Athira Pharma Q1 2024 Financial Results and Updates

Athira Pharma Inc., a late clinical-stage biopharmaceutical company specializing in the development of small molecules to restore neuronal health and slow neurodegeneration, has released its financial results for the quarter ending March 31, 2024, along with recent updates on their pipeline and business activities.

Dr. Mark Litton, President and CEO, emphasized the potential impact of their forthcoming topline data from the Phase 2/3 LIFT-AD clinical trial of fosgonimeton, an investigational treatment for mild-to-moderate Alzheimer's disease, expected in the latter half of 2024. He highlighted the robust clinical and nonclinical data supporting the LIFT-AD trial and the innovative approach in targeting the neurotrophic HGF system to produce neuroprotective effects across various neurodegenerative diseases.

Athira's drug development pipeline features fosgonimeton, potentially a first-in-class, once-daily, subcutaneous drug aimed at treating Alzheimer’s disease. The LIFT-AD trial is examining the effects of fosgonimeton compared to a placebo in patients with mild-to-moderate Alzheimer's disease, with primary endpoints including the Global Statistical Test (GST), which integrates results from key cognitive and functional assessments. Secondary and exploratory endpoints focus on changes in plasma biomarkers related to neurodegeneration, protein pathology, and neuroinflammation. Furthermore, an Open Label Extension (OLEX) trial allows participants from LIFT-AD or ACT-AD studies to continue treatment, with over 85% opting in.

In December 2023, Athira announced positive outcomes from the SHAPE Phase 2 clinical trial of fosgonimeton for Parkinson’s disease dementia and dementia with Lewy bodies, demonstrating directional improvements in cognitive and functional markers. Fosgonimeton showed a favorable safety profile with no serious adverse events related to treatment.

In parallel, Athira is advancing ATH-1105, an orally administered small molecule drug candidate for amyotrophic lateral sclerosis (ALS). They have submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration and plan to initiate a first-in-human study in the second quarter of 2024. Preclinical data indicate significant improvements in nerve and motor function, inflammation biomarkers, and survival in various ALS models.

The company recently welcomed Dr. Javier San Martin as Chief Medical Officer. With over 25 years of experience in drug development, Dr. San Martin will play a pivotal role in advancing Athira’s therapeutic candidates.

Athira has also been active in presenting their findings. In April 2024, they presented at the American Academy of Neurology (AAN) Annual Meeting, highlighting the therapeutic potential of their candidates targeting the neurotrophic HGF system. Additionally, they published preclinical data on fosgonimeton’s potential in Alzheimer’s disease in the journal Neurotherapeutics, detailing mechanisms that may disrupt the neurodegenerative cascade caused by amyloid-beta toxicity.

Financially, Athira reported cash, equivalents, and investments of $122.1 million as of March 31, 2024, down from $147.4 million at the end of 2023, attributed to operational expenditures. Research and development expenses were $21.2 million, slightly down from $21.3 million in the previous year, primarily due to reduced costs in the ATH-1020 program and personnel. General and administrative expenses saw a decrease to $6.5 million from $8.5 million, driven by reduced legal and business development costs. The net loss for the quarter was $26.3 million, or $0.69 per share, compared to $27.8 million, or $0.73 per share, in the same period last year.

Athira Pharma continues its mission to alter the trajectory of neurological diseases with its innovative pipeline. The company remains focused on advancing its products through critical clinical milestones and ultimately improving patient outcomes in neurodegenerative diseases.