S1PR1

The agreement gives Angelini Pharma an option to exclusive licensing rights to develop and commercialize CV-011, a clinical Phase 1 investigational novel compound with broad potential to treat brain health diseasesCureverse receives undisclosed upfront payments and is eligible for future milestone-dependent payments and royalties, while retaining rights to commercialize CV-01 in the Republic of Korea, China, Hong Kong, Macau and TaiwanThe collaboration builds on Angelini Pharma’s strong portfolio and deep therapeutic expertise in brain health as well as Cureverse’s early development know-how and capabilities ROME, Oct. 21, 2024 (GLOBE NEWSWIRE) -- Angelini Pharma, part of the privately owned Angelini Industries, and Cureverse Inc., an early-stage research and development company, announced today that they entered into an exclusive global option agreement for the development and commercialization of Cureverse’s innovative brain health asset CV-01. Under the terms of the agreement, Angelini Pharma will lead all the development efforts for CV-01 and, following an initial option period, will have the right to obtain the global exclusive development and commercialization license for the compound, outside of the Republic of Korea, China, Hong Kong, Macau and Taiwan. CV-01 is a novel and innovative investigational compound that activates protective pathways regulated by the nuclear factor erythroid 2-related factor 2 (Nrf2) and has a strong potential to be a medication with disease-modifying properties across a range of brain health disorders, including epilepsy.i CV-01 is an investigational compound currently undergoing a Phase 1 clinical trial in the Republic of Korea and is being developed by Cureverse for Alzheimer’s Disease. Cureverse will receive an upfront payment and will also be eligible to receive additional payments upon pre-defined development and commercial milestones of up to approx. US$360 million, as well as tiered royalties on post-approval net sales. “Our strategic collaboration with Cureverse further strengthens Angelini Pharma’s position as an emerging leader in brain health,” said Jacopo Andreose, Chief Executive Officer of Angelini Pharma. “Neurological conditions such as epilepsy are among leading causes of disease burden worldwide.ii While significant progress has been achieved in the past 15 years, many people living with epilepsy are still unable to reach seizure control despite combination treatment of several anti-seizure medications.iii Through the development of CV-01 and potentially other compounds, we aim to provide much-needed solutions for people living with brain health conditions across the world.” “Our research has unveiled the remarkable potential of CV-01 to transform the landscape of brain health, from epilepsy to Alzheimer’s and Parkinson’s Disease,” said Sung Jin Cho, Chief Executive Officer at Cureverse Inc. “We are truly delighted to be partnering with Angelini Pharma on this journey. Their deep therapeutic expertise and commitment to brain health perfectly align with our vision. Together, we are not just developing a treatment—we are paving the way for a future where patients with neurological conditions have access to truly life-changing therapies.” About Brain HealthBrain health as a therapeutic area includes both neurological and mental health conditions.iv Brain health is defined by the World Health Organization as a state of brain functioning across cognitive, sensory, social-emotional, behavioral and motor domains, allowing a person to realize their full potential over the course of their life, irrespective of the presence or absence of disorders.v Brain health represents an urgent global health priority. An estimated 179 million Europeans are living with brain health conditionsvi and more than 18% of all health loss around the world is associated with brain conditions.vii Additionally, brain health conditions are responsible for considerable individual, economic and societal impact, including loss of independence, reduced productivity, strained relationships, increased risk of suicide as well as high healthcare costs.viii There is an urgent need to raise awareness, and reduce stigma, prejudice and discrimination, to ensure that brain health is valued, promoted and protected for all.v About EpilepsyEpilepsy is one of the most widespread neurological diseases in the world, affecting globally approximately 50 million people of all ages.ix In Europe, up to six million people are estimated to be living with this disease.x Epilepsy can have multiple potential causes, including structural, metabolic, genetic and other factors, though approximately half of cases worldwide do not have a known cause.ix The complications associated with epilepsy are severe, with a risk of premature mortality up to three times higher than the general population.ix The recurrent seizures associated with this condition also have wide-ranging effects on a person’s broader physical and mental health, education and employment opportunities and other quality of life factors. ix Treatments are available to help reduce seizures and improve quality of life, however approximately 40% of people living with epilepsy are still uncontrolled despite the treatment with two anti-seizure medications.iii About Angelini PharmaAngelini Pharma is an international pharmaceutical company, part of the privately owned multi-business Angelini Industries. The Company researches, develops and commercializes health solutions with a focus on the areas of Brain Health, including Mental Health and Epilepsy, and Consumer Health. Founded in Italy at the beginning of the 20th century, Angelini Pharma operates directly in 20 countries, employing more than 3,000 people. Its products are marketed in over 70 countries through strategic alliances with leading international pharmaceutical groups. For more information about Angelini Pharma please visit https://www.angelinipharma.com. About Angelini IndustriesAngelini Industries is a multinational industrial group founded in Ancona in 1919 by Francesco Angelini. Today, Angelini Industries represents a solid and diversified industrial reality that employs approximately 5,800 employees and operates in 21 countries around the world with revenues of over 2 billion euros, generated in the health, industrial technology, and consumer goods sectors. A targeted investment strategy for growth; constant commitment to research and development; deep knowledge of markets and business sectors, make Angelini Industries one of the Italian companies of excellence in the sectors in which it operates. To learn more visit www.angeliniindustries.com. About Cureverse Inc.Founded in 2021, Cureverse has rapidly become a key innovator in the Korean biotech landscape, with a bold vision to revolutionize brain health on a global scale. Specializing in cutting-edge small-molecule therapies, Cureverse focuses on tackling central nervous system (CNS) disorders like Alzheimer’s disease (AD), aiming to bring hope to millions worldwide. While many AD drugs have made it to market, a true breakthrough has yet to be realized—until now. At the heart of our innovation is CV-01, a 'First-in-Class' therapy that uniquely targets the Keap1/Nrf2 pathway, activating Nrf2 through precise modulation. This approach offers unprecedented selectivity, effectively controlling neuroinflammation with precision unmatched by existing treatments. Alongside CV-01, Cureverse is actively advancing CV-02, a biased S1P1 agonist that is now IND-ready, as well as several promising follow-up non-clinical programs. With recent IND approvals and strong clinical progress, Cureverse is well-positioned to transform the way we treat neurological conditions and improve patients' lives across the globe. Media Contact Chiara AntoniucciGlobal Head of Brand and Media Communications, Angelini PharmaPhone: +39 3477133926Email: chiara.antoniucci@angelinipharma.com Sung Jin ChoChief Executive Officer, Cureverse Inc.Email: sjcho@cureverse.co.kr, sjcho@kist.re.kr ________________________________ 1 CV-01 is an investigational compound, not approved for use by regulatory authorities i Data on file from Cureverse.ii Institute for Health Metrics and Evaluation. Global burden of conditions affecting the nervous system. Available at: https://www.healthdata.org/research-analysis/library/global-burden-conditions-affecting-nervous-system Last accessed: October 2024.iii Chen Z, Brodie MJ, Liew D, Kwan P. Treatment Outcomes in Patients With Newly Diagnosed Epilepsy Treated With Established and New Antiepileptic Drugs: A 30-Year Longitudinal Cohort Study. JAMA Neurol. 2018 Mar 1;75(3):279-286.iv Winkler AS, et al. Lancet Glob Health. 2024;12(5):e735-e736.v World Health Organization. Optimizing brain health across the life course: WHO position paper. Geneva: World Health Organization; 2022.vi Nutt D, et al. Eurohealth (Int) 2017;23:21–5.vii Institute for Health Metrics and Evaluation. Understanding brain health around the world. Available at: https://brainhealthatlas.org/ Last accessed: October 2024.viii World Health Organization. World mental health report: transforming mental health for all. Geneva: World Health Organization; 2022.ix WHO. “Epilepsy Key Facts.” N.p., 9 Feb. 2023. Web. 24 Aug. 2023.x Behr et al. Epidemiology of epilepsy. Revue Neurologique 2016 Jan; 172(1):27-36. doi: 10.1016/j.neurol.2015.11.003.

Late-breaking abstract highlights high rates of clinical and endoscopic remission among LTE completers at Week 52SAN DIEGO, Oct. 15, 2024 (GLOBE NEWSWIRE) -- Ventyx Biosciences, Inc. (Nasdaq: VTYX) (“Ventyx”), a clinical-stage biopharmaceutical company focused on advancing novel oral therapies that address a broad range of inflammatory diseases with significant unmet medical need, today announced that a late-breaking abstract including new long-term extension (LTE) data from the Phase 2 trial of tamuzimod in ulcerative colitis was presented on October 15, 2024 during the United European Gastroenterology (UEG) Week meeting in Vienna, Austria. “We are excited to present the new long-term extension data from the tamuzimod Phase 2 trial in patients with ulcerative colitis at UEG Week,” said Raju Mohan, PhD, Chief Executive Officer. “These 52-week data continue to reinforce the potential best-in-class profile of our S1P1R modulator tamuzimod in ulcerative colitis, with a potential best-in-disease safety profile amongst all the oral options for UC therapy. We believe the high rates of clinical remission and endoscopic remission position tamuzimod as the backbone of future combination therapies for UC.” Oral Presentation Details: Title: “Efficacy and safety of tamuzimod in moderately to severely active ulcerative colitis through 52 weeks: phase 2 long-term extension data” Presenter: Silvio Danese, MD, PhD; Department of Gastroenterology and Endoscopy, IRCCS Ospedale San Raffaele, Vita-Salute San Raffaele University, Milan, Italy Session: From IBS and IBD: Late-breaking abstracts Session Date/Time: Tuesday, October 15, 2024, 08:30 - 09:30 (CEST) More information can be found in the conference program on the UEG website. Slides from the presentation will be available in the Investors section of the company’s website at www.ventyxbio.com. About Ventyx Biosciences Ventyx is a clinical-stage biopharmaceutical company focused on developing innovative oral medicines for patients living with autoimmune and inflammatory disorders. We believe our ability to efficiently discover and develop differentiated drug candidates will allow us to address important unmet medical needs with novel oral therapies that can shift inflammation and immunology markets from injectable to oral drugs. Our current pipeline includes internally discovered clinical programs targeting NLRP3, S1P1R and TYK2, positioning us to become a leader in the development of oral immunology therapies for peripheral and neuroinflammatory diseases. Ventyx is headquartered in San Diego, California. For more information about Ventyx, please visit www.ventyxbio.com. Forward-Looking Statements Ventyx cautions you that statements contained in this press release regarding matters that are not historical facts are forward-looking statements. These statements are based on Ventyx’s current beliefs and expectations. Such forward-looking statements include, but are not limited to, statements regarding: the potential of Ventyx’s product candidates and the anticipated continued progression of the development pipeline for such product candidates; the therapeutic and commercial potential of VTX002 in ulcerative colitis, including its efficacy profile, potential as a best-in-disease oral agent and its potential best-in-class safety profile; and the use of tamuzimod in combination with other therapies for ulcerative colitis. The inclusion of forward-looking statements should not be regarded as a representation by Ventyx that any of its plans will be achieved. Actual results may differ from those set forth in this press release due to the risks and uncertainties inherent in Ventyx’s business, including, without limitation: the scientific or commercial utility achievable by combing tamuzimod with other therapies; potential delays in the enrollment and completion of clinical trials; Ventyx’s dependence on third parties in connection with product manufacturing, research and preclinical and clinical testing; disruptions in the supply chain, including raw materials needed for manufacturing and animals used in research, delays in site activations and enrollment of clinical trials; the results of preclinical studies and clinical trials; early clinical trials not necessarily being predictive of future results; unexpected adverse side effects or inadequate efficacy of Ventyx’s product candidates that may limit their development, regulatory approval and/or commercialization, or may result in recalls or product liability claims; Ventyx’s ability to obtain and maintain intellectual property protection for its product candidates; the use of capital resources by Ventyx sooner than expected; and other risks described in Ventyx’s prior press releases and Ventyx’s filings with the Securities and Exchange Commission (SEC), including in Part II, Item 1A (Risk Factors) of Ventyx’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2024, filed on August 8, 2024, and Ventyx’s subsequent filings with the SEC. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and Ventyx undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement, which is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Investor Relations ContactPatti BankManaging DirectorICR Westwicke(415) 513-1284IR@ventyxbio.com

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