DDW 2020 Abstracts Accepted

Innovate Biopharmaceuticals Announces Acceptance of Three Abstracts for the 2020 Digestive Disease Week (DDW) Conference

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Highlighting Larazotide’s Effect across the Gut-Vascular Barrier – a Fundamental Disease Mechanism in a Variety of Autoimmune and Inflammatory Diseases

RALEIGH, NC / ACCESSWIRE / February 19, 2020 / Innovate Biopharmaceuticals, Inc. (NASDAQ:INNT), a clinical-stage biotechnology company focused on developing novel therapeutics for autoimmune and inflammatory diseases, announced that three abstracts were accepted for poster presentations during the 2020 Digestive Disease Week (DDW) conference being held May 2-5, 2020, in Chicago, IL. These abstracts, separately authored with University of Maryland and North Carolina State University, continue to show larazotide’s ability to reduce permeability in various in-vitro models and to develop further understanding of tight junction regulation. These data further add to the accumulating body of knowledge on the complexity, selectivity and dynamic character of the intestinal epithelial barrier. Combining this evidence with the totality of work to date with larazotide, a consistent picture of restoring epithelial integrity is emerging, which could be further explored in patients with a variety of diseases involving antigen and bacterial end product trafficking across the gut-vascular barrier.

TitleEXPLORING THE MECHANISMS OF LARAZOTIDE IN THE REGULATION OF THE TIGHT JUNCTION BARRIER (Abstract # 3348407)

Date/Time: Saturday, May 2, 2020, from 12:30pm – 1:30pm CT
Poster Session Title: Epithelial Junctions and Barrier Function

TitleCHIRALLY-MODIFIED LARAZOTIDE COMPOUND ANALOG #6 FACILITATES RECOVERY OF ISCHEMIC-INJURED PORCINE JEJUNUM VIA RE-ASSEMBLY OF INTRAEPITHELIAL TIGHT JUNCTIONS (Abstract # 3353776)

Date/Time: May 5, 2020, from 12:30pm – 1:30pm CT
Poster Session Title: Molecular Mechanisms of Disease: Genetics, Signaling

TitleIN-VIVO ASSESSMENT OF CELIAC CLINICAL FORMULATION OF LARAZOTIDE IN THE PORCINE GASTROINTESTINAL TRACT USING A NOVEL ULTRAFILTRATION MODEL (Abstract # 3348457)

Date/Time: May 5, 2020, from 12:30pm – 1:30pm CT
Poster Session Title: Celiac Disease and Gluten Related Disorders Pathogenesis

Executive Chairman of Innovate, Sandeep Laumas, M.D., stated, “Targeting the restoration of the gut-vascular barrier is an emerging field with exciting data from GI diseases, oncology and neurodegenerative diseases. Further data elucidating the mechanism of action and novel formulations of larazotide such as the development of chirally different larazotide molecules helps us address larazotide’s pharmacology and bring the next generation of tight junction regulators for the treatment of autoimmune and inflammatory diseases.”

“This exciting new work from our collaboration with Innovate is revealing not only novel mechanisms by which larazotide repairs interepithelial tight junctions in injured, or leaky, intestines, but also how to pharmaceutically ensure optimal stability of the peptide therapeutic within the intestine,” remarked Anthony Blikslager, DVM, PhD, DACVS, AGAF, Professor of Equine Surgery and Gastroenterology at NC State University’s College of Veterinary Medicine.

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, ASH, 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. On October 7, 2019, the Company announced that it had entered into a definitive merger agreement pursuant to which the Company agreed to acquire all of the outstanding capital stock of privately held RDD in an all-stock transaction. This transaction includes a concurrent capital raise led by OrbiMed Advisors LLC. After closing the Company will change its name to 9 Meters Biopharma. The transaction is expected to close in the beginning of the second quarter of 2020, subject to the completion of the remaining closing conditions and receipt of regulatory approval in Israel.

For more information, please visit www.innovatebiopharma.com.

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. 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 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; 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 for the year ended December 31, 2018, and Quarterly Report on Form 10-Q 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.