Can-Fite BioPharma (CANF) Investor Update summary

Clinical development and pipeline progress

• Advancing two lead drug candidates, Piclidenoson and Namodenoson, both in pivotal phase III studies for psoriasis and advanced liver cancer, respectively, with regulatory alignment from FDA and EMA.

• Piclidenoson also being developed for Lowe Syndrome and licensed for veterinary use in osteoarthritis, with positive animal study results.

• Namodenoson is in phase IIb for MASH (formerly NASH) and preparing for a phase IIa study in pancreatic cancer, with orphan drug and fast track status for liver cancer.

• A preclinical candidate, CF602, is being explored for erectile dysfunction based on observed patient benefits.

Financial and partnership status

• Ended last year with approximately $9 million in cash, with additional short-term milestone payments expected to fund operations for at least 12 months.

• Secured six territorial licensing deals, generating $20 million in upfront and milestone payments, with potential for $130 million more and double-digit royalties.

• Monetizing portfolio through partnerships, including a veterinary partner for Piclidenoson.

Intellectual property and regulatory updates

• Holds a broad IP portfolio with 15 patent families, including use and synthesis patents for each indication, and benefits from orphan drug exclusivity.

• Recently submitted an FDA application for orphan drug designation for Namodenoson in pancreatic carcinoma, expecting a response within 60 days.