Bavarian Biotech News March 2025 Bavaria Tradition meets Innovation Shutterstock / istock DEAR READER RECENT HEADLINES BAVARIAN RESEARCHERS Page 2 BAVARIAN START-UPS Page 3 - 4 EVENTS & CONTACT Page 5 Page 7 - 8 Page 10

Recent headlines Helmholtz invests EUR 18 million in AI innovation ecosystems The new ‘HPC Gateway’ initiative aims to open up access to the Helmholtz Association's world- leading HPC infrastructure for companies. The Helmholtz Association is investing EUR 18 million in this endeavour. Artificial intelligence (AI) and high-performance computing (HPC) are crucial technologies for the competitiveness of companies. However, many companies, especially small and medium-sized enterprises (SMEs), face the challenge of gaining access to high-performance computing resources and specialized data analyses. The Helmholtz Association addresses this challenge through the HPC Gateway initiative, investing EUR18 million in the program. The program aims to give companies access to the world-leading HPC infrastructure of the Helmholtz Centers and connect them with AI experts. In the one-year pilot phase now underway, nine Helmholtz Centers at eight locations – including Helmholtz Munich – are opening their high-performance computing capacities to companies. The aim is to dovetail research and business more closely and to promote the formation of regional innovation ecosystems. Companies will receive hands-on support to advance AI-driven innovations, digital twins, and HPC-based developments. Read more © Pixabay Formycon launches FYB202/Otulfi®, a biosimilar to Stelara®, in the United States and the European Union Formycon AG and its commercialization partner Fresenius announced the commercial availability of Otulfi®, a biosimilar to Stelara®2 in the United States (U.S.) and the European Union (EU). FYB202/Otulfi® is now commercially available in both subcutaneous and intravenous formulations in the United States and the European Union. Classification as an interchangeable biosimilar in the USA is expected in the near future. © Pixabay Ustekinumab is a human monoclonal antibody that targets the cytokines interleukin-12 and interleukin-23 which play an important role in inflammatory and immune responses. Otulfi® was approved by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) in September 2024, having successfully met the agency’s standards for biosimilarity to the reference product, including equivalent efficacy, safety and pharmacokinetics. In the U.S., Otulfi® is indicated for the treatment of Crohn’s disease, ulcerative colitis, moderate to severe plaque psoriasis and active psoriatic arthritis. The FDA has provisionally determined that Otulfi® will be interchangeable with the reference drug Stelara®, following the expiration of a competitor’s interchangeability exclusivity. In the EU, Otulfi® has been launched to treat moderately to severely active Crohn’s disease, moderate to severe plaque psoriasis and active psoriatic arthritis. Read more Bavarian Biotech News, March 2025 www.bio-m.org 3

Bavarian researchers Erlangen University Hospital receives USD 600,000 in funding for translational study on CAR-T cell therapy for lupus erythematosus More than 45 people with autoimmune diseases have been successfully treated with a novel CAR-T cell therapy at the University Hospital Erlangen, part of Friedrich-Alexander University Erlangen- Nürnberg (FAU). Among them, over 15 patients with systemic lupus erythematosus – who had previously not responded to any other treatments – are now symptom-free. A new study, supported by a USD 600,000 grant from the U.S.-based Lupus Research Alliance, will now investigate the underlying mechanisms of this therapy. In lupus, immune cells known as B cells produce antibodies against the body's own tissues. As part of the CAR-T cell therapy developed in Erlangen, patients' own immune cells (T cells) are extracted and equipped with a special artificial receptor (CAR). These CAR-T cells are then returned to the patient, where they bind to harmful B cells in the blood and tissues and destroy them. The result is a reboot of the immune system. However, the disease lupus is not only driven by B cells; other immune cells such as T cells and macrophages also play an important role. Prof. Ricardo Grieshaber-Bouyer © Friedrich-Alexander-Universität-Erlangen-Nürnberg In a new study, Prof. Ricardo Grieshaber-Bouyer wants to investigate the underlying mechanisms of the therapy. Read more Researchers from Bayreuth create hyrdogel with self-healing properties TUM scientists develop efficient method to purify proteins with light A research team from the Universität Bayreuth and Aalto University in Finland has, for the first time, succeeded in developing a hydrogel with a unique structure that combines strength, flexibility and self-healing properties of natural skin. This breakthrough opens up new possibilities for applications such as targeted drug delivery, wound healing, sensors in soft robotics, and artificial skin. Read more Scientists at the Technical University of Munich (TUM) have developed a method that relies on physics rather than conventional chemistry to obtain proteins. Using short-wave, UV light invisible to humans, they have succeeded in purifying proteins from cell extracts or cultures. This method is more efficient and gentler than existing techniques and could be used in the future for high-throughput drug development in pharmaceutical or biotechnology companies. Read more y a b a x P © i x Bavarian Biotech News, March 2025 www.bio-m.org M U T / r e u a B a n i r b a S © 5

Bavarian start-ups m4 Awardee Invitris wins EIC Accelerator funding The Martinsried-based start-up Invitris, winner of the m4 Award coordinated by BioM, has been selected as one of 71 companies in the latest funding round of the EIC Accelerator. The biotech start-up impressed with its platform technology for the production of bacteriophages for the treatment of antibiotic-resistant infections and will receive a combination of grants and equity funding. Invitris utilizes bacteriophages to treat antibiotic-resistant infections and has developed a unique technology that enables, for the first time, the in vitro production of genetically optimized bacteriophages for therapeutic use. The spin-off from the Technical University of Munich had already received funding through INCATE in 2022. Co-founder & CEO Dr. Patrick Grossmann and co- founder and CTO Dr. Kilian Vogele (left) of Invitris © Invitris Winners of the EIC Accelerator receive up to EUR 2.5 million in grants, with some also benefiting from equity investments. Nearly 80% of the companies opt for blended finance, combining grants and equity investments. Read more Caire.ai secures EUR 850,000 for smart AI based health monitoring Munich-based healthtech start-up Caire.ai has raised EUR 850,000 in a pre-seed round. The company is developing technology that uses video recordings of a person’s face to determine vital parameters such as heart rate, blood pressure, oxygen saturation, and stress levels. Lead investor is VC YZR Capital. Bayern Kapital, capacura, online pharmacy DocMorris, and healthcare angel investor Martin Blüggel also participated in the round. The Caire.ai team. © Caire.ai The smart AI-based health monitoring solution operates completely contactless and is compatible with almost any standard camera. With its technology, Caire.ai aims to provide the clinical sector with faster ways to capture patients’ vital signs. Hospitals could thus implement rapid, contactless, and fully digital triage systems. Beyond clinical applications, the technology can also be used in the automotive industry or consumer technology—envisioning, for instance, vehicles that monitor drivers’ health or smartphones offering enhanced, continuous health monitoring features. Read more Bavarian Biotech News, March 2025 www.bio-m.org 7