Telexos Next Generation Liquid Biopsy for Personalized Cancer Diagnostics - Presentation, March 2020 Contact: Dr. Erhard Fernholz CEO E-Mail: erhard.fernholz@telexos.de
Telexos Overview Telexos/Current Status Area of activity: Cancer Diagnostics in particular Liquid Biopsy ; lab started in 2019 Business concept: Development and distribution of products for Cancer Research and Cancer Diagnostics (clinics), minor activities in service (support of clin. studies). Developmental Status: Next milestone: First introductions (4 Products) in 2021 Competitor situation: Superiority demonstrated Patent Situation: 5 Patent Families Financials: 2019 First investment received 2019 Governmental Grant received Financial needs to reach MS1: 4.9 Mio€ Further Achievements : 2019 Cooperating started with Cancer Research Group 2020 Contract signed with drug-producing company 1
Telexos 1. Cancer is the Second Leading Cause of Death, Globally http://gco.iarc.fr/today/data/factsheets/cancers/39-All-cancers-fact-sheet.pdf • Cancer was responsible for an estimated 9.6 million deaths in 2018. • About 1 in 6 deaths is due to cancer • The economic impact of cancer is significant and is increasing. The total annual economic cost of cancer in 2010 was estimated at approximately USD 1.16 trillion (Source: WHO: http://www.who.int/news-room/fact-sheets/detail/cancer) 2
Telexos 2. Challenges in Cancer Diagnostics General Needs Details Telexos Technology Doable Details Early Detection of Cancer Need for earlier detection to increase Circulating tumor cells (CTCs) the chances for survival enter blood stream early on. Telexos can detect 1 CTC out of 10 bn cells Stratification of Patients Need for much more Telexos can analyze each CTC for Selection of Cancer detailed/personalized and reliable for protein (drug targets) and Therapy diagnostics genomic markers (resistances) Personalized Therapy- - Need to detects progress or stagnancy Telexos can follow the therapy Monitoring of the therapy in personalized manner any time and repetitively. - Need to detects timely dynamic Therefore, adaptations/ changes (e.g. resistances) in interventions are possible any personalized manner time, saving costs. - judge efficiencies of new therapies/new drugs Follow-up, early Detection Follow-up analysis after CTCs enter blood stream early of relapse surgery/therapy according to the on. Telexos can detect 1 CTC guidelines but in personalized manner. out of 10 bn cells 3
Telexos 3. The Liquid Biopsy Market is Huge Telexos Technology can be used for all Segments. J. P. Morgan 2020: 22.4 bn USD (worldwide) Telexos technology can be used for all segments. However, Telexos will focus initially on patient stratification and monitoring. 4
Telexos 4. About Technology Telexos Analysis of whole blood (liquid biopsy) Analysis based on circulating tumor cells (CTCs) (rare white blood cells possible as well) Unlike other competitors, all CTCs are detected because Blood is stabilized (unique) Red blood cells are selectively lysed while keeping all white blood cells (WBCs) and CTCs intact (unique) CTCs are stabilized without effects on further characterization (unique) Single cell deposition possible because aggregation is avoided (unique) Analysis of protein markers (drug targets) and genomic markers (e.g. resistances recognized by mutations) 5 patent families Telexos technology demonstrated the superiority over other CTC-technologies. 5
Telexos 4. Telexos Unique Workflow 1. Blood 3. CTC 4. Single CTC 5. Single CTC 2. Cell Detection Analysis-IHC Genomic Analysis Collection Enrichment Stabilized whole CTCs and Labelled and extra- Deposited Detailed blood White stabilized CTCs single CTCs analysis of Stable for >48 hrs blood cells single CTCs 6
Telexos 5. Clinical Data: Demonstration of Superiority Purpose: Comparison to Market Leader Results of Clinical Pilot Study 180 Set-up of Clinical Pilot Study 160 Breast cancer patients • 140 Number of detected CTCs Results 120 Telexos Veridex 100 Telexos detects all CTC-positive samples • analyzed via Veridex, and never less CTCs. 80 But: Telexos detects > 150% more CTC- • 60 positive samples compared to Veridex. 40 AND: Telexos detects > 400% more CTCs than • Veridex. 20 0 1 3 5 7 9 11 13 15 17 19 21 23 25 * Veridex is currently most often used. Patients samples 7
Telexos 5. Clinical Data: Telexos Technology can guide Cancer Therapy Patients: Only Biopsy M1= neg or 1 Purpose: Stratification of patients in no Treatment based on M1 comparison to tissue biopsy based on a known therapy guiding marker M1 180 160 140 Set-up : • CTCs were isolated according to the Telexos 120 sample preparation protocol 100 • Only the blood sample of those patients were further analyzed who did not undergo 80 therapy based on M1-positivity. 60 Results: 40 • Surprisingly, a significant number of samples could be detected which s how 20 predominantly M1-positive CTCs although 0 the primary tumor was judged M1- 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 negative . Her2 pos M1-pos Her2 neg. M1-neg 8
Telexos 6. Product Pipeline / Product Introduction Plan Time Q1/2023 Q2/2021 Q4/2021 Products CTC Workflow Kits CTC Analysis Kit CTC-IVD Test Kit - for General Use (Breast) Breast CTC Analysis Kit CTC-IVD Test Kit – (Colon) Colon ( Single cell Cell Deposition deposition device ) Device Market Research Market Research Market Diagnostic Market 9
Telexos 7. Risk Assessment/Risk Mitigation General remarks This risk assessment is based on the proposed product requirement and determines - Risks by competition - technical development risks/production risks/production cost issues in respect to the planned products. - Marketing risks About 25 risks had been analyzed. Risk Counter action Product Category (1 – 10; defined 1 = lowest risk) (yes/no) CTC Workflow Kit Competition 2 yes Development/Production risk 3 yes Marketing risks 3 yes CTC Analysis Kits Competition 2 yes Development/Production risk 4 yes Marketing risks 4 yes Single Cell dep. device Competition 2 yes Development/Production risk 7 yes Marketing risks 3 yes 10
Telexos 8. Management Team Dr. Erhard Fernholz, cofounder, CEO • Chemist, >20 years at Roche Diagnostics in diagnostics R&D department • Portfolio/R&D team/project and innovation leader • Developed more than 30 products • > 6 years experience in analysis of circulating tumor cells (project leader including a governmental project) Dr. Klaus Raddatz, cofounder, managing director • Biologist, > 20 years experience in the Pharmaceutical and Diagnostic Industry • Sales, Marketing, Business Development, IP-Management, Licensing and Partnering • 14 years with Roche Diagnostics 11
Telexos 9. Telexos USPs Allows to capture all CTCs in a blood sample, base for diagnostic use Recovery of 93-99% of white blood cells (WBCs): Allows to analyze rare WBCs (e.g. PD-L1 positive white blood cells). Allows deep analysis of each CTC . This finally enables a personalized cancer diagnosis and therapy recommendation. no contaminating cells in the analysis . Is much cheaper than the latest Liquid Biopsy approaches. Allows much faster data analysis than the latest Liquid Biopsy approaches. Does not need a central lab for analysis. The workflow is patent protected 12
Telexos Many Stakeholders Benefit from CTC-Analysis Physicians Patients Find the best therapy available Get the best therapy available Health Care Insurances Regulatory authorities (e.g. FDA), Drug developer Cost reduction by avoiding ineffective drug Proof for effectiveness of new and existing treatment drugs 13
Telexos Contact Dr. Erhard Fernholz CEO Mobil: +49 (0)176/78996877 E-Mail: erhard.fernholz@telexos.de www.telexos.de Address: Office: Telexos GmbH Weidenstraße 27 82362 Weilheim Germany Lab: Telexos GmbH Am Biopark 11 93053 Regensburg Germany 14
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