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AiCuris: 10 years of successful R&D in anti-infective therapy BIO Europe Cologne, Germany; 08 November 2016 AiCuris: The Powerhouse for Anti-Infectives Committed to making the difference AiCuris at a Glance The Powerhouse for

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AiCuris: 10 years of successful R&D in anti-infective therapy

BIO Europe Cologne, Germany; 08 November 2016

SLIDE 2

AiCuris: The Powerhouse for Anti-Infectives

“Committed to making the difference”

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AiCuris at a Glance

The Powerhouse for Anti-Infectives

Foundation Spin-out from Bayer’s Antiinfective research in March 2006. Built up with 21 Bayer experts – today 55 employees Approach Development of resistance-breaking antiviral & antibacterial agents with new mode-of-actions and/or from new chemical classes Projects / Products - addressing high medical need Antivirals (HCMV, HSV, HBV, Adenovirus) and Hospital Antibiotics Lead candidate Letermovir (prophylaxis and treatment of HCMV) licensed to Merck & Co (MSD), currently in clinical Phase 3

AiCuris - BioEurope 2016

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Achievements in Research & Development

AiCuris’ research activities in Virology and Bacteriology resulted in several new development candidates AiCuris’ development activities

 Currently 5 projects in Phase 1  2 compounds achieved proof of concept and successfully completed dose-range-finding

in Phase 2

 1 compound reached Phase 3 clinical testing (cooperation with MSD)

AiCuris - BioEurope 2016

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Indication Program Discovery Preclinical Phase I Phase II Phase III HCMV

Human cytomegalovirus

Letermovir (AIC246)

[Licensed to Merck&Co (MSD)]

AIC476 AIC387 AIC813

[Licensed to Merck&Co (MSD)]

HSV

Herpes simplex virus

Pritelivir (AIC316), oral

Pritelivir (AIC316), topical

Autoimmune diseases AIC284 HBV

Hepatitis B virus

AIC649 Research Adenovirus Research Hospital antibiotic AIC499

[supported by IMI]

Research Research

AiCuris – R&D Pipeline

AiCuris - BioEurope 2016

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Gram-negative Resistance Breaker (AIC499)

Superior Drug with Blockbuster Potential

Indication Multidrug resistant (MDR) Gram-negative infections caused by a broad range of bacterial species incl.

P. aeruginosa and Enterobacteriaceae

Mode of action Resistance-breaking β-lactam for broad empiric use in combination antibiotic with β-lactamase inhibitor (BLI) Status of development Advanced Preclinical development Next events Start clinical Phase 1 expected end 2016 USPs

 Hospital-treated

Gram-negative bacteria, expected market volume (2021) $3.8B

 No approved drug

with comparable MDR coverage so far

 Premium pricing

due to high unmet medical needs in life-threatening situations

AiCuris - BioEurope 2016

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AIC499 + BLI allows to treat a vast proportion of infections caused by Gram- negative wild-type and MDR pathogens

Enterobac- teriaceae wt strains ESBL strains AmpC strains KPC strains OXA-48 strains NDM strains

P. aerugi-

nosa wt

P. aerugi-

nosa MDR strains Acineto- bacter wt strains

A. bau-

mannii MDR strains meropenem imipenem piperacillin + tazobactam ceftazidime ceftazidime + avibactam aztreonam aztreonam + avibactam AIC499 AIC499 + tazobactam excellent coverage (>90%) good coverage (70% - 89%) partial coverage (30% - 69%) no coverage (<29%) BLI combination data was not determined

AIC499 profile – Pathogen Coverage

AiCuris - BioEurope 2016

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Pritelivir (AIC316)

A Perfect Protection against Herpes Simplex Virus

Mode of action: Inhibition of HSV helicase-primase Indication: HSV infections in immune suppressed patients (“last resort”), treatment and suppression of recurrent genital and labial herpes Status of development:

 In preparation for clinical Phase 2 for “Last Resort”  In preparation for clinical Phase 2 for “Labial herpes”

Next events

 Start Phase 2 for “Last Resort” in immunocompromised

patients

 Start Phase 2 for labial herpes

USPs

 Novel mode of action  Protection of

uninfected cells

AiCuris - BioEurope 2016

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Pritelivir

A Perfect Protection Against HSV

 Cells protected for >24 h due to long half-life  no activation required

 Present drugs do not cover sufficient exposure for continuous control of HSV  Viral enzyme (TK) needs to be present for activation of nucleosides

Highly effective suppression of recurrent episodes, shedding and transmission

No protection of uninfected cells Perfect protection

HSV

AiCuris - BioEurope 2016

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2.4 5.2 1.7 5.4 1 2 3 4 5 6 Pritelivir Valacyclovir Pritelivir Valacyclovir Shedding rate (%)

Shedding rate

*** ***

1.9 3.9 1.1 4 0.5 1 1.5 2 2.5 3 3.5 4 4.5 Pritelivir Valacyclovir Pritelivir Valacyclovir Lesion rate (%)

Lesion rate

*** *** ITT PP *** p<0.0001

Not shown: log HSV DNA, shedding AUC, as well as number of subjects reporting pain was significantly lower under pritelivir than under valacyclovir

Pritelivir superior to valacyclovir in primary and secondary endpoints

Pritelivir - AIC316-01-II-01

Phase 2 Pritelivir vs. Valtrex™

AiCuris - BioEurope 2016

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Indication

HCMV infections in cases of immune incompetency, deficiency

r immunosuppressed patients (e.g. transplant patients)

Mode of action

Antiviral drug, inhibition of HCMV viral terminase

Status of development

 Met primary endpoint in Phase 3 efficacy / safety study

for prevention of HCMV infection in bone-marrow-transplant recipients (conducted by Merck & Co.)

 Orphan drug status in EU and the US,

FDA Fast Track Designation

Letermovir (AIC246)

New Treatment Approach against HCMV

USPs

 Novel mechanism

f action

 Good oral

bioavailability and lack of toxicity

AiCuris - BioEurope 2016

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Partnering Track Record

Breakthrough Alliance Award 2013 by Deloitte Recap

AiCuris and Merck & Co, USA Enter Exclusive Worldwide License Agreement for Investigational Portfolio Targeting Human Cytomegalovirus

 Letermovir, first-in-class

small molecule candidate against the Human Cytomegalovirus (HCMV) plus back-up project

 Upfront payment €110 m  Milestone payments

€332.5 m

 Royalties on worldwide

sales

 Option to co-promote in

selected countries

 Biggest licensing deal

f a German biotech

company

 Awarded „Deal of the

Year“ 2013 with prestigious Deloitte Recap Breakthrough Alliance Award

Asset The deal structure Highlights

AiCuris - BioEurope 2016

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Summary – 10 years of AiCuris

A Company with Proven Track Record in R&D

The Powerhouse for Anti-Infectives Scientists and experts in all focus research fields and for all pre-clinical and clinical development activities Proven track record as PoC company

 Current pipeline comprises

advanced projects originating from

wn in-house research

 Multiple new research and

development projects since foundation in 2006

Global network of experts, partners and service providers In addition to in-house R&D, focused scouting activities towards identification of:

 New interesting targets/MoAs for

antivirals and antibacterials

 Potential joint development partners

and in-licensing opportunities

 Opportunities to expand our pipeline

and business

AiCuris - BioEurope 2016

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