Earnings release
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* Athira PHARMA Athira Pharma Reports Second Quarter 2021 Financial Results and Business Update August 16 , 2021 - Initiated open label extension for LIFT - AD and ACT - AD trials of ATH - 1017 allowing for an additional six months of treatment -ACT - AD and LIFT - AD are actively recruiting ; topline data of ACT - AD are targeted by first half 2022 and topline data from LIFT - AD are targeted by end of 2022 BOTHELL , Wash . , Aug. 16 , 2021 ( GLOBE NEWSWIRE ) -- Athira Pharma , Inc. ( NASDAQ : ATHA ) , a late clinical - stage biopharmaceutical company focused on developing small molecules to restore neuronal health and stop neurodegeneration , today reported its financial results for the second quarter ended June 30 , 2021 and provided an update on the company's operations . " In the second quarter of 2021 , we made significant advancements across our corporate and clinical initiatives , " said Mark Litton , Ph.D. , MBA , Chief Operating Officer at Athira . " We recently initiated an open label extension study for our ongoing Phase 2/3 LIFT - AD and Phase 2 ACT - AD studies of ATH - 1017 in patients living with mild - to - moderate Alzheimer's disease , allowing for all study participants to receive active drug treatment for an additional 26 weeks . We anticipate that the additional data obtained from this extension will provide a more comprehensive understanding of the long - term safety and efficacy profile , and when combined with the promising preclinical and early clinical data generated both internally and externally , will inform our clinical development strategy . " Dr. Litton continued , " We remain encouraged by the therapeutic potential of ATH - 1017 to improve clinical outcomes and restore neuronal health through an approach that focuses on neuronal regeneration , agnostic to the underlying disease pathology . In addition to Alzheimer's disease , we plan to evaluate ATH - 1017 in Parkinson's disease dementia , and we remain committed to advancing our expanding pipeline of small molecule compounds . We look forward to providing updates on our progress as we deliver on our strategic plan and our mission to improve the lives of those suffering from neurological diseases . " Clinical Development and Upcoming Milestones ATH - 1017 : A small molecule therapeutic specifically designed to enhance the activity of hepatocyte growth factor ( HGF ) and its receptor , MET , to impact neurodegeneration and regenerate brain tissue . ATH - 1017 is currently being evaluated in two randomized , double - blind , placebo - controlled trials designed to evaluate the safety and efficacy of the investigational therapeutic in individuals with mild - to - moderate Alzheimer's disease . Recent Advancements • • Initiated Open Label Extension Study for LIFT - AD and ACT - AD trials of ATH - 1017 • Following completion of the 26 - week treatment period during the LIFT - AD or ACT - AD trials , patients from both the placebo and active groups may elect to continue the open label extension and receive treatment with ATH - 1017 at the high dose ( 70 mg / day ) for up to an additional 26 weeks . Investigators and patients will remain blinded to treatment group assignment in the original trials . Presented Ph1a / b ATH - 1017 data at the Alzheimer's Association International Conference 2021 ( AAIC ) • Results support the clinical utility of quantitative electroencephalogram ( qEEG ) biomarker of brain circuitry activity , and the translational utility for PK / PD modeling and dose - optimization across preclinical and clinical models of mild - to - moderate Alzheimer's disease . Upcoming Milestones • • The company anticipates reporting topline data from ACT - AD by the first half of 2022 , and topline data from LIFT - AD by the end of 2022 . A Phase 2 trial of ATH - 1017 for treatment of Parkinson's disease dementia is targeted to initiate by the end of 2021 . Pipeline ATH - 1020 : Novel , small molecule compound designed to be an orally available once - daily treatment , to activate the HGF / MET system and to distribute to the central nervous system as a potential candidate for neurodegenerative disorders . Upcoming Milestones IND filing expected by end of 2021. IND - enabling studies are proceeding for ATH - 1020 . As planned , Athira is targeting an IND submission to the U.S. Food and Drug Administration ( FDA ) by the end of 2021 . Recent Corporate Updates : • Mark Litton , Ph.D. , MBA , in his capacity as Chief Operating Officer , has assumed day - to - day leadership responsibilities for the Company . • Rachel Lenington , MBA , has been appointed as Chief Technology Officer , Head of Product Development Strategy .