Athersys, Inc. · OTC:ATHXQ
Athersys — Investor Presentation (2023)
22 slides from Athersys's investor presentation, Jun 9, 2023
Slide 1: Advanced Critical Care with Cell Therapy
Advanced Critical Care with Cell Therapy 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: Investment Highlights
Investment Highlights Strengthened & Experienced Leadership With strong clinical-to-commercial experience MultiStem Cell Therapy Platform: Ethical, Versatile & Favorable Tolerability Adult-derived stem cells with demonstrated efficacy across high unmet medical need indications Off-The-Shelf Product
Slide 4: Strengthened & Experienced Leadership
Strengthened & Experienced Leadership Broad Experience in Pharmaceutical & Life Science Dan Camardo, MBA Maia Hansen, MBA Kasey Rosado Chief Executive Officer Chief Operations Officer Interim Chief Financial Officer Manal Morsy, MD, PhD, MBA Robert (Willie) Mays, PhD EVP, Regulatory Affairs EVP, Reg
Slide 5: MultiStem Platform Advantages: Innovation From Donor to Patient
MultiStem Platform Advantages Innovation From Donor to Patient • One healthy human donor can be expanded to hundreds of thousands of clinical & commercial doses (1.2 Billion cells / dose) • Product can be prepared and administered from pharmacy to patient in less than one hour One donor → Master and
Slide 6: MultiStem Platform Advantages
MultiStem Platform Advantages Our data shows that early intervention with MultiStem therapy after an acute injury enhances healing by regulating an overactive immune response and re-establishing homeostasis. MultiStem cell Therapy Intervention Hyperactive Inflammatory MultiStem Fundamentally Acute I
Slide 7: MultiStem Platform: Opportunities Across Serious Unmet Need Indications
MultiStem Platform: Opportunities Across Serious Unmet Need Indications NONCLINICAL NONCLINICAL IND READY PHASE 3 Ischemic Stroke Hemorrhagic Stroke Parkinson's Disease Rheumatoid Arthritis NONCLINICAL Congestive Heart NONCLINICAL E IND READY PHASE Trauma Hypoxic Ischemia Alzheimer’s Disease 2 Failu
Slide 8: Expansive Therapeutic Opportunity: Advanced Portfolio for Substantial Unmet Need
Expansive Therapeutic Opportunity: Advanced Portfolio for Substantial Unmet Need Indication Clinical Trial Phase 2 Phase 3 Regulatory Target Market • Fast Track designation (FDA) MASTERS-1 • RMAT designation (FDA) • ~800K annual cases in the U.S. • Special Protocol Assessment (SPA - FDA) • ~2.2MM an
Slide 9: Ischemic Stroke: Market Opportunity
Ischemic Stroke: Market Opportunity Stem Cell Pioneer: Only cell therapy for ischemic stroke in pivotal phase 3 clinical stage Safety & Tolerability: Preclinical safety & favorable tolerability in 450+ patients Clinical Benefits: Continues to improve through one year compared to 90-day plateau with
Slide 10: Unmet Medical Need: Only 2 Approved Ischemic Stroke Treatments
Unmet Medical Need Only 2 Approved Ischemic Stroke Treatments Thrombolytics Mechanical Thrombectomy MultiStem® Cell Therapy Clot dissolving medications Removal of the clot using a catheter device Immunomodulatory single IV administration Must be performed within 6 - 24 Hours Treatment Duration Must
Slide 11: MASTERS-1 Phase 2 Ischemic Stroke Trial Results
MASTERS-1 Phase 2 Ischemic Stroke Trial Results 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 Outcome (%) – MultiStem vs All Placebo 29% Safety: Intr
Slide 12: TREASURE Study by HEALIOS KK in Japan
TREASURE Study by HEALIOS KK in Japan Topline Data Announced May 2022 and Full Data in October 2022 ✓ Sakigake designation Favorable results at one year in recovery measures • Indicates achievement of functional independence • Reflects clinically relevant recovery in MultiStem treated ✓ 206 patients
Slide 13: Read-through from TREASURE
Read-through from TREASURE Improvement in Measures of Functional Independence & Clinically Relevant Recovery 90 Days One Year MultiStem Placebo MultiStem Placebo mRS Shift Odds Ratio=1.7, p=0.13 Odds Ratio=1.8, p=0.06 (MASTERS-2 primary) mRS <=2 46.4% 27.9% p<0.05 50.0% 32.8% p=0.06 (key secondary)
Slide 14: MASTERS-2 Ongoing Pivotal Phase 3 Study
MASTERS-2 Ongoing Pivotal Phase 3 Study 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; Based on successful results from Phase 2, trea
Slide 15: Distinguished Regulatory Status for MASTERS-2
Distinguished Regulatory Status for MASTERS-2 Fast Track Designation (FDA – 68% industry success rate in achieving) Frequent communications, Rolling Submission eligibility, Priority Review eligibility RMAT designation (FDA – 23% industry success rate in achieving) Break-through equivalent for Regene
Slide 16: Trauma Market Opportunity
Trauma Market Opportunity Statistics Implications Treatment & Supporting Evidence • Very common - trauma is the • Approximately 2/3 of trauma patients will • Current treatments for trauma are limited leading cause of death for people experience SIRS (Systemic Inflammatory aged 1-45, and the leading
Slide 17: Trauma Overview and Demonstrated Efficacy
Trauma Overview and Demonstrated Efficacy Extensive Relevant Preclinical/Clinical Work Initial Injury Can Result • Acute pulmonary injury in Severe Complications: • Porcine models demonstrate improvement in lung function from treatment with MultiStem • Multipotent adult progenitor cells decrease col
Slide 18: 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 being conducted at Memorial Hermann Hospital, a leading Tier 1 Trauma Center in Houston Actively enrolling patients (~150 planned) with incidence of
Slide 19: ARDS Market Opportunity
ARDS (Acute Respiratory Distress Syndrome) Market Opportunity About + Statistics Implications Treatment + Life After ARDS • Occurs when inflammation • No currently approved treatment for ARDS • Most patients placed on mechanical effects the lungs, often as a ventilation to help them breathe, often r
Slide 20: 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 / standard of care • Mostly pneumonia-induced ARDS (85% MultiStem-treated subjects; 90% placebo / standard of care subjects) • Mul
Slide 21: Corporate Focus & Upcoming Milestones
Corporate Focus & Upcoming Milestones Strategic Initiatives Upcoming Milestones ✓ Established experienced leadership team • Decision from the Biomedical Advanced Research with a proven track record of success and Development Authority (BARDA) for proposed trial to explore the use of MultiStem for ac
Slide 22: Please Contact Us
Please Contact Us Investor Relations Department | [email protected]