Full Year 2024 Aethlon Medical Inc Earnings Call
Operator: Good day, and welcome to the Aethlon Medical Fiscal Year End of 2024 Earnings Conference Call. All participants will be in a listen-only mode. Should you need assistance, please signal a conference specialist by pressing the star key followed by zero. After today's presentation, there will be an opportunity to ask questions. To ask a question, you may press star then 1 on your touch-tone phone. And to withdraw your question, please press star then 2. Please note this event is being recorded. I would now like to turn the conference over to Mr. Michael Miller with RX Communications. Please go ahead, sir.
Operator: Good day and welcome to the Aethlon Medical fiscal year end of 2024 earnings conference call. All participants will be in a listen-only mode. Should you need assistance, please signal a conference specialist by pressing the star key followed by zero.
Speaker Change: Good day and welcome to the Aethlon Medical Fiscal Year End of 2024 Earnings Conference Call. All participants will be in a listen-only mode. Should you need assistance, please signal a conference specialist by pressing the star key followed by zero.
Operator: After today's presentation, there will be an opportunity to ask questions. To ask a question, you may press star, then one, or touch tone phone. And to withdraw your question, please press star, then two.
Speaker Change: After today's presentation, there will be an opportunity to ask questions.
Speaker Change: To ask a question you may press star then 1 on your touchtone phone and to withdraw your question Please press star then 2. Please note this event is being recorded. I would now like to turn the conference over to Mr. Michael Miller with RX Communications. Please go ahead sir
Operator: Please note, this event is being recorded.
Michael Miller: I would now like to turn the conference over to Mr. Michael Miller with Rx Communications. Please go ahead, sir.
Michael Miller: Thank you, Operator, and good afternoon everyone. Welcome to Aethlon Medical's Fiscal Year End 2024 Earnings Conference Call. My name is Michael Miller with Rx Communications.
Michael Miller: Thank you, operator.
Michael Miller: And good afternoon, everyone. Welcome to Aethlon Medical Fiscal Year End of 2024 Earnings Conference Call. My name is Michael Miller with Rx Communications. At 4.15 p.m. Eastern Times today, Aethlon Medical released financial results for its fiscal year end March 31st, 2024. If you have not seen or received Aethlon Medical's earnings release, please visit the investors page at www.aethlonmedical.com.
Michael Miller: Thank you, Operator, and good afternoon, everyone. Welcome to Aethlon Medical's Fiscal Year End 2024 Earnings Conference Call. My name is Michael Miller with Rx Communications.
Michael Miller: At 4.15 p.m. Eastern Time today, Aethlon Medical released financial results for its fiscal year-end, March 31st, 2024. If you have not seen or received Aethlon Medical's earnings release, please visit the investors page at www.aethlon.com, dot AethlonMedical dot com. Following this introduction and the reading of the company's forward-looking statement, Aethlon's Interim Chief Executive Officer and Chief Financial Officer, James Frakes, and Aethlon's Chief Medical Officer, Dr. Steven Larosa, will provide an overview of Aethlon's strategy and recent developments. Mr. Frakes will then make some brief remarks on Aethlon's financials. We will then open up the call for the Q&A session.
Michael Miller: At 4.15 p.m. Eastern Time today, Aethlon Medical released financial results for its fiscal year-end, March 31st, 2024. If you have not seen or received Aethlon Medical's earnings release, please visit the investor's page at www.aethlonmedical.com.
Michael Miller: Following this introduction and the reading of the company's forward-looking statement, Aethlon's interim Chief Executive Officer and Chief Financial Officer, James Frakes, and Aethlon's Chief Medical Officer, Dr. Steven Larosa, will provide an overview of Aethlon's strategy and recent developments. Mr. Frakes will then make some brief remarks on Aethlon's financials.
Michael Miller: Following this introduction and the reading of the company's forward-looking statement, Aethlon's Interim Chief Executive Officer and Chief Financial Officer, James Frakes, and Aethlon's Chief Medical Officer, Dr. Steven Larosa, will provide an overview of Aethlon's strategy and recent developments.
Michael Miller: Mr. Frakes will then make some brief remarks on Aethlon's financials. We will then open up the call for the Q&A session.
Michael Miller: We will then open up the call for the Q&A session.
Michael Miller: Before I hand the call over to Mr. Frakes, please note that the news release today and this call contain forward-looking statements within the meaning of the Securities Act of 1933, as amended, and the Securities Exchange Act of 1934, as amended. The company cautioned you that any statement that is not a statement of historical fact is a forward-looking statement. These statements are based on expectations and assumptions as of the date of this conference call. 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.
Michael Miller: Before I hand the call over to Mr. Frakes, please note that the news released today and this call contain forward-looking statements within the meaning of the Securities Act of 1933 as amended and the Securities Exchange Act of 1934 as amended. The company cautions you that any statement that is not a statement of historical fact is a forward-looking statement. These statements are based on expectations and assumptions as of the date of this conference call.
Michael Miller: Before I hand the call over to Mr. Frakes, please note that the news released today and this call contain forward-looking statements within the meaning of the Securities Act of 1933 as amended and the Securities Exchange Act of 1934 as amended.
Michael Miller: Such forward-looking statements are subject to significant risks and uncertainties, and actual results may differ materially from the results anticipated in such forward-looking statements. Factors that could cause results to differ materially from those anticipated and forward-looking statements can be found under the captioned risk factors in the company's annual report on Form 10-K for the fiscal year-end March 31, 2024, and the company's most recent quarterly report on Form 10-Q, and in the company 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. With that, I'll now turn the call over to Mr. James Frakes, Aethlon's Interim Chief Executive Officer and Chief Financial Officer.
Michael Miller: The company cautions you that any statement that is not a statement of historical fact is a forward-looking statement.
Michael Miller: These statements are based on expectations and assumptions as of the date of this conference call. 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.
Michael Miller: Factors that could cause results to differ materially from those anticipated and forward-looking statements can be found under the caption Risk Factors in the company's annual report on Form 10-K for the fiscal year ended March 31, 2024, and the company's most recent quarterly report on Form 10-Q, and then the company's other filings with the Securities Exchange Commission. Accepted 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 circumstance.
Michael Miller: factors that could
Michael Miller: Cause results to differ materially from those anticipated and forward look
Michael Miller: Forward-looking statements can be found under the caption Risk Factors in the company's annual report on Form 10-K for the fiscal year-end March 31, 2024, and the company's most recent quarterly report on Form 10-Q , and in the company's other filings with the Securities and Exchange Commission
Michael Miller: Acceptance 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.
James Frakes: With that, I'll now turn the call over to Mr. James Frakes, Aethlon's Interim Chief Executive Officer and Chief Financial Officer. Thank you, Mike. And I would like to thank all of you for dialing in. This is Jim Frakes. Aethlon Medical is continuing the research and clinical development of its single purifier, 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 and the organ transplant setting, initially focusing on the potential removal of viruses and exosomes with harmful cargo from a covered kidney.
Speaker Change: With that, I'll now turn the call over to Mr. James Frakes, Aethlon's Interim Chief Executive Officer and Chief Financial Officer.
James B. Frakes: Thank you, Mike. And I would like to thank all of you for dialing in. This is Jim Frakes.
Speaker Change: Thank you, Mike. And I would like to thank all of you for dialing in. This is Jim Frakes.
James B. Frakes: Aethlon Medical is continuing the research and clinical development of its single purifier, 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 metastases, and in Life-Threatening Infectious Diseases. Aethlon is also investigating the use of the hemopurifier in the organ transplant setting. Initially, they focused on the potential removal of viruses and exosomes with harmful cargo from a covered kidney.
Athlon Medical: Aethlon Medical is continuing the research and clinical development of its single purifier.
Athlon Medical: A therapeutic blood filtration system designed to bind and remove harmful exosomes and life-threatening viruses from blood and other biological fluids.
Athlon Medical: These qualities of the hemopurifier have potential applications in oncology,
Athlon Medical: where cancer-associated exosomes may promote immune suppression and metastases.
Athlon Medical: and Life-Threatening Infectious Diseases.
Athlon Medical: 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.
James Frakes: Please.
James Frakes: Dr. Steven Larosa will give you an update on our efforts to date on the oncology front and on potential milestones that we hope to achieve later on this year. However, before I turn the call over to Dr. Larosa, I want to note that we've received multiple inquiries regarding the current multi-state outbreak of H5N1 avian influenza virus and dairy cattle. While the hemopurifier has demonstrated the ability to capture prior iterations of the H5N1 bird flu virus in vitro experiments, we have not tested the hemopurifier against the current strain, nor have there been many cases of a current strain infecting humans.
James B. Frakes: Dr. Steven Larosa will give you an update on our efforts to date on the oncology front and on potential milestones that we hope to achieve later this year. However, before I turn the call over to Dr. Larosa, I want to note that we've received multiple inquiries regarding the current multi-state outbreak of H5N1 avian influenza. Viruses and Dairy Cattle. While the hemopurifier has demonstrated the ability to capture prior iterations of the H5N1 bird flu virus in in vitro experiments, we have not tested the hemopurifier against the current strain.
Speaker Change: Dr. Steven Larosa will give you an update on our efforts to date on the oncology front and on potential milestones that we hope to achieve later on this year.
Speaker Change: However, before I turn the call over to Dr. Larosa...
Speaker Change: I want to note that we've received multiple inquiries regarding the current multi-state outbreak of H5N1 avian influenza virus in dairy cattle.
Speaker Change: While the hemopurifier has demonstrated the ability to capture prior iterations of the H5N1 bird flu virus in in vitro experiments, we have not tested the hemopurifier against the current strain.
James B. Frakes: Nor have there been many cases of the current strain infecting humans. The company will continue to monitor the situation and provide any potential updates as needed. It's also worth noting that in April 2024, the U.S. Food and Drug Administration approved our internal manufacturing facility.
Speaker Change: Nor have there been many cases of the current strain infecting humans.
James Frakes: The company will continue to monitor the situation and provide any potential updates as needed.
Speaker Change: The company will continue to monitor the situation and provide any potential updates as needed.
James Frakes: It's also worth noting that in April 2024, the U.S. Food and Drug Administration approved our internal manufacturing facility under our Virology IDE.
Speaker Change: It's also worth noting that in April 2024, the U.S. Food and Drug Administration approved our internal manufacturing facility under our Virology IDE.
Steven Larosa: With that, I will now turn the call over to Dr. Steven Larosa, Aethlon's Chief Medical Officer. Thank you, Jim. As announced on June 18, 2024, the Human Research Ethics Committee of the Central Adelaide Local Health Network granted full ethics approval for Aethlon KZP's ability and dose-finding clinical trials of the hemopurifier in cancer patients to establish rumors to enable a progressive disease during anti-PD1 monotherapy treatment, such as Ketruda, Cembral Lizumath, or Vivo, Nivalunath. This is known as the AEMD-2022 Heroic Hemopurifier Stone. The approval is valid for three years until June 13, 2027.
Speaker Change: With that, I will now turn the call over to Dr. Steven Larosa, Aethlon's Chief Medical Officer.
James B. Frakes: has announced that on June 18, 2024, the Human Research Ethics Committee of the Central Adelaide Local Health granted full ethics approval for Aethlon's safety, feasibility, and dose-finding clinical trial of the chemopurifier in cancer patients with Solid Tumors to a stable of progressive disease during anti-PB1 monotherapy. Similar to Keytruda, Tembrolizumab, or Feebo, Nivolumab is known as the AEMD 2022 AeroStix Hemopuropil. The approval is valid for three years until June 13, 2020. The trial will be conducted by Professor Michael Brown and his staff at the Cancer Clinical Trials Unit, Central Adelaide Local Health. The Royal Adelaide Hotel, located in Adelaide, Australia.
Speaker Change: Thank you, Jim. As announced on June 18, 2024, the Uniman-Riegel for Aethlon safety, feasibility, and dose-finding clinical trial of the chemopurifier
Speaker Change: and Cancer Patients with Solid Tumors who have Stable or Progressive Disease during Anti-PD-1 Monotherapy Treatment.
Speaker Change: such as Keytruda, Embralizumab, or Feebo, Nivolumab.
Speaker Change: This is known as the AEMD 2022-06 Hemopurifier Study.
Speaker Change: The approval is valid for three years until June 13, 2027.
Speaker Change: The trial will be conducted by Professor Michael Brown and his staff at the Cancer Clinical Trials Unit, Central Adelaide Local Health Network.
Steven Larosa: The trial will be conducted by Professor Michael Brown and in staff at the Cancer Clinical Trial Unit, Central Adelaide Local Health Network, Royal Adelaide Hospital located in Adelaide, Australia. Currently, only approximately 30% of patients to receive Cembral Lizumath are in a volume now, will have a lasting clinical response to these aids. Extracellular vesicles, produced by tumors, have been implicated in the spread of cancers, as well as resistance to these anti-PD1 therapies. The Aethlon Pymopurifier has been designed to bind and remove these extracellular vesicles from the bloodstream, which may improve therapeutic response rates to anti-PD1 antibodies.
Speaker Change: Royal Adelaide Hospital, located in Adelaide, Australia.
Speaker Change: Currently, only approximately 30% of patients who receive Temporal Libs and Mouths or Nevolumab will have a lasting clinical response to these agents.
James B. Frakes: Currently, only approximately 30% of patients who receive Temporalizumab or Nevolumab will have a lasting clinical response to these drugs. Extracellular vesicles produced by tumors have been implicated in the spread of cancer, as well as resistance to these anti-TB1 therapies. The Aethlon Chemo Purifier has been designed to find and remove extracellular vesicles from the bloodstream, which may improve therapeutic response rates in BPD-1 antibodies. In a preclinical study, the hemopurifier has been shown to reduce the number of exosomes from the plasma.
Speaker Change: Extracellular vesicles produced by tumors have been implicated in the spread of cancers,
Speaker Change: as well as resistance to these anti-TDF policies.
Speaker Change: P1 Therapy.
Speaker Change: The Aethlon Chemo Purifier has been designed to bind and remove the extracellular vesicles from the bloodstream.
Speaker Change: which may improve therapeutic response rates in BPD-1 antibodies.
Speaker Change: In preclinical studies, the hemopurifier has been shown to reduce the number of eggs from the plasma of cancer patient samples.
Steven Larosa: In pre-clinical studies, the hemopurifier has been shown to reduce the number of eggulums from the plasma of cancer patient samples. During the fourth quarter and subsequent periods, we have continued to make significant progress advancing towards our plans, safety, speedability, and dose-finding oncology trials in Australia and India, punctuated by the recent approval from the Human Refits Research Ethics Committee at Central Adelaide Local Health Network. A confirmation to the Therapeutic Goods Administration, which is the National Health Regulatory Agency of Australia. Executive, obtaining approval from the Central Adelaide Local Health Research Governance Committee, and conducting a site initiation visit.
Speaker Change: During the fourth quarter and subsequent period, we have continued to make significant progress advancing towards our planned safety, feasibility, and dose-finding oncology trials.
James B. Frakes: During the fourth quarter and subsequent period, we have continued to make significant progress advancing towards our planned safety, feasibility, and dose-finding oncology trials in Australia, punctuated by the recent approval from the Human Research Ethics Committee at Central Adelaide Local Health, upon submission to the Therapeutic Goods Administration, the National Health Regulatory Agency of Australia.
Speaker Change: in Australia and India.
Speaker Change: Punctuated by the recent approval from the Human Research Ethics Committee.
Speaker Change: University, Central Adelaide, Local Health Network.
Speaker Change: Upon submission to the Therapeutic Goods Administration.
Speaker Change: which is the National Health Regulatory Agency of Australia.
Speaker Change: Obtaining approval from the Central Adelaide Local Health Research Governance Committee.
James B. Frakes: Obtaining approval from the Central Adelaide Local Health Research Governance and conducting a site initiation. We expect that we will be able to enroll and treat the first patient either in the September quarter or in the December quarter. We anticipate several upcoming potential value-creating milestones.
Speaker Change: and conducting a site initiation visit.
Speaker Change: We expect that we will be able to enroll and treat the first patient either in the September quarter or in the December quarter.
Steven Larosa: We expect that we will be able to enroll and treat the first patient either in the September quarter or in the December quarter. We anticipate several upcoming potential value creating milestones, including submission to the ethics committees at two additional sites in Australia, and one in India, with the expectation of possibly receiving approval from one or more of those three hospitals in the September quarter 2024. After which, we expect to be able to enroll patients of these additional sites by the end of 2024. As a reminder, the primary endpoint of the approximate 18 patients, safety, feasibility, and dose-finding trial is safety.
Speaker Change: Transcribed by https://otter.ai
Speaker Change: We anticipate several upcoming potential value-creating milestones.
Speaker Change: including submission to the ethics committees at two additional sites in Australia and one in India.
James B. Frakes: Submission to the Ethics Committees at two additional sites in Australia and one in India. We have received expectation of possibly receiving approval from one or more of those three hospitals, [inaudible] After which, we expect to be able to enroll patients, and others. As a reminder, the primary endpoint of the approximately 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 Hemopurified Treated Patients.
Speaker Change: with the expectation of possibly receiving approval from one or more of those three hospitals
Speaker Change: in the September quarter 2024.
Speaker Change: After which, we expect to be able to enroll patients at the
Speaker Change: These are the additional sites by the end of 2024.
Speaker Change: As a reminder, the primary endpoint of the approximate 18 patient safety, feasibility, and dose-finding trial is safety.
Speaker Change: The trial will monitor any adverse events.
Steven Larosa: The trial will monitor any adverse events and clinically significant changes in last test of hemocurifiders treated patients with solid tumors, with progressive or stable disease after a two month run in period of anti-PD1 antibody, intrudal oral fever. Patients who do not respond to the PD1 antibody therapy will be eligible to enter the hemocurifier period of the study, where sequential cohorts will receive one, two, or three hemocurifier treatments during a one-week period. In addition to monitoring safety, the study is designed to examine the number of hemocurifier treatments needed to decrease the concentration of EVs, and if these changes in EV concentrations improve the body's own natural ability to affect the muscle.
Speaker Change: and Clinically Significant Changes in Lab Tests of Hemopurified Treated Patients.
Speaker Change: with solid tumors with progressive or stable disease after a two month run-in period of anti-PD-1 antibodies, Keytruda or Acevo.
James B. Frakes: Solid Tumors with Progressive or Stable Disease After a two-month run-in period of anti-PD-1 antibodies, Keytruda oral, Patients who do not respond to the PD-1 antibody therapy will be eligible to enter the hemopurifier phase of this study, where sequential cohorts will receive one, two, or three hemopurifier treatments during a one-week period. In addition to monitoring faith, The study is designed to examine the number of chemo-purifier treatments needed to decrease the concentration of EVs and if these changes in EV concentration.
Speaker Change: Patients who do not respond to the PD-1 antibody therapy will be eligible to enter the hemopurifier period of this study.
Speaker Change: Where sequential cohorts will receive one, two, or three hemopurifier treatments during a one-week period.
Speaker Change: In addition to monitoring safety,
Speaker Change: The study is designed to examine the number of chemo-purifier treatments
Speaker Change: needed to decrease the concentration of EVs
Speaker Change: And if these changes in EV concentration...
Speaker Change: Improve the body's own natural ability to attack soon.
Steven P. Larosa: Unknown Speaker 05.02.38 Transcripts provided by Transcription Outsourcing, LLC. These exploratory central laboratory analyses... to inform the design of the subcommittee, including in pre-market. Approval, known as a PMA study, required by the FDA and other regulatory agencies. The company is also maintaining a position on the use of a chemopurifier. Treatment Against Life-Threatening Viral Infections through his COVID-19 trial. There are two participating sites for this trial, Medantha Meta City Hospital and Maulana Azad Medical College.
Speaker Change: and Michelle.
Speaker Change: These exploratory central laboratory analyses are expected to inform the design of a subsequent
Steven Larosa: These exploratory central laboratory analyses are expected to inform the design of a subsequent efficacy and safety trial, including a pre-market approval noted the PMA study required by BFBA and other regulatory agencies.
Speaker Change: Efficacy and Safety Trial.
Speaker Change: including a pre-market
Speaker Change: Approval noted the PMA study required by the SBA and other regulatory agencies.
Speaker Change: The company is also maintaining a position in the use of a chemo purifier as a treatment against life-threatening viral infections.
Steven Larosa: The company is also maintaining a position in the use of the hemocurifier as a treatment against life-threatening viral infection through its COVID-19 trial in India. There are two participating sites for this trial: the Dhanta Medicine Hospital and Malana Azad Medical College. One patient has been treated thus far. However, the company has been informed by its contract research organization that a new COVID-19 subvariant was recently detected in India. The COVID-19 trial in India remains open in the event that there are COVID-19 admissions to the intensive care unit of these two participating sites.
Speaker Change: through his COVID-19 trial in India.
Speaker Change: There are two participating sites for this trial, Magenta Meta City Hospital.
Speaker Change: and Maulana Azad Medical College.
Speaker Change: One patient has been treated thus far.
Steven P. Larosa: One patient has been treated. However, the company has been informed by its contract research organization that a new COVID-19 salivary was recently, and the COVID-19 trial in India remains open in the event that there are COVID-19 admissions to the intensive care unit. With that, I'll turn the call back over to Jim for the financials and open up.
Speaker Change: However, the company has been informed by its contract research organization.
Speaker Change: and a new COVID-19 sub-variant was diagnosed.
Speaker Change: was recently detected in India.
Speaker Change: The COVID-19 trial in India remains open.
Speaker Change: In the event that there are COVID-19 admissions to the event.
Speaker Change: Intensive Care Unit at these two participating sites.
Speaker Change: With that, I'll turn the call back over to Jim for the financial discussion.
James Frakes: With that, I'll turn the call back over to Jim for the financial discussion and then open up the question.
James B. Frakes: And then open up for questions.
James B. Frakes: Thank you, Steve, and good afternoon again everyone. Before I turn to the financial matters, I just want to say after being in this position for about six months, I'm
James Frakes: Thank you, Steve, and good afternoon again, everyone. Before I turn to the financial matters, I just want to say that after being in this position for about six months, I'm... I'm very pleased and excited that we are moving forward now with this clinical trial, and we're excited on to the finances. As of March 31, 2024, Aethlon Medical had a cash balance of approximately $5.4 million, and as of June 25, 2024, we had a cash balance of approximately $9.1 million. And as I've been previously, I'd encourage not to cover our expenses on such a granular basis, like I had done previously.
James B. Frakes: Thank you, Steve, and good afternoon again, everyone. Before I turn to the financial matters, I just want to say, after being in this position for about six months, I'm very pleased and excited that we are moving forward now with this clinical trial. We're excited. On to the finances. As of March 31, 2024, Aethlon Medical had a cash balance of approximately $5.4 million. And as of June 25, 2024, we had a cash balance of approximately $9.1 million. And, as I've been previously encouraged not to cover our expenses on such a granular basis. Like I've done previously, I'll try to keep my remarks at a higher level this quarter.
James B. Frakes: I'm very pleased and excited that we are moving forward now with this clinical trial and, you know, we're excited.
James B. Frakes: As of March 31, 2024, Aethlon Medical had a cash balance of approximately $5.4 million.
James B. Frakes: And as of June 25, 2024, we had a cash balance of approximately $9.1 million.
Speaker Change: And as I've been previously encouraged not to cover our expenses on such a granular basis.
Speaker Change: Like I've done previously, I'll try to keep my remarks at a higher level this quarter.
James Frakes: I'll try to keep my remarks at a higher level this quarter. You'll find detailed expense information on the financial statements attached to our earnings release that just hit the wire or in our soon-to-be filed report on Form 10-K. Our consolidated operating expenses for the fiscal year ended March 31, 2024. We're approximately $12.6 million compared to approximately $12.5 million for the fiscal year ended March 31, 2023. An increase of approximately $164,000. This increase in the fiscal year ended March 31, 2024, was due to an increase in payroll and related expenses of approximately $763,000. Partially offset by decreases in DNA expenses of approximately $578,000.
Speaker Change: You'll find detailed expense information on the financial statements attached to our earnings release. I just hit the wire.
James B. Frakes: You'll find detailed expense information on the financial statements attached to our earnings release, which I just hit the wire, or in our soon-to-be-filed report on Form 10-K. Our consolidated operating expenses for the fiscal year ended March 31, 2024 were approximately $12.6 million, compared to approximately $12.5 million for the fiscal year ended March 31, 2023. An increase of approximately $164,000. This increase, for the fiscal year ended March 31, 2024, was due to an increase in payroll and related expenses of approximately $763,000, partially offset by decreases in GNA expenses of approximately $578,000, and in professional fees of approximately $21,000.
Speaker Change: and our soon-to-be-filed report on Form 10-K .
Speaker Change: Our consolidated operating expenses for the fiscal year ended March 31, 2024, were approximately $12.6 million, compared to approximately $12.5 million for the fiscal year ended March 31, 2023.
James B. Frakes: The approximate $763,000 increase in payroll and related expenses was primarily due to separation expenses for the company's former chief executive officer of $862,000. Additionally, we had an increase of $127,000 associated with an increase in average head count.
James B. Frakes: And those were partially offset by a decrease in stock-based comp of $226,000. The approximate $578,000 decrease in general and administrative expenses was primarily driven by a decrease of $819,000 in Clinical Trial Expenses related to the closed U.S. COVID-19 clinical trial. A decrease of $280,000. Subcontract Expense Related to Contracts and Grants with the National Institutes of Health A $99,000 decrease in rent expense associated with a mobile clean room leased in the prior year.
Speaker Change: An increase of approximately $164,000.
Speaker Change: This increase in the fiscal year ended March 31, 2024, was due to an increase in payroll and related expenses of approximately $763,000.
Speaker Change: partially offset by decreases in GNA expenses of approximately $578,000.
Speaker Change: and in professional fees of approximately $21,000.
James Frakes: And in professional fees of approximately $21,000. The approximate $763,000 increase in payroll and related expenses was primarily due to separation expenses for the company's former Chief Executive Officer of $862,000. And we had an increase of $127,000 associated with an increase in average head count. And those were partially offset by a decrease in stock-based comp of $226,000. The approximate $578,000 decrease in general and administrative expenses was primarily driven by a decrease of $819,000 in clinical trial expenses related to the closed US COVID-19 clinical trial. A decrease of $280,000 in subcontract expense related to contracts and grants with the National Institutes of Health.
Speaker Change: The approximate $763,000 increase in payroll and related expenses
Speaker Change: It was primarily due to separation expenses for the company's former chief executive officer of $862,000.
Speaker Change: And we had an increase of $127,000 associated with an increase in average headcount.
Speaker Change: And those were partially offset by a decrease in stock-based comp of $226,000.
Speaker Change: The approximate $578,000 decrease in general and administrative expenses
Speaker Change: was primarily driven by a decrease of $819,000.
Speaker Change: In clinical trial expenses related to the closed U.S. COVID-19 clinical trial.
Speaker Change: a decrease of $280,000.
Speaker Change: Subcontract Expense Related to Contracts and Grants with the National Institutes of Health.
Speaker Change: A $99,000 decrease in rent expense associated with a mobile clean room leased in the prior year.
James Frakes: A $99,000 decrease in rent expense associated with a mobile clean room, at least in the prior year. A decrease of $30,000 in travel-related expenses associated with a former remote employee. And a decrease of $22,000 in expenses related to various other general office and operating expenses. These decreases were partially offset by an increase of $405,000 in manufacturing and R&D supplies. Related to manufacturing, hemipirifar devices, and various R&D activities. And the approximate $21,000 decrease in professional fees was primarily due to a decrease in outside scientific product research and regulatory services of $303,000. Cruz, a decrease of $60,000 in recruiting fees and a $33,000 decrease in legal fees.
Speaker Change: A decrease of $30,000 in travel-related expenses.
James B. Frakes: A decrease of $30,000 in travel-related expenses associated with a former remote employee, and a decrease of $22,000 in expenses related to various other general office and operating expenses. These decreases were partially offset by an increase of $405,000 in manufacturing and R&D supplies related to manufacturing Hema Purifier Devices and Various R&D Activities, and the approximate $21,000 decrease in professional fees was primarily due to a decrease in outside scientific, product research, and regulatory services of $303,000.
Speaker Change: Associated with a former remote employee.
Speaker Change: and a decrease of $22,000 in expenses related to various other general office and operating expenses.
Speaker Change: These decreases were partially offset by an increase of $405,000 in manufacturing and R&D supplies.
Speaker Change: Related to Manufacturing Hema Purifier Devices and Various R&D Activities.
Speaker Change: And the approximate $21,000 decrease in professional fees was primarily due to a decrease in outside scientific, product research, and regulatory services of $303,000.
Speaker Change: A decrease of $60,000 in recruiting fees and a $33,000 decrease in legal fees.
James B. Frakes: A decrease of $60,000 in recruiting fees and a $33,000 decrease in legal fees. These decreases were partially offset by increases in investor relations of $151,000, accounting fees of $137,000, and Board of Director fees of $34,000, and outside operational and administrative expenses of $53,000. As a result of the factors I just mentioned.
Speaker Change: These decreases were partially offset by increases in investor relations of $151,000.
James Frakes: These decreases were partially offset by increases in investor relations of $151,000, accounting fees of $137,000, and board of director fees of $34,000, and outside operational and administrative expenses of $53,000. As a result of the factors I just mentioned, Aethlon's net loss increased to $12.2 million for the fiscal year ended March 31, 2024, from $12.0 million for the fiscal year ended March 31, 2023. We included these earnings results and related commentary in a press release issued earlier this afternoon. That release included the balance sheet for March 31, 2024, and the statements of operations for the fiscal years ended March 31, 2024, and 2023.
Speaker Change: Accounting fees of $137,000 and Board of Director fees of $34,000.
Speaker Change: and outside operational and administrative expenses of $53,000.
Speaker Change: As a result of the factors I just mentioned, Aethlon's net loss increased to $12.2 million for the fiscal year ended March 31, 2024 from $12.0 million for the fiscal year ended March 31, 2023.
James B. Frakes: Aethlon's net loss increased to $12.2 million for the fiscal year ended March 31, 2024 from $12.0 million for the fiscal year ended March 31, 2023. We included these earnings results and related commentary in a press release issued earlier this afternoon. That release included the balance sheet for March 31, 2024, and the statements of operations for the fiscal years ended March 31, 2024, and 2023. We will file our annual report on Form 10-K following this call.
Speaker Change: We included these earnings results and related commentary in a press release issued earlier this afternoon.
Speaker Change: That release included the balance sheet for March 31, 2024, and the statements of operations for the fiscal years ended March 31, 2024, and 2023.
Speaker Change: We will file our annual report on Form 10-K following this call.
James Frakes: We will file our annual report on Form 10-K following this call.
Speaker Change: Our next earnings call for the fiscal first quarter ending June 30, 2024, will coincide with the filing of our quarterly report on Form 10-Q in August 2024.
James Frakes: Our next earnings call for the fiscal first quarter ending June 30, 2024, will coincide with the filing of our quarterly report on Form 10-K in August 2024.
James B. Frakes: Our next earnings call for the fiscal first quarter ending June 30, 2024 will coincide with the filing of our quarterly report on Form 10-Q in August 2024. And now, Steve and I would be happy to take any questions that you may have. Operator, please open the call for questions. We will now begin the question and answer session.
Speaker Change: And now, Steve and I would be happy to take any questions that you may have.
James Frakes: And now, Steven, I would be happy to take any questions that you may have.
Speaker Change: Operator, please open the call for questions.
Speaker Change: Yes sir, we will now begin the question and answer session.
Operator: Operator, please open the call for questions. Yes, sir. We will now begin the question and answer session. To ask a question, you may press star, then one, or in touch tone phone. If you're using a speaker phone, please pick up your handset before pressing the keys. If at any time your question has been addressed and you would like to withdraw your question, please press star then two.
Operator: Yes, sir. We will now begin the question and answer session. To ask a question, you may press star then 1 on your touch-tone phone. If you're using a speakerphone, please pick up your handset before pressing the keys. If at any time your question has been answered and you would like to withdraw your question, please press star then 2. And at this time, we'll pause momentarily to assemble our roster, and the first question will come from Marla Marin with Zax. Please go ahead.
Speaker Change: To ask a question, you may press star then 1 on your touch tone phone. If you're using a speakerphone, please pick up your handset before pressing the keys. If at any time your question has been addressed, and you would like to withdraw your question, please press star then 2. And at this time, we'll pause momentarily to assemble our roster.
Operator: And at this time, we'll pause momentarily to assemble our roster.
Speaker Change: And the first question will come from Marla Marin with Zax. Please go ahead.
Marla Marin: And the first question will come from Marla Marin with Zach. Please go ahead.
Speaker Change: Thank you.
Marla Marin: Thank you.
Marla Marin: So good afternoon. Can you talk a little bit, obviously it was a, you know, pretty big announcement you had about the approval from the ethics board. Can you talk a little bit about how you see that
Marla Marin: you. Um, So, good afternoon. Can you talk a little bit?
Steven Larosa: So good afternoon. Can you talk a little bit, obviously? It was a pretty big announcement. You had about the approval from the Ethics Board. Can you talk a little bit about how you see that possibly facilitating moving forward at additional venues?
Marla Marin: Obviously, it was a pretty big announcement you had about the approval from the ethics board. Can you talk a little bit about how you see that? possibly facilitating, you know, moving forward at additional venues.
Marla Marin: Possibly facilitating, you know, moving forward at additional venues.
Marla Marin: Steve, do you want to take that?
Steve: Sure. Thanks, Marla.
Steven Larosa: Steve, do you want to take that? Sure. Thanks, Marla. So in Australia, things work in a different fashion than in the US where the primary gatekeeper for going forward with the clinical trial is the FBA. In Australia, you go first to the ethics board committee, Ethics Committee at the hospital. They're the primary gatekeeper where they follow the rules and the national statement for the scientific merit and the ethics of doing a study. So the approval from the Central Adelaide Local Health Network is an important milestone because now we can submit to the governance committee at the hospital, which looks at the logistics of the study.
James B. Frakes: Sure. Thanks, Marla.
Speaker Change: In Australia, things work in a different fashion than in the U.S. where the primary gatekeeper for
James B. Frakes: So, in Australia, things work in a different fashion than in the U.S., where the primary gatekeeper for going forward with the clinical trial is the FDA. In Australia, you go first to the ethics board committees, or ethics committees at hospitals. They're the primary gatekeeper where they follow the rules and the national statement for the scientific merit and the ethics of doing a study. So, the approval from the central Adelaide local health network (inaudible)
Steve: Going forward, the clinical trial is the FDA. In Australia, you go first to the ethics board committee, ethics committees at the hospital. They're the primary gatekeeper where they...
Speaker Change: They follow the rules of the National Statement for the Scientific Merit and the Ethics of Doing a Study. The approval from the Central Adelaide Local Health Network is...
Speaker Change: is an important milestone because now we can submit to the governance committee at the hospital which will
Speaker Change: [inaudible]
Speaker Change: of the study, and we can inform the TGA, which is the FDA equivalent in Australia, we can inform them and notify them that we're going to go forward. So it really is...
Steven Larosa: And we can inform the TGA, which is the FBA equivalent in Australia. We can inform them and notify them that we're going to go forward. So it really is a big lever that's pressed to initiate. As we said, we will submit to the TGA for the identification. We'll get governance approval from the hospital, and then we'll do a site training. But this is the first thing that says everything.
Speaker Change: A big lever that's pressed to initiate, as you said, we'll submit to the TGA for a notification, we'll get governance, we'll seek governance approval from the hospital, and then we'll do a site training, but this is the first big step that sets everything else in motion.
Speaker Change: And the one thing I will say is the other hospitals that will be submitted to in Australia, it's important to them that an ethics committee at another site has already approved. That facilitates the process.
Steven Larosa: Daniels emotion. And the one thing I will say is the other hospital that will be submitted to in Australia; it's important to them that an ethics committee at another site has already approved. That facilitates things in their reviews.
James B. Frakes: And the one thing I will say is the other hospital that will be submitted to in Australia; it's important to them that an ethics committee at another site has already approved that. Mayer Review.
Speaker Change: and others. Thank you.
Speaker Change: Thank you. That makes sense. And in terms of
Marla Marin: Thank you. That makes sense.
James B. Frakes: Thank you, that makes sense. Um, and in terms of how this study is designed to include patients who are, you know, who have various different types of tumors, can you talk a little bit about how
Speaker Change: How this study is designed.
Steven Larosa: And in terms of how this study is designed to include patients who are, you know, who have various different types of tumors, can you talk a little bit about how you see that potentially helping to facilitate patient involvement? Yes. So the study that's going forward in Australia and India is what's called a path to trial, which means we're not, we're being agnostic to the tumor type that we made benefit. We're actually going to be able to enroll any patient who has a solid tumor type for which an amputee once there is a standard of care.
Speaker Change: to include patients who are, you know, who have various different types.
Speaker Change: Can you talk a little bit about how you see that potentially helping to facilitate patient enrollment?
Speaker Change: Yes so the study that's going forward in Australia and India is what's called a basket trial which means we're not we're being agnostic to
James B. Frakes: Yes, so the study that's going forward in Australia and India is what's called a basket trial, which means we're not being agnostic to any patient who has a solid tumor type for which an anti-TB1 therapy is standard of care. And after a two-month period, those that aren't responding will go on.
Speaker Change: The tumor type that we may benefit, we're actually going to be able to enroll.
Speaker Change: Any patient who has a solid tumor type for which an anti-TB1 therapy is standard of care.
Speaker Change: and after a two-month period those that aren't responding will go on so what will it the data from the trial will inform us
Steven Larosa: And after a two months period, those that aren't responding will go on. So what would the data from the trial inform us about the effects in more than a single tumor type? It will include such very common tumors as non-small cell lung cancer as well as melanoma, which is quite a problem in Australia. So we'll be able to get data from a variety of tumor types. It's also set up in such a way that we can examine the interval of dosing with the hemopurifier to determine how often would you need to administer the treatment at a lasting effect on decreasing exosomes and improving the immune system?
James B. Frakes: So what will the data from the trial inform us about the effects in more than a single tumor type? It will include such very common tumors as non-small cell lung cancer as well as melanoma, which is quite a problem in Australia. So we'll be able to get data from a variety of tumor types. It's also set up in such a way that we can examine the interval of dosing with the hemopurifier to determine how often you would need to administer the treatment to have a lasting effect on, [inaudible]
Speaker Change: about the effects in more than a single tumor type. It will include such very common tumors as non-small cell lung cancer as well as melanoma, which is quite a problem in Australia. So we'll be able to get data from a variety of tumor types.
Speaker Change: It's also set up in such a way that we can examine the interval of dosing with the hemopurifier to determine how often would you need to administer the treatment to have a lasting effect on decreasing exosomes and improving...
Speaker Change: So, it will provide a data set that will allow the design of the...
Steven Larosa: So it will provide a data set that will allow the design of the efficacy trial that I mentioned, the PNA trial.
Speaker Change: The efficacy trial that I mentioned, the PNA trial.
Speaker Change: and others. This is a production of the U.S. Department of State. This video was made possible by the U.S. Department of State.
Speaker Change: Thank you.
Marla Marin: Thank you.
Speaker Change: The next question will come from Anthony Vendetti with Maxim Group. Please go ahead.
Anthony Vandetti: The next question will come from Anthony Vandetti with Maxim Group. Please go ahead.
Operator: The next question will come from Anthony Vendetti with Maxim Group. Please go ahead.
Speaker Change: Hi, this is actually Jeremy on the line for Anthony. How are you doing? But the two quick questions, so if hopefully if you get all these other approvals that you need to begin this clinical trial
Jeremy Pearlman: Hi, this is actually Jeremy on the line for Anthony. How are you doing?
Jeremy Pearlman: Hi, this is actually Jeremy on the line for Anthony. How are you doing? That's two quick questions. So, hopefully, if you get all these other approvals that you need to begin this clinical trial, when do you think, you know, you have 18 patients, what do you think the timeline for that would be? You mentioned that you hope to get the first patient enrolled either in the third or fourth quarter of the calendar quarter, but then when do you think the rest of the timeline plays out, and then when could you start the next phase, the PMA study?
Jeremy Pearlman: That's a two quick questions. So hopefully, if you get all these other approvals that you need to begin this clinical trial, when do you think you know you have 18 patients? What do you think the timeline for that would be? You mentioned that you hope to get the first patient enrolled either in the third or fourth quarter of the calendar quarter. But then when do you think how do you think the rest of the timeline plays out, and then when you could start the next, the PNA study?
Jeremy: When do you think, you know, you have 18 patients, what do you think the timeline for that would be? You mentioned that you hope to get the first patient enrolled either in the, let's say, the third or fourth quarter of the calendar quarter, but then when do you think, how do you think the rest of the timeline plays out, and then when you could start the next, the PMA study?
Jeremy: Steve, do you want to reply?
Steve: Yes, so the way the study is set up, we...
Steven Larosa: Steve, do you want to move on? Yeah, so the way the study set up, we specifically did T's ability assessments after three flights that we mentioned in Australia as well as the site in India. So we know that these are high quality active cancer clinical trial units, and we've done due diligence, but they have the patients who are getting infeed, infeed, one therapy that we mentioned in the volume app and penpalism app. So I can't give you what the exact enrollment rates will be, but at least we've done our feasibility that these are sites that have a reasonable, large patient population with screening.
James B. Frakes: Yes, so the way the study is set up, we Unknown Speaker, Unknown Speaker, Unknown Speaker
Speaker Change: We did feasibility assessments at the three sites that we mentioned in Australia as well as the site in India so we know that these are high quality active cancer clinical trial units and
Speaker Change: We've done due diligence, but they have the patients who are getting the NPTD1 therapies that we mentioned.
James B. Frakes: and we've done due diligence, but they have the patients who are getting the MPTD1 therapy. [inaudible]
Speaker Change: I can't give you what the exact enrollment rates will be, but at least we've done our feasibility that these are sites that have a reasonably large patient population in which screening can take place.
James B. Frakes: I can't give you what the exact enrollment rates will be, but at least we've done our feasibility and found that these are sites that have a reasonably large patient population where screening can be done, which we're anticipating based on our feasibility.
Michael Miller: We're anticipating, based on our feasibility status, that enrollment will proceed.
Steven Larosa: and take place. So, we're, we're, we're anticipating based on our feasibility status that enrollment will proceed in a timely fashion.
Michael Miller: in a timely fashion.
Speaker Change: Okay, understood. Thank you. And then just moving, I know it seems like oncology is your number one focus right now, but you have mentioned, you know, in the press release and in the past, about an opportunity in organ transplant and you did say that you had some publications I think you may be working on. Is there, maybe you can give us some update on that, that would be helpful. Thank you.
Jeremy Pearlman: Okay, understood. Thank you.
Jeremy Pearlman: Okay, understood. Thank you. And then just moving, I know oncology is your number one focus right now, but you have mentioned in the press release and in the past about an opportunity, an organ transplant, and he did say that you had some publications I think you may be working on. Is there, maybe you can give us some update on that, that we have both. Sure.
Jeremy Pearlman: And then just moving.
James Frakes: I know it seems like oncology is your number one focus right now, but you have mentioned, you know, in the press release, and in the past, is that an opportunity in Oregon transplant. And he did say that you had some publications. I think you may be working on is there. Maybe you can give us some update on that that we have both. Thank you. Sure, Jeremy. This is Jim. We do have most of a publication drafted; I'm told, and we'll get that published sooner rather than later, I think. There's no date in mind. Aethlon perhaps has come across as a little schizophrenic in the past.
Speaker Change: Sure, Jeremy. This is Jim. We do have most of a publication drafted, I'm told, and we'll...
James B. Frakes: Sure, Jeremy. This is Jim.
James B. Frakes: Get that published.
James B. Frakes: sooner rather than later, I think. There's no date in mind.
James B. Frakes: We do have most of our publication drafted, I'm told, and we'll get that published sooner rather than later, I think. There's no date in mind. Aethlon perhaps has come across as a little schizophrenic in the past.
James B. Frakes: Aethlon perhaps has come across as a little schizophrenic in the past. I'm trying to really have a solid focus on oncology.
James B. Frakes: I'm trying to really have a solid focus on oncology. (Inaudible) The paper is mostly written. Our technology appears to work well in that setting, the Organ Transplant Setting and the Perfusates, so we do want to get that information out. And there may be opportunities to hook up in some fashion with Organ Procurement Operations across the country, or there are firms that, You know, our commercial firms that are playing in that industry and That might be a good opportunity to work with them instead of doing it on our own. But it's early days, but we will see how that works.
James Frakes: I'm trying to really have a solid focus on oncology. But the papers mostly written, the art technology appears to work well in that Oregon transplant setting and the propusates. So we do want to get that information out. And there may be opportunities to hook up in some fashion with Oregon procurement operations across the country, or there are firms that, you know, are commercial firms that play in that industry and that that might be a good opportunity to work with them instead of doing it on a run. But it's really days, but we will see how that works.
James B. Frakes: But.
James B. Frakes: The paper is mostly written, the art technology appears to work well in that.
Speaker Change: Organ Transplant Setting and Perfusates. So we do want to get that information out.
Speaker Change: And there may be.
Speaker Change: opportunities to hook up in some fashion with
Speaker Change: Organ Procurement Operations across the country or there are firms that
Speaker Change: You know, our commercial firms that play in that industry.
Speaker Change: That might be a good opportunity to work with them instead of doing it on our own. But it's early days, but we will see how that works.
Speaker Change: Okay, great. Thank you so much. Well, I'll hop back in the queue.
Jeremy Pearlman: Okay, great. Thank you so much. Well, I'll have that in the queue. Thanks, Jeremy.
Jeremy Pearlman: Okay, great. Thank you so much. I'll hop back in the queue.
Speaker Change: Thanks, Jeremy.
Speaker Change: This concludes our question and answer session. I would like to turn the conference back over to Mr. Jim Frakes for any closing remarks. Please go ahead, sir.
Operator: This concludes our question and answer session.
Operator: This concludes our question and answer session. I would like to turn the conference back over to Mr. Jim Frakes for any closing remarks. Please go ahead, sir.
James Frakes: I would like to turn the conference back over to Mr. Jim Freak for any closing remarks. Please go ahead, sir. Thank you again for joining us today to discuss our urine results. And we look forward to keeping you up to date on future calls.
Speaker Change: Thank you again for joining us today to discuss our year-end results, and we look forward to keeping you up to date on future calls. Have a good day. Thanks. Bye.
James B. Frakes: Thank you again for joining us today to discuss our year-end results, and we look forward to keeping you up to date on future calls.
James B. Frakes: Have a good day. Thanks. Bye. The conference is now concluded.
James Frakes: Have a good day. Thanks.
James Frakes: Bye.
Operator: The conference is now concluded. Thank you for attending today's presentation. You may now disconnect.
Operator: The conference is now concluded. Thank you for attending today's presentation.
unknown: [inaudible]
Operator: You may now disconnect. James Frakes, Michael Miller, James Frakes, Michael Miller,
Speaker Change: © BF-WATCH TV 2021