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Enabling Rapid and Accurate Cancer Diagnosis

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Presentation on theme: "Enabling Rapid and Accurate Cancer Diagnosis"— Presentation transcript:

1 Enabling Rapid and Accurate Cancer Diagnosis
SynderBio 4/29/2019 SynderBio Enabling Rapid and Accurate Cancer Diagnosis Partnering for Growth Biotech Innovation Showcase March 20, 2018 © 2018 SynderBio, Inc.

2 SynderBio Corridor Angels Presentation
4/29/2019 SynderBio: Lab Automation & Cancer Dx Company with Patented Core Technology Targeted Cell Depletion Rapid Results Biopsy Processing in Lab & Clinic R&D Labs Urology Product-Market Fit in Several Large Markets Oncology Contact:

3 SynderBio 4/29/2019 Millions of Bladder Cancer Survivors: Regular Surveillance, Invasive Procedures $1B spent annually in US on bladder cancer surveillance. Most costly cancer to manage per case. Patient Surveillance $1B 2.7M people worldwide are living with bladder cancer. 79,000 new cases in US in 2017. Bladder Cancer Patients 2.7M 4x per year, bladder cancer survivors undergo cystoscopy, an invasive and costly procedure. 4x/year Invasive Procedures No non-invasive test to diagnose recurrent bladder cancer is considered effective enough to replace invasive cystoscopy. Unmet Need American Cancer Society, 2017 Contact: Pharmacoeconomics, (11): p

4 SynderBio 4/29/2019 Current surveillance is costly and invasive. Non-invasive tests are not accurate for surveillance. VS Cystoscopy: The current standard of care is quarterly cystoscopy, an invasive procedure performed by urologist. Urine-Based Cytology: Non-invasive test use voided urine to screen for cancer. Currently not considered sensitive enough for recurrent bladder cancer. Contact:

5 Enhanced Non-Invasive, Urine-Based Cytology
SynderBio 4/29/2019 Enhanced Non-Invasive, Urine-Based Cytology Used for decades to detect advanced bladder cancer Performed using voided urine from patient SynderBio Solution : Cytology is enhanced by the removal of benign cells. Only cancer cells remain, leading to accurate diagnosis. Now: Pathologists cannot determine if some suspicious cells in recurrent cancer are malignant or benign. Benign Sample Malignant Sample Benign Sample Malignant Sample Standard Cytology After Processing with SynderBio Instrument Contact: Barkan, G.A., et al., The Paris System for Reporting Urinary Cytology: The Quest to Develop a Standardized Terminology. Acta Cytol, 2016.

6 Platform Technology Ideal for Bladder Cancer Surveillance
SynderBio 4/29/2019 Platform Technology Ideal for Bladder Cancer Surveillance US 2014/ A1 PCT/US15/58255 Current instrument: small, benchtop device with disposable cartridge Benign urothelial cells Malignant cells Benign cell debris SynderBio SynderBio Enhanced Cytology Patented Approach Enhanced Cytology Eliminates benign cells, removes uncertainty, enables urine-based detection Non-invasive Surveillance Reduces frequency of invasive cystoscopy while preserving quality of patient care Existing Workflow Keeps both urologists and pathologists engaged Low Cost $15k instrument avoids capital purchase; Main revenue: $100 test kit Contact:

7 SynderBio Enhanced Cytology Competitive Analysis
4/29/2019 SynderBio Enhanced Cytology Competitive Analysis Company Sensitivity Specificity Non-Invasive Cost SynderBio Enhanced Cytology High Yes $100 Traditional Urine-Based Cytology Low $70 Cystoscopy No $350 UroVysion™ (Abbott) Yes* $575 (Procedure Code: 88120) NPM22 Bladderchek® (Alere) $50 *Must be used with cystoscopy Contact:

8 Three Products Launched by 2021
SynderBio 4/29/2019 Three Products Launched by 2021 Research Labs – Direct Path to Market Product 1: Research Instrument Requires FDA 510(k) Clearance to Market Product 2: Diagnostic Instrument I Requires FDA 510(k) Clearance to Market Product 3: Diagnostic Instrument II R&D Labs Urology Oncology SBIR Awarded July 2017 STTR Awarded Sept 2017 Launch 2019 Launch 2020 Launch 2021 Contact:

9 Product-Market Fit in Major Markets
SynderBio 4/29/2019 Product-Market Fit in Major Markets R&D Labs Urology Oncology Non-invasive Preserves Cell Quality Fast, Accurate Diagnosis $3.3B (Global ) Cell Separation (Cancer) $1B (US ) Bladder Cancer Surveillance $27B (Global ) Lab Testing (Cancer) Launch 2019 Launch 2020 Launch 2021 Contact:

10 Need Validated through Customer Discovery
SynderBio 4/29/2019 Need Validated through Customer Discovery R&D Labs Urology Oncology Non-invasive Preserves Cell Quality Fast, Accurate Diagnosis Contact:

11 Projected Financials for 2018-2022
SynderBio Corridor Angels Presentation 4/29/2019 Projected Financials for Revenue Forecast 2018 2019 2020 2021 2022 Instrument Sales $ $ ,000 $ 2,390,000 $ 10,920,000 $ 28,410,000 Cartridge Sales $ ,500 $ ,500 $ 10,123,000 $ 61,202,500 Non-equity funding $ ,000 $ 1,000,000 $ ,000 $ $ Total revenue (w/grants) $ 1,503,500 $ 3,312,500 $ 21,043,000 $ 89,612,500 Gross profit $ 1,402,800 $ 2,745,280 $ 17,624,160 $ 76,651,120 Headcount 6 16 24 34 45 R&D/Eng/Outsource $ ,848 $ 1,169,183 $ 2,362,527 $ 2,677,066 $ 3,190,827 Sales & Marketing $ ,360 $ ,450 $ 1,029,135 $ 1,650,485 $ 2,315,618 G & A $ ,836 $ ,563 $ ,798 $ ,572 $ 1,053,955 Total Expenses $ 1,063,044 $ 2,250,196 $ 4,105,459 $ 5,249,123 $ 6,560,400 EBITDA $ (438,044) $ (847,396) $ (1,360,179) $ 12,375,037 $ 70,090,720 Product Launched Contact:

12 We’re raising $1.5M with three goals over 18 months
SynderBio 4/29/2019 We’re raising $1.5M with three goals over 18 months 1. Support & expand key personnel CEO, lead scientist Engineering, Regulatory 2. Finalize first commercial product Fabricate 10 pre-manufacture prototypes Cultivate demand through beta tests with strategic customers Launch in Q – Single Cell user base 3. Establish second product First diagnostic product launch in 2020 Prepare for FDA 510(k) Pathway – begin clinical tests Initial sales to large partners – to minimize S&M Contact:

13 SynderBio 4/29/2019 Why SynderBio? Why Now? Enabling technology for new products in rapidly growing fields Single Cell Genomics Non-invasive cancer surveillance Cancer diagnostics based on Next Generation Sequencing Personalized Medicine Company is ready to go Third party validation IP issued, license obtained Partner Interest Fast path to revenue Leveraging large non-dilutive investment $175k in university/state funds directly to prototype/company development $1.1M in federal funds to founder research $525k in recent SBIR/STTR grants to company, opportunity to seek >$3M in Phase II Two years of founder effort in company achievements Contact:

14 Dedicated Leadership Team
SynderBio 4/29/2019 Dedicated Leadership Team Mike Cable, PhD Co-Founder, COO SynderBio Inc. 20 years experience with device-related startups-CEO, CTO, VP Built first SynderBio working prototype Michael Henry, PhD Co-Founder, SynderBio Inc. Deputy Director for Research, Holden Comprehensive Cancer Center Cancer Biologist, made initial discoveries leading to SynderBio core technology Formerly Senior Scientist, Millennium Pharmaceuticals Christine Horton, BS Board Chair, SynderBio Inc. >20 years experience in executive leadership in medical device industry Experience in key corporate areas including marketing, sales, regulatory Sarah Vigmostad, PhD Co-Founder, CTO SynderBio Inc. Associate Professor, Biomedical Engineering, University of Iowa Expertise in fluid mechanics, medical device design Designed SynderBio prototype Contact: or

15 SynderBio Corridor Angels Presentation
4/29/2019 SynderBio Enabling Rapid and Accurate Cancer Diagnosis THANK YOU Contact: © 2018 SynderBio, Inc. Contact:


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