SAN DIEGO – August 14, 2024 (Investorideas.com Newswire) Aethlon Medical, Inc. (Nasdaq: AEMD), a medical therapeutic firm centered on creating merchandise to deal with most cancers and life-threatening infectious illnesses, right this moment reported monetary outcomes for its fiscal first quarter ended June 30, 2024 and supplied an replace on latest developments.
Paid Information Dissemination of behalf of AEMD.
Firm Updates
Aethlon Medical is continuous the analysis and medical growth of its Hemopurifier®, a therapeutic blood filtration system designed to bind and take away dangerous exosomes and life-threatening viruses from blood and different organic fluids. These qualities of the Hemopurifier have potential purposes in oncology, the place most cancers related exosomes could promote immune suppression and metastasis, in life-threatening infectious illnesses, and in organ transplantation.
As introduced on August 12, 2024, the Bellberry Human Analysis Ethics Committee (BHREC) granted full ethics approval to the Pindara Personal Hospital for a security, feasibility and dose-finding medical trial of the Hemopurifier® in sufferers with strong tumors who’ve secure or progressive illness throughout anti-PD-1 monotherapy remedy, equivalent to Merck’s Keytruda® (pembrolizumab) or Bristol Myers Squibb’s Opdivo® (nivolumab) (AEMD-2022-06 Hemopurifier Examine). The approval is legitimate for one yr, till August 6, 2025. The trial will likely be carried out by Dr. Marco Matos and his employees on the Pindara Personal Hospital, situated in Queensland, Australia.
Earlier, on June 18, 2024, the Human Analysis Ethics Committee (HREC) of the Central Adelaide Native Well being Community (CALHN) granted full ethics approval for a similar security, feasibility and dose-finding medical trial of the Hemopurifier in most cancers sufferers with strong tumors who’ve secure or progressive illness throughout anti-PD-1 monotherapy remedy, equivalent to Keytruda® (pembrolizumab) or Opdivo® (nivolumab) (AEMD-2022-06 Hemopurifier Examine). The approval is legitimate for 3 years, till June 13, 2027. The trial will likely be carried out by Prof. Michael Brown and his employees on the Most cancers Scientific Trials Unit, CALHN, Royal Adelaide Hospital, situated in Adelaide, Australia.
At present, solely roughly 30% of sufferers who obtain pembrolizumab or nivolumab could have lasting medical responses to those brokers. Extracellular vesicles (EVs) produced by tumors have been implicated within the unfold of cancers in addition to the resistance to anti-PD-1 therapies. The Aethlon Hemopurifier has been designed to bind and take away these EVs from the bloodstream, which can enhance therapeutic response charges to anti-PD-1 antibodies. In preclinical research, the Hemopurifier has been proven to scale back the variety of EVs in most cancers affected person plasma samples.
“In the course of the fiscal first quarter and subsequent interval, we’ve continued to make vital progress advancing in the direction of our deliberate oncology trials in Australia and India, punctuated by the latest approval from the Bellberry Human Analysis Ethics Committee (BHREC), which granted full ethics approval to the Pindara Personal Hospital and earlier from the Human Analysis Ethics Committee at Central Adelaide Native Well being Community, in June, for a security, feasibility and dose-finding medical trial of the Hemopurifier in sufferers with strong tumors who’ve secure or progressive illness throughout anti-PD-1 monotherapy remedy,” said James Frakes, Interim Chief Govt Officer and Chief Monetary Officer of Aethlon Medical.”
“Going ahead, the following steps are to obtain approval from the Analysis Governance Workplace at every hospital, which opinions indemnities and insurance coverage. As soon as these approvals are obtained, Aethlon, in live performance with our Australian Contract Analysis Group, ReSQ, will conduct Website Initiation Visits (SIVs), after which affected person enrollment within the trials could proceed. We anticipate that we’ll be open for enrollment in October 2024.”
Mr. Frakes continued, “We anticipate a number of upcoming, potential value-creating milestones, together with submission to the Ethics Committees at a 3rd web site in Australia and one in web site in India, with the expectation of presumably receiving approval from one or each of these hospitals within the September or December quarter of 2024. After approval is granted, we anticipate to have the ability to enroll sufferers at these further websites by the top of 2024.”
As a reminder, the first endpoint of the approximate 9 to 18-patient, security, feasibility and dose-finding trial, is security. The trial will monitor any antagonistic occasions and clinically vital modifications in lab assessments of Hemopurifier handled sufferers with strong tumors with secure or progressive illness at totally different remedy intervals, after a two-month run in interval of PD-1 antibody, Keytruda® or Opdivo® monotherapy. Sufferers who don’t reply to the PD-1 antibody remedy will likely be eligible to enter the Hemopurifier interval of the examine the place sequential cohorts will obtain 1, 2 or 3 Hemopurifier remedies throughout a one-week interval. Along with monitoring security, the examine is designed to look at the variety of Hemopurifier remedies wanted to lower the focus of EVs and if these modifications in EV concentrations enhance the physique’s personal pure potential to assault tumor cells. These exploratory central laboratory analyses are anticipated to tell the design of subsequent efficacy and security trials, together with a Premarket Approval (PMA) examine required by the FDA and different regulatory businesses.
The corporate continues to discover alternatives to broaden the usage of the Hemopurifier as a remedy for life-threatening viral infections. In vitro, it has proven effectiveness in capturing viruses equivalent to Zika, Lassa, MERS-CoV, cytomegalovirus, Epstein-Barr, Herpes simplex, Chikungunya, Dengue, West Nile, smallpox-related viruses, H1N1 swine flu, H5N1 hen flu, Monkeypox, and the reconstructed 1918 Spanish flu virus. The corporate’s COVID-19 trial in India stays open to accommodate any potential COVID-19 admissions to the intensive care items on the two collaborating websites, Medanta Medicity Hospital and Maulana Azad Medical School. To date, one affected person has been handled. The corporate is actively evaluating COVID-19 admissions and potential enrollment towards the continued prices of sustaining the trial.
Monetary Outcomes for the Fiscal First Quarter Ended June 30, 2024
As of June 30, 2024, Aethlon Medical had a money steadiness of roughly $9.1 million.
Consolidated working bills for the fiscal quarter ended June 30, 2024 have been roughly $2.6 million in comparison with $3.4 million for the fiscal quarter ended June 30, 2023. This lower of roughly $800,000, or roughly 24%, within the 2024 interval was on account of a lower of roughly $600,000 on the whole and administrative bills and a lower of roughly $300,000 in skilled charges partially offset by a rise in payroll and associated bills of roughly $100,000.
The $600,000 lower on the whole and administrative bills within the fiscal quarter ended June 30, 2024 was primarily on account of a $447,000 lower in provides associated to the acquisition of uncooked supplies for manufacturing of the Hemopurifier and for lab provides.
The approximate $300,000 lower in skilled charges was primarily on account of a $136,000 lower in consulting bills primarily associated to termination of companies with a contract manufacturing group, a $110,000 lower in scientific consulting, and a $78,000 lower in authorized charges regarding basic company issues.
The approximate $100,000 enhance in payroll and associated was primarily on account of a rise in separation bills of roughly $300,000 associated to the termination of an worker. That enhance was offset by a lower of $111,000 in stock-based compensation and an $89,000 lower on the whole and administration personnel expense.
On account of the components famous above, the corporate’s web loss decreased to roughly $2.6 million within the fiscal quarter ended June 30, 2024 from roughly $3.3 million within the fiscal quarter ended June 30, 2023.
The consolidated steadiness sheet for June 30, 2024, and the consolidated statements of operations for the fiscal quarters ended June 30, 2024 and 2023Â comply with on the finish of this launch.
Convention Name
Administration will host a convention name right this moment, Wednesday, August 14, 2024, at 4:30 p.m. ET to overview the corporate’s monetary outcomes and up to date company developments. Following administration’s formal remarks, there will likely be a query and reply session.
events can register for the convention by navigating to https://dpregister.com/sreg/10191735/fd44630e3d . Please observe that registered members will obtain their dial-in quantity upon registration.
events with out web entry or unable to pre-register could dial in by calling:
PARTICIPANT DIAL IN (TOLL FREE): 1-844-836-8741
PARTICIPANT INTERNATIONAL DIAL IN: 1-412-317-5442
All callers ought to ask for the Aethlon Medical, Inc. convention name.
A replay of the decision will likely be accessible roughly one hour after the top of the decision via September 14, 2024. The replay may be accessed by way of Aethlon Medical’s web site or by dialing 1-877-344-7529 (home) or 1-412-317-0088 (worldwide) or Canada toll free at 1-855-669-9658. The replay convention ID quantity is 3788019.
About Aethlon and the Hemopurifier®
Aethlon Medical is a medical therapeutic firm centered on creating the Hemopurifier, a medical stage immunotherapeutic gadget which is designed to fight most cancers and life-threatening viral infections and to be used in organ transplantation. In human research, the Hemopurifier has demonstrated the removing of life-threatening viruses and in pre-clinical research, the Hemopurifier has demonstrated the removing of dangerous exosomes from organic fluids, using its proprietary lectin-based expertise. This motion has potential purposes in most cancers, the place exosomes could promote immune suppression and metastasis, and in life-threatening infectious illnesses. The Hemopurifier is a U.S. Meals and Drug Administration (FDA) designated Breakthrough Machine indicated for the remedy of people with superior or metastatic most cancers who’re both unresponsive to or illiberal of normal of care remedy, and with most cancers varieties wherein exosomes have been proven to take part within the growth or severity of the illness. The Hemopurifier additionally holds an FDA Breakthrough Machine designation and an open Investigational Machine Exemption (IDE) utility associated to the remedy of life-threatening viruses that aren’t addressed with authorized therapies.
Further data may be discovered at www.AethlonMedical.com.
Ahead-Trying Statements
This press launch accommodates forward-looking statements inside the that means of Part 27A of the Securities Act of 1933 and Part 21E of the Securities Change Act of 1934 that contain dangers and uncertainties. Statements containing phrases equivalent to “could,” “consider,” “anticipate,” “anticipate,” “intend,” “plan,” “undertaking,” “will,” “projections,” “estimate,” “probably” or related expressions represent forward-looking statements. Such forward-looking statements are topic to vital dangers and uncertainties and precise outcomes could differ materially from the outcomes anticipated within the forward-looking statements. These forward-looking statements are based mostly upon Aethlon’s present expectations and contain assumptions which will by no means materialize or could show to be incorrect. Components which will contribute to such variations embrace, with out limitation, the Firm’s potential to lift further capital and to efficiently full growth of the Hemopurifier; the Firm’s potential to efficiently reveal the utility of the Hemopurifier in most cancers and infectious illnesses and within the transplant setting; the Firm’s potential to attain and notice the anticipated advantages from potential milestones; the Firm’s potential to submit purposes to and acquire approval from the extra Ethics Committees in Australia and India, together with on the timing anticipated by the Firm; the Firm’s potential to provoke its deliberate oncology medical trials in Australia and India, together with on the timing anticipated by the Firm; the Firm’s potential to handle and efficiently full its medical trials, if initiated; the potential influence of Hemopurifier on the H5N1 Avian Influenza (H5N1 HPAI) virus in dairy cattle; the Firm’s potential to efficiently manufacture the Hemopurifier in ample portions for its medical trials, and different potential dangers. The foregoing listing of dangers and uncertainties is illustrative, however will not be exhaustive. Further components that might trigger outcomes to vary materially from these anticipated in forward-looking statements may be discovered beneath the caption “Danger Components” within the Firm’s Annual Report on Type 10-Ok for the yr ended March 31, 2024, and within the Firm’s different filings with the Securities and Change Fee, together with its quarterly Experiences on Type 10-Q. All forward-looking statements contained on this press launch converse solely as of the date on which they have been made. Besides as could also be required by regulation, the Firm doesn’t intend, nor does it undertake any responsibility, to replace this data to replicate future occasions or circumstances.
Firm Contact:
Jim Frakes
Interim Chief Govt Officer and Chief Monetary Officer
Aethlon Medical, Inc.
Jfrakes@aethlonmedical.com
Investor Contact:
Susan Noonan
S.A. Noonan Communications, LLC
susan@sanoonan.com
917-513-5303
SOURCE Aethlon Medical, Inc.
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