Aethlon Medical, Inc. · NASDAQ:AEMD
Aethlon Medical — BIO International Convention 2017
37 slides from Aethlon Medical's conference presentation, Jun 21, 2017
Slide 1: BIO International Convention
Image of Ebola viruses exiting host cells - Courtesy of NIAID BIO I NTERNATIONAL C ONVENTION J IM J OYCE - C HAIRMAN , CEO N ASDAQ - AEMD / J UNE 21, 2017 1
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 Aethlon Hemopurifier® and
Slide 3: To Address Unmet Needs in Global Health & Biodefense
T O A DDRESS U NMET N EEDS IN G LOBAL H EALTH & B IODEFENSE F OCUS 3
Slide 4: Mission
MISSION TO SAVE LIVES 4 aethlon
Slide 5: Our Global Opportunity
T HE T REATMENT OF L IFE - T HREATENING V IRUSES T HAT ARE N OT A DDRESSED WITH A NTIVIRAL D RUGS O UR G LOBAL O PPORTUNITY 5
Slide 6: Human Viruses a Significant Unmet Need in Global Health & Biodefense
H UMAN V IRUSES A S IGNIFICANT U NMET N EED IN G LOBAL H EALTH & B IODEFENSE ~300 VIRUSES ARE INFECTIOUS TO HUMANS NINE (9) ARE ADDRESSED WITH AN APPROVED ANTIVIRAL DRUG AGENT 3 - 4 NEW HUMAN VIRUSES ARE IDENTIFIED EACH YEAR * G LOBAL WARMING , URBAN CROWDING AND TRANSCONTINENTAL TRAVEL ARE FUELING
Slide 7: Our Solution
OUR SOLUTION 7 aethlon
Slide 8: The Hemopurifier: First-in-Class Therapy in FDA Approved Studies
T HE FIRST - IN - CLASS THERAPY TO BE ADVANCED IN FDA APPROVED STUDIES T HE H EMOPURIFIER ® A B ROAD - SPECTRUM T REATMENT C OUNTERMEASURE D ESIGNED FOR THE SINGLE - USE REMOVAL OF VIRAL PATHOGENS FROM BLOOD 8
Slide 9: Hemopurifier Attributes
H EMOPURIFIER ® ATTRIBUTES E LIMINATES VIRUSES FROM THE ENTIRE CIRCULATORY SYSTEM D EPLOYED ON ESTABLISHED GLOBAL INSTRUMENT NETWORK G LYCAN SHIELD (T HE IMMUNE CLOAK ) CAPTURE MECHANISM Image of HIV glycan shield in green Courtesy of Oxford University 9
Slide 10: The Aethlon Hemopurifier: From Theoretical Concept to Clinical Reality
T HE A ETHLON H EMOPURIFIER ® F ROM THEORETICAL CONCEPT TO CLINICAL REALITY ᣌ >16 IN VITRO VIRUS CAPTURE STUDIES ᣌ F OUR INVESTIGATIONAL HUMAN STUDIES ( OUTSIDE U.S.) ᣌ ~150 HUMAN TREATMENT EXPERIENCES ᣌ ACHIEVED PRIMARY ENDPOINT IN FIRST FDA APPROVED STUDY 10
Slide 11: Concluded FDA Approved Feasibility Study
The Aethlon Hemopurifier® Concluded FDA Approved Feasibility Study on March 13th, 2017 P RIMA R Y O BJECTIVE : T O D EMONSTR A TE S AFETY OF THE H EMOPURIFIER ® IN HEALTH COMPROMISED INDIVIDUALS INFECTED WITH A VIRAL PATHOGEN E ND - S TAGE R ENAL DISEASE SUBJECTS INFECTED WITH HEPATITIS C VIRUS (HCV
Slide 12: FDA-Approved Feasibility Study Challenges to Overcome
FDA - Approved Feasibility Study Feasibility Study Challenges To Overcome H EMOPURIFIER ® MANUFACTURING DELAY R EPLACEMENT OF P RINCIPAL INVESTIGATOR L ACK OF SUBJECTS WHO MET STUDY INCLUSION - EXCLUSION CRITERIA 12
Slide 13: Virus Capture Validations
The Aethlon Hemopurifier® Courtesy of Aethlon Medical V IRUS C APTURE V ALIDATIONS A LEADING B ROAD - S PECTRUM C OUNTERMEASURE 13
Slide 14: In Vitro Capture Validations: Chronic & Latent Viruses
Hemopurifier® in vitro capture validations Chronic & Latent Viruses ᣌ Human Immunodeficiency Virus (HIV) ᣌ Hepatitis C Virus (HCV) ᣌ Cytomegalovirus (CMV) ᣌ Epstein - Barr Virus (EBV) ᣌ Herpes Simplex Virus - 1 (HSV - 1) 14
Slide 15: In Vitro Capture Validations: Pandemic Influenza Viruses
Hemopurifier® in vitro capture validations Pandemic Influenza Viruses ᣌ H1N1 Swine Flu ᣌ H5N1 Bird Flu ᣌ Spanish Flu of 1918 (reconstructed) Actual Spanish Flu of 1918 pandemic resulted in approximately 50 million deaths worldwide. 15
Slide 16: In Vitro Capture Validations: Mosquito-Borne Viruses
Hemopurifier® in vitro capture validations Mo s q ui to - B o rne Viruses ᣌ Chikungunya ᣌ Dengue ᣌ West Nile ᣌ Zika 16
Slide 17: In Vitro Capture Validations: Bioterror & Pandemic Threat Viruses
Hemopurifier® in vitro capture validations Bioterror & Pandemic Threat Viruses ᣌ Lassa ᣌ MERS - CoV ᣌ Smallpox (based on Monkeypox & Vaccinia models) ᣌ Ebola 17
Slide 18: The Treatment of Ebola Virus: A Hemopurifier Case Study
Ebola Image Courtesy of NIAID T HE TREATMENT OF E BOLA VIRUS A H EMOPURIFIER ® CASE STUDY 18
Slide 19: Frankfurt University Hospital Emergency-Use Approval
Frankfurt University Hospital APPRO V AL E MERGENCY - USE FROM G ERMANY ' S F EDERAL I NSTITUTE FOR D RUGS AND M EDICAL D EVICES (B F A R M) TO ADMINISTER H EMOPURIFIER ® THERAPY TO AN E BOLA - INFECTED PHYSICIAN AT F RANKFURT U NIVERSITY H OSPITAL . 19
Slide 20: The Treatment of Ebola Virus
T HE TREATMENT OF E BOLA VIRUS A SINGLE 6.5 - HOUR ADMINISTRATION THERAPY W AS OF H EMOPURIFIER ® DELIVERED TO THE P A TIEN T , WHO WITH MU L TIPLE W AS COM A T OSE ORGAN FAILURE . 20
Slide 21: The Treatment of Ebola Virus: Dr. Stefan Büttner
T HE TREATMENT OF E BOLA VIRUS D R . S TEFAN B ÜTTNER HOLDING THE H EMOPURIFIER ® AFTER TREATMENT 21
Slide 22: Ebola Treatment Results
E BOLA T REATMENT R ESULTS P RESENTED AT THE A MERICAN S OCIETY OF N EPHROLOGY A NNUAL M EETING BY H ELMUT G EIGER , M.D., C HIEF OF N EPHROLOGY AT F RANKFURT U NIVERSITY H OSPITAL • H EMOPURIFIER ® THERAPY WAS WELL TOLERATED WITH NO ADVERSE EVENTS • P RE - TREATMENT VIRAL LOAD PRIOR WAS MEASURED TO
Slide 23: Hemopurifier Virus Capture Assay
H EMOPURIFIER ® V IRUS C APTURE A SSAY Q UANTIFIES VIRUSES CAPTURED WITHIN THE H EMOPURIFIER ® AND NO LONGER CIRCULATING IN THE PATIENT A SSAY R EINFORCES SINGLE - USE REMOVAL OF VIRAL PATHOGENS LABEL INDICATION P ROVIDES BETTER DEPICTION OF INFECTIOUS VS . NON - INFECTIOUS VIRUS CAPTURE E STABLISHE
Slide 24: Virus Capture Assay Result
V IRUS C APTURE A SSAY R ESULT 242 MILLION COPIES OF E BOLA VIRUS CAPTURED WITHIN THE HEMOPURIFIER ® DURING 6.5 HOUR TREATMENT Analysis: BSL4 Lab Philipps University Marburg (O. Dolnik/M. Eickmann/S. Becker) 24
Slide 25: Virus Capture Assay Results: FDA Feasibility Study
The Aethlon Hemopurifier® Courtesy of Aethlon Medical V IRUS C APTURE A SSAY R ESULTS FDA F EASIBILITY S TUDY Values measured post 500 ml/min high pressure 1 - 2 liter saline wash A major deviation from our previous virus capture assay 25
Slide 26: DaVita Dialysis Virus Capture Study
DaVita Med Center Dialysis Virus Capture Study Houston, Texas USA / HCV - Infected ESRD Subjects / 4 - Hour Treatment 26 Patient Cartridge Code IU Capture Value Total Virus Capture 01 - V1* N/A N/A 01 - V2 1.62 x 10 9 1,620,000,000 02 - V1 3.99 x 10 6 3,990,000 02 - V2 1.18 x 10 7 11,800,000 * Assay
Slide 27: DaVita Dialysis Virus Capture Study
DaVita Med Center Dialysis Virus Capture Study Houston, Texas USA / HCV - Infected ESRD Subjects / 4 - Hour Treatment 27 Patient Cartridge Code IU Capture Value Total Virus Capture 03 - V1 1.38 x 10 7 13,800,000 03 - V2 1.29 x 10 7 12,900,000 04 - V1 1.24 x 10 8 124,000,000 04 - V2 6.38 x 10 7 63,80
Slide 28: DaVita Dialysis Virus Capture Study
DaVita Med Center Dialysis Virus Capture Study Houston, Texas USA / HCV - Infected ESRD Subjects / 4 - Hour Treatment 28 Patient Cartridge Code IU Capture Value Total Virus Capture 05 - V2 7.10 x 10 6 7,100,000 06 - V1 1.71 x 10 6 1,710,000 06 - V2 5.89 x 10 5 589,000 07 - V1 2.84 x 10 6 2,840,000 0
Slide 29: aethion/®)
29 aethion/®)
Slide 30: The Aethlon Hemopurifier Next Steps - July 2017
The Aethlon Hemopurifier® NEXT STEPS - JULY 2017 S UBMITTING E XPEDITED A CCESS P ATHWAY (EAP) APPLICATION TO FDA. S EEKING "B REAKTHROUGH T ECHNOLOGY " DESIGNATION UNDER 21 ST C ENTURY C URES A CT T O SPEED THE AD V ANCEMENT OF DEVICES FOR UNMET NEEDS AGAINST LIFE - THRE A TENING DISEASE CONDITIONS
Slide 31: 2016 PHEMCE Strategy and Implementation Plan
2016 Public Health Emergency Medical Countermeasures Enterprise (PHEMCE) Strategy and Implementation Plan 31
Slide 32: Meeting the PHEMCE Objectives
M EETING THE PHEMCE O BJECTIVES PHEMCE goal is to procure medical countermeasures (MCMs) for the strategic national stockpile ᣌ PHEMCE seeks broad - spectrum MCMs that address high - priority threats and also have commercial viability in other medical applications ᣌ Broad - spectrum approach to addr
Slide 33: The Aethlon Hemopurifier Aligns to Meet U.S. PHEMCE Goals & Objectives
T HE A ETHLON H EMOPURIFIER ® A LIGNS TO MEET U.S. PHEMCE G OALS & O BJECTIVES 33
Slide 34: To Address Unmet Needs in Global Health & Biodefense
T O A DDRESS U NMET N EEDS IN G LOBAL H EALTH & B IODEFENSE F OCUS 34
Slide 35: Mission
MISSION TO SAVE LIVES eo aethlon
Slide 36: Our Global Opportunity
T HE T REATMENT OF L IFE - T HREATENING V IRUSES T HAT ARE N OT A DDRESSED WITH A NTIVIRAL D RUGS O UR G LOBAL O PPORTUNITY 36
Slide 37: Forward-looking statements and contact details
This 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 Aethlon Hemopurifier® and other product offerings ; regulatory