Nanexa Ab · OMXSTO:NANEXA
Nanexa Ab — Technical Presentation (May 2026)
23 slides from Nanexa Ab's technical presentation, May 19, 2026
Slide 1: PharmaShell – Enabling once-monthly and once-quarterly semaglutide depots
PharmaShell® – Enabling once-monthly and once-quarterly semaglutide depots Uppsala, Sweden Joel Hellrup, PhD Head of Pharmaceutical R&D May 19, 2026
Slide 2: In this talk
In this talk • PharmaShell® platform and release mechanism • Clinical proof-of-concept (liraglutide) • Programmable profiles: once-monthly and once-quarterly semaglutide (modelled to humans) 19MAY2026 2
Slide 3: More than 50% of patients do not follow their treatment correctly
More than 50% of patients do not follow their treatment correctly 19MAY2026 3 10.1001/jama.2018.19271
Slide 4: Smarter Care with Long-Acting Injectables
Smarter Care with Long-Acting Injectables Immediate release multiple administrations Drug plasma concentration Drug toxic level Therapeutic window Sub-therapeutic drug level PharmaShell® profile 0 2 4 6 Time (days) 19MAY2026 4
Slide 5: Why longer-acting injectables matter: GLP-1 as an example
GLP-1 as an example Why longer-acting injectables matter Treatment adherence Blood glucose levels after 6 months • GLP-1 case study: weekly GLP-1 treatments 100 0.0 6 month post-index (%) significantly increased adherence compared to Mean HbA1c change p<0.01 from baseline to 80 -0.5 daily treatments
Slide 6: PharmaShell at a glance
PharmaShell® at a glance • PharmaShell® platform programmable profiles: once-monthly to once-quarterly • Clinical PoC: once-monthly liraglutide demonstrated in Phase 1 • Suitable for wide range of molecules • Broad internal and partnered programs, incl. Moderna mRNA program • GMP-certified site and
Slide 7: PharmaShell technology
PharmaShell® technology Liraglutide plasma conc 100 10 (nmol/L) 1 0.1 0 7 14 21 28 35 42 SUBCUTANEOUS Time (days) FORMULATION OR LOCAL INJECTION LONG-ACTING Tailored formulations: The coated API particles The active pharmaceutical • Micronized active pharmaceutical create a depot at the ingredient (
Slide 8: PharmaShell technology
PharmaShell® technology Coated API particle Coating (micrometer size) composition • Designed for high-load peptide depots • Nano-thin coating around every individual API particle • The properties of the coating controls the duration of the depot Coating thickness (10-30 nanometers) • The coating pro
Slide 9: PharmaShell technology
PharmaShell® technology • Designed for high-load peptide depots • Nano-thin coating around every individual API particle • The properties of the coating controls the duration of the depot • The coating protects the API If the Brandenburg Gate (26 m tall) were a PharmaShell® particle at the same scal
Slide 10: Administration
Administration • PharmaShell® is administered as a suspension • The depot remains at the injection site • PharmaShell® coating gradually dissolves, releasing the API for systemic circulation • The coating dissolves into ions which are eliminated via urine, faeces and sweat 19MAY2026 10
Slide 11: Patient-friendly dosing
PharmaShell® Patient-friendly dosing Low injection volume • <1-mL injections due to high API load (70-90%) • Thin needles, 30G Low • Room temperature storage injection force Infrequent Room dosing temperature storage Thin needles Phase 1: powder and a solvent for injection Target commercial product
Slide 12: Stability
Stability 10% 5±3°C 10% 25°C/60% RH 5±3°C 8% The PharmaShell® coating Total impurities 8% 25°C/60%RH 40°C/75% RH Total impurities 6% 6% preserves product quality, 4% 4% omitting the need for cold 2% storage requirements 2% 0% 0% 0 3 6 9 12 15 18 0 3 6 12 18 24 Time (months) Time (months) Real-time d
Slide 13: The Chemistry behind PharmaShell
The Chemistry behind PharmaShell® Atomic Layer Deposition Metal source pulse Purging pulse (N2) ALD is made up of pulses each with its own function: 0.1 nm • Two types of pulses 0.1 nm 0.1 nm • Precursor - growth occur ALD 0.1 nm cycle • Purging – by product and excess removed • A set of, typically
Slide 14: PharmaShell development
PharmaShell® development Partner project pipeline • PharmaShell® has been shown to be suitable for peptides and a wide range of APIs, including small molecules, proteins, oligonucleotides, and mAbs • 3 clinical Phase 1 studies: NEX-18, NEX-20, NEX-22 small molecules peptides / proteins monoclonal an
Slide 15: From platform to proof-of-concept
From platform to proof-of-concept Liraglutide with PharmaShell® shows clinical exposure over 36 days 85th American Diabetes Association , Chicago June 22nd, Poster 1975-LB • Phase 1 results in GLP-1 naïve participants with type 2 diabetes, n=3 • Release of liraglutide over 36 days after a single sub
Slide 16: From platform to proof-of-concept: well tolerated
From platform to proof-of-concept Liraglutide with PharmaShell® was well tolerated Can a delayed Tmax limit the GI adverse effects? • Subcutaneous NEX-22 was generally well tolerated • No nausea or diarrhea reported • Decreased appetite and occasional heartburn reported as GI adverse effects • Injec
Slide 17: Taking the concept beyond liraglutide
Taking the concept beyond liraglutide • A strategic shift from PharmaShell® liraglutide to PharmaShell® semaglutide was done in 2025 due to following reasons: • Market and partner alignment. • Superior clinical efficacy, not only in type 2 diabetes but also in obesity. • Clinical proof-of-concept fo
Slide 18: PharmaShell coated semaglutide in rats
PharmaShell® coated semaglutide in rats • Study Formulations: PharmaShell® coated semaglutide formulations aiming for monthly and quarterly dosing • Test Animals: Male Sprague Dawley Rats, n=4 per formulation • Administration: Single dose, 1.4 mg/kg, subcutaneous • Sampling: Blood sampling at 0 to 3
Slide 19: From rat PK data to human simulation
From rat PK data to human simulation Modelling and simulation of human plasma profiles • Human steady state simulation was based on published data1 (see Table below). • Parameter related to absorption was translated from preclinical data using a double Weibull function and a 2-compartment model base
Slide 20: Simulation of repeated dosing in humans
Simulation of repeated dosing in humans Monthly or quarterly dosing PharmaShell® semaglutide outperforms marketed semaglutide’s narrow peak-to-trough ratio when dosed monthly (every 28 days) or quarterly (every 90 days). 150 Linear scale Formulation Dose (mg) Peak-to- Semaglutide concentration (nmol
Slide 21: PharmaShell semaglutide
PharmaShell® semaglutide • Simulated repeated-dose peak-to-trough ratios were 1.2 and 1.5 for monthly and quarterly dosing, respectively, as compared to 1.8 observed for weekly dosed marketed semaglutide. • The excellent narrow peak-to-trough ratios suggest that monthly and quarterly dosing of Pharm
Slide 22: Beyond GLP-1: long-acting formulations for your program
Beyond GLP-1: long-acting formulations for your program PharmaShell® enables safe and convenient long-acting peptide depots Low injection • Tailored depots volume • Monthly or quarterly dosing • Applicable for narrow therapeutic window drugs Low injection force • Patient friendly • Thin needles, 30G
Slide 23: Thank you for listening!
Thank you for listening! Do you want to know more or initiate partner discussions? Reach out to: Dr. Joel Hellrup, joel.hellrup@nanexa.se Dr. Oliver Hedge, oliver.hedge@nanexa.se Dr. Stefan Grudén, stefan.gruden@nanexa.se