Sorrento Therapeutics, Inc.

Plus, news about Anthos, Ascendis, Royalty Pharma, Semnur, Sonoma, Atara, Feldan, Indivior, Aelis Farma and Acepodia: Vaxcyte launches $1B offering: The raise comes fresh off the company’s pneumococcal vaccine data that sent its stock $PCVX soaring on Tuesday. Vaxcyte selected VAX-31 to advance to a Phase 3 trial in mid-2025 over another vaccine, VAX-24. It can tack on an additional $150 million if all the options are exercised. — Max Gelman Genentech to lay off 93 staffers: In another round of layoffs, Roche’s Genentech is cutting 93 roles at its South San Francisco site starting in October, according to a Californian WARN notice. The site houses over 40 buildings and includes scientific research, manufacturing and other business functions. Genentech said earlier this year that it has plans to cut around 400 workers and restructure its portfolio . — Anna Brown Anthos Therapeutics suggests patients can stay on experimental anticoagulant before surgery: The company on Tuesday shared additional data from a clinical study of its once-monthly factor XI antibody treatment in people with atrial fibrillation, suggesting they do not need to interrupt treatment with abelacimab before elective procedures. In the study, people on the control arm received Xarelto and were allowed to stop taking it 24 to 48 hours prior to their procedure. Seven of 852 patients (0.8%) in the abelacimab arm had major procedure-related bleeds, compared to 6 of 428 (1.4%) in the Xarelto arm. — Lei Lei Wu Ascendis snags $150M in new Royalty Pharma deal: Less than a month after snagging FDA approval for Yorvipath, Ascendis is selling off US royalties of the hypoparathyroidism drug. In exchange for paying $150 million upfront, Royalty Pharma gets 3% royalties on new US sales. The length of the payments is contingent on how quickly Royalty earns back its investment. — Max Bayer Semnur hits Wall Street via SPAC: The company is merging with special-acquisition company Denali Capital Acquisition Corp. in a $2.5 billion deal. Semnur is owned by Scilex Holding Company, which itself took the SPAC route to go public in 2022. — Max Bayer Sonoma Biotherapeutics records $45M milestone: The payment from Regeneron Pharmaceuticals stems from a deal inked in 2023 to develop and commercialize T cell therapies for inflammatory bowel disease and two other undisclosed indications. — Jaimy Lee Atara Biotherapeutics seeks $36M: The company raised the money in a registered direct offering, getting funding from Redmile Group, EcoR1 Capital and Adiumentum Capital Management. An unnamed “large public biotechnology company” also participated in the offering. — Max Gelman Feldan Therapeutics closes $21M Series B: The money will go toward completing a Phase 1/2a trial for the company’s non-invasive intralesional treatment for basal cell carcinoma, which is meant to be an alternative to surgery. Genesys Capital and Fonds de solidarité FTQ co-led the round . — Katherine Lewin Indivior, Aelis Farma drug fails Phase 2b trial: A study investigating a treatment for patients with moderate-to-severe cannabis use disorder didn’t hit the primary or secondary endpoints. The primary endpoint was the proportion of participants who reduced their cannabis use to one day or less per week. Indivior said it will not exercise an exclusive option to license the global rights to the treatment. — Katherine Lewin Acepodia inks Pfizer Ignite collab: The company is collaborating with Pfizer Ignite to advance its off-the-shelf cell therapies to treat autoimmune diseases. Financial terms weren’t disclosed. Acepodia said it retained all rights to its lead program, ACE1831, and Pfizer Ignite “will provide strategic guidance and resources.” — Max Bayer

In a deal announcement, Semnur Pharmaceuticals' parent company touted the commercial potential of Semdexa for sciatica pain. Semnur Pharmaceuticals, which is working on a non-opioid prospect for sciatica, has agreed to merge with special purpose acquisition company Denali Capital Acquisition Corp. in a deal worth $2.5 billion.Upon closure of the deal, which is expected by the first quarter of 2025, Semnur plans to continue the road to potential commercialization for its lead candidate Semdexa. Semdexa is an injectable corticosteroid gel formulation of dexamethasone sodium phosphate that’s meant to treat patients with moderate to severe lumbosacral radicular pain, or sciatica. The condition causes pain in patients' lower back and hips, symptoms that are often treated with opioids, Semnur’s parent company Scilex Holding Company has previously noted.In a phase 3 study of 401 patients, treatment with Semdexa triggered a “rapid onset” of pain relief and continued to reduce pain intensity for over one month, Scilex said in March 2022. If approved, the med would be the first cleared to specifically treat the condition.In a pain field where UCB and Biogen have have come up short, Semdexa could represent a major commercial boon. The drug could rake in sales of $1.5 billion to $2 billion by the fifth year of launch in just the sciatica indication, Scilex has forecast, citing independent market research by Syneos Health Consulting.The treatment holds an FDA fast-track designation, and a 700-patient trial needed to support a potential approval was previously projected to finish enrollment in 2025.  “With Semnur on its way to becoming a publicly-traded company, our unique model continues to demonstrate the multiple ways that we can unlock the value of Scilex and enhance our shareholders’ value,” Scilex’s CEO Jaisim Shah said in the company’s release. “I believe this business combination will enable us to advance our growth strategy, which includes gaining access to public markets and exploring potential partnerships and global pharma collaborations for our product candidate, Semdexa.”Scilex, a former subsidiary of troubled Sorrento Therapeutics, also made its way to the U.S. public markets through a SPAC merger with Vickers Vantage Corp. in a deal that closed in 2022. The company now markets migraine treatment Elyxyb and gout flare preventative Glopera as well as pain patch ZTlido.

PALO ALTO, Calif., Aug. 30, 2024 (GLOBE NEWSWIRE) -- Scilex Holding Company (Nasdaq: SCLX, “Scilex” or the “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 oral, poster presentations, and symposia on ZTlido (lidocaine topical system) at the 2024 Annual PAINWeek conference in Las Vegas, NV on September 3-5, 2024. Key highlights of the ZTlido (lidocaine topical system) 1.8% presentation: September 4, 2024 (Wednesday) NON-CME Presentation in the Castellana Ballroom. 12:00PM PT - 1:00PM PT TITLE: What to do when pain relief with Gabapentinoids isn’t enough? SPEAKER: Dr. Charles Argoff DESCRIPTION: Gabapentinoids (gabapentin and pregabalin) are the foundational analgesics used to treat neuropathic pain of PHN, and their usage has grown rapidly in recent years given increasing scrutiny around opioid prescribing. The unmet need, though, remains high, given the challenges with titrating them to an effective dose. Dr Charles Argoff will review what analgesic options exist to optimize gabapentinoids, and the trade-offs that come with different agents. Dr. Argoff is Professor of Neurology and Director of the Comprehensive Pain Program at Albany Medical Center in New York. He is an internationally renowned for his work in Pain Management - in research, teaching and patient care, and serves as the President of AAPM (American Academy of Pain Management). September 5, 2024 (Thursday) 5:50PM PT – 6:00PM PT: Decreased Opioid Utilization with Lidocaine Topical System 1.8% Compared to Lidocaine 5% Patch: A Retrospective Claims Analysis to be Presented by Srinivas Nalamachu, M.D. 6:05PM PT – 6:15PM PT: Decreased Cost Utilization with Lidocaine Topical System 1.8% Compared to Lidocaine 5% Patch: A Retrospective Claims Analysis to be Presented by Srinivas Nalamachu, M.D. For more information on Scilex Holding Company, refer to . For more information on Scilex Holding Company Sustainability Report, refer to . For more information on ZTlido ® including Full Prescribing Information, refer to . For more information on ELYXYB ® , including Full Prescribing Information, refer to . For more information on Gloperba ® , including Full Prescribing Information, refer to . 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 is 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) (“SEMDEXA™” 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. 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 estimates for the gout treatment market and affected patient population, estimates for potential demand for Gloperba, the belief that Scilex is well-positioned to market and distribute Gloperba, Scilex’s expectations for Gloperba to be the first liquid colchicine formulation allowing providers to prescribe precision dosing and Scilex’s expectations for Gloperba to last more than 30 days in patients who are treated with lower doses than 0.6 mg. 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: 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 most recent periodic reports filed with the Securities and Exchange Commission, including Scilex’s Annual Report on Form 10-K for the year ended December 31, 2023 and subsequent Quarterly Reports on Form 10-Q that the Company has 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 undertakes no obligation to update any forward-looking statement in this press release except as may be required by law. Contacts: Investors and Media Scilex Holding Company 960 San Antonio Road Palo Alto, CA 94303 Office: (650) 516-4310 Email: investorrelations@scilexholding.com Website: 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.