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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): October 29, 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 2.02. Results of Operations and Financial
Condition.
On October 29, 2026, Rafael Holdings, Inc. (the “Company”)
distributed over a wire service and posted an earnings release to the investors page of its website (www.rafaelholdings.com) announcing
its results of operations for the fiscal quarter and fiscal year ended July 31, 2026. A copy of the earnings release concerning the foregoing
results 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
7.01. Regulation FD
On October 29, 2026, the Company distributed over a wire service and
posted the attached press release (the “Release”) to the investors page of its website announcing Cyclo Therapeutics, LLC,
has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval of remibetadex (Trappsol®
Cyclo™, previously identified as intravenous hydroxypropyl-β-cyclodextrin), for the proposed indication of the treatment of
the neurovisceral manifestations of Niemann-Pick Disease Type C (NPC) in adult and pediatric patients from birth. NPC is a rare, fatal
and progressive genetic disorder for which there is no known cure. The Company also announced that the United States Adopted Names (USAN)
Council has assigned the nonproprietary name “remibetadex” to the compound known until now as intravenous hydroxypropyl-β-cyclodextrin.
A copy of the Release is furnished herewith as Exhibit 99.2 and is
incorporated herein by reference.
The Company is furnishing the information contained in this Report,
including Exhibit 99.2, pursuant to Item 7.01 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 October 29, 2026, reporting the results of operations for the fiscal quarter and fiscal year ended July 31, 2026. |
| 99.2 |
|
Press Release, dated October 29, 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: October 29, 2026
EXHIBIT INDEX
Exhibit
Number |
|
Document |
| 99.1 |
|
Press Release, dated October 29, 2026, reporting the results of operations for the fiscal quarter and fiscal year ended July 31, 2026. |
| 99.2 |
|
Press Release, dated October 29, 2026. |
| 104 |
|
Cover Page Interactive Data File, formatted in Inline XBRL document. |
Exhibit 99.1
Rafael Holdings Reports Fourth Quarter and Full
Year Fiscal 2026
Financial Results and Provides Corporate Update
NEWARK,
NJ – October 29, 2026 (GLOBE NEWSWIRE) - Rafael Holdings,
Inc. (NYSE: RFL) today reported its financial results for the fourth quarter and full fiscal year 2026 ended July 31, 2026.
Fiscal 2026 and Recent Corporate Highlights
| ● | NDA submitted for remibetadex (Trappsol® Cyclo™). On October 28, 2026, Cyclo Therapeutics submitted a New Drug Application
(NDA) to the FDA seeking approval of remibetadex for the treatment of Niemann-Pick Disease Type C. The NDA is supported by the Phase 3
TransportNPC™ study, completed in June 2026, which did not meet its primary endpoint in the overall population (p=0.19) but showed
71% slowing of disease progression in a prespecified analysis of patients receiving background miglustat and/or leucine therapy (p=0.046),
and by an overall survival analysis versus matched registry controls. The NDA includes a request for a rare pediatric disease priority
review voucher. |
| ● | MIT license in Alzheimer’s disease. In April 2026, Cyclo entered into an exclusive, worldwide license with the Massachusetts
Institute of Technology for the use of hydroxypropyl-β-cyclodextrin in Alzheimer’s disease. |
| ● | LipoMedix. In June 2026, an investigator-initiated Phase II trial of Promitil® with radiotherapy in patients with cisplatin-ineligible
head and neck cancer was launched in Israel. |
| ● | Rafael Medical Devices. Continued the U.S. commercial build-out of the FDA-cleared VECTR™ System, including its regional
distributor network. |
Rafael Holdings, Inc. Fourth Quarter Fiscal Year 2026 Financial
Results
As of July 31, 2026, we had cash and cash equivalents of $22.1 million.
For the three months ended July 31, 2026, we recorded a net loss attributable
to Rafael Holdings of $9.2 million, or $0.18 per share, versus a net loss of $12.1 million, or $0.28 per share in the year ago period.
The year over year decrease in net loss is largely attributable to a decrease in general and administrative expenses.
Research and development expenses were $7.5 million for each of the
three months ended July 31, 2026 and 2025.
General and administrative expenses were $2.4 million for the three
months ended July 31, 2026, compared to $5.5 million in the year ago period. The year over year decrease relates to a decrease in payroll,
stock-based compensation expense and professional fees.
Rafael Holdings, Inc. Full Fiscal Year 2026 Financial Results
For the twelve months ended July 31, 2026, we recorded a net loss attributable
to Rafael Holdings of $29.6 million, or $0.58 per share, versus a net loss of $30.5 million, or $1.04 per share in the year ago period.
The year over year decrease in net loss reflects a $4.4 million gain on Cornerstone’s settlements of accounts payable and convertible
notes payable and the absence of prior-year unrealized losses on our investment in Cyclo, partially offset by higher research and development
expenses following the consolidation of Cyclo Therapeutics in March 2025.
Research and development expenses were $24.3 million for the twelve
months ended July 31, 2026, compared to $12.8 million in the year ago period. The year over year increase was primarily attributable to
a $13.4 million increase in Cyclo’s research and development expenses in fiscal 2026, as well as an increase in R&D stock-based
compensation expense of $0.4 million, offset by decreases in R&D payroll of $1.5 million, and in clinical trial and other expenses
of $0.8 million.
General and administrative expenses were $9.7 million for the twelve
months ended July 31, 2026, compared to $13.8 million in the year ago period. The decrease of $4.1 million versus the prior year is primarily
attributable to decreases in professional fees of $1.3 million, primarily due to merger-related costs in the prior year, stock-based compensation
expense of $1.2 million, payroll expense of $0.6 million due to terminations, and other expenses.
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 remibetadex
(Trappsol® Cyclo™), for which we have completed a pivotal Phase 3 study in Niemann-Pick Disease Type C (“NPC”) and
submitted an NDA to the FDA in October 2026. NPC is 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.
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; the FDA’s review of
our NDA for remibetadex, including whether it will be accepted for filing, granted priority review or approved; our eligibility for and
ability to monetize a priority review voucher; plans regarding the further evaluation of clinical data; and the potential of our pipeline.
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, the risk that the FDA may not accept for filing
or approve our NDA, including because the Phase 3 TransportNPC™ study did not meet its primary endpoint in the overall population,
our need for additional financing and the substantial doubt about our ability to continue as a going concern, and those disclosed under
the caption “Risk Factors” in our Annual Report on Form 10-K for the year ended July 31, 2026, 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
# # #
RAFAEL HOLDINGS, INC.
CONSOLIDATED BALANCE SHEETS
(in thousands, except share and per
share data)
| | |
July 31, | |
| | |
2026 | | |
2025 | |
| | |
| | |
| |
| ASSETS | |
| | |
| |
| CURRENT ASSETS | |
| | |
| |
| Cash and cash equivalents | |
$ | 22,074 | | |
$ | 52,769 | |
| Prepaid clinical costs | |
| 1,839 | | |
| 1,045 | |
| Other receivables | |
| — | | |
| 1,206 | |
| Accounts receivable, net of allowance for credit losses of $245 at July 31, 2026 and July 31, 2025 | |
| 444 | | |
| 627 | |
| Inventory | |
| 377 | | |
| 281 | |
| Prepaid expenses and other current assets | |
| 1,083 | | |
| 786 | |
| Total current assets | |
| 25,817 | | |
| 56,714 | |
| | |
| | | |
| | |
| Property and equipment, net | |
| 1,503 | | |
| 1,596 | |
| Non-current prepaid clinical costs | |
| 457 | | |
| 1,399 | |
| Convertible notes receivable classified as available-for-sale | |
| 2,044 | | |
| 1,858 | |
| Goodwill | |
| 19,939 | | |
| 19,939 | |
| Intangible assets, net | |
| 863 | | |
| 994 | |
| In-process research and development | |
| 31,575 | | |
| 31,575 | |
| Investments | |
| 750 | | |
| — | |
| Other assets | |
| 107 | | |
| 34 | |
| TOTAL ASSETS | |
$ | 83,055 | | |
$ | 114,109 | |
| | |
| | | |
| | |
| LIABILITIES AND EQUITY | |
| | | |
| | |
| CURRENT LIABILITIES | |
| | | |
| | |
| Accounts payable | |
$ | 7,014 | | |
$ | 6,893 | |
| Accrued expenses | |
| 2,943 | | |
| 3,304 | |
| Convertible notes payable | |
| 608 | | |
| 614 | |
| Due to related parties, net | |
| 355 | | |
| 723 | |
| Other current liabilities | |
| 67 | | |
| 66 | |
| Total current liabilities | |
| 10,987 | | |
| 11,600 | |
| | |
| | | |
| | |
| Accrued expenses, noncurrent | |
| — | | |
| 3,895 | |
| Convertible notes payable, noncurrent | |
| 2 | | |
| 78 | |
| Deferred income tax liability | |
| 43 | | |
| 138 | |
| Other liabilities | |
| 53 | | |
| 27 | |
| TOTAL LIABILITIES | |
$ | 11,085 | | |
$ | 15,738 | |
| | |
| | | |
| | |
| COMMITMENTS AND CONTINGENCIES | |
| | | |
| | |
| | |
| | | |
| | |
| EQUITY | |
| | | |
| | |
| Class A common stock, $0.01 par value; 35,000,000 shares authorized, 787,163 shares issued and outstanding as of July 31, 2026 and July 31, 2025 | |
| 8 | | |
| 8 | |
| Class B common stock, $0.01 par value; 200,000,000 shares authorized, 51,393,279 issued and outstanding (excluding treasury shares of 101,487) as of July 31, 2026, and 50,789,697 issued and outstanding (excluding treasury shares of 101,487) as of July 31, 2025 | |
| 514 | | |
| 508 | |
| Additional paid-in capital | |
| 323,438 | | |
| 322,161 | |
| Accumulated deficit | |
| (261,898 | ) | |
| (232,263 | ) |
| Treasury stock, at cost; 101,487 Class B shares as of July 31, 2026 and July 31, 2025 | |
| (168 | ) | |
| (168 | ) |
| Accumulated other comprehensive income related to unrealized income on available-for-sale securities | |
| 544 | | |
| 358 | |
| Accumulated other comprehensive income related to foreign currency translation adjustment | |
| 3,871 | | |
| 3,787 | |
| Total equity attributable to Rafael Holdings, Inc. | |
| 66,309 | | |
| 94,391 | |
| Noncontrolling interests | |
| 5,661 | | |
| 3,980 | |
| TOTAL EQUITY | |
| 71,970 | | |
| 98,371 | |
| | |
| | | |
| | |
| TOTAL LIABILITIES AND EQUITY | |
$ | 83,055 | | |
$ | 114,109 | |
RAFAEL HOLDINGS, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except share and per
share data)
| | |
Three Months Ended
July 31, | | |
Year Ended
July 31, | |
| | |
2026 | | |
2025 | | |
2026 | | |
2025 | |
| | |
(unaudited) | | |
| |
| Revenues | |
$ | 244 | | |
$ | 350 | | |
$ | 874 | | |
$ | 917 | |
| | |
| | | |
| | | |
| | | |
| | |
| Cost of infusion technology revenue | |
| — | | |
| — | | |
| — | | |
| 106 | |
| Cost of product revenue | |
| 13 | | |
| 19 | | |
| 42 | | |
| 28 | |
| G&A expenses | |
| 2,444 | | |
| 5,497 | | |
| 9,704 | | |
| 13,781 | |
| R&D expenses | |
| 7,467 | | |
| 7,547 | | |
| 24,333 | | |
| 12,823 | |
| Depreciation and amortization | |
| 51 | | |
| 50 | | |
| 204 | | |
| 288 | |
| Loss on impairment of goodwill | |
| — | | |
| — | | |
| — | | |
| 3,050 | |
| Operating Loss | |
| (9,731 | ) | |
| (12,763 | ) | |
| (33,409 | ) | |
| (29,159 | ) |
| Interest income | |
| 213 | | |
| 467 | | |
| 1,236 | | |
| 1,996 | |
| Realized gain on available-for-sale securities | |
| — | | |
| — | | |
| — | | |
| 178 | |
| Unrealized (loss) gain on investment - Cyclo | |
| — | | |
| — | | |
| — | | |
| (5,144 | ) |
| Unrealized (loss) gain on convertible notes receivable, due from Cyclo | |
| — | | |
| — | | |
| — | | |
| (719 | ) |
| Interest expense | |
| (6 | ) | |
| (168 | ) | |
| (333 | ) | |
| (658 | ) |
| Gain on settlement of accounts payable and convertible notes payable | |
| 464 | | |
| — | | |
| 4,422 | | |
| — | |
| Other income | |
| 63 | | |
| 236 | | |
| 117 | | |
| 310 | |
| Loss before income taxes | |
| (8,997 | ) | |
| (12,228 | ) | |
| (27,967 | ) | |
| (33,196 | ) |
| Benefit from taxes | |
| 65 | | |
| 174 | | |
| 13 | | |
| 2,553 | |
| Consolidated net loss | |
| (8,932 | ) | |
| (12,054 | ) | |
| (27,954 | ) | |
| (30,643 | ) |
| | |
| | | |
| | | |
| | | |
| | |
| Consolidated net loss | |
| (8,932 | ) | |
| (12,054 | ) | |
| (27,954 | ) | |
| (30,643 | ) |
| Net income (loss) attributable to noncontrolling interests | |
| 244 | | |
| 40 | | |
| 1,681 | | |
| (123 | ) |
| Net loss attributable to Rafael Holdings, Inc. | |
$ | (9,176 | ) | |
$ | (12,094 | ) | |
$ | (29,635 | ) | |
$ | (30,520 | ) |
| | |
| | | |
| | | |
| | | |
| | |
| Loss per share attributable to common stockholders | |
| | | |
| | | |
| | | |
| | |
| Basic and Diluted | |
$ | (0.18 | ) | |
$ | (0.28 | ) | |
$ | (0.58 | ) | |
$ | (1.04 | ) |
| | |
| | | |
| | | |
| | | |
| | |
| Weighted average number of shares used in calculation of loss per share - basic and diluted | |
| 51,586,276 | | |
| 43,011,360 | | |
| 51,393,118 | | |
| 29,422,221 | |
Exhibit
99.2
Rafael
Holdings Announces Submission of New Drug Application to FDA for Trappsol®
Cyclo™ (remibetadex) for the
Treatment of Niemann-Pick Disease Type C
NDA
supported by the Phase 3 TransportNPC™ study, data from earlier clinical studies, and
an overall survival analysis versus
external registry controls
Remibetadex
has received Orphan Drug, Fast Track and Rare Pediatric Disease
designations from the FDA; approval would make remibetadex eligible for
a Rare Pediatric
Disease Priority Review Voucher
United
States Adopted Names (USAN) Council assigns nonproprietary name “remibetadex” to Trappsol® Cyclo™
NEWARK,
N.J., October 29, 2026 — Rafael Holdings, Inc. (NYSE: RFL) today announced that its subsidiary, Cyclo Therapeutics, LLC, has
submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval of remibetadex (Trappsol®
Cyclo™, previously identified as intravenous hydroxypropyl-β-cyclodextrin), for the proposed indication of the
treatment of the neurovisceral manifestations of Niemann-Pick Disease Type C (NPC) in adult and pediatric patients from birth. NPC is
a rare, fatal and progressive genetic disorder for which there is no known cure. The Company also announced that the United States Adopted
Names (USAN) Council has assigned the nonproprietary name “remibetadex” to the compound known until now as intravenous hydroxypropyl-β-cyclodextrin.
Within
60 days of receiving the application, the FDA will determine whether the application is filed and, if filed, whether Priority Review
will be granted. If the application is filed, the FDA will assign a Prescription Drug User Fee Act (PDUFA) target action date.
“This
submission is an important milestone for Rafael Holdings and, most importantly, for patients living with NPC,” said Howard Jonas,
Chairman and Chief Executive Officer of Rafael Holdings. “I believe the totality of the data, including the Phase 3 trial results
and the overall survival analysis, supports the potential of remibetadex for patients with limited treatment options. Pending FDA approval,
we are excited to bring remibetadex to patients and families who urgently need new options to treat NPC.”
The NDA includes results from the global, double-blind, placebo-controlled
Phase 3 TransportNPC™ study. Although the study did not achieve statistical significance on its primary endpoint, remibetadex
showed a directionally favorable 64% relative slowing of disease progression compared with placebo (p=0.19) and in a prespecified analysis
of patients receiving background therapy (approximately 83% of the study population), remibetadex showed a 71% relative slowing of disease
progression (p=0.046). The NDA also includes data from earlier clinical studies and an overall survival analysis in which remibetadex
was associated with an 85% reduction in the risk of mortality in patients with infantile-onset NPC compared with matched registry controls
(p=0.044). Remibetadex was generally well tolerated, with no new safety signals observed, although serious adverse events occurred more
frequently with remibetadex than with placebo (35.9% vs. 16.7%). Topline results from TransportNPC™ were reported on
September 30, 2026.
“The
remibetadex NDA is the culmination of more than 15 years of research and investment and, if approved, could help address a significant
unmet need in a rare, and fatal disease,” said Joshua Fine, Chief Operating Officer of Rafael Holdings. “With the data in
the NDA and Orphan Drug, Fast Track and Rare Pediatric Disease designations in place, upon the FDA’s filing of the NDA, we believe
remibetadex is well positioned for review, and an approval would make it eligible for a Priority Review Voucher, a potential source of
non-dilutive capital. With this important milestone completed, we are preparing for a potential commercial launch, and we look forward
to working with the FDA as the regulatory review process advances. We are grateful to the investigators, patients, families and advocates
who made this milestone possible.”
About
Remibetadex (Trappsol® Cyclo™)
Remibetadex
is an investigational, intravenously administered therapy containing a proprietary formulation of hydroxypropyl-β-cyclodextrin and
is being developed for the treatment of the neurovisceral manifestations of Niemann-Pick Disease Type C (NPC) in adult and pediatric
patients from birth. Remibetadex is designed to mobilize cholesterol from late endosomes and lysosomes, facilitating the transport of
accumulated cholesterol out of cells so it can be further processed and excreted. Remibetadex has been granted Orphan Drug, Fast Track
and Rare Pediatric Disease designations by the FDA for the treatment of NPC.
Remibetadex
is an investigational product and has not been approved by the FDA or any other regulatory agency for any indication.
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 remibetadex (Trappsol® Cyclo™, previously
identified as intravenous hydroxypropyl-β-cyclodextrin) for which we have completed a pivotal Phase 3 study in Niemann-Pick Disease
Type C (“NPC”) and submitted an NDA to the FDA in October 2026. NPC is 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.
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; the FDA’s review of our NDA, including whether the NDA will be accepted for filing or receive Priority
Review; our eligibility for a Priority Review Voucher; our commercial preparations; plans regarding the further evaluation of clinical
data; and the potential of our pipeline. 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, the risk
that the FDA may not accept for filing or approve an NDA for remibetadex based on the available data; the risk that we may not receive
or be able to monetize a Priority Review Voucher; and those disclosed under the caption “Risk Factors” in our Annual Report
on Form 10-K for the year ended July 31, 2026, 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
#
# #
