Gossamer Bio(GOSS) - 2025 Q2 - Quarterly Results

Overview and Business Update This section outlines Gossamer Bio's business, including management insights and updates on seralutinib's clinical development programs Management Commentary Management commentary emphasizes the company's commercial transition and key upcoming clinical milestones for seralutinib in PH-ILD and PAH - Gossamer Bio is actively engaged in commercial planning with its partner, Chiesi Group, preparing to evolve from a clinical-stage to a commercial organization[2] - The company is preparing to initiate a global, registrational Phase 3 clinical study in PH-ILD (SERANATA Study), with the first clinical sites expected to be activated in Q4 2025[2] - The upcoming pivotal readout from the PROSERA Study in PAH is viewed as the foundation for seralutinib's potential multi-billion-dollar franchise, with topline results anticipated in February 2026[3][8] Seralutinib (GB002) Clinical Program Update This section details the clinical development progress of seralutinib for Pulmonary Arterial Hypertension and PH-Interstitial Lung Disease Pulmonary Arterial Hypertension (PAH) The Phase 3 PROSERA study for PAH completed enrollment, with topline results expected in February 2026, showing a more severe patient population - Enrollment for the Phase 3 PROSERA Study was completed on June 11th with 390 Functional Class II and III PAH patients[4] - The primary endpoint is the change in six-minute walk distance (6MWD) from baseline compared to placebo at week 24. Topline results are expected in February 2026[4][8] Baseline Characteristics: PROSERA Phase 3 vs. TORREY Phase 2 | | PROSERA Phase 3* | TORREY Phase 2 | | :--- | :--- | :--- | | Study Participants | n = 390 | n = 86 | | Mean 6MWD | 374 meters | 408 meters | | Mean NT-proBNP | 987 ng/L | 628 ng/L | | Functional Class III Patients | 290 (74%) | 36 (42%) | Pulmonary Hypertension Associated with Interstitial Lung Disease (PH-ILD) The registrational Phase 3 SERANATA study for PH-ILD is set to begin in Q4 2025, enrolling 480 patients with 6MWD as the primary endpoint - The first clinical sites for the global, registrational Phase 3 SERANATA Study in PH-ILD are expected to be activated in Q4 2025[9] - The study will enroll approximately 480 patients randomized 1:1:1 to receive 90mg seralutinib twice-daily, 120mg seralutinib twice-daily, or a placebo[9] - The primary endpoint is change in 6MWD from baseline at week 24, with key secondary endpoints including time to clinical worsening and change in forced vital capacity (FVC)[9] Second Quarter 2025 Financial Results This section presents Gossamer Bio's financial performance for Q2 2025, encompassing key highlights, statement of operations, and balance sheet Financial Highlights Q2 2025 financial highlights show a net loss of $38.3 million, influenced by the absence of prior year's one-time license revenue - Cash, cash equivalents, and marketable securities totaled $212.9 million as of June 30, 2025, expected to fund operating and capital expenditures into 2027[9] Q2 2025 vs Q2 2024 Financial Summary | Metric | Q2 2025 (Millions USD) | Q2 2024 (Millions USD) | Change Driver | | :--- | :--- | :--- | :--- | | Collaboration Revenue | $11.5 | $95.8 | Q2 2024 included a one-time $88.8M license sale | | R&D Expenses | $41.6 | $35.1 | Increased research and development activities | | G&A Expenses | $8.7 | $8.7 | Remained flat year-over-year | | Net Income (Loss) | ($38.3) | $49.2 | Primarily due to the one-time license revenue in 2024 | | Net Income (Loss) Per Share | ($0.17) | $0.22 | - | Consolidated Statement of Operations The consolidated statement of operations details a net loss of $38.3 million for Q2 2025, driven by reduced revenue and increased expenses Condensed Consolidated Statement of Operations (in thousands, except per share amounts) | | Three months ended June 30, 2025 | Three months ended June 30, 2024 | | :--- | :--- | :--- | | Total revenue | $11,489 | $95,842 | | Total operating expenses | $50,254 | $43,755 | | Research and development | $41,575 | $35,086 | | General and administrative | $8,679 | $8,669 | | Income (loss) from operations | ($38,765) | $52,087 | | Net income (loss) | ($38,273) | $49,232 | | Net income (loss) per share, basic | ($0.17) | $0.22 | Consolidated Balance Sheet The consolidated balance sheet as of June 30, 2025, shows $212.9 million in cash and a total stockholders' deficit of $46.1 million Condensed Consolidated Balance Sheet Data (in thousands) | | June 30, 2025 (unaudited) | December 31, 2024 | | :--- | :--- | :--- | | Cash, cash equivalents, and marketable securities | $212,918 | $294,518 | | Working capital | $182,304 | $264,878 | | Total assets | $240,925 | $315,292 | | Total liabilities | $287,032 | $285,800 | | Total stockholders' equity (deficit) | ($46,107) | $29,492 | Corporate Information This section provides an overview of Gossamer Bio and includes important forward-looking statements and associated risk disclosures About Gossamer Bio Gossamer Bio is a late-stage clinical biopharmaceutical company focused on developing seralutinib for PAH and PH-ILD - The company is a late-stage clinical biopharmaceutical company focused on developing and commercializing seralutinib for PAH and PH-ILD[10] Forward-Looking Statements This section contains forward-looking statements regarding clinical timelines, market opportunities, and financial runway, with associated risks - The press release contains forward-looking statements regarding clinical trial timelines (PROSERA data readout, SERANATA trial commencement), the market opportunity for seralutinib, and the company's financial runway[11] - Key risks that could cause actual results to differ include clinical trial delays, manufacturing and testing dependencies on third parties, unexpected adverse side effects of seralutinib, and unstable market conditions[11]