Latest news with #Organovo
Associated Press
02-04-2025
- Business
- Associated Press
Organovo Provides Update on Cash and Nasdaq Continued Listing Requirements
SAN DIEGO, April 02, 2025 (GLOBE NEWSWIRE) -- Organovo Holdings, Inc. (Nasdaq: ONVO) ('Organovo' or the 'Company'), a clinical stage biotechnology company focused on developing novel treatment approaches in inflammatory bowel disease (IBD), today reported preliminary unaudited cash for the fiscal year ending March 31, 2025, and net cash utilization results for the fiscal fourth quarter of 2025. The Company expects to release full fiscal second-quarter financial results the week of June 9-13, 2025. The Company also gave guidance that, as its common stock has been trading above the $1.00 minimum bid price required, it expects to meet the requirements for continued listing on the Nasdaq Capital Market should the closing price of its common stock remain at similar levels. Cash The Company's preliminary cash and cash equivalents balance was approximately $11.3 million as of the end of the fiscal year on March 31, 2025. Organovo's preliminary net cash utilization during the fourth quarter from January 1, 2025 to March 31, 2025 was approximately $2.0 - $2.2 million. The preliminary financial information presented in this press release is based on Organovo's current expectations and may be adjusted as a result of, among other things, the completion of customary annual audit procedures. Nasdaq Compliance Update The Company further clarified it expects to meet all requirements for continued listing on the Nasdaq Capital Market. The Company's common stock has closed above the $1.00 minimum bid price requirement since March 21, 2025 and believes it has met the minimum stockholder equity requirements of continued listing, pending Nasdaq confirmation. Nasdaq requires a minimum of 10 consecutive trading days where the stock closes at a minimum bid price of $1.00, and the Company has closed above $1.00 since March 21, 2025. Potential Receipt of Future Milestone Payments Although the Company does not control the clinical development of products for which it may receive milestone payments, it currently reasonably expects to receive a $5M milestone payment within the next 12 months associated with the anticipated start of a Phase 2 clinical trial for the FXR agonist that it recently sold. In connection with the sale of the FXR agonist, the Company may receive future milestones of up to an aggregate of $50M, which is inclusive of the $5M milestone payment that would be received upon the commencement of a Phase 2 clinical trial. About Organovo 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 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 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. Any forward-looking statements contained herein are based on current expectations but are subject to a number of risks and uncertainties, including the completion of the audit of its financial statements, general economic and market factors, and global economic and marketplace uncertainties. Forward-looking statements include statements regarding the Company's expectation that it will meet the requirements for continued listing on the Nasdaq Capital Market, the Company's expectations regarding its cash and cash equivalents balance and net cash utilization and the potential receipt of any milestone payments associated with the FXR agonist, . Such forward-looking statements are not guarantees of performance and actual actions or events could differ materially from those contained in such statements. For example, there can be no assurance that the Company will meet the bid price requirement or the minimum value of stockholders' equity requirement during any compliance period or otherwise in the future, that the Company will otherwise meet Nasdaq compliance standards, or that the Company can ultimately meet or maintain compliance with applicable Nasdaq continued listing requirements. 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 May 31, 2024, as such risk factors are updated in its most recently filed Quarterly Report on Form 10-Q filed with the SEC on February 19, 2025. 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. Investor Relations
Yahoo
25-03-2025
- Business
- Yahoo
Organovo Announces Close of the Sale of FXR Program to Eli Lilly and Company
SAN DIEGO, March 25, 2025 (GLOBE NEWSWIRE) -- Organovo Holdings, Inc. (Nasdaq:ONVO) ('Organovo' or the 'Company'), a clinical stage biotechnology company focused on developing novel treatment approaches in inflammatory bowel disease (IBD), today announced the successful close of the sale of its FXR program, including lead asset FXR314, to Eli Lilly and Company (NYSE:LLY) ('Lilly'). The transaction was completed on March 25, 2025. With the closing, Organovo receives an upfront payment, with future milestones to be paid as FXR314 hits key regulatory and commercial milestones. Lilly is acquiring all commercial and intellectual property rights to Organovo's FXR program for worldwide development and will be responsible for all future clinical development. About OrganovoOrganovo 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 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 Forward Looking StatementsAny 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. Any forward-looking statements contained herein are based on current expectations but are subject to a number of risks and uncertainties. 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 May 31, 2024, as such risk factors are updated in its most recently filed Quarterly Report on Form 10-Q filed with the SEC on February 19, 2025 and the Registration Statement on Form S-1 (File No. 333-282841). 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. Contact Investor Relationsinfo@ Source: Organovo, in to access your portfolio
Associated Press
06-03-2025
- Business
- Associated Press
Organovo Announces the Issuance of Additional Shares in Conjunction with Warrant Exercises
SAN DIEGO, March 06, 2025 (GLOBE NEWSWIRE) -- Organovo Holdings, Inc. (Nasdaq:ONVO) ('Organovo' or the 'Company'), a clinical stage biotechnology company focused on developing novel treatment approaches in inflammatory bowel disease (IBD) today announced it has issued additional shares in conjunction with warrant exercises by investors and at-the-market stock sales. An additional 2,967,144 shares of common stock of the Company have been issued. The shares of common stock issuable upon exercise of the outstanding warrants were registered pursuant to a registration statements that was declared effective on May 8, 2024. The aggregate gross proceeds from the exercise of the existing warrants and at-the-market stock sales are expected to total approximately $2.3 million, before deducting financial advisory fees and commissions. After giving effect to the issuance of these additional shares, the Company has 20,421,617 shares of outstanding common stock. About Organovo 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 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 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. Any forward-looking statements contained herein are based on current expectations but are subject to a number of risks and uncertainties. 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 May 31, 2024, as such risk factors are updated in its most recently filed Quarterly Report on Form 10-Q filed with the SEC on February 19, 2025. 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. Contact
Yahoo
28-02-2025
- Business
- Yahoo
Organovo's FXR Program, including FXR314, to Be Acquired by Eli Lilly and Company
SAN DIEGO, Feb. 25, 2025 (GLOBE NEWSWIRE) -- Organovo Holdings, Inc. (Nasdaq:ONVO) ('Organovo' or the 'Company'), a clinical stage biotechnology company focused on developing novel treatment approaches in inflammatory bowel disease (IBD) today announced that Eli Lilly and Company (NYSE:LLY) ('Lilly') will acquire Organovo's FXR program, including its lead asset, FXR314. 'This is a significant milestone for our efforts to advance medicines for IBD using insights from our proprietary 3D human tissue models,' said Keith Murphy, Executive Chairman. 'We are excited to deliver FXR314 and our FXR program to Lilly for Phase 2 and further development. Their world-class development excellence and dedication to delivering for patients will provide an excellent pathway for FXR314 success, and we are pleased to have this opportunity to deliver for patients.' Under this transaction, Organovo will receive an upfront payment as well as milestones to be paid as FXR314 achieves key regulatory and commercial milestones. Lilly is acquiring all commercial and intellectual property rights to Organovo's FXR program for worldwide development. About OrganovoOrganovo 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 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 Forward Looking StatementsAny 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. Any forward-looking statements contained herein are based on current expectations but are subject to a number of risks and uncertainties. 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 May 31, 2024, as such risk factors are updated in its most recently filed Quarterly Report on Form 10-Q filed with the SEC on February 19, 2025 and the Registration Statement on Form S-1 (File No. 333-282841). 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. ContactCORE IRpr@ Source: Organovo, in to access your portfolio
