Organovo Provides Business Update
Organovo Holdings (NASDAQ:ONVO), a clinical stage biotechnology company focused on inflammatory bowel disease (IBD), provided a business update following the sale of its FXR Program to Lilly (NYSE:LLY). The company has received upfront payments and expects future milestone payments from this deal.
The company anticipates reduced expenditures in the coming year due to the elimination of FXR314-related costs. With current capital and excluding potential milestone payments, Organovo expects to maintain operations through FY2026. The company plans to report FY2025 financials around June 6-10, 2025.
Organovo utilizes 3D human cellular models of Crohn's disease and ulcerative colitis to evaluate therapeutic opportunities. In 2024, FXR314 showed promising results in IBD treatment, demonstrating improved epithelial barrier function and fibrotic activity in ulcerative colitis, as well as synergistic benefits when combined with JAK inhibitors. The drug also showed potential in treating liver fibrosis in Phase 2 MASH trials.
Organovo Holdings (NASDAQ:ONVO), una società biotecnologica in fase clinica focalizzata sulle malattie infiammatorie intestinali (IBD), ha fornito un aggiornamento aziendale dopo la vendita del suo Programma FXR a Lilly (NYSE:LLY). L'azienda ha ricevuto pagamenti anticipati e si aspetta futuri pagamenti legati a traguardi da questo accordo.
L'azienda prevede una riduzione delle spese nell'anno a venire grazie all'eliminazione dei costi legati a FXR314. Con il capitale attuale e escludendo i potenziali pagamenti legati ai traguardi, Organovo prevede di mantenere le operazioni fino all'esercizio 2026. L'azienda intende riportare i risultati finanziari dell'esercizio 2025 intorno al 6-10 giugno 2025.
Organovo utilizza modelli cellulari umani 3D della malattia di Crohn e della colite ulcerosa per valutare opportunità terapeutiche. Nel 2024, FXR314 ha mostrato risultati promettenti nel trattamento dell'IBD, dimostrando un miglioramento della funzione della barriera epiteliale e dell'attività fibrotica nella colite ulcerosa, oltre a benefici sinergici quando combinato con inibitori JAK. Il farmaco ha anche mostrato potenziale nel trattamento della fibrosi epatica nei trial di fase 2 MASH.
Organovo Holdings (NASDAQ:ONVO), una empresa biotecnológica en etapa clínica centrada en la enfermedad inflamatoria intestinal (IBD), proporcionó una actualización empresarial tras la venta de su Programa FXR a Lilly (NYSE:LLY). La compañía ha recibido pagos iniciales y espera futuros pagos por hitos de este acuerdo.
La empresa anticipa una reducción de gastos en el próximo año debido a la eliminación de los costos relacionados con FXR314. Con el capital actual y excluyendo los posibles pagos por hitos, Organovo espera mantener sus operaciones hasta el año fiscal 2026. La compañía planea informar sobre los resultados financieros del año fiscal 2025 alrededor del 6-10 de junio de 2025.
Organovo utiliza modelos celulares humanos 3D de la enfermedad de Crohn y colitis ulcerosa para evaluar oportunidades terapéuticas. En 2024, FXR314 mostró resultados prometedores en el tratamiento de la IBD, demostrando una mejora en la función de la barrera epitelial y la actividad fibrotica en la colitis ulcerosa, así como beneficios sinérgicos cuando se combina con inhibidores de JAK. El fármaco también mostró potencial en el tratamiento de la fibrosis hepática en ensayos de fase 2 MASH.
Organovo Holdings (NASDAQ:ONVO), 염증성 장질환(IBD)에 집중하는 임상 단계의 생명공학 회사가 Lilly(NYSE:LLY)에게 FXR 프로그램을 매각한 후 사업 업데이트를 제공했습니다. 회사는 선불금을 수령했으며, 이 거래로부터 향후 이정표 지급금을 기대하고 있습니다.
회사는 FXR314 관련 비용의 제거로 인해 내년에 지출이 줄어들 것으로 예상하고 있습니다. 현재 자본과 잠재적인 이정표 지급금을 제외하고, Organovo는 2026 회계연도까지 운영을 유지할 것으로 예상합니다. 회사는 2025 회계연도의 재무 보고를 2025년 6월 6일부터 10일 사이에 할 계획입니다.
Organovo는 3D 인간 세포 모델을 사용하여 크론병 및 궤양성 대장염의 치료 기회를 평가합니다. 2024년에 FXR314는 IBD 치료에서 유망한 결과를 보여주었으며, 궤양성 대장염에서 상피 장벽 기능과 섬유화 활동이 개선되었고, JAK 억제제와 함께 사용했을 때 시너지 효과를 나타냈습니다. 이 약물은 2상 MASH 시험에서 간 섬유증 치료에도 잠재력을 보였습니다.
Organovo Holdings (NASDAQ:ONVO), une entreprise de biotechnologie en phase clinique axée sur les maladies inflammatoires de l'intestin (IBD), a fourni une mise à jour commerciale suite à la vente de son programme FXR à Lilly (NYSE:LLY). L'entreprise a reçu des paiements initiaux et s'attend à des paiements futurs liés à des jalons dans le cadre de cet accord.
L'entreprise anticipe une réduction des dépenses dans l'année à venir grâce à l'élimination des coûts liés à FXR314. Avec le capital actuel et en excluant les paiements potentiels liés aux jalons, Organovo s'attend à maintenir ses opérations jusqu'à l'exercice 2026. L'entreprise prévoit de publier les résultats financiers de l'exercice 2025 vers le 6-10 juin 2025.
Organovo utilise des modèles cellulaires humains 3D de la maladie de Crohn et de la colite ulcéreuse pour évaluer les opportunités thérapeutiques. En 2024, FXR314 a montré des résultats prometteurs dans le traitement de l'IBD, démontrant une amélioration de la fonction de barrière épithéliale et de l'activité fibrotique dans la colite ulcéreuse, ainsi que des bénéfices synergiques lorsqu'il est combiné avec des inhibiteurs de JAK. Le médicament a également montré un potentiel dans le traitement de la fibrose hépatique lors des essais de phase 2 MASH.
Organovo Holdings (NASDAQ:ONVO), ein biopharmazeutisches Unternehmen in der klinischen Phase, das sich auf entzündliche Darmerkrankungen (IBD) konzentriert, hat ein Geschäftsupdate nach dem Verkauf seines FXR-Programms an Lilly (NYSE:LLY) bereitgestellt. Das Unternehmen hat Vorauszahlungen erhalten und erwartet zukünftige Meilensteinzahlungen aus diesem Deal.
Das Unternehmen rechnet mit reduzierten Ausgaben im kommenden Jahr aufgrund der Eliminierung der Kosten im Zusammenhang mit FXR314. Mit dem aktuellen Kapital und ohne potenzielle Meilensteinzahlungen erwartet Organovo, seine Aktivitäten bis zum Geschäftsjahr 2026 aufrechtzuerhalten. Das Unternehmen plant, die Finanzzahlen für das Geschäftsjahr 2025 etwa zwischen dem 6. und 10. Juni 2025 zu veröffentlichen.
Organovo nutzt 3D menschliche Zellmodelle der Morbus Crohn und Colitis ulcerosa, um therapeutische Möglichkeiten zu bewerten. Im Jahr 2024 zeigte FXR314 vielversprechende Ergebnisse in der Behandlung von IBD und verbesserte die epithelialen Barrierefunktionen sowie die fibrotische Aktivität bei Colitis ulcerosa und zeigte synergistische Vorteile in Kombination mit JAK-Inhibitoren. Das Medikament zeigte auch Potenzial zur Behandlung von Leberfibrose in Phase-2-MASH-Studien.
- Sale of FXR Program to Lilly provides immediate upfront payments and potential future milestone payments
- Reduced operational expenses expected due to elimination of FXR314-related costs
- Sufficient capital to fund operations through FY2026
- Successful clinical results for FXR314 in IBD and MASH trials during 2024
- Divestment of promising FXR Program may impact future revenue potential
Insights
Organovo's strategic sale of its FXR Program to Lilly represents a significant financial transformation for this micro-cap biotech. The transaction provides immediate capital through upfront payments while establishing a pathway for future milestone revenue as FXR314 advances through clinical development under Lilly's stewardship. This deal structure is particularly advantageous for Organovo's
The company's operational streamlining eliminates expenses related to clinical advancement, regulatory interactions, drug manufacturing, and IP protection for the FXR program. This reduction in cash burn, combined with previously secured capital through warrant exercises and equity sales, significantly strengthens Organovo's financial position.
Looking forward, Organovo maintains its valuable 3D human cellular IBD models, which have already demonstrated their utility through the successful development and monetization of FXR314. These proprietary models position the company to identify additional IBD therapeutic candidates with potentially higher probabilities of clinical success – essentially functioning as a specialized drug discovery engine that can generate partnerable assets. The clear demonstration of value with the FXR program creates a repeatable business model: identify promising candidates through their platform, develop to proof-of-concept, then partner or sell to larger pharmaceutical companies.
SAN DIEGO, March 27, 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 provided a business update.
With the closing of the sale of its FXR Program to Lilly (NYSE:LLY), Organovo has received upfront payments and anticipates future milestone payments. When combined with funding from previously reported warrant exercises and additional monies raised through equity sales, the company believes it is well-positioned to repeat the FXR314 success with another IBD opportunity. The company expects an overall decrease in expenditures in the coming year, due to the elimination of costs related to pushing FXR314 into and through the clinic, as well as from eliminating spending relating to regulatory issues, drug supply, intellectual property, and other aspects of the FXR program. Organovo now expects to establish an operating cadence that leverages existing capital at a rate sufficient to push through the end of FY2026. For clarity, capital from future milestone payments expected as FXR314 advances in the clinic would be in addition to this, allowing for longer runway or increased expenditures. The Company expects to report its full year financials for the fiscal year ended March 31, 2025, on or about June 6-10, 2025.
Organovo’s 3D human cellular models of both Crohn’s disease and ulcerative colitis are used by the company to evaluate therapeutic opportunities. Organovo believes that targets and therapies that it finds attractive based on predictive date from these models, made with primary cells from IBD patients, have a greater chance of success in clinical trials. Stated Organovo Executive Chairman Keith Murphy, “As we demonstrated in 2024 with FXR, we can position an asset for a significant return to investors using our 3D human cellular models of IBD. We expect to tailor our going forward business plan to leverage our newly replenished capital levels to pursue such opportunities.”
In 2024, Organovo demonstrated the strong potential of FXR314 in IBD, with data that showed strong performance of FXR314 in 3D human cellular models. In ulcerative colitis, FXR314 broadly improved measures of epithelial barrier function and fibrotic activity in all donors, in data presented at the Crohn’s and Colitis Congress (January 25-27, Las Vegas, NV). In further studies in data presented at Digestive Disease Week (May 18-21, Washington DC), FXR314 demonstrated a combination therapeutic synergistic benefit when paired with an approved Janus kinase (JAK) inhibitor. In November, the liver fibrosis treatment potential of FXR314 was highlighted in a presentation by Dr. Eric Lawitz of Phase 2 results in Metabolic Dysfunction-Associated Steatohepatitis (MASH), at the Liver Meeting in San Diego (November 15-19, San Diego, CA).
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.
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