Cyclo Therapeutics completed enrollment for a Phase 3 trial on a treatment for Niemann-Pick Disease, with interim results expected mid-2025.
Quiver AI Summary
Cyclo Therapeutics’ Phase 3 clinical trial of TransportNPC™ for treating Niemann-Pick Disease Type C1 is fully enrolled, with interim results expected in mid-2025. Following the merger with Cyclo Therapeutics, Rafael Holdings announced leadership changes, with Howard Jonas taking over as CEO from Bill Conkling, who transitions to an advisory role. Conkling's leadership was pivotal in transforming Rafael into a late-stage clinical development company, and both he and Jonas are optimistic about the upcoming trial results. Rafael Holdings, through its subsidiary Cyclo Therapeutics, is focused on advancing the development of Trappsol® Cyclo™, aimed at addressing the needs of patients with this rare genetic disorder, alongside its other pharmaceutical ventures.
Potential Positives
- Cyclo Therapeutics’ TransportNPC™ Phase 3 clinical trial for Trappsol® Cyclo™ has been fully enrolled, indicating significant progress in the development of a treatment for a rare genetic disease.
- The expected results from the 48-week interim analysis in the middle of 2025 highlight the company's commitment to advancing clinical research and the potential impact of Trappsol® Cyclo™ on patients suffering from Niemann-Pick Disease Type C1.
- The leadership transition with Howard Jonas taking over as CEO demonstrates a strategic reshaping of the company to strengthen its focus on late-stage clinical development and shareholder value.
Potential Negatives
- Bill Conkling stepping down as CEO raises concerns about leadership stability during a critical phase of clinical trials.
- Dependence on interim analysis results in mid-2025 introduces uncertainty, as outcomes are crucial for future funding and development.
- Vague forward-looking statements highlight potential risks and uncertainties that could affect the company's performance and shareholder confidence.
FAQ
What is the status of the TransportNPC™ Phase 3 trial?
The TransportNPC™ Phase 3 clinical trial is fully enrolled, with interim results expected in mid-2025.
Who is the new CEO of Rafael Holdings?
Howard Jonas has assumed the role of CEO after the merger with Cyclo Therapeutics.
What is Trappsol® Cyclo™ used to treat?
Trappsol® Cyclo™ is being evaluated for the treatment of Niemann-Pick Disease Type C1, a rare genetic disorder.
What role will Bill Conkling take after stepping down?
Bill Conkling will step down as CEO and take on an advisory role with the company.
What significance does the merger with Cyclo Therapeutics have?
The merger positions Rafael Holdings as a late-stage clinical development company focused on advanced biotechnology solutions.
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.
$RFL Hedge Fund Activity
We have seen 13 institutional investors add shares of $RFL stock to their portfolio, and 15 decrease their positions in their most recent quarter.
Here are some of the largest recent moves:
- ACUITAS INVESTMENTS, LLC removed 281,659 shares (-100.0%) from their portfolio in Q4 2024, for an estimated $464,737
- KAHN BROTHERS GROUP INC removed 100,135 shares (-37.4%) from their portfolio in Q4 2024, for an estimated $165,222
- MARQUETTE ASSET MANAGEMENT, LLC removed 49,256 shares (-100.0%) from their portfolio in Q1 2025, for an estimated $92,108
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- GEODE CAPITAL MANAGEMENT, LLC added 26,493 shares (+17.9%) to their portfolio in Q4 2024, for an estimated $43,713
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- WEALTH ENHANCEMENT ADVISORY SERVICES, LLC added 13,695 shares (+inf%) to their portfolio in Q1 2025, for an estimated $25,609
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Full Release
Cyclo Therapeutics’ TransportNPC™ Phase 3 clinical trial for Trappsol ® Cyclo™ for the treatment of Niemann-Pick Disease Type C1, a rare and fatal genetic disease, is fully enrolled and results from the 48-week interim analysis are expected in the middle of 2025
NEWARK, N.J., April 24, 2025 (GLOBE NEWSWIRE) -- Rafael Holdings, Inc. (NYSE: RFL; NYSE American: RFL-WT) today announced that, following the merger with Cyclo Therapeutics, Bill Conkling will be stepping down as CEO and assuming an advisory role with the Company. Rafael’s Executive Chairman and Chairman of the Board, Howard Jonas will assume the role of CEO.
During his tenure as CEO, Bill played a pivotal role in identifying investment opportunities with the potential to re-establish Rafael as a late-stage clinical development company. With the completion of our merger with Cyclo Therapeutics, Rafael Holdings has accomplished that goal and is working to bring a much-needed new treatment to market with the potential to improve the lives of patients suffering with Niemann-Pick Disease Type C1 (“NPC1”), a rare, fatal, and progressive genetic disorder.
“On behalf of the Board and the entire Rafael Holdings team, I extend our deepest gratitude to Bill for his dedication to our company and success in transforming Rafael into a late-stage clinical biotechnology company. We are pleased that we will be able to continue to benefit from Bill’s guidance and experience as he seeks out new challenges and opportunities. Bill is committed to a seamless transition which strengthens our focus to ensure that we are well prepared for the mid-year 48-week interim analysis of the TransportNPC™ Phase 3 clinical trial,” said Howard Jonas, Executive Chairman and Chairman of the Board.
Bill Conkling commented, “It has been an honor to lead Rafael Holdings and work with the Cyclo Therapeutics board and leadership team to bring the two companies together. I am excited to see the results from the 48-week interim analysis of the TransportNPC™ Phase 3 clinical trial , and believe that Trappsol ® Cyclo™ has the potential to be a market leader in the treatment of NPC1. Howard and I have full confidence in Scott Fine, CEO of Cyclo Therapeutics, and his team to successfully execute and create value for Rafael Holdings shareholders.”
About Rafael Holdings, Inc.
Rafael Holdings, Inc. holds interests in clinical and early-stage pharmaceutical and certain other companies, including our wholly-owned subsidiary, Cyclo Therapeutics, LLC, a clinical stage biotechnology company dedicated to developing Rafael’s lead clinical candidate, Trappsol ® Cyclo™, which is being evaluated in clinical trials for the potential treatment of Niemann-Pick Disease Type C1 (“NPC1”), a rare, fatal, and progressive genetic disorder. Rafael also holds majority equity interests in LipoMedix Pharmaceuticals Ltd., a clinical stage pharmaceutical company, Cornerstone Pharmaceuticals, Inc., formerly known as Rafael Pharmaceuticals Inc., a cancer metabolism-based therapeutics company, Rafael Medical Devices, LLC, an orthopedic-focused medical device company developing instruments to advance minimally invasive surgeries, and Day Three Labs, Inc., a company which empowers third-party manufacturers to reimagine their existing cannabis offerings.
Forward Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including without limitation statements regarding our expectations surrounding the potential, safety, efficacy, and regulatory and clinical progress of our product candidates; plans regarding the further evaluation of clinical data; and the potential of our pipeline, including our internal cancer metabolism research programs. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, those disclosed under the caption “Risk Factors” in our Annual Report on Form 10-K for the year ended July 31, 2024, and our other filings with the SEC. These factors could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management’s estimates as of the date of this press release. While we may elect to update such forward-looking statements at some point in the future, we disclaim any obligation to do so, even if subsequent events cause our views to change.
Contact:
Barbara Ryan
[email protected]
(203) 274-2825