Dawson James - Can-Fite (CANF) Buy Rated - Expected Milestones

Can-Fite in a letter to shareholders outlined the milestones ahead for the year. 

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COMFORT-Plaque Psoriasis: Topline Phase 3 Psoriasis Data Expected Q122

• Comfort Phase 3 study of Piclidenoson enrolled and treated approximately 400 patients with moderate to severe plaque psoriasis. In Q1 Can-Fite expects to announce results from the first 16 weeks of treatment, with the primary endpoint of the study being a statistically significant improvement in achieving a PASI score of 75 in Piclidenoson treated patients vs. placebo.
• Later in 2022, the company expects to announce the study's secondary endpoint at 32 weeks of treatment which is non-inferiority of Piclidenoson vs. Otezla. The study has four treatment arms: Piclidenoson 2 mg, Piclidenoson 3 mg, Otezla, and placebo.

Namodenoson in NASH: Phase 2b study: NASH Study Expected to Commence Patient Enrollment in Q122

• The study will enroll 140 patients with biopsy-confirmed NASH with a primary endpoint to evaluate the efficacy of Namodenoson as compared to placebo, as determined by a histological endpoint. Patients will be randomly assigned in a 2:1 ratio to oral doses of Namodenoson 25 mg or placebo every 12 hours for 36 weeks.

Liver Cancer: Patient Enrollment Expected to Commence in the Phase 3 Study H122

• In December, we announced that a prior Phase II liver cancer study patient who continues to be treated with Namodenoson has survived five years and cleared all cancer lesions. We see this as a very positive sign as we expect to commence enrollment in Q1 of 2022.
• Approximately 450 patients diagnosed with hepatocellular carcinoma (HCC) and underlying Child Pugh B7 (CPB7) who have not responded to other approved therapies will be enrolled through clinical sites worldwide. Patients will be randomized to oral treatment with either 25 mg Namodenoson or a matching placebo given twice daily. The primary efficacy endpoint of the trial is overall survival.
• An interim analysis is set once 50% of patients are enrolled.

Valuation. We evaluate Piclidenoson in Psoriasis, Namodenoson in HCC, and NAFLD. We apply a probability of success in these patient-based models. These metrics then flow into our valuation models. For Can-Fite, we use a 30% discount rate and apply a therapeutic probability of success rate (in that model). Our risk rate in our financial models is 30% as Can-Fite is not yet profitable, and most of the products are still dependent on the outcome of the clinical trials. Our valuation conclusion is an equally-weighted average of our FCFF, EPS, and sum-of-the-parts analysis. We use a projected fully diluted end-year share count and assume multiple raises. The conclusion of this method is a $5.00 price target.

Risks to our thesis include the following: (1) commercial; (2) regulatory; (3) clinical; (4) manufacturing; (5) financial; (6) liability; and (7) intellectual property.

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