Gossamer Bio Announces Fourth Quarter and Full-Year 2019 Financial Results and Provides Business Update
– Clinical trial results for all four clinical-stage product candidates in target areas of immunology, inflammation and oncology expected in 2020 –
– Cash, cash equivalents and marketable securities totaled
“Our hearts are with the patients, families, caregivers and medical professionals suffering and sacrificing in the ongoing Covid-19 viral pandemic. We are monitoring the situation on a daily basis to understand the impact on Gossamer and our programs and are taking the necessary actions now to do what is best for our patients, employees and company,” said
“2019 was a year of execution for
Clinical-Stage Product Candidate Updates
GB001: Oral DP2 Antagonist for Eosinophilic Asthma and Chronic Rhinosinusitis (CRS)
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Gossamer has made available three poster presentations from its GB001 program for patients with asthma. All three posters, which Gossamer had planned to present at the now cancelled 2020
American Academy of Allergy , Asthma & Immunology (AAAAI) Annual Meeting, can be found in the Posters and Publications section of Gossamer’s website:- “Effect of the DP2 Antagonist GB001 on Asthma Worsening in Patients with Mild-Moderate Asthma” showed that GB001 treatment is associated with longer time to asthma worsening / exacerbation and observed treatment effects were greater in the populations with higher baseline FeNO and / or eosinophils.
- “In Vitro and In Vivo Profile of GB001, a Potent and Selective DP2 Antagonist for the Treatment of Moderate-Severe Asthma” demonstrates that, in pre-clinical studies, GB001 is an insurmountable antagonist and compares favorably to other DP2 antagonists in functional residence time and prolonged pharmacodynamic effects, while inhibiting immune cell infiltration and improving airway function.
- “Corticosteroid Use Across Asthma Healthcare Providers: A Real-world Experience.” The widespread use of OCS revealed by this claims analysis underscores the high level of unmet need for these patients and the need for new therapies.
- Enrollment in the ongoing Phase 2b LEDA study in patients with moderate-to-severe eosinophilic asthma has been completed. We are on track to conduct an interim analysis in the second quarter of this year, following study completion by approximately two thirds of patients. Topline results are expected in the second half of this year.
- Enrollment in the ongoing Phase 2 TITAN proof-of-concept study in chronic rhinosinusitis, both with and without nasal polyps has been completed. Topline data from the TITAN study are expected in the second half of this year.
- We continue to evaluate the possibility of initiating a Phase 2 study in chronic spontaneous urticaria and expect to make this decision in the second half of the year following a review of available data and the competitive landscape.
GB002: Inhaled PDGFR Inhibitor for Pulmonary Arterial Hypertension (PAH)
- Enrollment is underway in the Phase 1b study of GB002 in patients with PAH. Gossamer expects to report initial topline results from the study in the second quarter of this year.
- Due to the ongoing Covid-19 viral pandemic, the Phase 2 study in patients with PAH will likely commence in the second half of this year. This trial will enroll functional class II and III PAH patients. Patients will remain on their background therapies throughout the study. The primary endpoint for this 24-week study will be change in PVR from baseline. A key secondary endpoint will be change from baseline in 6-minute walk distance at week 24.
GB004: Oral HIF-1α Stabilizer for Inflammatory Bowel Disease
- Enrollment is complete in the Phase 1b study of GB004 in patients with active mild-to-moderate ulcerative colitis (UC). The primary goals of the study are to assess safety, tolerability, PK, PD and target engagement in patients with active disease. Gossamer expects to report topline results from this Phase 1b study in the second quarter of this year.
GB1275: Oral CD11b Modulator for Oncology Indications
- Enrollment for the KEYNOTE-A36 Phase 1/2 study to evaluate GB1275 as a monotherapy and in combination with either KEYTRUDA® (pembrolizumab) or chemotherapy in patients with selected advanced solid tumors is underway, and we expect to report initial Phase 1 data in the second half of this year.
Financial Results for Quarter and Full Year Ended
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Cash,
Cash Equivalents and Marketable Securities : Cash, cash equivalents and marketable securities as ofDecember 31, 2019 , were$401.8 million . In response to the ongoing Covid-19 viral pandemic and anticipated potential challenges to clinical trials globally, Gossamer has planned a series of cost-optimization initiatives. 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 to the middle of 2022. -
Research and Development (R&D) Expenses: For the quarter ended
December 31, 2019 , R&D expenses were$42.6 million , compared to R&D expenses of$25.9 million for the same period in 2018. R&D expenses for the full year endedDecember 31, 2019 , were$143.4 million compared to$55.3 million for the full year endedDecember 31, 2018 . The increases were primarily due to an increase in expenses for GB001, GB002, GB004 and GB1275 and increased headcount. -
In-Process Research and Development (IPR&D) Expenses: For the quarter endedDecember 31, 2019 , IPR&D expenses were$1.6 million , compared to$0.0 million for the same period in 2018. IPR&D expenses for the full year endedDecember 31, 2019 , were$3.6 million compared to$49.7 million for the full year endedDecember 31, 2018 . -
General and Administrative (G&A) Expenses: For the quarter ended
December 31, 2019 , G&A expenses were$11.6 million , compared to$13.9 million for the same period in 2018. G&A expenses for the full year endedDecember 31, 2019 , were$39.1 million compared to$44.1 million for the full year endedDecember 31, 2018 . The decreases were primarily attributable to a decrease in stock-based compensation costs, which was partially offset by increases in personnel-related costs, professional and legal fees, costs associated with insurance, and facility and office-related costs. -
Net Loss: Net loss for the three months ended
December 31, 2019 , was$54.7 million , or$0.89 per share, compared to a net loss of$38.8 million , or$4.92 per share, for the same period in 2018. Net loss for the full year endedDecember 31, 2019 , was$180.3 million , or$3.29 per share compared to a net loss of$147.0 million , or$22.59 per share, for the full year endedDecember 31, 2018 .
About
Forward-Looking Statements
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; disruption to our operations from the recent global outbreak of the Covid-19 pandemic; 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 developments in
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CONDENSED CONSOLIDATED FINANCIAL STATEMENT DATA |
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(UNAUDITED; IN THOUSANDS, EXCEPT SHARE AND PER SHARE DATA) |
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Three months ended |
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Year Ended |
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STATEMENTS OF OPERATIONS DATA: |
|
2019 |
|
|
2018 |
|
|
2019 |
|
|
2018 |
|
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|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
$ |
42,596 |
|
|
$ |
25,872 |
|
|
$ |
143,403 |
|
|
$ |
55,283 |
|
In process research and development |
|
|
1,600 |
|
|
|
- |
|
|
|
3,600 |
|
|
|
49,659 |
|
General and administrative |
|
|
11,591 |
|
|
|
13,935 |
|
|
|
39,136 |
|
|
|
44,051 |
|
Total operating expenses |
|
|
55,787 |
|
|
|
39,807 |
|
|
|
186,139 |
|
|
|
148,993 |
|
Loss from operations |
|
|
(55,787 |
) |
|
|
(39,807 |
) |
|
|
(186,139 |
) |
|
|
(148,993 |
) |
Other income, net |
|
|
1,089 |
|
|
|
1,013 |
|
|
|
5,832 |
|
|
|
2,024 |
|
Net loss |
|
$ |
(54,698 |
) |
|
$ |
(38,794 |
) |
|
$ |
(180,307 |
) |
|
$ |
(146,969 |
) |
Net loss per share, basic and diluted |
|
$ |
(0.89 |
) |
|
$ |
(4.92 |
) |
|
$ |
(3.29 |
) |
|
$ |
(22.59 |
) |
Weighted average common shares outstanding, basic and diluted |
|
|
61,282,084 |
7,878,824 |
54,740,170 |
6,504,871 |
|
|
|
|
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BALANCE SHEET DATA: |
|
2019 |
|
|
2018 |
|
||
|
|
|
|
|
|
|
|
|
Cash, cash equivalents, and marketable securities |
|
$ |
401,829 |
|
|
$ |
228,658 |
|
Working capital |
|
|
372,394 |
|
|
|
211,550 |
|
Total assets |
|
|
426,604 |
|
|
|
239,419 |
|
Total liabilities |
|
|
74,119 |
|
|
|
21,121 |
|
Accumulated deficit |
|
|
(334,170 |
) |
|
|
(153,863 |
) |
Total stockholders' equity (deficit) |
|
|
352,485 |
|
|
|
(120,069 |
) |
View source version on businesswire.com: https://www.businesswire.com/news/home/20200324005164/en/
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gossamerbio@argotpartners.com
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david.rosen@argotpartners.com
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