Innovate Biopharmaceuticals Reports First Quarter 2018 Key Financial and Corporate Highlights
May 16 2018 - 9:10AM
Innovate Biopharmaceuticals, Inc. (Nasdaq:INNT), a clinical stage
biotechnology company focused on developing novel therapeutics for
immuno-inflammatory diseases, today reported its first quarter 2018
financial results and key highlights.
Recent Achievements and Upcoming Milestones
Corporate
- Attendance at the Digestive Disease Week (DDW) conference;
KOL/analyst event and 1-on-1 meetings with management planned for
Monday, June 4
- Presentation at the BIO Convention planned for Tuesday, June 5
at 4:45PM ET in Theater 2 and 1-on-1 partnering meetings
- Attendance at the Gut-Liver Axis EASL Monothematic Conference
in Leuven, Belgium, planned for June 8-9 (focused meeting on liver
diseases due to a dysfunctional intestinal barrier)
Research
- As previously announced, presentation of two poster abstracts
planned for June 2-3 at DDW highlighting larazotide’s novel
mechanism of action, dose response and pharmacology
CMC/Manufacturing
- Ongoing stability and testing of INN-202 for celiac disease;
preparing for expected final release of drug product in the third
quarter
Clinical
- Phase 3 celiac disease trial preparations underway
- World-renowned celiac Scientific Advisory Board in place:
Ciaran Kelly, M.D. (Beth Israel/Harvard), Joseph Murray, M.D.
(Mayo), Anthony DiMarino, M.D. (Jefferson), Peter Green, M.D.
(Columbia), Markku Mäki, M.D, Ph.D. (Tampere (emeritus)), and Elena
Verdu, M.D., Ph.D. (McMasters)
- Leading nonalcoholic steatohepatitis (NASH) experts Manal F.
Abdelmalek, M.D. (Duke), Anna Mae Diehl, M.D. (Duke) and Stephen A.
Harrison, M.D. joined our Scientific Advisory Board
Christopher Prior, Ph.D., CEO of Innovate, said, “To our
knowledge, Innovate has the only oral therapeutic offering promise
to restore intestinal barrier function and reduce the
immuno-inflammatory responses that culminate in celiac disease and
NASH. Based on what we believe to be a unique mechanism of action,
we believe we are well positioned to build a robust pipeline of
product candidates either as standalone therapies or in combination
with other therapies working at different targets.”
June Almenoff, M.D., Ph.D., COO and CMO of Innovate, added,
“I’ve been delighted to become part of the Innovate team as we plan
to initiate our Phase 3 trial for celiac disease. We believe our
program will be the first Phase 3 trial for this unmet need.”
First Quarter 2018 Financial Results
Net loss for the quarter ended March 31, 2018, was $16.2
million, or ($0.76) per share, compared to net loss of $4.0
million, or ($0.34) per share for the same period ended March 31,
2017.
Research and development expenses were $6.4 million for the
quarter ended March 31, 2018, an increase of $5.0 million compared
to $1.3 million for the same period ended March 31, 2017. The
increase in research and development expenses was primarily
attributable to a $4.9 million increase in non-cash, non-employee
share-based compensation expense primarily due to the significant
increase in the market value of our common stock. The
remaining increase was primarily due to an increase of $0.1 million
related to an increase in manufacturing, clinical and regulatory
costs for the development of larazotide as we prepare for the Phase
3 clinical trial later in 2018. Share-based compensation expense,
non-cash expense for the three months ended March 31, 2018 and 2017
was $5.8 million and $0.9 million, respectively.
General and administrative expenses were $6.2 million for the
quarter ended March 31, 2018, an increase of $3.6 million compared
to $2.6 million for the same period ended March 31, 2017. The
increase was driven by approximately $1.2 million in share-based
compensation, non-cash expense primarily due to the increase in the
market value of our common stock. The additional $2.4 million
increase in costs was primarily due to certain transaction and
merger-related fees and expenses, including legal, accounting and
advisory fees and expenses, and an increase in personnel and salary
costs. Share-based compensation, non-cash expense for the
three months ended March 31, 2018 and 2017 was $2.6 million and
$1.4 million, respectively.
At March 31, 2018, the company held $13.0 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 immuno-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 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 the 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 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 Statements This 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 Annual Report on Form 10-K filed
with the U.S. Securities and Exchange Commission (the “SEC”) on
March 14, 2018, our Quarterly Report on Form 10-Q filed with the
SEC on May 15, 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.com
www.innovatebiopharma.com
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