Slide 1: ACT-AD Topline Results Investor Webinar
ACT-AD Topline Results Investor Webinar June 22, 2022 Exhibit 99.2
Slide 2: Forward Looking Statements
Forward Looking Statements © Athira Pharma, Inc. All Rights Reserved. This presentation and the accompanying oral commentary contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are based on our management’s b
Slide 3: ACT-AD Topline Results
Hans Moebius, M.D., Ph.D. Chief Medical Officer ACT-AD Topline Results © Athira Pharma, Inc. All Rights Reserved.
Slide 4: Proof of concept ACT-AD trial provides insights for further fosgonimeton development
Proof of concept ACT-AD trial (N=77) provides important insights for further fosgonimeton development program Phase 1b study conducted with fosgonimeton as a monotherapy; Phase 2 allowed for add-on standard of care (AChEIs) to obtain safety data in a more representative real-world patient population
Slide 5: Fosgonimeton Phase 2 Trial (ACT-AD) design
PROOF-OF-CONCEPT TRIAL TO HELP BETTER UNDERSTAND NATURE OF NOVEL INTERVENTION Fosgonimeton Phase 2 Trial (ACT-AD) POPULATION TREATMENT DURATION ENDPOINTS AND TIMELINE Fosgonimeton (70 mg) Placebo Fosgonimeton (40 mg) ACT-AD: N=77 (recruitment complete) mild-to-moderate AD dementia subjects (55-85 ye
Slide 6: Phase 2 ACT-AD: baseline demographics
Overall (N = 77) Age at informed consent (years); mean (SD) 71.4 ± 7.3 Body mass index (kg/m2), mean (SD) 25.4 ± 3.7 Sex, n (%) Female 39 (50.6%) Male 38 (49.4%) Years of education, mean (SD) 14.9 ± 2.8 Baseline MMSE, mean (SD) 19.0 ± 2.9 Concomitant AChEI, n (%) 47 (61%) P300 Latency (SD) 376 ± 38.
Slide 7: Primary endpoint ERP P300 latency MMRM analysis
Modified intent to treat (mITT) population by a mixed model repeated measures (MMRM) analysis Primary endpoint of a statistically significant change in biomarker ERP P300 latency was not met Visit W2 W6 W12 W16 W20 W26 Placebo ±AChEI CFB -15.22 -1.26 -0.75 -6.06 -4.01 -4.95 SE 5.582 5.601 5.817 5.81
Slide 8: ADAS-Cog11 key secondary endpoint analysis
Modified intent to treat (mITT) population by a mixed model repeated measures (MMRM) analysis No signal identified in key secondary endpoint of ADAS-Cog11 Visit W2 W6 W12 W20 W26 Placebo ±AChEI CFB -0.83 -0.81 -0.19 0.69 1.19 SE 1.052 1.052 1.067 1.083 1.082 N 23 23 22 21 21 Visit W2 W6 W12 W20 W26
Slide 9: Pre-specified subgroup analysis suggested differential effects with concomitant standard of care
Pre-specified subgroup analysis suggested differential effects with concomitant standard of care Severity (mild or moderate) ApoE (carriers or non-carriers) AChEI use (+/- current use of acetylcholinesterase inhibitors including donepezil, rivastigmine, or galantamine) Analysis of the subgroups sugg
Slide 10: Subgroup analysis suggests differential ERP P300 latency effect
Modified intent to treat (mITT) population by Wilcoxon analysis Subgroup analysis suggests differential ERP P300 latency effect Data presented as unadjusted mean ± SEM Visit W2 W6 W12 W16 W20 W26 Placebo +AChEI CFB -10.2 1.6 1.5 -2.5 4.0 -2.1 SD 32.97 32.03 30.3 17.38 16.07 20.87 SEM 8.51 8.27 7.82
Slide 11: Subgroup analysis suggests differential ADAS-Cog11 effect
Modified intent to treat (mITT) population by Wilcoxon analysis Subgroup analysis suggests differential ADAS-Cog11 effect Visit W2 W6 W12 W20 W26 Placebo +AChEI CFB -0.8 -1.3 -0.3 -0.6 0.1 SD 3.28 4.78 3.52 5.79 5.62 SEM 0.85 1.23 0.91 1.55 1.45 N 15 15 15 14 15 Visit W2 W6 W12 W20 W26 Fosgonimeton
Slide 12: AChEI and placebo effects consistent with published literature
AChEI and placebo effects consistent with published literature; provide external validation of experiment Fosgonimeton and standard of care monotherapy suggests positive treatment effects in ERP P300 latency and ADAS-Cog11 Modified intent to treat (mITT) population by Wilcoxon analysis © Athira Phar
Slide 13: Fosgonimeton generally well tolerated with favorable safety profile
Treatment with fosgonimeton was generally well tolerated with a favorable safety profile Safety population analysis © Athira Pharma, Inc. All Rights Reserved. VARIABLE Placebo (N=24) N (%) 40mg Fosgonimeton (N=27) N (%) 70mg Fosgonimeton (N=26) N (%) Overall (N=77) N (%) Treatment Emergent AEs (TEAE
Slide 14: Fosgonimeton Phase 3 Trial (LIFT-AD)
Fosgonimeton Phase 3 Trial (LIFT-AD) POPULATION TREATMENT DURATION ENDPOINTS AND TIMELINE Fosgonimeton (70 mg) Placebo Fosgonimeton (40 mg) LIFT-AD: Target N=~420 mild-to-moderate AD dementia subjects (55-85 years; CDR 1 and 2; MMSE 14-24 incl.) PRIMARY ENDPOINT Global Statistical Test (GST) – unbia
Slide 15: First small interventional trial supports fosgonimeton's potential in Alzheimer's disease
This first small interventional trial with the positive HGF/MET modulator fosgonimeton supports its potential in Alzheimer’s disease Primary analysis not statistically significant; fosgonimeton suggests potentially beneficial treatment effect as a monotherapy By pre-specified analysis, background AC
Slide 16: Conclusion
Mark Litton, Ph.D. Chief Executive Officer Conclusion © Athira Pharma, Inc. All Rights Reserved.
Slide 17: ACT-AD results to benefit LIFT-AD probability of success
ACT-AD results to benefit LIFT-AD probability of success ACT-AD is the first study to show potential cognitive improvement with ADAS-Cog11 in AD patients by positive modulation of the HGF/MET receptor by fosgonimeton ACT-AD outcomes support our conviction that we have a unique opportunity to make a