Human Organoid Data Supports the Therapeutic Rationale for INM-901 Program Ahead of Human Clinical TrialsConsistent Anti-Inflammatory Effects Demonstrate Translation from Animal Models to Three-Dimensional Human Brain Tissue SystemsVancouver, British Columbia--(Newsfile Corp. - March 23, 2026) - InMed Pharmaceuticals Inc. (NASDAQ: INM) ("InMed" or the "Company"), a pharmaceutical company developing a pipeline of disease-modifying small molecule drug candidates targeting CB1 and CB2 receptors, today announc ...

Plenary Presentation Highlights How Aligning Inflammatory Biomarker Enrichment with Mechanism of Action Offers a Blueprint for Success in Alzheimer’s Drug Development Boca Raton, FL, March 19, 2026 (GLOBE NEWSWIRE) -- INmune Bio Inc. (NASDAQ: INMB) (“INmune Bio” or the “Company”), a clinical-stage inflammation and immunology company, today announced that Malú Gámez Tansey, Ph.D., Professor of Neurology at the Stark Neuroscience Research Institute at Indiana University School of Medicine, will feature the Co ...

Core Insights - New analyses from the Phase 2b RewinD-LB clinical trial indicate that DLB patients with lower plasma pTau181 levels experienced greater clinical benefits from neflamapimod, suggesting its potential to target the underlying causes of dementia with Lewy bodies (DLB) [1][2][12] - The findings support the company's patient enrichment strategy and dosing regimen for the upcoming Phase 3 trial [1][2] Clinical Trial Details - The RewinD-LB trial included an initial randomized phase comparing neflamapimod to placebo, followed by a neflamapimod-only extension phase [3][8] - In the initial phase, participants did not achieve expected plasma drug concentration levels, resulting in no statistically significant improvement on the primary endpoint [3][4] - The extension phase with a new batch of capsules (DP Batch B) showed statistically significant and clinically meaningful slowing of disease progression [4] Treatment Response and Biomarkers - Treatment response increased across DLB patient subgroups with lower pTau181 levels, indicating a higher likelihood of patients without Alzheimer's disease (AD) co-pathology benefiting from neflamapimod [2][5] - The analyses revealed a consistent improvement in clinical endpoints at progressively lower plasma pTau181 levels, with a significant difference in CDR-SB scores between treatment groups [5][6] Future Directions - The company plans to initiate a global Phase 3 trial in the second half of 2026, focusing on patients with DLB and low pTau181 levels [14] - The planned trial will utilize a pTau181 cut-off of <21 pg/mL, estimated to include 80-90% of patients without AD co-pathology, who are believed to be most likely to respond to treatment [6][12] Drug Mechanism and Efficacy - Neflamapimod is an investigational drug that inhibits p38 MAP kinase, targeting neuroinflammation and synaptic dysfunction [12][13] - Previous studies have shown that neflamapimod can restore synaptic function and improve cognitive and functional outcomes in DLB patients [13]

Annexon (NasdaqGS:ANNX) Update / briefing March 18, 2026 02:00 PM ET Company ParticipantsBill Maughan - Managing Director of Equity ResearchCharles Wykoff - Chair of Clinical TrialsDarryl Wise - SVP of InvestmentsDoug Love - President and CEOEleonora Lad - Vice Chair of Clinical Research and Professor of OphthalmologyJamie Dananberg - Chief Medical OfficerLloyd Clark - SVP of Ophthalmology Strategy and InnovationSamantha Schaefer - Biotech Equity Research AssociateTazeen Ahmad - Managing Director in US Equi ...

InMed Pharmaceuticals Conference Call Summary Company Overview - **Company Name**: InMed Pharmaceuticals - **Ticker Symbol**: INM (NasdaqCM) - **Industry**: Drug Development - **Focus**: Targeting CB1 and CB2 receptors for neurodegenerative diseases, particularly Alzheimer's disease [2][3] Key Drug Candidates - **INM-901**: - Targets neural inflammation in Alzheimer's disease - Orally bioavailable, disease-modifying therapeutic - Can cross the blood-brain barrier [2][3] - **INM-089**: - Focuses on dry age-related macular degeneration (AMD) - Aims to stop disease progression and potentially reverse damage [22][24] - **INM-755**: - Targets chronic severe itch in epidermolysis bullosa - Phase 2A studies showed meaningful improvement in itch scores [27][28] Alzheimer's Disease Insights - **Neuroinflammation**: - Emerging research indicates it may be a precursor to Alzheimer's, rather than a result [6][10] - INM-901 aims to modulate inflammation by targeting CB1 and CB2 receptors [7][8] - **Preclinical Results**: - INM-901 showed neuroprotective effects, reduced inflammation, and improved cognitive outcomes in animal models [9][20] - Significant reduction in pro-inflammatory markers observed [19][20] Dry AMD Insights - **Market Opportunity**: - Dry AMD has a larger patient population and high unmet medical need [22] - INM-089 demonstrated preservation of retinal function in preclinical studies [25][26] Financial Snapshot - **Cash Position**: Approximately $7 million as of December 31, sufficient to reach Q4 of the current year [31] - **Market Capitalization**: Around $4 million, considered low for the technology and team in place [31][32] Development Timeline - **INM-901**: - Targeting pre-IND meeting with the FDA in Q3 2026 - Clinical trials expected to begin in 2027 [32][33] - **INM-089**: - Similar timeline, potentially a quarter behind INM-901 [33] Intellectual Property - **Patent Portfolio**: - Broad patents covering the class of compounds and their modifications - Positioned for both in-house development and potential out-licensing opportunities [41][42] Strategic Initiatives - Focus on strategic partnerships and co-development opportunities to accelerate product development [34][33] Conclusion - InMed Pharmaceuticals is positioned with promising drug candidates targeting significant medical needs in neurodegenerative diseases and ocular conditions. The company is actively pursuing regulatory pathways and strategic partnerships to enhance its development capabilities and market presence [34][32]

Core Insights - BioVie Inc. announced the acceptance of an abstract for its SUNRISE-PD study on bezisterim (NE3107) for treating Parkinson's Disease at the AD/PD 2026 conference [1][2] Group 1: Study and Results - The abstract titled "Demographics and Baseline Characteristics of Participants in a Study of Bezisterim (NE3107) in Early Parkinson's Disease (SUNRISE-PD)" summarizes initial data from the study, which will be presented as a poster [2] - Topline results from the SUNRISE-PD study are expected in mid-2026, following the enrollment of 60 patients to evaluate bezisterim's efficacy in improving motor and non-motor symptoms in untreated Parkinson's patients [4] Group 2: Drug Mechanism and Applications - Bezisterim (NE3107) is an oral drug that crosses the blood-brain barrier, aiming to reduce inflammation and improve insulin sensitivity without immune suppression, showing potential for various neurological conditions including Parkinson's, Long COVID, and Alzheimer's [3][7] - In previous Phase 2 studies for Parkinson's, patients taking bezisterim with levodopa exhibited better motor control and fewer symptoms compared to those on levodopa alone, with minimal side effects reported [4] Group 3: Other Clinical Trials - The ADDRESS-LC trial is currently enrolling about 200 patients to assess bezisterim's ability to alleviate neurological symptoms associated with Long COVID, with topline data also expected in mid-2026 [5] - BioVie has conducted Phase 2 and Phase 3 trials for Alzheimer's disease, with early results indicating improvements in cognition and biomarkers, warranting further investigation [6] Group 4: Company Overview - BioVie Inc. is a clinical-stage biopharmaceutical company focused on therapies for neurological disorders and advanced liver disease, with bezisterim targeting neuroinflammation and insulin resistance [7] - The company is also advancing BIV201, a treatment for liver disease that has received FDA Orphan and Fast Track designations, and plans to conduct a Phase 3 trial for patients with cirrhosis and ascites [8]

Core Insights - InMed Pharmaceuticals is advancing its Alzheimer's disease program, particularly focusing on the INM-901 drug candidate, with plans to initiate a Phase 1 clinical trial in 2027 [1][3][10] INM-901 Program Outlook - INM-901 is a proprietary, orally bioavailable small molecule drug candidate that targets neuroinflammation in Alzheimer's disease by acting as a CB1/CB2 signaling agonist [3][4] - The company has generated preclinical evidence showing that INM-901 reduces inflammatory biomarkers and neurodegenerative markers, indicating its potential therapeutic effects [4][9] - The program aims to clarify its focus on neuroinflammation, which is believed to be a primary driver of Alzheimer's progression, rather than a secondary effect [4][5] Development Plans for 2026 - The company plans to conduct a pre-IND meeting with the FDA in Q3 2026 to discuss the INM-901 program, which is seen as a critical milestone [3][10] - Continued development of INM-089, a candidate for dry age-related macular degeneration, is also planned, with a pre-IND meeting targeted for Q4 2026 [6][10] - The company is executing IND-enabling pharmacology and toxicology studies, with a focus on advancing drug substance and product development [9][10] Scientific and Operational Progress - Significant progress has been made in understanding the anti-neuroinflammatory effects of INM-901, with data supporting its multifactorial mechanism of action [2][5] - Preclinical studies have shown improvements in cognitive function and neuronal regeneration, reinforcing the drug's potential efficacy [9][10] - The company is also working on optimizing drug formulation and scaling up manufacturing processes to support future studies [9][10]

Summary of Annexon Biosciences Conference Call Company Overview - **Company**: Annexon Biosciences - **Focus**: Targeting the classical pathway with a next-generation neuroinflammatory approach, addressing diseases with a commercial potential exceeding $10 billion and impacting over 10 million patients [1][2] Core Programs 1. **Geographic Atrophy (GA)** - Late-stage Phase 3 program demonstrating significant vision preservation, the only program to do so [2][5] - Phase 2 study involved 270 patients, showing 50%-60% protection in central retina at 12 months [6][11] - Primary endpoint for Phase 3 is best corrected visual acuity, with results expected at month 15 [10][11] 2. **Guillain-Barré Syndrome (GBS)** - Landmark Phase 3 win, with significant improvement in muscle strength and recovery rates [21][22] - Approximately 7,000 cases annually in the U.S. and 15,000 in Europe, with a high treatment rate [32] - Filed for global regulatory approval in Europe and preparing for the U.S. filing [21][26] 3. **ANX1502** - First-in-kind small molecule drug candidate targeting classical pathway, currently in proof of concept study [2][40] - Aimed at neuromuscular autoimmune diseases, providing a potential oral alternative to current IV therapies [40] Strengths and Opportunities - **Innovation**: Unique approaches in GA and GBS, not following a "me-too" strategy, aiming to change market outlook [3][4] - **Education**: High educational curve due to novel approaches, particularly in GBS where no placebo-controlled study had been conducted in over 50 years [3][4] - **Safety Profile**: Differentiated safety profile in GA, with no significant difference in conversion to wet AMD compared to other therapies [6][13] Market Dynamics - **Commercialization Strategy**: Focus on educating key treatment practices and enhancing disease awareness, particularly in GA [16][17] - **Pricing Strategy**: Analysts estimate therapy costs between $100,000-$150,000, justified by significant healthcare savings [37][38] - **Reimbursement**: Active engagement with payers to ensure formulary inclusion and reimbursement [36] Financial Position - **Cash Balance**: Over $200 million, with a runway extending into late 2027, covering key upcoming catalysts [49] Key Takeaways - **Platform Approach**: Consistency in understanding the classical pathway across various neuroinflammatory diseases is a core strength [51] - **Asymmetric Value**: Current valuation does not reflect the potential advancements and outcomes expected in the next 12 months [51] Conclusion Annexon Biosciences is positioned to make significant impacts in the neuroinflammatory landscape with its innovative therapies targeting GA and GBS, backed by a strong financial position and a clear commercialization strategy. The company is focused on educating the market and ensuring successful product launches while maintaining a differentiated approach in treatment mechanisms.

Core Insights - Jupiter Neurosciences, Inc. is advancing its FDA-cleared Phase IIa clinical program targeting Parkinson's disease, with a focus on neuroinflammation and central nervous system disorders [2][5] - The company is also generating revenue through its consumer product Nugevia, which utilizes the patented JOTROL technology to enhance resveratrol bioavailability [3][5] Clinical Development - The FDA granted the Investigational New Drug (IND) application for the Phase IIa trial in November 2025, following preclinical data showing a nine-fold improvement in JOTROL bioavailability compared to standard resveratrol formulations [2] - The clinical program is supported by translational proof-of-concept data from Parkinson's disease models, which underpins the scientific rationale for the trial [2] Revenue Generation - Nugevia has demonstrated early commercial validation with a repeat purchase rate of approximately 25% and a product return rate of about 3%, indicating a capital-efficient operating model [3] - The dual-path strategy of combining clinical development with revenue generation through Nugevia differentiates Jupiter from other biotechnology peers that rely solely on external financing [3][5] Management's Outlook - The CEO expressed confidence in the company's execution plan and the importance of achieving clinical milestones while continuing to build revenue through Nugevia [4] - Management will engage with investors and potential partners at the BIO Investment and Growth Summit 2026, highlighting the company's commitment to disciplined execution [3][4]

Core Economic Terms - Jupiter Neurosciences, Inc. has deferred the commencement of repayment for its financing to April 1, 2026, while the core economic terms of the $6.0 million financing remain unchanged [1][2][8] - The amendment does not introduce new pricing provisions, reset features, or additional financing commitments, focusing solely on installment timing and application mechanics [2] Strategic Alignment - The amendment reflects a strategic decision between Jupiter and Yorkville, demonstrating Yorkville's commitment to Jupiter's long-term strategy by adjusting installment timing without altering pricing or other economic terms [3] - This alignment allows the company to focus on advancing its Phase II Parkinson's program and scaling its product Nugevia™, which is generating commercial cash flow [3] Commercial Performance - Jupiter's strategy combines clinical development with active commercial revenue generation, with Nugevia™ showing repeat purchase activity of approximately 25% and product return rates of about 3% [3] - The company believes that early commercial validation, along with continued clinical progress, strengthens its capital profile and differentiates it from biotechnology peers reliant solely on capital markets funding [3] Company Overview - Jupiter Neurosciences, Inc. is a clinical-stage pharmaceutical company focused on therapies for neuroinflammation and central nervous system disorders, with its lead clinical program in a Phase IIa trial for Parkinson's disease [5] - The company is also commercializing Nugevia™, a consumer product based on its patented JOTROL™ technology platform designed to enhance resveratrol bioavailability [5]