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Can-Fite Completes Patient Enrollment in Phase 2a Pancreatic Cancer Study of Namodenoson

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Can-Fite (NYSE American: CANF) completed patient enrollment in its multicenter, open-label Phase 2a study of Namodenoson in advanced pancreatic adenocarcinoma on Jan 20, 2026. The trial evaluates safety (primary endpoint), clinical activity, and pharmacokinetics with oral Namodenoson 25 mg twice daily in continuous 28-day cycles. To date the drug has demonstrated a favorable safety profile. The study is led by Prof. Salomon Stemmer at Davidoff Center, Rabin Medical Center. Can-Fite expects top-line efficacy data in Q3 2026. Namodenoson is a selective A3 adenosine receptor agonist with preclinical anti-tumor activity and has received FDA Orphan Drug Designation for pancreatic cancer.

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Positive

  • Patient enrollment in the Phase 2a pancreatic cancer trial is complete
  • Primary safety endpoint demonstrated to date with a favorable safety profile
  • Top-line efficacy data expected in Q3 2026
  • Namodenoson has FDA Orphan Drug Designation for pancreatic cancer

Negative

  • No top-line efficacy results reported yet; efficacy pending Q3 2026 readout
  • Phase 2a is open-label and in previously treated advanced patients, limiting generalizability

News Market Reaction – CANF

-0.25%
5 alerts
-0.25% News Effect
+6.9% Peak in 6 min
-$9K Valuation Impact
$3M Market Cap
2K Volume

On the day this news was published, CANF declined 0.25%, reflecting a mild negative market reaction. Argus tracked a peak move of +6.9% during that session. Our momentum scanner triggered 5 alerts that day, indicating moderate trading interest and price volatility. This price movement removed approximately $9K from the company's valuation, bringing the market cap to $3M at that time.

Data tracked by StockTitan Argus on the day of publication.

Key Figures

Namodenoson dose: 25 mg Dosing frequency: Twice daily Treatment cycle length: 28-day cycles +2 more
5 metrics
Namodenoson dose 25 mg Oral dose given in the Phase 2a pancreatic cancer study
Dosing frequency Twice daily Namodenoson administered twice daily in continuous cycles
Treatment cycle length 28-day cycles Continuous 28-day cycles in the Phase 2a trial
Trial phase Phase 2a Advanced pancreatic adenocarcinoma clinical study of Namodenoson
Top-line data timing Q3 2026 Efficacy top-line data expected from the Phase 2a study

Market Reality Check

Price: $4.93 Vol: Volume 67,630 is well bel...
low vol
$4.93 Last Close
Volume Volume 67,630 is well below the 20-day average of 558,271 (about 0.12x average turnover). low
Technical Shares at $4.00 are trading below the 200-day moving average of $14.61 and far under the $46.60 52-week high.

Peers on Argus

CANF fell 6.54% while biotech peers showed mixed action: ADAP -17.57%, CYCC -5.8...

CANF fell 6.54% while biotech peers showed mixed action: ADAP -17.57%, CYCC -5.84%, MTVA -6.89% versus modest gains in BIVI +1.26% and NXTC +0.62%, indicating a stock-specific move rather than a unified sector rotation.

Historical Context

5 past events · Latest: Dec 26 (Positive)
Pattern 5 events
Date Event Sentiment Move Catalyst
Dec 26 Patent grant Brazil Positive +18.6% Brazilian patent granted for A3AR agonist use in sexual dysfunction.
Dec 23 Reverse split action Negative -1.7% Announced 1-for-3,000 reverse split and ADS ratio change.
Dec 16 Clinical/financial update Positive +9.1% Updated status of multiple Namodenoson and Piclidenoson trials plus cash position.
Nov 26 Conference presentation Neutral +0.0% Outlined advanced-stage pipeline at NobleCon21 investor conference.
Nov 24 Partnership outreach Positive +12.0% Pursuit of veterinary partnerships for Namodenoson at BioFIT 2025.
Pattern Detected

Recent CANF news has generally seen directionally aligned price reactions: positive pipeline or IP updates coincided with gains, while the reverse split announcement saw a modest decline.

Recent Company History

Over the last few months, CANF has highlighted IP expansion, capital structure changes, and pipeline progress. A Brazilian patent grant on Dec 26, 2025 coincided with a +18.64% move, while a 1-for-3,000 reverse split announcement on Dec 23, 2025 saw shares slip 1.72%. Clinical and financial updates and partnership-oriented news in November–December 2025 produced positive or flat reactions, suggesting news flow has often aligned with short-term price direction.

Market Pulse Summary

This announcement marks completion of enrollment in a Phase 2a trial of Namodenoson for advanced pan...
Analysis

This announcement marks completion of enrollment in a Phase 2a trial of Namodenoson for advanced pancreatic adenocarcinoma, with a favorable safety profile reported so far and top-line efficacy data planned for Q3 2026. Against a backdrop of recent clinical updates and partnership efforts, it reinforces CANF’s focus on advancing its A3AR pipeline. Investors may watch forthcoming efficacy data, broader pipeline milestones, and capital structure developments as key future catalysts.

Key Terms

pancreatic adenocarcinoma, pharmacokinetics (PK), A3 adenosine receptor (A3AR) agonist, orphan drug designation, +1 more
5 terms
pancreatic adenocarcinoma medical
"enrolling patients with advanced pancreatic adenocarcinoma whose disease has progressed"
Pancreatic adenocarcinoma is a type of cancer that starts in the cells of the pancreas, the organ that helps digestion and controls blood sugar. It matters to investors because it is often aggressive and hard to detect early, so progress or setbacks in diagnostics, drugs or clinical trials can strongly affect the value of companies working on treatments—similar to how a breakthrough or failure in fixing a critical bridge can change the fortunes of contractors and insurers.
pharmacokinetics (PK) medical
"evaluating the safety (primary endpoint), clinical activity, and pharmacokinetics (PK)"
Pharmacokinetics (PK) is the study of how a drug moves through and is processed by the body over time. It tracks how quickly a drug is absorbed, how it spreads, how it is broken down, and how it exits the body—similar to following a recipe’s ingredients from start to finish. For investors, understanding pharmacokinetics helps assess a drug’s effectiveness and safety, which can influence its market potential and valuation.
A3 adenosine receptor (A3AR) agonist medical
"Namodenoson is a highly selective A3 adenosine receptor (A3AR) agonist"
An A3 adenosine receptor (A3AR) agonist is a drug that acts like a key to activate a specific protein 'lock' on cell surfaces called the A3 adenosine receptor, triggering signals inside cells that can reduce inflammation, protect tissue or alter cell growth. Investors watch these drugs because successful activation of this receptor can lead to new treatments for diseases, and progress through testing, safety data and regulatory approval can materially affect a drug maker’s value.
orphan drug designation regulatory
"Namodenoson has received Orphan Drug Designation from the U.S. Food and Drug Administration"
Orphan drug designation is a special status given to medicines developed to treat rare diseases affecting only a small number of people. This status often provides benefits like faster approval processes and financial incentives, making it more attractive for companies to develop these drugs. For investors, it signals potential for exclusive market rights and reduced competition, which can impact the drug’s profitability.
Phase 2a medical
"patient enrollment has been completed in its Phase 2a pancreatic cancer clinical trial"
Phase 2a is an early stage in testing a new medical treatment or drug, where the main goal is to assess its safety and find the right dosage. For investors, this stage indicates whether the treatment shows initial promise before moving on to larger, more definitive studies; progress here can influence expectations for future development and potential success.

AI-generated analysis. Not financial advice.

Primary Safety Endpoint Demonstrated to Date; Top-Line Efficacy Data Expected in Q3 2026

Ramat Gan, Israel, Jan. 20, 2026 (GLOBE NEWSWIRE) -- Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CANF), a clinical-stage biotechnology company developing a pipeline of proprietary small molecule drugs for the treatment of cancer and inflammatory diseases, today announced that patient enrollment has been completed in its Phase 2a pancreatic cancer clinical trial of Namodenoson.

The Phase 2a study is a multicenter, open-label trial enrolling patients with advanced pancreatic adenocarcinoma whose disease has progressed following at least one line of prior therapy. The study is evaluating the safety (primary endpoint), clinical activity, and pharmacokinetics (PK) of Namodenoson in this patient population. Participants receive oral Namodenoson at a dose of 25 mg, administered twice daily in continuous 28-day cycles. Patients are regularly monitored for safety, and to date, Namodenoson has demonstrated a favorable safety profile. The study is led by Prof. Salomon Stemmer, a renowned oncologist and key opinion leader at the Davidoff Center, Rabin Medical Center, Israel.

“This achievement marks a significant step forward in the clinical development of Namodenoson in pancreatic cancer,” said Pnina Fishman, Ph.D., Chief Scientific Officer of Can-Fite BioPharma. “With enrollment now complete and safety continuing to be favorable, we believe we are well positioned to generate meaningful efficacy top-line data in Q3 2026.”

Namodenoson is a highly selective A3 adenosine receptor (A3AR) agonist, which has shown a compelling safety profile and demonstrated anti-tumor activity in preclinical pancreatic cancer models. The drug is also being evaluated in clinical trials for advanced liver cancer.

Namodenoson has received Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) for the treatment of pancreatic cancer.

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 3 trial for psoriasis and commenced a pivotal Phase 3 trial. Can-Fite’s liver drug, Namodenoson, is being evaluated in a Phase III trial for hepatocellular carcinoma (HCC), a Phase 2b trial for the treatment of MASH, and in a Phase 2a 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.canfite.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, timing of efficacy data and prospects for generating meaningful efficacy data. 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. For example, the Company is using forward-looking statements when it discusses the completion of the offerings, the satisfaction of customary closing conditions related to the offerings and the intended use of proceeds therefrom. 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 market and other conditions, 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 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 April 14, 2025 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 did Can-Fite (CANF) announce about the Namodenoson pancreatic cancer trial on Jan 20, 2026?

Can-Fite completed patient enrollment in its multicenter, open-label Phase 2a trial and reported that the primary safety endpoint has been demonstrated to date.

When will Can-Fite (CANF) report top-line efficacy data for Namodenoson in pancreatic cancer?

Can-Fite expects to release top-line efficacy data in Q3 2026.

What dose of Namodenoson is being used in the Phase 2a pancreatic cancer study (CANF)?

Participants receive 25 mg of oral Namodenoson twice daily in continuous 28-day cycles.

What is the primary endpoint of Can-Fite's Phase 2a Namodenoson pancreatic cancer trial (CANF)?

The primary endpoint is safety, with additional evaluation of clinical activity and pharmacokinetics.

Does Namodenoson have any regulatory designations for pancreatic cancer?

Yes; Namodenoson has received FDA Orphan Drug Designation for the treatment of pancreatic cancer.
Can-Fite BioPharma Ltd.

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