On May 10, 2022 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 first quarter ended March 31, 2022 and provided a business update (Press release, Gossamer Bio, MAY 10, 2022, View Source [SID1234614070]).
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"We are looking forward to the fourth quarter release of topline data from the ongoing Phase 2 TORREY Study, which has now completed enrollment," said Faheem Hasnain, Co-Founder, Chairman and Chief Executive Officer of Gossamer Bio.
"Additionally, through a recent internal reprioritization and the implementation of certain cost containment measures, we are pleased to see Gossamer’s expected capital runway further extended into the first half of 2024. As part of this reprioritization, we now anticipate moving GB7208 into the clinic in the first half of 2023, pending the TORREY Study results."
Product Candidate Updates
Seralutinib (GB002): Inhaled PDGFR, CSF1R and c-KIT Inhibitor for Pulmonary Arterial Hypertension (PAH)
Enrollment has completed in the ongoing TORREY Study, a Phase 2 clinical trial in patients with PAH whose disease has progressed despite standard-of-care therapy. The primary endpoint is change in pulmonary vascular resistance from baseline at week 24.
Topline data from the TORREY Study are expected in the fourth quarter of 2022.
GB5121: Oral, CNS-Penetrant BTK Inhibitor for Primary CNS Lymphoma (PCNSL) and other Rare CNS Malignancies
We expect to initiate the Phase 1b/2 STAR CNS Study in relapsed / refractory PCNSL and other rare CNS malignancies in the second quarter of 2022.
GB7208: Oral, CNS-Penetrant BTK Inhibitor for Neuroinflammatory Diseases
Pending the outcomes of ongoing preclinical studies and the seralutinib Phase 2 TORREY Study topline results, we expect to initiate a Phase 1 clinical trial in healthy volunteers in the first half of 2023.
Financial Results for Quarter Ended March 31, 2022
Cash, Cash Equivalents and Marketable Securities: Cash, cash equivalents and marketable securities as of March 31, 2022, were $271.6 million. The Company expects the combination of current cash, cash equivalents and marketable securities, and access to its debt facility will be sufficient to fund its operating and capital expenditures into 2024.
Research and Development (R&D) Expenses: For the quarter ended March 31, 2022, R&D expenses were $42.3 million, compared to R&D expenses of $41.8 million for the same period in 2021.
General and Administrative (G&A) Expenses: For the quarter ended March 31, 2022, G&A expenses were $12.0 million, compared to $11.3 million for the same period in 2021.
Net Loss: Net loss for the quarter ended March 31, 2022, was $57.8 million, or $0.76 per share, compared to a net loss of $57.6 million, or $0.78 per share, for the same period in 2021.