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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities
Exchange Act of 1934
Date of Report (Date of earliest event reported):
April 22, 2026
RAFAEL HOLDINGS, INC.
(Exact name of registrant as specified in its
charter)
| Delaware |
|
1-38411 |
|
82-2296593 |
(State or other jurisdiction
of Incorporation) |
|
(Commission File Number) |
|
(IRS Employer
Identification No.) |
520 Broad Street
Newark, New Jersey |
|
07102 |
| (Address of principal executive offices) |
|
(Zip Code) |
Registrant’s telephone number, including
area code: 212 658-1450
Not Applicable
(Former name or former address, if changed since
last report.)
Check the appropriate box below if the Form 8-K filing is intended
to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2.
below):
| ☐ |
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
| ☐ |
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| ☐ |
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| ☐ |
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Indicate by check mark whether the registrant
is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the
Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company ☐
If an emerging growth company, indicate by check
mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting
standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Securities registered pursuant to Section 12(b)-2 of the Exchange Act:
| Title of each class |
|
Trading Symbol |
|
Name of each exchange on which
registered |
| Class B common stock, par value $0.01 per share |
|
RFL |
|
New York Stock Exchange |
Item 7.01. Regulation
FD
On April 22, 2026,
Rafael Holdings, Inc. (the “Company”) issued the attached press release (the “Release”) announcing that the
Company’s subsidiary, Cyclo Therapeutics, LLC, has entered into an exclusive licensing agreement with Massachusetts Institute
of Technology (“MIT”) covering U.S. Patent No.12285440. The patent covers the use of cyclodextrins in patients
with Alzheimer’s Disease (AD) who carry an ApoE4 genetic mutation.
A copy of the Release is furnished herewith as Exhibit 99.1 and is incorporated herein by reference.
The Company is furnishing the information contained in this Report, including Exhibit 99.1, pursuant to Item 2.02 of Form 8-K promulgated by the Securities and Exchange Commission (the “SEC”). This information shall not be deemed to be “filed” with the SEC or incorporated by reference into any other filing with the SEC unless otherwise expressly stated in such filing. In addition, this Report and the press release contain statements intended as “forward-looking statements” that are subject to the cautionary statements about forward-looking statements set forth in the press release.
Item 8.01. Other Events.
The information contained in Item 7.01 above is incorporated herein by reference into this Item 8.01.
Item 9.01 Financial Statements and Exhibits.
(d)
Exhibits.
| Exhibit No. |
|
Document |
| 99.1 |
|
Press Release, dated April 22, 2026. |
| 104 |
|
Cover Page Interactive Data File, formatted in Inline XBRL document. |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act
of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| |
RAFAEL HOLDINGS, INC. |
| |
|
|
| |
By: |
/s/ David Polinsky |
| |
|
Name: |
David Polinsky |
| |
|
Title: |
Chief Financial Officer |
Dated: April 22, 2026
EXHIBIT INDEX
Exhibit
Number |
|
Document |
| 99.1 |
|
Press Release, dated April 22, 2026. |
| 104 |
|
Cover Page Interactive Data File, formatted in Inline XBRL document. |
Exhibit 99.1
Rafael Holdings Announces Patent Licensing Agreement
with MIT for “Small Molecules to Improve Myelination in ApoE4 positive Alzheimer’s Disease”
License of the MIT patent strengthens Rafael’s
intellectual property around cyclodextrins as an Active Pharmaceutical Ingredient (API) in the treatment of ApoE4-positive Alzheimer’s
Disease
NEWARK, NJ – April 22, 2026 (GLOBE NEWSWIRE)
- Rafael Holdings, Inc. (NYSE: RFL) today announced that its subsidiary, Cyclo Therapeutics, has entered into an exclusive licensing
agreement with Massachusetts Institute of Technology (“MIT”) covering U.S. Patent No.12285440. This license covers the use
of cyclodextrins in patients with Alzheimer’s Disease (AD) who carry an ApoE4 genetic mutation, strengthening the company’s intellectual
property portfolio around Trappsol® Cyclo™ in this important AD patient population.
The ApoE4 gene variant is estimated to be present
in 50-70% of patients with AD and is believed to be a key risk factor in the development early onset sporadic AD. Dysregulated cholesterol
metabolism is believed to contribute to amyloid and tau pathology, especially in those patients with the ApoE4 gene variant, which has
been shown to accelerate AD as it is the key lipids/cholesterol transporter in the brain.
The established mechanism of action (MOA) for
Trappsol® Cyclo™ could have a direct impact in ApoE4 positive patients as it has been shown to improve cholesterol
transport between central nervous system (CNS) cells. Preclinical data suggest Trappsol® Cyclo™ can improve delivery
of cholesterol between CNS cells, reduce tau-pathology and improve learning/memory in mice.
“Securing this exclusive license from MIT
represents a transformative milestone for our company and greater potential positive news for the millions of patients and their families
affected by Alzheimer’s disease. By combining the results of MIT’s world-class foundational research with our clinical development expertise,
we are well positioned to accelerate a potential breakthrough that addresses the underlying pathology of this devastating condition. This
agreement underscores our commitment to pursuing the highest caliber of innovation to deliver life-changing therapies to patients in need,”
said Howard Jonas, CEO, Executive Chairman and Chairman of the Board of Rafael Holdings.
“With
Phase 3 results from Transport NPC due in calendar Q3, 2026, we’re excited by Trappsol® Cyclo™’s
potential across multiple disease areas. Our NPC1 phase 3 study is the largest ever conducted in
patients with NPC, yielding crucial clinical and safety data needed to advance the treatment paradigm for patients and families dealing
with NPC ” said Joshua Fine, COO of Rafael Holdings.
About Rafael Holdings, Inc.
Rafael Holdings, Inc. is a biotechnology company
that develops pharmaceuticals and holds interests in clinical and early-stage companies that develop pharmaceuticals and medical devices.
Our lead candidate is 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. We also hold interests in other clinical-stage and
early-stage pharmaceutical development companies and an orthopedic-focused medical device company. Our lead candidate, Trappsol®
Cyclo™ is the subject of an ongoing pivotal Phase 3 clinical trial.
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, 2025, 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
# # #
