– Multiple trial initiations and data readouts expected in the next
12 months –
– Company to host conference call today at 8:30 a.m. ET –
SAN DIEGO–(BUSINESS WIRE)–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, today announced its financial results for the quarter ended
March 31, 2019 and provided a corporate update.
“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: 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 Bio is a clinical-stage biopharmaceutical company focused on
discovering, acquiring, developing and commercializing therapeutics in
the disease areas of immunology, inflammation and oncology. Its goal is
to be an industry leader in each of these therapeutic areas and to
enhance and extend the lives of patients suffering from such diseases.
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; 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 the United States and foreign countries; unexpected
adverse side effects or inadequate efficacy of the Company’s product
candidates that may limit their development, regulatory approval and/or
commercialization, or may result in recalls or product liability claims;
Gossamer’s ability to obtain and maintain intellectual property
protection for its product candidates; Gossamer’s ability to comply with
its obligations in the agreements under which it licenses intellectual
property rights from third parties; the risk that the funding under the
new senior debt facility may not be completed on the timeframe Gossamer
expects, or at all, including as a result of Gossamer’s failure to meet
the conditions required for such funding or failure to comply with the
affirmative and negative covenants under the credit facility; and other
risks described in the Company’s prior press releases and the Company’s
filings with the Securities and Exchange Commission (SEC), including
under the heading “Risk Factors” in the Company’s annual report on Form
10-K and any subsequent filings with the SEC. You are cautioned not to
place undue reliance on these forward-looking statements, which speak
only as of the date hereof, and Gossamer undertakes no obligation to
update such statements to reflect events that occur or circumstances
that exist after the date hereof. All forward-looking statements are
qualified in their entirety by this cautionary statement, which is made
under the safe harbor provisions of the Private Securities Litigation
Reform Act of 1995.
|
Gossamer Bio Statement of Operations Condensed Consolidated Statement of Operations (in thousands, except share and per share amounts) (unaudited) |
||||||
| Quarter Ended March 31, | ||||||
| STATEMENTS OF OPERATIONS DATA: | 2019 | 2018 | ||||
| Operating expenses: | ||||||
| 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) | ||||||
| Interest income | 1,049 | 89 | ||||
| Interest expense | (19) | – | ||||
| 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 (in thousands) (unaudited) |
||||||
| Quarter Ended March 31, | ||||||
| BALANCE SHEET DATA: | March 31, 2019 | December 31, 2018 | ||||
| Cash, cash equivalents, and marketable securities | $ 481,222 | $ 228,658 | ||||
| Working capital | 472,637 | 211,550 | ||||
| Total assets | 515,949 | 239,419 | ||||
| Total liabilities | 35,689 | 21,121 | ||||
| Accumulated deficit | (186,474) | (153,863) | ||||
| Total stockholders equity (deficit) | 480,260 | (120,069) | ||||
Contacts
Gossamer Bio:
For Investors:
Argot Partners
Kimberly
Minarovich
Tel 212.600.1902
gossamerbio@argotpartners.com
For Media:
Argot Partners
David Rosen
Tel 212.600.1902
david.rosen@argotpartners.com