Gossamer Bio, Inc. Q2 FY2021 earnings call

Key Points - Faheem Hasnain: 2021 is a year of execution for Gossamer, with plans for 2022 to be transformative. Two Phase 2 data readouts for Seralutinib and GB004 are expected in the first half of 2022, subject to COVID-19. - Richard Aranda: Update on Seralutinib Phase 1b open-label extension showing safety, tolerability, PK, and PD data supporting pharmacologic activity. GB004's SHIFT-UC study enrollment continuing, with top line results for clinical remission at 12 weeks expected in first half of 2022. Discontinuation of GB1275 clinical activities due to focus on other programs.

In the second quarter of 2021, research and development expenses were approximately $44.3 million, compared to $38.7 million in the same period of 2020. General and administrative expenses were $11.3 million in Q2 2021, versus $11.7 million in Q2 2020. The net loss for the quarter was $59.8 million, equating to $0.80 per share, whereas in Q2 2020, the net loss was $66.9 million, or $1.00 per share. Cash and cash equivalents ended the quarter at $405.9 million.

Top line data for the TORREY study (Seralutinib) and SHIFT-UC study (GB004) are expected in the first half of 2022, with a caveat for potential impacts from the ongoing COVID-19 pandemic. The TORREY study is evaluating change in PVR at 24 weeks as the primary endpoint, and GB004's SHIFT-UC study is evaluating clinical remission at 12 weeks as the primary endpoint.

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: Characterize the current status and pace of enrollment in TORREY and SHIFT-UC.

A: Faheem Hasnain stated they won't comment on specific enrollment data but continue to point to guidance of first half 2022 for top line data, with a COVID caveat.

Q: Thoughts on what it will take for GB004 to break into the market where other new agents have struggled.

A: Faheem Hasnain mentioned GB004's non-immunosuppressive profile, potential to slot into an important treatment slot, and promising mechanism of action as key factors.

Q: Current status of oncology focus within the pipeline.

A: Faheem Hasnain stated oncology remains a focus with preclinical assets in the pipeline to be vectored towards oncology indications.

Q: Impact of JAK class uncertainty on GB004.

A: Faheem Hasnain said it reinforces confidence in GB004 due to its non-immunosuppressive profile and need for novel approaches in IBD.

Q: Clinical relevance of OLE data for Seralutinib with two patients.

A: Richard Aranda said the data is encouraging with directional improvements in NT-proBNP and 6-minute walk distance, though cautioning on overinterpretation with only two patients.

Q: Impact on expenses of winding down GB1275 program.

A: Bryan Giraudo said expenses were very minimal as it was a limited study, allowing focus on other programs.