Spectral Medical Inc.

Transcription

1 Spectral Medical Inc. Targeted therapy for septic shock AGM May 31,2018

2 Forward Looking Statements Certain statements contained in this presentation constitute forward-looking information within the meaning of securities laws. Forwardlooking information may relate to our future outlook and anticipated events or results and may include statements regarding our future financial position, business strategy, budgets, litigation, projected costs, capital expenditures, financial results, taxes and plans and objectives. In some cases, forward-looking information can be identified by terms such as may, will, should, expect, plan, anticipate, believe, intend, estimate, predict, potential, continue or other similar expressions concerning matters that are not historical facts. These statements are based on certain factors and assumptions regarding, among other things, expected growth, results of operations, performance, and business prospects and opportunities. While we consider these assumptions to be reasonable based on information currently available to us, they may prove to be incorrect. Forward looking-information is also subject to certain factors, including risks and uncertainties that could cause actual results to differ materially from what we currently expect. These factors include, among other things, the availability offunds and resources to pursue development projects, the successful and timely completion of clinical studies, and the ability to take advantage of business opportunities, the granting of necessary approvals by regulatory authorities, and general economic, market and business conditions. For more exhaustive information on these risks and uncertainties you should refer to our most recently filed Annual Information Form which is available at Forward-looking information contained in this presentation is based on our current estimates, expectations and projections, which we believe are reasonable as of the current date. You should not place undue importance on forward-looking information and should not rely upon this information as of any other date. While wemay elect to, weare under no obligation and do not undertake to update this information at any particular time. 2

3 Spectral s products for treating endotoxemic Septic Shock 6 Approval Pending Small confirmatory study 1 FDA Cleared to Measure Endotoxin a predictor of ICU mortality in septic patients 2 First and Only Diagnostic for Endotoxemia Sold globally. Evidence in thousands of patients Randomized, Controlled U.S. Trials Demonstrated reduced risk for mortality by >40% in key subgroup Proven to Remove Endotoxin Evidence in thousands of patients. Large U.S. Unmet Need 1.7 million sepsis patients per year. No new therapy approved to reduce mortality in 10+ years 3

4 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) (1) Endotoxins and other sepsis triggers. Opal SM. Contrib Nephrol. 2010;167: Jun 1. 4

5 Septic Shock in the US: A very large unmet medical need SEPSIS 1.7M patients 20% mortality SEPTIC SHOCK 330k patients 40% mortality Increased severity organ dysfunction 50%+ with high endotoxemia Sources: 1. Sepsis numbers from CDC 2. Septic Shock and MOF from NIS database Guidelines from surviving sepsis campaign 2016 Unacceptable mortality & limited therapeutic options 5

6 Spectral s targeted approach: Measure, then treat! Remove endotoxin Measure endotoxin levels Resolve Increase survival rate Septic Shock & Multi Organ Dysfunction 6

7 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 7

8 PMX: How it works Extracorporeal Hemoperfusion In-vivo Endotoxin removal by PMX Femoral V. PMX Femoral V. Blood Pump Novelli G,. Early management of endotoxemia using the endotoxin activity assay and polymyxin B-based hemoperfusion. Contrib Nephrol. 8

9 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. 9

10 Target patients for PMX based on EUPHRATES PMX reduces mortality rate in patients with Septic Shock, Multi Organ Dysfunction and EAA between Top line data showed a trend for mortality benefit in favor of PMX It was observed that 17% of patients had EAA levels beyond adsorption capacity of the PMX cartridge 10

11 Burden of Endotoxin: Calculated quantity of circulating endotoxin in an average size adult Burden of Endotoxin :Volume of blood + interstitial fluid m Low (non-measureable) Low-Mid Measurable High Measurable High (non-measureable) EAA < to 0.9 >0.9 Endotoxin Conc. (pg/ml) Approximately to 4000 >4000 Endotoxin Burden 8 µg µg >50 µg EUPHRATES EAA NA 83% 17% 13

12 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= Days 42 HR 0.58, p = 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 EUPHRATES trial results check 12

13 Spectral s approach significantly improves multiple organ function The survival benefit is achieved by reversing organ dysfunction 13

14 FDA Decision March 2018: Further evidence to be added Non Approvable: While acknowledging the potential effectiveness of PMX based on our posthoc, analysis, given the extreme vulnerability of the target population, the Agency would like to see more data prospectively collected to confirm efficacy The suggested path forward The FDA recognize the unmet needs of therapies for sepsis as well as the difficulty to conduct a second randomized trial. They therefore suggested Spectral evaluate different methods such as Bayesian statistics Single Arm trial 14

15 Market Exclusivity for the PMX/EAA therapy Intellectual Property Patent protection for EAA expires Patent protection for PMX expires (Patent Term Protection increase of 5 years following PMA approval) Regulatory 6 year rule prevents dissemination of important knowledge to competitors Competitors must perform a similar clinical trial (RCT) and demonstrate similar benefits Competitors cannot follow a non-inferiority or equivalency regulatory pathway Adds 5-10 years of market exclusivity for Spectral PMX manufacturing know how Toray Industries manufactures the PMX cartridge from proprietary products and uses specific process for Polymyxin binding; very difficult to reproduce 15

16 Study design options beyond frequentist statistics Assumptions: A) Using standard statistics would require 800 subjects to detect a 10 % mortality benefit B) A desire to leverage existing data from EUPHRATES (both control and treated arms) C) Strong desire to do a single arm trial 1)Bayesian approach Requires a contemporary control group (randomization) Not suitable for a single arm trial 2) Single Arm with appropriate comparator Propensity matching for comparator Requires retrospective dataset identified as a comparison, such as the control arm of EUPHRATES May limit use of the active arm in EUPHRATES EUPHRATES control arm as comparator Allows pooling of data from Active arm of EUPHRATES with new data obtained from TIGRIS trial

17 TIGRIS Study Design Established with input from: - clinician-users of PMX, consultants and using the least burdensome approach suggested by the US FDA, Number of Centers: Approximately 10 in the USA only Number of Subjects: significance Goal is to recruit minimum amount needed to show Study Design: proposed Single arm, open-label study of standard care plus the PMX cartridge.

18 Significant milestones achieved 2010 License agreement with Toray IDE approved by the FDA First patient enrolled 2014 Interim analysis Trial amendment 2016 Enrolment completion Top line results 2017 PMA submission FDA 100 Day meeting SAM pump cleared by FDA $60 Million equity raise in 3 tranches 450 Patients enrolled in a double blinded RCT with 50 sites Regulatory Development of a proprietary CRRT/Hemoperfusion Pump (SAM) 18

19 Upcoming milestones Q TIGRIS trial design Submission and interactive review Q Agreement with FDA Beginning of TIGRIS Q Full speed Patient enrolments Expansion of Canadian Market Expansion of international EAA sales 2019 TIGRIS completion and analysis Result submission FDA approval 2020 Market launch 19

20 Spectral s pump SAM is received 510k approval in late Q SAM will be the most user friendly machine to perform minimally invasive extracorporeal treatments - such as CRRT, hemoperfusion, SLED and TPE in an ICU setting. SAM is conceived as an open platform, and its intended use can be extended to perform a litany of extracorporeal therapies such as Toraymyxin, or CO2 removal. SAM has the potential to compete in a double digit growing market of around $200M in US as third player on the market. 20

21 CRRT in US: Competitor landscape 200,000 AKI patients per year in RRT treated with NXSTAGE treated with Baxter conventional dialysis EASY to learn EASY to use EASY to mantain SAM s target market will the 65% market segment still utilizing standard Dialysis 21

22 Machine and disposable & Fluids Machine Selling price $25,000 $35,000 Life cycle 10 years Disposable Blood line and dialyzer $ pcs. per machine per year Fluids Dialysate and reinfusion solution bags Bag market price $40 for 25L 1600 L per machine per Year 22

23 SAM Go To Market Dec - Feb 510K HC clearance CE Mark TUV electrical certification March First Marketable Version May Identification of first clinical test site. UoM Ann Arbor June-Oct In-Vitro Clinical tests in hospital Nov/Dec First use in Human subject 23

24 Company Highlights TSX: EDT Established 1991 Number of employees 19 Offices & Facilities Toronto, Canada Recent Share Price $0.33 Shares Outstanding 207M Market Capitalization ~ $70 M Insider Ownership ~ 45% Cash & Cash Equivalents $ M following raise in April 2018 Total Debt Nil Shareholder Base 70% - Institutional 30% - Retail 24

25 Management Team Paul Walker, MD, PhD, FRCSC Richard Wieland Debra Foster, BSc Gualtiero Guadagni, PhD Lisa Sauve, CPA, CA Director, President & CEO Joined Spectral in 2001 as CEO. Previously Surgeon in Chief University Health Network, Program Director of Intensive Care Medicine, University of Toronto. Graduate of Harvard Business school AMP. Chief Financial Officer Joined Spectral in years of Life Science CFO experience in both private and public companies having extensive experience in capital raising and M&A transactions. VP, Clinical Development Joined Spectral in Brings 20+ years experience in critical care clinical trials. Strong clinical and regulatory background. VP, Sales and Marketing Joined Spectral in Biomedical engineering background 20 years of experience in medical devices for extracorporeal blood purification, R&D, market development and sales Controller Joined Spectral in Obtained CA with Ernst & Young and progressed to a senior manager role before joining a privately held company in the engineering metallurgical and automated welding industry. Over 30+ years of experience in accounting, audit, tax and finance. 25

26 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. Paul Walker President & CEO, Spectral Medical Inc. William Stevens Former Principal, Birch Hill Equity Partners & Managing Director, Westerkirk Capital Inc. 26

27 Investor contacts Spinnaker Capital Markets Inc. 10 King Street East, Suite 1202 Toronto, ON M5C 1C3 Ali Mahdavi Managing Director