Q1 2025 Aethlon Medical Inc Earnings Call

Speaker Change: Thank you for watching.

Operator: Good day and welcome to the Aethlon Medical Physical First Quarter 2025 Earnings and Corporate Update Conference Call. All participants will be in listen-only mode. Should you need assistance, please signal a conference specialist by pressing the star key followed by zero.

Operator: Paul, Paul, Paul, Dr. Prado, Dr. Prado, Dr. Prado, Good day and welcome to the Aethlon Medical Fiscal First Quarter 2025 Earnings and Corporate Update Conference Call. All participants will be in listen-only mode.

Speaker Change: Good day and welcome to the Athlon Medical Fiscal First Quarter 2025 Earnings and Corporate Update Conference Call. All participants will be in listen-only mode.

Operator: Richard Union Assistant, Police Signal, and 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 telephone keypad. 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 Michael Miller of RX Communications. Please go ahead.

Speaker Change: 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 on your telephone keypad. To withdraw your question, please press star, then two. Please note, this event is being recorded.

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 telephone keypad. 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 Michael Miller of RX Communications. Please go ahead.

Michael Miller: I would now like to turn the conference over to Michael Miller of Rx Communications. Please go ahead.

Michael Miller: Thank you, operator, and good afternoon, everyone. Welcome to Aethlon Medical's first quarter 2025 earnings conference call. My name is Michael Miller with Rx Communications.

Michael Miller: Thank you, operator, and good afternoon, everyone. Welcome to Athlon Medical's fiscal first quarter 2025 burning conference call. My name is Michael Miller with Rx Communicase.

Michael Miller: Thank you, operator, and good afternoon, everyone. Welcome to Athlon Medical's fiscal first quarter 2025 earnings conference call. My name is Michael Miller with Rx Communication.

Michael Miller: At 4:15 PM Eastern Time today, Aethlon Medical released financial results for its fiscal first quarter ended June 30th, 2024. If you have not seen or received Aethlon Medical's earnings release, please visit the investors page at www.aethlonmedical.com. Following this introduction and the reading of the company's forward-looking statement disclaimer, 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: At 4.15 p.m. Eastern Time today, Aethlon Medical released financial results for its fiscal first quarter ended June 30, 2024. If you have not seen or received Aethlon Medical's earnings release, please visit the investor's page at www.aethlonmedical.com. Following this introduction and the reading of the company's forward-looking statement disclaimer, 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.

Speaker Change: At 4.15 p.m. Eastern Time today, Aethlon Medical released financial results for its fiscal first quarter ended June 30, 2024.

Speaker Change: If you have not seen or received Athlon Medical's earnings release, please visit the investors page at www.athlonmedical.com.

Speaker Change: Following this introduction and the reading of the company's forward-looking statement disclaimer, 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: We'll then open up the call for the Q&A session.

James Frakes: Mr. Frakes will then make some brief remarks on Athlon's financials, we'll 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 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. 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: We'll then open up the call for the Q&A session. 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. 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. Such forward-looking statements are subject to significant risks and uncertainties, and actual results may differ materially from those anticipated in the forward-looking statement.

Speaker Change: 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: 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 fiscal year ended March 31st, 2024, the company's most recent quarterly report on Form 10-Q, and in the company's other filings with the Securities and Exchange Commission. Except as may be required by law, the company does not intend, nor does it undertake any duty, to update this information to reflect a future event or circle.

Speaker Change: The company cautions you that any statement that is not a statement of a historical fact is a forward-looking statement.

Speaker Change: 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 captioned risk factors in the company's annual report on Form 10-K for the fiscal year ended March 31st, 2024. The company's most recent quarterly report on Form 10-K and in the company's other filings with the Securities and Exchange Commission.

Speaker Change: 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 fiscal year ended March 31, 2024.

Speaker Change: The company's most recent quarterly report on Form 10Q, and in the company's other filing the Securities and Exchange Commission.

Michael Miller: Except as may be required by law, the company does not intend, in order to undertake any duty to update this information to reflect future events or circumstances.

Speaker Change: 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.

Michael Miller: 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, the In Room CEO and longtime CFO of Aethlon Medical. 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.

James Frakes: With that, I'll now turn the call over to Mr. James Frakes, ATLON'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, interim CEO and longtime CEO of ATLON Medical. ATLON 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, which we also refer to as extracellular vesicles, may promote immune suppression and metastasis; also in life-threatening infectious diseases and in organ transplantation.

James Frakes: With that, I'll now turn the call over to Mr. James Frakes, Athbon's Interim Chief Executive Officer and Chief Financial Officer.

James Frakes: These qualities of the hemopurifier have potential applications in oncology, or Cancer Associated Ex-Azones, which we also refer to as extracellular vesicles, may promote immune suppression and metastasis. Also in life-threatening infectious diseases and in organ transplantation. Now, before I turn the call over to Dr. Steven Larosa, who will give you an update on our efforts to date on the oncology front, on the milestones we just hit, and on other potential milestones that we hope to achieve later on this year.

James Frakes: Thank you, Mike, and I would like to thank all of you for dialing in. This is Jim Frakes, Enron CEO and longtime CFO of affluent medical.

Speaker Change: Apple on Medical is continuing the research and clinical development of its hemopterofire.

Speaker Change: A therapeutic blood filtration system designed to bind and remove harmful exosomes and life-threatening viruses from blood and other biological fluids.

Speaker Change: These qualities of the hemopurifier have potential applications in oncology.

Speaker Change: were cancer-associated exosomes, which we also refer to as extracellular vesicles.

Speaker Change: may promote immune suppression and metastasis.

Speaker Change: Also in life-threatening infectious diseases and in organ transplantation.

James Frakes: Now, before I turn the call over to Dr. Steve and Larosa, who will give you an update on our efforts to date on the oncology front, on the milestones we just hit, and on other potential milestones that we hope to achieve later on this year. I would like to take a moment to emphasize that we are starting to achieve the two goals that I stated were our objectives when I was appointed as interim CEO last November. Those goals were to get the company moving forward on our oncology indication and to reduce our expenses. As you will hear shortly, we have made measurable progress on both those fronts.

Speaker Change: Now, before I turn the call over to Dr. Steven Larosa, who will give you an update on our efforts to date on the oncology front...

Steven Larosa: On the milestones we just hit.

Steven Larosa: and on other potential milestones that we hope to achieve later on this year.

James Frakes: I would like to take a moment to emphasize that we are starting to achieve the two goals that I stated were our objectives when I was appointed as interim CEO last November. Those goals were to get the company moving forward on our oncology indication and to reduce our expenses. As you will hear shortly, we have made measurable progress on both those fronts.

Speaker Change: I would like to take a moment to emphasize that we are starting to achieve the two goals that I stated were our objectives when I was appointed as interim CEO last November.

Speaker Change: Those goals were to get the company moving forward on our oncology indication and to reduce our expenses.

Speaker Change: As you will hear shortly, we have made measure will progress on both those fronts.

James Frakes: I'm gratified by this progress and hope that if it continues, our shareholders will be rewarded by that progress.

James Frakes: I'm gratified by this progress and hope that if it continues, then our shareholders will be rewarded by that progress. With that, I will now turn the call over to Dr. Steven Larosa, Aethlon's Chief Medical Officer. Thank you, Jim.

Speaker Change: I'm gratified by this progress and hope that if it continues that our shareholders will be rewarded by that progress.

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 August 12, 2024, two days ago, the Belvary Human Research Ethics Committee (BHREC) granted full ethics approval to the Pandora Private Hospital for a safety feasibility and dose-finding clinical trial of the hemopurifier in patients with solid tumors who have stable or progressive disease during anti-PD-1 monotherapy treatment, such as Merck's Ketruda, Pembrolyz Mab, a personal Myers quib's up-devo of all you met.

Speaker Change: With that, I will now turn the call over to Dr. Steven Larosa, Aethlon's Chief Medical Officer.

Steven Larosa: As announced on August 12th, 2024, two days ago, the Bellary Human Research Ethics Committee, the BHREC, granted full ethics approval to the Pindara Private Hospital for a safety, feasibility, and dose-finding clinical trial of the hemopurifier in patients with solid tumors who have stable or progressive disease during anti-PD-1 monotherapy treatment, such as Merck's Keytruda, Temporalizumab, or Bristol-My The approval is valid for one year until August 6th, 2025, after which time it will be eligible for renewal.

Steven Larosa: Thank you, Jim.

Steven Larosa: As announced on August 12th,

Speaker Change: 2024, two days ago.

Speaker Change: The Belvary Human Research Ethics Committee, the B-H-R-E-C, granted full ethics approval to the Pindara Private Hospital.

Speaker Change: for a safety, feasibility, and those finding clinical trial of the hemocurifier in patients with solid tumors who have stable or progressive disease during antipd1 monotherapy treatment.

Speaker Change: such as Merck's Keytruda, Fembrolizumab, or Bristol-Myers Squibb's Opdivo, Novolumab.

Steven Larosa: The approval is valid for one year until August 6, 2025, after which time it will be eligible for renewal. The trial will be conducted by Dr. Marco Matos and its staff at the Pandora Private Hospital located in Queensland, Australia.

Speaker Change: The approval is valid for one year until August 6, 2025, after which time it will be eligible for renewal.

Steven Larosa: The trial will be conducted by Dr. Marco Matos and his staff at the Pindara Private Hospital located in Queensland, Australia. Earlier, on June 18, 2024, the Human Research Ethics Committee of the Central Adelaide Local Health Network, the CALHN, granted full ethics approval for this same multi-center clinical trial. The approval is valid for three years until June 13th, 2020.

Speaker Change: The trial will be conducted by Dr. Marco Matos and his staff at the Pindara Private Hospital located in Queensland, Australia.

Steven Larosa: Earlier, on June 18, 2024, the Human Research Ethics Committee of the Central Adelaide Local Health Network, the CALHN, granted full ethics approval for this same multi-center clinical trial. The approval is valid for three years until June 13, 2027. The trial will be conducted at this site by Dr. Professor Michael Brown in a staff at the Cancer Clinical Trials Unit at CALHN Royal Adelaide Hospital in Adelaide, Australia.

Speaker Change: Earlier, on June 18, 2024, the Human Research Ethics Committee of the Central Adelaide Local Health Network, the CALHN, granted full ethics approval for this same multi-center clinical trial.

Speaker Change: The approval is valid for three years until June 13, 2027.

Steven Larosa: The trial will be conducted at this site by Professor Michael Brown and his staff at the Cancer Clinical Trials Unit at CALHN Royal Adelaide Hospital in Adelaide, Australia. Going forward, the next steps are to receive approval from the research governance offices at each hospital. The Research Governance Office reviews indemnities and insurance.

Speaker Change: The trial will be conducted at this site by Professor Michael Brown and his staff at the Cancer Clinical Trials Unit at CALHN Royal Adelaide Hospital in Adelaide, Australia.

Steven Larosa: Going forward, the next steps are to receive approval from the Research Governance Offices at each hospital. The research governance office reviews indemnities and insurps. Once these approves are obtained, AXLON, in concert with our Australian Contract Research Organization Rescue, will conduct site initiation visits, noted SIVs, after which patient enrollment in the trial may proceed.

Speaker Change: Going forward, the next steps are to receive approval from the research governance offices at each hospital.

Speaker Change: The Research Governance Office reviews indemnities and insurance.

Steven Larosa: Once these approvals are obtained, Aethlon, in concert with our Australian Contract Research Organization, RESQ, will conduct site initiation, known as S.I.V., after which patient enrollment in the trial may proceed. We expect that we will be open for enrollment in mid to late September 2020.

Speaker Change: Once these approvals are obtained, Athlon, in concert with our Australian Contract Research Organization, RESQ, will conduct site initiation visits.

Speaker Change: Unknown Attendee, Michael Miller, Steven Larosa

Steven Larosa: We expect that we will be open for enrollment in mid to late September 2024. We anticipate several upcoming potential value-creating milestones, including submission to the governance committee at an additional site in Australia that is under the jurisdiction of the Belgari HREEC, which has already reviewed the study for the Pandora site. The timeframe for activation of this third site should be in line with the activation of the other two sites.

Speaker Change: After which, patient enrollment in the trial may proceed.

Speaker Change: We expect that we will be open for enrollment in mid to late September 2024.

Steven Larosa: We anticipate several upcoming potential value-creating milestones, including submission to the governance committee at an additional site in Australia that is under the jurisdiction of the Bellberry HREEC, which has already reviewed the study for the Pandarus. The time frame for activation of this third site should be in line with the activation of the other two sites. We also await the response from the Scientific Committee at a site in India, with the expectation that that will be followed by a Human Research Ethics Committee review.

Speaker Change: We anticipate several upcoming potential value-creating milestones.

Speaker Change: including submission to the Governance Committee at an additional site in Australia that is under the jurisdiction of the Belberry HREEC which has already reviewed the study for the Pandora site.

Speaker Change: The time frame for activation of this third site should be in line with the activation of the other two sites.

Steven Larosa: We also await the response from the Scientific Committee at a site in India, with the expectations that that will be followed by a Human Research Ethics Committee review. As a reminder, the primary endpoint of these studies is a 9-18 patient safety feasibility and dose-finding trial, and the primary endpoint is safety. The trial will monitor any adverse events and clinically significant changes in lab tests of hemopurapyretreated patients with solid tumors, with stable or progressive disease at different treatment intervals after a two-month running period of PD-1 antibody, anti-PD-1 antibody, either Petruda or Optimal. Patients who do not respond to the anti-PD-1 antibody therapy will be eligible to enter the hemopurapyret of the study, where sequential cohorts will receive either one, two, or three hemopurapyret treatments during a one-week period.

Speaker Change: We also await the response from the Scientific Committee at a site in India with the expectation that that will be followed by a Human Research Ethics Committee review.

Steven Larosa: As a reminder, the primary endpoint of these studies is a 9 to 18 patient safety, feasibility, and dose finding trial, and the primary endpoint is safety. The trial will monitor any adverse events and clinically significant changes in lab tests of hemopurifier-treated patients with solid tumors, would be stable a progressive disease, at different treatment intervals after a two-month run-in period of PD-1 antibody, anti-PD one antibody either Keytruda or up to Patients who do not respond to the anti-PD-1 antibody therapy will be eligible to enter the hemopurifier phase of the study.

Speaker Change: As a reminder, the primary endpoint of these studies is a 9 to 18 patient safety, feasibility, and dose finding trial, and the primary endpoint is safety.

Speaker Change: The trial will monitor any adverse events and clinically significant changes in lab tests of hemopurifier-treated patients with solid tumors.

Speaker Change: would stable a progressive disease at different treatment intervals after a two-month run-in period of PD-1 antibody, anti-PD-1 antibody, either Keytruda or Opdivo.

Speaker Change: Patients who do not respond to the anti-PD-1 antibody therapy will be eligible to enter the hemopurifier period of the study.

Steven Larosa: Where sequential cohorts will receive either one, two, or three hemopurapyrate, 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 extracellular vesicles. And if these changes in extracellular vesicle concentrations improve the body's own natural ability to attack tumor cells.

Speaker Change: Where sequential cohorts will receive either one, two, or three hemopurifier treatments during a one-week period.

Steven Larosa: In addition to monitoring safety, the study is designed to examine the number of hemopurapyret treatments needed to decrease the concentration of extracellular vesicles. And if these changes in extracellular vesicle concentrations improve the body's own natural ability to attack tumor cells. These exploratory central laboratory analyses are expected to inform the design of a subsequent efficacy and safety trial, including a pre-market approval known as a PMA study required by the FDA and other regulatory agencies.

Speaker Change: In addition to monitoring safety, the study is designed to examine the number of hemopurifier treatments needed to decrease the concentration of extracellular vesicles.

Speaker Change: and if these changes in extracellular vesicle concentrations improve the body's own natural ability to attack tumor cells.

Steven Larosa: These exploratory central laboratory analyses are expected to inform the design of a subsequent efficacy and safety trial, including a premarket approval study known as a PMA study required by the FDA and other regulatory agencies. Currently, only approximately 30% of patients who receive femoralizumab or nivolumab will have lasting clinical responses to these agents. Extracellular vesicles produced by tumors have been implicated in the spread of cancers as well as resistance to anti-PD-1 therapies.

Speaker Change: These exploratory central laboratory analyses are expected to inform the design of a subsequent efficacy and safety trial including a pre-market approval known as a PMA study required by the FDA and other regulatory agencies.

Steven Larosa: Currently, only approximately 30% of patients who receive femoralism ab or nevolumab will have lasting clinical responses to these agents. Extracellular vesicles produced by tumors have been implicated in the spread of cancers as well as the resistance to these anti-PD-1 therapies. The aphlon hemopurapyret has been designed to bind and remove these extracellular vesicles from the bloodstream, which may improve therapeutic response rates to the anti-PD-1 therapies. In pre-clinical studies, the hemopurapyret has been shown to reduce the number of EVs in cancer patient plasma samples.

Speaker Change: Currently, only approximately 30% of patients who receive femoralizumab or nivolumab will have lasting clinical responses to these agents.

Speaker Change: Extracellular vesicles produced by tumors have been implicated in the spread of cancers, as well as the resistance to these anti-PD-1 therapies.

Steven Larosa: The Aethlon Hemopurifier has been designed to bind and remove these extracellular vesicles from the bloodstream, which may have, may improve therapeutic response rates to the NTPD-1 third. In preclinical studies, the hemopurifier has been shown to reduce the number of EVs in cancer patient plasma samples. The company also stands poised to address outbreaks due to life-threatening envelope viruses for which no treatment exists. We have previously demonstrated the ability of a benchtop version of the hemopurifier to bind a number of envelope viruses of interest in in vitro experiments. These include dengue, not limited to but including dengue and H5-1 avian influenza, known as bird flu.

Speaker Change: The Athlon Hemopurifier has been designed to bind and remove these extracellular vesicles from the bloodstream.

Speaker Change: which may have, may improve therapeutic response rates to the anti-PD-1 therapies.

Speaker Change: In preclinical studies, the hemopurifier has been shown to reduce the number of EVs in cancer patient plasma samples.

Steven Larosa: The company also stands poised to address outbreaks in pandemics due to life-threatening envelope viruses, which no treatment exists. Davis. We have previously demonstrated the ability of a benchtop version of the hemopurifier to bind a number of envelope viruses of interest in in vitro experiments. These include dengue, not limited to, but include dengue and H51 avian influenza, known as bird flu.

Speaker Change: The company also stands poised to address outbreaks and pandemics due to life-threatening envelope viruses for which no treatment exists.

Speaker Change: We have previously demonstrated the ability of a benchtop version of the hemopurifier to bind a number of envelope viruses of interest in in vitro experiments.

Speaker Change: These include dengue, not limited to, but include dengue and H5N1 avian influenza, known as bird flu.

Steven Larosa: Additionally, the company's COVID-19 trial in India remains open to enroll patients with severe COVID-19 infection who require admission to the intensive care unit. The date one patient has been treated, the company is actively evaluating COVID-19 admissions at our site and potential enrollment against the ongoing costs of maintaining this trial.

Steven Larosa: Additionally, the company's COVID-19 trial in India remains open to enroll patients with severe COVID-19 infection who require admission to the intensive care unit until the date one patient has been treated. The company is actively evaluating COVID-19 admissions at our sites and potential enrollment against the ongoing costs of maintaining them. Distribe, With that, I'll turn the call back over to Jim for the financial discussion and then open up. Thanks, Steve, and good afternoon again, everyone.

Speaker Change: Additionally, the company's COVID-19 trial in India remains open to enroll patients with severe COVID-19 infection who require admission to the intensive care unit.

Speaker Change: To date, one patient has been treated.

Speaker Change: The company is actively evaluating COVID-19 admissions at our sites and potential enrollment against the ongoing costs of maintaining.

James Frakes: With that, I'll turn the call back over to Jim for the financial discussion and then open up for questions.

Speaker Change: Distrial.

Speaker Change: With that, I'll turn the call back over to Jim for the financial discussion and then open up for questions.

James Frakes: Thanks, Steve. Good afternoon again, everyone. I will try to keep my remarks on our financial discussion at a high level. You'll find detailed expense information in the financial statements attached to our earnings release that just hit the wire, or in our soon-to-be-file quarterly report on Form 10-Q. As of June 30, 2024, Aethlon Medical had a cash balance of approximately $9.1. Our consolidated operating expenses for the fiscal quarter ended June 30, 2024 were approximately $2.6 million compared to $3.4 million for the fiscal quarter ended June 2023. This decrease of approximately $800,000, or approximately 24% in the 2024 period, was due to a decrease of approximately $600,000 in general and administrative expenses and a decrease of approximately $300,000 in professional fees, partially offset by an increase in payroll and related expenses of approximately $100,000.

James Frakes: I will try to keep my remarks on our financial discussion at a high level. You'll find detailed expense information in the financial statements attached to our earnings release that just hit the wire or in our soon-to-be-filed quarterly report on Form 10-Q. As of June 30, 2024, Aethlon Medical had a cash balance of approximately $9.1 million.

Jim Frakes: Thanks, Steve, and good afternoon again, everyone.

Jim Frakes: I will try to keep my remarks on our financial discussion at a high level.

Jim Frakes: You will find detailed expense information in the financial statements attached to our earnings release that just hit the wire or in our soon-to-be-filed quarterly report on Form 10-Q.

Jim Frakes: As of June 30, 2024, Athlon Medical had a cash balance of approximately $9.1 million.

James Frakes: Our consolidated operating expenses for the fiscal quarter ended June 30, 2024, were approximately $2.6 million, compared to $3.4 million for the fiscal quarter ended June 2023. This decrease of approximately $800,000, or approximately 24%, in the 2024 period was due to a decrease of approximately $600,000 in general and administrative expenses and a decrease of approximately $300,000 in professional fees, partially offset by an increase in payroll and related expenses of approximately $100,000. The approximate $600,000 decrease in G&A expenses in the fiscal quarter ended June 30, 2024, was primarily due to a $447,000 decrease and supplies related to the purchase of raw materials for manufacturing a pima purifier and for lab supplies.

Jim Frakes: Our consolidated operating expenses for the fiscal quarter ended June 30, 2024, were approximately $2.6 million.

Jim Frakes: compared to $3.4 million for the fiscal quarter ended June 2023.

Jim Frakes: This decrease of approximately $800,000 or approximately 24% in the 2024 period was due to a decrease of approximately $600,000 in general and administrative expenses.

Jim Frakes: and the decrease of approximately $300,000 in professional fees.

Jim Frakes: Partially upset by an increase in payroll and related expenses.

James Frakes: The approximate $600,000 decrease in GNA expenses in the fiscal quarter ended June 30, 2024 was primarily due to a $447,000 decrease in supplies related to the purchase of raw materials for manufacturing a pima purifier and for lab supplies. The approximate $300,000 decrease in professional fees was primarily due to a $136,000 decrease in consulting expenses, primarily related to determination of services with a contract manufacturing organization, a $110,000 decrease in scientific consulting, and a $78,000 decrease in legal fees relating to general corporate matters. The approximate $100,000 increase in payroll and related expenses was primarily due to an increase in separation expenses of approximately $300,000 related to the termination of an employee.

Jim Frakes: of approximately $100,000.

Jim Frakes: The approximate $600,000 decrease in G&A expenses in the fiscal quarter ended June 30, 2024, was primarily due to a $447,000 decrease.

Jim Frakes: in supplies related to the purchase of raw materials for manufacturing a hemopurifier and for lab supplies.

James Frakes: The approximate $300,000 decrease in professional fees was primarily due to a $136,000 decrease in consulting expenses, primarily related to the termination of services with a contract manufacturing organization, a $110,000 decrease in scientific consulting, and a $78,000 decrease in legal fees relating to general corporate matters. The approximate $100,000 increase in payroll and related expenses was primarily due to an increase in separation expense of approximately $300,000 related to the termination of an employee. That increase was partially offset by a decrease of $111,000 in stock-based compensation and an $89,000 decrease in general and administrative personnel.

Jim Frakes: The approximate $300,000 decrease in professional fees was primarily due to a $136,000 decrease in consulting expenses.

Jim Frakes: primarily related to termination of services with a contract manufacturing organization.

Jim Frakes: A $110,000 Decrease in Scientific Consulting.

Jim Frakes: And a $78,000 decrease in legal fees relating to general corporate matters.

Jim Frakes: The approximate $100,000 increase in payroll and related expenses

Jim Frakes: was primarily due to an increase in separation expenses.

Jim Frakes: of approximately $300,000 [inaudible]

James Frakes: That increase was partially offset by a decrease of in Stock Base Compensation, and an $89,000 decrease in general and administrative personnel expenses. As a result of the factors I just noted, Aethlon's net loss decreased by approximately $700,000 to approximately $2.6 million in the fiscal quarter ended June 30, 2024, from approximately $3.3 million in the fiscal quarter ended June 30, 2023. I like to note and emphasize that if we exclude the $300,000 provision related to that employee termination, expenses decreased by over $1 million. Order of the quarter. We included these earnings results and related commentary in a press release issued earlier this afternoon.

Jim Frakes: related to the termination of an employee.

Jim Frakes: That increase was partially upset by a decrease of $111,000.

Jim Frakes: and Stock Based Compensation.

Jim Frakes: and an $89,000 decrease in general and administrative personnel expenses.

James Frakes: As a result of the factors I just noted, Aethlon's net loss decreased by approximately $700,000 to approximately $2.6 million in the fiscal quarter ended June 30, 2024, from approximately $3.3 million in the fiscal quarter ended June 30, 2023. I'd like to note and emphasize that if we exclude the $300,000 provision related to that employee termination, our operating expenses decreased by over $1 million. Order in the court. We included these earnings results and related commentary in a press release issued earlier this afternoon.

Jim Frakes: Christopher.

Jim Frakes: As a result of the factors I just noted, Aethlon's net loss decreased by approximately $700,000 to approximately $2.6 million in the fiscal quarter ended June 30, 2024, from approximately $3.3 million in the fiscal quarter ended June 30, 2023.

Speaker Change: I'd like to note and emphasize that if we exclude the $300,000 provision related to that employee termination, our operating expenses decrease by over $1 million.

Speaker Change: Order of the Court.

Speaker Change: We included these earnings results and related commentary in a press release issued earlier this afternoon. Thank you. Thank you.

James Frakes: That release included the balance sheet for June 30, 2024, and the statements of operations for the fiscal quarter ended June 30, 2024, and 2023. We will file our quarterly report on Form 10-Q following this call. Our next earnings call for the fiscal second quarter ending September 30, 2024, will coincide with the filing of our quarterly report on Form 10-Q in November 2024.

James Frakes: That release included the ballot sheet for June 30, 2024, and the statements of operations for the fiscal quarters ended June 30, 2024, and 2023. We will file our quarterly report on Form 10-Q following this call. Our next earnings call for the fiscal second quarter ending September 30, 2024, will coincide with the filing of our quarterly report on Form 10Q in November 2024.

Speaker Change: That release included the balance sheet for June 30, 2024, and the statements of operations for the fiscal quarters ended June 30, 2024, and 2023.

Speaker Change: We will file our quarterly report on Form 10-Q following this call.

Speaker Change: Our next earnings call for the fiscal second quarter ending September 30, 2024, will coincide with the filing of our quarterly report on Form 10-Q in November 2024.

James Frakes: And now, Stephen, I would be happy to take any questions that you may have.

Operator: 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. To ask a question, you may press Star Ben One on your telephone keypad. If you are using a speakerphone, please pick up your handset before pressing the keys.

Operator: Operator, please open the call for questions. We will now begin the question and answer session. To ask a question, you may press star, then one on your telephone keypad. If you are using a speeder 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.

Speaker Change: And now, Steve and I would be happy to take any questions that you may have. Operator, please open the call for questions.

Speaker Change: We will now begin the question and answer session. To ask a question, you may press star then 1 on your telephone keypad.

Speaker Change: If you are 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.

Operator: If at any time your question has been addressed and you would like to withdraw your question, please press star then 2. The first question comes from Marla Marin with Zax. Please go ahead.

Marlon Marin: The first question comes from Marlon Marin with Zach's. Please go ahead.

Speaker Change: The first question comes from Marla Maron with Zax. Please go ahead.

Marlon Marin: Thank you.

Marla Marin: Thank you. Um, so just I wanted to Jim, I want to get back to something you just said about the operating expense, if you normalize it, you know, to exclude the payment to the former employee. Is that a good run rate going forward?

Marlon Marin: So, I wanted to, Jim, I want to get back to something you just said about the operating expense. If you normalize it, you know, to exclude the payment to the former employee, is that a good run rate going forward? Understanding of course that as, you know, some of the clinical development efforts begin to ramp, we will see that reflected in higher R&D.

Marla Maron: Thank you. So just, I wanted to, Jim, I want to get back to something you just said about the operating expense. If you normalize it, you know, to exclude the payment to the former employee, is that a good run rate going forward?

James Frakes: Understanding, of course, that as some of the clinical development efforts begin to ramp, we will see that reflected in higher R&D. Hi Marla, that's a good question. We have things moving in different directions. On the expense reduction side, And this is public information now if you look at our website and filings. We change. Law firms and accounting firms. Unknown Speaker That should be somewhat less expensive.

Speaker Change: Understanding, of course, that as some of the clinical development efforts begin to ramp, we will see that reflected in higher R&D.

James Frakes: Hi, Marlon. That's a good question. We have things moving in different directions. On the expense reduction side, and this is public information now. If you look at our website and the filing. So, we changed law firms and accounting firms. The firms that should be some with less expensive. So, we didn't have that benefit in the June quarter. So, there should be further expense reductions from those professional fees going forward. But, as you noted, starting in September, month to month, we expect much more activity in the Australian clinical trials. Steve and some colleagues are going to fly over there and do the site initiation to train the people.

Speaker Change: Hi, Marlo. That's a good question.

Jim Frakes: We have things moving in different directions. On the expense reduction side,

Speaker Change: And this is public information now, if you look at our website and filings, we changed.

Speaker Change: Law Firms and Accounting Firms.

James Frakes: So we didn't have that benefit in the June quarter. However, there should be further expense reductions from those professional fees going forward. But, as you noted, starting in September, the month of the month, we expect much more activity in Australian clinical trials. Steve and some colleagues are going to fly over there and do the site initiation to train the people so that there will be additional resources, and it will probably remain higher on the clinical platforms on these.

Speaker Change: Unknown Attendee, Michael Miller, Steven Larosa

Speaker Change: We expect much more activity in the Australian clinical trials.

Speaker Change: and some colleagues are going to fly over there and do the site initiation to train the people. So there will be...

James Frakes: So, there will be additional land and will probably remain higher on the clinical expansives. So they may offset; we can't predict exactly, but they should be somewhat offsetting.

Additional Attendee: Additional and will probably remain higher on the clinical trial front on the expenses.

James Frakes: So they may offset, we can't, for this exactly, but they should be someone else. Okay, so then follow up with Steve, you know, in terms of any kind of training that you have to provide. Do you expect that to be a relatively short-term process, and how will you provide support once you've left and you've returned to the city? Yeah, great question. Thank you, Marla.

Speaker Change: So they may offset, we can't predict exactly, but they should be somewhat offsetting.

Steven Larosa: Okay, so then follow up to Steve, you know, in terms of any kind of training that you have to provide, do you expect that to be a relatively, you know, short-term process, and, you know, how will you provide support once you've left and you return back to the States? Yes, no, great question. Thank you, Marla. So, as I mentioned, the research governance approvals are both that review process is underway. We've already got the site initiation visits at those two sites scheduled in September. Provided the governance goes okay, once you're done with the site initiation visits, which me and my colleague at Aethlon will participate in virtually, those sites can actually begin screening and enrolling patients. That's kind of the on switch. That will be followed by a site investigator meeting in the October timeframe, which will actually travel to Australia and meet with all the personnel at the site.

Speaker Change: Do you expect that to be a relatively short term process and how will you provide support once you've left and you've returned back to the states?

Steven Larosa: So, as I mentioned, the research governance approvals are both underway, and that review process is underway. We've already got the site initiation visits at those two sites scheduled in September, provided the governance goes okay. Once you're done with the site initiation visits, which me and my colleague at Aethlon will participate in virtually, those sites can actually begin screening and enrolling patients. That's kind of the on switch.

Speaker Change: Great question. Thank you, Marla. So, as I mentioned, the research governance approvals are both, that review process is underway. We've already got the site initiation visits at those two sites.

Steven Larosa: That will be followed by an investigator meeting in the October timeframe, which will actually travel to Australia and meet with all the personnel at the sites. But those sites will already be; the two sites will already be open for enrollment by then. At both the site initiation visit timeframe and the investigator meeting timeframe, there'll be lots of technical training on the actual device. And then we are also in the phase now of interviewing people for a technical position at Aethlon who would provide real-time assistance to those sites. So they'd actually be boots on the ground, if you will, to help the site.

Steven Larosa: So yeah, there'll be as well as my colleague and I here who will be available, of course, at all times for any patient that's enrolled. Okay, thank you. And then last question. It's really more of a housekeeping question.

Speaker Change: Unknown Attendee, Michael Miller, Steven Larosa

Speaker Change: Those sites can actually begin screening and enrolling patients. That's kind of the on switch.

Speaker Change: That will be followed by an investigator meeting in the October timeframe, which will actually travel to Australia and meet with all the personnel at the site. But those sites will already be, the two sites will already be open.

Steven Larosa: But those sites will already be the two sites will already be open for enrollment by then. At both the site initiation visit timeframe and the investigator meeting timeframe, there'll be lots of technical training on the actual device. And then we are also in the phase now of interviewing people for a technical position at Aethlon who would provide real-time assistance to those sites, so they'd actually be boots on the ground, if you will, to help the site. So, yeah, there'll be, as well as my colleague and I here, who will be available, of course, at all times for any patient that's enrolled.

Speaker Change: for enrollment by then. At both the site initiation visit timeframe and the investigator meeting timeframe, there'll be lots of technical training on the actual device.

Speaker Change: And then we are also in the.

Speaker Change: In the phase now of interviewing people for a technical position at Aethlon who would provide real-time assistance.

Speaker Change: to those sites, so there'd actually be boots on the ground, if you will, to help the sites. So, yeah, they'll be, as well as my colleague and I here, who will be available, of course, at all times for any patient that's enrolled.

Marlon Marin: Okay, thank you.

Marla Marin: I just want to, you know, make sure that I understand what you said in your prepared remarks as far as the paperwork at your end. You've completed all of the paperwork from, you know, that you needed to submit. Is that correct? For both the ethics committees, you know, we had paperwork that had to be submitted and responses. And so we're through that phase. And now we've provided our CRO rescue with all the paperwork that they need from our end for the governance review.

Marlon Marin: And then last question, it's one more of a housekeeping question. I just want to make sure that I'm understanding what you said in your prepared remarks as far as the paperwork at your end. You've completed all of the paperwork from, you know, that you needed to submit. Is that correct? For both the ethics committees, you know, we had a paperwork that had to be submitted and responses, and so we're through that phase. And now we've provided our CRO rescue with all the paperwork that they need for our and for the governance for you. Yes, we've done everything we could do.

Speaker Change: Okay, thank you. And then last question. It's really more of a housekeeping question. I just want to, you know, make sure that I'm understanding what you said in your prepared remarks as far as like the paperwork at your end.

Speaker Change: You've completed all of the paperwork from, you know, that you needed to submit. Is that correct?

Speaker Change: For both the ethics committees, you know, we had a paperwork that had to be submitted and responses. And so we're through that phase. And now we've provided our CRO rescue with all the paperwork that they need from our end for the for the governance review. Yes, we've done all we've done everything we could do. We're waiting for the governance offices at those two sites to rule.

Steven Larosa: We've done everything we could do. We're waiting for the governance offices at those 2 sites to rule. Okay, great. Thank you. And again, Marla, those are just kind of straightforward business issues. We're showing them our insurance policies, and we've signed indemnity. I think they've even countersigned some of them or what tracking down a PI agreed upon budgets are agreed upon. So it's a straightforward business thing in terms of nailing down Okay, Again, if you have a question, please press star then 1.

Steven Larosa: We're waiting for the governance offices at those two sites to rule.

Steven Larosa: Okay, great. Thank you. And again, Marla, those are just kind of straightforward business issues. We're showing them our insurance policies. We've signed indemnities. I think they've even countersigned some of them, or what's tracking down a P.I. Agreed upon budget; budgets are agreed upon. So, straightforward business thing in terms of to nail down. Got it. Okay.

Speaker Change: Okay, great. Thank you. And again, Marla, those are just kind of straightforward business issues.

Speaker Change: We're showing them our insurance policies. We've signed indemnities.

Speaker Change: I think they've even countersigned some of them or we're tracking down a PI. Agreed upon budget. Budgets are agreed upon. So it's a straightforward business thing to nail down. Got it, okay. Thank you.

Marlon Marin: Thank you.

Operator: Again, if you have a question, please press star, then one.

Speaker Change: Again, if you have a question, please press star then 1.

Speaker Change: Thank you very much for watching this video, and I'll see you in the next video, and I'll see you in the next video, and I'll see you in the next video.

Speaker Change: [inaudible]

Operator: This concludes our question and answer session.

Operator: Ends our question and answer session. I would like to turn the conference back over to Jim Frakes for any closing remarks. Thank you, operator. And thank you again, everybody, for joining us today to discuss our first fiscal quarter results. We're pleased that we're making progress and we look forward to keeping you up to date on future calls. The conference is now concluded. Thank you for attending today's presentation. You may now disconnect.

James Frakes: I would like to turn the conference back over to Jim Frakes for any closing remarks. Marks. Thank you, operator, and thank you again, everybody, for joining us today to discuss our first fiscal quarter results.

Speaker Change: This concludes our question and answer session. I would like to turn the conference back over to Jim Frakes for any closing remarks.

Jim Frakes: Thank you, Operator, and thank you again, everybody, for joining us today to discuss our first fiscal quarter results.

James Frakes: We're pleased that we're making progress, and we look forward to keeping you up-to-date on future calls.

Jim Frakes: We're pleased that we're making progress and we look forward to keeping you up to date on future calls.

James Frakes: Bye.

Operator: The conference is now concluded. Thank you for attending today's presentation.

Jim Frakes: Thank you. Bye.

Speaker Change: The conference is now concluded. Thank you for attending today's presentation. You may now disconnect.

Operator: You may now disconnect.

Speaker Change: Unknown Attendee, Michael Miller, Steven Larosa Unknown Attendee, Michael Miller, Steven Larosa

Operator: Good day and welcome to the Aethlon Medical Physical First Quarter 2025 Earnings and Corporate Update Conference Call. All participants will be in 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 on your telephone keypad. To withdraw your question, please press star then two. Please note, this event is being recorded.

Michael Miller: I would now like to turn the conference over to Michael Miller of Rx Communications. Please go ahead.

Michael Miller: Thank you operator and good afternoon everyone. Welcome to Aethlon Medical's First Quarter 2025 Earnings Conference Call. My name is Michael Miller with Rx Communications.

Michael Miller: At 4.15 PM Eastern time today, Aethlon Medical released financial results for its fiscal first quarter ended June 30th, 2024. If you have not seen or received Aethlon Medical's earnings release, please visit the investors page at www.aethlonmedical.com.

Michael Miller: Following this introduction and the reading of the company's forward-looking statement disclaimer, 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'll 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 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 caution 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: 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. 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 10K for the fiscal year ended March 31st, 2024. The company's most recent quarterly report on Form 10K and in the company's other filings with the Securities and Exchange Commission. Except as may be required by law, the company does not intend in order to undertake any duty to update this information to reflect a future events or circumstances.

James Frakes: With that, I'll now turn the call over to Mr. James Frakes, ATLON'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, Interim CEO and longtime CEO of ATLON Medical. ATLON 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.

James Frakes: These qualities of the hemopurifier have potential applications in oncology, where cancer-associated exosomes, which we also refer to as extracellular vesicles, may promote immune suppression and metastasis, also in life-threatening infectious diseases and in organ transplantation. Now before I turn the call over to Dr. Steve and Larosa, who will give you an update on our efforts to date on the oncology front, on the milestones we just hit, and on other potential milestones that we hope to achieve later on this year.

James Frakes: I would like to take a moment to emphasize that we are starting to achieve the two goals that I stated were our objectives when I was appointed as interim CEO last November. Those goals were to get the company moving forward on our oncology indication and to reduce our expenses. As you will hear shortly, we have made measurable progress on both those fronts. I'm gratified by this progress and hope that if it continues to our shareholders will be rewarded by that progress.

Steven Larosa: With that, I will now turn the call over to Dr. Steven Larosa, Aethlon's Chief Medical Officer. Thank you, Jim.

Steven Larosa: As announced on August 12, 2024, two days ago, the Belvary Human Research Ethics Committee the BHREC granted full ethics approval to the Pandora Private Hospital for a safety feasibility and dose-finding clinical trial of the hemopurifier in patients with solid tumors who have stable or progressive disease during anti-PD-1 monotherapy treatment, such as Merck's Ketruda, Pembrolyz Mab, a personal Myers quib's up-devo of all you met. The approval is valid for one year until August 6, 2025, after which time, it will be eligible for renewal. The trial will be conducted by Dr. Marco Matos and its staff at the Pandora Private Hospital located in Queensland, Australia.

Steven Larosa: Earlier, on June 18, 2024, the Human Research Ethics Committee of the Central Adelaide Local Health Network, the CALHN, granted full ethics approval for this same multi-center clinical trial. The approval is valid for three years until June 13, 2027. The trial will be conducted at this site by Dr. Professor Michael Brown in a staff at the Cancer Clinical Trials Unit at CALHN Royal Adelaide Hospital in Adelaide, Australia.

Steven Larosa: Going forward, the next steps are to receive approval from the research governance offices at each hospital. The research governance office reviews indemnities and insurps. Once these approves are obtained, AXLON in concert with our Australian Contract Research Organization Rescue will conduct site initiation visits, noted SIVs, after which patient enrollment in the trial may proceed.

Steven Larosa: We expect that we will be open for enrollment in mid to late September 2024. We anticipate several upcoming potential value-creating milestones, including submission to the governance committee at an additional site in Australia, that is under the jurisdiction of the Belgari HREEC, which has already reviewed the study for the Pandora site. The timeframe for activation of this third site should be in line with the activation of the other two sites.

Steven Larosa: We also await the response from the Scientific Committee at a site in India with the expectations that that will be followed by a Human Research Ethics Committee review. As a reminder, the primary endpoint of these studies is a 9-18 patient safety feasibility and dose-finding trial, and the primary endpoint is safety. The trial will monitor any adverse events and clinically significant changes in lab tests of hemopurapyretreated patients with solid tumors, with stable or progressive disease at different treatment intervals after a two-month running period of PD-1 antibody, anti-PD-1 antibody, either Petruda or optimal.

Steven Larosa: Patients who do not respond to the anti-PD-1 antibody therapy will be eligible to enter the hemopurapyret of the study, where sequential cohorts will receive either one, two, or three hemopurapyret treatments during a one-week period. In addition to monitoring safety, the study is designed to examine the number of hemopurapyret treatment needed to decrease the concentration of extracellular vesicles. And if these changes in extracellular vesicle concentrations improve the body's own natural ability to attack tumor cells.

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 known as a PMA study required by the FDA and other regulatory agencies. Currently, only approximately 30% of patients who receive femoralism ab or nevolumab will have lasting clinical responses to these agents. Extracellular vesicles produced by tumors have been implicated in the spread of cancers as well as the resistance to these anti-PD-1 therapies.

Steven Larosa: The aphlon hemopurapyret has been designed to bind and remove these extracellular vesicles from the bloodstream, which may improve therapeutic response rates to the anti-PD-1 therapies. In pre-clinical studies, the hemopurapyret has been shown to reduce the number of EVs in cancer patient plasma samples.

Steven Larosa: The company also stands poised to address outbreaks in pandemics due to life-threatening envelope viruses, which no treatment exists. Davis. We have previously demonstrated the ability of a Benchtop version of the hemopurifier to bind a number of envelope viruses of interest in in vitro experiments. These include dengue, not limited to, but include dengue and H51 avian influenza known as bird flu.

Steven Larosa: Additionally, the company's COVID-19 trial in India remains open to enroll patients with severe COVID-19 infection who require admission to the intensive care unit. The date one patient has been treated, the company is actively evaluating COVID-19 admissions at our site and potential enrollment against the ongoing costs of maintaining this trial.

James Frakes: With that, I'll turn the call back over to Jim for the financial discussion and then open up for questions. Thanks, Steve. Good afternoon again, everyone. I will try to keep my remarks on our financial discussion at a high level. You'll find detailed expense information in the financial statements attached to our earnings release that just hit the wire or in our soon-to-be-file quarterly report on form 10Q. As of June 30, 2024, Aethlon Medical had a cash balance of approximately $9.1 Our consolidated operating expenses for the fiscal quarter ended June 30, 2024 were approximately $2.6 million compared to $3.4 million for the fiscal quarter ended June 2023.

James Frakes: This decrease of approximately $800,000 or approximately 24% in the 2024 period was due to a decrease of approximately $600,000 in general and administrative expenses and a decrease of approximately $300,000 and professional fees partially offset by an increase in payroll and related expenses of approximately $100,000. The approximate $600,000 decrease in GNA expenses in the fiscal quarter ended June 30, 2024 was primarily due to a $447,000 decrease in supplies related to the purchase of raw materials for manufacturing a pima purifier and for lab supplies.

James Frakes: The approximate $300,000 decrease in professional fees was primarily due to a $136,000 decrease in consulting expenses, primarily related determination of services with a contract manufacturing organization, a $110,000 decrease in scientific consulting and a $78,000 decrease in legal fees relating to general corporate matters. The approximate $100,000 increase in payroll and related expenses was primarily due to an increase in separation expenses of approximately $300,000 related to the termination of an employee. That increase was partially offset by a decrease of in Stock Base Compensation, and an $89,000 decrease in general and administrative personnel expenses.

James Frakes: As a result of the factors I just noted, Aethlon's net loss decreased by approximately $700,000 to approximately $2.6 million in the fiscal quarter ended June 30, 2024 from approximately $3.3 million in the fiscal quarter ended June 30, 2023. I like to note and emphasize that if we exclude the $300,000 provision related to that employee termination are offered in the expenses decreased by over $1 million.

James Frakes: Order of the quarter. We included these earnings results and related commentary in a press release issued earlier this afternoon. That release included the balance sheet for June 30, 2024, and the statements of operations for the fiscal quarter ended June 30, 2024, and 2023. We will file our quarterly report on Form 10Q following this call.

James Frakes: Our next earnings call for the fiscal second quarter ending September 30, 2024 will coincide with the filing of our quarterly report on Form 10Q in November 2024.

Operator: And now, Stephen, 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. To ask a question, you may press star then one on your telephone keypad. If you are using a speeder 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.

Marlon Marin: The first question comes from Marlon Marin with Zach's. Please go ahead. Thank you. So, I wanted to, Jim, I want to get back to something you just said about the operating expense. If you normalize it, you know, to exclude the payment to the former employee, is that a good run rate going forward? Understanding of course that as, you know, some of the clinical development efforts begin to ramp, we will see that reflected in higher R&D.

Marlon Marin: Hi, Marlon. That's a good question. We have things moving in different directions. On the expense reduction side, and this is public information now if you look at our website and the filing. So, we changed law firms and accounting firms. The firms that should be some with less expensive. So, we didn't have that benefit in the June quarter. So, there should be further expense reductions from those professional fees going forward. But, as you noted, starting in September, month to month, we expect much more activity in the Australian clinical trials. Steve and some colleagues are going to fly over there and do the site initiation to train the people. So, there will be additional land and will probably remain higher on the clinical Expansives.

James Frakes: So they may offset, we can't predict exactly, but they should be somewhat offsetting.

Steven Larosa: Okay, so then follow up to Steve, you know, in terms of any kind of training that you have to provide, do you expect that to be a relatively, you know, short term process, and, you know, how will you provide support once you've left and you return back to the states? Yes, no, great question. Thank you, Marla. So, as I mentioned, the research governance approvals are both that review process is underway. We've already got the site initiation visits at those two sites scheduled in September.

Steven Larosa: Provided the governance goes, okay, once you're done with the site initiation visits, which me and my colleague at Aethlon will participate in virtually, those sites can actually begin screening and enrolling patients, that's kind of the on switch, that will be followed by a site of an investigator meeting in the October timeframe, which will actually travel to Australia and meet with all the personnel at the site. But those sites will already be the two sites will already be open for enrollment by then at both the site initiation visit timeframe and the investigator meeting timeframe, there'll be lots of technical training on the actual device.

Steven Larosa: And then we are also in the phase now of interviewing people for a technical position at Aethlon who would provide real-time assistance to those sites, so they'd actually be boots on the ground if you will to help the site. So, yeah, there'll be as well as my colleague and I here who will be available, of course, at all times for any patient that's enrolled. Okay, thank you.

Marlon Marin: And then last question, it's one more of a housekeeping question. I just want to make sure that I'm understanding what you said in your prepared remarks as far as the paperwork at your end. You've completed all of the paperwork from, you know, that you needed to submit. Is that correct? For both the ethics committees, you know, we had a paperwork that had to be submitted and responses and so we're through that phase.

Marlon Marin: And now we've provided our CRO rescue with all the paperwork that they need for our and for the governance for you. Yes, we've done everything we could do. We're waiting for the governance offices at those two sites to rule.

James Frakes: Okay, great. Thank you. And again, Marla, those are just kind of straightforward business issues. We're showing them our insurance policies. We've signed indemnities. I think they've even countersigned some of them or what's tracking down a P.I. Agreed upon budget, budgets are agreed upon. So, straightforward business thing in terms of to nail down. Got it. Okay. Thank you. Again, if you have a question, please press star then one.

Operator: This concludes our question and answer session.

James Frakes: I would like to turn the conference back over to Jim Frakes for any closing remarks. Marks. Thank you, operator, and thank you again, everybody, for joining us today to discuss our first fiscal quarter results. We're pleased that we're making progress, and we look forward to keeping you up-to-date on future calls.

James Frakes: Bye.

Operator: The conference is now concluded. Thank you for attending today's presentation.

Operator: You may now disconnect.