Aethlon Medical, Inc. · NASDAQ:AEMD
Aethlon Medical — Roth Investor Conference 2017
46 slides from Aethlon Medical's conference presentation, Mar 14, 2017
Slide 1: Aethlon Medical Roth Investor Conference
A e thlon Medical, Inc . Nasdaq: AEMD ROTH INVESTOR CONFERENCE MARCH 14, 2017 Jim Joyce Chairman, CEO
Slide 2: Forward Looking Statements
FORWARD LOOKING STATEMENTS The following presentation may contain predictions, estimates, and other forward looking statements that involve risks and uncertainties, including whether and when our products are successfully developed and introduced ; market acceptance of the A e thlon Hemopurifier ® a
Slide 3: Therapeutic Technologies to Address Unmet Needs in Global Health & Biodefense
THERAPEUTIC TECHNOLOGIES TO ADDRESS UNMET NEEDS IN GLOBAL HEALTH & BIODEFENSE
Slide 4: Save Lives
SAVE LIVES
Slide 5: Corporate Focus
CORPORATE FOCUS • The Treatment of Infectious Viral Pathogens • Candidate Pipeline – Cancer – Neurological Disorders • Exosome Sciences Subsidiary – Focused on the discovery of companion biomarkers that underlie Aethlon therapeutic targets
Slide 6: The Aethlon Hemopurifier
The A e thlon Hemopurifier® A First - In - Class Broad - Spectrum Technology Designed For The Single - Use Removal of Viruses From Blood
Slide 7: Deployed Within the Global Infrastructure of Dialysis & CRRT Machines
DEPLOYED WITHIN THE GLOBAL INFRASTRUCTURE OF DIALYSIS & CRRT MACHINES
Slide 8: The Aethlon Hemopurifier
The A e thlon Hemopurifier® x Immediate virus elimination x Prior to cell & organ infection x Inhibits progeny virus replication x Companion assay quantifies v irus capture x Broad - spectrum mechanism
Slide 9: Clinical Development History
Clinical Development History • Initiated & Completed x >20 in vitro validation studies x Four investigational human studies (outside U.S.) x ~150 human treatment experiences Hepatitis C virus (HCV), HIV and Ebola virus (EBV) x FDA feasibility study on March 13, 2017
Slide 10: About the Feasibility Study
About the Feasibility Study • A Clinical Safety Study in End - Stage Renal Disease (ESRD) Subjects Infected with Hepatitis C Virus (HCV) • DaVita Med Center Dialysis – Houston, TX. • Primary Objective x To demonstrate the safety of the Aethlon Hemopurifier® x No device - related adverse events repor
Slide 11: Forthcoming FDA Submissions
Forthcoming FDA Submissions • Submit Feasibility Study Final Report • File Pre - Submission Document To Request Follow - on Guidance Underlying – Market clearance pathways for virulent viruses that do not permit for controlled human studies – Study design for viral targets for which controlled human
Slide 12: The Global Health Threat of Viral Pathogens
The Global Health Threat of Viral Pathogens A Significant Therapeutic Void • 300+ viruses known to be infectious to man – Only a fraction are addressed with an antiviral drug • Only 1 of 13 Category “A” viruses are addressed – Easily transmitted, high fatality rate threats likely to disrupt the norm
Slide 13: Bill Gates quote on engineered viruses
“A genetically engineered virus could kill more people than nuclear weapons — and yet no country on Earth is ready for the threat . ” Bill Gates Munich Security Conference February 18, 2017
Slide 14: Strategic Goal
To fulfill the broad - spectrum medical countermeasure objective of the U . S . Department of Health and Human Services (HHS) 2016 Public Health Emergency Medical Countermeasure Enterprise (PHEMCE) . This initiative is directed toward bioterror, pandemic threats and other pathogens that are not well
Slide 15: The Aethlon Hemopurifier
“ The only strategy to address the breadth of viruses that could emerge naturally through mother nature or be created by man as agents of bioterror” Ken Alibek Keynote Speech at Crossing Boundaries International Symposium on Bioterrorism Former Director of the Soviet Union’s Biological Weapon Progra
Slide 16: Opportunities in Viral Indications with an Approved Antiviral Drug
The A e thlon Hemopurifier® Opportunities in Viral Indications with an Approved Antiviral Drug x Adjunct to improve benefit of antiviral drug agents x Antiviral drug resistance
Slide 17: Opportunities in Viruses not Addressed with an Antiviral Drug
The A e thlon Hemopurifier® Opportunities in Viruses not Addressed with an Antiviral Drug x Known pandemic viral t hreats x Naturally emerging viruses x Agents of Bioterrorism Including genetically engineered viruses
Slide 18: In vitro capture study validations
I n vitro capture study validations
Slide 19: Chronic Viral Threats
Chronic Viral Threats • Hemopurifier Capture Validations x Human Immunodeficiency Virus (HIV) x Hepatitis C Virus (HCV) • Approved Antiviral Drug (U.S.) – HIV antivirals suppress disease progression – HCV antivirals are often curative □ Drug resistance remains a significant issue
Slide 20: Reactivated Latent Viral Threats
Reactivated Latent Viral Threats • Hemopurifier Capture Validations x Cytomegalovirus (CMV) x Epstein - Barr Virus (EBV) x Herpes Simplex Virus - 1 (HSV - 1) • Approved Antiviral Drug (U.S. ) – CMV ( Yes), EBV (No), HSV (Yes) □ Significant need for broad - spectrum solution to address immune - suppr
Slide 21: Bioterror/Pandemic Threats
Bioterror/Pandemic Threats • Hemopurifier Capture Validations x Ebola Virus x Lassa Virus x Middle - East Respiratory Syndrome (MERS - CoV) x Smallpox (Based on Monkeypox & Vaccinia Models) • Approved Antiviral Drug (U.S.) – None – Smallpox vaccine in the U.S. National Stockpile
Slide 22: Pandemic Influenza Threats
Pandemic Influenza Threats • Hemopurifier Capture Validations x H1N1 Swine Flu Virus x H5N1 Bird Flu Virus x Spanish Flu of 1918 Virus (reconstructed) • Approved Antiviral Drug (U.S.) – None for highly virulent influenza strains
Slide 23: Mosquito-Borne Pandemic Threats
Mosquito - Born Pandemic Threats • Hemopurifier Capture Validations x Chikungunya Virus x Dengue Virus x West Nile Virus x Zika Virus • Approved Antiviral Drug (U.S.) – None
Slide 24: Proof of Concept Against a Highly Virulent Virus
Proof of Concept Against a Highly Virulent Virus
Slide 25: The Treatment of Ebola Virus
The Treatment of Ebola Virus Frankfurt University Hospital Special approval from The Federal Institute for Drugs and Medical Devices (BfArM)
Slide 26: Hemopurifier therapy administration to a comatose Ebola patient
Hemopurifier® therapy administration to a comatose Ebola patient with multiple - organ failure
Slide 27: Dr. Stefan Büttner Holding Hemopurifier After Ebola Treatment
Dr. Stefan Büttner Holding Hemopurifier® After Ebola Treatment
Slide 28: Ebola Treatment Data
Ebola Treatment Data Presented By Dr. Helmut Geiger American Society of Nephrology Annual Meeting • 6.5 hour Hemopurifier® therapy administration • Pre - treatment viral load: 400,000 copies/ml • Post - treatment viral load: 1,000 copies/ml • Patient made full recovery • Companion assay validated ca
Slide 29: Top Best Inventions
“Top 25 Best Inventions” “11 Most Remarkable Advances in Healthcare”
Slide 30: A Potential Role in Other Disease Conditions
The A e thlon Hemopurifier® A Potential Role in Other Disease Conditions
Slide 31: Candidate Pipeline Targeting Disease Promoting Exosomes
Candidate Pipeline Targeting Disease Promoting Exosomes • Cancer – Tumor - derived exosomes promote spread of metastasis and immune suppression x Capture of Breast, Ovarian and Melanoma Validated • Tauopathies – A class of 20+ neurodegenerative disorders – Hallmark is abnormal aggregation of tau pro
Slide 32: Exosome Sciences
eo000e e0000000 Exosome eoessooee SCIENCES
Slide 33: Discovery of TauSome: A Candidate Tauopathy Biomarker
Discovery of TauSome™ A Candidate Tauopathy Biomarker
Slide 34: A Biomarker to Diagnose CTE in the Living?
A BIOMARKER TO DIAGNOSE CHRONIC TRAUMATIC ENCEPHALOPATHY (CTE) IN THE LIVING?
Slide 35: DETECT Study
• TauSome testing was conducted in the DETECT study – In collaboration with the Boston University CTE Center – First NIH funded CTE research study – 78 former NFL players (high risk CTE group) – 16 athlete controls (low risk CTE group)
Slide 36: Preliminary Study of Plasma Exosomal Tau as a Potential CTE Biomarker
Preliminary Study of Plasma Exosomal Tau as a Potential Biomarker for Chronic Traumatic Encephalopathy Stern , Tripodis, Baugh, Fritts, Martin, Chaisson, Cantu, Joyce, Shah, Ikezu, Zhang, Gercel - Taylor, & Taylor J Alzheimer’s Disease, 2016 • Findings suggest that TauSome plasma levels may be an ac
Slide 37: TauSome Concentration by Patient Samples
0 2 4 6 8 10 12 14 16 18 1 3 5 7 9 11 13 15 17 19 21 23 25 27 29 31 33 35 37 39 41 43 45 47 49 51 53 55 57 59 61 63 65 67 69 71 73 75 77 79 81 83 85 87 89 91 93 TauSome Concentration (x10 9 /mL) Patient Samples *Horizontal lines represent average TauSome concentration for each group. Control Samples
Slide 38: TauSome Levels in Alzheimer's Patients
WE ALSO HAD THE OPPORTUNITY TO EXPLORE TAUSOME™ LEVELS IN ALZHEIMERS’S PATIENTS
Slide 39: TauSome Concentration: Control, NFL and Alzheimer's Samples
0 2 4 6 8 10 12 14 16 18 TauSome Concentration (x10 9 /mL) *Horizontal lines represent average TauSome concentration for each group 16 Control Samples 78 NFL Player Samples 33 Alzheimer’s Patient Samples Control Samples - Avg: 0.31 - SD: 0.19 NFL Samples - Avg: 2.8 - SD: 2.9 AD Samples - Avg: 3.1 -
Slide 40: Next Steps
• Next Steps – Continued AD and CTE Validations – Follow - on TauSome study in former NFL players to kick - off in Q2
Slide 41: Therapeutic Technologies to Address Unmet Needs in Global Health & Biodefense
THERAPEUTIC TECHNOLOGIES TO ADDRESS UNMET NEEDS IN GLOBAL HEALTH & BIODEFENSE
Slide 42: The Aethlon Hemopurifier
The A e thlon Hemopurifier® A First - In - Class Broad - Spectrum Technology Designed For The Single - Use Removal of Viruses From Blood
Slide 43: A Broad-Spectrum Strategy
The A e thlon Hemopurifier® A Broad - Spectrum Strategy To Address x Drug Resistant Viruses x Emerging Pandemic Threats x Bioterror Threats x Genetically Engineered Viruses
Slide 44: Save Lives
SAVE LIVES
Slide 45: Acknowledgement and Thanks
Acknowledgement and Thanks • Team Aethlon • Battelle Memorial Research Institute • Boston University CTE Center • DaVita Med Center Dialysis • Defense Advanced Research Projects Agency (DARPA ) • Frankfurt University Hospital • Medanta Medicity, Fortis and Apollo Hospitals • National Institute of Vi
Slide 46: Contact
CONTACT: A e thlon Medical, Inc 9635 Granite Ridge Drive Suite 100 San Diego, California 92123 Jim Joyce Chairman & CEO [email protected] 858.459.7800 x301