On November 10, 2020 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 of 2020 and provided a corporate update (Press release, Gossamer Bio, NOV 10, 2020, View Source [SID1234570489]).

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"We are very excited about the continued advancement of our pipeline with the start of two robust Phase 2 clinical trials for GB002 and GB004 and the planned dose expansion cohort for GB1275," said Sheila Gujrathi, M.D., Co-Founder and Chief Executive Officer of Gossamer. "We believe that these clinical programs hold tremendous potential to benefit high unmet need patient populations."

Clinical-Stage Product Candidate Updates

GB002: Inhaled PDGFR Inhibitor for Pulmonary Arterial Hypertension (PAH)

GB002 is currently being evaluated in an ongoing Phase 1b trial in PAH. Gossamer will discuss the initial results from this ongoing trial at as part of a GB002-focused investor webinar in December 2020.
Sites activated in the TORREY Study, a 24-week Phase 2 clinical trial in functional class II and III PAH patients. Gossamer expects to begin enrollment for this trial in the fourth quarter of 2020. 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.
GB004: Oral HIF-1α Stabilizer for Inflammatory Bowel Disease

Several patients dosed in the SHIFT-UC Study, a Phase 2 clinical trial in UC patients. 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.
Data presented from completed Phase 1b study in patients with active mild-to-moderate ulcerative colitis (UC) at UEG Week Virtual 2020. These posters and presentations are available at www.gossamerbio.com, on the "Posters and Publications" page.
GB1275: Oral CD11b Modulator for Oncology Indications

Two GB1275 posters are being presented at the 35th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) (SITC 2020), being held virtually from November 9 – 14. This includes clinical and biomarker data from the ongoing GB1275 Phase 1/2 clinical trial, KEYNOTE-A36, in advanced solid tumors and corresponding presentations from Johanna Bendell, M.D. and Wells Messersmith, M.D.
Poster Title: Preliminary results from KEYNOTE-A36, a study of GB1275, a first-in-class oral CD11b modulator, alone and with pembrolizumab or chemotherapy in specified advanced solid tumors
Poster / Abstract Number: 388
Presenting Author: Johanna Bendell, M.D.
Link: View Source

Poster Title: Combining transcriptomic- and tissue-based immune biomarkers to evaluate GB1275, a CD11b modulator, as a single agent or with pembrolizumab in patients with advanced solid tumors
Poster / Abstract Number: 389
Presenting Author: Wells Messersmith, M.D.
Link: View Source

Encouraging biological activity, particularly at GB1275 doses greater than or equal to 800 mg BID, was seen in tumor types that are known to be less responsive to checkpoint inhibitors. This activity supports the mechanism of action of GB1275 in modulating myeloid cell biology in the tumor microenvironment, with potential to enhance anti-tumor response when it is combined with a checkpoint inhibitor.

Prolonged stable disease has been observed in seven patients, in both the monotherapy and combination dose groups. Five of seven patients with observed prolonged stable disease received doses of 800mg BID or higher of GB1275.

One microsatellite stable-colorectal cancer patient receiving oral GB1275 800 mg twice daily, in combination with pembrolizumab, achieved a partial response. The patient had received five lines of therapy prior to trial enrollment and is continuing on study treatment.

Clinical safety data to date suggest that GB1275 alone and combined with pembrolizumab (up to 1200 mg twice daily) is generally well tolerated, and the maximum tolerated dose of GB1275 has not been reached.
GB001: Oral DP2 Antagonist for Moderate-to-Severe Asthma

Engaging with global regulatory authorities regarding the forward clinical development path of an oral DP2 antagonist in moderate-to-severe asthma to inform potential partnerships or strategic alternatives.
Financial Results for the Quarter Ended September 30, 2020

Cash, Cash Equivalents and Marketable Securities: Cash, cash equivalents and marketable securities as of September 30, 2020, were $555.4 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 half of 2023.
Research and Development (R&D) Expenses: For the quarter ended September 30, 2020, R&D expenses were $41.8 million, compared to R&D expenses of $40.1 million for the same period in 2019.
General and Administrative (G&A) Expenses: For the quarter ended September 30, 2020, G&A expenses were $11.4 million, compared to $9.8 million for the same period in 2019.
Net Loss: Net loss for the quarter ended September 30, 2020, was $57.8 million, or $0.80 or share, compared to a net loss of $48.5 million, or $0.80 per share, for the same period in 2019. The increase was primarily attributable to an increase in interest expense of $4.0 million and a decrease in investment income of $1.7 million.
Conference Call and Webcast

Gossamer’s management team will host a conference call and live audio webcast at 4:30 p.m. ET today, Tuesday, November 10, to discuss its third quarter 2020 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.