Innovate closes an equity financing with gross
proceeds of $9.7 million
Innovate Biopharmaceuticals, Inc. (Nasdaq: INNT), a clinical stage
biotechnology company focused on developing novel therapeutics for
autoimmune and inflammatory diseases, announced today that on March
18, 2019, it closed its previously announced equity financing,
resulting in gross proceeds of $9.7 million. The Company expects to
use the estimated net proceeds of approximately $9.6 million from
the offering to initiate its first Phase 3 registration trial of
larazotide acetate, or INN-202, for celiac disease , and for
working capital and general corporate purposes. On March 18, 2019,
the Company also reported its year end 2018 financial results and
key highlights.
Recent Achievements and Upcoming
MilestonesClinical
- Innovate entered into an agreement with ICON Clinical Research
Limited to facilitate the Company’s completion of startup
activities required to initiate its Phase 3 clinical trial for
celiac disease.
- Manufacturing of the drug product for our Phase 3 trial has
been completed.
R&D
- Acceptance of three abstracts to the 2019 Digestive Disease
Week (DDW) through collaboration with North Carolina State
University and Massachusetts General Hospital, including one with
Prof. Anthony Blikslager of North Carolina State University to
understand the molecular biology and mechanism of action of
larazotide.
Upcoming Milestones
- Start of the first Phase 3 celiac disease trial
- Continuation of pre-clinical studies for non-alcoholic
steatohepatitis (NASH) and alcoholic steatohepatitis (ASH).
- Initiation of additional scientific and clinical
collaborations.
Sandeep Laumas, M.D., CEO of Innovate, said, “The fourth quarter
of 2018 was focused on continued preparation for our first celiac
disease phase 3 clinical trial, which we plan to initiate in the
second quarter of 2019. We are also encouraged by the pre-clinical
data we have seen for NASH so far and Innovate intends to continue
further pre-clinical work for the use of larazotide in the
treatment of NASH.”
2018 Financial ResultsNet loss for the year
ended December 31, 2018, was $24.2 million, or $(0.98) per basic
and diluted share, compared to net loss of $11.6 million, or
$(0.98) per basic and diluted share for the same period ended
December 31, 2017.
Research and development expenses were $7.6 million for the year
ended December 31, 2018, an increase of $3.6 million, compared to
$4.0 million for the same period ended December 31, 2017, primarily
due to an increase in costs associated with the preparation for our
Phase 3 clinical trials of INN-202 for celiac disease and an
increase in compensation costs related to an increase in research
and development personnel.
General and administrative expenses were $10.7 million for the
year ended December 31, 2018, an increase of $3.5 million, compared
to $7.2 million for the same period ended December 31, 2017,
primarily due to an increase in compensation costs for general and
administrative personnel, an increase in accounting, legal and
transaction advisory fees associated with our reverse merger, SEC
filings and outsourced accounting personnel as well as an increase
in costs associated with operating as a public company. The
increase in these costs was partially offset by a decrease in
non-cash stock compensation expense.
At December 31, 2018, Innovate had $5.7 million in cash and cash
equivalents compared to $0.4 million at December 31, 2017.
Webcast
As previously announced, Innovate plans to host an earnings
conference call at 8:00 am ET today, March 19, 2019, to discuss its
financial results for the fourth quarter and full year ended
December 31, 2018, and to provide corporate and operational
progress updates. Please visit the Investor section of
Innovate’s website for further details on accessing the
webcast.
A live and archived audio webcast of the conference call will be
available on the Events and Presentations page of Innovate’s
corporate website at www.innovatebiopharma.com.
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.
Forward Looking Statements This press release
includes forward-looking statements including, but not limited to,
statements related to the development of drug candidates, our
operations and business strategy, capital raising, our expected
financial results, and corporate updates. 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, including, without
limitation, raising additional funds for our Phase 3 registration
trial for INN-202, and the success, timing and cost of our drug
development program and our ongoing or future preclinical studies
and 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. These risks and
uncertainties include, but may not be limited to, those described
in our Annual Report on Form 10-K filed with
the SEC on March 18, 2019, 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.
SOURCE: Innovate Biopharmaceuticals, Inc.
Contact: Jennifer K. Zimmons, Ph.D. Investor
Relations Tel: +1-917-214-3514 Email:
jzimmons@innovatebiopharma.com www.innovatebiopharma.com
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