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, visit www.athira.com. You can also follow Athira on Facebook, LinkedIn, X and Instagram.
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.
Investor & Media Contact:
Julie Rathbun
Athira Pharma
Julie.rathbun@athira.com
206-769-9219
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 Ended December 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 | |||||
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