INNT Innovate Biopharmaceuticals Inc

Innovate Biopharmaceuticals, Inc. (Nasdaq: INNT), a clinical stage biotechnology company focused on developing novel therapeutics for autoimmune and inflammatory diseases, announced today that larazotide acetate, a new class of medicine based on gut-restricted peptides which re-normalize the intestinal epithelial barrier and gut-liver axis, announced that three posters were presented on May 19 and 20, 2019 during the 2019 Digestive Disease Week (DDW) conference in San Diego, CA (Abstract Search).

Title:  Larazotide acetate prevents and rescues from ethanol-induced permeability changes in an in vitro model systemDate/Time: Saturday, May 18, 2019, 12:00pm – 2:00pm PTPoster Session Title: Alcoholic Liver Diseases – Clinical & Experimental Session Number: 6130Presentation Number: 1517

Title:  Larazotide protects the intestinal tight junction barrier during anoxia/reoxygenation injury via inhibition of myosin light chain kinaseDate/Time:  Sunday, May 19, 2019, 12:00pm – 2:00pm PTPoster Session Title: Epithelial Junctions and Barrier FunctionSession Number: 7020Presentation Number: 1019

Title:  Establishment and characterization of a leaky porcine jejunal cell line grown as a 2-dimensional monolayer using crypt culture media and their response to the tight junction agent larazotide acetate Date/Time:  Sunday, May 19, 2019, 12:00pm – 2:00pm PTPoster Session Title: Cell Biology, Biochem and Integrative PhysiologySession Number: 7015Presentation Number: 1017

Analyst Meeting will be held at 4:30pm ET today, May 20, 2019 to discuss NASH data and provide clinical updates.  To access the webcast, please visit the tab in the Events and Presentations section of Innovate’s investor relations website.

About Alcoholic Liver Diseases (ALD) and Alcoholic Steatohepatitis (ASH)Alcoholic liver disease (ALD) comprises a spectrum of conditions arising from excessive alcohol intake, from reversible fatty liver to acute alcoholic hepatitis, chronic fibrosis and cirrhosis and hepatocellular cancer (HCC). ALD, including progression from alcoholic fatty liver to alcoholic steatohepatitis (ASH) is characterized by hepatic inflammation which could lead to a chronic form leading to cirrhosis and, in some cases, hepatocellular carcinoma. In addition, severe ASH (with or without cirrhosis) can lead to alcoholic hepatitis, which is an acute clinical presentation of ALD that is associated with liver failure and high mortality. The Global Burden of Disease (GBD) project estimated there were more than 1.2 million deaths in 2016 due to cirrhosis and chronic liver disease, of which more than one quarter were related to alcoholic liver diseases.3 Patients with severe ASH may develop the acute clinical entity of alcoholic hepatitis, a disease characterized by jaundice and liver failure. Of the patients who survive alcoholic hepatitis, 70% will develop cirrhosis. By contrast, 40% of patients with alcoholic liver cirrhosis may also develop alcoholic hepatitis (acute-on-chronic disease), with very high mortality rates.1

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 StatementsThis 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 RelationsTel: +1-917-214-3514Email: jzimmons@innovatebiopharma.comwww.innovatebiopharma.com

References:1. Seitz H.K., Mueller S. (2010) Alcoholic Liver Disease. In: Clinical Hepatology. Springer, Berlin, Heidelberg (DOI: https://doi.org/10.1007/978-3-642-04519-6_34)