Can-Fite BioPharma ($CANF) Stock Hub: Phase III Liver Survival Longer Than Assumed, ESMO Pancreatic Data Accepted

01Scenario framework: no false price targets

Numerical price targets would imply a precision the current post-transaction share structure does not support. The framework should move when randomized data and issuer-declared capitalization move.

02Latest verified status

September 2 produced two distinct material events. At 07:00 ET, Can-Fite reported that blinded overall survival across the entire ongoing LIVERATION Phase III population appears longer than originally anticipated based on the assumptions used in the study design. The wording matters. The subtitle of the release says the company plans to advance the interim analysis; the body says Can-Fite is evaluating an earlier timing for it. The second formulation is the operative one, and no new date has been published.

The key limitation is explicit in the issuer release: the observation is pooled and blinded. The population contains both Namodenoson and placebo. No efficacy conclusion or between-arm difference can be drawn from the current observation. A longer pooled survival curve can be consistent with treatment benefit, stronger control-arm survival, patient-mix differences, subsequent therapy, censoring or several of those factors together.

At 09:02 ET, Can-Fite announced a separate warrant-inducement transaction. Under a definitive agreement, warrants over 1,591,738 ADSs issued in March 2026 were exercised immediately at a reduced price of $2.50 per ADS, down from $5.00; the release names no holder. The ADSs issued on exercise are covered by an already effective registration statement on Form F-3, File No. 333-294760. Gross proceeds were approximately $4.0 million. In consideration, Can-Fite issued new unregistered warrants to purchase 3,183,476 ADSs at $2.50 per ADS. The H1 report filed on September 8 states that the transaction closed on September 3, 2026.

03Investment summary and central debate

The central question is simple: can late-stage clinical value grow faster than the capital structure? Can-Fite has more clinical maturity than its nano-cap size suggests. Namodenoson is in pivotal Phase III development in advanced HCC, and Piclidenoson is in a pivotal Phase III psoriasis program with a pre-specified interim cohort already enrolled. Pancreatic cancer, MASH, Lowe syndrome and a partnered veterinary program add optionality around the same A3 adenosine receptor platform.

The clinical side is real. LIVERATION uses overall survival as its primary endpoint in a randomized, double-blind, placebo-controlled study. The psoriasis program is also randomized and pivotal. These are not preclinical assets dressed up as catalysts.

At June 30, 2026, cash and cash equivalents were $7.037 million; the first-half net loss was approximately $4.60 million. On September 8 the company confirmed receipt of $4 million gross from the September warrant transaction. These proceeds are subsequent to the balance-sheet date, not part of June cash. Financing and dilution risks remain.

What could be mispriced

The market may underweight the convexity of two pivotal programs. A convincing randomized HCC survival benefit would validate a prospective Phase III test of the Child-Pugh B7 subgroup signal and could materially change the strategic value of Namodenoson. A successful psoriasis interim would provide a second independent late-stage proof point.

What remains rationally discounted

Clinical success does not automatically equal per-ADS success. Cash requirements, the repeated warrant-replacement pattern, the gap between historical share counts and the post-financing structure declared on September 25, 2026, and the breadth of the pipeline all justify a financing discount.

What kills the thesis

A weak or futile HCC interim, a psoriasis miss, repeated timeline slippage, or financing at progressively lower prices would challenge the idea that asset value can outrun dilution.

04What Can-Fite is in 2026: an A3AR platform with no commercial drug revenue

Can-Fite BioPharma is an Israeli clinical-stage biotechnology company developing orally bioavailable small molecules that target the A3 adenosine receptor, or A3AR. The platform thesis is that A3AR is expressed at higher levels in several diseased inflammatory and cancer tissues than in normal tissue, creating a pharmacologic target that may allow selective signaling effects.

The lead molecules are Namodenoson, focused on oncology and liver disease, and Piclidenoson, focused on inflammatory disease and additional indications. CF602 is an earlier-stage A3AR-related asset being investigated for erectile dysfunction.

Can-Fite is not a commercial drug company. Its historical revenue has come primarily from out-licensing and distribution arrangements. In 2025, revenue was only $0.405 million. The economic thesis therefore depends on clinical development, partnerships and access to capital rather than on an established product cash engine.

05Namodenoson in HCC: why this is the core value driver

The HCC program is rooted in an earlier randomized Phase II study in patients with advanced hepatocellular carcinoma and Child-Pugh B cirrhosis who had failed first-line Nexavar. The full 78-patient population did not meet the primary overall-survival endpoint: median OS was 4.1 months with Namodenoson versus 4.3 months with placebo.

The pre-planned Child-Pugh B7 subgroup told a different story. In 56 CPB7 patients, median overall survival was 6.8 months in the Namodenoson group versus 4.3 months in placebo; the hazard ratio was 0.77 with a wide 95% confidence interval of 0.49–1.40. One-year survival was 44% versus 18% and the company reported p=0.028 for that comparison. These data generated the hypothesis now being tested prospectively in Phase III.

That history creates both the opportunity and the main scientific risk. LIVERATION is designed around the subgroup in which the prior signal looked strongest. If the effect reproduces prospectively, the Phase II subgroup becomes clinically meaningful. If it does not, the earlier signal will look like a subgroup result that failed replication.

Can-Fite also reports a long-term compassionate-use patient who achieved complete response and has remained cancer-free for years. The case is notable evidence of possible durable activity in an individual patient, but it is anecdotal and cannot substitute for randomized Phase III evidence.

06LIVERATION Phase III: design, endpoint and timeline drift

LIVERATION is a pivotal randomized, double-blind, placebo-controlled Phase III trial expected to enroll approximately 450 patients with advanced HCC and underlying Child-Pugh B7 cirrhosis at centers worldwide. Patients are randomized 2:1 to oral Namodenoson 25 mg twice daily or matching placebo.

Overall survival is the primary efficacy endpoint. Radiographic response, progression-free survival and safety are additional outcomes. The design was developed after regulatory interaction with the FDA and EMA, and Can-Fite states that a successful trial is intended to support an NDA in the United States and a marketing authorization application in Europe.

Regulatory standing, as the company describes it. In the release of August 12, 2026, Can-Fite set out the regulatory position of both lead candidates: Namodenoson holds FDA Fast Track designation and orphan drug designation in the United States and in Europe, and the pivotal liver study is being run under guidance from both the FDA and the EMA with the intention of supporting marketing applications on both sides of the Atlantic if the endpoints are met. Designations shorten and structure the path; they do not lower the evidentiary bar, and none of them substitutes for the randomised result. Intellectual property moved in the same direction over the summer: on July 14, 2026 the Australian Patent Office allowed application 2021290439, “Treatment of Advanced Metastatic Cancer”, and on June 26 a Japanese allowance covered the anti-obesity technology around Namodenoson.

The correct current catalyst label is therefore timing to be announced. Reverting automatically to Q4 2026 would manufacture a date the company has not restored.

07Pipeline map: two Phase III assets plus broader optionality

One caution on the registry entries. The public records on ClinicalTrials.gov are older than the company disclosures. Read on September 2, 2026, LIVERATION (NCT05201404) was listed as recruiting with an estimated enrolment of 471 patients, a last update posted on April 29, 2025 and an estimated primary completion date of February 2026 that has passed. The pivotal psoriasis study (NCT06643260) was still listed as not yet recruiting, with 705 patients estimated and the same April 29, 2025 update date, although the company announced completion of the 247-patient interim cohort on July 6, 2026. The MASH study (NCT04697810) carried the status unknown, last updated July 31, 2024, and the pancreatic study (NCT06387342) was still listed as recruiting with 20 patients estimated and a January 31, 2025 update, although the company has described that Phase 2a as completed. Where the registry and the issuer disagree on stage or timing, the company disclosure is the more recent document, and neither should be read as a schedule.

08September 2 HCC update: important trial information, not efficacy evidence

The September 2 release says blinded overall survival across the entire LIVERATION population appears longer than originally anticipated based on the study-design assumptions. In an event-driven survival trial, event accumulation affects when an interim analysis can be conducted, so the observation can change planning even before treatment assignments are known.

What the release does not disclose is just as important: no treatment-arm median OS, no placebo median OS, no hazard ratio, no confidence interval, no event count and no statistical comparison between Namodenoson and placebo.

The observation may still be strategically useful. It tells investors that the survival behavior of the enrolled population differs from the assumptions used to design the study and that management considers the dataset mature enough to evaluate an earlier interim. It changes the timing importance of the trial, not yet its treatment effect.

09Piclidenoson Phase III psoriasis: the second major binary

On July 6, Can-Fite announced completion of enrollment of the first 247 patients required for the pre-specified interim analysis in its pivotal randomized, double-blind, placebo-controlled Phase III study of Piclidenoson in moderate-to-severe plaque psoriasis. The company guides interim efficacy and safety results to Q1 2027.

The program matters because it is a late-stage catalyst independent of the HCC thesis. A strong randomized result would support Piclidenoson and broaden confidence in the A3AR platform. A weak result would remove one of CANF’s two largest near-term value drivers.

The commercial hurdle is high. Psoriasis already has highly effective biologics and oral therapies. A statistically positive outcome is necessary but may not be sufficient for strong commercial positioning. Efficacy magnitude, onset, durability, safety, convenience and eventual pricing/reimbursement would all matter.

10Pancreatic cancer: a real clinical signal with major evidentiary limits

Can-Fite’s completed Phase 2a pancreatic ductal adenocarcinoma study enrolled 20 patients with advanced disease who had progressed after standard therapy. Fourteen received Namodenoson as third-line treatment, five as second-line treatment and one as fourth-line treatment. The study achieved its primary safety endpoint.

Can-Fite has described durable survival and disease stabilization in subsets, including a second-line patient alive beyond 18 months at the July update. Those observations are encouraging in a difficult disease setting, but the study was small, open-label and non-randomized. It cannot establish comparative efficacy.

The next development step is moving toward a randomized Phase IIb combination study. On August 17, Can-Fite reported preclinical work showing that Namodenoson enhanced gemcitabine activity and described a planned combination with gemcitabine and nab-paclitaxel. That is more concrete than earlier 2026 language that referenced an immunotherapy combination; the final registered protocol remains the controlling document once available.

The Phase 2a abstract has been accepted for poster presentation at ESMO Congress 2026 in Madrid. ESMO begins October 23. The poster can add transparency and scientific context, but it cannot convert an uncontrolled 20-patient study into randomized evidence.

11MASH, Lowe syndrome and veterinary optionality

MASH

Namodenoson remains in Phase IIb development for metabolic dysfunction-associated steatohepatitis. The indication is commercially large but increasingly competitive, and it is not the principal near-term driver of CANF. For the equity thesis, MASH is best treated as additional pipeline optionality until a clearly defined readout becomes imminent.

Lowe syndrome

On August 3, Can-Fite announced submission of a Phase II protocol for Piclidenoson to Bambino Gesù Children’s Hospital in Rome for Lowe syndrome, a rare X-linked genetic disorder. The study is described as open-label and single-centre in five adult patients with genetically confirmed disease, six months of oral treatment twice daily, with the primary endpoint the improvement in renal uptake of 99mTc-DMSA as a measure of proximal tubular reabsorption; Professor Francesco Emma is named as lead investigator and the programme runs under a collaboration agreement with Fondazione Telethon. This is a new clinical direction and may have orphan-development relevance, but protocol submission is not the same as an activated, enrolling trial.

Vetbiolix

Can-Fite’s veterinary partner Vetbiolix completed enrollment of a randomized, double-blind, placebo-controlled Phase II study in 118 client-owned dogs with osteoarthritis. Vetbiolix funds development and the company guides top-line results to Q3 2026. Can-Fite describes the licensing economics as potentially generating up to $325 million over a decade, but that figure is contingent on successful development and commercialization and should not be treated as contracted cash.

Why the optionality needs discipline

More indications can create more partnership opportunities, but they also create more work. For a company with a small cash base, HCC and psoriasis should remain the execution benchmarks. New indications are additive only if they do not delay or weaken the pivotal programs.

September 9, 2026 — Namodenoson: a single-patient cirrhosis report

Can-Fite announced a published case report on September 9 describing resolution of ascites and regression of esophageal varices during namodenoson treatment in one patient with decompensated cirrhosis. The patient remained clinically stable for approximately 28 months before liver transplantation in January 2026. The company explicitly reports continued deterioration in hepatic synthetic function despite those clinical improvements.

This is a single-patient observation, not randomized evidence of efficacy, a new approval or a result from the Phase 3 HCC trial. The report is separate from the oncology and MASH trial programs. The summary here is based on the company release; the scientific paper has not been independently reviewed in full.

Company release

12FY2025 financial scorecard

September 8 update: Can-Fite reported $7.03 million in cash, cash equivalents and short-term deposits at June 30, 2026, and an H1 net loss of $4.60 million. The approximately $4 million gross September warrant transaction is a separate subsequent event, not part of June cash. In the ongoing HCC Phase 3, longer-than-assumed pooled survival remains blinded and cannot establish a treatment benefit. The company is evaluating earlier timing for the planned interim analysis without announcing a firm date. The psoriasis interim remains expected in Q1 2027.

Can-Fite’s latest annual financial baseline is the year ended December 31, 2025. Because the company has no commercial product revenue, the income statement is principally a record of licensing-recognition revenue and development spending.

The annual report says R&D will remain the company’s primary expense and may increase as clinical programs advance. That matters because the two Phase III programs and the planned pancreatic Phase IIb are not cheap relative to the reported balance sheet.

13Cash, capital structure and dilution remain the binding constraint

At June 30, 2026, cash and cash equivalents were $7.037 million; the first-half net loss was approximately $4.60 million. On September 8 the company confirmed receipt of $4 million gross from the September warrant transaction. These proceeds are subsequent to the balance-sheet date, not part of June cash. Financing and dilution risks remain.

The share structure changed rapidly even before September. The 20-F reported 2,618,425 ordinary shares outstanding at December 31, 2025. The resale registration statement filed on March 31, 2026 reported 4,285,093 ordinary shares outstanding, and the Form F-3 of August 28, 2026 restates the same count at August 25, 2026. One ADS currently represents two ordinary shares.

The March inducement, announced on March 4, 2026, took 795,869 ADS warrants issued in July 2025 at $9.34 per ADS, cut the price to $5.00 to bring the exercise forward, and issued 1,591,738 new ADS warrants at $5.00. The strike has therefore stepped down twice in six months: $9.34, then $5.00, now $2.50. The September 2 transaction now uses that March block: 1,591,738 ADS warrants are being exercised at $2.50, and Can-Fite will issue 3,183,476 new ADS warrants at $2.50, subject to closing.

The August 28 shelf, and the ceiling the float puts on it

The Form F-3 filed on August 28, 2026 contains two prospectuses. The base prospectus covers up to $100 million of ordinary shares, ADSs, warrants, subscription rights and units. Inside that amount sits an at-the-market prospectus supplement for up to $1,065,000 of ADSs to be sold through H.C. Wainwright under an offering agreement; the supplement models 641,566 ordinary shares, represented by 320,783 ADSs, at an assumed price of $3.32 per ADS, which would take the count to 4,926,659 ordinary shares.

The $100 million headline is not the usable number. Can-Fite states that the aggregate market value of its equity held by non-affiliates was approximately $9.9 million at July 1, 2026 on the Instruction I.B.5 basis, and that while the public float stays below $75 million it may not sell more than one-third of that float in a primary offering over any twelve-month period. It also discloses having already offered approximately $2.2 million under the same instruction in the preceding twelve months. The at-the-market size of $1,065,000 sits inside that limit rather than beside it: one-third of a $9.9 million float is about $3.3 million, and roughly $2.2 million of it has already been used. That is also the background against which warrant inducements — which are exercises of existing securities rather than primary sales — have been the working funding route.

Two states should not be blurred. The shelf is filed, and a Form F-3 of this type becomes usable only once it is declared effective; the at-the-market agreement is capacity that may or may not be drawn. Neither is cash received, and neither is included in the December 31, 2025 liquidity figure above.

On that point the EDGAR record at the September 30, 2026 reading separates three things. The two post-effective amendments filed on September 8, 2026, file numbers 333-288890 and 333-269485, were declared effective on September 11, 2026. The $100 million shelf filed on August 28 carries no effectiveness notice, so it remains filed. And a third registration statement, the resale Form F-3 filed on September 25 with an F-3/A the same day, registers the resale of up to 6,589,796 ordinary shares represented by 3,294,898 ADSs: 3,183,476 ADSs issuable under the new warrants and 111,422 under the placement-agent warrants. No ADSs are registered for sale by the company under it, and the company receives no proceeds from those resales — it is the document that lets the warrant holders sell what they get, which is the exit the inducement was built around.

Two terms of that inducement were only stated in the September 25 filing. The placement agent, H.C. Wainwright, receives warrants over up to 111,422 ADSs, 7.0% of the ADSs exercised, on the same terms as the new warrants except for the price, which is $3.125 per ADS, 125% of the reduced exercise price. And the closing is dated September 4, 2026 in that filing, while the half-year report of September 8 dates it September 3. Two issuer documents, two dates; both are recorded here rather than one being chosen.

14Warrant mechanics, ADS conversion and what the $4 million really buys

The September transaction is not simply “$4 million of new cash.” It is an exchange of immediate liquidity for a larger contingent equity claim.

At the current depositary ratio, one ADS represents two ordinary shares. The September exercise therefore represents 3,183,476 ordinary shares if and when the ADSs are issued on closing. The new 3,183,476 ADS warrant block corresponds to a potential 6,366,952 ordinary shares if fully exercised in the future, before considering any other securities.

Those other securities are large, and the Form F-3 of August 28, 2026 quantifies them. On the same 4,285,093-share base at August 25, 2026, the document lists as excluded 4,228,828 ordinary shares, represented by 2,114,414 ADSs, issuable on the exercise of outstanding warrants at a weighted-average price of $6.50 per ADS, plus 204,465 ordinary shares under stock options at a weighted-average $23.10 per ordinary share and 23,686 shares reserved for future awards. Warrant coverage alone is therefore close to the entire issued share count. The September 2 transaction moves inside that figure rather than sitting entirely on top of it: 1,591,738 of those ADS warrants are the ones being exercised, and 3,183,476 new ones replace them, which on the August 25 base works out at about 3.71 million ADS warrants outstanding once the deal closes — a Merlintrader calculation, not a company figure.

This does not mean all new warrants will be exercised. Their economic value depends on the share price, terms, registration status and future corporate actions. It does mean the contingent dilution pool is large relative to the last issuer-declared share count.

The company says the net proceeds will fund R&D, clinical trials, working capital and general corporate purposes. That use is consistent with the current business model: external financing is funding the period before pivotal clinical outcomes.

15Governance, management and ownership alignment

Motti Farbstein serves as Chief Executive Officer and Chief Financial Officer. Pnina Fishman, Ph.D. is Executive Chairperson and Chief Scientific Officer. The 2025 20-F reported the audit committee as composed of three independent non-executive directors: Guy Regev, Yoseph Borenstein and Ilan Tamir.

Beneficial ownership by senior management and directors was modest at the March 25, 2026 reference date. The 20-F reported 24,068 ordinary shares beneficially owned by the seven-person group, equal to 1.0% under the filing’s ownership calculation. It reported no holder known by the company to own more than 5% of voting securities at that date.

A June 2026 Form 4 for Motti Farbstein reported an option grant rather than an open-market insider purchase. Compensation grants, vesting and tax withholding should not be treated as discretionary insider conviction trades.

16Competition and clinical positioning

HCC / Child-Pugh B7

Can-Fite is targeting a difficult population with impaired liver function, a group often underrepresented in oncology development. A clean overall-survival advantage with tolerable safety could create differentiation because the clinical need is high. The advantage must be demonstrated prospectively; a targeted subgroup is not a moat until the Phase III trial confirms benefit.

Psoriasis

Psoriasis is the opposite competitive problem. The market contains highly effective IL-17 and IL-23 biologics as well as oral therapies. Piclidenoson can potentially compete on oral convenience, safety and cost, but the efficacy threshold for adoption is high. A positive trial that is clinically modest may have less commercial value than a headline implies.

Pancreatic cancer

Advanced pancreatic cancer has major unmet need, but uncontrolled early signals frequently fail when randomized. The planned gemcitabine/nab-paclitaxel combination is more informative only once the comparator, sample size, statistical design and endpoints are registered.

Platform competition

The larger question is whether A3AR targeting produces reproducible efficacy across unrelated indications. One positive program can validate a molecule; multiple positive randomized programs would be needed to validate the broader platform thesis.

17Valuation and Merlintrader Health Score

The market capitalisation now rests on a post-financing count, because the company restated its share count in the Form F-3 filed on September 25, 2026: 6,063,093 ordinary shares outstanding at that date, against 4,285,093 at August 25, which at the depositary ratio of two ordinary shares per ADS is 3,031,546 ADSs, rounded down from 3,031,546.5. At the September 30, 2026 close of $2.20 per ADS that is approximately $6.67 million of equity value, the same figure Finviz Elite reads on the same day by its own route. It still stops there: it does not include the 3,187,574 ADSs underlying warrants outstanding at September 25, whose weighted-average exercise price is $7.29 per ADS, nor the 102,233 ADS-equivalent of options. Between the September 1 close of $3.29 and September 30 the ADS fell about a third while the declared share count rose about 41%, and those two movements are the same event seen from two sides.

That is also why a per-share target would be false precision rather than analysis. The useful framework is comparative: clinical maturity, cash resources, annual cash use, warrant overhang and proximity to randomised readouts. The figure to re-check first is still the share count, in the next issuer document that states one after September 25, 2026. The Merlintrader Health Score built on that framework is set out in full further down the page, outside the gate.

The Merlintrader Health Score is editorial judgment, not a probability of approval, credit rating, price target or investment recommendation.

18Catalyst calendar and monitoring windows

Hard dates are separated from company timing windows. The HCC interim is intentionally listed as TBA until management publishes a replacement date.

19Bottom line: the clinical story is stronger than the capitalization story

September 2 did not prove Namodenoson works in Phase III. It did make LIVERATION more important. Survival across the pooled blinded population is running longer than the assumptions used to design the trial, and Can-Fite is now evaluating an earlier interim analysis. The randomized comparison remains the evidence that matters.

The same day also made the financing problem more visible. The company confirmed on September 8 that it received roughly $4 million of gross cash from exercising the March warrants at $2.50, but it is creating a new warrant block for twice as many ADSs at the same exercise price. That pattern can keep the company funded while continuously changing the economics for common holders.

CANF therefore has two true descriptions at once. It is a late-stage biotech with two pivotal Phase III programs and several additional clinical options. It is also a small-capital-base company whose per-share outcome is highly sensitive to financing terms.

20Ranked risks and falsifiable checklist

• 1. Dilution and financing: the September inducement adds cash but creates a new 3.183M-ADS warrant block at $2.50.
• 2. HCC efficacy: pooled blinded survival does not show treatment-arm benefit.
• 3. HCC timing: guidance moved from roughly Q4 2026 to Q2 2027 before September management said it is evaluating an earlier timing, without publishing a replacement date.
• 4. Psoriasis binary: pivotal randomized data are expected Q1 2027.
• 5. Small financial base: annual operating cash use was $8.949M in 2025 against $8.539M of year-end cash and deposits.
• 6. Pancreatic evidence: the Phase 2a study had 20 patients, no comparator and survival subset analysis.
• 7. Pipeline breadth: multiple programs can strain a small organization and balance sheet.
• 8. Commercial competition: psoriasis has an especially high efficacy and adoption bar.
• 9. Micro-cap trading: thin liquidity and event-driven volume can amplify both rallies and declines independently of fundamental change.