Innovate Biopharmaceuticals Reports Second Quarter 2018 Earnings and Key Corporate Highlights
August 15 2018 - 7:10AM
Innovate Biopharmaceuticals, Inc. (Nasdaq: INNT), a clinical stage
biotechnology company focused on developing novel therapeutics for
autoimmune and inflammatory diseases, today reported its second
quarter 2018 financial results and key highlights.
Recent Achievements and Upcoming Milestones
Upcoming Milestones
- Phase 3 celiac disease trial startup preparations underway with
clinical site evaluations and patient dosing targeted before year
end
- Pre-clinical studies for non-alcoholic steatohepatitis (NASH)
expected to readout in late Q3
- Innovate plans to host a Clinical and Scientific Update on
Thursday, September 6, 2018, from 8:15am-11:00am at the Omni Hotel
(52nd St. & Madison Ave.) in New York City
Corporate
- Innovate Biopharmaceuticals Inc. was added as a member of the
broad-market Russell 3000®, 2000® and Microcap® Indexes effective
June 25, 2018, as part of the 2018 Russell indexes
reconstitution
- Innovate intends to present at the 20th Annual Rodman &
Renshaw Global Investment Conference on September 5, 2018, at
12:05pm at the St. Regis in New York City
Research
- Presented two posters in collaboration with North Carolina
State University at the Digestive Disease Week medical conference
2018 highlighting larazotide’s novel mechanism of action and
pharmacology
- Continued collaboration with Anthony Blikslager, DVM, PhD,
DACVS, AGAF, of NC State to understand and characterize the
mechanism of action and dose response of larazotide
- Initiated collaboration with O. Colin Stine, PhD, of the
University of Maryland, Baltimore to study larazotide’s corrective
effect on the dysfunctional intestinal barrier and the
dysfunctional microbiome (see press release from June 28,
2018)
- Initiated collaboration with James Nataro, MD, PhD, MBA, of
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 second
quarter of 2018 marked continued progress for Innovate as we
continued to advance the startup activities for our celiac disease
Phase 3 trials and progress our NASH program. We are also excited
about our ongoing and new research collaborations with various
partners to leverage our mechanism of action to address unmet
medical needs.”
Second Quarter 2018 Financial ResultsNet loss
for the three months ended June 30, 2018, was $4.2 million, or
$(0.16) per basic and diluted share, compared to net loss of $2.8
million, or $(0.23) per basic and diluted share for the same period
ended June 30, 2017.
Research and development expenses were $1.2 million for the
three months ended June 30, 2018, an increase of $0.1 million,
compared to $1.1 million for the same period ended June 30,
2017.
General and administrative expenses were $2.1 million for the
three months ended June 30, 2018, an increase of $0.6 million,
compared to $1.5 million for the same period ended June 30,
2017.
At June 30, 2018, Innovate had $10.7 million in cash and cash
equivalents, compared to $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
successfully 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 later in 2018. Larazotide
has been exposed to more than 800 subjects in clinical trials
demonstrating a favorable safety profile comparable to placebo for
long-term chronic administration. 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, the success, timing and cost
of our drug development program and our ongoing or future clinical
trials, 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 August 14, 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.Kendyle
WoodardTel: 919-275-1933Email:
investor.relations@innovatebiopharma.comwww.innovatebiopharma.com
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