[PPT] - Telexos Next Generation Liquid Biopsy for Personalized Cancer PowerPoint Presentation

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Telexos Next Generation Liquid Biopsy for Personalized Cancer Diagnostics

Presentation, March 2020

Contact:

Dr. Erhard Fernholz

CEO E-Mail: erhard.fernholz@telexos.de

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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

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Telexos

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)

1. Cancer is the Second Leading Cause of Death, Globally

http://gco.iarc.fr/today/data/factsheets/cancers/39-All-cancers-fact-sheet.pdf

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Telexos

2. Challenges in Cancer Diagnostics

General Needs Details Telexos Technology

Doable Details

Early Detection of Cancer Need for earlier detection to increase the chances for survival

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Circulating tumor cells (CTCs) enter blood stream early on. Telexos can detect 1 CTC out of 10 bn cells Stratification of Patients for Selection of Cancer Therapy Need for much more detailed/personalized and reliable diagnostics

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Telexos can analyze each CTC for protein (drug targets) and genomic markers (resistances) Personalized Therapy- Monitoring

Need to detects progress or stagnancy
f the therapy in personalized manner
Need to detects timely dynamic

changes (e.g. resistances) in personalized manner

judge efficiencies of new

therapies/new drugs

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Telexos can follow the therapy any time and repetitively. Therefore, adaptations/ interventions are possible any time, saving costs. Follow-up, early Detection

f relapse

Follow-up analysis after surgery/therapy according to the guidelines but in personalized manner.

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CTCs enter blood stream early

n. Telexos can detect 1 CTC
ut of 10 bn cells

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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.

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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.
4. About Technology Telexos

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Telexos

1. Blood

Collection

2. Cell

Enrichment

3. CTC

Detection

4. Telexos Unique Workflow
4. Single CTC

Analysis-IHC

5. Single CTC

Genomic Analysis Stabilized whole blood Stable for >48 hrs CTCs and White blood cells Labelled and extra- stabilized CTCs Deposited single CTCs Detailed analysis of single CTCs

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Telexos

5. Clinical Data: Demonstration of Superiority

Purpose: Comparison to Market Leader Set-up of Clinical Pilot Study

Breast cancer patients

Results

Telexos detects all CTC-positive samples

analyzed via Veridex, and never less CTCs.

But: Telexos detects > 150% more CTC-

positive samples compared to Veridex.

AND: Telexos detects > 400% more CTCs than

Veridex.

* Veridex is currently most often used.

20 40 60 80 100 120 140 160 180 1 3 5 7 9 11 13 15 17 19 21 23 25 Number of detected CTCs Patients samples Telexos Veridex

Results of Clinical Pilot Study

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Telexos

Purpose: Stratification of patients in comparison to tissue biopsy based on a known therapy guiding marker M1 Set-up:

CTCs were isolated according to the Telexos

sample preparation protocol

Only the blood sample of those patients

were further analyzed who did not undergo therapy based on M1-positivity. Results:

Surprisingly, a significant number of

samples could be detected which show predominantly M1-positive CTCs although the primary tumor was judged M1- negative.

20 40 60 80 100 120 140 160 180 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24

Patients: Only Biopsy M1= neg or 1  no Treatment based on M1

Her2 pos Her2 neg.

5. Clinical Data: Telexos Technology can guide Cancer Therapy

M1-pos M1-neg

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Telexos

6. Product Pipeline / Product Introduction Plan

Products Market Time

Research Market Q2/2021 CTC Workflow Kits for General Use Q4/2021 Q1/2023 CTC Analysis Kit (Breast) CTC Analysis Kit (Colon) (Single cell deposition device) CTC-IVD Test Kit - Breast CTC-IVD Test Kit – Colon Cell Deposition Device Research Market Diagnostic Market

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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.

Product Category Risk (1 – 10; 1 = lowest risk) Counter action defined (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

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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

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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

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Many Stakeholders Benefit from CTC-Analysis

Patients

Get the best therapy available

Physicians

Find the best therapy available

Health Care Insurances

Cost reduction by avoiding ineffective drug treatment

Regulatory authorities (e.g. FDA), Drug developer

Proof for effectiveness of new and existing drugs

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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