A first-in-class immunotherapy platform targeting cocaine and opioid addiction — where no FDA-approved solutions currently exist.
Xatca Biotech, Ltd. is developing next-generation treatments for cocaine and opioid addiction. We’re closing the critical gaps where FDA-approved options simply don’t exist, with a speed-to-market approach that leverages our team’s deep regulatory relationships to fast-track studies at the lowest cost.
Our lead compound, XAT-100, is a detoxified derivative of lipopolysaccharide (LPS) already used in approved vaccines — giving us an accelerated regulatory pathway that traditional drug developers cannot access.
U.S. Patent US 10,328,092 B2 · Licensed exclusively through 2036
Zero FDA-approved treatments for cocaine addiction. Blockbuster potential with $1B+ revenue opportunity.
XAT-100 may qualify for FDA Breakthrough Therapy designation and potential bypass of Phase 1 trials.
Deep industry connections and a proven track record in biotech development and commercialization.
$1B+ valuation target within 2–3 years based on market comparables and M&A activity.
Total addressable opioid treatment market globally
6–8% CAGRTotal addressable cocaine treatment market globally
4–5% CAGRU.S. share driven by the national opioid crisis and MAT funding
Gov. FundedZero approved therapies — entirely open market for first mover
Blue OceanOpioid addiction affects over 40 million people globally. The U.S. alone spends billions annually on treatment, with government programs actively funding novel pharmacological interventions. XAT-100 addresses a multi-billion dollar market with strong institutional support and no adequate existing solutions.
Cocaine addiction represents a completely open market — no FDA-approved pharmacotherapy exists. Xatca’s first-mover position, protected by an exclusive patent through 2036, creates an unparalleled commercial opportunity with $1B+ revenue potential within 2–3 years.
First demonstration of glial cell modulation in substance use disorder via TNF-alpha signaling at McGill University.
Exclusive license to US 10,328,092 B2 secured. New scientific and management team recruited.
Opioid animal study initiated at McGill. Patent filed for new IP. Chemists engaged for XAT-100 IP expansion.
Gap analysis complete. Chemistry team engaged for GMP/non-GMP production. CRO and CDMO identified.
Pre-IND study plan complete. Dose ranging study through McGill. Pre-clinical study plan finalized.
GLP toxicology studies and Pre-IND file preparation. Pre-IND meeting with FDA. Key investor inflection point.
Initiate clinical trials leveraging 505(b)(2) pathway and prior adjuvant safety data for accelerated progression.
Phase 2/3 clinical trials, commercialization, and strategic acquisition or IPO exit.
Xatca’s approach is grounded in a key discovery: immune signaling molecules regulate neurological function including learned behaviours. The inflammatory cytokine TNF-alpha can alter drug-induced behavioural changes — and microglia are the cellular source.
By activating microglia using XAT-100, we measurably suppress the sensitization and reinstatement that define addiction.
Blocking TNF signaling increases drug-induced sensitization and relapse behaviours in animal models
Cell-specific genetic studies confirm microglia as the TNF-alpha source regulating cocaine sensitization
MPLA activates microglia, increases TNF, and suppresses locomotor sensitization — preventing drug reinstatement
Pre-clinical studies at McGill University demonstrate that XAT-100 (MPLA) activates microglia, increases TNF-alpha, and measurably suppresses cocaine-related behavioural sensitization. Effects replicated across multiple dose cohorts of 10–12 mice per group.
TLR4 is now established as a therapeutic target for cocaine addiction with extension potential to opioid addiction. XAT-100 is a fully characterized TLR4 agonist with low toxicity and existing FDA approval as a vaccine adjuvant — drastically de-risking the regulatory pathway.
Detoxified LPS derivative, already FDA-approved as vaccine adjuvant in GSK’s FENDrix and Cervarix. TLR4 agonist with established safety profile, enabling an accelerated 505(b)(2) regulatory pathway and potential Phase 1 bypass.
Prior regulatory approval as a vaccine adjuvant enables potential bypass of Phase 1 trials and qualifies Xatca for the accelerated 505(b)(2) review pathway.
28-day repeat dose toxicology studies underway in Sprague Dawley rats across four dose groups (vehicle, 10mg, 50mg, 150mg) with immunogenicity profiling for IL-6, TNF-alpha, and IFN-beta.
Chemistry team engaged to develop new IP for XAT-100, including a patient-friendly thin strip formulation to maximize commercial potential and patient compliance.
GMP and non-GMP production protocols established. CRO and CDMO identified for pre-IND animal studies and CMC package development.
Visionary MedTech entrepreneur with over 25 years of expertise in biotechnology, drug and device development. Founder of SYNG Pharmaceuticals and Orange Neurosciences. Most recently led Apollo Green through a successful merger and public listing.
Chartered Accountant with 15 years in healthcare and technology companies undergoing IPOs and M&A. Former CFO of ASEP, a publicly-traded healthcare company, where she led the company’s IPO and managed all financial aspects.
Physician, humanitarian and entrepreneur. CEO of My Next Health Inc. Founded MSF Canada — Nobel Peace Prize 1999. Focus: genomics and AI in global healthcare.
Fellow of the CPA of British Columbia. Former Tax Partner and Managing Partner at KPMG. Frequent speaker on Canadian tax planning across Canada and Asia.
Seasoned healthcare executive. Former BC health advisory leader at KPMG, Partner at Deloitte Canada, and President of Healthtech — a Nordic Global Company.
Associate Professor, Department of Psychology, McGill University. Research focuses on molecular and cellular mechanisms of brain plasticity. Founder of Xatca’s patented technology and primary investigator on XAT-100 addiction studies.
40 years of academic and research experience in exercise physiology. Professor, Faculty of Kinesiology & Health Studies, University of Regina. Active member of CIPSRT focusing on PTSD in first responders.
XAT-100 has an FDA track record as a vaccine adjuvant, enabling a 505(b)(2) pathway that bypasses traditional Phase 1 requirements and compresses the timeline to market.
No FDA-approved cocaine addiction treatment exists. Xatca’s exclusive patent creates a substantial moat in an entirely open market with growing government and private investment.
Comparable pre-Phase 1 acquisitions range from $150M (Braeburn/Indivior) to $1.3B (Opiant/Novo Nordisk), validating Xatca’s $1B+ target valuation at exit.
Exclusive license to US 10,328,092 B2. New IP in active development to extend and deepen the patent portfolio and increase licensing value.
Contact us to discuss the investment opportunity or request additional documentation.
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