Corteria Pharmaceuticals SAS

The FDA approved the first treatment for MASH in March this year. Image credit: Shutterstock/ Iurii Motov. Inventiva has secured up to €348m ($380m) in financing to help wrap up a Phase III trial for its lead, and sole, clinical asset lanifibranor in metabolic dysfunction-associated steatohepatitis (MASH). The funds will mostly go towards completing the Phase III trial (NCT04849728) for lanifibranor. Preparation for marketing approval filings and drug commercialisation also stand to benefit, as per a 14 October press release. The French biopharma will immediately receive $103.4m of the multi-tranche equity financing, with the remainder coming through future issuance phases. Inventiva also announced a further $30m that has been secured separately in milestone payments via an existing license and collaboration agreement with Chinese pharma company CTTQ. Shares in the Nasdaq-listed company were up 27% at market open on 14 October compared to the market close on 11 October. Inventiva has a market cap of $98.6m. The transaction was led by New Enterprise Associates, BVF Partners LP and Samsara BioCapital, with the participation of additional existing and new investors. Dr. Mark Pruzanski, current chairman of Corteria Pharmaceuticals and biotech Abcuro, will join Iventiva as company chairman. Srinivas Akkaraju, founder of Samsara BioCapital, will serve as a director following the deal. Four additional directors from the other four largest investors will also join the board, with at least two replacing existing directors. See Also: FDA approves Pfizer’s HYMPAVZI to treat haemophilia Cell and gene therapy approvals drive paradigm change in manufacturing Lanifibranor is Inventiva’s only clinical candidate, and the biopharma previously estimated it would need around €250m to finance its activities until Phase III topline results in MASH patients are reached. The study, called NATiV3, is expected to hit this milestone in the second half of 2026. The randomised, double-blind, placebo-controlled trial aims to assess the long-term efficacy and safety of lanifibranor in adults with biopsy-proven non-cirrhotic MASH and F2/F3 stage liver fibrosis. Around 1,000 patients are expected to enrol in the study across 494 study locations, as per a ClinicalTrials.gov entry. The trial is back on track following a halt in recruitment earlier this year due to a possible treatment-related serious adverse event (AE). The MASH treatment space has seen increased interest this year, with Madrigal Pharmaceuticals winning the first US Food and Drug Administration (FDA)-approval in the arena for Rezdiffra (resmetirom). GlobalData estimates the MASH market to reach sales of $25.7bn in 2032 across the seven major markets (7MM: US, France, Germany, Italy, Spain, the UK, and Japan). Lanifibranor is an orally administered small molecule that activates three peroxisome proliferator-activated receptor (PPAR) isoforms. These ligand-activated transcription factors are known to regulate four components of MASH, such as inflammation, fibrosis, steatosis and metabolism.  Inventiva’s pan-PPAR agonist demonstrated positive results in a Phase IIb trial, meeting primary and key secondary endpoints. Inventiva’s CEO Frederic Cren said: “This [financing] reflects the confidence of the participating investors and our partner CTTQ in the value of lanifibranor as a breakthrough therapy for patients suffering from MASH. The total proceeds from the financing will support the MASH programme and subsequent filing for marketing approval, along with preparations for the potential commercialisation of lanifibranor.”

PARIS, France I September 07, 2023 I Corteria Pharmaceuticals (“Corteria”), a biopharmaceutical company specialized in the development of transformative therapies for unaddressed heart failure subpopulations, today announced an oversubscribed €65M ($71M [1] ) Series A co-led by US investment firm OrbiMed and EU-based leading investment firm Jeito Capital, with the participation of all existing seed investors (Kurma Partners, Fountain Healthcare Partners, V-Bio Ventures, Invivo Capital, Omnes Capital). As a result, Erez Chimovits from OrbiMed and Andreas Wallnoefer from Jeito Capital will join the board of Directors of Corteria. The funding will be used to advance Corteria’s cardiovascular pipeline into the clinic. Heart failure is a serious disease with a prevalence of more than 60 million patients globally and still growing. Corteria’s innovative approach is centered on selecting therapeutic targets involved in the worsening and acute forms of human heart failure, as well as a stratification strategy to identify specific subgroups that are most likely to benefit from the treatments. These forms of heart failure are widespread, life-threatening, and not directly addressed by the current standards of care. Corteria was founded in 2021 by Sanofi’s former head of cardiovascular research, Philip Janiak, and Marie-Laure Ozoux, former cardiovascular project leader at Sanofi, around two cardiovascular programs in-licensed from Sanofi. [2] Since then, Corteria’s pipeline has expanded rapidly and comprises today three first-in-class therapies that are highly differentiated as they produce multi-organ benefits, acting on the kidneys, the heart, and the vessels: The lead asset for Worsening Heart Failure is expected to enter the clinic in early 2024. “This financing marks a major milestone in our mission to bring therapies to heart failure subpopulations with high unmet needs,” said Philip Janiak, Founder and President of Corteria Pharmaceuticals. “ We are extremely grateful to Jeito and OrbiMed as our new investors for their trust in our science and team and to our existing investors for their support and commitment since inception. We are looking forward to working all together to develop next generation transformative therapeutics.” Andreas Wallnoefer, Partner at Jeito Capital, said: “Despite current treatments, heart failure is a progressing disease that impacts severely the lives of many patients and remains one of the leading causes of mortality worldwide. Corteria focuses on translating important therapeutic innovation in cardiology into clinical practice. Our investment in Corteria reflects Jeito’s commitment to address significant unmet needs in the realm of cardiology. We are excited to join forces with Corteria’s dedicated team to develop a portfolio of medicines with important clinical benefit for patients.” “We are proud to have been involved with Corteria since its early days and impressed with the progress made to date. The company is now at a turning point of entering the clinic with its lead asset early next year and validating its unique positioning in well-defined heart failure subpopulations with high unmet medical needs. Kurma Partners is pleased to continue supporting the company during this key step that we hope will bring transformative clinical outcome for patients,” said Thierry Laugel, Managing Partner at Kurma Partners, and Chairman of the board of Corteria. About OrbiMed OrbiMed is a healthcare investment firm, with over $17 billion in assets under management. OrbiMed invests globally across the healthcare industry through a range of private equity funds, public equity funds, and royalty/credit funds. OrbiMed’s team of over 100 professionals is based in New York City, San Francisco, Shanghai, Hong Kong, Mumbai, Herzliya, and other key global markets. www.orbimed.com About Jeito Capital Jeito Capital is a global leading Private Equity company with a patient benefit driven approach that finances and accelerates the development and growth of ground-breaking medical innovation. Jeito empowers and supports managers through its expert, integrated, multi-talented team and through the investment of significant capital to ensure the growth of companies, building market leaders in their respective therapeutic areas with accelerated patients’ access globally, especially in Europe and the United States. Jeito Capital has €534 million under management and a rapidly growing portfolio of investments. Jeito Capital is based in Paris with a presence in Europe and the United States. For more information, please visit www.jeito.life or follow @Jeito_life on Twitter or LinkedIn . About Corteria Pharmaceuticals Founded in 2021, Corteria Pharmaceuticals is a privately held biopharmaceutical company developing first-in-class drugs in heart failure subpopulations. Despite some improvements in the management of this serious disease, the prevalence of heart failure keeps increasing with more than 60 million patients worldwide. Corteria’s strategy involves innovative patient stratification and target selection based on human evidence and a better understanding of disease biology in patients with a focus on worsening and acute heart failure and right heart failure. More information available at: www.corteriapharma.com [1] Applying a 1.0886 EUR/USD exchange rate as of 30 August 2023 (Banque de France) rounded to $71M [2] CRF2 peptide agonist and AVP neutralizing monoclonal antibody programs [3] Corticotropin-releasing hormone receptor 2 SOURCE: Corteria Pharmaceuticals

SAN MATEO, Calif., March 22, 2023 /PRNewswire/ -- Regencor Inc. a life sciences company that is focused on the development of therapies for treatment of cardiovascular disease, today announced it has appointed Philip Janiak, Ph.D. and Ken Mahaffey, M.D. to its Scientific Advisory Board. They join Nabil Dib, M.D. who was previously appointed to the Regencor S.A.B. Dr. Ken Mahaffey, M.D. is a professor of cardiovascular medicine at the Stanford University School of Medicine. His primary area of research is the design and execution of multicenter clinical trials, focusing on analyses of important clinical cardiac outcome measures using large patient databases. Current research activities include standardization of the definition of myocardial infarction used in clinical trials, the adjudication of suspected clinical endpoint events by Clinical Event Committees (CEC), and the efficient operational conduct of large multinational clinical trials. He has led or served on the Executive Committees for many cardiovascular outcome trials, over 125 Clinical Endpoint Committees, and multiple Data Safety Monitoring Boards. He has worked with the FDA and is a consultant for the Endocrinologic and Metabolic Drugs Advisory Committee. Dr. Mahaffey received a B.S. in Chemistry from Stanford University, followed by his M.D. from the University of Arizona Health Sciences Center. He completed a cardiology fellowship at Duke, including research training in the Duke Databank for Cardiovascular Disease. He is recognized as an international leader in the design and execution of large-scale cardiovascular trials. Philip Janiak, PhD, received his PhD degree in Cardiovascular Pharmacology from the University of Iowa, USA (1989) and graduated from the Faculty of Pharmacy (Paris XI University) in 1984. He started his career at Servier where he contributed to the discovery of ivabradine as a co-inventor. Until the end of 2020 he was the head of Cardiovascular Research at Sanofi focusing on the development of new treatments in selected areas of unmet medical need where emerging science and a better understanding of human disease biology intersects with heart failure at the molecular level. During his career he developed extensive experience in the management of international R&D groups and in leading multiple research collaborations with biopharmaceutical companies such as MyoKardia, and academic institutions such as IMI. He is currently the CEO of Corteria Pharmaceuticals "I am thrilled to join Regencor's SAB and delighted to be able to provide guidance to the team," said Dr. Mahaffey. "The Company has generated compelling data on the use of unglycosylated FSTL1, and I am eager to collaborate with, and help guide the scientific team regarding the Company's future development plans." "Regencor is uniquely positioned to advance treatments for myocardial infarction and to help prevent the progression to heart failure." said Dr. Janiak. "I look forward to working with this team to help shape new clinical approaches for the treatment of cardiovascular disease." "We are delighted and honored to have such accomplished scientific leaders join our Scientific Advisory Board," said Sean Edwards, Chief Executive Officer of Regencor. "Dr. Mahaffey and Dr. Janiak bring tremendous expertise in the field of cardiovascular disease. Feedback and collaboration with our SAB will be a vital component of our efforts to continue the development of our unique therapies." For more information on Regencor, please visit About Regencor Inc. Regencor, Inc. is a life sciences company focused on the development of therapeutics for cardiovascular disease. REG 101 is a proprietary recombinant protein that has been shown to stimulate the proliferation of cardiomyocytes post myocardial infarction. The regenerative properties of REG 101 have been demonstrated in several in-vivo large animal studies. The Company is targeting initial indications of acute myocardial infarction and also chronic heart failure. View original content to download multimedia: SOURCE Regencor, Inc.