Athira Pharma(ATHA) - 2025 Q2 - Quarterly Results

Introduction and Second Quarter 2025 Business Update Athira Pharma reported Q2 2025 financial results and pipeline updates, highlighting encouraging ATH-1105 Phase 1 data and ongoing strategic alternatives exploration Overview of Q2 2025 Results and Strategic Direction Athira Pharma reported its financial results for the second quarter ended June 30, 2025, alongside updates on its pipeline and business, highlighting encouraging Phase 1 data for ATH-1105 and its ongoing exploration of strategic alternatives to maximize stockholder value - Athira Pharma reported financial results for the quarter ended June 30, 2025, and provided recent pipeline and business updates[1] - CEO Mark Litton expressed satisfaction with the progress of ATH-1105 as a potential therapy for ALS, citing encouraging first-in-human safety and pharmacokinetic data from its Phase 1 clinical trial[2] - The company has substantially completed preparation activities for a future clinical trial of ATH-1105 in people living with ALS, subject to continued exploration of strategic alternatives focused on maximizing stockholder value[2] Clinical Development & Pipeline Programs This section details the clinical progress of ATH-1105, including positive Phase 1 data, and the discontinuation of fosgonimeton development after LIFT-AD trial failures ATH-1105 Development Update ATH-1105, a novel small molecule designed to modulate the HGF system, is in clinical development for ALS, with its Phase 1 trial demonstrating a favorable safety and tolerability profile, dose-proportional pharmacokinetics, and CNS penetration, supported by robust preclinical evidence - ATH-1105 is a novel, orally available, brain-penetrant, next-generation small molecule drug candidate designed to positively modulate the neurotrophic HGF system for potential treatment of neurodegenerative diseases, including ALS[4] - Data from the first-in-human Phase 1 clinical trial (completed November 2024) showed a favorable safety profile, was well tolerated in healthy volunteers, and demonstrated dose proportional pharmacokinetics and central nervous system (CNS) penetration[4][7] - Preclinical evidence supports ATH-1105's potential, demonstrating statistically significant improvements in nerve and motor function, biomarkers of inflammation and neurodegeneration, and survival in various models of ALS[7] Fosgonimeton (ATH-1017) Development Update The LIFT-AD Phase 2/3 clinical trial of fosgonimeton in mild-to-moderate Alzheimer's disease did not meet its primary or key secondary endpoints, leading to a pause in its further development - In September 2024, Athira announced topline results from the LIFT-AD Phase 2/3 clinical trial of fosgonimeton in mild-to-moderate Alzheimer's disease, which did not meet its primary or key secondary endpoints[5] - Biomarker and subgroup data from the LIFT-AD study were directionally consistent with the broad neuroprotective mechanism of action[5] - Following the LIFT-AD results, Athira paused further development of fosgonimeton, including the related open label extension clinical trial[8] Exploration of Strategic Alternatives Following LIFT-AD trial results, Athira initiated a strategic review to maximize stockholder value, engaging Cantor Fitzgerald & Co. as an advisor Strategic Review and Advisor Engagement Following the topline results of the LIFT-AD trial, Athira initiated an exploration of strategic alternatives aimed at maximizing stockholder value and engaged Cantor Fitzgerald & Co. as an advisor for this process - Following Athira's receipt of the topline results of LIFT-AD, the company made the determination to explore strategic alternatives focused on maximizing stockholder value[8] - Athira engaged Cantor Fitzgerald & Co. to act as an advisor in this process[8] - Further development of fosgonimeton, including the related open label extension clinical trial, was paused while continuing the development of ATH-1105 and exploring partnering options[8] Second Quarter 2025 Financial Results Athira's Q2 2025 financial results show a reduced net loss due to decreased R&D and G&A expenses, alongside a decline in cash and investments Key Financial Highlights (Q2 2025) Athira reported a significant reduction in net loss for Q2 2025 compared to Q2 2024, primarily due to substantial decreases in R&D and G&A expenses, while the company's cash position decreased from the end of 2024 Cash, cash equivalents and investments (millions) | Metric | June 30, 2025 | December 31, 2024 | | :-------------------------------- | :-------------- | :---------------- | | Cash, cash equivalents and investments | $29.8 million | $51.3 million | Expense Category (millions) | Expense Category | Q2 2025 | Q2 2024 | YoY Change | | :------------------------ | :------ | :------ | :--------- | | Research and Development | $3.7 million | $22.2 million | -83.3% | | General and Administrative | $3.6 million | $5.9 million | -38.9% | Net Loss (millions) | Metric | Q2 2025 | Q2 2024 | YoY Change | | :------------------------ | :------ | :------ | :--------- | | Net Loss | $7.0 million | $26.9 million | -74.0% | | Net Loss per Share | $0.18 | $0.70 | -74.3% | - Net cash used in operations was $21.7 million for the six months ended June 30, 2025, compared to $48.1 million for the six months ended June 30, 2024[8] Condensed Consolidated Balance Sheets As of June 30, 2025, Athira's total assets were $35.5 million, a decrease from $58.8 million at December 31, 2024, primarily driven by a reduction in cash and cash equivalents, with total liabilities also decreasing significantly Balance Sheet Items (thousands) | Balance Sheet Item | June 30, 2025 (unaudited, thousands) | December 31, 2024 (thousands) | | :-------------------------------- | :------------------------ | :---------------- | | Cash and cash equivalents | $19,888 | $48,438 | | Short-term investments | $9,935 | $2,837 | | Other short-term assets | $2,395 | $3,566 | | Other long-term assets | $3,327 | $3,938 | | Total assets | $35,545 | $58,779 | | Current liabilities | $2,981 | $13,135 | | Long-term liabilities | $578 | $803 | | Total liabilities | $3,559 | $13,938 | | Stockholders' equity | $31,986 | $44,841 | | Total liabilities and stockholders' equity | $35,545 | $58,779 | Condensed Consolidated Statements of Operations and Comprehensive Loss For the three months ended June 30, 2025, Athira reported a net loss of $7.0 million, or $0.18 per share, a substantial improvement from a net loss of $26.9 million, or $0.70 per share, in the prior year period, primarily due to reduced operating expenses Operating Expenses and Loss (Three Months Ended June 30, thousands) | Operating Expenses (Three Months Ended June 30,) | 2025 (thousands) | 2024 (thousands) | | :----------------------------------------------- | :--------------- | :--------------- | | Research and development | $3,661 | $22,154 | | General and administrative | $3,630 | $5,874 | | Total operating expenses | $7,291 | $28,028 | | Loss from operations | $(7,291) | $(28,028) | | Other income, net | $325 | $1,169 | | Net loss | $(6,966) | $(26,859) | | Unrealized (loss) gain on available-for-sale securities | $1 | $99 | | Comprehensive loss attributable to common stockholders | $(6,965) | $(26,760) | | Net loss per share attributable to common stockholders, basic and diluted | $(0.18) | $(0.70) | | Weighted-average shares used in computing net loss per share attributable to common stockholders, basic and diluted | 39,092,961 | 38,379,733 | About Athira Pharma, Inc. Athira Pharma is a clinical-stage biopharmaceutical company focused on developing small molecules to restore neuronal health and slow neurodegeneration Company Overview and Mission Athira Pharma is a clinical-stage biopharmaceutical company based in the Seattle area, dedicated to developing small molecules that restore neuronal health and slow neurodegeneration by modulating the neurotrophic HGF system - Athira Pharma, Inc. is a clinical-stage biopharmaceutical company focused on developing small molecules to restore neuronal health and slow neurodegeneration[7] - The company aims to alter the course of neurological diseases by advancing drug candidates that modulate the neurotrophic HGF system[3][9] Forward-Looking Statements This section contains cautionary forward-looking statements regarding Athira's drug candidates and future plans, subject to various clinical, regulatory, and financial risks Disclaimer and Risk Factors This section serves as a cautionary statement, indicating that the communication contains forward-looking statements subject to various risks and uncertainties, which could cause actual results to differ materially from expectations - This communication contains 'forward-looking statements' regarding Athira's drug candidates, future development plans, potential efficacy, commercial potential, and exploration of strategic alternatives[10] - These statements are based on management's current expectations and are subject to numerous risks and uncertainties, including that data from preclinical and clinical trials may not support safety, efficacy, and tolerability; development may cease or be delayed; and regulatory authorities could object to submissions[10] - Other risks include potential negative interactions with other treatments, FDA regulatory delays, financial condition assumptions being incorrect, adverse economic conditions, competition, and risks related to strategic alternatives[10] Investor & Media Contact This section provides contact information for investor and media inquiries, listing Julie Rathbun from Athira Pharma Contact Information This section provides the contact details for investor and media inquiries, listing Julie Rathbun from Athira Pharma - Contact information for investor and media inquiries is provided, listing Julie Rathbun from Athira Pharma[11]