Aethlon Medical, Inc. · NASDAQ:AEMD
Aethlon Medical — Life Sciences Investor Forum 2022
28 slides from Aethlon Medical's conference presentation, September 2022
Slide 1: Life Sciences Investor Forum Presentation
Life Sciences Investor Forum Presentation September 2022 11555 Sorrento Valley Rd, Suite 203 San Diego, California 92121 619.941.0360 Nasdaq: AEMD www.AethlonMedical.com
Slide 2: Forward Looking Statements
FORWARD LOOKING STATEMENTS This investor presentation contains forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. All statements other than statements of historical fact contained in this presentation are forward-looking statements, including,
Slide 3: Aethlon Medical, Inc.
Aethlon Medical, Inc. • Headquartered in San Diego, CA (Nasdaq: AEMD) • Focused on combating cancer and infectious diseases with immunotherapeutic technologies • Hemopurifier® has demonstrated the capture of disease promoting exosomes, circulating viruses in clinical trials and emergency use, throug
Slide 4: Aethlon's senior management team has extensive experience with both medical devices and therapeutics
Aethlon’s senior management team has extensive experience with both medical devices and therapeutics Companies Charles J. Fisher, Jr., MD, FACP, FCCP, FCCM, Chief Executive Officer • Academic & Industry thought leader in sepsis & inflammation • Head of critical care—Cleveland Clinic • 35 years indus
Slide 5: The Aethlon Hemopurifier
The Aethlon Hemopurifier® FDA designated “Breakthrough Device” • Safely administered in 160 Hemopurifier sessions in 37 patients • Proprietary mechanism of action • Clears life-threatening glycosylated viruses • Designed to clear cancer- promoting exosomes 5
Slide 6: The Hemopurifier's unique mechanism of action captures virus and exosomes from a patient's blood
The Hemopurifier®’s unique mechanism of action captures virus and exosomes from a patient’s blood via extracorporeal circuit A B The Hemopurifier captures enveloped viral pathogens and exosomes in circulating blood C • Hollow-fiber plasma separator filled with proprietary “affinity resin” [figures B
Slide 7: Hemopurifier Pipeline
Hemopurifier® Pipeline Early Feasibility Indication Pre-Clinical Pivotal Study Study HNSCC IDE Protocol – Before Pembrolizumab Solid Tumors TBD failing anti- PDL-1 therapy COVID-19 Emergency Use & IDE Protocol Viral Infection Ebola Emergency Use HCV Safety Testing Completed HIV IDE study completed E
Slide 8: Oncology
ee hl Oncology
Slide 9: Rationale for exosome removal in cancer
Rationale for exosome removal in cancer • Exosomes 50-150nm extracellular vesicles that are released by all cell types including tumor cells • Communicate with other cells to modulate local and distant microenvironment • Allow tumor growth and tissue invasion • Promote Metastasis by establishing pre
Slide 10: National Cancer Institute studies underway or completed
National Cancer Institute studies underway or completed • Phase I contract from NCI — Completed • “Device Strategy for Differential Isolation of Oncosomes* and Non-Malignant Exosomes” • NCI SBIR Grant — Completed • “The Hemopurifier® Device for Targeted Removal of Breast Cancer Exosomes from the Blo
Slide 11: Early Feasibility Study in Head and Neck Cancer
Early Feasibility Study in Head and Neck Cancer • NCT #04453046 • University of Pittsburgh Hillman Cancer Center • 10-12 subjects with advanced or metastatic HNSSC • Combination with pembrolizumab (Keytruda®) • Keytruda approved June 2019 in front line setting • 4-hour Hemopurifier treatment immedia
Slide 12: Early Feasibility Study in Head and Neck Cancer: Update
Early Feasibility Study in Head and Neck Cancer: Update • 2 patients have been enrolled to date • Protocol supplement application submitted to the FDA July 28, 2022 • Supplement will allow for inclusion of patients who have failed Platinum chemotherapy • This was not an indication for Pembrolizumab
Slide 13: Safety, Feasibility and Dose-Finding Basket Trial in Solid Tumors Failing anti-PD-1 therapy
Safety, Feasibility and Dose-Finding “Basket” Trial in Solid Tumors Failing anti-PD-1 therapy • Currently being designed with academic investigators • Will examine the effects of the Hemopurifier in multiple solid tumor types • Hemopurifier treatment will follow a run-in period Checkpoint Inhibitor
Slide 14: COVID-19 and Other Viral Infections
COVID-19 and Other Viral Infections 14
Slide 15: Hemopurifier data in Single Patient Emergency Use COVID-19 Cases
Hemopurifier data in Single Patient Emergency Use COVID-19 Cases 15
Slide 16: Exosomal Removal with Hemopurifier Treatment of Patient with COVID-19
Exosomal Removal with Hemopurifier Treatment of Patient with COVID-19 Laboratory values over time: Total Exosomes and Exosomal miRNA over time: ALC (absolute D-dimer Platelet Ferritin Lactate PaO2 /FIO2 LDH Date PT/INR lymphocyte count) (ng/ml) (cells/mcl) (ng/ml) (mmol/l) ratio (U/L) (cells/mcl) mi
Slide 17: Evidence of SARS-CoV-2 Capture and Clearance by Hemopurifier in a patient with COVID-19
Evidence of SARS-CoV-2 Capture and Clearance by Hemopurifier® in a patient with COVID-19 • Independent Physician Assessment confirmed request for emergency use 14JAN2021 ESTIMATE HEMOPURIFIER CAPTU RE • IRB approval and Signed Inform Consent obtained (14JAN2021) Total 1 PCR Rxn Total RNA Total Trizo
Slide 18: COVID-19 Clinical Trials
ee hl COVID-19 Clinical Trials
Slide 19: Treatment of COVID-19 With Hemopurifier Device - US IDE Study update (1)
Treatment of SARS-CoV-2 Virus Disease (COVID-19) in Humans With Hemopurifier® Device- US IDE Study update (1) • ICU patients with severe or life-threatening disease • Approved for up to 40 patients at up to 20 sites • 8 hospitals now open and actively screening • Hoag Newport Beach and Irvine • UC D
Slide 20: Treatment of COVID-19 With Hemopurifier Device - US IDE Study update (2)
Treatment of SARS-CoV-2 Virus Disease (COVID-19) in Humans With Hemopurifier® Device- US IDE Study update (2) • Versions 1-5 of the Protocol required that patients enrolled in the study: • Already have a dialysis catheter in place • Have previously tolerated Hemodialysis • This language relegated th
Slide 21: Treatment of COVID-19 With Hemopurifier Device - India Trial
Treatment of SARS-CoV-2 Virus Disease (COVID-19) in Humans With Hemopurifier® Device- India Trial • ICU patients with severe or life-threatening disease • The study is approved for up to 15 patients at up to 3 centers • Medanta Medicity Hospital is active and screening. • 1 patient enrolled and trea
Slide 22: In Vitro Removal of COVID-19 Variants by Galanthus nivalis agglutinin affinity resin
In Vitro Removal of COVID-19 Variants by Galanthus nivalis agglutinin affinity resin 22
Slide 23: Removal of clinically relevant SARS-CoV-2 variants by GNA affinity resin
•Published: July 28, 2022 •https://doi.org/10.1371/journal.pone.0272377 Removal of clinically relevant SARS-CoV-2 variants by an affinity resin containing Galanthus nivalis agglutinin •Melanie Gooldy, •Christelle M. Roux, •Steven P. LaRosa , •Nicole Spaulding, •Charles J. Fisher Jr. Table 2: Average
Slide 24: Monkeypox (MPXV)
ee hl Monkeypox (MPXV)
Slide 25: Monkeypox (MPXV) Outbreak: Aethlon's Preparation
Monkeypox (MPXV) Outbreak: Aethlon’s Preparation • ~ 43,000 Global Cases and > 15,000 US Cases • No drugs specifically approved for Monkeypox • Severe cases associated with involvement of eyes, genitalia, rectum and in very young, pregnant and immunocompromised population • Viremia associated in pat
Slide 26: Strong Cash Position
Strong Cash Position • June 30, 2022 Company’s cash balance was approximately $14.9 million with an additional $8.3 million raised in July and August 2022. • No debt • Nasdaq: AEMD ~22.9 million shares outstanding as of August 24, 2022 26
Slide 27: Summary
Summary ▪ Unique Hemopurifier® blood purification device ▪ Two FDA Breakthrough Therapy Designations ▪ Activities underway to improve the feasibility of current clinical trials in COVID-19 and Head and Neck Cancer ▪ In vitro data indicate that Hemopurifier does not need to be modified for developing
Slide 28: 11555 Sorrento Valley Road, Suite 203, San Diego, California
11555 Sorrento Valley Road, Suite 203 San Diego, California 92121 619.941.0360 Nasdaq: AEMD www.AethlonMedical.com This presentation may contain predictions, estimates, and other forward looking statements that involve risks and uncertainties, including whether and when our products are successfully