Core Insights - A major new discovery has been made within the Mineralized RIB Corridor (MRC), specifically the RIB North Discovery, located approximately 1.4 km from the nearest drillhole at the RIB East Discovery [1] - The first drillhole at RIB North, RIBN-DD-001, has yielded the most robust mineralized intersection to date within the MRC and is considered one of the most significant intersections within the Angilak Uranium Project [1] - Drillhole RIBN-DD-001 intersected a total of 26.3 meters of composite uranium mineralization, including 1.9 meters of high-grade mineralization, across over 10 zones from 345.55 meters to 460.05 meters [1] - The hole featured 13.6 meters of continuous mineralization from 426.25 meters to 439.85 meters, which included 1.7 meters of high-grade mineralization with a maximum radioactivity of 55,730 counts per second (CPS) [1] - Mineralization was initially encountered directly above the unconformity at 356.7 meters, extending into graphitic basement rock [1]

Core Insights - ATHA has successfully closed a previously announced CAD $11.5 million over-subscribed bought deal [1] - The first two drill holes at the RIB West Discovery have intersected uranium mineralization over a strike length of approximately 340 meters [1] - This marks the third new discovery of uranium mineralization during the 2025 Angilak Exploration Program within the Angikuni Basin [1] - The RIB East Discovery is defined by eight mineralized drill holes, indicating shallow uranium mineralization across 7 million acres [1] - ATHA holds a 10% carried interest in key exploration projects in the Athabasca Basin operated by NexGen Energy Ltd [1]

Core Points - Athira Pharma, Inc. is a clinical-stage biopharmaceutical company focused on therapies for neurodegenerative diseases [1] - A reverse stock split will occur on September 18, 2025, consolidating shares at a ratio of 1-for-10, approved by stockholders [1][2] - The reverse stock split aims to enhance the stock's marketability and potentially attract more investors [1][4] Stock Performance - Currently, ATHA's stock is priced at $0.38, with a slight increase of 0.29% or $0.0011 [3] - The stock has shown volatility, with a low of $0.35 and a high of $0.40 on the current trading day [3] - Over the past year, ATHA's stock has fluctuated between a high of $0.83 and a low of $0.22 [3] Market Capitalization and Trading Volume - Athira Pharma's market capitalization is approximately $15.1 million [4] - The trading volume on the NASDAQ exchange is 586,605 shares [4] - The reverse stock split may reduce the number of shares outstanding, potentially increasing the stock price [4]

Core Viewpoint - Athira Pharma, Inc. will implement a 10-for-1 reverse stock split to comply with Nasdaq's minimum bid price requirement and enhance the marketability and liquidity of its common stock [1][2][3]. Group 1: Reverse Stock Split Details - The reverse stock split will take effect on September 17, 2025, at 5:00 p.m. Eastern Time, with trading on a split-adjusted basis starting on September 18, 2025 [2]. - Every ten shares of Athira's common stock will be combined into one share, reducing the total number of authorized shares from 900 million to 90 million [3]. - The par value per share will remain unchanged at $0.0001, and adjustments will be made to outstanding options and restricted stock units [3]. Group 2: Impact and Purpose - The reverse stock split aims to increase the share price to meet the $1.00 minimum bid price requirement for continued listing on Nasdaq [2]. - The company anticipates that the split will improve the marketability and liquidity of its common stock, potentially attracting a broader range of investors [2][3]. Group 3: Administrative Aspects - Computershare Inc. will act as the exchange agent for the reverse stock split, and registered stockholders will not need to take action to receive post-split shares [4]. - Stockholders holding shares in brokerage accounts will have their positions automatically adjusted to reflect the reverse stock split [4].

Core Points - ATHA Energy Corp. has issued a news release to clarify certain disclosures following a review by the British Columbia Securities Commission [1] - The company has filed an updated technical report regarding its CMB property located in Newfoundland and Labrador, Canada [1] - The technical report is dated July 8, 2025, and is effective as of June 14, 2025, titled "NI 43-101 Technical Report, Central Mineral Belt Property, Newfoundland and Labrador, Canada" prepared by Stefan Kruse, Ph.D. [1]

Core Insights - Athira Pharma, Inc. presented results from its Phase 1 clinical trial of ATH-1105 at the ALS Nexus 2025 conference, focusing on developing treatments for neurodegenerative diseases like ALS [1][3] - ATH-1105 is a novel, orally available small molecule designed to modulate the neurotrophic HGF system, potentially offering new treatment options for ALS [2][3] Group 1: Clinical Trial Results - The Phase 1 trial of ATH-1105 involved 80 healthy volunteers and evaluated the safety, tolerability, and pharmacokinetics of the drug, showing a favorable safety profile and good tolerability [5] - Results indicated dose-proportional pharmacokinetics and CNS penetration, supporting the continued development of ATH-1105 [3][5] Group 2: Company Overview - Athira Pharma is a clinical-stage biopharmaceutical company based in the Seattle area, focused on developing small molecules to restore neuronal health and slow neurodegeneration [6] - The company aims to alter the course of neurological diseases through its pipeline of drug candidates targeting the neurotrophic HGF system [6]

Core Viewpoint - Athira Pharma reported zero revenue for Q2 2025, focusing on cost containment and strategic pipeline refocus, particularly on its lead candidate ATH-1105 for ALS trials [1][5][10] Financial Performance - EPS (GAAP) for Q2 2025 was $(0.18), an improvement of 74.3% from $(0.70) in Q2 2024 [2] - Research and Development Expenses decreased to $3.7 million, down 83.4% from $22.2 million in Q2 2024 [2][5] - General and Administrative Expenses were reduced to $3.6 million, a 38.8% decrease from $5.9 million in Q2 2024 [2][5] - Net Loss for the quarter was $7.0 million, significantly lower than the $26.9 million loss in Q2 2024, marking a 74.0% reduction [2][5] - Cash reserves stood at $29.8 million as of June 30, 2025, down from $51.3 million at the end of 2024 [6] Strategic Focus - Athira Pharma is concentrating its efforts on ATH-1105, a candidate targeting the HGF pathway to address ALS, following the halt of its previous Alzheimer's candidate, fosgonimeton [3][4][9] - The company completed a Phase 1 clinical trial for ATH-1105, demonstrating a favorable safety profile and the ability to cross the blood-brain barrier [7][10] - Management is exploring strategic alternatives, including potential licensing deals or partnerships, to maximize shareholder value [8][10] Operational Outlook - The company has not provided forward financial or trial guidance for the remainder of 2025 or 2026, creating uncertainty for shareholders [11] - The focus on a single program (ATH-1105) necessitates successful clinical development and securing external partnerships to ensure future funding and operational viability [10]

[PART I. FINANCIAL INFORMATION](index=6&type=section&id=PART%20I.%20FINANCIAL%20INFORMATION) [Item 1. Financial Statements (Unaudited)](index=6&type=section&id=Item%201.%20Financial%20Statements%20(Unaudited)) This section presents the unaudited condensed consolidated financial statements, including balance sheets, statements of operations, equity, and cash flows, along with notes, reflecting significant losses and decreased cash and investments [Condensed Consolidated Balance Sheets](index=6&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) Condensed Consolidated Balance Sheets (in thousands) | Metric (in thousands) | June 30, 2025 | December 31, 2024 | | :-------------------- | :------------ | :---------------- | | Cash and cash equivalents | $19,888 | $48,438 | | Short-term investments | $9,935 | $2,837 | | Total current assets | $32,218 | $54,841 | | Total assets | $35,545 | $58,779 | | Total current liabilities | $2,981 | $13,135 | | Total liabilities | $3,559 | $13,938 | | Total stockholders' equity | $31,986 | $44,841 | - Total assets decreased from **$58.8 million** at December 31, 2024, to **$35.5 million** at June 30, 2025, primarily due to a significant reduction in cash and cash equivalents[13](index=13&type=chunk) - Total liabilities decreased from **$13.9 million** to **$3.6 million**, mainly driven by a decrease in accrued liabilities[13](index=13&type=chunk) [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) Condensed Consolidated Statements of Operations and Comprehensive Loss (in thousands) | Metric (in thousands) | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :-------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Research and development | $3,661 | $22,154 | $7,963 | $43,390 | | General and administrative | $3,630 | $5,874 | $8,864 | $12,325 | | Total operating expenses | $7,291 | $28,028 | $16,827 | $55,715 | | Net loss | $(6,966) | $(26,859) | $(16,109) | $(53,196) | | Net loss per share (basic and diluted) | $(0.18) | $(0.70) | $(0.41) | $(1.39) | - Net loss significantly decreased by **74%** for the three months ended June 30, 2025, to **$6.966 million** from **$26.859 million** in the prior year, and by **70%** for the six months ended June 30, 2025, to **$16.109 million** from **$53.196 million**[15](index=15&type=chunk) - Research and development expenses decreased by **83%** for the three months and **82%** for the six months, primarily due to pausing the fosgonimeton program and reduced personnel-related costs[15](index=15&type=chunk) [Condensed Consolidated Statements of Stockholders' Equity](index=8&type=section&id=Condensed%20Consolidated%20Statements%20of%20Stockholders'%20Equity) Condensed Consolidated Statements of Stockholders' Equity (in thousands) | Metric (in thousands) | Balance as of Jan 1, 2025 | Balance as of June 30, 2025 | | :-------------------- | :------------------------ | :-------------------------- | | Common Stock Shares | 39,040,945 | 39,439,326 | | Additional Paid-In Capital | $450,982 | $454,240 |\ | Accumulated Deficit | $(406,146) | $(422,255) | | Total Stockholders' Equity | $44,841 | $31,986 | - Total stockholders' equity decreased from **$44.841 million** at January 1, 2025, to **$31.986 million** at June 30, 2025, primarily due to net losses[18](index=18&type=chunk) - Issuance of common stock upon vesting of restricted stock units and under the employee stock purchase plan contributed to an increase in common stock shares and additional paid-in capital[18](index=18&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=9&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Condensed Consolidated Statements of Cash Flows (in thousands) | Cash Flow Activity (in thousands) | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :-------------------------------- | :----------------------------- | :----------------------------- |\ | Net cash used in operating activities | $(21,664) | $(48,134) | | Net cash (used in) provided by investing activities | $(6,910) | $39,603 | | Net cash provided by financing activities | $24 | $148 | | Net decrease in cash, cash equivalents and restricted cash | $(28,550) | $(8,383) | | Cash, cash equivalents and restricted cash, end of period | $20,519 | $82,832 | - Net cash used in operating activities decreased significantly from **$48.1 million** in H1 2024 to **$21.7 million** in H1 2025, primarily due to a reduced net loss and changes in operating assets and liabilities[20](index=20&type=chunk)[129](index=129&type=chunk)[130](index=130&type=chunk) - Investing activities shifted from providing **$39.6 million** in H1 2024 to using **$6.9 million** in H1 2025, mainly due to changes in purchases and maturities of available-for-sale securities[20](index=20&type=chunk)[131](index=131&type=chunk)[132](index=132&type=chunk) [Notes to Unaudited Condensed Consolidated Financial Statements](index=10&type=section&id=Notes%20to%20Unaudited%20Condensed%20Consolidated%20Financial%20Statements) [1. Description of Business](index=10&type=section&id=1.%20Description%20of%20Business) Athira Pharma is a clinical-stage biopharmaceutical company focused on developing small molecules to restore neuronal health and slow neurodegeneration - Athira Pharma, Inc. is a clinical-stage biopharmaceutical company focused on developing small molecules to restore neuronal health and slow neurodegeneration[22](index=22&type=chunk) - The company has funded operations primarily through equity sales, raising **$407.4 million** net cash proceeds since inception through June 30, 2025[23](index=23&type=chunk)[99](index=99&type=chunk) - As of June 30, 2025, cash, cash equivalents, and investments totaled **$29.8 million**, estimated to fund operations for at least the next 12 months[24](index=24&type=chunk)[25](index=25&type=chunk)[101](index=101&type=chunk) [2. Significant Accounting Policies](index=10&type=section&id=2.%20Significant%20Accounting%20Policies) This section details the company's significant accounting policies, including financial statement preparation, restricted cash, R&D costs, and recent accounting pronouncement adoption - Financial statements are prepared in conformity with U.S. GAAP and include operations of its wholly-owned Australian subsidiary[26](index=26&type=chunk) - Restricted cash of **$631 thousand** at June 30, 2025, and December 31, 2024, serves as collateral for corporate credit cards[30](index=30&type=chunk)[31](index=31&type=chunk) - Research and development costs are expensed as incurred, including direct and indirect costs for drug discovery and development[35](index=35&type=chunk)[38](index=38&type=chunk) - The company adopted ASU 2023-09, Income Taxes (Topic 740) - Improvements to Income Tax Disclosures, in fiscal year 2025, with no material impact expected[50](index=50&type=chunk) [3. Fair Value](index=16&type=section&id=3.%20Fair%20Value) This section outlines the fair value measurements of financial assets, primarily consisting of Level 1 and Level 2 instruments Financial Assets Measured at Fair Value (in thousands) | Financial Asset (in thousands) | Level | June 30, 2025 Fair Value | December 31, 2024 Fair Value | | :----------------------------- | :---- | :----------------------- | :--------------------------- | | Money market fund | 1 | $31 | $30 | | U.S. government debt and agency securities | 2 | $2,584 | $10,299 | | Commercial paper | 2 | $11,692 | $19,393 | | Total cash equivalents | | $14,307 | $29,722 | | Short-term investments: Commercial paper | 2 | $500 | $1

[Introduction and Second Quarter 2025 Business Update](index=1&type=section&id=Introduction%20and%20Second%20Quarter%202025%20Business%20Update) 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](index=1&type=section&id=Overview%20of%20Q2%202025%20Results%20and%20Strategic%20Direction) 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](index=1&type=chunk) - 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](index=2&type=chunk) - 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](index=2&type=chunk) [Clinical Development & Pipeline Programs](index=1&type=section&id=Clinical%20Development%20%26%20Pipeline%20Programs) 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](index=1&type=section&id=ATH-1105%20Development%20Update) 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](index=4&type=chunk) - 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](index=4&type=chunk)[7](index=7&type=chunk) - 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](index=7&type=chunk) [Fosgonimeton (ATH-1017) Development Update](index=2&type=section&id=Fosgonimeton%20(ATH-1017)%20Development%20Update) 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](index=5&type=chunk) - Biomarker and subgroup data from the **LIFT-AD study** were **directionally consistent** with the broad neuroprotective mechanism of action[5](index=5&type=chunk) - Following the **LIFT-AD results**, Athira **paused further development of fosgonimeton**, including the related open label extension clinical trial[8](index=8&type=chunk) [Exploration of Strategic Alternatives](index=2&type=section&id=Exploration%20of%20Strategic%20Alternatives) 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](index=2&type=section&id=Strategic%20Review%20and%20Advisor%20Engagement) 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](index=8&type=chunk) - Athira engaged **Cantor Fitzgerald & Co.** to act as an advisor in this process[8](index=8&type=chunk) - 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](index=8&type=chunk) [Second Quarter 2025 Financial Results](index=2&type=section&id=Financial%20Results) 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)](index=2&type=section&id=Key%20Financial%20Highlights%20(Q2%202025)) 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](index=8&type=chunk) [Condensed Consolidated Balance Sheets](index=5&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) 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](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) 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.](index=2&type=section&id=About%20Athira%20Pharma%2C%20Inc.) Athira Pharma is a clinical-stage biopharmaceutical company focused on developing small molecules to restore neuronal health and slow neurodegeneration [Company Overview and Mission](index=2&type=section&id=Company%20Overview%20and%20Mission) 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](index=7&type=chunk) - The company aims to alter the course of neurological diseases by advancing drug candidates that modulate the neurotrophic **HGF system**[3](index=3&type=chunk)[9](index=9&type=chunk) [Forward-Looking Statements](index=3&type=section&id=Forward-Looking%20Statements) 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](index=3&type=section&id=Disclaimer%20and%20Risk%20Factors) 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](index=10&type=chunk) - 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](index=10&type=chunk) - 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](index=10&type=chunk) [Investor & Media Contact](index=4&type=section&id=Investor%20%26%20Media%20Contact) This section provides contact information for investor and media inquiries, listing Julie Rathbun from Athira Pharma [Contact Information](index=4&type=section&id=Contact%20Information) 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](index=11&type=chunk)

Core Insights - Athira Pharma, Inc. announced favorable results from a Phase 1 clinical trial of ATH-1105, indicating a good safety and tolerability profile, which supports its continued development for treating ALS [1][5][3] - The company is on track to initiate a clinical trial in ALS patients by late 2025 [1][3] Group 1: ATH-1105 Overview - ATH-1105 is a novel, orally available small molecule designed to modulate the neurotrophic HGF system for potential treatment of neurodegenerative diseases, including ALS [2] - The Phase 1 trial involved 80 healthy volunteers and evaluated both single and multiple ascending doses of ATH-1105, completed in November 2024 [5] Group 2: Clinical Trial Results - The Phase 1 trial demonstrated a favorable safety profile and good tolerability in healthy volunteers, supporting further clinical development [5][7] - Data from the trial showed dose proportional pharmacokinetics and CNS penetration, reinforcing the drug's potential for ALS treatment [7][8] Group 3: Future Development Plans - The company plans to present data at the 4th Annual ALS Drug Development Summit, highlighting ATH-1105's effects on ALS validated biomarkers [1][3] - Preclinical evidence supports ATH-1105's potential, showing significant improvements in nerve and motor function, inflammation biomarkers, and survival in ALS models [4]