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Organovo Provides Update on Cash and Nasdaq Continued Listing Requirements

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Organovo Holdings (NASDAQ: ONVO), a clinical stage biotechnology company focused on IBD treatments, has provided a financial and listing status update. The company reported preliminary unaudited cash and cash equivalents of approximately $11.3 million as of March 31, 2025, with net cash utilization of $2.0-$2.2 million in Q4 FY2025.

The company expects to maintain its Nasdaq Capital Market listing as its stock has traded above the required $1.00 minimum bid price since March 21, 2025. Full fiscal Q2 results are expected between June 9-13, 2025.

Additionally, Organovo anticipates receiving a $5 million milestone payment within the next 12 months upon the start of a Phase 2 clinical trial for its recently sold FXR agonist. The company could receive up to $50 million in total future milestone payments related to this asset.

Organovo Holdings (NASDAQ: ONVO), un'azienda biotecnologica in fase clinica focalizzata sui trattamenti per le IBD, ha fornito un aggiornamento sulla situazione finanziaria e di quotazione. L'azienda ha riportato una liquidità preliminare non verificata di circa $11,3 milioni al 31 marzo 2025, con un utilizzo netto di liquidità di $2,0-$2,2 milioni nel quarto trimestre dell'anno fiscale 2025.

L'azienda si aspetta di mantenere la sua quotazione nel mercato Nasdaq Capital, poiché le sue azioni sono state scambiate a un prezzo superiore al minimo richiesto di $1,00 dal 21 marzo 2025. I risultati finanziari completi del secondo trimestre sono attesi tra il 9 e il 13 giugno 2025.

Inoltre, Organovo prevede di ricevere un pagamento di milestone di $5 milioni entro i prossimi 12 mesi all'inizio di uno studio clinico di Fase 2 per il suo recentemente venduto agonista FXR. L'azienda potrebbe ricevere fino a $50 milioni in pagamenti di milestone futuri totali relativi a questo asset.

Organovo Holdings (NASDAQ: ONVO), una empresa de biotecnología en etapa clínica enfocada en tratamientos para IBD, ha proporcionado una actualización sobre su situación financiera y de cotización. La compañía reportó una liquidez preliminar no auditada de aproximadamente $11.3 millones al 31 de marzo de 2025, con una utilización neta de efectivo de $2.0-$2.2 millones en el cuarto trimestre del año fiscal 2025.

La empresa espera mantener su cotización en el Nasdaq Capital Market, ya que sus acciones han cotizado por encima del precio mínimo requerido de $1.00 desde el 21 de marzo de 2025. Se esperan los resultados completos del segundo trimestre fiscal entre el 9 y el 13 de junio de 2025.

Además, Organovo anticipa recibir un pago por hitos de $5 millones dentro de los próximos 12 meses al inicio de un ensayo clínico de Fase 2 para su agonista FXR recientemente vendido. La compañía podría recibir hasta $50 millones en total de pagos por hitos futuros relacionados con este activo.

Organovo Holdings (NASDAQ: ONVO), 염증성 장질환(IBD) 치료에 중점을 둔 임상 단계의 생명공학 회사가 재무 및 상장 상태 업데이트를 제공했습니다. 회사는 2025년 3월 31일 기준으로 약 $11.3 백만의 초기 감사되지 않은 현금 및 현금성 자산을 보고했으며, 2025 회계연도 4분기 동안 순 현금 사용량은 $2.0-$2.2 백만으로 나타났습니다.

회사는 2025년 3월 21일부터 주가가 요구되는 최소 입찰가인 $1.00 이상으로 거래되고 있어 Nasdaq Capital Market의 상장을 유지할 것으로 예상하고 있습니다. 전체 회계 연도 2분기 결과는 2025년 6월 9일부터 13일 사이에 발표될 예정입니다.

또한, Organovo는 최근 판매된 FXR 작용제에 대한 2상 임상 시험 시작 시점에 $5 백만의 이정표 지급을 받을 것으로 예상하고 있습니다. 이 자산과 관련하여 회사는 총 $50 백만의 미래 이정표 지급을 받을 수 있습니다.

Organovo Holdings (NASDAQ: ONVO), une entreprise de biotechnologie en phase clinique axée sur les traitements des IBD, a fourni une mise à jour sur sa situation financière et son statut de cotation. La société a rapporté une liquidité préliminaire non vérifiée d'environ $11,3 millions au 31 mars 2025, avec une utilisation nette de liquidités de $2,0-$2,2 millions au quatrième trimestre de l'exercice 2025.

L'entreprise s'attend à maintenir sa cotation sur le Nasdaq Capital Market, car ses actions se sont échangées au-dessus du prix d'enchère minimum requis de $1,00 depuis le 21 mars 2025. Les résultats financiers complets du deuxième trimestre fiscal sont attendus entre le 9 et le 13 juin 2025.

De plus, Organovo prévoit de recevoir un paiement d'étape de $5 millions au cours des 12 prochains mois lors du début d'un essai clinique de Phase 2 pour son agoniste FXR récemment vendu. La société pourrait recevoir jusqu'à $50 millions de paiements d'étape futurs liés à cet actif.

Organovo Holdings (NASDAQ: ONVO), ein biopharmazeutisches Unternehmen in der klinischen Phase, das sich auf IBD-Behandlungen konzentriert, hat ein Update zu seiner finanziellen Lage und dem Listing-Status gegeben. Das Unternehmen berichtete über vorläufige, nicht geprüfte Zahlungsmittel und Zahlungsmitteläquivalente von etwa $11,3 Millionen zum 31. März 2025, mit einer Nettobarverwendung von $2,0-$2,2 Millionen im vierten Quartal des Geschäftsjahres 2025.

Das Unternehmen erwartet, seine Nasdaq Capital Market-Listung aufrechtzuerhalten, da die Aktien seit dem 21. März 2025 über dem erforderlichen Mindestgebotspreis von $1,00 gehandelt werden. Die vollständigen Ergebnisse des zweiten Geschäftsjahresquartals werden zwischen dem 9. und 13. Juni 2025 erwartet.

Darüber hinaus rechnet Organovo damit, innerhalb der nächsten 12 Monate eine Meilensteinzahlung von $5 Millionen zu erhalten, sobald eine Phase-2-Studie für seinen kürzlich verkauften FXR-Agonisten beginnt. Das Unternehmen könnte insgesamt bis zu $50 Millionen an zukünftigen Meilensteinzahlungen im Zusammenhang mit diesem Vermögenswert erhalten.

Positive
  • Strong cash position of $11.3M as of March 31, 2025
  • Expected $5M milestone payment within 12 months
  • Potential future milestone payments up to $50M
  • Compliance with Nasdaq listing requirements
Negative
  • Quarterly cash burn of $2.0-$2.2M in Q4 FY2025
  • No control over clinical development timing for milestone payments
  • Recent trading history suggests previous listing compliance issues

Insights

Organovo's financial update reveals a $11.3 million cash position as of March 31, 2025, with a quarterly burn rate of $2.0-2.2 million. This provides approximately 5 quarters of runway at current spending levels - a critical metric for clinical-stage biotechs without revenue.

The company's compliance with Nasdaq listing requirements is significant for maintaining institutional investor access and capital market opportunities. Avoiding delisting removes a substantial risk factor that often triggers forced selling and liquidity constraints for small-cap biotechs.

The expected $5 million milestone payment within 12 months would extend their operational runway by more than two additional quarters at current spending rates. This non-dilutive funding source is particularly valuable given the company's small $4 million market capitalization, representing over 100% of their current market value.

The potential for up to $50 million in total milestone payments from their divested FXR agonist asset represents a significant opportunity relative to Organovo's current valuation. However, investors should note these payments depend on clinical development progress controlled by the asset's new owner.

While this update demonstrates improved financial stability, the lack of specific details regarding the company's own inflammatory bowel disease (IBD) clinical programs represents an information gap for assessing long-term value creation potential.

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 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, 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. 

Contact
Investor Relations
info@organovo.com

Source: Organovo, Inc.


FAQ

What is Organovo's (ONVO) current cash position as of March 31, 2025?

Organovo reported preliminary unaudited cash and cash equivalents of approximately $11.3 million as of March 31, 2025.

How much cash did Organovo (ONVO) use in Q4 FY2025?

Organovo's preliminary net cash utilization during Q4 FY2025 (January 1 to March 31, 2025) was approximately $2.0-$2.2 million.

What milestone payments can Organovo (ONVO) expect from its FXR agonist sale?

Organovo expects a $5M milestone payment within 12 months for the Phase 2 trial start, with potential future milestones totaling up to $50M.

Is Organovo (ONVO) compliant with Nasdaq listing requirements?

Yes, Organovo expects to meet all Nasdaq Capital Market listing requirements, with its stock trading above $1.00 since March 21, 2025.
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Biotechnology
Biological Products, (no Disgnostic Substances)
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United States
SAN DIEGO