Spectral Medical Inc · TSX:EDT
Spectral Medical — Investor Day (April 2023)
31 slides from Spectral Medical's investor day presentation, Apr 6, 2023
Slide 1: Spectral Medical Investor Day
Spectral Medical Investor Day April 6, 2023
Slide 2: Today's Speakers
Today’s Speakers 2 4/5/2023 Spectral Medical Inc.
Slide 3: Forward Looking Statements
Forward Looking Statements Certain statements contained in this presentation constitute forward-looking information within the meaning of securities laws. Forward-looking information may relate to our future outlook and anticipated events or results and may include statements regarding our future fi
Slide 4: Agenda
Agenda • Management Presentation • Q&A session 4 4/5/2023 Spectral Medical Inc.
Slide 5: Spectral's Transformative Journey
Spectral’s Transformative Journey 2019: 2020: 2021: 2022: TODAY: A Fresh Start Building Commercial Blocking and Tackling Re-positioning Foundation • FDA approves Tigris • Entered into Exclusive • Appointment of Dr. • FDA grants study; data collected in Distribution Agreement Kellum as CMO Breakthrou
Slide 6: Tigris Enrollment Status
Tigris Enrollment Status No. Patients • 53 (35% enrolled) Randomized • 16 sites No. Sites Open to • Recent new site additions: Enrollment o South Carolina – Jan o UCSF – Feb o Wisconsin – Apr • 6 additional sites in contracting phase (“CTA”) Additional Trial Sites • … 25 sites projected by Sept/23 (
Slide 7: Challenges Faced and Steps Being Taken
Challenges Faced and Steps Being Taken Challenges faced Steps being taken • Enrollment rate slower than • Increase in number / quality anticipated of Tigris trial sites to 25 • Clinical site staffing and • Increase in trial resources workflow issues and site presence • Clinical research enterprises
Slide 8: Pre-Screening Data
Pre-Screening Data • Since June/22, aggregate site pre-screening has been robust with average 50-100 per week Screening Commentary Tigris Screening to Enrollment Waterfall 120 • Tigris trial inclusion criteria is strict… • … creating a tough enrollment 100 environment… • … But tight criteria benefit
Slide 9: Tigris Enrollment – Spectrum of Enrollment Levers
Tigris Enrollment – Spectrum of Enrollment Levers • Spectral has considered a wide range of strategies to increase enrollment rates… with each strategy weighed against potential impact on PMX regulatory outcome Strategy Approaches Risks Effectiveness EDT Action • Site training/motivation • Minimal •
Slide 10: Increasing Trial Sites
Increasing Trial Sites 10 4/5/2023 Spectral Medical Inc.
Slide 11: Clinical Site Requirements
Clinical Site Requirements • Significant criteria required for Tigris trial suitability… resulting in a reduced pool of potential ICU sites Criteria: • Experience with Sepsis trials Center • Full-time board-certified Intensive care • Sepsis volume > 50 patients/month • Physician Investigators: o Pri
Slide 12: Tigris Sites Overview
Tigris Sites Overview • Pipeline of potential trial sites - culmination of screening and onboarding activity throughout 2022… with all pipeline sites in the CTA phase EUPHRATES-US + OTHERS TOTAL No. Sites Screened 51 44 95 Did not qualify / not interested 35 33 68 Sites Open 101 6 16 25 sites Pipeli
Slide 13: Tigris Revised Timeline and Site History
Tigris Revised Timeline and Site History • Average time to onboard a new site is 6 to 9 months Q3 2024 – Q4 2019 Q2 2020 Q4 2020 Q2 2021 Q4 2021 Q2 2022 Q4 2022 Q2 2023 Q4 2023 Q1 2025 Tigris start 10/12 sites Detroit & Stanford Site selection open Terminated continues Anticipated 9/12 sites CMO joi
Slide 14: Site Productivity
Site Productivity 14 4/5/2023 Spectral Medical Inc.
Slide 15: Site Training / Motivation
Site Training / Motivation Site Visits Additional Targeted Measures • Spectral has many touchpoints at trial • Site Investigators are highly motivated… sites • . . . But what motivates nursing team? o Technical field team (CRCs, bedside nurses) o CRAs (including new CRO) o CMO – academic detailing C
Slide 16: CRO Transition
CRO Transition • Beaufort specifically chosen for… o Strong Regulatory group with track record of success with FDA for medical devices Why Beaufort? o Highly regarded and experienced team assigned to Tigris o Strong biostats personnel and Bayesian statistics • Change in CRO will. . . o Allow for man
Slide 17: Clinical Resources and Trial Site Coverage
Clinical Resources and Trial Site Coverage • Spectral has a significant number of dedicated clinical resources to execute the Tigris trial Focused Resources Clinical Resource / Site Touchpoint Mapping • Senior clinical leadership committed to Beaufort Clinical Spectral: Spectral Clinical Resources R
Slide 18: Investigator Meeting
Investigator Meeting Investigator meeting represents first in-person investigator meeting since launch of Tigris trial in late2019 Details • Date: May 17th-18th • Location: Charlotte NC • Site representation: 21 sites represented – combination of existing, new, and pipeline sites Agenda: • Keynote s
Slide 19: Awareness: M.E.S.A.
Awareness: M.E.S.A. Goal: to convert “endotoxin is old news” into “we need a treatment for this stuff” before commercial launch Making Endotoxin Sexy Again • Ongoing investigator-initiated study funding (Stonybrook, George Washington, Japan, Germany, others) -- in addition to Eden • KOL outreach and
Slide 20: Awareness: M.E.S.A Project
Published • Subtypes and Mimics of Sepsis. Kellum JA, Formeck CL, Kernan KF, Gómez H, Carcillo JA. Crit Care Clin. 2022 Apr;38(2):195-211. doi: 10.1016/j.ccc.2021.11.013. PMID: 35369943 Review. Awareness: • Extracorporeal Blood Purification and Organ Support in the Critically Ill Patient during COVI
Slide 21: Awareness and Motivation – Public Domain
Awareness and Motivation – Public Domain Purpose: Utilizing focused media content to raise awareness of PMX therapy in addition to motivating key stakeholders in the Tigris Trial • Targeted social media/digital activation in conjunction with airings-250K impressions beyond broadcast. • 7-9 minute se
Slide 22: Impact on Enrollment Timeline
Impact on Enrollment Timeline • Last twelve months (“LTM”) represents first consecutive 12-month period where COVID was not a factor since Tigris started… this has allowed us to re-base our enrollment rate assumptions • Actual LTM enrollment from April 2022 – March 2023: o 23 Patients; 14 active sit
Slide 23: It's Open Label… Interim Mortality Data Release?
It’s Open Label… Interim Mortality Data Release? • Trial results will be analyzed at the end of the Preliminary results from Tigris show similar relative trial when all data are cleaned and verified differences… o Tigris has no interim analysis (there are statistical penalties for analyzing data at
Slide 24: Could Tigris Be Stopped Early?
Could Tigris Be Stopped Early? • Currently no mechanism to stop the trial early Could Tigris Be o Statistical analysis plan has no provision for early end Stopped Early? o FDA would need to agree to a change – unlikely as 150 is already considered small Depending on enrollment rate, difference in st
Slide 25: PMX Commercialization
PMX Commercialization • Estimated U.S. addressable market ~US$2 billion1 p.a. Pre-Commercialization Illustrative Potential US Net Economics to Spectral – PMX + EAA (per annum) Assumptions: • Baxter relationship continues to be strong • PMX premium priced (gross margins anticipated at >70%): with col
Slide 26: Addressable Market
Addressable Market • Tigris inclusion criteria is strict – Tigris Trial vs. Potential Clinical Practice institutes constraints on PMX utilization 120 in a clinical trial setting… these same Tigris Trial constraints not likely impediments to 100 Potential Clinical Practice clinical practice PMX use 8
Slide 27: Spectral Relative Share Price Performance
Spectral Relative Share Price Performance EDT Relative Share Price Performance - LTM (Apr 2023) 180 160 140 120 CytoSorbents +7% 100 Spectral – 3% 80 S&P TSX small cap –13% Nasdaq Composite – 16% 60 Russell Micro Cap – 20% 40 Aethlon – 72% 20 SeaStar – 82% 0 Mar 22 Apr 22 May 22 Jun 22 Jul 22 Aug 22
Slide 28: iDialco Joint Venture Update
iDialco Joint Venture Update Dialco Medical Inc. (“Dialco”): • Formed in 2019 with the objective of commercially developing the SAMI and DIMI dialysis machines; • SAMI: requires further development – limited commercial activity to date; • DIMI: requires further development in addition to costly Home
Slide 29: Spectral Catalysts
Spectral Catalysts ✓ Tigris new sites ✓ Tigris enrollment… acceleration ✓ Euphas 2 Publication ✓ Tigris interim patient enrollment - 90 patients ✓ Baxter milestone payment #2 ✓ Tigris last patient enrollment - 150 patients ✓ Tigris topline results ✓ PMX FDA submission ✓ PMX FDA approval ✓ Baxter mil
Slide 30: Conclusions
Conclusions Current Tigris results continue to exceed expectations We have built a strong foundation for success – both clinical (Tigris trial design) and commercialization (Baxter partnership)… Taking significant steps to increase enrollment – with biggest levers on enrollment being i) increase in
Slide 31: Q&A
Q&A 31 4/5/2023 Spectral Medical Inc.