Slide 1: Next-Gen Drug Delivery in Neurology and Autoimmune Diseases
Next-Gen Drug Delivery in Neurology and Autoimmune Diseases Corporate Presentation September 2026
Slide 2: Forward looking statements
INTRODUCE Forward looking statements This presentation has been prepared by BioNxt Solutions Inc. (the These statements are based on management’s current beliefs and “Company”) for informational purposes only and does not constitute an assumptions, but are not guarantees of future performance. Forwa
Slide 3: Transforming Approved Drugs into Differentiated Therapies
EXECUTIVE SUMMARY Platform Lead Program Transforming Approved Sublingual thin-film (ODF) drug Cladribine ODF Drugs into Differentiated delivery for Multiple Sclerosis (MS) and Myasthenia Gravis (MG) Therapies A platform-driven approach to enhance existing medicines and accelerate time to market. IP
Slide 4: Leaders in thin-film drug delivery
who we are Leaders BioNxt Solutions Inc. is a Canadian in thin-film bioscience company focused on advanced thin-film drug delivery technologies, with drug delivery R&D and formulation in Germany. Specialized in Focused on Lead program: sublingual thin-film neurological and Cladribine ODF (ODF) drug
Slide 5: Limitations of Conventional Drug Delivery
Problem Limitations of Conventional Drug Delivery Specific limitations of oral Cladribine (Mavenclad®) Low bioavailability Degradation in the High variability Oral Cladribine delivery (~40%) due to first-pass gastrointestinal tract due to GI factors (food, limits both therapeutic metabolism enzymes)
Slide 6: Unmet Needs in Neurology and Autoimmune Diseases
Opportunity Millions of patients High prevalence Unmet Needs in Neurology affected by neurological of dysphagia and and Autoimmune Diseases and autoimmune disorders adherence challenges Large patient populations and evolving treatment expectations create demand for better delivery solutions. Demand
Slide 7: Sublingual Thin-Film Drug Delivery (ODF Platform)
Solution Sublingual Thin-Film Drug Delivery (ODF Platform) BioNxt’s ODF platform enables efficient, patient- friendly delivery of established drugs. Direct systemic absorption via oral mucosa Rapid and predictable Designed to improve drug absorption bioavailability and dosing consistency Transforms
Slide 8: Partners and consultants of project
Partners Partners and consultants Gen-Plus GmbH & Co KG of project 81477 München, Germany CCDRD AG 15366 Hoppegarten, Germany Entomus GmbH 76593 Gernsbach, Germany Next-gen drug delivery BioNxt Solutions Inc.
Slide 9: Orodispersible films – ODF
Product Orodispersible films – ODF Active Administration to the substance embedded oral cavity: on/below in a flexible film the tongue Next-gen drug delivery BioNxt Solutions Inc.
Slide 10: ODF advantages compared to other dosage forms
Advantages Sublingual Thin Film Formulation ODF advantages compared to other dosage forms Well defined No risk of suffocation Improved Easy to apply dosage form and shocking stability Does not require water use Easy application Bypasses the Lower dosage Provides rapid onset to patients with gastroin
Slide 11: Multiple Sclerosis prevalency
Market MULTIPLE SCLEROSIS Multiple Sclerosis Countries with Highest Prevalence prevalency >700,000 people MULTIPLE SCLEROSIS Around 2.8 million suffer from multiple sclerosis Cases in the U.S. have been diagnosed with MS (MS) in Europe. in the world. According to an MS prevalence classification syst
Slide 12: How Cladribine works
Science Like adenosine, cladribine is taken up by the cell How via specialized transporters. Cladribine Adenosine is either broken down by an enzyme works called ADA (adenosine deaminase) to be used for the creation of DNA and protein or activated for use in energy metabolism by an enzyme called Cla
Slide 13: Mavenclad key facts
Drug Mavenclad key facts Mavenclad is presented Cladribine is classified by as immediate release tablet, originator as BCS class III intended for oral compound (low permeability, administration. Each tablet high solubility ). contains 10 mg cladribine, sorbitol, hydroxypropyl betadex and magnesium s
Slide 14: Mavenclad oral route of administration difficulties and disadvantages
Treatment Mavenclad oral route associated i culties and disadvantages of administration of peroral route D ffi of Cladribine administration It can only be used in Mavenclad is a subject of Mavenclad absorption may Changes in drug conscious patients and those BCRP (ABCG2) transporter vary. Examples o
Slide 15: Cladribine ODF manufacturing method
Manufacturing Cladribine ODF manufacturing method Сoating mass Beaker Beaker Matis oven before vacuum, with bubbles Purified water Lipoid S 75 Purified water Glycerol Heat Kleptose HPB Mixing and Heating Mixing Spread onto plastic foil Coating after vacuum, Cladribine Mixing and Heating Pullulan Dry
Slide 16: Cladribine Formulation Development Concept
Development CLA:CD 1:12 w/w ratio was Cladribine Formulation chosen as the candidate Development Concept ODF platform based on starch / pullulan mixture In all media the release of cladribine at 15 minutes is more than 85% Development Strategy: optimization of physical properties and CD/API ratio wi
Slide 17: Pharmacokinetic comparative study Oral Mavenclad vs. Sublingual Cladribine ODF In Dogs
Study Pharmacokinetic comparative study Oral Mavenclad® vs. Sublingual Cladribine ODF In Dogs Plasma Concentration-Time Profiles of Cladribine Following a Single 5 mg/animal Oral Mavenclad® or Sublingual Cladribine ODF Administration to Female Dogs The pharmacokinetics of Cladribine in female dogs a
Slide 18: Pharmacokinetic comparative study Oral Cladribine vs. Sublingual ODF In Mini-Pigs
Study Pharmacokinetic comparative study Oral Cladribine vs. Sublingual Cladribine ODF In Mini-Pigs Results of Mean Pharmacokinetic (PK) Parameters Variable Group 1 — Cladribine 10 mg tablet Group 2 — Cladribine 10 mg ODF Mean SD CV% Mean SD CV% t1/2 (hr) 5.395 5.143 95.33 2.443 ND ND Tmax (hr) 2.833
Slide 19: Pharmacokinetic comparative study In Mini-Pigs: Individual Profiles
Results Pharmacokinetic comparative study Oral Cladribine vs. Sublingual Cladribine ODF In Mini-Pigs Individual Plasma Concentration–Time Profile 10 mg Cladribine ODF was Cladribine 10 mg Tablets was Cladribine 10 mg administered sublingually to Bama pigs administered Oral Gavage to Bama pigs Tablet
Slide 20: Cladribine ODF Patenting strategy and IP rights
THE IP EP4539857 “Sublingual Formulation of anticancer compound for treatment of autoimmune Cladribine ODF neurodegenerative diseases” Patenting strategy Applicants: Vektor Pharma TF GmbH ( 100% Bio-Nxt affiliated company) and IP rights Priority date: 15 June 2022. European patent granted: 11 March
Slide 21: Cladribine ODF development plan
Roadmap Cladribine ODF development plan Activity Development time-line Responsible subcontractor DP non-GMP Development Completed Delim s.r.l., Italy Comparative PK Study in Dogs Completed Accelera s.r.l., Italy Local Tolerability Study in Dogs Completed Accelera s.r.l., Italy Hunan Prima Drug Resea
Slide 22: Hybrid applications under Article 10(3) of Directive 2001/83/EC
Hybrid applications This is necessary in three cases: under Article 10(3) of Where the strict definition of ‘generic medicine’ is not met Directive 2001/83/EC Where the bioavailability studies cannot be used to demonstrate bioequivalence A hybrid application differs in certain cases, where results o
Slide 23: Flexible Structures for Strategic Collaboration
Partnership Opportunities Flexible Structures for Strategic Collaboration BioNxt offers multiple entry points for pharmaceutical partners to engage across assets and geographies. Collaboration Models Regional licensing (Europe, Eurasia, U.S.) Partner Benefits Multiple entry points for pharma partner
Slide 24: Key Milestones and Value Inflection Points
Points Key Milestones and Initiation of human bioavailability study Clinical data readout Value Inflection Points BioNxt is entering a critical phase of clinical validation and commercialization readiness. GMP manufacturing Execution of strategic of clinical batches partnerships underway Regulatory
Slide 25: Strong Leadership Across Science and Commercialization
Team Strong Leadership Across Science and Commercialization BioNxt is entering a critical phase of clinical validation and commercialization readiness. Hugh Dr. Oleksandr Wolfgang Rogers Zabudkin Probst Co-founder, CEO DIRECTOR OF BUSINESS CO-FOUNDER, & Director DEVELOPMENT CFO & Director Dr. Wolf
Slide 26: Research & Technology Partners
NETWORK Research & Technology Partners Collaborating with specialized partners across formulation, analytics, and clinical development. Conscio Group provides Gen-Plus is a German Quinta-Analytica is a European The University of Alberta scientific and analytical company specializing in Contract Rese
Slide 27: Thank you!
Thank you! Investor & Media Contact Hugh Rogers (CEO) hrogers@bionxt.com +1 604 250 6162 linkedin.com/company/bionxt-solutions instagram.com/bionxt bionxt.com Next-gen drug delivery BioNxt Solutions Inc.