Can-Fite BioPharma (CANF) Investor Update summary

Clinical and regulatory progress

• Two lead drug candidates, Piclidenoson and Namodenoson, are in advanced clinical stages, with pivotal phase III studies underway for psoriasis and advanced liver cancer, respectively.

• Both drugs have agreements with the FDA and EMA on clinical protocols, and interim analyses may enable accelerated registration if positive.

• Namodenoson is also being developed for pancreatic cancer (phase IIa starting soon) and MASH (phase IIb ongoing), with recent IND submission in the US.

• Piclidenoson is being explored for Lowe Syndrome and has veterinary applications, with successful pet studies and licensing to Vetbiolix.

• Orphan drug and fast track statuses have been granted for Namodenoson in certain indications.

Financial and partnership status

• Cash position at year-end was around $9 million, with additional short-term milestone payments expected to fund operations for at least 12 months.

• Six territorial licensing deals have generated $20 million in upfront and milestone payments, with up to $130 million possible based on future success.

• The business model focuses on out-licensing, with double-digit royalties anticipated from partners.

• Market cap is approximately $20 million, and the company is dually listed in Tel Aviv and New York.

Scientific and clinical highlights

• Both lead drugs are small molecules, orally bioavailable, and have demonstrated excellent safety profiles in nearly 2,000 patients.

• Piclidenoson achieved primary and secondary endpoints in a completed phase III psoriasis study and is positioned as a safer alternative to biologics.

• Namodenoson has shown unique efficacy in Child-Pugh B liver cancer patients, with mechanistic rationale tied to higher target expression in sicker patients.

• Compassionate use cases have shown improvement in liver function for patients awaiting transplantation.

• Preclinical development is ongoing for CF602, targeting erectile dysfunction based on observed patient benefits.