CatalYm to Present Updated GDFATHER-NEO Clinical Data and Highlight Ongoing Phase 2b Visugromab Trials at ESMO 2026

• Rapid oral presentation will feature final pathological and radiological outcomes and event-free survival data from the Phase 2 GDFATHER-NEO trial in muscle-invasive bladder cancer
• Two additional presentations to highlight ongoing Phase 2b trials evaluating visugromab in non-small cell lung cancer and hepatocellular carcinoma

CatalYm today announced that updated clinical results from its Phase 2 GDFATHER-NEO trial will be presented in a rapid oral presentation at the European Society for Medical Oncology (ESMO) Congress 2026, taking place October 23-27, 2026, in Madrid, Spain.

The oral presentation will feature updated findings from the Phase 2 GDFATHER-NEO trial (NCT06059547) and will include final pathological and radiological outcomes as well as event-free survival from the stratified, blinded trial evaluating visugromab versus placebo in combination with nivolumab as neoadjuvant treatment for patients with muscle-invasive bladder cancer (MIBC). These updated findings will provide further insights into the potential of GDF-15 inhibition in combination with immune checkpoint blockade.

In addition, two Trial in Progress presentations will provide an overview of the ongoing GDFATHER-NSCLC-02 (NCT07246863) and GDFATHER-HCC-01 (NCT07219459) Phase 2b trials, which are evaluating visugromab in second-line metastatic non-squamous non-small cell lung cancer (NSCLC) and hepatocellular carcinoma (HCC), respectively. Together, these studies reflect CatalYm's continued advancement of visugromab across multiple solid tumor indications.

Presentation Details

Rapid Oral Presentation – GDFATHER-NEO

Abstract #9061 
Title: Final pathological and radiological outcomes and initial EFS from a blinded, exploratory Phase 2 trial of nivolumab ± visugromab in MIBC (GDFATHER-NEO) 
Session: Rapid oral 1: Genitourinary tumours, renal and urothelial 
Presentation Date and Time: October 24, 2026; 10:15 - 11:45 am CEST 
Presenter: Andrea Necchi 
Location: Bilbao Auditorium - Hall 3

Trials in Progress Poster Presentation – GDFATHER-NSCLC-02

Abstract #4316 
Title: Phase 2b randomized, blinded, placebo-controlled trial investigating the efficacy and safety of visugromab plus nivolumab with or without docetaxel in second line metastatic non-squamous NSCLC: GDFATHER-NSCLC-02 
Presentation Date and Time: October 26, 2026; 12:00 - 12:45 pm CET 
Presenter: Martin Reck 
Presentation Number: 2725TiP

Trials in Progress e-Poster Presentation – GDFATHER-HCC-01

Abstract #7627 
Title: Phase 2b randomized, blinded trial to investigate the efficacy and safety of visugromab in combination with nivolumab and lenvatinib in unresectable or metastatic hepatocellular carcinoma after failure of first-line treatment including an anti-PD-(L)1 compound: GDFATHER-HCC-01 
Presenter: Richard S. Finn 
Presentation Number: 1761eTiP

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.

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