Organovo appoints Norman Staskey as CFO, enhancing its focus on innovative therapies for inflammatory bowel disease.
Quiver AI Summary
Organovo Holdings, Inc., a clinical stage biotechnology company focused on treating inflammatory bowel disease (IBD), has appointed Norman Staskey as the new Chief Financial Officer. Staskey brings over 25 years of experience in capital markets and M&A transactions, having most recently served as Managing Director at EY and worked as CFO for various biotech firms. Organovo's lead drug, FXR314, has shown promising results in treating liver fibrosis and IBD, with recent studies indicating its effectiveness in improving epithelial barrier function in ulcerative colitis and demonstrating synergistic benefits when combined with a JAK inhibitor. The company plans to initiate a Phase 2 study for FXR314 targeting moderate to severe ulcerative colitis in the near future.
Potential Positives
- Appointment of Norman Staskey as Chief Financial Officer brings extensive experience in biotechnology and M&A transactions, potentially enhancing the company's strategic direction.
- Positive results from Phase 2 studies of FXR314 in metabolic liver disease and inflammatory bowel disease (IBD) demonstrated significant efficacy and safety, which could bolster investor confidence and market position.
- Organovo's proprietary technology for developing 3D human tissues indicates a strong foundation for advancing drug development and potential competitive advantage in the biotechnology sector.
Potential Negatives
- The announcement of a new Chief Financial Officer (CFO) may signal instability or a lack of continuity in the company's leadership, which could raise concerns among investors and stakeholders.
- The press release includes significant forward-looking statements that acknowledge inherent risks and uncertainties, suggesting caution regarding the company's future performance and prospects.
- The lack of detailed financial information or metrics regarding the progress and impact of FXR314 and other therapeutic developments may lead to skepticism about the company's actual performance and viability.
FAQ
Who has been appointed as Chief Financial Officer of Organovo Holdings?
Norman Staskey has been appointed as Chief Financial Officer of Organovo Holdings, Inc.
What is FXR314 and its significance?
FXR314 is Organovo's lead drug currently under Phase 2 investigation for treating inflammatory bowel disease and has potential in liver disease.
What are the recent study results for FXR314?
Recent studies showed FXR314 significantly reduced liver fat content in MASH patients and improved epithelial barrier function in ulcerative colitis.
How does FXR314 perform in combination therapy?
FXR314 demonstrated synergistic benefits when paired with an approved Janus kinase (JAK) inhibitor in ulcerative colitis treatment.
Where can I find more information about Organovo?
More information about Organovo can be found on their official website at www.organovo.com.
Disclaimer: This is an AI-generated summary of a press release distributed by GlobeNewswire. The model used to summarize this release may make mistakes. See the full release here.
$ONVO Hedge Fund Activity
We have seen 7 institutional investors add shares of $ONVO stock to their portfolio, and 16 decrease their positions in their most recent quarter.
Here are some of the largest recent moves:
- ARMISTICE CAPITAL, LLC added 289,000 shares (+31.1%) to their portfolio in Q3 2024
- CITADEL ADVISORS LLC removed 76,920 shares (-97.1%) from their portfolio in Q3 2024
- PRESCOTT GROUP CAPITAL MANAGEMENT, L.L.C. removed 59,969 shares (-12.7%) from their portfolio in Q3 2024
- MORGAN STANLEY removed 21,451 shares (-51.2%) from their portfolio in Q3 2024
- RENAISSANCE TECHNOLOGIES LLC removed 19,359 shares (-30.5%) from their portfolio in Q3 2024
- XTX TOPCO LTD added 17,503 shares (+inf%) to their portfolio in Q3 2024
- GEODE CAPITAL MANAGEMENT, LLC added 15,116 shares (+13.7%) to their portfolio in Q3 2024
To track hedge funds' stock portfolios, check out Quiver Quantitative's institutional holdings dashboard.
Full Release
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
pr@coreir.com
Source: Organovo, Inc.
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