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Dec 31, 2022
Gossamer Bio Q4 2022 Earnings Report
Announced fourth quarter and full-year 2022 financial results and provided business update.
Key Takeaways
Gossamer Bio reported its Q4 2022 financial results, with a net loss of $55.8 million, or $0.59 per share. The company's cash, cash equivalents, and marketable securities totaled $255.7 million as of December 31, 2022.
FDA feedback on Seralutinib Phase 3 Clinical Trial Received; Expected to Commence in the Second Half of 2023
Topline Data from TORREY Study Open-Label Extension Expected in Mid-2023
Enrollment in GB5121 Phase 1b/2 Clinical Trial in PCNSL Paused
Cash, cash equivalents and marketable securities totaled $256 million at year-end 2022
Gossamer Bio
Gossamer Bio
Forward Guidance
Gossamer Bio provided forward-looking statements regarding the anticipated timing of initiation and enrollment of clinical trials, the trial design of the Phase 3 clinical trial of seralutinib, plans to discuss the benefit/risk profile for GB5121, plans to advance product candidates, expectations on the timing of data readouts, and the expected timeframe for funding the operating plan with current resources.
Positive Outlook
- Anticipated timing of initiation and enrollment of clinical trials for product candidates.
- Trial design of Phase 3 clinical trial of seralutinib based on regulatory feedback.
- Plans to discuss benefit / risk profile for GB5121 with Data Review Committee.
- Plans to advance product candidates.
- Expectations on the timing of data readouts from clinical studies.
Challenges Ahead
- Potential delays in the commencement, enrollment and completion of clinical trials.
- Later developments with and / or feedback from global regulatory authorities or the FDA that may differ from prior feedback which may alter planned Phase 3 clinical trial design and timing of initiation thereof.
- Disruption to operations from the COVID-19 pandemic, including clinical trial delays.
- Dependence on third parties in connection with product manufacturing, research and preclinical and clinical testing.
- Unexpected adverse side effects or inadequate efficacy of product candidates that may limit their development, regulatory approval and/or commercialization, or may result in clinical holds, recalls or product liability claims.