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]

Financial Data and Key Metrics Changes - For Q2 of fiscal 2025, total revenue was $124.3 million, up from $119.0 million in Q2 of fiscal 2024, representing a year-over-year increase of $5.3 million or 4.4% [9][26] - Adjusted EBITDA for Q2 was $8.0 million, or 6.4% of total revenue, compared to $3.1 million, or 2.6% of total revenue in the prior year [28][29] - Consolidated net loss attributable to common shareholders was $14.9 million, or a loss of $0.44 per diluted share, compared to a loss of $48.1 million, or $1.86 per diluted share in Q2 of fiscal 2024 [28] Business Line Data and Key Metrics Changes - RMS segment revenue increased by $6.6 million or 9.1% year-over-year, primarily due to higher NHP revenue [9][26] - DSA revenue decreased to $45.3 million from $46.6 million in Q2 of fiscal 2024, driven by a decline in general toxicology services revenue [27] - DSA net new orders were $44.5 million, a 27% increase over Q2 of fiscal 2024, with a book-to-bill ratio of 1.01:1 [27][30] Market Data and Key Metrics Changes - The company noted geopolitical and macroeconomic risks affecting the industry, but expects continued year-over-year revenue growth for the next two quarters [9][24] - The company has not seen significant changes in demand due to current tariffs, although there is some cost inflation linked to them [23][24] Company Strategy and Development Direction - The company is focused on client satisfaction, integration of scientific services, and optimizing RMS site operations [8][10] - A revised RMS site optimization plan is expected to yield annual cost savings of $6 million to $7 million, with completion anticipated by March 2026 [11][12] - The company is adapting to FDA goals of reducing animal testing and is investing in technologies that align with these objectives [18][19] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about revenue growth in the upcoming quarters and a potential reversal in declines in discovery business [49] - The company is closely monitoring NIH funding impacts but has not yet seen significant effects on business [52][55] - Management remains confident in the ability to improve DSA margins and overall operational efficiency [62][69] Other Important Information - The company plans to hold an Investor Day on May 29 to discuss its strategic plan and focus on client excellence [90] - The company has settled a litigation case for approximately $7.6 million, which positively impacted its financials [8] Q&A Session Summary Question: Changes in marketing post-FDA announcement - Management has integrated new services into the discovery sales process and is seeing some growth, but not at the expected pace [36][37] Question: Focus areas in RMS optimization plan - The revised plan aims to improve efficiencies and reduce costs, with a focus on maximizing existing resources rather than expanding capacity [40][41] Question: Current demand and quoting activity - Management reported a positive start to the current quarter with good quoting and closing activity [45][47] Question: Impact of NIH funding on customer mix - No significant impact has been observed yet, although the company is monitoring the situation closely [52][55] Question: DSA margin improvement timeline - Management expects to see benefits from margin improvement efforts sooner rather than later, with some improvements already noted [67][69] Question: Pricing discounting trends - Price discounting has decreased compared to six to twelve months ago, with a more stable pricing environment currently [71][72] Question: Integration of scientific services - The integration involves improving project management systems and enhancing service delivery speed to add value for clients [79][80]

AI and Drug Discovery - Isomorphic Labs is applying cutting-edge AI to reimagine drug discovery [1] - The company is building generalisable AI models capable of learning from the entire universe of protein and chemical interactions [1] - This approach fundamentally breaks from the target-specific, siloed approach of conventional drug development [1] Technology and Innovation - The company's CTO and Chief AI Officer discussed their work on the NVIDIA AI Podcast [1] Future Implications - The AI advancements have implications for the future of precision medicine [1]