Innovative therapies. FIT Biotech Oy Chief Scientific Officer Santeri Kiviluoto, PhD, BSc (Econ & Bus Adm)
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1 Innovative therapies FIT Biotech Oy Chief Scientific Officer Santeri Kiviluoto, PhD, BSc (Econ & Bus Adm)
2 Disclaimer Any forward-looking statements, estimates and calculations included herein, relating to the Company or the market that it operates in, are based on the best knowledge of the management of the Company at the time they were made and reflect the assumptions they are based on. The Company does not give any affirmation or commitment relating to these statements, estimates or calculations. Due to the nature of such statements, estimates and calculations, they include known and unknown risks as well as uncertainties, and are liable to change e.g. in the event of significant changes in the general economic conditions or industry development. Where certain information contained herein has been supplied or derived from third-party sources, such sources have been identified herein. The Company confirms that such third-party information has been accurately reproduced herein and that as far as the Company is aware and is able to ascertain from information supplied or derived by such third party, no facts have been omitted which would render the reproduced information inaccurate or misleading. However, the Company is not responsible for the accuracy or reliability of such third-party information. Users wishing to rely upon this information should consult directly with the source of the information. All necessary consents for including such third-party information herein has been obtained from the concerned parties. However, use of such information does not imply any affiliation with or endorsement by such third-party.
3 Why invest in FIT Biotech?
4 A changing biopharmaceutical market Biologicals are conquering markets from conventional chemical drugs Source: Evaluate Pharma World Preview 2017, copyright Evaluate Ltd
5 A changing biopharmaceutical market Many blockbuster biologicals are facing thepatent cliff Source: Pharmaceuticals 2012, 5(12), ; doi: /ph
6 Application areas for our technology Therapeutic area Market size (estimate year 2022) Rare diseases $ 209 billion 10,5 % Cancer $ 192 billion 12,7 % Vaccines $ 34 billion 4,2 % CAGR (estimate year 2022) 350 million people worldwide suffer of a rare disease Modern biotechnology creates new opportunities for gene therapies Source: National Organization for Rare Disorders,
7 FIT Biotech develops next generation biotherapeutics From biologicals to gene-based therapies Gene-based therapies: Produced by the body ü ü Less costly to produce Long-lasting effect ü Safe to use ü Solution: The gtgtu -technology efficiently delivers genes to the cell, making next generation therapies a reality
8 Business and revenue model A scalable and cost-effective R&D model FIT Biotech finances preclinical-phase studies Licensing agreement Licensee finances and carries out clinical studies Preclinical Phase I Phase II Phase III FIT Biotech Partner Revenue model Royalties Signing fee Milestone payments R&D Marketed product
9 The strengths of FIT Biotech Responding to the needs of the biopharmaceutical market by developing better and safer biotherapeutics An experienced core team with decades of industry experience A unique patented technology A broad international network Our goal: To develop therapies for diseases with high unmet medical need Through our own research By out-licensing our technology A scalable business model that enables steady returns High upside for investors remember the risks involved
10 Our patented GTU technology 12/7/17 10
11 GTU -technology has been utilized in several clinical trials A DNA plasmid that encodes for a E2 protein system The E2 protein anchors the plasmid to cellular structures without being integrated into the genome Unlike many competing technologies, GTU is not a viral technology GTU has been shown to be clinically safe and well tolerated Regular plasmid GTU
12 The GTU -technology for producing therapeutic proteins in the cell GTU -vector The vector penetrates the cell wall Genetic code to be delivered Nucleus New gene The vector transports the gene into the cell The GTU -technology delivers the gene into the cell, producing a safe treatment Target cell The cell produces protein based on the inserted code Nucleus Desirable therapeutic effect
13 R&D portfolio Our HIV vaccine enters clinical phase 2 Target Description Research Preclinical Stage of development Phase I Phase IIa Phase IIb/III HIV (GTU HIVimmunotherapy) Cancer * (gtgtu antibody therapy) Cancer * (gtgtu antibody therapy) Infectious disease * (gtgtu antibody therapy) * Not dislosed, early stage
14 gtgtu for targeted cancer therapy gtgtu produces high serum antibody levels Cancer grwoth is dealyed with a gtgtu-based therapy and increases survival in a cancer model gtgtu gtgtu gtgtu
15 R&D portfolio Preclinical research Target Description Research Preclinical Stage of development Phase I Phase IIa Phase IIb/III HIV (GTU HIVimmunotherapy) Cancer * (gtgtu antibody therapy) Cancer * (gtgtu antibody therapy) Infectious disease * (gtgtu antibody therapy) Gene therapy collaboration: * Not disclosed, early stage
16 Why invest in FIT Biotech? (1/2) 1. A changing biopharmaceutical market Biological drugs are conquering markets from traditional chemical drugs Many key biologicals are facing the patent cliff Next generation gene therapies will conquer (new) markets 2. Increased licensing activity Licensing activity is growing at a strong pace Large biopharmaceutical companies are looking for partners to develop next generation therapies
17 Why invest in FIT Biotech? (2/2) An experienced core team Several decades of experience in the biotech business, drug development and research 4. A patented technology with many applications Our proprietary technologies respond to the demand created by the changing biopharma market Several national regulatory authorities have deemed the GTU technology safe and well tolerated We focus on two areas of research, each having several product opportunities - scalable technology
18 Largest shareholders FIT Biotech holds 11, 23% of total shares Shareholder % SUOMEN ITSENÄISYYDEN JUHLARAHASTO 14,81 KESKINÄINEN TYÖELÄKEVAKUUTUSYHTIÖ VARMA 4,43 AC INVEST OY 2,25 SVENSKA HANDELSBANKEN AB (PUBL) FILIAL VERKSAMHETEN I FINLAND 1,95 POHJOLA ARTO JUHANI 1,33 PIIROINEN KERTTU MIRJAMI 1,29 BIOTHOM OY 1,26 SARARDA OY 1,22 TRANSLINK CORPORATE FINANCE OY 1,13 KESKINÄINEN ELÄKEVAKUUTUSYHTIÖ ILMARINEN 1,08 FIT Biotech is listed on the First North Finland marketplace with the ticker FITBIO FIT Biotech has over 2200 shareholders (+57% since June 2017)
19 Thank you! FIT Biotech Oy Chief Scientific Officer Santeri Kiviluoto, PhD, BSc (Econ & Bus Adm)
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