Visugromab

MUNICH & SAN FRANCISCO--(BUSINESS WIRE)-- CatalYm today announced the appointment of seasoned biotech executive Christian S. Schade as Chairman of the Board of Directors. With over 30 years of executive leadership experience across private and public biopharma companies, Mr. Schade will provide board leadership at a crucial stage for the company, following the initiation of four late-stage clinical studies of its lead candidate, the GDF-15 inhibitor visugromab. “With recent positive clinical data, multiple ongoing clinical studies, and a strong leadership team with deep biotechnology and drug development expertise, CatalYm is well positioned for continued clinical and corporate success,” said Christian S. Schade, Chairman of the Board at CatalYm . “The company’s differentiated approach, targeting GDF-15 to address both checkpoint-refractory tumors and cancer cachexia, has shown encouraging anti-tumor activity in multiple solid tumor indications. I look forward to working with the Board of Directors and the CatalYm team at this pivotal inflection point in the company’s development.” “Chris’ extensive industry experience and track record of supporting the growth of biotech organizations strengthens our Board and adds further strategic depth,” said Scott Clarke, Chief Executive Officer at CatalYm . “His insights and board leadership will be invaluable as we advance visugromab through late-stage clinical development and continue to broaden its potential impact for patients.” Mr. Schade most recently served as President and Chief Executive Officer of Halda Therapeutics, a company developing a novel class of cancer therapeutics, until its $3.05 billion acquisition by Johnson & Johnson in December 2025. Prior to Halda, Chris was a Growth Partner at Flagship Pioneering. His leadership experience includes serving as President, Chief Executive Officer and Board Member of Aprea Therapeutics (Nasdaq: APRE) from 2016 to 2022, and as Chairman from 2020 to 2023. Under his leadership, Aprea advanced its pipeline of oncology therapeutics and completed its IPO in 2019. Before joining Aprea, he held several executive roles at biotechnology companies, including: Chief Executive Officer of Novira, a privately held antiviral drug discovery company until its acquisition by Johnson & Johnson, Chief Financial Officer of Omthera Pharmaceuticals, Inc., a Nasdaq-listed specialty pharmaceuticals company until its acquisition by AstraZeneca Plc, and Senior Vice President of Administration and Chief Financial Officer at Medarex, Inc., a biopharmaceutical company focused on antibody-based therapeutics until its acquisition by Bristol Myers Squibb. Earlier in his career, Mr. Schade was Managing Director at Merrill Lynch in London, following nearly 20 years in corporate finance and capital markets roles at Merrill Lynch and J.P. Morgan in New York and London. Chris received his A.B. degree from Princeton University and an M.B.A. from the Wharton School at the University of Pennsylvania. He currently serves as Senior Advisor to Frazier Life Sciences and is on the Board of Integra LifeSciences. About CatalYm CatalYm is developing visugromab, a first-in-class anti-GDF-15 antibody, in solid tumors and cachexia. In its first-in-human Phase 1/2a study, visugromab demonstrated deep and durable anti-tumor efficacy with long-lasting objective responses in relapsed and checkpoint refractory metastatic solid tumor patients in combination with anti-PD-1 treatment. In addition, data from the same study demonstrated that visugromab can significantly counteract the effects of cachexia in these patients. This data was published in Nature and presented at the International Conference on Sarcopenia, Cachexia & Wasting Disorders. CatalYm is now advancing visugromab into multiple Phase 2b studies including first-line metastatic non-squamous NSCLC ( NCT07098988 ), second-line metastatic non-squamous NSCLC ( NCT07246863 ), second-line hepatocellular carcinoma ( NCT07219459 ) and cachexia ( NCT07112196 ). Founded in 2016 and based in Munich, Germany, and San Francisco, USA, CatalYm is backed by leading international investors including Canaan Partners, Omega Funds, Bioqube Ventures, Forbion, Jeito Capital, Brandon Capital, Gilde Healthcare, Novartis Venture Fund, Vesalius, Bayern Kapital, BioGeneration Ventures, and Coparion. Contacts CatalYm GmbH Clinton Musil, CFO and CBO info@catalym.com Media Inquiries Trophic Communications Dr. Stephanie May or Anja Heuer Phone: +49 171 185 56 82 or +49 151 106 199 05 catalym@trophic.eu

MUNICH & SAN FRANCISCO--(BUSINESS WIRE)--CatalYm today announced that the first patient has been dosed in the Phase 2/3 VINCIT trial (Visugromab IN Cachexia International Trial, NCT07112196). The global study is evaluating the company’s lead anti-GDF-15 antibody visugromab in patients with cancer-associated cachexia. The randomized, double-blind, placebo-controlled Phase 2/3 trial will enroll about 518 patients with cachexia associated with a range of advanced cancers, including non-small cell lung cancer (NSCLC), colorectal cancer (CRC), and other solid tumors. Cachexia is a severe metabolic condition marked by involuntary weight loss, muscle wasting, and impaired treatment tolerance. In some types of cancer, it can affect up to 70% of patients and is responsible for 20-40% of cancer-related deaths1. Elevated GDF-15 levels are known to play a central role in the development of cachexia. Despite a high unmet medical need, there are currently no approved pharmacological treatments available. “Cachexia remains one of the most debilitating and under-addressed complications in oncology,” said Sujata Rao, MD, Chief Medical Officer at CatalYm. “Following the promising weight gain data observed in our earlier trial and growing evidence of GDF-15’s role in metabolic wasting, this trial is a critical step in establishing visugromab as a novel therapeutic option for patients with advanced cancers.” “The data guiding this trial show that GDF-15 is more than a bystander in cancer progression. It plays a central role in both immune resistance and metabolic decline,” said Scott Clarke, Chief Executive Officer at CatalYm. “By targeting GDF-15, visugromab has the potential to open a new therapeutic path for patients whose treatment outcomes are severely impacted by cachexia.” The VINCIT trial is an adaptive Phase 2/3 study to evaluate the efficacy and safety of visugromab in reversing cachexia. In Part 1, participants are randomized to receive one of three visugromab dose levels or placebo every four weeks for 12 weeks. Based on interim analyses, a recommended dose will be selected for Part 2, which will randomize patients 2:1 to visugromab or placebo for up to 52 weeks. The trial will include clinical sites across the globe. Primary endpoints include changes in body weight and appetite over 12 weeks. Secondary endpoints assess muscle mass and function, physical activity, tumor response, overall survival, patient-reported quality of life, and safety. The study also includes exploratory pharmacodynamic and biomarker assessments. Visugromab is a humanized, monoclonal antibody that targets Growth Differentiation Factor-15 (GDF-15), a tumor-derived cytokine known to drive immune suppression and cachexia. In the exploratory Phase 1/2a GDFATHER trial (NCT04725474), visugromab in combination with PD-1 inhibitor nivolumab demonstrated deep and durable anti-tumor activity as well as a favorable safety profile in patients with relapsed or refractory NSCLC, hepatocellular carcinoma (HCC) and urothelial cancer (UC). The trial also provided early clinical evidence for visugromab’s potential to alleviate cancer cachexia, including meaningful weight gain in the subset of patients with moderate or severe weight loss at trial entry. These findings support visugromab’s dual potential to maintain or restore immune function and counteract cancer cachexia. About cancer cachexia and GDF-15 Cancer cachexia is a complex and debilitating syndrome that affects up to 70% of patients with advanced cancer1. The condition is closely linked to elevated GDF-15 levels, which drive severe and progressive weight loss, muscle wasting, reduced appetite, and metabolic disturbances through activation of the GFRAL receptor in the brainstem. Unlike starvation, cachexia cannot be fully reversed with nutritional support alone, as it is driven by a combination of systemic inflammation, tumor-derived factors, and metabolic dysregulation. This condition significantly diminishes the quality of life for cancer patients and severely impacts their ability to tolerate and respond to treatment, often leading to poorer outcomes and increased mortality. About Visugromab Visugromab is a monoclonal antibody that neutralizes Growth Differentiation Factor-15 (GDF-15), a locally acting immunosuppressant produced by tumors which fosters immunotherapy resistance and drives cachexia in people with cancer. Neutralizing GDF-15 with visugromab reverses key cancer resistance mechanisms to reinstate an efficient anti-tumor response by re-enabling immune cell activation, proliferation and induction of interferon-γ. In addition, visugromab also mitigates cancer cachexia, a severe condition affecting a significant number of advanced cancer patients by inhibiting the activation of the GFRAL pathway in the brainstem, a key driver of weight loss and appetite suppression in cancer patients. About CatalYm CatalYm is developing visugromab, a first-in-class anti-GDF-15 antibody, in solid tumors and cachexia. In its first-in-human Phase 1/2a study, visugromab demonstrated deep and durable anti-tumor efficacy with long-lasting objective responses in relapsed and checkpoint refractory metastatic solid tumor patients in combination with anti-PD-1 treatment. In addition, data from the same study demonstrated that visugromab can significantly counteract the effects of cachexia in these patients. This data was published in Nature and presented at the International Conference on Sarcopenia, Cachexia & Wasting Disorders. CatalYm is now advancing visugromab into multiple Phase 2b studies including first-line metastatic non-squamous NSCLC (NCT07098988), second-line metastatic non-squamous NSCLC (NCT07246863), second-line hepatocellular carcinoma (NCT07219459) and cachexia (NCT07112196). Founded in 2016 and based in Munich, Germany and San Francisco, USA, CatalYm is backed by leading international investors including Canaan Partners, Omega Funds, Bioqube Ventures, Forbion, Jeito Capital, Brandon Capital, Gilde Healthcare, Novartis Venture Fund, Vesalius, Bayern Kapital, BioGeneration Ventures, and Coparion. 1 Fearon K. et al. Lancet Oncol. 2011;12(8):489–495.