Matinas BioPharma Holdings, Inc 10-K for FY2025

Matinas BioPharma Holdings, Inc. (MTNB)

10-K 2026-03-31 For: 2025-12-31

Added on April 06, 2026

About this 10-K

Matinas BioPharma Holdings, Inc filed this 10-K on March 31, 2026, covering the fiscal year ended December 31, 2025 (FY2025).

Headline figures

Fiscal year ended December 31, 2025, as reported in this filing, compared with the same period a year earlier where the filing states it.

Net loss: $10.35M; compared with a net loss of $24.25M a year earlier
Diluted EPS: -$2.00; compared with -$4.98 a year earlier

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Title of Each Class		Trading Symbol		Name of Each Exchange on Which Registered
Common Stock, par value $0.0001		MTNB		NYSE American

Large accelerated filer	☐	Accelerated filer	☐

Non-accelerated filer	☒	Smaller reporting company	☒

		Page
PART I		2
Item 1.	Business	2
Item 1A.	Risk Factors	24
Item 1B.	Unresolved Staff Comments	55
Item 1C.	Cybersecurity	55
Item 2.	Properties	56
Item 3.	Legal Proceedings	56
Item 4.	Mine Safety Disclosures	56
PART II		56
Item 5.	Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities	56
Item 6.	[Reserved]	56
Item 7.	Management’s Discussion and Analysis of Financial Condition and Results of Operations	57
Item 7A.	Quantitative and Qualitative Disclosures About Market Risk	63
Item 8.	Financial Statements and Supplementary Data	63
Item 9.	Changes in and Disagreements With Accountants on Accounting and Financial Disclosure	63
Item 9A.	Controls and Procedures	63
Item 9B.	Other Information	64
Item 9C.	Disclosure Regarding Foreign Jurisdictions that Prevent Inspections	64
PART III		65
Item 10.	Directors, Executive Officers and Corporate Governance	65
Item 11.	Executive Compensation	68
Item 12.	Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters	72
Item 13.	Certain Relationships, Related Transactions, and Director Independence	75
Item 14.	Principal Accounting Fees and Services	76
PART IV		77
Item 15.	Exhibits and Financial Statement Schedules	77
Item 16.	Form 10-K Summary	79
Financial Statements		F-1

●	our ability to complete one or more strategic transactions that will maximize our asset or otherwise provide value to stockholders;

●	our ability to raise capital when needed;

●	our history of operating losses in each year since inception and the expectation that we will continue to incur operating losses for the foreseeable future;

●	our ability to maintain compliance with the continued listing requirements of the NYSE American LLC (the “NYSE American”);

●	our ability to maintain or protect the validity of our patents and other intellectual property; and

●	other risks and uncertainties, including those listed under the caption “Risk Factors.”

	●	In February 2024, we announced agreement with the FDA on the design of a single Phase 3 registration trial of MAT2203 in patients with invasive aspergillosis who have limited treatment options, including consensus on all critical elements of the ORALTO trial.

	●	In March 2024, we announced that we would require either (i) the consummation of a partnership transaction, or (ii) raising significant additional capital, prior to commencing the ORALTO trial. We continued to support (a) the ongoing MAT2203 Compassionate/Expanded Use Access Program, (b) all MAT2203 regulatory requirements, (c) the prosecution and maintenance of all intellectual property relevant to MAT2203 and the LNC Platform and (d) the early stage research and development of other applications of the LNC Platform in the oncology and inflammation spaces.

	●	On April 2, 2024, we announced entry into a securities purchase agreement (the “April 2024 Purchase Agreement”), with certain institutional investors. The April 2024 Purchase Agreement provided for the sale and issuance by the Company of (i) 666,667 shares of common stock and warrants (the “April 2024 Warrants”) to purchase up to 666,667 shares of common stock. The offering price per share and accompanying warrant was $15.00. The April 2024 Warrants have an exercise price of $17.50, were exercisable beginning October 2, 2024 and expire on the five-and-a-half year anniversary of the date of issuance, or October 5, 2029. The offering resulted in gross proceeds to the Company of approximately $10 million before deducting placement agent’s fees and related offering expenses.

	●	On August 20, 2024, pursuant to the NYSE American’s Compliance Guidance Memo which requires ten calendar days public notice for certain corporate actions, we announced that our Board of Directors (the “Board”) approved a reduction in the total number of authorized shares of our common stock from 500,000,000 to 250,000,000 (the “Authorized Share Reduction”) and a reverse stock split of the common stock at a ratio of one-for-fifty (1:50) (the “Reverse Stock Split”), which would become effective at 5:00PM (EST) on August 30, 2024.

	●	On August 27, 2024, we received notice that trading of our shares of common stock had been halted by the NYSE American due to its low trading price. The trading halt remained in effect until after we consummated the communicated reverse stock split of the common stock and the market opened on September 3, 2024.

	●	On August 30, 2024, the Authorized Share Reduction and the Reverse Stock Split became effective at 5:00 P.M. (EST) and the shares of our common stock began trading on the split-adjusted basis under the Company’s existing trading symbol, “MTNB,” when the market opened on September 3, 2024.

	●	On October 31, 2024, we announced that negotiations under a non-binding term sheet with a single partner for global licensing rights to develop, manufacture and commercialize MAT2203 for all future treatment indications (the “MAT2203 Term Sheet”), including the intended initial indication of treatment for patients with invasive aspergillosis with limited or no other treatment options, were terminated following notification from the perspective partner for reasons unrelated to MAT2203. As a result, we implemented an immediate 80% workforce reduction, eliminating 15 positions, including three members of senior management, and ceased certain product development activities to preserve cash while we evaluated a potential sale of MAT2203 and/or other strategic alternatives, including a potential winddown or dissolution of the Company.

	●	On January 10, 2025, we announced that we received a deficiency letter (the “January 2025 NYSE Notice”) from the NYSE American stating that the Company failed to hold an annual meeting of stockholders during the fiscal year ended December 31, 2024, as required by Section 704 of the NYSE American Company Guide. The January 2025 NYSE Notice had no immediate impact on the listing of our common stock, which continued to be listed and traded on the NYSE American during the applicable cure period but was assigned a “.BC” indicator by the NYSE American to indicate that the Company was below compliance. We received a letter from the NYSE American on June 23, 2025 that we had resolved the deficiency set forth in the January 2025 NYSE Notice by virtue of holding our Annual Meeting for the fiscal year ended December 31, 2023 on June 23, 2025. As a result, the BC indicator was removed from our stock symbol.

	●	On February 13, 2025, we entered into a securities purchase agreement (the “February 2025 Agreement”) with a certain group of investors (the “February 2025 Investors”), pursuant to which they agreed to purchase from the Company 3,300 shares of our Series C Convertible Preferred Stock, par value $0.0001 per share (the “Preferred Stock”), and warrants to purchase up to 11,262,808 shares of common stock (the “2025 Warrants”) at a purchase price of $1,000 per share of Preferred Stock and accompanying 2025 Warrants, for aggregate gross proceeds of $3.3 million before deducting offering expenses payable by the Company. The February 2025 Investors purchased 1,650 shares of Preferred Stock and accompanying 2025 Warrants to purchase up to 5,631,404 shares of common stock for gross proceeds to the Company of $1.65 million at an initial closing on February 13, 2025. Subject to the satisfaction of certain closing conditions, the February 2025 Investors purchased an additional 1,650 shares of Preferred Stock and accompanying 2025 Warrants to purchase up to 5,631,404 shares of common stock for gross proceeds to the Company of $1.65 million at a second closing on April 8, 2025. The shares of Preferred Stock are convertible into common stock at a conversion price of $0.586, and each share of Preferred Stock is initially convertible into 1,706 shares of common stock. The 2025 Warrants have an exercise price of $0.6446 per share. The 2025 Warrants purchased in the initial closing became exercisable on April 4, 2025, the effective date of the approval by our stockholders of the Stock Issuance Proposal (as defined below) (the “Shareholder Approval”) and will expire five years from the effective date of the Shareholder Approval, or April 4, 2030. The 2025 Warrants purchased in the second closing were immediately exercisable and will expire on April 8, 2030. In connection with the February 2025 Agreement, Dr. Robin L. Smith, MD, MBA was appointed to the Board.

	●	On March 3, 2025, we filed a Notice of Special Meeting of Stockholders to be held on April 4, 2025 (the “Special Meeting). At the Special Meeting, stockholders approved: (1) for purposes of complying with the applicable provisions of Section 713 of the NYSE American Company Guide (a) the issuance of up to an aggregate of 16,894,212 shares of common stock upon the conversion of the Preferred Stock and the exercise of the 2025 Warrants (the “Stock Issuance Proposal”), and (b) the terms thereof, which may constitute a “Change of Control” as defined in the NYSE American Company Guide; and (2) ratified the appointment of EisnerAmper LLP as our independent registered public accounting firm for the year ended December 31, 2025.

	●	On April 30, 2025, we amended our bylaws to reduce the quorum requirement for stockholders meetings from a majority to one-third of the voting power of the outstanding shares of capital stock entitled to vote at such meeting.

	●	On June 23, 2025, at our annual meeting of stockholders, our stockholders approved (i) an amendment to our Certificate of Incorporation, as amended (the “Certificate of Incorporation”), to effect up to two reverse stock splits of our common stock having an aggregate ratio in the range of 1-for-2 to 1-for-199 over a period of two years, with such reverse stock splits to be effected at such ratios, times and dates, if at all, as determined by the Board in its sole discretion, (ii) an amendment to our Certificate of Incorporation to increase the number of our authorized shares of common stock from 250,000,000 shares to 500,000,000 and to make a corresponding change to the number of authorized shares of capital stock and (iii) our 2025 Equity Incentive Plan.

	●	On August 6, 2025, we filed a Certificate of Amendment to our Certificate of Incorporation with the Secretary of State of the State of Delaware to increase the number of authorized shares of common stock from 250,000,000 shares to 500,000,000 shares. The Certificate of Amendment was approved by the Company’s stockholders at the annual meeting on June 23, 2025 and became effective upon filing.

	●	On August 15, 2025, we entered into Warrant Exchange Agreements (the “Exchange Agreements”) with certain holders (the “Exchanging Holders”) of April 2024 Warrants to purchase an aggregate of 466,666 shares of common stock. Pursuant to the Exchange Agreements, on August 15, 2025, the Company issued to the Exchanging Holders one share of common stock for each April 2024 Warrant, for an aggregate of 466,666 shares of common stock.

	(a)	demonstration of superiority of oral-step down treatment with MAT2203 compared with AmBisome for treatment-related toxicities leading to changes in treatment (i.e., dose adjustment/discontinuations or changes to treatment regimens);

	(b)	long-term survival benefit of MAT2203 using all-cause mortality at study day 84;

	(c)	evaluation of the impact of MAT2203 on healthcare resource utilization and quality of life impact.

●	the patient has no other treatment options.

●	the invasive fungal infection is serious and/or life-threatening.

●	the patient is expected to benefit from oral MAT2203 treatment and can tolerate oral medication; and

●	the patient has a reasonable life expectancy, and their underlying conditions are under control.

●	Securing one or more partners to monetize the value of MAT2203 and raising additional non-dilutive capital through the licensing or sale of our lead LNC Platform product candidate. A partnership, whether through a license, sale or other transaction, would likely seek to advance MAT2203 into Phase 3 development as quickly as possible, which could position a partner to commercialize MAT2203 upon approval.

●	Conserving our cash resources while identifying and evaluating other strategic options for the Company, which could include the in-licensing of one or more assets or seeking a merger partner for the Company.

●	completion of nonclinical laboratory tests, animal studies and formulation studies in compliance with FDA’s good laboratory practice (cGLP), regulations;

●	submission to FDA of an investigational new drug applications (IND), which must take effect before human clinical trials may begin;

●	approval by an independent institutional review board (IRB) representing each clinical site before each clinical trial may be initiated;

●	performance of adequate and well-controlled human clinical trials in accordance with current good clinical practices (GCP), to establish the safety and efficacy of the proposed drug product for each indication;

●	preparation and submission to FDA of an NDA or BLA;

●	review of the product by an FDA advisory committee, where appropriate or if applicable;

●	satisfactory completion of one or more FDA inspections of the manufacturing facility or facilities at which the product, or components thereof, are produced to assess compliance with current Good Manufacturing Practices (cGMP), requirements and to assure that the facilities, methods and controls are adequate to preserve the product’s identity, strength, quality and purity;
●	payment of user fees and securing FDA approval of the NDA or BLA; and

●	compliance with any post-approval requirements, including a risk evaluation and mitigation strategy (REMS), and post-approval studies required by FDA.

●	restrictions on the marketing or manufacturing of the product, complete withdrawal of the product from the market or product recalls;

●	fines, warning or untitled letters or holds on post-approval clinical trials;

●	refusal of FDA to approve pending NDAs or supplements to approved NDAs, or suspension or revocation of product approvals;

●	product seizure or detention, or refusal to permit the import or export of products; or

●	injunctions or the imposition of civil or criminal penalties.

●	the required patent information has not been filed;

●	the listed patent has expired;

●	the listed patent has not expired, but will expire on a particular date and approval is sought after patent expiration; or

●	the listed patent is invalid, unenforceable or will not be infringed by the new product.

●	the federal False Claims Act imposes civil penalties, and provides for civil whistleblower or qui tam actions, against individuals or entities for knowingly presenting, or causing to be presented, to the federal government, claims for payment that are false or fraudulent or making a false statement to avoid, decrease or conceal an obligation to pay money to the federal government;

●	the HIPPA imposes criminal and civil liability for executing a scheme to defraud any healthcare benefit program or making false statements relating to healthcare matters;

●	HIPAA, as amended by the HITECH and its implementing regulations, also imposes obligations, including mandatory contractual terms, with respect to safeguarding the privacy, security and transmission of individually identifiable health information;

●	the federal false statements statute prohibits knowingly and willfully falsifying, concealing or covering up a material fact or making any materially false statement in connection with the delivery of or payment for healthcare benefits, items or services;
●	the federal transparency requirements under the ACA requires manufacturers of drugs to report to the Department of Health and Human Services information related to payments and other transfers of value to physicians and teaching hospitals and physician ownership and investment interests and the reported information will be made publicly available on a searchable website; and

●	analogous state and foreign laws and regulations, such as state anti-kickback and false claims laws, may apply to sales or marketing arrangements and claims involving healthcare items or services reimbursed by non-governmental third-party payors, including private insurers.

●	We have paused clinical development of our lead product candidate, MAT2203, and are devoting significant time and resources to identifying and evaluating strategic alternatives, which may not be successful.
●	We have incurred significant losses since our inception. We expect to incur losses for the foreseeable future and may never achieve or maintain profitability.
●	We will need substantial additional funding. If we are unable to raise capital when needed, we could be forced to delay, reduce or eliminate our product development programs or commercialization efforts.
●	Raising additional capital may cause dilution to stockholders, restrict operations or require us to relinquish rights to our technologies or product candidates.
●	Our operating history to date may make it difficult to evaluate the success of our business and assess our future viability.
●	We are early in our development efforts, which may not be successful.
●	We cannot market our product candidates without regulatory approval, and any delay in this process will harm our business
●	We depend in part on third-party technology, the loss of which could harm our business.
●	We may not have or be able to obtain sufficient quantities of our products to meet our supply and clinical studies obligations and our business, financial condition and results of operation may be adversely affected.
●	If we are unable to successfully commercialize our products our ability to generate revenue will be limited.
●	If our studies or trials produce negative results, are delayed, or identify serious side effects, we may face delays, additional costs, and be unable to commercialize our product candidates.
●	If we cannot enroll enough patients to complete our clinical trials, our business, financial condition and results of operations may be adversely affected.
●	We may not be able to maintain orphan drug designation or exclusivity for our anti-infective product candidates.
●	Fast Track designation or priority review status by the FDA may not speed up development, review, or approval, nor guarantee approval and our current or future product candidates may also treat indications that do not qualify for priority review vouchers.
●	Any breakthrough therapy designation granted by the FDA for our product candidates may not lead to a faster development or regulatory review or approval process, and it does not increase the likelihood that our product candidates will receive marketing approval.

●	Designation of our current or future product candidates as qualified infectious disease products is not assured and, in any event, even if granted, may not actually lead to a faster development or regulatory review, and would not assure FDA approval of our product candidates.
●	We may not obtain or maintain orphan drug, Fast Track, qualified infection disease, or breakthrough therapy designations for our product candidates and, even if granted, these designations may not speed up development or review and do not guarantee FDA approval.
●	If we are unsuccessful in identifying and developing additional product candidates, our potential for growth may be impaired.
●	We lack a sales and marketing organization. Without establishing these capabilities, we may not successfully commercialize our product candidates, even with regulatory approval.
●	If we cannot file for MAT2203 approval under Section 505(b)(2) of the FDCA or need additional safety and efficacy data, development and commercialization timelines may be delayed.
●	We face competition from other biotechnology and pharmaceutical companies and our operating results will suffer if we fail to compete effectively.
●	Even with marketing approval, we will face ongoing regulatory obligations and reviews, potentially incurring significant expenses. Our product candidates could face labeling restrictions, market withdrawal, and penalties for non-compliance or unforeseen issues.
●	Future legislation, and/or regulations and policies adopted by the FDA may increase the time and cost required for us to conduct and complete clinical trials.
●	Changes in health care law and implementing regulations may have a material adverse effect on us.
●	Our future growth depends, in part, on our ability to penetrate foreign markets, where we would be subject to additional regulatory burdens and other risks and uncertainties.
●	If we market our product candidates in a manner that violates healthcare fraud and abuse laws, or if we violate government price reporting laws, we may be subject to civil or criminal penalties.
●	Reductions in staffing and funding at FDA and other federal agencies could cause delays in the development and approval of our current or future product candidates.
●	We have been and expect to be significantly dependent on our collaborative agreements for the development of MAT2203, which exposes us to the risk of reliance on the performance of third parties.
●	We expect that we will rely on third parties to conduct clinical trials for our product candidates, which exposes us to the risk of reliance on the performance of third parties.
●	We will be completely dependent on third parties to manufacture MAT2203 and any future product candidates, and our commercialization efforts could be halted, delayed or made less profitable if those third parties fail to obtain manufacturing approval from the FDA or comparable foreign regulatory authorities, fail to provide us with sufficient quantities of any product candidate or fail to do so at acceptable quality levels or prices.
●	Unfavorable pricing regulations, third-party reimbursement practices or healthcare reform initiatives could harm our business.
●	Outbreaks of communicable diseases may materially and adversely affect our business, financial condition and results of operations.
●	Adverse global conditions, including economic uncertainty, may negatively impact our financial results.
●	We depend on certain technologies that are licensed to us. We do not control these technologies and any loss of our rights to them could prevent us from discovering, developing and commercializing product candidates.
●	It is difficult and costly to protect our intellectual property rights, and we cannot ensure the protection of these rights.
●	If we fail to obtain or maintain patent or trade secret protection for our technologies, third parties could use our proprietary information, which could impair our ability to compete in the market and adversely affect our ability to generate revenues and attain profitability.
●	Our product candidates may infringe the intellectual property rights of others, which could increase our costs and delay or prevent our development and commercialization efforts.
●	We will need to increase the size of our organization to grow our business, and we may experience difficulties in managing this growth.
●	If product liability lawsuits are brought against us, we may incur substantial liabilities and may be required to limit commercialization of our product candidates.
●	Our internal computer systems, or those of our CROs or other contractors or consultants, may fail or suffer security breaches, which could result in a material disruption of our product development programs.

●	We may acquire businesses or products, or form strategic alliances, in the future, and we may not realize the benefits of such acquisitions.
●	Pursuant to the terms of our Series A Preferred Stock, we may be obligated to pay significant royalties.
●	The rights of the holders of common stock may be impaired by the potential issuance of preferred stock.
●	We do not intend to pay dividends on our common stock in the foreseeable future.
●	An active public trading market for our common stock may not be sustained.
●	Our share price has been and could remain volatile.
●	Any issuance of shares of our common stock upon conversion of the shares of Preferred Stock will cause dilution to our then existing stockholders and may depress the market price of our common stock.
●	If securities or industry analysts do not publish research or reports about our business, or if they change their recommendations regarding our stock adversely, our stock price and trading volume could decline.
●	If we are unable to maintain an effective system of internal control over financial reporting, the reliability of our financial reporting, investor confidence in us and the value of our common stock could be adversely affected.
●	We could be delisted from the NYSE American, which could seriously harm the trading price of our common stock, the liquidity of our stock and our ability to raise capital.
●	Upon dissolution of our Company, you may not recoup all or any portion of your investment.
●	Our Certificate of Incorporation allows for our Board to create new series of preferred stock without further approval by our stockholders, which could adversely affect the rights of the holders of our common stock.
●	Anti-takeover provisions of our Certificate of Incorporation, bylaws and Delaware law could make an acquisition of us, which may be beneficial to our stockholders, more difficult and may prevent attempts by our stockholders to replace or remove the current members of our Board and management.
●	Stockholders’ ability to obtain a favorable judicial forum for disputes with us or our directors, officers or employees could be limited.
●	Our ability to use our net operating loss carryforwards and certain other tax attributes may be limited.

●	conduct further clinical and preclinical studies of MAT2203, our lead LNC product candidate;

●	support the conduct of further clinical studies of MAT2203, even if such studies are partially financed with non-dilutive funding;

●	seek to discover and develop additional product candidates;

●	seek regulatory approvals for any product candidates that successfully complete clinical trials;

●	require the manufacture of larger quantities of product candidates for clinical development and potentially commercialization;

●	maintain, expand and protect our intellectual property portfolio;

●	hire additional clinical, quality control and scientific personnel; and

●	add operational, financial and management information systems and personnel, including personnel to support our product development and planned future commercialization efforts and personnel and infrastructure necessary to help us comply with our obligations as a public company.

●	the progress, timing, costs, and results of our clinical trials of our current and future product candidates, if any;

●	the scope, progress, timing, costs, and results of clinical trials of, and research and preclinical development efforts for, other product candidates, including MAT2203, any future product candidates based upon our LNC Platform, and any preclinical or clinical work done to further validate our LNC Platform, generally;

●	our ability to enter into and the terms and timing of any collaborations, licensing or other arrangements that we may establish;

●	the number and development requirements of other product candidates that we pursue;

●	the costs, timing, and outcome of regulatory review of our product candidates by the FDA and comparable non-U.S. regulatory authorities;

●	the costs and timing of future commercialization activities, including product manufacturing, marketing, sales, and distribution, for any of our product candidates for which we receive marketing approval;

●	the revenue, if any, received from commercial sales of our product candidates for which we receive marketing approval;

●	our headcount growth and associated costs if we expand our research and development and establish a commercial infrastructure;

●	the costs and timing of preparing, filing and prosecuting patent applications, maintaining and enforcing our intellectual property rights and defending any intellectual property-related claims;

●	the extent to which we acquire or in-license other products and technologies;

●	the costs of operating as a public company; and

●	the effect of competing technological and market developments.

●	successful completion of preclinical studies;

●	successful enrollment in, and completion of, clinical trials:

●	demonstrating safety and efficacy;

●	receipt of marketing approvals from applicable regulatory authorities;

●	establishing clinical and commercial manufacturing capabilities or making arrangements with third-party manufacturers;

●	obtaining and maintaining patent and trade secret protection and non-patent exclusivity for our product candidates and technologies;

●	launching commercial sales of the product candidates, if approved, whether alone or selectively in collaboration with others;

●	acceptance of the product candidates, if approved, by patients, the medical community and third-party payers;

●	effectively competing with other therapies;

●	a continued acceptable safety profile of the products following approval; and

●	enforcing and defending intellectual property rights and claims.

●	identify potential drug product candidates;

●	design and conduct appropriate laboratory, preclinical and other research;

●	submit for and receive regulatory approval to perform clinical studies;

●	design and conduct appropriate preclinical and clinical studies according to good laboratory and good clinical practices;

●	select and recruit clinical investigators;

●	select and recruit subjects for our studies;

●	collect, analyze, and correctly interpret the data from our studies;

●	submit for and receive regulatory approvals for marketing; and

●	manufacture the drug product candidates according to cGMP.

●	regulators or institutional review boards may not authorize us to commence a clinical trial or conduct a clinical trial at a prospective trial site;

●	conditions imposed on us by the FDA or any non-U.S. regulatory authority regarding the scope or design of our clinical trials may require us to resubmit our clinical trial protocols to institutional review boards for re-inspection due to changes in the regulatory environment;

●	the number of patients required for our clinical trials may be larger than we anticipate, or participants may drop out of our clinical trials at a higher rate than we anticipate;

●	our third-party contractors or clinical investigators may fail to comply with regulatory requirements or fail to meet their contractual obligations to us in a timely manner;

●	we might have to suspend or terminate one or more of our clinical trials if we, the regulators or the institutional review boards determine that the participants are being exposed to unacceptable health risks;

●	regulators or institutional review boards may require that we hold, suspend or terminate clinical research for various reasons, including noncompliance with regulatory requirements;

●	the cost of our clinical trials may be greater than we anticipate;

●	the supply or quality of our product candidates or other materials necessary to conduct our clinical trials may be insufficient or inadequate or we may not be able to reach agreements on acceptable terms with prospective clinical research organizations; and

●	the effects of our product candidates may not be the desired effects or may include undesirable side effects or the product candidates may have other unexpected characteristics.

●	be delayed in obtaining, or may not be able to obtain, marketing approval for one or more of our product candidates;

●	obtain approval for indications that are not as broad as intended or entirely different than those indications for which we sought approval; or

●	have the product removed from the market after obtaining marketing approval.

●	investigator identification and recruitment;

●	regulatory approvals to initiate study sites;

●	patient population size;

●	the nature of the protocol to be used in the trial;

●	patient proximity to clinical sites;

●	eligibility criteria for the study;

●	competition from other companies’ clinical studies for the same patient population; and

●	ability to obtain comparator drug/device.

●	demonstration of clinical safety and efficacy of such product candidate;

●	relative convenience and ease of administration;

●	the prevalence and severity of any adverse effects;

●	the willingness of physicians to prescribe such product candidates and of the target patient population to try new therapies;

●	pricing and cost-effectiveness;

●	the inclusion or omission of such product candidate in applicable treatment guidelines;

●	the effectiveness of our or any future collaborators’ sales and marketing strategies;

●	limitations or warnings contained in FDA approved labeling;

●	our ability to obtain and maintain sufficient third-party coverage or reimbursement from government health care programs, including Medicare and Medicaid, private health insurers and other third-party payors; and

●	the willingness of patients to pay out-of-pocket in the absence of third-party coverage or reimbursement.