FXR-314

May 21, 2024 -- Organovo Holdings, Inc. (Nasdaq:ONVO), a clinical stage biotechnology company focused on developing novel treatment approaches in inflammatory bowel disease (IBD) including ulcerative colitis, today announces data from a poster presented at Digestive Disease Week (DDW2024) demonstrating the potential of the Company’s lead clinical-stage compound, FXR314, in combination with tofacitinib for treating inflammatory bowel disease (IBD) using 3D models and preclinical models. DDW2024 is being held in Washington, D.C. May 18-21, 2024. The poster, titled, “Combination therapy of the FXR agonist FXR314 with tofacitinib in models of inflammatory bowel disease” was presented on Saturday May 18, 2024, in the session “Translational application of intestinal stem cells and organoid models”. “The study highlights the synergistic benefits of combining the Company’s non-steroidal, non-bile acid FXR agonist with the JAK inhibitor tofacitinib, supporting the notion of FXR314 as both a monotherapy and as part of a combination approach in IBD”, said Dr. Fabrice Piu, Vice President of Research and Development. Key findings showed that FXR314 and tofacitinib improved various measures of intestinal barrier function, inflammation, and fibrosis at optimal concentrations. Further, when combined at sub-efficacious concentrations, FXR314 and tofacitinib combined resulted in further improvements. In addition, FXR314 alone improved measures of colon health and colon histopathology similarly to approved IBD therapies tofacitinib and IL-12/23 antagonist. Investigators arrived at these conclusions in two ways. The first used Organovo’s proprietary 3D IBD model in which multiple cell types derived from IBD patients (either Crohn’s disease or ulcerative colitis) are co-cultured. The researchers evaluated target engagement, epithelial barrier integrity, inflammation, and fibrosis in the 3D IBD model using a variety of functional assays. The other approach made use of the adoptive T-Cell transfer model, a well-accepted and predictive preclinical model of colitis, where the effects of combining FXR314 and tofacitinib were evaluated in the treatment paradigm. “We believe strongly in the opportunity with regard to FXR314 in monotherapy in IBD, but these results, our first in a combination therapy approach, are exciting,” stated Keith Murphy, Organovo’s Executive Chairman. “These results further bolster our belief in the potential of FXR314 in combination therapy, and such data will be beneficial both in terms of potential combination development and also when used in monotherapy. As these data at the prestigious Digestive Disease Week show, FXR314 has the potential to show positive results in future clinical studies when used with an already prescribed biologic by improving a patient’s outcomes relative to the use of the already prescribed therapy alone.” Organovo is a clinical stage biotechnology company that is developing drugs that are demonstrated to be effective in three-dimensional (3D) human tissues as candidates for drug development. The company’s lead molecule, FXR314, is on the path for Phase 2 investigation in inflammatory bowel disease and has potential application in metabolic liver disease and oncology. The company has proprietary technology used to build 3D human tissues that mimic key aspects of native human tissue composition, architecture, function, and disease. For more information visit Organovo's website at www.organovo.com. The content above comes from the network. if any infringement, please contact us to modify.

SAN DIEGO, May 08, 2024 (GLOBE NEWSWIRE) -- Organovo Holdings, Inc. (Nasdaq: ONVO) (“Organovo” or the “Company”), a clinical stage biotechnology company focused on developing novel treatment approaches based on demonstration of clinical promise in three-dimensional (3D) human tissues, today announced the pricing of a public offering consisting of 6,562,500 shares of common stock (or pre-funded warrants in lieu thereof) and common warrants to purchase up to an aggregate of 6,562,500 shares of its common stock, at a combined public offering price per share of common stock and accompanying common warrant to purchase one share of common stock of $0.80 (or $0.799 per share subject to pre-funded warrants and accompanying warrant to purchase one share of common stock). The common warrants will have an exercise price of $0.80 per share, will be immediately exercisable upon issuance and have a term of five years after their original issuance date. The gross proceeds from the offering, before deducting placement agent fees and other offering expenses payable by the Company, are expected to be $5.25 million (excluding any proceeds that may be received upon the exercise of the common warrants). The offering is expected to close on or about May 13, 2024, subject to the satisfaction of customary closing conditions. JonesTrading Institutional Services LLC (“Jones”) is acting as the exclusive placement agent for the offering. The securities described above are being offered pursuant to a registration statement on Form S-1 (File No. 333-278668), as amended, that was declared effective by the Securities and Exchange Commission (the “SEC”) on May 8, 2024. The offering is being made only by means of a prospectus forming part of the effective registration statement relating to the offering. A preliminary prospectus relating to the offering has been filed with the SEC. Electronic copies of the final prospectus, when available, may be obtained on the SEC’s website at http://www.sec.gov and may also be obtained, when available, by contacting Jones, 325 Hudson Street, 6th Floor, New York, New York 10013, or by telephone at (212) 907-5332, or by email at JTCM@jonestrading.com. This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction. About Organovo Holdings, Inc. Organovo is a clinical stage biotechnology company that is developing drugs that are demonstrated to be effective in three-dimensional (3D) human tissues as candidates for drug development. The company’s lead molecule, FXR314, is on the path for Phase 2 investigation in inflammatory bowel disease and has applications in metabolic liver disease and oncology. The company has proprietary technology used to build 3D human tissues that mimic key aspects of native human tissue composition, architecture, function, and disease. Forward-Looking Statements Any statements contained in this press release that do not describe historical facts constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995, including statements with respect to the public offering. No assurance can be given that the public offering discussed above will be completed. Any forward-looking statements contained herein are based on current expectations but are subject to a number of risks and uncertainties, including, but not limited to, those risks and uncertainties related to market and other conditions and satisfaction of customary closing conditions related to the public offering. These risks and uncertainties and other factors are identified and described in more detail in the Company’s filings with the SEC, including its Annual Report on Form 10-K filed with the SEC on July 14, 2023, as such risk factors are updated in its most recently filed Quarterly Report on Form 10-Q filed with the SEC on February 8, 2024 and the Registration Statement on Form S-1 (File No. 333-278668), as amended. You should not place undue reliance on these forward-looking statements, which speak only as of the date that they were made. These cautionary statements should be considered with any written or oral forward-looking statements that the Company may issue in the future. Except as required by applicable law, including the securities laws of the United States, the Company does not intend to update any of the forward-looking statements to conform these statements to reflect actual results, later events, or circumstances or to reflect the occurrence of unanticipated events. For More Information: ContactCORE IRpr@coreir.com