▸ As of December 31, 2024, outstanding SPAC Warrants (as defined below) to purchase an aggregate of 6,958,309 shares of our Common Stock are exercisable in accordance with the terms of the Warrant Agreement (the “Warrant Agreement”),· · ● 1 ▸ Assuming we continue to timely file our required Exchange Act reports, the earliest we would regain the ability to use Form S-3 is February 1, 2026.· · ● 1 ▸ If we do not obtain patent term extension and data exclusivity for any of our product candidates we are developing or may develop, our business may be materially harmed.· · ● 1 ▸ Our business could be adversely affected by the effects of health pandemics or other health crises, which could cause significant disruptions in our operations and those of our CMOs, CROs and other third parties upon whom we rely.· · ● 1 ▸ Our business may be impacted by actions of the new U.S. administration, including executive orders, policies, new legislation and judicial decisions.· · ● 1 ▸ We may in the future conduct clinical trials for current or future product candidates outside the U.S., and the FDA and comparable foreign regulatory authorities may not accept data from such trials.· · ● 1 ▸ We may not be able to generate sufficient cash to service our indebtedness and other liquidity needs.· · ● 1 ▸ We rely on a single third-party logistics distribution provider for ZTlido, ELYXYB and GLOPERBA.· · ● 1 ▸ Our cash and cash equivalents could be adversely affected if the financial institutions in which we hold our cash and cash equivalents fail.· ● ● 2 ▸ The market price of our Common Stock may fluctuate significantly, and investors in our Common Stock may lose all or a part of their investment.· ● ● 2 ▸ The terms of the Oramed Note and the Tranche B Notes place restrictions on our operating and financial flexibility.· ● ● 2 rw ▸ Any disruption in the above-mentioned distribution channel would adversely affect our business, financial condition and results of operations.· ● · 1 ▸ Sorrento’s voluntary proceedings under Chapter 11 of the United States Bankruptcy Code;· ● · 1 ▸ The terms of the eCapital Credit Agreement may restrict the operation of our business and limit the cash available for investment in our business operations.· ● · 1 ▸ Certain manufacturers in the market in which we compete distribute certain products without completing the FDA approval process. For example, we believe certain lidocaine topical patches, plaster or poultice products marketed● · · 1 ▸ Certain of our directors and officers may have actual or potential conflicts of interest because of their positions with Sorrento.● ● · 2 ▸ Established pharmaceutical companies may invest heavily to accelerate discovery and development of novel compounds or to in-license novel compounds that could make our product candidates less competitive. Accordingly,● · · 1 ▸ HIPAA and its implementing regulations, which imposes certain requirements relating to the privacy, security and transmission of individually identifiable health information;● · · 1 ▸ If approved, our products candidates regulated as biologics may face competition from biosimilars approved through an abbreviated regulatory pathway.● · · 1 ▸ If our commercial supply of ZTlido, clinical supply of our product candidates and certain of the raw materials used in our product candidates are disrupted or delayed, there can be no assurance that alternative sources can serve as● · · 1 ▸ In order to market any products in any particular jurisdiction, we must establish and comply with numerous and varying regulatory requirements on a country-by-country basis regarding safety and efficacy.● · · 1 ▸ Of the large number of drugs in development, only a small percentage successfully complete the FDA regulatory approval processes and are commercialized. This lengthy approval process, as well as the unpredictability of future● · · 1 ▸ Our execution of any collaborative, licensing or similar arrangements, and the timing of payments we may make or receive under these arrangements.● · · 1 ▸ Our principal stockholders, directors and executive officers will own a significant percentage of our capital stock, and have significant influence over our management.● · · 1 ▸ Our product candidate SEMDEXA is expected to be a physician-administered injectable viscous gel and as such, separate reimbursement for the product itself may not be available. Instead, if SEMDEXA receives regulatory● · · 1 ▸ Our product development costs will increase if we experience delays in testing or marketing approvals. The FDA and other regulatory agencies may impose new or refined testing expectations based on experience and increased● · · 1 ▸ Pursuant to the Amended and Restated Registration Rights Agreement entered into in connection with the Business Combination (the “Registration Rights Agreement”) and our Restated Certificate of Incorporation (the “Certificate of● · · 1 ▸ Pursuant to the terms of the Stockholder Agreement, for so long as the Sorrento Group beneficially owns any shares of Series A Preferred Stock, among other things, (i) Sorrento shall have the right, but not the obligation, to designate● · · 1 ▸ group Risks Related to Scilex’s Intellectual Property● · · 1 ▸ Sorrento has recently filed for bankruptcy protection, which may impair our relationship with Sorrento● · · 1 ▸ Sorrento, as the holder of Series A Preferred Stock, has rights, preferences and privileges that are not held by, and are preferential to, the rights of holders of our Common Stock.● · · 1 ▸ There can be no assurance that we will be completely effective in ensuring our compliance with all applicable anti-corruption laws, including the FCPA or other legal requirements, such as trade control laws. Any investigation of● · · 1 ▸ These anti-takeover provisions and other provisions in the Certificate of Incorporation, the Bylaws and Delaware law could make it more difficult for stockholders or potential acquirors to obtain control of the Board or initiate actions● · · 1 ▸ We are controlled by Sorrento, whose interests may differ from those of our public shareholders.● · · 1 ▸ We are currently a single commercial product company that is heavily dependent on the commercial success of ZTlido and we may be unable to generate sufficient revenue to support our operations.● · · 1 ▸ We are subject to recently enacted state laws in California that require gender and diversity quotas for boards of directors of public companies headquartered in California.● ● · 2 ▸ We currently do not have the ability to independently conduct any clinical trials. The FDA and regulatory authorities in other jurisdictions require us to comply with regulations and standards, commonly referred to as GCP requirements● · · 1 ▸ We face potential business disruptions and related risks resulting from the COVID-19 pandemic, which could have a material adverse effect on our business, financial condition and results of operations.● ● · 2 ▸ We rely on a single third-party logistics distribution provider, Cardinal Health 105, which until recently had also been our only customer.● ● · 2 ▸ Although we endeavor to obtain appropriate insurance coverage for insurable risks that we identify, we do not carry insurance for all categories of risk that our business may encounter.● ● ● 3 ▸ Any approved product candidate will be subject to ongoing and continued regulatory requirements, which may result in significant expense and limit our ability to commercialize such products.● ● ● 3 rw ▸ Any disruption in our research and development facilities could adversely affect our business, financial condition and results of operations.● ● ● 3 ▸ Any of these risks, if encountered, could significantly harm our future international expansion and operations and, consequently, negatively impact our business, financial condition and results of operations.● ● ● 3 ▸ Changes in patent laws or patent jurisprudence could diminish the value of patents in general, thereby impairing our ability to protect our product candidates.● ● ● 3 ▸ Comprehensive U.S. federal income tax reform could adversely affect the Company.● ● ● 3 ▸ Confidentiality agreements with employees may not adequately prevent disclosure of our trade secrets and other proprietary information and may not adequately protect our intellectual property, which could limit our ability to compete.● ● ● 3 ▸ Delays in clinical trials could result in increased costs to us and delay our ability to obtain commercial approval and generate additional revenue.● ● ● 3 ▸ Drug development involves a lengthy and expensive process with an uncertain outcome, and results of earlier studies and trials may not be predictive of future trial results.● ● ● 3 ▸ Even if we complete the necessary clinical trials, we cannot predict when, or if, we will obtain regulatory approval for our product candidates and the approval may be for a more narrow indication than we seek.● ● ● 3 ▸ Even if we obtain FDA approval for any of our product candidates in the United States, we may never obtain approval for or commercialize any of them in any other jurisdiction, which would limit our ability to realize their full market potential.● ● ● 3 ▸ Future sales, or the perception of future sales, of a substantial number of shares of our Common Stock may cause the price of our Common Stock to decline.● ● ● 3 rw ▸ Healthcare reform measures could hinder or prevent our product candidates’ commercial success.● ● ● 3 ▸ If our intellectual property rights are invalidated or circumvented, our business, financial condition and results of operations will be adversely affected.● ● ● 3 ▸ If our operations and performance do not meet the expectations of investors or securities analysts, the market price of our securities may decline.● ● ● 3 ▸ If our trademarks and trade names are not adequately protected, then we may not be able to build name recognition and our business, financial condition and results of operations may be adversely affected.● ● ● 3 ▸ If product liability lawsuits are brought against us, we may incur substantial liabilities and may be required to limit commercialization of our product candidates.● ● ● 3 ▸ If securities or industry analysts do not publish research or reports about our business, or if they issue an adverse opinion regarding our stock, our stock price and trading volume could decline.● ● ● 3 ▸ If we are unable to maintain patent protection for ZTlido, GLOPERBA, ELYXYB and our product candidates, or if the scope of the patent protection obtained is not sufficiently broad, we may not be able to compete effectively in our markets.● ● ● 3 rw ▸ If we are unable to protect the confidentiality of our trade secrets, our business and competitive position would be harmed.● ● ● 3 ▸ If we are unable to retain our key executives, it may delay our development efforts and harm our business, financial condition and results of operations.● ● ● 3 ▸ If we cannot successfully execute any one of the foregoing, our business may not succeed or become profitable.● ● ● 3 ▸ If we fail to achieve certain milestones in our Product Development Agreement with Itochu and Oishi, we could lose rights that are important to our business.● ● ● 3 ▸ Intellectual property rights and regulatory exclusivity rights do not necessarily address all potential threats to our competitive advantage.● ● ● 3 ▸ International components of our business expose us to business, legal, regulatory, political, operational, financial and economic risks associated with conducting business outside of the United States.● ● ● 3 ▸ Issued patents that we own or have exclusively licensed may not provide us with any competitive advantage, or may be held invalid or unenforceable, as a result of legal challenges by our competitors;● ● ● 3 ▸ Our Warrants are exercisable for our Common Stock, which would increase the number of shares eligible for future resale in the public market and result in dilution to our stockholders.● ● ● 3 ▸ Our ability to use our net operating loss and tax credit carryforwards may be subject to limitation.● ● ● 3 ▸ Our business and operations would suffer in the event of a system failure.● ● ● 3 ▸ Our business involves the use of hazardous materials and we and third parties with whom we contract must comply with environmental laws and regulations, which can be expensive and restrict how we do business.● ● ● 3 rw ▸ Our business may suffer reputational harm due to failures of our product candidates.● ● ● 3 ▸ Our failure to meet the continued listing standards of Nasdaq could result in a delisting of our Common Stock.● ● ● 3 rw ▸ Our insurance policies are expensive and protect us only from some business risks, which leaves us exposed to significant uninsured liabilities.● ● ● 3 ▸ Our position as a relatively small company may cause us to be at a significant disadvantage in defending our intellectual property rights and in defending against infringement claims by third parties.● ● ● 3 ▸ Our recurring losses from operations, negative cash flows and substantial cumulative net losses raise substantial doubt about our ability to continue as a going concern.● ● ● 3 ▸ Our reliance on third parties may require us to share our trade secrets, which increases the possibility that our trade secrets will be misappropriated or disclosed.● ● ● 3 ▸ Potential disputes over intellectual property rights that we have licensed may prevent or impair our ability to maintain our current licensing arrangements on acceptable terms.● ● ● 3 ▸ Raising additional capital may cause dilution to our existing stockholders, restrict our operations or require us to relinquish rights to ZTlido or our product candidates.● ● ● 3 ▸ group Risks Related to Government Regulations● ● ● 3 ▸ group Risks Related to Ownership of our Common Stock● ● ● 3 ▸ group Risks Related to our Business and Operations● ● ● 3 ▸ group Risks Related to our Commercial Operations and Product Development● ● ● 3 ▸ group Risks Related to our Intellectual Property● ● ● 3 ▸ Risks Related to our Limited Operating History, Financial Condition and Capital Requirements● ● ● 3 ▸ group Risks Related to our Relationship with Sorrento● ● ● 3 ▸ Should any of these events occur, they could significantly harm our business, financial condition and results of operations.● ● ● 3 ▸ The FDA and other regulatory agencies actively enforce the laws and regulations prohibiting the promotion of off-label uses.● ● ● 3 ▸ The increasing use of social media platforms presents new risks and challenges.● ● ● 3 ▸ The patents of others may have an adverse effect on our business.● ● ● 3 ▸ TheSPAC Warrants may never be in the money, they may expire worthless and the terms of the SPAC Warrants may be amended in a manner adverse to a holder if holders of a majority of the then-outstanding SPAC Warrants approve of such amendment. In● ● ● 3 rw ▸ Third-party claims of intellectual property infringement may prevent or delay our drug discovery and development efforts.● ● ● 3 ▸ Unstable market and economic conditions may have serious adverse consequences on our business, financial condition and results of operations.● ● ● 3 ▸ We are an emerging growth company, and we cannot be certain if the reduced reporting requirements applicable to emerging growth companies will make our Common Stock less attractive to investors.● ● ● 3 ▸ We face significant competition and our competitors may discover, develop or commercialize products faster or more successfully than us.● ● ● 3 ▸ We have in the past and may in the future be subject to short selling strategies that may drive down the market price of our Common Stock.● ● ● 3 rw ▸ We may be required to make milestone payments to the former stockholders of Semnur in connection with our development and commercialization of SEMDEXA, which could adversely affect the overall profitability of SEMDEXA, if approved.● ● ● 3 ▸ We may be subject to claims that we have wrongfully hired an employee from a competitor or that we or our employees have wrongfully used or disclosed alleged confidential information or trade secrets of their former employers.● ● ● 3 ▸ We may become involved in lawsuits to protect or enforce our patents or other intellectual property, which could be expensive, time-consuming and unsuccessful.● ● ● 3 ▸ We may become subject to claims challenging the inventorship or ownership of our patents and other intellectual property.● ● ● 3 ▸ We may find it difficult to enroll or maintain patients in our clinical trials, which could delay or prevent us from proceeding with clinical trials of our product candidates.● ● ● 3 ▸ We may need to increase the size of our company and may not effectively manage our growth.● ● ● 3 ▸ We may not be able to protect our intellectual property rights throughout the world.● ● ● 3 ▸ We may not be successful in obtaining or maintaining necessary rights to product components and processes and brands for our development pipeline through acquisitions and in-licenses.● ● ● 3 ▸ We may redeem any unexpired SPAC Warrants prior to their exercise at a time that is disadvantageous to you, thereby making the SPAC Warrants worthless.● ● ● 3 rw ▸ We may seek to grow our business through acquisitions and may fail to realize the anticipated benefits of any acquisition, and acquisitions can be costly and dilutive.● ● ● 3 ▸ We will incur increased costs as a result of operating as a public company, and our management will devote substantial time to related compliance initiatives.● ● ● 3 ▸ We will need to obtain prior FDA authorization for any proposed product brand names, and any failure or delay associated with such approval may adversely impact our business, financial condition and results of operations.● ● ● 3 ▸ We will require substantial additional funding, which may not be available to us on acceptable terms, or at all.● ● ● 3 ▸ ZTlido, GLOPERBA and ELYXYB may have undesirable properties that could result in significant negative consequences, and our product candidates may cause undesirable side effects that could delay or prevent their regulatory approval.● ● ● 3 rw