Can-Fite BioPharma Ltd. 10 Bareket Street Kiryat Matalon Petah Tikva, 4951778, Israel Phone: 972 3 924 1114 http://www.canfite.com
Company Overview
Advanced clinical stage company - Small molecule drug products for treatment of inflammatory and cancer indications
Robust clinical proof of concept - Phase II and Phase III clinical studies; technology is covered by 15 patent families
Successful out-licensingdeals - ~$20M received to date and an additional ~$130M in potential milestone payments plus double-digit royalties on net sales following regulatory approval
Equity Overview
NYSE American: CANF (as of July 2022)
TASE: CFBI
1 ADR = 30 ordinary TASE shares ADRs Outstanding: ~27 M Ordinary Shares Outstanding: ~816 M
Unique Platform Technology
- Therapeutic Target - A3 adenosine receptor
- Pipeline Drugs are Agonists - Bind only to pathological cells, not normal cells; small molecule, orally bioavailable drugs
- Proven Therapeutic Effect - high efficacy and good safety with anti-inflammatoryand anti-cancereffects shown in Phase II and Phase III studies
- Excellent Safety Profile - demonstrated in >1,500 patients
Pathological Cell | Normal Cell |
A3 Adenosine Receptor
Out-licensing Deals
Psoriasis | Psoriasis, Liver Cancer, NASH |
Psoriasis
Psoriasis, Liver Cancer, NASH
$20M | Typical Deal Structure | ||
received in upfront and | • | Up-front money upon signing | Psoriasis, Liver Cancer, NASH |
milestone payments | a distribution deal | ||
$130M | • | Regulatory milestone | |
payments | |||
• | Royalties (double-digits) | ||
potential based on | • | Sales milestone payments | |
regulatory and sales | |||
milestones |
Investor Contact:
Motti Farbstein, CFO, + 972 3 924 1114
Disclaimer: Except for historical information contained herein, the statements in this fact sheet are "forward-looking" within the meaning of the Private Securities Litigation Act of 1995. This fact sheet includes estimates and projections and, as such, reflects only management's current expectations. A fuller discussion of Can-Fite BioPharma Ltd's risks and uncertainties are described in the Company's filings with the Securities and Exchange Commission, which should be reviewed in conjunction with this overview.
*Sources for market size estimates: Evaluate Pharma, DelveInsight, Deutsche Bank, Grand View Research, Adroit Market Research. Source for Otezla sales Evaluate Pharma
Drug Development Pipeline
Drug/ | Pre-Clinical | Phase I | Phase II | Phase III | ||||||
Indication | ||||||||||
Piclidenoson | ||||||||||
Psoriasis | Positive | Topline Results Released Q2 2022 | ||||||||
Namodenoson | Open for Enrollment | |||||||||
Liver Cancer | ||||||||||
NASH | Enrollment Ongoing | |||||||||
CF602 | Ongoing | |||||||||
Erectile | ||||||||||
Dysfunction | ||||||||||
Cannabinoids | ||||||||||
Liver Diseases | Ongoing | |||||||||
Piclidenoson Clinical Development
- Phase III Psoriasis Study Achieves Primary Endpoint
The pivotal Phase III Comfort™ trial enrolled ~400 patients to evaluate oral Piclidenoson in moderate-to-severe psoriasis. Patients treated with Piclidenoson had a statistically significant improvement in the PASI scores (a measure of psoriasis severity) compared to placebo. Piclidenoson's excellent safety profile was the same as placebo and better than Otezla, a leading oral psoriasis drug on the market.
Namodenoson Clinical Development
-
Phase III in Liver Cancer - Open for Enrollment
Can-Fite received agreement from both the U.S. FDA and European Medicines Agency (EMA) on the protocol for its pivotal Phase III study for market registration. Namodenoson has Orphan Drug status with both the FDA and EMA, as well as Fast Track Status with the FDA for treatment of hepatocellular carcinoma (HCC). The study will enroll 450 patients and an interim analysis will be conducted after 50% of enrolled patients are treated. Namodenoson will be evaluated as a 2nd or 3rd line treatment for advanced (Child Pugh B7) liver cancer patients, with the primary endpoint of improved overall survival.
New clinical data shows that a patient with advanced HCC, the most common form of liver cancer, was cleared of all tumor lesions following treatment with Namodenoson. - Phase IIb in NASH - Enrollment Ongoing
Namodenoson's Phase IIa NASH/NAFLD double-blindplacebo-controlled study met all efficacy and safety endpoints including anti-inflammatory effects, reduced liver fat content, inhibition of fibrosis, decrease in body weight, and demonstrated an excellent safety profile. NASH is an unmet medical need with no FDA approved treatment to date and a market projected to be worth $35-$40 billion by 2025.
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Can Fite Biofpharma Ltd. published this content on 06 July 2022 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 07 July 2022 16:43:02 UTC.