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Item 1A. Risk Factors
Our business, financial condition, results of operations and future growth prospects are subject to various risks, including those described under Risk Factors in our Annual Report on Form 10-K filed with the SEC on March 25, 2026, as amended on March 27, 2026 (collectively, the Form 10-K), which we encourage you to review. There have been no material changes from the risk factors disclosed in the Form 10-K, except as set forth below:
Our March 2026 purchase agreement involving a member of our Board of Directors and related governance arrangements may result in conflicts of interest, dilution, stockholder approval risks, aand 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 Companys common stock, pre-funded warrants, and redeemable warrants. As a result of this transaction, and subject tofollowing the receipt of stockholder approval and future warrant the exercises of certain of these warrants, Dr. Bailey and the other investors may aacquired significant ownership interests in the Company, resulting in dilution to existing stockholders and potentially iincreasing the influence of these investors over matters submitted to stockholders. If allBecause the issuance of shares of our common stock to Dr. Bailey required stockholder approvals are obtained at under the rules of the NYSE American, Dr. Bailey received his allocation in the March 2026 PIPE in the form of pre-funded warrants the Companys at were not exercisable until such approval was obtained. At our 2026 Annual Meeting of Stockholders currently scheduled for June 17, 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 prefunded warrants became exercisable, and in June 2026, the Company expects that Dr. Baileys 6,666,667 pre-funded warrants were net exercised into shares of our common stock. As of August 10, 2026, Dr. Bailey will beneficially owned approximately 37.941% of the then-outstanour common stock (including 3,333,333 shares of the Companys common stockissuable 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.
FurThe potential issuance of a substantial number of shares upon exercise of ther, the issuance redeemable warrants and other outstanding warrants, as well as the perception of shares to 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.
Dr. Bailey reand Juvenescence together hold a significant concentration of our common stock and are able to control or substantially influence matters requires ing stockholder approval, which limits the ability of our other stockholder as to influence corporate matters.
As of August 10, 2026, Gregory H. Bailey, M.D., a member of our Board of Directors (Board) and CoChairman of our Board, beneficially owned approval under NYSE American rules. If such approval is not obtained in a timely manner, or aximately 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
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opport all, tunity 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 anticipated issuancetrading 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 cofounder of shares underlyingJuvenescence, 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 the prefunded warrants will be delayed or may not occur, which could negativey 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:
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 a$21.2 million, and we have also raised capital under our at-the-market offect our capital structure, liquidity plannring 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 investsuch financing may not be available to us on acceptable terms, or confidence. Our obligatioat 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.
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 to conthat we were not in compliance with the continue seeking sd listing standard set forth in Section 1003(a)(i) and (ii) of the NYSE American Company Guide, based on stockholder s equity of approval at subsequeximately $1.6 million reported in our Quarterly Report on Form 10Q for the fiscal period ended September 30, 2025, which was below both the $2.0 million stockholders equity requirement meetings until approvof 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 is obtained may also result in additional costyears. 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 and management distractionpproximately $18.7 million; however, our continued listing remains subject to the NYSE Americans 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.
The potenticompletion of the March 2026 PIPE significantly changed our capital issstructure, and the exercise of outstanding warrants and other potential issuance of a substantial number of shares upon exercis 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 of the prefin our authorized common stock from 40,000,000 to 125,000,000 shares, and, following that approval, an aggregate of 8.2 million prefunded warrants and redeewere 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, as well as t and other securities exercisable for or convertible into additional shares of common stock. The perception exercise of these warrants, sales under our at-the-market offering program, and any future issuances of future equity or equity-linked securities to fund our operations could result in substantial dilution or changes in conto our stockholders and could cause the market price of our common stock to decline.
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Our lead productrol, could adversely affect the m candidate, SER-252, is in early-stage clinical development, and our business depends substantially on its progress.
In January 2026, the FDA cleared our investigational new drug application for SER-252, and in February 2026 we enrolled and dosed the first patient in our Phase 1b registrational clinical trial of SER252 in patients with advanced Parket price and volatility of our common stockinsons disease. SER-252 remains in early-stage clinical development, and the risks described in the Form 10-K relating to the conduct, timing, enrollment and outcome of our clinical trials continue to apply. Clinical development is lengthy, expensive and uncertain, and the results of earlystage trials may not be predictive of later results or of any regulatory determination.
Our recent financing and equity issuances may limit our ability to use our net operating loss carryforwards and our ther tax attributes.
As disclosed in the Form 10-K, our ability to raise additional capital on favorable termsutilize our federal and state net operating loss (NOL) carryforwards and other tax attributes to offset future taxable income may be limited under Sections 382 and 383 of the Internal Revenue Code if we experience one or more ownership changes (generally, a cumulative increase of more than 50 percentage points in ownership by 5% stockholders over a rolling three-year period). The March 2026 PIPE, the automatic conversion of our Series A Convertible Preferred Stock, and other recent issuances of our common stock may have resulted in, or may in the future result in, such an ownership change. If an ownership change has occurred or occurs, our ability to use our prechange NOL carryforwards and other tax attributes could be materially limited, which could increase our future tax liability and adversely affect our cash flows.