N-Acetyl-Leucine

Scilex today announced that the U.S. Patent and Trademark Office has allowed numerous claims from U.S. patent application no. 17/562,229 and will issue a new patent containing those claims related to the treatment of acute pain (the “Patent”), to Scilex in late 2024, further strengthening the Company’s intellectual property position and coverage for its acute migraine treatment drug product, ELYXYB®, a liquid, micro-encapsulation formulation of celecoxib.ELYXYBTM is a first-line treatment and the only FDA-approved, ready-to-use oral solution for the acute treatment of migraine, with or without aura, in adults.1 The U.S. oral migraine drug market size is estimated to be $1.8 billion in 2022.2ELYXYB®, a rapid onset and ready to use formulation of Celecoxib, delivers a first line non-opioid therapeutic alternative to habit-forming opioids and acetaminophen, the leading cause of acute liver failure in the U.S.3DelveInsight estimates there were approximately 100 million cases of acute pain in the U.S. and that the total acute pain market in the U.S. was approximately $3 billion in 2021.4There is strong evidence for the use of non-steroidal anti-inflammatory drugs (NSAIDs) as a first-line treatment for migraine. ELYXYB® (celecoxib oral solution) is in the same class of agents, is fast acting, and has the potential to have the lowest gastrointestinal (GI) side effects of all NSAIDs.5 PALO ALTO, Calif., Aug. 21, 2024 (GLOBE NEWSWIRE) -- Scilex Holding Company (Nasdaq: SCLX, “Scilex” or “Company”), an innovative revenue-generating company focused on acquiring, developing and commercializing non-opioid pain management products for the treatment of acute and chronic pain, today announced that the U.S. Patent and Trademark Office has allowed numerous claims from U.S. patent application no. 17/562,229 and will issue a new patent containing those claims related to the treatment of acute pain (the “Patent”), to Scilex in late 2024, further strengthening the Company’s intellectual property position and coverage for its acute migraine treatment drug product, ELYXYB®, a liquid, micro-encapsulation formulation of celecoxib. The Patent, titled “Methods of Treating Pain,” covers methods of treating acute pain. Clinicians in a recent market research study expressed their desire for fast and safe alternatives for two large pools of acute migraine patients – those who have an insufficient response to triptan therapy and those who have contraindications to triptan use. ELYXYB®’s product profile mapped with a high degree of certainty to these stated unmet needs. In clinical studies, patients treated with ELYXYB® demonstrated pain relief in as little as 15 minutes, and significant pain relief compared to placebo within 45 minutes in approximately 50% of patients.6,7 “We are very excited about the potential of ELYXYB® since launching the product in the U.S. in April 2023. This is a highly complementary commercial asset that allows us to provide physicians with another tool in their pain management armamentarium to treat migraines earlier in the patient’s journey. These new patents will provide the ability to file application in the future for acute pain,” said Jaisim Shah, Chief Executive Officer and President of Scilex. For more information on Scilex Holding Company, refer to www.scilexholding.com For more information on Semnur Pharmaceuticals, Inc., refer to www.semnurpharma.com For more information on Scilex Holding Company Sustainability Report, refer to www.scilexholding.com/investors/sustainability For more information on ZTlido® including Full Prescribing Information, refer to www.ztlido.com. For more information on ELYXYB®, including Full Prescribing Information, refer to www.elyxyb.com. For more information on Gloperba®, including Full Prescribing Information, refer to www.gloperba.com. https://www.facebook.com/scilex.pharm https://www.linkedin.com/company/scilex-holding-company/ info@scilexholding.com About Scilex Holding Company Scilex Holding Company is an innovative revenue-generating company focused on acquiring, developing and commercializing non-opioid pain management products for the treatment of acute and chronic pain. Scilex targets indications with high unmet needs and large market opportunities with non-opioid therapies for the treatment of patients with acute and chronic pain and are dedicated to advancing and improving patient outcomes. Scilex’s commercial products include: (i) ZTlido® (lidocaine topical system) 1.8%, a prescription lidocaine topical product approved by the U.S. Food and Drug Administration (the “FDA”) for the relief of neuropathic pain associated with postherpetic neuralgia, which is a form of post-shingles nerve pain; (ii) ELYXYB®, a potential first-line treatment and the only FDA-approved, ready-to-use oral solution for the acute treatment of migraine, with or without aura, in adults; and (iii) Gloperba®, the first and only liquid oral version of the anti-gout medicine colchicine indicated for the prophylaxis of painful gout flares in adults. In addition, Scilex has three product candidates: (i) SP-102 (10 mg, dexamethasone sodium phosphate viscous gel) (“SEMDEXATM” or “SP-102”), a novel, viscous gel formulation of a widely used corticosteroid for epidural injections to treat lumbosacral radicular pain, or sciatica, for which Scilex has completed a Phase 3 study and was granted Fast Track status from the FDA in 2017; (ii) SP-103 (lidocaine topical system) 5.4%, (“SP-103”), a next-generation, triple-strength formulation of ZTlido, for the treatment of chronic neck pain and for which Scilex has recently completed a Phase 2 trial in low back pain. SP-103 has been granted Fast Track status from the FDA in low back pain; and (iii) SP-104 (4.5 mg, low-dose naltrexone hydrochloride delayed-release capsules) (“SP-104”), a novel low-dose delayed-release naltrexone hydrochloride being developed for the treatment of fibromyalgia, for which Phase 1 trials were completed in the second quarter of 2022. Scilex Holding Company is headquartered in Palo Alto, California. About Semnur Pharmaceuticals, Inc. Semnur Pharmaceuticals, Inc. (“Semnur”) is a clinical-late stage specialty pharmaceutical company focused on the development and commercialization of novel non-opioid pain therapies. Semnur’s lead program, SP-102 (SEMDEXA™), is the first non-opioid novel gel formulation administered epidurally in development for patients with moderate to severe chronic radicular pain/sciatica. Semnur Pharmaceuticals, Inc. is headquartered in Palo Alto, California. About Denali Capital Acquisition Corp. Denali Capital Acquisition Corp. (“SPAC”) is a blank check company formed for the purpose of effecting a merger, share exchange, asset acquisition, share purchase, reorganization or similar business combination with one or more businesses or entities. Important Information and Where to Find It This press release relates to a proposed transaction between Semnur and the SPAC and does not contain all the information that should be considered concerning the potential business combination and is not intended to form the basis of any investment decision or any other decision in respect of the potential business combination. This press release does not constitute an offer to sell or exchange, or the solicitation of an offer to buy or exchange, any securities, nor shall there be any sale of securities in any jurisdiction in which such offer, sale or exchange would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction. In connection with the transaction described herein, the SPAC will file relevant materials with the SEC, including a registration statement on Form S-4, which will include a proxy statement/prospectus. Investors and security holders of the SPAC are urged to read these materials (including any amendments or supplements thereto) and any other relevant documents in connection with the transaction that the SPAC files with the SEC when, and if, they become available because they will contain important information about the SPAC, Semnur and the proposed transaction. The preliminary proxy statement/prospectus, the definitive proxy statement/prospectus and other relevant materials in connection with the transaction (when and if they become available), and any other documents filed by the SPAC with the SEC, may be obtained free of charge at the SEC’s website (www.sec.gov). The documents filed by the SPAC with the SEC also may be obtained free of charge upon written request to: Denali Capital Acquisition Corp.437 Madison Avenue, 27th FloorNew York, NY 10022 Participants in the Solicitation The SPAC and its directors and executive officers may be deemed participants in the solicitation of proxies from the SPAC’s shareholders with respect to the proposed business combination. Information about the SPAC’s directors and executive officers and a description of their interests in the SPAC will be included in the proxy statement/prospectus for the proposed transaction and will be available at the SEC’s website (www.sec.gov). Additional information regarding the interests of such participants will be contained in the proxy statement/prospectus for the proposed transaction when available. Semnur and its directors and executive officers may also be deemed to be participants in the solicitation of proxies from the shareholders of the SPAC in connection with the proposed business combination. Information about Semnur’s directors and executive officers and information regarding their interests in the proposed transaction will be included in the proxy statement/prospectus for the proposed transaction. Non-Solicitation This press release is not a proxy statement or solicitation of a proxy, consent or authorization with respect to any securities or in respect of the potential transaction and shall not constitute an offer to sell or a solicitation of an offer to buy the securities of the SPAC, the combined company or Semnur, nor shall there be any sale of any such securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of such state or jurisdiction. No offer of securities shall be made except by means of a prospectus meeting the requirements of the Securities Act of 1933, as amended. Forward-Looking Statements This press release and any statements made for and during any presentation or meeting concerning the matters discussed in this press release contain forward-looking statements related to Scilex and its subsidiaries and the SPAC and are subject to risks and uncertainties that could cause actual results to differ materially from those projected. Forward-looking statements include statements regarding the SPAC, Scilex and its subsidiaries, including but not limited to Semnur, statements regarding the proposed business combination between Semnur and the SPAC, including the potential listing of the combined company’s common stock and warrants on Nasdaq, obtaining the approval from the SPAC’s shareholders, the expectation that the SPAC will file a registration statement on Form S-4 with the SEC, which would include a proxy statement/prospectus, the estimated or anticipated future results and benefits of the combined company following the proposed business combination, including the ability of the parties to successfully consummate the proposed business combination, the timing of the closing of the proposed business combination, future opportunities for the combined company, Semnur and the combined company’s proposed business strategies, the estimated pre-transaction equity valuation of Semnur, the estimated sales for SP-102, the Company’s outlook, goals and expectations for 2024, and the Company’s development and commercialization plans. Although each of the SPAC and Scilex and its subsidiaries believes that it has a reasonable basis for each forward-looking statement contained in this press release, each of the SPAC and Scilex and its subsidiaries caution you that these statements are based on a combination of facts and factors currently known and projections of the future, which are inherently uncertain. In addition, there will be risks and uncertainties described in the proxy statement/prospectus included in the registration statement on Form S-4 relating to the proposed transaction, which is expected to be filed by the SPAC with the SEC, and described in other documents filed by the SPAC or Scilex from time to time with the SEC. These filings may identify and address other important risks and uncertainties that could cause actual events and results to differ materially from those contained in the forward-looking statements. Neither the SPAC nor Scilex and its subsidiaries can assure you that the forward-looking statements in this communication will prove to be accurate. Risks and uncertainties that could cause actual results of Scilex and the SPAC to differ materially and adversely from those expressed in our forward-looking statements, include, but are not limited to: the inability of the parties to consummate any proposed business combination transaction for any reason, including any failure to meet applicable closing conditions; changes in the structure, timing and completion of the proposed transaction between the SPAC and Semnur; the SPAC’s ability to continue its listing on the Nasdaq Capital Market until closing of the proposed transaction; the combined company’s ability to list its securities on Nasdaq after closing of the proposed transaction; the ability of the parties to achieve the benefits of the proposed transaction, including future financial and operating results of the combined company; the ability of the parties to realize the expected synergies from the proposed transaction; risks related to the outcome of any legal proceedings that may be instituted against the parties following the announcement of the proposed business combination; risks associated with the unpredictability of trading markets; general economic, political and business conditions; the risk that the potential product candidates that Scilex develops may not progress through clinical development or receive required regulatory approvals within expected timelines or at all; risks relating to uncertainty regarding the regulatory pathway for Scilex’s product candidates; the risk that Scilex will be unable to successfully market or gain market acceptance of its product candidates; the risk that Scilex’s product candidates may not be beneficial to patients or successfully commercialized; the risk that Scilex has overestimated the size of the target patient population, their willingness to try new therapies and the willingness of physicians to prescribe these therapies; risks that the outcome of the trials and studies for SP-102, SP-103 or SP-104 may not be successful or reflect positive outcomes; risks that the prior results of the clinical and investigator-initiated trials of SP-102 (SEMDEXA™), SP-103 or SP-104 may not be replicated; regulatory and intellectual property risks; and other risks and uncertainties indicated from time to time and other risks described in Scilex’s and the SPAC’s most recent periodic reports filed with the SEC, including their Annual Reports on Form 10-K for the year ended December 31, 2023 and subsequent Quarterly Reports on Form 10-Q that the Company and the SPAC have respectively filed or may file, including the risk factors set forth in those filings. Investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release, and Scilex and the SPAC undertakes no obligation to update any forward-looking statement in this press release except as may be required by law. Contacts: Investors and MediaScilex Holding Company 960 San Antonio RoadPalo Alto, CA 94303Office: (650) 516-4310 Email: investorrelations@scilexholding.com Website: www.scilexholding.com Investors and MediaDenali Capital Acquisition Corp. 437 Madison Avenue, 27th FloorNew York, NY 10022 Reference 1) Source: Celecoxib Oral Solution Approved for Acute Migraine March 2020. https://www.neurologylive.com/view/celecoxib-oral-solution-gets-goahead-for-acute-migraine2) Source: Evaluate Pharma data February 16, 20233) Bunchorntavakul C, Reddy K. Acetaminophen (APAP or N-Acetyl-p-Aminophenol) and Acute Liver Failure. Clin Liver Dis. 2018 May;22(2):325-346. PMID: 296050694) DelveInsight Acute Pain - Market Insight, Epidemiology And Market Forecast – 2032; Dec 2022; https://www.delveinsight.com/report-store/acute-pain-market#:~:text=The%20DelveInsight's%20acute%20pain%20market,be%20either%20acute%20or%20chronic 5) Source: Acute Migraine Headache: Treatment Strategies. https://www.aafp.org/pubs/afp/issues/2018/0215/p243.html6) Data on file. Scilex Holding Company7) Lipton RB, et al. J Pain Res 2021; 14:549-560. SEMDEXA™ (SP-102) is a trademark owned by Semnur Pharmaceuticals, Inc., a wholly-owned subsidiary of Scilex Holding Company. A proprietary name review by the FDA is planned. ZTlido® is a registered trademark owned by Scilex Pharmaceuticals Inc., a wholly-owned subsidiary of Scilex Holding Company. Gloperba® is the subject of an exclusive, transferable license to Scilex Holding Company to use the registered trademark. ELYXYB® is a registered trademark owned by Scilex Holding Company. All other trademarks are the property of their respective owners. © 2024 Scilex Holding Company All Rights Reserved.

PALO ALTO, Calif., Jan. 08, 2024 (GLOBE NEWSWIRE) -- Scilex Holding Company (Nasdaq: SCLX, “Scilex” or “Company”), an innovative revenue-generating company focused on acquiring, developing and commercializing non-opioid pain management products for the treatment of acute and chronic pain, today issued a letter from Jaisim Shah, its Chief Executive Officer and President, to its stockholders highlighting the Company’s accomplishments in 2023 and its forward outlook for 2024. A MESSAGE FROM OUR CHIEF EXECUTIVE OFFICER AND PRESIDENT Dear Scilex Holding Company Stockholders, I would like to express my deepest gratitude for your unwavering support, patience, and invaluable feedback throughout the transformative year in 2023. It is our hope that this communication serves as both a reflection on Scilex’s significant strides in the past year and an insightful preview into the challenges and opportunities that lie ahead in 2024. Our guiding principle has always been and remains a patient-first approach, which drives our mission to meet the increasing global demand for more effective and safer non-opioid pain management solutions. Through rigorous research and development, we believe we are on the cusp of establishing Scilex as the preeminent name in commercial non-opioid pain management, specifically targeting the unmet needs in both acute and chronic pain sectors with our innovative and leading therapies. We've not only responded to the global demand for safer, more effective pain relief solutions but also made substantial progress in demonstrating the rapid onset and enhanced safety of our products. The unmet need in pain management is not just a medical challenge; it's a societal imperative. Every day, countless individuals grapple with pain, yet are left with limited options due to the risks associated with opioid treatments. At Scilex, we recognize our vital role in addressing this unmet need. Our efforts are concentrated on pioneering non-opioid alternatives that are not just innovative but also aim to re-define the standards of safety and accessibility in pain management. As we continue to navigate the complexities of the pharmaceutical landscape, your role as stockholders in this journey is invaluable. Thank you for being an integral part of our mission and for your unwavering belief in our vision. Together, we are not just witnessing, but actively shaping, a pivotal chapter in healthcare history. 2023 Accomplishments We accomplished all of the goals that we set out at the beginning of 2023, including: Built on our late 2022 transformation into an independent publicly traded company listed in Nasdaq under the ticker symbol “SCLX” with three FDA approved non-opioid agents to address acute and chronic pain.Continuous growth for ZTlido®. ZTlido® gross sales for the fiscal year ended December 31, 2023 were in the range of $145.0 million to $150.0 million, compared to $96.0 million for the fiscal year ended December 31, 2022, representing growth in the range of approximately 51% to 56%. ZTlido® net sales for the fiscal year ended December 31, 2023 were in the range of $46.0 million to $52.0 million, compared to $38.0 million for the fiscal year ended December 31, 2022, representing growth in the range of approximately 21% to 37%.ZTlido® profile being viewed as a leading prescription lidocaine patch by pain specialists. Based on the independent market research conducted by Syneos Health Consulting (“Syneos”), with the new campaign, health care providers (HCPs) report increased awareness and substantial intent to utilize for ZTlido® with peak sales potential projected to reach over $500 million in the next 6 years in the U.S.Expanded the market for ZTlido® by entering into a territory distribution agreement for the commercialization of ZTlido® in the Middle East and North Africa (MENA) with $105 Million minimum multi-year purchase commitment.Successfully completed a Good Manufacturing Practices (GMP) inspection by the U.S. Food and Drug Administration (“FDA”) of the enhanced 250kg manufacturing facility in Japan, which assures increased capacity to meet the rapidly growing demand for ZTlido®.Issued two new patents by the U.S. Patent and Trademark Office: (a) Patent No. 11,786,455, titled “Non-aqueous Patch”, which covers a non-aqueous lidocaine patch with certain specifications, as well as a method of relieving pain through the application of a non-aqueous lidocaine-containing patch, and (b) Patent No. 11,793,766, titled “Non-aqueous Patch for the Relief of Pain”, which covers a method of relieving pain through the application of a lidocaine-containing patch. These two new patents further strengthen the Company’s intellectual property position and coverage for ZTlido®, and will not expire until 2031. These two new issued patents will be listed in the FDA’s Orange Book in connection with ZTlido®.Continued to add ZTlido® as a preferred agent to the Medicaid Preferred Drug List (PDL) in a number of U.S. States.ZTlido® was recognized as the most prescribed non-opioid branded pain treatment by pain specialists, according to Prescription Data from Symphony Health.Acquired rights to ELYXYB® (celecoxib oral solution) in the U.S. and Canada, the only FDA-approved ready-to-use oral solution for the acute treatment of migraine, with or without aura, in adults, and successfully launched ELYXYB® in the U.S. in April 2023. Launched major pharmacy initiative with two leading national pharmacy chains to stock ELYXYB® in most of their stores throughout the U.S.Expanded access to ELYXYB® by the execution of the first ELYXYB® insurance coverage agreement with one of the top three national Pharmacy Benefit Manager’s for its Medicare population.Filed a New Drug Submission (NDS) with Health Canada’s Pharmaceutical Drugs Directorate, Bureau of Cardiology, Allergy and Neurological Sciences for the approval of ELYXYB® for acute treatment of migraine with or without aura in Canada.Continued preparing for the potential launch of Gloperba® in 2024. Scilex is well-positioned to market and distribute Gloperba®. Scilex has a direct distribution network to national and regional wholesalers and pharmacies throughout the U.S., and an experienced commercial and managed care team that has successfully launched and grown market access for ZTlido® (lidocaine topical system) to more than 225 million covered lives in the U.S. as well as successfully launching ELYXYB® (celecoxib oral solution) in the U.S.Completed SP-103 (lidocaine topical system) 5.4%, Triple Strength Formulation of ZTlido®, Phase 2 trial which achieved its objectives to evaluate the safety and efficacy of SP-103 in subjects with moderate to severe acute lower back pain (LBP).Held positive Type C meeting with the FDA and reached agreement on path forward to file a New Drug Application (NDA) for SP-102 (SEMDEXATM) in lumbosacral radicular pain (Sciatica). Scilex is planning to commence an open-label multi-center safety and efficacy trial in the first half of 2024 in which it will seek to enroll approximately 700 patients with moderate-to-severe Lumbosacral Radicular Pain (LRP) requiring an epidural steroid injection. SP-102 (SEMDEXATM) is expected to be administered in up to 3 injections during a 6-month observation period. Completion of enrollment in the trial is projected to occur in 2025.Repurchased all of the shares of Scilex common stock and preferred stock and warrants previously owned by our former parent company, Sorrento Therapeutics, Inc. Outlook for 2024 The lessons learned from the challenges we faced as a company in 2023 have positioned us for incredible opportunities in 2024, as the team has laid the foundation for the execution of a commercially appealing strategy which will transform how Scilex is viewed on the world stage. We are determined to continue to expand our pain management products and product candidates and mark a major milestone in our strategy to build a robust offering of novel, non-opioid treatments to improve patient care along the acute and chronic pain pathway. Importantly, ZTlido®, ELYXYB®, and Gloperba® will enhance our topline, and we believe will provide meaningful synergies that we expect to drive substantial near- and long-term accretion to our cash flows and earnings. Despite the challenges that remain ahead, we are setting ambitious goals for the Company in 2024, including: Expected launch of Gloperba®. Gloperba® is the first line therapy and first and only liquid oral version of the anti-gout medicine colchicine indicated for the prophylaxis of painful gout flares in adults. Gout is a painful arthritic disorder affecting an estimated 9.2 million people in the United States.(1) As gout cases increase every year, treatment requirements increase. The gout treatment market is projected to reach $2.0 billion in the U.S. by 2028 with a well-defined area of unmet need.(2)Seek FDA approval for the modification of Gloperba® label to address unmet medical needs and to provide specific dosing guidance to patients with renal impairment.Continue to grow our gross sales with a goal of exceeding $200 million.Seek FDA approval of ELYXYB® in acute pain in the U.S. ELYXYB®, a rapid onset and ready to use formulation of Celecoxib, delivers a first line non-opioid therapeutic alternative to habit-forming opioids and acetaminophen, the leading cause of acute liver failure in the U.S.(3) DelveInsight estimates there were approximately 100 million cases of acute pain in the United States and that the total acute pain market in the U.S. was approximately $3 billion in 2021.(4)Continue to develop our novel clinical pipeline with the goal of launching another product from one of our pipeline molecules within 24 months. We will utilize existing data to advance our clinical research program, and work with leading researchers to get the best possible data for assessment by regulators.Initiation of ELYXYB® pediatric study for migraine.Finalize plan with FDA for Phase 2/3 study for SP-103 in acute pain.Initiation of SP-102 chemistry, manufacturing and controls (CMC) activities for commercial scale manufacturing for NDA filing in the U.S.File ZTlido® applications in ex-US markets. We will work to launch our product and develop a distribution network in Middle East to serve the new ZTlido® market there, while continuing to support our clinical trials and other potential customers around the world.Prepare for the next major international change affecting the demand for non-opioid therapeutics and be ready to capitalize on that change.Continue to enhance our product portfolio by in-licensing and out-licensing commercial products.Continue to enhance stockholder value and optimize our capitalization structure. As we look beyond our immediate goals, it's important to recognize the foundational beliefs that have guided the creation and growth of our company: True stability comes from revenue generating products that not only meet significant medical needs but also have a strong commercialization track record.The pace at which a company moves from development to commercialization is a key determinant of success. By focusing on projects with a higher likelihood of market entry, a firm can not only innovate but also realize quicker returns and greater market impact.n an era marked by the opioid crisis, there is a vital need for timely and effective non-opioid solutions. Companies that respond to such urgent needs, especially in pain management, are not just making a business move; they are addressing a critical societal imperative recognized by both regulators and healthcare providers. There are many challenges that we have to overcome before our goals can become reality, but as a leading non-opioid therapeutics company, we know that we have a valuable and important role to play as a supplier for our patients. Our focus is on fostering robust relationships with all stakeholders – including patients, neurologists, pain specialists, rheumatologists, distributors, and clinic health care professionals. This collaboration is key to ensuring that prescribers have access to our comprehensive portfolio of non-opioid drugs, with the ultimate aim of significantly improving patient lives. In closing, my heartfelt thanks go to the remarkable team at Scilex. Your unwavering dedication, creativity, and resilience are the driving forces behind our success. To our partners, our stockholders, and our dedicated board members: thank you for your confidence in us as we continue to forge ahead with our mission. Best Regards, Jaisim ShahChief Executive Officer and PresidentScilex Holding Company About Scilex Holding Company Scilex Holding Company is an innovative revenue-generating company focused on acquiring, developing and commercializing non-opioid pain management products for the treatment of acute and chronic pain. Scilex is uncompromising in its focus to become the global pain management leader committed to social, environmental, economic, and ethical principles to responsibly develop pharmaceutical products to maximize quality of life. Results from the Phase III Pivotal Trial C.L.E.A.R. Program for SEMDEXATM, its novel, non-opioid product for the treatment of lumbosacral radicular pain (sciatica), were announced in March 2022. Scilex participated in the type C meeting for purposes of pre-NDA discussion with the FDA and reached agreement on a path forward to file an NDA for SP-102 (SEMDEXATM) in Lumbosacral Radicular Pain (Sciatica) with the FDA. Scilex targets indications with high unmet needs and large market opportunities with non-opioid therapies for the treatment of patients with moderate to severe pain. Scilex launched its first commercial product ZTlido® in October 2018, in-licensed a commercial product Gloperba® in June 2022, and launched its third FDA-approved product Elyxyb® in April 2023. It is also developing its late-stage pipeline, which includes a pivotal Phase 3 candidate, and one Phase 2 and one Phase 1 candidate. Its commercial product, ZTlido® (lidocaine topical system) 1.8%, or ZTlido®, is a prescription lidocaine topical product approved by the U.S. Food and Drug Administration for the relief of pain associated with post-herpetic neuralgia, which is a form of post-shingles nerve pain. Scilex in-licensed the exclusive right to commercialize Gloperba® (colchicine USP) oral solution, an FDA-approved prophylactic treatment for painful gout flares in adults, in the U.S. Scilex in-licensed the exclusive rights to commercialize Elyxyb® (celecoxib oral solution) in the U.S. and Canada, the only FDA-approved ready-to-use oral solution for the acute treatment of migraine, with or without aura, in adults. Scilex launched Elyxyb® in April 2023, and is planning to commercialize Gloperba® by 2024, and is well-positioned to market and distribute those products. Scilex’s three product candidates are SP-102 (injectable dexamethasone sodium phosphate viscous gel product containing 10 mg dexamethasone), or SEMDEXA™, a Phase 3, novel, viscous gel formulation of a widely used corticosteroid for epidural injections to treat lumbosacral radicular pain, or sciatica, with FDA Fast Track status; SP-103 (lidocaine topical system) 5.4%, a Phase 2 study, triple-strength formulation of ZTlido®, for the treatment of chronic neck pain. We received our SP-103 Phase 2 top-line results in August 2023 and the trial achieved its objectives characterizing safety, tolerability and preliminary efficacy of SP-103 in acute low back pain associated with muscle spasms. SP-103 was safe and well-tolerated. Increase of lidocaine load in topical system by three times, compared with approved ZTlido, 5.4% vs. 1.8%, did not result in signs of systemic toxicity or increased application site reactions with daily applications over one month treatment. SP-103 received FDA Fast Track status in low back pain. We will continue to analyze the SP-103 Phase 2 trial data along with a recently completed investigator study of ZTlido in patients with chronic neck pain which also has showed promising top-line efficacy and safety results. Scilex is planning to initiate Phase 2/3 trial in chronic neck pain in 2024; and SP-104, 4.5 mg Delayed Burst Release Low Dose Naltrexone Hydrochloride (DBR-LDN) Capsule, for the treatment of chronic pain, fibromyalgia that has completed multiple Phase 1 trial programs and is expected to initiate Phase 2 trials in 2024. Scilex Holding Company is headquartered in Palo Alto, California. Forward-Looking Statements This press release and any statements made for and during any presentation or meeting concerning the matters discussed in this press release contain forward-looking statements related to Scilex and its subsidiaries under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995 and are subject to risks and uncertainties that could cause actual results to differ materially from those projected. Forward-looking statements include statements regarding the Company’s preliminary unaudited financial results for the fiscal year ended December 31, 2023, the Company’s outlook, goals and expectations for 2024, projected figures for ZTlido peak sales in the next six years, the Company’s ongoing preparations for the expected launch of Gloperba in 2024, the Company’s plans to commence an open label trial for SP-102 and the anticipated enrollment timing and figures, projections and goals for the Company’s gross sales figures, the status of any ongoing discussions with the FDA and other regulators, the Company’s plans for launching other pipeline products and plans to file ZTlido applications in ex-U.S. markets, the timing of the FDA’s review process and whether the FDA approves the sNDA for ELYXYB, ELYXYB’s potential to further expand Scilex’s non-opioid portfolio and its potential to address high unmet needs in treating acute pain, the potential market size and the size of the patient population for acute pain in the U.S., Scilex’s plans to initiate a Phase 2/3 trial in chronic neck pain in 2024 and plans to initiate Phase 2 trials in 2024 for SP-104, Scilex’s belief that it is well positioned to continue its growth over the next several years, Scilex’s long-term objectives and commercialization plans, Scilex’s potential to attract new capital, future opportunities for Scilex, Scilex’s future business strategies, the expected cash resources of Scilex and the expected uses thereof; Scilex’s current and prospective product candidates, planned clinical trials and preclinical activities and potential product approvals, as well as the potential for market acceptance of any approved products and the related market opportunity; statements regarding ZTlido®, Gloperba®, ELYXYB®, SP-102 (SEMDEXA™), SP-103 or SP-104, if approved by the FDA; Scilex’s development and commercialization plans; and Scilex’s products, technologies and prospects. Risks and uncertainties that could cause Scilex’s actual results to differ materially and adversely from those expressed in our forward-looking statements, include, but are not limited to: the risk that Scilex’s actual unaudited financial results for the fiscal year ended December 31, 2023, and any projections or estimates for sales figures may differ from those set forth in this press release, risks associated with the unpredictability of trading markets and whether a market will be established for Scilex’s common stock; general economic, political and business conditions; risks related to COVID-19 (and other similar disruptions); the risk that the potential product candidates that Scilex develops may not progress through clinical development or receive required regulatory approvals within expected timelines or at all; risks relating to uncertainty regarding the regulatory pathway for Scilex’s product candidates; the risk that Scilex will be unable to successfully market or gain market acceptance of its product candidates; the risk that Scilex’s product candidates may not be beneficial to patients or successfully commercialized; the risk that Scilex has overestimated the size of the target patient population, their willingness to try new therapies and the willingness of physicians to prescribe these therapies; risks that the outcome of the trials for SP-102, SP-103 or SP-104 may not be successful; risks that the prior results of the clinical trials of SP-102 (SEMDEXA™), SP-103 or SP-104 may not be replicated; regulatory and intellectual property risks; and other risks and uncertainties indicated from time to time and other risks set forth in Scilex’s filings with the Securities and Exchange Commission. Investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release, and Scilex undertakes no obligation to update any forward-looking statement in this press release except as may be required by law. Contacts: Investors and MediaScilex Holding Company 960 San Antonio RoadPalo Alto, CA 94303Office: (650) 516-4310 Email: investorrelations@scilexholding.com Website: www.scilexholding.com References https://jamanetwork.com/journals/jama/fullarticle/2787544#:~:text=How%20Common%20Is%20Gout%3F,%25%20of%20the%20adult%20population Evaluate Pharma dataBunchorntavakul C, Reddy K. Acetaminophen (APAP or N-Acetyl-p-Aminophenol) and Acute Liver Failure. Clin Liver Dis. 2018 May;22(2):325-346. PMID: 29605069DelveInsight Acute Pain - Market Insight, Epidemiology And Market Forecast – 2032; Dec 2022; https://www.delveinsight.com/report-store/acute-pain-market#:~:text=The%20DelveInsight's%20acute%20pain%20market,be%20either%20acute%20or%20chronic # # # SEMDEXA™ (SP-102) is a trademark owned by Semnur Pharmaceuticals, Inc., a wholly-owned subsidiary of Scilex Holding Company. A proprietary name review by the FDA is planned. ZTlido® is a registered trademark owned by Scilex Pharmaceuticals Inc., a wholly-owned subsidiary of Scilex Holding Company. Gloperba® is the subject of an exclusive, transferable license to use the registered trademark by Scilex Holding Company. ELYXYB® is the subject of an exclusive, transferable license to use the registered trademark by Scilex Holding Company. All other trademarks are the property of their respective owners. © 2024 Scilex Holding Company All Rights Reserved.