Spectral Medical Inc · TSX:EDT
Spectral Medical — Investor Presentation (May 2018)
25 slides from Spectral Medical's investor presentation, May 2018
Slide 1: Spectral Medical Inc. - Targeted therapy for septic shock
Spectral Medical Inc. Targeted therapy for septic shock Q2 2018
Slide 2: 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 f
Slide 3: Investment highlights for Spectral's program in septic shock diagnosis and treatment
Investment highlights for Spectral’s program in septic shock diagnosis and treatment 1. Well-recognized unmet medical need with a market potential in excess of $1.5B US with no competition in the United States. 2. Proven product with demonstrated clinical benefit and commercial success in thousands
Slide 4: Spectral's products for treating endotoxemic Septic Shock
Spectral’s products for treating endotoxemic Septic Shock 6 Approval Pending Small confirmatory study 5 Large U.S. Unmet Need 1.7 million sepsis patients per year. No new therapy approved to 1 reduce mortality in 10+ years FDA Cleared to Measure Endotoxin 4 Randomized, Controlled U.S. Trials a predi
Slide 5: Sepsis and Septic Shock Key Definitions
Sepsis and Septic Shock Key Definitions Sepsis is life-threatening organ dysfunction Septic shock is a subset of sepsis in which profound circulatory, cellular and metabolic abnormalities are associated with a greater risk of mortality than with sepsis alone Endotoxin is a powerful sepsis trigger(1)
Slide 6: Septic Shock in the US: A very large unmet medical need
Septic Shock in the US: A very large unmet medical need • 1.7M patients SEPSIS • 20% mortality • 330k patients • 40% mortality SEPTIC SHOCK • Increased severity organ dysfunction • 50%+ with high endotoxemia Sources: 1. Sepsis numbers from CDC 2. Septic Shock and MOF from NIS database 2013 3. Guidel
Slide 7: Spectral's targeted approach: Measure, then treat!
Spectral’s targeted approach: Measure, then treat! Remove endotoxin Measure Resolve endotoxin levels Increase survival rate Septic Shock & Multi Organ Dysfunction 7
Slide 8: Measuring Endotoxin with the Endotoxin Activity Assay (EAA)
Measuring Endotoxin with the Endotoxin Activity Assay (EAA) • Measures Endotoxin activity in whole blood • Results available in 30 minutes • Available worldwide: FDA cleared, CE mark and HC approved • Key to Spectral ’s targeted approach to identify patients who may benefit from PMX 8
Slide 9: PMX: How it works
PMX: How it works Extracorporeal Hemoperfusion In-vivo Endotoxin removal by PMX Femoral V. PMX Femoral V. Novelli G,. Early management of endotoxemia using the endotoxin Blood Pump activity assay and polymyxin B-based hemoperfusion. Contrib Nephrol. 9
Slide 10: PMX: Real world clinical evidence
PMX: Real world clinical evidence • Regulatory acceptance in Japan, Europe, Canada and many other countries • >180 published papers • Approx. 10,000 patients entered into trials • 150,000+ patients treated worldwide • 20+ years of proven safety profile worldwide • Spectral recently completed the EUP
Slide 11: PMX: Real world commercial evidence
PMX: Real world commercial evidence • ≈16,000 sold yearly in Japan (the only country with a mature market) • Manufacturing plant has significantly expanded capacity to meet US demands • Commercial development is ongoing in Asia, Europe and Canada based on combined EAA and PMX. 11
Slide 12: Target patients for PMX based on EUPHRATES
Target patients for PMX based on EUPHRATES PMX reduces mortality rate in patients with Septic Shock, Multi Organ Dysfunction and EAA between 0.6-0.9 • Top line data showed a trend for mortality benefit in favor of PMX • It was observed that 18% of patients had EAA levels beyond adsorption capacity o
Slide 13: Burden of Endotoxin: Calculated quantity of circulating endotoxin in an average adult
Burden of Endotoxin: Calculated quantity of circulating endotoxin in an average size adult Burden of Endotoxin :Volume of blood + interstitial fluid ≈13000 m Low Low-Mid Measurable High Measurable High (non-measureable) (non-measureable) EAA <0.6 0.6 to 0.9 >0.9 Endotoxin Conc. (pg/ml) Approximately
Slide 14: Spectral's approach reduces the mortality risk by up to 52%
Spectral’s approach reduces the mortality risk by up to 52% Time Risk Reduction % HR and p-value 14 Days 52 HR 0.48, p= 0.02 28 Days 42 HR 0.58, p = 0.04 90 Days 41 HR 0.594, p=0.04 PMX Sham EUPHRATES trial mPP population EAA ≥ 0.6 and < 0.9, MODS > 9 (n=194) For complete information on the EUPHRATE
Slide 15: Spectral's approach significantly improves multiple organ function
Spectral’s approach significantly improves multiple organ function The survival benefit is achieved by reversing organ dysfunction 15
Slide 16: FDA Decision March 2018: Further evidence to be added
FDA Decision March 2018: Further evidence to be added Non Approvable: • While acknowledging the potential effectiveness of PMX based on our post- hoc, analysis, given the extreme vulnerability of the target population, the Agency would like to see more data prospectively collected to confirm effic
Slide 17: The TIGRIS trial - still in design phase
The TIGRIS trial – still in design phase 1. US sites only 2. Open label, likely single arm 3. Bayesian statistics borrowing power from data collected in EUPHRATES trial 4. Limited number of sites and patients 17
Slide 18: Market Exclusivity for the PMX/EAA therapy
Market Exclusivity for the PMX/EAA therapy Intellectual Property • Patent protection for EAA expires 2022 +5 • Patent protection for PMX expires 2019 +5 (Patent Term Protection increase of 5 years following PMA approval) Regulatory • 6 year rule prevents dissemination of important knowledge to c
Slide 19: Company Highlights
Company Highlights TSX: EDT Established 1991 Number of employees 20 Offices & Facilities Toronto, Canada Recent Share Price $0.33 Shares Outstanding 225M Market Capitalization ~ $70 M Insider Ownership ~ 45% Cash & Cash Equivalents $5.7 M estimated ( April2018) Total Debt Nil Shareholder Base 70% -
Slide 20: Significant milestones achieved
Significant milestones achieved 2010 2014 2016 2017-2018 License agreement with Interim analysis Enrolment PMA submission FDA Toray Trial amendment completion 100 Day meeting IDE approved by the FDA Top line results SAM pump cleared by FDA & HC First patient enrolled $5.3M rais
Slide 21: Upcoming milestones
Upcoming milestones Q2 2018 Q3 2018 Q4 2018 2019 2020 TIGRIS trial design Agreement with FDA Full speed Patient TIGRIS completion and Market launch Submission and enrolments analysis Beginning of TIGRIS interactive review Expansion of Result submission Canadian Market FDA approva
Slide 22: Management Team
Management Team Director, President & CEO Joined Spectral in 2001 as CEO. Previously Surgeon in Chief University Health Network, Program Paul Walker, MD, PhD, FRCSC Director of Intensive Care Medicine, University of Toronto. Graduate of Harvard Business school AMP. Chief Financial Officer Richard Wi
Slide 23: Board of Directors
Board of Directors Anthony Bihl Chairman of the Board, CEO, Bioventus LLC Kevin Giese Former CEO and Director, Medwell Capital Guillermo Herrera Former Chairman & Founder, Pinnacle Biologics Inc. Masayuki Kaneko Director & General Manager, Medical Products Division, Toray Industries Inc. Paul Walker
Slide 24: The Opportunity
The Opportunity 1. Large unmet medical need • Market potential in excess of $1.5B US • No competition 2. Value drivers • Completed Phase 3 Trial • PMA review mature • Least burdensome trial to be agreed with the FDA within Q3 2018 3. Potential for approval before 2020 • TIGRIS to start in Q4 2018 an
Slide 25: Investor contacts
Investor contacts Spinnaker Capital Markets Inc. 10 King Street East, Suite 1202 Toronto, ON M5C 1C3 Ali Mahdavi Managing Director am@spinnakercmi.com 416.962.3300 25