Can-Fite Reports Q2 2026 Financial Results and Ongoing Clinical Progress Highlighting Longer-Than-Anticipated Overall Survival in Ongoing Pivotal Phase III Liver Cancer Study

Can-Fite pairs a narrower H1 2026 loss with encouraging survival trends in Namodenoson cancer studies and a pivotal psoriasis trial at interim readout.

Rhea-AI Summary

Can-Fite BioPharma (CANF) reported H1 2026 results with a $4.6 million net loss and highlighted late-stage clinical progress.

Revenues were stable at $0.20 million versus H1 2025, while research and development expenses rose 13.86% to $3.45 million, mainly due to Namodenoson and Piclidenoson trials. General and administrative expenses decreased 31.40% to $1.42 million, narrowing the net loss from $4.87 million to $4.60 million. Cash, cash equivalents and short-term deposits stood at $7.03 million on June 30, 2026, before approximately $4.0 million gross proceeds from September warrant exercises.

Clinically, a Phase IIa pancreatic cancer study of Namodenoson met its primary safety endpoint and showed durable overall survival in heavily pretreated patients. In the pivotal Phase III HCC trial, blinded overall survival appears longer than study design assumptions, prompting evaluation of an earlier interim analysis. Piclidenoson’s pivotal psoriasis Phase 3 reached its pre-specified interim analysis, with results expected in Q1 2027, and new patents expanded protection for both drugs in multiple countries.

Positive

• Net loss decreased to $4.60 million in H1 2026 from $4.87 million in H1 2025
• General and administrative expenses fell 31.40% to $1.42 million, mainly from lower investor relations costs
• R&D investment increased 13.86% to $3.45 million, reflecting advancement of Phase 3 and Phase 2b programs
• Cash, cash equivalents and short-term deposits were $7.03 million at June 30, 2026, supplemented by about $4.0 million gross warrant proceeds in September 2026
• Namodenoson pancreatic Phase IIa met its primary safety endpoint and showed durable overall survival in heavily pretreated patients
• Blinded overall survival in the pivotal Phase III HCC study appears longer than anticipated, leading the company to assess earlier interim analysis timing
• Piclidenoson psoriasis Phase 3 reached its protocol-defined interim analysis, with efficacy and safety results expected in Q1 2027
• Intellectual property expanded with multiple patent allowances for Namodenoson and Piclidenoson in Israel, Canada, Brazil, Australia and Japan

Negative

• Revenues remained minimal at $0.20 million for H1 2026, unchanged from H1 2025 and limited to out-licensing payments
• Ongoing operating loss persisted at $4.60 million in H1 2026 despite lower G&A spending
• Cash and short-term deposits declined to $7.03 million at June 30, 2026 from $8.53 million at December 31, 2025 before later warrant proceeds
• R&D expenses increased by $0.42 million year over year, raising cash outflows as late-stage trials progress
• Pivotal trials in HCC and psoriasis remain blinded or at interim stage, so no definitive efficacy outcomes are yet available

News Explained

Can-Fite’s H1 2026 report lists $4,285,093 issued and outstanding ordinary shares on June 30, 2026, versus $2,618,425 on December 31, 2025; if that higher count reflects additional issuance, the stated dilution mechanics mean existing holders’ percentage ownership is reduced.

Key Figures

Phase IIa enrollment: 20 patients Phase 3 enrollment: 247 patients Interim results timing: Q1 2027 +5 more

Phase IIa enrollment

20 patients

Advanced pancreatic ductal adenocarcinoma study

Phase 3 enrollment

247 patients

Pivotal moderate-to-severe plaque psoriasis study

Interim results timing

Q1 2027

Psoriasis Phase 3 interim analysis

Revenue

$0.20 million

Six months ended June 30, 2026, versus $0.20 million in 2025

Research and development expenses

$3.45 million

Six months ended June 30, 2026, up $0.42 million from 2025

Net loss

$4.60 million

Six months ended June 30, 2026, versus $4.87 million in 2025

Cash and short-term deposits

$7.03 million

As of June 30, 2026, versus $8.53 million at December 31, 2025

Warrant exercise proceeds

$4.0 million

Aggregate gross proceeds received during September 2026

Historical Context

2 past events · Latest: Sep 02

2 events

1. Sep 02

   Phase III liver study

   24h Move

   -27.4%

   Blinded survival appeared longer than design assumptions; earlier interim analysis was evaluated.

2. Sep 02

   Warrant exercise

   24h Move

   -27.4%

   Warrant exercises generated gross proceeds while new warrants were issued at $2.50.

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

Key Terms

overall survival, hepatocellular carcinoma, interim analysis, out-licensing agreements, +1 more

5 terms

overall survival medical

"demonstrated durable overall survival outcomes"

Overall survival is the average or median length of time patients remain alive after starting a treatment or entering a clinical study, measured regardless of cause of death. Investors care because it is a clear, hard measure of a therapy’s real-world benefit — like timing how long a new battery actually runs — and strong improvements in overall survival can drive regulatory approval, market adoption and revenue potential.

hepatocellular carcinoma medical

"ongoing pivotal Phase III study in advanced hepatocellular carcinoma"

Hepatocellular carcinoma is the most common form of primary liver cancer, arising from the main functional cells of the liver. For investors it matters because its serious health impact drives demand for diagnostic tests, treatments and long-term care; progress in trials or approvals can change a drugmaker’s revenue outlook much like a successful product launch can reshape a company’s future.

interim analysis technical

"the study’s planned interim analysis"

An interim analysis is an early review of a project or process before it is fully completed. For investors, it provides a snapshot of progress or performance, helping to identify whether things are on track, need adjustment, or should be stopped early. Think of it as a progress report that can influence decisions before the final outcome is known.

out-licensing agreements financial

"under our existing out-licensing agreements"

Out-licensing agreements are contracts where a company grants another firm the rights to develop, manufacture, sell, or market a product or technology that the first company owns, usually in exchange for upfront payments, milestone payments, and royalties. Investors care because these deals can generate revenue, share development risk, and expand market reach much like renting out a patent to a specialist who will do the heavy lifting.

us gaap financial

"presented in accordance with US GAAP Reporting Standards"

U.S. GAAP is the set of official accounting rules and standards companies in the United States use to record and report their financial results. Like a common recipe book for financial statements, it makes company reports consistent and easier to compare, so investors can better judge profitability, risk and trends when deciding to buy, hold or sell shares.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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RAMAT GAN, Israel, Sept. 08, 2026 (GLOBE NEWSWIRE) -- Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CANF), a biotechnology company developing a pipeline of proprietary small molecule drugs targeting oncological and inflammatory diseases, today announced clinical updates and financial results for H1 2026.

Advances in Clinical Programs

Pancreatic Cancer
Phase 2a study evaluating Namodenoson in patients with advanced pancreatic ductal adenocarcinoma achieved its primary safety endpoint and demonstrated durable overall survival outcomes. The open-label Phase IIa study enrolled 20 patients with advanced pancreatic ductal adenocarcinoma who had progressed following standard therapies. Fourteen patients received Namodenoson as third-line treatment, five as second-line treatment, and one as fourth-line treatment. Namodenoson was well tolerated. Overall survival findings identify a subset of heavily pretreated pancreatic cancer patients achieving prolonged survival despite receiving Namodenoson as third-line therapy. A Phase IIb study protocol which combines chemotherapy and Namodenoson is under development. An abstract highlighting the positive results has been accepted for poster presentation at the European Society for Medical Oncology (ESMO) Congress 2026.

Hepatocellular Carcinoma (HCC)
Blinded overall survival observed across the entire patient population in the Company’s ongoing pivotal Phase III study of Namodenoson in advanced hepatocellular carcinoma (HCC) appears longer than originally anticipated based on the assumptions underlying the study design.

In view of the longer-than-anticipated survival observed in the study population, Can-Fite is evaluating an earlier timing for the study’s planned interim analysis.

Clinical Progress in Psoriasis
The Company completed enrolment of the first 247 patients in its pivotal Phase 3 study evaluating Piclidenoson for the treatment of moderate-to-severe plaque psoriasis. The study has now reached the pre-specified interim analysis stage under a protocol agreed with both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). The interim analysis will evaluate efficacy and safety data from the enrolled patients. Results are expected during Q1 2027.

Strengthening of Intellectual Property Portfolio
Can-Fite continued to expand its global intellectual property estate with multiple patent allowances across key territories, including Israel, Canada, Brazil, Australia and Japan, covering novel therapeutic uses of Namodenoson and Piclidenoson. These additions further strengthen the Company’s long-term commercial positioning and pipeline value.

Motti Farbstein Can-Fite’s CEO&CFO stated: “The first half of 2026 was marked by meaningful progress across our clinical programs. We are particularly encouraged by the longer-than-anticipated overall survival observed to date in our ongoing pivotal Phase III liver cancer study, while recognizing that the study remains blinded. In parallel, the durable survival outcomes observed in heavily pretreated pancreatic cancer patients and the advancement of our pivotal psoriasis study to its interim analysis stage further strengthen our clinical pipeline. We remain focused on disciplined execution of these late-stage programs and on advancing Namodenoson and Piclidenoson toward important clinical and regulatory milestones.”

Financial Results

Revenues

Revenues for the six months ended June 30, 2026 were $0.20 million compared to $0.20 million for the six months ended June 30, 2025. Revenues for the six months ended June 30, 2026 and for the six months ended June 30, 2026 comprise of a portion of advance payments received under our existing out-licensing agreements with Cipher, CKD Gebro and Ewopharma.

Research and development expenses

Research and development expenses for the six months ended June 30, 2026 were $3.45 million, an increase of $0.42 million, or 13.86%, compared to $3.03 million for the six months ended June 30, 2025. Research and development expenses for the first half of 2026 comprised primarily of expenses associated with the ongoing of the Phase 3 study of Piclidenoson for the treatment of psoriasis and two ongoing studies for Namodenoson, a Phase 3 study in the treatment of advanced liver cancer and a Phase 2b study for MASH. The increase is primarily due to acceleration in expenses associated with both the Namodenoson and Piclidenoson programs.

General and administrative expenses

General and administrative expenses for the six months ended June 30, 2026 were $1.42 million, a decrease of $0.65 million, or 31.40%, compared to $2.07 million for the six months ended June 30, 2025. The decrease is primarily due to lower investors relations expenses. We expect that general and administrative expenses will remain at the same level through 2026.

Financial income, net

Financial income, net for the six months ended June 30, 2026 was $0.08 million compared to $0.02 million for the six months ended June 30, 2025. The increase in financial income, net was mainly due to higher interest income from bank deposits. 

Net loss for the six months period ended June 30, 2026 was $4.60 million compared with a net loss of $4.87 million for the six months period ended June 30, 2025 . The decrease in net loss for the six months period ended June 30, 2026 was primarily attributable to a decrease in general and administrative expenses which was offset by an increase in research and development expenses .

As of June 30, 2026, Can-Fite had cash and cash equivalents and short term deposits of $7.03 million as compared to $8.53 million at December 31, 2025. The decrease in cash during the six months period ended June 30, 2026 is mainly due to the Company's operating loss which was offset by proceeds from issuance of shares and warrants. During September 2026, the Company received aggregate gross proceeds of approximately $4.0 million from warrant exercises and a warrant inducement.

The Company's consolidated financial results for the six months period ended June 30, 2026 are presented in accordance with US GAAP Reporting Standards.

CONDENSED CONSOLIDATED BALANCE SHEETS
U.S. dollars in thousands (except for share and per share data)
		June 30,			December 31,
		2026			2025
		Unaudited
ASSETS
CURRENT ASSETS:
Cash and cash equivalents		$	2,985		$	5,528
Short term deposits			4,052			3,011
Prepaid expenses and other current assets			960			900
Short-term investment			6			1
Total current assets			8,003			9,440
NON-CURRENT ASSETS:
Operating lease right of use assets			47			69
Property, plant and equipment, net			5			5
Total non-current assets			52			74
Total assets		$	8,055		$	9,514

CONDENSED CONSOLIDATED BALANCE SHEETS
U.S. dollars in thousands (except for share and per share data)
		June 30,				December 31,
		2026				2025
		Unaudited
LIABILITIES AND SHAREHOLDERS’ EQUITY
CURRENT LIABILITIES:
Trade payables		$	681			$	1,161
Current maturity of operating lease liability			48				56
Deferred revenues			405				405
Other accounts payable			1,091				1,109
Total current liabilities			2,225				2,731
NON-CURRENT LIABILITIES:
Long - term operating lease liability			1				15
Deferred revenues			974				1,176
Total long-term liabilities			975				1,191
CONTINGENT LIABILITIES AND COMMITMENTS
SHAREHOLDERS’ EQUITY:
Ordinary shares of no-par value - Authorized: 30,000,000 and 14,000,000 shares at June 30, 2026 and December 31, 2025, respectively; Issued and outstanding: 4,285,093 and 2,618,425 shares as of June 30, 2026 and December 31, 2025, respectively			-				-
Additional paid-in capital			184,518				180,654
Accumulated other comprehensive income			1,127				1,127
Accumulated deficit			(180,790	)			(176,189	)
Total shareholders’ equity			4,855				5,592
Total liabilities and shareholders’ equity		$	8,055			$	9,514

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
U.S. dollars in thousands (except for share and per share data)
		Six months ended June 30,
		2026				2025
		Unaudited
Revenues		$	202			$	202
Research and development expenses			(3,456	)			(3,034	)
General and administrative expenses			(1,426	)			(2,066	)
Operating loss			(4,680	)			(4,898	)
Financial income, net			79				22
Operating loss			(4,601	)			(4,876	)
Basic and diluted net loss per share			(1.24	)			(4.29	)
Weighted average number of ordinary shares used in computing basic and diluted net loss per share			3,711,018				1,137,303

About Can-Fite BioPharma Ltd.
Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CANF) is an advanced clinical stage drug development Company with a platform technology that is designed to address multi-billion dollar markets in the treatment of cancer, liver, and inflammatory disease. The Company's lead drug candidate, Piclidenoson recently reported topline results in a Phase III trial for psoriasis and is expected to commence a pivotal Phase III. Can-Fite's cancer and liver drug, Namodenoson, is being evaluated in a Phase IIb trial for the treatment of steatotic liver disease (SLD), a Phase III pivotal trial for hepatocellular carcinoma (HCC), and the Company is planning a Phase IIa study in pancreatic cancer. Namodenoson has been granted Orphan Drug Designation in the U.S. and Europe and Fast Track Designation as a second line treatment for HCC by the U.S. Food and Drug Administration. Namodenoson has also shown proof of concept to potentially treat other cancers including colon, prostate, and melanoma. CF602, the Company's third drug candidate, has shown efficacy in the treatment of erectile dysfunction. These drugs have an excellent safety profile with experience in over 1,600 patients in clinical studies to date. For more information please visit: www.can-fite.com.

Forward-Looking Statements
This press release may contain forward-looking statements, about Can-Fite’s expectations, beliefs or intentions regarding, among other things, its product development efforts, business, financial condition, results of operations, strategies or prospects. All statements in this communication, other than those relating to historical facts, are “forward looking statements”. Forward-looking statements can be identified by the use of forward-looking words such as “believe,” “expect,” “intend,” “plan,” “may,” “should” or “anticipate” or their negatives or other variations of these words or other comparable words or by the fact that these statements do not relate strictly to historical or current matters. Forward-looking statements relate to anticipated or expected events, activities, trends or results as of the date they are made. Because forward-looking statements relate to matters that have not yet occurred, these statements are inherently subject to known and unknown risks, uncertainties and other factors that may cause Can-Fite’s actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Important factors that could cause actual results, performance or achievements to differ materially from those anticipated in these forward-looking statements include, among other things, our history of losses and needs for additional capital to fund our operations and our inability to obtain additional capital on acceptable terms, or at all; uncertainties of cash flows and inability to meet working capital needs; the initiation, timing, progress and results of our preclinical studies, clinical trials and other product candidate development efforts; our ability to advance our product candidates into clinical trials or to successfully complete our preclinical studies or clinical trials; our receipt of regulatory approvals for our product candidates, and the timing of other regulatory filings and approvals; the clinical development, commercialization and market acceptance of our product candidates; our ability to establish and maintain strategic partnerships and other corporate collaborations; the implementation of our business model and strategic plans for our business and product candidates; the scope of protection we are able to establish and maintain for intellectual property rights covering our product candidates and our ability to operate our business without infringing the intellectual property rights of others; competitive companies, technologies and our industry; risks related to the security situation in Israel; risks related to not satisfying the continued listing requirements of NYSE American; and statements as to the impact of the political and security situation in Israel on our business. More information on these risks, uncertainties and other factors is included from time to time in the “Risk Factors” section of Can-Fite’s Annual Report on Form 20-F filed with the SEC on March 26, 2026 and other public reports filed with the SEC and in its periodic filings with the TASE. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Can-Fite undertakes no obligation to publicly update or review any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by any applicable securities laws.

Contact
Can-Fite BioPharma
Motti Farbstein
info@canfite.com
+972-3-9241114

FAQ

What were Can-Fite’s main revenue sources in the first half of 2026?

Revenues of $0.20 million for the six months ended June 30, 2026 comprised a portion of advance payments received under existing out-licensing agreements with Cipher, CKD Gebro and Ewopharma.

How is Can-Fite’s R&D spending distributed across its key programs?

Research and development expenses of $3.45 million in H1 2026 were primarily related to the ongoing Phase 3 Piclidenoson study in psoriasis and two Namodenoson studies: a pivotal Phase 3 trial in advanced liver cancer and a Phase 2b study in MASH.

What change has been observed so far in the Phase III liver cancer study of Namodenoson?

In the ongoing blinded pivotal Phase III hepatocellular carcinoma study, overall survival observed across the entire patient population appears longer than originally anticipated based on the assumptions used in the study design, and the company is evaluating an earlier timing for the planned interim analysis.

What is the status and expected timing of the Piclidenoson psoriasis Phase 3 interim analysis?

The company has completed enrolment of the first 247 patients in its pivotal Phase 3 study in moderate-to-severe plaque psoriasis, reaching the pre-specified interim analysis agreed with the FDA and EMA. The interim analysis will assess efficacy and safety, with results expected during Q1 2027.

What recent financing-related inflows has Can-Fite reported after June 30, 2026?

During September 2026, the company received aggregate gross proceeds of approximately $4.0 million from warrant exercises and a warrant inducement.

Under which accounting standards are Can-Fite’s H1 2026 financials prepared?

The consolidated financial results for the six months ended June 30, 2026 are presented in accordance with US GAAP Reporting Standards.