Athira Pharma, Inc. Stock Price, News & Analysis

Athira Pharma (NASDAQ: ATHA) presented Phase 1 clinical trial results for ATH-1105, their novel oral drug candidate for ALS treatment, at the ALS Nexus 2025 conference. The trial demonstrated a favorable safety and tolerability profile, along with dose-proportional pharmacokinetics and CNS penetration in healthy volunteers.

The drug candidate, designed to modulate the neurotrophic HGF system, has shown consistent and robust beneficial effects in preclinical ALS models. Chief Medical Officer Dr. Javier San Martin emphasized the importance of developing new ALS treatments to prolong survival and improve patients' quality of life.

Athira Pharma (NASDAQ: ATHA) reported Q2 2025 financial results and provided updates on its clinical pipeline. The company's lead candidate ATH-1105 showed promising Phase 1 results for ALS treatment, demonstrating favorable safety, tolerability, and CNS penetration. The trial involved 80 healthy volunteers and was completed in November 2024.

Financial highlights include cash position of $29.8M as of June 30, 2025, reduced R&D expenses of $3.7M (vs $22.2M in Q2 2024), and a net loss of $7.0M. The company is exploring strategic alternatives after its Alzheimer's candidate fosgonimeton failed to meet primary endpoints in the LIFT-AD trial, leading to a pause in its development.

Athira Pharma (NASDAQ: ATHA) announced the presentation of Phase 1 clinical trial data for ATH-1105, their novel oral drug candidate for ALS treatment, at the 4th Annual ALS Drug Development Summit in Boston. The first-in-human trial demonstrated favorable safety and tolerability profiles in healthy volunteers, with dose proportional pharmacokinetics and CNS penetration.

The company plans to initiate clinical trials in ALS patients in late 2025. ATH-1105 has shown promising results in preclinical studies, including significant improvements in nerve and motor function, reduced inflammation, and increased survival in various ALS models. The drug works by modulating the neurotrophic HGF system and has demonstrated effectiveness in reducing TDP-43 pathology in preclinical ALS models.

Preclinical data has been previously presented at major scientific meetings including AAN, AAIC, NEALS, and MNDA, and published in Frontiers in Neuroscience, 2024.

Athira Pharma (NASDAQ: ATHA) reported Q1 2025 financial results and provided updates on its pipeline, particularly focusing on ATH-1105, its potential treatment for ALS. The company completed a Phase 1 clinical study of ATH-1105 in healthy volunteers, demonstrating favorable safety and tolerability. The full data is expected in H2 2025, with plans to begin dosing ALS patients in late 2025. Financially, Athira reported cash and investments of $36.7 million as of March 31, 2025, with a net loss of $9.1 million ($0.23 per share). The company's R&D expenses decreased to $4.3 million from $21.2 million year-over-year, while G&A expenses reduced to $5.2 million from $6.5 million. Following unsuccessful results of its previous lead candidate fosgonimeton in Alzheimer's disease, Athira is exploring strategic alternatives with Cantor Fitzgerald & Co. to maximize stockholder value.

Athira Pharma (NASDAQ: ATHA) has completed its Phase 1 clinical study of ATH-1105 for amyotrophic lateral sclerosis (ALS) treatment. The study, involving 80 healthy volunteers, demonstrated favorable safety profiles and good tolerability, positioning the company to begin dosing ALS patients in 2025.

The company reported significant financial changes, with cash positions decreasing to $51.3 million as of December 31, 2024, compared to $147.4 million in 2023. Net loss improved to $96.9 million ($2.52 per share) from $117.7 million ($3.09 per share) in 2023. R&D expenses decreased to $70.7 million from $93.8 million, while G&A expenses reduced to $26.1 million from $33.3 million.

Following unsuccessful LIFT-AD Phase 2/3 trial results for fosgonimeton in Alzheimer's disease, Athira has paused its development and engaged Cantor Fitzgerald & Co. to explore strategic alternatives for maximizing stockholder value.

Athira Pharma (NASDAQ: ATHA) presented preclinical data for ATH-1105 at the Motor Neurone Disease Association's 35th International Symposium on ALS/MND. The research demonstrated the drug's neuroprotective effects in human models of ALS, specifically in human iPSC-derived motor neurons expressing the SOD1-A4V mutation.

Key findings showed that ATH-1105 promoted activation of MET receptor in ALS patient-derived motor neurons, enhanced motor neuron survival, and preserved neurite networks following glutamate challenge. The drug demonstrated neuroprotective activity through the MET receptor, with effects diminishing when MET was knocked down. In a neuromuscular junction model, ATH-1105 showed protective effects on motor neuron survival and neurite networks.

Athira Pharma reported Q3 2024 financial results and provided updates on its pipeline and business. The company is advancing ATH-1105, an oral drug candidate for ALS, with Phase 1 trials in healthy volunteers expected to complete by year-end and ALS patient dosing to begin in 2025. ATH-1105 has shown promising preclinical results in ALS models. However, the LIFT-AD Phase 2/3 trial for fosgonimeton in Alzheimer's did not meet primary or key secondary endpoints. Consequently, Athira is exploring strategic alternatives and has paused further fosgonimeton development. Financially, Athira's cash position was $68.9 million, with a net loss of $28.7 million for Q3 2024. R&D expenses decreased to $17.9 million, while G&A expenses remained stable at $7.6 million. Legal expenses were $4.1 million due to a DOJ investigative demand.

Athira Pharma (NASDAQ: ATHA) announced that results from the Phase 2/3 LIFT-AD clinical trial of fosgonimeton for Alzheimer's disease will be presented at the 17th Annual Clinical Trials on Alzheimer's Disease (CTAD) meeting in Madrid, Spain. The presentation, titled "Fosgonimeton for the Treatment of Alzheimer's Disease; Efficacy and Safety Results from the LIFT-AD Trial," will be given by Dr. Anton P. Porsteinsson on October 29, 2024.

While the trial did not achieve statistical significance for its primary and key secondary endpoints, cognition and function directionally favored fosgonimeton treatment. In pre-specified subgroups with more rapid disease progression, improvements or stabilization were observed. Biomarker data showed directional changes supporting fosgonimeton's neuroprotective mechanism.

Athira is now focusing on ATH-1105, a novel oral small molecule for neurodegenerative diseases, currently in a Phase 1 trial with healthy volunteers. The company aims to begin dosing ALS patients in 2025.

Athira Pharma (NASDAQ: ATHA) announced a strategic shift to focus on advancing ATH-1105, an oral, next-generation small molecule positive modulator of the HGF system, for treating neurodegenerative diseases like ALS and Alzheimer's. This decision follows the topline data readout from the Phase 2/3 LIFT-AD trial of fosgonimeton. The company is implementing cost containment measures, including a 70% workforce reduction, expecting one-time costs of $2.8 million and annual savings of $13.4 million. These measures aim to extend Athira's cash runway into Q1 2026.

Athira is currently conducting a Phase 1 trial of ATH-1105, expecting completion by year-end 2024 and plans to begin dosing ALS patients in 2025. The company is encouraged by ATH-1105's potential, citing its enhanced blood-brain-barrier penetration and improved pharmacokinetic properties. Preclinical data has shown neuroprotective effects, including consistent reduction in plasma neurofilament light chain (NfL) levels, a marker of disease progression in ALS.