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Athira Pharma Reports Full Year 2024 Financial Results and Pipeline and Business Updates

Key Takeaway: Athira Pharma has completed a Phase 1 clinical study of ATH-1105, a potential treatment for ALS, and is on track to begin dosing patients in 2025. The company reported positive preclinical results indicating ATH-1105's ability to enhance motor and nerve function. Athira's pipeline includes several drug candidates targeting neurodegenerative diseases, with ongoing exploration of strategic alternatives.

Market Sentiment Analysis

POSITIVE FACTORS

  • Completion of Phase 1 study for ATH-1105 shows progress.
  • Potential to start dosing ALS patients in 2025.
  • Positive preclinical results for ATH-1105 in improving motor function.

CONCERNS & RISKS

  • Future development plans are subject to regulatory approval.
  • Risks associated with recruitment for clinical trials.
  • Potential delays in drug candidate development.

Full Press Release Details

Completed healthy volunteer Phase 1 clinical study of ATH-1105 as a potential treatment for amyotrophic lateral sclerosis (ALS)
On-track to enable dosing ALS patients in 2025
BOTHELL, Wash., Feb. 27, 2025 (GLOBE NEWSWIRE) --Athira Pharma, Inc.(NASDAQ: ATHA), a clinical stage biopharmaceutical company focused on developing small molecules to restore neuronal health and slow neurodegeneration, today reported financial results for the year ended December 31, 2024, and provided recent pipeline and business updates.
“We look forward to the opportunity to continue to advance ATH-1105 as a potential therapy for ALS, which in various preclinical models has demonstrated a consistent ability to improve motor and nerve function, enhance neuronal survival, and improve biomarkers of inflammation and neurodegeneration, including neurofilament light chain (NfL), a key marker of ALS disease progression,” said Mark Litton, Ph.D, President and Chief Executive Officer of Athira. “With the healthy volunteer Phase 1 clinical study of ATH-1105 complete, we are pleased to remain on track to enable dosing ALS patients in 2025.”

Clinical Development & Pipeline Programs

Athira’s drug development pipeline includes novel next-generation small molecule drug candidates designed to promote the neurotrophic hepatocyte growth factor (HGF) system, which activates neuroprotective, neurotrophic and anti-inflammatory pathways in the central and peripheral nervous system.
ATH-1105– A novel, orally available, brain-penetrant, next-generation small molecule drug candidate designed to positively modulate the neurotrophic HGF system for potential treatment of neurodegenerative diseases, including amyotrophic lateral sclerosis (ALS), Alzheimer’s disease, and Parkinson’s disease. ATH-1105 is currently in development for the potential treatment of ALS.
Fosgonimeton (ATH-1017) –A once daily, subcutaneously administered drug candidate initially targeted for the potential treatment of Alzheimer’s disease.

Exploration of Strategic Alternatives

Financial Results

About Athira Pharma, Inc.Athira Pharma, Inc., headquartered in the Seattle, Washington area, is a clinical-stage biopharmaceutical company focused on developing small molecules to restore neuronal health and slow neurodegeneration. Athira aims to alter the course of neurological diseases by advancing its pipeline of drug candidates that modulate the neurotrophic HGF system. For more information, visitwww.athira.com. You can also follow Athira onFacebook,LinkedIn,XandInstagram.

Forward-Looking Statements

This communication contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995. These forward-looking statements are not based on historical fact and include statements regarding: Athira’s drug candidates as potential treatments for amyotrophic lateral sclerosis, Alzheimer’s disease, Parkinson’s disease, and other neurodegenerative diseases; future development plans; the potential learnings from preclinical studies and other nonclinical data and their ability to inform and improve future clinical development plans; the potential learnings from our Phase 1 ATH-1105 clinical trial and its implications for future development plans; expectations regarding the potential efficacy and commercial potential of Athira’s drug candidates; Athira’s ability to advance its drug candidates into later stages of development; and Athira’s plans and expectations regarding Athira’s exploration of strategic alternatives and partnering options. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as “may,” “will,” “should,” “on track,” “would,” “expect,” “plan,” “believe,” “intend,” “pursue,” “continue,” “suggest,” “potential,” “target,” and similar expressions. Any forward-looking statements are based on management’s current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to, the data from preclinical and clinical trials may not support the safety, efficacy and tolerability of Athira’s drug candidates; development of drug candidates may cease or be delayed; regulatory authorities could object to protocols, amendments and other submissions; future potential regulatory milestones for drug candidates, including those related to current and planned clinical studies, may be insufficient to support regulatory submissions or approval; whether Athira’s trials are sufficiently powered to meet the planned endpoints; Athira may not be able to recruit sufficient patients for its clinical trials; the outcome of legal proceedings that have been or may in the future be instituted against Athira, its directors and officers; possible negative interactions of Athira's drug candidates with other treatments; Athira’s assumptions regarding its financial condition and the sufficiency of its cash, cash equivalents and investments to fund its planned operations may be incorrect; adverse conditions in the general domestic and global economic markets; the impact of competition; the impact of drug candidate development and clinical activities on operating expenses; the impact of new or changing laws and regulations; risks related to Athira’s exploration of strategic alternatives; as well as the other risks detailed in Athira’s filings with the Securities and Exchange Commission from time to time. These forward-looking statements speak only as of the date hereof and Athira undertakes no obligation to update forward-looking statements. Athira may not actually achieve the plans, intentions, or expectations disclosed in its forward-looking statements, and you should not place undue reliance on the forward-looking statements.

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Athira Pharma, Inc.Condensed Consolidated Balance Sheets(Amounts in thousands)
December 31, December 31,
2024 2023
Assets
Cash and cash equivalents $ 48,438 $ 90,584
Short-term investments 2,837 56,835
Other short-term assets 3,566 7,310
Other long-term assets 3,938 5,516
Total assets $ 58,779 $ 160,245
Liabilities and stockholders' equity
Current liabilities $ 13,135 $ 28,840
Long-term liabilities 803 1,217
Total liabilities 13,938 30,057
Stockholders' equity 44,841 130,188
Total liabilities and stockholders' equity $ 58,779 $ 160,245
Athira Pharma, Inc.Condensed Consolidated Statements of Operations and Comprehensive Loss(Amounts in thousands, except share and per share amounts)
Year EndedDecember 31,
2024 2023
Operating expenses:
Research and development $ 70,682 $ 93,790
General and administrative 26,093 33,304
Legal expense 4,127
Insurance recovery related to legal settlement (1,628 )
Total operating expenses 100,902 125,466
Loss from operations (100,902 ) (125,466 )
Grant income 157
Other income, net 3,962 7,637
Net loss $ (96,940 ) $ (117,672 )
Unrealized gain on available-for-sale securities 350 1,607
Comprehensive loss attributable to common stockholders $ (96,590 ) $ (116,065 )
Net loss per share attributable to common stockholders, basic and diluted $ (2.52 ) $ (3.09 )
Weighted-average shares used in computing net loss per share attributable to common stockholders, basic and diluted 38,480,875 38,020,182

Frequently Asked Questions

What is ATH-1105?

ATH-1105 is a novel small molecule drug candidate aimed at treating ALS.

When will ALS patients be dosed with ATH-1105?

Dosing of ALS patients with ATH-1105 is expected to begin in 2025.

What are the results of the Phase 1 study?

The Phase 1 study of ATH-1105 has been completed successfully.

What other diseases is Athira targeting?

Athira is also developing treatments for Alzheimer's and Parkinson's diseases.

What are the financial results for 2024?

Athira reported its financial results for the year ending December 31, 2024.

Last updated: Feb 27, 2025