Small Molecules for Big Clinical NeedsTM
Presentation July 2024
NYSE:CANF
Forward Looking Statement
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; 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; risks related to the COVID-19 pandemic and the Russian invasion of Ukraine; risks related to not satisfying the continued listing requirements of NYSE American; 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 30, 2023 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.
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Company Overview
NYSE: CANF
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Safe Drugs for the Treatment of
Oncological and Inflammatory Diseases
Advanced Clinical Stage
Pipeline; Short Regulatory
Approval Pathway (FDA & EMA)
Successful Out-licensing
Deals
Financial Summary
(Ticker: CANF) Listed on NYSE American and Tel-Aviv Stock Exchange ~6 M ADRs outstanding; ~1,225 M ordinary shares outstanding
(1 ADR = 300 Ordinary Shares)
Cash: $8.9M as of December 31, 2023
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Unique Platform Technology
Specific oral therapy aimed at diseased cells
Therapeutic Target
- Global leader in discovering and developing drugs that target the A3 adenosine receptor (A3AR)
Pipeline Drugs
- Small molecule, orally bioavailable drugs
- Bind only to pathological cells, not normal cells
Proven Therapeutic Effect
- High efficacy and good safety with anti-inflammatory and anti-cancer effects shown in Phase 2 and Phase 3 studies
Excellent Safety Profile
- Demonstrated in >1600 patients
NYSE: CANF
Pathological Cells | A3 Adenosine |
Pathological Cell | Receptor (A3AR) |
A3 Adenosine Receptor
Normal Cell Normal Cells
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Pipeline Drugs
Drug/Indication Pre-Clinical | Phase 1 | Phase 2 | Phase 3 | ||
Piclidenoson | |||||
Psoriasis | Pivotal Phase III agreed with FDA & EMA | ||||
Namodenoson
Liver Cancer | Pivotal Phase III agreed with FDA & EMA Ongoing |
Pancreatic Cancer | Phase IIa to be initiated Q2 |
MASH | Phase IIb Ongoing |
CF602
Erectile Dysfunction | Ongoing |
NYSE: CANF | 5 |
Corporate Partnerships: Current Out-Licensing Deals
VETBIOLIX
Eastern Europe
Spain, Switzerland, Austria China, Taiwan, Hong Kong, Macao
South Korea
South Korea
Canada
Global
Psoriasis, Liver Cancer, MASH Pancreatic cancer
Psoriasis
Psoriasis, Liver Cancer, MASH
Liver Cancer, MASH
Psoriasis
Psoriasis
Piclidenoson
- Pets' Osteoarthritis
$20M received in upfront and milestone payments
$130M potential based on regulatory and sales milestones
Typical Deal Structure
- Up-frontmoney upon signing a distribution deal
- Regulatory milestone payments
- Royalties (double-digits)
- Sales milestone payments
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*$8.5M was from a license with a Japanese company, SKK; the license was terminated due to SKK's strategic change of focus to indications not related to autoimmune diseases.
Piclidenoson Drug Candidate
Chemical Properties | |
• Nucleoside derivative | |
• Highly Selective A3AR Agonist | |
• Molecular weight - 510.29 | |
• Water insoluble | |
• Half lifetime in blood - 8-9 hours | Piclidenoson |
Inflammatory Indications |
Piclidenoson
Moderate to Severe Psoriasis
Piclidenoson for the Treatment of Plaque Psoriasis
Rational for Development
- Overexpression of the A3AR target in Keratinocytes of psoriasis patients
- Robust anti-inflammatory effect manifested by specific apoptosis of inflammatory cells
- Piclidenoson inhibits IL-17& IL-23 production in keratinocytes
- Piclidenoson had significant anti- psoriatic effects and promising safety profile in a Phase 3 trial in patients with moderate-to-severe plaque psoriasis.
IL-23 & IL-17
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Phase III Study Endpoints - Achieved
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Primary Endpoint
PASI 75 Significant Superiority of Piclidenoson 3 mg vs. Placebo
Secondary Endpoint
Subjects Achieving PGA2 for Piclidenoson vs Placebo
Study Design
Excellent Safety Profile | 10 |
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Disclaimer
Can Fite Biofpharma Ltd. published this content on 08 July 2024 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 08 July 2024 09:38:05 UTC.