On November 9, 2023 Gossamer Bio, Inc. (Nasdaq: GOSS), a clinical-stage biopharmaceutical company focused on the development and commercialization of seralutinib for the treatment of pulmonary arterial hypertension (PAH), reported its financial results for the third quarter ended September 30, 2023 and provided a business update (Press release, Gossamer Bio, NOV 9, 2023, View Source [SID1234637366]).
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"We are pleased with the progress our team has made with the launch of the seralutinib Phase 3 PROSERA Study. With sites opening up across the globe, we are hearing incredible enthusiasm and interest from investigators, patients and patient advocates, alike," said Faheem Hasnain, Chairman, Co-Founder and CEO of Gossamer Bio.
"Additionally, we were excited to have presented the results from the Phase 2 TORREY lung imaging sub-study presented at the European Respiratory Society International Congress 2023. These data provide encouraging clinical evidence of seralutinib’s ability to improve the pulmonary arterial blood vessel volume distribution for patients treated with seralutinib, as compared to placebo, and are supportive of the growing body of preclinical evidence showing the effect of seralutinib on reverse remodeling."
Seralutinib (GB002): Inhaled PDGFR, CSF1R and c-KIT Inhibitor for PAH
•Site and country activations in the global Phase 3 PROSERA Study in patients with Functional Class II and III PAH are proceeding ahead of schedule, with sites projected to be active in North America, Latin America, Europe and Asia Pacific by year end. Gossamer expects to dose its first Phase 3 PROSERA Study patient in the fourth quarter. The primary endpoint is change in six-minute walk distance (6MWD) from baseline at week 24.
•Gossamer expects to release further TORREY OLE data from the ongoing extension study in PAH patients in the fourth quarter of 2023.
•A functional respiratory imaging, or FRI, sub-study of the successful Phase 2 TORREY Study of seralutinib in patients with PAH was presented in September at the European Respiratory Society International Congress 2023, by Dr. Roham Zamanian, Professor of Pulmonary and Critical Care Medicine at Stanford University.
◦Presentation Link: View Source
Financial Results for Quarter Ended September 30, 2023
•Cash, Cash Equivalents and Marketable Securities: Cash, cash equivalents and marketable securities as of September 30, 2023, were $328.9 million. The Company expects the combination of current cash, cash equivalents and marketable securities will be sufficient to fund its operating and capital expenditures into the first half of 2026.
•Research and Development (R&D) Expenses: For the quarter ended September 30, 2023, R&D expenses were $31.2 million, compared to $44.5 million for the same period in 2022, for a decrease of $13.3 million, which was primarily attributable to a decrease of $12.7 million of costs associated with preclinical studies and clinical trials for GB5121, a decrease of $5.5 million of costs associated with preclinical studies and clinical trials for other programs and a decrease of $4.3 million of costs associated with preclinical studies and clinical trials for other terminated programs, offset by an increase of $9.2 million of costs associated with preclinical studies and clinical trials for seralutinib.
•General and Administrative (G&A) Expenses: For the quarter ended September 30, 2023, G&A expenses were $9.3 million, compared to $11.5 million for the same period in 2022.
•Net Loss: Net loss for the quarter ended September 30, 2023, was $40.0 million, or $0.21 per share, compared to a net loss of $59.4 million, or $0.65 per share, for the same period in 2022.