Aethlon Medical, Inc. · NASDAQ:AEMD
Aethlon Medical — NYC Oncology Conference 2018
34 slides from Aethlon Medical's conference presentation, Oct 30, 2018
Slide 1: NYC Oncology Conference - Aethlon Medical
Image of Ebola viruses exiting host cells - Courtesy of NIAID NYC O NCOLOGY C ONFERENCE N ASDAQ : AEMD - M ARKET CAP : ~$20 M J IM J OYCE - F OUNDER & CEO O CTOBER 30, 2018 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
T O A DDRESS U NMET N EEDS IN G LOBAL H EALTH F OCUS 3
Slide 4: Mission: To Save Lives
MISSION TO SAVE LIVES ‘4 aethlon
Slide 5: A First-in-Class Therapeutic Technology: The Hemopurifier
A FIRST - IN - CLASS THERAPEUTIC TECHNOLOGY T HE H EMOPURIFIER ® D ESIGNED FOR THE SINGLE - USE DEPLETION OF CIRCULATING VIRUSES AND CANCER - PROMOTING EXOSOMES O UR L EAD THERAPEUTIC C ANDIDATE 5
Slide 6: Deployed on the Global Infrastructure of Dialysis & CRRT Instruments
D EPLOYED FOR USE ON THE GLOBAL INFRASTRUCTURE OF DIALYSIS & CRRT INSTRUMENTS T HE H EMOPURIFIER ® D ESIGNED FOR THE SINGLE - USE DEPLETION OF CIRCULATING VIRUSES AND CANCER - PROMOTING EXOSOMES 6
Slide 7: The Aethlon Hemopurifier Mechanism of Action
The Aethlon Hemopurifier® M ECHANISM OF ACTION F ULL CIRCULATION DEPLETION OF VIRUSES AND CANCER PROMOTING EXOSOMES TARGETS ARE GLYCAN SHIELDED TO EVADE THE HOST IMMUNE RESPONSE C OMBINATION M ECHANISM OF ACTION P LASMA SEPARATION / LECTIN AFFINITY CAPTURE 7
Slide 8: Hemopurifier Viral Clinical Accomplishments
The Aethlon Hemopurifier® V IRAL C LINICAL ACCOMPLISHMENTS I N VITRO C APTURE VALIDATIONS OF 15 HIGH - THREAT VIRAL PATHOGENS C OMPLETED F OUR INVESTIGATIONAL HUMAN STUDIES OUTSIDE U.S. C ONCLUDED U.S. HUMAN FEASIBILITY STUDY (M ARCH 2017) R ECEIVED “ EXPEDITED A CCESS P ATHWAY ” (EAP) D ESIGNATION
Slide 9: Hemopurifier Designated FDA Breakthrough Device
T HE H EMOPURIFIER ® IS AN FDA DESIGNATED “B REAKTHROUGH D EVICE ” FOR THE TRE A TMENT OF LIFE - THREATENING G L YCOSYL A TED VIRUSES T H A T ARE NOT ADDRESSED WITH APPROVED THERAPIES . T HE A ETHLON H EMOPURIFIER ® Designated a “Breakthrough Device” by FDA 9
Slide 10: Ebola Virus: A Case Study in Treating a Life-Threatening Virus
Ebola Image Courtesy of NIAID E BOLA VIRUS A CASE STUDY IN TREATING A LIFE - THREATENING VIRUS NOT ADDRESSED WITH AN APPROVED THERAPY 10
Slide 11: 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 . 11
Slide 12: 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 . 12
Slide 13: Ebola Treatment Results Presented at American Society of Nephrology
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 14: 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 OF E BOLA VIRUS 14
Slide 15: Virus Capture Assay Result
V IRUS C APTURE A SSAY R ESULT 253 MILLION COPIES OF E BOLA VIRUS CAPTURED WITHIN THE HEMOPURIFIER ® DURING THE 6.5 HOUR TREATMENT Analysis: BSL4 Lab Philipps University Marburg (O. Dolnik/M. Eickmann/S. Becker) 15
Slide 16: The Hemopurifier to Treat Cancer?
T HE H EMOPURIFIER ® TO TREAT CANCER ? 16
Slide 17: Addressing a Significant Unmet Need in Cancer Care
A DDRESSING A SIGNIFICANT UNMET NEED IN CANCER CARE M ISSION 17
Slide 18: Tumor Derived Exosomes: A Significant Unmet Need in Cancer Care
T UMOR DERIVED EXOSOMES (T EX ) A SIGNIFICANT UNMET NEED IN CANCER CARE Image of exosomes being released by a tumor cell 18
Slide 19: Tumor Derived Exosomes: A Significant Unmet Need in Cancer Care
T UMOR DERIVED EXOSOMES (T EX ) A SIGNIFICANT UNMET NEED IN CANCER CARE T EX SEED THE SPREAD OF METASTASIS ( ASSOCIATED WITH 90% OF CANCER DEATHS ) T EX PROMOTE IMMUNE SUPPRESSION & DIRECTLY INHIBIT T - CELL RESPONSE T EX PREVALENCE CORRELATES WITH CANCER PROGRESSION T EX PROMOTE CANCER THERAPY RESI
Slide 20: Tumor Derived Exosomes: Promoting Resistance to Cancer Therapies
T UMOR DERIVED EXOSOMES (T EX ) P ROMOTING RESISTANCE TO CANCER THERAPIES T EX DECOY CHEMOTHERAPEUTIC AGENTS T EX INHIBIT HIGH - VALUE CAR - T THERAPIES J UNO ACQUIRED FOR $9 BILLION BY CELGENE K ITE ACQUIRED FOR $11.9 BILLION BY G ILEAD T EX PROMOTE ANTI - CANCER DRUG RESISTANCE I NCLUDING PD - 1 C
Slide 21: Top Cancer Drugs Known to Be Inhibited by Tumor-Derived Exosomes
7 OF T OP 10 CANCER DRUGS T UMOR - DERIVED EXOSOMES KNOWN TO INHIBIT TREATMENT EFFICACY 21 Rituxin (Roche - $7.5bn) Avastin (Roche - $6.7bn) Herceptin (Roche - $6.5bn) Imbruvica (J&J - $5.3bn) Gleevec (Novartis - $4.7bn) Velcade (J&J - $2.6bn) Erbitux (BMS/Merck - $1.9bn) 0 2 4 6 Represents $35.2 bi
Slide 22: Tumor Derived Exosomes: Links to Drug Resistance Publication References
T UMOR DERIVED EXOSOMES (T EX ) L INKS TO DRUG RESISTANCE PUBLICATION REFERENCES R ITUXIN - WWW . NCBI . NLM . NIH . GOV / PMC / ARTICLES /PMC3174603 A VASTIN - WWW . NATURE . COM / ARTICLES / NCOMMS 14450 H ERCEPTIN - WWW . NCBI . NLM . NIH . GOV / PMC / ARTICLES /PMC5706614/ I MBRUVICA - WWW . HAE
Slide 23: Interest in the Hemopurifier to Treat Cancer Cited 183 Times
INTEREST IN THE H EMOPURIFIER TO TREAT CANCER F OLLOWING PUBLICATION HAS BEEN CITED 183 TIMES 23 J Transl Med. 2012 Jun 27;10:134. doi: 10.1186/1479 - 5876 - 10 - 134 . EXOSOME REMOVAL AS A THERAPEUTIC ADJUVANT IN CANCER Marleau AM 1, Chen CS , Joyce JA , Tullis RH . Author information 1 : Aethlon M
Slide 24: 2018 Cancer Initiatives
2018 C ANCER I NITIATIVES M ISSION 24
Slide 25: 2018 Initiative #1: NIH/NCI Contract
NIH/NCI Contract 2018 I NITIATIVE #1 “D EVICE S TRATEGY FOR SELECTIVE ISOLATION OF ONCOSOMES AND NON - MALIGNANT EXOSOMES ” C OMPLETED J UNE 2018 D EMONSTRATED ISOLATION AND CAPTURE OF METASTATIC MELANOMA EXOSOMES P REPARING P HASE II CONTRACT SUBMISSION ( VALUED AT $2 MILLION ) 25
Slide 26: 2018 Initiative #2: NIH/NCI Contract
NIH/NCI Contract 2018 I NITIATIVE #2 “T HE H EMOPURIFIER DEVICE FOR TARGETED REMOVAL OF BREAST CANCER EXOSOMES FROM THE BLOOD CIRCULATION ” CONTRACT AWARD ON S EPTEMBER 18, 2018 PROGRAM INITIATED 26
Slide 27: 2018 Initiative #3: UCI Clinical Study
UCI Clinical Study 2018 I NITIATIVE #3 “P LASMA EXOSOME CONCENTRATION IN CANCER PATIENTS UNDERGOING TREATMENT ” M ULTI - INDICATION ENROLLMENT OF CANCER PATIENTS D EMONSTRATED ( MAY - AUGUST 2018) IN VITRO CAPTURE OF EXOSOMES UNDERLYING : B REAST CANCER E SOPHAGEAL CANCER O VARIAN CANCER 27
Slide 28: 2018 Initiative #4: NIH/NCI Submission
NIH/NCI SUBMISSION 2018 I NITIATIVE #4 H UMAN CLINICAL STUDY PROPOSAL ENTITLED : “ DEPLETING EXOSOMES TO IMPROVE RESPONSES TO IMMUNE THERAPY IN HEAD AND NECK CANCER SQUAMOUS CELL CANCER ” A DJUNCT STUDY WITH O PDIVO C URRENTLY P ENDING REVIEW PANEL DECISION 28
Slide 29: 2018 Initiative #5: FDA Breakthrough Device Submission
FDA Breakthrough Device Submission 2018 I NITIATIVE #5 “U SE OF THE A ETHLON H EMOPURIFIER AS AN ADJUNCT THERAPY IN PATIENTS WITH DIAGNOSED METASTATIC CANCER ” B REAKTHROUGH SUBMISSION ON S EPTEMBER 25, 2018 P ENDING DECISION FROM FDA 29
Slide 30: 2018 Initiative #6: DOD/U.S. Army Breakthrough Award
DOD/U.S. Army Breakthrough Award 2018 I NITIATIVE #6 “I SOLATION OF TRIPLE NEGATIVE BREAST CANCER E XOSOMES USING THE H EMOPURIFIER ” D EPARTMENT OF DEFENSE ( DOD ) CONGRESSIONALLY DIRECTED MEDICAL RESEARCH PROGRAM (CDMRP), BREAST CANCER BREAKTHROUGH RESEARCH AWARD A WARD NOTIFICATION ON O CTOBER 23
Slide 31: A First-in-Class Therapeutic Technology: The Hemopurifier
A FIRST - IN - CLASS THERAPEUTIC TECHNOLOGY T HE H EMOPURIFIER ® D ESIGNED FOR THE SINGLE - USE DEPLETION OF CIRCULATING VIRUSES AND CANCER PROMOTING EXOSOMES O UR L EAD THERAPEUTIC C ANDIDATE 31
Slide 32: To Address Unmet Needs in Global Health
T O A DDRESS U NMET N EEDS IN G LOBAL H EALTH F OCUS 32
Slide 33: Mission: To Save Lives
MISSION TO SAVE LIVES 2 aethlon
Slide 34: 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