hadasit bio-holdings ltd. 7.06 for capital markets v3.pdf · operating or financial performance...
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Hadasit Bio-Holdings Ltd.
(Tel Aviv Stock Exchange: HDST)
Presentation to:Israeli Capital Markets
July 2006
www.hbl.co.il
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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 operating or financial performance 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 orcircumstances 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 therefor.
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Agenda HBL – BackgroundBasic concepts – science & technology, inclusion criteria, Hadassah leverage, commercialization, risk managementCompany progress since the IPOPortfolio companies - the “underlying assets”Stock performance, Market Making, ResearchSummary – Investment highlights
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Hadasit Bio-Holdings Ltd. – The BasicsThe concept : pick most attractive companies within the Hadasit portfolio, “re-package” in new, public entity (HDST)Maintain controlling interest, while aggressively advancing the portfolio companies towards the next key value adding milestone (Phase I)Criteria for inclusion in the portfolio – science / technology as well as business / market based Continuous stream of positive developments from the companies (currently 9) – to build share valuePart of TASE Tel-Tech Index and BioMed sector
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Hadassah Medical Center
HBL Bio-Park
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HBL – OverviewHadasit Bio-Holdings Ltd. (TASE – HDST):
Founded - September 2005. Traded Since Jan. 2006 Management company – Hadasit Ltd. Main Shareholders – Hadasit: 67%, Public: 33%Management: Dr. Rafi Hofstein, CEO
Adv. Ophir Shahaf, Man. Dir.Board members: – Prof. S. Mor-Yossef (Man. Dir., Hadassah MO)– Dr. R. Hofstein (CEO, Hadasit)– Mr. Y. Cohen (CEO, Fortissimo Private Equity) – Public Representatives.: Yaron Kulas, Tzipi Gal-Yam
Counsel: E. Abramson & Co. Mkt. Maker: ExcellenceAuditors: Brightman Almagor (Deloitte)
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Hadasit Bio-Holdings Ltd. :A Unique Investment Vehicle
Access to leading companies based on the IP generated by Israel’s foremost medical research center Highly selective portfolio – the stock provides investment in a cluster of 9 biotech companies -based on IP generated and owned by HMOSectors: Oncology, Regenerative Medicine and Auto-Immune DiseasesInclusion Criteria: all companies have passed animal model testing and each company is addressing a multi-billion dollar market;
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Risk Management StrategyUnique Risk/Reward Profile for Investors: 1. Distribution of technologies – diversification2. Focus on Phase I and preparation for Phase II –
significant upside and attractive risk-reward ratio3. Conservative valuation allowing exit events to be
translated into increase of HBL value (Hapto –Ortec Merger, TK Signal Funding)
4. Economies of scale and strong infrastructure based on HMO
5. Experienced management team and support staff
VertoVerto IncureIncure Cell CureCell Cure TK SignalTK Signal ProtabProtab KAHRKAHRHapto Hapto
BioTech BioTech (Ortec(Ortec
Int.)Int.)
Thrombotech Thrombotech TechnologiesTechnologies
27%27%100%100%100%100%
7.7%7.7%39%39%45%45%66%66%75%75%
Researcher Researcher 4040%%100%100%
67%67%
H.B.L Ltd.H.B.L Ltd.
Public 33%Public 33%
TolarexTolarex
100%100%HBL Structure
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Portfolio - 9 Biotechnology CompaniesStructured process applied in order to select the HBL portfolio companies, from 25 Hadasit CompaniesCriteria:
• 1. Proof of Concept in an animal model (“it works”) • 2. Business potential assessed by members of
Hadasit’s Scientific Advisory Board (“it’s worthwhile”)
Selection completed by panel of international experts –scientific, industrial and financial (Burrill, Arnon, Howsen)Hadassah representative to each company – control & monitoring in place
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Portfolio Companies - OverviewHBL’s Holdings (%)
Founded Field / TreatingCompany
27 %2000Thrombosis, Myocardial Infarction - Invested
Thrombotech Technologies Ltd.
21.0%(7.7% post M.)
2000Tissue Regeneration (Merged with ORTEC Int.) - Invested
Hapto-Biotech Inc.
100 %2005Inflammatory DiseaseKAHR Inc.100%2005Inflammatory DiseaseProtab Ltd.39.3%2001Cancer monitoring and cure –
InvestedTK-Signal Ltd.
45%(Post Inv.)
2005Cell Therapy – Parkinson Disease (Post Inv.) - Invested
Cell Cure Ltd.
66%2002Cancer Diagnostics and Cure Processes – Invested
Incure Ltd.
100%2005Graft Vs. Host Disease – InvestedTolarex Ltd.74.6%2004Lupus Therapy – InvestedVerto Ltd.
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Portfolio Company Progress Since IPOCell Cure Neurosciences – Raised $ 3 M (HBL), completed transfer of all IP related to Neurodegenerative applications from Singapore partner, major IP issued, FDA approached, included in the “Genesis” consortium
TK Signal – Raised $ 1.8 M from UK investors. Key collaborations in place, relocated to new offices and labs. Funding at $ 10.7 M pre-money - HBL invested at $ 5 pre-$, in January 2006
Hapto Biotech – Completed merger with Ortec International (NASDAQ: ORTN) and raised $ 6.7 M. Expanded pipeline of applications (Orthopedics, Cosmetics). Current Market Cap: $ 18.3 M - HBL invested at $ 2.5 M
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Portfolio Company Progress (II)Thrombotec – Raised funds, completed production of peptide, successfully completed major animal trials, preparing protocol in order to enter the clinicVerto – Raised funds, about to commence clinical trials.Incure – Fundraising – completed assembly of blood sample databank in order to enable development of a diagnostic kit. Key IP assets granted. Recruiting CEO.Tolarex – Advancing device towards beginning of Phase I trial for GVHD – staff and equipment secured (fast track regulation). Filed IP on 2nd generation therapeuticsKAHR – Tech transfer completed, manufacturing protocol in place, identified relevant animal modelProtAb – Adjusted product to humanized model for trials.
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Vision – Cure neurodegenerative diseases using human embryonic stem cell based cell replacement therapies
1st Product – Committed dopaminergic neural progenitor cells for Parkinson’s disease
Status – Pre-clinical testing in animal models
Team – leading scientific group in the fieldheaded by Benjamin Reubinoff
IP – key patents in the field in-licensed fromES Cell International
Investment - $3 M in addition to $3M from Hadasit Bio-Holding to reach clinical trials
Jointly owned with ES Cell International from Singapore. Part of “Genesis” Consortium
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Hapto Biotech Hapto Biotech –– Ortec InternationalOrtec International
During April 2006, Hapto Merged with ORTN (NASDAQ)Key Platform Technologies:
Haptides™ (~20 amino acids) synthetic peptidesSynthetic peptides, Non-toxic up to high concentrationsProducts: 1. Coat biological materials to produce “smart dressings”. 2. Augment penetration of drugs and gene delivery into cell.
Fibrin Micro Beads (FMB) (50-300 µm) Fabricated fibrin beads to attach and grow cells in suspension, able to bind different cell types, well tolerated in vivo, biodegradableProducts: 1. Non cellular tissue regeneration matrix – tissue filling2. Cellular – Grow cells in suspension; select stem cells for expansion & implantationMajor IP Estate in place, Fully Operative Team and GMP FacilityR&D collaboration agreements - TEVA & Major US Pharma Co.
The product: GMP produced Haptized-collagen sponge
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TK Signal - ProfileTK Signal TK Signal -- ProfileProfile• Development and commercialization of targeted
EGFR radiopharmaceuticals for application in cancer diagnostics and cancer therapy using PET imaging
• Radiopharmaceutical market estimated at $ 2 B at 2005 and growing at 10% per year
• Key personnel - 2 world renowned cancer and imaging researchers from Hadassah and Hebrew U.
• Multi disciplinary team (chemists, radio-chemists, nuclear-engineers, biologists)
• Strong IP position (2 approved, 1 pending)• Feasibility demonstrated in vitro and in vivo• Wide collaboration network• Completed UK funding of $ 1.6 M
ThromboTech Ltd.ThromboTech Ltd.Novel Thrombolytic AgentsNovel Thrombolytic Agents
• Discovered Unique peptide that dissolves blood clots. • Utilizing this peptide with tPA increases the safety profile of
current thrombolytic therapeutics and offers key advantages: Expanded treatment window, PAI-1 resistance & Fibrin specificity
• Market: All drugs existing today cause severe side effects as they damage blood vessels, increasing internal hemorrhage. Only 3% of the patients receive tPA after stroke due to these side-effects
• IP: Wide claims covering the use of the derived peptide for dissolving of blood clots
• The peptide production is manufactured in GMP conditions, Tox. and pre-clinical testing to be completed during 2006.
• Initial clinical indications to be tested: Myocardial Infarction17
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Vision – Treat autoimmune diseases by highly selective removal of the damaging antibodies from circulation
1st Product – Revolutionary treatment of Lupus (SLE) using the Lupusorb plasmapheresis immuno-absorption column
Status – Clinical studies to start within 4 months
Team – Scientific group led by leading authority in the field, Prof. Yaakov Naparstek
IP – Therapeutic and diagnostic patents issued
Business Model – Alliance with major US supplier of plasmapheresis equipment
Investment - $ 1 M to extend clinical studies
Systemic Lupus Erythematosus (SLE)US Prevalence 500K, Cost of SeverePatients $20K/yr, No specific drugMarket $500M
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Developing New Therapies for AutoimmunityDeveloping New Therapies for AutoimmunityProtabProtabVision – A new type of drug that activates anti-inflammatory agents to supplement or replace current blockbusters
1st Product – anti-peptide 6 monoclonal antibody for RA arthritis and diabetes
Status – Animal studies completed; awaiting production of humanized monoclonal antibody
Team –Scientific group led by leading authority in the field: Prof. Y. Naparstek
IP – Strong core patent on HSP65 peptides, antibodies and use in inflammatory diseases
Business Model – Out-licensing to pharma / biotechs after demonstration of efficacy
Investment - to produce humanized mAB
Rheumatoid Arthritis, affects 2.1M Americans, $5B/yr spent on antiarhritic drugs, Blockbuster inhibitors of anti-inflammatory agents, Enbrel, Remicade, Humira, reduce scores 50% in 50% of patients.
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Developing a patent protected diagnostic kit based on a unique peptide, for the detection and treatment of tumor metastatic spread - in blood samplesInitial indications to be explored: Breast, Ovary, Colon, ProstateMetastatic cancers are very difficult to treat -Therapeutic intervention could be:
Too aggressive – Adverse side-effectsInsufficiently aggressive – no cure
Early detection of potential tumor invasion is critical for determining the appropriate treatment strategies and improving recovery prospectsDevelopment status: In vitro assay – established, assay for peptide detection in patients – in progress, collection of breast cancer patients blood samples (various stages) – in progress
KAHR MKAHR Medicaledical Ltd.Ltd.PP14 Based ImmunoPP14 Based Immuno--Therapeutic ProteinsTherapeutic Proteins
• During pregnancy auto-immune diseases undergo remarkable remissions - KAHR has discovered this is probably due to the production of a unique immuno-regulatory protein -PP14• In- Vivo Results: Ectopically expressed PP14 inhibits the activation and proliferation of Human peripheral blood mononuclear cells (PBMC) in SCID mice• Positioned to move forward with preclinical studies with PP14 to treat Psoriasis, Multiple Sclerosis, Rheumatoid arthritis, Organ Transplant Rejection and Graft-versus-Host Disease• The value of biological drugs indicated for autoimmune diseases was roughly $6.8 billion in 2003 and is predicted to triple by 2008• IP: KAHR’s IP covers the use of PP14 and its therapeutic derivatives for treatment of all auto-immune diseases
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A Treatment Device For A Treatment Device For Recipients of Transplanted Recipients of Transplanted Organs and for Other AutoOrgans and for Other Auto--
Immune DiseasesImmune DiseasesPatient material does not normally trigger an immune response
due to a conditioning of the immune system. This conditioning iscalled tolerance. An important mechanism of creating tolerance is the sampling of apoptotic cells that die daily in the body
The anti-inflammatory properties of self apoptotic cells can be used in a variety of clinical conditions including in GVHD
The use of autologous apoptotic cells ensures a high safety profile. The repeated “pulses” of treatment maintain peripheral tolerance
Potential Indications: GVHD, Auto-immune Disorders, Inflammatory Conditions
Milestones expected: Q1 2007: Completion of human in-vitro studies. Completion of validation of the final mode of delivery of autologous cells, Q3 2007: Phase I clinical trial Acute GVHD
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Portfolio Companies – Addressable Market SizeMarket Size Field/TreatingCompany
Stroke – US$ 500 mm;Cardiac Arrest – US$ 1 billion;
Thrombosis, Myocardial Infarction
Thrombotech Technologies Ltd.
Chronic Wound Healing – US$ 9 billionCosmetic Market – US$ 3 billion
Tissue RegenerationHapto-Biotech Inc.
Cancer + Autoimmune diseases – US$ 5 billion;Cancer, Inflammatory DiseasesKAHR Inc.
RA – US$ 5 billion;Diabetes – US$ 3 billion
Inflammatory and autoimmune Disease
Protab Ltd.
Diagnostics – US$ 500 mm;Treatment related drugs – US$ 1 billion
Cancer monitoring and cureTK-Signal Ltd.
Parkinson – US$ 1 billionMS - US$ 1 billion
Cell Therapy – Parkinson Disease and MS
Cell Cure Ltd.
Diagnostics – US$ 500 mm;Treatment related drugs – US$ 2 billion
Cancer Diagnostics and cure processes
Incure Ltd.
US $300 mm. Autoimmune disease – us $ 20 billion.
Graft Vs. Host DiseaseTolarex Ltd.
US$ 2 billionLupus TherapyVerto Ltd.
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Goals and Tasks for Next 18 MonthsAdvance leading product of each company into Phase IComplete preparations for additional Phase I trials (CMC, Regulatory Approval, Manufacturing)Recruit senior management for 3 of the portfolio companiesInitiate Business Development efforts for 4 of the portfolio companies, including additional (external, non-HBL) fundingExecute at least one new additional investment as an addition to the HBL portfolioAssume leading position in the TASE BioMed Index
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Summary : Investment HighlightsHigh quality companies – strong science, huge potential, Hadassah backing and commitmentHDST and all companies priced at major discountAll companies in ”hot” medical areas: Oncology, Auto-Immune Disease, Tissue Regeneration and Stem CellsAll cluster companies are targeting multi billion product markets – success will create value for investorsHadassah provides managerial support, world class expertise, equipment and facilitiesHBL targets the value-appreciation phase: End of phase I and beginning of Phase IIOffering structure limits risk and ensures major upside
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THANK YOU
Contact: Adv. Ophir ShahafManaging Director
Hadasit Bio-Holdings Ltd.Tel.: 972-2-677-8757Cell: [email protected]
Please Visit Our New Web Site: www.hbl.co.il