Vicore Pharma (6Y4) 2025 Conference Transcript

Vicore Pharma Conference Call Summary Company Overview - Company: Vicore Pharma - Focus: Advancing a drug into late-stage clinical development for idiopathic pulmonary fibrosis (IPF), a disease with a poor prognosis and limited treatment options [4][5] Industry Context - Market Size: The standard of care for IPF generated over $4 billion in sales last year, indicating a significant commercial opportunity for improved therapies [5] - Challenges: Many companies have failed in late-stage trials for IPF, highlighting the difficulty in developing effective treatments [5][6] Core Mechanism and Approach - Mechanism: Vicore's therapy targets upstream processes in the fibrosis pathway, aiming to reactivate and proliferate alveolar epithelial type two cells, which are crucial for lung function [6][15] - Benefits: The therapy is expected to improve gas exchange capability, reduce fibrosis, and address vascular remodeling, potentially leading to better patient outcomes [17][18] Competitive Landscape - Recent Developments: - BI reported a positive phase three trial for a PDE4 inhibitor, showing a 68 ml improvement in lung function [20] - United Therapeutics announced a positive phase three trial for inhaled treprostinil, showing a 195 ml improvement [21] - Vicore's Position: Vicore believes its approach is more comprehensive, addressing multiple aspects of IPF pathology compared to competitors [22] Phase 2a Study Insights - Study Design: The phase 2a study was an open-label trial with treatment-naive patients, showing a significant improvement in lung function over 36 weeks [23][30] - Results: - Greater than 200 ml increase in lung function, representing a 7.5% improvement [31] - 65% of patients showed improvement, indicating a robust response across diverse patient demographics [34] Upcoming Phase 2b ASPIRE Study - Study Design: The ASPIRE study will include a lower dose (50 mg BID) to mitigate side effects observed in the phase 2a study [39] - Powering Assumptions: The study is designed to detect a 125 ml difference in lung function, reflecting a conservative approach based on previous results [47] Corporate Strategy - Funding: Vicore is fully funded for the phase 2b study, with approximately $100 million in cash on hand [48] - U.S. Listing Plans: The company is considering a U.S. listing to capture greater market interest, potentially before the phase 2b readout [49] - Partnerships: Vicore has a partnership in Japan with Nippin Chinyaku, focusing on leveraging local expertise in the pulmonary space [51] Conclusion - Vicore Pharma is positioned at a critical juncture in the IPF landscape, with promising clinical data and a strategic approach to drug development. The upcoming phase 2b study is anticipated to be a significant milestone for the company and the treatment of IPF [53]