On August 9, 2021 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 of 2021 and provided a corporate update (Press release, Gossamer Bio, AUG 9, 2021, View Source [SID1234586133]).
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"I am tremendously proud of the dedication and perseverance the Gossamer team has shown this year, pressing forward with the execution of two Phase 2 studies for our lead clinical programs, seralutinib and GB004, in the face of operational challenges presented by the pandemic," said Faheem Hasnain, Co-Founder, Chairman and Chief Executive Officer of Gossamer. "We are also very happy to share data from the first extended clinical experience of seralutinib, the first such data from an inhaled kinase inhibitor in patients with PAH. Though the pandemic limited the number of patients who were able to continue onto the OLE, these patient experiences provide additional evidence supporting the potential of seralutinib to improve the lives of PAH patients."
Clinical-Stage Product Candidate Updates
Seralutinib (GB002): Inhaled PDGFR, CSF1R and C-KIT Inhibitor for PAH
While the conduct of the Phase 1b study of seralutinib in patients with Functional Class II and III PAH was interrupted by the COVID-19 pandemic, two of the eight patients that completed the two-week Phase 1b study were also able to complete the optional 6-month open-label extension period.
Both patients entered and completed the extension study on three classes of background therapy, including oral prostacyclins.
No serious adverse events were reported, and no safety concerns identified with longer term treatment over a six-month period at a twice daily 90mg dose.
In both patients, decreases in NT-proBNP, a biomarker for right heart strain, and increases in six-minute walk distance, a potential registrational endpoint for PAH, were observed.
Enrollment is ongoing in the 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 (PVR) from baseline at week 24. Topline data from the TORREY study are expected in the first half of 2022, subject to developments in the ongoing COVID-19 pandemic.
Additional exploratory biomarker data from the completed seralutinib two-week Phase 1b in eight PAH patients will be presented via ePoster at the Virtual European Respiratory Society (ERS) International Congress 2021 being held virtually from September 5 – 8, 2021. Abstract content will be available online at the ERS website, starting on August 23, 2021, two weeks prior to the beginning of the virtual ERS Congress. ePoster details:
ePoster Title: Evidence of Target Engagement and Pathway Modulation: Biomarker Analysis of the Phase 1b Inhaled Seralutinib Study
Session Date: Sunday, September 5, 2021
Session Time: 1:15pm CEST / 7:15am EDT / 4:15am PDT
GB004: Oral, Gut-Targeted HIF-1α Stabilizer for Inflammatory Bowel Disease (IBD)
Enrollment is ongoing in the SHIFT-UC Study, a Phase 2 clinical trial in patients with active UC despite treatment with 5-ASAs. The primary endpoint is proportion of patients with clinical remission at week 12. Topline data from the SHIFT-UC study are expected in the first half of 2022, subject to developments in the ongoing COVID-19 pandemic.
Additional post-hoc analysis of clinical data from the completed GB004 Phase 1b in patients with active UC will be presented at the United European Gastroenterology (UEG) Virtual Week 2021 being held virtually from October 3 – 5, 2021. Presentation details:
Abstract Title: Assessment of Composite Endpoints Comprising Symptomatic, Histologic, Endoscopic, and Molecular Improvement in a Phase 1b Study of GB004, a Gut-Targeted, Hypoxia-Inducible Factor (HIF)-1α Stabilizer, in Mild-to-Moderate Ulcerative Colitis
Presenting Author: Silvio Danese, MD, PhD
Abstract Number: OP124
Session Title: IBD Clinical Trials III
Session Date: Monday, October 4, 2021
Session Time: 3:00pm CEST / 9:00am EDT / 6:00am PDT
GB1275: Oral CD11b Modulator for Solid Tumor Oncology Indications
Gossamer will discontinue clinical development of its immuno-oncology product candidate, GB1275, which is currently in a Phase 1/2 clinical trial in solid tumor indications as a monotherapy and in combination with either pembrolizumab or chemotherapy.
Financial Results for the Quarter Ended June 30, 2021
Cash, Cash Equivalents and Marketable Securities: Cash, cash equivalents and marketable securities as of June 30, 2021, were $405.9 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 half of 2023.
Research and Development (R&D) Expenses: For the quarter ended June 30, 2021, R&D expenses were $44.3 million, compared to R&D expenses of $38.7 million for the same period in 2020.
General and Administrative (G&A) Expenses: For the quarter ended June 30, 2021, G&A expenses were $11.3 million, compared to $11.7 million for the same period in 2020.
Net Loss: Net loss for the quarter ended June 30, 2021, was $59.8 million, or $0.80 per share, compared to a net loss of $66.9 million, or $1.00 per share, for the same period in 2020.
Conference Call and Webcast
Gossamer’s management team will host a conference call and live audio webcast at 4:30 p.m. ET today, Monday, August 9, to discuss its second quarter 2021 financial results, provide a corporate update, and present the seralutinib Phase 1b open-label extension data.
The live audio webcast may be accessed through the "Events / Presentations" page in the "Investors" section of the Company’s website at www.gossamerbio.com. Alternatively, the conference call may be accessed through the following: