- GB001 interim analysis of LEDA trial in
moderate-to-severe eosinophilic asthma completed -
- GB001 intellectual property estate
strengthened with issuance of new patent by USPTO covering lysine
salt drug substance forms -
- GB004 completed successful Phase 1b in
ulcerative colitis; Phase 2 trial planned to commence in 2020 -
- GB004 license agreement with Aerpio amended
to provide financial, milestone and royalty benefit to Gossamer
-
- Chief Medical Officer Jakob Dupont, M.D. to
depart Gossamer; will continue to provide medical support to
Gossamer’s GB1275 oncology program as a consultant -
- Cash, cash equivalents and marketable
securities totaled $346 million as of March 31, 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 first quarter 2020 and provided a
corporate update.
“We are very pleased today to share initial results of the
Gossamer team’s great execution and hard work, including that we
have successfully completed the interim analysis of the LEDA study
of GB001,” said Sheila Gujrathi, M.D., Co-Founder and Chief
Executive Officer of Gossamer. “We have begun initial Phase 3
planning and supportive activities, while awaiting final data from
the study which will inform our decision to proceed to Phase
3.”
“We are also excited to share topline results from our four-week
Phase 1b study of GB004 in patients with active mild-to-moderate
ulcerative colitis,” said Dr. Gujrathi. “The safety and
tolerability data, in addition to the promising efficacy data
observed in the study, give us confidence as we move into Phase
2.”
“The trends observed in the clinical endpoints from a 28-day
study with a limited number of patients, especially those endpoints
that reflect GB004’s novel mechanism of action, such as histologic
remission and mucosal healing, are very exciting,” said William
Sandborn, M.D., Chief of the Division of Gastroenterology of
University of California San Diego. “An oral, gut-targeted therapy
with a non-immunosuppressive mechanism of action and a robust
effect on mucosal healing would be a very meaningful addition to
the treatment options for patients with ulcerative colitis. These
early signals of activity, combined with the tolerability data
generated to date, position GB004 as a promising and differentiated
potential treatment for IBD.”
Clinical-Stage Product Candidate Updates
GB001: Oral DP2 Antagonist for Eosinophilic Asthma and
Chronic Rhinosinusitis (CRS)
- Gossamer recently completed a pre-specified interim analysis of
LEDA, its Phase 2b clinical study of GB001 in moderate-to-severe
eosinophilic asthma. The interim analysis was based on
approximately the first two thirds (~320) of patients who either
completed or withdrew from the study. The Independent Data
Monitoring Committee (IDMC) reviewed results from the interim
analysis and recommended continuation of the study to its
completion without modification. Based on the results of the
interim analysis and the IDMC recommendation, Gossamer has
commenced initial Phase 3 planning and supportive activities in
anticipation of the completion of the study and final analysis of
the study data. The final decision to proceed to Phase 3 will be
made based on the totality of the final data from the LEDA study,
as well as discussions with global regulatory authorities. Topline
results from LEDA continue to be expected in the second half of
2020.
- On April 21, 2020, the United States Patent and Trademark
Office issued patent US 10,626,089. This key patent protects the
lysine salt that is being studied in the clinical development of
GB001. These compound claims further enhance the intellectual
property protection around GB001. This patent is not due to expire
before 2037.
- The TITAN Phase 2 clinical study of GB001 in CRS, both with and
without nasal polyps, is on track to report topline data in the
second half of 2020.
GB004: Oral HIF-1α Stabilizer for Inflammatory Bowel
Disease
- Gossamer today announced promising topline results from its
Phase 1b study of GB004 in patients with active mild-to-moderate
ulcerative colitis (UC). GB004 is designed to restore intestinal
epithelial barrier integrity and function in patients with
inflammatory bowel disease.
- The Phase 1b study was designed to evaluate the safety,
tolerability, and pharmacokinetics of a 120mg once-daily dose of
GB004 in a solution formulation over a 28-day treatment period in
UC patients with active disease despite treatment with 5-ASA
therapy. In addition, pharmacodynamics and certain outcomes related
to clinical activity were studied as exploratory measures.
Thirty-four patients were randomized 2:1 to receive either GB004
(n=23) or placebo (n=11).
- Safety and Tolerability:
GB004 was well tolerated during the study with no effects on
systemic erythropoietin or vascular endothelial growth factor
observed. The most frequent adverse events experienced by patients
on the GB004 arm were nausea and dysgeusia, all of which were mild
in severity aside from one case of moderate nausea. All patients
completed the study, except for a single patient on the GB004 arm
who experienced a serious adverse event of worsening UC, which was
deemed by the investigator to be unrelated to study drug.
- PK / PD and Target
Engagement: The gut-targeted pharmacokinetic (PK)
profile of GB004 was shown with rapid clearance from systemic
circulation and multi-fold higher concentrations of drug in the gut
as compared to the plasma after eight hours of dosing. Preliminary
data from gut biopsies showed increased expression of genes
associated with HIF-1α stabilization and enhanced epithelial
barrier function, such as TJP1 and CLDN1, and evidence of reduced
gut epithelial neutrophil activity in the GB004 arm compared to the
placebo arm.
- Clinical Activity: While
this four-week study was not powered to show differences in
clinical outcomes, several encouraging trends related to treatment
with GB004 were observed at Day 28. Mucosal healing, defined as the
achievement of both histologic remission and endoscopic improvement
in the sigmoid or rectum, was observed in 4 of 23 patients (17%) in
the GB004 arm compared to 0 of 11 patients in the placebo arm. Ten
of 23 patients (43%) in the GB004 arm achieved histologic remission
in either the sigmoid or rectum compared to 2 of 11 patients (18%)
in the placebo arm. Favorable trends were also observed in clinical
response (6/20 [30%] vs. 2/11 [18%]) and improvement in the rectal
bleeding sub-score (13/21 [62%] vs. 5/11 [45%]). One patient in the
GB004 arm achieved clinical remission; no patients in the placebo
arm achieved clinical remission.
- Further data from the Phase 1b study will be presented at
future medical conferences.
- Gossamer also recently completed a successful Phase 1 clinical
study in healthy volunteers to support the selection of a tablet
formulation to be used in future clinical studies of GB004. In the
study, the tablet formulation showed improved tolerability compared
to solution at higher doses.
- Subject to the developments in the ongoing COVID-19 viral
pandemic, Gossamer plans to initiate a Phase 2 study of GB004 in UC
with an oral tablet formulation of the product candidate in a
12-week induction setting in the second half of 2020.
- Gossamer gives its thanks to the patients and physicians that
participated in its Phase 1b study of GB004. We are grateful for
the opportunity to take this novel mechanism to patients in
need.
GB002: Inhaled PDGFR Inhibitor for Pulmonary Arterial
Hypertension (PAH)
- GB002 is currently being evaluated in an ongoing Phase 1b study
in PAH. Given COVID-19 related delays in study enrollment, Gossamer
now anticipates reporting initial results from this study in the
second half of this year.
- Subject to the developments in the ongoing COVID-19 viral
pandemic, Gossamer plans to commence a Phase 2 study in functional
class II and III PAH patients in the second half of 2020. The
primary endpoint for this 24-week study will be change in pulmonary
vascular resistance (PVR) from baseline. A key secondary endpoint
will be change from baseline in 6-minute walk distance at week
24.
GB1275: Oral CD11b Modulator for Oncology Indications
- Enrollment continues in the KEYNOTE-A36 Phase 1/2 study to
evaluate GB1275 as a monotherapy and in combination with either
KEYTRUDA® (pembrolizumab) or chemotherapy in patients with selected
solid tumors.
- The American Society for Clinical Oncology (ASCO) accepted an
abstract for poster presentation (abstract 3085; poster 149)
containing initial dose-escalation data from the KEYNOTE-A36 study,
which will be presented in the Developmental
Therapeutics—Immunotherapy Poster Session at the ASCO20 Virtual
Scientific Program. Gossamer also expects to present further data
from the study in the second half of the year.
- During the first quarter 2020, the European Medicines Agency
granted orphan designation to GB1275 for the treatment of
pancreatic cancer. GB1275 had previously received orphan drug
designation from the U.S. Food and Drug Administration for the
treatment of pancreatic cancer.
Corporate Updates
- On May 11, 2020, Gossamer paid Aerpio Pharmaceuticals, Inc. $15
million as part of an amendment to the GB004 license agreement.
Under the amended terms, all development milestones have been
obviated, total remaining milestones were reduced from $400 million
to $90 million, and royalties on worldwide net sales now range from
a low- to mid-single digit percentage. Gossamer continues to be
responsible for the remaining development, regulatory, and
commercialization expenses for GB004. Aerpio’s participation right
on a disposition of GB004 remains.
- Chief Medical Officer Jakob Dupont, M.D. will depart Gossamer
to pursue oncology opportunities closer to his family in the San
Francisco Bay Area. He will serve as a consultant to Gossamer to
support the development of GB1275 through a transitional period.
Chief Executive Officer Sheila Gujrathi, M.D., together with
Richard Aranda, M.D., Senior Vice President for Clinical
Development, Caryn Peterson, Senior Vice President for Regulatory
and Quality, Heather Smith, Senior Vice President for Clinical
Operations, and Matt Cravets, Vice President for Biometrics will
assume Dr. Dupont’s responsibilities.
“I would like to thank our Chief Medical
Officer, Jakob Dupont, for his contributions to Gossamer,
especially with respect to our GB1275 program, which Jakob will
continue to support as a consultant,” said Dr. Gujrathi. “I respect
and support his personal decision to be closer to his family in the
Bay Area in this unprecedented time,” she added.
- Gossamer will participate in the upcoming Bank of America
Securities Virtual Healthcare Conference. Chief Executive Officer
Dr. Sheila Gujrathi will present at the conference on Thursday, May
14, 2020, at 6:40 p.m. ET. A live webcast will be available on the
“Events & Presentations” page within the Investors section of
the Gossamer website and a replay will be available for 30 days
following the event.
Financial Results for the Quarter Ended March 31,
2020
- Cash, Cash Equivalents and Marketable Securities: Cash,
cash equivalents and marketable securities as of March 31, 2020,
were $346.2 million. The Company expects the combination of current
cash, cash equivalents and marketable securities, and access to our
debt facility will be sufficient to fund its operating and capital
expenditures to mid-2022.
- Research and Development (R&D) Expenses: For the
quarter ended March 31, 2020, R&D expenses were $41.4 million,
compared to R&D expenses of $25.0 million for the same period
in 2019. This increase reflects a continued ramp-up of clinical
expenses in connection with the further advancement of the GB001,
GB002, GB004 and GB1275 programs and increased expenses related to
the development of proprietary pre-clinical programs.
- In-Process Research and Development (IPR&D)
Expenses: For the quarter ended March 31, 2020, IPR&D
expenses were $2.8 million, compared to $1.0 million for the same
period in 2019.
- General and Administrative (G&A) Expenses: For the
quarter ended March 31, 2020, G&A expenses were $10.7 million,
compared to $8.0 million for the same period in 2019.
- Net Loss: Net loss for the quarter ended March 31, 2020,
was $54.1 million, or $0.87 per share, compared to a net loss of
$32.6 million, or $0.90 per share, for the same period in
2019.
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, May 12, to discuss
its first 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: 8593375 Domestic Dial-in Number: (833) 646-0603
International Dial-in Number: (929) 517-9782 Live Webcast:
https://edge.media-server.com/mmc/p/wf9kdou9
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 the GB004 Phase 1b Study
The Phase 1b study of GB004 was a multi-center, randomized,
double-blind, placebo-controlled study which enrolled 34 patients
with active mild-to-moderate ulcerative colitis. Patients were
randomized 2:1 to receive either a 120mg once-daily dose of a
solution formulation of GB004 (n=23) or placebo (n=11). The primary
objective of the study was to evaluate the safety and tolerability
of GB004 administered over 28 days. Pharmacokinetics were evaluated
as a secondary objective, while exploratory objectives included
measurements of pharmacodynamics and clinical outcomes. Histology,
endoscopic improvement, and mucosal healing were evaluated
individually in two segments of the large intestine: the sigmoid
colon and rectum.
Exploratory clinical outcomes in the study were defined as
follows:
- Histology: evaluated using the Robarts Histopathology Index, or
RHI.
- Histologic remission: RHI ≤ 3 with lamina propria neutrophils
sub-score = 0 and neutrophils in epithelium sub-score = 0, among
patients with baseline RHI > 3 and baseline lamina propria
neutrophils and neutrophils in epithelium sub-scores > 0.
- Endoscopic improvement: endoscopic sub-score of 0 or 1 if
baseline endoscopic sub-score > 1, or 0 if baseline endoscopic
sub-score = 1.
- Mucosal healing: achievement of both histologic remission and
endoscopic improvement in the same segment.
- Clinical response: reduction in Mayo score of ≥ 3 points and ≥
30% from baseline with an accompanying decrease in rectal bleeding
sub-score of ≥ 1 point or absolute rectal bleeding sub-score of ≤ 1
point, among patients with baseline rectal bleeding sub-score ≥ 1
and baseline sigmoid endoscopy sub-score ≥ 1.
- Clinical remission: Mayo score ≤ 2, with no individual
sub-score > 1, among patients with baseline sigmoid endoscopy
sub-score ≥ 1.
- Improvement in rectal bleeding: reduction from baseline in
rectal bleeding sub-score of ≥ 1, among patients with a baseline
rectal bleeding sub-score ≥ 1.
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:
our plans to begin Phase 3 planning and supportive activities for
GB001; 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 of our
product candidates; the expected impact of COVID-19; the length of
our intellectual property protection; 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 whether based on final data or otherwise;
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 March
31,
STATEMENTS OF OPERATIONS
DATA:
2020
2019
Operating expenses:
Research and development
$
41,414
$
24,983
In process research and development
2,805
1,000
General and administrative
10,748
8,034
Total operating expenses
54,967
34,017
Loss from operations
(54,967
)
(34,017
)
Other income, net
893
1,406
Net loss
$
(54,074
)
$
(32,611
)
Net loss per share, basic and diluted
$
(0.87
)
$
(0.90
)
Weighted average common shares
outstanding, basic and diluted
61,890,323
36,317,230
Condensed Consolidated Balance
Sheet
(in thousands)
(unaudited)
BALANCE SHEET DATA:
March 31, 2020
December 31, 2019
Cash, cash equivalents, and marketable
securities
$
346,165
$
401,829
Working capital
327,076
372,394
Total assets
371,478
426,604
Total liabilities
65,015
74,119
Accumulated deficit
(388,244
)
(334,170
)
Total stockholders' equity (deficit)
306,463
352,485
View source
version on businesswire.com: https://www.businesswire.com/news/home/20200512005809/en/
Bryan Giraudo, Chief Financial Officer Gossamer Bio Investor
Relations IR@gossamerbio.com
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