Corporate Presentation

Transcription

1 Corporate Presentation December2014

2 Forward Looking Statement Please be advised that the information and projections provided in this presentation may include forward-looking statements with respect to plans, projections or future performance of the Company, the occurrence of which involves certain risks and uncertainties, some of which may not be under the control of Exalenz, including, but not limited to, changes in regulatory environment, Exalenz's success in implementing its research, development, sales, marketing and manufacturing plans, protection and validity of patents and other intellectual property rights, the impact of currency exchange rates and the effect of competition. Additionally, please be advised, that certain solutions or applications for Exalenz s products, included in this presentation, may not yet be commercially available and/or regulatory cleared for marketing. All trademarks and registered trademarks are the property of their respective owners. Slide No. 2 December 2014

3 Exalenz Mission Slide No. 3 December 2014

4 Investment Summary Slide No. 4 December 2014

5 BreathID Hp for H. pylori Slide No. 5 December 2014

6 H. pylori: Potentially Lethal, But Easily Treatable Spreads quickly through saliva/easily transmitted H. pylori reduces the stomach s ability to produce mucous leading to chronic irritation If diagnosed, can be treated with PPIs, H2As, antibiotics Proven links to: Gastritis 25% Prevalence Over 75M Infected Peptic ulcers Gastric cancer Slide No. 6 December 2014

7 H. pylori Detection Available Tests Blood Test Sensitivity 85% Specificity 79% Stool Test Sensitivity 90.6% Specificity 91.5% Urea Breath Test (UBT) Sensitivity 100% Specificity 99.2% UBT has superior clinical efficacy when detecting H. pylori infection Slide No. 7 December 2014

8 Our Solution: The BreathID Hp Test Human Exhalation 13 78%-N2 16%-O2 Constant ratio: 13 CO2 12 CO2 12 CO2 CO2 5%-CO2 ~1% Start Quick results in minutes ~99% Results 30 Baseline measurement Slide No. 8 December 2014 Patient drinks 13 C-labelled substrate Real-time Results

9 BreathID for H. pylori Testing Point-of-Care device High Volume Lab System 99+% sensitivity & specificity ~300 US Sites Fast: minutes total test time facilitates test and treat Non-invasive, patient friendly Significant economic incentive $65-$110 reimbursement Small footprint/emr compatible Slide No. 9 December 2014 To be launched in Q3/15 Fast: 3-4 min per test Automatic analysis of 10 tests in succession Significant economic incentive $55-$100 reimbursement Integrated into Lab EMR

10 BreathID Lab; Launch in Q High Volume Lab System Automatic Analysis of 10 Tests in Succession Walk-Away Operation Slide No. 10 December 2014

11 Total Hp Test Market, Lab and POC All Segments ( Number of tests per year in USA) Blood Tests 4,600,000 Stool Tests 600,000 Urea Breath Tests 780,000 (140,000 POC) H. Pylori Total Slide No. 11 December ,980,000 Note: Requires confirmation of applicability to European markets

12 Three Distinct Opportunities National Labs Regional Labs IDNs/ACOs Efficiently & profitably serve diverse customers Serve customer base but prioritize profitable tests Treat patients in holistic (and profitable) manner Slide No. 12 December 2014 Note: Requires confirmation of applicability to European markets

13 Powerful Clinical and Reimbursement Support Slide No. 13 December 2014

14 UBT Vs. Blood Test; Leading Reimbursement Positions Organization Cigna1 Aetna2 Anthem Blue Cross and Blue Shield3 Geisinger Health Plan4 Blood Antibody Test Urea Breath Test (UBT) Serology blood testing will not be covered to test for H. pylori... The overall body of literature suggests that non -invasive testing with UBT is as clinically useful as endoscopy in managing select patients with uncomplicated upper gastrointestinal symptoms. Blood antibody testing for H. pylori is experimental and investigational because of insufficient evidence of its effectiveness. Serologic (in H. pylori testing) use is no longer recommended because it has poor predictive value, leads to increased antibiotic resistance. Eliminate the use of serology testing. Serology testing will not be reimbursed... Stenstrom et al (2008) stated that urea breath tests are the best way to diagnose current H. pylori infection. UBT (CPT codes 83013, 83014) is FDAcleared for the initial diagnosis and to confirm eradication. UBT (CPT codes 83013, 83014) is FDAcleared for the initial diagnosis and to confirm eradication. 1) Helicobacter pylori Serology Testing, Cigna, Cigna Medical Coverage Policy, Aug 2014 ( 2) Clinical Policy Bulletin: Helicobacter Pylori Infection Testing, Aetna, April 2014, ( 3) Anthem Adopts AGA and ACG Recommendations for Helicobacter Pylori Testing, Anthem Blue Cross and Blue Shield, Jan 2011, Network Rapid Update ( 4) Operations Bulletin: Helicobacter pylori (H. pylori), Geisinger Health Plan, Jun 2011, ( Slide No. 14 December 2014

15 Attractive Lab Testing Economics Regional Labs Blood Testing Reimb. Code CMS Reimb. Private Insur. Materials Urea Breath $8-20 $8-12 $5 $70-95 $50-75 $35 Potential Revenue $3-15 $15-60 Slide No. 15 December 2014

16 The US H. pylori Opportunity Launch into Laboratory market Q3 2015, IDN, HMOs in H2/2015 Slide No. 16 December 2014 Transform 3M Serology Tests into Breath Tests Gain Market Share in POC Market Leverage national Leverage footprint,national favorable footprint, favorable reimbursement reimbursement support, support, society society guidelines guidelines Direct Directsales-force sales-forcerazorrazorblade business razor-razorblade model business model Economic incentive average breath test Economic incentive reimbursement 65$ average breath test to $100 (serology reimbursement 65$ $8to 20) (serology $8-20) $100 EffectiveAug Aug18, 18,2014, Effective 2014,(14M Cigna (14M to Cigna insured) to no longer noinsured) longer reimburse for for tests H. H.reimburse pylori blood pylori blood tests

17 Broad Pipeline of Diagnostic Solutions for Liver Diseases Slide No. 17 December 2014

18 Underscoring the Need Trial Designs and Endpoints for Liver Disease Secondary to Nonalcoholic Fatty Liver Disease (NAFLD) Meeting sponsored by September 5-6, 2013 FDA White Oak Campus There is an acute need for well-validated functional test(s) in liver that correlate(s) with clinical outcomes and/or fibrosis progression and with the response to anti-fibrotic therapy, not only in advanced disease, but also in patients with intermediate stages of fibrosis The development of noninvasive correlates to HVPG is a high priority. Scott L. Friedman, MD Guadalupe Garcia-Tsao MD Icahn School of Medicine at Mount Sinai Medical Center Professor of Medicine, Yale Medical Group Slide No. 18 December 2014

19 The Optimal Solution Slide No. 19 December 2014

20 Exalenz Liver Applications Opportunity Indication NASH Market Potential Clinical Relevance The most extreme form of NAFLD (nonalcoholic fatty liver disease) major cause of: cirrhosis, need for liver transplantation and liver cancer CSPH An increase in portal hypertension is a complication of chronic liver disease and cirrhosis, closely related to increase in liver associated complications. HCC HCC is Primary liver cancer mostly related to chronic liver disease. 700,000 people die every year from HCC, majority in China. ALF Acute liver failure in patients not previously suffering from liver disease is a rare and fatal condition Slide No. 20 December 2014 OBT may be used to rule-in NAFLD patients for liver biopsy which is required for treatment initiation.mbt and HVPG are being used as end points for the new treatments that are being developed for NASH $2.6B (33M Patients with NAFLD) A $100M annual (US only) market potential as noninvasive measure of CSPH replacing HVPG $100M A $380M annual (China only) market potential as a tool for early deduction of HCC in HBV and cirrhotic patients $380M Prediction of spontaneous recovery/deterioration of acute liver failure patients may be life saving and supported by the NIH (US Only) (China Only) N/A

21 Exalenz Liver Pipeline Development Indication Intended Use Status 2014 NASH CSPH HCC Diagnosis of NASH and follow up on pts. under treatment OBT - Completed phase IIa (58 pts) Diagnostic of significant portal hypertension Completed phase II (120 pts) Phase III Completed phase IIA ( 45 pts) Phase IIb (China) Diagnosis of HCC MBT (vs. HVPG) Completed phase II Market Potential Pipeline Development 2017 Clinical studies with strategic partners 2018 Approval (120 pts) Prediction of death/recovery Completed phase II ( 71 pts) (US Only) Approval $380M Phase IIb (NIH) (China Only) N/A Approval Slide No. 21 December 2014 (33M Patients with NAFLD) $100M Approval ALF $2.6B

22 Exalenz NASH/NAFLD Strategy Market Potential $2.6B - 33M Patients with NAFLD Active development of Drugs to treat NASH FDA mandate biopsy proven NASH as inclusion criteria Slide No. 22 December 2014 A major impediment on drug development and future potential. Exalenz s breath test is used to identify NAFLD patients who are very likely (>90%) to have advanced NASH Enrich study population and accelerate time for approval Discriminating severe from non severe NAFLD Monitoring response to treatment Signing partnerships with major pharmaceutical players to incorporate BreathID

23 Experienced Management Team Lawrence Cohen, CEO Susan Alpert, MD, PhD, Executive VP Regulatory Ted Foltyn, VP WW Marketing & Bizdev Gavin Doree, VP Sales Raffi Werner, COO, General Manager Dudy Stolick, CFO Yaron Ilan, MD, Medical Director Ilan Ben-Oren, CTO Slide No. 23 December 2014

24 Financials Traded on Tel Aviv Stock Exchange (TASE) since 2007 Current market cap- ~ $17.5M Shareholders: Arkin Holdings 60% Migdal Insurance 14% Public (mostly funds that hold <2% each ) - 26% Current Burn rate - ~$700k monthly Cash in the bank - ~$4.1M H. pylori business break-even point Q1/2016 Slide No. 24 December 2014

25 Near-term Milestones H. pylori Q3/15 Q3/15 Co-marketing agreement with large laboratories Q3/15 Q3/15 Launch of H. pylori Lab System Q2/15 Q2/15 CFDA approval of Breath ID Hp Q3/15 Q3/15 Launch Breath ID Hp in China Liver Q4/14 Q4/14 CSPH pivotal study -Start Q1/15 Q1/15 NASH clinical trial for Algorithm development (OBT) Q1/15 Q1/15 HCC phase II study in China Q2/15 Q2/15 NASH Clinical trials in collaboration with Pharma (OBT+MBT) Slide No. 25 December 2014

26 Investment Risk Factors Slide No. 26 December 2014

27 Thank You.

28 Liver Applications Appendix Slide No. 28 December 2014

29 NASH- Non-Alcoholic Steatohepatitis What is NASH? The most extreme form of NAFLD (non-alcoholic fatty liver disease) marked by inflammation and fibrosis of the liver Regarded as a major cause of cirrhosis accompanied by varying stages of fibrosis Considered as a major risk factor for the need for liver transplantation and for development of hepatocellular carcinoma (HCC, primary liver cancer) How is NASH diagnosed? Liver biopsy an invasive, complex, operator dependent procedure with high degree of sampling error. What is the relation between NASH and OBT? NASH is associated with a defect in the mitochondrial beta oxidation, a pathway that is associated with the metabolism of fats Octanoate Breath Test (OBT) - highly sensitive breath test using Octanoate, a fat molecule being metabolized via the mitochondrial beta oxidation OBT highly correlates with NASH on liver biopsy, and can differentiate NASH from simple steatosis Slide No. 29 December 2014 OBT may be used to rule-in NAFLD patients for liver biopsy which is required for treatment initiation

30 CSPH - Clinically Significant Portal Hypertension (HVPG test) What is CSPH? An increase in portal hypertension is a complication of chronic liver disease and cirrhosis, closely related to increase in liver associated complications. How is CSPH diagnosed? CSPH is measured by Hepatic Vein Portal Gradient (HVPG), an invasive, complex, and highly operator dependent procedure, involving radiation and contrast material injection. HVPG is measured in order to: Assess the risk of developing complications Monitor/adjust therapies to reduce portal hypertension What is the relation between HVPG and MBT? CSPH results in impaired hepatic function as measured by MBT Slide No. 30 December 2014 A $100M annual (US only) market potential as non-invasive measure of CSPH replacing HVPG

31 HCC - Hepatocellular Carcinoma What is HCC? HCC is Primary liver cancer mostly related to chronic liver disease. 700,000 people die every year from HCC, majority in China. How is HCC diagnosed? HCC is diagnosed by expensive MRI or CT studies. Screening can be done with ultrasound and AFP both of which have low (<60%) sensitivity. Resulting in delay diagnostics for most patients. What is the relation between HCC and OBT? Mitochondrial beta oxidation in the liver is defective in patients with HCC. This is independent of tumor size. OBT can detect defects in mitochondrial beta oxidation, thereby serving as a highly sensitive tool for early detection of liver cancer patients. Slide No. 31 December 2014 A $380M annual (China only) market potential as a tool for early detection of HCC in HBV and cirrhotic patients