Breaking Medical
Technology Stock News: Aethlon Medical (NASDAQ: $AEMD) Announces Fiscal Third Quarter Financial Results
and Provides Corporate Update
Conference Call to be Held Today at 4:30 p.m. ET
SAN DIEGO, CA, February 14, 2024 -- (Investorideas.com
Newswire) Aethlon
Medical, Inc. (NASDAQ:AEMD), a medical therapeutic company focused on developing products to treat
cancer and life-threatening infectious diseases, today reported financial results for its fiscal third quarter ended December
31, 2023 and provided an update on recent developments.
Read this news, featuring AEMD in full at https://www.investorideas.com/news/2024/02141AEMD-Q3-Results-and-Corporate-Update.asp
Company Updates
Aethlon
Medical is continuing the research and clinical development of its Hemopurifier®,
a therapeutic blood filtration system designed to bind and remove harmful
exosomes and life-threatening viruses from blood and other biological fluids. These
qualities of the Hemopurifier have potential applications in oncology, where
cancer associated exosomes may promote immune suppression and metastasis, and
in life-threatening infectious diseases. Aethlon is
also investigating the use of the Hemopurifier in the organ transplant setting,
initially focusing on the potential removal of viruses and exosomes with
harmful cargo from recovered kidneys.
In October 2023, Aethlon received clearance from the Drug Controller
General of India (DCGI), the country’s central drug authority, to conduct a
phase 1 safety, feasibility and dose-finding trial of the Hemopurifier in
patients with solid tumors who have stable or progressive disease during
anti-PD-1 monotherapy treatment, such as Keytruda® or Opdivo®. The trial is
expected to begin following completion of an in vitro binding study of relevant
targets, and subsequent approval by the respective Ethics Boards of interested
sites in India.
“In addition
to an interested initial site in India, we have two interested sites in
Australia that are also awaiting the data from our in vitro binding study,”
stated James Frakes, Interim Chief Executive Officer and Chief Financial
Officer. “Our in vitro binding study of relevant oncology targets is complex
and stands on the cutting edge of extracellular vesicle science. Our goal is to
quantify the potential impact of our Hemopurifier on plasma from cancer
patients that have been treated with anti-PD-1 monotherapy treatment in order
to provide pre-clinical evidence to support our trial design.
“While our
research and development team has started to quantify our internal data, the
results, to date, are somewhat inconclusive. Therefore, while our internal team
continues to finetune their work, in parallel we have engaged several third-party
laboratories to independently perform assays on the samples.
“We are also maintaining
a position in the use of our Hemopurifier as a treatment against
life-threatening viral infections through our COVID-19 trial in India. We have
two participating sites for this trial -- the Medanta Medicity Hospital and
Maulana Azad Medical College, or MAMC. One patient has been treated thus far, however,
we have been informed by our contract research organization that a new COVID-19
subvariant was recently detected in India. Our COVID-19 trial in India remains
open in the event that there are COVID-19 admissions to the intensive care
units at our two participating sites.
“Finally, since
being named interim Chief Executive Officer three months ago, I have focused
our efforts on our oncology program, as well as on reducing our expenses. As previously
reported, we disclosed some interesting pre-clinical proof on concept data of
the Hemopurifier in organ transplantation. As a result, we plan to submit one
or more articles for publication on our pre-clinical data,” concluded Mr.
Frakes.
Financial Results for the Third Quarter Ended December
31, 2023
As of December 31, 2023, Aethlon Medical had a cash balance of
approximately $8.0 million.
Consolidated operating expenses for the three
months ended December 31, 2023 were approximately $3.6 million, compared to $2.8
million for the three months ended December 31, 2022. This increase of
approximately $717,000, or 25.2%, in the 2023 period was due to increase in
payroll and related expenses of approximately $871,000, offset by decreases in general
and administrative expenses of approximately $92,000 and in professional fees
of approximately $61,000.
The $871,000 increase in payroll and related expenses
was primarily due to separation expenses for our former chief executive officer
of $873,000 and an increase in salary expense of $81,000 associated with an
increase in average headcount, offset by a decrease in stock-based compensation
of $83,000.
The $92,000 decrease in general and
administrative expenses was primarily due to a decrease in clinical trial
expense of approximately $399,000 and a $33,000 decrease in travel and
conferences expenses. Decreases were offset by a $284,000 increase in supplies
for manufacturing and research and development expense, a $31,000 increase in
insurance expense, a $13,000 increase in depreciation expense and a $12,000
increase in outside services and repairs. The increase in insurance expense
included $16,000 of health insurance related to the separation agreement with
our former chief executive officer.
The $61,000 decrease in professional fees was due
to a $54,000 decrease in scientific consulting, a $22,000 decrease in
marketing, a $21,000 decrease in recruiting and a net $33,000 decrease in
contract labor related to general research and development. These decreases
were offset by an increase of $44,000 in legal expenses relating to the reverse
stock split, an $11,000 increase in director fees associated with the addition
of a new director and a $14,000 increase in investor relations and
accounting fees.
As a result of the changes in expenses noted
above, the company’s net loss increased to $3.6 million for the three months
ended December 31, 2023, from $2.8 million in the three months ended December 31,
2022.
The condensed consolidated balance
sheet for December 31, 2023, and the condensed consolidated statements of
operations for the three- and nine-month periods ended December 31, 2023
and 2022 follow at the end of this release.
Aethlon Medical will hold a
conference call today, Wednesday, February 14, 2023, at 4:30 p.m. ET to review
its financial results for its fiscal third quarter ended December 31, 2023 and
recent corporate developments. Interested parties can register for the
conference by navigating to https://dpregister.com/sreg/10186345/fb902976dd. Please note
that registered participants will receive their dial-in number upon
registration.
Interested parties without internet access or who
are unable to pre-register, may dial in as follows:
Participant Dial In (Toll Free): 1-844-836-8741
Participant International Dial In: 1-412-317-5442
All callers should ask for the Aethlon Medical,
Inc. conference call.
A replay of the call will be available
approximately one hour after the end of the call through March 14, 2024. The
replay can be accessed via Aethlon Medical's website or by dialing
1-877-344-7529 (domestic) or 1-412-317-0088 (international) or Canada toll free
at 1-855-669-9658. The replay conference ID number is 7691190.
About Aethlon and the Hemopurifier®
Aethlon Medical is a medical therapeutic company focused on developing
the Hemopurifier, a clinical stage immunotherapeutic device which is designed
to combat cancer and life-threatening viral infections and for use in organ
transplantation. In human studies, the Hemopurifier has demonstrated the
removal of life-threatening viruses and in pre-clinical studies, the
Hemopurifier has demonstrated the removal of harmful exosomes from biological fluids, utilizing its proprietary lectin-based technology. This action has
potential applications in cancer, where exosomes may promote immune suppression
and metastasis, and in life-threatening infectious diseases. The Hemopurifier
is a U.S. Food and Drug Administration (FDA) designated Breakthrough Device
indicated for the treatment of individuals with advanced or metastatic cancer
who are either unresponsive to or intolerant of standard of care therapy, and
with cancer types in which exosomes have been shown to participate in the
development or severity of the disease. The Hemopurifier also holds an FDA
Breakthrough Device designation and an open Investigational Device Exemption
(IDE) application related to the treatment of life-threatening viruses that are
not addressed with approved therapies.
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 and to successfully complete development of the Hemopurifier; the
Company’s ability to successfully demonstrate the utility of the Hemopurifier
in cancer and infectious diseases and in the transplant setting; the Company’s
ability to initiate its oncology clinical trials in India and Australia; the
Company’s ability to manage and successfully complete its clinical trials, if
initiated; the Company’s ability to maintain its Nasdaq listing; the Company’s
ability to successfully manufacture the Hemopurifier in sufficient quantities
for its clinical trials, and other potential risks. The foregoing list of risks
and uncertainties is illustrative, but is not exhaustive. Additional factors
that could cause results to differ materially from those anticipated in
forward-looking statements can be found under the caption "Risk
Factors" in the Company's Annual Report on Form 10-K for the year ended
March 31, 2023, and in the Company's other filings with the Securities and
Exchange Commission, including its quarterly Reports on Form 10-Q. All
forward-looking statements contained in this press release speak only as of the
date on which they were made. Except as may be required by law, the Company
does not intend, nor does it undertake any duty, to update this information to
reflect future events or circumstances.
Company Contact:
Jim Frakes
Interim Chief Executive Officer and Chief Financial Officer
Aethlon Medical, Inc.
Jfrakes@aethlonmedical.com
Investor Contact:
Susan Noonan
S.A. Noonan Communications, LLC
susan@sanoonan.com
917-513-5303
Aethlon
Medical Inc. (Nasdaq:AEMD) is a featured biotech stock on Investorideas.com
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