EX-99.2 3 atha-ex99_2.htm EX-99.2

Phase 2/3 LIFT-AD Interim Analysis Results and Next Steps October 17, 2022 Exhibit 99.2

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 beliefs and assumptions and on information currently available to our management. Forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantiﬁed. In some cases, you can identify forward-looking statements by terminology such as “may,” “will,” “should,” “could,” “expect,” “plan,” anticipate,” “believe,” “estimate,” “predict,” “intend,” “potential,” “would,” “continue,” “ongoing” or the negative of these terms or other comparable terminology. 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Forward-Looking Statements © Athira Pharma, Inc. All Rights Reserved.

Independent Unblinded Interim Analysis Supports Potential Clinically Meaningful Activity of Fosgonimeton WITHOUT BACKGROUND THERAPY and Mitigates Program Risk Phase 2 exploratory ACT-AD study results suggested congruent positive effects Cognition (ADAS-Cog11); Function (ADCS-ADL23); Neurodegeneration (neurofilament light chain or NfL) Data driven approach was used to determine best path forward to optimize ongoing Phase 2/3 LIFT-AD study in the same patient population as in ACT-AD Analysis of ~100 patients supports potential clinically meaningful effects of cognition and function and informs the sample size required to power LIFT-AD Enrollment target of <150 additional patients enables LIFT-AD to be well-powered for the primary endpoint Enrollment completion target by mid 2023 with topline data in early 2024 Phase 2/3 LIFT-AD Study Advances ADAS-Cog11, Alzheimer's Disease Assessment Scale–Cognitive Subscale; ADCS-ADL23, Alzheimer's Disease Cooperative Study–Activities of Daily Living; NfL, neurofilament light chain. © Athira Pharma, Inc. All Rights Reserved.

Exploratory study to inform larger LIFT-AD in Patients without background therapy Summary of Phase 2 ACT-AD Study Results ADAS-Cog11, Alzheimer's Disease Assessment Scale–Cognitive Subscale; ADCS-ADL23, Alzheimer's Disease Cooperative Study–Activities of Daily Living; ERP, event related potential; NfL, neurofilament light chain. 1 Data presented are least squares mean ± SE. 2 Data shown as mean NfL concentration (SEM). Favorable safety and tolerability profile Fosgonimeton signals without background therapy compared to placebo (limited subgroup size) Reduced ERP P300 latency (n.s.) Improved cognition as measured by ADAS-Cog11 (n.s.) Improved function as measured by ADCS-ADL23 (n.s.) Showed a statistically significant improvement in plasma levels of NfL (p=0.018) n = 6 n = 13 NfL at week 26 (fosgonimeton without background therapy)1 Placebo Fosgonimeton Baseline mean2 NfL concentration, pg/mL 23.81 (5.07) 21.35 (2.08) p = 0.018 © Athira Pharma, Inc. All Rights Reserved. ACT-AD was a similar study design to LIFT-AD to help inform larger LIFT-AD Both are randomized, double-blind, placebo-controlled, parallel-group studies of fosgonimeton for patients with mild-to-moderate Alzheimer’s disease

LEARNINGS FROM ACT-AD INFORM STUDY DESIGN OPTIMIZATION Fosgonimeton Phase 2/3 LIFT-AD Study Design POPULATION TREATMENT DURATION RESULTS LIFT-AD: Target N=TBD, informed by interim analysis Mild-to-moderate AD subjects 55-85 years CDR 1 and 2 MMSE 14-24 Approximately 40% of patients not on background AChEI PRIMARY ENDPOINT Global Statistical Test (GST) – unbiased composite of data from two key co-secondary endpoints (ADAS-Cog11 and ADCS-ADL23) Safety SECONDARY ENDPOINTS Cognition: ADAS-Cog11 Function: ADCS-ADL23 Global clinical change: ADCS CGIC – Clinician EXPLORATORY ENDPOINTS Fluid biomarkers (e.g., NfL) TIMELINE Enrollment ongoing Placebo Fosgonimeton (70 mg) Fosgonimeton (40 mg) Randomization (1:1:1) 26-week randomized, double-blind treatment, + optional 18-month OLEX Path Forward: Exclusion criterion added for subjects on background AChEIs (Sept 2022) Independent, unblinded interim analysis to inform sample size for primary endpoint (Oct 2022) AChEI, acetylcholinesterase inhibitor; ADAS-Cog11, Alzheimer's Disease Assessment Scale–Cognitive Subscale; ADCS-ADL23, Alzheimer's Disease Cooperative Study–Activities of Daily Living; ADCS-CGIC, Alzheimer's Disease Cooperative Study–Clinical Global Impression of Change; CDR, clinical dementia rating; GST, global statistical test; MMSE, mini-mental state examination; NfL, neurofilament light chain; OLEX, open-label extension. © Athira Pharma, Inc. All Rights Reserved.

Steps completed since ACT-AD Readout in June 2022 Additional analysis of ACT-AD DSMB unblinded adjudication of LIFT-AD Blinded analysis of LIFT-AD Proactively amended Phase 2/3 LIFT-AD in September Independent unblinded interim analysis in October Systematic and Data-driven Process to Support LIFT-AD DSMB, Data Safety and Monitoring Board © Athira Pharma, Inc. All Rights Reserved. Development plan optimized with mitigated risk

Stringent criteria applied to increase probability of demonstrating a clinically meaningful effect size for cognition and function LIFT-AD Sample Size Well Powered for Primary Endpoint *Mehta and Pocock, 2000, 2011 © Athira Pharma, Inc. All Rights Reserved. 0 +1 +2 +2.5 +3 +4 0 -1 -2 -2.5 -3 -4 ADAS-Cog11 ADCS-ADL23 DMC Recommendation: "Continue LIFT-AD Study" Promising Zone* confirmed <150 patients needed to complete study Target enrollment complete by mid 2023 with data in early 2024 Promising Zone* Futility Pre-specified Decision Framework

Moving Forward © Athira Pharma, Inc. All Rights Reserved. *As of June 30, 2022 Target enrollment completion by mid 2023 with data in early 2024 Continued focus on LIFT-AD recruitment and completion to meet timelines Strong cash and cash equivalents of approximately $282M* provides support through key data points and beyond

Fosgonimeton – A New Potential Therapy for Alzheimer’s Disease 35 million Estimated Alzheimer’s cases worldwide1 1 https://www.who.int/news-room/fact-sheets/detail/dementia 2 https://www.alz.org/media/documents/alzheimers-facts-and-figures.pdf 3 GlobalData AD prevalence data access and analysis 4 https://www.nia.nih.gov/news/half-alzheimers-disease-cases-may-be-mild Over 100 million globally by 2050 ~900,000 new patients diagnosed annually in the US alone1,2 Mild to Moderate comprises 81% of all patients with Alzheimer’s disease3,4 6.2 million treatment eligible patients in the US in 2021 based on prevalence data Growing at 3% per year2,3 Significant opportunity for fosgonimeton Limited treatment options exist today for those with Alzheimer’s disease; novel approaches to improve cognition, function and neuroprotection are needed Multi-Billion $ MarketDespite generic entries Zero New marketed products since 2003 © Athira Pharma, Inc. All Rights Reserved.