies can impact the viability of these institutions. In the event of failure of any of the financial institutions where we maintain our cash and cash equivalents, there can be no assurance that we would be able to access uninsured funds in a timely manner or at all. Any inability to access or delay in accessing these funds could adversely affect our business and financial position. In addition, changes in regulations governing financial institutions are beyond our control and difficult to predict; consequently, the impact of such changes on our business and results of operations is difficult to predict and may have an adverse effect on us.

 

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We, or the third parties upon whom we depend, may be adversely affected by natural disasters, pandemics and epidemics, public health crises or other business interruptions and our business continuity and disaster recovery plans may not adequately protect us from a serious disaster.

Natural disasters, pandemics, epidemics or public health crises could severely disrupt our operations, and have a material adverse impact on our business, financial condition, results of operations and growth prospects. If natural disasters, pandemics, epidemics, power outages, public health crises or other events occurred that affected our supply chains or prevented us from conducting our clinical trials, releasing clinical trial results or delaying our ability to obtain regulatory approval for our product candidates, it may be difficult or, in certain cases, impossible for us to continue our business for a substantial period of time.

International trade policies, including tariffs, sanctions and trade barriers may adversely affect our business, financial condition, results of operations and prospects.

We operate in a global economy, which includes utilizing third-party suppliers in several countries outside the United States. There is inherent risk, based on the complex relationships among the United States and the countries in which we conduct our business, that political, diplomatic, and national security factors can lead to global trade restrictions and changes in trade policies and export regulations that may adversely affect our business and operations. The current international trade and regulatory environment is subject to significant ongoing uncertainty. The U.S. government has recently announced substantial new tariffs affecting a wide range of products and jurisdictions and has indicated an intention to continue developing new trade policies, including with respect to the pharmaceutical industry. In response, certain foreign governments have announced or implemented retaliatory tariffs and other protectionist measures. These developments have created a dynamic and unpredictable trade landscape, which may adversely impact our business, results of operations, financial condition and prospects.

We currently rely, and expect to continue to rely, on third parties for the manufacture of our product candidates for clinical testing, as well as for manufacture of any products that we may commercialize, if approved. Currently, several of our suppliers are located outside of the United States, and our principal suppliers of certain raw materials are located outside of the United States. We are in the process of transferring the manufacturing process of WIN378 to contract manufacturing organizations in the United States, which is expected to complete by the end of 2026. We plan to transfer the manufacturing process for WIN027 to the United States in the future. We also rely on specialized laboratory equipment, supplies, materials, and precursor compounds, all or part of which we believe may be ultimately sourced from multiple countries outside the United States, to advance our research and development efforts.

Current or future tariffs will result in increased research and development expenses, including with respect to increased costs associated with APIs, raw materials, laboratory equipment and research materials and components. In addition, such tariffs will increase our supply chain complexity and could also potentially disrupt our existing supply chain. Trade restrictions affecting the import of materials necessary for clinical trials could result in delays to our development timelines. Increased development costs and extended development timelines could place us at a competitive disadvantage compared to companies operating in regions with more favorable trade relationships and could reduce investor confidence, negatively impacting our ability to secure additional financing on favorable terms or at all. In addition, as we advance toward commercialization in the future, tariffs and trade restrictions could hinder our ability to establish cost-effective production capabilities, negatively impacting our growth prospects.

The complexity of announced or future tariffs may also increase the risk that we or our customers or suppliers may be subject to civil or criminal enforcement actions in the United States or foreign jurisdictions related to compliance with trade regulations. Foreign governments may also adopt non-tariff measures, such as procurement preferences or informal disincentives to engage with, purchase from or invest in U.S. entities, which may limit our ability to compete internationally and attract non-U.S. investment, employees, customers and suppliers. Foreign governments may also take other retaliatory actions against U.S. entities, such as decreased intellectual property protection, increased enforcement actions, or delays in regulatory approvals, which may result in heightened international legal and operational risks. In addition, the United States and other governments have imposed and may continue to impose additional sanctions, such as trade restrictions or trade barriers, which could restrict us from doing business directly or indirectly in or with certain countries or parties and may impose additional costs and complexity to our business.

 

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Trade disputes, tariffs, restrictions and other political tensions between the United States and other countries may also exacerbate unfavorable macroeconomic conditions including inflationary pressures, foreign exchange volatility, financial market instability, and economic recessions or downturns. The ultimate impact of current or future tariffs and trade restrictions remains uncertain and could materially and adversely affect our business, financial condition, and prospects. While we actively monitor these risks, any prolonged economic downturn, escalation in trade tensions, or deterioration in international perception of U.S.-based companies could materially and adversely affect our business, ability to access the capital markets or other financing sources, results of operations, financial condition and prospects. In addition, tariffs and other trade developments have and may continue to heighten the risks related to the other risk factors described elsewhere in this prospectus.

We will incur significant increased costs as a result of operating as a public company, and our management will be required to devote substantial time to new compliance initiatives and corporate governance practices.

As a public company, we will incur significant legal, accounting and other expenses that we did not incur as a private company. In connection with this offering, we will become subject to the reporting requirements of the Exchange Act, which require, among other things, that we file with the Securities and Exchange Commission, or SEC, annual and current reports with respect to our business and financial condition. In addition, the Sarbanes-Oxley Act of 2002, as amended, or the Sarbanes-Oxley Act, as well as rules subsequently adopted by the SEC and Nasdaq to implement provisions of the Sarbanes-Oxley Act, impose significant requirements on public companies, including requiring establishment and maintenance of effective disclosure and financial reporting controls and changes in corporate governance practices. Further, in July 2010, the Dodd-Frank Wall Street Reform and Consumer Protection Act, or the Dodd-Frank Act was enacted. Recent legislation permits emerging growth companies to implement many of these requirements over a longer period and up to five years from the pricing of this offering. Shareholder activism, the current political environment and the current high level of government intervention and regulatory reform may lead to substantial new regulations and disclosure obligations, which may lead to additional compliance costs and impact the manner in which we operate our business in ways we cannot currently anticipate. In addition, in Switzerland, certain legislation affecting public companies will impose additional disclosure and compliance requirements on us, including in respect of executive compensation.

We expect the rules and regulations applicable to public companies to substantially increase our legal and financial compliance costs and to make some activities more time-consuming and costly. If these requirements divert the attention of our management and personnel from other business concerns, they could have an adverse effect on our business. The increased costs will decrease our net income or increase our net loss, and may require us to reduce costs in other areas of our business or increase the prices of our products or services. For example, we expect these rules and regulations to make it more difficult and more expensive for us to obtain director and officer liability insurance and we may be required to incur substantial costs to maintain the same or similar coverage. We cannot predict or estimate the amount or timing of additional costs we may incur to respond to these requirements. The impact of these requirements could also make it more difficult for us to attract and retain qualified persons to serve on our board of directors, our board committees or on our executive committee. In addition, these rules and regulations are often subject to varying interpretations, in many cases due to their lack of specificity and, as a result, their application in practice may evolve over time as new guidance is provided by regulatory and governing bodies. This could result in continuing uncertainty regarding compliance matters and higher costs necessitated by ongoing revisions to disclosure and governance practices.

If we fail to establish and maintain an effective system of internal control over financial reporting, we may not be able to accurately report our financial results or prevent fraud. As a result, shareholders could lose confidence in our financial and other public reporting, which would harm our business and the trading price of our common shares.

Ensuring that we have adequate internal financial and accounting controls and procedures in place so that we can produce accurate financial statements on a timely basis is a costly and time-consuming effort that needs to be reevaluated frequently. Our internal control over financial reporting is a process designed to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements in accordance with IFRS. In connection with this offering, we intend to begin the process of documenting, reviewing and improving our internal controls and procedures for compliance with Section 404 of the Sarbanes-Oxley Act, which will require annual management assessment of the effectiveness of our internal control over financial reporting. Any failure to implement required new or improved controls, or difficulties encountered in their implementation could cause us to fail to meet our reporting obligations. In addition, any testing by us conducted in connection with Section 404, or

 

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any subsequent testing by our independent registered public accounting firm, may reveal deficiencies in our internal controls over financial reporting that are deemed to be material weaknesses or that may require prospective or retroactive changes to our financial statements or identify other areas for further attention or improvement. Inferior internal controls could also cause investors to lose confidence in our reported financial information, which could have a negative effect on the trading price of our shares.

Upon becoming a publicly traded company, we will be required, pursuant to Section 404 of the Sarbanes-Oxley Act, to furnish a report by management on, among other things, the effectiveness of our internal control over financial reporting as of the end of the fiscal year that coincides with the filing of our second annual report on Form 20-F. However, for as long as we are an emerging growth company or a non-accelerated filer, our independent registered public accounting firm will not be required to attest to the effectiveness of our internal controls over financial reporting pursuant to Section 404(b) of the Sarbanes-Oxley Act. We could be an emerging growth company for up to five years following completion of this initial public offering. An independent assessment of the effectiveness of our internal controls over financial reporting could detect problems that our management’s assessment might not. Undetected material weaknesses in our internal controls over financial reporting could lead to restatements of our financial statements and require us to incur the expense of remediation.

Our disclosure controls and procedures may not prevent or detect all errors or acts of fraud.

In connection with this offering, we will become subject to the periodic reporting requirements of the Exchange Act. We must design our disclosure controls and procedures to reasonably assure that information we must disclose in reports we file or submit under the Exchange Act is accumulated and communicated to management, and recorded, processed, summarized, and reported within the time periods specified in the rules and forms of the SEC. We believe that any disclosure controls and procedures, no matter how well-conceived and operated, can provide only reasonable, not absolute, assurance that the objectives of the control system are met. These inherent limitations include the realities that judgments in decision-making can be faulty, and that breakdowns can occur because of simple error or mistake. For example, our directors or executive officers could inadvertently fail to disclose a new relationship or arrangement causing us to fail to make a required related party transaction disclosure. Additionally, controls can be circumvented by the individual acts of some persons, by collusion of two or more people or by an unauthorized override of the controls. Accordingly, because of the inherent limitations in our control system, misstatements due to error or fraud may occur and not be detected.

We may become involved in securities class action litigation that could divert management’s attention and harm our business, and insurance coverage may not be sufficient to cover all costs and damages.

In the past, securities class action litigation has often followed certain significant business transactions, such as the sale of a company or announcement of any other strategic transaction, or the announcement of negative events, such as negative results from clinical trials. These events may also result in or be concurrent with investigations by the SEC. We may be exposed to such litigation or investigation even if no wrongdoing occurred. Litigation and investigations are usually expensive and divert management’s attention and resources, which could adversely affect our business and cash resources and our ability to consummate a potential strategic transaction or the ultimate value our shareholders receive in any such transaction.

As a foreign private issuer, we are exempt from a number of rules under the U.S. securities laws and are permitted to file less information with the SEC than a U.S. company. This may limit the information available to holders of our common shares.

We are a foreign private issuer, as defined in the SEC’s rules and regulations and, consequently, we are not subject to all of the disclosure requirements applicable to public companies organized within the United States. For example, we are exempt from certain rules under the Exchange Act that regulate disclosure obligations and procedural requirements related to the solicitation of proxies, consents or authorizations applicable to a security registered under the Exchange Act, including the U.S. proxy rules under Section 14 of the Exchange Act. In addition, our officers, directors and significant shareholders are exempt from the “short-swing” profit recovery provisions of Section 16 of the Exchange Act and related rules with respect to their purchases and sales of our securities. Moreover, while we expect to file financial reports on an annual and semi-annual basis, we will not be required to file periodic reports and financial statements with the SEC as frequently or as promptly as U.S. public companies and will not be required to file quarterly reports on Form 10-Q under the Exchange Act. Moreover, we are not required to comply with Regulation FD, which restricts the selective disclosure of material information.

 

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Accordingly, there will be less publicly available information concerning our company than there would be if we were not a foreign private issuer.

As a foreign private issuer, we are permitted, and we expect, to follow certain home country practices in relation to corporate governance matters that differ significantly from Nasdaq’s corporate governance standards. These practices may afford less protection to shareholders than they would enjoy if we complied fully with the corporate governance standards of the Nasdaq.

As a foreign private issuer to be listed on Nasdaq, we will be subject to Nasdaq’s corporate governance standards. However, Nasdaq rules provide that foreign private issuers are permitted to follow home country corporate governance practices in lieu of Nasdaq’s corporate governance standards as long as notification is provided to Nasdaq of the intention to take advantage of such exemptions. We intend to rely on exemptions for foreign private issuers and follow Swiss corporate governance practices in lieu of Nasdaq’s corporate governance standards, to the extent possible. Certain corporate governance practices in Switzerland, which is our home country, may differ significantly from Nasdaq’s corporate governance standards. For example, as a Swiss company, neither Swiss law nor our articles of association require a majority of our directors to be independent and we can include non-independent directors as members of our compensation committee, and our independent directors are not required to hold regularly scheduled meetings at which only independent directors are present.

We are also exempt from provisions set forth in Nasdaq rules which require an issuer to provide in its by-laws for a generally applicable quorum, and that such quorum may not be less than one-third of the outstanding voting shares. Consistent with Swiss law, our articles of association do not provide for any quorum requirement applicable to the general meeting of shareholders.

As a foreign private issuer, we are required to comply with Rule 10A-3 of the Exchange Act, relating to audit committee composition and responsibilities. Under Swiss law, the audit committee may only have an advisory role and appointment of our statutory auditors, in particular, must be decided by the shareholders at our annual general meeting. Therefore, our shareholders may be afforded less protection than they otherwise would have under Nasdaq’s corporate governance standards applicable to U.S. domestic issuers. For an overview of our corporate governance practices, see “Management—Corporate Governance Practices.”

We may lose our foreign private issuer status in the future, which could result in significant additional cost and expense.

While we currently qualify as a foreign private issuer, the determination of foreign private issuer status is made annually on the last business day of an issuer’s most recently completed second fiscal quarter and, accordingly, the next determination will be made with respect to us on June 30, 2027. In the future, we could lose our foreign private issuer status if we fail to meet the requirements necessary to maintain our foreign private issuer status as of the relevant determination date. We will remain a foreign private issuer until such time that more than 50% of our outstanding voting securities are held by U.S. residents and any of the following three circumstances applies: (i) the majority of our executive officers or directors are U.S. citizens or residents; (ii) more than 50% of our assets are located in the United States; or (iii) our business is administered principally in the United States. For additional information relating to our principal shareholders, see “Principal Shareholders.” Furthermore, on June 4, 2025, the SEC published a Concept Release highlighting potential amendments to the foreign private issuer definition, such as updating eligibility requirements or adding foreign stock exchange trading volume and listing criteria. If we lose our status as a foreign private issuer due to new requirements adopted by the SEC or because we no longer meet the current definition, or if certain of the exemptions currently available to foreign private issuers will be cancelled or limited, the regulatory and compliance costs to us under U.S. securities laws as a U.S. domestic issuer may be significantly more than costs we incur as a foreign private issuer. If we are not a foreign private issuer, we will be required to file periodic reports and registration statements on U.S. domestic issuer forms with the SEC, which are more detailed and extensive in certain respects than the forms available to a foreign private issuer. We would be required under current SEC rules to prepare our financial statements in accordance with U.S. GAAP, rather than IFRS, and modify certain of our policies to comply with corporate governance practices associated with U.S. domestic issuers. Such conversion of our financial statements to U.S. GAAP would involve significant time and cost. In addition, we may lose our ability to rely upon exemptions from certain corporate governance requirements on U.S. stock exchanges that are available to foreign private issuers such as the ones described herein and exemptions from procedural requirements related to the solicitation of proxies.

 

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We are eligible to be treated as an “emerging growth company” and a “smaller reporting company” and our election of reduced reporting requirements applicable to emerging growth companies and smaller reporting companies may make our common shares less attractive to investors.

We are an “emerging growth company” as defined in the Jumpstart Our Business Startups Act, or JOBS Act. For as long as we continue to be an emerging growth company, we may take advantage of exemptions from various reporting requirements that are applicable to other public companies that are not emerging growth companies, including:

 

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reduced disclosure obligations regarding executive compensation in this prospectus and our periodic reports, proxy statements and registration statements;

 

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exemptions from the requirements of holding a nonbinding advisory vote on executive compensation and shareholder approval of any golden parachute payments not previously approved;

 

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being permitted to provide only two years of audited financial statements in addition to any required unaudited interim financial statements and a correspondingly reduced “Management’s Discussion and Analysis of Financial Condition and Results of Operations” disclosure in this prospectus;

 

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an exemption from compliance with the auditor attestation requirements of Section 404 in the assessment of our internal control over financial reporting; and

 

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an exemption from compliance with the requirements of the Public Company Accounting Oversight Board regarding the communication of critical audit matters in the auditor’s report on the financial statements.

We may take advantage of these exemptions for up to five years following the completion of this offering or such earlier time that we are no longer an emerging growth company. We would cease to be an emerging growth company on the date that is the earliest of (i) the last day of the fiscal year in which we have total annual gross revenue of $1.235 billion; (ii) the last day of our fiscal year following the fifth anniversary of the date of the completion of this offering; (iii) the date on which we have issued more than $1.0 billion in non-convertible debt during any three-year period before that time; or (iv) the date on which we are deemed to be a “large accelerated filer,” which would occur if the aggregate market value of our equity securities held by non-affiliates exceeds $700.0 million as of the last business day of our most recently completed second fiscal quarter. For so long as we remain an emerging growth company, we are permitted and intend to rely on exemptions from certain disclosure requirements that are applicable to other public companies that are not emerging growth companies.

Section 107 of the JOBS Act also provides that an emerging growth company that prepares its financial statements in accordance with U.S. GAAP can take advantage of the extended transition period provided in Section 13(a) of the Exchange Act, for complying with new or revised accounting standards. As a result, an emerging growth company can delay the adoption of certain U.S. GAAP accounting standards until those standards would otherwise apply to private companies. Given that we currently prepare our financial statements in accordance with IFRS, as issued by the IASB, we will comply with new or revised accounting standards on the relevant dates on which adoption of such standards is required by the IASB.

Even after we no longer qualify as an emerging growth company, we could still qualify as a “smaller reporting company,” which would allow us to take advantage of many of the same exemptions from disclosure requirements and reduced disclosure obligations regarding executive compensation in this prospectus and our periodic reports and proxy statements. We cannot predict if investors will find our common shares less attractive because we may rely on these exemptions. If some investors find our common shares less attractive as a result, there may be a less active trading market for our common shares and our share price may be more volatile.

We may be a “passive foreign investment company” for U.S. federal income tax purposes, which could result in adverse U.S. federal income tax consequences to U.S. investors.

Based on the nature and composition of our income and the nature, composition and estimated value of our assets, we do not believe we were a passive foreign investment company, or PFIC, during the taxable year ended December 31, 2025. Generally, for any taxable year, if at least 75% of our gross income is passive income, or at least 50% of the value of our assets (based on an average of the quarterly values of the assets during a taxable year) is attributable to assets that produce passive income or are held for the production of passive income, including cash, we would be characterized as a PFIC for U.S. federal income tax purposes. For purposes of these tests, passive income includes, among other things, dividends, interest, net gains from the sale or exchange of investment

 

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property, and rents or royalties other than rents or royalties which are received from unrelated parties in connection with the active conduct of a trade or business. Cash and cash equivalents are generally treated as passive assets. Goodwill is treated as an active asset to the extent associated with business activities that produce active income. For purposes of the PFIC rules, a non-U.S. corporation that owns, directly or indirectly, at least 25% by value of the equity interests of another corporation or partnership is treated as if it held its proportionate share of the assets of the other corporation or partnership, and received directly its proportionate share of the income of the other corporation or partnership. Equity interests of less than 25% by value in any other corporation or partnership are generally treated as passive assets, regardless of the nature of the other corporation or partnership’s business. If we are a PFIC for any taxable year in which a U.S. Holder (as defined in “Material U.S. Federal Income Tax Considerations for U.S. Holders”) holds our common shares, certain adverse U.S. federal income tax consequences could apply to such U.S. Holder including increased tax liability on disposition gains and certain “excess distributions” and additional reporting requirements. See “Material U.S. Federal Income Tax Considerations for U.S. Holders—Passive Foreign Investment Company Consequences” included elsewhere in this prospectus.

Whether we are a PFIC for any taxable year will depend on the nature and composition of our income and the nature, composition and value of our assets from time to time (including the value of our goodwill, which may be determined in large part by reference to the market price of our common shares from time to time, which could fluctuate considerably and increase our risk of being a PFIC). The composition of our income and assets is also affected by how we spend the cash we raise in any offering, including this offering. Furthermore, whether and to which extent our income and assets, including goodwill, will be characterized as active or passive will depend on various factors that are subject to uncertainty, including our future business plans and the application of laws that are subject to varying interpretation. As a result, there can be no assurance that we will not be treated as a PFIC for the current or any future taxable year and our U.S. counsel expresses no opinion with respect to our PFIC status for any prior, current or future taxable year. Even if we determine that we are not a PFIC for a taxable year, there can be no assurance that the Internal Revenue Service, or the IRS, will agree with our conclusion and that the IRS would not successfully challenge our position. Each U.S. Holder is strongly urged to consult its tax advisor regarding these issues and any available elections to mitigate such tax consequences.

We may be unable to carry forward existing tax losses.

As of December 31, 2025, we carried forward accumulated tax losses of $40.2 million. In Switzerland, such tax loss carryforwards could, with certain limitations, be used to offset future taxable income. However, if not used, Swiss tax loss carryforwards expire ten years after the tax year in which they were incurred. There is a high risk that our Swiss tax loss carryforwards will expire in part or in their entirety and will not be used to offset future taxable income for Swiss corporate income tax purposes.

Furthermore, any Swiss tax loss carryforwards that we report in our tax returns are subject to review and confirmation by the competent Swiss tax authorities in their tax assessment of the tax year for which the tax loss carryforwards are used to offset taxable income. Consequently, we are exposed to the risk that the competent Swiss tax authorities may not accept the reported tax loss carryforwards in part or in their entirety. Any limitations in our ability to use tax loss carryforwards to offset taxable income could adversely affect our financial condition.

Changes in our effective tax rate or tax liability may have an adverse effect on our results of operations.

Our effective tax rate could increase due to several factors, including:

 

∎

changes in the relative amounts of income before taxes in the various jurisdictions in which we operate that have differing statutory tax rates;

 

∎

changes in tax laws, tax treaties, and regulations or the interpretation of them;

 

∎

changes to our assessment about our ability to realize any deferred tax assets that are based on estimates of our future results, the prudence and feasibility of possible tax planning strategies, and the economic and political environments in which we do business;

 

∎

the outcome of current and future tax audits, examinations, or administrative appeals; and

 

∎

limitations or adverse findings regarding our ability to do business in some jurisdictions.

Any of these developments could adversely affect our business, financial condition and results of operations.

 

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As a result of changes in tax laws, treaties, rulings, regulations or agreements, or their interpretation, of Switzerland or any other country in which we operate, the loss of a major tax dispute or a successful challenge to our operating structure, intercompany pricing policies or the taxable presence of our key subsidiaries in certain countries, or other factors, our effective income tax rates may increase in the future, which could adversely affect our net income and cash flows.

We operate in multiple jurisdictions and our profits are taxed pursuant to the tax laws of these jurisdictions. The tax laws applicable to our business activities, however, are subject to changes in interpretation. Our tax position could be adversely impacted by changes in tax rates, tax laws, tax practice, tax treaties or tax regulations or changes in the interpretation thereof by the tax authorities in jurisdictions in which we do business. Our effective income tax rate may be affected by changes in or interpretations of tax laws, treaties, rulings, regulations or agreements in any given jurisdiction, the resolution of issues arising from any future tax audits with various tax authorities, utilization of net operating loss and tax credit carryforwards, changes in geographical allocation of income and expense, and changes in management’s assessment of matters such as the realizability of deferred tax assets. In the past, we have experienced fluctuations in our effective income tax rate. Our actual tax rate may vary from our expectation and that variance may be material. Our effective income tax rate in a given fiscal year reflects a variety of factors that may not be present in the succeeding fiscal year or years. There is no assurance that our effective income tax rate will not change in future periods.

We file Swiss and non-Swiss tax returns. We are subject to tax audits, examinations and assessments in various jurisdictions. If any tax authority successfully challenges our operational structure, allocation of income by tax jurisdiction, or amounts paid between our affiliated companies pursuant to our intercompany arrangements or transfer pricing policies, if any tax authority successfully asserts that we are subject to income, withholding or other taxes in a jurisdiction by reason of our activities and operations or our other taxable presence in such jurisdiction, if the terms of certain income tax treaties are interpreted in a manner that is adverse to our structure, or if we lose a material tax dispute in any country, our effective income tax rate could increase. A tax authority may take the position that material income or other tax liabilities, interest and penalties are payable by us, in which case, we expect that we might contest such assessment. Contesting such an assessment may be lengthy and costly and if we were unsuccessful in disputing the assessment, the implications could increase our anticipated effective tax rate, which could adversely affect our profitability. If our effective income tax rate increases in future periods, our net income and cash flows could be adversely affected, including in future tax years.

We urge our shareholders to consult with their legal and tax advisors with respect to the potential tax consequences of investing in or holding our common shares.

 

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USE OF PROCEEDS

We estimate that our net proceeds from the sale of 10,294,117 common shares in this offering will be approximately $155.6 million, based on an assumed initial public offering price of $17.00 per share, which is the midpoint of our estimated offering price range set forth on the cover page of this prospectus, after deducting underwriting discounts, commissions and estimated expenses payable by us related to the offering. If the underwriters exercise their option in full to purchase 1,544,117 additional common shares, our estimated net proceeds will be approximately $179.7 million, after deducting underwriting discounts, commissions and estimated expenses payable by us related to the offering. We also expect to receive net proceeds of approximately $48.2 million from the concurrent private placement with Sanofi, after deducting estimated private placement expenses, including placement agent fees, payable by us.

Each $1.00 increase or decrease in the assumed initial public offering price of $17.00 per share, which is the midpoint of our estimated offering price range set forth on the cover page of this prospectus, would increase or decrease, respectively, our net proceeds from this offering and the concurrent private placement by $9.5 million, assuming the number of common shares offered for sale remains the same, and after deducting estimated underwriting discounts and commissions and estimated offering and the concurrent private placement expense payable by us.

Each 1.0 million share increase or decrease in the number of common shares we offer would increase or decrease, respectively, our proceeds from the offering by $15.7 million, assuming no change in the assumed initial public offering price of $17.00 per share, which is the midpoint of our estimated offering price range set forth on the cover page of this prospectus, and after deducting estimated underwriting discounts and commissions and estimated offering expenses payable by us. The actual net proceeds payable to us will be determined based on the actual number of common shares sold by us, the actual initial public offering price and other terms of the offering determined at pricing.

The principal purpose of this offering is to create a public market for our common shares and facilitate future access to the public equity markets, increase our visibility in the marketplace and obtain additional capital. We currently intend to use the net proceeds from this offering and the concurrent private placement, together with our existing cash, cash equivalents and marketable securities for the following purposes:

 

∎

Approximately $217.5 million to $227.5 million to fund (i) the completion of our ongoing POLARIS-1 Phase 2/3 trial and a confirmatory POLARIS-2 Phase 3 trial of WIN378 in asthma; (ii) the completion of our ongoing SIRIUS Phase 2 trial of WIN378 in COPD; and (iii) related research and development activities, including clinical development, regulatory affairs, quality, research, translational sciences, clinical supply, and drug substance and drug product manufacturing;

 

∎

Approximately $80 million to $85 million to fund the completion of (i) our planned global Phase 2b trial of WIN027 in COPD; (ii) our planned global Phase 2 trial of WIN027 in atopic dermatitis; and (iii) related research and development activities, including clinical development, regulatory affairs, quality, research, translational sciences, clinical supply, and drug substance and drug product manufacturing;

 

∎

Approximately $5 million to $10 million to fund the advancement of our bispecific programs through IND-enabling studies; and

 

∎

The remainder for working capital and general corporate purposes, including personnel costs, facilities, and other operational expenses.

Our expected use of our net proceeds from this offering and the concurrent private placement represents our intentions based on our current plans and business conditions, which could change in the future as plans and conditions evolve. As of the date of this prospectus, we cannot predict with certainty all of the particular uses for the net proceeds to be received upon the completion of this offering or the amounts that we will actually spend on the uses set forth above. We expect to require additional funds to fully accomplish our planned uses of the proceeds of our offering and the concurrent private placement. Additionally, we may use a portion of our net proceeds to license, acquire or invest in additional product candidate assets or technologies to continue building our pipeline and our research and development capacities. We are not currently party to any agreements or commitments to any such type of transaction.

 

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Due to inherent uncertainties in the development of our product candidates, the amount and timing of our actual expenditures may vary significantly depending on many factors, including the progress of our research and development activities, timing of patient enrollment in our studies, evolving regulatory requirements, timing and success of nonclinical studies, ongoing and future clinical trials, timing of any future regulatory submissions, any partnerships or alliances we may enter into with third parties, unforeseen cash needs and other factors described in the “Risk Factors” included elsewhere in this prospectus.

Based on our current plans and business conditions, we believe our existing cash, cash equivalents and marketable securities, together with the net proceeds from this offering and the concurrent private placement, will be sufficient to enable us to fund our operating expenses and capital expenditure requirements into the first half of 2029. This determination is based on certain assumptions that may prove incorrect and we may use our available capital resources sooner than expected. We do not have any committed external sources of funds as of the date of this prospectus. In the future, we may meet any future cash needs through the sale of additional equity securities, raising debt financing, obtaining working capital lines of credit, interest income earned on our interest-bearing cash deposits, or a combination of these sources.

Pending our use of the net proceeds from this offering and the concurrent private placement, we intend to invest the net proceeds in a variety of capital preservation instruments, including investment-grade corporate bonds, fixed-income instruments, money market funds and interest-bearing deposits held at reputable institutions. We cannot guarantee that the net proceeds invested will yield a favorable return. Our management retains broad discretion in the application of the net proceeds received from this offering and the concurrent private placement, and investors will rely on the judgement of our management regarding the application of our net proceeds.

 

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DIVIDEND POLICY

Since our incorporation, we have not declared or paid any dividends on our issued share capital. We expect to continue incurring losses for the foreseeable future and therefore do not currently anticipate paying dividends on our common shares. We cannot predict how any potential future earnings may be allocated, as this will depend on the Company’s financial position, business needs and other relevant circumstances at that time. As a result, investors in our common shares will benefit in the foreseeable future only if our common shares appreciate in value. Any future determination related to our dividend policy will be made at the discretion of our board of directors and will depend upon, among other factors, our results of operations, capital requirements, financial condition, contractual restrictions, business prospects, any future debt agreements or applicable laws and other factors that our board of directors may deem relevant.

Under Swiss law, any dividend or interim dividend must be proposed by our board of directors or, to the extent permitted by, and subject to the requirements of, applicable law and our articles of association, one or several shareholders and be approved at a general meeting of shareholders by a majority of the votes represented. In addition, our auditors must confirm that the dividend proposal of our board of directors conforms to Swiss statutory law and our articles of association. We may pay dividends or interim dividends only if we have sufficient distributable profits, either brought forward from the previous financial years (Bilanzgewinn) or of the current financial year for interim dividends, or if we have distributable reserves, in each case (i) as presented on our annual statutory stand-alone balance sheet or for interim dividends on an interim statutory stand-alone balance sheet prepared in accordance with Swiss law and (ii) after allocations to reserves required by Swiss law or our articles of association have been deducted.

Distributable reserves are generally booked either as voluntary retained earnings (freiwillige Gewinnreserven), as statutory retained earnings (gesetzliche Gewinnreserve), or as statutory capital reserves (gesetzliche Kapitalreserve), including as reserves from capital contributions (Kapitaleinlagereserven). In accordance with the requirements of Swiss law, we are required to retain at least 5% of our annual net income as statutory retained earnings (gesetzliche Gewinnreserve) for so long as these reserves, together with the statutory capital reserves (gesetzliche Kapitalreserve), amount to less than 20% of our paid-in nominal share capital. If there is a loss carried forward, such loss must be eliminated by way of set-off with the profit, before the latter may be allocated to statutory retained earnings (gesetzliche Gewinnreserve). Furthermore, we can make distributions to our shareholders out of reserves from capital contributions (Reserven aus Kapitaleinlagen) if and to the extent (i) we have sufficient freely distributable equity and (ii) the statutory capital reserves (gesetzliche Kapitalreserve) and statutory retained earnings (gesetzliche Gewinnreserve), taken together and after deduction of losses, if any, exceed 20% of our paid in nominal share capital. Distributions out of issued share capital, which is the aggregate nominal value of a corporation’s issued shares, may be made only by way of a share capital reduction. See the section of this prospectus titled “Description of Share Capital and Articles of Association—Dividends and Other Distributions.”

Dividends are usually due and payable after the resolution has been passed by the general meeting of shareholders or at a later date as determined by the shareholders’ resolution. Under Swiss law, the statute of limitations with respect to dividend payments is five years. Dividends not collected within five years of their due date accrue to the Company and will be allocated to our statutory retained earnings.

Dividends and other distributions (except, in the amount permitted under Swiss tax law and subject to certain restrictions, for distributions from reserves from capital contributions or from reductions of the Company’s share capital) paid on our common shares are subject to Swiss federal withholding tax. For a discussion of the taxation of dividends, see the section in this prospectus entitled “Swiss Tax Implications for Our Holders.”

We are a holding company with no material direct operations. As a result, we are largely dependent on dividends or other distributions from our subsidiaries in order to pay a dividend to our shareholders. Our subsidiaries are subject to legal requirements of their respective jurisdictions of incorporation that may restrict them from paying dividends or making other distributions to us. Accordingly, investors cannot rely on dividend income from our common shares and any returns on an investment in our common shares will likely depend entirely upon any future appreciation in the price of our common shares.

 

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CAPITALIZATION

The following table sets forth our cash and cash equivalents and total capitalization as of June 30, 2026:

 

∎

on an actual basis

 

∎

on a pro forma basis, giving effect to (i) the Preferred Share Conversion, as if the preferred shares had been converted to common shares as of June 30, 2026, (ii) the Series B Warrant Settlement, as if the Series B Warrants had been exercised as of June 30, 2026, and (iii) the filing and effectiveness of our amended and restated articles of association, which will occur immediately prior to the completion of this offering; and

 

∎

on a pro forma as adjusted basis, giving effect to (i) the pro forma adjustments set forth above, (ii) the issuance and sale of 10,294,117 common shares in this offering at the assumed initial public offering price of $17.00 per share, which is the midpoint of the estimated offering price range listed on the cover page of this prospectus, after deducting estimated underwriting discounts and commissions and estimated offering expenses payable by us (assuming the underwriters do not exercise their option to purchase additional common shares), and (iii) the issuance and sale to Sanofi of 1,532,691 common shares and pre-funded warrants to purchase 1,408,485 common shares in the concurrent private placement at an assumed purchase price per common share and per common share underlying the pre-funded warrants equal to the assumed initial public offering price, after deducting estimated private placement expenses, including placement agent fees, payable by us in connection with the concurrent private placement.

The pro forma as adjusted information below is for illustrative purposes only, and our capitalization following the completion of this initial public offering and the concurrent private placement will be adjusted based on the actual initial public offering price and other terms of this offering and the concurrent private placement, as determined at pricing.

 

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The following table should be read together with “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” “Use of Proceeds” and the unaudited condensed consolidated interim financial statements and related notes included elsewhere in this prospectus.

 

 

		AS OF JUNE 30, 2026
		ACTUAL				PRO FORMA (UNAUDITED)				PRO FORMA AS ADJUSTED (2) (UNAUDITED)
		(in millions, except share and per share amounts)
Cash and cash equivalents		$	18.9			$	18.9			$	222.7
Shareholders’ equity:
Preferred shares (Series A preferred shares, Series A junior preferred shares and Series B preferred shares), par value CHF 0.015 per share; 35,619,380 preferred shares issued and outstanding, actual; no preferred shares issued and outstanding, pro forma and no preferred shares issued and outstanding, pro forma as adjusted(1)		$	0.7			$	—			$	—
Common shares, par value CHF 0.015 per share; 10,361,646 shares issued, actual; 46,245,740 common shares issued, pro forma and 58,072,548 common shares issued, pro forma as adjusted(1)			0.2				0.8				1.1
Share capital			0.8				0.8				1.1
Treasury shares (Common shares, par value CHF 0.015 per share; 33,800 shares)			—				—				—
Reserves			358.1				359.6				563.2
Accumulated losses			(93.2	)			(93.2	)			(93.2	)
Total equity		$	265.7			$	267.3			$	471.1
Total capitalization		$	265.7			$	267.3			$	471.1

 

(1)

CHF amounts contained in this table have been translated into U.S. dollars at the rate of CHF1.00 to $1.2372, solely for the convenience of the reader, which was the noon buying rate of the Federal Reserve Bank of New York on June 30, 2026. U.S. dollar amounts contained in this table are rounded to the nearest $0.1 million based on underlying values. In the pro forma column, the Preferred Share Conversion reclassifies $0.7 million of preferred share capital to common share capital. The Series B Warrant Settlement, a cashless exercise, increases share capital by $0.0 million with an offsetting decrease in reserves, and increases reserves by $1.6 million through the reclassification of the derivative warrant liability to equity, so total equity increases by $1.6 million. Because the derivative warrant liability is measured at fair value through profit or loss, it will be remeasured to fair value immediately prior to the Series B Warrant Settlement, with any change in fair value since June 30, 2026 recognized in profit or loss, and the remeasured fair value of the derivative warrant liability will then be reclassified to equity. The pro forma adjustment reflects the carrying amount of the derivative warrant liability as of June 30, 2026 and does not give effect to this remeasurement. The amount actually reclassified to equity upon the Series B Warrant Settlement may therefore differ from the amount presented above. In the pro forma as adjusted column, share capital increases by $0.2 million (11,826,808 common shares, comprising 10,294,117 common shares in this offering and 1,532,691 common shares in the concurrent private placement, at CHF 0.015 per share) and reserves increase by $203.6 million, together equal to the net proceeds of $203.8 million.

(2)

The pro forma as adjusted column reflects net proceeds of $203.8 million (gross proceeds of $225.0 million less underwriting discounts and commissions and estimated offering expenses payable by us in connection with this offering, and estimated private placement expenses, including placement agent fees, payable by us in connection with the concurrent private placement, assuming the underwriters do not exercise their option to purchase additional common shares), which increase cash and cash equivalents from $18.9 million to $222.7 million and total equity and total capitalization from $267.3 million to $471.1 million, of which $0.2 million is recorded in share capital and $203.6 million in reserves. Each $1.00 increase or decrease, as applicable, in this assumed initial public offering price of $17.00 per share, which is the midpoint of the estimated offering price range listed on the cover page of this prospectus, would increase or decrease, as applicable, the pro forma as adjusted amount of each cash and cash equivalents, total equity and total capitalization by $9.5 million, assuming that the number of shares offered by us in this initial public offering and the concurrent private placement remains the same, and after deducting estimated underwriting discounts and commissions and estimated offering expenses and estimated private placement expenses, including placement agent fees, payable by us. Similarly, each increase or decrease, as applicable, of 1.0 million common shares offered by us at the assumed initial public offering price per share of $17.00, the midpoint of the estimated offering price range listed on the cover page of this prospectus would increase or decrease, as applicable, the pro forma as adjusted amount of each of cash and cash equivalents, total equity and total capitalization by $15.7 million, after deducting estimated underwriting discounts and commissions and estimated offering expenses and estimated private placement expenses, including placement agent fees, payable by us.

 

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The number of common shares to be outstanding after the offering and concurrent private placement is based on 10,327,846 common shares (including 4,527,355 restricted shares subject to repurchase rights based on continued service requirements), 21,265,292 Series A preferred shares, 3,721,430 Series A junior preferred shares, 10,632,658 Series B preferred shares outstanding as of June 30, 2026 and 264,714 common shares to be delivered upon the cashless exercise of the 264,998 outstanding Series B Warrants, assuming an initial public offering price of $17.00 per common share, the midpoint of the estimated price range set forth on the cover page of this prospectus, and excludes:

 

∎

1,296,368 common shares issuable upon the exercise of outstanding options under our Amended and Restated 2025 Equity Incentive Plan, or the 2025 Plan, as of June 30, 2026, and 256,672 common shares issuable upon the exercise of options granted under the 2025 Plan subsequent to June 30, 2026, in each case with a weighted-average exercise price of $0.02 per share, as more fully described in the section titled “Management—Equity Incentive Plans”;

 

∎

379,748 common shares issuable upon the settlement of outstanding restricted share units under our 2025 Plan, as of June 30, 2026, and 133,334 common shares issuable upon the settlement of restricted share units granted under our 2025 Plan subsequent to June 30, 2026, as more fully described in the section titled “Management—Equity Incentive Plans”;

 

∎

6,300,000 common shares issuable upon exercise or settlement of awards pursuant to our 2026 Equity Incentive Plan, or the 2026 Plan, as more fully described in the section titled “Management—Equity Incentive Plans”;

 

∎

630,000 common shares issuable under our 2026 Employee Share Purchase Plan, or the ESPP;

 

∎

approximately 2,390,010 common shares issuable upon the exercise of the IPO Awards, as more fully described in “Management—Equity Incentive Plans—2026 Equity Incentive Plan—IPO Equity Awards”, assuming (i) the sale of 10,294,117 common shares by us in this offering, (ii) an initial public offering price of $17.00 per common share, which is the midpoint of the estimated offering price range set forth on the cover page of this prospectus, (iii) the sale of 1,532,691 common shares and pre-funded warrants to purchase 1,408,485 common shares in our concurrent private placement for aggregate gross proceeds of $50.0 million, (iv) the exercise in full of the pre-funded warrants to be issued in the concurrent private placement and (v) no exercise by the underwriters of their option to purchase additional common shares;

 

∎

1,408,485 common shares issuable upon exercise of the pre-funded warrants sold in the concurrent private placement, and

 

∎

33,800 common shares we hold in treasury and an additional number of common shares to be issued in connection with the capital increases as further described in the section titled “Description of Share Capital and Articles of Association” such that the total number of common shares to be held in treasury upon completion of this offering corresponds to 10% of the share capital registered in the Commercial Register.

 

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DILUTION

If you invest in our common shares during this offering, your ownership interest will be immediately diluted to the extent of the difference between the initial public offering price per share of our common shares and the pro forma as adjusted net tangible book value per share of our common shares immediately after the completion of this offering and concurrent private placement.

Our historical net tangible book value as of June 30, 2026 was $185.4 million, or $17.95 per share of our outstanding common shares. Our historical net tangible book value is the amount of our total tangible assets less our total liabilities, excluding the deferred offering costs of $0.3 million. Historical net tangible book value per share represents historical net tangible book value divided by the number of common shares outstanding as of June 30, 2026.

Our pro forma net tangible book value as of June 30, 2026 was $187.0 million or $4.05 per share. Pro forma net tangible book value per share represents the amount of our total tangible assets (net of deferred offering costs of $0.3 million) less our total liabilities and divided by the number of our common shares outstanding as of June 30, 2026, after giving effect to the Preferred Share Conversion and the Series B Warrant Settlement. Pro forma net tangible book value per share represents our pro forma net tangible book value divided by the total number of common shares outstanding as of June 30, 2026, after giving effect to the pro forma adjustments described above.

After giving further effect to (i) the sale of 10,294,117 common shares that we are offering at the assumed initial public offering price of $17.00 per share, which is the midpoint of the estimated offering range set forth on the cover page of this prospectus, and (ii) the issuance and sale to Sanofi of 1,532,691 common shares and pre-funded warrants to purchase 1,408,485 common shares in the concurrent private placement at an assumed purchase price per common share and per common share underlying the pre-funded warrants equal to the assumed initial public offering price (excluding common shares issuable upon exercise of the pre-funded warrants), and after deducting estimated underwriting discounts and commissions and estimated offering expenses payable by us in connection with this offering, and estimated private placement expenses, including placement agent fees, payable by us in connection with the concurrent private placement (assuming the underwriters do not exercise their option to purchase additional common shares), our pro forma as adjusted net tangible book value as of June 30, 2026 would have increased by the net proceeds of $203.8 million (deferred offering costs of $0.3 million being released) and would have been $391.1 million or $6.74 per share. This amount represents an immediate increase in our pro forma net tangible book value of $2.69 per share to our existing shareholders and an immediate dilution in pro forma as adjusted net tangible book value of $10.26 per share to investors purchasing our common shares in this offering and Sanofi in the concurrent private placement.

Dilution per share to new investors is determined by subtracting pro forma as adjusted net tangible book value per share after this offering and concurrent private placement from the initial public offering price per share paid by new investors. The following table illustrates this dilution (without giving effect to any potential exercise by the underwriters of their option to purchase additional 1,544,117 common shares):

 

 

Assumed initial public offering price per share						$	17.00
Historical net tangible book value per share as of June 30, 2026		$	17.95
Pro forma decrease in net tangible book value per share as of June 30, 2026 attributable to the pro forma adjustment described above			(13.90	)
Pro forma net tangible book value per share as of June 30, 2026			4.05
Increase in pro forma net tangible book value per share attributable to this initial public offering and concurrent private placement		$	2.69
Pro forma as adjusted net tangible book value per share after this initial public offering and concurrent private placement							6.74
Dilution per share to new investors in this initial public offering and concurrent private placement						$	10.26

 

The dilution information discussed above is for illustrative purposes only and may change based on our actual initial public offering price and other terms of this offering and concurrent private placement.

 

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Each $1.00 increase or decrease (as applicable) in the assumed initial public offering price of $17.00 per share, which is the midpoint of the estimated offering price range set forth on the cover page of this prospectus, would increase or decrease, as applicable, the pro forma as adjusted net tangible book value per share after this offering and concurrent private placement by $0.16 and dilution in pro forma net tangible book value per share to new investors by $0.84, assuming that the number of common shares offered by us, as set forth on the cover page of this prospectus, remains the same, and after deducting underwriting discounts and commissions and estimated offering expenses and estimated private placement expenses, including placement agent fees, payable by us.

Each $1.00 increase or decrease in the assumed initial public offering price of $17.00 per share would increase or decrease, as applicable, the total consideration paid by new investors by $10.3 million. In the case of an increase, this would also increase the percentage of total consideration paid by new investors to 43.1%; in the case of a decrease, it would decrease that percentage to 40.9%. Each increase or decrease of 1.0 million in the number of shares offered by us, at the assumed initial public offering price of $17.00 per share, would increase or decrease, as applicable, the total consideration paid by new investors by $17.0 million. In the case of an increase, this would increase the percentage of total consideration paid by new investors to 43.8%; in the case of a decrease, it would decrease that percentage to 40.1%.

Similarly, each increase or decrease (as applicable) of 1.0 million shares in the number of common shares offered by us would increase or decrease, as applicable, our pro forma as adjusted net tangible book value per share after the completion of this offering and the concurrent private placement by $0.15 per share and $0.16 per share, respectively, and decrease or increase (as applicable) the dilution to investors participating in this offering by $0.15 per share and $0.16 per share, respectively, assuming that the assumed initial public offering price remains the same, and after deducting estimated underwriting discounts and commissions and estimated offering expenses and estimated private placement expenses, including placement agent fees, payable by us.

If the underwriters exercise their option to purchase up to 1,544,117 additional common shares in full, based on net proceeds of $228.0 million, the pro forma as adjusted net tangible book value after the offering and the concurrent private placement would be $6.97 per share, the increase in pro forma as adjusted net tangible book value per share to existing shareholders would be $2.92 per share and the dilution per share to new investors would be $10.03 per share, in each case assuming an initial public offering price of $17.00 per share, which is the midpoint of the estimated offering range set forth on the cover page of this prospectus, and after deducting estimated underwriting discounts and commissions of $14.1 million and estimated offering expenses payable by us of $7.4 million in connection with this offering, and estimated private placement expenses, including placement agent fees, payable by us of $1.8 million in connection with the concurrent private placement.

The following table summarizes, on the pro forma as adjusted basis described above, as of June 30, 2026, the differences between the number of common shares purchased by our existing shareholders and common shares purchased by new investors as part of this initial public offering and concurrent private placement, the total consideration paid to us in cash and the average price per share paid by existing shareholders for common shares issued prior to this initial public offering and the price to be paid by new investors for common shares in this initial public offering. The calculation in the table below is based on the assumed initial public offering price of $17.00 per share, which is the midpoint of the estimated offering price range set forth on the cover page of this prospectus, before deducting underwriting discounts and commissions and estimated offering expenses payable by us.

 

 

		SHARES PURCHASED								TOTAL CONSIDERATION
		NUMBER				PERCENTAGE				AMOUNT				PERCENTAGE				WEIGHTED AVERAGE PRICE PER SHARE
		(in thousands, except share, per share and percentage data)
Existing shareholders before this initial public offering			46,211,940				79.6	%		$	310,180				58.0%			$	6.71
New investors purchasing shares in this offering and the concurrent private placement			11,826,808(1)				20.4%			$	225,000				42.0%			$	17.00
Total			58,038,748				100.0%			$	535,180				100.0%			$	9.00

 

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(1)

Excludes 1,408,485 common shares issuable upon exercise of pre-funded warrants purchased by investors in the concurrent private placement, as such pre-funded warrants have not been exercised. Total consideration includes the gross proceeds from the entire concurrent private placement, including the proceeds from the sale of the pre-funded warrants.

The table above assumes there is no exercise of the underwriters’ option to purchase additional shares in this offering. If the underwriters’ option to purchase additional 1,544,117 common shares is exercised in full, the number of shares held by existing shareholders would be reduced to 77.6% of the total number of common shares outstanding after this initial public offering and the number of common shares held by new investors purchasing common shares in this offering would be increased to 22.4% of the total number of common shares outstanding after this offering.

The number of common shares to be outstanding after the offering and concurrent private placement is based on 10,327,846 common shares (including 4,527,355 restricted shares subject to repurchase rights based on continued service requirements), 21,265,292 Series A preferred shares, 3,721,430 Series A junior preferred shares, 10,632,658 Series B preferred shares outstanding as of June 30, 2026 and 264,714 common shares to be delivered upon the cashless exercise of the 264,998 outstanding Series B Warrants, assuming an initial public offering price of $17.00 per common share, the midpoint of the estimated price range set forth on the cover page of this prospectus, and excludes:

 

∎

1,296,368 common shares issuable upon the exercise of outstanding options under our 2025 Plan, as of June 30, 2026, and 256,672 common shares issuable upon the exercise of options granted under our 2025 Plan subsequent to June 30, 2026, in each case with a weighted-average exercise price of $0.02 per share, as more fully described in the section titled “Management—Equity Incentive Plans”;

 

∎

379,748 common shares issuable upon the settlement of restricted share units under our 2025 Plan, as of June 30, 2026, and 133,334 common shares issuable upon the settlement of restricted share units granted under our 2025 Plan subsequent to June 30, 2026, as more fully described in the section titled “Management—Equity Incentive Plans”;

 

∎

6,300,000 common shares issuable upon exercise or settlement of awards pursuant to our 2026 Plan, as more fully described in the section titled “Management—Equity Incentive Plans”;

 

∎

630,000 common shares issuable under our ESPP;

 

∎

approximately 2,390,010 common shares issuable upon the exercise of the IPO Awards, assuming (i) the sale of 10,294,117 common shares by us in this offering, (ii) an initial public offering price of $17.00 per common share, which is the midpoint of the estimated offering price range set forth on the cover page of this prospectus, (iii) the sale of 1,532,691 common shares and pre-funded warrants to purchase 1,408,485 common shares in our concurrent private placement for aggregate gross proceeds of $50.0 million, (iv) the exercise in full of the pre-funded warrants to be issued in the concurrent private placement and (v) no exercise by the underwriters of their option to purchase additional common shares, as more fully described in “Management—Equity Incentive Plans—2026 Equity Incentive Plan—IPO Equity Awards”;

 

∎

1,408,485 common shares issuable upon exercise of the pre-funded warrants sold in the concurrent private placement; and

 

∎

33,800 common shares we hold in treasury and an additional number of common shares to be issued in connection with the capital increases as further described in the section titled “Description of Share Capital and Articles of Association” such that the total number of common shares to be held in treasury upon completion of this offering corresponds to 10% of the share capital registered in the Commercial Register.

To the extent any outstanding options are exercised, new options or other equity awards are issued under our equity incentive plans, or we issue additional equity or we issue convertible debt securities in the future, there will be further dilution to new investors.

 

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MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION

AND RESULTS OF OPERATIONS

You should read the following discussion of our financial condition and results of operations in conjunction with our audited consolidated financial statements as of December 31, 2025 and 2024 and for the year ended December 31, 2025 and for the period from July 5, 2024 (inception) to December 31, 2024, and the related notes thereto included elsewhere in this prospectus and in conjunction with our unaudited condensed consolidated interim financial statements as of June 30, 2026 and for the six months ended June 30, 2026 and 2025 and the related notes included elsewhere in this prospectus. In addition to historical information, the following discussion and analysis contains forward-looking statements that reflect our plans, estimates and beliefs. Our actual results and the timing of events could differ materially from those anticipated in the forward-looking statements. Factors that could cause or contribute to these differences include those discussed below and elsewhere in this prospectus, particularly in sections titled “Risk Factors” and “Special Note Regarding Forward-Looking Statements.” The audited consolidated financial statements as of December 31, 2025 and 2024 and for the year ended December 31, 2025 and for the period from July 5, 2024 (inception) to December 31, 2024, or the 2024 period, and the unaudited condensed consolidated interim financial statements as of June 30, 2026 and for the six months ended June 30, 2026 and 2025, were prepared in accordance with the IFRS, as issued by the IASB and IAS 34, respectively. As permitted by the applicable rules of the SEC for foreign private issuers, using IFRS, as issued by the IASB, we do not reconcile our consolidated financial statements to U.S. GAAP.

Overview

We are a clinical-stage biotechnology company developing ultra-long-acting antibody medicines for patients with serious respiratory and dermatologic diseases, including asthma, COPD, and atopic dermatitis. We estimate these diseases collectively represent a $60 billion peak market opportunity for biologic therapies, as we believe that the majority of patients eligible to receive biologic treatment for these diseases remain untreated. Our product candidates can potentially address this significant unmet need, allow for treatment of a broader population of patients, improve efficacy, and improve dosing convenience and adherence to treatment. We estimate that these diseases collectively affect more than 100 million people in the United States, EU5, and Japan and more than 8 million are eligible for biologics treatment.

Our product candidates, WIN378 and WIN027, target clinically validated disease pathways and are engineered to remain in the body for extended periods of time, enabling less frequent dosing than currently available treatments. This design feature is combined with additional properties including enhanced target affinity, dual target binding or effector function silencing. We believe our product candidates have the potential to deliver better clinical outcomes while offering the convenience of less frequent dosing than currently available treatments.

WIN378 is currently being evaluated in POLARIS-1, a Phase 2/3 study in severe uncontrolled asthma. Study start-up activities were initiated in September 2026 for a second Phase 3 study (POLARIS-2), which is planned to begin patient recruitment in the first half of 2027. A Phase 2 study of WIN378 in COPD, SIRIUS, was initiated in June 2026. A preplanned analysis of the Phase 2 portion of POLARIS-1 was completed in the second half of 2026.

WIN027 is currently in a Phase 1 healthy volunteer study with INDs open in the United States, Australia and the PRC, assessing safety and pharmacokinetics. We initiated study start-up activities in September 2026 for our two global Phase 2 studies—a global Phase 2b study in COPD powered on the registrational endpoint of exacerbation rate ratio and a second global Phase 2 study in atopic dermatitis, which are planned to begin patient recruitment in the first half of 2027. We expect that the next data readout for WIN027 will be the full Phase 1 results in the first half of 2027.

Since our inception, we have incurred significant net operating losses and negative cash flows. Since inception, we have devoted the majority of our resources to organizing and staffing our company, business planning, raising capital, establishing licensing, developing our product candidates, conducting research studies and trials (nonclinical and clinical), establishing relationships with third parties for research and manufacture of products for use in our trials as well as general and administrative activities to support these operations.

 

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During the year ended December 31, 2025, we generated a net loss of $48.3 million. For the six months ended June 30, 2026, we have generated a net loss of $42.6 million, and a net loss of $22.8 million in the six months ended June 30, 2025. We expect to continue to incur significant losses and that our expenses and operating losses will continue to increase for the foreseeable future if and as we:

 

∎

expand the number of our research and development projects;

 

∎

add new product candidates to our portfolio;

 

∎

continue our clinical trials and expand the scope of our clinical trials for our product candidates;

 

∎

begin additional nonclinical, clinical or other studies for our product candidates (current and future), including pursuing additional license and collaboration agreements and new partnerships;

 

∎

identify and contract with additional CROs, contract development manufacturing organizations, or CDMOs, and other suppliers and manufacturers;

 

∎

establish additional infrastructure required to support our operations as a public company;

 

∎

establish and maintain a sales, marketing and distribution infrastructure to commercialize any product candidates for which we may obtain regulatory approval in the future;

 

∎

acquire or license additional product candidates or other related technology;

 

∎

make additional payments under our existing license and collaboration agreements, including development and sales related milestone payments and royalties; and

 

∎

maintain and protect our intellectual property portfolio.

To date, we have not generated any revenue and we have raised capital primarily through our Series A and Series B financing rounds, through the issuance of our Series A preferred shares and the issuance of our Series B preferred shares (together with Series A preferred shares, Preferred Shares). Since inception and up to June 30, 2026, we have received total gross proceeds of $310.0 million from our financing rounds. As needed, we will seek additional funding through public or private equity or debt financing. We may not be able to obtain funding on acceptable terms, or at all. The terms of future financing may adversely affect the holdings or rights of our current shareholders.

If we are unable to obtain future funding, we may pause, restrict, or even eliminate some or all of our research and development activities, product candidate expansion or commercialization efforts, which could negatively impact our business prospects, or cause us to cease operations entirely. Although we continue to pursue our strategy and existing business plans, there is no assurance that we will be successful in obtaining the funding needed on acceptable terms for continuing our operations.

Series A and Series B Financing

Series A Financing

On January 10, 2025, we launched a $200.0 million Series A financing round, which was paid in two tranches. On January 23, 2025, we completed the first tranche for $75.0 million. In connection with the closing of the first tranche, we issued 7,974,483 Series A preferred shares and 808,082 common shares at a price of $9.40 and $0.02 per share, respectively. On July 11, 2025, we completed the second tranche for $125.0 million. In connection with the closing of the second tranche, we issued 13,290,809 Series A Preferred Shares at a price of $9.40 per share.

Series B Financing

On April 17, 2026, we launched a $165.0 million Series B financing round, which was payable in two tranches. On May 12, 2026, we completed the first tranche for $110.0 million. On October 30, 2026, the parties to the Series B investment agreement waived the second tranche and, as a result, no additional Series B preferred shares will be issued under the Series B investment agreement. In connection with the closing of the first tranche, we issued 10,632,658 Series B preferred shares at a price of $10.35 per share. Additionally, on May 12, 2026, we entered into warrant agreements with certain of the investors who participated in our Series B financing round. Each warrant we granted allows the warrant holder to purchase one common share of Windward Bio Group AG. Each warrant has an exercise price of CHF 0.015.

 

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License and Collaboration Agreements

Below is a summary of the key terms for certain of our license and collaboration agreements. For a more detailed description of these agreements, see the section titled “Business—License and Collaboration Agreements.”

Agreement with Kelun and HBM

On December 31, 2024, we, through our Swiss subsidiary, Windward Bio AG, entered into a License and Collaboration Agreement with Kelun and HBM, and the agreement became effective on January 30, 2025. Under the agreement, we received a license, or our WIN378 License, to certain antibodies targeting TSLP to be used in the development of products for use in the treatment of conditions such as asthma. The WIN378 License allows us to manufacture, develop and commercialize products globally, excluding certain Asian countries and territories, such excluded countries including Greater China, which are reserved to Kelun and HBM.

As consideration for the WIN378 License, we made upfront payments of cash and equity interests to Kelun and HBM. Such upfront payments totaled $40.0 million, $20.0 million of which was paid in cash, and the remaining $20.0 million paid in our equity interest, during the year ended December 31, 2025.

We may be required to make additional payments to Kelun and HBM based on the occurrence or non-occurrence of future events, including development milestones of up to $320.0 million for WIN378 (excluding the total $10.0 million milestone payments as described below), as well as sales-related milestones of up to $600.0 million. Additionally, we may be required to pay tiered royalties through six tiers, ranging from low single digits to low double-digits (a spread of not more than 5 percentage points) on net sales of WIN378 products, to Kelun and HBM.

On September 25, 2025, we achieved the first development milestone associated with the WIN378 License, which required us to make a payment to Kelun and HBM, in total, of $5.0 million, during the year ended December 31, 2025.

On June 9, 2026, we achieved the second development milestone associated with the WIN378 License, which required us to make a payment to Kelun and HBM, in total, of $5.0 million. The second development milestone payment of $5.0 million was paid in July 2026.

Agreement with Qyuns

On December 19, 2025, we entered into a License and Collaboration Agreement with Qyuns, which became effective on the same day. Under this agreement, we received a license, or our WIN027 License, for a clinical-stage, long-acting anti-TSLPxIL-13 bispecific antibody developed by Qyuns, or WIN027, with broad therapeutic application across immunological diseases. The WIN027 License allows us to research, manufacture, develop and commercialize products globally, except for Greater China.

As consideration for the WIN027 License, we made payments of cash and equity interests to Qyuns and its affiliates, totaling $30.0 million. In the first quarter of 2026, $15.0 million was paid in cash, and the remaining was paid in our equity interest valued at $15.0 million.

We may be required to make additional payments to Qyuns based on the occurrence or non-occurrence of future events, including development milestones of up to $100.0 million, as well as sales-related milestones of up to $570.0 million. Additionally, we may be required to pay mid-single digit to high-single digit tiered royalties to Qyuns.

Factors Affecting the Comparability of Results of Operations

Our business was incorporated on July 5, 2024 and as such, financial conditions and results of operation for the period from July 5, 2024 to December 31, 2024, or the 2024 period, does not represent an entire twelve-month fiscal year. As such, the year ended December 31, 2025 and the 2024 period are not directly comparable. At the time of our inception, we were in the early stages of organizational activity and the nature of our expenses incurred differed from the expenses incurred more recently in the normal course of our business.

Components of Results of Operations

Revenue

To date, we have not generated any revenue from product sales or services, and we do not expect to generate any revenue from the sale of products in the near future, if ever. If our development efforts for WIN378 or other product

 

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candidates are successful and result in regulatory approval, we may generate revenues in the future from product sales, payments from existing or potential future collaboration or license agreements with third parties, or any combination thereof.

Operating expenses

Our operating expenses consist of (i) research and development expenses and (ii) general and administrative expenses.

Research and development expenses

Our research and development expenses primarily consist of internal and external expenses incurred to support research and development activities including our clinical trials and development of future product candidates. These expenses include:

 

∎

Services and materials expenses, including expenses incurred under arrangements with third-party CROs, CDMOs, third-party consultants and other advisors

 

∎

Intellectual property and related future payments dependent on the achievement of development and regulatory milestones

 

∎

Personnel-related costs, including salaries, bonuses, benefits and share-based compensation for employees engaged in research and development activities

 

∎

Depreciation expenses related to assets used in research and development activities

We do not capitalize any of these development costs that we incur, as the costs do not meet the criteria for capitalization in IFRS. Instead, we expense research and development costs as incurred. We accrue the cost of external research and development services based on an estimate of the stage of completion for such contracted services.

We expect our research and development expenses to increase for the foreseeable future as we work to advance the development of our product candidates through ongoing nonclinical studies and clinical trials as well as the development of any potential future product candidates we may acquire.

At this time, we cannot reasonably estimate or know the nature, timing, or estimated costs of the efforts that will be necessary to complete the development of our product candidates. Currently, the Company does not track research and development expenses by program or product candidate. This is because our current activities remain in the discovery phase, where resources, personnel and external costs are shared across multiple research efforts and are not yet attributable to specific programs or product candidates in a systematic manner. We manage our research and development efforts dynamically, taking into account activities needed to support, expand and develop our product candidates. These activities include product formulation, nonclinical testing, clinical studies, data analysis, pharmacovigilance and regulatory submissions. As our development programs transition into the nonclinical stage and final product candidates are selected, we will begin tracking research and development expenses by product candidate.

General and administrative expenses

Our general and administrative expenses are primarily related to operating expenses such as insurance costs, travel expenses and facility expenses not otherwise included in research and development expenses, as well as expenses of external advisors, including professional fees for legal, accounting, audit, and tax services. These expenses also include salaries and benefits for our general and administrative personnel, including share-based compensation for the personnel in our executive, finance, accounting, legal, human resources, business development, information technology and other administrative areas. Depreciation expense is recognized on our assets used in supporting our general and administrative functions.

We expect our general and administrative expenses will continue to increase as we increase our headcount in order to support our ongoing research and development activities and potential commercialization of our product candidates, if approval is ultimately received. We expect to incur additional expenses associated with operating as a public company, including increased costs of accounting, audit, legal, regulatory, tax, investor relations, information technology, director and office insurance premiums and other costs associated with complying with SEC rules and regulations and listing requirements.

 

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Financial income (expense) and foreign exchange differences, net

Our financial income (expense) consists primarily of interest income earned on our money market funds and other interest-bearing deposits, fair value gains (both realized and unrealized) on our financial assets measured at fair value through profit or loss, and interest expense on our lease liabilities. The financial assets measured at fair value through profit or loss include our investment in money market funds and high-grade corporate bonds.

Foreign exchange differences, net, are gains and losses recognized on the settlement or translation of monetary assets and liabilities denominated in foreign currencies. While our functional and presentation currency is the U.S. dollar, we are exposed to foreign currencies as a result of transactions denominated in Swiss francs, Great British pounds, and euros.

Income taxes

We have a presence in different countries and are subject to different income and expense items that are non-taxable and/or may be taxed at different rates in the different tax jurisdictions, based on the pre-tax income of each of our entities. Specifically, we are subject to corporate taxation in Switzerland and the United States.

We have incurred tax losses in each period and year since our inception. We have currently assessed that it is not probable that future taxable profits will be available against which we can use our tax losses. As such, we have not recognized any deferred tax assets. Information on our unrecognized deferred taxes is included in our consolidated financial statements included elsewhere in this prospectus.

Results of Operations

Comparison of the Year ended December 31, 2025 and the 2024 Period

The following table provides our results of operations for the year ended December 31, 2025 and the 2024 period:

 

 

		YEAR ENDED DECEMBER 31,				PERIOD FROM JULY 5, 2024 TO DECEMBER 31,
(in thousands)		2025				2024				CHANGE				% CHANGE
Research and development expenses		$	(32,592	)		$	(84	)		$	(32,508	)			n.m.
General and administrative expenses			(19,237	)			(1,104	)			(18,133	)			n.m.
Operating loss			(51,829	)			(1,188	)			(50,641	)			n.m.
Financial income			3,593				—				3,593				—
Financial expense			(5	)			—				(5	)			—
Foreign exchange differences, net			(34	)			—				(34	)			—
Loss before income taxes			(48,275	)			(1,188	)			(47,087	)			n.m.
Income taxes			(48	)			—				(48	)			—
Net loss		$	(48,323	)		$	(1,188	)		$	(47,135	)			n.m.

 

“n.m.” – not meaningful

Research and development expenses

 

 

		YEAR ENDED DECEMBER 31,				PERIOD FROM JULY 5, 2024 TO DECEMBER 31,
(in thousands)		2025				2024				CHANGE				% CHANGE
Service and materials expenses		$	23,501			$	84			$	23,417				n.m.
Payroll expenses			5,866				—				5,866				.
Share-based compensation			3,108				—				3,108				—
Depreciation expense			117				—				117				—
Total		$	32,592			$	84			$	32,508				n.m.

 

“n.m.” – not meaningful

 

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