Sorrento Therapeutics, Inc.

The anti-CD38 mAb market is projected to experience substantial growth in the coming years owing to strong uptake of DARZALEX (along with DARZALEX FASPRO), the expected entry of subcutaneous formulation of SARCLISA in Multiple Myeloma. This growth is also driven by a rising number of cancer and autoimmune disorder diagnoses, as well as an increasing number of Anti-CD38 mAbs undergoing clinical trials and seeking approval. LAS VEGAS, Oct. 23, 2024 /PRNewswire/ -- DelveInsight's Anti-CD38 mAb Market Insights report includes a comprehensive understanding of current treatment practices, emerging anti-CD38 mAb, market share of individual therapies, and current and forecasted anti-CD38 mAb market size from 2020 to 2034, segmented into 7MM [the United States, the EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan]. Key Takeaways from the Anti-CD38 mAb Market Report As per DelveInsight's analysis, the total market size of anti-CD38 mAb in the 7MM is expected to surge significantly by 2034. Multiple Myeloma is the only indication for which anti-CD38 therapies, Johnson&Johnson's (J&J) DARZALEX and Sanofi's SARCLISA have been approved until now. Around 50% of DARZALEX usage comes from second-line treatment in Multiple Myeloma. Additionally, in the frontline multiple myeloma clinical trials, DARZALEX has emerged triumphant, surpassing all expectations and solidifying its position as the gold standard of therapy. Its unparalleled effectiveness and exceptional safety profile have exceeded rivals' predictions and soon positioned DARZALEX to dominate the multiple myeloma market. The filing submission of SARCLISA subcutaneous in 3L R/R MM (IRAKLIA) is anticipated in 2025 and beyond. Somehow, SARCLISA is way behind DARZALEX in terms of market expansion, and DARZALEX has also got an early mover advantage of over 4 years. Multiple Myeloma is the leading indication, other emerging indications with commercial opportunity include Systemic Lupus Erythematosus (SLE), Chronic Kidney Disease (CKD), and IgA Nephropathy Leading emerging anti-CD38 mAb companies such as Takeda Pharmaceuticals, HI-Bio, Genmab, CASI Pharmaceuticals, and others are developing novel anti-CD38 mAb that can be available in the market in the coming years. Some of the key anti-CD38 mAb in the pipeline include Mezagitamab (TAK-079), Felzartamab, GEN3014, CID-103 , and others. In June 2024, data from the IMROZ Phase III study by Sanofi demonstrated that SARCLISA is the first anti-CD38 to significantly improve progression-free survival in combination with bortezomib, lenalidomide, and dexamethasone (VRd) for newly diagnosed transplant-ineligible multiple myeloma. In May 2024, Biogen and Human Immunology Biosciences (HI-Bio), announced the companies have entered into a definitive agreement under which Biogen has agreed to acquire HI-Bio for USD 1.15 billion upfront and up to USD 650 million in potential milestone payments. Discover which therapies are expected to grab the anti-CD38 mAb market share @ Anti-CD38 mAb Market Report Anti-CD38 mAb Market Dynamics The market for anti-CD38 mAbs has undergone significant growth and transformation in recent years, driven primarily by the increasing prevalence of multiple myeloma and the d emand for more effective treatment options. The market dynamics are further influenced by ongoing research into the broader application of anti-CD38 mAbs beyond multiple myeloma. There is growing interest in exploring their efficacy in other CD38-expressing malignancies, such as chronic lymphocytic leukemia and certain solid tumors. Additionally, research into combination therapies, where anti-CD38 mAbs are paired with immune checkpoint inhibitors, CAR-T cells, or other novel agents, is expanding the horizon for these treatments. Such advancements are likely to further propel the market, attracting substantial investment and fueling innovation. However, challenges such as biosimilar competition, pricing pressures, and the need for differentiation in a crowded market pose potential hurdles. The entrance of biosimilars could reduce costs but also threaten market share for existing products. Companies must navigate these challenges through strategic pricing, market access strategies, and continuous innovation to maintain their competitive edge. The anti-CD38 mAb market is poised for continued expansion, with a promising pipeline of new therapies and combinations on the horizon, making it a dynamic and evolving sector within oncology. Anti-CD38 mAb Treatment Market Monoclonal antibodies targeting CD38 are crucial in the treatment of newly diagnosed and refractory multiple myeloma. Currently, DARZALEX and SARCLISA are the two approved anti-CD38 therapies. SARCLISA is a prescription medication used to treat multiple myeloma in adults. It is administered alongside pomalidomide and dexamethasone for patients who have undergone at least two previous treatments, including lenalidomide and a proteasome inhibitor. Additionally, SARCLISA is used with carfilzomib and dexamethasone for patients who have received one to three prior therapies that were either ineffective or have stopped working. In March 2020, the US FDA approved SARCLISA in combination with pomalidomide and dexamethasone for multiple myeloma patients who had at least two prior therapies, including lenalidomide and a proteasome inhibitor. Later, in May 2020, the European Commission approved SARCLISA. By March 2021, the US FDA also approved SARCLISA with carfilzomib and dexamethasone for those with relapsed or refractory multiple myeloma who had received one to three previous treatments. DARZALEX is an innovative monoclonal antibody that the US FDA approved for treating multiple myeloma in patients with at least one prior treatment. It works by inducing tumor cell death through several mechanisms, including antibody-dependent cell-mediated cytotoxicity, complement-dependent cytotoxicity, and antibody-dependent cellular phagocytosis. In November 2015, the FDA granted DARZALEX accelerated approval as a monotherapy for multiple myeloma patients who had undergone at least three prior treatments. By November 2016, it was also approved for use in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for patients who had received at least one prior therapy. From 2015 to 2021, DARZALEX gained further approvals for use in various drug combinations. Their effectiveness in managing multiple myeloma and plasma cell disorders has been confirmed by numerous Phase III clinical trials. Moreover, CD38-targeted therapies are being explored for other conditions such as primary immune thrombocytopenia, IgA nephropathy, antibody-mediated transplant rejection, lupus nephritis, and various hematologic cancers. Learn more about the FDA-approved anti-CD38 mAb @ Anti-CD38 mAb Drugs Key Emerging Anti-CD38 mAb and Companies Several key players, including Takeda Pharmaceuticals, HI-Bio, CASI Pharmaceuticals, and others, are involved in developing drugs for Anti-CD38 mAb for various indications such as multiple myeloma, myasthenia gravis, and others. Mezagitamab is a fully human IgG1 monoclonal antibody that targets CD38 and is being developed by Takeda for the treatment of multiple myeloma, myasthenia gravis, and primary immune thrombocytopenia. On March 14, 2024, the FDA granted Fast Track designation and Orphan Drug status to mezagitamab for idiopathic thrombocytopenic purpura (ITP). Takeda also revealed plans to begin a global Phase III trial for mezagitamab in ITP later in 2024. The drug is currently in Phase II of clinical development. HI-Bio's leading candidate, felzartamab, is a fully human anti-CD38 monoclonal antibody. Clinical studies have demonstrated its ability to selectively target and deplete CD38+ cells, including plasma cells and NK cells, potentially enabling broader therapeutic applications and enhanced clinical outcomes across various immune-mediated diseases. Felzartamab has been granted Breakthrough Therapy and Orphan Drug Designations by the FDA for primary membranous nephropathy and also received Orphan Drug Designation for treating antibody-mediated kidney transplant recipients. Phase II trials have been completed for primary membranous nephropathy and antibody-mediated transplant rejection, with ongoing studies in IgA nephropathy. HI-Bio intends to progress each of these indications to Phase III. The anticipated launch of these emerging therapies are poised to transform the anti-CD38 mAb market landscape in the coming years. As these cutting-edge therapies continue to mature and gain regulatory approval, they are expected to reshape the anti-CD38 mAb market landscape, offering new standards of care and unlocking opportunities for medical innovation and economic growth. To know more about anti-CD38 mAb clinical trials, visit @ Anti-CD38 mAb Treatment Drugs Anti-CD38 mAb Overview Anti-CD38 monoclonal antibodies (mAbs) are a class of therapeutic agents that target CD38, a surface protein widely expressed on plasma cells, including malignant ones in multiple myeloma. By binding to CD38, these mAbs can induce direct cytotoxicity, promote antibody-dependent cellular cytotoxicity (ADCC), and facilitate complement-dependent cytotoxicity (CDC) to destroy the targeted cells. Beyond their role in multiple myeloma, anti-CD38 mAbs are being explored for their potential in treating other hematologic malignancies and autoimmune diseases. CD38 is not only a marker for plasma cells but also involved in processes like calcium signaling and NAD+ metabolism, which are crucial for cell survival and proliferation. By targeting CD38, these antibodies can modulate the immune microenvironment, making them a promising tool for both oncology and immunology. The ongoing research is focused on optimizing their efficacy, managing resistance, and exploring their use in combination with other immunotherapies to enhance patient outcomes. Anti-CD38 mAb Epidemiology Segmentation Epidemiology assessed for multiple myeloma showed that the United States, in 2023, accounted for 36,800 incident cases of multiple myeloma. The anti-CD38 mAb market report proffers epidemiological analysis for the study period 2020–2034 in the 7MM segmented into: Total Incident Cases of Selected Indication for Anti-CD38 mAb Total Eligible Patient Pool for Anti-CD38 mAb in Selected Indication Total Treatable Cases of Selected Indications for Anti-CD38 mAb Scope of the Anti-CD38 mAb Market Report Anti-CD38 mAb Therapeutic Assessment: Anti-CD38 mAb current marketed and emerging therapies Anti-CD38 mAb Market Dynamics: Conjoint Analysis of Emerging Anti-CD38 mAb Drugs Competitive Intelligence Analysis: SWOT analysis and Market entry strategies Unmet Needs, KOL's views, Analyst's views, Anti-CD38 mAb Market Access and Reimbursement Discover more about anti-CD38 mAb in development @ Anti-CD38 mAb Clinical Trials Table of Contents Related Reports Multiple Myeloma Market Multiple Myeloma Market Insight, Epidemiology and Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key multiple myeloma companies, including Johnson & Johnson (Janssen), Pfizer, AbbVie and Roche (Genentech), Regeneron Pharmaceuticals, Bristol-Myers Squibb, Celgene, Roche (Genentech), Arcellx, Novartis, Regeneron Pharmaceuticals, BeiGene, CARsgen Therapeutics, Cartesian Therapeutics, C4 Therapeutics, Heidelberg Pharma, Bristol-Myers Squibb, RAPA Therapeutics, AbbVie (TeneoOne), Takeda , among others. Multiple Myeloma Pipeline Multiple Myeloma Pipeline Insight – 2024 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key multiple myeloma companies, including Janssen, Pharmacyclics, Novartis, Incyte Corporation, Gracell Biotechnology, SpringWorks Therapeutics, Sana Biotechnology, Cytovia Therapeutics, Pfizer, MorphoSys, Biokine Therapeutics, Arcellx, Rapa Therapeutics, iTeos Therapeutics, Sorrento Therapeutics, CARsgen, Ascentage Pharma, Cartesian Therapeutics, Bristol-Myers Squibb, Juno Therapeutics, Nanjing IASO Biotherapeutics, Arch Oncology, Oncoceutics, TeneoBio, Nerviano Medical Sciences, among others. Relapse/Refractory Multiple Myeloma Market Relapse/Refractory Multiple Myeloma Market Insights, Epidemiology, and Market Forecast – 2032 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key R/R multiple myeloma companies, including NexImmune, Amgen, AbbVie, Allogene Therapeutics, Precision Biosciences, Takeda Oncology, ORIC Pharmaceuticals, Ionis Pharmaceuticals, Cellectis S.A., YZY Biopharma, Janssen Research & Development, Bristol Myers Squibb, Lava Therapeutics, Prelude Therapeutics, among others. Relapse/Refractory Multiple Myeloma Pipeline Relapse/Refractory Multiple Myeloma Pipeline Insight – 2024 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key R/R multiple myeloma companies, including Bristol-Myers Squibb, I-MAB Biopharma, Pfizer, Arcellx, Gilead Sciences, Novartis, Array Biopharma, Hrain Biotechnology Co., Ltd., Cartesian Therapeutics, Xencor, Takeda, Sorrento Therapeutics, Heidelberg Pharma AG, Ichnos Sciences, Allogene Therapeutics, Harpoon Therapeutics, Cellectis, Poseida Therapeutics, Regeneron Pharmaceuticals, ONK Therapeutics, TeneoOne, iTeos Therapeutics, Oricell Therapeutics, Anaveon AG, Luminary Therapeutics, Seagen Inc., Trillium Therapeutics Inc., Virtuoso BINco, Inc., Seagen Inc., Trillium Therapeutics Inc., among others. About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve . Contact Us Shruti Thakur [email protected] +14699457679 Logo: SOURCE DelveInsight Business Research, LLP WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

UCB and Biogen reported encouraging topline findings from the Phase III PHOENYCS GO trial, which assessed dapirolizumab pegol, a novel Fc-free anti-CD40L drug candidate, in individuals with moderate-to-severe SLE. The promising outcomes with dapirolizumab pegol signify significant advancements in creating treatments that can enhance the quality of life for individuals with lupus, a condition that continues to have considerable unmet medical needs, particularly impacting women. LAS VEGAS, Oct. 7, 2024 /PRNewswire/ -- Systemic lupus erythematosus is a long-lasting autoimmune disorder that can impact various areas of the body. Lupus arises when the immune system, typically responsible for defending against infections and illnesses, mistakenly targets the body's own tissues. This misguided response leads to inflammation and, in some instances, lasting damage to tissues, potentially affecting a wide range of organs including the skin, joints, heart, lungs, kidneys, blood cells, and brain. As per the estimates, the prevalence of systemic lupus erythematosus in the United States is approximately 500K cases in 2023. In females, prevalence rates are observed to be much greater than that of males, constituting more than 90% of the total prevalent cases in the US. In 2023, among the treated SLE patients, nearly 40% of patients became relapsed or refractory after the first line of therapy. The main goals of SLE treatment are to alleviate symptoms, prevent or reduce organ damage and disease flare-ups, minimize drug toxicity, and improve the patient's overall quality of life. The SLE treatment plan primarily includes antimalarial medications (like hydroxychloroquine), glucocorticoids (such as prednisone or similar), immunosuppressive drugs (including methotrexate, azathioprine, or mycophenolate), and biologics, in addition to nonsteroidal anti-inflammatory drugs (NSAIDs) for managing inflammation and pain. Biologics are specifically used for patients who do not respond to standard treatments or for those with severe, organ-threatening diseases. Currently, the biologics approved by the US FDA as adjunct therapies for SLE patients are BENLYSTA and SAPHNELO. In contrast, the use of rituximab for treating SLE is considered off-label. Learn more about the FDA-approved SLE drugs @ Drugs for Systemic Lupus Erythematosus Treatment BENLYSTA (belimumab) is a fully human monoclonal antibody that targets and inhibits BLyS (B-lymphocyte stimulator), a protein found at elevated levels in patients with systemic autoimmune diseases such as systemic lupus erythematosus and lupus nephritis. By binding to soluble BLyS, BENLYSTA prevents the prolonged survival of B cells, including autoreactive B cells, and reduces their differentiation into plasma cells that produce immunoglobulins. However, BENLYSTA does not directly bind to B cells. First approved by the US FDA in 2011, it is the only biologic therapy approved for the treatment of active SLE and LN in more than 50 years, including for pediatric patients. SAPHNELO (anifrolumab) is a fully human monoclonal antibody and the first of its kind, targeting subunit 1 of the type I interferon (IFN) receptor to inhibit type I IFN activity. Type I IFNs, including IFN-alpha, IFN-beta, and IFN-kappa, are cytokines that play a role in the inflammatory pathways associated with systemic lupus erythematosus. Most adults with SLE exhibit increased type I IFN signaling, which correlates with greater disease activity and severity. SAPHNELO has been approved for the treatment of SLE in over 60 countries, including the US, EU, and Japan, with ongoing reviews in additional regions. To know more about SLE treatment options, visit @ New Treatment for Systemic Lupus Erythematosus SLE pipeline possesses some drugs in mid and late-stage developments to be approved in the near future. The emerging landscape holds a diverse range of therapeutic alternatives for treatment, including Litifilimab (Biogen), Ianalumab (Novartis), Cenerimod (Idorsia/Viatris), Dapirolizumab pegol (UCB/Biogen), Telitacicept (RC18) (RemeGen), and others in different lines of treatment. The expected launch of these therapies shall further create a positive impact on the market. Discover which therapies are expected to grab major SLE market share @ Systemic Lupus Erythematosus Market Report Dapirolizumab pegol is a novel investigational treatment, consisting of a humanized, Fc-free antigen-binding (Fab') fragment conjugated with polyethylene glycol (PEG). It works by inhibiting CD40L signaling, which has been shown to reduce B cell activation, decrease autoantibody production, limit type 1 interferon (IFN) secretion, and suppress the activation of T cells and antigen-presenting cells (APCs). In September 2024, UCB and Biogen announced that the Phase III PHOENYCS GO trial achieved its primary goal, showing clinical improvements in patients with moderate-to-severe systemic lupus erythematosus. Additionally, key secondary endpoints, assessing disease activity and flare-ups, also demonstrated clinical improvements. Following the positive results from the PHOENYCS GO study, UCB and Biogen are launching a second Phase 3 trial of dapirolizumab pegol in 2024, named PHOENYCS FLY. Participants from the PHOENYCS GO study will continue to be monitored in a long-term open-label extension. Biogen is working on developing Litifilimab (BIIB059), an experimental humanized monoclonal antibody. This antibody specifically targets and binds to blood dendritic cell antigen 2 (BDCA2), a receptor found on plasmacytoid dendritic cells (pDCs). When BDCA2 is engaged, it inhibits the production of type I interferons (IFN-I) and other inflammatory molecules. BDCA2 is exclusively expressed on the surface of human pDCs. Litifilimab acts as an inhibitor of B-cell lymphocyte stimulator. Currently, Biogen is conducting Phase III clinical trials to evaluate its use for treating SLE. Ianalumab, developed by Novartis, is an antibody aimed at the B-cell activating factor receptor (BAFF-R). It is designed to inhibit BAFF-R signaling and deplete B cells through antibody-dependent cellular cytotoxicity. The drug is currently undergoing a Phase III clinical trial for systemic lupus erythematosus, with the company expecting to submit it for approval by 2027, according to a recent presentation. Cenerimod is an oral, once-daily tablet that acts as a highly selective modulator of the sphingosine-1-phosphate receptor 1 (S1P1). Although the exact cause of systemic lupus erythematosus is not fully understood, T and B lymphocytes are believed to be the primary immune cells involved in the disease's progression. These cells express the S1P1 receptor on their surface. In February 2024, Idorsia Pharmaceuticals formed a major global research and development partnership with Viatris to advance and commercialize two Phase III assets, selatogrel and cenerimod, on a global scale. Discover more about drugs for SLE in development @ Systemic Lupus Erythematosus Clinical Trials The anticipated launch of these emerging therapies for SLE are poised to transform the market landscape in the coming years. As these cutting-edge therapies continue to mature and gain regulatory approval, they are expected to reshape the SLE market landscape, offering new standards of care and unlocking opportunities for medical innovation and economic growth. DelveInsight estimates that the market size for SLE is expected to grow from USD 3.2 billion in 2023 with a significant CAGR by 2034. This growth is mainly driven by ongoing clinical research and better diagnostic tools that might improve the prognosis of the disease. DelveInsight's latest published market report titled as Systemic Lupus Erythematosus Market Insight, Epidemiology, and Market Forecast – 2034 will help you to discover which market leader is going to capture the largest market share. The report provides comprehensive insights into the SLE country-specific treatment guidelines, patient pool analysis, and epidemiology forecast to help understand the key opportunities and assess the market's underlying potential. The SLE market report proffers epidemiological analysis for the study period 2020–2034 in the 7MM segmented into: Total SLE Diagnosed Prevalent Cases Total SLE Diagnosed Prevalent Cases by Gender Total SLE Diagnosed Prevalent Cases by Age SLE Severity-Based Diagnosed Prevalent Cases Total SLE Treated Cases The report provides an edge while developing business strategies by understanding trends shaping and driving the 7MM SLE market. Highlights include: 11-year Forecast 7MM Analysis Epidemiology-based Market Forecasting Historical and Forecasted Market Analysis upto 2034 Emerging Drug Market Uptake Peak Sales Analysis Key Cross Competition Analysis Industry Expert's Opinion Access and Reimbursement Download this SLE market report to assess the epidemiology forecasts, understand the patient journeys, know KOLs' opinions about the upcoming treatment paradigms, and determine the factors contributing to the shift in the SLE market. Also, stay abreast of the mitigating factors to improve your market position in the SLE therapeutic space. Related Reports Systemic Lupus Erythematosus Pipeline Systemic Lupus Erythematosus Pipeline Insight – 2024 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key myasthenia gravis companies, including Yake Biotechnology, UCB, Sorrento Therapeutics, SinoMab Bioscience Ltd, Shanghai Junshi Biosciences, Sareum, Sanofi, Roche, Rheos Medicine, Resolve, Provention Bio, Pfizer, Novartis, Neovacs, Merck, Medsenic, Landos Biopharma, Kezar Life Sciences, Kangpu Biopharmaceuticals, Janssen Research & Development, Janssen, InnoCare, ImmuPharma, I-MAB Biopharma, ILTOO, Idorsia Pharmaceuticals, Horizon Therapeutics, Genovax, Exinda Thearapeutics, Equillium, Eli Lilly and Company, Eisai, Daiichi Sankyo Company, Corestem, Corbus Pharmaceuticals, Citryll BV, Chipscreen Biosciences, Carna Bioscience, Bristol-Myers Squibb, Brickell Biotech, Boston Pharmaceuticals, Biogen, Athos Therapeutics, Asahi Kasei Pharma, Aria Pharmaceuticals, Antengene Therapeutics, Amgen, Alpine Immune Sciences, Akeso Biopharma, AbbVie, among others. Systemic Lupus Erythematosus Epidemiology Systemic Lupus Erythematosus Epidemiology Forecast – 2032 report delivers an in-depth understanding of the disease, historical, and forecasted SLE epidemiology in the 7MM. Lupus Nephritis Market Lupus Nephritis Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key lupus nephritis companies, including NOVARTIS, MORPHOSYS, ASTRAZENECA, ROCHE, KEZAR LIFE SCIENCES, ALEXION PHARMACEUTICALS, NOVARTIS, CABALETTA BIO, among others. Lupus Nephritis Pipeline Lupus Nephritis Pipeline Insight – 2024 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key lupus nephritis companies, including Inflection Biosciences, Equillium, Roche, Horizon Therapeutics, BeiGene, Janssen Research & Development, ImmPACT Bio, among others. About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve . Contact Us Shruti Thakur [email protected] +14699457679 Logo: SOURCE DelveInsight Business Research, LLP WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

NEW YORK, Oct. 7, 2024 /PRNewswire/ -- Oramed Pharmaceuticals Inc. (Nasdaq: ORMP) (TASE: ORMP) ("Oramed"), a clinical-stage pharmaceutical company focused on the development of oral drug delivery platforms, today announced the execution of definitive agreements for the restructuring of a portion of its existing Senior Secured Promissory Note from Scilex Holding Company (Nasdaq: SCLX) ("Scilex"), a company focused on non-opioid pain management products. Key Highlights: Oramed, affiliates of Murchinson and 3i LP, entered into definitive agreements with Scilex for the purchase and sale of new tranche B senior secured convertible notes ("Notes") in the aggregate principal amount of $50 million (the "New Financing") and warrants to purchase up to 7,500,000 shares of the Company's common stock in the aggregate in a registered direct offering. Oramed has agreed to restructure $22.5 million of the outstanding principal balance under Scilex's existing Senior Secured Promissory Note, originally due to Oramed between September 2024 and March 2025. In exchange, Oramed will receive: A Note having an aggregate principal amount of $25 million at issuance, with an original issue discount of 10.0%, that bears interest at a rate of 5.5% per annum, is convertible into shares of Scilex common stock at the option of holder at a conversion price equal to $1.09 (subject to certain adjustments) and matures on the two -year anniversary of issuance; Warrants to purchase up to 3.75 million shares of Scilex common stock with an exercise price of $1.09 (subject to certain adjustments) that are immediately exercisable and expire five years from issuance; and the application by Silex at closing of $12.5 million of the proceeds from the New Financing from the non-Oramed purchasers towards the repayment of such amount of outstanding principal under the Oramed Senior Secured Promissory Note. In order to facilitate the ongoing negotiation of the New Financing, Oramed agreed to further extend certain payments due from Scilex under the Senior Secured Promissory Note on September 23, 2024 to October 7, 2024. The closing of the New Financing is expected to occur on or about October 7, 2024, subject to satisfaction of certain closing conditions. After giving effect to these transactions, an aggregate of $54.2 million of the original principal amount under the Senior Secured Promissory Note has been repaid or refinanced. Separately, Oramed and certain other institutional investors anticipate acquiring the right to receive an 8% royalty on the net sales of certain of Scilex's products, including ZTlido (lidocaine topical system). Oramed is entitled to receive 50% of such proceeds from the net sales of the products. Oramed's purchase consideration in such transaction is intended to be satisfied through a reduction of $2.5 million of the outstanding principal balance on the Senior Secured Promissory Note. The closing of the royalty transaction is anticipated to occur contemporaneous with the closing of the New Financing. "We believe that this restructuring significantly enhances the potential value of our investment in Scilex," said Nadav Kidron, CEO of Oramed Pharmaceuticals. "While slightly extending the payment schedule of a portion of our investment, it offers us substantial potential upside, including through warrants and conversion options. We are also excited to have a stake in the growth and prospects of ZTlido. This aligns perfectly with our strategy of maximizing value for our shareholders while supporting innovative healthcare solutions." About Oramed Pharmaceuticals Oramed Pharmaceuticals (Nasdaq/TASE: ORMP) is a platform technology pioneer in the field of oral delivery solutions for drugs currently delivered via injection. The Company's novel Protein Oral Delivery (POD™) technology is designed to protect drug integrity and increase absorption. Oramed has offices in the United States and Israel. For more information, please visit . Forward-looking statements: This press release contains forward-looking statements, which may generally be identified by the use of the words "anticipates," "expects," "intends," "plans," "should," "could," "would," "may," "will," "believes," "estimates," "potential," "target," or "continue" and variations or similar expressions and include statements about the completion of the New Financing and royalty transaction, the satisfaction of customary closing conditions related to the New Financing, the benefits and value of the New Financing, the royalty transaction and related transactions with Scilex, the value of Scilex's securities, its growth trajectory, commercial portfolio and infrastructure and clinical stage pipeline. These statements are based upon the current expectations and beliefs of management and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. These risks and uncertainties include, but are not limited to, risks and uncertainties discussed in the Company's most recent annual or quarterly report and detailed from time to time in the Company's other filings with the Securities and Exchange Commission, which factors are incorporated herein by reference and the following factors: risks that the New Financing and royalty transaction do not close; the risk that Scilex may be unable to service the debt provided by the Note and the existing Senior Secured Promissory Note and the impact of the New Financing's obligations on Scilex's liquidity; risks associated with the Company's ability to recover the proceeds and/or collateral under the Note, the existing Senior Secured Promissory Note and related agreements; the possibility that the anticipated benefits of the transactions with Scilex are not realized when expected or at all, including as a result of the impact of, or problems arising from, the ability of Scilex to repay the indebtedness and the ability of the Company to realize the value of the warrants and Notes; risks associated with the fluctuating market price and liquidity of the Scilex common stock underlying the warrants and Notes; and risks associated with the unpredictability of trading markets, all of which could cause the actual results or performance of Oramed to differ materially from those contemplated in such forward-looking statements. These forward-looking statements speak only as of the date hereof. Oramed undertakes no obligation to update any of these forward-looking statements to reflect events or circumstances after the date hereof or to reflect actual outcomes, unless required by law. Company Contact: +1-844-9-ORAMED [email protected] Logo: SOURCE Oramed Pharmaceuticals Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED