Can-Fite Presentation – November 2014
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. In addition, from time to time, Can-Fite or its representatives have made or may make forward-looking statements, orally or in writing. 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. These forward-looking statements may be included in, but are not limited to, various filings made by Can-Fite with the U.S. Securities and Exchange Commission (the “SEC”), press releases or oral statements made by or with the approval of one of Can-Fite’s authorized executive officers. 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 risks and uncertainties that could cause Can-Fite’s actual results to differ materially from any future results expressed or implied by the forward-looking statements. Many factors could cause Can-Fite’s actual activities or results to differ materially from the activities and results anticipated in such forward-looking statements, including, but not limited to, the factors summarized in Can-Fite’s filings with the SEC and in its periodic filings with the Tel-Aviv Stock Exchange. Forward Looking Statement 2
Company Profile Advanced clinical stage drug development company Phase II and Phase II/III clinical studies Small molecule drugs Autoimmune Inflammatory diseases Cancer Ophthalmic diseases Company Operations Headquarters and Discovery Labs – Petach-Tikva, Israel. Drug Development & Clinical Operations – Boston, USA. Two regional out-licensing deals Japan: for inflammation Korea: for rheumatoid arthritis 3
Equity Profile Ticker on NYSE: CANF Ticker on Israeli TASE: CFBI Price of ADR (11/4/14): $2.69 (1 ADR = 2 Ordinary Shares) 52 Week Range: $ $9.46 Shares Out: 17.7M Ordinary Shares Market Capitalization: $24M Avg. Trading Volume (30 day): 14,723 ADRs As of October 29,
From Concept to Technology 5
Therapeutic Target A 3 adenosine receptor (A 3 AR) Highly expressed in inflammatory and cancer cells Drug product Small molecules Orally bioavailable drugs Therapeutic Effect Anti-inflammatory and anti-cancer effects in Phase II studies; Excellent safety profile A 3 AR is utilized as Predictive Biomarker Used to predict patient’s response to the drug Platform Technology Targeted therapy, specifically aimed at diseased cells Inflammatory / Tumor Cells Normal Cells A 3 Adenosine Receptor (A 3 AR) 6
Market Opportunity* *Global Data, GIA, Visiongain 7
Drug Development Pipeline 8
[Traded on the Tokyo Stock Exchange (Ticker:4548)] Exclusive license to develop and commercialize CF101 in Japan Up to $20 M in upfront, milestone and annual payments ($7.5M received to date) Up to 12% royalties Collaborations with two leading medicinal chemistry laboratories in the field of A 3 AR for supply of new molecules U.S. National Institutes of Health (NIH) Leiden University, the Netherlands Corporate Partnership Regional out-licensing deals Scientific Collaborations [Traded on South Korean Stock Exchange (Ticker: A009290)] Exclusive regional license to develop and commercialize CF101 for the treatment of rheumatoid arthritis in Korea $1.5 M in upfront and milestone payments ($0.5M received to date) 7% royalties. Such payments are subject to development and marketing milestones 9
CF101 Drug Profile Highly Selective A 3 AR Agonist Nucleoside derivative Molecular weight Water insoluble Orally bioavailable Half life time in blood – 8-9 hours Is not metabolized in the body (secreted unchanged ) Properties Proof of concept in pre-clinical pharmacology studies: Rheumatoid Arthritis Osteoarthritis Inflammatory Bowel Disease Uveitis Anti-Inflammatory Effect Mechanism of Action Fishman et al. Drug Discovery Today 17: CF101 A 3 Adenosine Receptor (A 3 AR) 10
Phase IIb study, Placebo controlled, 80 patients, enrolled based on the biomarker Rheumatoid Arthritis - Positive Data from Phase II Study
Interim analysis after 100 patients Excellent safety profile in all tested dosages Linear improvement along the 24 week study period (PGA-53%; PASI 75-41%) The linear response predicts better PASI &PGA under longer treatment The 2 mg treated group yielded the best response Additional 200 patients were enrolled, 100 placebo and mg, total 300 patients Data are expected on Q Interim Data - PGAPhase II data Psoriasis – Positive Data from Phase II/III Study Before After
CF102 Drug Profile Highly Selective A3AR Agonist Nucleoside derivative Molecular weight Water insoluble Orally bioavailable Half life time in blood – 12 hours Properties Proof of concept in pre-clinical pharmacology studies: Hepatocellular Carcinoma Colon Carcinoma Prostate Cancer Melanoma Anti-Cancer Effect Mechanism of Action CF102 A 3 Adenosine Receptor (A 3 AR) 13
Liver Cancer – Positive Data in Phase I/II Phase I/II Proof of Concept Study Phase I/II, open-label, dose-escalation study evaluating the safety, tolerability, pharmacokinetics, and pharmacodynamics of orally administered CF102 in patients with advanced primary liver cancer Study Synopsis Very favorable safety profile and lack of hepatotoxicity Prolongation of survival time Regression of skin tumor metastases Stable disease (22%) Proof of concept for A3AR utilization as a biomarker U.S. FDA Orphan Drug Approval (Feb 2012) Results Stemmer et al. The Oncologist, 2012 Initiation of Phase II study - Second-Line Treatment of Advanced Hepatocellular Carcinoma in Subjects with Child-Pugh B 78 patients; US, Europe and Israel Current Status 14
Intellectual Property Portfolio Exclusive licensee of the U.S. National Institutes of Health (NIH) and Leiden University in the Netherlands for patents covering A 3 AR Agonists 15 patent families 150 patents issued and pending patents applications internationally IP covers composition of matter, synthesis of matter, and clinical applications 15
Capitalization / Ownership Table OWNERSHIP TABLE (1) Holder Name Number of Fully Diluted Shares % of Fully Diluted Shares Officers & Directors Pnina Fishman, Ph. D. – CEO569, % Other Officer & Directors361, % Total Officers & Directors930,9373.7% Israeli Funds / Greater than 5% Ownership Shaked Group 1,223,7964.8% Total Israeli Funds / Greater than 5% ownership1,223,7964.8% OphthaliX Inc446,8271.8% Public Float22,633, % TOTAL Fully Diluted Shares25,235, % CAPITALIZATION TABLE (1) (1)Source: Company Internal Data and Tel-Aviv Stock Exchange Filings (2)W eighted average (3)Adjusted for a 1:25 reverse share split such that split so 1 warrant represented in the table above is currently equal to 25 warrants which are exercisable for 1 ordinary share (4)Exercise price of $3.21 (5)17,667,938 not including treasury shares Security typeNumberExercise Price (NIS)Index linkedExpiration date Common Shares Outstanding (5) 18,114,765 N/A Warrants (3) 1,124,785 (2) 15.13No Warrants to PIPE investors982,344 (4) 11.15NoMarch 9, 2018 Options no. 9 (3) 486, No May 1, 2015 Options no. 10 (3) 1,561, NoOct. 31, 2015 Options no. 11 (3) 1,494, NoApril 30, 2016 Options no. 121,470, NoOctober 22, 2016 Total Fully Diluted25,235,194 16
Financials – Balance Sheet / Income Statement MONTHLY CASH BURN RATE in thousands $USD Research$30 Development$190 Patent & Royalties $20 G&A $200 Total $440 BALANCE SHEET (ILS=$USD as of of June 30, 2014) ASSETS in thousands $USD of June 30, 2014 LIABILITIES & EQUITY in thousands $USD of June 30, 2014 Current AssetsCurrent Liabilities Cash & Equivalents $5,580Trade Payables $549 Accounts Receivable 790Other accounts payable 739 Non Current Assets 53Total Current Liabilities 1,288 Total Assets $6,423Other liabilities492 Total Liabilities 1,780 Total Equity 4,643 Total Liabilities & Equity $6,423 INCOME STATEMENT (U.S. $ 1 = NIS as of June 30, 2014) in thousands $USDLTM of June 30, 2014 Total Revenue- Operating Income($9,171) EBITDA($9,157) Net Income / (Loss)($8,523) The Company has sufficient resources to support its activities at least for the next 12 months 17
Spotlight on 2014 Milestones CF102 – PRIMARY LIVER CANCER – PHASE I/II 18 IndicationMilestoneStatus Liver Cancer Phase II Trial 78 patients study Initiation: Q Rheumatoid ArthritisPhase III planningQ BiomarkerDevelopment of a commercial kitQ Psoriasis Data from II/III 300 patients study Q Glaucoma Data from Interim Analysis of Phase II study 88 patients study H2 2015
Contact Information Can-Fite BioPharma Ltd. 10 Bareket Street Kiryat Matalon Petah Tikva, , Israel Phone: Pnina Fishman, Ph.D. Chief Executive Officer Phone: Motti Farbstein Chief Financial Officer Phone: Robert Haag IRTH Communications Phone: