Nasus Pharma Ltd F-1/A, filed Aug 7, 2025

Nasus Pharma Ltd (NSRX)

F-1/A 2025-08-07

View Original

Added on October 17, 2026

Search and read filings like this one from Claude or ChatGPT with the SEC filings MCP server →

State of Israel		2834		Not Applicable
(State or other jurisdiction of incorporation or organization)		(Primary Standard Industrial Classification Code Number)		(I.R.S. Employer Identification Number)

	Per Share	Total
Initial public offering price	$	$
Underwriting discounts and commissions ⁽¹⁾	$	$
Proceeds to us (before expenses)	$	$

	Page
Prospectus Summary	1
Risk Factors	8
Cautionary Note Regarding Forward-Looking Statements	59
Listing Details	61
Use of Proceeds	62
Dividend Policy	63
Capitalization	64
Dilution	66
Management’s Discussion and Analysis of Financial Condition and Results of Operations	68
Business	77
Management	124
Beneficial Ownership of Principal Shareholders and Management	147
Related Party Transactions	148
Description of Share Capital and Governing Documents	150
Shares Eligible for Future Sale	154
Taxation	156
Underwriting	163
Expenses	172
Legal Matters	173
Experts	174
Enforceability of Civil Liabilities	174
Where You Can Find Additional Information	175
Index of Financial Statements	F-1

	●	We have not generated revenues from our continued activities, have incurred significant losses since our inception and anticipate that we will continue to incur significant losses for the foreseeable future, and we may never achieve or maintain profitability, which raise a substantial doubt about our ability to continue as a going concern and could prevent us from obtaining new financing on reasonable terms or at all.
	●	We are a clinical stage pharmaceutical company and we have incurred significant operating losses since our inception and anticipate that we will incur continued losses for the foreseeable future.
	●	Notwithstanding our legacy product and business activity, we have not generated revenue from any product candidate and may never be profitable, even if we receive regulatory approval to commercialize our products.
	●	We do not believe that our current cash on hand will be sufficient to fund our projected operating requirements. This raises substantial doubt about our ability to continue as a going concern.
	●	We have identified material weaknesses in our internal control over financial reporting. If our remediations are not effective, or if we experience additional material weaknesses in the future or otherwise fail to maintain an effective system of internal controls in the future, we may not be able to accurately or timely report our financial conditions or results or operations, or prevent fraud, which may adversely affect investor confidence in our Company and as a result, the market price of our Ordinary Shares.

	●	We depend substantially on the success of our proprietary intranasal powder product candidates. We cannot give any assurance that any of our product candidates will receive regulatory approval, which is necessary before they can be commercialized.
	●	All of our product candidates are in various stages of clinical development. Clinical drug development is a lengthy and expensive process with uncertain timelines and uncertain outcomes. If clinical trials of our product candidates are prolonged, delayed or not commercially viable, we or our collaborators may be unable to obtain required regulatory approvals, and therefore may be unable to commercialize our product candidates on a timely basis or at all, which will adversely affect our business.
	●	The denial of regulatory approval for NS002 could mean that we need to delay or even cease operations, and a delay in obtaining such approval would delay commercialization of our products and adversely impact our ability to generate revenue, business and results of operations.
	●	The results of pre-clinical studies, early-stage clinical trials, data obtained from real-world use, and published third-party studies may not be indicative of results in future clinical trials and we cannot assure you that any planned or future clinical trials will lead to results sufficient for the necessary regulatory approvals.
	●	We or others could discover that NS002, NS001, or any product candidate we may pursue in the future (including current pre-clinical programs) lacks sufficient efficacy, or that it causes undesirable side effects that were not previously identified, which could delay or prevent regulatory approval or commercialization.
	●	Our clinical trials or the clinical trials of any of our current or potential future partners may encounter delays, suspensions or other problems.
	●	Even if we obtain regulatory approval for a product candidate, our products will remain subject to ongoing regulatory oversight.

	●	We are dependent on manufacturers for Naloxone and Epinephrine. Any delay, price increase or unavailability of our manufacturers could materially adversely affect our ability to conduct clinical trials and, if this were to occur after we obtained commercialization and marketing approval, could materially impact our operations.
	●	We rely on a limited number of suppliers or, in some cases, single suppliers, for some of our laboratory instruments and materials and may not be able to find replacements or immediately transition to alternative suppliers on a cost-effective basis, or at all.
	●	We rely on third parties to conduct our pre-clinical and clinical studies and perform other tasks for us. If these third parties do not successfully carry out their contractual duties, meet expected deadlines or comply with regulatory requirements, we may not be able to obtain regulatory approval for or commercialize our product candidates and our business could be substantially harmed.
	●	We have limited manufacturing experience and could experience production problems that result in delays in our development or commercialization programs or otherwise adversely affect our business. We currently have no manufacturing facilities and anticipate reliance on third-party manufacturers for our products.

	●	We own several issued patents but may require filing of additional patents in the future. There can be no assurance that all or some of our patent applications will result in issued patents. Consequently, our ability to protect our proprietary technology in the marketplace beyond the intellectual property already protected by our currently issued patents may be limited.
	●	Our proprietary position for our product candidates currently depends upon patents protecting the method of use, which may not prevent a competitor or other third party from using the same product candidate for another use.
	●	Even if our patents are issued, because the patent status of pharmaceutical products can be complex and uncertain, we cannot predict the scope and extent of patent protection for our product candidates.
	●	We may not be able to enforce our intellectual property rights throughout the world.

	●	Our future success depends on our ability to retain key executives and to attract, retain and motivate qualified personnel.
	●	Our product candidates for which we intend to seek approval may face competition sooner than anticipated.
	●	We manage our business through a small number of employees and key consultants. We will need to significantly increase the size of our organization, and we may experience difficulties in managing growth.

	●	The market price of our Ordinary Shares may be highly volatile, and you may not be able to resell your shares at or above the initial public offering price.
	●	Sales of a substantial number of our Ordinary Shares in the public market by our existing shareholders could cause our share price to fall.
	●	Raising additional capital would cause dilution to our existing shareholders and may adversely affect the rights of existing shareholders.
	●	Our principal shareholders and management own a significant percentage of our Ordinary Shares and will be able to exert significant influence over matters subject to shareholder approval.
	●	Management will have broad discretion as to the use of the proceeds from this offering, and we may not use the proceeds effectively.

	●	We conduct our operations in Israel. Conditions in Israel, including the multi-front war Israel is facing, may affect our operations.
	●	We expect to be exposed to fluctuations in currency exchange rates, which could adversely affect our results of operations.
	●	The termination or reduction of tax and other incentives that the Israeli government provides to Israeli companies may increase our costs and taxes.

Issuer		Nasus Pharma Ltd.

Ordinary Shares issued and outstanding prior to this offering⁽¹⁾		7,362,906 Ordinary Shares

Ordinary Shares offered by us		1,250,000 Ordinary Shares⁽²⁾

Ordinary Shares to be outstanding after this offering⁽¹⁾		9,009,999 Ordinary Shares or 9,197,499 Ordinary Shares if the underwriters exercise in full the over-allotment option to purchase additional Ordinary Shares.

Over-allotment option		We have granted the underwriters an option for a period of up to 45 days to purchase, at the public offering price less underwriting discounts and commissions, up to 187,500 additional Ordinary Shares, to cover over-allotments, if any.

Underwriter’s Warrants		We will issue to Laidlaw & Company (UK) Ltd. and to Craft Capital Management LLC, the Underwriters, or their permitted designees, Underwriter’s Warrants, to purchase up to an aggregate amount of 37,500 Ordinary Shares (or up to 43,125 Ordinary Shares if the underwriters exercise their over-allotment option in full). The Underwriter’s Warrants will have an exercise price equal to $11.25, or 125% of the per Ordinary Share assumed public offering price of $9.00 per Ordinary Share, which is the midpoint of the price range set forth on the cover page of this prospectus, will be exercisable beginning on a date which is 180 days from the commencement of sales under the registration statement of which this prospectus forms a part and will expire four and a half years from such commencement of sales.

Use of proceeds		We expect to receive approximately $9.5 million in net proceeds from the sale of Ordinary Shares offered by us in this offering (approximately $11.1 million if the underwriters exercise their over-allotment option in full), based upon an assumed public offering price of $9.00 per Ordinary Share, which is the midpoint of the price range set forth on the cover page of this prospectus, and after deducting the underwriting discounts and commissions and estimated offering expenses payable by us. We intend to use the net proceeds from this offering for our research and development efforts as well as general and administrative corporate purposes, including working capital and capital expenditures. We currently expect that such use of the net proceeds from this offering would specifically support the development of our Intranasal Epinephrine program, including, manufacturing scale-up and additional Phase 2 studies. The amounts and schedule of our actual expenditures will depend on multiple factors. As a result, our management will have broad discretion in the application of the net proceeds of this offering. See “Use of Proceeds” for more information about the intended use of proceeds from this offering.

Lock Up		Our directors, executive officers and certain shareholders, including all 5% or greater shareholders, have agreed with the underwriters not to offer for sale, issue, sell, contract to sell, pledge or otherwise dispose of any of our Ordinary Shares or securities convertible into Ordinary Shares for a period of six (6) months commencing on the date of this prospectus. See “Underwriting.”

Risk factors		Investing in our securities involves a high degree of risk. You should read the “Risk Factors” section starting on page 8 of this prospectus for a discussion of factors to consider carefully before deciding to invest in the Ordinary Shares.

Proposed NYSE American symbol		We have applied to list the Ordinary Shares to be issued in this offering on the NYSE American under the symbol “NSRX”. This offering is contingent upon the Ordinary Shares being listed on the NYSE American. There is no assurance that such listing will be approved.

(1)	The actual number of Ordinary Shares that we will offer and that will be outstanding after this offering will be determined based on the actual public offering price.

(2)	The number of the Ordinary Shares to be outstanding immediately after this offering as shown above assumes that all of the Ordinary Shares offered hereby are sold, and is based on 7,362,906 ordinary shares, outstanding as of December 31, 2024. This number excludes:

	●	346,537 Ordinary Shares issuable upon the exercise of options, or share options, granted subsequent to December 31, 2024, at a weighted average exercise price of $6.05 per ordinary share;
	●	191,700 Ordinary Shares issuable upon the exercise of share options to directors, employees and consultants under our 2019 Incentive Option Plan, or the 2019 Plan, outstanding as of December 31, 2024, at a weighted average exercise price of $2.77, of which 180,201 were vested as of December 31, 2024; and
	●	184,612 Ordinary Shares reserved for future grants under the 2019 Plan as of August 7, 2025.

	●	an assumed initial public offering price of $9.00 per Ordinary Share, which is the midpoint of the price range set forth on the cover page of this prospectus;
	●	the automatic conversion of all outstanding existing classes of ordinary shares, including Class A, Class A-1, Class A-2, Class A-3, Class A-3A, Class A-3B ordinary shares into 2,592,496 Ordinary Shares, which will occur upon the effectiveness of the registration statement for this offering;
	●	397,081 Ordinary Shares issuable upon the conversion of the Simple Agreements for Future Equity, or the SAFEs, entered into between March 2024 and March 2025, or, collectively, the 2024 SAFEs, in the aggregate amount of $2,322,922, which will automatically convert into Ordinary Shares upon the effectiveness of the registration statement for this offering, based on an assumed public offering price of $9.00, which is the midpoint of the price range set forth on the cover page of this prospectus, assuming this offering occurs within 18 months of the execution of such SAFEs, otherwise such SAFEs will be converted into our securities on the basis of a previous round of equity financing consummated by the Company;
	●	the adoption of our amended and restated articles of association upon the effectiveness of the registration statement for this offering (except that, where Ordinary Shares as of a date prior to the effectiveness of this registration statement are mentioned, the par value of our ordinary shares is NIS 0.01 per share), which will replace our amended and restated articles of association as currently in effect;
	●	no exercise of the underwriters’ over-allotment option and the Underwriter’s Warrants; and
	●	a 1-for-4.77008 forward share split, which was effected on August 6, 2025, and the customary adjustments to our outstanding options and warrants;

	Year Ended December 31,
U.S. dollars in thousands, except share and per share data	2024			2023
Consolidated statements of operations:
Operating expenses:
Research and development⁽¹⁾	$	335		$	567
General and administrative⁽²⁾		743			580
Total operating expenses		1,078			1,147
Operating loss from continuing operations		(1,078	)		(1,147	)

Interest expense⁽³⁾		(29	)		(49	)
Change in fair value of convertible securities		(443	)		219
Other expenses, net		(2	)		(28	)
Loss from continuing operations		(1,552	)		(1,005	)
Net income (loss) from discontinued operations		20			(46	)
Net loss	$	(1,532	)	$	(1,051	)

Per share data:
Loss per share attributable to shareholders:
Basic	$	(0.22	)	$	(0.15	)
Diluted		(0.22	)	$	(0.20	)
Weighted average ordinary shares outstanding - basic		7,027,725			6,889,708
Weighted average ordinary shares outstanding - diluted		7,027,725			7,057,820

	As of December 31, 2024
U.S. dollars in thousands	Actual			Pro Forma ⁽¹⁾			**Pro Forma As Adjusted ⁽²⁾**
Consolidated Balance Sheet Data:				Unaudited

Cash and cash equivalents	$	284			969			11,319
Total assets		717			1,402			11,492
Convertible securities		1,802			-			-
Total current liabilities		3,929			2,127			2,127
Accumulated deficit		(12,664	)		(12,664	)		(12,664	)
Total shareholders’ deficit		(3,212	)		(725	)		9,365

(1)	Research and development expenses includes $208 thousand and $228 thousand in expenses to related parties in the years ended December 31, 2024 and 2023, respectively.
(2)	General and administrative expenses includes $307 thousand and $288 thousand in expenses to related parties in the years ended December 31, 2024 and 2023, respectively.
(3)	Interest expenses includes $17 thousand and $27 thousand in expenses to related parties in the years ended December 31, 2024 and 2023, respectively.

	●	continue the research and development of our product candidates;
	●	expand the scope of our current clinical studies for our product candidates;
	●	seek regulatory and marketing approvals for our product candidates that successfully complete clinical studies;
	●	establish a sales, marketing, and distribution infrastructure to commercialize our product candidates;
	●	seek to identify, assess, acquire, license, and/or develop other product candidates and subsequent generations of our current product candidates;
	●	seek to maintain, protect, and expand our intellectual property portfolio;
	●	seek to attract and retain skilled personnel; and
	●	create additional infrastructure to support our operations as a public company and our product candidate development and planned future commercialization efforts.

	●	obtaining favorable results from and progress the pre-clinical and clinical development of our product candidates, including Intranasal Epinephrine, Intranasal Naloxone and other current or future product candidates;
	●	developing and obtaining regulatory approval for registration studies protocols for our product candidates, including Intranasal Epinephrine, Intranasal Naloxone and other current or future product candidates;
	●	subject to successful completion of registration and clinical trials of Intranasal Epinephrine, Intranasal Naloxone and other current or future product candidates, applying for and obtaining marketing approval;
	●	establishing and maintaining supply and manufacturing relationships with third parties that can provide adequate (in amount and quality) products, and at acceptable costs, to support market demand for our product candidates, if marketing approval is received;
	●	identifying, assessing, acquiring and/or developing new product candidates;
	●	accurately identifying demand for our product candidates;
	●	continued consumer interest in treatments for products for intranasal drug delivery;
	●	obtaining market acceptance of our product candidates, if approved for marketing, as viable treatment options;
	●	negotiating favorable terms in any collaboration, licensing or other arrangements into which we may enter;
	●	obtaining and maintaining CIV labeling (no FDA-imposed boxed warning, commonly referred to as a “Black Box” warning) of our lead product candidates, Intranasal Epinephrine, Intranasal Naloxone and other current or future product candidates;
	●	establishing and nurturing relationships with the leading physicians in the United States; and
	●	attracting, hiring and retaining qualified personnel.

	●	our clinical trial results;
	●	the cost, timing and outcomes of seeking marketing approval of Intranasal Epinephrine, Intranasal Naloxone and other current or future product candidates;
	●	the cost of filing and prosecuting patent applications and the cost of defending our patents;
	●	the cost of prosecuting patent infringement actions against third parties;
	●	development of other early-stage development product candidates;
	●	the costs associated with commercializing Intranasal Epinephrine or any other product candidate, if we receive marketing approval, including the cost and timing of establishing sales and marketing capabilities to market and sell such product candidates;
	●	subject to receipt of marketing approval, revenue received from sales of approved products, if any, in the future;
	●	any product liability or other lawsuits related to our products;
	●	the expenses needed to attract and retain skilled personnel; and
	●	the costs associated with being a public company.

	●	create or permit to subsist any security interest over any of our assets;
	●	sell, transfer or otherwise dispose of any or our assets on recourse terms;
	●	pay dividends;
	●	buy back our own securities;
	●	incur or permit additional indebtedness;
	●	merge or conduct any other corporate reconstruction; and
	●	change the nature of our business.

	●	successful completion of nonclinical studies and clinical trials;
	●	successful patient enrollment in clinical trials;
	●	successful data from our nonclinical studies and clinical trials that support an acceptable risk-benefit profile of our product candidates in the intended populations and indications;
	●	satisfaction of applicable regulatory requirements, including to satisfy applicable rules governing combination products;
	●	potential unforeseen safety issues or adverse side effects;
	●	receipt and maintenance of marketing approvals from applicable regulatory authorities;
	●	remaining in compliance with post-marketing regulatory requirements;
	●	obtaining and maintaining patent and trade secret protection and regulatory exclusivity for our product candidates;

	●	making arrangements or maintaining existing arrangements with third-party manufacturers, or establishing manufacturing capabilities, for both clinical and commercial supplies of our product candidates;
	●	entry into collaborations to further the development of NS002, NS001 or any future product candidates;
	●	establishing sales, marketing and distribution capabilities and launching commercial sales of any approved products, whether alone or in collaboration with others;
	●	successfully launching commercial sales of our product candidates, if and when approved;
	●	acceptance of our product candidates, if and when approved, by patients, the medical community and third-party payors;
	●	obtaining and maintaining third-party coverage and adequate reimbursement;
	●	products, following approval, maintaining a continued acceptable safety profile;
	●	effectively competing with other therapies;
	●	ensuring that we promote and distribute our products consistent with all applicable healthcare laws; and
	●	enforcing and defending intellectual property rights and claims.

	●	difficulties obtaining regulatory approval to commence a clinical trial or complying with conditions imposed by a regulatory authority regarding the scope or term of a clinical trial;
	●	delays in reaching or failing to reach agreement on acceptable terms with prospective contract research organizations, or CROs, and trial sites, the terms of which can be subject to extensive negotiation and may vary significantly among different CROs and trial sites;
	●	insufficient or inadequate supply or quality of a product candidate or other materials necessary to conduct our clinical trials;
	●	if the FDA or EMA elect to enact policy changes, as a result of the COVID-19 pandemic or otherwise;
	●	difficulties obtaining institutional review board, or IRB, approval to conduct a clinical trial at a prospective site; and
	●	challenges recruiting and enrolling patients to participate in clinical trials for a variety of reasons, including fears resulting from the COVID-19 pandemic or due to government actions enacted and as a result of such pandemic, size and nature of patient population, proximity of patients to clinical sites, eligibility criteria for the trial, nature of trial protocol, the availability of approved effective treatments for the relevant disease and competition from other clinical trial programs for similar indications.

	●	failure to conduct the clinical trial in accordance with regulatory requirements or our clinical protocols;
	●	inspection of the clinical trial operations or trial sites by the FDA or other regulatory authorities;
	●	unforeseen safety issues or lack of effectiveness; and
	●	lack of adequate funding to continue the clinical trial.

	●	regulatory authorities may withdraw their approval of the product;

	●	we may be required to recall the product, change the way this product is administered, conduct additional clinical trials or change the labeling or distribution of the product;

	●	additional restrictions may be imposed on the marketing of, or the manufacturing processes for, the product;

	●	we may be subject to fines, injunctions or the imposition of civil or criminal penalties;

	●	we could be sued and held liable for harm caused to patients;

	●	the product may be rendered less competitive and sales may decrease; or

	●	our reputation may suffer generally both among clinicians and patients.

	●	we may not be able to demonstrate to their satisfaction that the product candidate is a safe or effective treatment for a given indication;
	●	the results of clinical trials may not meet the level of statistical significance or clinical significance required by the regulatory agencies;
	●	disagreements regarding the number, design, size, conduct or implementation of our clinical trials, or with our interpretation of data from pre-clinical studies or clinical trials;
	●	a lack of acceptance of the accuracy or sufficiency of the data generated at our clinical trial sites to demonstrate, among others, that clinical and other benefits outweigh its safety risks or to support the submission of an NDA or MAA;
	●	difficulties scheduling an advisory committee meeting in a timely manner or the advisory committee, or such other similar committee, may recommend against approval of our application or may recommend that such regulators require, as a condition of approval, additional pre-clinical studies or clinical trials, limitations on approved labeling, or distribution and use restrictions;
	●	the requirement that we develop a Risk Evaluation and Mitigation Strategy, or REMS, as a condition of approval, which may or may not be feasible for us;
	●	the identification of deficiencies in the manufacturing processes or facilities of third-party manufacturers with which we enter into agreements for clinical and commercial supplies;
	●	changes in approval policies or the adoption of new regulations by such regulators; and
	●	we may be unable to be granted a pediatric investigation plan, or PIP, deferral which we intend to request from the EMA for delayed clinical trials and subsequent approval in children; this may delay our clinical trial program or approvals for adults, or we may have successful clinical trial results for adults but not children (if we were required to conduct pediatric studies prior to the receipt of an NDA or MMA for use of our product candidates in adults), or vice versa.

	●	regulatory authorities may suspend or withdraw approvals of such a product candidate;
	●	regulatory authorities may require additional warnings on the label;
	●	regulatory authorities may issue negative publicity regarding the affected product, including safety communications;
	●	we may be required to change the way the product is distributed, dispensed or administered, or conduct additional pre-clinical studies or clinical trials;
	●	we may need to voluntarily recall our products; and
	●	we could be sued and held liable for harm caused to patients.

	●	issue an untitled letter or warning letter that we are in violation of the law;
	●	seek an injunction or impose administrative, civil or criminal penalties or monetary fines;
	●	suspend or withdraw regulatory approval;
	●	suspend any ongoing clinical trials;
	●	refuse to approve pending applications or supplements to applications;
	●	restrict the marketing or manufacturing of the product;
	●	seize or detain the products or require the withdrawal of the product from the market;
	●	refuse to permit the import or export of the products; or
	●	refuse to allow us to enter into supply contracts, including government contracts.

	●	different regulatory requirements for drug approvals in foreign countries;
	●	differing United States and foreign drug import and export rules, tariffs and other trade barriers;
	●	reduced protection for intellectual property rights in foreign countries;
	●	failure by us to obtain regulatory approvals for the use of our products in various countries;
	●	different reimbursement systems;
	●	economic weakness, including inflation, or political instability in particular foreign economies and markets;
	●	multiple, conflicting and changing laws and regulations such as privacy regulations, tax laws, export and import restrictions, employment laws, regulatory requirements and other governmental approvals, permits and licenses;

	●	complexities associated with managing multiple payor reimbursement regimes, government payors or patient self-pay systems;
	●	financial risks, such as longer payment cycles, difficulty collecting accounts receivable, the impact of local and regional financial crises on demand and payment for our products and exposure to foreign currency exchange rate fluctuations, which could result in increased operating expenses and reduced revenues;
	●	workforce uncertainty in countries where labor unrest is more common than in the United States;
	●	production shortages resulting from any events affecting raw material supply or manufacturing capabilities abroad;
	●	regulatory and compliance risks that relate to maintaining accurate information and control over sales and activities that may fall within the purview of the U.S. Foreign Corrupt Practices Act, or FCPA, its books and records provisions or its anti-bribery provisions;
	●	potential liability resulting from development work conducted by these distributors; and
	●	business interruptions resulting from a local or worldwide pandemic, such as COVID-19, geopolitical actions, including war and terrorism, or natural disasters.

	●	the efficacy and safety of the product;
	●	the potential advantages of the product compared to available therapies;
	●	the convenience and ease of administration compared to alternative treatments;
	●	limitations or warnings, including use restrictions contained in the product’s approved labeling;
	●	distribution and use restrictions imposed by the EMA, FDA or other regulatory authority or agreed to by us as part of a mandatory or voluntary risk management plan;
	●	pricing and cost effectiveness in relation to alternative treatments;
	●	if the product is included under physician treatment guidelines as a first-, second,- or third-line therapy;
	●	the strength of sales, marketing and distribution support;
	●	the availability of third-party coverage and adequate reimbursement and the willingness of patients to pay out-of-pocket in the absence of coverage by third-party payors;
	●	the strength of sales, marketing and distribution support;
	●	the willingness of patients to pay for drugs out of pocket in the absence of third-party coverage; and
	●	the willingness of the target patient population to try new therapies and of physicians to prescribe these therapies.

	●	decreased demand for our product candidates;
	●	termination of clinical trial sites or entire trial programs;
	●	injury to our reputation and negative media attention;
	●	product recalls or increased warnings on product labels;
	●	withdrawal of clinical trial participants;
	●	costs of to defend the related litigation;
	●	diversion of management and our resources;
	●	substantial monetary awards to, or costly settlements with, clinical trial participants, patients or other claimants;
	●	higher insurance premiums;
	●	loss of initiation of investigations by regulators or other authorities; and
	●	the inability to successfully commercialize our product candidates, if approved.

	●	changes to manufacturing methods;

	●	change in protocol design;

	●	additional treatment arm (control);

	●	recall, replacement, or discontinuance of one or more of our products; and

	●	additional recordkeeping.

	●	untitled letters or warning letters;
	●	fines, injunctions, consent decrees and civil penalties;
	●	recalls, termination of distribution, administrative detention, or seizure of our products;
	●	customer notifications or repair, replacement or refunds;
	●	operating restrictions or partial suspension or total shutdown of production;
	●	delays in or refusal to grant our requests for future clearances or approvals or foreign marketing authorizations of new products, new intended uses, or modifications to existing products;
	●	withdrawals or suspensions of product clearances or approvals, resulting in prohibitions on sales of our products;
	●	FDA refusal to issue certificates to foreign governments needed to export products for sale in other countries; and criminal prosecution.

	●	any issued patents may not be broad or strong enough to prevent competition by other drug products including identical or similar drug products;
	●	if we are not issued patents or if issued patents expire, there would be no protection against competitors making generic equivalents;
	●	there may be prior art of which we are not aware that may affect the validity or enforceability of a patent claim throughout the patent term;
	●	there may be other patents existing, now or in the future, in the patent landscape for PBI products, or any other product candidates that we seek to commercialize or develop, if any, that will affect our freedom to operate;
	●	if our patents are challenged, a court could determine that they are not valid or enforceable;
	●	a court could determine that a competitor’s technology or product does not infringe our patents;
	●	a court could determine we infringe a competitor’s patents;
	●	our patents could irretrievably lapse due to failure to pay fees or otherwise comply with regulations, or could be subject to compulsory licensing; and
	●	if we encounter delays in our development or clinical trials, the period of time during which we could market our products under patent protection would be reduced.