Pila Pharma

Analyst Group today, December 5, 2025, initiates equity research coverage on Pila Pharma AB (“Pila Pharma” or “the Company”). The coverage includes equity research with biannual updates as well as analyst comments on press releases.

About Pila Pharma

Pila Pharma is a Swedish biotechnology company developing the drug candidate XEN-D0501, primarily focused on an oral treatment for obesity and type 2 diabetes based on inhibition of TRPV1, the so-called “chili receptor.” The Company’s lead candidate, XEN-D0501, is a selective small-molecule TRPV1 antagonist with an approved tablet formulation. Founder and Chief Scientific Officer Dorte X. Gram were the first to demonstrate, through preclinical studies at Novo Nordisk, that blocking TRPV1 can counteract glucose intolerance and weight gain. This discovery laid the foundation for the Company’s patent portfolio relating to the treatment of obesity and diabetes using TRPV1 antagonists.

To date, XEN-D0501 has been evaluated in eight clinical trials involving over 300 persons, including two Phase IIa studies in patients with obesity and type 2 diabetes, where the candidate demonstrated good safety, improved glucose control, and indications of cardiovascular benefits, with an especially large reduction in a heart failure biomarker called ANP. The Company also holds orphan drug designation for XEN-D0501 in the rare pain disorder erythromelalgia, a condition characterized by intense episodes of “flare-ups” with pain occurring without a known cause. This designation, if converted to actual orphan drug status, which is pending successful trials, could provide significant data exclusivity. The Company has most recently also conducted a preclinical study within abdominal aortic aneurysm, a cardiovascular disease, achieving proof of concept, further strengthening the perceived cardio-protective benefits of the candidate.

Pila Pharma is now to conduct preclinical obesity studies in collaboration with Gubra in two established obesity rat models (DIO and Zucker rats) to achieve proof-of-concept within obesity, funded by a recently completed and oversubscribed rights issue. The ambition thereafter is to pursue two parallel development tracks, in overweight patients with and without type 2 diabetes, to build a comprehensive and commercially attractive data package. These would comprise of Phase Ib/IIa trials, in people living with obesity, and in people living with obesity and diabetes of three months treatment. The trials will aim to determine the maximum tolerable dose, confirm the safety profile, and generate preliminary data on weight reduction that could form the basis for a partnership/acquisition with a larger pharmaceutical company and position XEN-D0501 as a potential first-in-class oral treatment for obesity and obesity-related comorbidities.

Strengthening the Company’s Scientific Advisory Board through the recruitment of an expert in preclinical obesity and metabolic research

On December 4, Pila Pharma announced that Professor Thomas Lutz, DVM, PhD, from the University of Zurich, has joined the Company’s Scientific Advisory Board. Professor Lutz is an internationally recognized expert in preclinical obesity and metabolic research. His appointment strengthens Pila Pharma’s scientific capabilities at a time when the Company is preparing to initiate preclinical obesity studies in DIO and Zucker rats. While the Company’s existing advisors primarily represent clinical expertise in obesity and diabetes, Professor Lutz brings deep preclinical knowledge that is essential for evaluating and interpreting the mechanistic effects of XEN-D0501. This addition complements the Company’s research strategy and enhances Pila Pharma’s ability to build a robust and commercially attractive data package ahead of future clinical development steps. Moreover, Professor Lutz holds a prominent position within the international scientific community, and his recruitment is therefore expected to further increase external visibility and scientific credibility ahead of the upcoming launch of Pila Pharma’s obesity studies, which constitute one of the Company’s key near-term milestones.

Analyst Group will return with an equity research report on Pila Pharma. The Company will also present at our capital markets on December 10^th.