Gossamer Bio Announces Fourth Quarter and Full-Year 2022 Financial Results and Provides Business Update
March 17 2023 - 07:31AM
Business Wire
- FDA Feedback on Seralutinib Phase 3 Clinical
Trial Received; Expected to Commence in the Second Half of 2023
-
- Topline Data from TORREY Study Open-Label
Extension Expected in Mid-2023 -
- Enrollment in GB5121 Phase 1b/2 Clinical
Trial in PCNSL Paused -
- Cash, cash equivalents and marketable
securities totaled $256 million at year-end 2022 -
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 fourth quarter and year ended December
31, 2022 and provided a business update.
Clinical-Stage Product Candidate Updates
Seralutinib (GB002): Inhaled PDGFR, CSF1R and c-KIT Inhibitor
for Pulmonary Arterial Hypertension (PAH)
- 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. We anticipate reporting results from this ongoing
open-label extension trial in the middle of 2023.
- We expect to commence a Phase 3 PAH clinical trial in the
second half 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 feedback, we expect to test a single dose of 90 mg
twice daily in the planned PAH Phase 3 clinical trial, and we
expect the primary endpoint of the trial to be change in six-minute
walk distance from baseline. However, the final trial design is
subject to further feedback from global regulatory
authorities.
GB5121: Oral, CNS-Penetrant BTK Inhibitor for Primary CNS
Lymphoma (PCNSL)
- Based upon the benefit / risk profile observed to date and a
prioritization of resources to support the seralutinib program,
Gossamer has decided to pause enrollment in the Phase 1b/2 STAR CNS
study.
- Gossamer plans to discuss available data with the study’s Data
Review Committee to determine next steps.
Financial Results for Quarter and Full Year Ended December
31, 2022
- Cash, Cash Equivalents and Marketable Securities: Cash,
cash equivalents and marketable securities as of December 31, 2022,
were $255.7 million. As a result, we expect our current cash, cash
equivalents and marketable securities will be sufficient to fund
operating and capital expenditures into the second half of
2024.
- Research and Development (R&D) Expenses: For the
quarter ended December 31, 2022, R&D expenses were $41.5
million compared to R&D expenses of $40.9 million for the same
period in 2021. R&D expenses for the full year ended December
31, 2022, were $170.9 million compared to $170.3 million for the
full year ended December 31, 2021.
- General and Administrative (G&A) Expenses: For the
quarter ended December 31, 2022, G&A expenses were $12.8
million compared to $10.7 million for the same period in 2021.
G&A expenses for the full year ended December 31, 2022, were
$47.6 million compared to $45.8 million for the full year ended
December 31, 2021.
- Net Loss: Net loss for the three months ended December
31, 2022, was $55.8 million, or $0.59 per share, compared to a net
loss of $56.3 million, or $0.74 per share, for the same period in
2021. Net loss for the full year ended December 31, 2022, was
$229.4 million, or $2.71 per share, compared to a net loss of
$234.0 million, or $3.13 per share, for the full year ended
December 31, 2021.
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, including the anticipated timing
of initiation of the Phase 3 clinical trial of seralutinib in PAH;
the trial design of such Phase 3 clinical trial of seralutinib
based on regulatory feedback; plans to discuss our benefit / risk
profile for GB5121 with our Data Review Committee, plans to advance
our product candidates; expectations on the timing of data readouts
from our clinical studies, including our Phase 2 open-label
extension trial of 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 its product candidates;
regulatory developments in the United States and foreign countries;
unexpected adverse side effects or inadequate efficacy of our
product candidates 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 its product
candidates; 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, INC.
CONDENSED CONSOLIDATED FINANCIAL
STATEMENT DATA
(UNAUDITED; IN THOUSANDS, EXCEPT
SHARE AND PER SHARE DATA)
Three months ended December
31,
Year ended December
31,
STATEMENTS OF OPERATIONS DATA:
2022
2021
2022
2021
Operating expenses:
Research and development
$
41,508
$
40,932
$
170,919
$
170,267
In process research and development
15
15
65
75
General and administrative
12,834
10,714
47,609
45,782
Total operating expenses
54,357
51,661
218,593
216,124
Loss from operations
(54,357
)
(51,661
)
(218,593
)
(216,124
)
Other income (expense)
Interest income
594
236
1,583
761
Interest expense
(3,457
)
(4,937
)
(13,880
)
(19,440
)
Other income (expense)
1,456
78
1,512
799
Total other expense, net
(1,407
)
(4,623
)
(10,785
)
(17,880
)
Net loss
$
(55,764
)
$
(56,284
)
$
(229,378
)
$
(234,004
)
Net loss per share, basic and diluted
$
(0.59
)
$
(0.74
)
$
(2.71
)
$
(3.13
)
Weighted average common shares
outstanding, basic and diluted
94,280,553
75,587,851
84,574,869
74,843,482
BALANCE SHEET DATA:
December 31, 2022
December 31, 2021
Cash, cash equivalents, and marketable
securities
$
255,678
$
325,218
Working capital
212,650
291,921
Total assets
272,450
343,657
Total liabilities
260,373
222,194
Accumulated deficit
(1,032,223
)
(811,534
)
Total stockholders' equity
12,077
121,463
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version on businesswire.com: https://www.businesswire.com/news/home/20230317005063/en/
For Investors and Media: Bryan Giraudo, Chief Financial
Officer & Chief Operating Officer Gossamer Bio Investor
Relations ir@gossamerbio.com
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