hbl financing 7.08

23
Hadasit Bio-Holdings Ltd. – “HBL” ((Tel Aviv Stock Exchange: HDST July 2008

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Page 1: HBL Financing 7.08

Hadasit Bio-Holdings Ltd. – “HBL”

((Tel Aviv Stock Exchange: HDST

July 2008

Page 2: HBL Financing 7.08

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.

Page 3: HBL Financing 7.08

The Value Chain in Israeli Biotech The Value Chain in Israeli Biotech

Academy & TTO’s

Incubation Govt. Support

ClusteringSpecialized

Angels & VC’s

PublicInvestment

Co.

Strategic Partnering

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

July 2008

Support: GMP, Regul., CRC, Underwriting, IPOs, PR/IR, Analysis, Market-making,

Page 4: HBL Financing 7.08

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HBL - Company ProfileHoldings 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%)

Page 5: HBL Financing 7.08

VertoVertoCell CureCell Cure ProtAbProtAb KAHRKAHR

100%100%

52%52%

H.B.L Ltd. H.B.L Ltd.

Public 43%Public 43%

TolarexTolarex

75%34% 100% 80% 92%

Auto-immune Disease

ForticellForticellBio.Bio.

(Nasdaq)(Nasdaq)

4.5%

Tissue Engineeringand Stem-cell Medicine

IncureIncure TK SignalTK Signal(UK)(UK)

66% 25%

Oncology

22%

Thrombo Thrombo techtech

C.B.G 5%C.B.G 5% ConjuGateConjuGate 30%

Drug Engineering

HBL Structure (7/08)

Page 6: HBL Financing 7.08

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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.D’s / M.D’s

“Bio-Park”:

6 floors of 1,500 m2 o

Fully customized for

Biotech companies

GMP, GLP, Animal

facilities, Phase I center

Page 7: HBL Financing 7.08

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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)

Page 8: HBL Financing 7.08

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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

Page 9: HBL Financing 7.08

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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

Product target markets measured in the billions of dollars (“Blockbuster”)

– Oncology, tissue engineering, stem-cell medicine, auto-immune diseases

– Answer to Unmet Clinical Needs (not improvement of existing drugs)

2

Risk Management– Dispersing risk through a portfolio of 9 companies in different fields

– Professional identification of investments and guidance of the companies by a team of technology and business experts

– Reducing company “burn-rate” by utilizing the infrastructure of Hadassah Hospital for development and clinical research

– Huge pool of future investment options (IP) – getting in at “ground level” with rapid increase in value

3

Page 10: HBL Financing 7.08

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1

At Phase I Increase in value of

10x to 30x

HBL’s “Sweet Spot” Highest rate of success

vis-à-vis required investment

Focus - Return on Investment

% required investment

Percent of total investment

Odds that company will advance from this phase to the next

Required investment $m Years

Approval

Page 11: HBL Financing 7.08

The Biggest Growth in Value Has Been atClinical Proof of Concept

Phase I/II Deals

$0

$100

$200

$300

$400

$500

$600

$700

2001 2002 2003 2004 2005 2006

$ M

illio

ns

0

2

4

6

8

10

12

14

16

18

20

No

. of T

ransa

ction

s

$ Upfront Total

No. of Deals

SOURCE: Windhover’s Strategic Transactions Database, June 2007

Upfront only (No milestones or royalties) – Ave. of 35 M

Page 12: HBL Financing 7.08

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Market Size Field/TreatingCompany

Stroke – US$ 500 mm;

Cardiac Arrest – US$ 1 billion

Thrombosis, Myocardial Infarction

Thrombotech

Systemic infections – US$ 6 billionDrug Reformulation – Systemic infections

ConjuGate

Cancer + Autoimmune diseases – US$ 5 billion;Cancer, Inflammatory DiseasesKAHR 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 CureTK-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 DiseaseTolarex

US$ 2 billionLupus TherapyVerto

2 Market Size Market size in

billions

Unmet clinical needs

Page 13: HBL Financing 7.08

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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.

Page 14: HBL Financing 7.08

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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

Page 15: HBL Financing 7.08

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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 R&D, 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

External Investments in Companies

Page 16: HBL Financing 7.08

IncurePR Marker

Early Stage Cancer detect

ConjuGateAmpho. B

Systemic Infections

BiolineRxBL1040BL2030

Acute MIProstate C

Thromb.TBT218Myocardial. Infar. Stroke

KAHRTSCP'sAuto Immune Disease

CellCureNeural Progen.

Multiple Scel. Parkinson

ForticellOrCell / FMB's

Hard-to-heal Wounds

ProtAbAP6Reum. Arth. Inf. B. Disease

TK SignalFenolDopam

MultipleMyeloma

TolarexApoCellGraft Vs. Host Disease

VertoLuposorbLupusDone

CompanyProductIndicationDiscoveryLead Selection

Efficacy in Animal Models

IND Prep.

Phase I

Phase I / II

Pha. II

Phase III

PMA

HBL Product Pipeline (7/08)

Page 17: HBL Financing 7.08

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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,

Alzheimer’s) – permanently released and owned by the company• Receipt of $ 2 M in "soft funding" – Michael J. Fox, ALS,

Beresheet, OCS• New VP of R&D, 4 additional researchers (>20 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

Page 18: HBL Financing 7.08

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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 R&D 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

Page 19: HBL Financing 7.08

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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 R&D

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 TSCP’s - 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)

Page 20: HBL Financing 7.08

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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 kitConjuGate 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.

Page 21: HBL Financing 7.08

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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 MD’s/PhD’s 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.

Page 22: HBL Financing 7.08

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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

Page 23: HBL Financing 7.08

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Thank You

Ophir Shahaf, CEO Hadasit Bio-Holdings Ltd. Tel.: +972-54-520-1177