On May 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 first quarter ended March 31, 2023 and provided a business update (Press release, Gossamer Bio, MAY 9, 2023, View Source [SID1234631272]).
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"Our team continues to build momentum across multiple fronts following the positive results from our Phase 2 TORREY study of seralutinib in PAH patients. With recent feedback from both the FDA and EMA, we are well positioned to commence our registration program," said Faheem Hasnain, Chairman, Co-Founder and CEO of Gossamer. "We remain on track to begin our Phase 3 clinical trial of seralutinib in the coming months, moving one step closer towards our goal of bringing a potential new medicine to patients suffering from PAH."
"Additionally, we made the difficult decision to undergo an operational restructuring and headcount reduction to prioritize resources around the development of seralutinib. We believe that this restructuring was a necessary step to focus the organization on activities which maximize the potential of seralutinib. We truly appreciate the hard work and dedication of all of our employees, past and present."
Seralutinib (GB002): Inhaled PDGFR, CSF1R and c-KIT Inhibitor for (PAH)
•Gossamer has successfully concluded an End-of-Phase 2 Meeting with the U.S. Food and Drug Administration (FDA) and the Scientific Advice process with the European Medicines Agency (EMA) following the completion of its positive Phase 2 TORREY Study in patients with PAH. The Company has reached agreement with both FDA and EMA regarding key design elements of the Phase 3 program and expects to commence a single registrational Phase 3 PAH clinical trial in the third quarter 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 and EMA feedback,
we will test a single dose of 90 mg, twice daily versus placebo. The primary endpoint of the trial will be change in six-minute walk distance from baseline.
•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. Gossamer plans to report initial results from this ongoing open-label extension trial in the middle of 2023.
•Clinical development of seralutinib for the treatment of pulmonary hypertension associated with interstitial lung disease (PH-ILD) is expected to begin in the first half of 2024.
Corporate Updates
• As part of a structural reorganization to center Gossamer around seralutinib and its continued development in PAH, Gossamer reduced its headcount by over 25%. Further development of all clinical and pre-clinical product candidates, outside of seralutinib, has been terminated, and strategic options are being assessed for those candidates. Gossamer is working diligently with affected employees to assist in their transition to new opportunities.
Financial Results for Quarter Ended March 31, 2023
•Cash, Cash Equivalents and Marketable Securities: Cash, cash equivalents and marketable securities as of March 31, 2023, were $201.9 million. The Company expects the combination of current cash, cash equivalents and marketable securities will be sufficient to fund operations through at least the next 12 months from the date our first quarter 2023 financial statements were available to be issued.
•Research and Development (R&D) Expenses: For the quarter ended March 31, 2023, R&D expenses were $37.8 million, compared to $42.3 million for the same period in 2022.
•General and Administrative (G&A) Expenses: For the quarter ended March 31, 2023, G&A expenses were $10.1 million, compared to $12.0 million for the same period in 2022.
•Net Loss: Net loss for the quarter ended March 31, 2023, was $49.2 million, or $0.52 per share, compared to a net loss of $57.8 million, or $0.76 per share, for the same period in 2022.