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C OMMERCIALIZING P ROTEIN M ICROARRAY D IAGNOSTICS C ALENDAR Q2 2014 - PowerPoint PPT Presentation

May 25, 2023 •214 likes •399 views

C OMMERCIALIZING P ROTEIN M ICROARRAY D IAGNOSTICS C ALENDAR Q2 2014 D ISCLAIMER AND F ORWARD L OOKING S TATEMENTS This presentation contains forward-looking statements. Forward-looking statements include statements regarding the Companys future

  1. C OMMERCIALIZING P ROTEIN M ICROARRAY D IAGNOSTICS C ALENDAR Q2 2014

  2. D ISCLAIMER AND F ORWARD L OOKING S TATEMENTS This presentation contains forward-looking statements. Forward-looking statements include statements regarding the Company’s future financial position, business strategy, projected costs, strategic partnering, regulatory actions, the capabilities of the Company’s platform, and plans and objectives of management for future operations. These forward-looking statements are based on the Company’s current expectations and beliefs, as well as a number of assumptions concerning future events. Typically, these statements contain words such as “believe,” “may,” “estimate,” “continue,” “anticipate,” “intend,” “expect,” “plan,” and similar expressions. These statements are subject to risks, uncertainties, assumptions and other important factors, many of which are outside of the Company’s control, that could cause actual results to differ materially from the results discussed in the forward-looking statements – including, but not limited to, the extent of our future losses, our ability to develop and market our products, development or commercialization of similar products by our competitors, and our ability to comply with applicable governmental and securities regulations and standards. You are cautioned not to place undue reliance on such forward-looking statements because actual results may vary materially from those expressed or implied. All forward-looking statements are based on information available to the Company on this date and, except as required under applicable law, the Company assumes no obligation to, and expressly disclaims any obligation to, update or revise any forward-looking statements, whether as a result of new information, future events or otherwise. 2

  3. SQI D IAGNOSTICS Unique dual-layer protein microarray tests TSX-Venture: SQD Growing test menu with FDA Shares outstanding: 56,336,058 pedigree Market Cap: ~27 M 52 week high/low: $1.14 - $0.42 Products address critical issues Expected burn: ~$4M in F2014 of Global Pharmaceutical companies 4 Global Pharmas signed on as customers in 2013 3

  4. SQI Overview SQI Diagnostics was founded in 1999 on the simple idea that the number of blood tests performed to diagnose a patient was large and growing and that reducing the effort to complete these multiple tests would create a significant benefit. SQI has invested over $45 million dollars to develop products and automated systems that enable customers to produce many test results simultaneously saving them time and money (“multiplexing”) while delivering the technical performance they demand. SQI targets two large markets: (1) Diagnostic testing laboratories and (2) Drug development companies (Global pharmaceutical companies and biotechnology companies) Our target pharmaceutical development customers have publically presented the superior technical performance of our products and compared this performance to competing and current test technologies. Our tests significantly decrease the total cost of delivery for drug development programs and diagnostics testing laboratories by running numerous test simultaneously, reducing total labour costs. Since mid- 2013 we have signed four Master Service Agreements with some of the globe’s largest pharmaceutical companies to evaluate our drug development testing products. We have completed prototypes under each of these agreements, each in a matter of weeks. We have since converted two of these initial evaluations into paying customers and are confident of converting the remaining two as we also continue to make progress winning new customers. We continue to develop and file for approval of our in vitro diagnostic tests targeting diagnostic testing labs. We estimate that labour reductions alone could decrease the cost-base of processing tests using our products by much as 40% in a market comprised of mare than 1,000 US-based labs. 4

  5. SQI D IAGNOSTICS sqid ™ Analyzers and Ig_plex ™ Protein Microarrays We sell a range of fully automated analyzers (sqid-lite above), standardized and custom products as well as product development and testing services 5

  6. SQI’ S C ORE B USINESS F OCUS Our automated platforms, certified products and custom assay development services satisfy an unmet need in two distinct life sciences markets Big Pharma / Big Biotech Reference Laboratories Custom and routine Regulatory cleared high-volume assays for In-Vitro Diagnostic (IVD) clinical drug development assays for disease diagnosis and monitoring 6

  7. C OMPLEX PROTEIN ANALYSIS DEMANDS BETTER TOOLS …to quantitative panels From qualitative tests… ELISA (enzyme-linked immunosorbent assay) The gold-standard manual test for Today’s customers are demanding protein detection more…more test, more data. currently performed as single tests today What are the patient’s levels of – one test, one result testosterone, estrogen (estradiol, estrone, estriol), progesterone, prolactin, IGF-1, homocysteine, cortisol/cortisone ,follicle Does the patient have low stimulating hormone, luteinizing hormone, estrogen? human growth hormone. What if these could be done all at the same time - one test, many results? 7 7

  8. SQI C AN - S IGNIFICANT L ABOUR AND T IME S AVINGS Standard ELISA SQiDlite (manual operation) (fully automated – multiplexed results) 32 Minutes of Labour / Patient 30 Seconds of Labour / Patient to produce 8 results to produce 8 results Saved time and decreased costs, with superior technical performance 8 8

  9. SQI P ROVIDES T ANGIBLE B ENEFITS TO C USTOMERS • Nearly eliminates labour Customized and outsourced test development: • Shortens time to regulatory • Classify and quantify complete patient filing immune responses in a single test • Reduces costs • Report on multiple proteins, multiple • Reduces valuable blood needed immunoglobulin isotypes and subclasses • Systems exceed all FDA and simultaneously EMEA immunogenicity and • Conduct a side-by-side analysis of biosimilar testing guidelines therapeutic proteins, drug metabolites, subunits and oligonucleotides Example: Clinical Immunogenicity Test for Global Pharma/CRO: 30 employees x 20 days 2 employees x 5 days Shift to multiplexed, automated tests significantly reduces time and labour 9 9

  10. I G _P LEX ™ BMS A NTI -D RUG A NTIBODY A SSAY Reference: Bristol-Myers Squibb Presentation, Bioassays and Bioanalytical Method Development Conference in Berkeley, CA, Oct 8, 2013 Summary and Conclusions • Adnectin Fc Immunogenicity assay developed focused on high sensitivity and drug tolerance • Plate based assay format showed significant increase in drug tolerance • Assay was successfully developed at SQI with increased sensitivity and drug tolerance while providing additional isotyping data • SQI assay was automated and qualified with high reproducibility 10

  11. SQ I D A NALYZERS S IZED TO M EET D EMAND SQiDworks SQiDlite SQiD-X Throughput 1000+ results / hour 300+ results / hour 200+ results / hour Foot Print Bench Top Bench Top Size 36" x 66" 20" x 48" 18" x 24" Target Top 1,000 high volume Research / non-IVD Top 5,000 laboratories Customer reference laboratories laboratories Hands-on Time 15 minutes 15 minutes 45 minutes for 1 Plate 11

  12. SQI’ S C OMMERCIALIZATION S TRATEGY 2009 - 2012 2013 2014 2015 - Reference Laboratories • IVD RA test • Drive laboratory customer • Develop increasingly establishes Ig_plex™ adoption with expanding US proprietary and product line sales force valuable tests • IVD clearances • Expand menu of approved • Develop companion validate QA/QC, reference laboratory tests diagnostics manufacturing Drug Development Companies • Co-develop tests in • IVD pedigree Four Global Pharma agreements signed in 2013 partnership with brings credibility to drug developers pharmaceutical customers • Provide “CRO” services 12

  13. R APID C OMMERCIALIZATION S UCCESS IN 2013 Drug Agreement candidates • Master agreement signed • 11-plex ADA assay development complete; evaluation Global complete 1 of 33 Pharma 1 • 21-plex Epitope Mapping assay under PAID development in first half of 2014 • Master agreement signed • 21-plex ADA assay development complete Global 1 of 25 • 8-plex cytokine assay development complete; evaluation Pharma 2 underway • Master agreement signed Q4 2013 • 6-plex ADA assay development and evaluation complete; Global 1 of 20 • 2 nd phase agreement being finalized to run pre-clinical Pharma 3 samples at SQI (current quarter) • Master agreement signed Q4 2013 • 8-plex ADA assay evaluation complete; ISIS 1 of 34 • Currently finalizing first commercial contract with its CRO 13

  14. P OTENTIAL S OURCES OF P HARMA C USTOMER R EVENUE Custom ADA panels and Epitope Mapping panels Potential revenue unique to each drug Development Platform Validation Pre-clinical Clinical test under Services purchases test purchase test purchases development; purchases path to additional drug candidates Biomarker panels (Cytokines, etc.) High volume tests conducted at central labs; Platform Validation Clinical test purchases potential purchases test purchase revenue per customer 14

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