www. isotopeworld.com Advanced Medical Isotope Corporation

Transcription

1 www. isotopeworld.com Advanced Medical Isotope Corporation

2 www. isotopeworld.com James C. Katzaroff Founder, CEO, Chairman December 5, 2016

3 Safe Harbor Statement This Overview contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of You can identify these statements by the use of the words "may," "will," "should," "plans," "expects," "anticipates," "continue," "estimates," "projects," "intends," and similar expressions. Forward-looking statements involve risks and uncertainties that could cause results to differ materially from those projected or anticipated. These risks and uncertainties include, but are not limited to, AMIC's ability to successfully execute its expanded business strategy, including by entering into definitive agreements with suppliers, commercial partners and customers; general economic and business conditions, effects of continued geopolitical unrest and regional conflicts, competition, changes in technology and methods of marketing, delays in completing various engineering and manufacturing programs, changes in customer order patterns, changes in product mix, continued success in technical advances and delivering technological innovations, shortages in components, production delays due to performance quality issues with outsourced components, regulatory requirements and the ability to meet them, government agency rules and changes, and various other factors beyond the Company's control. This Overview does not purport to be all-inclusive or to contain all the information that the recipient may desire in evaluating the Company. This Overview does not constitute an offer to sell any securities or a solicitation of an offer to purchase any securities. Except as otherwise indicated herein, information is presented as of December 5, The delivery of this Overview after this date does not imply there has been no change in the affairs of the Company after the date hereof. The Company is under no obligation to update this Overview. Certain information contained in this Overview has been obtained by the Company and/or its officers and directors from sources deemed reliable by the Company. Such information necessarily incorporates significant assumptions and estimates as well as factual matters. No representation or warranty is made by AMI that it will be able to: (i) implement the business plan discussed herein, or any of it; (ii) achieve the operating or sale results discussed herein, or any of them; or (iii) operate in a manner which permits AMIC s securities to retain their value or appreciate in value. Any investment in AMI involves risk.

4 www. isotopeworld.com 4

5 AMI s Solution Y-90 RadioGel Device A new treatment in development for direct injection into non-resectable tumors 5

6 AMI Overview A late stage radiation oncology focused medical device company Quick path to product launch Innovative brachytherapy solutions Offers safety, efficacy and cost benefits over existing therapies Robust IP position Exclusive rights under 15 patents that cover medical isotope applications, processing and manufacturing Y-90 RadioGel device trademark in 35 countries Recognized as a leader by local, state and federal agencies Awarded federal and state grants totalling $1.45M 6

7 We believe in better solutions to cancer 7

8 We believe in better solutions to cancer 8

9 We believe in better solutions to cancer 9

10 Brachytherapy Brachytherapy The radiation source is placed at the treatment site One of the earliest forms of cancer therapy Therapeutic index Provides a measure of therapeutic efficacy and safety The ratio of the radiation absorbed dose to a target region (tumor) relative to the limiting normal tissue dose T.I. = Dtumor / Dnormal A high therapeutic index reflects successful targeting of tumor tissue with high doses of radiation relative to any critical, limiting normal tissue 10

11 Brachytherapy Competition Cs-131 I-125 Pd-103 Y-90 Y-90 advantage Primary Emissions Auger x-rays Beta rays Average Path length Infinite 4mm Half-Life 9.7 days 60 days 17 days 2.7 days High energy, finite path Safer for healthy tissue and medical staff Short half-life Shorter treatment Delivery Form Metal seeds Biodegradable polymer No casing remains Cost Utilize expensive isotopes and delivery systems Readily accessible, less expensive Cost Savings 11

12 Y-90 Brachytherapy Competition Y-90 Microspheres 1 Y-90 RadioGel Device 2 Method of Administration Systemic injection near tumor Injected at site of tumor Migration Dose to Normal Tissue Migration expected, pretreatment required Dose to Normal Tissue Expected No migration expected >99% of radiation stays in tumor 3 High Therapeutic Ratio Minimal Dose to Normal Tissue Indication Liver tumors Broad range of tumors Dose to Normal Tissue Lower therapeutic index Higher therapeutic Index 1. Y-90 Micropspheres data based on SIR-Spheres 2. The Y-90 RadioGel Device* has not been approved by the FDA 3. Based on AMI studies 12

13 AMI s Y-90 Product Line Maximum Therapeutic Index High energy, short path length emissions enable high localized doses while sparing normal tissues 1 Y-90 RadioGel Device Localized, direct delivery of radioactive treatment to tumor 2 Y-90 Resorbable Polymer Seeds Polymer seed, as opposed to a metal or glass brachytherapy seed Y-90 Polymer Surgical Paste To be applied directly to tissue surfaces after surgical tumor removals to treat residual tumor cells 3 13

14 Y-90 RadioGel Device Regulatory Overview : Multiple formal interactions with the FDA on product characteristics and regulatory clearance requirements Currently: Reviewing opportunities for clearance in several international markets Aug 12, 2013: FDA concluded that the Y-90 RadioGel device is a medical DEVICE not a drug or combination product Currently: Completing additional studies to address FDA comments, including planning for a large scale, blinded and randomized animal study Future: Anticipate submitting a de novo filing for clearance as a Class II medical device 14

15 What if your best friend got cancer? 150M ~150 million pet dogs and cats in the US 1/3 1/2 Nearly 1/2 of dogs 1/3 of cats are diagnosed with cancer at some point in their lifetime #1 Cancer is the leading cause of death in dogs and cats $5,000-$7,000 The average cost of treating tumors in dogs using radiation is $5,000-$7, : 15

16 Wholly Owned Subsidiary of AMI Yttrium-90 brachytherapy for the Veterinary Market 2016 Veterinary Cancer Society Annual Meeting Sponsor Dr. Alice Villalobos, DVM, FNAP - Chair of the Veterinary Medicine Advisory Board leading initial treatments Active Companion Study First cat treated, actively recruiting 16

17 World Class Team A prominent team of radiochemists, scientists and engineers, collaborating with strategic partners, including national laboratories, universities and private corporations, lead the AMI s development efforts. Management James C. Katzaroff Chairman, Founder and CEO Leonard Bruce Jolliff, CFO Dr. Fu Min Su, Chief Radio-Chemist and Safety Officer Maren Ohaks Katzaroff, Director Strategic Planning Board of Directors James C. Katzaroff Chairman, Founder and CEO Dr. Carlton Cadwell Director Thomas J. Clement - Director Scientific Advisors Dr. Alan Waltar Chair Scientific Committee Dr. Nigel R. Stevenson Dr. Donald A. Ludwig Dr. Andrej Matthies Medical Advisory Board Dr. Barry Pressman MD, FACR Chairman Medical Advisory Board Dr. Albert S. DeNittis MD, MS, FCPP Dr. Ludwig E. Feinendegen, M.D. Dr. Darrell Fisher Dr. Alice Villalobos, DVM, FNAP - Chair Veterinary Medicine Advisory Board 17

18 ADMD 29.2 M Common Shares Outstanding ~2,400 Shareholders ~21 countries 4M Preferred Series A ~55 shareholders

19 Y-90 RadioGel Device Treatment Prescribed, Planned & Delivered Therapeutic radiation doses to tumors may be prescribed, planned & delivered Direct Local Delivery Multiple animal studies confirm the device remains at the site of injection Remarkably Safe Product Biodegradable No metal or glass housing, no migration Small Amount of Y-90 Bottom Line- Dramatic Expansion of Treatment Toolkit More options for physicians Safer, more effective, lower cost options for patients Over 15 Years of R&D Therapy requires only small amounts of Y-90, normal tissue doses are negligible Pacific Northwest National Laboratories and AMI have conducted extensive product characterization and optimization studies 19

20 Near Term Focus Y-90 RadioGel Device Complete studies and submit de novo to the FDA for marketing clearance Long Term Focus: Better Solutions to Cancer Treatment Veterinary Market Continue building partnerships, establishing infrastructure and ensuring regulatory compliance to provide products to the veterinary market Position for Growth Pursue uplisting to a national exchange 20

21 James C. Katzaroff Founder, CEO, Chairman