Patient treatments begin in AEMD’s basket oncology trial, enrollments expected to accelerate
Aethlon Medical (NASDAQ:AEMD) reported FY 3Q results yesterday and provided a business update. We present our key takeaways in this note:
Key takeaways
Lead asset the Aethlon Hemopurifier® is being evaluated in combination with checkpoint inhibitors as a potential treatment for patients suffering from various solid tumor types
The 1st patient treated tolerated Hemopurifier treatment with no adverse effects
With three Australian medical centers participating and following recent protocol amendments, AEMD expects patient enrollments and treatments to accelerate
AEMD recently made some headcount reductions and other cost reductions and also stands to benefit from the up to 43.5% cash tax rebate on clinical trial-related R&D costs in Australia
The company expects to conduct a capital raise that, along with the expected (and recent) exercise of outstanding warrants, could extend its cash runway significantly
While the company’s near-term focus is on assessing the Hemopurifier as a potential treatment for oncology, longer-term AEMD continues to view the device as a potential tool in the treatment of viruses, organ transplants and other medical areas
Aethlon has implemented initiatives to constrain costs. Operating expenses were roughly 50% lower in FY 3Q compared to the prior year 3Q ($1.8 million in 3Q FY25 versus $3.6 million), reflecting AEMD initiatives and the absence of 1-time expenses associated with the former CEO. Specifically, about $1.3 million of the decrease reflected lower payroll and related expenses. Roughly $400,000 reflected that the company has reduced headcount. Another roughly $300,000 of the OpEx decrease was related to lower professional fees, which the company expects to continue to contain.
The company’s lead asset, the Aethlon Hemopurifier®, is being evaluated as a potential treatment for cancer and life threatening infectious diseases and for use in organ transplantation. The Hemopurifier is an extracorporeal device – in other words, it works outside the body, as illustrated in the figure below. The device is used on existing blood circulatory equipment such as dialysis and CRRT machines that are already installed in hospitals and clinics, making the Hemopurifier essentially a plug & play tool for medical centers.
The Hemopurifier has received FDA Breakthrough Devicedesignation for two independent indications. The Hemopurifier has Breakthrough Device designation for the treatment of people with advanced or metastatic cancer who are either unresponsive to or cannot tolerate standard of care therapy, and with cancer types in which exosomes are indicated in the development or severity of the disease and also for life-threatening viruses that are not addressed with approved therapies.
First patient treated tolerated Hemopurifier treatment without complications
AEMD has made significant strides in moving its clinical activities forward over the past few months. In the near-term, AEMD’s primary focus currently is on researching the Hemopurifier therapeutic blood filtration system as a potential treatment in oncology. The company enrolled the first three patients in its oncology trial and treated the first. Last month Aethlon announced that the first patient in its Australian safety, feasibility and dose-finding clinical trial has been treated with the Hemopurifier. The first patient treated in the study was enrolled in the trial on October 29, 2024 at the Cancer Clinical Trials Unit, CALHN, Royal Adelaide Hospital in Australia. After a two-month run in period of treatment with the anti-PD-1 drug Nivolumab during which serial measurements of EVs and anti-tumor T cell activity were taken, it was determined that the disease had progressed. The patient was then treated with the Hemopurifier on January 29, 2025.
Hemopurifier treatment was for four hours on a single day. The patient tolerated the procedure without complications. AEMD anticipates that data from the first treatment cohort will provide insight into the Hemopurifier's potential ability to reduce tumor-derived EVs and enhance T cell activity against tumors. Follow-up safety visits, EV and T cell measurements as well as imaging for clinical response, are planned as part of the clinical study.
Protocol amendments, participation of 3rd medical center in trial, expected to accelerate patient enrollments
Aethlon has implemented protocol amendments in the oncology study that include enrolling patients only after it has been confirmed that they are not to be responding to anti-PD-1 therapy. Two patients previously recruited were withdrawn from the study due to outcomes related to their anti-PD-1 therapies; this protocol adjustment eliminates the need to identify patients within the first 2 weeks of their beginning anti-PD-1 therapy and also removes the two-month run-in period that was required previously to assess response to therapy. In other words, it is expected to shorten the time required to enroll patients.
In addition, restrictions on commonly prescribed concomitant medications that do not impact patient safety have been lifted. The amended protocol also broadens eligibility to include patients receiving all approved dosing regimens of Pembrolizumab and Nivolumab, rather than limiting enrollment to specific schedules. As The company continues to pursue approval of a similar clinical trial in India, these protocol amendments inform the design of that trial, as well.
A third site that will participate in the study, the Genesis Care/ Royal North Shore Hospital, can begin enrollment under this amendment following a planned Site Initiation Visit (SIV) on February 14, 2025. The company believe this site has a sizable patient population undergoing treatment that might be eligible to participate in its study.
As noted, AEMD expects to realize benefits from attractive economic incentives the Australian government provides for clinical development efforts and lower costs in India, where R&D expenses are substantially lower than in the U.S., according to management, and thereby maximize its R&D dollars. Australia offers an R&D tax incentives rebate program, which enables companies to receive a cash tax rebate of up to 43.5% on clinical trial related R&D costs and is expected to help it reduce costs, lower risk, and accelerate time to market. The company also expects to extend its cash runway substantially with a planned capital raise and the expected and ongoing exercise of warrants.
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