Gossamer Bio Announces First Quarter 2023 Financial Results and Provides Business Update
May 09 2023 - 04:01PM
Business Wire
- Feedback on Planned Registrational Program
for Seralutinib Received from FDA and EMA following Successful
Phase 2 TORREY Study -
- Registrational Phase 3 Clinical Trial in PAH
Patients Expected to Initiate in 3Q23 -
- Initial TORREY Study Open-Label Extension
Data Expected Mid 2023 -
- Operational Restructuring Implemented to
Prioritize Seralutinib -
- $202 million in cash, cash equivalents &
marketable securities, as of March 31, 2023 -
Gossamer Bio, Inc. (Nasdaq: GOSS), a clinical-stage
biopharmaceutical company focused on the development and
commercialization of seralutinib for the treatment of pulmonary
arterial hypertension (PAH), today announced its financial results
for the first quarter ended March 31, 2023, and provided a business
update.
“Our team continues to build momentum across multiple fronts
following the positive results from our Phase 2 TORREY study of
seralutinib in PAH patients. With recent feedback from both the FDA
and EMA, we are well positioned to commence our registration
program,” said Faheem Hasnain, Chairman, Co-Founder and CEO of
Gossamer. “We remain on track to begin our Phase 3 clinical trial
of seralutinib in the coming months, moving one step closer towards
our goal of bringing a potential new medicine to patients suffering
from PAH.”
“Additionally, we made the difficult decision to undergo an
operational restructuring and headcount reduction to prioritize
resources around the development of seralutinib. We believe that
this restructuring was a necessary step to focus the organization
on activities which maximize the potential of seralutinib. We truly
appreciate the hard work and dedication of all of our employees,
past and present.”
Seralutinib (GB002): Inhaled PDGFR, CSF1R and c-KIT Inhibitor
for PAH
- Gossamer has successfully concluded an End-of-Phase 2 Meeting
with the U.S. Food and Drug Administration (FDA) and the Scientific
Advice process with the European Medicines Agency (EMA) following
the completion of its positive Phase 2 TORREY Study in patients
with PAH. The Company has reached agreement with both FDA and EMA
regarding key design elements of the Phase 3 program and expects to
commence a single registrational Phase 3 PAH clinical trial in the
third quarter of 2023.
- The planned Phase 3 clinical trial will be a randomized,
double-blind, placebo-controlled, global clinical trial in PAH
patients. Patients will be randomized to receive either seralutinib
or placebo, in addition to their background PAH therapies. Based on
FDA and EMA feedback, we will test a single dose of 90 mg, twice
daily versus placebo. The primary endpoint of the trial will be
change in six-minute walk distance from baseline.
- Upon completion of the 24-week blinded portion of the Phase 2
TORREY Study, patients were able to enroll into an open-label
extension trial. Gossamer plans to report initial results from this
ongoing open-label extension trial in the middle of 2023.
- Clinical development of seralutinib for the treatment of
pulmonary hypertension associated with interstitial lung disease
(PH-ILD) is expected to begin in the first half of 2024.
Corporate Updates
- As part of a structural reorganization to center Gossamer
around seralutinib and its continued development in PAH, Gossamer
reduced its headcount by over 25%. Further development of all
clinical and pre-clinical product candidates, outside of
seralutinib, has been terminated, and strategic options are being
assessed for those candidates. Gossamer is working diligently with
affected employees to assist in their transition to new
opportunities.
Financial Results for Quarter Ended March 31, 2023
- Cash, Cash Equivalents and Marketable Securities: Cash,
cash equivalents and marketable securities as of March 31, 2023,
were $201.9 million. The Company expects the combination of current
cash, cash equivalents and marketable securities will be sufficient
to fund operations through at least the next 12 months from the
date our first quarter 2023 financial statements were available to
be issued.
- Research and Development (R&D) Expenses: For the
quarter ended March 31, 2023, R&D expenses were $37.8 million,
compared to $42.3 million for the same period in 2022.
- General and Administrative (G&A) Expenses: For the
quarter ended March 31, 2023, G&A expenses were $10.1 million,
compared to $12.0 million for the same period in 2022.
- Net Loss: Net loss for the quarter ended March 31, 2023,
was $49.2 million, or $0.52 per share, compared to a net loss of
$57.8 million, or $0.76 per share, for the same period in
2022.
About Gossamer Bio
Gossamer Bio is a clinical-stage biopharmaceutical company
focused on the development and commercialization of seralutinib for
the treatment of pulmonary arterial hypertension. Its goal is to be
an industry leader in, and to enhance the lives of patients
suffering from, pulmonary hypertension.
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 seralutinib; including the expected initiation of a
Phase 3 clinical program for seralutinib; the trial design of such
Phase 3 clinical trial of seralutinib, plans to advance seralutinib
in PH-ILD; expectations on the timing of data readouts from our
clinical studies, including our Phase 2 open-label extension trial
of for seralutinib; and the expected timeframe for funding our
operating plan with current cash, cash equivalents and marketable
securities. 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; later developments with and / or feedback from global
regulatory authorities or the FDA that may differ from prior
feedback which may alter our planned Phase 3 clinical trial design
and timing of initiation thereof; disruption to our operations from
the COVID-19 pandemic, including clinical trial delays; the
Company’s dependence on third parties in connection with product
manufacturing, research and preclinical and clinical testing; the
results of preclinical studies and early clinical trials are not
necessarily predictive of future results; the success of Gossamer’s
clinical trials and preclinical studies for seralutinib; regulatory
developments in the United States and foreign countries; unexpected
adverse side effects or inadequate efficacy of seralutinib that may
limit their development, regulatory approval and/or
commercialization, or may result in clinical holds, recalls or
product liability claims; Gossamer’s ability to obtain and maintain
intellectual property protection for seralutinib; Gossamer’s
ability to comply with its obligations in collaboration agreements
with third parties or the agreements under which it licenses
intellectual property rights from third parties; unstable market
and economic conditions and adverse developments with respect to
financial institutions and associated liquidity risk may adversely
affect our business and financial condition and the broader economy
and biotechnology industry; Gossamer may use its capital resources
sooner than it expects; 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)
Three months ended March
31,
2023
2022
Operating expenses:
Research and development
$
37,795
$
42,322
In process research and development
15
20
General and administrative
10,132
12,001
Total operating expenses
47,942
54,343
Loss from operations
(47,942
)
(54,343
)
Other income (expense), net
Interest income
587
224
Interest expense
(3,500
)
(3,467
)
Other income (expense)
1,690
(199
)
Total other income (expense), net
(1,223
)
(3,442
)
Net loss
$
(49,165
)
$
(57,785
)
Net loss per share, basic and diluted
$
(0.52
)
$
(0.76
)
Weighted average common shares
outstanding, basic and diluted
94,870,293
75,894,692
Condensed Consolidated Balance
Sheet
(in thousands)
BALANCE SHEET DATA:
March 31, 2023
December 31, 2022
(unaudited)
Cash, cash equivalents, and marketable
securities
$
201,856
$
255,678
Working capital
169,842
212,650
Total assets
219,906
272,450
Total liabilities
248,362
260,373
Accumulated deficit
(1,081,388
)
(1,032,223
)
Total stockholders' equity (deficit)
(28,456
)
12,077
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version on businesswire.com: https://www.businesswire.com/news/home/20230509005943/en/
For Investors and Media: Bryan Giraudo, Chief Operating
Officer and Chief Financial Officer Gossamer Bio Investor Relations
ir@gossamerbio.com
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