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Serina Therapeutics (2BO) Risk Analysis

Public companies are required to disclose risks that can affect the business and impact the stock. These disclosures are known as “Risk Factors”. Companies disclose these risks in their yearly (Form 10-K), quarterly earnings (Form 10-Q), or “foreign private issuer” reports (Form 20-F). Risk factors show the challenges a company faces. Investors can consider the worst-case scenarios before making an investment. TipRanks’ Risk Analysis categorizes risks based on proprietary classification algorithms and machine learning. Serina Therapeutics disclosed 74 risk factors in its most recent earnings report. Serina Therapeutics reported the most risks in the “Finance & Corporate” category.

Risk Overview Q2, 2026

Source: the company's latest filing for the period ended Jun 30, 2026, filed Aug 13, 2026

Risk Distribution
74Risks
Sector Avg.Finance & CorporateTech & InnovationLegal & RegulatoryProductionAbility to SellMacro & Political
Finance & Corporate - Financial and accounting risks. Risks related to the execution of corporate activity and strategy

Risk Change Over Time

Serina Therapeutics disclosed risks per quarterNo. of Risks5060708090100Q3Q4Q12023Q2Q3Q4Q12024Q2Q3Q12026Q2Showing: Q2, 2026
Risks removedRisks addedRisks changedSerina Therapeutics Risk Factors
Risk Changed (1)
  • Share Price & Shareholder Rights - Risk 1
    Our March 2026 purchase agreement involving a member of our Board of Directors and related governance arrangements may result in conflicts of interest, dilution, and increased investor influence over our affairs.

    In the March 2026 PIPE, Gregory H. Bailey, M.D., a current member of our Board of Directors, acting as lead investor, and certain other investors, purchased shares of the Company's common stock, pre-funded warrants, and redeemable warrants. As a result of this transaction, and following the receipt of stockholder approval and the exercise of certain of these warrants, Dr. Bailey and the other investors acquired significant ownership interests in the Company, resulting in dilution to existing stockholders and increasing the influence of these investors over matters submitted to stockholders. Because the issuance of shares of our common stock to Dr. Bailey required stockholder approval under the rules of the NYSE American, Dr. Bailey received his allocation in the March 2026 PIPE in the form of pre-funded warrants that were not exercisable until such approval was obtained. At our 2026 Annual Meeting of Stockholders held on June 17, 2026, our stockholders approved the issuance of the shares of common stock underlying the securities held by Dr. Bailey, as well as an increase in our authorized common stock from 40,000,000 to 125,000,000 shares. Following receipt of such approval, the pre-funded warrants became exercisable, and in June 2026 Dr. Bailey's 6,666,667 pre-funded warrants were net exercised into shares of our common stock. As of August 10, 2026, Dr. Bailey beneficially owned approximately 41% of our common stock (including 3,333,333 shares issuable upon exercise of redeemable warrants held by him). Although the transaction was reviewed and approved by a special committee of independent and disinterested directors, transactions involving directors may present actual or perceived conflicts of interest and may be subject to heightened scrutiny by stockholders, regulators, proxy advisory firms, or courts. Any such scrutiny could result in reputational harm, stockholder litigation, increased costs, or adverse effects on the trading price of our common stock. In addition, pursuant to the March 2026 PIPE, Dr. Bailey was appointed as Co-Chairman of our Board of Directors, and the investors obtained the right, subject to specified conditions, to designate an additional non-executive director. These governance rights may lead to increased investor influence over the composition of our Board and our strategic direction and could result in decisions that do not align with the interests of all stockholders. The potential issuance of a substantial number of shares upon exercise of the redeemable warrants and other outstanding warrants, as well as the perception of future dilution or changes in control, could adversely affect the market price and volatility of our common stock and our ability to raise additional capital on favorable terms.

  • Share Price & Shareholder Rights - Risk 2
    Dr. Bailey and Juvenescence together hold a significant concentration of our common stock and are able to control or substantially influence matters requiring stockholder approval, which limits the ability of our other stockholders to influence corporate matters.

    As of August 10, 2026, Gregory H. Bailey, M.D., a member of our Board of Directors ("Board") and Co-Chairman of our Board, beneficially owned approximately 41% of our common stock (including shares issuable upon exercise of redeemable warrants held by him), and Juvenescence beneficially owned approximately 17% of our common stock (including shares issuable upon exercise of certain warrants held by them). Dr. Bailey is the Executive Chairman and a co-founder of Juvenescence, and Richard Marshall, CBE, M.D., Ph.D., another member of our Board, is the Chief Executive Officer of Juvenescence. Although Dr. Bailey and Juvenescence are separate beneficial owners of our common stock and report their holdings separately, their interests are closely aligned. As a result, Dr. Bailey and Juvenescence, if they act together, are able to control or substantially influence the election of our directors and the outcome of substantially all matters submitted to a vote of our stockholders, including the approval of mergers, amalgamations, sales of assets or other major corporate transactions, amendments to our organizational documents, and the approval of our equity incentive plans. This concentration of ownership may have the effect of delaying, deterring or preventing a change in control of the Company, could deprive our other stockholders of an opportunity to receive a premium for their shares as part of a sale of the Company, and may reduce the ability of our other stockholders to influence corporate matters, any of which could adversely affect the trading price of our common stock. The interests of Dr. Bailey and Juvenescence may not always align with the interests of our other stockholders, and they may exercise their voting power in a manner that our other stockholders do not consider to be in their best interests. Because Dr. Bailey serves as the Executive Chairman and a co-founder of Juvenescence, and Dr. Marshall, another member of our Board, serves as its Chief Executive Officer, the interests of Dr. Bailey and Juvenescence are likely to be aligned, and, although they report their beneficial ownership separately and have not reported as a group under Section 13(d) of the Exchange Act, they may act in a similar fashion with respect to matters submitted to a vote of our stockholders. The following risk factors update the corresponding risk factors set forth in the Form 10-K:

  • Share Price & Shareholder Rights - Risk 3
    We are operating under an accepted plan to regain compliance with the continued listing standards of the NYSE American; if we fail to regain and maintain compliance, our common stock could be delisted.

    On January 9, 2026, we received notice from the NYSE American that we were not in compliance with the continued listing standard set forth in Section 1003(a)(i) and (ii) of the NYSE American Company Guide, based on stockholders' equity of approximately $1.6 million reported in our Quarterly Report on Form 10-Q for the fiscal period ended September 30, 2025, which was below both the $2.0 million stockholders' equity requirement of Section 1003(a)(i) and the $4.0 million requirement of Section 1003(a)(ii), together with reported losses from continuing operations and/or net losses in two of our three, and three of our four, most recent fiscal years. We submitted a compliance plan on February 8, 2026, and on March 24, 2026 the NYSE American notified us that it had accepted our plan, permitting our common stock to continue to be listed during a plan period through July 9, 2027, subject to periodic review, including quarterly monitoring, for compliance with the plan. As of June 30, 2026, our total stockholders' equity was approximately $18.7 million; however, our continued listing remains subject to the NYSE American's ongoing review under the plan, and there can be no assurance that we will maintain compliance with the continued listing standards. If we fail to do so, the NYSE American may commence delisting proceedings, which could reduce the trading volume, price and liquidity of our common stock and impair our ability to raise capital.

  • Share Price & Shareholder Rights - Risk 4
    The completion of the March 2026 PIPE significantly changed our capital structure, and the exercise of outstanding warrants and other potential issuances could result in substantial dilution.

    In connection with the closing of the March 2026 PIPE, (i) all outstanding shares of our Series A Convertible Preferred Stock, together with accrued but unissued paid-in-kind dividends, automatically converted into shares of our common stock (resulting in the issuance of approximately 2.3 million shares), and (ii) the Senior Unsecured Convertible Promissory Note entered into on September 9, 2025 was amended to remove any further obligations to borrow or lend funds thereunder. At our 2026 Annual Meeting of Stockholders held on June 17, 2026, our stockholders approved an increase in our authorized common stock from 40,000,000 to 125,000,000 shares, and, following that approval, an aggregate of 8.2 million pre-funded warrants were net exercised into shares of our common stock in June 2026. As of August 10, 2026, we had 25,400,473 shares of common stock outstanding, and we had outstanding redeemable warrants and other securities exercisable for or convertible into additional shares of common stock. The exercise of these warrants, sales under our at-the-market offering program, and any future issuances of equity or equity-linked securities to fund our operations could result in substantial dilution to our stockholders and could cause the market price of our common stock to decline.

  • Accounting & Financial Operations - Risk 5
    We have a history of operating losses and negative cash flows, and although our recent financings improved our liquidity and stockholders' equity, substantial doubt about our ability to continue as a going concern continues to exist.

    As disclosed in the Form 10-K, the report of our independent registered public accounting firm on our audited consolidated financial statements as of and for the year ended December 31, 2025 contained an explanatory paragraph expressing substantial doubt about our ability to continue as a going concern. In March and April 2026, we completed the March 2026 PIPE, resulting in aggregate gross proceeds of approximately $21.2 million, and we have also raised capital under our at-the-market offering program. As of June 30, 2026, we had cash and cash equivalents of approximately $23.0 million, total stockholders' equity of approximately $18.7 million and an accumulated deficit of approximately $76.8 million. Management has concluded that our existing cash and cash equivalents are not expected to be sufficient to fund our operations for the 12 months following the issuance of our unaudited condensed consolidated financial statements for the period ended June 30, 2026, and that substantial doubt about our ability to continue as a going concern continues to exist. We will require substantial additional financing to advance SER-252 and our other programs, and such financing may not be available to us on acceptable terms, or at all. If we are unable to raise capital when needed, we may be required to delay, limit, reduce or terminate one or more of our research and development programs.

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Risk Highlights Q2, 2026

Main Risk Category
Finance & Corporate
With 26 Risks
Number of Disclosed Risks
74
+5
From last report
S&P 500 Average: 32
Recent Changes
6Risks added
0Risks removed
1Risks changed
Since Jun 2026
Number of Risk Changed
1
+1
From last report
S&P 500 Average: 1

Risk Word Cloud

we may be subject to patent infringement claims that could be costly to defend, which may limit our ability to use disputed technologies, and which could prevent us from pursuing research and development or commercialization of some of our technologies or products, require us to pay licensing fees to have freedom to operate and/or result in monetary damages or other liability for us.subject to patent infringement claimsunless agex common stock continues to be listed on a national securities exchange, agex will become subject to the so-called "penny stock" rules that impose restrictive sales practice requirements.impose restrictive sales practice requirementsconflicts of interest may arise from our relationship with juvenescence, which owns a significant percentage of agex common stock and is a significant creditor and will be able to substantially influence us and exert control over matters subject to stockholder approval.matters subject to stockholder approvalwe may determine to expand our organization and obtain laboratory facilities if we are able to raise sufficient capital to do so, and we may experience difficulties in managing this growth, which could disrupt our operations.determine to expand our organizationassessing the value of agex and serina through a relative valuation as opposed to an absolute valuation carries potential risk.absolute valuation carries potential riskso-called penny stock rulesso-called penny stock ruleswe face significant competition in an environment of rapid technological change and the possibility that our competitors may achieve regulatory approval before us or develop therapies that are more advanced or effective than ours, which may harm our business and financial condition, and our ability to successfully market or commercialize our product candidates.environment of rapid technological changeclinical studies are costly, time consuming and inherently risky, and we may fail to demonstrate safety and efficacy to the satisfaction of applicable regulatory authorities.satisfaction of applicable regulatory authoritiesif we are unable to obtain and enforce patents and to protect our trade secrets, others could use our technology to compete with us, which could limit opportunities for us to generate revenues by licensing our technology and selling our products.to protect our trade secretsdue to our limited financial resources, we have reduced our staffing, eliminated our research laboratory facilities, and eliminated in-house research and product development work. we will seek opportunities to outsource or license product development and commercialization but there is no assurance that we will be able to do so successfully.eliminated our research laboratory facilities

Risk Factors Full Breakdown - Total Risks 74

Share Price & Shareholder Rights13 | 17.6%
  • Share Price & Shareholder Rights - Risk 1Added
    Our March 2026 purchase agreement involving a member of our Board of Directors and related governance arrangements may result in conflicts of interest, dilution, and increased investor influence over our affairs.

    In the March 2026 PIPE, Gregory H. Bailey, M.D., a current member of our Board of Directors, acting as lead investor, and certain other investors, purchased shares of the Company's common stock, pre-funded warrants, and redeemable warrants. As a result of this transaction, and following the receipt of stockholder approval and the exercise of certain of these warrants, Dr. Bailey and the other investors acquired significant ownership interests in the Company, resulting in dilution to existing stockholders and increasing the influence of these investors over matters submitted to stockholders. Because the issuance of shares of our common stock to Dr. Bailey required stockholder approval under the rules of the NYSE American, Dr. Bailey received his allocation in the March 2026 PIPE in the form of pre-funded warrants that were not exercisable until such approval was obtained. At our 2026 Annual Meeting of Stockholders held on June 17, 2026, our stockholders approved the issuance of the shares of common stock underlying the securities held by Dr. Bailey, as well as an increase in our authorized common stock from 40,000,000 to 125,000,000 shares. Following receipt of such approval, the pre-funded warrants became exercisable, and in June 2026 Dr. Bailey's 6,666,667 pre-funded warrants were net exercised into shares of our common stock. As of August 10, 2026, Dr. Bailey beneficially owned approximately 41% of our common stock (including 3,333,333 shares issuable upon exercise of redeemable warrants held by him). Although the transaction was reviewed and approved by a special committee of independent and disinterested directors, transactions involving directors may present actual or perceived conflicts of interest and may be subject to heightened scrutiny by stockholders, regulators, proxy advisory firms, or courts. Any such scrutiny could result in reputational harm, stockholder litigation, increased costs, or adverse effects on the trading price of our common stock. In addition, pursuant to the March 2026 PIPE, Dr. Bailey was appointed as Co-Chairman of our Board of Directors, and the investors obtained the right, subject to specified conditions, to designate an additional non-executive director. These governance rights may lead to increased investor influence over the composition of our Board and our strategic direction and could result in decisions that do not align with the interests of all stockholders. The potential issuance of a substantial number of shares upon exercise of the redeemable warrants and other outstanding warrants, as well as the perception of future dilution or changes in control, could adversely affect the market price and volatility of our common stock and our ability to raise additional capital on favorable terms.

  • Share Price & Shareholder Rights - Risk 2Added
    Dr. Bailey and Juvenescence together hold a significant concentration of our common stock and are able to control or substantially influence matters requiring stockholder approval, which limits the ability of our other stockholders to influence corporate matters.

    As of August 10, 2026, Gregory H. Bailey, M.D., a member of our Board of Directors ("Board") and Co-Chairman of our Board, beneficially owned approximately 41% of our common stock (including shares issuable upon exercise of redeemable warrants held by him), and Juvenescence beneficially owned approximately 17% of our common stock (including shares issuable upon exercise of certain warrants held by them). Dr. Bailey is the Executive Chairman and a co-founder of Juvenescence, and Richard Marshall, CBE, M.D., Ph.D., another member of our Board, is the Chief Executive Officer of Juvenescence. Although Dr. Bailey and Juvenescence are separate beneficial owners of our common stock and report their holdings separately, their interests are closely aligned. As a result, Dr. Bailey and Juvenescence, if they act together, are able to control or substantially influence the election of our directors and the outcome of substantially all matters submitted to a vote of our stockholders, including the approval of mergers, amalgamations, sales of assets or other major corporate transactions, amendments to our organizational documents, and the approval of our equity incentive plans. This concentration of ownership may have the effect of delaying, deterring or preventing a change in control of the Company, could deprive our other stockholders of an opportunity to receive a premium for their shares as part of a sale of the Company, and may reduce the ability of our other stockholders to influence corporate matters, any of which could adversely affect the trading price of our common stock. The interests of Dr. Bailey and Juvenescence may not always align with the interests of our other stockholders, and they may exercise their voting power in a manner that our other stockholders do not consider to be in their best interests. Because Dr. Bailey serves as the Executive Chairman and a co-founder of Juvenescence, and Dr. Marshall, another member of our Board, serves as its Chief Executive Officer, the interests of Dr. Bailey and Juvenescence are likely to be aligned, and, although they report their beneficial ownership separately and have not reported as a group under Section 13(d) of the Exchange Act, they may act in a similar fashion with respect to matters submitted to a vote of our stockholders. The following risk factors update the corresponding risk factors set forth in the Form 10-K:

  • Share Price & Shareholder Rights - Risk 3Added
    We are operating under an accepted plan to regain compliance with the continued listing standards of the NYSE American; if we fail to regain and maintain compliance, our common stock could be delisted.

    On January 9, 2026, we received notice from the NYSE American that we were not in compliance with the continued listing standard set forth in Section 1003(a)(i) and (ii) of the NYSE American Company Guide, based on stockholders' equity of approximately $1.6 million reported in our Quarterly Report on Form 10-Q for the fiscal period ended September 30, 2025, which was below both the $2.0 million stockholders' equity requirement of Section 1003(a)(i) and the $4.0 million requirement of Section 1003(a)(ii), together with reported losses from continuing operations and/or net losses in two of our three, and three of our four, most recent fiscal years. We submitted a compliance plan on February 8, 2026, and on March 24, 2026 the NYSE American notified us that it had accepted our plan, permitting our common stock to continue to be listed during a plan period through July 9, 2027, subject to periodic review, including quarterly monitoring, for compliance with the plan. As of June 30, 2026, our total stockholders' equity was approximately $18.7 million; however, our continued listing remains subject to the NYSE American's ongoing review under the plan, and there can be no assurance that we will maintain compliance with the continued listing standards. If we fail to do so, the NYSE American may commence delisting proceedings, which could reduce the trading volume, price and liquidity of our common stock and impair our ability to raise capital.

  • Share Price & Shareholder Rights - Risk 4Added
    The completion of the March 2026 PIPE significantly changed our capital structure, and the exercise of outstanding warrants and other potential issuances could result in substantial dilution.

    In connection with the closing of the March 2026 PIPE, (i) all outstanding shares of our Series A Convertible Preferred Stock, together with accrued but unissued paid-in-kind dividends, automatically converted into shares of our common stock (resulting in the issuance of approximately 2.3 million shares), and (ii) the Senior Unsecured Convertible Promissory Note entered into on September 9, 2025 was amended to remove any further obligations to borrow or lend funds thereunder. At our 2026 Annual Meeting of Stockholders held on June 17, 2026, our stockholders approved an increase in our authorized common stock from 40,000,000 to 125,000,000 shares, and, following that approval, an aggregate of 8.2 million pre-funded warrants were net exercised into shares of our common stock in June 2026. As of August 10, 2026, we had 25,400,473 shares of common stock outstanding, and we had outstanding redeemable warrants and other securities exercisable for or convertible into additional shares of common stock. The exercise of these warrants, sales under our at-the-market offering program, and any future issuances of equity or equity-linked securities to fund our operations could result in substantial dilution to our stockholders and could cause the market price of our common stock to decline.

  • Share Price & Shareholder Rights - Risk 5
    Conflicts of interest may arise from our relationship with Juvenescence, which will own a significant percentage of our common stock as well as warrants to purchase additional shares of our common stock and will be able to substantially influence the Company and exert control over matters subject to stockholder approval.

    As of March 1, 2026, Juvenescence Limited ("Juvenescence") owned approximately 33.0% of the outstanding shares of our common stock, including shares issuable upon exercise of warrants held by Juvenescence. One member of our Board is the Executive Chairman and Co-Founder of Juvenescence and another member of our Board is the Chief Executive Officer of Juvenescence. Based on Juvenescence's ownership of shares of our common stock, Juvenescence will be able to substantially influence us and exert control over matters subject to stockholder approval, the elections of directors, approval of our equity incentive plans, amendments to our organizational documents, or approval of any merger, amalgamation, sale of assets or other major corporate transaction. Juvenescence's interests may not always coincide with our corporate interests or the interests of our other stockholders, and we may exercise our voting and other rights in a manner with which other stockholders may not agree or that may not be in our best interests or the best interests of our stockholders other than Juvenescence. So long as Juvenescence owns a significant amount of our equity, it will be able to strongly influence our decisions. While the directors affiliated with Juvenescence will be obligated to act in accordance with their fiduciary duty, they may have equity or other interests in Juvenescence and, accordingly, their interests may be aligned with Juvenescence's interests, which may not always coincide with our corporate interests or the interests of our other stockholders.

  • Share Price & Shareholder Rights - Risk 6
    If equity research analysts do not publish research or reports, or publish unfavorable research or reports, about us, our business or our market, our stock price and trading volume could decline.

    The trading market for our common stock will be influenced by the research and reports that equity research analysts publish about it and our business. Equity research analysts may elect not to provide research coverage of our common stock, and such lack of research coverage may adversely affect the market price of our common stock. In the event we do have equity research analyst coverage, we will not have any control over the analysts, or the content and opinions included in their reports. The price of our common stock could decline if one or more equity research analysts downgrade our stock or issue other unfavorable commentary or research. If one or more equity research analysts ceases coverage of us or fails to publish reports on us regularly, demand for our common stock could decrease, which in turn could cause our stock price or trading volume to decline.

  • Share Price & Shareholder Rights - Risk 7
    Future sales of shares by existing stockholders could cause our stock price to decline.

    If our stockholders sell, or indicate an intention to sell, substantial amounts of our common stock in the public market after legal restrictions on resale discussed in this annual report lapse, the trading price of our common stock could decline. We are not able to predict the effect that sales may have on the prevailing market price of our common stock.

  • Share Price & Shareholder Rights - Risk 8
    An active trading market for our common stock may not develop and our stockholders may not be able to resell their shares of common stock for a profit, if at all.

    An active trading market for the shares of our common stock may never develop or be sustained. If an active market for our common stock does not develop or is not sustained, it may be difficult for our stockholders to sell their shares at an attractive price or at all.

  • Share Price & Shareholder Rights - Risk 9
    The Amended and Restated Certificate of Incorporation will provide that the Court of Chancery of the State of Delaware is the exclusive forum for substantially all disputes between us and our stockholders, which could limit our stockholders' ability to obtain a favorable judicial forum for disputes with us or our directors, officers or other employees.

    The Amended and Restated Certificate of Incorporation and the Amended and Restated Bylaws provide, among other things, that that the Court of Chancery of the State of Delaware (or, in the event that the Court of Chancery does not have jurisdiction, the federal district court for the District of Delaware or other state courts of the State of Delaware) is the exclusive forum for any derivative action or proceeding brought on our behalf, any action asserting a claim of breach of fiduciary duty, any action asserting a claim against us arising pursuant to the DGCL, the Amended and Restated Certificate of Incorporation or the Amended and Restated Bylaws, or any action asserting a claim against us that is governed by the internal affairs doctrine; provided that, the exclusive forum provision will not apply to suits brought to enforce any liability or duty created by the Exchange Act or any other claim for which the federal courts have exclusive jurisdiction; and provided further that, if and only if the Court of Chancery of the State of Delaware dismisses any such action for lack of subject matter jurisdiction, such action may be brought in another state or federal court sitting in the State of Delaware. The Amended and Restated Certificate of Incorporation and the Amended and Restated Bylaws will also provide the federal district courts of the United States of America will be the exclusive forum for the resolution of any complaint asserting a cause of action against the Company or any of our directors, officers, employees, or agents and arising under the Securities Act. Nothing in the Amended and Restated Certificate of Incorporation or the Amended and Restated Bylaws will preclude stockholders that assert claims under the Exchange Act from bringing such claims in state or federal court, subject to applicable law.

  • Share Price & Shareholder Rights - Risk 10
    Anti-takeover provisions in our governance documents and under Delaware law could make an acquisition of Serina more difficult and may prevent attempts by our stockholders to replace or remove our management.

    Provisions in the Amended and Restated Certificate of Incorporation and the Amended and Restated Bylaws may delay or prevent an acquisition or a change in management. In addition, because we are incorporated in Delaware, we are governed by the provisions of Section 203 of the Delaware General Corporation Law (the "DGCL"), which prohibits stockholders owning in excess of 15% of our outstanding voting stock from merging or combining with us. Although we believe these provisions collectively will provide for an opportunity to receive higher bids by requiring potential acquirors to negotiate with our Board, they would apply even if the offer may be considered beneficial by some stockholders. In addition, these provisions may frustrate or prevent any attempts by our stockholders to replace or remove then current management by making it more difficult for stockholders to replace members of the board of directors, which is responsible for appointing the members of management.

  • Share Price & Shareholder Rights - Risk 11
    If we do not continue to satisfy the NYSE American continued listing requirements, our Common Stock could be delisted from NYSE American

    The listing of our Common Stock on the NYSE American is contingent on our compliance with the NYSE American's conditions for continued listing. Other than as set forth in the following two paragraphs, while we are presently in compliance with all such conditions, it is possible that we will fail to meet one or more of these conditions in the future. On January 9, 2026, we were notified by the NYSE American that due to our disclosure in our Quarterly Report on Form 10-Q filed for the fiscal period ended September 30, 2025, which reported stockholders' equity of approximately $1.6 million, we no longer met the requirement that we must have no less than $4 million or more in stockholders' equity pursuant to the listing standard set forth under Section 1003(a)(ii) of the NYSE American Company Guide (the "Listing Standards") because we had reported losses from continuing operations and/or net losses in three of our last four most recent fiscal years ended December 31, 2024. Under the applicable rules of the NYSE American, the Company submitted a compliance plan on February 8, 2026 that demonstrated how it intends to regain compliance with the Listing Standards within 18 months of the receipt of the notice, or July 9, 2027. If we were to fail to meet a NYSE American listing requirement, we may be subject to delisting by the NYSE American. In the event our Common Stock is no longer listed for trading on the NYSE American, our trading volume and share price may decrease, and we may experience further difficulties in raising capital which could materially affect our operations and financial results. Further, delisting from the NYSE American could also have other negative effects, including potential loss of confidence by partners, lenders, suppliers, and employees, and could also trigger various defaults under our lending agreements and other outstanding agreements. Finally, delisting could make it harder for us to raise capital and sell securities.

  • Share Price & Shareholder Rights - Risk 12
    We expect to take advantage of reduced disclosure and governance requirements applicable to smaller reporting companies, which could result in our common stock being less attractive to investors.

    As of June 30, 2025, we had a public float of less than $250 million and therefore qualify as a smaller reporting company under the rules of the SEC as of the date of this annual report. As a smaller reporting company, we will be able to take advantage of reduced disclosure requirements, such as simplified executive compensation disclosures and reduced financial statement disclosure requirements in our SEC filings. Decreased disclosures in our SEC filings due to our status as a smaller reporting company may make it harder for investors to analyze our results of operations and financial prospects. We cannot predict if investors will find our common stock less attractive if it relies on these exemptions. If some investors find our common stock less attractive as a result, there may be a less active trading market for our common stock and our stock price may be more volatile. We may take advantage of the reporting exemptions applicable to a smaller reporting company until we are no longer a smaller reporting company, which status would end once we have a public float greater than $250.0 million. In that event, we could still be a smaller reporting company if our annual revenues were below $100.0 million and we have a public float of less than $700.0 million.

  • Share Price & Shareholder Rights - Risk 13
    The market price of our common stock is expected to be volatile.

    The market price of our common stock could be subject to significant fluctuations. Market prices for securities of early-stage pharmaceutical, biotechnology and other life sciences companies have historically been particularly volatile. Some of the factors that may cause the market price of our common stock to fluctuate include: - our ability to obtain regulatory approvals for our product candidates, and delays or failures to obtain such approvals;- failure of any of our product candidates, if approved, to achieve commercial success;- failure by us to maintain our existing third-party license and supply agreements;- failure by us or our licensors to prosecute, maintain, or enforce our intellectual property rights;- changes in laws or regulations applicable to our product candidates;- any inability to obtain adequate supply of our product candidates or the inability to do so at acceptable prices;- adverse regulatory authority decisions;- introduction of new products, services or technologies by our competitors;- failure to meet or exceed financial and development projections we may provide to the public;- failure to meet or exceed the financial and development projections of the investment community;- the perception of the pharmaceutical industry by the public, legislatures, regulators and the investment community;- announcements of significant acquisitions, strategic collaborations, joint ventures or capital commitments by us or our competitors;- disputes or other developments relating to proprietary rights, including patents, litigation matters, and our ability to obtain patent protection for our technologies;- additions or departures of key personnel;- significant lawsuits, including patent or stockholder litigation;- if securities or industry analysts do not publish research or reports about our business, or if they issue an adverse or misleading opinion regarding our business and stock;- changes in the market valuations of similar companies;- general market or macroeconomic conditions;- sales of our common stock by us or our stockholders in the future;- trading volume of our common stock;- failure to maintain compliance with the listing requirements of the NYSE American;- announcements by commercial partners or competitors of new commercial products, clinical progress or the lack thereof, significant contracts, commercial relationships or capital commitments;- adverse publicity generally, including with respect to other products and potential products in such markets;- the introduction of technological innovations or new therapies that compete with our potential products;- changes in the structure of health care payment systems; and- period-to-period fluctuations in our financial results. Moreover, the stock markets in general have experienced substantial volatility that has often been unrelated to the operating performance of individual companies. These broad market fluctuations may also adversely affect the trading price of our common stock. In the past, following periods of volatility in the market price of a company's securities, stockholders have often instituted class action securities litigation against those companies. Such litigation, if instituted, could result in substantial costs and diversion of management attention and resources, which could significantly harm our profitability and reputation. Additionally, a decrease in the stock price of our common stock may cause our common stock to no longer satisfy the continued listing standards of the NYSE American. If we are not able to maintain the requirements for listing on the NYSE American, it could be delisted, which could have a materially adverse effect on our ability to raise additional funds as well as the price and liquidity of our common stock.

See a full breakdown of risk according to category and subcategory. The list starts with the category with the most risk. Click on subcategories to read relevant extracts from the most recent report.

FAQ

What are “Risk Factors”?
Risk factors are any situations or occurrences that could make investing in a company risky. The Securities and Exchange Commission (SEC) requires that publicly traded companies disclose their most significant risk factors. This is so that potential investors can consider any risks before they make an investment. They also offer companies protection, as a company can use risk factors as liability protection. This could happen if a company underperforms and investors take legal action as a result. It is worth noting that smaller companies, that is those with a public float of under $75 million on the last business day, do not have to include risk factors in their 10-K and 10-Q forms, although some may choose to do so.
How do companies disclose their risk factors?
Publicly traded companies initially disclose their risk factors to the SEC through their S-1 filings as part of the IPO process. Additionally, companies must provide a complete list of risk factors in their Annual Reports (Form 10-K) or (Form 20-F) for “foreign private issuers”. Quarterly Reports also include a section on risk factors (Form 10-Q) where companies are only required to update any changes since the previous report. According to the SEC, risk factors should be reported concisely, logically and in “plain English” so investors can understand them.
How can I use TipRanks risk factors in my stock research?
Use the Risk Factors tab to get data about the risk factors of any company in which you are considering investing. You can easily see the most significant risks a company is facing. Additionally, you can find out which risk factors a company has added, removed or adjusted since its previous disclosure. You can also see how a company’s risk factors compare to others in its sector. Without reading company reports or participating in conference calls, you would most likely not have access to this sort of information, which is usually not included in press releases or other public announcements. A simplified analysis of risk factors is unique to TipRanks.
What are all the risk factor categories?
TipRanks has identified 6 major categories of risk factors and a number of subcategories for each. You can see how these categories are broken down in the list below. 1. Financial & Corporate Accounting & Financial Operations - risks related to accounting loss, value of intangible assets, financial statements, value of intangible assets, financial reporting, estimates, guidance, company profitability, dividends, fluctuating results. Share Price & Shareholder Rights – risks related to things that impact share prices and the rights of shareholders, including analyst ratings, major shareholder activity, trade volatility, liquidity of shares, anti-takeover provisions, international listing, dual listing. Debt & Financing – risks related to debt, funding, financing and interest rates, financial investments. Corporate Activity and Growth – risks related to restructuring, M&As, joint ventures, execution of corporate strategy, strategic alliances. 2. Legal & Regulatory Litigation and Legal Liabilities – risks related to litigation/ lawsuits against the company. Regulation – risks related to compliance, GDPR, and new legislation. Environmental / Social – risks related to environmental regulation and to data privacy. Taxation & Government Incentives – risks related to taxation and changes in government incentives. 3. Production Costs – risks related to costs of production including commodity prices, future contracts, inventory. Supply Chain – risks related to the company’s suppliers. Manufacturing – risks related to the company’s manufacturing process including product quality and product recalls. Human Capital – risks related to recruitment, training and retention of key employees, employee relationships & unions labor disputes, pension, and post retirement benefits, medical, health and welfare benefits, employee misconduct, employee litigation. 4. Technology & Innovation Innovation / R&D – risks related to innovation and new product development. Technology – risks related to the company’s reliance on technology. Cyber Security – risks related to securing the company’s digital assets and from cyber attacks. Trade Secrets & Patents – risks related to the company’s ability to protect its intellectual property and to infringement claims against the company as well as piracy and unlicensed copying. 5. Ability to Sell Demand – risks related to the demand of the company’s goods and services including seasonality, reliance on key customers. Competition – risks related to the company’s competition including substitutes. Sales & Marketing – risks related to sales, marketing, and distribution channels, pricing, and market penetration. Brand & Reputation – risks related to the company’s brand and reputation. 6. Macro & Political Economy & Political Environment – risks related to changes in economic and political conditions. Natural and Human Disruptions – risks related to catastrophes, floods, storms, terror, earthquakes, coronavirus pandemic/COVID-19. International Operations – risks related to the global nature of the company. Capital Markets – risks related to exchange rates and trade, cryptocurrency.