ATH-1018

Fosgonimeton treatment showed results suggestive of neuroprotection and potential disease modification in models of Parkinson’s disease Small molecule positive modulators of HGF/MET improved symptoms of diabetic neuropathy with a persistent response even following a washout period BOTHELL, Wash., Nov. 16, 2022 (GLOBE NEWSWIRE) -- Athira Pharma, Inc. (NASDAQ: ATHA), a late clinical-stage biopharmaceutical company focused on developing small molecules to restore neuronal health and slow neurodegeneration, today announced data highlighting the potential therapeutic benefits of enhancing the HGF/MET neurotrophic system in preclinical models of Parkinson’s disease (PD) and diabetic neuropathy. These findings were presented at the Neuroscience 2022 conference, hosted by the Society for Neuroscience. “Our studies continue to show that enhancing the HGF/MET pathway may have significant therapeutic benefit in various neuropathologies,” said Kevin Church, Ph.D., Executive Vice President, Research of Athira Pharma. “The data presented at Neuroscience 2022 show that fosgonimeton (ATH-1017) promotes neuroprotection, reduces alpha-synuclein aggregation in vitro, and improves motor performance in animal models of Parkinson’s disease.” “We look forward to advancing the development of our pipeline and broadening our footprint in clinical neurobiology,” added Mark Litton, Ph.D., President and Chief Executive Officer of Athira. An oral nanosymposium presentation highlighted the neuroprotective effects of fosgonimeton against neuronal damage and motor deficits in preclinical models of Parkinson’s disease. Study results show: Rat cortical neurons incubated with fosgo-AM, the active metabolite of fosgonimeton, demonstrated significant improvement in neuronal survival over controls when exposed to neurotoxic insults implicated in neurodegeneration, including glutamate excitotoxicity, neuroinflammation, and oxidative stress. Following exposure to neurotoxins, rotenone or 6-OHDA, rat dopaminergic neurons treated with fosgo-AM showed significantly increased protection of neuron numbers and the neurite network, as well as a reduction in alpha-synuclein aggregation (a protein pathology of PD) compared to controls. In rats with 6-OHDA-induced striatal lesions, daily subcutaneous injections of fosgonimeton significantly improved motor function across several behavioral assessments. A separate presentation described the effects of HGF/MET small molecule positive modulators in reducing pain-related behaviors in a preclinical model of diabetic neuropathy. Study results show: Two small molecule positive modulators of the HGF/MET pathway, ATH-1018 and ATH-1020, significantly reduced measures of pain in a streptozotocin (STZ)-induced rat model of diabetic neuropathy. Treatment with either ATH-1018 or ATH-1020 resulted in a sustained reduction of pain after a washout period of 23 hours. For ATH-1020 there was a sustained reduction of pain after a washout period of seven days. The effects of these small molecules demonstrate the therapeutic potential for painful diabetic neuropathy. Both presentations can be found on the Scientific Publications & Presentations page of the company’s website at www.athira.com. About Fosgonimeton Fosgonimeton is a small molecule designed to enhance the activity of hepatocyte growth factor (HGF) and its receptor, MET, to impact neurodegeneration and regenerate brain tissue. The function of the HGF/MET receptor system may be impaired in the brain under conditions of neurodegeneration. In addition to Alzheimer’s disease, fosgonimeton has the potential to address the broader dementia population, including Parkinson’s disease dementia and Dementia with Lewy bodies, as the mode of action focuses on network recovery and synaptic signal transmission in the brain. 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 provide rapid cognitive improvement and alter the course of neurological diseases with its novel mechanism of action. Athira is currently advancing its pipeline of therapeutic candidates targeting the HGF/MET neurotrophic system for Alzheimer’s and Parkinson’s disease dementia, Dementia with Lewy bodies and neuropsychiatric indications. For more information, visit . You can also follow Athira on Facebook, LinkedIn and @athirapharma on Twitter 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 fosgonimeton and other product candidates as potential treatments for Alzheimer’s disease, Parkinson’s disease dementia, Dementia with Lewy bodies, and other dementias, neuropathy and neuropsychiatric indications; Athira’s platform technology and potential therapies; future development plans; clinical and regulatory objectives and the timing thereof; 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,” 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 for our product candidates from or preclinical and clinical trials will not support the safety, efficacy and tolerability of our product candidates; cessation or delay of any of the ongoing clinical trials and/or Athira’s development of fosgonimeton and other product candidates may occur; future potential regulatory milestones of fosgonimeton and other product candidates, including those related to current and planned clinical studies may be insufficient to support regulatory submissions or approval; the impact of the COVID-19 pandemic on Athira’s business, research and clinical development plans and timelines, and the regulatory process for Athira product candidates; 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 us and certain of our directors and officers; clinical trials may not demonstrate safety and efficacy of any of Athira’s product candidates; 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 the COVID-19 pandemic, 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. 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