Core Insights - XTL Biopharmaceuticals Ltd. has announced a binding agreement to acquire 85% of NeuroNOS Ltd., a subsidiary of Beyond Air, Inc., which focuses on disease-modifying therapeutics for Autism Spectrum Disorder (ASD) and neuro-oncology [1][2] - The acquisition positions XTL as a significant player in the autism therapeutics market, addressing a critical unmet medical need as 1 in 31 U.S. children are affected by autism, with no FDA-approved disease-modifying therapies currently available [3][4] Company Overview - NeuroNOS was founded by Professor Haitham Amal, a leading autism researcher, and has strengthened its scientific leadership by adding two Nobel Laureates in Chemistry, enhancing its potential for therapeutic innovation [5][7] - The company’s drug development platform targets the underlying molecular mechanisms of autism through a proprietary family of small molecules that can cross the blood-brain barrier [8] Market Opportunity - The autism crisis has led to increased strain on healthcare systems and families, with a significant rise in cases prompting urgent calls for new therapeutic pathways and research funding from U.S. policymakers [3][4] - The U.S. government has allocated $50 million in new NIH funding for autism research initiatives, indicating a shift in regulatory priorities towards autism treatment development [4] Transaction Details - XTL will acquire 85% of NeuroNOS for a combination of cash, shares, and milestone payments totaling up to $32.5 million, with the transaction subject to shareholder approval [10][11] - The milestone payments include up to $5.5 million for clinical development and up to $26 million for achieving product sales targets [11] Scientific Validation - NeuroNOS has secured FDA Orphan Drug Designations for Phelan-McDermid Syndrome and Glioblastoma, which provide market exclusivity and expedited regulatory review upon approval [9] - Preclinical studies have shown that the platform addresses core pathological mechanisms in autism, validating nitric oxide dysregulation as a therapeutic target [8]

Core Insights - XTL Biopharmaceuticals is acquiring 85% of NeuroNOS, a subsidiary of Beyond Air, to enhance its position in the autism therapeutics market, which is currently underserved with no FDA-approved disease-modifying therapies available [1][2] - The acquisition is expected to provide XTL with a strong scientific foundation, including leadership from Nobel Laureates and a focus on addressing the underlying biological mechanisms of Autism Spectrum Disorder (ASD) [7][12] Industry Overview - Autism Spectrum Disorder affects approximately 1 in 31 children in the U.S., highlighting a significant public health crisis that has strained healthcare systems and families [3][4] - The U.S. government has recognized the urgency of addressing autism, allocating $50 million in new NIH funding for research initiatives, indicating a shift in regulatory priorities towards autism treatment development [4] Scientific Leadership - NeuroNOS was founded by Professor Haitham Amal, a leading autism researcher, and has recently added two Nobel Laureates, enhancing its scientific credibility and potential for innovation in autism therapeutics [5][7] - The company's research focuses on nitric oxide dysregulation, which has been linked to both autism and brain cancer, establishing a novel therapeutic target [6][8] Technology and Regulatory Status - NeuroNOS's drug development platform utilizes small molecules designed to cross the blood-brain barrier and target nitric oxide abnormalities, aiming to address core pathological mechanisms rather than just symptoms [8] - The company has secured FDA Orphan Drug Designations for Phelan-McDermid Syndrome and Glioblastoma, which provide market exclusivity and expedited regulatory review [9] Transaction Details - The acquisition terms include a 19.9% stake in XTL's post-transaction share capital, $1 million in cash, and milestone payments up to $32.5 million based on clinical and commercial achievements [10][11] - Both XTL and Beyond Air are committed to advancing NeuroNOS's autism treatment programs with urgency [11][12]