On March 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 fourth quarter and year ended December 31, 2021 and provided a business update (Press release, Gossamer Bio, MAR 3, 2022, View Source [SID1234609453]).

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"After a considerable amount of planning and effort, the Gossamer team is excited to enter 2022 with two ongoing Phase 2 trials expected to readout this year," said Faheem Hasnain, Co-Founder, Chairman and Chief Executive Officer of Gossamer Bio.

"In the near term, we are eager to review GB004 Phase 2 SHIFT-UC 12-week topline data in patients with mild-to-moderate ulcerative colitis in the second quarter. We believe that, in contrast to other IBD therapies, GB004 has the potential to restore the epithelial barrier without systemic immune suppression. If this thesis bears out, GB004 could address the large swath of ulcerative colitis patients who are reticent to progress to systemic immunomodulatory or biologic agents, despite their disease being uncontrolled by 5-ASA therapy."

Clinical-Stage Product Candidate Updates

GB004: Oral HIF-1α Stabilizer for Inflammatory Bowel Disease (IBD)

Primary endpoint week 12 topline data from the Phase 2 SHIFT-UC study in patients with mild-to-moderate ulcerative colitis (UC) are expected in the second quarter of 2022.
Treat through week 36 topline data from the Phase 2 SHIFT-UC study in patients with mild-to-moderate UC are expected in the fourth quarter of 2022.
Seralutinib (GB002): Inhaled PDGFR, CSF1R and c-KIT Inhibitor for Pulmonary Arterial Hypertension (PAH)

Enrollment 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 from baseline at week 24. Topline data from the TORREY study are expected in the second half of 2022, subject to developments in the ongoing COVID-19 pandemic.
GB5121: Oral, CNS-Penetrant BTK Inhibitor for Primary CNS Lymphoma (PCNSL)

An investigational new drug (IND) application for GB5121 is now active, following a fourth quarter filing with the U.S. Food and Drug Administration (FDA).
Gossamer expects to initiate a global Phase 1b/2 clinical trial of GB5121 in PCNSL patients in the first half of 2022.
Financial Results for Quarter and Full Year Ended December 31, 2021

Cash, Cash Equivalents and Marketable Securities: Cash, cash equivalents and marketable securities as of December 31, 2021, were $325.2 million. As a result, we currently expect cash, cash equivalents and marketable securities, and access to our debt facility will be sufficient to fund operating and capital expenditures into the second half of 2023.
Research and Development (R&D) Expenses: For the quarter ended December 31, 2021, R&D expenses were $40.9 million compared to R&D expenses of $38.9 million for the same period in 2020. R&D expenses for the full year ended December 31, 2021, were $170.3 million compared to $160.9 million for the full year ended December 31, 2020. The increase was primarily attributable to an increase of clinical trial and preclinical study costs associated with seralutinib, GB004, GB5121, and preclinical programs. This increase was partially offset by decreases in clinical trial and preclinical study costs related to GB001 and GB1275.
In-Process Research and Development (IPR&D) Expenses: There were no significant IPR&D expenses for the quarter and year ended December 31, 2021. For the quarter ended December 31, 2020, IPR&D expenses were $5.3 million. IPR&D expenses for the full year ended December 31, 2020, were $23.4 million.
General and Administrative (G&A) Expenses: For the quarter ended December 31, 2021, G&A expenses were $10.7 million compared to $15.9 million for the same period in 2020. G&A expenses for the full year ended December 31, 2021, were $45.8 million compared to $49.7 million for the full year ended December 31, 2020.
Net Loss: Net loss for the three months ended December 31, 2021, was $56.3 million, or $0.74 per share, compared to a net loss of $64.6 million, or $1.05 per share, for the same period in 2020. Net loss for the full year ended December 31, 2021, was $234.0 million, or $3.13 per share compared to a net loss of $243.4 million, or $3.55 per share, for the full year ended December 31, 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, Thursday, March 3, to discuss its fourth quarter and full year 2021 financial results and provide a corporate update.

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:

A replay of the audio webcast will be available for 30 days on the "Investors" section of the Company’s website, www.gossamerbio.com.