Clinical Trials and Drug Development - The primary and secondary endpoints of the Phase 2 ACT-AD clinical trial of fosgonimeton in Alzheimer's Disease (AD) were not met, with a post hoc analysis showing a non-statistically significant improvement in cognitive performance [153]. - The topline data from the Phase 2/3 LIFT-AD clinical trial of fosgonimeton indicated that neither the primary endpoint nor key secondary endpoints reached statistical significance compared to placebo at 26 weeks [154]. - Following the LIFT-AD results, the company announced a focus on advancing the clinical development program for ATH-1105 as a potential treatment for Amyotrophic Lateral Sclerosis (ALS) [155]. - ATH-1105 completed its first-in-human Phase 1 clinical trial in November 2024, demonstrating a favorable safety profile and tolerability in healthy volunteers [155]. - The company has decided to pause further development of fosgonimeton after its Phase 2 ACT-AD clinical trial did not meet primary and secondary endpoints [169]. - The Phase 1a/b clinical trial of fosgonimeton enrolled 88 patients, with only 11 patients having mild-to-moderate Alzheimer's Disease (AD), showing some improvements in brain network activity [168]. - The company may initiate open-label trials for its product candidates, which could introduce biases affecting the interpretation of results [172]. - There is a high attrition rate for drug candidates in clinical trials, with many failing to demonstrate safety and efficacy despite earlier promising results [170]. - The company may face significant challenges in developing and commercializing drug candidates for CNS and PNS disorders, including regulatory approval and optimal dose selection [166]. - Clinical development is lengthy and expensive, with uncertain outcomes, and early studies may not predict results in larger trials [167]. Financial Position and Revenue Generation - The company anticipates no revenue from drug product sales for the next several years, if ever, as it has no approved drug products [159]. - The company reported that as of December 31, 2024, it had cash, cash equivalents, and investments totaling $51.3 million, which is expected to fund operations for at least the next 12 months [203]. - The company incurred net losses of $96.9 million and $117.7 million for the years ended December 31, 2024 and 2023, respectively, with an accumulated deficit of $406.1 million as of December 31, 2024 [208]. - The company has not generated any revenue from drug product sales and anticipates significant future expenses related to research and development, including clinical studies and manufacturing [210]. - The company has federal net operating loss carryforwards of approximately $196.0 million generated after the 2017 tax year, which will carry forward indefinitely but are subject to an 80% limitation of taxable income [219]. - The company recorded a full valuation allowance related to its net operating losses and other deferred tax assets due to uncertainty regarding future realizations [222]. - The company has financed its operations primarily through the sale of common stock and convertible notes, with limited income from grants and stock option exercises [209]. Regulatory Challenges and Compliance - The regulatory approval processes for the company's drug candidates are lengthy and unpredictable, potentially delaying commercialization and revenue generation [231]. - The company has not submitted for or obtained regulatory approval for any drug candidate, and it is possible that none will ever receive approval [233]. - The lengthy approval process and unpredictability of clinical trial results may result in failure to obtain regulatory approval for drug candidates, significantly harming the company's business and prospects [235]. - A small percentage of drugs in development successfully complete the FDA approval process, indicating high risks associated with regulatory approval [236]. - Regulatory authorities may approve drug candidates for fewer or more limited indications than requested, affecting commercialization strategies [235]. - Obtaining regulatory approval in one jurisdiction does not guarantee approval in others, leading to potential delays and increased costs [243]. - The FDA's ability to review and approve new products can be affected by various factors, including political changes and funding levels, which may disrupt normal operations [250]. - The company intends to seek FDA feedback before pursuing accelerated approval for drug candidates, with no assurance of successful submission or timely approval [253]. - Legislative changes, including the FDORA, have reformed the accelerated approval pathway, potentially impacting clinical development plans and regulatory approvals [254]. - The company faces potential legal and regulatory challenges related to healthcare fraud and abuse laws, which could expose it to penalties and reputational harm [267]. Strategic Partnerships and Competition - The company is actively seeking a partner for the development of ATH-1105 through joint collaboration agreements or non-dilutive funding [201]. - The company faces significant competition in the biotechnology and pharmaceutical industries, which could negatively impact its commercial opportunities [197]. - The company faces significant competition in establishing strategic partnerships, which may delay the development and commercialization of drug candidates [281]. - Collaborators may not commit sufficient resources to marketing and distribution, impacting the success of drug products [286]. - The company may need to obtain additional capital to fund development or commercialization activities if unable to secure partnerships [282]. Intellectual Property Risks - The company’s success depends on its ability to protect intellectual property, with uncertainties surrounding patent applications and potential challenges from competitors [325]. - The patent application process is fraught with risks, including the possibility of non-compliance leading to loss of patent rights and challenges to the validity of issued patents [329]. - The validity and enforceability of patents are uncertain, and pending applications may not result in effective patent protection for drug candidates [334]. - The risk of patent infringement claims from third parties is significant, which could lead to liability for damages and hinder commercialization efforts [344]. - The biopharmaceutical industry is subject to extensive litigation regarding patent rights, increasing the risk of infringement claims against the company [345]. Operational and Market Risks - The company may face increased expenses and operational risks associated with any strategic transaction, which could adversely affect its financial condition [228]. - The company may struggle to obtain sufficient product liability insurance, which could inhibit commercialization efforts [315]. - Uncertainty in insurance coverage and reimbursement for newly approved products could limit the company's ability to market drugs and generate revenue [316]. - Adequate coverage and reimbursement from governmental and private payors are critical for the acceptance of new products, and lack thereof could hinder commercialization [317]. - The company anticipates pricing pressures due to cost containment trends in the healthcare industry, which may impact demand and pricing for drug candidates [319]. - International marketing efforts may face additional risks, including differing regulatory requirements and economic instability in foreign markets [324].

Exhibit 99.1 Athira Pharma Reports Full Year 2024 Financial Results and Pipeline and Business Updates Completed healthy volunteer Phase 1 clinical study of ATH-1105 as a potential treatment for amyotrophic lateral sclerosis (ALS) On-track to enable dosing ALS patients in 2025 BOTHELL, Wash., February 27, 2025 – Athira Pharma, Inc. (NASDAQ: ATHA), a clinical stage biopharmaceutical company focused on developing small molecules to restore neuronal health and slow neurodegeneration, today reported financial re ...

Completed healthy volunteer Phase 1 clinical study of ATH-1105 as a potential treatment for amyotrophic lateral sclerosis (ALS) On-track to enable dosing ALS patients in 2025 BOTHELL, Wash., Feb. 27, 2025 (GLOBE NEWSWIRE) -- Athira Pharma, Inc. (NASDAQ: ATHA), a clinical stage biopharmaceutical company focused on developing small molecules to restore neuronal health and slow neurodegeneration, today reported financial results for the year ended December 31, 2024, and provided recent pipeline and business up ...

About this content About Angela Harmantas Angela Harmantas is an Editor at Proactive. She has over 15 years of experience covering the equity markets in North America, with a particular focus on junior resource stocks. Angela has reported from numerous countries around the world, including Canada, the US, Australia, Brazil, Ghana, and South Africa for leading trade publications. Previously, she worked in investor relations and led the foreign direct investment program in Canada for the Swedish government ...

About this content About Emily Jarvie Emily began her career as a political journalist for Australian Community Media in Hobart, Tasmania. After she relocated to Toronto, Canada, she reported on business, legal, and scientific developments in the emerging psychedelics sector before joining Proactive in 2022. She brings a strong journalism background with her work featured in newspapers, magazines, and digital publications across Australia, Europe, and North America, including The Examiner, The Advocate, ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ____ to ____ Commission File Number: 001-39503 Athira Pharma, Inc. (Exact name of registrant as specified in its charter) Delaware 45-3368487 (State or other jurisdict ...

Exhibit 99.1 Athira Pharma Reports Third Quarter 2024 Financial Results and Pipeline and Business Updates Expects to complete healthy volunteer Phase 1 clinical study of ATH-1105 by year end and begin dosing ALS patients in 2025 BOTHELL, Wash., November 7, 2024 – Athira Pharma, Inc. (NASDAQ: ATHA), a clinical-stage biopharmaceutical company focused on developing small molecules to restore neuronal health and slow neurodegeneration, today reported financial results for the quarter ended September 30, 2024, a ...

Clinical Development & Pipeline Programs - Athira Pharma is advancing ATH-1105, a next-generation, orally administered small molecule drug candidate, as a potential treatment for ALS and other neurodegenerative diseases [2][4] - ATH-1105 has shown preclinical efficacy in reducing plasma neurofilament light chain (NfL) levels, improving motor and nerve function, enhancing neuronal survival, and improving biomarkers of inflammation and neurodegeneration in ALS models [2] - The company is conducting a Phase 1 trial (NCT 06432647) in healthy volunteers to evaluate the safety, tolerability, and pharmacokinetics of ATH-1105, with completion expected by year-end 2024 and plans to dose ALS patients in 2025 [5] - Fosgonimeton (ATH-1017), a drug candidate for Alzheimer's disease, did not meet primary or key secondary endpoints in the LIFT-AD Phase 2/3 trial, though biomarker and subgroup data were directionally consistent with its neuroprotective mechanism [6] Financial Results - Cash, cash equivalents, and investments totaled $68.9 million as of September 30, 2024, down from $147.4 million as of December 31, 2023 [8] - Net cash used in operations was $71.2 million for the nine months ended September 30, 2024, compared to $74.5 million for the same period in 2023 [8] - R&D expenses decreased to $17.9 million for Q3 2024 from $27.2 million in Q3 2023, while G&A expenses remained stable at $7.6 million compared to $7.8 million in the prior year [8] - The company accrued $4.1 million in legal expenses related to a U.S. Department of Justice investigative demand [8] - Net loss for Q3 2024 was $28.7 million ($0.75 per share), compared to a net loss of $33.0 million ($0.87 per share) in Q3 2023 [8] Strategic Initiatives - Following the topline results of the LIFT-AD trial, Athira is exploring strategic alternatives to maximize stockholder value, including potential partnerships, while pausing further development of fosgonimeton [7] - The company has engaged Cantor Fitzgerald & Co. as an advisor in the process of exploring strategic alternatives [7] Company Overview - Athira Pharma is a clinical-stage biopharmaceutical company focused on developing small molecules to restore neuronal health and slow neurodegeneration by modulating the neurotrophic HGF system [9]

About this content About Emily Jarvie Emily began her career as a political journalist for Australian Community Media in Hobart, Tasmania. After she relocated to Toronto, Canada, she reported on business, legal, and scientific developments in the emerging psychedelics sector before joining Proactive in 2022. She brings a strong journalism background with her work featured in newspapers, magazines, and digital publications across Australia, Europe, and North America, including The Examiner, The Advocate, ...

About this content About Emily Jarvie Emily began her career as a political journalist for Australian Community Media in Hobart, Tasmania. After she relocated to Toronto, Canada, she reported on business, legal, and scientific developments in the emerging psychedelics sector before joining Proactive in 2022. She brings a strong journalism background with her work featured in newspapers, magazines, and digital publications across Australia, Europe, and North America, including The Examiner, The Advocate, ...