Athira Pharma, Inc.

For full-year 2021, research and development expense was $42.8 million versus $13.3 million in 2020, and general and administrative expense was $21.2 million versus $6.7 million in 2020. Net loss was $54.9 million, or $1.49 per share basic and diluted, compared with a net loss of $19.9 million, or $1.67 per share, in 2020. Cash, cash equivalents and investments ended 2021 at $319.7 million versus $268.2 million at December 31, 2020. On guidance, management said ACT-AD topline data are on track for Q2 2022, LIFT-AD enrollment is expected to complete in Q3 2022, and LIFT-AD topline data are expected in the first half of 2023.

Mark Litton framed 2022 as an inflection year, pointing to ACT-AD, LIFT-AD, SHAPE, and ATH-1020 as the main clinical catalysts. He said the company wants to show not just statistical movement on P300, but also trends in cognition and function, while acknowledging those secondary endpoints are exploratory in the 77-patient ACT-AD study. His tone was upbeat and confident, with repeated emphasis on the company’s novel HGF/MET approach and the size of the unmet need in Alzheimer’s disease.

Glenna Mileson’s financial commentary focused on heavy investment ahead of data readouts. R&D rose to $42.8 million from $13.3 million year over year, mainly due to increased clinical trial activity, expanded personnel, and higher preclinical spending, while G&A increased to $21.2 million from $6.7 million due to headcount, infrastructure, insurance, legal, facilities, new product planning, and investor relations costs. She reported a net loss of $54.9 million, or $1.49 per share, and highlighted year-end cash, cash equivalents and investments of $319.7 million as support for the lead programs.

Analysts focused on what ACT-AD topline will include, whether the company needs both cognitive and functional success in LIFT-AD, and how the expanded LIFT sample size affects enrollment timing and statistical planning. Management said the ACT-AD press release will center on P300 and ADAS-Cog11, with more detail at a later scientific conference, and noted the 77-patient study is exploratory for co-secondary endpoints. On LIFT-AD, they said they have enough time to use ACT-AD results to refine the statistical analysis plan and select the additional co-key secondary endpoint before unblinding, while still targeting full enrollment by the end of Q3.