Innovate Biopharmaceuticals to Announce First Quarter 2019 Financial Results and to Provide Operational Progress Updates on April 29, 2019

Innovate plans to provide an operational progress update, including regarding its first phase 3 celiac disease clinical trial

Topline NASH preclinical data expected to be released at the Digestive Disease Week (DDW) medical conference to be held May 18-21, 2019 in San Diego

RALEIGH, N.C., April 02, 2019 (GLOBE NEWSWIRE) -- Innovate Biopharmaceuticals Inc. (Nasdaq: INNT), a clinical stage biotechnology company focused on developing novel therapeutics for autoimmune and inflammatory diseases with its lead drug, larazotide acetate, comprising a new class of medicines based on gut-restricted peptides which re-normalize the gut-epithelial barrier and the gut-liver axis, announced today it intends to host an audio webcast on Monday, April 29, 2019, at 8:00 a.m. ET, to report financial results for the first quarter ended March 31, 2019 and provide an operational progress update, including with respect to its first phase 3 celiac disease clinical trial.

Please visit the Investor section of Innovate’s website for further details on how accessing the webcast.

A live and archived audio webcast of the conference call will be available on the Events and Presentations page of the Innovate’ corporate website at www.innovatebiopharma.com.

About larazotide acetate for celiac disease
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 and is preparing to launch the Phase 3 registration clinical trials for celiac disease in the second quarter 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

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, 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 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