Can-Fite BioPharma (CANF) Investor Update summary

Clinical development progress

• Two pivotal phase III studies are underway: one for psoriasis (Piclidenoson) and one for advanced liver cancer (Namodenoson), both with protocols agreed upon by FDA and EMA.

• Namodenoson is also advancing toward a phase IIa study in pancreatic carcinoma and a phase IIb study in MASH (formerly NASH), with ongoing patient enrollment.

• CF602, a preclinical candidate for erectile dysfunction in patients with diabetes or hypertension, is progressing based on strong proof of concept.

• Cannabinoid-based research targeting A3AR is in preclinical stages with promising early data.

Financial and partnership status

• Approximately $9 million in cash is available, with expected short-term partner payments supporting operations for 15 months.

• Seven out-licensing deals have been signed across multiple regions, generating $20 million to date and up to $130 million in potential milestone payments.

• Out-licensing deals provide third-party validation, development funding, and future royalties.

• The company is actively seeking additional non-dilutive funding and new partners to extend its financial runway.

Drug positioning and differentiation

• Piclidenoson is an orally available small molecule for psoriasis, offering advantages over biologics in administration, long-term efficacy, and safety.

• Namodenoson has orphan drug and Fast Track designations for liver cancer, with potential for conditional approval after interim analysis.

• Drugs selectively target pathological cells, sparing normal cells, resulting in a strong safety profile demonstrated in over 1,600 patients.