On August 9, 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 second quarter ended June 30, 2022 and provided a business update (Press release, Gossamer Bio, AUG 9, 2022, View Source [SID1234617944]).
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"Everyone at Gossamer is looking forward to the upcoming TORREY Phase 2 results, as we actively prepare for seralutinib’s next steps in clinical development," said Faheem Hasnain, Chairman, Co-Founder and CEO of Gossamer.
"Our strong financial position, bolstered by our recent private placement, has enabled us to accelerate investment into a registrational Phase 3 program for seralutinib. Despite existing treatments that improve symptoms of the disease, PAH remains a progressive illness, with a heavy burden on patients and caregivers. Seralutinib is one of the few therapies in development with the potential to directly address the pathology of the underlying disease, underscoring the need to accelerate seralutinib’s registrational Phase 3 program."
Product Candidate Updates
Seralutinib (GB002): Inhaled PDGFR, CSF1R and c-KIT Inhibitor for Pulmonary Arterial Hypertension (PAH)
Ongoing TORREY Study is 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 Phase 2 TORREY Study are expected in the second half of November or first half of December.
Ahead of these data, Gossamer has commenced investment in operational activities to enable the commencement of a registrational PAH Phase 3 clinical program in the third quarter of 2023.
GB5121: Oral, CNS-Penetrant BTK Inhibitor for Primary CNS Lymphoma (PCNSL) and other Rare CNS Malignancies
First patient dosed in Phase 1b/2 STAR CNS Study in relapsed / refractory PCNSL and other rare CNS malignancies.
Results from open-label Phase 1b/2 STAR CNS to be presented at relevant medical conferences, as data become available.
Corporate Updates
On July 15, the Company sold 16.6 million shares of its common stock to a select group of institutional and accredited investors in a private placement, raising approximately $120 million in gross proceeds.
Financial Results for Quarter Ended June 30, 2022
Cash, Cash Equivalents and Marketable Securities: Cash, cash equivalents and marketable securities as of June 30, 2022, were $222.2 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 the second quarter of 2024.
Research and Development (R&D) Expenses: For the quarter ended June 30, 2022, R&D expenses were $42.6 million, compared to $44.3 million for the same period in 2021.
General and Administrative (G&A) Expenses: For the quarter ended June 30, 2022, G&A expenses were $11.3 million, compared to $11.3 million for the same period in 2021.
Net Loss: Net loss for the quarter ended June 30, 2022, was $56.5 million, or $0.74 per share, compared to a net loss of $59.8 million, or $0.80 per share, for the same period in 2021.