Core Viewpoint - CervoMed Inc. has announced that its investigational drug neflamapimod has been included in the EXPERTS-ALS platform for rapid testing in amyotrophic lateral sclerosis (ALS), with the first patient expected to be dosed by the end of 2026 [1][4] Group 1: Neflamapimod and Its Mechanism - Neflamapimod is an oral small molecule drug candidate that targets critical disease processes underlying neurodegenerative disorders by selectively inhibiting p38 MAP kinase, a key driver of neuroinflammation [6][11] - The drug has shown positive clinical activity in dementia with Lewy bodies, demonstrating a potent effect on blood biomarkers of neurodegeneration [3][8] - Neflamapimod is currently in clinical development for multiple indications, including dementia with Lewy bodies, recovery after ischemic stroke, and primary progressive aphasia [7][11] Group 2: EXPERTS-ALS Platform - EXPERTS-ALS is a UK-based platform designed to rapidly evaluate potential therapies for ALS through a randomized, multicenter trial that measures neurofilament light chain (NfL) levels, which correlate with disease progression [2][9] - The initial evaluation of neflamapimod will involve approximately 35 ALS participants over 18-24 weeks, with the potential to expand to a total of 80 patients [2] - The platform is funded by the UK National Institute for Health and Care Research and supported by various motor neuron disease charities [2][9] Group 3: Clinical Trial Insights - Previous clinical trials of neflamapimod have involved over 800 participants, showing it to be generally well tolerated and effective in improving dementia severity and functional mobility in patients with dementia with Lewy bodies [8] - The Phase 2a AscenD-LB trial and Phase 2b RewinD-LB trial provided evidence of neflamapimod's potential clinical benefits, particularly in patients without Alzheimer's disease co-pathology [8] Group 4: ALS Overview - Amyotrophic lateral sclerosis (ALS) is a progressive neurodegenerative disease affecting approximately 168,000 people worldwide, with no approved therapies to stop or reverse its progression [5]

Core Insights - Harness Therapeutics has nominated HRN001 as its lead drug candidate for Huntington's disease, aiming for first-in-human studies in 2027 [1][5] - The company has formed a Clinical Advisory Board (CAB) to provide strategic guidance for the clinical development of HRN001 [6][8] - Dr. Andy Billinton, the Chief Scientific Officer, will present preclinical data at the CHDI Foundation Huntington's Disease Therapeutics Conference [7] Company Overview - Harness Therapeutics is a biotechnology company focused on addressing previously undruggable targets to transform treatments for neurodegenerative diseases [20] - The company utilizes its proprietary MISBA® platform technology to enable precise upregulation of target protein levels, which is crucial for developing disease-modifying therapies [20][21] - The company is based in Cambridge, UK, and has attracted leading life science investors, including Takeda Ventures and SV Health Investors' Dementia Discovery Fund [22] Product Development - HRN001 is an antisense oligonucleotide designed to upregulate FAN1, a key DNA repair nuclease, which has shown promise in slowing somatic expansion in Huntington's disease models [4][5] - Preclinical development of HRN001 will continue throughout 2026, with the goal of supporting clinical entry in 2027 [5] - The MISBA® platform is also being explored for other triplet repeat disorders and a broader pipeline of neurodegenerative diseases [5] Clinical Advisory Board - The CAB consists of leading experts in Huntington's disease, including Dr. Irina Antonijevic, Dr. Anne Rosser, and Dr. Jeffrey Long, among others [9][10] - The CAB will provide strategic guidance on clinical development, trial design, and translational strategy as the program advances [6][10] Scientific Rationale - Huntington's disease is caused by the expansion of CAG repeats in the huntingtin gene, with ongoing somatic expansion recognized as a key driver of disease progression [2][3] - FAN1 has emerged as a compelling target for suppressing somatic expansion, demonstrating a strong genetic association with disease onset [3][10]

Hangzhou Highlightll Pharmaceutical Co., Ltd. 杭州高光製藥股份有限公司 (A joint stock company established in the People's Republic of China with limited liability) WARNING The publication of this Application Proof is required by The Stock Exchange of Hong Kong Limited (the "Stock Exchange") and the Securities and Futures Commission (the "Commission") solely for the purpose of providing information to the public in Hong Kong. This Application Proof is in draft form. The information contained in it is incomplete and is s ...

Core Insights - Annovis Bio, Inc. is set to present at the 2025 Annual Meeting of the Parkinson Study Group, showcasing its advancements in therapies for neurodegenerative diseases like Alzheimer's and Parkinson's [1][5] Group 1: Presentation Highlights - The presentation will build on recent Phase 3 PD biomarker data, indicating that patients with amyloid co-pathology show significant cognitive decline, which is counteracted and reversed by the drug buntanetap [2] - A cross-study comparison of completed trials will be introduced, providing a comprehensive overview of cognitive outcomes across all tested indications, particularly highlighting the benefits for patients with amyloid pathology [3] - Findings suggest that individuals with biomarker-confirmed amyloid presence experience the greatest cognitive gains following treatment with buntanetap, validating the drug's mechanism as a translational inhibitor of neurotoxic aggregating proteins [3] Group 2: Company Overview - Annovis Bio is headquartered in Malvern, Pennsylvania, and focuses on developing innovative therapies aimed at improving outcomes and quality of life for patients suffering from neurodegenerative diseases [6] - The company is committed to advancing research and showcasing best practices in the field of Parkinson's disease [5]

Core Insights - Annovis Bio, Inc. announced new results indicating that its drug candidate, buntanetap, can reduce inflammation and improve cellular health in Alzheimer's patients, suggesting potential disease-modifying effects beyond just symptomatic relief [1][2]. Group 1: Clinical Study Results - The Phase 2/3 study analysis showed that buntanetap effectively targets key biomarkers of neuroinflammation and neurodegeneration, leading to reductions in inflammatory markers such as IL-5, IL-6, S100A12, IFN-γ, and IGF1R compared to placebo [2]. - Buntanetap also decreased levels of neurofilament light chain (NFL), a marker of neuronal damage, indicating improved cellular integrity and neuronal health, particularly in patients with positive pTau217 plasma levels [2][3]. Group 2: Mechanism and Therapeutic Potential - The drug's ability to target multiple neurotoxic proteins simultaneously is highlighted as a significant advantage, potentially interrupting the toxic cascade associated with Alzheimer's disease [3]. - Previous clinical benefits were noted in mild Alzheimer's patients, who experienced significant cognitive improvements, reinforcing the potential of buntanetap as a disease-modifying therapy [3]. Group 3: Ongoing Research and Future Outlook - Buntanetap is currently undergoing a pivotal Phase 3 trial in early Alzheimer's disease, with a 6-month readout focused on symptomatic improvement and an 18-month readout aimed at assessing disease modification [3][4]. - The full biomarker data will be presented at the Clinical Trials on Alzheimer's Disease (CTAD) conference in December 2025, which is expected to provide further insights into the drug's efficacy [4].

Summary of Elektor's Conference Call Company Overview - **Company**: Elektor - **Focus**: Development of disease-modifying therapies for neurodegenerative diseases, including Alzheimer's and frontotemporal dementia (FTD) [6][7] Key Industry Insights - **Neurodegenerative Diseases**: Elektor is addressing urgent unmet needs in neurodegenerative diseases through an integrated biotech approach combining genetics, immunology, and neuroscience [6] - **Progranulin Elevating Franchise**: The company is developing therapies targeting progranulin levels to treat FTD caused by granulin mutations and Alzheimer's disease [9][10] Core Points and Arguments - **Pipeline Overview**: Elektor has a multistage pipeline with late-stage programs, including: - **Latazimumab**: For FTD GRN, received breakthrough therapy and orphan drug designations, with phase three data expected by mid-Q4 2025 [7][22] - **Nivisibart (formerly AL101)**: For Alzheimer's disease, fully enrolled in a phase two trial [8][25] - **ABC Technology**: The proprietary electro brain carrier (ABC) technology enhances drug delivery across the blood-brain barrier, improving therapeutic efficacy [7][27] - **Clinical Data**: In the INFRANT2 phase two study, Latazimumab demonstrated a 48% slowing of clinical progression in symptomatic FTD GRN patients compared to matched historical controls [22] - **Economic Burden**: The economic burden per patient for FTD is nearly double that of Alzheimer's, highlighting the urgency for effective therapies [11] Additional Important Content - **Genetic Testing**: Increased uptake of genetic testing is anticipated as disease-specific treatments become available, which could shift the diagnostic landscape for FTD GRN [12] - **Partnership with GSK**: The collaboration includes significant financial commitments, with $700 million in upfront payments and potential milestones totaling $1.5 billion [26] - **Future Programs**: Elektor is developing additional therapies, including: - **Anti-amyloid beta antibodies**: Targeting Alzheimer's disease with two candidates, AL037 and AL137, showing promising preclinical results [46][45] - **Enzyme replacement therapy for Parkinson's disease**: Targeting GBA mutations with engineered GK's enzyme [47][50] - **siRNA programs**: Targeting tau, alpha-synuclein, and NLRP for various neurodegenerative diseases [76][77] Financial Position - **Cash Resources**: Elektor has over $300 million in demand to support ongoing and future programs [82] Conclusion - Elektor is positioned to make significant advancements in the treatment of neurodegenerative diseases through its innovative therapies and technologies, with multiple catalysts expected in the near future [82]

Core Insights - Annovis Bio, Inc. is a late-stage clinical drug platform company focused on developing transformative therapies for neurodegenerative diseases such as Alzheimer's disease and Parkinson's disease [1][4] Group 1: Company Overview - Annovis Bio is headquartered in Malvern, Pennsylvania and is dedicated to addressing neurodegeneration in diseases like Alzheimer's and Parkinson's [4] - The company aims to develop innovative therapies that improve patient outcomes and quality of life [4] Group 2: Upcoming Events - CEO Maria Maccecchini, Ph.D., will present at the H.C. Wainwright 27th Annual Global Investment Conference from September 8-10, 2025, at the Lotte New York Palace Hotel [1] - Interested parties can schedule one-on-one meetings with Dr. Maccecchini through the conference portal [3]

Core Insights - ProMIS Neurosciences has received Fast Track designation from the U.S. FDA for its Alzheimer's disease treatment candidate PMN310, enhancing its potential for priority review [2][11] - The PRECISE-AD Phase 1b trial for PMN310 is progressing well, with over 50% of the planned 128 patients enrolled, no cases of amyloid-related imaging abnormalities (ARIA) reported, and no patient dropouts [2][9] - The company has strengthened its financial position by raising approximately $21.6 million in gross proceeds in July 2025 [2][14] Company Overview - ProMIS Neurosciences is a clinical-stage biotechnology company focused on developing antibody therapeutics targeting toxic misfolded proteins associated with neurodegenerative diseases, including Alzheimer's disease, ALS, and Parkinson's disease [10] - The company's proprietary platform, EpiSelect™, is designed to identify conformational epitopes on toxic misfolded proteins, enabling the generation of selective therapeutic antibodies [4][10] Clinical Development - PMN310 is a humanized IgG1 monoclonal antibody specifically targeting toxic amyloid-beta oligomers (AβO), which are believed to be a major driver of Alzheimer's disease [5][11] - The PRECISE-AD trial is a randomized, double-blind, placebo-controlled study aimed at evaluating the safety, tolerability, and pharmacokinetics of PMN310, with interim results expected in Q2 2026 and final results in Q4 2026 [12][9] Financial Performance - As of June 30, 2025, ProMIS reported cash and cash equivalents of $4.5 million, an increase from $1.0 million a year earlier [14] - Research and development expenses for Q2 2025 were $8.7 million, significantly higher than $1.6 million in the same period of 2024, primarily due to costs associated with the PRECISE-AD trial [14][20] - The net loss for Q2 2025 was $10.1 million, compared to a net loss of $2.6 million in Q2 2024, reflecting increased clinical trial expenditures [14][20]

Core Viewpoint - Annovis Bio, Inc. is advancing its pivotal Phase 3 trial for early Alzheimer's disease, with significant progress in patient enrollment and global intellectual property protection [2][6]. Clinical Highlights - The pivotal Phase 3 study in early Alzheimer's disease has secured 76 clinical sites in the U.S. and has screened over 400 patients, with 38 patients currently receiving treatment [2][6]. - The screen failure rate for the trial is as expected at 50% [6]. - Annovis presented four scientific posters at AAIC 2025, showcasing advancements in the Alzheimer's Phase 3 study and the pharmacokinetic profile of its lead drug candidate, buntanetap [6]. Business Highlights - The company has successfully transferred all patent families to crystal buntanetap, achieving comprehensive global intellectual property coverage [2][6]. - Annovis welcomed a new Director of Biostatistics to maintain the statistical integrity of clinical trial data [6]. - A webcast was hosted in June to provide updates on the Phase 3 trial, allowing for direct engagement with the audience [6]. Financial Results - As of June 30, 2025, Annovis reported cash and cash equivalents of $17.1 million, an increase from $10.6 million as of December 31, 2024 [6]. - Research and development expenses for Q2 2025 were $5.2 million, down from $5.8 million in Q2 2024 [6]. - General and administrative expenses decreased to $1.1 million in Q2 2025 from $2.0 million in Q2 2024 [6]. - The net loss per common share for Q2 2025 was $0.32, an improvement from a loss of $0.44 per share in Q2 2024 [6].

Core Points - Annovis Bio, Inc. is a clinical-stage drug platform company focused on developing therapies for neurodegenerative diseases such as Alzheimer's disease and Parkinson's disease [1][4] - The company will host a live webcast featuring updates on its pivotal Phase 3 trial in early Alzheimer's disease and feedback from the FDA regarding its Parkinson's disease program [2] - The webcast is open to various stakeholders including shareholders, patients, and investigators, allowing for direct engagement with the CEO [3] Company Overview - Annovis Bio is headquartered in Malvern, Pennsylvania, and aims to address neurodegeneration by targeting multiple neurotoxic proteins to restore brain function and improve patient quality of life [4] - The company encourages interested investors and shareholders to sign up for press releases and industry updates through its investor website [5]