HBL Financing 7.08

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HBL Financing 7.08

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Receipt of $ 2 M in 'soft funding' Michael J. Fox, ALS, Beresheet, OCS ... Next step commercialization via design of diagnostic kit. ConjuGate Ltd. ... – PowerPoint PPT presentation

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Title: HBL Financing 7.08


1
Hadasit Bio-Holdings Ltd. HBL ((Tel Aviv
Stock Exchange HDST July 2008
2
Forward Looking Statements
  • This document/presentation contains forward
    looking statements. Words such as estimates,
    expects, intends, plans, believes and
    terms of similar substance used in connection
    with any discussion of future operational
    performance or financial results, identify
    forward looking statements.
  • Such statements are subject to risks and
    uncertainties that could cause the actual results
    to differ materially from these statements. The
    forward-looking statements contained herein speak
    only as of the date of this document.
  • The Company expressly disclaims any obligation or
    undertaking to release publicly any updates or
    revisions to any forward-looking statements
    contained herein to reflect any change in the
    Company's expectations with regard thereto or to
    reflect any change in events, conditions or
    circumstances on which any such forward-looking
    statement is based, in whole or in part.
  • This document does not constitute or form any
    part of any offer or invitation to sell, or any
    solicitation of any offer to purchase or
    subscribe for any shares in Hadasit Bio-Holdings
    Ltd. or any of its affiliated entities nor shall
    it form the basis of, or be relied on in
    connection with, any contract therefore.

3
The Value Chain in Israeli Biotech
July 2008
Specialized Angels VCs
Public Investment Co.
Academy TTOs
Govt. Support
Incubation
Clustering
Yeda Yissum Ramot BG Negev Hadasit
Meytav Rad-BIO Naiot Capital- Point
OCS Magnet BIRD Bio-Disc BriTech
Bioline Biomedix HMO Bio-Park
Ofer HT Glenrock Coronis Pontifax
BioLight Clal Bio Maayan HBL
Support GMP, Regul., CRC, Underwriting, IPOs,
PR/IR, Analysis, Market-making,
4
HBL - Company Profile
  • Holdings in early-stage biotech companies (until
    completion of Phase I)
  • 10 companies All IP developed at Hadassah
  • 3 areas (Oncology, Auto-immune diseases, Tissue
    engineering / Stem cells)
  • Criteria Demonstration of Proof of Concept,
    Blockbuster Market
  • Exit strategy - at end of Phase I
  • Leveraging Hadassah Hospital
  • Source of Intellectual Property and future
    investment opportunities
  • Skilled personnel, infrastructure, GMP facilities
    and clinical trials
  • Established September 2005
  • Traded Tel Aviv Stock Exchange (HDST) since
    January 2006
  • Investment rounds
  • IPO (January 2006) 8 m
  • Convertible Bonds (August 2006) 10 m , 5 m
    converted (Feb. 2007)
  • Strategic Investment (May 2007) - 2 m
    (Consensus Business Group)
  • Stockholders Hadasit (owned by Hadassah) (52),
    public (43), CBG - (5)

5
HBL Structure (7/08)
6
4 Key Building Blocks F.I.M.S
Finance
I.P.
Mgt.
Space
IPO Bond PIPE - CBG OCS Venture
Philanthropy FP7 NIH
Hadassah 50 new Patents per year Partnering Heb.U.
U.PENN
Experienced Managers All HMO Experts Seasoned
Pharma VC Execs. Ph.Ds / M.Ds
Bio-Park 6 floors of 1,500 m2 o Fully
customized for Biotech companies GMP, GLP, Animal
facilities, Phase I center
6
7
2008 Value Adding Milestones
  • KAHR HBL Investment, 5 New Compounds from
    UPENN, OCS approval for 400 K, new VP,
    external investment
  • Tolarex HBL Investment, IND approval from FDA,
    Phase I start, external investment
  • ProtAb Completion of humanization external
    investment
  • TK Signal Preparation for Phase I, Phase I
    start
  • Verto Completion of Phase I trial, strategic
    partnership
  • Incure Expansion of trial data, Exit via
    strategic partnership
  • ConjuGate External Investment, Manuf., Phase I
    start
  • BiolineRx 2 X Phase II completions (BL1020,
    BL1040)
  • HBL Investment ( 5-7 M)

7
8
Hadassah Bio-Park - 2008
  • First medical center on-site bio park custom
    built for life science companies (including
    labs,Phase I center)
  • Building upon infrastructure of Hebrew U. Med.
    School and Hadassah University Hospital
    (conducting more than 50 of all translational
    medicine research in Israel)
  • HU conducts over 40 of all Biotechnology
    research in Israel.
  • Hadassah Ein-Kerem campus includes Med. and
    Dentistry schools, Nursing, Pharmacy
    Public Health
    schools
  • First building to include 6 floors
    total available
    space 10,000 m2
  • Jerusalem municipality and JDA
    provide significant
    financial incentives
    tax breaks and grants
  • 5 HBL companies ( HQ) to relocate

HBL
8
9
Investment Strategy
  • High return on investment through investments
    before the first clinical phase (Phase I)
  • After proof of concept in animals and before
    completion of Phase I
  • Value multipliers X 10 to X 50
  • Midway Exit planned after Phase I, clear dividend
    policy

1
10
Focus - Return on Investment
1
At Phase I Increase in value of 10x to 30x
HBLs Sweet Spot Highest rate of success
vis-à-vis required investment
required investment
Approval
Odds that company will advance from this phase
to the next
Percent of total investment
Required investment m
Years
11
The Biggest Growth in Value Has Been atClinical
Proof of Concept
Upfront only (No milestones or royalties) Ave.
of 35 M
SOURCE Windhovers Strategic Transactions
Database, June 2007
12
Market Size
Unmet clinical needs
Market size in billions
2
Market Size Field/Treating Company
Stroke US 500 mm Cardiac Arrest US 1 billion Thrombosis, Myocardial Infarction Thrombotech
Systemic infections US 6 billion Drug Reformulation Systemic infections ConjuGate
Cancer Autoimmune diseases US 5 billion Cancer, Inflammatory Diseases KAHR Medical
RA US 5 billion Diabetes US 3 billion Inflammatory and Autoimmune Disease Protab
Diagnostics US 1 billion Treatment related drugs US 6 billion Cancer Monitoring and Cure TK-Signal
Parkinson US 1 billion MS - US 1 billion Cell Therapy Parkinson Disease and MS Cell Cure NeuroSciences
Diagnostics US 500 mm Treatment related drugs US 2 billion Cancer Diagnostics and cure processes Incure
US 300 mm Autoimmune disease US 20 billion Graft Vs. Host Disease Tolarex
US 2 billion Lupus Therapy Verto

13
Management
  • Dr. Rafi Hofstein - Chairman of the Board.
    President and CEO of Hadasit Ltd., the Technology
    Holdings Company of Hadassah Medical
    Organization. Ex-President of Mindsense
    Biosystems Ltd. Business Unit Director of Ecogen
    Inc., Langhorne PA after serving as the
    Scientific Director of its Israel office. Ph.D.
    and M.Sc. in life-sciences and chemistry from the
    Weizmann Institute of Science, B.Sc. in chemistry
    and physics from the Hebrew University in
    Jerusalem. Dr. Hofstein completed postdoctoral
    training at the Harvard Medical School in Boston,
    MA, in the departments of biological chemistry
    and neurobiology. Founder of ILSI, advisor to
    Israeli Govt., BoDs Breath ID, Evogene, Bioline,
    ConjuGate, KAHR, ProtAb, Tolarex.

Adv. Ophir Shahaf - CEO. Appointed March 2007
after serving as VP of the Company since Jan.
2006. Ex-VP business development at Protalix
Biotherapeutics Ltd. Part of the founding and
management team of Clal Biotechnology Industries
Ltd. as VP and general counsel. LL.B. from Tel
Aviv University, MBA from the Stern School of
Business at New York University. Teaches
biotechnology entrepreneurship and management,
fellow of the Merage Foundation at Irvine, CA.
BoDs Tolarex, ProtAb, Biokine, Thrombotech,
ConjuGate.
13
14
Board of Directors / Advisory Board
  • Prof. Shlomo Mor-Yosef, HMO Director General
  • Yuval Cohen, Fortissimo Private Equity
  • Doron Debbie (Consensus Business Group)
  • Tsipi Gal-Yam (External)
  • Yaron Kulas (External)
  • Prof. Ruth Arnon (Weizmann)
  • Steven G. Burrill Burrill Co.
  • Tamar Howson (Bristol Myers Squibb, LexPharma)
  • Mary Tanner (Biogen, NY Hedge Funds)
  • Jonathan Silverstein (Orbimed VC)
  • Jonathan Fleming (Oxford Biopartners VC)
  • Cheryl Reicin (Torys LLP)
  • All department heads and leading physicians of HMO

14
15
External Investments in Companies
  • 2 Major Strategic Investors / Partners have
    Invested in HBL Portfolio Companies,
  • TEVA Pharmaceutical Industries - 1 M in Cell
    Cure NeuroSciences (Aug. 2007)
  • Recognition of leadership in HESC field
  • Attractive terms for company (value, rights)
  • Significant role in RD, production and
    regulation
  • Clal Biotechnology (CBI) Option Exercise
    additional in Thrombotech (Sept. 2007)
  • 750 K exercise fee 500 K in follow on round
  • Major shareholder participation (Total 1.75 M)
  • Sufficient to complete Phase I trials (Stroke /
    MI)
  • Experienced CEO and Chairman recruited

15
16
HBL Product Pipeline (7/08)
Company Product Indication Discovery Lead Selection Efficacy in Animal Models IND Prep. Phase I Phase I / II Pha. II Phase III PMA
Verto Luposorb Lupus Done
Tolarex ApoCell Graft Vs. Host Disease
TK Signal Fenol Dopam Multiple Myeloma
ProtAb AP6 Reum. Arth. Inf. B. Disease
Forticell OrCell / FMB's Hard-to-heal Wounds
Incure PR Marker Early Stage Cancer detect
CellCure Neural Progen. Multiple Scel. Parkinson
KAHR TSCP's Auto Immune Disease
Thromb. TBT218 Myocardial. Infar. Stroke
BiolineRx BL1040 BL2030 Acute MI Prostate C
ConjuGate Ampho. B Systemic Infections
17
Progress in Portfolio Companies (I)
  • Cell Cure NeuroSciences
  • Investment agreement with TEVA ( 1 M at 13
    pre-)
  • HBL holdings increased to 34.5
  • All IP related to Neurological Disorders
    (Parkinson, MS, Alzheimers) permanently
    released and owned by the company
  • Receipt of 2 M in "soft funding" Michael J.
    Fox, ALS, Beresheet, OCS
  • New VP of RD, 4 additional researchers (gt20
    employees overall)
  • Verto
  • Completion of Phase I/II trial 10 patients w.
    no side effects, measurable therapeutic benefits.
    Trial complete analysis and preparation of
    final report - ongoing.
  • Discussions with potential strategic partners
    awaiting additional clinical data

17
18
Progress in Portfolio Companies (II)
  • ProtAb (PTK)
  • Humanization and production of the lead
    antibody underway (Antitope Cambridge, UK).
    First samples arrived and tested.
  • OCS approved 60 of RD budget ( 500 K).
  • Discussions with private and VC investors.
  • Significant interest from strategic partners.
  • Thrombotech
  • Closed investment following option agreement
    with CBI ( 1.75 M), including 300 K from HBL.
  • Recruited experienced CEO and Chairman.
  • Full set of pre-clinical and toxicology trials
    repeated in "external" lab with excellent
    results

18
19
Progress in Portfolio Companies (III)
  • Tolarex (PTK)
  • Advanced preparations for clinical trial
    Q1/08, Passed IRB, awaiting MOH approval and
    pre-IND at the FDA
  • Additions of personnel (7) and equipment. OCS
    approved RD budget of 1.1 M (60 support)
  • CEO experience in drug development (Alon Moran
    BioMass)
  • KAHR Medical (PTK)
  • Negotiations with U. Penn for significant
    expansion of IP basis (5 new Compounds, based on
    TSCPs - immune-related proteins)
  • Additional investment by HBL, Application for
    OCS support
  • Manufacturing contracts signed with Cobra and
    Invitrogen
  • CEO Ex-VP of Compugen (Dr. Noam Shani)

19
20
Progress in Portfolio Companies (IV)
  • Incure
  • Expansion of ELISA study 40 patients. Groups
    added elders, smokers, pregnant.
  • Data showing detection of cancer metastases via
    blood sample.
  • Negotiation with US strategic partner licensing
    financing deal.
  • Next step commercialization via design of
    diagnostic kit
  • ConjuGate Ltd.
  • Platform targeted at unmet need highly toxic
    drugs with adverse side effects
  • Products to improve efficacy while eliminating
    toxicity, close to phase I with lead product
  • Leading scientists, strong IP, 3 batches
    already produced.
  • Significant equity (33), BOD representation (2
    of 5) and leading position in BD effort.

20
21
Financial Data
  • 3.0 in cash, as of 1/6/08
  • 3 Leading companies (PTK) raising between 3-5 M
    each
  • All companies show major progress since HBL
    Investment
  • Timeline 3 companies in Phase I within 12-18
    months
  • Pipeline Potential exclusive mandate (first
    look) for IP from 1,200 MDs/PhDs at Hadassah,
    250 patents yearly
  • Top-notch science, IP protection, management
  • HMO infrastructure allows for efficient
    financing, low BR
  • Current PIPE
  • 5-7 M at par warrants. Commitment from
    Hadassah, CBG and other key shareholders to
    participate.

21
22
Summary
  • All companies are funded by HBL, partners
  • Leverage of soft funds OCS, research
    foundations
  • Science, IP and Infrastructure HMO
  • Key milestone events expected (Phase I, analyst
    coverage and external investment)
  • Validation of strategic model via external
    strategic investors (CBG, Teva, CBI)
  • Clear Exit strategy at end of Phase I
  • NAV 65 discount. Target of 7.5 NIS.
  • Share price allows major appreciation linked to
    milestones

23
Thank You
  • Ophir Shahaf, CEO
  • Hadasit Bio-Holdings Ltd.
  • Tel. 972-54-520-1177
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