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Corporate presentation, BIO, Chicago 2013

Developing novel antimicrobials against ”difficult to treat” multi drug resistant bacteria. Corporate presentation, BIO, Chicago 2013. Summary – Adenium Biotech. A spin-out from Novozymes, founded in 2011, strong VC syndicate

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Corporate presentation, BIO, Chicago 2013

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  1. Developing novel antimicrobials against ”difficult to treat” multi drug resistant bacteria Corporate presentation, BIO, Chicago 2013

  2. Summary – Adenium Biotech A spin-out from Novozymes, founded in 2011, strong VC syndicate Management team with extensive experience, industry experienced Board of Directors and strong Scientific Advisory Board of KOL´s ”First-in-class” Arenicin compounds with potent and selective activity against multi-drug resistant Gram-negative bacteria - Lead optimization w. selection of clinical candidate/back-ups in 2013 - ”First in man” by end of 2014 Funding requirement: - USD 10 mio to progress through phase I - USD 25 mio to progress through clinical ”proof of concept” in phase II 2

  3. Adenium Biotech ApS • Management: - Peter Nordkild, MD, CEO, ex Novo Nordisk, Ferring, Egalet, ARTS Biologics - Søren Neve, PhD, project dir, ex Lundbeck, Novozymes • Investors: - Novo Seeds - Sunstone Capital • Board of Directors: - Khalid Islam, PhD, ex Arpida, chairman - Anker Lundmose, MD, ex Novo Nordisk, OSI Pharmaceuticals - Andreas Segerros, MSc, MBA, Sunstone Capital - Stephan Christgau, PhD, Novo Seeds - Casper Tind Hansen, MSc, Novo Ventures - Ejner Bech Jensen, MSc, VP R&D Novozymes A/S • Scientific advisory board: - Prof Brad Spellberg, US- Prof David Livermore, UK- Dr Bruce Montgomery, US- Dr Frank Fildes, UK - Prof Matt Cooper, AUS 3

  4. Arenicin selection process: Adenium benefits from extensive know how > 500 organisms screened for antimicrobial activity 1500 hits but only 10 variants selected Several G+ but only one G- identified ! NZ17074 Lead First Hit Second variant library (~90.000 variants) Variant library generation (~250.000 variants) ~40 AMP’s identified 4

  5. Medical need for broad spectrum Gram-negative antimicrobial Bacteria are rapidly becoming resistant to known antibiotics - 160.000 patients with nosocomial XDR Gram-negative infections in 2011 in USA alone - Carbapenem resistant Klebsiella increased from < 5 % to 29.6% in Italy over 5 years Increasing resistance even to last and toxic resorts e.g. Colistin GAIN legislation approved to grant priority review, fast track status and extend market exclusivity period with 5 years GAIN pathogens: Acinetobacter, Klebsiella, Pseudomonas and E. Coli 5

  6. Ideal Target Product Profile for multidrug resistant broad spectrum Gram-negative antimicrobial Novel mode of action Bactericidal Selective and specific Low frequency of resistance Active against GAIN pathogens Chemically amenable 6

  7. Arenicin: Unique MoA and broad spectrum Gram-negative activity • Arenicin is bactericidal with a novel dual mode of action • Bacterial membrane penetration • Protein synthesis inhibition • Selective and specific: no haemolytic or cytotoxic activity in mammalian cells • Very low spontaneous mutational frequency and resistance • Broad spectrum activities against a wide range of XDR Gram-negative pathogens • Wide therapeutic window. 50 – 200 fold difference between effective dose and MTD in vivo • 21 AA peptide synthesized by standard solid phase synthesis 7

  8. Arenicin-3 and the cell membrane -MoA TEM of P.aeruginosa after incubation with AA143 Extracellular ATP after 10 min Fold change P. aeruginosaincubated with 32 μg/mL AA143. Red arrow shows the membrane disruption. Blue arrow shows release of the cytoplasm. x MIC Arenicin (Ar), colistin (col), and piperacillin (pip) induced releaseof ATP from E. coli. Exponential cells were incubated with drug for 10 minutes and ATP measured. y-axis is fold change relative to untreated and x-axis is fold MIC applied. 8

  9. Arenicin is selective and specific for bacteria with low hemolytic and cytotoxic activity wt 9

  10. Arenicin shows favorable efficacy compared to current treatment options MIC90 determinations 10

  11. Arenicin shows low potential for resistance development 11

  12. Arenicin shows good activity in animal models of UTI and Pneumonia • Arenicin shows good efficacy in the UTI model • with ED50 at 1.8 mg/kg in the bladder • Arenicin exhibits bioload reduction similar • to Meropenem in the Pneumonia model 12

  13. Arenicin is well tolerated with a wide therapeutic window • Favorable MTD in mini-pigs and mice at 30-50 mg/kg • No observed adverse effect level (NOAEL) at 30 mg/kg • Therapeutic window (NOAEL/ED50 bladder) of 75 • Three times longer half-life than Meropenem in mini-pigs • Well distributed with a high volume of distribution of 900 ml 13

  14. Milestone plan In vivo efficacy against key pathogens Pseudomonas, Acinetobacter and Klebsiella in pneumonia Completed Three leads identified for lead optimization Completed Lead candidate selection Q4 2013 IND enabling tox/safety completed Q4 2014 IND filing Q4 2014 First in man initiation Q1 2015 Initiation of clinical ”Proof of Concept” (phase II) Q2 2016 Completion of clinical PoC Q2 2017 14

  15. Key Value Drivers for Investment Broad spectrum XDR Gram-negative first in class drug with unique MoA and strong patent position Significantly increased interest in antimicrobials area with GAIN Act/LPAD introduction No new MoA programs in clinical development Good safety and tox properties and solid in vivoPoC package Phase II data package to be established for USD 25 mio Experienced team to execute development plan 15

  16. Plectasin – an MRSA/VISA/GISA opportunity MRSA is the largest XDR pathogen Very compelling Plectasin MICs against MRSA & GISA Plectasin superior to Daptomycin/Vancomycin in infectious endocarditis MRSA device/implant infections is a large unmet need 16

  17. Plectasin superior to Vancomycinand Daptomycinin infectious endocarditis model Days -1 0 1 2 3 4 5 Infection Treatment IV Relapse 17

  18. In vitro efficacy, tox and kinetics of Plectasin variants *2h iv infusion ** iv bolus administration

  19. Contact details Dr Peter Nordkild Mobile: + 45 25 47 16 46 Email: pno@adeniumbiotech.com Website: www. Adeniumbiotech.com 19

  20. Additional information 20

  21. External activities and cost for development of Arenicin in cUTI 5 3 9 3 12 6 3 3 12 18 6 21

  22. Intellectual property Broad IP portfolio with composition of matter and method of use patents. Future patents on specific variants and formulations possible. 22

  23. Competitive Gram-negative antibiotics with novel MoA in development 23

  24. Antimicrobial deals 2009-2012 24

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