Fosgonimeton

Company to provide overview of Phase 2/3 LIFT-AD clinical trial of fosgonimeton in mild-to-moderate Alzheimer’s disease (AD); LIFT-AD topline data expected in second half of 2024 Two key opinion leaders will discuss ongoing unmet medical need and LIFT-AD’s primary endpoint, the Global Statistical Test, designed to measure overall impact on disease Webinar event on Tuesday, June 18th at 11:30 a.m. ET BOTHELL, Wash., June 12, 2024 (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 that it will host a webinar event with key opinion leaders to discuss the unmet medical need and the potential opportunity for fosgonimeton to improve cognition and function in mild-to-moderate Alzheimer’s disease. The event titled, “Lead Up to LIFT-AD Readout: Understanding the Primary Endpoint and Continued Need for Effective New Treatments in Alzheimer’s Disease,” will take place on Tuesday, June 18th, 2024, beginning at 11:30 a.m. ET. “With the Phase 2/3 LIFT-AD study expected to report topline data in the second half of 2024, we look forward to being joined by two renowned leaders in the neurodegeneration field to discuss the continued need for new treatment options in Alzheimer’s disease. We will address important aspects of AD pathology relevant to this patient population and will review the potential opportunity for fosgonimeton to improve cognition and function in patients suffering with mild-to-moderate AD,” said Javier San Martin, M.D., Chief Medical Officer of Athira. “Additionally, we will provide an overview of the Phase 2/3 LIFT-AD trial and review the relevance of the trial’s primary endpoint, the Global Statistical Test (GST), a combination of the results from the co-key secondary endpoints of cognition (ADAS-Cog11) and function (ADCS-ADL23), which we believe is a comprehensive measure of overall disease burden.” The webcast event will feature presentations from Suzanne Hendrix, Ph.D., Founder and CEO of Pentara Corporation, and Anton P. Porsteinsson, M.D., Director of the University of Rochester Alzheimer’s Disease Care, Research, and Education Program (AD-CARE). In addition, Dr. San Martin will provide an overview of the ongoing LIFT-AD trial and fosgonimeton’s novel mechanism of action. Registration for the live webinar and biographies of the key opinion leaders can be accessed here. The event can also be accessed from the Investors section of the Athira website at https://investors.athira.com/news-and-events/events-and-presentations-investor. An archived replay of the event will be available on the Athira website following the event. About Phase 2/3 LIFT-AD Clinical TrialAthira is currently evaluating fosgonimeton in the Phase 2/3 LIFT-AD clinical trial, which enrolled approximately 315 patients with mild-to-moderate Alzheimer’s disease in a 26-week, randomized, double-blind, placebo-controlled clinical trial evaluating once-daily subcutaneous injections of fosgonimeton 40 mg compared to placebo. The primary endpoint is the Global Statistical Test (GST), a combination of the results from the co-key secondary endpoints ADAS-Cog11 and ADCS-ADL23, measurements of cognition and function, respectively. Additional key secondary and exploratory endpoints include changes in plasma biomarkers of neurodegeneration, protein pathology, and neuroinflammation. Additional information about the LIFT-AD study can be found at: NCT04488419. About FosgonimetonFosgonimeton is a potentially first-in-class, once daily, subcutaneously administered small molecule drug candidate. Targeting the protection and repair of neuronal networks, fosgonimeton has disease-modifying potential to address a broad range of neurodegenerative diseases, including Alzheimer’s disease, Parkinson’s disease, and dementia with Lewy bodies. 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 that modulate the neurotrophic HGF system, including fosgonimeton, which is being evaluated for the potential treatment of mild-to-moderate Alzheimer’s disease in the Phase 2/3 LIFT-AD trial that is expected to report topline data in the second half of 2024. For more information, visit www.athira.com. You can also follow Athira on Facebook, LinkedIn and @athirapharma on X, formerly known as 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: Athira’s drug candidates as potential treatments for Alzheimer’s disease, Parkinson’s disease, dementia with Lewy bodies, and other neurodegenerative diseases; future development plans; the anticipated reporting of data; the potential learnings from preclinical studies and other nonclinical data and their ability to inform and improve future clinical development plans; expectations regarding the potential efficacy and commercial potential of Athira’s drug candidates; and Athira’s ability to advance its drug 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 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; 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 expanded drug candidate 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. Investor Contacts:Julie RathbunAthira PharmaJulie.rathbun@athira.com206-769-9219 Anne Marie FieldsPrecision AQ (formally Stern IR)annemarie.fields@precisionaq.com 332-213-1956 Media Contact: Janine BogrisInizio Evoke CommsJanine.bogris@inizioevoke.com 201-245-6838