Aethlon Medical Announces Financial Results for the Fiscal First Quarter Ended June 30, 2024 and Provides Corporate Update
Received Two Australian Ethics Committee Approvals for a Safety, Feasibility, and Dose Finding Study of Aethlon's Hemopurifier® in Patients with Solid Tumors Not Responding to Anti-PD-1 Antibodies; Expects to Open Patient Enrollment in October of 2024
Achieved Significant 24% Reduction in Fiscal First Quarter Operating Expenses Compared to the Same Period in 2023
Conference Call to be Held Today at
Company Updates
As announced on
Earlier, on
Currently, only approximately 30% of patients who receive pembrolizumab or nivolumab will have lasting clinical responses to these agents. Extracellular vesicles (EVs) produced by tumors have been implicated in the spread of cancers as well as the resistance to anti-PD-1 therapies. The Aethlon Hemopurifier has been designed to bind and remove these EVs from the bloodstream, which may improve therapeutic response rates to anti-PD-1 antibodies. In preclinical studies, the Hemopurifier has been shown to reduce the number of EVs in cancer patient plasma samples.
"During the fiscal first quarter and subsequent period, we have continued to make significant progress advancing towards our planned oncology trials in
"Going forward, the next steps are to receive approval from the Research Governance Office at each hospital, which reviews indemnities and insurance. Once these approvals are obtained, Aethlon, in concert with our
As a reminder, the primary endpoint of the approximate 9 to 18-patient, safety, feasibility and dose-finding trial, is safety. The trial will monitor any adverse events and clinically significant changes in lab tests of Hemopurifier treated patients with solid tumors with stable or progressive disease at different treatment intervals, after a two-month run in period of PD-1 antibody, Keytruda® or Opdivo® monotherapy. Patients who do not respond to the PD-1 antibody therapy will be eligible to enter the Hemopurifier period of the study where sequential cohorts will receive 1, 2 or 3 Hemopurifier treatments during a one-week period. In addition to monitoring safety, the study is designed to examine the number of Hemopurifier treatments needed to decrease the concentration of EVs and if these changes in EV concentrations improve the body's own natural ability to attack tumor cells. These exploratory central laboratory analyses are expected to inform the design of subsequent efficacy and safety trials, including a Premarket Approval (PMA) study required by the FDA and other regulatory agencies.
The company continues to explore opportunities to expand the use of the Hemopurifier as a treatment for life-threatening viral infections. In vitro, it has shown effectiveness in capturing viruses such as Zika, Lassa, MERS-CoV, cytomegalovirus, Epstein-Barr, Herpes simplex, Chikungunya, Dengue, West Nile, smallpox-related viruses, H1N1 swine flu, H5N1 bird flu, Monkeypox, and the reconstructed 1918 Spanish flu virus. The company's COVID-19 trial in
Financial Results for the Fiscal First Quarter Ended
As of
Consolidated operating expenses for the fiscal quarter ended
The
The approximate
The approximate
As a result of the factors noted above, the company's net loss decreased to approximately
The consolidated balance sheet for
Conference Call
Management will host a conference call today,
Interested parties can register for the conference by navigating to https://dpregister.com/sreg/10191735/fd44630e3d . Please note that registered participants will receive their dial-in number upon registration.
Interested parties without internet access or unable to pre-register may dial in by calling:
PARTICIPANT DIAL IN (TOLL FREE): 1-844-836-8741
PARTICIPANT INTERNATIONAL DIAL IN: 1-412-317-5442
All callers should ask for the
A replay of the call will be available approximately one hour after the end of the call through
About Aethlon and the Hemopurifier®
Additional information can be found at www.AethlonMedical.com.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 that involve risks and uncertainties. Statements containing words such as "may," "believe," "anticipate," "expect," "intend," "plan," "project," "will," "projections," "estimate," "potentially" or similar expressions constitute forward-looking statements. Such forward-looking statements are subject to significant risks and uncertainties and actual results may differ materially from the results anticipated in the forward-looking statements. These forward-looking statements are based upon Aethlon's current expectations and involve assumptions that may never materialize or may prove to be incorrect. Factors that may contribute to such differences include, without limitation, the Company's ability to raise additional capital on terms favorable to the Company, or at all; the Company's ability to successfully complete development of the Hemopurifier; the Company's ability to successfully demonstrate the utility and safety of the Hemopurifier in cancer and infectious diseases and in the transplant setting; the Company's ability to achieve and realize the anticipated benefits from potential milestones; the Company's ability to submit applications to, and obtain approval from, the additional Ethics Committees in
Company Contact:
Interim Chief Executive Officer and Chief Financial Officer
Jfrakes@aethlonmedical.com
Investor Contact:
susan@sanoonan.com
917-513-5303
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Condensed Consolidated Balance Sheets |
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ASSETS |
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CURRENT ASSETS |
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Cash and cash equivalents |
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$ 9,072,379 |
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$ 5,441,978 |
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Deferred offering costs |
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- |
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277,827 |
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Prepaid expenses |
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478,058 |
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505,983 |
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TOTAL CURRENT ASSETS |
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9,550,437 |
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6,225,788 |
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Property and equipment, net |
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929,306 |
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1,015,229 |
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Right-of-use lease asset |
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813,900 |
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883,054 |
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Patents, net |
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963 |
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1,100 |
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Restricted cash |
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87,506 |
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87,506 |
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Deposits |
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33,305 |
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33,305 |
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TOTAL ASSETS |
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$ 11,415,417 |
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$ 8,245,982 |
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LIABILITIES AND STOCKHOLDERS' EQUITY |
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CURRENT LIABILITIES |
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Accounts payable |
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$ 1,068,135 |
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$ 777,862 |
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Due to related parties |
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732,518 |
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546,434 |
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Lease liability, current portion |
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296,093 |
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290,565 |
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Other current liabilities |
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32,203 |
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215,038 |
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TOTAL CURRENT LIABILITIES |
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2,128,949 |
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1,829,899 |
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Lease liability, less current portion |
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573,852 |
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649,751 |
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TOTAL LIABILITIES |
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2,702,801 |
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2,479,650 |
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COMMITMENTS AND CONTINGENCIES |
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EQUITY |
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Common stock, par value of |
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authorized; 13,937,227 and 2,629,725 issued and outstanding |
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13,937 |
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2,629 |
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Additional-paid in capital |
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165,844,620 |
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160,337,371 |
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Accumulated other comprehensive loss |
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(7,773) |
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(6,940) |
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Accumulated deficit |
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(157,138,168) |
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(154,566,728) |
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TOTAL STOCKHOLDERS' EQUITY |
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8,712,616 |
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5,766,332 |
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TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY |
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$ 11,415,417 |
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$ 8,245,982 |
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Consolidated Statements of Operations |
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For the three month periods ended |
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Fiscal Year |
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Fiscal Year |
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Ended |
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Ended |
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OPERATING COSTS AND EXPENSES |
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Professional fees |
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614,082 |
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976,638 |
Payroll and related |
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1,254,802 |
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1,123,239 |
General and administrative |
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751,974 |
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1,308,283 |
Total operating expenses |
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2,620,858 |
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3,408,160 |
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OPERATING LOSS |
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(2,620,858) |
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(3,408,160) |
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OTHER EXPENSE (INCOME) |
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Interest Income |
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49,418 |
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125,981 |
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NET LOSS |
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OTHER COMPREHENSIVE LOSS |
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(833) |
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(994) |
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COMPREHENSIVE LOSS |
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Basic and diluted net loss available to |
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common stockholders per share |
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$ (0.34) |
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$ (1.35) |
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Basic and diluted weighted average number of |
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common shares outstanding |
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7,457,888 |
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2,431,476 |
View original content:https://www.prnewswire.com/news-releases/aethlon-medical-announces-financial-results-for-the-fiscal-first-quarter-ended-june-30-2024-and-provides-corporate-update-302221447.html
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