- GB004: SHIFT-UC Phase 2 trial enrolling
patients with active ulcerative colitis (UC) -
- GB002: TORREY Phase 2 trial activated in
patients with pulmonary arterial hypertension (PAH) -
- GB1275: Two posters with data from ongoing
Phase 1/2 KEYNOTE-A36 clinical trial in advanced solid tumors
presented at Society for Immunotherapy of Cancer Meeting 2020 -
- GB001: Engaging with global regulatory
authorities about forward clinical development path for an oral DP2
antagonist in moderate-to-severe asthma -
- Cash, cash equivalents and marketable
securities totaled $555 million as of September 30, 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 third quarter of 2020 and provided a
corporate update.
“We are very excited about the continued advancement of our
pipeline with the start of two robust Phase 2 clinical trials for
GB002 and GB004 and the planned dose expansion cohort for GB1275,”
said Sheila Gujrathi, M.D., Co-Founder and Chief Executive Officer
of Gossamer. “We believe that these clinical programs hold
tremendous potential to benefit high unmet need patient
populations.”
Clinical-Stage Product Candidate Updates
GB002: Inhaled PDGFR Inhibitor for Pulmonary Arterial
Hypertension (PAH)
- GB002 is currently being evaluated in an ongoing Phase 1b trial
in PAH. Gossamer will discuss the initial results from this ongoing
trial at as part of a GB002-focused investor webinar in December
2020.
- Sites activated in the TORREY Study, a 24-week Phase 2 clinical
trial in functional class II and III PAH patients. Gossamer expects
to begin enrollment for this trial in the fourth quarter of 2020.
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.
GB004: Oral HIF-1α Stabilizer for Inflammatory Bowel
Disease
- Several patients dosed in the SHIFT-UC Study, a Phase 2
clinical trial in UC patients. 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.
- Data presented from completed Phase 1b study in patients with
active mild-to-moderate ulcerative colitis (UC) at UEG Week Virtual
2020. These posters and presentations are available at
www.gossamerbio.com, on the “Posters and Publications” page.
GB1275: Oral CD11b Modulator for Oncology Indications
- Two GB1275 posters are being presented at the 35th Annual
Meeting of the Society for Immunotherapy of Cancer (SITC 2020),
being held virtually from November 9 - 14. This includes clinical
and biomarker data from the ongoing GB1275 Phase 1/2 clinical
trial, KEYNOTE-A36, in advanced solid tumors and corresponding
presentations from Johanna Bendell, M.D. and Wells Messersmith,
M.D.
- Poster Title: Preliminary results from KEYNOTE-A36, a
study of GB1275, a first-in-class oral CD11b modulator, alone and
with pembrolizumab or chemotherapy in specified advanced solid
tumors Poster / Abstract Number: 388 Presenting
Author: Johanna Bendell, M.D. Link:
https://goss.bio/35CX8Rl
- Poster Title: Combining transcriptomic- and tissue-based
immune biomarkers to evaluate GB1275, a CD11b modulator, as a
single agent or with pembrolizumab in patients with advanced solid
tumors Poster / Abstract Number: 389 Presenting
Author: Wells Messersmith, M.D. Link:
https://goss.bio/3mlGsEQ
- Encouraging biological activity, particularly at GB1275 doses
greater than or equal to 800 mg BID, was seen in tumor types that
are known to be less responsive to checkpoint inhibitors. This
activity supports the mechanism of action of GB1275 in modulating
myeloid cell biology in the tumor microenvironment, with potential
to enhance anti-tumor response when it is combined with a
checkpoint inhibitor.
- Prolonged stable disease has been observed in seven patients,
in both the monotherapy and combination dose groups. Five of seven
patients with observed prolonged stable disease received doses of
800mg BID or higher of GB1275.
- One microsatellite stable-colorectal cancer patient receiving
oral GB1275 800 mg twice daily, in combination with pembrolizumab,
achieved a partial response. The patient had received five lines of
therapy prior to trial enrollment and is continuing on study
treatment.
- Clinical safety data to date suggest that GB1275 alone and
combined with pembrolizumab (up to 1200 mg twice daily) is
generally well tolerated, and the maximum tolerated dose of GB1275
has not been reached.
GB001: Oral DP2 Antagonist for Moderate-to-Severe
Asthma
- Engaging with global regulatory authorities regarding the
forward clinical development path of an oral DP2 antagonist in
moderate-to-severe asthma to inform potential partnerships or
strategic alternatives.
Financial Results for the Quarter Ended September 30,
2020
- Cash, Cash Equivalents and Marketable Securities: Cash,
cash equivalents and marketable securities as of September 30,
2020, were $555.4 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 September 30, 2020, R&D expenses were $41.8
million, compared to R&D expenses of $40.1 million for the same
period in 2019.
- General and Administrative (G&A) Expenses: For the
quarter ended September 30, 2020, G&A expenses were $11.4
million, compared to $9.8 million for the same period in 2019.
- Net Loss: Net loss for the quarter ended September 30,
2020, was $57.8 million, or $0.80 or share, compared to a net loss
of $48.5 million, or $0.80 per share, for the same period in 2019.
The increase was primarily attributable to an increase in interest
expense of $4.0 million and a decrease in investment income of $1.7
million.
Conference Call and Webcast
Gossamer’s management team will host a conference call and live
audio webcast at 4:30 p.m. ET today, Tuesday, November 10, to
discuss its third quarter 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: 2879501 Domestic Dial-in Number: (833) 646-0603
International Dial-in Number: (929) 517-9782 Live Webcast:
https://edge.media-server.com/mmc/p/e6ppaa7u
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 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; our plans to discuss
the results of the recent Phase 2b study of GB001 in asthma with
global regulatory authorities to inform potential partnerships or
strategic alternatives; 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;
Gossamer may not proceed into Phase 3 clinical trials for GB001,
including because the Phase 2b study results in asthma may not
support continued clinical development of GB001; 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 September
30,
Nine months ended September
30,
STATEMENTS OF OPERATIONS DATA:
2020
2019
2020
2019
Operating expenses:
Research and development
$
41,846
$
40,148
$
121,944
$
100,807
In process research and development
275
—
18,080
2,000
General and administrative
11,448
9,838
33,851
27,544
Total operating expenses
(53,569
)
(49,986
)
(173,875
)
(130,351
)
Loss from operations
(53,569
)
(49,986
)
(173,875
)
(130,351
)
Other income (expense), net
(4,243
)
1,486
(4,881
)
4,742
Net loss
$
(57,812
)
$
(48,500
)
$
(178,756
)
$
(125,609
)
Net loss per share, basic and diluted
$
(0.80
)
$
(0.80
)
$
(2.67
)
$
(2.39
)
Weighted average common shares
outstanding, basic and diluted
72,245,897
60,755,872
66,931,512
52,535,569
Condensed Consolidated Balance
Sheet
(in thousands)
(unaudited)
BALANCE SHEET DATA:
September 30, 2020
December 31, 2019
Cash, cash equivalents, and marketable
securities
$
555,378
$
401,829
Working capital
533,599
372,394
Total assets
584,178
426,604
Total liabilities
212,077
74,119
Accumulated deficit
(512,926
)
(334,170
)
Total stockholders' equity (deficit)
372,101
352,485
View source
version on businesswire.com: https://www.businesswire.com/news/home/20201110006132/en/
For Investors and Media: Bryan Giraudo, Chief Financial
Officer Gossamer Bio Investor Relations ir@gossamerbio.com
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