Presentation: what is WE CAN Young? Presentation: What is WE CAN Young?
Can-Fite Presentation – November 2014. This presentation contains forward-looking statements,...
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Transcript of Can-Fite Presentation – November 2014. This presentation contains forward-looking statements,...
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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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•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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[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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