Rafael Holdings Reports Fourth Quarter and Full Year Fiscal 2026 Financial Results and Provides Corporate Update

The FDA application follows a Phase 3 study that missed its overall primary endpoint but showed slower progression in a prespecified subgroup.

Rhea-AI Summary

Rafael Holdings (NYSE: RFL) reported a fiscal 2026 net loss attributable to the company of $29.635 million, narrower than a year earlier. Loss per share was $0.58 versus $1.04; the prior-year loss was $30.520 million. Fourth-quarter loss narrowed to $9.176 million from $12.094 million. Cash fell to $22.074 million from $52.769 million at July 31, 2025.

Cyclo Therapeutics submitted an FDA application for remibetadex in Niemann-Pick Disease Type C on October 28, 2026. Phase 3 missed its overall primary endpoint (p=0.19), but a prespecified subgroup receiving background miglustat and/or leucine showed 71% slower disease progression (p=0.046). Fiscal 2026 research and development expenses rose to $24.333 million from $12.823 million, while general and administrative expenses fell to $9.704 million from $13.781 million. A $4.422 million gain on settlements of payables and convertible notes also supported results.

13 points · 0 major

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1 major · 10 points

How the balance works

Positive

• Moderate pointRemibetadex FDA application submitted October 28, 2026 for Niemann-Pick Disease Type C.
• Moderate pointFiscal 2026 attributable net loss narrowed to $29.635 million from $30.520 million; loss per share fell to $0.58 from $1.04.
• Moderate pointFourth-quarter attributable net loss narrowed to $9.176 million from $12.094 million; loss per share fell to $0.18 from $0.28.
• Moderate pointFiscal 2026 general and administrative expenses fell to $9.704 million from $13.781 million.
• Moderate pointFourth-quarter general and administrative expenses fell to $2.444 million from $5.497 million.
• Moderate pointFiscal 2026 settlements of accounts payable and convertible notes generated a $4.422 million gain. 7% of market cap
• Moderate pointFiscal 2026 Cyclo investment unrealized loss was zero, versus $5.144 million a year earlier.

6 minor points

• Minor pointPrespecified subgroup receiving background miglustat and/or leucine showed 71% slower disease progression (p=0.046).
• Minor pointFourth-quarter research and development expenses decreased to $7.467 million from $7.547 million.
• Minor pointFiscal 2026 interest expense decreased to $333,000 from $658,000.
• Minor pointCyclo secured an exclusive worldwide MIT license in April 2026 for hydroxypropyl-β-cyclodextrin in Alzheimer’s disease.
• Minor pointPromitil’s investigator-initiated Phase II trial launched in June 2026 with radiotherapy for cisplatin-ineligible head and neck cancer.
• Minor pointFDA-cleared VECTR System U.S. commercial build-out continued, including its regional distributor network.

Negative

• Major pointRemibetadex Phase 3 missed its primary endpoint in the overall population (p=0.19).
• Moderate pointCash and cash equivalents fell to $22.074 million at July 31, 2026, from $52.769 million a year earlier.
• Moderate pointFiscal 2026 research and development expenses rose to $24.333 million from $12.823 million.
• Moderate pointFiscal 2026 operating loss widened to $33.409 million from $29.159 million.
• Moderate pointEquity attributable to Rafael Holdings fell to $66.309 million from $94.391 million at July 31, 2025.

5 minor points

• Minor pointFiscal 2026 revenue decreased to $874,000 from $917,000.
• Minor pointFourth-quarter revenue decreased to $244,000 from $350,000.
• Minor pointFiscal 2026 interest income declined to $1.236 million from $1.996 million.
• Minor pointFiscal 2026 tax benefit declined to $13,000 from $2.553 million.
• Minor pointClass B shares outstanding increased to 51,393,279 from 50,789,697 at July 31, 2025, diluting existing holders.

News Explained

At July 31, 2026, Rafael reported 51,393,279 Class B shares issued and outstanding, versus 50,789,697 at July 31, 2025; for a holder whose share count stayed constant, the larger share count means a smaller proportionate ownership of the Class B class.

Key Figures

Primary endpoint p-value: p=0.19 Disease progression slowing: 71% (p=0.046) Cash and cash equivalents: $22.1 million +3 more

Primary endpoint p-value

p=0.19

Phase 3 TransportNPC study, overall population

Disease progression slowing

71% (p=0.046)

Prespecified analysis of patients receiving background miglustat and/or leucine

Cash and cash equivalents

$22.1 million

As of July 31, 2026

Quarterly net loss

$9.2 million vs. $12.1 million

Q4 FY2026 vs. year-ago period

Full-year net loss

$29.6 million vs. $30.5 million

FY2026 vs. FY2025

Full-year R&D expenses

$24.3 million vs. $12.8 million

FY2026 vs. FY2025

Previous Earnings Reports

1 past event · Latest: Jun 11

Same Type 1 event

1. Jun 11

   Q3 earnings

   24h Move

   +19.1%

   Reported Q3 results and anticipated NDA submission in the second half of 2026.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Key Terms

new drug application, primary endpoint, prespecified analysis, priority review voucher, +1 more

5 terms

new drug application regulatory

"submitted a New Drug Application (NDA) to the FDA"

A new drug application is a formal request submitted to government regulators seeking approval to market a new medicine. It is like a detailed proposal that shows the drug has been tested for safety and effectiveness. For investors, receiving approval signals that the drug may soon become available for sale, potentially leading to revenue growth and impacting the company's value.

primary endpoint medical

"did not meet its primary endpoint in the overall population"

The primary endpoint is the single main result a clinical study is designed to measure to decide if a treatment works, like the finish line in a race that tells you who won. Investors care because meeting or missing this goal drives regulatory decisions, future sales expectations and stock value — it turns trial data into a clear yes-or-no signal about a drug’s commercial prospects.

prespecified analysis medical

"showed 71% slowing of disease progression in a prespecified analysis"

An analysis that was planned and recorded before investigators saw the trial’s outcome data or before a study began, usually specified in the study protocol or a formal statistical analysis plan; it sets which outcomes, populations, comparisons, and statistical methods will be used. Prespecifying an analysis limits the chance that results are shaped by hindsight or selective reporting and is the basis for primary, confirmatory claims; analyses done later or without prior documentation are considered post hoc or exploratory and carry different evidentiary weight.

priority review voucher regulatory

"request for a rare pediatric disease priority review voucher"

A priority review voucher is a transferable regulatory incentive that lets a company move a future drug or device application to the front of the review line, shortening the review period by several months. For investors it matters because the voucher can speed up market access for a high-value product or be sold to other companies for significant cash, acting like a tradable fast-pass that can accelerate revenue or create immediate financial upside.

matched registry controls technical

"an overall survival analysis versus matched registry controls"

Matched registry controls are patients selected from an external database or patient registry to serve as a comparison group for a clinical study by matching them to trial participants on key baseline characteristics (for example age, disease severity, prior treatments). Researchers choose and pair registry records to resemble the trial cohort using matching techniques (such as propensity scores, exact matching, or covariate adjustment) so that outcomes observed in the registry can be compared with outcomes in the treated group when a randomized control arm is absent or impractical. Because these controls come from observational data, differences in how patients were enrolled, measured, or treated can introduce bias or unmeasured confounding, so matched registry controls provide inferential evidence rather than the causal certainty of a randomized controlled trial.

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NEWARK, N.J., Oct. 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

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What were Rafael Holdings’ fiscal 2026 earnings results?

Rafael Holdings reported a fiscal 2026 attributable net loss of $29.635 million, or $0.58 per share, compared with $30.520 million, or $1.04 per share, a year earlier. Fourth-quarter attributable net loss was $9.176 million, or $0.18 per share, versus $12.094 million, or $0.28 per share.

What did Rafael Holdings report about the remibetadex FDA application and Phase 3 results?

Cyclo Therapeutics submitted the remibetadex application on October 28, 2026 for Niemann-Pick Disease Type C. Phase 3 missed its overall primary endpoint (p=0.19), while a prespecified subgroup receiving background miglustat and/or leucine showed 71% slower disease progression (p=0.046).

What additional evidence and request are included in the remibetadex FDA application?

The application includes an overall survival analysis versus matched registry controls and a request for a rare pediatric disease priority review voucher.

Why did Rafael Holdings’ fiscal 2026 research and development expenses increase?

Rafael Holdings attributed the increase primarily to $13.4 million higher Cyclo research and development expenses, following Cyclo’s consolidation in March 2025. Research and development stock-based compensation increased $0.4 million, partly offset by payroll reductions of $1.5 million and clinical trial and other expense reductions of $0.8 million.