Bluejay Investor Presentation Deck

Made public by

sourced by PitchSend

3 of 16

Category

Healthcare

Published

November 2022

Slides

Transcriptions

#1Improving Patient Outcomes In Critical Care Settings Developing rapid, near-patient products for treatment guidance and monitoring bluejay DIAGNOSTICS#2Disclaimer Forward-looking Statements CAUTIONARY STATEMENT CONCERNING FORWARD LOOKING STATEMENTS This document contains forward-looking statements. In addition, from time to time, we or our representatives may make forward-looking statements orally or in writing. We base these forward-looking statements on our expectations and projections about future events, which we derive from the information currently available to us. Such forward-looking statements relate to future events or our future performance, including: our financial performance and projections; our growth in revenue and earnings; and our business prospects and opportunities. You can identify forward-looking statements by those that are not historical in nature, particularly those that use terminology such as "may," "should," "expects," "anticipates," "contemplates," "estimates," "believes," "plans," "projected," "predicts," "potential," or "hopes" or the negative of these or similar terms. In evaluating these forward-looking statements, you should consider various factors, including: our ability to obtain additional funding to develop our product candidates; our ability to satisfy any requirements imposed by the FDA (or its foreign equivalents); the impact of COVID-19 on our clinical trials, preclinical activities and our ability to raise future financing; our ability to continue our relationship with Toray; the need to obtain and retain regulatory approval of our products, both in the United States and in countries deemed necessary for future trials; our ability to complete our clinical trials in a timely fashion and within our expected budget and resources; compliance with obligations under intellectual property licenses with third parties; our ability to commercialize our product candidates; market acceptance of our products; and our dependency on third-party manufacturers to successfully, and timely, supply or manufacture our products. These and other factors may cause our actual results to differ materially from any forward-looking statement. Forward-looking statements are only predictions. The forward-looking events discussed in this document and other statements made from time to time by us or our representatives, may not occur, and actual events and results may differ materially and are subject to risks, uncertainties and assumptions about us. We are not obligated to publicly update or revise any forward-looking statement, whether as a result of uncertainties and assumptions, the forward-looking events discussed in this document and other statements made from time to time by us or our representatives might not occur. For a discussion of other risks and uncertainties, and other important factors, any of which could cause Bluejay's actual results to differ from those contained in the forward-looking statements, see Item 1A. "Risk Factors" in Bluejay's most recent Form 10-K filed with the Securities and Exchange Commission, as updated by the Company's subsequent Quarterly Reports on Form 10-Q. bluejay DIAGNOSTICS Copyright ©2022 Bluejay Diagnostics, Inc. All rights reserved in all slides | October 2022 2#3Bluejay Diagnostics: Optimizing Turnaround Times to Improve Patient Outcomes Novel Proprietary Platform Symphony™ Product Lead Candidate: IL-6 Assay Market Opportunity Commercial Strategy Capital Efficient Model DIAGNOSTICS >> >> >>> >> Uses whole blood (no pre-processing) Results in less than 20 minutes Completed initial clinical studies for measuring IL-6 in critical care settings to support de novo FDA Marketing Application Symphony™ Product Pipeline addresses multi-billion-dollar market Near-patient testing (NPT) for monitoring of disease progression Large, well-respected clinical testing sites are built-in commercial customers Reagent-rental model and DRG-based reimbursement simplifies adoption for hospitals $13.3MM cash as of Sept 30, 2022, sufficient to fund operations for next 12 months The SymphonyTM System and SymphonyTM Cartridge have not been cleared or approved by the U.S. FDA Copyright ©2022 Bluejay Diagnostics, Inc. All rights reserved in all slides | October 2022 3#4The SymphonyTM Technology Platform: Analyzer and Assay Cartridge Developing tests for clinically relevant biomarkers in critical care settings ●●● 12.5 in Symphony Touch Panel Display 14.5 in bluejay DIAGNOSTICS Sympheny SUN 10.5 in bluejay Printer Cartridge Insertion Slot (1-6) Runs up to 6 tests simultaneously Fluorescence-based immunoanalyzer The SymphonyTM System and SymphonyTM Cartridge have not been cleared or approved by the U.S. FDA SymphonyTM Cartridge 150μl Wastel Waste2 000 bluejay 研究用試藥 Symphony IL-6 HIGH LOW No additional chemicals No pre-processing of the sample Advanced microfluidics nanotechnology ELISA = Enzyme-Linked Immunosorbent Assay Copyright ©2022 Bluejay Diagnostics, Inc. All rights reserved in all slides | October 2022 4#5Symphony™M IL-6 Test: Rapid Results in Critical Care Settings Quantitative determination of IL-6 by fluorescence enzyme immunoassay from whole blood specimens ●●● bluejay DIAGNOSTICS Interleukin-6 (IL-6) is an Early Responder Biomarker During Trauma or Infection. Important in: Sepsis And Covid-19 Related Sepsis Acute Respiratory Distress Syndrome Measuring IL-6 could help medical professionals make earlier and actionable treatment decisions. Rapid turnaround time crucial as IL-6 specimens become more unstable over time Multi-organ Failure Rheumatoid Arthritis Autoimmune Disorders Cardiovascular Diseases Copyright ©2022 Bluejay Diagnostics, Inc. All rights reserved in all slides | October 2022 5#6SymphonyTM Product Pipeline ●●● Products Symphony ™M IL-6 Test patient acuity for sepsis triage/monitoring TM Symphony ™M hsTNT/I patient acuity with chest pain Symphony ™M NT-proBNP patient acuity with chest pain bluejay DIAGNOSTICS Research Development Clinical Testing New Tests Will Follow the IL-6 Development Pathway Plan to expand testing menu to include: (1) other well-validated critical care biomarkers (2) tests with potential clinical and cost-saving benefits gained from faster turnaround times Regulatory Copyright ©2022 Bluejay Diagnostics, Inc. All rights reserved in all slides | October 2022 6#7Current Testing Methods: Time is the Enemy Significantly longer turnaround times to get results back to patients minimizes utility for critical care Require highly trained technicians to operate Large equipment located in central lab settings ● ● SymphonyTM Transforms Care Through Rapid, Near-Patient Testing (NPT) Enables Physicians to make actionable treatment decisions earlier for patient stratification Symphony's Differentiated Features: • Faster results to actionable decisions Quantitative, lab quality results System utilizes whole blood (no pre-processing required) Mobile, near-patient system ● ●●● ●● DIAGNOSTICS Physician orders test Patient (critical care setting) Physician orders test I Patient (ICU/long- term care setting) The SymphonyTM System and Symphony Cartridge have not been cleared or approved by the U.S. FDA Blood drawn from patient Turnaround time: several hours Physician uses test results to guide treatment Blood drawn from patient Turnaround time: -20 minutes Blood sample transported to testing site Physician uses test results to guide treatment Lab results reported back to physician Sample processed near patient Sachery bluejay bluejay Sympheny SymphonyTM System Sample processed at central testing site Central Testing Lab Copyright ©2022 Bluejay Diagnostics, Inc. All rights reserved in all slides | October 2022 7#8SymphonyTM System Potential Advantages¹ v. Other Clinical Analyzer Systems Advantages Near Patient Test System Size Sample Type Separate Sample Processing Step Total Turnaround Time Requires Dedicated Personnel* System/Infrastructure Cost NPV2 for IL-6 Assay ::bluejay DIAGNOSTICS Bluejay Symphony Near patient Desktop Whole blood No ~20 minutes No $ TM 98% Beckman Coulter Central Lab Very Large Serum/plasma Yes 4-48hr³ Yes $$$ 78.6%4 Source: 1. Bluejay Diagnostics market research. 2. NPV = Negative Predictive Value. 3. Bluejay/Industry information, pending the location of the testing lab. 4. from FDA Emergency Use Authorization company filings Siemens Central Lab Very Large Serum/plasma Yes 4-48hr³ Yes $$$ 86%4 Roche Central lab Very Large Serum/plasma Yes 4-48hr³ Yes $$$ 92.9%4 *(phlebotomist/MedTech) Copyright ©2022 Bluejay Diagnostics, Inc. All rights reserved in all slides | October 2022 8#9IL-6 is Following a Well-Established Clinical Testing Pathway Studies will document SymphonyTM performance versus standard of care Milestone Initial Testing Program at UT Southwestern Medical Center File FDA Pre-submission application Initial Clinical Trials Expansion of Clinical Trial Program File De Novo Marketing Application with FDA Commercial Launch 00 bluejay DIAGNOSTICS Timing Q4 2021: Complete January 2022: Complete Q3 2022: Complete Q4 2022 1H 2023 1H 2024 Copyright ©2022 Bluejay Diagnostics, Inc. All rights reserved in all slides | October 2022 9#10Launch Plan Starts by Converting Bluejay Test Sites to Commercial Sites Existing multi-location healthcare testing sites are built-in initial commercial customers ●●● 01 Stage 1 Clinical Study testing sites DIAGNOSTICS 02 03 Stage 2 Convert testing sites to commercial sites Stage 3 Expand to additional sites within same hospital system 04 Stage 4 Broaden commercialization to wider customer base beyond testing sites Commercial Strategy Leveraging internal champions to drive adoption Reagent-Rental Model SymphonyTM Analyzer will be leased or sold Cartridges provide recurring revenue and favorable margins#11Financial Highlights Sympheny bluejay DIAGNOSTICS Symphony bluejay bluejay HIGH- Sympheny Low- IL-6 Financial Info (September 30, 2022) Cash* Est. Cash Runway Clean Balance Sheet Market Capitalization $13.3 MM Average daily trading volume Shares outstanding Approx. 12 months BJDX (NASDAQ) (September 30, 2022) No outstanding warrants or debt $15.7MM 175K shares 20.2MM *Cash is comprised of cash, cash equivalents and investments, per the Q3 2022 10Q filing. Warrants based on Q3:22 Balance Sheet#12Management & Advisors: Leadership, Diagnostic & Product Launch Expertise ●●● ●● Indranil "Neil" Dey CEO and Co-founder ● ● Involved in introducing Her2neu test for Herceptin Lead numerous global teams • Ph.D. in Biochemistry (UNESCO fellow) from BRC, Hungary, MBA (Fulbright Scholar) from Cambridge University, UK IMPATH The Cancer Information Company DIAGNOSTICS Kenneth Fisher Chief Financial Officer ● Responsible for Bluejay finance, investor relations, accounting and administrative operations • CPA: BA, Business Administration, Isenberg School of Management, UMass Amherst East Boston Savings Bank Jason Cook Chief Technology Officer ● ● •15+ years in POC/ diagnostics product development Responsible for Bluejay product development and manufacturing operations ● Ph.D. in Biomedical Engineering, University of Texas at Austin TEXAS The University of Texas at Austin Kevin Vance Chief Commercial Officer ● Responsible for Bluejay worldwide direct sales ● and strategic partnerships. • Prior Chief BD Executive for Vibra Healthcare BS, Industrial Engineering & Operations Research UMass Amherst; MBA, Western New England University YV VIBRA HEALTHCARE Mark Feinberg Chief Medical Advisor ● ● Guide Bluejay clinical development programs provide strategic medical and scientific leadership • Associate Professor, Harvard Medical School/Cardiovascular, Brigham & Women's; Medical College of Pennsylvania Brigham and Women's Hospital Founding Member, Mass General Brigham Copyright ©2022 Bluejay Diagnostics, Inc. All rights reserved in all slides | October 2022 12#13Board of Directors Douglas C. Wurth Chairman Indranil "Neil" Dey CEO Svetlana Dey Donald R. Chase Fred S. Zeidman Gary Gemignani ●●● ●● J.P.Morgan DIAGNOSTICS Skadden 20-year career at J.P. Morgan Chase (CEO of the International Private Bank & Alternative Investments, Asset Management) B.A Notre Dame University; J.D. University of Virginia School of Law; practiced law at Skadden, Arps, Meagher and Flom Involved in introducing Her2neu test for Herceptin and introduction of Erbitux Ph.D. in Biochemistry (UNESCO fellow) from BRC, Hungary; MBA (Fulbright Scholar) from Cambridge University, UK Co-founder of Bluejay; President & CEO of LMBRI LLC; 15 years+ of management experience in healthcare industry Masters Degree in Mathematics from the State University of Mari El Republic, Russia 35 years in executive roles at well-known community banks in New England B.S. Accounting, Western New England University 50+ years of corporate advisory experience; Chairman Emeritus University of Texas Health Science System Bachelor's degree from Washington University in St. Louis; Masters in Business Administration from New York University Senior executive with experience in life sciences, public companies, accounting/finance Prior experience with Acacia Pharma, Biodel, Prudential Financial, Gentium, Novartis, Wyeth and Arthur Andersen IMPATH The Cancer Information Company Imbri merchants BANCSHARES INC westbank UNITED STATES MEMORIAL MUSEUM ARTHUR ANDERSEN Copyright ©2022 Bluejay Diagnostics, Inc. All rights reserved in all slides | October 2022 13#14Symphony Improving Patient Outcomes In Critical Care Settings Developing rapid, near-patient products for treatment guidance and monitoring DIAGNOSTICS Sympheny bluejay bluejay 研究用試藥 Ⓡ Sympheny IL-6 HIGH- LOW-#15bluejay DIAGNOSTICS Contact Bluejay Diagnostics, Inc. 360 Massachusetts Avenue, Suite 203, Acton, MA 01720 Toll-free: 844.327.7078 Main: 978.631.4884 [email protected]

Download to PowerPoint

Download presentation as an editable powerpoint.

Related

Fiscal 3Q Investor Presentation image

Fiscal 3Q Investor Presentation

Healthcare

FY23 Full-Year Results Presentation image

FY23 Full-Year Results Presentation

Healthcare

Healthcare Network P&L Statement and Expansion Projects image

Healthcare Network P&L Statement and Expansion Projects

Healthcare

Accreditation and Quality Assurance Overview image

Accreditation and Quality Assurance Overview

Healthcare

Investment Highlights image

Investment Highlights

Healthcare

Investor Presentation image

Investor Presentation

Healthcare

IDEAYA Biosciences Interim IDE397 Phase 1 Clinical Data and Q1 2022 Corporate Update image

IDEAYA Biosciences Interim IDE397 Phase 1 Clinical Data and Q1 2022 Corporate Update

Healthcare

BioAtla Investor Presentation Deck image

BioAtla Investor Presentation Deck

Healthcare