Aethlon Medical, Inc. · NASDAQ:AEMD
Aethlon Medical — IPO Roadshow (December 2019)
22 slides from Aethlon Medical's IPO roadshow presentation, Dec 2, 2019
Slide 1: Free writing prospectus legend
The issuer has filed a registration statement (including a prospectus) with the SEC for the offering to which this communication relates. Before you invest, you should read the prospectus in that registration statement and other documents the issuer has filed with the SEC for more complete informati
Slide 2: Aethlon Medical, Inc. - December 2019
N ASDAQ : AEMD T IMOTHY C. R ODELL , M.D., C HIEF E XECUTIVE O FFICER J AMES B. F RAKES , C HIEF F INANCIAL O FFICER D ECEMBER 201 9 A ETHLON M EDICAL , I NC .
Slide 3: Forward Looking Statements
The following presentation contain s 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 ; re
Slide 4: Medical device candidates for life threatening diseases
A ETHLON M EDICAL , I NC . M EDICAL DEVICE CANDIDATES FOR LIFE THREATENING DISEASES • H EMOPURIFIER ® - EXOSOMES IN CANCER - A CUTE AND CHRONIC VIRAL DISEASES • E XOSOME S CIENCES , I NC . - 80% OWNED SUBSIDIARY - D IAGNOSTICS FOR CANCER AND NEURODEGENERATION NASDAQ: AEMD 4
Slide 5: Hemopurifier designated a Breakthrough Device by FDA
FDA DESIGNATED “B REAKTHROUGH D EVICE ” FOR THE TREATMENT OF BOTH LIFE - THREATENING GLYCOSYLATED VIRUSES THAT ARE NOT ADDRESSED WITH AN IMPROVED TREATMENT AND THE REMOVAL OF CANCER PROMOTING EXOSOMES IN INDIVIDUALS WITH ADVANCED OR METASTATIC CANCER WHO ARE EITHER UNRESPONSIVE OR INTOLERANT OF SOC
Slide 6: Hemopurifier uses established dialysis infrastructure
T HE A E TH LON H EMOPURIFIER ® U SES ESTABLISHED DIALYSIS INFRASTRUCTURE P OTENTIAL FOR CLOSED SELF - CONTAINED PUMP SYSTEM 6
Slide 7: Hemopurifier mechanism of action
T HE H EMOPURIFIER M ECHANISM OF ACTION • Single use hollow fiber plasmapheresis cartridge that is operated using dialysis infrastructure • Contains a lectin affinity matrix comprising Galanthus nivalis agglutinin (GNA) bound to Chromosorb - Binds mannose displaying membranes - Includes most viruses
Slide 8: Lectins bind membrane sugar molecules
L ECTINS B IND M EMBRANE S UGAR M OLECULES Mannose (sugar) molecules in gray 8
Slide 9: Hemopurifier programs: oncology
H EMOPURIFIER ® P ROGRAMS 9 O NCOLOGY • C LEARANCE OF CANCER PROMOTING EXOSOMES - S UB - CELLULAR PARTICLES CARRYING CELLULAR PROTEINS AND NUCLEIC ACIDS - I NTRACELLULAR COMMUNICATION SYSTEM IN NORMAL AND MALIGNANT CELLS • T UMOR DERIVED EXOSOMES (TEX) PROMOTE - C HEMOTHERAPY R ESISTANCE - M ETASTAS
Slide 10: Exosomes: previously unrecognized targets for clinical applications
E XOSOMES P REVIOUSLY U NRECOGNIZED T ARGETS F OR C LINICAL A PPLICATIONS • L ARGELY I GNORED B Y THE S CIENTIFIC C OMMUNITY U NTIL R ECENTLY • I N 2006, ONLY 76 P EER - R EVIEWED P UBLICATIONS • T ODAY , MORE THAN 5,000 • 25% OF EXOSOME PUBLICATIONS IN LAST TWO YEARS J Cancer Immunol Ther . 2018; 1
Slide 11: Tumor-derived exosomes: a significant unmet need in cancer care
T UMOR - DERIVED EXOSOMES A SIGNIFICANT UNMET NEED IN CANCER CARE E xosomes being released by a tumor cell (representative illustration) 11
Slide 12: National Cancer Institute (NCI) studies
• P HASE I C ONTRACT FROM NCI - C OMPLETED “D EVICE S TRATEGY FOR S ELECTIVE I SOLATION OF O NCOSOMES AND N ON - M ALIGNANT E XOSOMES ” • NCI SBIR G RANT - O NGOING “T HE H EMOPURIFIER ® D EVICE FOR T ARGETED R EMOVAL OF B REAST C ANCER E XOSOMES FROM THE B LOOD C IRCULATION ” • A WARDED S EPTEMBER
Slide 13: Hemopurifier captures exosomes from diverse cancers
H EMOPURIFIER ® C APTURES E XOSOMES F ROM D IVERSE C ANCERS • M ELANOMA • B REAST CANCER • O VARIAN CANCER • H EAD & NECK CANCER • E SOPHAGEAL CANCER • O THER TUMOR TYPES UNDER INVESTIGATION N ONCLINICAL D ATA 13
Slide 14: Hemopurifier development
H EMOPURIFIER D EVELOPMENT M ANUFACTURING • GMP P ROCESS - CMO QUALIFIED R EGULATORY • IDE FOR LIFE - THREATENING VIRAL INDICATIONS ACTIVE • >125 SUCCESSFUL TREATMENT EPISODES IN 29 VIRAL SUBJECTS • E BOLA EXPANDED ACCESS PROTOCOL APPROVED IN U.S. AND C ANADA • 1 E BOLA PATIENT SUCCESSFULLY TREATED
Slide 15: Breakthrough designation IDE sprint review
B REAKTHROUGH D ESIGNATION IDE “ SPRINT ” REVIEW • I NITIAL INDICATION – ADVANCED / METASTATIC HEAD AND NECK CANCER • F ILED S EPTEMBER 5 TH • F IRST ROUND OF COMMENTS 3 DAYS LATER • S IX ADDITIONAL ROUNDS OF COMMENTS • S EVEN AMENDMENTS FILED IN 25 DAYS • A PPROVED O CTOBER 4 TH • N OTIFIED @ 4 PM
Slide 16: EFS in head and neck squamous cell carcinoma
EFS IN H EAD AND N ECK S QUAMOUS C ELL C ARCINOMA • 10 - 12 SUBJECTS WITH ADVANCED OR METASTATIC HNSSC • C OMBINATION WITH PEMBROLIZUMAB AS FRONT LINE TREATMENT • P EMBRO A PPROVED J UNE 2019 IN FRONT LINE SETTING • F OUR HOUR H EMOPURIFIER TREATMENT IMMEDIATELY PRIOR TO PEMBRO • E NDPOINTS • S AFET
Slide 17: Exosome Sciences, Inc. exosome based diagnostics
E XOSOME S CIENCES , I NC . E XOSOME BASED DIAGNOSTICS • E XOSOMAL TAU PROTEIN CORRELATES WITH EXPOSURE TO TRAUMA IN NFL PLAYERS - J. A LZHEIMERS D IS . 2016 • C ONFIRMATORY CTE STUDY ONGOING AT T RANSLATIONAL G ENOMICS I NSTITUTE • P OTENTIAL DIAGNOSTIC FOR CTE IN LIVING PLAYERS • O NCOLOGY APPLICA
Slide 18: Selected financial information
A ETHLON M EDICAL , I NC . S ELECTED F INANCIAL I NFORMATION 18 Balance Sheet Data: Cash and cash equivalents $785,658 Working capital $(268,824) Total assets $1,281,790 Accumulated deficit $(109,423,894) Total stockholders’ equity $20,672 As of September 30, 2019, Aethlon Medical, Inc. had: · Six M
Slide 19: Aethlon leadership
A ETHLON L EADERSHIP T IMOTHY C. R ODELL , M.D., C HIEF E XECUTIVE O FFICER • P HYSICIAN S CIENTIST WITH > 30 YEARS OF DEVELOPMENT EXPERIENCE IN PUBLIC & PRIVATE COMPANIES , 3 IPO S IN U.S. AND ABROAD , 10 PRODUCTS FROM BENCH THROUGH LATE STAGE CLINICAL TRIALS J AMES B. F RAKES , C HIEF F INANCIAL O
Slide 20: Outside directors
O UTSIDE D IRECTORS C HARLES J. F ISHER , J R ., M.D., C HAIRMAN OF THE B OARD • A CADEMIC & I NDUSTRY THOUGHT LEADER IN SEPSIS , INFLAMMATION & COAGULATION • H EAD OF CRITICAL CARE - C LEVELAND C LINIC • S ENIOR EXECUTIVE - L ILLY , A BBOTT , C ARDIOME • F OUNDER AND CEO OF FOUR BIOTECH COMPANIES C
Slide 21: Summary
SUMMARY • U NIQUE H EMOPURIFIER ® BLOOD PURIFICATION DEVICE • T WO FDA B REAKTHROUGH DESIGNATIONS • M ULTIPLE THERAPEUTIC TARGETS IN CANCER AND VIRAL DISEASE • M ANAGEMENT TEAM WITH OVER 100 COMBINED YEARS HEALTHCARE EXPERIENCE • E XOSOME S CIENCES SUBSIDIARY - D IAGNOSTICS IN CANCER AND NEURODEGENE
Slide 22: Forward-looking statements and contact details
This presentation contain s 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