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Corporate presentation, February 2013

Anti microbial peptides for the fight against multi drug resistant bacteria

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Summary – Adenium Biotech• New biotech company - Spin out of Novozymes AMP program - Strong scientific advisory board and VC syndicate• Target XDR Gram negative bacteria - Gram-negative platform with novel mode of action - No novel bactericidal Gram-neg antibiotics in clinical development• Adenium Biotech pre-clinical studies - In vivo efficacy against XDR Klebsiella, Pseudomonas, Acinetobacter and E. coli in several animal models - Wide therapeutic window in mice and pigs - Lead optimization for selection of lead product candidate in 2013• Strong intellectual property position

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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 avid Livermore, UK - Dr Bruce Montgomery, US - Dr Frank Fildes, UK - Prof Niels Høiby, Denmark

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Arenicin selection process

Variant library generation(~250.000 variants)

~40 AMP’s identified

Several G+ but only one G- identified !

> 500 organisms screened for antimicrobial activity

NZ17074

Second variant library (~90.000 variants)

1500 hits but only 10 variants selected

First HitLead

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Unique MoA and broad spectrum Gram-negative activity

• Arenicin has dual mode of action and is bactericidal– Bacterial membrane penetration– Protein synthesis inhibition– No haemolytic or cytotoxic activity in mammalian cells

• 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

• Very low spontaneous mutational frequency and resistance• 21 AA peptide synthesized by standard solid phase synthesis

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Arenicin-3 and the cell membrane -MoA

A. E. coli exposed for 30 min to wt and stained with TRITC. Treatment with wt results in influx of TRITC into the E. coli

B. E. coli exposed for 30 min with TRITC labelled wt. Clusters of wt were localized in the bacterial membrane

At OD600 =0.4 E.coli cells were exposed to 32ug/ml Arenicin, 64ug/ml Fosfomycin and 16ug/ml Polymycin B. Even at very high concentration of Arenicin-3, no dramatic morphological changes of the cells were observed.

0 16 64 256 1024 40960

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Arcolpip

Extracellular ATP after 10 min

x MICFo

ld c

hang

e

Arenicin-3 (Ar), colistin (col), and piperacillin (pip) induced release 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.

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Low hemolytic and low cytotoxic activity

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wt

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# strains wt AA139 AA143 AA230 Ceftazidime Ciprofloxacin Colistin Gentamicin Meropenem Tigecycline

N=325 MIC (µg/ml) MIC (µg/ml)

CLSI MIC (µg/ml)

CLSI MIC (µg/ml)

CLSI MIC (µg/ml)

CLSI MIC (µg/ml)

CLSI MIC (µg/ml)

CLSI

E.coli N=55 0.5 1 0.5 0.5 >32 R >4 R 0.25 S >32 R 4 S 0.5 S

K.pneumonia N=75 4 4 16 4 >32 R >4 R 8 R >32 R >16 R 4 I

P.aeruginosa N=75 2 8 16 2 >32 R >4 R 2 S >32 R >16 R >8 R

A.baumanii N=120 1 2 32 2 >32 R >4 R 8 R >32 R >16 R 4 I

Efficacy compared to current treatment options. MIC90 determinations

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Spontaneous mutational frequency

Organism Isolate ID Resistance Frequency (4XMIC)

wt AA139 AA143 AA230

E. coli ATCC 25922≤ 3,57E-11 ≤ 2,50E-12 ≤ 3,57E-11 ≤ 2,50E-12

E. coli 3083559≤ 2,08E-11 ≤ 8,90E-11 ≤ 2,08E-11 ≤ 8,90E-11

K. pneumoniae 3083832≤ 9,09E-11 ≤ 4,16E-10 ≤ 9,09E-11 ≤ 4,16E-10

K. pneumoniae 3083583≤ 5,00E-11 ≤ 1,38E-11 ≤ 5,00E-11 ≤ 1,38E-11

P. aeruginosa ATCC 27853≤ 8,30E-11 ≤ 2,61E-12 ≤ 8,30E-11 ≤ 2,61E-12

P. aeruginosa 3083655≤ 7,14E-11 ≤ 2,68E-12 ≤ 7,14E-11 ≤ 2,68E-12

A. baumannii 3083835≤ 3,44E-11 ≤ 2,65E-12 ≤ 3,44E-11 ≤ 2,65E-12

A. baumannii 3083684≤ 7,14E-10 ≤ 4,80E-10 ≤ 7,14E-10 ≤ 4,80E-10

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Klebsiella/Pseudomonas/Acinetobacter bioload

reduction

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Klebsiella Pneumonia ATCC 43816

Variantlog

reductionAA143 -2,29

AA139 -1,89

AA230 -1,71

wt -1,59

Meropenem -0.67

Pseudomonas aeruginosa VL-98

Variant log reductionAA139 -1,12

AA230 -0,92

AA143 -0,10

wt 0,26

Meropenem -2.72

Acinetobacter baumanii 377

Variant log reductionAA143 -1,01

wt -0,92

AA139 -0,18

AA230 -0,04

Meropenem -1.49

HoursMouse lung infection

Bacteria ~108

Mouse strain : CD-1

0 4Inoculum

6Treatment

8Evaluation of CFU in

lung

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ED50 ~1.5 mg/kg in urine and ~ 1.8 mg/kg in the bladder

Dose response in the UTI mouse model

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DaysMouse urinary tract infection

E.coli ~108

Mouse strain : OF-1

5% glucose in drinking water

-4 0Inoculum

1Treatment BID

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Evaluation of CFU inUrine, Bladder And Kidney

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Toxicological overview after 7 days of daily dosing in mice

Variant wt AA139 AA143 AA230

MTD iv (mg/kg) 25 30 50 40

NOAEL iv (mg/kg) 10 - 30 -

HED (mg/kg) 9,5 N/A 28,5 N/A

E. coli ED50 Bladder (mg/kg) 1,8 N/A 0,4 N/A

NOAEL/ED50 Bladder 6 N/A 75 N/A

Protein binding 99 95 85 97

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Comparison of kinetics in pigsand mice

Mini pig  mg/kg wt wt AA143 AA143

2h IV Infusion 18 20 38 42Mini pig Mouse Mini pig Mouse

HL_Lambda_z hr4.8 3.4 2.2 1.9

Cmax ug/ml18 27 57 54

Cmax_D ug/ml/mg1.0 1.3 1.5 1.3

AUCall hr*ug/ml98 77 212 120

AUC_%Extrap_obs %

34 20 10 6

Vz_obs ml826 102 505 895

Cl_obs ml/hr120 208 162 324

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Development program

• Selection of lead product candidate in Q3 2013

• CMC and preclinical tox initiated in Q4 2013

• First human dose in Q4 2014• Phase IIa initiated in 2015

– Initial registration in cUTI– Main indication HAP/VAP

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External activities and cost for development of Arenicin in

cUTITask 2013 2014 2015 2016 2017 2018 2019 CostMUSD

Lead candidate selection

Synthesis of 2 kg of cGMP material (Pre clin , phI) 2.0

Fill and finish ( phI ) 0.3

Pre-clinical tox/ safety 0.5

CTA/IND 0.1

Phase I (SAD/MAD) 2.0

cGMP production for ph II and III 10.0

Fill and finish (phII, phIII) 0.7

SPA meeting 0.3

Phase II (a and b) cUTI 6.0

Phase III studies cUTI 30.0

NDA submission 0.3

Total / Year 1.0 1.8 2.1 13.0 14.0 10.0 10.3 52.2

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Milestone plan • In vivo efficacy demonstrated against Pseudomonas,

Acinetobacter and Klebsiella in pneumonia Completed• Three leads identified for lead optimization Completed• Bronchioalveolar lavage study April 2013• Mode of action May 2013• ED 50 in pneumonia Sept 2013• PK/PD in UTI Oct 2013• Lead candidate selection Oct 2013• Pre-clinical tox/safety completed Dec 2014• IND filing Q1 2015• Phase I SAD/MAD study completed Q1 2016• Phase IIa completed Q1 2017

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Intellectual property

NZ familyWO #

Type Description Issued/priority Expires

10865WO07023163

Composition of matter

Arenicin-3 26.08.2005 26.08.2025

11526WO154525A1

Composition of matter

Arenicin-3 variants 12.06.2010 12.06.2030

11704WO070032A1

Medical use Treatment of UTI with Arenicin-3 11.12.2009 11.12.2029

EP12166275 Medical use Treatment of pneumonia with Arenicin-3 variants

01.05.2012 01.05.2033

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Broad IP portfolio with composition of matter and method of use patents.

Future patents on specific variants and formulations possible.

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Key Value Drivers for Investment

• Broad spectrum XDR Gram-negative first in class drug with unique MoA

• Significantly increased interest in anti-infectives area with GAIN Act/LPAD introduction

• No new MoA programs in clinical development• Good safety and tox properties and solid in vivo

PoC package• Phase IIa data package to be established for USD

15 mio• Experienced team to execute development plan

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Contact details

Dr Peter NordkildMobile: + 45 25 47 16 46

Email: pno@adeniumbiotech.comWebsite: www.

Adeniumbiotech.com

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