SenzaGen AB2030 – Hållbar konsumtion och produktion i en cirkulär ekonomi Miljötillståndsdagen 201830 januari 2018

Anki Malmborg Hager, VD

GARD – Säkrare tester för hållbar produktion

Den nya globala standarden för djurfria tester

• 120 000 – 145 000 kemikalier i världen

• 22 000 kemikalier är klassade som

ingredienser i kosmetika

• 1000-2000 nya kemikalier varje år

Kemikalier omger oss dagligen

Kemikalier kan påverka vår hälsa

Alla hälsopåverkande egenskaper måste dokumenteras

Lagstiftning tvingar till testning• REACH-förordningen(EG) nr 1907/2006Alla kemikalier måste testas

• CLP-förordningen(EG) nr 1272/2008Alla kemikalier måste klassas

• EMAEuropean Medicines Agency – det Europeiskaläkemedelsverket.

Kemikaliemarknaden• GLOBAL REGULATORY ENVIRONMENT FOR CHEMICAL USAGE

REACH-like regulations being considered. Current only requires minimum hazard assessment

CEPA 1999

REACH: Full data set requirement on chemicals

3 000

Japan Others NAFTA EU Asia Total

Chemical industry EUR bn5

2010 2020

Kosmetikamarknaden

Animal ban

Prohibitions are considered

Guidelines to use alternatives

20132015

2013

2014

2014

GLOBAL REGULATORY ENVIRONMENT FOR ANIMAL TESTING

2016 2017 2018 2019 2020 2021

Cosmetic industry EUR bn

301.1

Läkemedelsmarknaden

9.6%

0%

20%

40%

60%

80%

100%

Phase I to II Phase II to III Phase III toNDA/BLA

NDA/BLA tpoApproval

Phase I toapproval

Success rate and time line clinical drug development

0

500

1 000

1 500

1970's 1980's 1990's 2010

Clinical drug development EUR m

Preclinical Clinical

12.9 years

1 approvedchemical

Product development

Rule of thumb is that of 10 000 tested chemicals for a

new clinically testedpharmaceutical product, only

1 makes it to the final product

OVERVIEW DRUG DEVELOPMENT STATISTICS

EU 2013Israel 2013Indien 2013Delstater i Brasilien 2014Nya Zeeland 2015Australien 2016Sydkorea 2016Taiwan 2016

… och processer pågår i de flesta delar av världen ...

Förbud mot djurförsök vid tester av kosmetika

Från uppfinning till företag2005-2010EU program Sens-it-ive. Resultatet blev GARD, ett djurfritt hudallergitest.

2010SenzaGen AB grundades av professorerna Carl Borrebaeck och Malin Lindstedt.

2010 - 2011De första patentansökningarna skickades in.Industriella samarbeten.

2014SenzaGen AB spinns ut från Lunds Universitet, och börjar bygga organisationen.

2017Bolaget noteras på Nasdaq First NorthMarknadsvärde 575 MSEK17 anställdaDotterbolag i USA

Kemikalier måste testas och djurförsök förbjuds i allt fler länder och branscher

3

8

13

18

23

28

2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022

Global in vitro toxicology market 2012-2022 EUR bn14

Average BBC Mordor Intelligence Grand View Reserach

Stratistics MRC Markets and Markets Marketers Media

MARKET GROWTH EXPECTATIONS

12

GARD - DEN ENDA IN VITRO METOD SOM ANALYSERAR EN GENETISK SIGNATUR HOS CELLER SOM UTSATTS FÖR KEMIKALIERS PÅVERKAN

Analysmetoder som speglar verkligheten

• Mänskliga celler från immunförsvaret

• Mäter 200 gener relevanta för hudallergier

• 90% tillförlitlighet

GARD – ett djurfritt hudallergitest

1. Allergisk reaction (GARDskin)• Positiv• Negativ

2. Styrkan i reaktionen (GARDpotency)• 1A – kraftig allergen• 1B – mild allergen

15

GARD i praktiken

Senzagen’s patented test process

ExposureSelection Isolation Quantification Readout

A human cell line mimicking the human immune system is used as target for exposure of substances to be tested.

The cells are exposed to the substance to be tested.

Their genomic product (transcripts) are isolated for downstream quantification.

The gene transcripts are quantified using multiplex Nanostringtechnology.

The readout is processed using advanced computer algorithms to assess a chemical’s ability to induce an allergic reaction.

GARD TECHNOLOGY

GARD i jämförelse med andra testmetoder

Test method Company Test system Accuracy Markers Measures strenght

GARDTMHuman immune

cells 90% >200 ✔

DPRA Cell free 80% 1 ✘

hCLAT Human cells 75% 2 ✘

KeratinoSens Human cells 77% 1 ✘

LLNA (in vivo / animal testing) N.a. Mice 72% N/A ✔

Valid

erad

e av

OEC

D

GARD-testerna stöds av omfattande vetenskaplig dokumentation

‣ Forreryd A, Johansson H, Albrekt AS, Borrebaeck CA, Lindstedt M. Prediction of chemical Respiratory sensitizersusing GARD, a novel in vitro assay based on a genomicbiomarker signature. PLoS One. 2015 Mar 11;10(3)

‣ Forreryd A., Johansson H., Albrekt A.S., Lindstedt M. Evaluation of high throughput gene expression platforms usingGARD – an assay for prediction of skin sensitization based on a genomic biomarker signature. BMC Genomics, 2014.

‣ Johansson H., Rydnert F., Kuehnl J., Schepky A., BorrebaeckC.A.K., Lindstedt M. GARD in-house validation – A proof of concept. Tox Sci, 2014.

‣ Larsson K., Lindstedt M., Borrebaeck C.A.K. Functional and transcriptional profiling of MUTZ-3, a myeloid cell line actingas a model for dendritic cells

URVAL AV LEDANDE PUBLIKATIONER TIDSKRIFTER

GARDplattformGARDskinGARDpotencyGARDairGARDmixturesGARDproteinGARDxxx

AffärsmodellKontraktslaboratorier

Distributörer

Global kommersialisering

Country Company AgreementUnited States Burleson Research Technologies

IQ BioscienceEndev Laboratories

Collaboration agreementDistribution agreementDistribution agreement

United Kingdom XCellR8Charles River

Distribution agreementDistribution agreement

Germany Eurofins Collaboration agreement

South-Korea Woojung Distribution agreement

“Our customers include every major pharmaceutical and biotechnology company in the world, major academic institutions and government research centers”

SenzaGen offices

SenzaGen partner agreements

GARDskin validation update

BRT (US)

Eurofins(DE)

SenzaGen (SE)

Lead Laboratory

Transfer Phase Validation Phase I Validation Phase II

N = 28 blinded

compounds

N = 28 blinded

compounds

N = 28 blinded

compoundsN = 50

GARDskin GARDpotency

BRT (US)93.8%

22

MÄNNISKORNA BAKOM

StyrelseCarl Borrebaeck / Chairman of the board

Professor Carl Borrebaeck founded BioInvent International AB, Alligator BioScience AB, and Immunovia AB. Received AkzoNobel’s science prize and the Royal Academy of Fine Arts Academy gold medal.

Director of CREATE Health Center for Translational Cancer Research, as well as former vice-principal at Lund University. He is a founding mentor for NOME (Nordic Mentor Network), chairman of the board at Immunovia AB and SenzaGen AB as well as a board member at Clinical Laserthermia Systems AB and CB Ocean Capital AB.

Ann Gidner / Member of the board

Ann Gidner has a MSc in Chemical Engineering, LTH in Sweden, ENSIGC in France, and an MBA from Lund University. Leading global positions within Cambrex Corporation and LanxessCorporation where she successfully built large international commercial organizations with strong sales development.

Former head of the life science division at Semcon Caran and CEO of Monocl AB. Currently, business development director at Albumedix A / S, responsible for international licensing of a technology platform for drug development in drug delivery.

Laura Chirica / Member of the board

Laura Chirica has a Bachelor degree in biotechnology from the University of Bucharest in Romania, a biochemistry degree from the MET University in Turkey and a PhD in medical biochemistry from Umeå University in Sweden.

Currently Chief Commercial Officer at Immunovia AB with responsibility for the company’s global commercialisation strategy. Has extensive experience in designing and implementing sales, marketing and commercialization strategies in pharmaceutical and medical technology companies.

Ian Kimber / Member of the board

Ian Kimber is Professor of Toxicology at the University of Manchester who has developed the LLNA (Local Lymph Node Assay) test method (animal testing). Former vice president of the MRC Physiological Medicine and Infection Board, chairman of the British Toxicology Society, and chairman of the British Board of the UK NC3Rs.

Received a number of awards incl. Smithkline Beecham Laboratory Animal Welfare Prize and the Society of Toxicology Immunotoxicology Career Achievement Award, amongst others.

Carl-Henric Nilsson / Member of the board

Carl-Henric Nilsson is technical director in Industrial Organization and University lecturer in business administration and has started and runs successful courses in collaboration between Lund University of Technology and Economics. He has also published many scientific articles and studies.

Management consultant and entrepreneur and has a wide network of industry contacts in Europe, China and the United States.

LedningAnki Malmborg Hager / CEO

CEO of SenzaGen since 2014. Holds an MSc in chemical engineering as well as a PhD in immunotechnology and a pharma MBA from Falconbury.

Board member of Immunovia and Diaprost. Authored 30 scientific articles and book chapters and has written several patents.

Anna Cherouvrier Hansson / CCO

Bachelor’s degree in business economics from Lund University, Master’s degree in business economics from ESC Reims.

Extensive business development experience within industry at Camurus, Invest in Skåne, Zitha Consulting AB.

Steve Smith / Intellectual property counsel

Patent Attorney at Potter Clarkson LLP.

Serves as an adviser to SenzaGen for intellectual property rights and management of the company's growing IP portfolio.

Marianne Olsson / CFO

CFO of SenzaGen since 2016.

25 years of experience as economist from previous position as administrative manager at the Institution of Immunotechnology at Lund University.

Sandra Reynoso / Director business development SenzaGen Inc

Bachelor's degree in molecular biology, San Jose University, USA. Philosophy PhD in immunology and MBA from UCLA, USA.

Experience of medical development. CEO and owner of LabVet BioPacific LCC. Prev. at Pacific Biodevelopment and Sialogen.

Henrik Appelgren / CSO

Bachelor's degree in biology and has a philosophy PhD in genetic toxicology at Stockholm University.

Previously OECD test program coordinator, toxicologist at Kemikalieinspektionen. Extensive experience in development and evaluation of test methods.

Maria Agemark / Laboratory & quality manager

Dr. Maria Agemark has been laboratory and quality manager since 2015.

Background in research of membrane proteins at the Department of Chemistry, Lund University, as well as in the development of antibodies at the Institution of Immunotechnology.

Brian Rogers / CEO SenzaGen Inc

PhD in toxicology, University of North Carolina, USA. MBA from UCLA, USA.

Founder/owner of Pacific BioDevelopment. Successfully assisted companies with pharmaceutical authorities approvals. Prev. at Genentech, Chevron Health and National Institute of Environmental Health Sciences.