FWP 1 aethlon_fwp.htm FREE WRITING PROSPECTUS

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 information about the issuer and this offering. You may get these documents for free by visiting EDGAR on the SEC Web site at www.sec.gov. Alternatively, the issuer, any underwriter or any dealer participating in the offering will arrange to send you the prospectus if you request it by contacting H.C. Wainwright & Co., LLC, 430 Park Avenue, 3rd Floor, New York, New York 10022 by email at placements@hcwco.com. 1 Issuer Free Writing Prospectus dated December 2, 2019 Filed pursuant to Rule 433 under the Securities Act of 1933 Relating to the Preliminary Prospectus dated November 14, 2019 Registration Statement No . 333 - 234712

 
 

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 .

 
 

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 ; regulatory delays, manufacturing delays, and other risks detailed in our SEC filings, which are accessible at www . sec . gov or on our website : www . AethlonMedical . com FORWARD LOOKING STATEMENTS 3

 
 

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

 
 

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 T HE A ETHLON H EMOPURIFIER ® D ESIGNATED A “B REAKTHROUGH D EVICE ” BY FDA 5

 
 

T HE A E TH LON H EMOPURIFIER ® U SES ESTABLISHED DIALYSIS INFRASTRUCTURE P OTENTIAL FOR CLOSED SELF - CONTAINED PUMP SYSTEM 6

 
 

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 and exosomes • Fiber pores allow <200 nm particles to pass into extra - lumenal space and contact the affinity matrix • Blood recirculates through the hollow fibers running the length of the device 7

 
 

L ECTINS B IND M EMBRANE S UGAR M OLECULES Mannose (sugar) molecules in gray 8

 
 

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 ETASTASIS - I MMUNE SUPPRESSION • E XOSOME CLEARANCE POTENTIALLY SYNERGISTIC WITH - C HEMOTHERAPY - IMMUNOTHERAPY - TARGETED AGENTS • M ULTIPLE POTENTIAL CLINICAL TARGETS - BREAST , HEAD AND NECK , GASTROINTESTINAL , MELANOMA , PANCREAS

 
 

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(1): 9 - 16 10

 
 

T UMOR - DERIVED EXOSOMES A SIGNIFICANT UNMET NEED IN CANCER CARE E xosomes being released by a tumor cell (representative illustration) 11

 
 

• 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 2019 – P HASE II NCI SBIR C ONTRACT $1.8 MILLION OVER 2 YEARS “A D EVICE P ROTOTYPE FOR I SOLATION OF M ELANOMA E XOSOMES FOR D IAGNOSTICS AND T REATMENT M ONITORING ” N ATIONAL C ANCER I NSTITUTE (NCI) S TUDIES 12

 
 

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

 
 

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 IN G ERMANY • O NCOLOGY IDE APPROVED O CTOBER 2019 C LINICAL • E ARLY FEASIBILITY STUDY (EFS) IN HEAD AND NECK CANCER BEING INITIATED 14

 
 

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 ON LAST DAY OF REVIEW CYCLE 15

 
 

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 AFETY • E XOSOME CLEARANCE AND CHARACTERIZATION • ORR, PFS, OS 16

 
 

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 APPLICATIONS IN DEVELOPMENT • C OLLABORATION TO STUDY CANCER EXOSOMES WITH H OAG H OSPITAL S YSTEMS - I NITIATED S EPTEMBER 2019 - I DENTIFICATION OF E XOSOMAL M ARKERS OF C ANCER R ISK & P ROGRESSION 17

 
 

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 $20,672 As of September 30, 2019, Aethlon Medical, Inc. had: · Six Months Fiscal Year Ended Ended 9/30/2019 3/31/2019 (Unaudited) Net cash used in operating activities (2,320,866)$ (4,293,433)$ Net cash used in operating activities: 11,854 shares of common stock reserved for future issuance under stock incentive plans. 323,242 shares of common stock reserved for issuance under outstanding warrants with a weighted average exercise price of $38.26 per share; and 51,124 shares of common stock issuable upon exercise of outstanding stock options at a weighted average exercise price of $44.12 per share; As of September 30, 2019 Actual (Unaudited) 1,337,259 shares of common stock issued and outstanding, which excludes:

 
 

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 FFICER • 29 YEARS OF PUBLIC COMPANY CFO EXPERIENCE , I NVESTMENT B ANKING & VC A NNETTE M ARLEAU , P H D, DIRECTOR OF R ESEARCH • E XPERT IN IMMUNOLOGY , VIROLOGY , AND CELL BIOLOGY WHO FORMERLY HELD ACADEMIC RESEARCH POSITIONS AT THE S CRIPPS R ESEARCH I NSTITUTE AND THE U NIVERSITY OF N EBRASKA M EDICAL C ENTER . M ICHAEL J ACOBS , S ENIOR S CIENTIST • E XTENSIVE BACKGROUND IN MEDICAL DEVICE PRODUCT DEVELOPMENT AND PROCESS IMPROVEMENT . H IS PREVIOUS RESEARCH HAS LED TO MULTIPLE PUBLICATIONS IN VARIOUS PEER - REVIEWED JOURNALS FROM E LSEVIER AND THE R OYAL S OCIETY OF C HEMISTRY . 19

 
 

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 HETAN S HAH , M.D. • BOARD CERTIFIED O TOLARYNGOLOGIST AND F OUNDER OF ESI S ABRINA M ARTUCCI J OHNSON • F OUNDER AND CEO OF DARÉ B IOSCIENCE (NASDAQ: DARE) E D B ROENNIMAN • ENTREPRENEUR WITH SUBSTANTIAL EXPERIENCE IN THE FORMATION AND DEVELOPMENT OF HIGH TECHNOLOGY BUSINESSES - DIRECTOR OF A ETHLON M EDICAL , I NC . SINCE 1999 G UY C IPRIANI • C HIEF B USINESS O FFICER AT M ICROBION C ORPORATION WITH NEARLY 20 YEARS OF EXPERIENCE IN THE PHARMACEUTICAL AND BIOTECH INDUSTRIES 20

 
 

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 NEURODEGENERATIVE DISEASE • NASDAQ: AEMD 21

 
 

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 delays, manufacturing delays, and other risks detailed in our SEC filings, which are accessible at www . sec . gov or on our website : www . AethlonMedical . com 9635 Granite Ridge Drive, Suite 100 San Diego, California 92123 858.459.7800 Nasdaq: AEMD www.AethlonMedical.com