Athira Pharma, Inc. Stock Price, News & Analysis

Athira Pharma (NASDAQ: ATHA) reported Q2 2024 financial results and provided pipeline updates. Key highlights include:

1. Topline data from Phase 2/3 LIFT-AD trial of fosgonimeton for Alzheimer's disease expected in September 2024.

2. Phase 1 trial of ATH-1105 for ALS underway.

3. Cash position of $91.8 million as of June 30, 2024.

4. Net loss of $26.9 million ($0.70 per share) for Q2 2024.

5. R&D expenses increased to $22.2 million, while G&A expenses decreased to $5.9 million.

The company remains focused on developing small molecules to restore neuronal health and slow neurodegeneration, with fosgonimeton showing potential as a first-in-class therapy for Alzheimer's disease.

Athira Pharma (NASDAQ: ATHA) presented new preclinical data on fosgonimeton at the Alzheimer's Association International Conference (AAIC) 2024. The data demonstrated fosgonimeton's ability to mitigate amyloid-β-induced toxicity, lower pTau levels, and reduce disruption of protein clearance mechanisms in Alzheimer's disease models. Notably, fosgonimeton showed neuroprotective effects against amyloid-β toxicity in primary neurons, both alone and in combination with lecanemab. The research suggests that fosgonimeton may attenuate pTau pathology by improving autophagy, a cellular process impaired in Alzheimer's. These findings support Athira's approach of targeting the neurotrophic HGF system as a potential Alzheimer's treatment and suggest potential benefits of combining fosgonimeton with amyloid-β-targeting monoclonal antibodies.

Athira Pharma announced the completion of dosing for the last patient in their Phase 2/3 LIFT-AD clinical trial of fosgonimeton, aimed at treating mild-to-moderate Alzheimer's disease (AD). The trial involved approximately 315 patients, assessing the efficacy and safety of fosgonimeton through once-daily subcutaneous injections over a 26-week period. Athira plans to release topline results by the end of Q3 2024 and will present detailed data at the CTAD conference on October 29, 2024, in Madrid. The primary endpoint, the GST, evaluates changes in cognition and function using the ADAS-Cog11 and ADCS-ADL23 tests. The trial also includes serum biomarker analysis to explore the neuroprotective effects of fosgonimeton. Additionally, a significant portion of participants have enrolled in an open-label extension study, with over 70 patients continuing treatment beyond 18 months.

Athira Pharma will host a webinar on June 18, 2024, to discuss the potential of fosgonimeton for treating mild-to-moderate Alzheimer's disease (AD). The event will cover the ongoing Phase 2/3 LIFT-AD trial, with topline data expected in the second half of 2024. Chief Medical Officer Javier San Martin, alongside two neurodegeneration experts, will review the trial's primary endpoint, the Global Statistical Test (GST), which measures cognition and function. The webinar will provide insights into the unmet medical needs in AD and the potential benefits of fosgonimeton.

Athira Pharma has completed the first cohort in its Phase 1 clinical trial for ATH-1105, a potential treatment for ALS. This first-in-human, dose-escalation study aims to assess the safety, tolerability, and pharmacokinetics of the drug in healthy volunteers. The trial is expected to conclude by the end of 2024, with a Phase 2 study in ALS patients slated for 2025. Preclinical data indicates that ATH-1105 can improve motor function, preserve nerve health, and extend survival in ALS models. The Phase 1 trial will involve up to 80 healthy participants and will evaluate single and multiple ascending doses of the drug.

Athira Pharma (NASDAQ: ATHA), a late-stage clinical biopharmaceutical company, announced its participation in two investor conferences in June 2024. The company will present at the Jefferies Healthcare Conference on June 5 and the Goldman Sachs 45th Annual Healthcare Conference on June 12. These events will feature fireside chats where Athira’s management will discuss the company’s robust pipeline focused on neurodegenerative diseases. They will also highlight the progress of the LIFT-AD Phase 2/3 trial in Alzheimer’s Disease, with topline data expected in the second half of 2024. The fireside chats will be webcast live on Athira's Investor Relations website, with replays available for 30 days post-event.

Athira Pharma (NASDAQ: ATHA) announced a proposed settlement for stockholder derivative actions. The settlement, preliminarily approved by the U.S. District Court for the Western District of Washington, involves adopting corporate governance reforms and paying legal fees and service awards to lead plaintiffs. A final approval hearing is scheduled for July 18, 2024. Relevant documents have been posted on Athira's Investor Relations website.

Athira Pharma (NASDAQ: ATHA) released its Q1 2024 financial results and highlighted pipeline and business updates. The company is anticipating topline data from its Phase 2/3 LIFT-AD clinical trial of fosgonimeton for Alzheimer's disease in H2 2024. They've also filed an IND application for ATH-1105 for ALS treatment and plan a first-in-human study in Q2 2024. Financially, Athira reported a net loss of $26.3 million, or $0.69 per share, compared to $27.8 million, or $0.73 per share, in Q1 2023. Cash reserves stand at $122.1 million, down from $147.4 million in December 2023. R&D expenses were $21.2 million, while G&A expenses dropped to $6.5 million. The company remains focused on advancing its small molecule drug candidates targeting the HGF system to treat neurodegenerative diseases.

Summary: Athira Pharma, Inc. (NASDAQ: ATHA) will be participating in the Sidoti May 2024 Virtual Investor Conference and The Citizens JMP Life Sciences Conference in May. The Company management will present at these conferences to discuss their focus on developing small molecules to restore neuronal health and slow neurodegeneration. Live webcasts and archived replays will be available on the Athira website.