Athira Pharma Q3 2024 Financial Results and Business Updates

Athira Pharma, Inc., based in Bothell, Washington, is engaged in the clinical-stage research of small molecules aimed at restoring neuronal health and slowing neurodegeneration. In their latest update, Athira revealed their financial results for the quarter ending September 30, 2024, and shared several developments within their pipeline and business activities.

One of the key highlights is the progress of ATH-1105, a novel, orally administered drug candidate targeted at amyotrophic lateral sclerosis (ALS) and other neurodegenerative conditions. This next-generation HGF-modulating drug has shown promising preclinical results, particularly in reducing plasma neurofilament light chain (NfL) levels, a critical marker of ALS progression. Additionally, ATH-1105 has demonstrated improvements in motor and nerve function, along with enhanced neuronal survival and reduced biomarkers of inflammation and neurodegeneration in various ALS models. According to Mark Litton, Ph.D., President and CEO of Athira, the company remains on track to complete the Phase 1 clinical study in healthy volunteers by the end of the year and aims to commence dosing for ALS patients in 2025.

Athira’s development pipeline includes a range of drug candidates designed to activate neuroprotective, neurotrophic, and anti-inflammatory pathways within the central nervous system. Their portfolio of potential first-in-class and next-generation drug candidates is believed to have applications across numerous neurodegenerative diseases.

The ongoing Phase 1 trial of ATH-1105 is a double-blind, placebo-controlled study enrolling up to 80 healthy volunteers. The trial evaluates the safety and tolerability of single and multiple oral ascending doses, with pharmacokinetic outcomes also being measured. In June 2024, the first cohort of healthy volunteers completed the study, and Athira plans to finish the entire Phase 1 study by the end of 2024, transitioning to ALS patient dosing in 2025.

Supporting the potential of ATH-1105 are extensive preclinical studies that consistently show improvements in nerve and motor function, biomarkers of inflammation and neurodegeneration, and enhanced survival. These findings have been presented at significant scientific and medical conferences, including the American Association of Neurology (AAN), the Alzheimer’s Association International Congress (AAIC), the Northeast Amyotrophic Lateral Sclerosis Consortium® (NEALS), and the Motor Neurone Disease Association (MNDA).

On another front, Athira announced in September 2024 the topline results from the LIFT-AD Phase 2/3 clinical trial of fosgonimeton (ATH-1017), targeting mild-to-moderate Alzheimer’s disease. Although the study did not meet its primary or key secondary endpoints, the biomarker and subgroup data align with the broad neuroprotective mechanism of action proposed by Athira.

In response to these results, Athira decided to explore strategic alternatives to maximize stockholder value, pausing further development of fosgonimeton while continuing the progress of ATH-1105. They have engaged Cantor Fitzgerald & Co. to advise on possible strategic alternatives.

Financially, Athira's cash, cash equivalents, and investments were $68.9 million as of September 30, 2024, compared to $147.4 million as of December 31, 2023. The net cash used in operations for the nine months ending September 30, 2024, was $71.2 million, slightly less than the $74.5 million used in the same period in 2023.

Research and Development expenses for the third quarter of 2024 were $17.9 million, a decrease from $27.2 million in the same quarter of 2023. General and Administrative expenses were $7.6 million, compared to $7.8 million in the previous year’s quarter. Legal expenses for the third quarter of 2024 amounted to $4.1 million, tied to a United States Department of Justice investigative demand. Consequently, Athira recorded a net loss of $28.7 million, or $0.75 per share, for the quarter ended September 30, 2024, compared to a net loss of $33.0 million, or $0.87 per share, in the same period the prior year.

Athira Pharma remains committed to advancing its drug candidates and exploring new avenues to maximize stockholder value amidst financial adjustments and strategic recalibrations.