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]

Core Viewpoint - Anavex Life Sciences Corp. is advancing its clinical-stage biopharmaceutical portfolio focused on innovative treatments for neurodegenerative diseases, particularly Alzheimer's disease and schizophrenia, with recent positive developments in clinical trials and financial results for Q2 fiscal 2025 [1][2]. Recent Highlights - The company successfully completed enrollment in its Phase 2 clinical study of ANAVEX®3-71 for schizophrenia, with a total of 71 participants [5]. - Anavex presented open-label-extension data for blarcamesine at the AD/PD™ 2025 conference, confirming its clinical benefits for early Alzheimer's patients [2]. - The appointment of Professor Dr. Audrey Gabelle to the Scientific Advisory Board enhances the company's expertise in Alzheimer's disease [5]. Financial Highlights - Cash and cash equivalents decreased to $115.8 million as of March 31, 2025, from $132.2 million at the end of fiscal 2024, indicating a runway of approximately 4 years at current utilization rates [5]. - General and administrative expenses for Q2 were $2.6 million, down from $2.9 million in the same quarter of fiscal 2024 [5]. - Research and development expenses increased slightly to $9.9 million compared to $9.7 million in the prior year [5]. - The net loss for Q2 was $11.2 million, or $0.13 per share, compared to a net loss of $10.5 million, or $0.13 per share, for the same quarter in fiscal 2024 [5][10].

Core Insights - Alterity Therapeutics is set to present multiple clinical program findings related to ATH434 for Multiple System Atrophy (MSA) at the 2025 International MSA Congress in Boston, MA, from May 9 to 11, 2025 [1][2] - The company has received Fast Track Designation from the US FDA for ATH434, indicating significant interest in its clinical advancements [2][4] Company Overview - Alterity Therapeutics is a biotechnology company focused on developing disease-modifying treatments for neurodegenerative diseases, particularly MSA and Parkinson's disease [3][9] - The lead candidate, ATH434, is designed to inhibit the aggregation of pathological proteins and has shown preclinical efficacy in reducing α-synuclein pathology [3][4] Clinical Trial Details - The ATH434-201 Phase 2 clinical trial involved 77 adults and demonstrated statistically significant improvements in the modified Unified Multiple System Atrophy Rating Scale (UMSARS) Part I compared to placebo [5] - The trial also indicated that ATH434 stabilized or reduced iron accumulation in MSA-affected brain regions and was well tolerated with no serious adverse events attributed to the drug [5][4] Research Collaborations - The bioMUSE natural history study, conducted in collaboration with Vanderbilt University Medical Center, aims to track MSA progression and has enrolled approximately 20 individuals [6] - This study provides valuable data for optimizing clinical trial designs and evaluating biomarkers for target engagement and efficacy [6] Disease Context - MSA is a rare, rapidly progressive neurodegenerative disease affecting at least 15,000 individuals in the U.S., characterized by autonomic dysfunction and impaired movement [7] - Currently, there are no approved therapies that can slow the progression of MSA, highlighting the significance of Alterity's efforts in this area [7]

Core Viewpoint - Clene Inc. is focused on advancing its CNM-Au8 programs for treating neurodegenerative diseases, particularly ALS and MS, with plans for potential NDA submissions and ongoing clinical evaluations [2][3][6]. Financial Results - As of March 31, 2025, Clene reported cash and cash equivalents of $9.8 million, down from $12.2 million as of December 31, 2024, indicating a cash runway into the third quarter of 2025 [8]. - Research and development expenses for Q1 2025 were $1.5 million, significantly lower than $5.9 million for the same period in 2024, primarily due to grant revenue from the NIH-funded ALS EAP [9]. - General and administrative expenses decreased to $2.7 million in Q1 2025 from $3.4 million in Q1 2024, attributed to lower public relations and personnel costs [10]. - Clene reported a net loss of $0.8 million, or $0.09 per share, for Q1 2025, a substantial improvement from a net loss of $11.1 million, or $1.73 per share, in Q1 2024 [12]. CNM-Au8 Program Updates - Clene is preparing for a meeting with the FDA in Q2 2025 to finalize its statistical analysis plan for NfL biomarker data, with analysis scheduled for Q3 2025 to support the NDA submission for ALS [3][6]. - New analyses from the HEALEY ALS Platform Trial indicated a survival improvement of 4.1 months for patients receiving CNM-Au8 compared to a control group, with significant benefits observed in patients with severe ALS [4]. - Clene presented evidence of remyelination and neuronal repair associated with CNM-Au8 treatment at the AAN 2025 Annual Meeting, highlighting improvements in cognition and visual function [5][7]. Company Overview - Clene Inc. is a late clinical-stage biopharmaceutical company focused on treating neurodegenerative diseases through its investigational therapy CNM-Au8, which targets mitochondrial function and reduces oxidative stress [13][14].

Core Viewpoint - Anavex Life Sciences Corp. is set to release its financial results for the second fiscal quarter on May 13, 2025, and will host a conference call to discuss these results and the company's growth strategy [1][2]. Company Overview - Anavex Life Sciences Corp. is a clinical-stage biopharmaceutical company focused on developing innovative treatments for various CNS disorders, including Alzheimer's disease, Parkinson's disease, schizophrenia, and Rett syndrome [1][4]. - The company's lead drug candidate, ANAVEX2-73 (blarcamesine), has completed multiple clinical trials for Alzheimer's disease and is also being studied for Parkinson's disease dementia and Rett syndrome [4]. - ANAVEX2-73 is designed to restore cellular homeostasis by targeting SIGMAR1 and muscarinic receptors, with preclinical studies indicating its potential to halt or reverse Alzheimer's disease progression [4]. - Another promising drug candidate, ANAVEX3-71, targets SIGMAR1 and M1 muscarinic receptors and has shown beneficial effects in preclinical trials related to Alzheimer's disease [4]. Conference Call Details - The conference call will take place on May 13, 2025, at 8:30 am ET, and will include a question-and-answer session following management's remarks [2][3]. - Participants can access the call via a live webcast on Anavex's website or by dialing a specific number for U.S. participants [3].

Core Viewpoint - Alterity Therapeutics reported significant progress in its clinical trials for ATH434, a treatment for Multiple System Atrophy (MSA), highlighting its potential to change the treatment landscape for this condition [3][8]. Financial Summary - As of March 31, 2025, Alterity's cash position was A$17.96 million, with operating cash outflows of A$0.73 million for the quarter [4]. - The company raised approximately A$15.0 million during the period and an additional A$27.1 million after the quarter ended [11]. Clinical Trial Updates - The ATH434-201 Phase 2 trial demonstrated a 48% relative treatment effect at the 50 mg dose and a 30% effect at the 75 mg dose, indicating significant efficacy in reducing disease severity compared to placebo [7]. - The ATH434-202 open-label trial in advanced MSA was completed, with topline data expected to be reported mid-year 2025 [10]. Operational Activities - The ATH434-201 trial involved 77 participants and utilized wearable sensors to assess outpatient activity levels, showing clinically meaningful improvements in various metrics [6][9]. - The company plans to engage with regulatory authorities to advance ATH434's development for MSA [3]. Corporate Activities - Alterity received a refund of A$1.65 million from the Australian Taxation Office under the Research and Development Tax Incentive Scheme for eligible activities conducted in the financial year ending June 30, 2020 [11].

Company Overview - Anavex Life Sciences Corp. is a clinical-stage biopharmaceutical company focused on developing innovative treatments for Alzheimer's disease, Parkinson's disease, schizophrenia, neurodevelopmental, neurodegenerative, and rare diseases, including Rett syndrome [1][2] - The company's lead drug candidate, ANAVEX2-73 (blarcamesine), has completed multiple clinical trials for Alzheimer's disease and has shown potential in treating other CNS disorders [2] Clinical Development - ANAVEX2-73 has successfully completed a Phase 2a and a Phase 2b/3 clinical trial for Alzheimer's disease, a Phase 2 proof-of-concept study in Parkinson's disease dementia, and studies in adult and pediatric patients with Rett syndrome [2] - The drug candidate is designed to restore cellular homeostasis by targeting SIGMAR1 and muscarinic receptors, with preclinical studies indicating its potential to halt or reverse Alzheimer's disease [2] Upcoming Events - Anavex will present at The Citizens Life Sciences Conference in New York on May 7-8, 2025, with a scheduled presentation by CEO Christopher U Missling at 3:30 PM (ET) on May 7 [1]

As filed with the Securities and Exchange Commission on May 20, 2024. Registration No. 333-279324 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 AMENDMENT NO. 1 FORM F-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 NeuroSense Therapeutics Ltd. (Exact Name of Registrant as Specified in Its Charter) Not Applicable (Translation of Registrant's name into English) State of Israel 2834 Not Applicable (State or Other Jurisdiction of Incorporation or Organization) (Primary Standa ...

As filed with the Securities and Exchange Commission on May 10, 2024. Registration No. 333- UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM F-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 NeuroSense Therapeutics Ltd. (Exact Name of Registrant as Specified in Its Charter) Not Applicable (Translation of Registrant's name into English) (State or Other Jurisdiction of Incorporation or Organization) State of Israel 2834 Not Applicable (Primary Standard Industrial Classifi ...

| State of Israel | 2834 | Not Applicable | | --- | --- | --- | | (State or Other Jurisdiction of | (Primary Standard Industrial | (I.R.S. Employer | | Incorporation or Organization) | Classification Code Number) | Identification Number) | As filed with the Securities and Exchange Commission on July 21, 2023. Registration No. 333- UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM F-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 NeuroSense Therapeutics Ltd. (Exact Name o ...