A NEW ERA for the treatment of blood diseases

Transcription

1 A NEW ERA for the treatment of blood diseases Bone marrow and blood stem cell transplantation products Dr Vladislav Sandler CO-FOUNDER & CHIEF EXECUTIVE OFFICER Dr Robin Campbell CHAIRMAN Lawrence Pemble CHIEF OPERATING OFFICER Peter Redmond DIRECTOR SILVER FALCON 1

2 IMPORTANT NOTICE This presentation is issued on behalf of Silver Falcon plc (the Company ) solely for the purposes of preliminary discussions in relation to a potential placing of shares in the Company (the Placing ) in connection with the Company s proposed acquisition of Hemogenyx LLC (the Acquisition ). This presentation does not constitute a prospectus nor does it constitute or form part of any offer or invitation to sell or issue, or any solicitation of any offer to purchase or subscribe for or otherwise acquire any securities of the Company or of a subsidiary undertaking of the Company, nor does this presentation constitute or form part of any invitation or inducement to engage in investment activity under section 21 of the Financial Services and Markets Act 2000 ( FSMA ), nor does it constitute a recommendation regarding securities of the Company, nor shall it or any part of it form the basis of or be relied on in connection with any contract or investment decision. 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3 Bone marrow, or a Haematopoietic stem cell The Problem (HSC) transplant, is a potentially life-saving option in treating blood diseases 2 Key issues: 01 Dangerous 02 Finding a Donor Procedure is dangerous and preparing patients ( conditioning ) is toxic At least 60% of patients requiring a donor fail to find one Even so, up to 50% of transplants fail Hemogenyx has a potential solution for both 3

4 HemoGenyx an overview Reverse takeover by Silver Falcon plc, listed on the Main Market of the LSE 2.0M Biotech company focusing on life threatening blood Novel therapies to transform Bone Marrow and Blood Stem Cell transplant treatments: diseases, like leukaemia, Raised 2.0M to progress its lead multiple myeloma and lymphoma. Conditioning product to replace harmful chemotherapy / irradiation currently used candidate in readiness for start of Phase 1 studies Technology developed by CEO, Dr Vladislav Sandler Cell Therapy that generates cancer free, patient matched stem cells for transplantation TIMETABLE General meeting and admission, DE-RISKED FAST TRACKING WELL PROTECTED Oct 2017 Established sound proof- Lead product expected to Exclusive worldwide of-principle in humanised be ready for clinical trials sub-license from Cornell University animal studies within next 18 months plus additional patent applications filed 4

5 The Team Board of Directors BOARD OF ADVISORS FOUND IN THE APPENDIX Dr. Vladislav Sandler PhD Dr Robin Campbell PhD Lawrence Pemble Tim Le Druillenec FOUNDER AND CHIEF EXECUTIVE OFFICER CHAIRMAN CHIEF OPERATING OFFICER FINANCE DIRECTOR Director Widely published stem cell scientist with decades +30 years pharma and Experienced in M&A CIMA qualified of experience in scientific research Research conducted at Children s Hospital at large company experience Reputation of building activities, financing roles Worked extensively in the Former CEO of Richards Walford & Company Ltd, plus extensive Harvard Medical School, the Salk Institute for shareholder value and Private Equity industry experience working on AIM and Biological Sciences, Harvard University and Albert Einstein College of Medicine. He also led a team of scientists at Advanced Cell Technologies, Inc, and Weill Cornell Medical College Dr. Sandler was awarded the inaugural Daedalus Fund Award for Innovation at Cornell. Discovered the science behind Hemogenyx helping smaller companies raise capital Former pharmaceutical & biotech analyst (including Credit Suisse & Jefferies) Held executive positions up to and including CEO in Private Equity backed ventures, both public and private University of Oxfords Said Business School Alumni the full market NON EXECUTIVE DIRECTORS: Adrian Beeston Alexis Sandler Peter Redmond 5

6 The Team Advisory Board Sir Marc Feldmann Scientific Advisor and Chairman of the Board of Advisors Dr Alexander Tarakhovsky M.D., Ph.D. - Scientific Advisor Dr Mark Pykett Dr Jules Mitchel Dr Boris Shor Dr Koen van Besien VMD, Ph.D. - Business Development Advisor Ph.D. - Clinical Trials Advisor Ph.D. Corporate Development Advisor M.D., Ph.D. Clinical Advisor Director Director Director PhD in Immunology from Professor and Head President and CEO of Agilis President of Target Executive Director Professor of Medicine and Walter and Eliza Hall Institute of Laboratories at The Biopharmaceuticals Health Inc, a CRO at Immune Director of the Stem Cell of Medical Research Discovered the pivotal role of TNFa in rheumatoid arthritis Albert Lasker Clinical Medical Research Award Winner Passionate to define treatments for major unmet needs Rockefeller University An expert and recognized thought leader in immunology and epigenetics 20+ years experience in the pharma industry Former CEO of Navidea Biopharmaceuticals Former President & COO of Alseres Pharmaceuticals Established a broad base pharma experience including three NDA submissions, many FDA discussions Expertise in Pharmacokinetics Pharmaceuticals Former group leader at the Oncology Research Unit of Pfizer 15+ years experience with biotech start-ups Transplant Program at NYP-Weill Cornell College of Medicine. Developed novel methods of transplantation for those patients who lack matching donors. >200 publications in peer reviewed journals Editor in Chief of the journal, Leukemia and Lymphoma 6

7 New Treatment BM/HSC transplant - 3 stages 01 Methodology STAGE 1: CURRENT STAGE 2: CURRENT STAGE 3 CONDITIONING CDX antibodies to replace traditional patient conditioning for BM/HSC transplantations that Conditioning High/low dose chemo/radiation Non specific Highly toxic BM/HSC Transplant 50% rejection rate At least 60% fail to find a match Postprocedure recovery currently involves chemotherapy and/or radiation HEMOGENYX HEMOGENYX HEMOGENYX 02 CELL THERAPY Cells that can generate cancer-free, patient matched blood stem cells from adults or umbilical cord Conditioning CDX Antibodies Specific target Less toxic Cell Therapy Hu-PHEC Special class of cells that can generate cancer- Postprocedure recovery HU-PHEC = POSTNATAL HEMOGENIC ENDOTHELIAL CELLS free blood stem cells Patient matched blood stem cells Breakthrough therapy with potential to revolutionise BM/HSC transplants and address highest clinical needs A significant number of patients cannot undergo conditioning, find a matching donor or the transplantation fails 7

8 Conditioning (CDX) KEY ACHIEVEMENTS Antibodies for 01 Immunosuppression of patient and clearing of space in BM for transplanted HSC Patent application filed for use of a class of antibodies for conditioning patients conditioning patients for BM/HSC transplantation undergoing BM/HSC transplants 02 Potential direct treatment of certain sub-types of Leukaemia Functionality validated in vitro 2015 Highly specific CDX antibodies Functionality validated in humanised mice in vivo 2016 Hemogenyx s method selectively eliminates HSC and hematopoietic progenitors using highly specific CDX antibodies, which redirect a patient s own immune cells to eliminate HSC 8

9 Cell Therapy (HU-PHEC) Hu-PHEC advantages: New discovery of naturally occurring cell type and easily isolated KEY ACHIEVEMENTS Adult hemogenic endothelial cells (Hu-PHEC) generating cancer-free HSC Do not accumulate blood cancer-related mutations or chromosomal rearrangements Allow introduction of therapeutic genes and gene modifications LIVER Hu-PHEC isolated from mouse & human livers, engraftment shown in mice Three products in development Hu-PHEC Umbilical Hu-PHEC Liver Hu-PHEC Expanded UMBILICAL CORD Proof of principle in immunocompromised mice Prepared for pre-ind programme Umbilical cord & placenta Hu-PHEC Used in combination with donor provided cord blood Complementary with existing treatment Derived from patient s own liver Hu-PHEC Derived from patients own liver Replaces all autologous transplants and most donor derived transplants Liver expanded Hu-PHEC - potential correction of disease causing mutations Provide unlimited source of healthy HSC Eliminate need for donors for most blood diseases EXPANDED Data obtained on the method of expansion of umbilical Hu-PHEC 9

10 What is the opportunity? USA and Europe c. $8-9 Billion Total value of BM/HSC transplants, of which $3.7bn is for conditioning c.60,000 BM/HSC transplants in 2015 HemoGenyx products expected to substantially increase the market size Every 4mins someone is diagnosed with a type of blood cancer, in the US alone 10

11 Hemogenyx products to address problems at all 3 stages CONDITIONING TRANSPLANT RECOVERY Suitable Patients Donor available Clinical success Unsuitable Patients Donor not available Relapse or rejection Patient age and status determines suitability for conditioning CDX - A safer solution for unsuitable patients C. 60% fail to find a donor C. 50% of transplants fail or are rejected Hu-PHEC - To address donor and Hemogenyx to improve rejection limitations chances of clinical success 11

12 Hemogenyx Stages of development Dr Sandler starts stem cell therapy research at the Salk Institute for Biological Sciences Dr Sandler discovered Hu-PHECS North Award Hemogenyx LLC obtains exclusive worldwide license to the Hu-PHEC patent Proof of Principle Studies of CDX antibodies completed Patent application filed (composition of matter) for CDX antibodies PRESENT HemoGenyx founded Weill Cornell Medicine Daedalus Award Proof of Principle Studies of Hu-PHEC Umbilical Completed Patent application filed for CDX antibodies 12

13 Key development milestones Conditioning product development Cell Therapy product development Final preparations in readiness for start of Phase 1 trials 13

14 USE OF FUNDS Proceeds of Placing Profits from consul:ng services over 18 months R&D tax credit Exis:ng Funds Total 2.0m 0.29m 0.11m 1.02m 3.42m Comple:on of CDX condi:oning and Hu-PHEC Pre-clinical studies Working capital IP & licensing* Con:ngency Costs of transac:on Total 1.89m 0.58m 0.35m 0.12m 0.48m 3.42m * *including repayment of Cornell Loan 14

15 Summary NOVEL AND MORE EFFECTIVE TREATMENTS Removing need for painful and dangerous conditioning and eliminating need for bone marrow donors CLEAR MILESTONES Pathway to clinical trials within 18 months END TO END SOLUTION Products aim to solve all major problems associated with BM/HSC Transplants 15

16 GET IN TOUCH HemoGenyx Pharmaceuticals Ltd 10 Bloomsbury Way London WC1A 2SL United Kingdom VIA WALBROOK PR LTD

17 APPENDIX 17

18 Recent Transac+ons In Market Segments Deals Structure Date Type Phase Value 2017, from macro forces and an Jounce Therapeu+cs IPO Jan 2017 Immuno- oncology Phase 1 $555M Corvus Pharmaceu+cals IPO March 2016 Immuno- oncology Phase 1 $298M unusually full M&A pipeline, is likely to Argenx / AbbVie Strategic Alliance April 2016 Immuno- oncology Preclinical $685M push biopharma deal- making to new heights. - Ernst & Young Delinia / Celgene Trade Sale Jan 2017 Immunotherapy Preclinical $775M EngMab / Switzerland Celgene Trade Sale Oct 2016 Immuno- oncology Preclinical $600M Tolero / Sumitomo Dainippon Trade Sale Jan 2017 Hematology oncology Phase 1 $780M Kolltan Pharmaceu+cals / Celldex Trade Sale Nov 2016 Immuno- oncology Phase 1 $235M 11