On November 3, 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 third quarter ended September 30, 2022 and provided a business update (Press release, Gossamer Bio, NOV 3, 2022, View Source [SID1234622953]).
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"It has been a productive quarter as we eagerly await topline results from the Phase 2 TORREY Study," said Faheem Hasnain, Chairman, Co-Founder and CEO of Gossamer Bio. "Additionally, our team continues to enroll the dose escalation portion of the STAR CNS Study of GB5121, our CNS-penetrant BTK inhibitor for the treatment of CNS lymphomas."
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
Enrollment ongoing in Phase 1b/2 STAR CNS Study in relapsed / refractory PCNSL and other rare CNS malignancies.
Results from the STAR CNS study to be presented at relevant medical conferences, as data become available.
GB7208: Oral, CNS-Penetrant BTK Inhibitor for Multiple Sclerosis
Program highlighted in two poster presentations at the 38th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS; October 2022):
P556: GB7208 is a CNS-Penetrant BTK Inhibitor Demonstrating Potent Activity on Pathogenic Pathways Implicated in Multiple Sclerosis
P690: GB7208 is a Novel, Highly Potent and Selective CNS-Penetrant BTK Inhibitor for Neuroinflammatory and Neurodegenerative Diseases
Posters are available online at: View Source
Preclinical Pipeline Updates
Data generated for two internally developed preclinical programs presented at recent medical conferences:
10th Annual Meeting of the International Cytokine & Interferon Society (September 2022):
P109: Identification of Novel Inhibitor(s) Targeting NLRP3 Inflammasome Activation
34th EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) Symposium (October 2022):
P350: An Orally Bioavailable ENPP1-Selective Inhibitor Demonstrates Superior Immune Preservation Effects over STING Agonists and Confers Anti-Tumor Efficacy in Combination with Other Therapies in Syngeneic Tumor Models
Poster highlighting a third internally developed program to be presented at the upcoming 37th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper), or SITC (Free SITC Whitepaper), in Boston from November 8-12, 2022:
P855: Diacylglycerol Kinase Alpha and Zeta Dual Inhibitors Enhance T Cell Responses and Promote Robust and Durable Anti-Tumor T Cell Immunity
Posters are available, or will be available, online at: View Source
Financial Results for Quarter Ended September 30, 2022
Cash, Cash Equivalents and Marketable Securities: Cash, cash equivalents and marketable securities as of September 30, 2022, were $304.4 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 September 30, 2022, R&D expenses were $44.5 million, compared to $43.2 million for the same period in 2021.
General and Administrative (G&A) Expenses: For the quarter ended September 30, 2022, G&A expenses were $11.5 million, compared to $12.5 million for the same period in 2021.
Net Loss: Net loss for the quarter ended September 30, 2022, was $59.4 million, or $0.65 per share, compared to a net loss of $60.2 million, or $0.80 per share, for the same period in 2021.