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Sep 30, 2021
Gossamer Bio Q3 2021 Earnings Report
Announced third quarter 2021 financial results and provided a corporate update.
Key Takeaways
Gossamer Bio reported a net loss of $60.2 million for the third quarter of 2021, with cash, cash equivalents, and marketable securities totaling $366 million as of September 30, 2021.
Topline results from the Phase 2 TORREY study of Seralutinib in PAH patients are now expected in the second half of 2022 due to COVID-19-related delays.
Enrollment has been completed for the Phase 2 SHIFT-UC study of GB004 in UC patients, with 12-week topline results expected in the second quarter of 2022.
GB5121, a covalent, CNS-penetrant BTK inhibitor for PCNSL, has advanced into a Phase 1 trial in healthy volunteers.
As of September 30, 2021, the company's cash, cash equivalents, and marketable securities totaled $366 million.
Gossamer Bio
Gossamer Bio
Forward Guidance
Gossamer Bio anticipates several key milestones and activities in the near term.
Positive Outlook
- Advancement of GB5121 into a Phase 1 trial.
- Initiation of a Phase 1b/2 clinical trial of GB5121 in PCSNL patients in the first half of 2022.
- Initiation of a first-in-human Phase 1 clinical trial of GB7208 in healthy volunteers in the second half of 2022.
- Funding its operating and capital expenditures into the second half of 2023.
- 12-week topline data from the SHIFT-UC study are expected in the second quarter of 2022.
Challenges Ahead
- Potential delays in the commencement, enrollment and completion of clinical trials
- Disruption to our operations from the ongoing global outbreak of the COVID-19 pandemic, including clinical trial delays and clinical site staff shortages
- Dependence on third parties in connection with product manufacturing, research and preclinical and clinical testing
- Unexpected adverse side effects or inadequate efficacy of our product candidates that may limit their development
- May use its capital resources sooner than it expects