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Corporate presentation, April 2012

Corporate presentation, April 2012. Adenium Biotech. Management: - Peter Nordkild, MD, CEO, ex Novo Nordisk, Ferring, Egalet - Søren Neve, PhD, project director, ex Lundbeck, Novozymes Board of Directors: - Khalid Islam, PhD, ex Arpida, chairman

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Corporate presentation, April 2012

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  1. Corporate presentation, April 2012

  2. AdeniumBiotech Management: - Peter Nordkild, MD, CEO, ex Novo Nordisk, Ferring, Egalet - Søren Neve, PhD, project director, ex Lundbeck, Novozymes Board of Directors: - Khalid Islam, PhD, ex Arpida, chairman - Stephan Christgau, PhD, Novo A/S - Andreas Segerros, Sunstone Capital - Anker Lundemose, MD, ex Novo Nordisk, OSI Pharmaceuticals - Ejner Bech Jensen, MSc, VP R&D Novozymes A/S - Casper Tind Hansen, MSc, Novo A/S Current Investor: - Novo A/S Special advisor: professor Brad Spellberg

  3. Bad Bugs – No Drugs (IDSA, 2004) Resistance The total US market of hospital acquired infections was in 2006 estimated at USD 7.9 billion. 65% of hospital acquired infections are caused by Gram-negative bacteria (Clin Infect Dis 2005;41:848–854)

  4. ESKAPE pathogens • Enterococcusfaecium • Staphylococcusaureus • Klebsiella species • Acinetobacterbaumannii • Pseudomonasaeruginosa • Enterobacter • E.coli • E. aerogenes • E. cloacae

  5. Nosocomial indications - volume/value Source : Datamonitor 03/2007

  6. Key antibacterial needs 2011 Source: Datamonitor 02/2011.

  7. Competitive Gram-negative antibiotics in development

  8. Arenicin-3 NZ17000 • Isolated from lugworm (Arenicola marina) • 21 amino acids • Very stable beta-hairpin structure • MW 2.613 kDa • pI ~ 11.27

  9. Arenicin program highlights • Novel mode of action, no cross resistance to existing antibiotics • Bactericidal on broad range of multidrug resistant Gram-negative bacteria • Wide therapeutic window established in mice and pigs • No novel bactericidal Gram-negative antibiotics in clinical development • Strong lead/back up product candidates • Stable IV formulations • Strong IP (2025-2030) • Addresses significant unmet Gram-negative clinical need • Large, growing and non-generic hospital market of USD 8 billion • Hospital and primarily ICU based specialist target group requiring small sales force

  10. Wildtype has broad spectrum in vitro activity against clinical isolates

  11. MIC and protein binding of selected variants

  12. MoA - localization of Arenicin Extracellular ATP after 10 min Fold change • B.E. coli exposed for 30 min with TRITC labelled NZ17000. Clusters of NZ17000 were localized in the bacterial membrane A. E. coli exposed for 30 min to NZ17000 and stained with TRITC. Treatment with NZ17000 results in influx of TRITC into the E. coli x MIC • Perturbs the membrane potential increasing the permeability of the bacterial membrane. • Inhibits the protein synthesis. Arenicin-3 (Ar), colistin (col), and piperacillin (pip) inducedrelease of ATP from E. coli. Exponential cells were incubated with drug for 10 minutes and ATP measured. y-axis is fold change relative to untreated (0xmic) and x-axis is fold MIC applied.

  13. Wildtype has low hemolytic and low cytotoxic activity

  14. Wildtype time to kill vsE.coli and Pseudomonas

  15. Effect of NZ17143 in a 24 hour mouse pneumonia model against Klebsiellapneumoniae(ATCC 43816)

  16. Efficacy of NZ17143/NZ17211 against MDR E. coli in the murine Urinary Tract Infection model Urine 2 day post infection Bladder 3 days post infection Kidney 3 days post infection

  17. Dose response of NZ17211 in the UTI mouse model • ED50~0.2 mg/kg in urine and the bladder

  18. Pharmacokinetic properties after IV administration

  19. In vivo toxicological overview after 7 days of multiple dosing in pigs and mice

  20. Intellectual property

  21. Arenicin summary • New mode of action • Spontaneous mutational frequency for E. coli is 3X10-9 and P. aeruginosa<10-8 • Potent in vitro activity against a wide spectrum of MDR Gram-negative bacteria • Rapidly bactericidal – MBCs ~ MICs • No cross resistance to known antibiotics • No or little inoculum effect • Favorable efficacy in experimental animal models of infection: • Pneumonia against Klebsiella • UTI against E. coli • Septicemia against E. coli and P. aeruginosa • Thigh infections against E. coli.

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