Slide 1: HNSA-5487 demonstrates very rapid and highly robust IgG reduction and clear redosing potential
HNSA-5487 demonstrates very rapid and highly robust IgG reduction and clear redosing potential in Phase 1 FIH trial 7 October 2024 Søren Tulstrup, CEO Hitto Kaufmann, CR&DO
Slide 2: IgG cleaving technologies have the potential to transform autoantibody treatment landscape
IgG cleaving technologies have the potential to transform autoantibody treatment landscape 80 + types of autoimmune diseases, which Current approaches to care have are chronic, unpredictable, and have significant side effects, are time debilitating, recurring symptoms. IgG is a consuming, and may no
Slide 3: HNSA-5487 is a next generation molecule that can very rapidly and robustly reduce IgG
HNSA-5487 is a next generation molecule that can very rapidly and robustly reduce IgG with clear redosing potential HNSA-5487 • Reduces IgG levels by more than 95 percent within a few hours ❑ Next generation IgG cleaving Rapid & robust • IgG levels returning to normal range six months after initial
Slide 4: NICE-01 is the first in human trial of HNSA-5487
NICE-01 is the first in human trial of HNSA-5487 Double blind, randomized, placebo-controlled trial in 36 healthy volunteers received a Key Takeaways single ascending doses of HNSA-5487 administered as a single intravenous (IV) infusion. Assessed safety, tolerability, PK and PD, and immunogenicity •
Slide 5: HNSA-5487 demonstrated rapid, robust reduction of IgG by 95% after a single dose
HNSA-5487 demonstrated rapid, robust reduction of IgG by 95% after a single dose HNSA-5487 is as efficacious as imlifidase in reducing IgG levels • In the analysis, IgG levels were reduced by more than 95 percent • Six months after initial dosing, IgG levels returned to normal range 0.02 0.06 0.18 0
Slide 6: HNSA-5487 achieved lower peak ADA responses and faster return to cleavable levels
HNSA-5487 achieved lower peak ADA responses and faster return to cleavable levels confirming clear redosing potential Data plotted using two separate Phase 1 trials in healthy human subjects No head-to-head trial has been conducted between HNSA-5487 and imlifidase HNSA-5487 can be redosed effectivel
Slide 7: ADA reduction confirms HNSA-5487 redosing potential with optimized IgG reduction
ADA reduction confirms HNSA-5487 redosing potential with optimized IgG reduction HNSA-5487 Development of in vitro efficacy assay provided a method to assess potential redosing efficacy of HNSA-5487 Data confirmed potential for short term redosing to extend IgG low window Data confirmed robust reduc
Slide 8: HNSA-5487 is uniquely positioned to treat acute and chronic conditions
HNSA-5487 is uniquely positioned to treat acute and chronic conditions due to its rapid IgG reduction HNSA-5487 provides unmatched speed in reducing IgG IgG cleaving enzymes cleave antibodies across all domains IgG lowering Intravascular Extravascular Cell bound IgG IgG IgG modalities Imlifidase HNS
Slide 9: An opportunity to address high unmet medical need: Neuromyelitis Optica
An opportunity to address high unmet medical need in autoantibody driven conditions Neuromyelitis Optica (NMO) In NMO, more than 80% of patients have IgG antibodies The body's immune system mistakenly attacks healthy against the water-channel aquaporin 4 (AQP4)* cells and proteins in the body, most
Slide 10: An opportunity to address high unmet medical need: Myasthenia Gravis
An opportunity to address high unmet medical need in autoantibody driven conditions Myasthenia Gravis (MG) Most people with MG have IgG antibodies against the A rare, chronic autoimmune neuromuscular disorder acetylcholine receptor that is characterized by fluctuating weakness of the In Myasthenia G
Slide 11: An opportunity to address high unmet medical need: MOGAD
An opportunity to address high unmet medical need in autoantibody driven conditions Myelin Oligodendrocyte Glycoprotein MOGAD is associated with the presence of antibodies directed Antibody Disease (MOGAD) against MOG which disrupts the transmission of nerve signals Inflammatory disorder of the cent
Slide 12: HNSA-5487 demonstrates very rapid and highly robust IgG reduction and clear redosing potential
HNSA-5487 demonstrates very rapid and highly robust IgG reduction and clear redosing potential in Phase 1 FIH trial 7 October 2024 Søren Tulstrup, CEO Hitto Kaufmann, CR&DO