Hemostemix Inc · TSXV:HEM
Hemostemix — Investor Presentation (September 2015)
21 slides from Hemostemix's investor presentation, September 2015
Slide 1: Your Cells. Our Technology.
YOUR CELLS. OUR TECHNOLOGY. WWW.HEMOSTEMIX.COM TSXV: HEM
Slide 2: Safe Harbor
SAFE HARBOR This presentation contains forward-looking statements that involve risks and uncertainties, which may cause actual results to differ materially from the statements made. For this purpose, any statements that are contained herein that are not statements of historical fact may be deemed to
Slide 3: Company Overview
COMPANY OVERVIEW Clinical-stage cell-therapy company Platform technology derived from simple draw of autologous (patient’s own) blood for treatment of vascular diseases • Strong evidence of angiogenic (blood-vessel forming) capacity in humans • Shown to be safe in 45 clinical trial patients and >400
Slide 4: Company Overview
COMPANY OVERVIEW Trading TSXV: “HEM” Stock Listings Headquarters Calgary, AB Current Share Price (CA$) $0.84 Fiscal Year End April 30 Shares Outstanding 65.6 million Accounting Firm MNP LLP Market Cap $55 million Legal Counsel HLF LLP 30-Day Average Trading Volume 17,000 Investor Relations Stonegate
Slide 5: Management Team
MANAGEMENT TEAM Developed HEM’s GMP cell manufacturing system • Director of R&D at Theravitae Dr. Ina Sarel • Former Project Manager at ProNeuron Biotechnologies VP R&D & • 15+ years as a scientist and project manager in cell Manufacturing therapy companies Dr. Elmar Burchardt • PhD from Boston Univ
Slide 6: Critical Limb Ischemia disease profile and incidence
CRITICAL DISEASE PROFILE INCIDENCE & PREVALENCE LIMB ISCHEMIA Chronic, inadequate blood flow to limbs, resulting in tissue loss and gangrene1,2 Millions of Patients Globally NO treatment for most critical patients United States & Canada Estimates (2015): 25 % Mortality 4.2 Million UP TO Rate Current
Slide 7: Critical Limb Ischemia: gateway to broader ischemic market
CRITICAL LIMB Critical Limb Ischemia & Buergers Disease Tip of the Iceberg ISCHEMIA $2B Market Ventricular Device Assist (orphan indication) Ischemic Dilated Cardiomyopathy Gateway Congestive Heart Failure TO BROADER Ischemic Diseases Market Acute Myocardial Infarction $20B+ Market Peripheral Arteri
Slide 8: Lead Clinical Product
LEAD CLINICAL PRODUCT ACP-01 for Critical Limb Ischemia
Slide 9: ACP-01
Extract and enrich desired cell 1 population from patient’s blood Inject cell population to form 2 new blood vessels in dying tissue self- uses patient’s own cells, no immune donor rejection, no observed safety issues cell harvest simple ACP-01 via blood draw Offers Hope for quick 7 days from draw t
Slide 10: ACP-01 Technology Platform
Shipping: Blood shipped to manufacturing facility isolate Collection: desired Simple 250 ml cells blood draw Isolation: enrich Cells are selected and & collect collect enriched from blood patient’s desired Manufacturing: blood cells Cells are incubated with proprietary cocktail of factors package in
Slide 11: ACP-01 Case Study
Progressive healing of chronic toe ulcer in CLI patient after treatment with ACP-01 Pre-Treatment Day 17 Day 33 Day 90 ACP-01 Case Study
Slide 12: ACP-01 Ongoing Clinical Trial
O N G O I N G TARGET PATIENTS DATA COLLECTION ACP-01 CLINICAL TRIAL PHASE 2 Diagnosed with CLI 33 control 66 treated No treatment options adverse events treatment failure1 Controlled levels in blood sugar, blood international pressure, cholesterol 6 multicentre prospective No previous amputations MO
Slide 13: ACP-01 Clinical Endpoints: Treatment Failure
O N G O I N G CLINICAL ENDPOINTS WHY USE ACP-01 defined by “TREATMENT FAILURE” “TREATMENT FAILURE” CLINICAL TRIAL • Each category contributes in approximately equal proportions PHASE 2 • Mortality to treatment failure 33 control 66 treated • Treatment failure is much more or likely to occur during 6
Slide 14: Timeline
TIMELINE 15/Q3 15/Q4 16/Q1 16/Q2 16/Q3 16/Q4 17/Q1 17/Q2 Interim Phase-2 trial for CLI Data Complete US FDA IND clearance ✔ Mechanistic MRI study (Israel/Germany) Add US manufacturing site Automation of manufacturing process to further reduce COGS è IND & CTA submission for additional indication/s
Slide 15: Comparable Companies
COMPARABLE COMPANIES Company Ticker Mkt Cap* Cell/source Approach Phase Indication(s) Hemostemix HEM $58M ACP/peripheral blood Autologous 2 Critical limb ischemia (CLI) Critical limb ischemia (CLI), Pluristem PSTM $193M MSC/placenta Allogeneic 1, 2 Intermittent claudication (IC) Dilated cardiomyopat
Slide 16: Comparable Transactions
COMPARABLE TRANSACTIONS Licensor Licensee Technology Disease Area/Indication(s) Stage Modality Upfront Deal Value* Date Territory Cha Cell South Pluristem PLX-PAD Critical Limb Ischemia 2 $10M $10M 2013 Bio&Diosteck therapy Korea Cell Pervasis Shire Vascugel Cardiovascular 2 Undisclosed $200M 2012 W
Slide 17: Investment Opportunity
INVESTMENT OPPORTUNITY Strong human evidence of angiogenic (blood-vessel forming) capacity • Platform technology derived from simple draw of autologous blood • Shown to be safe in 40 clinical trial patients and >400 compassionate use patients • Robust intellectual property portfolio • Established ma
Slide 18: Summary
Early SUMMARY Studies Cost-Effective Angiogenic & Scalable Platform Lead Indicate Potential Efficacy Product Phase-2 CT ACP-01 for CLI: Significant unmet need Technology Team Focus One Protocol Canada, U.S., S. Africa, Asia Long-Term Focus: IP Experienced Exploit Platform & Expertise for Other Ische
Slide 19: Appendix
APPENDIX HEM@STEMIX
Slide 20: Board of Directors
BOARD OF DIRECTORS Victor Redekop R Lee Buckler CW (Bill) Baker Elmar Burchardt David Wood Director Director Chairman President & CEO Director 35+ years international executive Founder & Managing Director of 40+ years diverse senior executive Medical Doctor with 20+ years in CEO, CFO, and Director o
Slide 21: Scientific Advisory Board
SCIENTIFIC ADVISORY BOARD Mark Jay Zucker Norman CW Wong Heinz Redl MD, JD, FACC, FACP MD, FRCP (C) PhD Director, Harvey & Georgina Weinstein National Heart Co-founder & CSO, Resverlogic Corp (TSX:RVX) Chair-elect, Tissue Engineering and Regenerative Transplant Center (Beth Israel Medical Center) Me