Improving Cancer Diagnostics

Transcription

1 Fall 2015

2 Safe Harbor Safe Harbor Statement under the Private Securities Litigation Reform Act of A number of the matters and subject areas discussed in this presentation that are not historical or current facts deal with potential future circumstances and developments. The discussion of such matters and subject areas is qualified by the inherent risks and uncertainties surrounding future expectations generally and also may materially differ from Guided Therapeutics actual future experience involving any of or more of such matters and subject areas. Such risks and uncertainties include: access to sufficient debt or equity capital to meet our operating and financial needs; the effectiveness and ultimate market acceptance of our products; whether our products in development will prove safe, feasible and effective; whether and when we or any potential strategic partners will obtain approval from the FDA and corresponding foreign agencies; our need to achieve manufacturing scale-up in a timely manner, and our need to provide for the efficient manufacturing of sufficient quantities of our products; the lack of immediate alternate sources of supply for some critical components of our products; our patent and intellectual property position; the need to fully develop the marketing, distribution, customer service and technical support and other functions critical to the success of our product lines; the dependence on potential strategic partners or outside investors for funding, development assistance, clinical trials, distribution and marketing of some of our products, as well as those that are more fully described from time to time under the heading Risk Factors in Guided Therapeutics reports filed with the SEC, including Guided Therapeutics Annual Report on Form 10-K for the fiscal year ended December 31, 2014 and subsequent quarterly reports. 2

3 Improving Cancer Diagnostics Point of Care, Painless Testing Platform for Early Cancer Detection Multiple Billion-Dollar Market Opportunities Device and High-Margin Disposable Business Model Clearly Defined Unmet Clinical Need Strong Intellectual Property Second year of generating revenue with international sales Cash Flow Breakeven Internationally within Sight Advanced Progress with FDA for US Market 3

4 Biophotonic Technology Platform Using multiple wavelengths of light to penetrate tissue and noninvasively detect chemical and structural changes associated with early cancer development Can be used to detect most carcinomas Fluorescence spectroscopy detects metabolic changes Reflectance spectroscopy detects structural changes Sophisticated algorithm optimizes early cancer detection and reduces false positive cases 4

5 Proven Technology/Market Acceptance First commercial product based on the company s biophotonic technology was sold to U.S. marketing partner. Now sold worldwide by Philips Medical. BiliChek bilirubin assessment tool Replaced blood test for monitoring infant jaundice Device and single-patient-use disposable model Key members of BiliChek team involved in LuViva Standard of care in many parts of the world 5

6 Strong Intellectual Property Intellectual property 23 issued U.S. patents 2 U.S. patents issued this year 4 patent applications Trade secrets Sophisticated, proprietary software algorithm Publications 7 peer-reviewed articles 4 in flagship U.S. Colposcopy society journal, 1 in premier Gynecology journal 14 posters and oral presentations in U.S., South America and Europe 6

7 Multiple Billion Dollar Market Opportunities Cervical Cancer ** Initial Target ** Esophageal Cancer Head and Neck Cancer Anal Cancer Colorectal Cancer Skin Cancer 7

8 Cervical Cancer: A Costly Worldwide Killer Second only to breast cancer, worldwide 530,000 cases of invasive cancer 200,000 deaths Leading cause of cancer deaths in developing world for women of childbearing age In the U.S. alone: 500,000 cases of precancer in the U.S. 12,200 cases of cancer in the U.S. $2.8 billion to treat cervical cancer $6 billion to diagnose cervical cancer million Pap tests annually million follow-up referrals 8

9 Cervical Cancer: Unmet Clinical Needs In Developing World: Cervical cancer remains a leading cause of death for women of childbearing age due to the lack of laboratory infrastructure Clinical Need: A noninvasive screening product that provides an immediate result in countries with little Pap/HPV screening In Developed World: Up to 80% of colposcopies and biopsies for Pap positive women are found to be normal/not necessary. Potential for rising false positive rates with recent HPV screening approval Clinical Need: A noninvasive triage product to determine which patients that screen positive with Pap/HPV need a biopsy (true positives) and which don t (normal or false positives) 9

10 LuViva Advanced Cervical Scan Safe, Effective, Efficient No sample taken No Laboratory needed 1 minute to scan entire cervix Technician operated, touch screen technology Immediate results Accurate Reduces false positives in triage Finds disease earlier Solid Economics (triage) Device and single-use disposable Designed to appeal to payers, doctors and patients Savings in reduced spend on biopsies and pathology Reduces costs to healthcare system by ~7-13% 10

11 Summary of Clinical Trial Results - Screening Study Sensitivity CIN2+ Specificity Normal/CIN1 # Subjects PI Kitap, Turkey 78% 81% 523 Ali Ayhan Hacetteppe Univ., Turkey No Disease 80% 254 Ali Ayhan Maslak Acibaden, Turkey 100% 85% 140 Ali Ayhan SOGON, Asaba, Nigeria, 2014 No Disease 87% 254 B. Olusola Fasubaa Turkish Society of Gynecologic Oncology Congress Society of Gynecology & Obstetrics of Nigeria 1,100+ subjects Additional studies underway to improve specificity Consistent performance Performance comparable to Pap smear

12 LuViva Pivotal Clinical Study: Triage Use 1,600 patients referred for cervical disease follow up due to abnormal Pap, HPV positive, previous disease Conducted over 4 years with additional 2-year follow up at 9 clinical sites Reduction of false positives by up to 40% = reduced need for colposcopies 99% negative predictive value = 99% confidence that when LuViva says the patient is negative, they are truly normal/without cervical cancer Earlier detection of cancer than standard of care Results published in Gynecologic Oncology (April, 2013). Authors include three past presidents of the American Society for Colposcopy and Cervical Pathology 12

13 Post-Launch Study Confirms LuViva Triage Results Study detected 100% of pre-cancers False positives cut by 44% 13

14 Patients Prefer LuViva Vast majority of women say: Wanted their doctor to have LuViva Liked LuViva better than Pap Would recommend LuViva to a friend Wanted insurance coverage MHS (LuViva) offers the potential of a cost effective and efficient modality for earlier detection of CIN2+ disease in women at risk for cervical disease, while at the same time reducing the number of colposcopies and biopsies currently performed on normal and benign cervices. * * American Society for Colposcopy and Cervical Pathology 2010 Biennial Meeting Abstract 14

15 LuViva Razor/Razor Blade Business Model LuViva device and single-patient-use disposables Attractive pricing LuViva device sold to distributors for <$20,000 Disposables sold to distributors (list price) for $12.50 (screening) to $25 (triage) Up to 80% margin on disposables Targeted sales and marketing focus High-volume centers to drive disposable usage High-profile key opinion leaders 15

16 Cervical Cancer Market Opportunity International Market Opportunity Screening ~60 million women in age range In 35 of 52 countries under contract: Turkey, Nigeria, Kenya, Mexico, Bangladesh, etc. Assume maximum 50% of women get screened once every 3 years Estimated Market Opportunity: $1.2 billion Triage Estimated based on number of colposcopies currently done annually Canada, Brazil, Western Europe, excluding Germany Estimated Market Opportunity: $477 million US Market Opportunity Triage Estimated based on number of colposcopies currently done annually Estimated Market Opportunity: $460M International Market significantly bigger than US Market 16

17 Current Regulatory Status Health Canada approved 2012 Singapore Health Authority approved 2012 CE Mark approved 2013 Mexican COFEPRIS approved 2014 US FDA amended PMA submitted July 2014 Secured meeting date with FDA to review the Company s plan to submit approvable application of the LuViva Advanced Cervical Scan 17

18 Advanced Progress with FDA Filed original PMA in September 2010 Filed PMA Supplement November 2012 Answered >100 FDA questions Face to face meeting held with FDA in May 2014 Amended PMA filed July 24, 2014 Received Non Approvable Letter on May 15, 2015 Held November 30, 2015 meeting with the FDA Positive meeting with new FDA team members General agreement on framework for collecting additional data for the LuViva 18

19 International Demand Building Initial commercial units shipped August 2013 Distribution agreements covering 52 countries today Sales ramp expected to be measured as customers evaluate the product before acquisition Evaluations typically include a few dozen to several hundred patients and can last from 2 weeks to 6 months Sales occur after data is analyzed and funding is identified 2014 sales $800k 2015 sales forecast >$1 million (backorders due to large orders) Focused on growing high-volume disposable sales in key existing markets $14.4 million multi-year contract with Turkey for 1.1 million disposables 19

20 Current Status: Turkey $14.4 million contract signed in September instruments and 1.1 million disposables through 2018 Even this large order represents ~15% of total opportunity in Turkey for cervical cancer screening 2016 (MOH) order expected to be 4X 2015 projected revenue Distribution Partner: ITEM Medical Technologies 33 Devices shipped through August 2015 Growing orders of Cervical Guide disposables Additional devices on order Distributor has good payment record Completed 1,250 patient evaluation of LuViva for primary screening LuViva performs comparably to the Pap smear but has many other advantages 20

21 Current Status: Kenya Proposal submitted to Federal Government for 100 instruments and 1 million disposables/year (>$10 million/year) Additional proposals submitted to key County Ministries of Health Expect to hear results this year 21

22 Other International Sales Activity Shipments have been made to the following additional countries Canada Europe (Netherlands, Italy) Bangladesh Indonesia Nigeria Costa Rica Guatemala Mexico Saudi Arabia Kuwait UAE Chile 22

23 Screening Opportunity Continues to Expand Multi-site Screening Study Initiated Blinded trial of women (160 women in US, remainder in Peru) Results to update and validate LuViva software for screening indication Comparison to Visual Examination with Acetic Acid, cytology, HPV, colposcopy and biopsy, where taken Trial to take approximately 6 to 9 months Bangladesh Distributor awarded government tender for 8 units Potential for larger future order in women s health centers throughout country 23

24 Management Gene Cartwright Recruited to Guided Therapeutics in January, years at Abbott Diagnostics GM of Hematology business GM of Molecular Diagnostics business VP of Marketing for Diagnostics ($3B) for 5 years Recruited to GE as President Molecular Diagnostics Spun out GE JV (Omnyx, LLC), Founder and CEO for 5 years PhD in Chemistry Stanford, MBA Northwestern 24

25 Board of Directors Ronald Hart, Ph.D. Vice Chairman Former Director of the FDA National Center for Toxicological Research to 1992 Linda Rosenstock, M.D., Board Member Dean Emeritus of UCLA Fielding School of Public Health Jonathan Niloff, M.D. Board Member Associate Professor of OBGYN and Reproductive Biology at Harvard Medical School Michael James Chairman Managing Partner of Kuekenhof Capital Management, LLC John Imhoff, M.D. Board Member Ophthalmic surgeon who specializes in cataract and refractive surgery Gene Cartwright CEO Over 30 years of experience working in the IVD diagnostics industry 25

26 Key Take Aways Product on the market, generating revenue since early 2014 Patent protected with Regulatory approvals (CE, Canada, Mexico) Multi-Billion dollar market potential due to screening use Largest market is for primary screening in the developing world Turkish Ministry of Health contract signed ($15 million) and orders being shipped Potential deal in Kenya, plus the Turkey deal would get Company to Cash Flow positivity Demonstrated Unmet Clinical Need High-Margin Disposable Business Model Following up with FDA to propose additional studies Completed recent financing for $4 million 6/30/

27 Business Developments & Upcoming Events 2015 sales forecast $1.1 million, driven by international markets LuViva International Sales to Turkey Fulfilling $4.5 million MOH order in 2016 Recently announced increase in MOH order: 150 LuViva units & 275k Cervical Guides in 2016 LuViva International Sales to Kenya Proposal to Kenyan government to test 110,000 Women /Month Expanded access of LuViva to Bulgaria in August 2014 Expanded access of LuViva to Costa Rica in August 2014 LuViva Domestic Sales 11/30/2015 Meeting to Review PMA Amendment following: Face to face meeting held with FDA in May 2014 US FDA amended PMA submitted July

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