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Organovo Announces Close of the Sale of FXR Program to Eli Lilly and Company

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Organovo Holdings (NASDAQ:ONVO) has successfully completed the sale of its FXR program, including lead asset FXR314, to Eli Lilly and Company (NYSE:LLY) on March 25, 2025. The transaction includes an upfront payment to Organovo, with additional milestone payments tied to FXR314's regulatory and commercial achievements.

As part of the deal, Lilly acquires worldwide development rights and all commercial and intellectual property rights to Organovo's FXR program. Lilly will assume responsibility for all future clinical development of the program.

Organovo Holdings (NASDAQ:ONVO) ha completato con successo la vendita del suo programma FXR, incluso l'asset principale FXR314, a Eli Lilly and Company (NYSE:LLY) il 25 marzo 2025. La transazione prevede un pagamento iniziale a Organovo, con ulteriori pagamenti legati a traguardi normativi e commerciali di FXR314.

Come parte dell'accordo, Lilly acquisisce i diritti di sviluppo a livello mondiale e tutti i diritti commerciali e di proprietà intellettuale relativi al programma FXR di Organovo. Lilly si assumerà la responsabilità di tutto lo sviluppo clinico futuro del programma.

Organovo Holdings (NASDAQ:ONVO) ha completado con éxito la venta de su programa FXR, incluido el activo principal FXR314, a Eli Lilly and Company (NYSE:LLY) el 25 de marzo de 2025. La transacción incluye un pago inicial a Organovo, con pagos adicionales vinculados a los logros regulatorios y comerciales de FXR314.

Como parte del acuerdo, Lilly adquiere los derechos de desarrollo a nivel mundial y todos los derechos comerciales e intelectuales del programa FXR de Organovo. Lilly asumirá la responsabilidad de todo el desarrollo clínico futuro del programa.

Organovo Holdings (NASDAQ:ONVO)는 2025년 3월 25일 Eli Lilly and Company (NYSE:LLY)에 FXR 프로그램, 주요 자산 FXR314의 판매를 성공적으로 완료했습니다. 이 거래에는 Organovo에 대한 선불 지급이 포함되며, FXR314의 규제 및 상업적 성과에 따라 추가 마일스톤 지급이 있습니다.

이번 계약의 일환으로 Lilly는 Organovo의 FXR 프로그램에 대한 전 세계 개발 권리와 모든 상업적 및 지적 재산권을 인수합니다. Lilly는 프로그램의 모든 향후 임상 개발에 대한 책임을 집니다.

Organovo Holdings (NASDAQ:ONVO) a réussi à finaliser la vente de son programme FXR, y compris l'actif principal FXR314, à Eli Lilly and Company (NYSE:LLY) le 25 mars 2025. La transaction comprend un paiement initial à Organovo, avec des paiements supplémentaires liés aux réalisations réglementaires et commerciales de FXR314.

Dans le cadre de l'accord, Lilly acquiert les droits de développement mondiaux ainsi que tous les droits commerciaux et de propriété intellectuelle liés au programme FXR d'Organovo. Lilly assumera la responsabilité de tout le développement clinique futur du programme.

Organovo Holdings (NASDAQ:ONVO) hat am 25. März 2025 erfolgreich den Verkauf seines FXR-Programms, einschließlich des Hauptassets FXR314, an Eli Lilly and Company (NYSE:LLY) abgeschlossen. Die Transaktion umfasst eine Vorauszahlung an Organovo sowie zusätzliche Meilensteinzahlungen, die an die regulatorischen und kommerziellen Erfolge von FXR314 gebunden sind.

Im Rahmen des Deals erwirbt Lilly die weltweiten Entwicklungsrechte sowie alle kommerziellen und geistigen Eigentumsrechte am FXR-Programm von Organovo. Lilly wird die Verantwortung für die gesamte zukünftige klinische Entwicklung des Programms übernehmen.

Positive
  • Immediate cash infusion through upfront payment
  • Potential future revenue through milestone payments
  • Transfer of development costs and risks to Eli Lilly
Negative
  • Loss of potential future revenues from FXR program if successful
  • Reduction in company's drug development pipeline

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 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

Investor Relations
info@organovo.com

Source: Organovo, Inc.


FAQ

What are the financial terms of Organovo's (ONVO) FXR program sale to Eli Lilly?

The deal includes an upfront payment to Organovo with additional payments tied to regulatory and commercial milestones for FXR314.

What assets did Eli Lilly acquire from Organovo (ONVO) in the March 2025 deal?

Eli Lilly acquired Organovo's FXR program, including lead asset FXR314, along with worldwide development rights and all commercial and intellectual property rights.

When did Organovo (ONVO) complete the sale of its FXR program to Eli Lilly?

The sale was completed on March 25, 2025.

Who will be responsible for the future development of Organovo's FXR314 asset?

Eli Lilly will be responsible for all future clinical development of the FXR program.
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Biotechnology
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