Abiopharma

INMED PHARMACEUTICALS INC. (INM) Announces Clinical Trial Update INMED PHARMACEUTICALS INC. (INM) provided an update on its clinical development programs. Clinical Development Highlights:

• Drug Program: results, conducted
• Diseases/Conditions: INM-901 into a human-relevant system
• Clinical Stage: Clinical Trial, clinical trial
• Collaboration: Animal Models
  • targeting CB1 and CB2 receptors, today announced new preclinical data demonstrating the effects of INM-901 in reducing neuroinflammation in 3D human brain organoid models of Alzheimer's disease. These studies, conducted in collaboration with Stem Pharm, Inc. ("Stem Pharm") using their proprietary platform of human neuro-immune organoids, represent a key step in translating prior animal model results for INM-901 into a human-relevant system, helping to de-risk the INM-901 program ahead of a first-in-human clinical trial. The in vitro human organoid models represent some of the closest approximations to human brain tissue currently available, incorporating a complex cellular environment relevant to neurodegenerative disease. The organoids are composed of neurons, astrocytes, vascular cells and feature microglia, the brain's resident immune cells, and can be used to bridge the gap between traditional animal models and human clinical trials. INM-901 was evaluated in two distinct human 3D organoid models: a general model of neuroinflammation induced with lipopolysaccharide ("LPS") and interferon-gamma ("IFN-γ"); and, Stem Pharm's proprietary neuroinflammation Alzheimer's disease model with specific features observed in Alzheimer's disease patients. Key Observations: INM-901 demonstrated significant reduction in neuroinflammation in Stem Pharm's LPS-induced model and in their Alzheimer's disease model. A dose-dependent reduction of key pro-inflammatory markers such as IL-6 and IL-8 was seen in both neuroinflammation models. Effects align with prior findings from an in vivo Alzheimer's model and an ex vivo LPS-induced neuroinflammation model. Provides supportive evidence of mechanistic translation from animal models to human tissue systems. The consistency of INM-901's anti-inflammatory effects across in vivo animal models, ex vivo systems and now human 3D brain organoids provide increasing confidence in the compound's potential to translate into clinical benefit in humans with neuroinflammatory conditions. Dr. Eric Hsu, InMed SVP of Preclinical Research and Development, commented, "These results represent an important milestone for INM-901. We have now demonstrated consistent anti-neuroinflammatory effects across multiple in vivo and ex vivo studies, and, importantly, these findings have now been translated into advanced human brain organoid systems. This systematic validation significantly de-risks the program and strengthens our confidence as we advance INM-901 toward human clinical trials." Key Datasets impacting Anti-Neuroinflammation to date: • In a long-term mouse model mimicking Alzheimer's disease, INM-901 significantly reduced inflammatory biomarkers IFN-γ, TNF-α, IL-1β, KC-GRO, IL-2 and neurodegenerative marker neurofilament light chain ("NfL"). • INM-901 significantly reduced inflammasome activation and multiple pro-inflammatory cytokines, including NLRP3, IL-1β, IL-6, IL-2 and KC-GRO in an LPS-induced neuroinflammation ex vivo model, demonstrated anti-inflammatory effects independent of amyloid-beta or tau pathology. • Reduction of neuroinflammation in 3D human brain organoid models of Alzheimer's disease. Next Steps for the INM-901 Program for Alzheimer's Disease • Conduct a pre-IND meeting with the U.S. Food and Drug Administration in Q3/2026
  • targeting submission of an IND and initiation of a Phase 1 clinical trial in 2027
  • targeting inflammation. Current research has demonstrated significant progress in understanding disease mechanisms and clinical interventions, with inflammation emerging as a critical factor influencing long-term patient outcomes. As such, neuroinflammation is increasingly recognized as a strategic therapeutic target for next-generation Alzheimer's treatments. About Stem Pharm, Inc. Stem Pharm is developing next-generation neurologic drugs using a human-first approach. Stem Pharm's proprietary drug discovery platform is based on human 3D neuro-immune organoids that feature microglia and model neuroinflammation, which play a critical role in many neurological diseases. The company applies this platform to discover and validate disease targets and therapeutics for its internal programs in Alzheimer's disease, epilepsy, and brain cancer as well as for its biopharma partners' therapeutic programs. Stem Pharm is based in Madison, WI, a hub for innovative stem cell and biosciences research. For more information, visit stempharm.com. About InMed: InMed Pharmaceuticals is a pharmaceutical company focused on developing a pipeline of proprietary small-molecule drug candidates targeting the CB1/CB2 receptors. InMed's pipeline consists of three separate programs in the treatment of Alzheimer's, ocular and dermatological indications. For more information, visit www.inmedpharma.com. Investor Contact: Colin Clancy Vice President, Investor Relations and Corporate Communications T: +1.604.416.0999