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This section augments and updates certain risk factors disclosed in Item 1A of Part I of our Annual Report on Form 10-K for the year ended December 31, 2025 (the Annual Report). The following risk factors should be read together with the other risk factors disclosed in the Annual Report. In addition to the other information in this Quarterly Report on Form 10-Q, all of the risk factors should be carefully considered in evaluating us and our common stock. Any of these risks, many of which are beyond our control, could materially and adversely affect our financial condition, results of operations or cash flows, or cause our actual results to differ materially from those projected in any forward-looking statements. We may also face other risks and uncertainties that are not presently known, are not currently believed to be material, or are not identified below because they are common to all businesses. Past financial performance may not be a reliable indicator of future performance, and historical trends should not be used to anticipate results or trends in future periods. For more information, see “Note Regarding Forward-Looking Statements” in this Quarterly Report on Form 10-Q.
RISKS RELATED TO OWNERSHIP OF OUR COMMON STOCK
The trading price of the shares of our common stock has been highly volatile, and purchasers of our common stock could incur substantial losses.
The price of our common stock is highly volatile and may be affected by developments directly affecting our business, as well as by developments out of our control or not specific to us. The pharmaceutical and biotechnology industries, in particular, and the stock market generally, are vulnerable to abrupt changes in investor sentiment. Prices of securities and trading volumes of companies in the pharmaceutical and biotechnology industries, including ours, can swing dramatically in ways unrelated to, or that bear a disproportionate relationship to, our performance. The price of our common stock and their trading volumes may fluctuate based on a number of factors including, but not limited to:
•clinical trials and their results, and other product and technological developments and innovations;
•the timing, costs and progress of our commercialization efforts;
•FDA and other domestic and international governmental regulatory actions, receipt and timing of approvals of our product candidates, and any denials and withdrawal of approvals;
•the duration, scope, and outcome of any governmental inquiries or investigations;
•competitive factors, including the commercialization of new products in our markets by our competitors;
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•statements, interviews, presentations, publications or other communications by third parties, including competitors, whether accurate or inaccurate, that may be perceived as negative with respect to us, our business, our product candidates, our preclinical and clinical data, or our prospects;
•advancements with respect to treatment of the diseases targeted by our product candidates;
•developments relating to, and actions by, our collaborative partners, including execution, amendment and termination of agreements, achievement of milestones and receipt of payments;
•the success of our collaborative partners in marketing any approved products and the amount and timing of payments to us;
•availability and cost of capital and our financial and operating results;
•actions with respect to pricing, reimbursement and coverage, and changes in reimbursement policies or other practices relating to our products or the pharmaceutical or biotechnology industries generally;
•meeting, exceeding or failing to meet analysts’ or investors’ expectations, and changes in evaluations and recommendations by securities analysts;
•the use of social media platforms by customers, or investors;
•the issuance of additional shares upon the exercise of currently outstanding options or warrants or upon the settlement of stock units;
•future sales of substantial amounts of shares of our common stock in the market;
•economic, industry and market conditions, changes or trends; and
•other factors unrelated to us or the pharmaceutical and biotechnology industries.
In addition, low trading volume in our common stock may increase their price volatility. Holders of our common stock may not be able to liquidate their positions at the desired time or price.
We have initiated legal proceedings and may in the future become subject to litigation, which could harm our business, financial condition, stock price and reputation.
We are involved, and may become involved in the future, in disputes and other legal proceedings that could be costly and time-consuming to prosecute or defend and result in unfavorable outcomes, which may have a material adverse effect on our business, operating results and financial condition, and negatively affect the price of our common stock. For example, on March 20, 2026, we filed a complaint against Ocular Therapeutix, Inc. (“Ocular”), in the Middlesex County Superior Court for the Commonwealth of Massachusetts. The complaint alleges, among other things, Ocular’s dissemination of false or misleading representations of fact concerning our company and the clinical results of DURAVYU, our lead product candidate (the “Ocular Litigation”). The complaint asserts several causes of action against Ocular, including defamation, commercial disparagement, violation of Mass. Gen. L. c. 93A, §§ 2 and 11, and tortious interference with advantageous business relations. We are seeking injunctive relief preventing Ocular from further disseminating the false or misleading representations of fact, requiring its public retraction of the false and misleading statements, monetary damages in the amount to be determined at trial, attorneys’ fees and costs, and such other relief that the court deems just and proper. Ocular filed its answer on April 13, 2026, seeking judgment in its favor, dismissal with prejudice of all claims, award of attorneys’ fees, costs, and expenses incurred in connection with the action, and such other and further relief as the court deems appropriate. We cannot predict whether the Ocular Litigation or any future legal matter will be resolved favorably for us. Legal proceedings in general, regardless of their merits or their ultimate outcomes, can be expensive and time-consuming to bring or defend against, requiring us to expend significant resources and divert the effort and attention of our management and other personnel from our business operations. The Ocular Litigation and any future litigation may adversely affect our business, results of operations, financial condition, prospects, and stock price. Furthermore, publicity surrounding legal proceedings, even if resolved favorably for us, could result in additional legal proceedings, damage to our reputation and cause volatility in our stock price.