- Seralutinib (GB002) and GB004 continue to
progress through ongoing Phase 2 TORREY and SHIFT-UC clinical
trials for Pulmonary Arterial Hypertension (PAH) and Ulcerative
Colitis (UC), respectively -
- Topline results for both ongoing Phase 2
trials expected in the first half of 2022, subject to developments
in the ongoing COVID-19 pandemic -
- Gossamer to conduct no further clinical
development of GB001 or related backup molecule without a partner
-
- Cash, cash equivalents and marketable
securities totaled $513 million at year-end 2020 -
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, 2020 and provided a business update.
“The Gossamer team enters 2021 excited and focused on clinical
trial execution,” said Faheem Hasnain, Co-Founder, Chairman and
Chief Executive Officer of Gossamer. “Both seralutinib and GB004
are potentially paradigm shifting product candidates in indications
of significant unmet patient need, and I am very proud of our
team’s ongoing efforts to conduct our Phase 2 proof-of-concept
studies for these programs despite the challenges of the
pandemic.”
Clinical-Stage Product Candidate Updates
Seralutinib (GB002): Inhaled PDGFR, CSF1R and c-KIT Inhibitor
for PAH
- Enrollment ongoing in the TORREY Study, a Phase 2 clinical
trial in patients with PAH whose disease has progressed despite
standard-of-care therapy. The primary endpoint is change in
pulmonary vascular resistance (PVR) from baseline at week 24.
Topline data from the TORREY study are expected in the first half
of 2022, subject to developments in the ongoing COVID-19
pandemic.
- Key opinion leader-led webcast and presentation regarding PAH
and seralutinib (GB002) held on December 15, 2020 available through
the “Events / Presentations” page in the “Investors” section of the
Company's website at www.gossamerbio.com.
GB004: Oral HIF-1α Stabilizer for Inflammatory Bowel Disease
(IBD)
- Enrollment ongoing in the SHIFT-UC Study, a Phase 2 clinical
trial in patients with active UC despite treatment with 5-ASAs. The
primary endpoint is proportion of patients with clinical remission
at week 12. Topline data from the SHIFT-UC study are expected in
the first half of 2022, subject to developments in the ongoing
COVID-19 pandemic.
- Key opinion leader-led webcast and presentation regarding IBD
and GB004 held on February 18, 2021 available through the “Events /
Presentations” page in the “Investors” section of the Company's
website at www.gossamerbio.com.
GB1275: Oral CD11b Modulator for Oncology Indications
- Enrollment ongoing in a Phase 1 expansion cohort studying the
recommended Phase 2 dose in KEYNOTE-A36, a Phase 1/2 clinical
trial, including patients with gastric or esophageal cancer who
have progressed after initial response to anti-PD-1 therapy and
patients with advanced MSS colorectal cancer. Further Phase 1 data
expected from this study in 2021.
GB001: Oral DP2 Antagonist for Eosinophilic Asthma
- Gossamer engaged with the FDA and the EMA about the clinical
development path in asthma, and based off those interactions,
Gossamer believes that there is a viable clinical development path
for GB001, or its backup molecule, in asthma. Gossamer does not
currently plan to move forward with GB001, or its backup molecule,
in further clinical trials without a partner.
Financial Results for Quarter and Full Year Ended December
31, 2020
- Cash, Cash Equivalents and Marketable Securities: Cash,
cash equivalents and marketable securities as of December 31, 2020,
were $512.6 million. 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 into the second half of 2023.
- Research and Development (R&D) Expenses: For the
quarter ended December 31, 2020, R&D expenses were $38.9
million compared to R&D expenses of $42.6 million for the same
period in 2019. R&D expenses for the full year ended December
31, 2020, were $160.9 million compared to $143.4 million for the
full year ended December 31, 2019. The increases were primarily due
to an increase in expenses for GB004, seralutinib, GB1275 and
preclinical programs.
- In-Process Research and Development (IPR&D)
Expenses: For the quarter ended December 31, 2020, IPR&D
expenses were $5.3 million compared to $1.6 million for the same
period in 2019. IPR&D expenses for the full year ended December
31, 2020, were $23.4 million compared to $3.6 million for the full
year ended December 31, 2019. The increases were primarily
attributable to a $15.0 million payment to Aerpio in connection
with the amendment to the in-license agreement of GB004 in 2020 and
a milestone payment of $5.0 million in connection with the
initiation of the first Phase 2 clinical trial of seralutinib in
2020.
- General and Administrative (G&A) Expenses: For the
quarter ended December 31, 2020, G&A expenses were $15.9
million compared to $11.6 million for the same period in 2019.
G&A expenses for the full year ended December 31, 2020, were
$49.7 million compared to $39.1 million for the full year ended
December 31, 2019. The increases were primarily attributable to an
increase in stock-based compensation costs and an increase in
personnel-related costs.
- Net Loss: Net loss for the three months ended December
31, 2020, was $64.6 million, or $0.88 per share, compared to a net
loss of $54.7 million, or $0.89 per share, for the same period in
2019. Net loss for the full year ended December 31, 2020, was
$243.4 million, or $3.55 per share compared to a net loss of $180.3
million, or $3.29 per share, for the full year ended December 31,
2019.
Conference Call and Webcast
Gossamer’s management team will host a conference call and live
audio webcast at 8:30 a.m. ET today, Thursday, February 25, to
discuss its fourth quarter and full year 2020 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: 5764004 Domestic Dial-in Number: (833) 646-0603
International Dial-in Number: (929) 517-9782 Live Webcast:
https://edge.media-server.com/mmc/p/vsbk8uqe
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 enrollment of clinical trials for our
product candidates; plans to advance our product candidates;
expectations on the timing of data readouts from our clinical
studies; the potential clinical benefits, safety profile and market
potential of our product candidates; the potential of our product
candidates to benefit high unmet need patient populations; the
expected impact of COVID-19; 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; disruption to our operations from the recent
global outbreak of 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; interim results do not necessarily predict
final results and one or more of the outcomes may materially change
as the trial continues and more patient data become available and
following more comprehensive audit and verification procedures;
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 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; 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:
2020
2019
2020
2019
Operating expenses:
Research and development
$
38,910
$
42,596
$
160,854
$
143,403
In process research and development
5,300
1,600
23,380
3,600
General and administrative
15,877
11,591
49,728
39,136
Total operating expenses
60,087
55,787
233,962
186,139
Loss from operations
(60,087
)
(55,787
)
(233,962
)
(186,139
)
Other income (expense)
Interest income
366
1,567
3,442
5,563
Interest expense
(4,753
)
(715
)
(12,666
)
(1,938
)
Other income (expense)
(130
)
237
(174
)
2,207
Total other income (expense), net
(4,517
)
1,089
(9,398
)
5,832
Net loss
$
(64,604
)
$
(54,698
)
$
(243,360
)
$
(180,307
)
Net loss per share, basic and diluted
$
(0.88
)
$
(0.89
)
$
(3.55
)
$
(3.29
)
Weighted average common shares
outstanding, basic and diluted
73,212,186
61,282,084
68,510,260
54,740,170
BALANCE SHEET DATA:
December 31, 2020
December 31, 2019
Cash, cash equivalents, and marketable
securities
$
512,628
$
401,766
Working capital
483,672
372,394
Total assets
539,433
426,604
Total liabilities
218,749
74,119
Accumulated deficit
(577,530
)
(334,170
)
Total stockholders' equity
320,684
352,485
View source
version on businesswire.com: https://www.businesswire.com/news/home/20210225005248/en/
For Investors and Media: Bryan Giraudo, Chief Financial
Officer Gossamer Bio Investor Relations ir@gossamerbio.com
Gossamer Bio (NASDAQ:GOSS)
Historical Stock Chart
From Mar 2024 to Apr 2024
Gossamer Bio (NASDAQ:GOSS)
Historical Stock Chart
From Apr 2023 to Apr 2024