can-fite presentation – november 2014. this presentation contains forward-looking statements,...

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Can-Fite Presentation – November 2014

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Can-Fite Presentation – November 2014

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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

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

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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: $2.59 - $9.46

Shares Out: 17.7M Ordinary Shares

Market Capitalization: $24M

Avg. Trading Volume (30 day): 14,723 ADRs

As of October 29, 2014

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From Concept to Technology

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•Therapeutic Target• A3 adenosine receptor (A3AR)• 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

•A3AR 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

A3 Adenosine Receptor (A3AR)

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Market Opportunity*

*Global Data, GIA, Visiongain

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Drug Development Pipeline

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[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 A3AR 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

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CF101 Drug Profile

• Highly Selective A3AR Agonist• Nucleoside derivative • Molecular weight - 510.29 • Water insoluble• Orally bioavailable• Half life time in blood – 8-9 hours• Is not metabolized in the body

(secreted unchanged)

PropertiesProof 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 17:359-366. 2011.

CF101

A3 Adenosine Receptor (A3AR)

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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 100 2 mg, total

300 patients• Data are expected on Q1 2015

Interim Data - PGA Phase II data

Psoriasis – Positive Data from Phase II/III Study

Before After

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CF102 Drug Profile

• Highly Selective A3AR Agonist• Nucleoside derivative • Molecular weight - 544.73 • Water insoluble• Orally bioavailable• Half life time in blood – 12 hours

PropertiesProof of concept in pre-clinical pharmacology studies:• Hepatocellular Carcinoma• Colon Carcinoma• Prostate Cancer • Melanoma

Anti-Cancer Effect

Mechanism of Action CF102

A3 Adenosine Receptor (A3AR)

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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

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Intellectual Property Portfolio

Exclusive licensee of the U.S. National Institutes of Health (NIH) and Leiden University in the Netherlands for patents covering A3AR Agonists

15 patent families

150 patents issued and pending patents applications internationally

IP covers composition of matter, synthesis of matter, and clinical applications

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Capitalization / Ownership Table OWNERSHIP TABLE(1)

Holder NameNumber of Fully Diluted Shares

% of Fully Diluted Shares

Officers & Directors Pnina Fishman, Ph. D. – CEO 569,863 2.3%Other Officer & Directors 361,074 1.4%

Total Officers & Directors 930,937 3.7% Israeli Funds / Greater than 5% Ownership

Shaked Group 1,223,796 4.8%Total Israeli Funds / Greater than 5% ownership 1,223,796 4.8%OphthaliX Inc 446,827 1.8%Public Float 22,633,634 89.7%TOTAL Fully Diluted Shares 25,235,194 100.0% CAPITALIZATION TABLE(1)

(1) Source: Company Internal Data and Tel-Aviv Stock Exchange Filings(2) Weighted 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 type Number Exercise Price (NIS) Index linked Expiration date

Common Shares Outstanding (5) 18,114,765 N/A N/A N/A

Warrants (3) 1,124,785 (2) 15.13 No 2014-2023

Warrants to PIPE investors 982,344 (4) 11.15 No March 9, 2018

Options no. 9 (3) 486,720 21.25 No May 1, 2015

Options no. 10 (3) 1,561,680 9.75 No Oct. 31, 2015

Options no. 11 (3) 1,494,900 9.75 No April 30, 2016

Options no. 12 1,470,000 15.29 No October 22, 2016

Total Fully Diluted 25,235,194

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Financials – Balance Sheet / Income Statement

MONTHLY CASH BURN RATE

in thousands $USD

Research $30Development $190Patent & Royalties $20G&A $200Total $440

BALANCE SHEET (ILS=$USD 0.2881 as of of June 30, 2014)

ASSETS in thousands $USD of June 30, 2014 LIABILITIES & EQUITY in thousands $USD of June 30, 2014

Current Assets Current LiabilitiesCash & Equivalents $5,580 Trade Payables $549Accounts Receivable 790 Other accounts payable 739

Non Current Assets 53 Total Current Liabilities 1,288Total Assets $6,423 Other liabilities 492

Total Liabilities 1,780Total Equity 4,643Total Liabilities & Equity $6,423

INCOME STATEMENT (U.S. $ 1 = NIS 3.438 as of June 30, 2014)

in thousands $USD LTM 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

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Spotlight on 2014 Milestones

CF102 – PRIMARY LIVER CANCER – PHASE I/II

Indication Milestone Status

Liver Cancer Phase II Trial78 patients study Initiation: Q3-2014

Rheumatoid Arthritis Phase III planning Q4-2014

Biomarker Development of a commercial kit Q4 2014

Psoriasis Data from II/III300 patients study Q1-2015

Glaucoma Data from Interim Analysis of Phase II study88 patients study H2 2015

Contact Information Can-Fite BioPharma Ltd.

10 Bareket Street Kiryat Matalon

Petah Tikva, 4951778, IsraelPhone: +972 3 924 1114

www.canfite.com

Pnina Fishman, Ph.D.Chief Executive Officer

[email protected] Phone: +972 3 924 1114

Motti Farbstein

Chief Financial [email protected]

Phone: +972 3 924 1114

Robert HaagIRTH Communications

[email protected] Phone: +1 866 976 4784

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