ATHA Athira Pharma Inc.

13.94
-0.52  -4%
Previous Close 14.46
Open 13.8
52 Week Low 8.88
52 Week High 34.79
Market Cap $520,674,390
Shares 37,351,104
Float 32,186,001
Enterprise Value $306,308,963
Volume 419,587
Av. Daily Volume 450,313
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Upcoming Catalysts

Drug Stage Catalyst Date
ATH-1017 (ACT-AD)
Mild-to-moderate Alzheimer's disease
Phase 2
Phase 2
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ATH-1017 (LIFT-AD)
Alzheimer’s disease
Phase 2/3
Phase 2/3
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Drug Pipeline

Drug Stage Notes
ATH-1017 - SHAPE
Parkinson’s disease dementia
Phase 2
Phase 2
Phase 2 trial to be initiated by end of 2021.

Latest News

  1. – Completed enrollment of ACT-AD trial with topline data expected in the first half of 2022; LIFT-AD is actively recruiting with topline data expected by the end of 2022 –

    – Presented program updates and baseline data from ATH-1017's ongoing Phase 2 and Phase 2/3 clinical trials at the 2021 CTAD conference –

    BOTHELL, Wash., Nov. 10, 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 third quarter ended September 30, 2021, and provided an update on the company's operations.

    "We remained focused on our development efforts during the third quarter…

    – Completed enrollment of ACT-AD trial with topline data expected in the first half of 2022; LIFT-AD is actively recruiting with topline data expected by the end of 2022 –

    – Presented program updates and baseline data from ATH-1017's ongoing Phase 2 and Phase 2/3 clinical trials at the 2021 CTAD conference –

    BOTHELL, Wash., Nov. 10, 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 third quarter ended September 30, 2021, and provided an update on the company's operations.

    "We remained focused on our development efforts during the third quarter of 2021, and our initiatives remain on track as we enter a potentially transformative phase with multiple near-term clinical events," said Mark Litton, Ph.D., President and Chief Executive Officer at Athira. "The completion of enrollment in our ACT-AD trial is an important step forward in advancing the development of ATH-1017 with the goal of improving the lives for those suffering from Alzheimer's disease. We look forward to sharing topline results from this Phase 2 trial in the first half of 2022. In parallel, our LIFT-AD trial is actively recruiting with topline results targeted by the end of 2022, and SHAPE, our Phase 2 trial for patients with Parkinson's disease dementia or dementia with Lewy bodies, is expected to initiate later this year. As we evaluate the year ahead, we are well-funded for the continued execution of our planned clinical development and look forward to advancing our pipeline of small molecule therapeutics."

    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, LIFT-AD and ACT-AD, designed to evaluate the safety and efficacy of the investigational therapeutic in individuals with mild-to-moderate Alzheimer's disease.

    Recent Advancements

    • ACT-AD Phase 2 trial: Completed enrollment with topline data expected in the first half of 2022. This Phase 2 randomized, double-blind, placebo-controlled, parallel-group study of ATH-1017 in patients with mild-to-moderate Alzheimer's disease has enrolled 77 subjects across 14 sites in the United States and Australia. The primary endpoint for ACT-AD is Event-Related-Potential (ERP) P300 latency, a functional measure of working memory processing speed, and secondary endpoints measuring cognition, function and behavior.  
    • 2021 Clinical Trials on Alzheimer's Disease Conference (CTAD): Provided program updates and baseline data from ATH-1017's ongoing Phase 2 and Phase 2/3 clinical trials in an oral presentation at CTAD.
    • Open Label Extension Study for LIFT-AD and ACT-AD trials of ATH-1017: The study is ongoing and was initiated in June 2021. Following completion of the 26-week treatment period during the LIFT-AD or ACT-AD trials, study participants may elect to continue on the open label extension and receive treatment with ATH-1017 at the high dose (70 mg/day) for up to an additional 26 weeks.

    Upcoming Milestones

    • LIFT-AD Phase 2/3 trial of ATH-1017 in patients with mild-to-moderate Alzheimer's disease is actively recruiting, with top-line data expected by the end of 2022.
    • SHAPE Phase 2 trial of ATH-1017 in patients with Parkinson's disease dementia or dementia with Lewy bodies is anticipated to initiate by the end of 2021.

    Pipeline Advancements

    ATH-1020: A novel, small molecule therapeutic designed to be an orally available, once-daily treatment. ATH-1020 is intended to enhance the HGF/MET system and distribute to the central nervous system as a potential candidate for neuropsychiatric indications.

    Upcoming Milestone

    • IND filing expected by end of 2021. IND-enabling studies are proceeding for ATH-1020. Athira is targeting an IND submission to the U.S. Food and Drug Administration (FDA) by the end of 2021.

    Recent Corporate Event

    • Educational webinar: On November 5, 2021, the company hosted an educational webinar on the clinical applications of ERP P300 latency as a functional measure of working memory processing speed, as well as its correlation to cognition. The webinar featured a discussion with John Michael Olichney, M.D., a board-certified behavioral neurologist and Professor of Neurology at UC Davis Health; Hans Moebius, M.D., Ph.D., Chief Medical Officer of Athira; and Kevin Church, Ph.D., EVP, Research at Athira. An archived replay of the webinar can be accessed from the investors' section of the Athira website at https://investors.athira.com/news-and-events/events-and-presentations.

    Third Quarter 2021 Financial Results

    • Cash Position. Cash, cash equivalents and investments were $339.4 million as of September 30, 2021, compared to $268.2 million as of December 31, 2020.



    • Research and Development (R&D) Expenses. R&D expenses were $10.7 million for the quarter ended September 30, 2021, as compared to $5.8 million for the same quarter in 2020.



    • General and Administrative (G&A) Expenses. G&A expenses were $7.1 million for the quarter ended September 30, 2021, as compared to $1.6 million for the same quarter in 2020.



    • Net Loss. Net loss was $15.7 million, or $0.42 per share basic and diluted, for the quarter ended September 30, 2021, compared to a net loss of $8.5 million, or $1.12 per share basic and diluted, for the same quarter in 2020.

    About Athira Pharma, Inc.

    Athira, headquartered in the Seattle area, is a late clinical-stage biopharmaceutical company focused on developing small molecules to restore neuronal health and stop neurodegeneration. Athira aims to provide rapid cognitive improvement and alter the course of neurological diseases with our novel mechanism of action. Athira is currently advancing its lead therapeutic candidate, ATH-1017, a novel small molecule for Alzheimer's and Parkinson's disease dementia. For more information, visit www.athira.com. You can also follow Athira on Facebook, LinkedIn and @athirapharma on Twitter and Instagram.

    Forward-Looking Statements

    This release 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 ATH-1017 as a potential treatment for Alzheimer's disease and other dementias; Athira's platform technology and potential therapies; future development plans; clinical and regulatory objectives and the timing thereof, including the timing of the ACT-AD and LIFT-AD clinical trials and the timing of the Phase 2 clinical trial of ATH-1017 for treatment of Parkinson's disease dementia; interactions with regulators and the timing thereof, including anticipated timing of IND or equivalent submissions; expectations regarding the potential efficacy and commercial potential of Athira's product candidates; the anticipated reporting of data; the sufficiency of Athira's cash, cash equivalents and investments to support its planned development activities; 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," "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 preliminary data for Athira's ATH-1017 product candidate from the Phase 1a/b trials will not continue or persist; cessation or delay of any of the ongoing clinical trials and/or Athira's development of ATH-1017 and other product candidates may occur; future potential regulatory milestones of ATH-1017 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 results of operations, including impact on Athira's clinical trial sites and contractors who act for or on Athira's behalf, may be more severe and more prolonged than currently anticipated; the outcome of legal proceedings which 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; Athira's assumptions regarding the sufficiency of its cash, cash equivalents and investments to fund its planned operations may be incorrect; Athira's research and development efforts and its ability to advance product candidates into later stages of development may fail; any one or more of Athira's product candidates may not be successfully developed, approved or commercialized; while P300 latency is a functional measure that is highly correlated with cognition, Athira may not successfully establish a connection between these P300 latency results and improved cognition; 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 competition; the impact of expanded product development and clinical activities on operating expenses; the impact of new or changing laws and regulations; adverse conditions in the general domestic and global economic markets; 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, Inc.



    206-769-9219

    Athira Pharma, Inc.

    Condensed Consolidated Balance Sheets

    (Amounts in thousands)

    (Unaudited)

      September 30,

    2021
      December 31,

    2020
     
    Assets        
    Cash and cash equivalents $107,328  $60,625 
    Short-term investments  128,447   124,057 
    Other short-term assets  3,217   7,655 
    Long-term investments  103,649   83,509 
    Other long-term assets  4,690   3,717 
    Total assets $347,331  $279,563 
    Liabilities and stockholders' equity        
    Current liabilities $9,386  $4,405 
    Long-term liabilities  1,708   876 
    Total liabilities  11,094   5,281 
    Stockholders' equity  336,237   274,282 
    Total liabilities and stockholders' equity $347,331  $279,563 

    Athira Pharma, Inc.

    Condensed Consolidated Statements of Comprehensive Loss

    (Amounts in thousands, except share and per share amounts)

    (Unaudited)

      Three Months Ended September 30, 
      2021  2020 
    Operating expenses:        
    Research and development $10,707  $5,830 
    General and administrative $7,119  $1,567 
    Total operating expenses  17,826   7,397 
    Loss from operations  (17,826)  (7,397)
    Grant income  2,079    
    Other income (expense), net  73   (1,059)
    Net loss $(15,674) $(8,456)
    Unrealized (loss) gain on available-for-sale securities  (33)  7 
    Comprehensive loss attributable to common stockholders $(15,707) $(8,449)
    Net loss per share attributable to common stockholders,

    basic and diluted
     $(0.42) $(1.12)
    Weighted-average shares used in computing net loss per

    share attributable to common stockholders, basic

    and diluted
      37,312,356   7,564,538 



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  2. – Balanced baseline characteristics in ACT-AD and LIFT-AD to date –
    – Topline data from ACT-AD trial targeted for first half of 2022 –

    BOTHELL, Wash., Nov. 10, 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 announced that Hans Moebius, M.D., Ph.D., Chief Medical Officer at Athira, presented an overview and updates from two ongoing late-stage clinical trials (ACT-AD and LIFT-AD) with Athira's lead development candidate ATH-1017 in mild-to-moderate Alzheimer's disease, in an oral presentation at the 2021 Clinical Trials on Alzheimer's Disease (CTAD) conference in Boston.

    ACT-AD and LIFT-AD…

    – Balanced baseline characteristics in ACT-AD and LIFT-AD to date –

    – Topline data from ACT-AD trial targeted for first half of 2022 –

    BOTHELL, Wash., Nov. 10, 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 announced that Hans Moebius, M.D., Ph.D., Chief Medical Officer at Athira, presented an overview and updates from two ongoing late-stage clinical trials (ACT-AD and LIFT-AD) with Athira's lead development candidate ATH-1017 in mild-to-moderate Alzheimer's disease, in an oral presentation at the 2021 Clinical Trials on Alzheimer's Disease (CTAD) conference in Boston.

    ACT-AD and LIFT-AD are both randomized, double-blind, placebo-controlled, parallel-group 26-week trials evaluating ATH-1017 for the treatment of mild-to-moderate Alzheimer's disease. ATH-1017 is designed to enhance synaptic activity.

    "Thus far, baseline characteristics are consistent between ACT-AD and LIFT-AD trials and the average disease severity from both trials is in keeping with the initial Phase 1b AD cohort which showed a statistically significant benefit in Event-Related-Potential (ERP) P300 latency, a functional measure of working memory processing speed. We are encouraged by the safety profile to-date and low early termination rates from both studies as well as the rate of enrollment," said Dr. Moebius. "We expect data read out from the ACT-AD trial, with a primary endpoint of ERP P300 Latency and secondary endpoints measuring cognition, function, and behavior, in the first half of 2022. These results will provide important insights into ATH-1017's treatment effects in Alzheimer's disease."

    Study participants in ACT-AD and LIFT-AD are stratified 1:1:1 to receive low dose ATH-1017 (40 mg/day), high dose ATH-1017 (70 mg/day), or placebo. Upon completion of either the ACT-AD or LIFT-AD treatment protocol, those interested may enroll in Athira's Open Label Extension study of ATH-1017. The ACT-AD trial has completed enrollment with topline data expected in the first half of 2022. "We are extremely grateful to the community of patients and researchers participating in this program and sincerely appreciate all that they have done to get us to this point," said Mark Litton, Ph.D., President and Chief Executive Officer at Athira. "Regardless of the root cause of Alzheimer's disease, a therapy that has potential to target the cognitive symptoms caused by neurodegeneration is needed to address the unmet patient need, and ATH-1017 has the potential to meet that need."

    The data slides presented during the oral presentation (#OC7) at CTAD can be found on the Athira website on the Events and Presentations page of the Investors section on the company's website at www.athira.com.

    About ATH-1017

    ATH-1017 is a small molecule therapeutic specifically designed to enhance the activity of Hepatocyte Growth Factor (HGF) and its receptor, MET, which are expressed in normal central nervous system function but depleted in Alzheimer's disease, in order to fight neurodegeneration and regenerate brain tissue. In addition to Alzheimer's disease, ATH-1017 is designed to address the broader dementia population, including Parkinson's disease dementia and dementia with Lewy bodies. ATH-1017 is designed to focus on network recovery and synaptic signal transmission in the brain, which has the potential to improve clinical outcomes for patients.

    About ACT-AD

    ACT-AD is a randomized, double-blind, placebo-controlled, parallel-group Phase 2 trial for ATH-1017 in subjects with mild-to-moderate Alzheimer's disease. The study has completed enrollment with 77 subjects in the United States and Australia. Study participants were randomized across two dose groups and one placebo group on a 1:1:1 basis to receive a subcutaneous injection of ATH-1017 or placebo once daily over a treatment course of 26 weeks. The primary endpoint for ACT-AD is Event-Related-Potential (ERP) P300 Latency, a functional measure of working memory processing speed, and secondary endpoints measuring cognition, function, and behavior. Additional information on the study can be found at: https://clinicaltrials.gov/ct2/show/NCT04491006. The ACT-AD trial is supported by a grant from the National Institute on Aging of the National Institutes of Health under Award Number R01AG06268. The information presented in this press release and at the CTAD conference is solely the responsibility of Athira and does not necessarily represent the official views of the National Institutes of Health.

    About LIFT-AD

    LIFT-AD is a randomized, double-blind, placebo-controlled, parallel-group Phase 2/3 trial for ATH-1017 for subjects with mild-to-moderate Alzheimer's disease. The study will enroll approximately 300 subjects in the United States, with enrollment ongoing. Subjects are randomized across two dose groups and one placebo group on a 1:1:1 basis to receive a subcutaneous injection of ATH-1017 or placebo once daily over a treatment course of 26 weeks. The primary endpoint for LIFT-AD will be measured by the Global Statistical Test, which is a mathematical algorithm that combines the scores from cognition (Alzheimer's Disease Assessment Scale-Cognitive Subscale [ADAS-Cog11]), and either global impression of change (Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change [ADCS-CGIC]), or function (Alzheimer's Disease Cooperative Study-Activities of Daily Living [ADCS-ADL23]). Additional information on the study can be found at: https://clinicaltrials.gov/ct2/show/NCT04488419.

    About Athira Pharma, Inc.

    Athira, headquartered in the Seattle area, is a late clinical-stage biopharmaceutical company focused on developing small molecules to restore neuronal health and stop neurodegeneration. Athira aims to provide rapid cognitive improvement and alter the course of neurological diseases with our novel mechanism of action. Athira is currently advancing its lead therapeutic candidate, ATH-1017, a novel small molecule for Alzheimer's and Parkinson's disease dementia. For more information, visit www.athira.com. You can also follow Athira on Facebook, LinkedIn and @athirapharma on Twitter and Instagram.

    Forward-Looking Statements

    This release 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 ATH-1017 as a potential treatment for Alzheimer's disease and other dementias; Athira's platform technology and potential therapies; future development plans; clinical and regulatory objectives and the timing thereof, including the timing of the ACT-AD and LIFT-AD clinical trials and the timing of the Phase 2 clinical trial of ATH-1017 for treatment of Parkinson's disease dementia; expectations regarding the potential efficacy and commercial potential of Athira's product candidates; the anticipated reporting of data; 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," "would," "expect," "plan," "believe," "intend," "pursue," 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 preliminary data for Athira's ATH-1017 product candidate from the Phase 1a/b trials will not continue or persist; cessation or delay of any of the ongoing clinical trials and/or Athira's development of ATH-1017 and other product candidates may occur; future potential regulatory milestones of ATH-1017, 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 results of operations, including impact on Athira's clinical trial sites and contractors who act for or on Athira's behalf, may be more severe and more prolonged than currently anticipated; the outcome of legal proceedings which 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; Athira's research and development efforts and its ability to advance product candidates into later stages of development may fail; any one or more of Athira's product candidates may not be successfully developed, approved or commercialized; while P300 latency is a functional measure that is highly correlated with cognition, Athira may not successfully establish a connection between these P300 latency results and improved cognition; 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 competition; the impact of new or changing laws and regulations; adverse conditions in the general domestic and global economic markets; 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, Inc.



    206-769-9219



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  3. -Stifel 2021 Virtual Healthcare Conference-
    - Jefferies 2021 London Healthcare Conference-

    BOTHELL, Wash., Nov. 08, 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 announced that Company management will participate in the following upcoming investor conferences:

    Stifel's 2021 Virtual Healthcare Conference

    • Format: Fireside chat
    • Date & Time: Monday, November 15, 2021 at 2:40 p.m. ET

    Jefferies London Healthcare Conference

    • Format: Fireside chat
    • Date & Time: Available on-demand starting Thursday, November 18, 2021 at 4:00 a.m. ET

    A live webcast of each fireside chat can be accessed from…

    -Stifel 2021 Virtual Healthcare Conference-

    - Jefferies 2021 London Healthcare Conference-

    BOTHELL, Wash., Nov. 08, 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 announced that Company management will participate in the following upcoming investor conferences:

    Stifel's 2021 Virtual Healthcare Conference

    • Format: Fireside chat
    • Date & Time: Monday, November 15, 2021 at 2:40 p.m. ET

    Jefferies London Healthcare Conference

    • Format: Fireside chat
    • Date & Time: Available on-demand starting Thursday, November 18, 2021 at 4:00 a.m. ET

    A live webcast of each fireside chat can be accessed from the Investors section of the Athira website at https://investors.athira.com/news-and-events/events-and-presentations. An archived replay of the webcast will be available for at least 30 days following the event.

    For more detail and to register for the events above, please visit https://investors.athira.com/news-and-events/events-and-presentations

    About Athira Pharma, Inc.

    Athira, headquartered in the Seattle area, is a late clinical-stage biopharmaceutical company focused on developing small molecules to restore neuronal health and stop neurodegeneration. We aim to provide rapid cognitive improvement and alter the course of neurological diseases with our novel mechanism of action. Athira is currently advancing its lead therapeutic candidate, ATH-1017, a novel small molecule for Alzheimer's and Parkinson's dementia. For more information, visit www.athira.com. You can also follow Athira on FacebookLinkedIn and @athirapharma on Twitter and Instagram.

    Investor & Media Contact:

    Julie Rathbun



    206-769-9219



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    • Neurologist Dr. John Michael Olichney to discuss utility of P300 to assess cognitive function
    • Webinar to be held Friday, Nov. 5, at 9 a.m. PT / 12 p.m. ET

    BOTHELL, Wash., Oct. 29, 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 announced it will host an educational webinar to review event-related potential (ERP) P300 latency as a functional measure of working memory processing speed, and its correlation to cognition. The webinar will be webcast live on Friday, Nov. 5, at 9 a.m. PT / 12 p.m. ET, and will feature presentations by:

    • Neurologist Dr. John Michael Olichney to discuss utility of P300 to assess cognitive function
    • Webinar to be held Friday, Nov. 5, at 9 a.m. PT / 12 p.m. ET

    BOTHELL, Wash., Oct. 29, 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 announced it will host an educational webinar to review event-related potential (ERP) P300 latency as a functional measure of working memory processing speed, and its correlation to cognition. The webinar will be webcast live on Friday, Nov. 5, at 9 a.m. PT / 12 p.m. ET, and will feature presentations by:

    • John Michael Olichney, M.D., a board-certified behavioral neurologist who specializes in the treatment of cognitive disorders and age-associated neurodegenerative diseases. Dr. Olichney is Professor of Neurology at UC Davis Health.
    • Kevin Church, Ph.D., Vice President of Discovery at Athira. Dr. Church will introduce the unique mechanism of ATH-1017, a small molecule therapeutic candidate designed to enhance the activity of HGF/MET, discuss the rationale for ERP P300 latency measurements and preclinical ATH-1017 data generated to date.
    • Hans Moebius, M.D., Ph.D., Chief Medical Officer at Athira. Dr. Moebius will review Athira's clinical development program and discuss the utility of ERP P300 latency in Athira's completed Phase 1 and ongoing Phase 2 ACT-AD trial of ATH-1017.

    Athira is measuring ERP P300 latency in a clinical trial of its investigational drug, ATH-1017, for the treatment of mild-to-moderate Alzheimer's disease to evaluate a connection between this functional measurement and improved cognition. The ACT-AD clinical study completed enrollment in October 2021 and topline data from the study is expected to be announced in the first half of 2022.

    To register for the webinar, please click [here] or email to receive a calendar invitation via email. The live event can be accessed from the investors' section of the Athira website at https://investors.athira.com/news-and-events/events-and-presentations. An archived replay will also be available on the company website for at least 30 days following the event.

    About ATH-1017

    ATH-1017 is a small molecule therapeutic specifically designed to enhance the activity of Hepatocyte Growth Factor (HGF) and its receptor, MET, which are expressed in normal central nervous system function but depleted in Alzheimer's Disease, in order to fight neurodegeneration and regenerate brain tissue. In addition to Alzheimer's disease, ATH-1017 is designed to address the broader dementia population, including Parkinson's disease dementia. ATH-1017's novel mechanism of action is agnostic to the underlying disease pathology of Alzheimer's and other dementias. It is designed to focus on network recovery and synaptic signal transmission in the brain, which has the potential to improve clinical outcomes for patients.

    About Athira Pharma, Inc.

    Athira, headquartered in the Seattle area, is a late clinical-stage biopharmaceutical company focused on developing small molecules to restore neuronal health and stop neurodegeneration. We aim to provide rapid cognitive improvement and alter the course of neurological diseases with our novel mechanism of action. Athira is currently advancing its lead therapeutic candidate, ATH-1017, a novel small molecule for Alzheimer's and Parkinson's dementia. For more information, visit www.athira.com. You can also follow Athira on FacebookLinkedIn and @athirapharma on Twitter and Instagram.

    Investor & Media Contact:

    Julie Rathbun



    206-769-9219



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  4. -Topline data targeted for 1H22-

    BOTHELL, Wash., Oct. 22, 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, announced today that it has completed enrollment in ACT-AD, a Phase 2 randomized, placebo-controlled study of ATH-1017 in patients with mild-to-moderate Alzheimer's disease. ATH-1017 is a small molecule designed to enhance the activity of Hepatocyte Growth Factor (HGF) at its receptor, MET, which are expressed in the central nervous system to promote brain health and function. Athira expects to report topline results from the trial in the first half of 2022.

    "The completion of…

    -Topline data targeted for 1H22-

    BOTHELL, Wash., Oct. 22, 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, announced today that it has completed enrollment in ACT-AD, a Phase 2 randomized, placebo-controlled study of ATH-1017 in patients with mild-to-moderate Alzheimer's disease. ATH-1017 is a small molecule designed to enhance the activity of Hepatocyte Growth Factor (HGF) at its receptor, MET, which are expressed in the central nervous system to promote brain health and function. Athira expects to report topline results from the trial in the first half of 2022.

    "The completion of enrollment in our ACT-AD trial is an important step forward in advancing ATH-1017 as a potential new treatment option for patients suffering from Alzheimer's and other dementias," said Mark Litton, Ph.D., M.B.A, President and Chief Executive Officer at Athira. "We look forward to building on this momentum and sharing topline results from this Phase 2 trial in the first half of 2022. As part of our overall clinical development program to maximize the full potential of ATH-1017, we plan to initiate a clinical trial in Parkinson's disease dementia later this year. At Athira, we are committed to improving the lives of patients and their caregivers, and we are proud of our progress towards this goal to date."

    "The completion of enrollment in ACT-AD is an important clinical milestone for Athira. Results from this trial may provide Athira with supportive information that can help optimize our ongoing potentially pivotal LIFT-AD trial and confirm the statistically significant improvement in P300 latency, a functional measure of working memory processing speed, demonstrated in our early trial. We are thankful to have reached this milestone and for the combined efforts of our researchers, partners and the patient and caregiver community," said Hans Moebius, M.D., Ph.D., Chief Medical Officer at Athira. "The pathophysiology of Alzheimer's disease is complex and includes not only the hallmarks of beta-amyloid deposits and neurofibrillary tangles, but neuroinflammation, vascular dysfunction, and neurodegeneration. By focusing on neuronal network recovery, ATH-1017's novel mechanism of action is agnostic to the underlying disease pathology of Alzheimer's and other dementias."

    The ACT-AD study (www.act-adtrial.com, NCT04491006) is a randomized, double-blind, placebo-controlled, 26-week Phase 2 clinical trial. Participants were randomized across two dose groups and one placebo group on a 1:1:1 basis to receive a daily subcutaneous injection of ATH-1017 or placebo over a treatment course of 26 weeks. The study has enrolled 77 patients with mild-to-moderate Alzheimer's disease across 14 sites in the United States and Australia. Patients will be evaluated for improvement in cognition, global, and functional assessments comparing treatment arms to placebo. ACT-AD will also use electroencephalogram (EEG), to measure quantitative electroencephalogram (qEEG), and Event-Related-Potential (ERP P300), a functional measure of working memory processing speed. Following completion of the 26-week treatment period during the LIFT-AD or ACT-AD trials, patients may elect to continue on the open label extension and receive treatment with ATH-1017 at the high dose (70 mg/day) for up to an additional 26 weeks.

    About ATH-1017

    ATH-1017, Athira's lead therapeutic candidate, is a positive modulator of HGF/MET. ATH-1017 is a prodrug that is administered via subcutaneous injection in its inactive form and rapidly converted in plasma to an active tyrosine metabolite (dihexa). Since 2018, ATH-1017 has been assessed in multiple preclinical and clinical studies by Athira and by its third-party contractors. Studies performed by third parties sponsored by Athira regarding ATH-1017's safety profile and treatment potential include the following:

    • A non-clinical study in an Alzheimer's disease (AD) animal model (APP1/PS1), which showed that ATH-1017 treatment increased the qEEG gamma power that is associated with cognitive processing and memory.
    • IND enabling studies including nonclinical GLP long-term toxicology and safety pharmacology studies performed by independent contract research organizations with validated methods and audited reports.
    • A Phase 1a/b clinical trial in healthy young, healthy elderly, and AD subjects, in which ATH-1017 was shown to be well-tolerated with no serious adverse events and demonstrated statistically significant improvement in Event-Related Potential, or ERP. ERP P300 latency, an objective measure of working memory processing speed, was noted in patients with AD following multiple dose treatments with ATH-1017 compared with those receiving placebo (P<0.05). Recently, an independent auditing firm affirmed the GCP compliance and data management quality of the Phase 1a/b clinical trial.

    About Athira Pharma, Inc.

    Athira, headquartered in the Seattle area, is a late clinical-stage biopharmaceutical company focused on developing small molecules to restore neuronal health and stop neurodegeneration. Athira aims to provide rapid cognitive improvement and alter the course of neurological diseases with our novel mechanism of action. Athira is currently advancing its lead therapeutic candidate, ATH-1017, a novel small molecule for Alzheimer's and Parkinson's disease dementia. For more information, visit www.athira.com. You can also follow Athira on Facebook, LinkedIn and @athirapharma on Twitter and Instagram.

    Forward-Looking Statements

    This release 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 ATH-1017 as a potential treatment for Alzheimer's disease and other dementias; Athira's platform technology and potential therapies; future development plans; clinical and regulatory objectives and the timing thereof, including the timing of the ACT-AD and LIFT-AD clinical trials and the timing of the Phase 2 clinical trial of ATH-1017 for treatment of Parkinson's disease dementia; expectations regarding the potential efficacy and commercial potential of Athira's product candidates; the anticipated reporting of data; 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," "would," "expect," "plan," "believe," "intend," "pursue," 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 preliminary data for Athira's ATH-1017 product candidate from the Phase 1a/b trials will not continue or persist; cessation or delay of any of the ongoing clinical trials and/or Athira's development of ATH-1017 and other product candidates may occur; future potential regulatory milestones of ATH-1017, 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 results of operations, including impact on Athira's clinical trial sites and contractors who act for or on Athira's behalf, may be more severe and more prolonged than currently anticipated; the outcome of legal proceedings which 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; Athira's research and development efforts and its ability to advance product candidates into later stages of development may fail; any one or more of Athira's product candidates may not be successfully developed, approved or commercialized; while P300 latency is a functional measure that is highly correlated with cognition, Athira may not successfully establish a connection between these P300 latency results and improved cognition; 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 competition; the impact of new or changing laws and regulations; adverse conditions in the general domestic and global economic markets; 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



    206-769-9219



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