Gossamer Bio Announces First Quarter 2019 Financial Results
– Multiple trial initiations and data readouts expected in the next 12 months –
– Company to host conference call today at
“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
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.
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
FDAand the initiation of a Phase 1/2 study in advanced solid tumor indications is planned for the second half of 2019, subject to the FDA30-day review period.
Closed Initial Public Offering (IPO)
February 2019, Gossamer closed its IPO, which generated over $291 millionin net proceeds.
Secured debt facility for up to
May 2019, Gossamer entered into a five-year $150 millionsenior debt facility, with $30 millionfunded at closing, and access to the remaining $120 millionsubject to the achievement of certain clinical development milestones and other customary conditions.
Financial Results for Quarter Ended
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
March 31, 2019, R&D expenses were $25.0 million, including $1.3 millionof stock-based compensation, compared to R&D expenses of $2.6 millionfor 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 Researchand Development (IPR&D) Expenses: For the quarter ended March 31, 2019, IPR&D expenses were $1.0 million, compared to $20.9 millionfor the quarter ended March 31, 2018, which included $19.3 millionassociated with the issuance of stock in connection with the acquisition of GB001.
- General and Administrative (G&A) Expenses: For the quarter
March 31, 2019, G&A expenses were $8.0 million, which included $1.8 millionof stock-based compensation. This compared to G&A expenses of $2.6 millionfor the quarter ended March 31, 2018, which included $0.6 millionof 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 $0.90per share.
Conference Call and Webcast
Gossamer’s management team will host a conference call and live audio
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
International Dial-in Number: (470) 495-9466
Live Webcast: https://edge.media-server.com/m6/p/x86987rf
A replay of the audio webcast will be available for 30 days on the Investors section of the Company's website, www.gossamerbio.com.
About Gossamer Bio
Gossamer cautions you that statements contained in this press release
regarding matters that are not historical facts are forward-looking
statements. These statements are based on the Company’s current beliefs
and expectations. Such forward-looking statements include, but are not
limited to, statements regarding the anticipated timing of initiation
and enrollment of clinical trials for our product candidates; plans to
rapidly advance our product candidates; expectations on the timing of
data readouts from our clinical studies; the potential clinical benefits
of our product candidates; the indications we intend to pursue and our
related business strategies; the expected timeframe for funding our
operating plan with current cash, cash equivalents and marketable
securities; and access to the Company’s senior debt facility. The
inclusion of forward-looking statements should not be regarded as a
representation by Gossamer that any of its plans will be achieved.
Actual results may differ from those set forth in this press release due
to the risks and uncertainties inherent in Gossamer’s business,
including, without limitation: potential delays in the commencement,
enrollment and completion of clinical trials; the Company’s dependence
on third parties in connection with product manufacturing, research and
preclinical and clinical testing; the success of Gossamer’s clinical
trials and preclinical studies for its product candidates; regulatory
Gossamer Bio Statement of Operations
Condensed Consolidated Statement of Operations
(in thousands, except share and per share amounts)
|Quarter Ended March 31,|
|STATEMENTS OF OPERATIONS DATA:||2019||2018|
|Research and development||$ 24,983||$ 2,624|
|In process research and development||1,000||20,898|
|General and administrative||8,034||2,604|
|Total operating expenses||34,017||26,126|
|Loss from operations||(34,017)||(26,126)|
|Other income (expenses)|
|Other income (expense)||376||—|
|Total other income (expense), net||1,406||89|
|Net loss||$ (32,611)||$ (26,037)|
|Net loss per share, basic and diluted||$ (0.90)||$ (4.49)|
|Weighted average common shares outstanding, basic and diluted||36,317,230||5,797,693|
Consolidated Balance Sheet
|Quarter Ended March 31,|
|BALANCE SHEET DATA:||March 31, 2019||December 31, 2018|
|Cash, cash equivalents, and marketable securities||$ 481,222||$ 228,658|
|Total stockholders equity (deficit)||480,260||(120,069)|