Adlai Nortye Group Ltd 6-K, filed Apr 16, 2026
Adlai Nortye Group Ltd. (ANL)
About this 6-K
Adlai Nortye Group Ltd filed this 6-K on April 16, 2026.
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 6-K
Report of Foreign Private Issuer
Pursuant to Rule 13a-16 or 15d-16
under the Securities Exchange Act of 1934
For the month of April 2026
Commission File Number: 001-41773
Adlai Nortye Ltd.
c/o PO Box 309, Ugland House
Grand Cayman, KY1-1104
Cayman Islands
(Address of principal executive offices)
Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F:
☒ Form 20-F ☐ Form 40-F
Content
On April 16, 2026, the Company issued a press release announcing the pricing of its private placement, which is furnished as Exhibit 99.1 to this report on Form 6-K (this “Report”). A form of the securities purchase agreement entered into in connection with the private placement and the Company’s corporate presentation are attached hereto as Exhibit 10.1 and Exhibit 99.1 to this Report.
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
| Adlai Nortye Ltd. | ||
| By: | /s/ Yang Lu | |
| Name: | Yang Lu | |
| Title: | Chief Executive Officer and Chairman of Board of Directors | |
Date: April 16, 2026
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Form 6-K Exhibit Index
Exhibits
| Exhibit No. | Description | |
| 10.1 | Form of Securities Purchase Agreement | |
| 99.1 | Press Release of the Registrant, dated April 16, 2026 | |
| 99.2 |
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Exhibit 10.1
Execution Version
SECURITIES PURCHASE AGREEMENT
This Securities Purchase Agreement (this “Agreement”) is dated as of April 16, 2026, between Adlai Nortye Ltd., an exempted company incorporated in the Cayman Islands (the “Company”), and each of the purchasers listed on the signature pages hereto, together with their permitted successors and assigns (each, a “Purchaser” and collectively, the “Purchasers”).
WHEREAS, subject to the terms and conditions set forth in this Agreement and pursuant to Section 4(a)(2) of the Securities Act (as defined below), the Company desires to issue and sell to the Purchasers, and the Purchasers, severally and not jointly, desire to purchase from the Company, shares of the Company as more fully described in this Agreement.
NOW, THEREFORE, IN CONSIDERATION of the mutual covenants contained in this Agreement, and for other good and valuable consideration the receipt and adequacy of which are hereby acknowledged, the Company and each Purchaser agree as follows:
ARTICLE I.
DEFINITIONS
1.1. Definitions. In addition to the terms defined elsewhere in this Agreement, for all purposes of this Agreement, the following terms have the meanings set forth in this Section 1.1:
“ADS” means American depositary shares, each of which represents three (3) Ordinary Shares, subject to adjustment for reverse and forward share splits, share dividends, share combinations and other similar transactions of the ADSs and/or the Ordinary Shares, as applicable, that occurs after the date of this Agreement.
“Affiliate” means any Person that, directly or indirectly through one or more intermediaries, controls or is controlled by or is under common control with a Person as such terms are used in and construed under Rule 405 under the Securities Act.
“Board of Directors” means the board of directors of the Company.
“Business Day” means any day other than Saturday, Sunday or other day on which commercial banks in The City of New York are authorized or required by law to remain closed.
“Closing” means the closing of the purchase and sale of the Shares pursuant to Section 2.1.
“Closing Date” means the Trading Day when all of the Transaction Documents have been executed and delivered by the applicable parties thereto, and all of the conditions set forth in Sections 2.3 hereof are satisfied or waived, as the case may be, or such other date as the parties may agree.
“Commission” means the United States Securities and Exchange Commission.
“Company Cayman Counsel” means Maples and Calder (Hong Kong) LLP.
“Company U.S. Counsel” means Han Kun Law Offices LLP.
“Company’s Knowledge” or “Knowledge” means with respect to any statement made to the Company’s Knowledge, that the statement is based upon the knowledge, after due inquiry, of the executive officers of the Company having responsibility for the matter or matters that are the subject of the statement.
“Cooley” means Cooley LLP, counsel to the Placement Agents, with offices located at 3 Embarcadero Center, 20th Floor, San Francisco, CA 94111-40004.
“Depositary” means The Bank of New York Mellon.
“Disclosure Time” means, (i) if this Agreement is signed on a day that is not a Trading Day or after 9:00 a.m. (New York City time) and before midnight (New York City time) on any Trading Day, 9:01 a.m. (New York City time) on the Trading Day immediately following the date hereof, unless otherwise instructed as to an earlier time by the Placement Agents, and (ii) if this Agreement is signed between midnight (New York City time) and 9:00 a.m. (New York City time) on any Trading Day, no later than 9:01 a.m. (New York City time) on the date hereof, unless otherwise instructed as to an earlier time by the Placement Agents.
“DTC” means The Depository Trust Company.
“Engagement Letter” means the Engagement Letter by and between the Company and the Placement Agents, dated April 15, 2026.
“Exchange Act” means the Securities Exchange Act of 1934, as amended, and the rules and regulations promulgated thereunder.
“Exempt Issuance” means the issuance of (a) shares of Ordinary Share, options, restricted stock units or other equity awards to employees, officers, directors or consultants of the Company pursuant to any stock or option plan duly adopted for such purpose, by a majority of the non-employee members of the board of directors of the Company or a majority of the members of a committee of non-employee directors established for such purpose for services rendered to the Company, (b) securities upon the exercise or exchange of or conversion of any securities issued hereunder and/or other securities exercisable or exchangeable for or convertible into shares of Ordinary Share issued and outstanding on the date of this Agreement, provided that such securities have not been amended, nor repriced, since the date of this Agreement to increase the number of such securities or to decrease the exercise price, exchange price or conversion price of such securities or to extend the term of such securities, (c) securities issued in connection with any debt financing transaction or royalty financing transaction and (d) securities issued pursuant to acquisitions or strategic transactions approved by a majority of the disinterested directors of the Company, provided that such securities are issued as “restricted securities” (as defined in Rule 144) and carry no registration rights that require the filing of any registration statement in connection therewith during the prohibition period in Section 5.12 herein, and provided that any such issuance shall only be to a person (or to the equityholders of a person) which is, itself or through its subsidiaries, an operating company or an owner of an asset in a business that shall provide to the Company additional benefits in addition to the investment of funds (if any), but shall not include a transaction in which the Company is issuing securities primarily for the purpose of raising capital or to an entity whose primary business is investing in securities.
“Force Majeure Event” means any occurrence or contingency beyond a party’s reasonable control, including, but not limited to, acts of God, pandemic, epidemic, earthquake, fire, labor disputes and strikes, riots, war, acts of terrorism, common carrier interruptions, network interruptions, breakdown in facilities and governmental requirements, government shutdowns and the acts or omissions of a third party that is not an Affiliate of the impacted party.
“IFRA” means International Financial Reporting Standards, as applied by the Company.
“Material Adverse Effect” means with respect to any event or circumstance, an effect that reasonably be expected to have a material adverse effect on the business, properties, management, financial position, stockholders’ equity, results of operations or prospects of the Company taken as a whole or on the performance by the Company of its obligations under this Agreement.
“Ordinary Share” means the Class A Ordinary Share of the Company, par value $0.0001 per share, and any other class of securities into which such securities may hereafter be reclassified or changed.
“Per Share Purchase Price” shall be US$13.25 per ADS, equals to approximately US$4.4167 per Ordinary Share.
“Person” means an individual or corporation, partnership, trust, incorporated or unincorporated association, joint venture, limited liability company, joint stock company, government (or an agency or subdivision thereof) or other entity of any kind.
“Placement Agents” means Leerink Partners LLC, Cantor Fitzgerald & Co., Lucid Capital Markets, LLC, H.C. Wainwright & Co., LLC and JonesTrading Institutional Services LLC.
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“PRC” means the People’s Republic of China, excluding, for the purposes of this Agreement only, the Hong Kong Special Administrative Region, the Macau Special Administrative Region and Taiwan.
“Rule 144” means Rule 144 promulgated by the Commission pursuant to the Securities Act, as such Rule may be amended or interpreted from time to time, or any similar rule or regulation hereafter adopted by the Commission having substantially the same purpose and effect as such Rule.
“Rule 424” means Rule 424 promulgated by the Commission pursuant to the Securities Act, as such Rule may be amended or interpreted from time to time, or any similar rule or regulation hereafter adopted by the Commission having substantially the same purpose and effect as such Rule.
“Securities Act” means the Securities Act of 1933, as amended, and the rules and regulations promulgated thereunder.
“SEC Reports” means reports, schedules, forms, statements and other documents required to be filed by it under the Securities Act and the Exchange Act, including pursuant to Section 13(a) or 15(d) thereof, for the two years preceding the date hereof (or such shorter period as the Company was required by law or regulation to file such material), including the exhibits thereto and documents incorporated by reference therein.
“Securities” means the Shares and the ADSs.
“Shares” means the shares of Ordinary Share issued or issuable to each Purchaser pursuant to this Agreement.
“Short Sales” means all “short sales” as defined in Rule 200 of Regulation SHO under the Exchange Act (but shall not be deemed to include locating and/or borrowing shares of Ordinary Share).
“Subscription Amount” means, as to each Purchaser, the aggregate amount to be paid for Shares purchased hereunder as specified below such Purchaser’s name on the signature page of this Agreement and next to the heading “Subscription Amount”, in United States dollars and in immediately available funds, which shall equal the number of Shares being acquired by such Purchaser multiplied by the Per Share Purchase Price.
“Trading Day” means a day on which the principal Trading Market is open for trading.
“Trading Market” means the Nasdaq Global Market.
“Transaction Documents” means this Agreement and all exhibits and schedules hereto and all other documents and certificates entered into or delivered by the parties in connection with the transactions contemplated by this Agreement.
“Transfer Agent” means Maples Fund Services (Cayman) Limited, the current transfer agent of the Company, and any successor transfer agent of the Company.
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ARTICLE II.
PURCHASE AND SALE
2.1. Closing. On the Closing Date, upon the terms and subject to the conditions set forth herein, the Company agrees to sell and issue to the Purchasers, and the Purchasers, severally and not jointly, agree to purchase, up to an aggregate of 33,962,265 Ordinary Shares, equivalent of 11,320,755 ADSs, at the Per Share Purchase Price. The Company shall deliver to each Purchaser its Shares pursuant to Section 2.2(a), and the Company and each Purchaser shall deliver the other items set forth in Section 2.2 at the Closing. Upon satisfaction of the covenants and conditions set forth in Sections 2.2 and 2.3, the Closing shall occur at the offices of Company Counsel or such other location as the parties shall mutually agree.
2.2. Deliveries.
(a) On or prior to the Closing Date (except as indicated below), the Company shall deliver or cause to be delivered to each Purchaser the following:
(i) this Agreement duly executed by the Company;
(ii) a legal opinion of Company Cayman Counsel, dated as of the Closing Date, in form and substance reasonably satisfactory to the Purchasers and the Placement Agents;
(ii) a legal opinion of Company U.S. Counsel, dated as of the Closing Date, in form and substance reasonably satisfactory to the Purchasers and the Placement Agents;
(iii) the Company shall have provided the Purchaser with the Company’s wire instructions, on Company letterhead and executed by the Company’s Chief Executive Officer or Chief Financial Officer;
(iv) a copy of the irrevocable instructions to the Transfer Agent instructing the Transfer Agent to deliver on an expedited basis uncertificated book entries representing the Shares purchased by the Purchaser hereunder and set forth on such Purchaser’s signature page (and bearing the restrictive securities legend pursuant to Section 5.9), registered in the name of such Purchaser.
(v) executed copies of a lock-up agreement from each executive officer, director and certain shareholders of the Company, in the form attached as Annex A hereto.
(b) On or prior to the Closing Date, each Purchaser shall deliver or cause to be delivered to the Company the following:
(i) this Agreement duly executed by such Purchaser; and
(ii) subject to the last sentence of Section 2.1, if applicable to the Purchaser, such Purchaser’s Subscription Amount.
2.3. Closing Conditions.
(a) The obligations of the Company hereunder in connection with the Closing are subject to the following conditions being met, unless otherwise waived in writing by the Company:
(i) the representations and warranties of the Purchasers contained herein shall be materially true and correct as of the Closing Date as if made as of the Closing Date (unless such representation or warranty was made as of a specific date, in which case such representation and warranty shall be true and correct as of such date);
(ii) all obligations, covenants and agreements required to be performed or complied with by each Purchaser on or prior to the Closing shall have been performed or complied with by it; and
(iii) the delivery by each Purchaser of the items set forth in Section 2.2(b) of this Agreement.
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(b) The respective obligations of the Purchasers hereunder in connection with the Closing are subject to the following conditions being met, unless otherwise waived in writing by a Purchaser solely as to itself:
(i) the representations and warranties of the Company contained herein shall be true and correct as of the date hereof and as of the Closing Date as if made as of the Closing Date (unless in each case such representation or warranty was made as of a specific date, in which case such representation and warranty shall be true and correct as of such date);
(ii) all obligations, covenants and agreements required to be performed or complied with by the Company on or prior to the Closing shall have been performed or complied with by it;
(iii) the delivery by the Company of the items set forth in Section 2.2(a) of this Agreement;
(iv) no Material Adverse Effect with respect to the Company shall have occurred since the date hereof;
(v) from the date hereof to the Closing Date, (A) trading in the ADSs shall not have been suspended by the Commission or the Company’s principal Trading Market, and, at any time prior to the Closing Date, trading in securities generally as reported by Bloomberg L.P. shall not have been suspended or limited, or minimum prices shall not have been established on securities whose trades are reported by such service, or on any Trading Market, (B) no banking moratorium shall have been declared either by the United States or New York State authorities, and (C) there shall not have occurred any material outbreak or escalation of hostilities or other national or international calamity of such magnitude in its effect on, or any material adverse change in, any financial market which, with respect to this clause (C), in the reasonable judgment of the Purchasers purchasing a majority of the Shares in the offering made hereunder, makes it impracticable or inadvisable to purchase the Shares at the Closing;
(vi) no objection shall have been raised by the Trading Market with respect to such notification and the consummation of the transactions contemplated by this Agreement; (vii) no governmental authority shall have issued any order, decree or ruling, and no law shall be in effect, enjoining, restraining or otherwise prohibiting any of the transactions contemplated hereby, and the Company shall have obtained all governmental, regulatory or third-party consents and approvals other than any waivers required under the Company’s existing amended and restated investors rights agreement, if any, necessary for the sale and issuance of the Shares, including without limitation, those required by the Nasdaq Global Select Market.
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ARTICLE III.
REPRESENTATIONS AND WARRANTIES
3.1. Representations and Warranties of the Company. The Company hereby represents and warrants as of the date hereof (except for the representations and warranties that speak as of a specific date, which shall be made as of such date), to the Purchasers and to the Placement Agents:
(a) Organization and Good Standing. The Company has been duly organized and is validly existing and in good standing under the laws of its jurisdiction of organization, is duly qualified to do business and is in good standing in each jurisdiction in which its ownership or lease of property or the conduct of its business requires such qualification, and has all power and authority necessary to own or hold its properties and to conduct the businesses in which it is engaged, except where the failure to be so qualified or in good standing or have such power or authority would not, individually or in the aggregate, have a Material Adverse Effect.
(b) Due Authorization. The Company has full right, power and authority to execute and deliver the Transaction Documents and to perform its obligations hereunder; and all action required to be taken for the due and proper authorization, execution and delivery by it of the Transaction Documents and the consummation by it of the transactions contemplated hereby has been duly and validly taken.
(c) No Violation or Default. The Company is not (i) in violation of its articles of associations or similar organizational documents; (ii) in default, and no event has occurred that, with notice or lapse of time or both, would constitute such a default, in the due performance or observance of any term, covenant or condition contained in any indenture, mortgage, deed of trust, loan agreement or other agreement or instrument to which the Company is a party or by which the Company is bound or to which any property or asset of the Company is subject; or (iii) in violation of any applicable law or statute or any judgment, order, rule or regulation of any court or arbitrator or governmental or regulatory authority having jurisdiction over the Company, except, in the case of clauses (ii) and (iii) above, for any such default or violation that would not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect.
(d) No Conflicts. The execution, delivery and performance by the Company of the Transaction Documents to which it is a party and the consummation by the Company of the transactions contemplated thereby will not (i) conflict with or result in a breach or violation of any of the terms or provisions of, or constitute a default under, result in the termination, modification or acceleration of, or result in the creation or imposition of any lien, charge or encumbrance upon any property, right or asset of the Company pursuant to, any indenture, mortgage, deed of trust, loan agreement or other agreement or instrument to which the Company is a party or by which the Company is bound or to which any property, right or asset of the Company is subject, (ii) result in any violation of the provisions of the articles of associations or similar organizational documents of the Company or (iii) result in the violation of any law or statute or any judgment, order, rule or regulation of any court or arbitrator or governmental or regulatory authority, except, in the case of clauses (i) and (iii) above, for any such conflict, breach, violation, default, lien, charge or encumbrance that would not, individually or in the aggregate, have a Material Adverse Effect.
(e) Filings, Consents and Approvals. No filing, consent, approval, authorization, order, license, registration or qualification of or with any court or arbitrator or governmental or regulatory authority having jurisdiction over the Company is required for the execution, delivery and performance by the Company of the Transaction Documents (including the issuance of the Shares), other than (i) the filing of any requisite notices and/or application(s) to the principal Trading Market for the issuance and sale of the Shares and the listing of the Shares for trading or quotation thereon in the time and manner required thereby, (ii) the filings required in accordance with Section 5.3 of this Agreement, (iii) the CSRC Filings to be completed pursuant to Section 5.11 of this Agreement, and (iv) those that have been made or obtained prior to the date of this Agreement (collectively, the “Required Approvals”).
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(f) Issuance of the Shares. The Shares to be issued and sold by the Company hereunder have been duly authorized by the Company and, when issued, delivered and paid for as provided herein, will be duly and validly issued and fully paid and nonassessable, and the issuance of the Shares is not subject to any pre-emptive or similar rights that have not been duly waived or satisfied. Assuming the accuracy of the representations and warranties of the Purchasers in this Agreement, the Shares will be issued in compliance with all applicable federal and state securities laws.
(g) Capitalization. The Company has an authorized capitalization as set forth in the SEC Reports; all the outstanding shares of capital stock of the Company have been duly and validly authorized and issued and are fully paid and non-assessable and are not subject to any pre-emptive or similar rights that have not been duly waived or satisfied; except as described in or expressly contemplated by the SEC Reports, there are no outstanding rights (including, without limitation, pre-emptive rights that have not been duly waived or satisfied), warrants or options to acquire, or instruments convertible into or exchangeable for, any shares of capital stock or other equity interest in the Company, or any contract, commitment, agreement, understanding or arrangement of any kind relating to the issuance of any capital stock of the Company, any such convertible or exchangeable securities or any such rights, warrants or options; the capital stock of the Company conforms in all material respects to the description thereof contained in the SEC Reports. Neither the execution of this Agreement nor the issuance of the Shares will result in the triggering of any anti-dilution or other similar rights (including a rights distribution under any “poison pill” plan or similar arrangement). Other than the Ordinary Share, there are no other shares of any other class or series of capital stock of the Company issued or outstanding.
(h) SEC Reports. The Company has filed all SEC Reports on a timely basis or has received a valid extension of such time of filing and has filed any such SEC Reports prior to the expiration of any such extension, except where the failure to file on a timely basis would not have or reasonably be expected to result in a Material Adverse Effect (including, for this purpose only, any failure to qualify to register the Shares for resale on Form S-1 or which would prevent the Purchaser from using Rule 144 to resell any Shares). As of their respective filing dates, or to the extent corrected by a subsequent restatement or amendment, the SEC Reports complied in all material respects with the requirements of the Securities Act and the Exchange Act and the rules and regulations of the Commission promulgated thereunder, and none of the SEC Reports, when filed, contained any untrue statement of a material fact or omitted to state a material fact required to be stated therein or necessary in order to make the statements therein, in light of the circumstances under which they were made, not misleading. The Company is not and has never been an issuer subject to Rule 144(i) under the Securities Act.
(i) Financial Statements. The financial statements (including the related notes thereto) of the Company included in the SEC Reports comply in all material respects with the applicable requirements of the Securities Act and the Exchange Act, as applicable, and present fairly in all material respects the financial position of the Company as of the dates indicated and the results of their operations and the changes in their cash flows for the periods specified; such financial statements have been prepared in conformity with IFRS applied on a consistent basis throughout the periods covered thereby, except in the case of unaudited financial statements, which are subject to normal year-end adjustments and do not contain certain footnotes as permitted by the applicable rules of the Commission; any supporting schedules included in the SEC Reports present fairly in all material respects the information required to be stated therein; and the other financial information included in the SEC Reports has been derived from the accounting records of the Company and presents fairly in all material respects the information shown thereby.
(j) No Material Adverse Change. Since the date of the most recent financial statements of the Company included the SEC Reports, (i) there has not been any material change in the capital stock (other than the issuance of shares of Ordinary Share upon exercise of stock options and vesting of other equity awards described as outstanding in, and the grant of options and awards under existing equity incentive plans described in, the SEC Reports), short-term debt or long-term debt of the Company, or any dividend or distribution of any kind declared, set aside for payment, paid or made by the Company on any class of capital stock, or any material adverse change, or any development that would reasonably be expected to result in a material adverse change, in or affecting the business, properties, management, financial position, stockholders’ equity, results of operations or prospects of the Company; (ii) the Company has not entered into any transaction or agreement (whether or not in the ordinary course of business) that is material to the Company or incurred any liability or obligation, direct or contingent, that is material to the Company; and (iii) the Company has not sustained any loss or interference with its business that is material to the Company and that is either from fire, explosion, flood or other calamity, whether or not covered by insurance, or from any labor disturbance or dispute or any action, order or decree of any court or arbitrator or governmental or regulatory authority, except, in each case, as otherwise disclosed in the SEC Reports.
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(k) Legal Proceedings. There are no legal, governmental or regulatory investigations, actions, demands, claims, suits, arbitrations, inquiries or proceedings (“Actions”) pending to which the Company is or may be a party or to which any property of the Company is or may be the subject that, individually or in the aggregate, if determined adversely to the Company, would reasonably be expected to have a Material Adverse Effect; to the Company’s Knowledge, no such Actions are threatened or contemplated by any governmental or regulatory authority or threatened by others that would reasonably be expected, individually or in the aggregate, to have a Material Adverse Effect. There are no current or pending Actions that are required under the Securities Act to be described in the SEC Reports that are not so described in the SEC Reports.
(l) No Labor Disputes; Employment Matters. No labor disturbance by or dispute with employees of the Company exists or, to the Company’s Knowledge, is contemplated or threatened, and the Company is not aware of any existing or imminent labor disturbance by, or dispute with, the employees of any of its principal suppliers, contractors or customers, except as would not reasonably be expected to have a Material Adverse Effect. The Company has not received any notice of cancellation or termination with respect to any collective bargaining agreement to which it is a party. To the Knowledge of the Company, no executive officer of the Company (as defined in Rule 501(f) of the Securities Act) is, or is now expected to be, in violation of any material term of any employment contract, confidentiality, disclosure or proprietary information agreement or non-competition agreement, or any other contract or agreement or any restrictive covenant in favor of any third party, and the continued employment of each such executive officer does not subject the Company to any liability with respect to any of the foregoing matters. The Company is in compliance with all U.S. federal, state, local and foreign laws and regulations relating to employment and employment practices, terms and conditions of employment and wages and hours, except where the failure to be in compliance could not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect.
(m) Licenses and Permits. The Company possesses, and is in compliance with the terms of, all licenses, sub-licenses, certificates, permits and other authorizations issued by, and have made all declarations and filings with, the appropriate federal, state, local or foreign governmental or regulatory authorities that are necessary for the ownership or lease of its respective properties or the conduct of its business as described in the SEC Reports, except where the failures to so possess, comply with, or make such declarations or filings would not, whether individually or in the aggregate, reasonably be expected to have a Material Adverse Effect; and the Company has not received written notice of any revocation or modification of any such license, sub-license, certificate, permit or authorization or has any reason to believe that any such license, sub-license, certificate, permit or authorization will not be renewed in the ordinary course, except for such revocations, modifications or non-renewals as would not, whether individually or in the aggregate, reasonably be expected to have a Material Adverse Effect. No event has occurred which allows, or after notice or lapse of time would allow, revocation or termination thereof or results in any other impairment of the rights of the holder, except for such revocations, terminations or impairments as would not, whether individually or in the aggregate, reasonably be expected to have a Material Adverse Effect. The Company has filed, obtained, maintained or submitted all reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required and that all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete and correct on the date filed (or were corrected or supplemented by a subsequent submission) as required for maintenance of its licenses, certificates, permits and other authorizations that are necessary for the conduct of its business, except where such failures to file, obtain, maintain, submit, correct or supplement the same would not, whether individually or in the aggregate, reasonably be expected to have a Material Adverse Effect.
(n) Title to Real and Personal Property. The Company has valid rights to lease or otherwise use, all items of real and personal property that are material to the business of the Company as currently conducted, in each case free and clear of all liens, encumbrances, claims and defects and imperfections of title except those that (i) do not materially interfere with the use made and proposed to be made of such property by the Company or (ii) could not reasonably be expected, individually or in the aggregate, to have a Material Adverse Effect.
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(o) Title to Intellectual Property. Except as disclosed in the SEC Reports, the Company owns or possesses valid and enforceable license rights under all material patents, patent applications, trademarks, service marks, trade names, trade dress, Internet domain names, copyrights, works of authorship, licenses, proprietary information and know-how (including trade secrets and other unpatented and/or unpatentable proprietary or confidential information, systems or procedures), or other intellectual property which are reasonably necessary for the conduct of its business in the manner described in the SEC Reports to be conducted (collectively, “Intellectual Property”), and, to the Company’s Knowledge, the conduct of its business does not infringe, misappropriate or otherwise violate any valid intellectual property rights of others. The Intellectual Property has not been adjudged by a court of competent jurisdiction to be invalid or unenforceable, in whole or in part, and to the Company’s Knowledge, the Company is unaware of any facts which would form a reasonable basis for any such adjudication. The Company has not received any written notice of any claim of infringement, misappropriation or violation of any valid intellectual property rights of another, and the Company is unaware of any facts which would form a reasonable basis for a notice of any claim of infringement, misappropriation or violation of any valid intellectual property rights of another. Except as disclosed in the SEC Reports, to the Company’s Knowledge: (i) there are no third parties who have rights to any Intellectual Property, except for customary reversionary rights of third-party licensors, with respect to Intellectual Property that is disclosed in the SEC Reports as owned by or licensed to the Company; and (ii) there is no infringement by third parties of any Intellectual Property. Except as disclosed in the SEC Reports, there is no pending or, to the Company’s Knowledge, threatened action, suit, proceeding or claim by others: (A) challenging the Company’s rights in or to any Intellectual Property, and the Company is unaware of any facts which would form a reasonable basis for any such action, suit, proceeding or claim; (B) challenging the validity, enforceability or scope of any Intellectual Property, and the Company is unaware of any facts which would form a reasonable basis for any such action, suit, proceeding or claim; or (C) asserting that the Company infringes, misappropriates, or otherwise violates, or would, upon the commercialization of any product or service described in the SEC Reports as under development, infringe, misappropriate, or otherwise violate, any valid intellectual property rights of others, and the Company is unaware of any facts which would form a reasonable basis for any such action, suit, proceeding or claim. To the Company’s Knowledge, there are no material defects in any of the material patents or patent applications included in the Intellectual Property. To the Company’s Knowledge, the Company has taken all reasonable steps to protect, maintain and safeguard their Intellectual Property, including the execution of appropriate nondisclosure or confidentiality agreements, invention assignment agreements and invention assignments with their employees, and, to the Company’s Knowledge, no employee of the Company is in or has been in violation of any material term of any of such agreements, or any restrictive covenant to or with a former employer where the basis of such violation relates to such employee’s employment with the Company. To the Company’s Knowledge, the duty of candor and good faith as required by the United States Patent and Trademark Office during the prosecution of the material United States patents and patent applications included in the Intellectual Property have been complied in all respects with; and in all foreign patent offices having similar requirements, all such requirements have been complied with in all respects. To the Company’s Knowledge, none of the Company owned Intellectual Property or technology (including information technology and outsourced arrangements) employed by the Company has been obtained or is being used by the Company in violation of any material contractual obligation binding on the Company or any of its respective officers, directors or employees or otherwise in violation of the valid rights of any persons. To the Company’s Knowledge, all material license agreements for the use of the Intellectual Property described in the SEC Reports are valid, binding upon, and enforceable by or against the parties thereto in accordance to its terms. To the Company’s Knowledge, the Company has complied in all material respects with, and is not in breach nor has received any asserted or threatened claim of breach of any material Intellectual Property license, and the Company has no Knowledge of any breach or anticipated breach by any other person to any material Intellectual Property license.
(p) Trade Secrets. The Company has taken reasonable and customary actions to protect their rights in and prevent the unauthorized use and disclosure of material trade secrets and confidential business information (including confidential source code, ideas, research and development information, know-how, formulas, compositions, technical data, designs, drawings, specifications, research records, records of inventions, test information, financial, marketing and business data, customer and supplier lists and information, pricing and cost information, business and marketing plans and proposals) owned by the Company, and, to the Company’s Knowledge, there has been no unauthorized use or disclosure.
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(q) IT Assets, Data Privacy and Security. Except as would not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect, (i) the computers, websites, applications, databases, software, servers, networks, data communications lines, and other information technology systems owned, licensed, leased or otherwise used by the Company (including any third party technology or services used by the Company but excluding any public networks) (collectively, the “IT Assets”) operate and perform as necessary for the operation of the business of the Company as currently conducted, (ii) to the Company’s Knowledge, the IT Assets are free and clear of all viruses, vulnerabilities, bugs, errors, defects, Trojan horses, time bombs, malware and other malicious code, and (iii) the Company has implemented and maintained commercially reasonable controls, policies, procedures, and safeguards to maintain and protect their confidential information and the privacy, confidentiality, integrity, and security of all IT Assets and data (including all Personal Data (defined below), sensitive, confidential, or regulated data (collectively, “Confidential Data”)) used in connection with their businesses. Except as would not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect, there have been no breaches, outages, or unauthorized uses of, or accesses to IT Assets or Confidential Data (each, a “Breach”), nor any Breaches under internal review or investigation by the Company in relation to the same. Except as would not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect, the Company complies, and has complied, with all applicable state and federal data privacy and security laws and regulations and industry standards applicable to the performance of Company’s obligations under any contracts regarding the collection, use, storage, retention, disclosure, transfer, disposal, or any other processing (collectively “Process” or “Processing”) and privacy, confidentiality, integrity and security of Personal Data (“Privacy Laws”). To ensure compliance with the Privacy Laws, the Company has in place, comply with, and take appropriate steps designed to ensure compliance in all material respects with the Company’s policies and procedures relating to data privacy and security and the collection, storage, use, disclosure, handling, and analysis of Confidential Data (the “Policies”). The Company and, to the Company’s Knowledge, any third parties performing operations involving Personal Data on behalf of Company, have at all times made all required disclosures to and obtained all necessary consents from the data subjects from whom such Personal Data was and will be collected, except where the failure to make such disclosures or obtain such consents would not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect. “Personal Data” means all information that relates to an identified or identifiable individual and is regulated as “personal data,” “personal information,” “individually identifiable health information,” “protected health information,” “personally identifiable information,” or any similar information under any Privacy Law.
(r) eXtensible Business Reporting Language. The interactive data in eXtensible Business Reporting Language included in the SEC Reports fairly presents the information called for in all material respects and has been prepared in accordance with the Commission’s rules and guidelines applicable thereto.
(s) Insurance. The Company has insurance covering its properties, operations, personnel and businesses, including business interruption insurance, which insurance is in amounts and insures against such losses and risks as the Company reasonably believes are adequate to protect the Company and its business; and the Company has not (i) received notice from any insurer or agent of such insurer that capital improvements or other expenditures are required or necessary to be made in order to continue such insurance or (ii) any reason to believe that it will not be able to renew its existing insurance coverage as and when such coverage expires or to obtain similar coverage at reasonable cost from similar insurers as may be necessary to continue its business.
(t) No Undisclosed Relationships. No relationship, direct or indirect, exists between or among the Company, on the one hand, and the directors, officers, stockholders, customers, suppliers or other affiliates of the Company, on the other, that is required by the Securities Act to be described in the SEC Reports and that is not so described in such documents.
(u) Internal Accounting Controls. Except as disclosed in the SEC Reports, the Company maintains a system of “internal control over financial reporting” (as defined in Rule 13a-15(f) of the Exchange Act) that are reasonably designed to comply with the applicable requirements of the Exchange Act and have been designed by, or under the supervision of, their respective principal executive and principal financial officers, or persons performing similar functions, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with IFRS. Except as disclosed in the SEC Reports, the Company maintains internal accounting controls sufficient to provide reasonable assurance that (i) transactions are executed in accordance with management’s general or specific authorizations; (ii) transactions are recorded as necessary to permit preparation of financial statements in conformity with IFRS and to maintain asset accountability; (iii) access to assets is permitted only in accordance with management’s general or specific authorization; and (iv) the recorded accountability for assets is compared with the existing assets at reasonable intervals and appropriate action is taken with respect to any differences; and (v) interactive data in eXtensible Business Reporting Language included in the SEC Reports fairly presents the information called for in all material respects and is prepared in accordance with the Commission’s rules and guidelines applicable thereto. Except as disclosed in the SEC Reports, there are no material weaknesses in the Company’s internal controls. The Company’s auditors and the Audit Committee of the Board of Directors have been advised of: (i) all significant deficiencies and material weaknesses in the design or operation of internal controls over financial reporting which have adversely affected or are reasonably likely to adversely affect the Company’s ability to record, process, summarize and report financial information; and (ii) any fraud, whether or not material, that involves management or other employees who have a significant role in the Company’s internal controls over financial reporting.
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(v) Sarbanes-Oxley; Disclosure Controls. There is and has been no failure on the part of the Company or any of the Company’s directors or officers, in their capacities as such, to comply with any applicable provision of the Sarbanes-Oxley Act of 2002, as amended, and the rules and regulations promulgated in connection therewith, including Section 402 related to loans. The Company maintains an effective system of “disclosure controls and procedures” (as defined in Rule 13a-15(e) of the Exchange Act) that complies with the applicable requirements of the Exchange Act and that has been designed to ensure that information required to be disclosed by the Company in reports that it files or submits under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the Commission’s rules and forms, including controls and procedures designed to ensure that such information is accumulated and communicated to the Company’s management as appropriate to allow timely decisions regarding required disclosure.
(w) Certain Fees. No person or entity will have, as a result of the transactions contemplated by this Agreement, any valid right, interest or claim against or upon the Company or a Purchaser for any commission, fee or other compensation pursuant to any agreement, arrangement or understanding entered into by or on behalf of the Company, other than the Placement Agents with respect to the offer and sale of the Shares (which placement agent fees are being paid by the Company). The Purchasers shall have no obligation with respect to any fees or with respect to any claims made by or on behalf of other Persons for fees of a type contemplated in this paragraph (w) that may be due in connection with the transactions contemplated by the Transaction Documents.
(x) Investment Company. The Company is not and, after giving effect to the offering and sale of the Shares, will not be, required to register as an “investment company” or an entity “controlled” by an “investment company” within the meaning of the Investment Company Act of 1940, as amended, and the rules and regulations of the Commission thereunder.
(y) Listing and Maintenance Requirements. The ADSs are registered pursuant to Section 12(b) or 12(g) of the Exchange Act, and the Company has taken no action designed to terminate the registration of the ADSs under the Exchange Act nor has the Company received any notification that the Commission is contemplating terminating such registration. The Company has not, in the twelve (12) months preceding the date hereof, received written notice from any Trading Market on which the ADSs are listed or quoted to the effect that the Company is not in compliance with the listing or maintenance requirements of such Trading Market. The Company is in compliance with all listing and maintenance requirements of the principal Trading Market. The Company agrees to maintain the eligibility of the ADSs for electronic transfer through the Depository Trust Company or another established clearing corporation, including, without limitation, by timely payment of fees to the Depository Trust Company or such other established clearing corporation in connection with such electronic transfer.
(z) Application of Takeover Protections; Rights Agreements. The Company and the Board of Directors have taken all necessary action, if any, in order to render inapplicable any control share acquisition, business combination, poison pill (including any distribution under a rights agreement) or other similar anti-takeover provision under the Company’s articles of associations or the laws of its state of incorporation that is or could reasonably be expected to become applicable to any of the Purchasers as a result of the Purchasers and the Company fulfilling their obligations or exercising their rights under the Transaction Documents, including, without limitation, the Company’s issuance of the Shares and the Purchasers’ ownership of the Shares.
(aa) Disclosure. The Company confirms that neither it nor any of its officers or directors nor any other Person acting on its or their behalf has provided, and it has not authorized the Placement Agents to provide, the Purchasers or their respective agents or counsel with any information that it believes constitutes material, non-public information except insofar as the existence, provisions and terms of the Transaction Documents and the proposed transactions hereunder may constitute such information, all of which will be disclosed by the Company in the press release as contemplated by Section 5.3 hereof. The Company understands and confirms that the Purchasers will rely on the foregoing representations in effecting transactions in securities of the Company.
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(bb) No Integrated Offering. Assuming the accuracy of the Purchasers’ representations and warranties set forth in Section 3.2, neither the Company, nor any of its Affiliates or any Person acting on its behalf has, directly or indirectly, at any time within the past six (6) months, made any offers or sales of any Company security or solicited any offers to buy any security under circumstances that would cause the offering of the Shares pursuant to the Transaction Documents to be integrated with prior offerings by the Company for purposes of any applicable law, regulation or stockholder approval provisions, including, without limitation, under the rules and regulations of any Trading Market on which any of the securities of the Company are listed or designated.
(cc) Taxes. Except as would not reasonably be expected to have a Material Adverse Effect, the Company has paid all federal, state, local and foreign taxes and filed all tax returns required to be paid or filed through the date hereof unless such taxes are being contested in good faith by appropriate proceedings for which reserves are being maintained in accordance with generally accepted accounting principles, and, except as otherwise disclosed in the SEC Reports or as would not reasonably be expected to have a Material Adverse Effect, there is no tax deficiency that has been, or could reasonably be expected to be, asserted against the Company or any of its properties or assets.
(dd) Environmental Matters. (i) The Company (x) is in compliance with all, and have not violated any, applicable federal, state, local and foreign laws (including common law), rules, regulations, requirements, decisions, judgments, decrees, orders and other legally enforceable requirements relating to pollution or the protection of human health or safety, the environment, natural resources, hazardous or toxic substances or wastes, pollutants or contaminants (collectively, “Environmental Laws”); (y) has received and is in compliance with all, and have not violated any, permits, licenses, certificates or other authorizations or approvals required of them under any Environmental Laws to conduct its business; and (z) has not received written notice of any actual or potential liability or obligation under or relating to, or any actual or potential violation of, any Environmental Laws, including for the investigation or remediation of any disposal or release of hazardous or toxic substances or wastes, pollutants or contaminants, and have no Knowledge of any event or condition that would reasonably be expected to result in any such notice; (ii) there are no costs or liabilities associated with Environmental Laws of or relating to the Company, except in the case of each of (i) and (ii) above, for any such matter as would not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect; and (iii) (x) there is no proceeding that is pending, or to the Company’s Knowledge contemplated, against the Company under any Environmental Laws in which a governmental entity is also a party, other than such proceeding regarding which the Company reasonably believes no monetary sanctions of $100,000 or more will be imposed, (y) the Company is not aware of any facts or issues regarding compliance with Environmental Laws, or liabilities or other obligations under Environmental Laws or concerning hazardous or toxic substances or wastes, pollutants or contaminants, that could reasonably be expected to have a Material Adverse Effect, and (z) the Company does not anticipate material capital expenditures relating to any Environmental Laws.
(ee) Hazardous Materials. There has been no storage, generation, transportation, use, handling, treatment, Release or threat of Release of Hazardous Materials by, relating to or caused by the Company (or, to the Company’s Knowledge, any other entity (including any predecessor) for whose acts or omissions the Company is or could reasonably be expected to be liable) at, on, under or from any property or facility now or previously owned, operated or leased by the Company, or, to the Company’s Knowledge, at, on, under or from any other property or facility, in violation of any Environmental Laws or in a manner or amount or to a location that could reasonably be expected to result in any liability under any Environmental Law, except for any violation or liability which would not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect. “Hazardous Materials” means any material, chemical, substance, waste, pollutant, contaminant, compound, mixture, or constituent thereof, in any form or amount, including petroleum (including crude oil or any fraction thereof) and petroleum products, natural gas liquids, asbestos and asbestos containing materials, naturally occurring radioactive materials, brine, and drilling mud, regulated or which can give rise to liability under any Environmental Law. “Release” means any spilling, leaking, seepage, pumping, pouring, emitting, emptying, discharging, injecting, escaping, leaching, dumping, disposing, depositing, dispersing, or migrating in, into or through the environment, or in, into from or through any building or structure.
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(ff) No Unlawful Payments. None of the Company or, to the Company’s Knowledge, any director, officer or employee of the Company or any agent, affiliate or other person acting on behalf of the Company, has (i) used any corporate funds for any unlawful contribution, gift, entertainment or other unlawful expense relating to political activity; (ii) made or taken an act in furtherance of an offer, promise or authorization of any direct or indirect unlawful payment or unlawful benefit to any foreign or domestic government or regulatory official or employee, including of any government-owned or controlled entity or of a public international organization, or any person acting in an official capacity for or on behalf of any of the foregoing, or any political party or party official or candidate for political office; (iii) violated or is in violation of any provision of the Foreign Corrupt Practices Act of 1977, as amended, or any applicable law or regulation implementing the OECD Convention on Combating Bribery of Foreign Public Officials in International Business Transactions, or committed an offence under the Bribery Act 2010 of the United Kingdom or any other applicable anti-bribery or anti-corruption law; or (iv) made, offered, agreed, requested or taken an act in furtherance of any unlawful bribe or other unlawful benefit, including, without limitation, any rebate, payoff, influence payment, kickback or other unlawful or improper payment or benefit. The Company will not use, directly or indirectly, the proceeds of the offering in furtherance of an offer, payment, promise to pay, or authorization of the payment or giving of money, or anything else of value, to any person in violation of any applicable anti-bribery or anti-corruption laws. The Company maintains and enforces policies and procedures designed to promote and ensure compliance with all applicable anti-bribery and anti-corruption laws.
(gg) Acknowledgment Regarding Purchasers’ Purchase of Shares. The Company acknowledges and agrees that each Purchaser is acting solely in the capacity of an arm’s length purchaser with respect to the Transaction Documents and the transactions contemplated hereby and thereby. The Company further acknowledges that no Purchaser is acting as a financial advisor or fiduciary of the Company (or in any similar capacity) with respect to the Transaction Documents and the transactions contemplated thereby and any advice given by any Purchaser or any of their respective representatives or agents in connection with the Transaction Documents and the transactions contemplated thereby is merely incidental to the Purchasers’ purchase of the Shares. The Company further represents to the Purchasers that the Company’s decision to enter into this Agreement and the other Transaction Documents has been based solely on the independent evaluation of the transactions contemplated hereby by the Company and its representatives.
(hh) No Conflicts with Sanctions Laws. None of the Company or, to the Company’s Knowledge, any director, officer, or employee, or any agent, affiliate or other person associated with or acting on behalf of the Company is currently the subject or the target of any economic, financial or trade sanctions administered or enforced by the U.S. government, (including, without limitation, the Office of Foreign Assets Control of the U.S. Department of the Treasury or the U.S. Department of State and including, without limitation, the designation as a “specially designated national” or “blocked person”), the United Nations Security Council, the European Union, His Majesty’s Treasury, the Swiss Secretariat of Economic Affairs, or other relevant sanctions authority (collectively, “Sanctions”), nor is the Company, or, to the Company’s Knowledge, any director, officer, or employee, or any agent, affiliate or other person associated with or acting on behalf of the Company, is located, organized or resident in a country or territory that is the subject or target of Sanctions, including, without limitation, the Crimea Region of Ukraine, the so-called Donetsk People’s Republic, the so-called Luhansk People’s Republic and the non-government controlled areas of the Zaporizhzhia and Kherson Regions, Cuba, Iran, North Korea and Syria (each, a “Sanctioned Country”); and the Company will not directly or indirectly use the proceeds of the offering of the Shares hereunder, or lend, contribute or otherwise make available such proceeds to any subsidiary, joint venture partner or other person or entity (i) to fund or facilitate any activities of or business with any person that, at the time of such funding or facilitation, is the subject or target of Sanctions, (ii) to fund or facilitate any activities of or business in any Sanctioned Country or (iii) in any other manner that will result in a violation by any person (including any person participating in the transaction, whether as underwriter, advisor, investor or otherwise) of Sanctions. The Company has not knowingly engaged in and are not now knowingly engaged in any dealings or transactions with any person that at the time of the dealing or transaction is or was the subject or the target of Sanctions or with any Sanctioned Country.
(ii) Compliance with Anti-Money Laundering Laws. The operations of the Company is and has been conducted at all times in compliance with applicable financial recordkeeping and reporting requirements, including those of the Bank Secrecy Act, as amended by Title III of the Uniting and Strengthening America by Providing Appropriate Tools Required to Intercept and Obstruct Terrorism Act of 2001 (USA PATRIOT Act), and the applicable money laundering statutes of all jurisdictions where the Company conducts business, the rules and regulations thereunder and any related or similar rules, regulations or guidelines issued, administered or enforced by any governmental or regulatory agency (collectively, the “Anti-Money Laundering Laws”) and no action, suit or proceeding by or before any court or governmental or regulatory agency, authority or body or any arbitrator involving the Company with respect to the Anti-Money Laundering Laws is pending or, to the Company’s Knowledge, threatened.
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(jj) Compliance with Health Care Laws. Except as disclosed in the SEC Reports, and except as would not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect, the Company and, to the Company’s Knowledge, its directors, officers, employees, independent contractors, agents and affiliates are, and at all times have been, in compliance with all applicable Health Care Laws. For purposes of this Agreement, “Health Care Laws” means: (i) the FDCA, the Public Health Service Act (42 U.S.C. § 201 et seq.) and the regulations promulgated thereunder; (ii) all applicable federal, state, local and foreign health care fraud and abuse laws, including, without limitation, the U.S. Anti-Kickback Statute (42 U.S.C. Section 1320a-7b(b)), the U.S. Civil False Claims Act (31 U.S.C. Section 3729 et seq.), the criminal False Statements Law (42 U.S.C. Section 1320a-7b(a)), all criminal laws relating to health care fraud and abuse, including but not limited to 18 U.S.C. Sections 286, 287 and 1349, the health care fraud criminal provisions under HIPAA, the civil monetary penalties law (42 U.S.C. Section 1320a-7a), the exclusions law (42 U.S.C. Section 1320a-7), the Physician Payments Sunshine Act (42 U.S.C Section 1320-7h), and the laws governing U.S. government funded or sponsored healthcare programs; and (iii) all other local, state, federal, national, supranational and foreign laws, relating to the regulation of the Company, and (iv) the directives and regulations promulgated pursuant to such statutes and any state or non-U.S. counterpart thereof. The Company has not received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any court or arbitrator or governmental or regulatory authority or third party alleging that any product, operation or activity is in violation of any Health Care Laws nor, to the Company’s Knowledge, is any such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action threatened, except where any of the foregoing, if resolved adversely to the Company, would not reasonably be expected to have a Material Adverse Effect. Except as would not, whether individually or in the aggregate, reasonably be expected to have a Material Adverse Effect, the Company has filed, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Health Care Laws, and all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete and accurate on the date filed (or were corrected or supplemented by a subsequent submission). The Company is not a party to any corporate integrity agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any governmental or regulatory authority or body. Additionally, none of the Company, its employees, officers, directors, or, to the Company’s Knowledge, independent contractors, affiliates or agents, has been excluded, suspended or debarred from participation in any U.S. federal health care program or human clinical research or is subject to a governmental inquiry, investigation, proceeding, or other similar action that could reasonably be expected to result in debarment, suspension or exclusion.
(kk) FDA Compliance. Except in each case as would not, whether individually or in the aggregate, reasonable be expected to have a Material Adverse Effect, the Company: (A) is and at all times has been in compliance with all applicable statutes, rules or regulations enforced by the U.S. Food and Drug Administration (“FDA”) and other comparable governmental entities having oversight over the ownership, testing, development, manufacture, packaging, processing, use, distribution, marketing, labeling, promotion, sale, offer for sale, storage, import, export or disposal of any product under development, manufactured or distributed by the Company (“Applicable Laws”); (B) has not received any FDA Form 483, written notice of adverse finding, warning letter, untitled letter or other written correspondence or notice from the FDA or any governmental entity alleging or asserting noncompliance with any Applicable Laws or any licenses, certificates, approvals, clearances, exemptions, authorizations, permits and supplements or amendments thereto required by any such Applicable Laws (“Authorizations”); (C) possesses all Authorizations, such Authorizations are valid and in full force and effect and the Company is not in violation of any term of any such Authorizations; (D) has not received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from the FDA or any governmental entity or third party alleging that any product operation or activity is in violation of any Applicable Laws or Authorizations and has no Knowledge that the FDA or any governmental entity or third party has threatened any such claim, litigation, arbitration, action, suit, investigation or proceeding; (E) has not received written notice that the FDA or any governmental entity has taken, is taking or intends to take action to limit, suspend, modify or revoke any Authorizations and has no Knowledge that the FDA or any governmental entity has threatened such action; and (F) has filed, obtained, maintained or submitted all reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Applicable Laws or Authorizations and that all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were materially complete and correct on the date filed (or were corrected or supplemented by a subsequent submission).
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(ll) Tests and Preclinical and Clinical Trials. The studies, tests and preclinical and clinical trials conducted by, on behalf of the Company were and, if still ongoing, are being conducted in all material respects in accordance with all Authorizations and Applicable Laws, including, without limitation, the Federal Food, Drug and Cosmetic Act (21 U.S.C. § 301 et seq.) and the rules and regulations promulgated thereunder (“FDCA”) and any other applicable rules, regulations and policies to which such trials and studies are subject; the descriptions of the results of such studies, tests and trials contained in the SEC Reports are, to the Company’s Knowledge, accurate in all material respects; the Company is not aware of any studies, tests or trials, the results of which the Company believes reasonably call into question the study, test, or trial results described or referred to in the SEC Reports when viewed in the context in which such results are described and the clinical state of development; and the Company has not received any written notices or correspondence from the FDA or any governmental entity requiring the termination or suspension of any studies, tests or preclinical or clinical trials currently being conducted or proposed to be conducted by or on behalf of the Company, other than ordinary course communications with respect to modifications in connection with the design and implementation of such trials. To the Company’s Knowledge, the studies, tests and preclinical and clinical trials involving the Company’s product candidates are accurately described in the SEC Reports in all material respects.
(mm) No Additional Agreements. The Company does not have any agreement or understanding with any Purchaser with respect to the transactions contemplated by the Transaction Documents other than as specified in the Transaction Documents.
3.2. Representations and Warranties of the Purchasers. Each Purchaser, for itself and for no other Purchaser, hereby represents, warrants and covenants to the Company and the Placement Agents as of the date hereof and as of the Closing Date as follows (unless as of a specific date therein, in which case they shall be accurate as of such date):
(a) Organization; Authority. The Purchaser is an entity duly organized, validly existing and in good standing under the laws of the jurisdiction of its organization with the requisite corporate or partnership power and authority to enter into and to consummate the transactions contemplated by the applicable Transaction Documents and otherwise to carry out its obligations hereunder and thereunder. The execution and delivery of this Agreement by the Purchaser and performance by the Purchaser of the transactions contemplated by this Agreement have been duly authorized by all necessary corporate or, if the Purchaser is not a corporation, such partnership, limited liability company or other applicable like action, on the part of the Purchaser. Each Transaction Document to which it is a party has been duly executed by the Purchaser, and when delivered by the Purchaser in accordance with the terms hereof, will constitute the valid and legally binding obligation of the Purchaser, enforceable against it in accordance with its terms, except as such enforceability may be limited by applicable bankruptcy, insolvency, reorganization, moratorium, liquidation or similar laws relating to, or affecting generally the enforcement of, creditors’ rights and remedies or by other equitable principles of general application.
(b) No Conflicts. The execution, delivery and performance by the Purchaser of this Agreement and the consummation by the Purchaser of the transactions contemplated hereby will not (i) result in a violation of the organizational documents of the Purchaser, (ii) conflict with, or constitute a default (or an event which with notice or lapse of time or both would become a default) under, or give to others any rights of termination, amendment, acceleration or cancellation of, any agreement, indenture or instrument to which the Purchaser is a party, or (iii) to the knowledge of the Purchaser, result in a violation of any law, rule, regulation, order, judgment or decree (including federal and state securities laws) applicable to the Purchaser, except in the case of clauses (ii) and (iii) above, for such conflicts, defaults, rights or violations which would not, individually or in the aggregate, reasonably be expected to have a material adverse effect on the ability of the Purchaser to perform its obligations hereunder.
(c) Purchaser Status. At the time the Purchaser was offered the Shares, it was, and at the date hereof it is, an “accredited investor” as defined in Rule 501(a) under the Securities Act and an “Institutional Account” as defined in FINRA Rule 4512(c). The Purchaser is not a registered broker-dealer registered under Section 15(a) of the Exchange Act, or a member of FINRA or an entity engaged in the business of being a broker-dealer.
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(d) Securities Act. The Purchaser is purchasing the Shares for its own account, for investment purposes only, and not with a present view to, or for, resale, distribution or fractionalization thereof, in whole or in part, within the meaning of the Securities Act. The Purchaser understands that its acquisition of the Shares has not been registered under the Securities Act or registered or qualified under any state securities law in reliance on specific exemptions therefrom, which exemptions may depend upon, among other things, the bona fide nature of the Purchaser’s investment intent as expressed herein, and that the Company is relying in part upon the truth and accuracy of, and the Purchaser’s compliance with, the representations, warranties, agreements, acknowledgments and understandings of the Purchaser set forth herein in order to determine the availability of such exemptions and the eligibility of the Purchaser to acquire the Shares. The Purchaser will not, directly or indirectly, offer, sell, pledge, transfer or otherwise dispose of (or solicit any offers to buy, purchase or otherwise acquire or take a pledge of) the Shares except in compliance with the Securities Act and the rules and regulations promulgated thereunder. The Purchaser represents and acknowledges that it has not been solicited to offer to purchase or to purchase any Shares by means of any advertising or, to such Purchaser’s knowledge, general solicitation within the meaning of Regulation D under the Securities Act.
(e) Experience of the Purchaser. The Purchaser, either alone or together with its representatives, has such knowledge, sophistication and experience in business and financial matters so as to be capable of evaluating the merits and risks of the prospective investment in the Shares, and has so evaluated the merits and risks of such investment. The Purchaser is able to bear the economic risk of an investment in the Shares and, at the present time, is able to afford a complete loss of such investment.
(f) Access to Information. The Purchaser acknowledges that it has had the opportunity to review the SEC Reports and has been afforded (i) the opportunity to ask such questions as it has deemed necessary of, and to receive answers from, representatives of the Company concerning the terms and conditions of the offering of the Shares and the merits and risks of investing in the Shares; (ii) access to information about the Company and their respective financial condition, results of operations, business, properties, management and prospects sufficient to enable it to evaluate its investment; and (iii) the opportunity to obtain such additional information that the Company possesses or can acquire without unreasonable effort or expense that is necessary to make an informed investment decision with respect to the investment. Neither such inquiries nor any other investigation conducted by or on behalf of the Purchaser or its representatives or counsel shall modify, amend or affect the Purchaser’s right to rely on the truth, accuracy and completeness of the SEC Reports and the Company’s representations and warranties contained in the Transaction Documents. The Purchaser has sought such accounting, legal and tax advice as it has considered necessary to make an informed decision with respect to its acquisition of the Shares.
(g) Certain Trading Activities. Other than with respect to the transactions contemplated herein, since the time that the Purchaser was first contacted by the Company, the Placement Agents or any other Person regarding the transactions contemplated hereby, the Purchaser has not, directly or indirectly, nor has any Person acting on behalf of or pursuant to any understanding with the Purchaser, effected or agreed to effect any purchases or any Short Sales involving the Company’s securities. Notwithstanding the foregoing, (i) in the case of the Purchaser that is a multi-managed investment vehicle whereby separate portfolio managers manage separate portions of the Purchaser’s assets and the portfolio managers have no direct knowledge of the investment decisions made by the portfolio managers managing other portions of the Purchaser’s assets, the representation set forth above shall apply only with respect to the portion of assets managed by the portfolio manager that made the investment decision to purchase the Shares pursuant to this Agreement and (ii) in the case of a Purchaser that is affiliated with other funds or investment vehicles or whose investment advisor or sub-advisor that routinely acts on behalf of or pursuant to an understanding with such Purchaser is also an investment advisor or sub-advisor to other funds or investment vehicles, the representation set forth above shall only apply with respect to the personnel of such other funds or investment vehicles or such investment advisor or sub-advisor who had knowledge of the transaction contemplated hereby and not with respect to any personnel who have been effectively walled off by appropriate information barriers. Other than to other Persons party to this Agreement and to such Persons’ representatives, including their respective lawyers, the Purchaser will hold in confidence all information concerning this Agreement and the sale and issuance of the Shares until the earlier of (i) the time the Company has made a public announcement concerning this Agreement and the sale and issuance of the Shares and (ii) the Disclosure Time. Notwithstanding the foregoing, for avoidance of doubt, nothing contained herein shall constitute a representation or warranty, or preclude any actions, with respect to the identification of the availability of, or securing of, available shares to borrow in order to effect short sales or similar transactions in the future.
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(h) Brokers and Finders. No Person will have, as a result of the transactions contemplated by this Agreement, any valid right, interest or claim against or upon the Company or the Purchaser for any commission, fee or other compensation pursuant to any agreement, arrangement or understanding entered into by or on behalf of the Purchaser.
(i) Independent Investment Decision. The Purchaser has independently evaluated the merits of its decision to purchase Shares pursuant to the Transaction Documents, and such Purchaser confirms that it has not relied on the advice of another Purchaser’s business and/or legal counsel in making such decision. The Purchaser understands that nothing in this Agreement or any other materials presented by or on behalf of the Company to the Purchaser in connection with the purchase of the Shares constitutes legal, tax or investment advice. The Purchaser has consulted such legal, tax and investment advisors as it, in its sole discretion, has deemed necessary or appropriate in connection with its purchase of the Shares. The Purchaser understands that the Placement Agents have acted solely as the agents of the Company in this placement of the Shares and the Purchaser has not relied on the business or legal advice of the Placement Agents or any of their respective agents, counsel or Affiliates in making its investment decision hereunder, and confirms that none of such Persons has made any representations or warranties to the Purchaser in connection with the transactions contemplated by the Transaction Documents.
(j) No Governmental Review. The Purchaser understands that no United States federal or state agency or any other government or governmental agency has passed on or made any recommendation or endorsement of the Shares or the fairness or suitability of the investment in the Shares nor have such authorities passed upon or endorsed the merits of the offering of the Shares.
(k) Regulation M. The Purchaser is aware that the anti-manipulation rules of Regulation M under the Exchange Act may apply to sales of Ordinary Share and other activities with respect to the Ordinary Share by the Purchaser.
(l) Residency. The Purchaser’s residence (if an individual) or offices in which its investment decision with respect to the Shares was made (if an entity) are located at the address immediately below the Purchaser’s name or as otherwise indicated on its signature page hereto.
(m) Foreign Purchasers. If the Purchaser is not a United States person (as defined by Section 7701(a)(30) of the Code), the Purchaser hereby represents that it has satisfied itself as to the full observance by it of the laws of its jurisdiction in connection with its decision to subscribe for the Shares, including (a) the legal requirements within its jurisdiction for the purchase of the Shares, (b) any foreign exchange restrictions applicable to such purchase or acquisition, (c) any government or other consents that may need to be obtained by it, and (d) the income tax and other tax consequences, if any, that may be relevant to the purchase, holding, redemption, sale or transfer of the Shares. The Purchaser’s subscription and payment for and continued beneficial ownership of the Shares will not constitute a violation by the Purchaser of any applicable securities or other laws of the Purchaser’s jurisdiction.
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ARTICLE IV.
REGISTRATION RIGHTS
4.1. Definitions.
(a) “Resale Registration Statement” means any registration statement required to be filed by Section 4.2 below, including the Mandatory Registration Statement and any Additional Registration Statement (as such terms are defined below), and shall include any preliminary prospectus, final prospectus, exhibit or amendment included in or relating to such registration statements. The definition of Resale Registration Statement shall also include amendments to any registration statement on Form F-3 previously filed with the Commission.
(b) “Registrable Shares” means the (i) the Shares (ii) ADSs representing the Shares and (iii) any other shares of Ordinary Share issued as a dividend or other distribution with respect to, in exchange for, or in replacement of the Shares; provided, however, that a Share shall cease to be a Registrable Share upon the earliest to occur of the following: (x) such Share is sold pursuant to Rule 144 under circumstances in which any legend borne by such Share relating to restrictions on transferability thereof, under the Securities Act or otherwise, is removed by the Company, (y) such Share is eligible to be sold pursuant to Rule 144 without any limitation as to volume of sales, and without the holder complying with any method of sale requirements or notice requirements under Rule 144 and without the requirement to comply with the current public information of Rule 144(c)(1), or (z) such Share shall cease to be outstanding following its issuance.
4.2. Registration Procedures and Expenses. The Company shall:
(a) use its commercially reasonable efforts, subject to receipt of necessary information from the Purchasers, to file a Resale Registration Statement (the “Mandatory Registration Statement”) with the Commission as promptly as possible following the Closing and no later than the 60th calendar day following the Closing Date (the “Filing Date”) to register all of the Registrable Shares for resale on Form F-1 or F-3, as applicable, under the Securities Act, and each Purchaser, upon written request that is received by the Company at least two (2) Business Days prior to the intended Filing Date, shall be provided with a copy of such draft Mandatory Registration Statement for review before filing;
(b) use its commercially reasonable efforts, subject to receipt of necessary information from the Purchasers, to cause such Mandatory Registration Statement to be declared effective, and any other qualifications or compliances (including, without limitation, the execution of any required undertaking to file post-effective amendments, appropriate qualifications or exemptions under applicable blue sky or other state securities laws and appropriate compliance with applicable securities laws, requirements or regulations) as promptly as possible after the filing thereof, but in any event no later than the earlier of (i) the 90th calendar day following the Closing Date (or if the Commission reviews such filing, the 180th calendar day following the Closing Date, provided, however, such time period shall be extended, upon written notification to the Purchasers, by the number of days the Company is subject to a Force Majeure Event that occurs during this period) and (ii) the 5th Business Day after the date the Company is notified (orally or in writing, whichever is earlier) by the Commission that the Mandatory Registration Statement will not be “reviewed” or will not be subject to further comments from the Staff (such date, the “Effectiveness Deadline”), such efforts to include, without limiting the generality of the foregoing, preparing and filing with the Commission any financial statements or other information that is required to be filed prior to the effectiveness of such Mandatory Registration Statement;
(c) notwithstanding anything contained in this Agreement to the contrary, in the event that the Commission limits the amount of Registrable Shares or otherwise requires a reduction in the number of Registrable Shares that may be included and sold by the Purchasers in the Mandatory Registration Statement (in each case, subject to Section 4.3), then the Company shall prepare and file (i) within ten (10) Business Days of the first date or time that such excluded Registrable Shares may then be included in a Resale Registration Statement if the Commission shall have notified the Company that certain Registrable Shares were not eligible for inclusion in the Resale Registration Statement or (ii) in all other cases, within twenty (20) days following the date that the Company becomes aware that such additional Resale Registration Statement is required (the “Additional Filing Date”), a Resale Registration Statement (any such Resale Registration Statement registering such excluded Registrable Shares, an “Additional Registration Statement”) to register any Registrable Shares that have been excluded (or, if applicable, the maximum number of such excluded Registrable Shares that the Company is permitted to register for resale on such Additional Registration Statement consistent with Commission guidance), if any, from being registered on the Mandatory Registration Statement;
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(d) use its commercially reasonable efforts to cause any such Additional Registration Statement to be declared effective as promptly as practicable following the Additional Filing Date, such efforts to include, without limiting the generality of the foregoing, preparing and filing with the Commission any financial statements or other information that is required to be filed prior to the effectiveness of any such Additional Registration Statement;
(e) prepare and file with the Commission such amendments and supplements to such Resale Registration Statements and the prospectus used in connection therewith as may be necessary to keep such Resale Registration Statements continuously effective and free from any material misstatement or omission to state a material fact therein until termination of such obligation as provided in Section 4.6 below, subject to the Company’s right to suspend pursuant to Section 4.5;
(f) furnish to the Purchasers such number of copies of prospectuses in conformity with the requirements of the Securities Act and such other documents as the Purchasers may reasonably request, in order to facilitate the public sale or other disposition of all or any of the Registrable Shares by the Purchasers;
(g) file such documents as may be required of the Company for normal securities law clearance for the resale of the Registrable Shares in such states of the United States as may be reasonably requested by the Purchasers and use its commercially reasonable efforts to maintain such blue sky qualifications during the period the Company is required to maintain effectiveness of the Resale Registration Statements; provided, however, that the Company shall not be required in connection with this Section 4.2(g) to qualify as a foreign corporation or execute a general consent to service of process in any jurisdiction in which it is not now so qualified or has not so consented;
(h) upon notification by the Commission that the Resale Registration Statement will not be reviewed or is not subject to further review by the Commission, the Company shall within three (3) Business Days following the date of such notification request acceleration of such Resale Registration Statement (with the requested effectiveness date to be not more than two (2) Business Days from the date of such acceleration request);
(i) upon notification by the Commission that the Resale Registration Statement has been declared effective by the Commission, the Company shall file the final prospectus under Rule 424 by 9:30 a.m. New York time on the Business Day following the date such Resale Registration Statement has been declared effective;
(j) advise the Purchasers promptly (provided that in no event shall such notice contain any material, non-public information):
(i) of the effectiveness of the Resale Registration Statement or any post-effective amendments thereto;
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(ii) of any request by the Commission for amendments to the Resale Registration Statement or amendments to the prospectus or for additional information relating thereto;
(iii) of the issuance by the Commission of any stop order suspending the effectiveness of the Resale Registration Statement under the Securities Act or of the suspension by any state securities commission of the qualification of the Registrable Shares for offering or sale in any jurisdiction, or the initiation of any proceeding for any of the preceding purposes; and
(iv) of the existence of any fact and the happening of any event that makes any statement of a material fact made in the Resale Registration Statement, the prospectus and amendment or supplement thereto, or any document incorporated by reference therein, untrue, or that requires the making of any additions to or changes in the Resale Registration Statement or the prospectus in order to make the statements therein, in the light of the circumstances under which they were made, not misleading, provided such notice shall not disclose any material, non-public information concerning the Company to the Purchasers;
(k) cause all Registrable Shares to be listed on each securities exchange, if any, on which equity securities by the Company are then listed; and
(l) bear all expenses in connection with the procedures in paragraphs (a) through (k) of this Section 4.2 and the registration of the Registrable Shares on such Resale Registration Statement and the satisfaction of the blue sky laws of such states (but excluding the fees of legal counsel for any Purchaser).
4.3. Rule 415; Cutback. If at any time the Staff takes the position that the offering of some or all of the Registrable Shares in a Resale Registration Statement is not eligible to be made on a delayed or continuous basis under the provisions of Rule 415 under the Securities Act or requires any Purchaser to be named as an “underwriter,” the Company shall use its commercially reasonable efforts to persuade the Commission that the offering contemplated by the Resale Registration Statement is a valid secondary offering and not an offering “by or on behalf of the issuer” as defined in Rule 415 and that none of the Purchasers is an “underwriter;” provided, that if the Commission requests that a Purchaser be identified as a statutory underwriter in the Resale Registration Statement, such Purchaser will have the opportunity to withdraw from the Resale Registration Statement upon its prompt written request to the Company. In the event that, despite the Company’s commercially reasonable efforts and compliance with the terms of this Section 4.3, the Staff refuses to alter its position, the Company shall (i) remove from the Resale Registration Statement such portion of the Registrable Shares (the “Cut Back Shares”) and/or (ii) agree to such restrictions and limitations on the registration and resale of the Registrable Shares as the Staff may require to assure the Company’s compliance with the requirements of Rule 415 (collectively, the “SEC Restrictions”); provided, however, that the Company shall not agree to name any Purchaser as an “underwriter” in such Resale Registration Statement without the prior written consent of such Purchaser. Any cutback imposed on the Purchasers pursuant to this Section 4.3 shall be allocated among the Purchasers on a pro rata basis, unless the SEC Restrictions otherwise require or provide. No damages shall accrue as to any Cut Back Shares until such date as the Company is able to effect the registration of such Cut Back Shares in accordance with any SEC Restrictions (such date, the “Restriction Termination Date” of such Cut Back Shares). From and after the Restriction Termination Date applicable to any Cut Back Shares, all of the provisions of this Section 4 shall again be applicable to such Cut Back Shares; provided, however, that (x) the filing deadline for the Resale Registration Statement including such Cut Back Shares shall be ten (10) Business Days after such Restriction Termination Date, and (y) the Effectiveness Deadline with respect to such Cut Back Shares shall be the 150th day immediately after the Restriction Termination Date or the 180th day if the Staff reviews such Resale Registration Statement (but in any event no later than three (3) Business Days from the Staff indicating it has no further comments on such Resale Registration Statement).
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4.4. Indemnification.
(a) Notwithstanding any termination of this Agreement, the Company agrees to indemnify, defend and hold harmless each Purchaser and each of their respective officers, directors, and each person, if any, who controls such Purchaser within the meaning of the Securities Act or the Exchange Act, to the fullest extent permitted by applicable law, from and against any losses, claims, damages, liabilities, costs (including without limitation reasonable costs of preparation and investigation and reasonable attorneys’ fees), expenses and disbursements (collectively, “Losses”) as incurred to which they become subject (under the Securities Act or otherwise) insofar as such Losses arise out of, or are based upon, (i) any material breach of this Agreement by the Company, (ii) any untrue statement or alleged untrue statement of a material fact contained in the Resale Registration Statement or any omission or alleged omission to state therein a material fact required to be stated therein or necessary to make the statements therein, in light of the circumstances under which they were made, not misleading, (iii) any misrepresentation or breach of any representation or warranty made by the Company in the Transaction Documents, or (iv) any failure by the Company to fulfill any undertaking included in the Resale Registration Statement and the Company will, as incurred, reimburse each Purchaser, and each of their respective officers, directors, agents, partners, members, managers, stockholders, Affiliates, investment advisers and employees of each of them, and each person, if any, who controls such Purchaser within the meaning of the Securities Act or the Exchange Act; provided, however, that the Company shall not be liable in any such case solely to the extent that such Loss is caused by an untrue statement or omission or alleged untrue statement or omission made in any prospectus if either (A) (1) the Purchaser failed to send or deliver a copy of the final prospectus with or prior to, or the Purchaser failed to confirm that a final prospectus was deemed to be delivered prior to (in accordance with Rule 172 of the Securities Act), the delivery of written confirmation of the sale by a Purchaser to the person asserting the claim from which such Loss resulted and (2) the final prospectus corrected such untrue statement or omission, (B) (1) such untrue statement or omission is corrected in an amendment or supplement to the prospectus and (2) having previously been furnished by or on behalf of the Company with copies of the prospectus as so amended or supplemented or notified by the Company that such amended or supplemented prospectus has been filed with the Commission, in accordance with Rule 172 of the Securities Act, any Purchaser thereafter fails to deliver such prospectus as so amended or supplemented, with or prior to or a Purchaser fails to confirm that the prospectus as so amended or supplemented was deemed to be delivered prior to (in accordance with Rule 172 of the Securities Act), the delivery of written confirmation of the sale by a Purchaser to the person asserting the claim from which such Loss resulted.
(b) Each Purchaser agrees, severally and not jointly, to indemnify and hold harmless the Company (and each person, if any, who controls the Company within the meaning of Section 15 of the Securities Act or Section 20 of the Exchange Act, each officer of the Company who signs the Resale Registration Statement and each director of the Company), from and against any Losses, claims, damages or liabilities to which the Company (or any such officer, director or controlling person) may become subject (under the Securities Act or otherwise), insofar as such losses, claims, damages or liabilities (or actions or proceedings in respect thereof) arise out of, or are based upon, any untrue statement or alleged untrue statement of a material fact contained in the Resale Registration Statement (or any omission or alleged omission to state therein a material fact required to be stated therein or necessary to make the statements therein, in light of the circumstances under which they were made, not misleading in each case, on the effective date thereof), if, and only to the extent, such untrue statement or omission or alleged untrue statement or omission was made in reliance upon and in conformity with written information furnished by or on behalf of such Purchaser relating to such Purchaser specifically for use in preparation of the Resale Registration Statement, and each Purchaser, severally and not jointly, will reimburse the Company (and each of its officers, directors or controlling persons) for any legal or other expenses reasonably incurred in investigating, defending or preparing to defend any such action, proceeding or claim; provided, however, that in no event shall any indemnity under this Section 4.4(b) for any Purchaser be greater in amount than the dollar amount of the net proceeds received by such Purchaser upon its sale of such Registrable Shares giving rise to such indemnification obligation.
(c) Promptly after receipt by any indemnified person of a notice of a claim or the beginning of any action in respect of which indemnity is to be sought against an indemnifying person pursuant to this Section 4.4, such indemnified person shall notify the indemnifying person in writing of such claim or of the commencement of such action, and, subject to the provisions hereinafter stated, in case any such action shall be brought against an indemnified person and such indemnifying person shall have been notified thereof, such indemnifying person shall be entitled to participate therein, and, to the extent that it shall wish, to assume the defense thereof, with counsel reasonably satisfactory to such indemnified person. After notice from the indemnifying person to such indemnified person of its election to assume the defense thereof, such indemnifying person shall not be liable to such indemnified person for any legal expenses subsequently incurred by such indemnified person in connection with the defense thereof; provided, however, that if there exists or shall exist a conflict of interest that would make it inappropriate in the reasonable judgment of the indemnified person for the same counsel to represent both the indemnified person and such indemnifying person or any affiliate or associate thereof, the indemnified person shall be entitled to retain its own counsel at the expense of such indemnifying person; and provided, further, that no indemnifying person shall be responsible for the fees and expense of more than one separate counsel for all indemnified parties. The indemnifying party shall not settle an action without the consent of the indemnified party, which consent shall not be unreasonably withheld.
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(d) If the indemnification provided for in this Section 4.4 is held by a court of competent jurisdiction to be unavailable to an indemnified party with respect to any losses, claims, damages or liabilities referred to herein, the indemnifying party, in lieu of indemnifying such indemnified party thereunder, shall to the extent permitted by applicable law contribute to the amount paid or payable by such indemnified party as a result of such loss, claim, damage or liability in such proportion as is appropriate to reflect the relative fault of the indemnifying party on the one hand and of the indemnified party on the other, as well as any other relevant equitable considerations; provided, that in no event shall any contribution by a Purchaser as an indemnifying party hereunder be greater in amount than the dollar amount of the net proceeds received by such Purchaser upon the sale of such Registrable Shares giving rise to such contribution obligation.
4.5. Prospectus Suspension. Each Purchaser agrees that, upon receipt of written notice from the Company of the occurrence of an event of the kind described in Sections 4.2(j)(iii) or 4.2(j)(iv), such Purchaser shall forthwith discontinue disposition of its Registrable Shares under the Registration Statement until it is advised by the Company in writing notice that the Purchasers may thereafter effect sales pursuant to said prospectus; provided, that such suspension periods shall in no event exceed thirty (60) days in any twelve (12)-month period.
4.6. Termination of Obligations. The obligations of the Company pursuant to Section 4.2 hereof shall cease and terminate, with respect to any Registrable Shares, upon the earlier to occur of (a) such time such Registrable Shares have been resold, (b) such Registrable Shares may be sold without registration pursuant to Rule 144 promulgated under the Securities Act (or any successor rule promulgated thereafter by the Commission) with no volume or other restrictions or limitations or (c) such time as such Registrable Shares no longer remain Registrable Shares pursuant to Section 4.1(b) (the “Effectiveness Period”).
4.7. Reporting Requirements.
(a) With a view to making available the benefits of certain rules and regulations of the Commission that may at any time permit the sale of the Shares to the public without registration or pursuant to a registration statement on Form F-1 or F-3, the Company agrees to:
(i) make and keep public information available, as those terms are understood and defined in Rule 144;
(ii) file with the Commission in a timely manner all reports and other documents required of the Company under the Securities Act and the Exchange Act; and
(iii) so long as any Purchaser owns Shares, to furnish to such Purchaser upon request (A) a written statement by the Company as to whether it is in compliance with the reporting requirements of Rule 144, the Securities Act and the Exchange Act, or whether it is qualified as a registrant whose securities may be resold pursuant to registration statement on Form F-1 or F-3, (B) a copy of the most recent annual or quarterly report of the Company and such other reports and documents so filed by the Company and (C) such other information as may be reasonably requested to permit the Purchaser to sell such securities pursuant to Rule 144.
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ARTICLE V.
OTHER AGREEMENTS OF THE PARTIES
5.1. Furnishing of Information. Until the earliest of the time that no Purchaser owns Shares, the Company shall use commercially reasonable efforts to timely file (or obtain extensions in respect thereof and file within the applicable grace period) all reports required to be filed by the Company after the date hereof pursuant to the Exchange Act.
5.2. Integration. The Company shall not sell, offer for sale or solicit offers to buy or otherwise negotiate in respect of any security (as defined in Section 2 of the Securities Act) that would be integrated with the offer or sale of the Shares for purposes of the rules and regulations of any Trading Market such that it would require shareholder approval prior to the closing of such other transaction unless shareholder approval is obtained before the closing of such subsequent transaction.
5.3. Securities Laws Disclosure; Publicity. The Company shall (a) by the Disclosure Time, issue a press release disclosing the material terms of the transactions contemplated hereby and all material, non-public information delivered to any of the Purchasers by the Company, or any of their respective officers, directors, employees or agents in connection with the transactions contemplated by the Transaction Documents, and (b) file a Current Report on Form 6-K, including the Transaction Documents filed as exhibits thereto, with the Commission within the time required by the Exchange Act. From and after the issuance of such press release, the Company represents to the Purchasers that it shall have publicly disclosed all material, non-public information delivered to any of the Purchasers by the Company, or any of their respective officers, directors, employees or agents in connection with the transactions contemplated by the Transaction Documents. The Company and the Placement Agents shall consult with each other in issuing any other press releases with respect to the transactions contemplated hereby, and neither the Company nor any Purchaser shall issue any such press release nor otherwise make any such public statement (other than any filing required pursuant to Section 13 or Section 16 of the Exchange Act) without the prior consent of the Company, with respect to any press release of any Purchaser, or without the prior consent of the Placement Agents, with respect to any press release of the Company, except if such disclosure is required by law, in which case the disclosing party shall promptly provide the other party with prior notice of such public statement or communication. Notwithstanding the foregoing, the Company shall not publicly disclose the name of any Purchaser or any of its affiliates or investment advisers, including in any press release, or include the name of any Purchaser or any of its affiliates or investment advisers in any filing with the Commission or any regulatory agency or Trading Market, without the prior written consent of such Purchaser, except (a) as required by federal securities law in connection with the filing of final Transaction Documents with the Commission and (b) to the extent such disclosure is required by law or Trading Market regulations, provided that the Company shall provide such Purchaser with reasonable prior notice of such disclosure permitted under clause (a) or clause (b) and reasonably cooperate with such Purchaser regarding such disclosure. The parties agree and understand that the Purchasers shall be listed in the selling stockholder section of the Resale Registration Statement filed in connection with the Shares issued to the Purchasers pursuant to this Agreement.
5.4. Non-Public Information. Except with respect to the material terms and conditions of the transactions contemplated by the Transaction Documents, which shall be disclosed pursuant to Section 5.3, the Company covenants and agrees that neither it, nor any other Person acting on its behalf will provide any Purchaser or its agents or counsel with any information that constitutes, or the Company reasonably believes constitutes, material non-public information, unless prior thereto such Purchaser shall have consented to the receipt of such information and agreed with the Company to keep such information confidential prior to the receipt of such information. The Company understands and confirms that each Purchaser shall be relying on the foregoing covenant in effecting transactions in securities of the Company.
5.5. Use of Proceeds. The Company shall use the net proceeds from the sale of the Shares hereunder for general corporate expenses, including but not limited to funding product development and research and development, and for working capital.
5.6. Reservation of Ordinary Share. As of the date hereof, the Company has reserved and the Company shall continue to reserve and keep available at all times, free of preemptive rights, a sufficient number of shares of Ordinary Share for the purpose of enabling the Company to issue Shares pursuant to this Agreement.
5.7. Listing of ADSs. The Company hereby agrees to use best efforts to maintain the listing or quotation of the ADSs on the Trading Market on which it is currently listed, and prior to Closing, the Company shall apply to list or quote all of the Shares on such Trading Market and promptly secure the listing of all of the Shares on such Trading Market.
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5.8. Certain Transactions and Confidentiality. Each Purchaser, severally and not jointly with the other Purchasers, covenants that neither it nor any Affiliate acting on its behalf or pursuant to any understanding with it will execute any purchases or sales, including Short Sales of any of the Company’s securities during the period commencing with the execution of this Agreement and ending on the earlier of (i) at such time that the transactions contemplated by this Agreement are first publicly announced pursuant to the initial press release as described in Section 5.3 and (ii) the Disclosure Time. Each Purchaser, severally and not jointly with the other Purchasers, covenants that until the earlier of (i) such time as the transactions contemplated by this Agreement are publicly disclosed by the Company pursuant to the initial press release as described in Section 5.3 and (ii) the Disclosure Time, such Purchaser will maintain the confidentiality of the existence and terms of this transaction, other than to other Persons party to this Agreement and to such Persons’ representatives, including their respective lawyers. Notwithstanding the foregoing and notwithstanding anything contained in this Agreement to the contrary, the Company expressly acknowledges and agrees that, (i) no Purchaser makes any representation, warranty or covenant hereby that it will not engage in effecting transactions in any securities of the Company after the time that is the earlier of (x) the transactions contemplated by this Agreement are first publicly announced pursuant to the initial press release as described in Section 5.3 and (y) the Disclosure Time, (ii) no Purchaser shall be restricted or prohibited from effecting any transactions in any securities of the Company in accordance with applicable securities laws from and after the earlier of (x) the time that the transactions contemplated by this Agreement are first publicly announced pursuant to the initial press release as described in Section 5.3 and (y) the Disclosure Time and (iii) no Purchaser shall have any duty of confidentiality or duty not to trade in the securities of the Company to the Company after the earlier of (x) the issuance of the initial press release as described in Section 5.3 and (y) the Disclosure Time. Notwithstanding the foregoing, in the case of a Purchaser that is a multi-managed investment vehicle whereby separate portfolio managers manage separate portions of such Purchaser’s assets and the portfolio managers have no direct knowledge of the investment decisions made by the portfolio managers managing other portions of such Purchaser’s assets, the covenant set forth above shall only apply with respect to the portion of assets managed by the portfolio manager that made the investment decision to purchase the Shares covered by this Agreement.
5.9. Restrictive Securities Legend. Upon original issuance thereof, and until such time as the same is no longer required under the applicable requirements of the Securities Act, the Shares shall bear the following legend:
“THE SECURITIES HAVE NOT BEEN REGISTERED UNDER THE SECURITIES ACT OF 1933, AS AMENDED, OR THE SECURITIES LAWS OF ANY STATE OF THE UNITED STATES. THE SECURITIES MAY NOT BE SOLD, OFFERED FOR SALE, PLEDGED, HYPOTHECATED, TRANSFERRED OR ASSIGNED IN THE ABSENCE OF AN EFFECTIVE REGISTRATION STATEMENT FOR THE SECURITIES UNDER APPLICABLE SECURITIES LAWS, OR UNLESS OFFERED, SOLD, PLEDGED, HYPOTHECATED OR TRANSFERRED PURSUANT TO AN AVAILABLE EXEMPTION FROM THE REGISTRATION REQUIREMENTS OF THOSE LAWS. THE COMPANY SHALL BE ENTITLED TO REQUIRE AN OPINION OF COUNSEL REASONABLY SATISFACTORY TO THE COMPANY THAT SUCH REGISTRATION PURSUANT TO THE SECURITIES ACT OF 1933, AS AMENDED IS NOT REQUIRED TO THE EXTENT THAT SUCH OPINION IS REQUIRED PURSUANT TO THAT CERTAIN SECURITIES PURCHASE AGREEMENT UNDER WHICH THE SHARES WERE ISSUED.”
| (a) | Certificates evidencing the Securities, shall not contain any legend (including the legend set forth in Section 5.9 hereof), (i) while a registration statement covering the resale of such security is effective under the Securities Act, (ii) following any sale of such ADSs or pursuant to Rule 144 , (iii) if such ADSs are eligible for sale under Rule 144, without the requirement for the Company to be in compliance with the current public information required under Rule 144 as to such ADSs and without volume or manner-of-sale restrictions, or (iv) if such legend is not required under applicable requirements of the Securities Act (including judicial interpretations and pronouncements issued by the staff of the Commission). The Company shall cause its counsel to issue a legal opinion to the Depositary (in a form reasonable acceptable to the Depositary) and/or the registrar or the Purchaser in a timely manner after the effective date of the Resale Registration Statement if required by the Depositary and/or the registrar to effect to removal of the legend hereunder, or if requested by a Purchaser, respectively. The Company agrees that following such time as such legend is no longer required under this Section 5.9(a), it will, no later than the earlier of (i) five (5) trading days and (ii) the number of trading days comprising the Standard Settlement Period (as defined below) following the delivery by a Purchaser to the Company of a certificate representing Shares, as the case may be, issued with a restrictive legend (such date, the “Legend Removal Date”), cause to be delivered to such Purchaser a certificate representing the applicable number of ADSs representing such Shares that is free from all restrictive and other legends. ADSs shall be transmitted by the Depositary to the Purchaser by crediting the account of the Purchaser’s prime broker with the Depository Trust Company System as directed by such Purchaser to the Company. The Company shall cooperate with each Purchaser and the Depository in exchanging such Purchaser’s Shares for ADSs. As used herein, “Standard Settlement Period” means the standard settlement period, expressed in a number of Trading Days, on the Company’s primary Trading Market with respect to the ADSs as in effect on the date of delivery of a certificate representing Shares, as the case may be, issued with a restrictive legend. The Company shall be responsible for any Depositary fees or DTC fees with respect to any issuance of Securities or the removal of any legends with respect to any Securities in accordance herewith. |
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5.10. Equal Treatment of Purchasers. No consideration shall be offered or paid to any Purchaser to amend or consent to a waiver or modification of any provision of this Agreement unless the same consideration is also offered to all of the Purchasers. For clarification purposes, this provision constitutes a separate right granted to each Purchaser by the Company and negotiated separately by each Purchaser and shall not in any way be construed as the Purchasers acting in concert or as a group with respect to the purchase, disposition or voting of shares of Ordinary Share or otherwise.
5.11. CSRC Filing. Following the Closing, the Company shall prepare and submit the filing report in relation to the transactions contemplated by this Agreement (the “CSRC Filing Report”) and any relevant supporting materials (including, but not limited to, the PRC legal opinion to be issued by the counsel for the Company on the PRC laws, where applicable) (together with the CSRC Filing Report and including any amendments, supplements and/or modifications thereof, the “CSRC Filings”) to the China Securities Regulatory Commission (the “CSRC”) pursuant to the applicable requirements under the Trial Administrative Measures of Overseas Securities Offering and Listing by Domestic Companies (境内企业境外发行证券和上市管理试行办法) and supporting guidelines issued by the CSRC on 17 February 2023 (as amended, supplemented or otherwise modified from time to time), and bear any costs, penalties or administrative liabilities arising from any failure to timely complete the CSRC Filing.
ARTICLE VI.
MISCELLANEOUS
6.1. Termination. This Agreement may be terminated (i) by mutual written agreement of a Purchaser and the Company only as to such Purchaser’s obligations hereunder, (ii) (x) by any Purchaser, as to such Purchaser’s obligations hereunder only and without any effect whatsoever on the obligations between the Company and the other Purchasers, by written notice to the Company, or (y) by written notice to each other, if the Closing has not been consummated on or before April 30, 2026; provided, however, that no such termination will affect the right of any party to sue for any breach by any other party (or parties).
6.2. Fees and Expenses. Except as expressly set forth in the Transaction Documents to the contrary, each party shall pay the fees and expenses of its advisers, counsel, accountants and other experts, if any, and all other expenses incurred by such party incident to the negotiation, preparation, execution, delivery and performance of this Agreement. The Company shall pay all Transfer Agent fees (including, without limitation, any fees required for same-day processing of any instruction letter delivered by the Company and any exercise notice delivered by a Purchaser), stamp taxes and other taxes and duties levied in connection with the delivery of any Shares to the Purchasers. The Company shall indemnify, pay and hold each Purchaser harmless against, any liability, loss or expense (including, without limitation, reasonable attorneys’ fees and out-of-pocket expenses) arising in connection with any such right, interest or claim.
6.3. Entire Agreement. The Transaction Documents, together with the exhibits and schedules thereto, contain the entire understanding of the parties with respect to the subject matter hereof and thereof and supersede all prior agreements and understandings, oral or written, with respect to such matters, which the parties acknowledge have been merged into such documents, exhibits and schedules.
6.4. Notices. Any and all notices or other communications or deliveries required or permitted to be provided hereunder shall be in writing and shall be deemed given and effective on the earliest of: (a) the time of transmission, if such notice or communication is delivered via facsimile at the facsimile number or email attachment at the email address as set forth on the signature pages attached hereto at or prior to 5:30 p.m. (New York City time) on a Trading Day, with no rejection or undeliverable notice received, (b) the next Trading Day after the time of transmission, if such notice or communication is delivered via facsimile at the facsimile number or email attachment at the email address as set forth on the signature pages attached hereto on a day that is not a Trading Day or later than 5:30 p.m. (New York City time) on any Trading Day, with no rejection or undeliverable notice received, (c) the second (2nd) Trading Day following the date of mailing, if sent by U.S. nationally recognized overnight courier service or (d) upon actual receipt by the party to whom such notice is required to be given. The address for such notices and communications shall be as set forth on the signature pages attached hereto.
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6.5. Amendments; Waivers. No provision of this Agreement may be waived, modified, supplemented or amended except in a written instrument signed, in the case of an amendment, by the Company and each Purchaser. No waiver of any default with respect to any provision, condition or requirement of this Agreement shall be deemed to be a continuing waiver in the future or a waiver of any subsequent default or a waiver of any other provision, condition or requirement hereof, nor shall any delay or omission of any party to exercise any right hereunder in any manner impair the exercise of any such right. No provision of this Agreement affecting the Placement Agents may be waived, modified, supplemented or amended except in a written instrument signed, in the case of an amendment by the Company and each Placement Agent.
6.6. Headings. The headings herein are for convenience only, do not constitute a part of this Agreement and shall not be deemed to limit or affect any of the provisions hereof.
6.7. Successors and Assigns. This Agreement shall be binding upon and inure to the benefit of the parties and their successors and permitted assigns. The Company may not assign this Agreement or any rights or obligations hereunder without the prior written consent of the Purchasers purchasing a majority of the Shares in the Offering (other than by merger). Any Purchaser may assign any or all of its rights under this Agreement to any Affiliate and to any Person to whom such Purchaser assigns or transfers any Shares, provided that such transferee agrees in writing to be bound, with respect to the transferred Shares, by the provisions of the Transaction Documents that apply to the “Purchasers.”
6.8. Third-Party Beneficiaries. The Placement Agents shall be the third-party beneficiaries of the representations and warranties of the Company in Section 3.1 and the representations and warranties of the Purchasers in Section 3.2. This Agreement is intended for the benefit of the parties hereto and their respective successors and permitted assigns and is not for the benefit of, nor may any provision hereof be enforced by, any other Person, except as otherwise set forth in Section 4.4 and this Section 6.8.
6.9. Governing Law. All questions concerning the construction, validity, enforcement and interpretation of the Transaction Documents shall be governed by and construed and enforced in accordance with the internal laws of the State of New York, without regard to the principles of conflicts of law thereof. Each party agrees that all legal proceedings concerning the interpretations, enforcement and defense of the transactions contemplated by this Agreement and any other Transaction Documents (whether brought against a party hereto or its respective affiliates, directors, officers, shareholders, partners, members, employees or agents) shall be commenced exclusively in the state and federal courts sitting in the City of New York. Each party hereby irrevocably submits to the exclusive jurisdiction of the state and federal courts sitting in the City of New York, Borough of Manhattan for the adjudication of any dispute hereunder or in connection herewith or with any transaction contemplated hereby or discussed herein (including with respect to the enforcement of any of the Transaction Documents), and hereby irrevocably waives, and agrees not to assert in any Action or proceeding, any claim that it is not personally subject to the jurisdiction of any such court, that such Action or proceeding is improper or is an inconvenient venue for such Action or proceeding. Each party hereby irrevocably waives personal service of process and consents to process being served in any such Action or proceeding by mailing a copy thereof via registered or certified mail or overnight delivery (with evidence of delivery) to such party at the address in effect for notices to it under this Agreement and agrees that such service shall constitute good and sufficient service of process and notice thereof. Nothing contained herein shall be deemed to limit in any way any right to serve process in any other manner permitted by law. If any party shall commence an Action or proceeding to enforce any provisions of the Transaction Documents, then, in addition to the obligations of the Company under Section 4.4, the prevailing party in such Action or proceeding shall be reimbursed by the non-prevailing party for its reasonable attorneys’ fees and other costs and expenses incurred with the investigation, preparation and prosecution of such Action or proceeding.
6.10. Survival. The representations and warranties contained herein shall survive the Closing and the delivery of the Shares.
6.11. Execution. This Agreement may be executed in two or more counterparts, all of which when taken together shall be considered one and the same agreement and shall become effective when counterparts have been signed by each party and delivered to each other party, it being understood that the parties need not sign the same counterpart. In the event that any signature is delivered by facsimile transmission, electronic mail, or otherwise by electronic transmission (including any electronic signature complying with the U.S. federal ESIGN Act of 2000, e.g., www.docusign.com) evidencing an intent to sign this Agreement, such facsimile transmission, electronic mail or other electronic transmission shall create a valid and binding obligation of the undersigned with the same force and effect as if such signature were an original. Execution and delivery of this Agreement by facsimile transmission, electronic mail or other electronic transmission is legal, valid and binding for all purposes.
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6.12. Severability. If any term, provision, covenant or restriction of this Agreement is held by a court of competent jurisdiction to be invalid, illegal, void or unenforceable, the remainder of the terms, provisions, covenants and restrictions set forth herein shall remain in full force and effect and shall in no way be affected, impaired or invalidated, and the parties hereto shall use their commercially reasonable efforts to find and employ an alternative means to achieve the same or substantially the same result as that contemplated by such term, provision, covenant or restriction. It is hereby stipulated and declared to be the intention of the parties that they would have executed the remaining terms, provisions, covenants and restrictions without including any of such that may be hereafter declared invalid, illegal, void or unenforceable.
6.13. Replacement of Shares. If any certificate or instrument evidencing any Shares is mutilated, lost, stolen or destroyed, the Company shall issue or cause to be issued in exchange and substitution for and upon cancellation thereof (in the case of mutilation), or in lieu of and substitution therefor, a new certificate or instrument, but only upon receipt of evidence reasonably satisfactory to the Company of such loss, theft or destruction. The applicant for a new certificate or instrument under such circumstances shall also pay any reasonable third-party costs (including customary indemnity) associated with the issuance of such replacement Shares.
6.14. Remedies. In addition to being entitled to exercise all rights provided herein or granted by law, including recovery of damages, each of the Purchasers and the Company will be entitled to seek specific performance under the Transaction Documents. The parties agree that monetary damages may not be adequate compensation for any loss incurred by reason of any breach of obligations contained in the Transaction Documents and hereby agree to waive and not to assert in any Action for specific performance of any such obligation the defense that a remedy at law would be adequate.
6.15. Payment Set Aside. To the extent that the Company makes a payment or payments to the Purchaser pursuant to any Transaction Document or a Purchaser enforces or exercises its rights thereunder, and such payment or payments or the proceeds of such enforcement or exercise or any part thereof are subsequently invalidated, declared to be fraudulent or preferential, set aside, recovered from, disgorged by or are required to be refunded, repaid or otherwise restored to the Company, a trustee, receiver or any other Person under any law (including, without limitation, any bankruptcy law, state or federal law, common law or equitable cause of action), then to the extent of any such restoration the obligation or part thereof originally intended to be satisfied shall be revived and continued in full force and effect as if such payment had not been made or such enforcement or setoff had not occurred.
6.16. Independent Nature of Purchasers’ Obligations and Rights. The obligations of each Purchaser under any Transaction Document are several and not joint with the obligations of any other Purchaser, and no Purchaser shall be responsible in any way for the performance or non-performance of the obligations of any other Purchaser under any Transaction Document. Nothing contained herein or in any other Transaction Document, and no action taken by any Purchaser pursuant hereto or thereto, shall be deemed to constitute the Purchasers as a partnership, an association, a joint venture or any other kind of entity, or create a presumption that the Purchasers are in any way acting in concert or as a group with respect to such obligations or the transactions contemplated by the Transaction Documents. Each Purchaser shall be entitled to independently protect and enforce its rights including, without limitation, the rights arising out of this Agreement or out of the other Transaction Documents, and it shall not be necessary for any other Purchaser to be joined as an additional party in any proceeding for such purpose. Each Purchaser has been represented by its own separate legal counsel in its review and negotiation of the Transaction Documents. For reasons of administrative convenience only, each Purchaser and its respective counsel have chosen to communicate with the Company through Cooley. Cooley does not represent any of the Purchasers and only represents the Placement Agents. Other than as set forth herein, the Company has elected to provide all Purchasers with the same terms and Transaction Documents for the convenience of the Company and not because it was required or requested to do so by any of the Purchasers. It is expressly understood and agreed that each provision contained in this Agreement and in each other Transaction Document is between the Company and a Purchaser, solely, and not between the Company and the Purchasers collectively and not between and among the Purchasers.
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6.17. Saturdays, Sundays, Holidays, etc. If the last or appointed day for the taking of any action or the expiration of any right required or granted herein shall not be a Business Day, then such action may be taken or such right may be exercised on the next succeeding Business Day.
6.18. Construction. The parties agree that each of them and/or their respective counsel have reviewed and had an opportunity to revise the Transaction Documents and, therefore, the normal rule of construction to the effect that any ambiguities are to be resolved against the drafting party shall not be employed in the interpretation of the Transaction Documents or any amendments thereto. In addition, each and every reference to share prices and shares of Ordinary Share in any Transaction Document shall be subject to adjustment for reverse and forward stock splits, stock dividends, stock combinations and other similar transactions of the Ordinary Share that occur after the date of this Agreement.
6.19. WAIVER OF JURY TRIAL. IN ANY ACTION, SUIT, OR PROCEEDING IN ANY JURISDICTION BROUGHT BY ANY PARTY AGAINST ANY OTHER PARTY, THE PARTIES EACH KNOWINGLY AND INTENTIONALLY, TO THE GREATEST EXTENT PERMITTED BY APPLICABLE LAW, HEREBY ABSOLUTELY, UNCONDITIONALLY, IRREVOCABLY AND EXPRESSLY WAIVES FOREVER TRIAL BY JURY.
6.20. Reliance by and Exculpation of Placement Agents.
(a) Each Purchaser hereto agrees for the express benefit of the Placement Agents, their affiliates and their representatives that (i) the Placement Agents, their affiliates and their representatives have not made, and will not make any representations or warranties with respect to the Company or the offer and sale of the Shares, and such Purchaser will not rely on any statements made by the Placement Agents, orally or in writing, to the contrary, (ii) such Purchaser will be responsible for conducting its own due diligence investigation with respect to the Company and the offer and sale of the Shares, (iii) such Purchaser will be purchasing Shares based on the results of its own due diligence investigation of the Company and the Placement Agents and each of its directors, officers, employees, representatives, and controlling persons have made no independent investigation with respect to the Company, the Shares, or the accuracy, completeness, or adequacy of any information supplied to the Purchaser by the Company, (iv) such Purchaser has negotiated the offer and sale of the Shares directly with the Company, and the Placement Agents will not be responsible for the ultimate success of any such investment and (v) the decision to invest in the Company will involve a significant degree of risk, including a risk of total loss of such investment. Each Purchaser further represents and warrants to the Placement Agents that it, including any fund or funds that it manages or advises that participates in the offer and sale of the Shares, is permitted under its constitutive documents (including, without limitation, all limited partnership agreements, articles of associations, limited liability company agreements, all applicable side letters with investors, and similar documents) to make investments of the type contemplated by this Agreement. This Section 6.20 shall survive any termination of this Agreement.
(b) The Company agrees and acknowledges that the Placement Agents may rely on its representations, warranties, agreements and covenants contained in this Agreement, and each Purchaser agrees that the Placement Agents may rely on such Purchaser’s representations and warranties contained in Section 4 of this Agreement as if such representations and warranties, as applicable, were made directly to the Placement Agents.
(c) Neither the Placement Agents nor any of their affiliates or representatives (1) shall be liable for any improper payment made in accordance with the information provided by the Company; (2) makes any representation or warranty, or has any responsibilities as to the validity, accuracy, value or genuineness of any information, certificates or documentation delivered by or on behalf of the Company pursuant to this Agreement or in connection with any of the transactions contemplated therein, including any offering or marketing materials; or (3) shall be liable (x) for any action taken, suffered or omitted by any of them in good faith and reasonably believed to be authorized or within the discretion or rights or powers conferred upon it by this Agreement or (y) for anything which any of them may do or refrain from doing in connection with this Agreement, except in each case for such party’s own gross negligence, willful misconduct or bad faith.
(d) The Company agrees that the Placement Agents, their affiliates and representatives shall be entitled to (1) rely on, and shall be protected in acting upon, any certificate, instrument, opinion, notice, letter or any other document or security delivered to any of them by or on behalf of the Company, and (2) be indemnified by the Company for acting as a Placement Agent hereunder pursuant to the indemnification provisions set forth in the Engagement Letter.
(Signature Pages Follow)
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IN WITNESS WHEREOF, the parties hereto have caused this Securities Purchase Agreement to be duly executed by their respective authorized signatories as of the date first indicated above.
| ADLAI NORTYE LTD. | ||
| By: | ||
| Name: | ||
| Title: | ||
[REMAINDER OF PAGE INTENTIONALLY LEFT BLANK
SIGNATURE PAGE FOR PURCHASER FOLLOWS]
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IN WITNESS WHEREOF, the undersigned have caused this Securities Purchase Agreement to be duly executed by their respective authorized signatories as of the date first indicated above.
| Name of Purchaser: | ||||
| Signature of Authorized Signatory of Purchaser: | ||||
| Name of Authorized Signatory: | ||||
| Title of Authorized Signatory: | ||||
| Email Address of Purchaser: | ||||
| Address for Notice to Purchaser: | ||||
| Place where investment decision made: | ||||
| Address for Delivery of Shares to Purchaser (if not same as address for notice): | ||||
| Subscription Amount: $ | ||||
| Shares: | ||||
| EIN Number: | ||||
[PURCHASER SIGNATURE PAGE TO SECURITIES PURCHASE AGREEMENT]
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ANNEX A
Form of Lock-up Agreement
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Form of Lock-up Agreement
April , 2026
[Placement Agent]
[Adress]
RE: Adlai Nortye Ltd. (the “Company”)
Ladies & Gentlemen:
The undersigned is an owner of ordinary shares, par value $0.0001 per share, of the Company (“Shares”) or of securities convertible into or exchangeable or exercisable for Shares. The Company proposes to conduct a private placement of securities of the Company (the “Private Placement”) for which [●] will act as the placement agents (collectively, the “Placement Agents”). The undersigned recognizes that the Private Placement will benefit each of the Company and the undersigned. The undersigned acknowledges that the Placement Agents are relying on the representations and agreements of the undersigned contained in this letter agreement in conducting the Private Placement and other arrangements with the Company with respect to the Private Placement.
Annex A sets forth definitions for capitalized terms used in this letter agreement that are not defined in the body of this letter agreement. Those definitions are a part of this letter agreement.
In consideration of the foregoing, and for other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the undersigned hereby agrees that, during the Lock-up Period, the undersigned will not (and, if the undersigned is a natural person, will cause any Family Member not to), without the prior written consent of the Placement Agents, which may withhold their consent in their sole discretion:
| ● | Sell or Offer to Sell any Shares or Related Securities currently or hereafter owned either of record or beneficially (as defined in Rule 13d-3 under the Exchange Act) by the undersigned or such Family Member, |
| ● | enter into any Swap, |
| ● | make any demand for, or exercise any right with respect to, the registration under the Securities Act of the offer and sale of any Shares or Related Securities, or cause to be filed a registration statement, prospectus or prospectus supplement (or an amendment or supplement thereto) with respect to any such registration, or |
| ● | publicly announce any intention to do any of the foregoing. |
The foregoing will not apply to the offer and sale of the Shares, and the sale of the Shares pursuant to the Private Placement. In addition, the foregoing restrictions will not apply to the transfer of Shares or Related Securities:
| i. | as a bona fide gift or gifts, |
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| ii. | by will or intestacy, |
| iii. | to any trust or other entities formed for the direct or indirect benefit of the undersigned or a Family Member of the undersigned, |
| iv. | to any Family Member, |
| v. | if the undersigned is a trust, to a trustor, trustee or beneficiary of the trust or to the estate of a beneficiary of such trust, |
| vi. | to a corporation, partnership, limited liability company or other entity of which the undersigned or any Family Member is the legal and beneficial owner of all of the outstanding equity securities or similar interests, |
| vii. | if the undersigned is a corporation, partnership, limited liability company, trust or other business entity, (A) to another corporation, partnership, limited liability company, trust or other business entity that is an affiliate (as defined in Rule 405 promulgated under the Securities Act) of the undersigned (including, for the avoidance of doubt, any wholly-owned direct or indirect subsidiary of the undersigned or to the immediate or indirect parent entity of the undersigned), or to any investment fund or other entity controlling, controlled by, managing or managed by or under common control with the undersigned (including, for the avoidance of doubt, where the undersigned is a partnership, to its general partner or a successor partnership or fund, or any other funds managed by such partnership), or (B) as part of a distribution, transfer or other disposition by the undersigned to its stockholders, partners, members or other equity holders, |
| viii. | by operation of law pursuant to a court order or settlement agreement related to the distribution of assets in connection with the dissolution of a marriage or civil union, provided that such Shares or Related Securities shall remain subject to the terms of this letter agreement, |
| ix. | in connection with the exercise or settlement on a cash basis of options granted under a stock incentive plan or other equity award plan, which plan is described in the Company’s filings with the SEC, provided that any Shares or Related Securities received as a result of such exercise, vesting or settlement shall remain subject to the terms of this letter agreement, |
| x. | to the Company in connection with the “net” or “cashless” exercise of options or other rights to purchase Shares or Related Securities from the Company (including any transfer to the Company for the payment of tax withholdings or remittance payments due as a result of such exercise), which options or rights are described in the Company’s filings with the SEC, provided that any Shares or Related Securities received as a result of such exercise, vesting or settlement shall remain subject to the terms of this letter agreement, and |
| xi. | pursuant to a bona fide third-party tender offer, merger, consolidation or other similar transaction that is approved by the Board of Directors of the Company and made to all holders of the Company’s capital stock involving a Change of Control of the Company, provided that in the event that such tender offer, merger, consolidation or other similar transaction is not completed, the undersigned’s Shares and Related Securities shall remain subject to the provisions of this letter agreement, |
provided, however, that in any such case, it shall be a condition to such transfer that:
| ● | in the case of any transfer pursuant to clauses (i) through (viii) above, each transferee executes and delivers to the Placement Agents a lock-up letter in the form of this letter agreement, |
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| ● | in the case of any transfer pursuant to clauses (i) through (vii) above, no public disclosure or filing shall be required, or made voluntarily, during the Lock-up Period reporting a reduction in beneficial ownership of Shares in connection with such transfer, |
| ● | in the case of any transfer pursuant to clauses (vii), (ix) and (x) above, no public disclosure or filing reporting a change in beneficial ownership of Shares or Related Securities shall be made voluntarily during the Lock-up Period, and if the undersigned is required to file a report under Section 16 of the Exchange Act reporting a change in beneficial ownership of Shares or Related Securities during the Lock-up Period, the undersigned shall include a statement in such report to the effect that such transfer relates to the circumstances described in clause (vii), (ix) or (x), as applicable, and |
| ● | in the case of any transfer pursuant to clauses (i) through (vii) above, such transfer shall not involve a disposition for value. |
Furthermore, notwithstanding the restrictions imposed by this letter agreement, the undersigned may establish a trading plan pursuant to Rule 10b5-1 under the Exchange Act for the transfer of Shares or Related Securities, provided that such plan does not provide for any transfers of Shares or Related Securities during the Lock-up Period and the entry into such plan is not publicly disclosed, including in any filing under the Exchange Act, during the Lock-up Period.
Moreover, notwithstanding the restrictions imposed by this letter agreement, the undersigned may demand for, or exercise any right with respect to, the registration under the Securities Act of the offer and sale of any Shares or Related Securities held by the undersigned, or cause to be filed a registration statement, prospectus or prospectus supplement (or an amendment or supplement thereto) with respect to any such registration; provided, that (i) the Resale Registration Statement (as defined below) shall have first been filed and declared effective by the SEC and (ii) no Shares or Related Securities shall be sold under any such registration during the Lock-up Period.
The undersigned also agrees and consents to the entry of stop transfer instructions with the Company’s transfer agent and registrar against the transfer of Shares or Related Securities held by the undersigned and, if the undersigned is a natural person, the undersigned’s Family Members, if any, except in compliance with the foregoing restrictions.
With respect to the registration statement that is contemplated to be filed with the SEC by the Company to register the resale of the Shares to be sold in the Private Placement (the “Resale Registration Statement”), the undersigned waives any registration rights relating to registration under the Securities Act of the offer and sale of any Shares and/or any Related Securities owned either of record or beneficially by the undersigned, including any rights to receive notice of the Private Placement or the Resale Registration Statement.
The undersigned confirms that the undersigned has not, and has no knowledge that any Family Member has, directly or indirectly, taken any action designed to or that might reasonably be expected to cause or result in the stabilization or manipulation of the price of any security of the Company to facilitate the sale of the Shares. The undersigned will not, and will cause any Family Member not to take, directly or indirectly, any such action.
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The undersigned acknowledges and agrees that the Placement Agents have not provided any recommendation or investment advice nor have the Placement Agents solicited any action from the undersigned with respect to the Private Placement and the undersigned has consulted their own legal, accounting, financial, regulatory and tax advisors to the extent deemed appropriate. The undersigned further acknowledges and agrees that, although the Placement Agents may be required or choose to provide certain Regulation Best Interest and Form CRS disclosures to the undersigned in connection with the Private Placement, the Placement Agents are not making a recommendation to the undersigned to enter into this letter agreement and nothing set forth in such disclosures is intended to suggest that the Placement Agents are making such a recommendation.
Whether or not the Private Placement occurs as currently contemplated or at all depends on market conditions and other factors. The Private Placement will only be made pursuant to the Stock Purchase Agreement. Notwithstanding anything to the contrary contained herein, this letter agreement will automatically terminate and the undersigned shall be released from all obligations under this letter agreement upon the earliest to occur, if any, of (i) the Company advising the Placement Agents in writing prior to the Private Placement that it has determined not to proceed with the Private Placement or (ii) April 30, 2026, in the event the Private Placement has not been conducted by such date.
The undersigned hereby represents and warrants that the undersigned has full power, capacity and authority to enter into this letter agreement. This letter agreement is irrevocable and will be binding on the undersigned and the successors, heirs, personal representatives and assigns of the undersigned. This letter agreement may be delivered via facsimile, electronic mail (including pdf or any electronic signature complying with the U.S. federal ESIGN Act of 2000, e.g., www.docusign.com or www.echosign.com) or other transmission method and any counterpart so delivered shall be deemed to have been duly and validly delivered and be valid and effective for all purposes.
This letter agreement shall be governed by, and construed in accordance with, the laws of the State of New York.
[Signature page follows]
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| Very truly yours, | ||
| Name of Security Holder (Print exact name) | ||
| By: | ||
| Signature | ||
| If not signing in an individual capacity: | ||
| Name of Authorized Signatory (Print) | ||
| Title of Authorized Signatory (Print) | ||
| (indicate capacity of person signing if signing as custodian, trustee, or on behalf of an entity) | ||
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Certain
Defined Terms
Used in Lock-up Agreement
For purposes of the letter agreement to which this Annex A is attached and of which it is made a part:
| ● | “Call Equivalent Position” shall have the meaning set forth in Rule 16a-1(b) under the Exchange Act. |
| ● | “Change of Control” means the consummation of any bona fide third party tender offer, merger, consolidation or other similar transaction following the completion of the Private Placement and approved by the Board of Directors of the Company, the result of which is that any “person” (as defined in Section 13(d)(3) of the Exchange Act), or group of persons, other than the Company or its subsidiaries, becomes the beneficial owner (as defined in Rules 13d-3 and 13d-5 of the Exchange Act) of more than 50% of the total voting power of the voting stock of the Company. |
| ● | “Exchange Act” shall mean the Securities Exchange Act of 1934, as amended. |
| ● | “Family Member” shall mean the spouse of the undersigned, an immediate family member of the undersigned or an immediate family member of the undersigned’s spouse, in each case living in the undersigned’s household or whose principal residence is the undersigned’s household (regardless of whether such spouse or family member may at the time be living elsewhere due to educational activities, health care treatment, military service, temporary internship or employment or otherwise). “Immediate family member” as used above shall have the meaning set forth in Rule 16a-1(e) under the Exchange Act. |
| ● | “Lock-up Period” shall mean the period beginning on the date hereof and continuing through the close of trading on the date that is 90 days after the effective date of the Stock Purchase Agreement in connection with the Private Placement. |
| ● | “Put Equivalent Position” shall have the meaning set forth in Rule 16a-1(h) under the Exchange Act. |
| ● | “Related Securities” shall mean any options or warrants or other rights to acquire Shares or any securities exchangeable or exercisable for or convertible into Shares, or to acquire other securities or rights ultimately exchangeable or exercisable for or convertible into Shares. |
| ● | “Securities Act” shall mean the Securities Act of 1933, as amended. |
| ● | “Stock Purchase Agreement” shall mean the definitive securities purchase agreement entered into in connection with the Private Placement. |
| ● | “Sell or Offer to Sell” shall mean to: |
| – | sell, offer to sell, contract to sell or lend, |
| – | effect any short sale or establish or increase a Put Equivalent Position or liquidate or decrease any Call Equivalent Position |
| – | pledge, hypothecate or grant any security interest in, or |
| – | in any other way transfer or dispose of, |
in each case whether effected directly or indirectly.
| ● | “Swap” shall mean any swap, hedge or similar arrangement or agreement that transfers, in whole or in part, the economic risk of ownership of Shares or Related Securities, regardless of whether any such transaction is to be settled in securities, in cash or otherwise. |
Capitalized terms not defined in this Annex A shall have the meanings given to them in the body of this lock-up agreement.
37
Exhibit 99.1
Adlai Nortye Announces $150.0 Million Private Placement Equity Financing
SINGAPORE and NORTH BRUNSWICK, N.J., April 16, 2026 (GLOBE NEWSWIRE) -- Adlai Nortye Ltd. (Nasdaq: ANL) (the “Company” or “Adlai Nortye”), a clinical-stage biotechnology company focused on the development of innovative cancer therapies, today announced that it has entered into a securities purchase agreement for a private investment in public equity financing that is expected to result in gross proceeds of approximately $150.0 million, before deducting placement agent fees and other private placement expenses.
The oversubscribed transaction includes participation from both new and existing institutional investors. New investors include Soleus Capital, Perceptive Advisors, ADAR1 Capital Management, MPM BioImpact, Octagon Capital, Eventide Asset Management and Kalehua Capital, ,DAFNA Capital Management, etc.with additional participation from existing investors including Cormorant Asset Management, Columbia Threadneedle Investments, Balyasny Asset Management, Casdin Capital, Squadron Capital Management and Superstring Capital Management, etc.
In the private placement, the Company is selling 11,320,755 ADSs, at a price of $13.25 per ADS, which equals the closing price of the Company’s ADSs on the Nasdaq Global Market on April 15, 2026. The private placement is expected to close on April 17, 2026, subject to the satisfaction of customary closing conditions.
Carsten Lu, Chairman and Chief Executive Officer of Adlai Nortye, said, “We are delighted to have brought together this group of high-quality healthcare investors to support Adlai Nortye and our innovative, potentially best-in-class RAS-targeting therapies. We thank our investors for their confidence in the broad potential of our RAS-targeting pipeline and our next-generation ADC payload platform, RASiCATM, as well as their commitment to our mission to transform deadly cancer into a chronic and eventually curable disease.”
Leerink Partners, Cantor, Lucid Capital Markets, H.C. Wainwright & Co. and Jones are acting as joint placement agents for the private placement.
The securities being issued and sold in this private placement have not been registered under the Securities Act of 1933, as amended, or applicable state securities laws, and may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements. Adlai Nortye has agreed to file a registration statement with the Securities and Exchange Commission registering the resale of the ADSs issued in the private placement.
This press release shall not constitute an offer to sell or the solicitation of an offer to buy any securities described herein, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or jurisdiction.
About Adlai Nortye
Adlai Nortye (Nasdaq: ANL) is a global clinical-stage company at the forefront of discovering and developing innovative cancer therapies. Leveraging its dual R&D presence in the United States and China, Adlai Nortye is building a robust pipeline of drug candidates focused on two key areas where it believes it can make a significant difference. (1) RAS-targeting therapies: Adlai Nortye is tackling RAS-driven cancers with AN9025, an oral pan-RAS(ON) inhibitor, and AN4035, a CEACAM5-targeting ADC delivering a potent pan-RAS(ON) inhibitor directly to the tumor. (2) Next-generation cancer immunotherapies: Adlai Nortye’s drug candidates, AN8025 (a tri-functional fusion protein of αPD-L1 x CD86 variant x LAG3 variant), a T-cell and antigen-presenting cell modulator, and AN4005 (a first-in-class oral small-molecule PD-L1 inhibitor), are designed to activate cancer immunity in novel ways.
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. In some cases, you can identify forward-looking statements by terminology such as “aim,” “anticipate,” “assume,” “believe,” “contemplate,” “continue,” “could,” “design,” “due,” “estimate,” “expect,” “goal,” “intend,” “may,” “objective,” “plan,” “positioned,” “potential,” “predict,” “seek,” “should,” “target,” “will,” “would” and other similar expressions that are predictions of or indicate future events and future trends, or the negative of these terms or other comparable terminology. All statements other than statements of historical facts contained in this press release are forward-looking statements. These forward-looking statements include, but are not limited to, statements about: the expected closing date of the private placement; cash operating runway; and the intended use of proceeds. These and other risks are described in greater detail under the section titled “Risk Factors” contained in the company’s Annual Report on Form 20-F and earnings release on Form 6-K and the Company’s other filings with the SEC. Any forward-looking statements that the Company makes in this press release are made pursuant to the Private Securities Litigation Reform Act of 1995, as amended, and speak only as of the date of this press release. Except as required by law, the company undertakes no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise.
Company contact:
Investor Relations
Email: ir@adlainortye.com
Exhibit 99.2
0 April 2026 Corporate Presentation NASDAQ: ANL
1 Disclaimer This presentation has been prepared by Adlai Nortye Ltd. (the "Company") for informational purposes only and does not constitute an offer to sell or the solicitation of an offer to buy any securities. This presentation contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements other than statements of historical facts, including statements regarding our business strategy, product candidates, preclinical and clinical development plans for each of our product candidates including AN9025, AN4035 and AN8025, anticipated milestones, potential therapeutic benefits, market opportunities, and other future events or prospects, are forward- looking statements. These statements may be identified by words such as "may," "will," "expect," "anticipate," "believe," "plan," "potential," "estimate," or similar expressions. Forward-looking statements are based on current expectations and assumptions and are subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. These risks include, but are not limited to, risks related to the discovery and development of our product candidates, the timing, progress, and likelihood of success of our preclinical studies and clinical trials, regulatory approval processes, reliance on third parties for manufacturing, research and development activities, intellectual property protection, competitive developments, our ability to obtain additional financing. Our product candidates are in preclinical or at various stages of clinical development. Our assumptions regarding the development potential of these product candidates are based in large part on preclinical data or early clinical readouts, and such data may not be predictive of future clinical outcomes. We may observe materially different results as we conduct further preclinical studies and any planned or ongoing clinical trials. Preclinical findings, including pharmacology, target engagement, biomarkers, efficacy, tolerability, safety, and translational data, may not be replicated in humans. Our development activities are subject to significant risks and uncertainties, including potential delays in the initiation, enrollment, data readout, and completion of preclinical studies and clinical trials, and the possibility of unexpected adverse events or insufficient efficacy, which may delay or prevent regulatory approval or commercialization. In addition, comparisons of product candidates between the Company and third parties based on preclinical and clinical data, are inherently limited due to differences in methodologies and models, experimental conditions, study design and patient populations, such comparisons should be interpreted with caution. This presentation concerns product candidates that are under preclinical or clinical investigation and have not been approved for marketing by the U.S. Food and Drug Administration (FDA) or any other regulatory authority. These product candidates are currently limited by federal law to investigational use, and no representation is made as to their safety or effectiveness for the purposes for which they are being investigated. Additional risks and uncertainties are described in the Company's prior filings with the U.S. Securities and Exchange Commission(SEC), including under the heading "Risk Factors" in the Company's annual report on Form 20-F for the year ended December 31, 2025, and any subsequent filings with the SEC. This presentation speaks only as of its date, the Company undertakes no obligation to update any forward-looking statements or other information contained herein, except as required by law. All copyrights and trademarks used herein are the property of their respective owners.
2 Product MOA Indication Discovery IND Enabling Phase 1a Phase 1b Phase 2 Phase 3 Upcoming Milestone Worldwide Rights AN9025 pan- RAS(ON)i RAS-addicted tumors Ph1 dose escalation completion in H1 2027 Ex-China1 AN4035 CEACAM5 pan- RAS(ON)i ADC CEACAM5- enriched RAS- addicted solid tumors IND submission in mid-2026 Global AN8025 αPD-L1 /Lag3v /CD86v Advanced tumors Ph1 dose escalation completion in 2026 YE Global Other Assets AN4005 Small molecule PD-L1i Advanced tumors Clinical update presentation at conference expected in H2 2026 Ex-China2 Palupiprant (AN0025) EP4 Neoadj RC (+CRT)3 Topline results of Ph2 study in H1 2027 Global except Japan, Korea, Taiwan and Southeast Asian Countries LA EC (+CRT)3 Clinical update in H2 2026 Pipeline Chart: Abbreviations: MOA = mechanism of action; Lag3v: Lag 3 variant; CD86v: CD86 variant; IND = Investigational New Drug; RC = rectal cancer; CRT = chemoradiation therapy; LA = locally advanced; EC = esophageal cancer Note 1. ASK Pharm holds exclusive rights to develop, manufacture, and commercialize AN9025 in mainland China, Hong Kong and Macao; 2. Xiamen Biotime Biotechnology Co., Ltd., holds exclusive rights to develop, manufacture, and commercialize AN4005 in mainland China, Hong Kong, Macao and Taiwan; 3. Investigator Initiated Trials
3 AN9025: An Oral Small-Molecule Pan-RAS(ON) Inhibitor
4 Why Targeting Pan-RAS(ON) KRAS (OFF)i KRAS (ON)i • RAS proteins cycle between an active GTP-bound ("ON") state and an inactive GDP-bound ("OFF") state to transmit signals from cell surface receptors. • Mutations in RAS result in constitutive activation and oncogenic signaling, with the GTP-bound ("ON") state driving this pathological activity. • Effectively traps RAS in the GTP-bound ("ON") state, avoiding continuous cycling between "ON" and "OFF" states. • Mitigates resistance driven by isoform switching or wildtype RAS upregulation in response to mutant-selective therapies Mechanism of Action Proposed Advantages of a Pan-RAS (ON) Inhibitor in Circumventing Resistance:
5 AN9025's Binding Affinity for CypA Suggests It May Offer More Sustained RAS Inhibition vs. RMC-6236 KD1 = 3.2 nM Kinetic Analysis of AN9025 Binding to CypA on Octet Binary Affinity KD1 (nM) ka (1/[M*S]) kdis (1/s) AN9025 3.2 1.6 E+05 5.0 E-04 RMC-6236 12.4 2.8 E+05 3.4 E-03 AN9025 demonstrates a binding affinity to cyclophilin A (CypA) that is 4-fold stronger than that of RMC-6236. AN9025 has a 7-fold slower dissociation rate from CypA compared to RMC-6236, potentially allowing for sustained RAS inhibition. KD1 = 12.4 nM Kinetic Analysis of RMC-6236 Binding to CypA on Octet CypA AN9025 Binary Complex KRAS(GMP PNP-bound) Tri-complex KRAS/RAF Disruption Source: AN9025 Poster, Abstract #4377, 2025 AACR Annual Meeting
6 AN9025 Shows Stronger Tri-Complex Binding Affinity vs. RMC-6236 KD2 = 24.8 nM Mutant RAS(ON) Protein AN9025 RMC-6236 KD (nM) ka (1/[M*S]) kdis (1/s) KD (nM) ka (1/[M*S]) kdis (1/s) KRASG12D 8.8 4.9 E+05 4.3 E-03 24.8 5.4 E+05 1.3 E-02 KRASG12V 8.3 3.2 E+05 2.7 E-03 68.4 1.8 E+05 1.2 E-02 KRASG12C 4.5 4.1 E+05 1.9 E-03 17.8 4.5 E+05 8.0 E-03 KRASG12S 12.6 1.6 E+05 2.0 E-03 48.5 1.9 E+05 9.1 E-03 KRASG12R 15.5 2.4 E+05 3.8 E-03 80.5 2.3 E+05 1.8 E-02 KRASG12A 11.9 2.1 E+05 2.5 E-03 60.3 1.8 E+05 1.0 E-02 KRASG13D 15.5 2.5 E+05 3.9 E-03 69.7 2.5 E+05 1.8 E-02 NRASQ61H 11.0 2.5 E+05 2.8 E-03 45.4 2.2 E+05 1.0 E-02 KRASWT 10.0 2.8 E+05 2.8 E-03 52.8 2.2 E+05 1.2 E-02 NRASWT 6.6 3.7 E+05 2.4 E-03 33.9 2.6 E+05 8.8 E-03 HRASWT 4.0 4.9 E+05 2.0 E-03 20.2 3.4 E+05 6.8 E-03 AN9025 exhibits a 3- to 8-fold higher binding affinity for tri-complex formation compared to RMC-6236, primarily attributed to its slower dissociation rate that leads to prolonged suppression of RAS signaling. AN9025 demonstrates strong binding affinity for the RAS(ON) protein, with no detectable binding to the RAS(OFF) protein. AN9025 (GMPPNP-bound KRASG12D) KD2 = 8.8 nM RMC-6236 (GMPPNP-bound KRASG12D) nm nm Source: AN9025 Poster, Abstract #4377, 2025 AACR Annual Meeting
7 AN9025 Demonstrates a Sensitivity Profile Comparable to RMC-6236 Across a Cancer Cell Line Panel but with Significantly Higher Potency AN9025 demonstrates approximately 100-fold more potent inhibition of cell proliferation across RAS mutant cell lines than RMC-6236. AN9025 shares similar RAS mutant sensitivity pattern with RMC6236. (G12X > G13X ≈Q61X > WT) Source: AN9025 Poster, Abstract #4377, 2025 AACR Annual Meeting
8 AN9025 Demonstrates More Sustained RAS Inhibition vs. RMC-6236 Phospho-ERK(T202/Y204) inhibition (IC50, nM) in HPAC AN9025 RMC-6236 4 h incubation 0.048 0.27 4 h incubation + 48 h washout 0.18 4.3 IC50 Shift 3.7 X 16 X AN9025 enables prolonged inhibition of the RAS pathway, maintaining its effects even after the drug is withdrawn. Phospho-ERK(T202/Y204) inhibition (IC50, nM) in PSN1 AN9025 RMC-6236 4 h incubation 0.60 2.83 4 h incubation + 48 h washout 0.48 7.49 IC50 Shift No shift 2.6 X
9 AN9025 Achieves Deep Tumor Regression and Provides More Sustained Anti-Tumor Effects vs. RMC-6236 in HPAC (KRASG12D) CDX Model AN9025 demonstrated comparable antitumor activity to RMC-6236; notably, AN9025 exhibited more sustained efficacy following drug withdrawal. Compounds HPAC CTG (IC50, nM) Dose (mg/kg) RTV1 (%) on Day 18 RTV1 (%) on Day 35 AN9025 0.056 0.10 47% 85% 0.04 150% 237% RMC-6236 9.4 25 31% 164% 10 80% 275% (1). RTV = relative tumor volume; relative to the tumor volume at the start of treatment Vehicle (p.o., QD) AN9025 (0.1 mg/kg, p.o., QD) AN9025 (0.04 mg/kg, p.o., QD) RMC-6236 (25 mg/kg, p.o., QD) RMC-6236 (10 mg/kg, p.o., QD) Source: AN9025 Poster, Abstract #4377, 2025 AACR Annual Meeting.
10 PK-PD Analysis Further Supports More Durable RAS Inhibition by AN9025 vs. RMC-6236 in HPAC (KRASG12D) CDX Model This study evaluated the PK–PD correlation at the end of 7 days of continuous oral dosing and also assessed PK after the first dose for comparison The results indicate that AN9025 has the flexibility to be investigated for an intermittent dosing strategy in a clinical setting. AN9025 Post-Treatment PK/PD Profile (144~192 hr) 0.2mg/kg, p.o., QD*7 0.1mg/kg, p.o., QD*7 0.04mg/kg, p.o., QD*7 AUC0-48 hr tumor (h*ng/g) / blood / plasma (h*ng/L) 6910 / 1476 / 69 3454 / 826 / 40 1802 / 438 / NA Cmax tumor (ng/g) / blood / plasma (ng/L) 186 / 72 / 6.4 83 / 29 / 2.5 44 / 17 / NA Tumor DUSP6 inhibition at 168 / 192 hr 96.2% / 96.2% 96.5% / 94.5% 87.2% / 76.2% RMC-6236 Post-Treatment PK/PD Profile (144~192 hr) 25 mg/kg, p.o., QD*7 10 mg/kg, p.o., QD*7 AUC0-48 hr tumor (h*ng/g) / blood / plasma (h*ng/L) 29227 / 7583 / 2542 14653 / 3169 / 782 Cmax tumor (ng/g) / blood / plasma (ng/L) 1911 / 1018 / 386 683 / 425 / 156 Tumor DUSP6 inhibition at 168 / 192 hr 85.5% / 46.3% 63.8% / 7.9%
11 AN9025 Achieves More Prolonged Anti-Tumor Effects Compared to RMC-6236 and RMC-9805 in KP-4 (KRASG12D) CDX Model Compounds Dose (mg/kg) RTV1 (%) on the day of best tumor regression RTV1 (%) on Day 42 AN9025 0.2 26.6% 41.0% 0.1 41.6% 58.2% RMC-6236 25 81.0% (D14) 1331% RMC-9805 100 25.7% (D14) 658% Days after the start of treatment Tumor volume mm3 0 7 14 21 28 35 42 0 500 1000 1500 2000 2500 3000 Group 1 Vehicle, PO Group 2 AN9025 0.2 mg/kg, PO Group 3 AN9025 0.1 mg/kg, PO Group 4 RMC-6236 25 mg/kg, PO Group 5 RMC-9805 100 mg/kg, PO Days after the start of treatment Body weight change (%) 0 7 14 21 28 35 42 80 90 100 110 120 Group 1 Vehicle, PO Group 2 AN9025 0.2 mg/kg, PO Group 3 AN9025 0.1 mg/kg, PO Group 4 RMC-6236 25 mg/kg, PO Group 5 RMC-9805 100 mg/kg, PO (1). RTV = relative tumor volume; relative to the tumor volume at the start of treatment AN9025 clearly showed more prolonged anti-tumor efficacy compared to RMC-6236 and RMC-9805 in KP-4 CDX model (RTK hyperactivation and Myc amplification). Group 1 Vehicle, PO Group 2 AN9025 0.2 mg/kg, PO Group 3 AN9025 0.1 mg/kg, PO Group 4 RMC-6236 25 mg/kg, PO Group 5 RMC-9805 100 mg/kg, PO Group 1 Vehicle, PO Group 2 AN9025 0.2 mg/kg, PO Group 3 AN9025 0.1 mg/kg, PO Group 4 RMC-6236 25 mg/kg, PO Group 5 RMC-9805 100 mg/kg, PO
12 AN9025 Demonstrates Overall Favorable PK Properties Mouse Rat Dog Monkey IV Dose (mpk) 0.25 0.03 0.005 0.1 T1/2 (h) 39 21 49 18 Vdss (L/Kg) 1.9 2.4 1.7 0.92 CL (mL/Kg/min) 1.2 1.6 0.44 0.7 AUC0-inf (ng/mL*h) 3350 324 203 2373 PO Dose (mpk) 0.50 0.10 0.02 0.5 Cmax (ng/mL) 46 16 9.5 100 T1/2 (h) 37 20 44 12 AUC0-inf (ng/mL*h) 3300 400 450 2100 Bioavailability (F%) 44% 37% 57% 18% The PK simulation model demonstrated good concordance with observed TK data at Day 28 from 4-week GLP toxicology studies in rats and dogs
13 Therapeutic Index (TI) and Human PK Stimulation of AN9025 for Once-Daily Dosing Drug Species TSC 1 nM MED 1 MTD (Observed in 4-week in-vivo efficacy study in mice and 2-week DRF toxicology studies in rats) TI b (MTD/MED) Dose mpk AUC nM*hour Cmax nM Dose mpk AUC nM*hour Cmax nM AN9025 Mouse 6.9 0.030 167 9.8 0.20 1390 72 6.6 Rat 8.2 0.058 198 12 0.20 418 25 3.4 Human 2 (60kg) 2.45 0.0022 (0.13 mg) 61 2.8 0.016 (0.93 mg) 417 19.5 6.9 RMC-6236 Mouse 3 145 8.6 3480 468 50 16900 3060 5.8 Rat 3 350 48 8400 1040 80 11400 1110 1.6 Human 4 (60 kg) 88 1.8 (105 mg)a 2160 195 9.2 (552 mg)a 11300 1020 5.3 (1) TSC and MED projections are derived from PK-Efficacy modeling using the HPAC CDX model, with blood average drug concentration = tumor static concentration (TSC); (2) AN9025 human PK was projected via allometric scaling from mice, rat and dog data shown on slide#12 of the deck; (3) The MED and MTD of RMC-6236 in mouse and rat were determined internally, with direct comparison to AN9025 performed in the same studies; (4) The human PK parameters of RMC-6236 were derived from RMVD's translational study published in Cancer Discovery (2024; Volume 14, pp. 994–1017) • aThe simulation model demonstrated good predictability for both the human starting efficacious dose and maximum tolerated dose of RMC-6236 • bAN9025 exhibited a therapeutic index comparable to or slightly superior to, that of RMC-6236 in a QD regimen, despite its significantly greater potency • Predicted AN9025 human PK based on allometric scaling: CL = 0.018 L/(h*kg); V = 1.3 L/kg; predicted human T1/2 = 40 h
14 A potentially lower tumor stasis concentration (TSC) was observed with QW dosing compared to QD dosing, supported by durable PD inhibition 0 2 4 6 8 10 12 14 16 18 20 22 24 26 28 30 0 200 400 600 800 1000 1200 1400 Days after the start of treatment Tumor volume(mm3) Vehicle (P.O.,QD) AN9025 (0.04mg/kg P.O.,QD) AN9025 (0.14mg/kg P.O.,BIW) AN9025 (0.07mg/kg P.O.,BIW) AN9025 (0.28mg/kg P.O.,QW) AN9025 (0.14mg/kg P.O.,QW) HPAC (KRASG12D, PDAC) 0 4 8 12 16 20 24 28 -10 -5 0 5 10 15 Days after the start of treatment Body weight changes(%) HPAC (KRASG12D, PDAC) Dose (mg/kg) RTV1 (%) on Day 28 DUSP6 inhibition % at the end of treatment Projected TSC (nM) 0.04, QD 48% 79.7% 6.2 0.14, BIW 40% 87.9% 5.9 0.07, BIW 135% 73.2% 0.28, QW 46% 89.4% 4.6 0.14, QW 96% 77.4% 0 10 20 30 -20 -15 -10 -5 0 5 10 15 Days after the start of treatm ent Body Weight Change (%) HuCCT1 (KRASG12D, Cholangiocarcinoma) Dose (mg/kg) RTV1 on Day 28 BW change2 (%) on Day 28 Vehicle 9.9 (Day 21) -5.2% (Day 21) 0.1, QD 1.11 -7.3% 0.35, BIW 0.94 +1.6% 0.7, QW 0.90 +1.0% (1) RTV = relative tumor volume; relative to the tumor volume at the start of treatment; (2) BW change % means the change compared to the one at Day 1 0 10 20 30 0 500 1000 1500 2000 Days after the start of treatment Tumor Volume (mm3) Vehicle (p.o., Q D) AN9025 (0.1 mg/kg, p.o., QD) AN9025 (0.7 mg/kg, p.o., QW) AN9025 (0.35 mg/kg, p.o., BIW) HuCCT1 (KRASG12D, Cholangiocarcinoma) AN9025 demonstrated comparable tumor regression in mouse CDX models with intermittent dosing relative to QD dosing, while slightly improved tolerability was observed with the intermittent regimen Intermittent Dosing of AN9025 Achieves Tumor Regression Comparable or Slightly Superior to QD Dosing in mouse CDX Models
15 Widening of AN025 Therapeutic Window with Intermittent Dosing Species Dosing Regimen TSC 1 nM (95% CI) MED 1 MTD(Observed in 4-week in-vivo efficacy model in mice and 2-week DRF toxicology study in rats) TI (MTD/MED) Dose mpk Weekly AUC nM*hour Cmax nM Dose mpk AUC nM*hour Cmax nM Mouse QD 6.2 0.028 1050 8.8 0.2 1390 72 7.3 BIW 5.8 0.09 983 22 . . . . QW 4.6 0.14 792 34 . . . . Rat QD 7.4 0.053 1300 11 0.2 378 Day14 AUC(0~24h) 24 3.8 BIW 7.1 0.18 1220 23 1.4 1750 Day11 AUC(0~72h) 87 7.8 QW 5.7 0.28 965 34 2.8 3320 Day8 AUC(0~72h) 290 9.8 Human (60 kg) QD 2.2 0.002 (0.12 mg) 377 2.5 0.014 (0.84 mg) 373 Day14 AUC(0~24h) 17 7.0 BIW 2.0 0.0064 (0.384 mg) 344 3.4 0.068 (4.1 mg) 1730 Day11 AUC(0~72h) 36 11 QW 1.5 0.01 (0.60 mg) 269 3.9 0.18 (11 mg) 3310 Day8 AUC(0~72h) 69 18 (1) TSC and MED projections are derived from PK-Efficacy modeling using the HPAC CDX model, with blood average drug concentration = tumor static concentration (TSC); (2) AN9025 human PK was projected via allometric scaling from mice, rat and dog data shown on slide#12 of the deck The broader therapeutic window observed for AN9025 supports the selection of a once-weekly (QW) dosing regimen for evaluation in the Phase 1 first-in-human clinical study.
16 Summary of AN9025 AN9025 holds best-in-class potential within the Pan-RAS(ON) inhibitor category: • Exhibited a binding affinity for cyclophilin A (CypA) that is 4-folder stronger than that of RMC-6236, driven by a slower dissociation rate from CypA, which may enable more sustained RAS inhibition • Showed 3- to 8-fold higher binding affinity for tri-complex formation, also attributable to slower dissociation, potentially leading to prolonged suppression of RAS signaling • Demonstrated 100-fold more potent inhibition of cellular proliferation and provided more sustained RAS inhibition compared to RMC-6236 • Induced deep tumor regression, superior and more sustained anti-tumor effects compared to RMC-6236 in mouse CDX models covering different RAS mutant types • Demonstrated favorable overall DMPK properties, with 20–55% bioavailability across multiple species and a 2- to 5-fold longer half-life compared with RMC-6236 • Demonstrated a therapeutic index comparable to or slightly superior to RMC-6236 in QD regimen despite significantly improved potency The first patient has been dosed in early February 2026 in the ongoing global Phase 1 clinical trial in the US and China. Initiation of the intermittent dosing cohort is anticipated in mid-2026, with completion of full dose escalation expected by H1 2027.
17 AN4035: A Novel CEACAM5 Pan-RAS(ON)i ADC
18 RAS Inhibitor Conjugated Antibodies (RASiCATM) - Diversifying ADC Payloads to Overcome Clinical Resistance References: 1. Abelman et al. Clin Cancer Res 2025; 2. Peng et al. Breast, 2025; 3. Tarantino et al. Clin Cancer Res 2025 (abstr P1-08-08) RASiCATM platform is designed to overcome TWO major challenges in oncology therapeutics ADC field: limited diversity of payload classes leading to cross-resistance RAS inhibitor field: on-target, off-tumor toxicities associated with tricomplex pan- RAS(ON) inhibitors Payload-related cross resistance limits treatment sequencing for ADCs1,2 Patients with HER2-high metastatic breast cancer who received a second ADC with a similar payload class showed significantly worse outcomes than those switched to an ADC with a different mechanism of action3 This demonstrates that payload-specific resistance is a key clinical challenge, creating an urgent need for novel payload classes to enable more effective treatment sequences
19 Pan-RAS(ON) Inhibitor as a Next-Generation ADC Payload • Cyclophilin A, an abundant intracellular protein (μM levels), is the target engaged by pan- RAS(ON) inhibitors, much like MMAE targeting tubulin • ADCs leveraging pan-RAS(ON) inhibitors could further enhance the therapeutic index MOA of Pan-RAS(ON)i: Background: tricomplex pan-RAS(ON) inhibitors (e.g. RMC-6236) are a promising class of therapeutics against RAS-driven cancers Potential limitations: on-target, off-tumor toxicities may restrict dose and limit safety in combinations Our hypothesis: targeted delivery via an ADC could localize pan-RAS(ON) inhibitor activity to tumors while minimizing systemic RAS pathway inhibition Widen therapeutic window Enable rational combinations
20 Payload Is a Proprietary Highly Potent Pan-RAS(ON) Inhibitor Binary (CYPA) KD1 (nM) Tri-complex (KRAS) KD2 (nM) G12C G12D G12V WT Payload 14.9 4.7 30.5 14.0 18.6 RMC-6236 12.5 19.1 174 45.9 52.8 Cancer Cell Indication RAS mutation type Payload 72h CTG IC50 (nM) Imax % NCI-H2009 NSCLC Kras G12A 0.02 65 NCI-H358 Kras G12C 0.06 93 NCI-H2030 Kras G12C 0.04 22 NCI-H2122 Kras G12C 0.01 93 NCI-H441 Kras G12V <0.01 44 SW900 Kras G12V 0.12 80 ASPC1 PDAC Kras G12D 0.06 63 HPAC Kras G12D 0.07 63 KP4 Kras G12D 0.75 56 Capan1 Kras G12V 0.02 57 Capan2 Kras G12V 0.09 61 SW620 CRC Kras G12V 0.01 80 HCT116 Kras G13D 0.41 93 LoVo Kras G13D 0.34 67 T84 Kras G13D 2.59 74 LS1034 Kras A146T 1.0 80 MOA of Payload: • Pan-RAS(ON) molecular glue Source: AN4035 Late-Breaking Oral Presentation, 2025 AACR-NCI-EORTC International Conference: Molecular Targets and Cancer Therapeutics.
21 Overview of AN4035 CEACAM5: overexpressed in CRC, PDAC, & NSCLC where RAS is frequently mutated Conjugator: homogenous DAR 8 with high stability; no retro-Michael reaction Linker: highly hydrophilic; excellent circulation stability and efficient payload release Payload: highly potent pan-RAS(ON) inhibitor Compound Human plasma incubation time LC-MS DAR AN4035 Day 0 8.04 Day 7 7.85 Stable Conjugator Compound Plasma incubation time Payload Released rate % Human plasma Mouse plasma Rat plasma Monkey plasma AN4035 Day 0 <0.05 <0.05 0.02 <0.05 Day 7 <0.05 <0.05 0.01 <0.05 Day 14 0.05 <0.05 0.01 0.06 Stable Linker-Payload No aggregation after incubation for 72h at 40℃ Compound Incubation time SEC-HPLC Aggregation % AN4035 0 hr 0 72 hr 0 Incubation buffer: 20 mM Histidine, 240 mM Sucrose, pH 5.5 Source: AN4035 Late-Breaking Oral Presentation, 2025 AACR-NCI-EORTC International Conference: Molecular Targets and Cancer Therapeutics.
22 CEACAM5 as a Compelling Target for Pan-RAS(ON) Inhibitor-Based ADC RAS-Mutant Cancer–Enriched, Skin-Sparing Expression Differential Expression in Normal Epithelium Adapted from ASCO 2024 Discussant on Abs #3000, 3001, 3002 Expression data are derived from TCGA, GTEx datasets HER2 mRNA-IHC threshold: https://doi.org/10.1136/jitc-2023-SITC2023.0143 Clinically Validated ADC Target Without Gastrointestinal Dose-Limiting Toxicity • Meaningful efficacy in RASmut-prevalent cancers including NSCLC & CRC • Minimal / manageable on-target GI AEs at doses up to 10mg/kg QW, despite the presence of CEACAM5 on normal gut epithelium ADC Payload / DAR RP2D Clinical Efficacy Diarrhea TRAE GI AEs as DLT All grade ≥G3 SAR408701 DM4 DAR: 3.8 100 mg/m2 Q2W (2.6 mg/kg @70kg) ORR 21.7% 2/3L CEA-high nsq-NSCLC, phIII 1 9.8% 1 0.5% 1 None 2 M9140 Exatecan DAR: 8 2.8 mg/kg Q3W ORR 26.8% 3L+ mCRC, phI 3 ~25% 3 0% 3 None 4 IMMU-130 SN38 DAR: 7.6 8 / 10 mg/kg QW DCR 62% / 55% Late-line mCRC phI/II 5 46% / 52% TEAE 5 * 56% TRAE 5% / 5% TEAE 5 * 7.9% TRAE None 5 (1). WCLC 2024 OA08.05; (2). Gazzah 2022, DOI:10.1016/j.annonc.2021.12.012; (3). ASCO GU 2026 #129P; (4). Kopetz 2024, DOI:10.1038/s41591-025-03843-z ; (5). Dotan 2017, DOI:10.1200/JCO.2017.73.9011
23 AN4035 Achieved Superior Target-Mediated Intracellular Payload Retention Incubation Time AN4035 (10 μg/mL) Isotype-payload (10 μg/mL) CEACAM5C (10 μg/mL) Cell supernatant payload conc. (nM) Cell lysate payload conc. (nM) lysate/ supernatant payload ratio Cell supernatant payload conc. (nM) Cell lysate payload conc. (nM) Cell supernatant payload conc. (nM) Cell lysate payload conc. (nM) Iysate / supernatant payload ratio 20 min BQL BQL - BQL BQL BQL BQL - 2 hr BQL 1.75 - BQL BQL BQL BQL - 4 hr BQL 12.9 - BQL BQL BQL 3.58 - 24 hr 5.97 261 44 BQL BQL 45.8 47.5 1.0 48 hr 14.4 516 36 BQL 1.41 83.1 66.0 0.79 BQL, below quantitation limit HPAC cancer cell Co-culture 20 min, 2, 4, 24, 48 h Media PBS wash Cancer Cell ADC drugs (10 μg/mL) Lysis buffer Cell supernatant conc. Cell lysate payload conc. 0 24 48 0 200 400 600 Payload release in HPAC cells Incubation Time (hr) Payload conc. (nM) AN4035, supernatant AN4035, lysate Isotype ADC, supernatant Isotype ADC, Iysate CEACAM5C, supernatant CEACAM5C, lysate Source: AN4035 Late-Breaking Oral Presentation, 2025 AACR-NCI-EORTC International Conference: Molecular Targets and Cancer Therapeutics.
24 AN4035 Demonstrated Potent Cytotoxicity and a Robust Bystander Effect in CEACAM5- Positive, RAS-Addicted Cancer Cell Models Cancer Cell Line Cancer Type CEACAM5 mRNA nTPM RAS mutation type 6-day CTG AN4035 Isotype ADC IC50 (nM) Imax % IC50 (nM) CL-40 CRC 1821 Kras G12D 0.77 98 SK-CO-1 784 Kras G12V 0.02 99 LS513 208 Kras G12D 0.15 100 SW403 443 Kras G12V 2.8 95 SW1463 198 Kras G12C 2.3 99 LoVo 122 Kras G13D 4.4 48 GP2D 42 Kras G12D 1.4 84 QGP-1 PDAC 1360 Kras G12V 0.05 91 HPAC 714 Kras G12D 0.10 73 >100 ASPC1 499 Kras G12D 0.31 88 Capan1 97 Kras G12V 0.23 76 NCI-H2122 NSCLC 616 Kras G12C 0.30 94 NCI-H727 332 Kras G12V 0.09 93 MKN45 Gastric cancer 1087 Kras WT 0.13 95 >100 AN4035 showed a superior bystander killing effect compared to CEACAM5 TopoI-based ADC SK-CO-1 (CEACAM5+) : SW480-Luc (CEACAM5 neg) = 10:1 SW480-Luc (CEACAM5 neg) only -2 -1 0 1 2 -20 0 20 40 60 80 100 AN4035 Log [nM] Inhibition Rate (%) -2 -1 0 1 2 -20 0 20 40 60 80 100 CEACAM5C Log [nM] Inhibition Rate (%) -2 -1 0 1 2 -20 0 20 40 60 80 100 AN4035 Log [nM] Inhibition Rate (%) -2 -1 0 1 2 -20 0 20 40 60 80 100 CEACAM5C Log [nM] Inhibition Rate (%) IC50 = 0.07 nM IC50 = 0.63 nM nTPM, normalized transcript per million Source: AN4035 Late-Breaking Oral Presentation, 2025 AACR-NCI-EORTC International Conference: Molecular Targets and Cancer Therapeutics.
25 AN4035 Demonstrated Robust Anti-Tumor Activity in CDX Models Compound CTG1 (IC50, nM) Dose (mg/kg) ΔRTV2 (%) on Day 25 AN4035 0.10 3.0, single dose -78% 10, single dose -85% (1) CTG = cell-titer glow in vitro assay (2). ΔRTV = relative tumor volume; relative to the tumor volume at the start of treatment, ΔRTV = (Vt-V0) / V0 × 100 HPACKRAS G12D model (PDAC, CEACAM5 mRNA 714): CL40KRAS G12D model (CRC, CEACAM5 mRNA 1821): 0 7 14 21 0 200 400 600 800 1000 1200 D ays after treatm en t Tumor volum(mm3) Vehicle, i.v., QW x 3 CEACAM5C, 10 mg/kg, i.v., QW x 3 AN4035, 10 mg/kg, i.v., QW x 3 Payload, 1 mg/kg, p.o., QD x 21 0 7 14 21 -20 -10 0 10 20 D ays after treatm ent Body weight change(%) Compound CTG1 (IC50, nM) Dose (mg/kg) ΔRTV2 (%) on Day 21 AN4035 0.38 10, QW -89% CEACAM5C 1.2 10, QW -36% payload 0.08 1.0, QD 276% • Durable tumor regression with single-dose of 3 mg/kg • Superior or comparable efficacy to CEACAM5 Topo I- based ADC (CEACAM5C) or naked payload at tolerable doses 0 7 14 21 28 -20 -10 0 10 20 Days after treatment Body weight change (%) 0 7 14 21 28 0 200 400 600 800 1000 1200 1400 Days after treatment Tumor volume (mm3) Vehicle (i.v.,single dose) AN4035 (10mg/kg,i.v.,single dose) AN4035 (3mg/kg,i.v.,single dose) CDX, cell line-derived xenograft Source: AN4035 Late-Breaking Oral Presentation, 2025 AACR-NCI-EORTC International Conference: Molecular Targets and Cancer Therapeutics.
26 AN4035 shows enhanced target-mediated tumor retention versus payload alone, with significantly improved tumor selectivity over normal tissues (1) Ratio of tumor/tissue concentration (or AUC exposure) over blood concentration; (2) Concentrations in these tissues were below the limit of quantification (BQL) at 504 hr. 0 72 144 216 288 360 432 504 0.1 1 10 100 1000 Tissue Distribution over time Time after ADC injection (hr) Payload conc. (ng/g or ng/mL) Blood (1.0x) Tumor (46x)1 Ear (11x)1 Skin (6.9x)1 Liver (5.4x)1, 2 Kidney (4.2x)1, 2 Colon (2.4x)1 Spleen (1.9x)1, 2 Lung (2.0x)1, 2 Heart (0.7x)1, 2 Free Payload concentrations in tumor, normal tissues and blood were measured at multiple time points after a single dose of AN4035 (10 mg/kg, IV) in the HPAC (KRAS G12D) CDX model (1) Ratio of tumor/tissue concentration (or AUC exposure) over blood concentration (2) Assume steady state has achieved after 7-day continuous oral dosing, CT0h = CT24h Free Payload concentrations in tumor, normal tissues and blood were measured at multiple time points after 7-day continuous dose of Payload alone (1 mg/kg, PO) in the HPAC (KRAS G12D) CDX model 0 4 8 12 16 20 24 1 10 100 1000 Tissue Distribution over time Time after 7th dosing (hr) Payload conc. (ng/g or ng/mL) Blood (1.0x) Tumor (2.1x)1 Ear (2.8x)1 Skin (2.9x)1 Liver (12x)1 Kidney (8.1x)1 Colon (14x)1 Spleen (4.1x)1 Lung (4.9x)1 Heart (1.6x)1 blood tumor blood tumor
27 AN4035 Exhibited Compelling Activity in Single-Mouse PDX Trials 27 The response was determined by comparing tumor volume change at time t to its baseline with ΔRTV = (Vt-V0) / V0 × 100; Criteria for response were adapted from RECIST clinical criteria; Complete Response (CR): at least an 85% decrease in the tumor volume compared to baseline; Partial Response (PR):At least a 30% decrease in the tumor volume compared to baseline; Progressive Disease (PD):At least a 20% increase in the tumor volume compared to baseline; Stable Disease (SD):Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD; ORR, overall response rate (CR+PR); DCR, disease control rate (CR+PR+SD); PDX, patient-derived xenograft Indication CR PR SD PD ORR DCR CRC 1 8 2 0 82% 100% PDAC 0 6 0 1 86% 86% NSCLC 3 1 0 4 50% 50% Total 4 15 2 5 73% 81% H-score (membrane) H-score (cytoplasma) mRNA PDX, patient-derived xenograft AN4035 10 mpk QW Source: AN4035 Late-Breaking Oral Presentation, 2025 AACR-NCI-EORTC International Conference: Molecular Targets and Cancer Therapeutics.
28 0 7 14 21 28 0.1 1 10 100 1000 CB17-SCID mouse Time after drug injection(day) Plasma Conc. (ug/mL) CEACAM5 mAb AN4035 AN4035 Demonstrated Favorable PK and Tolerability in Monkeys AN4035 showed an antibody-like PK profile, comparable to CEACAM5 mAb in mice1 Compound Dose C0 (μg/mL) AUC (h*μg/mL) T1/2 (day) AN4035 3 mg/kg, IV 72 13832 8.2 CEACAM5 mAb 3 mg/kg, IV 71 17218 9.7 AN4035 achieved high exposure with good tolerability (no skin or GI toxicities) in monkey1, 2 1) total antibody in plasma; total antibody and payload concentration was measured in plasma and whole blood, respectively; 2) PK data from one monkey after the second AN4035 administration were excluded due to ADA development 0 7 14 21 28 35 42 49 0.0001 0.001 0.01 0.1 1 10 100 1000 10000 Repeated doses in Monkey (AN4035 30 mg/kg x 2) Time after first dose injection(day) Drug Conc. (μg/mL) AN4035 Payload Compound Dose C0 (μg/mL) AUC (h*μg/mL) T1/2 (day) AN4035 30 mg/kg, IV 942 60377 3.3 Payload 0.038 5.40 4.3 AN4035 HNSTD has not been reached at 30 mpk Source: AN4035 Late-Breaking Oral Presentation, 2025 AACR-NCI-EORTC International Conference: Molecular Targets and Cancer Therapeutics.
29 Summary of AN4035 AN4035 is a potential first-in-class CEACAM5-targeting ADC armed with a highly potent pan-RAS(ON) inhibitor payload: • Favorable thermal and plasma stability with desirable pharmacokinetic properties • Strong intracellular payload retention, driving nanomolar to picomolar cytotoxicity in CEACAM5-positive/RAS-addicted cancer cell lines, along with a potent bystander-killing effect • Robust anti-tumor activity with deep regression in CEACAM5-positive/RAS-addicted CDX and PDX models, as monotherapy or in combination • Enhanced target-mediated tumor retention versus payload alone, with significantly improved tumor selectivity over normal tissues • Favorable therapeutic index in cynomolgus monkeys IND submission is on track to be completed by mid-2026