Spectral Medical Inc. Q1 2019

Transcription

1 Spectral Medical Inc. Q1 2019

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 of fundsandresources to pursue development projects, the successful and timelycompletion ofclinical 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 we may elect to, we are under no obligation and do not undertake to update this information at any particular time. 2

3 Spectral s Highlights 1. Spectral is committed to get a novel treatment for endotoxemic septic shock patients comprised of proprietary components (Diagnostic and therapeutic )on the US Market 2. Expect to complete PMX confirmatory trial, and launch in $1.5B US market in 2021: PMX demonstrated clinical benefit in prior studies and commercial success in Europe and Japan Target patient group faces >40% mortality rate with limited treatment options PMA submission modules 1-3 are FDA approved, waiting for clinical trial completion 3. In March 2019 Spectral created a wholly owned subsidiary, Dialco Medical, to: Commercialize their Proprietary CRRT machine (SAMI) Get regulatory approval for DIMI (home dialysis version of SAMI). SAMI is already revenue generating and its launch will continue Undervalued Canadian biotech = big potential upside 3

4 Spectral s Targeted therapy for septic shock

5 Measuring & Treating Endotoxemic Septic Shock 5 A clear registration pathway The Tigris Trial, designed to build on the Euphrates generated body of evidence has been reviewed and approved by the FDA 1 EAA, a diagnostic to measure Endotoxin Activity a predictor of ICU mortality in septic patients Sold globally. Evidence in thousands of patients. 4 The EUPHRATES Trial Post-Hoc analysis demonstrated reduced 28 days mortality in key subgroup Clinical Body of Evidence 3 More than 200 peer reviewed papers reporting on more than 10,000 patients More than 170,000 treatments around the world, less then 0.1% of SAE reported 2 Proven Efficacy: to Remove Endotoxin Polymyxin B coated fibers, bench test results - each cartridge can remove up to 20 mg of LPS. 5

6 Spectral s Targeted Approach: Measure, then treat! Remove endotoxin Measure Endotoxin activity Resolve Increase survival rate Septic Shock & Multiple Organ Dysfunction 6

7 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. 7

8 $1.5B US market: >40% mortality and limited therapeutic options SEPSIS 20% mortality 1.7M patients with sepsis SEPTIC SHOCK > 40% mortality 330k patients in septic shock TARGET > 40 % mortality $1.5B+ market k patients with multiple organ dysfunction and high level of EAA $15-30k per EAA+PMX treatment price models Sources: 1. Sepsis numbers from CDC 2. Septic data from NIS database Guidelines from surviving sepsis campaign 2016

9 Endotoxin Activity Assay (EAA ) Measures Endotoxin activity in whole blood Results available in 30 minutes Available and sold worldwide: FDA cleared, CE mark and HC approved Key to identify patients who may benefit from PMX 9

10 PMX: Real world clinical evidence Regulatory acceptance in Japan, Europe, Canada and many other countries >300 published papers Approx. 10,000 patients entered into trials 150,000+ patients treated worldwide 20+ years of proven safety profile worldwide Results from Spectral s recently completed EUPHRATES trial, have been published in JAMA and Intensive Care Medicine 10

11 Lessons Learned from the EUPHRATES Trial While the top line data did not demonstrate a mortality benefit, it did show a trend for cardiovascular improvements in the PMX group The post-hoc analysis identified a subset of 194 patients who benefitted from the PMX treatments When strict patient selection criteria are applied, including high severity of illness (MOD score > 9) and an endotoxin activity level as measured by EAA between 0.6 and 0.89, PMX use is associated with an relative mortality benefit over Sham patients of 29% at 28 days JAMA. 2018;320(14): doi: /jama Intensive Care Med. 2018; 44: doi.org/ /s

12 PMX can significantly reduce mortality when strict patient selection criteria are applied % mortality 12 Sham PMX Figure shows mortality over time from day 0 to day 90 for SHAM vs PMX The vertical line represents Day 28. At day 90 the SHAM mortality was 41% and PMX 30% 194 patients in the per protocol group with: Septic Shock, MODS>9 and baseline EAA between 0.60 and 0.89 Treatment with PMX versus Sham was associated with a significant difference (adjusted) in Kaplan-Meier survival to 28 and 90 days between the groups (HR 0.56, 95% CI (0.33, 0.95), P = 0.03) and (HR % CI 0.35, 0.93), P = 0.02) respectively Mortality results supported by secondary endpoints Intensive Care Med. 2018; 44: doi.org/ /s

13 PMX effect on organ dysfunction The survival benefit is achieved by reversing organ dysfunction 4.0 mmhg Greater Increase in MAP * P< Greater decrease in Vasopressor Index * P=ns 14 more Vent-Free Days ** P< more RRT-Free Days ** P=ns Intensive Care Med (2018) 44:

14 The TIGRIS trial Adding to the EUPHRATES evidence 1. Trial Design agreed upon with the FDA: US sites only, randomized (2:1), Open Label trial 2. Prior population consists of 179 patients from US sites in EUPHRATES (target weight* 75%) new patients to be added from the TIGRIS trial EUPHRATES evidence [TIGRIS Prior]: US patients with MOD>9 and EAA : N= 90 PMX with 38% mortality N= 89 controls with 48% mortality TIGRIS new patients 100 PMX 50 controls Same inclusion and exclusion criteria, same sites TIGRIS: Bayesian trial designed to show: Minimum 10% difference in mortality *Statistical analysis plan not finalized, prior weight may change 14

15 Next 2 Years of Milestones: PMX/EAA path Q Expansion of international EAA sales Beginning of TIGRIS Q First TIGRIS patient enrolment Expansion of PMX Canadian Market Q sites actively enrolling patients 2020 TIGRIS completion FDA submission 2021 FDA approval PMX launch

16 Patent and Regulatory Exclusivity EAA/PMX protection up to 10 years 8 years patent protection with EAA as companion diagnostic EAA Patent Term Protection adds up to 5 years after PMA approval with EAA as Companion Diagnostic 6-10 years market exclusivity with FDA approval of PMX as a PMA 6 year FDA market exclusivity when approved as a PMA White paper outlines potential exclusivity up to 10 years Competitors must perform a similar clinical trial (RCT) program and demonstrate similar benefits Competitors cannot follow a non-inferiority or equivalency regulatory pathway Significant PMX manufacturing knowledge barrier Toray Industries uses proprietary products and specific process for Polymyxin binding; very difficult to reproduce

17 Dialco Medical Inc. Wholly owned subsidiary of Spectral Medical

18 Investment highlights for Dialco Medical 1. Growing niches in within the $10B dialysis market with a potential market in excess of $1B US for Acute (CRRT) and Home (HHD) dialysis with the advantage of the second on the market in the United States and Canada. 2. Disruptive product concept Spectral s CRRT Machine is an innovative platform designed to remove any source of complexity from dialysis treatments. 3. Value drivers CRRT version is market ready. The Home Dialysis version is CE marked. Beta tester from major academic centers in US and Canada are beginning a product evaluation, with enthusiastic feedback over the training sessions 18

19 DialCo: Mission & Vision Dialysis Feasible as never before 1. Disrupting CRRT (Continuous renal Replacement Therapy) by removing complexity and thereby increasing its adoption. SAMI- CRRT Machine 1. Change the life of chronic dialysis patients by empowering them to take control of their life through a Simple, Safe and affordable home hemodialysis. DIMI- Home Dialysis Machine 19

20 CRRT and Home Hemodialysis 1 FDA Cleared Acute Dialysis (CRRT) in Hospital removing complexity and increasing its adoption. Second in the market in Canada, cost effective alternative in US Revenue generating since year Enhancement of in-hospital applications Open platform for hemoperfusion. Organ protection in dead brain patients Out of center Hospital Dialysis 4 5 Busting Home Dialysis adoptions empowering them to take control of their life through a Simple, Safe and affordable home hemodialysis Adapts the treatment according the patient s need. With a machine that keep the home patient connected with doctor and nurses Regulatory path for Home Dialysis 510k and Health Canada dossiers will be based on the already cleared CRRT version. CE mark already obtained more than 100 Dialysis sessions already performed 20

21 Dialco Medical Milestones Q SAMI Marketing material SAMI first training and installation Q First use in Human subject SAMI 510k & HC dossier preparation for DIMI Q Participation in RFPs in Canada SAMI 510k & HC dossier submission for DIMI Q SAMI First sale FDA and HC interactions DIMI 2020 HC & 510K Approval DIMI DIMI Launch 21

22 Conclusions 1. Large market Opportunity CRRT Market in US $200M growing 10% per year. Baxter and NxStage in US, Baxter alone in Canada HHD $500M increasing 14% per year - NxStage sole competitor 12 years of IPs protection and 20+ years of exclusive licence 2. Value drivers Disruptive Technology Robust Patents coverage till 2031 FDA & HC approval for the CRRT model 3. Revenues generation : CRRT in 2019, HHD in 2020 Active negotiation in 3 centers in US and Canada. First Customer training planned for April 10th Orders in house in excess of $500k in Q All key elements for DIMI s 510k Dossier ready to go 22

23 Spectral Medical Inc. Corporate Highlights

24 Company Highlights TSX: EDT Established 1991 Number of employees 20 Offices & Facilities Toronto, Canada Recent Share Price $0.45 Shares Outstanding 225M Market Capitalization ~ $100M (US$78m) Insider Ownership ~ 45% Cash & Cash Equivalents $5.0 M estimated ( March 31, 2019) Total Debt Nil Shareholder Base 70% - Institutional 30% - Retail

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.

26 Board of Directors Anthony Bihl Chairman of the Board, CEO, Bioventus LLC Kevin Giese Former CEO and Director, Medwell Capital Guillermo Herrera CEO Altan Pharmaceuticals SA Jun Hayakawa General Manager, Pharmaceutical & Medical Device Business Planning Dept. Paul Walker President & CEO, Spectral Medical Inc. William Stevens Former Principal, Birch Hill Equity Partners & Managing Director, Westerkirk Capital Inc.

27 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 $60 Million equity raise in 3 tranches PMA submission FDA 100 Day meeting SAM pump cleared by FDA & HC $5.3M raised through a private placement (non-brokered) 450 Patients enrolled in a double blinded RCT with 50 sites Regulatory Development of a proprietary CRRT/Hemoperfusion Pump (SAM) 27