Gossamer Bio, Inc. Q3 FY2020 earnings call

• Gossamer Bio is advancing multiple clinical product candidates across therapeutic areas like inflammation, immunology, and oncology.
• GB001: Phase 2b LEDA study results showed a 32%-35% reduction in asthma worsening vs placebo, with key secondary endpoint improvement; currently engaging with global regulatory authorities.
• GB002: Activated Phase 1b study in PAH, with plans for Phase 2 TORREY study; interrupted by COVID-19 but restarted, and to host a GB002 PAH focus webinar in December.
• GB004: Begun dosing patients in Phase 2 SHIFT-UC study for ulcerative colitis; completed Phase 1b trial, received positive feedback.
• GB1275: Updates on Phase 1/2 KEYNOTE-A36 trial at SITC, with well-tolerated profile and encouraging clinical and biologic activity, including prolonged stable disease and confirmed response in some patients.

Research and development expenses in the third quarter of 2020 were approximately $41.8 million, compared to $40.1 million for the same period in 2019. G&A expenses were $11.4 million in Q3 2020, versus $9.8 million in Q3 2019. The net loss for the quarter was $57.8 million, equating to $0.80 per share, compared to a net loss of $48.5 million, or $0.80 per share in the same period of 2019. No specific product segment revenue contribution percentages are detailed.

• Ability to meet guidance related to clinical studies and data release may be affected by the ongoing COVID-19 pandemic.
• Expect to read out top line data from Phase 2 TORREY study and SHIFT-UC study in the first half of 2022, subject to COVID-19 developments.
• Aim to have clarity from GB001 regulatory discussions in the first half of next year to inform potential partnerships.

• The ongoing COVID-19 pandemic may adversely affect the timely initiation and completion of clinical studies, as well as the release of results from clinical trials.

Q: Tyler Van Buren asked about GB002 lung exposure ratio vs imatinib and data from Phase 1b patients.

A: Sheila Gujrathi and Luisa Salter-Cid discussed lung exposure, low systemic PK to avoid safety issues, and upcoming data in December.

Q: Joseph Schwartz asked about bridging data from GB002 Phase 1b to healthy volunteers and PD markers for GB002.

A: Sheila Gujrathi spoke about bridging experience and PD markers to watch for in Phase 2.

Q: Geoff Meacham asked about GB001 strategic options and partnering.

A: Sheila Gujrathi and Bryan Giraudo discussed need for regulator input before substantive partnering discussions.

Q: Josh Schimmer asked about GB002 right-sided heart pressure data and operating expenses.

A: Sheila Gujrathi mentioned right heart catheterization data in Phase 2, and Bryan Giraudo discussed capital lasting into 2023.

Q: Carter Gould asked about GB002 clinical meaningfulness and GB1275 MDSC biomarker context.

A: Sheila Gujrathi and Luisa Salter-Cid talked about unmet need in PAH and totality of GB1275 biomarker data.

Q: Emma Nealon asked about GB004 physician excitement and combination potential.

A: Sheila Gujrathi and Luisa Salter-Cid discussed differentiated mechanism and synergy with standard therapies.

Q: David Hoang asked about GB002 PAH exercise testing and GB004 ulcerative colitis patient overlap.

A: Sheila Gujrathi spoke about exercise testing relevance and patient population overlap.

Q: Patrick Trucchio asked about GB004 endpoints and movement to Crohn's disease.

A: Sheila Gujrathi discussed endpoints and plan to move to Crohn's based on SHIFT-UC outcome.