Athira Pharma Presents Preclinical Data Further Supporting the Therapeutic Potential of ATH-1105 in Amyotrophic Lateral Sclerosis (ALS)

New results support the neuroprotective effects of ATH-1105 in preclinical models of ALS, as indicated by consistent reduction in plasma neurofilament light chain (NfL) levels and preservation of motor function

Data presented at invitational Northeast ALS Consortium (NEALS) meeting

BOTHELL, Wash., Oct. 05, 2023 (GLOBE NEWSWIRE) -- (NASDAQ: ATHA), a late clinical-stage biopharmaceutical company focused on developing small molecules to restore neuronal health and slow neurodegeneration, presented new preclinical data supporting the potential benefit of ATH-1105 for the treatment of amyotrophic lateral sclerosis (ALS) at the , taking place October 4-6, 2023, virtually and in-person in Clearwater, Florida. ATH-1105 is an orally administered small molecule therapeutic candidate designed to enhance the neurotrophic hepatocyte growth factor (HGF) system.

“Our findings add to the growing body of evidence that ATH-1105 offers broad neuroprotective activity in preclinical models of ALS, including the rescue of motor neurons from insults in vitro and reduction in plasma neurofilament light (NfL), decreased pTDP-43 accumulation in nerves, and improvements in motor and nerve function in vivo,” stated Kevin Church, Ph.D., Chief Scientific Officer, Athira Pharma. “There is an urgent need for new ALS treatment options, particularly those aimed at stopping or slowing neurodegeneration. We are encouraged by the consistent benefit of ATH-1105 in these animal models, whether given pre- or post-symptom onset or in combination with riluzole. These findings underscore the broad neuroprotective activity of ATH-1105 and support its ongoing development.”

Poster Presentation (Poster #146): ATH-1105, a small molecule positive modulator of the hepatocyte growth factor system, is neuroprotective in a mouse model of ALS when administered pre- or post-symptom onset, or in combination with riluzole

ATH-1105 demonstrated neuroprotective properties in several preclinical models of ALS:

• In vitro, ATH-1105 protected motor neurons from excitotoxicity, reduced TDP-43 mis-localization, preserved metabolic stability, and maintained neuromuscular junction integrity.
• In vivo, treatment with ATH-1105 improved motor and nerve function, mitigated inflammation and neurodegeneration, and reduced plasma NfL and pTDP-43 accumulation in ALS mice when administered alone or in combination with riluzole.

NEALS is a closed meeting, and the presentation will be available on the  page of the company’s website at .

About ATH-1105

ATH-1105 is an orally administered small molecule designed to positively modulate the neurotrophic hepatocyte growth factor (HGF) system, which plays a critical role in nervous system maintenance and repair, including stimulation of cell survival, increase in neuronal outgrowth and modulation of neuronal network repair. In preclinical models of amyotrophic lateral sclerosis (ALS), ATH-1105 has been shown to significantly increase survival and delay time to first death, enhance motor and nerve function, reduce motor neuron demyelination and axon degeneration, and improve biomarkers of neurodegeneration and inflammation.

About Athira Pharma, Inc.

Athira Pharma, Inc., headquartered in the Seattle, Washington area, is a late 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 therapeutic candidates targeting the neurotrophic HGF system for Alzheimer’s and Parkinson’s disease, Dementia with Lewy bodies, and amyotrophic lateral sclerosis. For more information, visit .

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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: product candidates as a potential treatment for Alzheimer’s disease, Parkinson’s disease, Dementia with Lewy bodies, and other neurodegenerative diseases, such as amyotrophic lateral sclerosis and frontotemporal dementia; future development plans; expectations regarding the potential efficacy and commercial potential of Athira’s product candidates; and Athira’s ability to advance its product candidates into later stages of development. 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,” and other similar expressions, among others. 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 product candidates; development of product candidates may cease or be delayed; regulatory authorities could object to protocols, amendments and other submissions; future potential regulatory milestones for product candidates, including those related to current and planned clinical studies, may be insufficient to support regulatory submissions or approval; 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 product candidates with other treatments; Athira’s assumptions regarding 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; regulatory agencies may be delayed in reviewing, commenting on or approving any of Athira’s clinical development plans as a result of pandemics or health epidemics, which could further delay development timelines; the impact of expanded product development and clinical activities on operating expenses; the impact of new or changing laws and regulations; 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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