Q1 2026 Aethlon Medical Inc Earnings Call

Operator: Good afternoon and welcome to the ATHLON MEDICAL Q1 Fiscal 2026 Earnings and Corporate Update. All participants will be in listen-only mode. Should you need assistance, please signal a conference specialist by pressing *0 on your telephone keypad. After today's presentation, there will be an opportunity to ask questions. To ask a question, you may press *1 on your telephone keypad. To withdraw your question, please press *2. Please note this event is being recorded. I would now like to turn the conference over to Jim Frakes, Chief Executive Officer and Chief Financial Officer. Please go ahead, sir.

Speaker #2: Should you need assistance, please signal a conference specialist by pressing star then zero on your telephone keypad. After today's presentation, there will be an opportunity to ask questions.

Speaker #2: 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 #2: I would now like to turn the conference over to Jim Frakes, Chief Executive Officer and Chief Financial Officer. Please go ahead, sir.

Speaker #3: Thank you, operator. And good afternoon, everyone. Welcome to AETHLON MEDICAL's Fiscal 1st Quarter 2026 Earnings Conference Call. My name is Jim Frakes, and I'm the Chief Executive Officer and Chief Financial Officer of AETHLON MEDICAL.

Jim Frakes: Thank you, Operator. And good afternoon, everyone. Welcome to ATHLON MEDICAL Q1 Fiscal 2026 Earnings Conference Call. My name is Jim Frakes, and I'm the Chief Executive Officer and Chief Financial Officer of ATHLON MEDICAL. At 4:15 PM Eastern Time today, ATHLON MEDICAL released financial results for its fiscal first quarter ended June 30, 2025. If you have not seen or received ATHLON MEDICAL's earnings release, please visit the Investors page at www.athlonmedical.com to view it. Following this introduction and the reading of the company's forward-looking statement disclaimer, Dr. Steven Larosa, our Chief Medical Officer, and I will provide an overview of ATHLON's strategy and recent developments. I will then make some brief remarks on ATHLON's financials. We will then open up the call for the Q&A session.

Speaker #3: At 4:15 PM Eastern Time today, AETHLON MEDICAL released financial results for its Fiscal 1st Quarter, ended June 30, 2025. If you have not seen or received AETHLON MEDICAL's earnings release, please visit the Investors page at www.AETHLONMEDICAL.COM to view it.

Speaker #3: Following this introduction and the reading of the company's forward-looking statement disclaimer, Dr. Steven Larosa, our Chief Medical Officer, and I will provide an overview of Aethlon's strategy and recent developments.

Speaker #3: I will then make some brief remarks on AETHLON's financials, we will then open up the call for the Q&A session. Before we start the business portion of the call, 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.

Jim Frakes: Before we start the business portion of the call, 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 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.

Speaker #3: 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.

Speaker #3: 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 in forward-looking statements can be found under the caption 'Risk Factors'.

Jim Frakes: 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, 2025, 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 future events or circumstances. With that, we will now cover the business update portion of this call. First, I'd like to note that because of our March 31st fiscal year, we report our fourth quarter and then the ensuing first quarter quite close in time, basically six weeks apart.

Speaker #3: In the company's annual report on Form 10-K for the fiscal year ended March 31, 2025, the company's most recent quarterly report on Form 10-Q, and in the company's other filings with the Securities and Exchange Commission.

Speaker #3: 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.

Speaker #3: With that, we will now cover the business update portion of this call. First, I'd like to note that because of our March 31, fiscal year, we report our fourth quarter and then the ensuing first quarter quite close in time.

Speaker #3: Basically six weeks apart. As a result, in this earnings call, we will also touch on some of the late-breaking news, from our previous earnings call in late June.

Jim Frakes: As a result, in this earnings call, we will also touch on some of the late breaking news from our previous earnings call in late June. Overall, we are pleased with the progress in our Australian oncology trial. Dr. Larosa will cover the specifics on that trial shortly, but I wanted to give some high-level thoughts first. Keep in mind that several of these points are forward-looking statements, as I just noted. In the first quarter, we advanced our lead oncology indication clinical program, delivered preclinical results supporting broader applications, including long COVID, all while significantly reducing operating expenses. Our focus remains on moving the chemopurifier towards regulatory approval and expanding use across multiple diseases.

Speaker #3: Overall, we are pleased with the progress in our Australian oncology trial. Dr. Larosa will cover the specifics on that trial shortly, but I wanted to give some high-level thoughts first.

Speaker #3: Keep in mind that several of these points are forward-looking statements, as I just noted. In the first quarter, we advanced our lead oncology indication clinical program, delivered preclinical results supporting broader applications, including long COVID, all while significantly reducing operating expenses.

Speaker #3: Our focus remains on moving the hemopurifier towards regulatory approval and expanding use across multiple diseases. While we received formal approval from India's Central Drug Standard Control Organization, or CDSCO, to initiate a similar oncology trial at Medanta-Medicity Hospital in New Delhi, India, discussions with our India-based CRO, showed first patient treatment would likely slip to early 2026.

Jim Frakes: While we received formal approval from India's Central Drug Standard Control Organization, or CDSCO, to initiate a similar oncology trial at Madanta MediCity Hospital in New Delhi, India, discussions with our India-based CRO showed first-patient treatment would likely slip to early 2026. Given this extended timeline and our broader strategic priorities, we decided not to proceed with the India study. This choice is about focus, not just savings, though we expect to conserve $500,000 to $1,000,000 by this decision. Based on our current progress in Australia, we could complete treatments by late 2025 or early 2026, analyze data, and be in a position to apply for a PMA or efficacy trial in Australia and engage strategic partners. If we were still early in the Indian trial at that point, regulators or potential strategic partners could require us to finish it first, delaying our path forward.

Speaker #3: Given this extended timeline and our broader strategic priorities, we decided not to proceed with the India study. This choice is about focus, not just savings.

Speaker #3: Though we expect a conserved $500,000 to $1 million dollars. by this decision. Based on our current progress in Australia, we could complete treatments by late 2025 or early 2026, analyze data, and be in a position to apply for a PMA or efficacy trial in Australia and engage strategic partners.

Speaker #3: If we were still early in the Indian trial at that point, regulators or potential strategic partners could require us to finish it first. Delaying our path forward.

Speaker #3: Avoiding that risk is why we are focusing our resources in Australia, which keeps us on the fastest track toward our next milestone. And now, I will turn the call over to Dr. Larosa, who will cover updates on the Australian oncology trial, and onto our R&D efforts, particularly in long COVID, and our recent preclinical data, regarding the removal of platelet-derived extracellular vesicles, or EVs.

Jim Frakes: Avoiding that risk is why we are focusing our resources in Australia, which keeps us on the fastest track toward our next milestone. And now I will turn the call over to Dr. Larosa, who will cover updates on the Australian oncology trial and on our R&D efforts, particularly in long COVID and our recent preclinical data regarding the removal of platelet-derived extracellular vesicles, or EVs. Steve.

Speaker #3: Steve?

Speaker #4: Thank you, Jim. Hello, everyone. I'm joining you live from the Keystone, Symposium Conference on Long COVID in Santa Fe, New Mexico, where last evening I presented preclinical data in long COVID.

Steven Larosa: Thank you, Jim. Hello, everyone. I'm joining you live from the Keystone Symposium Conference on long COVID in Santa Fe, New Mexico, where last evening I presented preclinical data in long COVID. More about that in a little bit. First, I'd like to give you our progress in our lead indication in oncology, our Australian clinical trial of patients with solid tumors not responding to immunotherapy with anti-PD-1 agents. We have completed chemopurifier treatments in the three patients in our first cohort. The first patient completed a chemopurifier treatment at our site at Royal Adelaide Hospital in January, and patients two and three were treated at Royal North Shore Hospital in Sydney on June 2nd and June 16th of this year. All three participants completed the entire four-hour chemopurifier treatment without any device deficiencies and no immediate complications.

Speaker #4: More about that in a little bit. First, I'd like to give you our progress and our lead indication in oncology, our Australian clinical trial.

Speaker #4: Of patients with solid tumors not responding to immunotherapy with anti-PD-1 agents, we could have completed hemopurifier treatments in the three patients in our first cohort.

Speaker #4: The first patient completed a hemopurifier treatment at our site at Royal Adelaide Hospital in January. Patients two and three were treated at Royal North Shore Hospital in Sydney on June 2 and June 16 of this year.

Speaker #4: All three participants completed the entire four-hour hemopurifier treatment without any device deficiencies, and no immediate complications. At the pre-specified seven-day safety follow-up period, none of these three participants experienced a dose-limiting toxicity or a device-related serious adverse event.

Steven Larosa: At the pre-specified seven-day safety follow-up period, none of these three participants experienced a dose-limiting toxicity or a device-related serious adverse event. The second patient enrolled, unfortunately, went on to die from progression of his cancer and can only provide a one-week follow-up worth of data. An independent data safety monitoring board, known as a DSMB, convened on July 11, 2025, to review the safety data on these first three patients in the first cohort. Following a closed session deliberation, the DSMB provided ATHLON MEDICAL senior leadership with a recommendation to advance to our second treatment cohort, where patients will receive two chemopurifier treatments during a one-week period. All three of our sites in Australia are actively screening patients for this second cohort. These sites are screening under an amended protocol that allows patients on either monotherapy or combination therapy that includes pembrolizumab or nivolumab.

Speaker #4: The second patient enrolled unfortunately went on to die from progression of his cancer and can only provide a one-week follow-up worth of data. An independent data safety monitoring board, known as a DSMB, convened on July 11, 2025, to review the safety data on these first three patients in the first cohort.

Speaker #4: Following a closed session deliberation, the DSMB provided AETHLON MEDICAL's senior leadership with a recommendation to advance to our second treatment cohort, where patients will receive two hemopurifier treatments during a one-week period.

Speaker #4: All three of our sites in Australia are actively screening patients for this second cohort. These sites are screening under an amended protocol that allows patients on either monotherapy or combination therapy that includes pembrolizumab or nivolumab.

Speaker #4: This protocol amendment was performed to reflect changes in standard of care leaning now more towards combo therapy and it thus increases the potential pool of patients for the study.

Steven Larosa: This protocol amendment was performed to reflect changes in standard of care, leaning now more towards combo therapy, and it thus increases the potential pool of patients for the study. The laboratory of Professor George Grau at the University of Sydney continues to work on the central lab tests on the first-patient cohort samples to look for the effects of the chemopurifier on extracellular vesicle numbers and antitumor T cell function. We would expect to be able to make some observations of this data sometime in September 2025. As a reminder, the primary endpoint of this approximate 9 to 18 patient safety, feasibility, and dose finding study is safety. The trial will monitor for any adverse events and clinically significant changes in lab tests of chemopurifier-treated patients with solid tumors who have stable or progressive disease while on a regimen that includes either Keytruda or Opdivo anti-PD-1 therapy.

Speaker #4: The laboratory of Professor George Grow at the University of Sydney continues to work on the central lab tests on the first patient cohort samples to look for the effects of the hemopurifier on extracellular vesicle numbers.

Speaker #4: And anti-tumor T-cell function. We would expect to be able to make some observations of this data sometime in September 2025. As a reminder, the primary endpoint of this approximate nine to eighteen patient safety feasibility and dose finding study is safety.

Speaker #4: The trial will monitor for any adverse events and clinically significant changes in lab tests of hemopurifier treated patients with solid tumors who have stable or progressive disease while on a regimen that includes either Keytruda or Opdivo anti-PD-1 therapy.

Speaker #4: The patients as mentioned, it's designed in three cohorts. The first we've completed, the second cohort where patients get two treatments a one-week period, and the third cohort where the patients get three hemopurifier treatments in a one-week period.

Steven Larosa: The patients, as mentioned, it's designed in three cohorts. The first we've completed, the second cohort where patients get two treatments in a one-week period, and the third cohort where the patients get three chemopurifier treatments in a one-week period. As mentioned, in addition to monitoring safety, we're examining the number of chemopurifier treatments needed to decrease the concentration of extracellular vesicles and if these decreases in EV numbers improve the body's own natural ability to attack tumor cells. These exploratory central laboratory analyses are expected to inform the dosing of a later efficacy and safety trial, including a PMA or premarket approval study that is required by the FDA and other regulatory agencies. Currently, only approximately 30 to 40 percent of patients who receive pembrolizumab or nivolumab will have a lasting clinical response to these agents.

Speaker #4: As mentioned, in addition to monitoring safety, we're examining the number of hemopurifier treatments needed to decrease the concentration of extracellular vesicles and if these decreases in EV numbers improve the body's own natural ability to attack tumor cells.

Speaker #4: These exploratory central laboratory analyses are expected to inform the dosing of a later efficacy and safety trial, including a PMA or pre-market approval study that is required by the FDA and other regulatory agencies.

Speaker #4: Currently, only approximately 30% to 40% of patients who receive pembrolizumab or nivolumab will have a lasting clinical response to these agents. Extracellular vesicles produced by tumors have been implicated in the spread of cancers as well as the resistance to anti-PD-1 therapies.

Steven Larosa: Extracellular vesicles produced by tumors have been implicated in the spread of cancers as well as the resistance to anti-PD-1 therapies. The ATHLON chemopurifier has been designed to bind and remove these EVs from the bloodstream, which may improve the therapeutic response rates to the anti-PD-1 drugs. In preclinical studies, the chemopurifier has been able to decrease the number of EVs in cancer patient samples. Now I'd like to segue to our R&D preclinical activities. Last evening, August 12, 2025, ATHLON presented a poster at the Keystone Symposium on long COVID and other post-acute infectious syndromes being held in Santa Fe, New Mexico. Longstanding symptoms following acute COVID-19 infection, known as long COVID, have been determined to affect approximately 400 million individuals worldwide with a global economic burden of approximately $1 trillion per year. This data can be found in a Nature Medicine 2024 publication.

Speaker #4: The AETHLON Hemopurifier has been designed to bind and remove these EVs from the bloodstream, which may improve the therapeutic response rates to the anti-PD-1 drugs.

Speaker #4: In preclinical studies, the hemopurifier has been able to decrease the number of EVs in cancer patient samples. Now I'd like to segue to our R&D preclinical activities.

Speaker #4: Last evening, August 12, 2025, AETHLON presented a poster at the Keystone Symposium on Long COVID and other post-acute infectious syndromes. Being held in Santa Fe, New Mexico.

Speaker #4: Longstanding symptoms following acute COVID-19 infection known as long COVID have been determined to affect approximately 400 million individuals worldwide with a global economic burden of approximately $1 trillion per year.

Speaker #4: This data can be found in a Nature Medicine 2024 publication. The presentations at this conference reviewed the clinical trials that have been conducted to date and show that there is currently no agent that is approved for the treatment of long COVID.

Steven Larosa: The presentations at this conference reviewed the clinical trials that have been conducted to date and show that there is currently no agent that is approved for the treatment of long COVID, indicating a large unmet medical need. Extracellular vesicles have been implicated in the pathogenesis of long COVID. Since we had previously demonstrated removal of extracellular vesicles by the chemopurifier in emergency use patients with severe acute COVID-19 infection, we hypothesized that the patients with long COVID would have extracellular vesicles with the nanosugar on their surface that would be amenable to removal by our device. With this in mind, we partnered with investigators at the University of California, San Francisco Medical Center long COVID LINC cohort, and they provided us samples from blood samples from patients with long COVID, as well as people who had had COVID but had fully recovered.

Speaker #4: Indicating a large unmet medical need, extracellular vesicles have been implicated in the pathogenesis of long COVID. Essentially, at previously demonstrated removal of extracellular vesicles by the hemopurifier in emergency use patients with severe acute COVID-19 infection, we hypothesize that the patients with long COVID would have extracellular vesicles with the manosugar on their surface that would be amenable to removal by our device.

Speaker #4: With this in mind, we partnered with investigators at the University of California, San Francisco, Medical Center, Long COVID LINC cohort, and they provided us samples from blood samples from patients with long COVID as well as people who had had COVID but had fully recovered.

Speaker #4: The data we presented last evening demonstrated that both large and small extracellular vesicles from long COVID patients bound to the GNA lectin and lectin affinity resin, respectively, in our device.

Steven Larosa: The data we presented last evening demonstrated that both large and small extracellular vesicles from long COVID patients bound to the GNA lectin and lectin affinity resin, respectively, in our device. We had active discussions with a number of participants, and we will take this feedback back to ATHLON to discuss potential next steps and other collaborations. We sent this data has now been presented publicly. We will share this poster on our ATHLON medical site in the very near future. On May 12, 2025, the results of our preclinical ex vivo study entitled "Ex vivo Removal of CD41 Positive Platelet Microparticles from Plasma by a Medical Device Containing Galanthus Nivalus Agglutinin Resin" was published in the preprint vehicle BioRx IV and is publicly available. This manuscript has also been submitted to a peer-reviewed publication for review.

Speaker #4: We had active discussions with a number of participants, and we will take this feedback back to Aethlon to discuss potential next steps and other collaborations.

Speaker #4: We since this data has now been presented publicly, we will share this poster on our AETHLON Medical site in the very near future. On May 12, 2025, the results of our preclinical Xvivo study entitled "Xvivo Removal of CD41 Positive Platelet Microparticles from Plasma" by a medical device containing galanthus nivalis, a glutenin resin, was published in the preprint vehicle BioRx by the and is publicly available.

Speaker #4: This manuscript has also been submitted to a peer-reviewed publication for review. Platelet-derived extracellular vesicles are the most numerous EV populations in the body and are released by platelets in response to a variety of stimuli.

Steven Larosa: Platelet-derived extracellular vesicles are the most numerous EV population in the body and are released by platelets in response to a variety of stimuli. The cargo contained within these platelet-derived EVs have been noted to take part in damage to blood vessels, activation of immune cells, and spread of tumor cells. Excessive levels of PDEVs have been implicated in a myriad of diseases, not only cancer, but also lupus, systemic sclerosis, multiple sclerosis, Alzheimer's disease, sepsis, and acute and long COVID. As a matter of fact, this morning, a presentation from the Paxlovid study indicated that platelets, activated platelets, are a source of viral persistence within long COVID. We hypothesized in our publication and our study that the ATHLON chemopurifier, which contains the proprietary GNA affinity resin, might be able to bind these platelet-derived EVs from plasma.

Speaker #4: The cargo contained within these platelet-derived EVs has been noted to participate in damage to blood vessels, activation of immune cells, and the spread of tumor cells.

Speaker #4: Excessive levels of PD-EVs have been implicated in a myriad of diseases. Not only cancer, but also lupus, systemic sclerosis, multiple sclerosis, Alzheimer's disease, sepsis, and acute and long COVID.

Speaker #4: As a matter of fact, this morning, a presentation from the Paxlovid study indicated that activated platelets are a source of viral persistence within long COVID.

Speaker #4: We hypothesized in our publication and our study that the AETHLON hemopurifier, which contains the proprietary GNA affinity resin, might be able to bind these platelet-derived EVs from plasma.

Speaker #4: In this experiment, we took 200 milliliters of healthy donated human plasma and circulated it over our AETHLON hemopurifier. The simulator clinical hemopurifier session. The data revealed that we removed 98.5 percent of platelet-derived EVs at a time point equivalent to a four-hour treatment in a patient.

Steven Larosa: In this experiment, we took 200 milliliters of healthy donated human plasma and circulated it over our ATHLON chemopurifier to simulate a clinical chemopurifier session. The data revealed that we removed 98.5 percent of platelet-derived EVs at a time point equivalent to a four-hour treatment in a patient. The results of this study support our current Australian clinical trial in oncology, as well as open the investigation of the chemopurifier in the diseases I just mentioned. With that, I'll turn the call back over to Jim for the financial discussion, and then we will take questions. Jim?

Speaker #4: The results of this study support our current Australian clinical trial in oncology as well as open the investigation of hemopurifier of the hemopurifier in the diseases I just mentioned.

Speaker #4: With that, I'll turn the call back to Jim for the financial discussion and then we will take questions. Jim?

Speaker #3: Thanks, Steve. And good afternoon again, everyone. Let's touch briefly on the financials now. As of June 30, 2025, we had a cash balance of approximately 3.8 million dollars.

Jim Frakes: Thanks, Steve. And good afternoon again, everyone. Let's touch briefly on the financials now. As of June 30, 2025, we had a cash balance of approximately $3.8 million. For the three months ended June 30, 2025, our consolidated operating expenses were approximately $1.8 million. That's down roughly $800,000 or 32 percent from $2.6 million a year ago. Most of the improvement came from payroll-related savings, including the absence of executive severance recorded last year, lower headcount, and a related drop in stock-based compensation. We also saw a meaningful reduction in legal fees after transitioning to a new firm and lower scientific consulting costs with the wrap-up of the project. Our general and administrative expenses were modestly lower as well, helped by reduced insurance costs, though we did see an uptick in clinical trial spending as our trial advances.

Speaker #3: For the three months ended June 30, 2025, our consolidated operating expenses were approximately 1.8 million dollars. That's down roughly $800,000 or 32 percent. From 2.6 million dollars a year ago.

Speaker #3: Most of the improvement came from payroll-related savings, including the absence of executive severance recorded last year. Lower headcount and a related drop in stock-based compensation.

Speaker #3: We also saw a meaningful reduction in legal fees after transitioning to a new firm, and lower scientific consulting costs with the wrap-up of a project.

Speaker #3: Our general and administrative expenses were modestly lower as well, felt by reduced insurance costs. However, we did see an uptick in clinical trial spending as our trial advances.

Speaker #3: All in, these efficiencies brought our operating loss down to 1.8 million dollars compared to 2.6 million dollars. In last year's June quarter. Reflecting solid progress in aligning our resources with our strategic priorities.

Jim Frakes: All in, these efficiencies brought our operating loss down to $1.8 million compared to $2.6 million in last year's June quarter, reflecting solid progress in aligning our resources with our strategic priorities. You can find more detail on these expense changes in our 10-Q, which breaks down specific drivers by category. We included these earnings results and the related commentary in our press release issued this afternoon. The release also included the balance sheet for June 30, 2025, and the statements of operations for the three-month periods ended June 30, 2025 and 2024. 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, 2025, will coincide with the filing of our quarterly report on Form 10-Q in November 2025. And now, I'd be happy to answer any questions that you may have.

Speaker #3: You can find more detail on these expense changes in our 10-Q, which breaks down specific drivers by category. We included these earnings results and related commentary in our press release issued this afternoon.

Speaker #3: The release also included the balance sheet for June 30, 2025, and the statements of operations for the three-month periods ended June 30, 2025, and 2024.

Speaker #3: 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, 2025, will coincide with the filing of our quarterly report on Form 10-Q in November 2025.

Speaker #3: And now, I'd be happy to answer any questions that you may have. Operator, please open the call for questions.

Jim Frakes: Operator, please open the call for questions.

Speaker #2: We 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 speakerphone, please pick up your handset before pressing the keys.

Operator: We will now begin the question and answer session. To ask a question, you may press *1 on your telephone keypad. 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 *2. Again, it is *1 to ask a question. At this time, we will pause momentarily to assemble our roster. The first question comes from Marla Marin with ZAX. Please go ahead.

Speaker #2: If at any time your question has been addressed and you would like to withdraw your question, please press star then two. Again, it is star then one to ask a question.

Speaker #2: At this time, we will pause momentarily to assemble our roster. The first question comes from Marla Marin with Zax, please go ahead.

Speaker #5: Thank you. So, there's a lot going on. and just a reminder, I think you said in the press release that the primary, the endpoint of the study in Australia is is safety.

Marla Marin: Thank you. So there's a lot going on. And just remind us, I think you said in the press release that the primary, the endpoint of the study in Australia is safety. And so far, with the first cohort having been treated, it looks like there's no adverse events related to treatment with the chemopurifier. So it looks like you're on track to meet the primary endpoint. Is that the right way to think about it?

Speaker #5: and so far with the first cohort having been treated, it looks like there's no adverse events related to treatment with the hemopurifier. So it looks like you're on track to meet the primary endpoint.

Speaker #5: Is that the right way to think about it?

Speaker #3: Steve, do you want to take that one?

Jim Frakes: Steve, do you want to take that one?

Speaker #4: Yeah. Yeah. So we've we've passed the first, you know, it's a three cohort study. We've passed the first cohort in independent data safety monitoring board made up of experts in oncology and nephrology.

Steven Larosa: Yeah. Yeah. So we've passed the first, you know, it's a three-cohort study. We've passed the first cohort, an independent data safety monitoring board made up of experts in oncology and nephrology, reviewed the safety data, and said, "Move forward to the second cohort for where patients get two treatments." So we think it's a big hurdle to pass.

Speaker #4: Reviewed the safety data and said move forward to the second cohort for where patients get two treatments. So we think it's a big hurdle to have passed.

Speaker #5: Okay. So now, I'm trying to put in perspective you know on preclinical data and extremely high metric 98 and a half percent of extracellular vesicles were removed.

Marla Marin: Okay. So now, I try to put in perspective, you know, on preclinical data, an extremely high metric, 98 and a half percent of extracellular vesicles were removed in stimulated treatment. But now we're looking at actual treatment, you know, in a clinical study. The kind of data that we should expect to see, I mean, I don't know. It would seem to me that that number, what, you know, in a laboratory setting, is not really what we should expect to see out of this study with actual, you know, with actual participants, patients who are ill. Is that not the way you're thinking about it?

Speaker #5: In simulated treatment. But now we're looking at actual treatment, you know, in a clinical study. Those are the kinds of data that we should expect to see. I mean, I don't know.

Speaker #5: It would seem to me that that number would, you know, in a laboratory setting, is not really what we should expect to see out of this study with actual you know with actual participants, patients who are ill.

Speaker #5: Is that not the way you're thinking about it?

Speaker #4: Yeah, no, I think you're tracking perfectly, Marla. What's in the lab is not what—what the proof is in the pudding is in what happens in actual patients.

Steven Larosa: Yeah. No, I think you're tracking perfectly, Marla. What's in the lab is not what the proof is in the pudding is in what happens in actual patients. So hopefully, soon we'll have our data from the first cohort from the Grau lab, and what matters ultimately is the reduction in actual from patients who have been treated.

Speaker #4: So, hopefully, soon we'll have our data data from the first cohort from the Grow lab and what matters ultimately is, the reduction in actual from from patients who've been treated.

Speaker #5: Mm-hmm. Okay, great. Thanks. And switching now, Jim, I have a question for you on, you know, you you have really, really done I think as much as you can do to try to cut expenses here.

Marla Marin: Okay. Great. Thanks. And switching now, Jim, I have a question for you on, you know, you have really, really done, I think, as much as you can do to try to cut expenses here. It doesn't seem that there's any more that you can do. The decision to not move forward with the trial in India, strategic as well as, you know, possibly some element of cost containment, but more so strategic. Have you thought in terms of, you know, what that implies for you right now in terms of, you know, obviously, you will need cash again at some point to continue funding clinical research, but have you thought about what that means for you in terms of timing?

Speaker #5: doesn't seem that there's any more that you can do. The decision to not move forward with the trial in India strategic as well as, you know, possibly some element of cost containment, but but more so strategic.

Speaker #5: Have you thought in terms of what that implies for you right now, in terms of, you know, obviously you will need cash again at some point to continue funding clinical research? But have you thought about what that means for you in terms of timing?

Speaker #3: Well, like every development stage, life science companies that don't have their products approved for sale yet will need to continue to raise money.

Jim Frakes: Well, like every development stage, life science company that doesn't have its products approved for sale yet, we will need to continue to raise money, hopefully, eventually, with strategic partners rather than financial investors. But we'll see what the appetite is going forward. As you say, the India decision was far more about the potential delay in getting approval to move forward into the PMA phase than the savings, even though the savings are nice. That was not the main factor.

Speaker #3: Hopefully, eventually, with strategic partners rather than financial investors. But we'll see what the appetite is going forward. As you say, the India decision was far more about the potential delay in getting approval to move forward into the PMA phase than the savings, even though the savings are nice.

Speaker #3: That was not the main factor.

Speaker #5: Mm-hmm. Okay. And again, just.

Marla Marin: Okay. And again, just.

Speaker #4: And And I must say, Marla, I was the driving force behind doing the Indian trial. The nephrologist has done a great job for us in the past and they're great.

Jim Frakes: And I must say, Marla, I was the driving force behind doing the Indian trial. The nephrologist has done a great job for us in the past, and they're great. But one advantage of India was that all of the previous viral trials we did, we got off the ground very quickly. They did a good job. That's not the case anymore. They have many new regulations. They're much more like the FDA in terms of bureaucracy. And it was just far slower bureaucratically than the Australian trial. And it just didn't make sense to potentially hamstring the company for one to two years waiting for that trial to conclude. It just, that put me over the edge with the decision.

Speaker #4: But one advantage of India was that all of the previous viral trials we did got off the ground very quickly. They did a good job.

Speaker #4: That's not the case anymore. They have many new regulations. They're much more like the FDA in terms of bureaucracy, and it was just far slower.

Speaker #4: Bureaucratically, it was more challenging than the Australian trial. It just didn't make sense to potentially hamstring the company for one to two years waiting for that trial to conclude.

Speaker #4: It just that put me over the edge with the decision.

Speaker #5: Right. I get it. That makes sense to me. And also you've talked in the past about, you know, one of the attractive factors about conducting clinical research in Australia is the cash tax rebate.

Marla Marin: Right. I get it. That makes sense to me. And also, you've talked in the past about, you know, one of the attractive factors about conducting clinical research in Australia is the cash tax rebate. I don't think there was any similar, I mean, I think expenses are, you know, relative to conducting research here in the US, you know, costs would have been lower in India, but there wasn't anything comparable in terms of a rebate.

Speaker #5: I don't think there was anything similar. I mean, I think expenses are, you know, relative to conducting research here in the U.S. You know, costs would have been lower in India.

Speaker #5: But there wasn't anything comparable in terms of a rebate. Okay.

Speaker #3: You are correct. We have that nice tax rebate in Australia. I think it's still 43 percent or thereabouts. I don't believe it's changed.

Jim Frakes: You are correct. We have that nice tax rebate in Australia. I think it's still 43 percent or thereabouts. I don't believe it's changed. And there's no rebate like that in India. So while the cost would have been lower by the hospital, I'm not sure. It might even have been so lower in Australia after factoring in the rebate.

Speaker #3: And there's no rebate like that in India. So while the costs would have been lower, while the hospital... I'm not sure. It might even have been a little lower in Australia after factoring in the rebate.

Speaker #5: Mm-hmm. Okay. Okay, thank you.

Marla Marin: Okay. Okay. Thank you.

Speaker #3: Thank you, Marla.

Jim Frakes: Thank you, Marla.

Speaker #2: The next question comes from RK with HC Wainwright. Please go ahead.

Operator: The next question comes from RK with HC Wainwright. Please go ahead.

Speaker #6: Thank you. Good afternoon, I have a couple of questions. The first question is regarding the Indian trial itself. I'm just trying to understand, you know, what was the reason to having set up in the first place, setting up and parallel Indian trial as that was going on in Australia?

Anthony Vendetti: Thank you. Good afternoon. I have a couple of questions. The first question is regarding the Indian trial itself. I'm just trying to understand, you know, what was the reason to having set up, in the first place, setting up a parallel Indian trial as that was going on in Australia? And the second question is, do you think, I know the first cohort is done, and you know, one of the physician scientists is actually doing the analysis, you know, with regards to, I'm assuming, the extravesicular, you know, the efficacy itself is what he or she is looking for.

Speaker #6: And the second question is, does do you think I know the first cohort is done and, you know, one of the physicians, scientists is actually doing the analysis you know with regards to I'm assuming the extra vesicular you know, the efficacy itself is what he's he or she is looking for.

Speaker #6: But have you, or do you think you can speed up the enrollment in those three centers? Are you trying to get additional centers in Australia so that you can add more patients if you wanted a larger data set to make the decision for the next development stage?

Anthony Vendetti: But have you, or do you think you can speed up the enrollment in those three centers, or are you trying to get additional centers in Australia so that you can add more patients if you wanted a larger data set to make the decision for the next development stage?

Speaker #3: Steve, do you want to reply?

Jim Frakes: Steve, do you want to reply?

Speaker #4: Sure. So first, on the EV and T-cell data, we've actually accelerated the timelines to try to get data back from the Grow lab quicker, and they have been very responsive.

Steven Larosa: Sure. So first, on the EV and T cell data, we've actually accelerated the timelines to try to get data back from the Grau lab quicker, and they have been very responsive. So like I said, I'm hopeful that there'll be some early data in September. For your second question, we're doing multiple efforts to try to speed things up. One is we're following pre-screening logs from all three active sites. We're keeping in close contact through our CRO with our activity. We are actively recruiting plans for two additional sites, again, to augment enrollment. And three, we are looking at a couple of different types of initiatives to help enrollment. One is the use of what's called clinical trial liaisons. The other is with social media campaigns.

Speaker #4: So, like I said, I’m hopeful that there’ll be some early data in September. I’m sure your second question— we’re doing multiple efforts to try to speed things up.

Speaker #4: One is we're following pre-screening logs from all three active sites. We're keeping in close contact through our CRO with our activity. We are actively recruiting plans for two additional sites.

Speaker #4: Again, to augment enrollment. And three, we are looking at a couple different types of initiatives. To help enrollment, one is the use of what's called clinical trial liaisons.

Speaker #4: The other is with social media campaigns. So, yeah, we are actively turning over every rock to look for ways to speed up enrollment and think that those will pay dividends.

Steven Larosa: So yeah, we are actively turning over every rock to look for ways to speed up enrollment and think that those will pay dividends.

Speaker #6: Okay. Thank you for that. So do you think when the Grow lab gets done with the analysis, will you be able to put out some sort of a press release or talk about it?

Anthony Vendetti: Okay. Thank you for that. And so do you think when the Grau lab gets done with the analysis, will you be able to put out some sort of a press release or talk about it, or do you need to wait for all the three cohorts to be done before you start talking about some of that efficacy data?

Speaker #6: Or do you need to wait for all three cohorts to be done before you start talking about some of the efficacy data?

Speaker #4: Well, so my feeling is we will have we'll be able to make some observations from this first cohort. But remember, it's only a single HP treatment and we do not know that that's why the dose finding component is part of it.

Steven Larosa: Well, so my feeling is we will have, we'll be able to make some observations from this first cohort. But remember, it's only a single HP treatment, and we do not know that that's why the dose finding component is part of it. We don't know if you need one, two, or three. So the trial, the jury really won't be out on the dosing until we're done with all three cohorts. So again, we'll be able to make some observations, but I want to, I truly want to see what the dose response is, what the treatment effects are from each individual cohort.

Speaker #4: We don't know if you need one, two, or three. So the trial, the jury really won't be out on the dosing until we're done with all three cohorts.

Speaker #4: So again, we'll be able to make some observations, but I want to I truly want to see what the dose responses, what the treatment effects are from each individual cohort.

Speaker #6: Okay. Thank you.

Anthony Vendetti: Okay. Thank you.

Speaker #3: And And Steve noted in his remarks, RK, our current expectation is that we'll be able to present those remarks our observations rather in September.

Jim Frakes: And as Steve noted in his remarks, RK, our current expectation is that we'll be able to present those remarks, our observations, rather, in September.

Speaker #6: Okay. No, that's great. Thank you.

Anthony Vendetti: Okay. No, that's great. Thank you.

Speaker #3: Sure.

Speaker #2: This concludes our question-and-answer session. I would like to turn the conference back over to James Frakes for any closing remarks.

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

Speaker #3: I'd like to thank you again for joining us today to discuss our first fiscal first quarter results. We look forward to keeping you up to date on future calls.

Jim Frakes: I'd like to thank you again for joining us today to discuss our fiscal first quarter results. We look forward to keeping you up to date on future calls. Thanks again. Goodbye.

Speaker #3: Thanks again. Goodbye.

Operator: The conference has now concluded. Thank you for attending today's presentation. You may now disconnect.