Athersys, Inc. · OTC:ATHXQ
Athersys — Investor Presentation (February 2022)
33 slides from Athersys's investor presentation, Feb 22, 2022
Slide 1: Changing the Future of Medicine
Changing the Future of Medicine Athersys Corporate Presentation NASDAQ: ATHX www.Athersys.com
Slide 2: Forward Looking Statements
Forward Looking Statements This presentation has been prepared solely for informational purposes. This presentation includes, and our responses to various questions may include, “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, or the Securitie
Slide 3: We Are Changing the Future of Medicine
We Are Changing the Future of Medicine • Built on exceptional science, we are innovators changing the future of medicine with a mission to extend and enhance the quality of human life. • Our proprietary, allogeneic cell therapy, MultiStem® (invimestrocel) product platform is in late-stage clinical s
Slide 4: Advanced Portfolio Targeting Areas of Substantial Unmet Need
Advanced Portfolio Targeting Areas of Substantial Unmet Need KEY: = Enrolling; in progress = Completed enrollment / study Indication Clinical Trial Phase 2 Phase 3 BLA Target Market MASTERS-1 • ~800K annual cases in the U.S. • ~2.2MM annual cases in the U.S., Europe and Japan Ischemic Stroke MASTERS
Slide 5: Managed by an Exceptional Team with Broad Experience in Pharmaceutical and Life Science Industries
Managed by an Exceptional Team with Broad Experience in Pharmaceutical and Life Science Industries Name Title Prior Experience Daniel Camardo, MBA CEO William (B.J.) Lehmann, JD, MBA President & COO John Harrington, PhD EVP and CSO, Board member Ivor Macleod, MBA, CPA CFO Manal Morsy, MD, PhD, MBA S
Slide 6: Strong Foundation in Science Has Created an Immense Opportunity
Strong Foundation in Science Has Created an Immense Opportunity Built on We have an Our platform is We are EXCELLENT SCIENCE INNOVATIVE THERAPY ROBUST AND DIVERSE LEADING THE WAY - with dozens of with strong intellectual with broad applicability – in innovating cell publications - providing property
Slide 7: Unique Attributes of MultiStem Cell Therapy Provide a Competitive Edge
Unique Attributes of MultiStem® Cell Therapy (invimestrocel) Provide a Competitive Edge Promotes healing and tissue repair Off-the-shelf and easy administration By regulating the overactive immune response after an MultiStem is easily administered intravenously or injury, our therapy can potentially
Slide 8: Objective: Dramatically Improve the Recovery Path
Objective: Dramatically Improve the Recovery Path Our data show that early intervention with MultiStem therapy after an acute injury enhances healing by regulating an overactive immune response and re-establishing homeostasis. 4. MultiStem cell Supports preservation of therapy intervention life and
Slide 9: MASTERS-1: Impact Across Outcome Measures
MASTERS-1: Impact Across Outcome Measures Patients who received treatment ≤ 36 hours after stroke onset Placebo group (n=61) MultiStem treatment group (n=31) p = 0.03* p < 0.01* 25% p = 0.09 10% p = 0.14 29% 32% Day 90 % Patients - Death or life- 16.1% 13% threatening adverse events 6.6% 8.2% (60% d
Slide 10: Supporting Data from our Completed Phase 2 ARDS Study (MUST-ARDS)
Supporting Data from our Completed Phase 2 ARDS Study (MUST-ARDS) Placebo / SOC group (n=10) MultiStem treatment group (n=20) Patients alive and off ventilator by day 7 20% Placebo 40% MultiStem-treated 18.5 45% days 25% 6.5 days Day 28 Day 28 27% Increase in ICU-free days in MultiStem-treated group
Slide 11: Multimodal Mechanism of Action: Interaction with Multiple Cells of the Immune System
Multimodal Mechanism of Action: Interaction with Multiple Cells of the Immune System MultiStem® M1 M2 Regulatory Endothelial cells Neutrophils T cells Macrophages Macrophages T cells Promotes MΦ2: Reduces Neutrophil: Promotes Treg: • M2 Phenotype • Infiltration • Differentiation • Anti-inflammatory
Slide 12: Supporting Data: Over Years of Preclinical and Clinical Research Publications
Supporting Data : Over 17 Years of Preclinical and Clinical Research Publications Years of preclinical research and data support mechanism of action hypothesis and demonstrates that MultiStem has the potential to treat a variety of clinical indications with unmet need. • Ischemic Stroke • ARDS • Hem
Slide 13: Scalable Manufacturing Platform Supports Production to Serve Large Markets
Scalable Manufacturing Platform Supports Production to Serve Large Markets Favorable Biology Scalable Production Platforms Practical Storage & Distribution • MultiStem is developed from a • Cells are expandable in bioreactors, as • Demonstrated product stability – long special class of MAPC® that we
Slide 14: Distinctive, Efficient, and Scalable Technologies Bioreactor SIFU
Distinctive, Efficient, and Scalable Technologies Bioreactor SIFU™ “Secure Integrated Freezer Unit” • Development of proprietary cryogenic storage system known as SIFU™ Technology • Enables transformational commercial scale at lower cost • Simplifies product preparation to a single step after order
Slide 15: Current MultiStem Clinical Trials
Current MultiStem Clinical Trials MASTERS-2 [PHASE 3] for Ischemic Stroke Most advanced program is in Phase 3 for treatment of ischemic stroke (with Fast Track and RMAT designations) and is being conducted under a Special Protocol Assessment (SPA) from the FDA MACOVIA [PHASE 2/3] for Acute Respirato
Slide 16: Large Market Opportunities in Lead Indications
Large Market Opportunities in Lead Indications Targeted Market – Full Market Size Value Creation current - potential development • Reduced hospital stays, mortality, • Moderate to moderate-severe strokes • ~800,000 new cases in U.S. annually rehabilitation Ischemic • ~2.2 million annually in U.S., E
Slide 17: Ischemic Stroke
Ischemic Stroke 17
Slide 18: Stroke Facts
Stroke Facts Ischemic Stroke Hemorrhagic Stroke A stroke occurs when the blood supply is interrupted or reduced to part of the brain. This prevents brain cells Caused by leaking or Caused by a blocked artery from getting oxygen and nutrients, leading to cell death bursting of a blood vessel and tiss
Slide 19: MASTERS-1: Phase 2 Ischemic Stroke Trial Results
MASTERS-1: Phase 2 Ischemic Stroke Trial Results Treatment with MultiStem Shows Meaningful Benefit Proportion of Subjects Treated within 36 Hours Achieving Excellent Outcome Increases Over Time (Excellent Outcome = Patients Achieving NIHSS 0 or 1 and mRS 0 or 1, and Barthel Index >95) Excellent Outc
Slide 20: MASTERS-1: Clinical Improvement Observed Across the Severity Spectrum
MASTERS-1: Clinical Improvement Observed Across the Severity Spectrum Patients who received treatment ≤ 36 hours after stroke onset Distribution of Subjects by Group using mRS scores – mRS "shift" analysis – over time 0 1 2 3 4 5/6 0 1 2 3 4 5/6 3.2% 3.2% 9.7% 22.6% 16.1% 38.7% 9.7% MultiStem 12.9%
Slide 21: MASTERS-2: Current Pivotal Phase 3 Clinical Study in Ischemic Stroke
MASTERS-2: Current Pivotal Phase 3 Clinical Study in Ischemic Stroke • Randomized, double-blind, placebo-controlled clinical trial, actively enrolling up to 300 patients in leading stroke centers in U.S. and Internationally • IV Administration of 1.2 billion MultiStem cells or placebo; Set up for su
Slide 22: Substantial Value Drivers for Treating Stroke with MultiStem
Substantial Value Drivers for Treating Stroke with MultiStem Based on the MASTERS-1 data, MultiStem-treated patients are likely to experience: • Reduced hospital stays, reduced mortality, reduced/lower intensity rehabilitation, and reduced institutionalization. • Lower rates of disability, contribut
Slide 23: Acute Respiratory Distress Syndrome (ARDS)
Acute Respiratory Distress Syndrome (ARDS) 23
Slide 24: ARDS: Acute Respiratory Distress Syndrome
ARDS: Acute Respiratory Distress Syndrome About + Statistics Implications Treatment + Life After ARDS • Occurs when our lungs are • No currently approved treatment for ARDS • Most patients placed on mechanical severely injured, often by ventilation to help them breathe, often infection or trauma • 3
Slide 25: MUST-ARDS: Results from Exploratory Clinical Study in ARDS
MUST-ARDS: Results from Exploratory Clinical Study in ARDS All Subjects (in efficacy cohort) MultiStem Placebo Patients who rated complete independence Number of Patients 20 10 in self care at 1 year Ventilator-free days (median) 18.5 6.5 40% Placebo Mortality (d28) 25% 40% 80% MultiStem-treated Pat
Slide 26: ONE-BRIDGE: Healios study in Japan for the treatment of ARDS
ONE-BRIDGE: Healios study in Japan for the treatment of ARDS MultiStem-treated patients experienced: Cohort 1 - Pneumonia-induced ARDS Patients MultiStem SOC Number of Patients 20 10 Ventilator-free days (median) 20 11 Mortality (d90) 26% 43% 82% Increase in Ventilator-free Cohort 2 – COVID-19 Induc
Slide 27: Analysis of Pooled MUST-ARDS & ONE-BRIDGE Data
Analysis of Pooled MUST-ARDS & ONE-BRIDGE Data – Results Signal MultiStem Treatment Potential • 60 ARDS (non-Covid) patients – 40 receiving MultiStem treatment – 20 placebo or standard of care • Mostly pneumonia-induced ARDS (85% MultiStem-treated subjects; 90% placebo / SOC subjects) • MultiStem do
Slide 28: Substantial Value Drivers for Treating ARDS with MultiStem
Substantial Value Drivers for Treating ARDS with MultiStem • Based on our MUST-ARDS data, MultiStem-treated patients have reduced number of days in the ICU, which is the most expensive area of the hospital for healthcare costs. • MultiStem-treated patients may be weaned off of mechanical ventilators
Slide 29: Serious Trauma
Serious Trauma: Blunt force injury to the body, such as falls, motor vehicle accidents, or any type of penetrating injury 29
Slide 30: Trauma: Heterogeneity in Cause, Impact and Severity
Trauma: Heterogeneity in Cause, Impact and Severity Extensive Relevant Preclinical/Clinical Work Pathophysiology • Acute pulmonary injury • Porcine models demonstrate improvement in lung function from treatment with MultiStem • Multipotent adult progenitor cells decrease cold ischemic injury in ex v
Slide 31: MATRICS: Phase 2 Clinical Study in Trauma
MATRICS: Phase 2 Clinical Study in Trauma • Randomized, double-blind, placebo-controlled Phase 2 clinical trial • First of its kind – working with UTHealth on this single center trauma trial being conducted at a Memorial Hermann Hospital, a leading Tier 1 Trauma Center in Houston • Actively enrollin
Slide 32: Progress & Important Upcoming Milestones
Progress & Important Upcoming Milestones Goal/Objective Progress Upcoming Milestones • >50 publications by Athersys and collaborating scientists • Upcoming Pivotal Readouts • Recent important articles re: MOA (e.g., Treg, MUST-ARDS) Therapeutic Validation • TREASURE (ischemic stroke) • 12 clinical s
Slide 33: Thank you!
Thank you! 33