Organovo Announces Appointment of Norman Staskey as Chief Financial Officer
Organovo Holdings (NASDAQ:ONVO) has appointed Norman Staskey as Chief Financial Officer. Staskey, who has worked at Danforth Advisors since 2021, brings over 25 years of experience in capital markets and M&A transactions, including his role as Managing Director in EY's national transactions practice.
The company recently presented Phase 2 results for its lead drug FXR314 in MASH treatment, showing statistically significant reduction in liver fat content with lower pruritus rates compared to other FXR agonists. The study involved 214 patients. Additionally, 2024 data demonstrated FXR314's potential in IBD treatment, showing improved epithelial barrier function and fibrotic activity in ulcerative colitis models, as well as synergistic benefits when combined with JAK inhibitors.
Organovo anticipates a Phase 2 study to demonstrate FXR314's effectiveness in moderate to severe ulcerative colitis, with potential development as both monotherapy and combination therapy.
Organovo Holdings (NASDAQ:ONVO) ha nominato Norman Staskey come Chief Financial Officer. Staskey, che ha lavorato presso Danforth Advisors dal 2021, porta con sé oltre 25 anni di esperienza nei mercati dei capitali e nelle transazioni di M&A, incluso il suo ruolo come Managing Director nella pratica nazionale delle transazioni di EY.
L'azienda ha recentemente presentato i risultati della Fase 2 per il suo farmaco principale FXR314 nel trattamento della MASH, mostrando una riduzione statisticamente significativa del contenuto di grasso nel fegato con tassi di prurito inferiori rispetto ad altri agonisti FXR. Lo studio ha coinvolto 214 pazienti. Inoltre, i dati del 2024 hanno dimostrato il potenziale di FXR314 nel trattamento della IBD, mostrando un miglioramento della funzione della barriera epiteliale e dell'attività fibrotica nei modelli di colite ulcerosa, nonché benefici sinergici quando combinato con inibitori della JAK.
Organovo prevede uno studio di Fase 2 per dimostrare l'efficacia di FXR314 nella colite ulcerosa da moderata a grave, con potenziale sviluppo sia come monoterapia che come terapia combinata.
Organovo Holdings (NASDAQ:ONVO) ha nombrado a Norman Staskey como Director Financiero. Staskey, que ha trabajado en Danforth Advisors desde 2021, aporta más de 25 años de experiencia en los mercados de capitales y transacciones de M&A, incluido su papel como Director General en la práctica nacional de transacciones de EY.
La compañía presentó recientemente los resultados de la Fase 2 de su fármaco principal FXR314 en el tratamiento de MASH, mostrando una reducción estadísticamente significativa en el contenido de grasa hepática con tasas de prurito más bajas en comparación con otros agonistas de FXR. El estudio involucró a 214 pacientes. Además, los datos de 2024 demostraron el potencial de FXR314 en el tratamiento de la IBD, mostrando una mejora en la función de la barrera epitelial y la actividad fibrótica en modelos de colitis ulcerosa, así como beneficios sinérgicos cuando se combina con inhibidores de JAK.
Organovo anticipa un estudio de Fase 2 para demostrar la efectividad de FXR314 en colitis ulcerosa moderada a severa, con un desarrollo potencial tanto como monoterapia como terapia combinada.
Organovo Holdings (NASDAQ:ONVO)는 Norman Staskey를 최고재무책임자(CFO)로 임명했습니다. Staskey는 2021년부터 Danforth Advisors에서 근무했으며, 25년 이상의 자본 시장 및 M&A 거래 경험을 보유하고 있으며, EY의 국가 거래 부문에서 전무 이사로서의 역할을 포함합니다.
회사에서는 최근 MASH 치료를 위한 주요 약물 FXR314의 2상 결과를 발표하였고, 다른 FXR 작용제에 비해 간 지방 함량의 통계적으로 유의미한 감소와 낮은 가려움증 비율을 보여주었습니다. 이 연구에는 214명의 환자가 포함되었습니다. 또한 2024년 데이터는 FXR314가 IBD 치료에서의 잠재력을 보여주었으며, 궤양성 대장염 모델에서 상피 장벽 기능과 섬유화 활동을 개선하고 JAK 억제제와 병용했을 때의 상승 효과를 나타냈습니다.
Organovo는 FXR314의 중등도에서 중증 궤양성 대장염에 대한 효과를 입증하기 위한 2상 연구를 계획하고 있으며, 단독 요법과 병합 요법으로 개발할 가능성을 염두에 두고 있습니다.
Organovo Holdings (NASDAQ:ONVO) a nommé Norman Staskey au poste de directeur financier. Staskey, qui a travaillé chez Danforth Advisors depuis 2021, apporte plus de 25 ans d'expérience sur les marchés des capitaux et dans les transactions de fusions-acquisitions, y compris son rôle en tant que directeur général dans la pratique nationale des transactions d'EY.
L'entreprise a récemment présenté les résultats de la phase 2 pour son médicament phare FXR314 dans le traitement de MASH, montrant une réduction statistiquement significative du contenu en graisse hépatique avec des taux de prurit plus faibles par rapport à d'autres agonistes FXR. L'étude a impliqué 214 patients. De plus, les données de 2024 ont démontré le potentiel de FXR314 dans le traitement de la maladie inflammatoire de l'intestin (IBD), montrant une amélioration de la fonction de la barrière épithéliale et de l'activité fibrotique dans des modèles de colite ulcéreuse, ainsi que des bénéfices synergiques en combinaison avec des inhibiteurs de JAK.
Organovo prévoit une étude de phase 2 pour démontrer l'efficacité de FXR314 dans la colite ulcéreuse modérée à sévère, avec un potentiel de développement à la fois en monothérapie et en thérapie combinée.
Organovo Holdings (NASDAQ:ONVO) hat Norman Staskey zum Chief Financial Officer ernannt. Staskey, der seit 2021 bei Danforth Advisors tätig ist, bringt über 25 Jahre Erfahrung in den Kapitalmärkten und M&A-Transaktionen mit, einschließlich seiner Rolle als Managing Director in der nationalen Transaktionspraxis von EY.
Das Unternehmen hat kürzlich die Ergebnisse der Phase 2 für sein Hauptmedikament FXR314 zur Behandlung von MASH präsentiert, das eine statistisch signifikante Reduktion des Leberfettgehalts und niedrigere Juckreizraten im Vergleich zu anderen FXR-Agonisten zeigt. Die Studie umfasste 214 Patienten. Darüber hinaus zeigten Daten aus 2024 das Potenzial von FXR314 bei der Behandlung von IBD, wobei eine verbesserte epitheliäre Barrierefunktion und fibrotische Aktivität in Modellen der kolorektalen Entzündung nachgewiesen wurden, sowie synergistische Vorteile bei Kombination mit JAK-Inhibitoren.
Organovo erwartet eine Phase-2-Studie, um die Wirksamkeit von FXR314 bei mäßiger bis schwerer colitis ulcerosa zu demonstrieren, mit einem möglichen Entwicklungsansatz sowohl als Monotherapie als auch als Kombinationstherapie.
- Appointment of experienced CFO with extensive M&A background
- Positive Phase 2 results for FXR314 in MASH treatment with 214 patients
- Demonstrated synergistic benefits of FXR314 with JAK inhibitors
- Lower pruritus rates compared to other FXR agonists
- None.
SAN DIEGO, Jan. 06, 2025 (GLOBE NEWSWIRE) -- Organovo Holdings, Inc. (Nasdaq:ONVO), a clinical stage biotechnology company focused on developing novel treatment approaches in inflammatory bowel disease (IBD) including ulcerative colitis, today announced that it had appointed Norman Staskey as Chief Financial Officer.
Mr. Staskey has worked for Danforth Advisors since 2021, working as Chief Financial Officer for clients such as Azitra, Inc., a biotechnology company developing novel dermatology therapeutic technologies. Norm has over 25 years working in capital market and M&A transactions most recently as a Managing Director in EY’s (formally Ernst & Young) national transactions practice where he led or advised on several fortune 500 M&A deals for both domestic and cross-border transactions, and was involved in the merger of Dell Inc. and EMC Corporation as a member of the EY team. Norm has also worked on several recent M&A deals in the biotech industry.
“We are excited to welcome Norm to the Organovo team,” said Keith Murphy, Executive Chairman. “With his extensive experience, including focus in the biotech industry, and his strong background in M&A transactions, he brings a skill set that opens up new possibilities for Organovo in 2025.”
In November, the liver fibrosis treatment potential of Organovo’s lead drug FXR314, was highlighted in a presentation of Phase 2 results in Metabolic Dysfunction-Associated Steatohepatitis (MASH). Dr. Eric Lawitz shared the complete details of the 16-week, randomized, placebo-controlled, multi-center Phase 2 study of FXR314 in MASH patients at the Liver Meeting (November 15-19, San Diego, CA). Study results in a total of 214 patients demonstrated statistically significant reduction in liver fat content from baseline in patients receiving FXR314 compared to placebo, and a safety profile demonstrating significantly lower pruritus rates than seen with other FXR agonists.
In 2024, Organovo also demonstrated the strong potential of FXR314 in IBD, with data that showed both strong performance of FXR314 in 3D human cellular models of Crohn’s disease and ulcerative colitis. 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.
Organovo expects a Phase 2 study to demonstrate effectiveness of FXR314 in moderate to severe ulcerative colitis, based on effects demonstrated in preclinical animal models and its own proprietary 3D models of disease, with the possibility of development as monotherapy or combination therapy to help ulcerative colitis and Crohn’s disease patients.
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’s lead molecule, FXR314, is on the path for Phase 2 investigation in inflammatory bowel disease and has potential application in metabolic liver disease and oncology. 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 November 8, 2024 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
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