Innovate Biopharmaceuticals Reports Third Quarter 2018 Earnings and Key Corporate Highlights
14 November 2018 - 9:26AM
Innovate Biopharmaceuticals, Inc. (Nasdaq: INNT), a clinical stage
biotechnology company focused on developing novel therapeutics for
autoimmune and inflammatory diseases, today reported its third
quarter 2018 financial results and key highlights.
Recent Achievements and Upcoming Milestones
Upcoming Milestones
- Continuation of pre-clinical studies for non-alcoholic
steatohepatitis (NASH).
- Initiation of additional NASH collaboration.
Clinical
- Innovate entered into an agreement with Amarex Clinical
Research for data management and biostatistics for Innovate's
planned Phase 3 celiac disease trial.
- Phase 3 celiac disease trial startup preparations continuing
with start planned in the first half of 2019.
- Over 150 clinical sites have been identified for the planned
Phase 3 celiac disease trial with positive feedback from sites to
enroll the first Phase 3 celiac disease trial.
- Clinical trial material for Phase 3 is currently being
manufactured.
Research
- Presented poster in collaboration with Sanyal Biotechnology at
The Liver Meeting® 2018, the annual meeting of the American
Association for the Study of Liver Diseases (AASLD) in November
2018. The data showed larazotide was effective in restoring gut
permeability in a NASH pre-clinical model. (see press release from
November 12, 2018)
- Continued collaboration with Anthony Blikslager, DVM, PhD,
DACVS, AGAF, of North Carolina State University to understand and
characterize the mechanism of action.
- Continued collaboration with James Nataro, MD, PhD, MBA, of the
University of Virginia to study larazotide’s effect on improving
the microbiome of children with environmental enteric dysfunction
(EED). (see press release from July 31, 2018)
Christopher Prior, Ph.D., CEO of Innovate, said, “The third
quarter of 2018 was focused on continued preparation for initiation
of the first Phase 3 clinical trial planned for the first half of
2019. With very encouraging pre-clinical data for NASH, Innovate
will continue further pre-clinical work and target the initiation
of a Phase 2 NASH clinical trial in 2019. We continue to forge our
collaborations to further enrich our pipeline.”
Third Quarter 2018 Financial Results
Net loss for the three months ended September 30, 2018, was $0.8
million, or $(0.03) per basic and diluted share, compared to net
loss of $2.5 million, or $(0.08) per basic and diluted share for
the same period ended September 30, 2017.
Research and development expenses were $(1.8) million for the
three months ended September 30, 2018, a decrease of $2.2 million,
compared to $0.4 million for the same period ended September 30,
2017 primarily due to a re-measurement of stock option compensation
expense related to a decline in our stock price from June 30, 2018
to September 30, 2018.
General and administrative expenses were $1.6 million for the
three months ended September 30, 2018, a decrease of $0.4 million,
compared to $2.0 million for the same period ended September 30,
2017 primarily due to a re-measurement of stock option compensation
expense related to a decline in our stock price from June 30, 2018
to September 30, 2018.
At September 30, 2018, Innovate had $8.1 million in cash and
cash equivalents, compared to $10.7 million at June 30, 2018 and
$0.4 million at December 31, 2017.
About Innovate Biopharmaceuticals, Inc. (Nasdaq:
INNT):Innovate is a clinical stage biotechnology company
focused on developing novel therapeutics for autoimmune and
inflammatory diseases. Innovate’s lead drug candidate, larazotide
acetate, has a mechanism of action that renormalizes the
dysfunctional intestinal barrier by decreasing intestinal
permeability and reducing antigen trafficking, such as gliadin
fragments in celiac disease, and bacterial toxins and immunogenic
antigens in nonalcoholic steatohepatitis (NASH). In several
diseases, including celiac disease, NASH, Crohn’s disease,
ulcerative colitis, irritable bowel syndrome (IBS), type 1 diabetes
mellitus (T1DM), chronic kidney disease (CKD), the intestinal
barrier is dysfunctional with increased permeability.
In celiac disease, larazotide is the only drug which has
successfully met its primary endpoint with statistical significance
in a Phase 2b efficacy clinical trial (342 patients). Innovate
completed the End of Phase 2 Meeting with the FDA in 2017 and is
preparing to begin Phase 3 registration clinical trials for celiac
disease, targeted to commence in the first half of 2019. Nearly 600
subjects have been exposed to larazotide in clinical trials, and a
safety profile comparable to placebo has been demonstrated.
Larazotide has received Fast Track designation from the FDA for
celiac disease.
Forward Looking StatementsThis press release
includes forward-looking statements including, but not limited to,
statements related to the potential for Innovate’s drug development
pipeline candidates in treating the diseases and conditions for
which they are being developed, Innovate’s start of clinical trials
for celiac disease, NASH, Crohn’s disease, and ulcerative colitis,
and Innovate’s ability to develop future collaborations. The
forward-looking statements contained in this press release are
based on management’s current expectations and are subject to
substantial risks, uncertainty and changes in circumstances. Actual
results may differ materially from those expressed by these
expectations due to risks and uncertainties, including, among
others, those related to our ability to obtain additional capital
on favorable terms to us, or at all, including, without limitation,
to fund our current and future preclinical studies and clinical
trials; the success, timing and cost of our drug development
program and our ongoing or future clinical trials, including,
without limitation, the possibility of unfavorable new clinical and
preclinical data and additional analyses of existing data, as well
as the risks that prior clinical and preclinical results may not be
replicated; the lengthy and unpredictable nature of the drug
approval process; and our ability to commercialize our product
candidates if approved. These risks and uncertainties include, but
may not be limited to, those described in our Quarterly Report on
Form 10-Q filed with the SEC on November 13, 2018, and in any
subsequent filings with the SEC. Forward-looking statements speak
only as of the date of this press release, and we undertake no
obligation to review or update any forward-looking statement except
as may be required by applicable law.
Innovate Biopharmaceuticals, Inc.Jennifer K.
Zimmons, Ph.D.Investor RelationsTel: +1-917-214-3514Email:
jzimmons@innovatebiopharma.com www.innovatebiopharma.com
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