Athersys, Inc. · OTC:ATHXQ
Athersys — Athersys First Quarter 2022 Results Conference Call
17 slides from Athersys's conference presentation, May 20, 2022
Slide 1: Changing the Future of Medicine: Overview of TREASURE Results
Changing the Future of Medicine Overview of TREASURE Results 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: Ischemic Stroke
Ischemic Stroke 3
Slide 4: Key Takeaways
Key Takeaways • MultiStem treatment was numerically better than placebo in essentially all functional endpoints and showed relative improvement over one year • Improvement in pre-specified measures of functional “independence,” such as Barthel Index ≥95, mRS ≤2 and Global Recovery • Results confirm
Slide 5: Background
Background • TREASURE study conducted in Japan • Sakigake designation • 206 subjects: 104 MultiStem-treated; 102 placebo • 48 sites in Japan involved in the trial • Moderate-to-moderate-Severe strokes (NIHSS 8-20 at baseline) • Patients get treatment / placebo + SOC (including possibly tPA or MR) •
Slide 6: TREASURE Baseline Patient Characteristics
TREASURE Baseline Patient Characteristics MultiStem Placebo n 104 102 Age, median 79 78 Sex (male) 53.8% 54.9% Severity NIHSS, median 14.0 14.0 Reperfusion Status No Prior 46.2% 49.0% Prior (tPA or MR) 53.8% 51.0% Overall Good Balance between Groups for Key Factors 6
Slide 7: Key TREASURE Results
Key TREASURE Results Favorable results from treatment in Good Recovery measures (indicating achievement of functional independence) at one year, reflecting slower and less robust expected recovery for this population One Year MultiStem Placebo p-value* Excellent Outcome 15.4% 10.8% n.s. Global Recov
Slide 8: TREASURE: MultiStem Improvement Over Time Relative to Placebo
TREASURE: MultiStem Improvement Over Time Relative to Placebo Proportion of Patients Achieving mRS <=2 and Barthel Index >=95 mRS <=2 Barthel Index >=95 50 50 45 45 40 40 * 35 35 Proportion (%) Proportion (%) 30 30 25 25 20 20 15 15 10 10 5 5 0 0 7 30 90 365 7 30 90 365 Days from Stroke Days from St
Slide 9: Summary of Key Findings
Summary of Key Findings • Less impact in this older population on achievement of “excellent or ideal” health status post-stroke: primary outcome – Excellent Outcome (NIHSS<=1, mRS<=1 and Barthel Index >=95) – not significant at day 90 and one year • Evidence of improvement in functional “independenc
Slide 10: TREASURE Read-through to MASTERS-2
TREASURE Read-through to MASTERS-2 Patient Age – Important Factor Related to Treatment Benefit and represents major expected difference between TREASURE and MASTERS-2 Box = middle quartiles Limited concentration of Oldest in MASTERS-2 • TREASURE Representative patient (<80-years) results most releva
Slide 11: Read-through: Improvement from MultiStem-treatment in Representative Patient Population
Read-through: Improvement from MultiStem-treatment in Representative Patient Population from TREASURE Improvement in measures of functional independence and good 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)
Slide 12: Summary Key Differences Across Studies
Summary Key Differences Across Studies Trial Sample Median Age Primary Endpoint MASTERS-1 Early-treated 92* 63 Global Stroke Recovery*** TREASURE 206 78 Excellent Outcome MASTERS-2 300 70** mRS Shift * MultiStem: 31 patients; Placebo: 61 patients ** Projected based on enrollment observed to date ***
Slide 13: Looking Forward
Looking Forward • Healios and Athersys teams will continue with further analyses of the TREASURE results as data is available • Biomarkers (e.g., inflammatory cytokines) and other outcomes • Evaluation of patient characteristics and factors with linkages to outcome +/- treatment • Comparison with MA
Slide 14: Appendix
Appendix 14
Slide 15: NIH Stroke Scale and Modified Rankin Score
NIH STROKE SCALE (NIHSS) 0-42 [NEUROLOGICAL DEFICIT] MODIFIED RANKIN SCORE (mRS) 0-6 [GLOBAL DISABILITY] Level Description Score / Time 0 No symptoms at all 1 No significant disability despite symptoms; able to carry out all usual duties and activities 2 Slight disability; unable to carry out all pr
Slide 16: Outcome Description
Outcome Description Modified Rankin Score (mRS) and translation to outcome measures mRS Excellent Key features Health State Valence Score • Excellent 0 No symptoms Normal Ideal Outcome • mRS≤1 Good 1 Do work/leisure/school activities Nondisabled Excellent • NIHSS≤1 • Global fulltime Recovery • BI≥95
Slide 17: Objective: Improvement of Outcomes post-Stroke
Objective: Improvement of Outcomes post-Stroke Modified Rankin Score (mRS) – Clinician-reported measure of Global Disability Moderate to moderate Severe Stroke (NIHSS 8-20): 18-36h post- stroke • Substantially Older (and relatively more severe) patient population in TREASURE than MASTERS-1 and expec
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