Hemostemix Inc · TSXV:HEM
Hemostemix — Investor Presentation (July 2015)
19 slides from Hemostemix's investor presentation, July 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 $0.90 (CA$) Fiscal Year End April 30 Shares Outstanding 65.6 million Accounting Firm MNP LLP Market Cap $60 million Legal Counsel HLF LLP 30-Day Average 23,000 Trading Volume 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, Incidence & Prevalence
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: CLI Is the Tip of the Iceberg & Gateway to Other Ischemic Diseases
Critical CRITICAL CLI IS THE TIP OF Limb Ischemia LIMB THE ICE BERG & Buerger’s Disease Ventricular Device Assist ISCHEMIA GATEWAY (Orphan Indication) TO OTHER Ischemic Dilated ISCHEMIC DISEASES Cardiomyopathy Congestive Heart Failure $2B CLI Market is Beachhead for Acute Myocardial Infarction Broad
Slide 8: Lead Clinical Product: ACP-01 for Critical Limb Ischemia
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 Technology Strengths
ACP-01 TECHNOLOGY STRENGTHS low patient risks covered by strong IP estate self-donation means no immune patents allowed in US and European rejection or disease transmission jurisdictions simple protocol efficient safe and easy to perform simple, scalable, cost-effective in outpatient clinic producti
Slide 12: ACP-01 Administered in Three Clinical Studies
Administered in three clinical studies with encouraging results • Severe Angina Pectoris – Bangkok (24 patients) • Critical Limb Ischemia – Safety trial – Bangkok (6 patients) • Critical Limb Ischemia – Phase 1b controlled – Budapest (10 treated and 10 control patients) ACP-01 Offers Hope for CLI Pa
Slide 13: 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 14: ACP-01 Ongoing Phase 2 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 multicenter pressure, cholesterol 6 prospective controlled No previous amputations MONTH
Slide 15: 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 • Major amputation to treatment failure 33 control 66 treated (above the talus) • Treatment failure is much more li
Slide 16: Product Pipeline: Ischemic Diseases
PRODUCT PIPELINE: ISCHEMIC DISEASES Critical Limb Ischemia Pre-Clinical Phase 1 Phase 2 Phase 3 Buerger’s Disease Pre-Clinical Phase 1 Phase 2 Phase 3 Ventricular Device Assist (Orphan) Pre-Clinical Phase 1 Phase 2 Phase 3 Ischemic Dilated Cardiomyopathy Pre-Clinical Phase 1 Phase 2 Phase 3 (Orphan)
Slide 17: 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 approval Marketing roadshow to institutional and retail investors Conduct clinical study using high-resolution imaging to demonstrate ACP-01 improves microcirculation Add US manufacturing
Slide 18: 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 m
Slide 19: Summary
Early SUMMARY Studies Cost-Effective Angiogenic & Scalable Platform Lead Indicate Potential Efficacy Product Phase II CT ACP-01 for CLI: Significant unmet need Technology Team Focus One Protocol Canada, USA, S. Africa, Asia Long Term Focus IP Experienced Exploit Platform & Expertise for Other Vascul