Upon completion of our proposed merger with Cyclo Therapeutics the Company intends to focus its efforts on Cyclo's lead clinical program Trappsol® Cyclo™

NEWARK, N.J., Dec. 11, 2024 (GLOBE NEWSWIRE) -- Rafael Holdings, Inc. (NYSE: RFL), today reported its financial results for the first quarter of fiscal year 2025 ended October 31, 2024.

"We anticipate proceeding to a shareholder vote on our pending merger agreement with Cyclo Therapeutics, Inc. (Nasdaq: CYTH) in the first calendar quarter of 2025 and closing promptly post shareholder approvals. Upon closing of the merger, the Company intends to focus its strategic efforts and resources on what will then be the Company's lead clinical program and core asset, Trappsol^® Cyclo™. Accordingly, we are currently evaluating our other operating entities and portfolio of assets,” said Bill Conkling, CEO of Rafael Holdings. Bill added, "We are encouraged that Cyclo Therapeutics has fully enrolled its pivotal Phase 3 study evaluating Trappsol^® Cyclo™ for the treatment of Niemann-Pick Disease Type C1, a rare and fatal genetic disease, and results from the 48-week interim analysis are expected in the middle of 2025. Despite recent FDA approvals of other treatments for NPC Type C1, we believe that Trappsol^® Cyclo™ has the potential to be a market leader.”

Rafael Holdings, Inc. First Quarter Fiscal Year 2025 Financial Results

As of October 31, 2024, we had cash, cash equivalents and marketable securities of $54.3 million.

For the three months ended October 31, 2024, we recorded a net loss attributable to Rafael Holdings of $9.0 million, or $0.37 per share, versus a net loss of $3.6 million, or $0.15 per share in the year ago period. The year over year increase in losses was attributable to the combined unrealized losses of $6.0 on the Company's investment in Cyclo as well as in the convertible notes receivable from Cyclo, versus $2.1 million in unrealized losses on the Company's investment in Cyclo in the year ago period.

Research and development expenses were $1.3 million for the three months ended October 31, 2024, compared to $0.5 million in the year ago period. The year over year increase relates to activity at Cornerstone and Day Three, which were consolidated with Rafael Holdings during fiscal 2024.

For the three months ended October 31, 2024, general and administrative expenses were $2.5 million. For the same period in the prior year, general and administrative expenses were $2.0 million. The increase was primarily due to additional expenses from Cornerstone and Day Three, as well as increased professional fees related to the proposed Cyclo merger.

About Rafael Holdings, Inc.

Rafael Holdings, Inc. is a holding company with interests in clinical and early-stage pharmaceutical companies including an investment in (and planned merger with) Cyclo Therapeutics Inc. (Nasdaq: CYTH), a biotechnology company dedicated to developing Trappsol^® Cyclo™, which is being evaluated in clinical trials, including an ongoing Phase 3 trial for the potential treatment of Niemann-Pick Disease Type C1 ("NPC1”), a rare, fatal, and progressive genetic disorder.  Rafael also holds a majority equity interest in LipoMedix Pharmaceuticals Ltd. a clinical stage pharmaceutical company, Barer Institute Inc., a wholly owned preclinical cancer metabolism research operation, a majority interest in Cornerstone Pharmaceuticals, Inc., formerly known as Rafael Pharmaceuticals Inc., a cancer metabolism-based therapeutics company, a majority interest in Rafael Medical Devices, LLC., an orthopedic-focused medical device company developing instruments to advance minimally invasive surgeries, and a majority interest in Day Three Labs, Inc., a company which empowers third-party manufacturers to reimagine their existing cannabis offerings enabling them to bring to market better, cleaner, more precise and predictable versions by utilizing Day Three's pharmaceutical-grade technology and innovation like Unlokt™. The Company's primary focus is to expand our investment portfolio through opportunistic and strategic investments including therapeutics, which address high unmet medical needs. Upon closing of the planned merger with Cyclo Therapeutics, the Company intends to focus its efforts on making Trappsol^®Cyclo™ its lead clinical program.

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

Barbara.ryan@rafaelholdings.com

(203) 274-2825