ATHA — Athira Pharma, Inc.

Summary of Athira Pharma Q4 2021 Earnings Call

1. Key Financial Results and Metrics:

• Research and Development Expenses: $42.8 million for FY 2021, up from $13.3 million in FY 2020, primarily due to increased clinical trial activities and personnel costs.
• General and Administrative Expenses: $21.2 million for FY 2021, compared to $6.7 million in FY 2020, driven by expanded headcount and infrastructure.
• Net Loss: $54.9 million, or $1.49 per share, for FY 2021, compared to a net loss of $19.9 million, or $1.67 per share, in FY 2020.
• Cash Position: Ended 2021 with $319.7 million in cash, cash equivalents, and investments, an increase from $268.2 million at the end of 2020.

2. Strategic Updates and Business Highlights:

• Athira made significant progress in its clinical programs, including the completion of enrollment in the Phase 2 ACT-AD study and the initiation of a Phase 2 study (SHAPE) for Parkinson's disease dementia.
• The company announced the dosing of the first patient in the SHAPE study and published Phase 1 study results of its lead candidate, fosgonimeton (fosgo).
• The Board of Directors was expanded with two new members, enhancing the company’s leadership in CNS drug development.
• Athira aims to leverage insights from the ACT-AD trial to optimize the Phase 3 LIFT-AD study, which is expected to complete enrollment in Q3 2022.

3. Forward Guidance and Outlook:

• Anticipates top-line data from the ACT-AD study in Q2 2022 and aims to complete enrollment in the LIFT-AD study by Q3 2022, with results expected in the first half of 2023.
• The company is optimistic about the potential of its HGF/MET approach to address significant unmet needs in neurodegenerative diseases, particularly Alzheimer's disease.

4. Bad News, Challenges, or Points of Concern:

• The net loss increased significantly year-over-year, raising concerns about the sustainability of financial resources as the company continues to invest heavily in R&D.
• The Phase 2 ACT-AD study is not powered to show statistical significance for secondary endpoints, which may limit the ability to demonstrate robust efficacy.
• There is inherent risk in clinical trials, including potential delays or failures in achieving desired outcomes, which could impact future funding and stock performance.

5. Notable Q&A Insights:

• Management clarified expectations for the ACT-AD topline release, indicating that while they hope for statistically significant data on the primary endpoint (P300), secondary endpoints will likely only show trends due to the study's design.
• Questions regarding the enrollment dynamics in the LIFT study highlighted the challenges posed by the Omicron variant, but management remains confident in achieving enrollment targets.
• The discussion emphasized the importance of both cognitive and functional endpoints for regulatory approval, with management indicating that they will refine their analysis plan based on ACT-AD results before finalizing the LIFT-AD endpoints.

Overall, Athira Pharma is positioned for significant developments in 2022, with a focus on advancing its clinical programs while navigating the challenges of increased expenditures and the inherent risks of drug development.