Organovo’s FXR Program, including FXR314, to Be Acquired by Eli Lilly and Company

Rhea-AI Summary

Organovo Holdings (Nasdaq: ONVO) has announced that Eli Lilly and Company (NYSE: LLY) will acquire its FXR program, including lead asset FXR314. This represents a significant milestone for Organovo's efforts to advance medicines for inflammatory bowel disease (IBD) using insights from their proprietary 3D human tissue models.

Under the transaction terms, Organovo will receive an upfront payment and additional milestone payments as FXR314 achieves key regulatory and commercial targets. Lilly is acquiring all commercial and intellectual property rights to Organovo's FXR program for worldwide development.

Keith Murphy, Executive Chairman of Organovo, expressed excitement about delivering FXR314 and the FXR program to Lilly for Phase 2 and further development, citing Lilly's world-class development excellence and dedication to patients as providing an excellent pathway for FXR314's success.

Positive

• Upfront payment to be received by ONVO
• Future milestone payments tied to regulatory and commercial achievements
• No further development costs for ONVO as Lilly takes over Phase 2 and beyond
• Partnership with major pharmaceutical company (Lilly) validates ONVO's technology
• ONVO retains its core 3D tissue platform technology while monetizing the FXR program

Negative

• ONVO giving up all commercial rights to potentially valuable FXR program
• Loss of future revenue potential if FXR314 becomes commercially successful
• Specific financial terms not disclosed, making value assessment difficult
• Reduces ONVO's pipeline of drug candidates

Insights

Financial Analyst

Eli Lilly's acquisition of Organovo's FXR program represents a potentially transformative transaction for the micro-cap biotech. With Organovo's market cap at just $5.6 million, even a modest upfront payment from pharmaceutical giant Lilly could significantly strengthen the company's financial position and extend its cash runway.

While financial terms weren't disclosed, this deal structure - featuring an upfront payment plus regulatory and commercial milestones - is particularly valuable for Organovo shareholders for three key reasons:

• It provides immediate non-dilutive capital, addressing near-term funding needs without issuing additional shares
• It transfers the substantial clinical development costs and risks of the FXR program to Lilly
• It maintains Organovo's economic exposure to FXR314's potential long-term success through milestone payments

The transaction validates Organovo's proprietary 3D human tissue modeling platform technology, which has been the company's distinguishing scientific approach. This external validation from a top-tier pharmaceutical company significantly de-risks the platform's perceived value.

For context, FXR (Farnesoid X Receptor) agonists represent a promising therapeutic approach for inflammatory bowel diseases like ulcerative colitis and Crohn's disease. The global IBD treatment market exceeds $20 billion annually with significant unmet needs remaining. FXR314 appears to be completing Phase 1 development, with Lilly now taking responsibility for Phase 2 trials and beyond.

Looking forward, investors should focus on:

• Organovo's strategy for its remaining pipeline assets and whether it will further leverage its 3D tissue platform for additional partnerships
• The company's cash position post-transaction and projected runway
• Any disclosed timeline for potential milestone achievements

For Lilly, this acquisition aligns with its expanding gastroenterology portfolio and broader strategy of supplementing internal R&D with external innovation. The relatively small acquisition (for Lilly) represents a calculated bet on a novel mechanism for IBD with financial risk given Organovo's size.

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 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 www.organovo.com.

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 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
CORE IR
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Source: Organovo, Inc.

FAQ

What is the financial value of Eli Lilly's acquisition of Organovo's FXR program?

The press release doesn't disclose the specific financial value of the acquisition. Organovo will receive an upfront payment plus milestone payments tied to FXR314's regulatory and commercial achievements.

What stage of development is Organovo's FXR314 drug currently in?

FXR314 appears to be completing Phase 1, as the announcement mentions Lilly will take over for 'Phase 2 and further development.'

How might the Eli Lilly acquisition impact ONVO stock?

The acquisition could positively impact ONVO stock as it provides validation of their technology, immediate capital from the upfront payment, and potential future milestone payments without further development costs.

What therapeutic area does Organovo's FXR314 target?

FXR314 targets inflammatory bowel disease (IBD), as stated in the press release.

Will Organovo retain any rights to FXR314 after the acquisition?

No, Lilly is acquiring all commercial and intellectual property rights to Organovo's FXR program for worldwide development.

What technology did Organovo use to develop FXR314?

Organovo developed FXR314 using insights from their proprietary 3D human tissue models.