Aethlon Medical trades on the Nasdaq under the symbol AEMD. It's a medical therapeutic company focused on developing products to treat cancer and life-threatening infectious diseases. Happy to welcome back its CEO, Jim Frakes. Welcome back to the conference today, Jim.
Thank you, Anna, and thanks again for the opportunity to give folks a little bit of an update on Aethlon Medical. As Anna mentioned, we're a small medical device company. Here's one of our devices. It's about the size of a dialysis cartridge, but it has a different functionality. It is designed to remove cancerous particles called exosomes or extracellular vesicles and life-threatening viral diseases. We ended December with about $4.8 million in cash. We have no debt on our balance sheet, and I'm reflecting my longtime role here as CFO to start with that. I was named CEO as well in November of 2023, and I've tried to focus the company very heavily on the oncology indication. I think our device has a lot of promise there. I just wanted to give a quick update before we take any questions.
At the end of January, we treated our first patient, cancer patient in Australia. It was at the Royal Adelaide Hospital. There were no issues at the seven-day safety follow-up checkup of the patient. It is the first, hopefully, of 9-18 patients in this small safety trial that's designed to treat patients with solid tumors. There are three hospitals involved in Australia: in Sydney, Gold Coast, and, as I said, Adelaide, Australia. We have a similar trial set up in India, and we're just working through some logistical issues. India has stiffened their import-export requirements, and we think we're pretty far along the process of getting that trial up and running. I'm often asked why Australia and why India. Australia has great science, great hospitals, world-class principal investigators.
Steve Larosa, our Chief Medical Officer, has run clinical trials in Australia before, and it's also helpful that they have a life science tax credit that currently is about 43.5%. This is a cash incentive. They call it a tax credit, but it's not a tax rebate. It's actually a cash rebate once a year, and it currently is at about 43.5% of expenses in Australia. They're trying to bolster their life science industry with that kind of incentive. The company's done a lot of clinical trial work in India. We have a very good relationship with some doctors that are big supporters of our product, and I wanted to keep them involved. There's a lot of history there, and the FDA has accepted data from India in the past, and I don't expect an issue with that or the Australian data down the road.
Since we treated that first patient, we did change our protocol on the oncology trial in Australia. In my opinion, it's improved it. It's shortened. There's not a two-month run-in period now. It's simply for patients that are either not getting better or getting worse, that are taking Keytruda or Opdivo, which are the principal cancer therapeutics in this moment. Those drugs are great when they work, but they work only 30-40% of the time. We're hoping to target some of the 60-70% that fail that treatment of Opdivo and Keytruda, and we're looking forward to treating more patients, hopefully soon. That's our main focus right now. There's a lot of history of the viruses. We're monitoring viral outbreaks, but no particular news on that front at the moment. Anna, that was a quick update here. I know we have limited time.
Great. Are you ready for some questions?
Of course.
Wonderful. All right. We'll talk a little bit about your focus on oncology and infectious diseases. However, you've also had news about the Hemopurifier's potential in the kidney transplant area. Can you give us an update on that?
Happy to. As Anna mentioned, we did put out a press release about an article that was published in a well-regarded peer-reviewed journal called the Transplant Immunology Journal. Prior to the board naming me CEO, the company did a lot of work looking at the use of our product in the organ transplantation field, particularly with kidneys. A lot of data had been generated, and I thought, why not publish the data? It may lead to corporate partnerships, licensing opportunities down the road. We wanted to let the people that follow that industry know that the Hemopurifier could provide some benefit to those organs that are being harvested and transplanted and put in to help save people's lives.
Perfect. Frank wants to know, is there anything like your Hemopurifier in the market currently, and what's the closest competitive solution?
There's nothing exactly like the Hemopurifier. Again, this is what it looks like. There are three or four extracorporeal devices that use different mechanisms of action, and they're not focused on removing exosomes, extracellular vesicles, monocylated viral particles like we are. Probably the closest device is the Siraf device by Xthera. It's a privately held company in Northern California, and they've done some work in COVID, and I believe they're exploring cancer as well. Again, a different mechanism of action, private company. I'm often asked by investors and potential investors about CytoSorbents. They're a publicly traded company in New Jersey. They're focused on production of inflammation, or at least that's been their historical focus. Again, completely different product. It's beads versus fibers in our case and a different binding mechanism. Those are probably the two closest, I would say. Yes.
Sabrina wants to know what type of approvals are required for such devices.
Medical devices require two steps of clinical trials versus drugs that require three. The first step is the safety trial phase. That's what we're doing in Australia and soon in India. Then there's the efficacy trial. These are typically much smaller trials than drug trials. As I mentioned, we're looking at 9-18 patients in our oncology trial in India and in Australia. We have not done the efficacy trial phase yet, so I can't speculate what number of patients would be required, but it would not be thousands. It would be perhaps hundreds. It's up to the regulatory body. Again, much smaller, a factor of 10 or more smaller than a drug trial and two phases rather than three.
With regard to your COVID studies in India, are you moving to treat all similar viruses with this technology?
We actually concluded that, like in the U.S., there just weren't any COVID patients in the intensive care units. To save costs and stop banging our head against the wall, we decided to stop that trial. Our entire focus in India is the soon-to-be-up-and-running oncology trial.
Phoenix has a financial question just saying you're trading at two times cash with no debt. Is that correct? Where do you think the disconnect is?
That's exactly right. That's about where we are trading, and his or her analysis is on the money. I just think, I mean, this is just my opinion, but these trials take time, and we are burning cash. We have no, like all small development stage life science companies in regulated industries, we have no revenues. We will need to raise money to offset the burn until we hit these milestones. Hopefully, we'll raise money at higher valuations down the road as we hit these milestones. I imagine that's the issue, but it could be other factors. It's hard to say.
Absolutely. Jim, tell us some closing remarks for our viewers today.
Sure. I’d very much like the listeners to keep an eye on Aethlon Medical as we move forward in these oncology trials. I mean, personally, it’s important to me. I think our device can help people. We’ve all had family members suffer from and die from cancer. It’s just awful. And our product could be very helpful. If people would track us, I’d be grateful.
Wonderful. Thank you, Jim, so much. We appreciate you, and we hope to see you again real soon with some more great updates.
Thank you very much. Have a good conference.
All right. All right, everyone. GeoVax Labs, they were supposed to be on next, but they have to postpone to April. That completes day one. We'll see you back here tomorrow morning at 9:00 A.M. Eastern for day two of our virtual investor conference. Thanks, everyone, for watching. We'll see you tomorrow.