Summary of Gossamer Bio FY Conference Call Company Overview - Gossamer Bio was founded in 2018 by Chairman and CEO Faheem Haznain, following a successful exit from Receptos, which was acquired by Celgene, now part of Bristol-Myers Squibb [4][6] - The company focuses on developing therapies for pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PHILD) [4][30] Key Developments and Data Readouts - Gossamer is nearing a key data readout for the PROCERRA study, a multinational Phase III registrational study involving 191 sites across 31 countries, with top-line results expected in February 2026 [6][10] - The company anticipates a 20 to 25 meter increase in six-minute walk distance as a primary endpoint for the PROCERRA study [6][16] - The PROCERRA study aims to enroll a patient population that is more representative of those who performed well in the previous Phase II Tory study, which was affected by the COVID-19 pandemic [8][10] Clinical Insights - The PROCERRA study has a patient demographic with a higher proportion of functional class III patients (approximately 70%) compared to the Tory study [9][10] - The study's design includes a focus on regions with historical efficacy, such as Latin America, which has shown better performance in similar studies [10][11] - The company has amended its protocol to allow patients on background therapy with cetatercept to enroll, but only a small number were able to do so due to adverse events associated with cetatercept [12][13] Commercial Strategy - Assuming positive trial results, Gossamer plans to position cerulutinib as a third-line treatment following standard care for PAH [19][20] - The company expects minimal payer resistance due to the rarity of the disease and the anticipated drop in treatment costs as existing therapies become generic by the time of cerulutinib's launch in 2027 [22][23] - Gossamer is building its commercial organization, with plans for a sales force of approximately 60 representatives to target major treatment centers [26][27] Market Opportunity - The economic opportunity for cerulutinib in PAH is estimated at $2.25 billion, with the potential for even greater revenue in the PHILD market due to less competition and a higher patient population [32][33] - The company has initiated a Phase III trial for PHILD, targeting a very sick patient population with high unmet medical needs [30][34] Pipeline Expansion - Gossamer has entered into a transaction to acquire an inhaled version of Vardenafil for PRN use, which could generate $500 to $750 million in the U.S. alone [39][41] - The acquisition is seen as a strategic move to enhance Gossamer's portfolio and establish long-term partnerships within the PAH community [42] Financial Position - Gossamer has sufficient cash to fund operations until May 2027, including the PROCERRA study and the PHILD trial [44]