On March 17, 2023 Gossamer Bio, Inc. (Nasdaq: GOSS), a clinical-stage biopharmaceutical company focused on discovering, acquiring, developing and commercializing therapeutics in the disease areas of immunology, inflammation and oncology, reported its financial results for the fourth quarter and year ended December 31, 2022 and provided a business update (Press release, Gossamer Bio, MAR 17, 2023, View Source [SID1234628986]).
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Clinical-Stage Product Candidate Updates
Seralutinib (GB002): Inhaled PDGFR, CSF1R and c-KIT Inhibitor for Pulmonary Arterial Hypertension (PAH)
•Upon completion of the 24-week blinded portion of the Phase 2 TORREY Study, patients were able to enroll into an open-label extension trial. We anticipate reporting results from this ongoing open-label extension trial in the middle of 2023.
• We expect to commence a Phase 3 PAH clinical trial in the second half of 2023. The planned Phase 3 clinical trial will be a randomized, double-blind, placebo-controlled, global clinical trial in PAH patients. Patients will be randomized to receive either seralutinib or placebo, in addition to their background PAH therapies.
• Based on FDA feedback, we expect to test a single dose of 90 mg twice daily in the planned PAH Phase 3 clinical trial, and we expect the primary endpoint of the trial to be change in six-minute walk distance from baseline. However, the final trial design is subject to further feedback from global regulatory authorities.
GB5121: Oral, CNS-Penetrant BTK Inhibitor for Primary CNS Lymphoma (PCNSL)
•Based upon the benefit / risk profile observed to date and a prioritization of resources to support the seralutinib program, Gossamer has decided to pause enrollment in the Phase 1b/2 STAR CNS study.
•Gossamer plans to discuss available data with the study’s Data Review Committee to determine next steps.
Financial Results for Quarter and Full Year Ended December 31, 2022
•Cash, Cash Equivalents and Marketable Securities: Cash, cash equivalents and marketable securities as of December 31, 2022, were $255.7 million. As a result, we expect our current cash, cash equivalents and marketable securities will be sufficient to fund operating and capital expenditures into the second half of 2024.
•Research and Development (R&D) Expenses: For the quarter ended December 31, 2022, R&D expenses were $41.5 million compared to R&D expenses of $40.9 million for the same period in 2021. R&D expenses for the full year ended December 31, 2022, were $170.9 million compared to $170.3 million for the full year ended December 31, 2021.
•General and Administrative (G&A) Expenses: For the quarter ended December 31, 2022, G&A expenses were $12.8 million compared to $10.7 million for the same period in 2021. G&A expenses for the full year ended December 31, 2022, were $47.6 million compared to $45.8 million for the full year ended December 31, 2021.
•Net Loss: Net loss for the three months ended December 31, 2022, was $55.8 million, or $0.59 per share, compared to a net loss of $56.3 million, or $0.74 per share, for the same period in 2021. Net loss for the full year ended December 31, 2022, was $229.4 million, or $2.71 per share compared to a net loss of $234.0 million, or $3.13 per share, for the full year ended December 31, 2021.