On May 14, 2019 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 quarter ended March 31, 2019 and provided a corporate update (Press release, Gossamer Bio, MAY 14, 2019, View Source [SID1234536266]).
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"In the three months since our initial public offering, we have made significant further advancements in building an operationally efficient biotechnology company with a diversified portfolio of potential new therapies in multiple disease areas with high unmet need," said Sheila Gujrathi, M.D., Co-Founder and Chief Executive Officer of Gossamer. "This is an exciting and productive time for Gossamer, and we look forward to numerous data readouts in 2020. Our team’s track record of success and our strong balance sheet positions us well to realize our goal of becoming an industry leader in immunology, inflammation and oncology."
Pipeline Updates
GB001: Oral DP2 Antagonist for Asthma and Allergic Disease
Enrollment in the Phase 2b LEDA study in moderate-to-severe eosinophilic asthma is on track, with results from an interim analysis expected in the first half of 2020.
Screening patients in the TITAN Phase 2 proof-of-concept study in chronic rhinosinusitis with and without nasal polyps is underway.
In February 2019, Gossamer presented results of a post-hoc analysis of a GB001 study at the American Academy of Allergy, Asthma and Immunology (AAAAI) 2019 Annual Meeting. The analysis suggested that high baseline levels of Fractional exhaled Nitric Oxide (FeNO), a marker of airway inflammation, could potentially be used as a prognostic marker for GB001 response in the treatment of asthma, as marked reductions in FeNO levels as well as greater numeric improvements in lung function and asthma control were observed relative to placebo in patients with high baseline FeNO as compared to patients with low baseline FeNO. Gossamer plans to further assess the utility of FeNO as a prognostic marker in future studies.
Initiation of a Phase 2 proof-of-concept study in chronic spontaneous urticaria is planned for the second half of 2019
GB002: Inhaled PDGFR Inhibitor for Pulmonary Arterial Hypertension (PAH)
Dosing of Phase 1 safety studies has been completed, and thus far the drug has been well tolerated with no serious adverse events observed to date.
Site initiation and patient screening for a Phase 1b study in patients with PAH is expected in the second quarter of 2019.
GB004: Oral HIF-1α Stabilizer for Inflammatory Bowel Disease
A Phase 1 safety study in healthy volunteers was recently completed, in which the drug was generally well tolerated with no serious adverse events observed to date.
An Investigational New Drug Application (IND) for GB004 is now active, following a first quarter filing with the U.S. Food and Drug Administration (FDA).
Screening patients in a Phase 1b study in active mild-to-moderate ulcerative colitis is underway.
GB1275: Oral CD11b Modulator for Oncology Indications
An IND has been filed with the FDA and the initiation of a Phase 1/2 study in advanced solid tumor indications is planned for the second half of 2019, subject to the FDA 30-day review period.
Corporate Updates
Closed Initial Public Offering (IPO)
In February 2019, Gossamer closed its IPO, which generated over $291 million in net proceeds.
Secured debt facility for up to $150 million.
In May 2019, Gossamer entered into a five-year $150 million senior debt facility, with $30 million funded at closing, and access to the remaining $120 million subject to the achievement of certain clinical development milestones and other customary conditions.
Financial Results for Quarter Ended March 31, 2019
Cash, Cash Equivalents and Marketable Securities: Cash, cash equivalents and marketable securities as of March 31, 2019, were $481.2 million. The Company expects 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 2021.
Research and Development (R&D) Expenses: For the quarter ended March 31, 2019, R&D expenses were $25.0 million, including $1.3 million of stock-based compensation, compared to R&D expenses of $2.6 million for the quarter ended March 31, 2018. The increase was primarily due to costs related to the research and development of GB001, GB002 and GB004.
In-Process Research and Development (IPR&D) Expenses: For the quarter ended March 31, 2019, IPR&D expenses were $1.0 million, compared to $20.9 million for the quarter ended March 31, 2018, which included $19.3 million associated with the issuance of stock in connection with the acquisition of GB001.
General and Administrative (G&A) Expenses: For the quarter ended March 31, 2019, G&A expenses were $8.0 million, which included $1.8 million of stock-based compensation.
This compared to G&A expenses of $2.6 million for the quarter ended March 31, 2018, which included $0.6 million of stock-based compensation. The increase was primarily attributable to personnel-related expenses, professional and legal fees, and stock-based compensation.
Net Loss: For the quarter ended March 31, 2019, net loss was $32.6 million, or a loss of $0.90 per share.
Conference Call and Webcast
Gossamer’s management team will host a conference call and live audio webcast at 8:30 a.m. ET today, Tuesday, May 14, 2019, to discuss its first quarter 2019 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:
Conference ID: 7791474
Domestic Dial-in Number: (866) 221-1654
International Dial-in Number: (470) 495-9466
Live Webcast: View Source
A replay of the audio webcast will be available for 30 days on the Investors section of the Company’s website, www.gossamerbio.com.