Marinomed Biotech Ag · VIE:MARI
Marinomed Biotech — Fact Sheet (February 2025)
16 slides from Marinomed Biotech's fact sheet, Feb 11, 2025
Slide 1: Budesolv
Budesolv Low-dose anti-allergic corticosteroid nasal spray with immediate relief February 2025
Slide 2: Disclaimer
Disclaimer These materials (the “Presentation”) have been provided to you by Marinomed Biotech AG together with its respective members, directors, officers, employees, advisers or agents (together “Marinomed”) in connection with a potential transaction relating to Marinomed’s asset Budesolv (the “Tr
Slide 3: Marinomed at a glance
Marinomed at a glance / 0) Marinomed
Slide 4: Marinomed at a glance
Marinomed at a glance Publicly listed biopharmaceutical company located in Korneuburg, Austria Launch of first Invention of Marinosolv New headquarter in Deal with Procter & Carragelose product solubilization technology Korneuburg Gamble 2008 2016 2020 2022 2006 2011 2019 2021 2023 Foundation as spi
Slide 5: Budesolv
Budesolv The only low-dose intranasal, preservative free corticosteroid with strong symptom relief after first dose Erich Durchschlag Marinomed Biotech AG s. Business Development Mgr. Hovengasse 25 +43 676 3253005 2100 Korneuburg, Austria erich.durchschlag@marinomed.com © Marinomed Biotech AG 5
Slide 6: Executive summary: Budesolv
Executive summary: Budesolv Innovative opportunity with strong USP to challenge the total allergic rhinitis market Budesolv Market opportunity Regulatory path Business model • Fast and strong efficacy after first dose • Fast growing (~4,5% • Hybrid application in EU • Classical license deal • Strong
Slide 7: Marinosolv® platform technology
Marinosolv® platform technology Formulation technology Capabilities / improvements • Solubilization of poorly water-soluble compounds • Significantly increases bioavailability • Allows dose reduction & faster onset of action • Reduces pharmaceutical compounds in wastewater • Clinically validated & p
Slide 8: Budesolv nasal spray
Budesolv nasal spray The only nasal spray providing solubilized corticosteroid Benefits of the solution • Highly increased bioavailability • Fast onset of action after first dose • Low dose application (~16% of originator) • Preservative - free formulation • Easy to use - no shaking, high-precision
Slide 9: Pathophysiology of Allergic Rhinitis (AR)
Pathophysiology of Allergic Rhinitis (AR) IgE/allergen (FcεRI) complex binding to mast cells causes release of histamines and pro-inflammatory cytokines Bildergebnis für mast cells allergic response histamine cytokine Block Histamine release with Anti-histamines Allergic reaction triggered by IgE pl
Slide 10: Allergic Rhinitis market
Allergic Rhinitis market Huge market potential for innovative drugs in a growing market Highest growth for antihistamines & corticosteroids Overall growth of global allergic rhinitis market 15.4bn US$ 11.4bn US$ +4.0bn US$ 1.2 Antihistamines 1.3 Decongestants 2023 4.7 Corticosteroids 2030 7.7 4.8 3.
Slide 11: Medical need in Allergic Rhinitis (AR)
Medical need in Allergic Rhinitis (AR) Range of therapies available, but high unmet medical need remains Antihistamines Corticosteroids Immunotherapy The unmet medical need in allergic rhinitis Effectiveness Marketed steroid drugs have slow onset of action Onset of action Antihistamines are less eff
Slide 12: Primary endpoint: Non-inferiority
Primary endpoint: Non-inferiority Budesolv clinically equivalent to the originator on day 8 in phase 3 study TNSS* Scores day 8 (n=75) Treatment Mean SD Median N Budesolv 10 4.98 2.57 4.47 75 Rhinocort 5.05 2.75 4.82 75 Aqua 64 Placebo 7.48 2.80 7.47 75 Budesolv 10 Rhinocort aqua 64 *TNSS = total na
Slide 13: Key secondary endpoint: Fast onset of action TNSS
Key secondary endpoint: Fast onset of action TNSS* Budesolv superior over originator on day 1 in phase 3 study TNSS onset day 1 TNSS before and after 0.5 treatment 7.6 0 7.4 7.2 TNSS -0.5 7 -1 6.8 TNSS 6.6 -1.5 6.4 0 30 60 90 120 150 180 210 240 6.2 min 6 5.8 Budesolv Placebo Rhinocort 5.6 Budesolv
Slide 14: Budesolv positioning with strong USP(s) & high market potential
Budesolv positioning with strong USP(s) & high market potential Budesolv: Competitor: Clear Suspension Budesolv Positioning Solution Bioavailability high low High bioavailability at low dose (tissue permeation) Onset of action hours 5-8 days First in class fast acting nasal spray Max. 40 µg Less sid
Slide 15: Path to launch formulation and marketing authorization
Path to launch formulation and marketing authorization Solutions to improve CIinical Phase 3 formulation manufacturing process and Further road towards MA insufficient stability at RT formulation • Metal free production • Oxygen-sealed packaging • Stable formulation at RT • APF pump • Stability test
Slide 16: Budesolv
Budesolv First low-dose intranasal corticosteroid with immediate relief after initial dose Erich Durchschlag Marinomed Biotech AG s. Business Development Mgr. Hovengasse 25 +43 676 3253005 2100 Korneuburg, Austria erich.durchschlag@marinomed.com © Marinomed Biotech AG 16