Nutritional and Metabolic Diseases

PLANEGG-MARTINSRIED, Germany I January 20, 2025 I Formycon AG (FSE: FYB, Prime Standard, “Formycon”) and its licensing partner Klinge Biopharma GmbH (“Klinge”) today jointly announce that the European Commission has granted central marketing authorization for FYB203 (Aflibercept), a biosimilar to Eylea ® 1 , under the brand names AHZANTIVE ® 2 and Baiama ® 3 . The approval encompasses the treatment of Age-Related Neovascular (wet) Macular Degeneration (nAMD) and other serious retinal diseases such as Diabetic Macular Edema (DME), visual impairment due to Myopic Choroidal Neovascularisation (CNV) and Macular Edema following Retinal Vein Occlusion (RVO). The decision of the European Commission follows the positive opinion of the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) from November 2024 and applies to all countries in the European Economic Area (EEA), including the 27 member states of the European Union (EU) as well as Iceland, Liechtenstein, and Norway. Dr. Stefan Glombitza, CEO of Formycon AG , commented: “The EU approval of FYB203, our biosimilar for Eylea ® , marks another milestone for Formycon and is based on the expertise and dedication of our entire team. As our second ophthalmic biosimilar, FYB203 significantly expands therapeutic options for patients with severe retinal diseases. With AHZANTIVE ® and Baiama ® , we are improving access to high-quality and affordable therapies that contribute sustainably to enhancing patients’ quality of life.” Aflibercept inhibits the vascular endothelial growth factor (VEGF), which is responsible for the excessive formation of blood vessels in the retina, thereby impairing vision. In 2023, the reference product Eylea ® achieved global sales of approximately USD 9 billion 4 , highlighting the significance and necessity of a cost-effective alternative like FYB203. In mid-January 2025, Formycon and Teva Pharmaceuticals International GmbH (Teva) signed a licensing agreement for the semi-exclusive commercialization of FYB203 across major parts of Europe and Israel. Concurrently, Formycon has concluded an agreement with Teva for product supply. FYB203 was already approved by the U.S. Food and Drug Administration (FDA) in June 2024. 1) Eylea ® is a registered trademark of Regeneron Pharmaceuticals Inc. 2) AHZANTIVE ® is a registered trademark of Klinge Biopharma GmbH 3) Baiama ® is a registered trademark of Klinge Biopharma GmbH 4) Source: https://investor.regeneron.com/news-releases/news-release-details/regeneron-reports-fourth-quarter-and-full-year-2023-financial/ About Formycon: Formycon AG (FSE: FYB) is a leading, independent developer of high-quality biosimilars, follow-on products of biopharmaceutical medicines. The company focuses on therapies in ophthalmology, immunology, immuno-oncology and other key disease areas, covering almost the entire value chain from technical development through clinical trials to approval by the regulatory authorities. For commercialization of its biosimilars, Formycon relies on strong, well-trusted and long-term partnerships worldwide. With FYB201/Ranibizumab, Formycon already has a biosimilar on the market in Europe, the USA, and the MENA-region. Two further biosimilars, FYB202/ustekinumab and FYB203/aflibercept, received FDA and European Commission approval; FYB202 is also approved in the UK and Canada. Another four biosimilar candidates are currently in development. With its biosimilars, Formycon is making an important contribution to providing as many patients as possible with access to highly effective and affordable medicines. Formycon AG, headquartered in Munich, is listed in the Prime Standard of the Frankfurt Stock Exchange: FYB / ISIN: DE000A1EWVY8 / WKN: A1EWVY and is part of the SDAX and TecDAX selection indices. Further information can be found at: https://www.formycon.com/ About Biosimilars: Since their introduction in the 1980s, biopharmaceutical drugs have revolutionized the treatment of serious and chronic diseases. By 2032, many of these drugs will lose their patent protection – including 45 blockbusters with an estimated total annual global turnover of more than 200 billion US dollars. Biosimilars are successor products to biopharmaceutical drugs for which market exclusivity has expired. They are approved in highly regulated markets such as the EU, the USA, Canada, Japan and Australia in accordance with strict regulatory procedures. Biosimilars create competition and thus give more patients access to biopharmaceutical therapies. At the same time, they reduce costs for healthcare providers. Global sales of biosimilars currently amount to around 21 billion US dollars. Analysts assume that sales could rise to over 74 billion US dollars by 2030. SOURCE: Formycon

Sionna Therapeutics and Odyssey Therapeutics have joined Metsera and Maze in an attempt to go public via the still rocky IPO route. The biotechs, focused on cystic fibrosis and immunology respectively, filed for their initial public offerings on Friday evening. Sionna and Odyssey departed last week’s annual JP Morgan Healthcare Conference with plans for public life as $SION and $ODTX . They join the Nasdaq queue alongside obesity drug developer Metsera and kidney disease startup Maze , which has spun out other companies and formed joint ventures over the years. None of the IPO hopefuls have yet outlined the size of their planned debuts. If all four biotechs follow through with their plans, they’d create a buzzy start to 2025 compared to the relatively dry IPO market of the past few years. The new entrants Sionna and Odyssey are both well-funded, clinical-stage biotechs with experienced management teams, ticking most of the boxes that public market investors seek for drug development startups in the current IPO environment. Last year, Boston-based Sionna in-licensed three cystic fibrosis drug candidates from AbbVie, just months after disclosing a $182 million Series C that would take it through 2026, CEO Mike Cloonan told Endpoints News last July. Cloonan was a long-time Biogen executive and Sage Therapeutics operating chief before joining Sionna in spring 2021. New details on the AbbVie deal were revealed in Sionna’s S-1 paperwork, which was filed on 17 January. AbbVie got $5 million upfront and $8.6 million worth of common stock. The pharma giant could also get up to $360 million in development and commercial biobucks, plus up to $130 million in commercial and sales-based milestones, according to the S-1 filing . Sionna had $180 million in cash, equivalents and marketable securities at the end of September, according to the filing. The mid-stage biotech spent about $43 million on R&D in the first nine months of 2024, a $12 million jump over the same period the prior year, per the S-1. Sionna has raised about $330 million since its 2019 founding. RA Capital owns the largest chunk of the biotech at 29.2%. TPG Growth holds 17.4%, Atlas Venture owns 11.4% and OrbiMed maintains a 9.9% stake. OrbiMed is also one of the largest stakeholders in Odyssey. SR One is the biggest shareholder at 16.2% followed by OrbiMed (14.3%), Fidelity (6.7%) and Foresite Capital (6%), according to Odyssey’s S-1 filing . Odyssey is developing small molecule therapies for ulcerative colitis, Crohn’s disease, atopic dermatitis, systemic sclerosis and other indications. It’s also creating protein therapeutics for vitiligo, type 1 diabetes, systemic lupus erythematosus and asthma. The preclinical asthma program is part of the burgeoning TSLP arena. Gary Glick, a chemistry professor-turned-serial entrepreneur, leads Odyssey. The biotech startup formed in 2021 and quickly disclosed three successive megaround financings, most recently a $101 million Series C in December 2023. Glick is also a co-founder of Scorpion Therapeutics. During last week’s JPM, Eli Lilly said it would buy Scorpion for up to $2.5 billion . Odyssey spent $81 million on R&D in the first nine months of 2024, a $5 million decrease compared with the same period of 2023. The company had about $155 million in cash, equivalents and marketable securities at the end of September.

The China-to-US experimental medicine pipeline is ballooning: yet another US-based biotech formed around a candidate from China’s Keymed Biosciences on Monday. Life sciences investment firm RTW has set up a company called Prolium to take forward a CD20×CD3 bispecific known as CM355 outside Asia, the companies said in a press release and Hong Kong Stock Exchange filing . Prolium will get rights to develop the antibody in both oncology and non-oncology indications in exchange for $17.5 million upfront and up to $502.5 million in biobucks. Keymed will split its earnings with partner Beijing InnoCare. The companies will also get a minority equity stake in the new company, according to the HKEX filing. China-derived drug candidates have featured prominently in the pipelines of recently launched biotechs: four of the 10 megarounds so far this year have gone to biotechs developing such assets. Chengdu-based Keymed is one of the many biopharmas driving the trend, having out-licensed candidates to two new companies earlier this month. Timberlyne Therapeutics emerged with $180 million and Ouro Medicines debuted with $120 million. And last year, Belenos Biosciences broke cover with two Keymed assets and a former Biohaven executive at the helm. RTW, meanwhile, has recently taken part in similar newco formations. It helped form Kailera Therapeutics , which launched last year with $400 million and a Phase 3-ready obesity drug candidate from China-headquartered Hengrui.