Aethlon Medical Announces Financial Results for the Fiscal Second Quarter Ended September 30, 2024 and Provides Corporate Update
Achieves
Two Australian Sites Open For Patient Enrollment in Hemopurifier® Cancer Trial
Conference Call to be Held Today at
Company Updates
During the second quarter, and subsequently, the company advanced its oncology trial efforts in
Clinical Trials: The first two patients have now been enrolled at the
In September, Aethlon received ethics committee approval from
Management Change: In October, Aethlon's board of directors appointed
Operational Efficiency: Strategic cost-cutting initiatives have allowed for optimized resource allocation, enabling continued focus on high-impact areas of the oncology trial.
"During the second fiscal quarter and subsequent period, we continued advancing our oncology trials, earlier this week announcing enrollment of the first patient at
As a reminder, the primary endpoint of the approximate nine to 18-patient, safety, feasibility and dose-finding trials, is safety. The trials 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.
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.
The company also 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 Ebola, Marburg virus, Zika, Lassa, MERS-CoV, Cytomegalovirus, Epstein-Barr, Herpes simplex, Chikungunya, Dengue, West Nile, H1N1 swine flu, H5N1 bird flu, and the reconstructed 1918 Spanish flu virus. The company's COVID-19 trial in
Financial Results for the Fiscal Second Quarter Ended
As of
Consolidated operating expenses for the fiscal quarter ended
The approximate
The approximate
The
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 call by navigating to https://dpregister.com/sreg/10194285/fdebe88214. 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 obtain approval from the Ethics Committee of its third location in
Company Contact:
Chief Executive Officer and Chief Financial Officer
Jfrakes@aethlonmedical.com
Investor Contact:
susan@sanoonan.com
|
|
||||
|
|
||||
|
ASSETS |
||||
|
|
|
|
|
|
CURRENT ASSETS |
|
|
|
|
|
|
Cash and cash equivalents |
|
$ 6,859,075 |
|
$ 5,441,978 |
|
Deferred offering costs |
|
- |
|
277,827 |
|
Prepaid expenses and other current assets |
|
279,008 |
|
505,983 |
|
|
|
|
|
|
|
TOTAL CURRENT ASSETS |
|
7,138,083 |
|
6,225,788 |
|
|
|
|
|
|
|
Property and equipment, net |
|
843,617 |
|
1,015,229 |
|
Operating lease right-of-use asset |
|
743,994 |
|
883,054 |
|
Patents, net |
|
825 |
|
1,100 |
|
Restricted cash |
|
87,506 |
|
87,506 |
|
Deposits |
|
33,305 |
|
33,305 |
|
|
|
|
|
|
|
TOTAL ASSETS |
|
$ 8,847,330 |
|
$ 8,245,982 |
|
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS' EQUITY |
|||||
CURRENT LIABILITIES |
|
|
|
|
|
|
Accounts payable |
|
$ 922,888 |
|
$ 777,862 |
|
Due to related parties |
|
1,011,544 |
|
546,434 |
|
Operating lease liability, current portion |
|
301,680 |
|
290,565 |
|
Accrued Professional Fees |
|
95,338 |
|
215,038 |
|
|
|
|
|
|
|
TOTAL CURRENT LIABILITIES |
|
2,331,450 |
|
1,829,899 |
|
|
|
|
|
|
|
Operating lease liability, less current portion |
|
496,772 |
|
649,751 |
|
|
|
|
|
|
|
TOTAL LIABILITIES |
|
2,828,222 |
|
2,479,650 |
|
|
|
|
|
|
EQUITY |
|
|
|
|
|
|
|
|
|
|
|
|
Common stock, par value |
|
|
|
|
|
|
13,962 |
|
2,629 |
|
|
Additional-paid in capital |
|
165,954,256 |
|
160,337,371 |
|
Accumulated other comprehensive loss |
|
(3,969) |
|
(6,940) |
|
Accumulated deficit |
|
(159,945,141) |
|
(154,566,728) |
|
|
|
|
|
|
|
TOTAL STOCKHOLDERS' EQUITY |
|
6,019,108 |
|
5,766,332 |
|
|
|
|
|
|
|
TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY |
|
$ 8,847,330 |
|
$ 8,245,982 |
|
||||||||
Consolidated Statements of Operations and Comprehensive Loss |
||||||||
For the three and six month periods ended |
||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months |
|
Three Months |
|
Six Months |
|
Six Months |
|
|
Ended |
|
Ended |
|
Ended |
|
Ended |
|
|
|
|
|
|
|
|
|
OPERATING COSTS AND EXPENSES |
|
|
|
|
|
|
|
|
Professional fees |
|
570,845 |
|
1,133,111 |
|
1,184,927 |
|
2,109,749 |
Payroll and related expenses |
|
1,372,899 |
|
1,191,426 |
|
2,627,701 |
|
2,314,665 |
General and administrative |
|
958,375 |
|
850,809 |
|
1,709,228 |
|
2,159,092 |
Total operating expenses |
|
2,902,119 |
|
3,175,346 |
|
5,521,856 |
|
6,583,506 |
|
|
|
|
|
|
|
|
|
OPERATING LOSS |
|
(2,902,119) |
|
(3,175,346) |
|
(5,521,856) |
|
(6,583,506) |
|
|
|
|
|
|
|
|
|
OTHER INCOME |
|
|
|
|
|
|
|
|
Interest Income |
|
95,146 |
|
140,890 |
|
143,442 |
|
266,871 |
|
|
|
|
|
|
|
|
|
NET LOSS |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
OTHER COMPREHENSIVE INCOME/(LOSS) |
|
3,804 |
|
(2,435) |
|
2,971 |
|
(3,429) |
|
|
|
|
|
|
|
|
|
COMPREHENSIVE LOSS |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted loss per share attributable to |
|
|
|
|
|
|
|
|
common stockholders |
|
$ (0.20) |
|
$ (1.22) |
|
$ (0.50) |
|
$ (2.57) |
|
|
|
|
|
|
|
|
|
Basic and diluted weighted average number of |
|
|
|
|
|
|
|
|
common shares outstanding - basic and diluted |
|
13,937,595 |
|
2,483,649 |
|
10,715,446 |
|
2,457,711 |
|
|
|
|
|
|
|
|
|
View original content:https://www.prnewswire.com/news-releases/aethlon-medical-announces-financial-results-for-the-fiscal-second-quarter-ended-september-30-2024-and-provides-corporate-update-302304742.html
SOURCE