Can-Fite BioPharma Ltd. Stock Price, News & Analysis

Can-Fite BioPharma Ltd. (NYSE American: CANF; TASE: CANF) is an advanced clinical-stage drug development company in the pharmaceutical preparation manufacturing industry. According to the company’s disclosures, it develops proprietary, orally administered small-molecule drugs that target the A3 adenosine receptor (A3AR) for the treatment of cancer, liver disease, inflammatory conditions, and sexual dysfunction-related indications. Its American Depositary Shares (ADSs), each representing two ordinary shares, trade under the symbol CANF.

Platform focus on the A3 adenosine receptor

Can-Fite describes its platform technology as centered on A3AR, a receptor that is highly expressed in diseased and cancerous cells while showing low expression in normal cells. The company states that this differential expression may help explain the favorable safety profile observed with its drug candidates in clinical studies. Across its pipeline, Can-Fite is advancing small molecules that bind to or modulate A3AR with the goal of addressing oncological, liver, inflammatory, and sexual health indications.

Key clinical-stage drug candidates

The company reports three main proprietary drug candidates:

• Piclidenoson – Can-Fite’s lead drug candidate. The company states that Piclidenoson is a highly selective A3AR agonist that has reported topline results in a Phase III trial for psoriasis and has commenced a pivotal Phase III trial in this indication. Piclidenoson has shown anti-inflammatory activity in prior Phase II and Phase III clinical studies in psoriasis. In addition, the company has developed a Phase II study protocol for the rare genetic disease Lowe Syndrome and has referenced preclinical work suggesting potential relevance in vascular dementia models.
• Namodenoson – Described as Can-Fite’s liver-focused drug candidate and a small, orally bioavailable A3AR agonist. Namodenoson is being evaluated in a pivotal Phase III trial for advanced hepatocellular carcinoma (HCC), a Phase IIb trial for metabolic dysfunction-associated steatohepatitis (MASH), and a Phase IIa study in pancreatic cancer. The company reports that Namodenoson has received Orphan Drug Designation in the U.S. and Europe and Fast Track Designation from the U.S. Food and Drug Administration (FDA) as a second-line treatment for HCC. Can-Fite has also reported proof-of-concept data suggesting potential activity in other cancers, including colon, prostate, and melanoma, and has highlighted compassionate use cases in advanced liver disease and cirrhosis.
• CF602 – Can-Fite’s third drug candidate, described as a novel A3AR allosteric modulator being developed for erectile dysfunction. The company reports that CF602 has shown efficacy in the treatment of erectile dysfunction in preclinical and clinical settings and is characterized by high selectivity at A3AR, with the ability to enhance receptor activity in the presence of the native ligand while avoiding receptor desensitization. CF602 is being developed as an oral or topical treatment for erectile dysfunction, including in patients with diabetes and in those who do not respond to existing erectile dysfunction drugs.

Therapeutic areas and indications

According to multiple company press releases and SEC filings, Can-Fite’s pipeline is designed to address multi-billion-dollar markets in cancer, liver disease, inflammatory disease, and sexual dysfunction. Key therapeutic areas and indications under investigation include:

• Psoriasis – Piclidenoson has completed a Phase III trial with topline results and has entered a pivotal Phase III study in psoriasis, with oral dosing twice daily and endpoints such as PASI 75 and Physician’s Global Assessment.
• Hepatocellular carcinoma (HCC) – Namodenoson is in a pivotal Phase III trial for advanced HCC, including patients with advanced liver disease (Child-Pugh B). The company has reported a long-term complete response in an advanced liver cancer patient from a prior Phase II study who remains cancer-free under compassionate use.
• MASH (Metabolic dysfunction-associated steatohepatitis) – Namodenoson is in a Phase IIb trial following a completed Phase IIa study that, according to the company, demonstrated anti-inflammatory, anti-steatotic, and anti-fibrotic effects, with data published in peer-reviewed literature.
• Pancreatic cancer – Namodenoson is being evaluated in a Phase IIa study in advanced pancreatic adenocarcinoma after at least one prior line of therapy, with safety as a primary endpoint. The company notes that Namodenoson has Orphan Drug Designation from the FDA for pancreatic cancer.
• Decompensated liver cirrhosis and complications – Through compassionate use, Can-Fite has reported cases in advanced liver disease, including a patient with decompensated cirrhosis who experienced disappearance of end-stage complications and complete resolution of esophageal varices while receiving Namodenoson.
• Erectile dysfunction and sexual dysfunction – CF602 is being developed for erectile dysfunction, and the company has reported patents and patent allowances in major markets, including Brazil, for the use of A3AR ligands in sexual dysfunction. Can-Fite has also highlighted that CF602 may have potential in erectile dysfunction among diabetic patients and non-responders to existing therapies.
• Veterinary indications – The company reports that Piclidenoson is in development for osteoarthritis in pets, with clinical studies showing efficacy in dogs, and that Namodenoson is being explored for veterinary oncology applications. Can-Fite has disclosed multiple out-licensing and global distribution agreements for veterinary indications.

Regulatory designations and safety profile

Can-Fite emphasizes that its drug candidates have an excellent safety profile based on experience in more than 1,600 patients in clinical studies. Namodenoson has received Orphan Drug Designation in both the U.S. and Europe and Fast Track Designation from the FDA as a second-line treatment for HCC. The company also notes Orphan Drug Designation for Namodenoson in pancreatic cancer. These regulatory designations are intended to support development in serious conditions with unmet medical needs.

Intellectual property and patents

The company reports a growing patent estate around its A3AR-targeted molecules. Recent disclosures include a granted Brazilian patent for the use of A3AR agonists in the treatment of sexual dysfunction and a Notice of Allowance in Brazil for a patent covering CF602 for sexual dysfunction, complementing patents already granted in the U.S. and Europe. Can-Fite states that these patents strengthen its global intellectual property position for both human and potential veterinary indications.

Partnerships and licensing

In its public communications, Can-Fite notes that it has numerous out-licensing and global distribution agreements for pharmaceutical and veterinary uses of its pipeline. The company cites agreements with partners such as Vetbiolix for Piclidenoson in osteoarthritis in dogs and cats and references aggregate potential milestone and royalty values in connection with these arrangements. It also reports distribution and licensing agreements in various territories for its human indications, with advance payments recognized as revenue over time.

Capital markets activity and share structure

Can-Fite is a foreign private issuer that files reports with the U.S. Securities and Exchange Commission on Form 20-F and Form 6-K. The company’s ADSs trade on the NYSE American under the symbol CANF, and its ordinary shares trade on the Tel-Aviv Stock Exchange. In a shareholder-approved action, the board authorized a 1-for-3,000 reverse split of its ordinary shares and a concurrent change in the ADS-to-ordinary-share ratio from one ADS representing 300 ordinary shares to one ADS representing two ordinary shares, with the ADSs continuing to trade under the CANF symbol. The company also reports periodic public offerings and warrant-related transactions as part of its financing strategy.

Business model and development stage

Can-Fite describes itself as an advanced clinical-stage company. Its primary activities are research, clinical development, regulatory interaction, and partnering for its A3AR-targeted drug candidates. Revenue reported to date is mainly associated with advance payments and licensing arrangements under distribution and out-licensing agreements. The company’s financial statements, filed under U.S. GAAP, reflect research and development expenses related to its ongoing clinical trials in psoriasis, advanced liver cancer, and MASH, as well as general and administrative expenses related to corporate operations and investor relations.

Geographic and regulatory footprint

The company is based in Ramat Gan, Israel, and conducts clinical trials in multiple regions, including Israel, Europe, and the United States, according to its press releases. It interacts with regulatory authorities such as the U.S. Food and Drug Administration and the European Medicines Agency for its pivotal and mid-stage studies. Can-Fite also participates in international industry conferences and partnering events, including European life sciences meetings, to advance licensing and collaboration opportunities for both human and veterinary applications.

Risk profile and development considerations

As a clinical-stage biopharmaceutical company, Can-Fite’s future prospects depend on the outcomes of its ongoing and planned clinical trials, regulatory reviews, and partnering activities. The company’s public communications include forward-looking statements about expected trial timelines, potential regulatory submissions, and market opportunities, and they highlight that such statements are subject to risks and uncertainties. Investors typically review the company’s SEC filings, including its annual report on Form 20-F and periodic Form 6-K reports, for detailed information on risk factors, clinical progress, financing, and corporate governance.