XTL Biopharmaceuticals Acquires 85% of NeuroNOS: A Major Move into the Autism Market
XTL Biopharmaceuticals Ltd. (NASDAQ: XTLB), based in Tel Aviv and Boston, announced today a significant acquisition, taking an 85% stake in NeuroNOS Ltd., a subsidiary of Beyond Air, Inc. (NASDAQ: XAIR). This strategic move positions XTLB to become a key player in the autism therapeutics sector, in response to the increasing need for effective treatments for Autism Spectrum Disorder (ASD).
The Rising Need for Autism Treatment
Current statistics reveal that approximately 1 in 31 children in the United States are now diagnosed with autism. Despite this alarming trend, there are currently zero FDA-approved disease-modifying therapies for ASD. The conventional treatments available today primarily manage symptoms rather than addressing the underpinning neurobiological causes.
This pressing issue has caught the attention of U.S. policymakers, including President Donald Trump, who remarked on the urgency of addressing the autism crisis, noting it as one of the most alarming public health developments in history. In response, the federal government has allocated $50 million in new NIH funding for autism research initiatives, demonstrating a commitment to advancing therapeutic options.
Scientific Leadership Driving Innovation
NeuroNOS, co-founded by renowned autism researcher Professor Haitham Amal, has developed a unique platform targeting the core biological mechanisms of autism, rather than merely alleviating symptoms. This approach is supported by a distinguished advisory team that includes two Nobel Laureates: Professor Dan Shechtman and Professor Roger Kornberg, bolstering the firm’s scientific credibility.
Professor Amal’s research on nitric oxide dysregulation has established the groundwork for NeuroNOS's innovative therapies, aiming to deliver transformative treatments for those affected by autism and related disorders.
FDA Orphan Drug Designations and Market Exclusivity
NeuroNOS’s platform has already secured two FDA Orphan Drug Designations for Phelan-McDermid Syndrome and Glioblastoma, diseases strongly correlated with autism. These designations offer vital advantages, including:
- Seven years of market exclusivity upon approval
- Tax credits for clinical trial costs
- Expedited regulatory review
- Enhanced engagement with the FDA
These factors position XTLB and NeuroNOS to significantly impact the autism therapeutics landscape effectively.
Transaction Details of the Acquisition
The acquisition terms state that XTLB will pay for 85% of NeuroNOS with a combination of cash, stock, and potential milestone payments totaling up to $32.5 million. This includes:
- $1 million in cash
- 19.9% of XTLB's issued share capital
- Up to $5.5 million in clinical development payments
- Up to $26 million in commercial milestone payments based on sales targets
This acquisition emphasizes XTLB's commitment to advancing NeuroNOS's product pipeline for autism treatment as quickly as possible, aiming to meet a critical unmet medical need.
Statements from Company Leadership
Noam Band, CEO of XTL Biopharmaceuticals, expressed enthusiasm regarding the acquisition, stating, “This acquisition positions XTLB at the forefront of autism therapeutics, and we are committed to advancing these programs with urgency.”
Steve Lisi, Chairman and CEO of Beyond Air, commented on the transaction, noting its potential to validate their groundbreaking research and enhance value for shareholders.
About NeuroNOS and Beyond Air
NeuroNOS is dedicated to developing innovative solutions for neurodevelopmental and neurodegenerative disorders through its proprietary small-molecule therapeutics, focusing on the regulation of nitric oxide. Collaborating with elite research institutions, NeuroNOS aims to provide transformative therapies for patients suffering from autism and other conditions.
Meanwhile, Beyond Air, Inc. focuses on developing medical devices and biopharmaceuticals targeting serious diseases, reinforcing its commitment to advancing health through innovation.
For more information, visit www.neuro-nos.com.