Can Fite Investor Presentation July 2021
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Can-Fite is a clinical stage drug development company developing oral small molecule drugs for inflammatory and cancer indications. Their lead drugs, Piclidenoson and Namodenoson, have shown efficacy and safety in Phase II/III studies for psoriasis, liver cancer, and NASH. Piclidenoson has commenced a Phase II study in COVID-19 patients. Can-Fite has outlicensed their drugs in select territories, receiving $20M to date with potential for $130M more in milestones and royalties. They are well positioned financially to advance their clinical programs targeting multi-billion dollar markets.
![(NYSE American: CANF) (TASE:CFBI)
CF602 – Erectile Dysfunction Drug
14
➢ Significant full recovery from
erectile dysfunction in diabetic rat
model
• Topically & Systemic
• Dose-dependent, linear effect
• Response after single dose of CF602
➢ Novel mechanism of action
• Up-regulation of eNOS and VEGF
• Improves vasodilation and smooth muscle
relaxation
➢ A3AR Allosteric Modulator
1H-imidazo[4,5-c]quinolin-4-amine Derivatives
➢ Properties
• A3AR allosteric modulator
• Molecular weight – 411.34
• Water insoluble
• Orally bioavailable
Rationale: anecdotal reports from patients treated with Can-Fite’s drugs, both women and men,
testifying that the drugs reversed their sexual dysfunction](https://image.slidesharecdn.com/20210711canfitepresentation-210723184743/85/Can-Fite-Investor-Presentation-July-2021-14-320.jpg)
Can Fite Investor Presentation July 2021
- 1. (NYSE American: CANF) (TASE:CFBI) Can-Fite Presentation July 2021 (NYSE American: CANF) (TASE:CFBI)
- 2. (NYSE American: CANF) (TASE:CFBI) Forward Looking Statement 2 • This presentation contains forward-looking statements, about Can-Fite’s expectations, beliefs or intentions regarding, among other things, its product development efforts, business, financial condition, results of operations, strategies or prospects. All statements in this communication, other than those relating to historical facts, are “forward looking statements”. • Forward-looking statements can be identified by the use of forward-looking words such as “believe,” “expect,” “intend,” “plan,” “may,” “should” or “anticipate” or their negatives or other variations of these words or other comparable words or by the fact that these statements do not relate strictly to historical or current matters. Forward-looking statements relate to anticipated or expected events, activities, trends or results as of the date they are made. Because forward-looking statements relate to matters that have not yet occurred, these statements are inherently subject to known and unknown risks, uncertainties and other factors that may cause Can-Fite’s actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Important factors that could cause actual results, performance or achievements to differ materially from those anticipated in these forward-looking statements include, among other things, our history of losses and needs for additional capital to fund our operations and our inability to obtain additional capital on acceptable terms, or at all; uncertainties of cash flows and inability to meet working capital needs; impact of the recent outbreak of the COVID-19 pandemic; the initiation, timing, progress and results of our preclinical studies, clinical trials and other product candidate development efforts; our ability to advance our product candidates into clinical trials or to successfully complete our preclinical studies or clinical trials; our receipt of regulatory approvals for our product candidates, and the timing of other regulatory filings and approvals; the clinical development, commercialization and market acceptance of our product candidates; our ability to establish and maintain strategic partnerships and other corporate collaborations; the implementation of our business model and strategic plans for our business and product candidates; the scope of protection we are able to establish and maintain for intellectual property rights covering our product candidates and our ability to operate our business without infringing the intellectual property rights of others; competitive companies, technologies and our industry; and statements as to the impact of the political and security situation in Israel on our business. More information on these risks, uncertainties and other factors is included from time to time in the “Risk Factors” section of Can-Fite’s Annual Report on Form 20-F filed with the SEC on March 25, 2021 and other public reports filed with the SEC and in its periodic filings with the TASE. • Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Can-Fite undertakes no obligation to publicly update or review any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by any applicable securities laws.
- 3. (NYSE American: CANF) (TASE:CFBI) 3 Company Profile • Advanced clinical stage drug development company with small molecule drug products for the treatment of inflammatory and cancer indications • Robust clinical proof of concept from Phase II and Phase III clinical studies; Technology is covered by 15 Patent Families • Successful out-licensing deals with ~$20 M received to date and an additional ~$130 M in potential milestone payments plus double-digit royalties on net sales following regulatory approval • Listed on NYSE American (CANF) and Tel-Aviv Stock Exchange (CFBI); ~17.2 M ADRs outstanding; ~516 M ordinary shares outstanding (*1 ADR = 30 Ordinary Shares) • Analyst Coverage from Aegis Capital Group, Alliance Global Partners, Dawson James and H.C. Wainwright 3
- 4. (NYSE American: CANF) (TASE:CFBI) Therapeutic Target • A3 adenosine receptor (A3AR) • Highly expressed in inflammatory and cancer pathological cells Pipeline Drugs are Agonists • Bind only to pathological cells, not normal cells • Small molecule, orally bioavailable drug Proven Therapeutic Effect • High efficacy and good safety with anti- inflammatory and anti-cancer effects shown in Phase II and Phase III studies Excellent Safety Profile • Demonstrated in >1500 patients Unique Platform Technology Specific oral therapy aimed at diseased cells Pathological Cells Normal Cells A3 Adenosine Receptor (A3AR) 4
- 5. (NYSE American: CANF) (TASE:CFBI) Drug Development Pipeline 5 ~$11.3B ~$3.8B ~$35B ~$3.2B Market *Sources: iHealthAnalyst estimated the global psoriasis drug market will be $11.3 B by the end of 2025; Morningstar projects sales of pharmaceuticals to treat COVID-19 will reach $10 B in 2021; DelveInsight estimates the HCC drug market at $3.8B in 2027; Deutsche Bank puts the peak market for NASH therapies at $35B to $40B by 2025; Grand View Research estimates the global erectile dysfunction drug market at $3.2B by 2022; Adroit Market Research estimates that the medical cannabis market is projected to grow at CAGR of 29% to $56.7B by 2026 Drug Pre-clinical Phase I Phase II Phase III Piclidenoson • Psoriasis Namodenoson • Liver Cancer • NASH CF602 • ED Under Preparation Ongoing Under Preparation ~$56.7B Cannabinoids • COVID-19 Enrollment Ongoing ~$10B Enrollment Ongoing Ongoing
- 6. (NYSE American: CANF) (TASE:CFBI) Psoriasis Phase III • Positive recommendation to continue patient enrollment has been received from a committee that looked at the data from 50% of patients that were enrolled NASH Phase IIa • Significant anti-steatotic, anti-fibrotic and anti-inflammatory effects Advanced Liver Cancer • Overall survival superiority in Child Pugh B7 patients treated with Namodenoson Robust Clinical Proof of Concept 6 MRI PDFF – Liver Fat Volume CFB at week 12
- 7. (NYSE American: CANF) (TASE:CFBI) Corporate Partnerships: Out-licensing deals 7 $20 million received in upfront and milestone payments $130 million more potential based on regulatory and sales milestones *$8.5M was from alicense with aJapanese company, SKK; the license wasterminated due to SKK’s strategic change of focus to indications not related to autoimmune diseases • Up-front money upon signing a distribution deal • Regulatory milestone payments • Royalties (double-digit) • Sales milestone payments Typical Deal Structure: Company Territory Indications China Psoriasis, Liver Cancer, NASH South Korea Psoriasis, Liver Cancer, NASH Canada Psoriasis Spain, Austria, Switzerland Psoriasis Eastern Europe Psoriasis, Liver Cancer, NASH
- 8. (NYSE American: CANF) (TASE:CFBI) 8 Piclidenoson Psoriasis & COVID-19 Piclidenoson – Anti-Inflammatory Drug Mechanism of Action 8 Chemical Formula
- 9. (NYSE American: CANF) (TASE:CFBI) Psoriasis Phase III – Positive Interim Analysis Data Comfort Phase III clinical study is designed to establish Piclidenoson superiority vs. placebo and non-inferiority vs. Otezla® in patients with moderate-to-severe plaque psoriasis • Randomized, double-blind, active and placebo- controlled • Primary endpoint: PASI 75 at week 16 vs. placebo • Secondary endpoints: non- inferiority vs. Otezla at week 32 • Study duration 32 weeks; optional extension to 48 weeks 9 Top Line Results Expected End of Year
- 10. (NYSE American: CANF) (TASE:CFBI) COVID-19 Phase II – Treatment of Moderate/Severe Disease 10 Piclidenoson 2 mg + SSC Placebo + SSC 28 Days 0 R • Randomized, double-blind, placebo-controlled • 40 patients randomized 1:1 into Piclidenoson 2mg, 2x per day or placebo Primary Endpoints • To evaluate the benefits of treatment with Piclidenoson plus standard supportive care (SSC) vs. placebo plus SSC in hospitalized subjects with moderate/severe COVID-19 • To evaluate the safety and tolerability of Piclidenoson Secondary Endpoints • To determine the pharmacokinetics of Piclidenoson • Enrolling patients under U.S. FDA protocol; IRBs approved Rationale: • Piclidenoson has anti-inflammatory effects proven in Phase II Psoriasis clinical studies and in an interim analysis of an ongoing Psoriasis Phase III study; the drug has anti-viral effect protected by U.S. patent US7589075. Piclidenoson also inhibits cytokine release syndrome and has an excellent safety profile Study Design: Currently Enrolling
- 11. (NYSE American: CANF) (TASE:CFBI) 11 Namodenoson Advanced Liver Cancer & NASH Namodenoson – Liver Disease Drug Mechanism of Action 11 Chemical Formula
- 12. (NYSE American: CANF) (TASE:CFBI) • FDA and EMA agreed on Pivotal Phase III Study Protocol • Interim analysis to be conducted by an Independent Data Monitoring Committee (IDMC) after 50% of planned 45 patients are enrolled and treated • Namodenoson will be evaluated as a 2nd or 3rd line treatment for advanced liver cancer patients in whom other approved therapies have not been or are no longer effective • Primary endpoint is overall survival • Orphan Drug Status - granted by FDA and EMA • Fast Track Status - granted by FDA • Compassionate Use Program - currently treating liver cancer patients in Israel Phase III Study Initiation Expected Q4 2021 Liver Cancer - Pivotal Phase III Under Preparation 12
- 13. (NYSE American: CANF) (TASE:CFBI) 13 13 NASH – Phase IIa Study Successfully Concluded • Reduced liver fat content (LFC) • Inhibition of Fibrosis • Anti-Inflammatory effect • Decrease in body weight • Dose selection for next clinical study has been determined • Excellent Safety Phase IIb Enrollment Expected to Commence: Q3 2021
- 14. (NYSE American: CANF) (TASE:CFBI) CF602 – Erectile Dysfunction Drug 14 ➢ Significant full recovery from erectile dysfunction in diabetic rat model • Topically & Systemic • Dose-dependent, linear effect • Response after single dose of CF602 ➢ Novel mechanism of action • Up-regulation of eNOS and VEGF • Improves vasodilation and smooth muscle relaxation ➢ A3AR Allosteric Modulator 1H-imidazo[4,5-c]quinolin-4-amine Derivatives ➢ Properties • A3AR allosteric modulator • Molecular weight – 411.34 • Water insoluble • Orally bioavailable Rationale: anecdotal reports from patients treated with Can-Fite’s drugs, both women and men, testifying that the drugs reversed their sexual dysfunction
- 15. (NYSE American: CANF) (TASE:CFBI) 15 • Rationale Cannabinoids induce their therapeutic effects via binding to Can-Fite’s drug target, the A3 adenosine receptor • Intellectual Property Can-Fite filed a patent protecting the discovery of cannabinoid-based treatment of diseases where A3AR is overexpressed including liver cancer, other cancers, autoimmune inflammatory and metabolic diseases • Medical cannabis market Projected to grow at CAGR of 29% to $56.7B by 2026* Cannabis Derived Pharmaceuticals *Source: Adroit Market Research CBD CBD CBD CBD 15
- 16. (NYSE American: CANF) (TASE:CFBI) Summary 16 ➢ Novel therapeutic approach – unique technology for the treatment of liver and inflammatory diseases; addressing multi-billion dollar markets ➢ Oral drugs with proven safety and efficacy – Piclidenoson and Namodenoson are Phase III assets in psoriasis and liver cancer; Namodenoson showed strong efficacy in a Phase II NASH study; Piclidenoson has commenced Phase II study in patients with moderate to severe COVID-19 ➢ Intellectual property portfolio – consists of 15 patent families issued and pending to protect the different indications ➢ Corporate partnerships – Piclidenoson and Namodenoson have been out-licensed in select territories with ~$20 million received to date and potentially up an additional $130 million plus royalties ➢ Financially well positioned – the company is well positioned to conduct all its clinical development programs and G&A for > 1 year