- Seralutinib and GB004 continue to enroll
ongoing Phase 2 TORREY and SHIFT-UC clinical trials for Pulmonary
Arterial Hypertension (PAH) and Ulcerative Colitis (UC),
respectively -
- Gossamer Announces Seralutinib Open Label
Extension Data in PAH Patients -
- Gossamer to Discontinue Clinical Development
of GB1275 -
- Cash, cash equivalents and marketable
securities totaled $406 million as of June 30, 2021 -
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 second quarter of 2021 and provided a
corporate update.
“I am tremendously proud of the dedication and perseverance the
Gossamer team has shown this year, pressing forward with the
execution of two Phase 2 studies for our lead clinical programs,
seralutinib and GB004, in the face of operational challenges
presented by the pandemic,” said Faheem Hasnain, Co-Founder,
Chairman and Chief Executive Officer of Gossamer. “We are also very
happy to share data from the first extended clinical experience of
seralutinib, the first such data from an inhaled kinase inhibitor
in patients with PAH. Though the pandemic limited the number of
patients who were able to continue onto the OLE, these patient
experiences provide additional evidence supporting the potential of
seralutinib to improve the lives of PAH patients.”
Clinical-Stage Product Candidate Updates
Seralutinib (GB002): Inhaled PDGFR, CSF1R and C-KIT Inhibitor
for PAH
- While the conduct of the Phase 1b study of seralutinib in
patients with Functional Class II and III PAH was interrupted by
the COVID-19 pandemic, two of the eight patients that completed the
two-week Phase 1b study were also able to complete the optional
6-month open-label extension period.
- Both patients entered and completed the extension study on
three classes of background therapy, including oral
prostacyclins.
- No serious adverse events were reported, and no safety concerns
identified with longer term treatment over a six-month period at a
twice daily 90mg dose.
- In both patients, decreases in NT-proBNP, a biomarker for right
heart strain, and increases in six-minute walk distance, a
potential registrational endpoint for PAH, were observed.
- Enrollment is 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.
- Additional exploratory biomarker data from the completed
seralutinib two-week Phase 1b in eight PAH patients will be
presented via ePoster at the Virtual European Respiratory Society
(ERS) International Congress 2021 being held virtually from
September 5 – 8, 2021. Abstract content will be available online at
the ERS website, starting on August 23, 2021, two weeks prior to
the beginning of the virtual ERS Congress. ePoster details:
- ePoster Title: Evidence of Target Engagement and Pathway
Modulation: Biomarker Analysis of the Phase 1b Inhaled Seralutinib
Study
- Session Date: Sunday, September 5, 2021
- Session Time: 1:15pm CEST / 7:15am EDT / 4:15am PDT
GB004: Oral, Gut-Targeted HIF-1α Stabilizer for Inflammatory
Bowel Disease (IBD)
- Enrollment is 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.
- Additional post-hoc analysis of clinical data from the
completed GB004 Phase 1b in patients with active UC will be
presented at the United European Gastroenterology (UEG) Virtual
Week 2021 being held virtually from October 3 – 5, 2021.
Presentation details:
- Abstract Title: Assessment of Composite Endpoints
Comprising Symptomatic, Histologic, Endoscopic, and Molecular
Improvement in a Phase 1b Study of GB004, a Gut-Targeted,
Hypoxia-Inducible Factor (HIF)-1α Stabilizer, in Mild-to-Moderate
Ulcerative Colitis
- Presenting Author: Silvio Danese, MD, PhD
- Abstract Number: OP124
- Session Title: IBD Clinical Trials III
- Session Date: Monday, October 4, 2021
- Session Time: 3:00pm CEST / 9:00am EDT / 6:00am PDT
GB1275: Oral CD11b Modulator for Solid Tumor Oncology
Indications
- Gossamer will discontinue clinical development of its
immuno-oncology product candidate, GB1275, which is currently in a
Phase 1/2 clinical trial in solid tumor indications as a
monotherapy and in combination with either pembrolizumab or
chemotherapy.
Financial Results for the Quarter Ended June 30, 2021
- Cash, Cash Equivalents and Marketable Securities: Cash,
cash equivalents and marketable securities as of June 30, 2021,
were $405.9 million. The Company expects the combination of 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 2023.
- Research and Development (R&D) Expenses: For the
quarter ended June 30, 2021, R&D expenses were $44.3 million,
compared to R&D expenses of $38.7 million for the same period
in 2020.
- General and Administrative (G&A) Expenses: For the
quarter ended June 30, 2021, G&A expenses were $11.3 million,
compared to $11.7 million for the same period in 2020.
- Net Loss: Net loss for the quarter ended June 30, 2021,
was $59.8 million, or $0.80 per share, compared to a net loss of
$66.9 million, or $1.00 per share, for the same period in
2020.
Conference Call and Webcast
Gossamer’s management team will host a conference call and live
audio webcast at 4:30 p.m. ET today, Monday, August 9, to discuss
its second quarter 2021 financial results, provide a corporate
update, and present the seralutinib Phase 1b open-label extension
data.
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: 1188932 Domestic Dial-in Number: (833) 646-0603
International Dial-in Number: (929) 517-9782 Live Webcast:
https://edge.media-server.com/mmc/p/ruj72hwq
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 of our product candidates;
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 ongoing
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; 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 Statement of
Operations
Condensed Consolidated
Statement of Operations
(in thousands, except share
and per share amounts)
(unaudited)
Three months ended June
30,
Six months ended June
30,
2021
2020
2021
2020
Operating expenses:
Research and development
$
44,318
$
38,684
$
86,145
$
80,098
In process research and development
15
15,000
45
17,805
General and administrative
11,263
11,655
22,609
22,403
Total operating expenses
55,596
65,339
108,799
120,306
Loss from operations
(55,596
)
(65,339
)
(108,799
)
(120,306
)
Other income (expense), net
Interest income
141
898
334
2,496
Interest expense
(4,834
)
(2,491
)
(9,614
)
(3,198
)
Other income
457
62
606
64
Total other expense, net
(4,236
)
(1,531
)
(8,674
)
(638
)
Net loss
$
(59,832
)
$
(66,870
)
$
(117,473
)
$
(120,944
)
Net loss per share, basic and diluted
$
(0.80
)
$
(1.00
)
$
(1.58
)
$
(1.88
)
Weighted average common shares
outstanding, basic and diluted
74,672,882
66,599,915
74,384,805
64,245,119
Condensed Consolidated Balance
Sheet
(in thousands)
(unaudited)
BALANCE SHEET DATA:
June 30, 2021
December 31, 2020
Cash, cash equivalents, and marketable
securities
$
405,919
$
512,628
Working capital
387,005
483,672
Total assets
432,510
539,433
Total liabilities
211,817
218,749
Accumulated deficit
(695,003
)
(577,530
)
Total stockholders' equity
220,693
320,684
View source
version on businesswire.com: https://www.businesswire.com/news/home/20210809005711/en/
For Investors and Media: Bryan Giraudo, Chief Financial
Officer Gossamer Bio Investor Relations ir@gossamerbio.com
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