InMed Pharmaceuticals Reports Full Year Fiscal 2025 Financial Results and Provides Business UpdateSeptember 23, 2025 8:30 AM EDT | Source: InMed PharmaceuticalsAdvances INM-901 program, addressing multiple key biological pathways implicated in Alzheimer's disease pathologyFurther develops INM-089 demonstrating neuroprotection in the treatment of dry Age-related Macular DegenerationCash of $11.1M to support pharmaceutical developments into the fourth quarter of calendar year 2026Vancouver, Brit ...

Core Viewpoint - Umecrine Cognition's drug candidate golexanolone shows promise in reversing neuroinflammation in a Parkinson's disease model, indicating its potential as a chronic treatment option [1][3]. Company Overview - Karolinska Development AB holds a 73% ownership stake in Umecrine Cognition prior to dilution, emphasizing its significant investment in innovative medical solutions [4]. - The company focuses on identifying and developing breakthrough medical innovations in the Nordic region, aiming to create and grow companies that advance these innovations into commercial products [5][6]. Research Findings - A preclinical study demonstrated that golexanolone completely reverses the activation of immune cells responsible for neuroinflammation in the brain, which is crucial for controlling voluntary movement and posture [3]. - The treatment with golexanolone not only reversed the increase of inflammation-promoting proteins but also provided robust protection against neuroinflammation as early as three weeks after disease onset [3]. - After nine weeks, golexanolone continued to counteract inflammation and aided in restoring protective immune cells, indicating a sustained effect on harmful brain inflammation [3]. Academic Collaboration - The study was conducted in collaboration with academic partners at Centro de Investigación Príncipe Felipe in Valencia, Spain, highlighting the importance of academic partnerships in advancing medical research [4].

Vonaprument (ANX007) in Geographic Atrophy (GA) - Vonaprument is the only GA program to demonstrate significant vision preservation, representing a potential blockbuster market opportunity[9, 15] - Phase 2 trial (ARCHER) showed significant time and dose-dependent vision preservation in GA patients, with a 73% risk reduction in BCVA ≥15-letter loss at two consecutive visits in the monthly (EM) dosing group (p = 0.0207) compared to sham[29] - In the ARCHER trial, 21.3% of patients in the sham group experienced persistent BCVA ≥15-letter loss through month 12+, compared to 5.6% in the Vonaprument EM group and 9.8% in the Vonaprument EOM group[25] - Photoreceptor protection was numerically greater in the central macula with Vonaprument, showing a 59% decrease in total Ellipsoid Zone (EZ) loss in the central 1.5 mm area compared to sham[34] - ARCHER II Phase 3 program is now fully enrolled with approximately 630 patients randomized in a 2:1 ratio (Vonaprument to Sham), with topline data expected in 2H'26[39] Safety and Clinical Development - ARCHER trial safety data showed Choroidal Neovascularization events in 3.4% of the sham group, 4.5% of the Vonaprument EM group, and 4.3% of the Vonaprument EOM group[36] - Global registration path established supporting potential first approval in both EU and US for dry AMD with GA; PRIME designation in EU[17] Pipeline and Platform - Annexon has a clinically validated scientific platform with broad potential across multiple therapeutic areas[9] - The company is pioneering a scientific approach to stop complement-driven neuroinflammation by blocking C1q[11, 12] - Annexon has a diverse late-stage clinical platform for classical complement-mediated neuroinflammatory diseases of the body, brain, and eye[14]

Core Insights - INmune Bio Inc. announced the upcoming release of a video detailing additional findings from the Phase 2 MINDFuL trial evaluating XPro™, a selective soluble TNF inhibitor, following the Alzheimer's Association International Conference (AAIC) in Toronto [1][2] - The video will provide a comprehensive overview of the latest clinical insights shared at the AAIC, focusing on the evaluation of XPro™ within the MINDFuL study design and its significance for patients, clinicians, and investors [2][4] - The MINDFuL trial is a double-blind, Phase 2 proof-of-concept study aimed at assessing XPro™'s potential to slow cognitive decline in early-stage Alzheimer's disease by targeting neuroinflammation [4] Company Overview - INmune Bio Inc. is a publicly traded clinical-stage biotechnology company focused on developing treatments that target the innate immune system to combat diseases [6] - The company has three product platforms: the Dominant-Negative Tumor Necrosis Factor (DN-TNF) platform, the Natural Killer Cell Priming Platform, and the CORDStrom™ platform, each targeting various diseases driven by chronic inflammation and cancer [6] - XPro™ is one of the product candidates in clinical trials aimed at treating Mild Alzheimer's disease, Mild Cognitive Impairment, and treatment-resistant depression [6]

Core Insights - INmune Bio Inc. announced additional analyses from its Phase 2 MINDFuL trial for XPro™, a selective soluble TNF inhibitor, to be presented at the Alzheimer's Association International Conference in Toronto on July 29, 2025 [1] - The MINDFuL trial is a double-blind, Phase 2 proof-of-concept study aimed at evaluating XPro™'s potential to slow cognitive decline in early-stage Alzheimer's disease by targeting neuroinflammation [2] - Although the primary endpoint was not met in the overall modified-intent-to-treat group, significant benefits were observed in a subpopulation with confirmed amyloid-beta pathology and systemic inflammation biomarkers [3] Study Details - The MINDFuL trial enrolled 208 participants with early Alzheimer's disease, requiring at least one biomarker of inflammation [2][6] - Participants received XPro™ or placebo in a 2:1 ratio for 24 weeks, with cognitive changes measured using the Early Mild Alzheimer's Cognitive Composite [2][6] - The trial's findings suggest a potential therapeutic approach for Alzheimer's by targeting inflammation [4] Future Plans - INmune Bio plans to submit a publication of the MINDFuL Phase 2 study results by mid-August [4] - The company is seeking strategic partnerships to expedite the development of XPro™ for Alzheimer's treatment [4] Product Information - XPro™ is designed to inhibit soluble TNF while preserving trans-membrane TNF and TNF receptors, potentially enhancing cognitive function and neuronal communication [7] - INmune Bio focuses on developing treatments that target the innate immune system, with XPro™ being part of its Dominant-Negative Tumor Necrosis Factor product platform [8][9]

Core Points - Jupiter Neurosciences, Inc. has regained compliance with Nasdaq's minimum share price requirement, confirming an average closing share price of at least $1.00 for 13 consecutive days [1][2] - The company is focused on developing JOTROL, a patented resveratrol-based platform, targeting neuroinflammation and promoting healthy aging [3] Company Overview - Jupiter Neurosciences is a clinical-stage pharmaceutical company with a dual-path strategy addressing central nervous system (CNS) disorders and rare diseases, while also entering the consumer longevity market with its Nugevia product line [3] - The therapeutic pipeline includes a Phase IIa trial for Parkinson's disease and targets conditions such as Alzheimer's Disease, Mucopolysaccharidoses Type I, Friedreich's Ataxia, and MELAS [3]

Core Insights - The Phase 2 MINDFuL trial of XPro™ in early Alzheimer's Disease (AD) patients with inflammation biomarkers did not meet the primary cognitive endpoint in the modified intent-to-treat (mITT) population, but showed cognitive, behavioral, and biological benefits in a predefined subgroup of amyloid-positive patients with two or more inflammation biomarkers [1][3][4] Group 1: Trial Results - The MINDFuL trial enrolled 208 participants with early-stage AD, assessing XPro™'s potential to slow cognitive decline by targeting neuroinflammation [4] - In the predefined subgroup of amyloid-positive early AD patients with two or more inflammation biomarkers (n=100), XPro™ demonstrated a cognitive benefit on the primary endpoint EMACC (effect size: 0.27) and a behavioral benefit on the Neuropsychiatric Inventory (effect size: -0.24) [7] - A biological benefit was observed in blood levels of pTau217 (effect size: -0.20), indicating a positive impact on AD pathology [7] Group 2: Safety and Tolerability - XPro™ treatment was well-tolerated and safe, with no occurrences of ARIA-E or ARIA-H reported [2][7] - The most common adverse events were injection site reactions, occurring in 80% of the XPro™ group compared to less than 20% in the placebo group [7] - There were no deaths or drug-related hospitalizations during the trial, indicating a favorable safety profile [7] Group 3: Future Plans - The company plans to submit for Breakthrough Therapy designation with the FDA and will present additional analyses at the Alzheimer's Association International Conference (AAIC) in July 2025 [2][10] - The company aims to engage regulatory authorities in the UK, EU, and other regions to define the path for a pivotal trial to support XPro™ approval in early AD [14]

Core Viewpoint - BioVie Inc. is advancing its clinical-stage drug candidate bezisterim (NE3107) for the treatment of early Parkinson's disease, with a Phase 2 SUNRISE-PD trial set to present findings at an upcoming congress [1][2]. Company Overview - BioVie Inc. (NASDAQ: BIVI) focuses on developing innovative therapies for neurological disorders, including Alzheimer's disease, Parkinson's disease, and long COVID, as well as advanced liver disease [12]. - The company's lead candidate, bezisterim, is designed to modulate inflammation and enhance insulin sensitivity without immunosuppressive effects [7][12]. Clinical Trial Details - The SUNRISE-PD trial is a Phase 2b, multicenter, randomized, double-blind, placebo-controlled study lasting 20 weeks, allowing patients to participate either from home or at clinical sites [2][3]. - The trial aims to evaluate the safety and efficacy of bezisterim on both motor and non-motor symptoms in patients not previously treated with carbidopa/levodopa, with topline data expected in late 2025 or early 2026 [8]. Parkinson's Disease Context - Parkinson's disease is characterized by the loss of dopamine-producing neurons, leading to motor and non-motor symptoms that significantly impact quality of life [4]. - Traditional treatment with levodopa has limitations, including motor fluctuations and dyskinesia, highlighting the need for new therapeutic approaches [5]. Mechanism of Action - Bezisterim targets neuroinflammation and insulin resistance, which are implicated in the progression of Parkinson's disease, potentially offering a new treatment avenue [6][7]. Previous Research Findings - A prior Phase 2 study of bezisterim showed significant improvements in motor control and "morning on" symptoms when combined with levodopa, with no drug-related adverse events reported [9].

Summary of Coia Therapeutics Inc. Presentation Company Overview - **Company**: Coia Therapeutics Inc. - **Focus**: Development of therapies for neurodegenerative diseases such as ALS, frontotemporal dementia, Alzheimer's disease, and Parkinson's disease [4][6][10]. Core Points and Arguments - **Vision**: To improve the quality of life for patients with neurodegenerative diseases, shifting the narrative from their illness to their life stories [4]. - **Target Diseases**: - **ALS**: High unmet need with few treatment options; patients typically have a life expectancy of 3-4 years post-diagnosis [5]. - **Frontotemporal Dementia**: No FDA-approved therapies available [5]. - **Alzheimer's and Parkinson's Diseases**: Significant societal impact, affecting both patients and caregivers [6]. - **Scientific Approach**: Focus on neuroinflammation and regulatory T cell dysfunction as a mechanism to potentially halt disease progression [6][13]. - **Pipeline**: - **COIA-302**: A proprietary combination therapy targeting ALS and other neurodegenerative diseases [16]. - **Combination Strategy**: Utilizes low-dose interleukin-2 and CTLA-4 to enhance Treg function and combat neuroinflammation [16][18]. Financial and Strategic Position - **Partnership**: Strategic collaboration with Dr. Reddy's, valued at over $700 million, providing non-dilutive funding and expertise [8][19]. - **Investor Base**: Strong backing from notable investors including Greenlight Capital and David Einhorn [7]. - **Cash Runway**: Strong financial position with a clean cap table [7]. Clinical Data and Milestones - **Promising Results**: Initial trials show potential to stop progression of ALS, with patients maintaining stable ALSFRS scores over six months [22][23]. - **Upcoming Milestones**: - Submission of data for a Phase 2b study in ALS to the FDA [10]. - Anticipated IND filing for frontotemporal dementia [11]. - Ongoing studies in Alzheimer's disease showing ability to halt cognitive decline [25][26]. Market Potential - **Commercial Opportunity**: High sales potential in orphan diseases like ALS and frontotemporal dementia due to lack of existing therapies, estimated in billions of dollars [13]. - **Regulatory Flexibility**: Orphan disease designation may facilitate faster market entry [6]. Additional Insights - **Combination Therapy Potential**: Research indicates that combining COIA-302 with GLP-1 agonists may enhance efficacy in treating Alzheimer's disease [28][29]. - **External Validation**: Support from the Alzheimer's Drug Discovery Foundation reinforces the credibility of Coia's approach [12]. Conclusion - **Future Outlook**: Coia Therapeutics is positioned for significant advancements in the treatment of neurodegenerative diseases, with multiple key milestones expected in the near future [30].

Core Viewpoint - InMed Pharmaceuticals has announced new preclinical data indicating that its drug candidate INM-901 significantly reduces neuroinflammation in ex vivo models, supporting its potential as a therapeutic option for Alzheimer's disease [1][5]. Group 1: Study Findings - The study evaluated INM-901 in an ex vivo model of lipopolysaccharide (LPS)-induced inflammation, showing that INM-901 treatment can reduce pro-inflammatory cytokines such as IL-6, IL-1β, IL-2, and KC/Gro, and the inflammasome marker NLRP3 [2][7]. - INM-901 demonstrated a statistically significant reduction in levels of NLRP3 and IL-1β, which are implicated in the pathogenesis of Alzheimer's disease and other neuroinflammatory conditions [8][4]. - The results suggest that INM-901's effects on neuroinflammation are independent of amyloid beta or tau pathology, indicating its potential to treat a broader range of dementia-related diseases [8][4]. Group 2: Implications for Alzheimer's Disease - The study highlights INM-901 as a promising therapeutic candidate for Alzheimer's disease, with plans for further preclinical studies and IND-enabling studies to follow [5][9]. - NLRP3-driven inflammation is recognized as a key contributor to neurodegenerative disease progression, and INM-901's ability to reduce this inflammation could have significant implications for treating Alzheimer's and other neurodegenerative diseases [4][8]. Group 3: Drug Characteristics - INM-901 is a proprietary small molecule drug candidate with multiple mechanisms of action, including neuroprotective effects and the ability to improve cognitive function and memory [14][9]. - The drug can be administered orally, achieving therapeutic levels in the brain comparable to those obtained through intraperitoneal injection, which may offer advantages over currently approved products [14].