Our first speaker today is Dr. Geoffrey Dow. He is the CEO of 60 Degrees Pharmaceuticals. Jeff, are you there?
I am. Nice to see you again, Craig. How are you?
Good. Nice to see you, Jeff. I see you've got your deck up as well. Excellent. We are ready to go. Jeff, let me just get some preliminaries out of the way. As will be the case throughout today, we're going to be taking your questions only through the Q&A button at the bottom of your Zoom window. Please push the button, type in your question, and then we will receive it. Let me just do the safe harbor statement here. This segment may contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995.
All statements pertaining to future financial and/or operating results, along with other statements about the future expectations, beliefs, goals, plans, or prospects expressed by management, constitute forward-looking statements. Any statements that are not historical facts should also be considered forward-looking statements. Of course, forward-looking statements involve risks and uncertainties. Jeff, please go right ahead.
Awesome. Thanks a lot, Craig. Good morning, everyone, and thank you for dialing in to this virtual conference. Just give me a second here while I move my screen forward. For those of you who are familiar with SXTP, we have an FDA-approved commercial product available in the U.S. market called ARAKODA, and that's the box depicted on the right-hand side of this screen. ARAKODA is approved for malaria prevention, and that box collectively represents our scientific, regulatory, and commercial expertise in being one of the very few companies that's gone all the way through the FDA process on their own.
On the left-hand side is what our current market cap is, and we think that reflects a symptom that many biotech companies experience or have experienced lately, which is a lot of under-recognition of what they're doing by investors. On the other hand, it's also an opportunity, and I hope to explain why I believe that in the next series of slides as we walk through our plans for ARAKODA. First, I just want to share what the commercial history of the product has been so far, and you can see here gross sales over time from when we put the product into the U.S. supply chain in the Q3 of 2019.
Now, of course, ARAKODA is approved for malaria prevention and travel medicine, and that was unfortunate timing given that we experienced a pandemic for the next effectively two years, which shut down international travel. We were not able to commercialize the product as you normally would following an FDA approval. At the end of the pandemic, we started to get phone calls from patients with a disease called chronic babesiosis, which at the time we hadn't heard of. These patients described a chronic illness a bit like chronic fatigue or Long COVID, but represented that they had had a diagnosis of this parasitic disease called babesiosis.
Sales continued to increase without much effort on our part, prompting us a couple of years ago to do a look back based on RX and physician types, and we found approximately 70% of our sales were attributable to this chronic babesiosis. Sales increased over the subsequent time period until we had a brief supply chain disruption halfway through last year. After that, we launched our commercial pilot program, in which we hired virtual sales representatives to do outreach to physicians in the space, and we've continued that program into 2026, which I'll tell you a bit about.
Our sales have continued to grow, and we've reached the point where our gross profit has stabilized at reasonable percentages, barring the stock out from last year. Our goal in the future is to increase the overall sales of ARAKODA, both through direct efforts as it relates to the approved malaria indication and then expansion of the therapeutic areas into this new disease called babesiosis, which is a parasitic disease like malaria that's transmitted by the same ticks that transmit Lyme disease. We think we can go from annual sales now of approximately $1 million in net revenue last year to potentially orders of magnitude higher than that based on the preliminary market research we've done, assuming that we're able to secure FDA approval for babesiosis.
That as we go, the market that we think is there can be proved out from a technical point of view and also a commercial point of view. We think that chronic babesiosis could be the lion's share of that potential revenue, and that's why we're focused on it from a research perspective. Malaria, of course, shifting back to the approved indication, is a disease that's transmitted by mosquitoes in tropical countries. To most Americans, it seems like a problem that's very far away and not really relevant to ordinary life here in the States. Except, of course, when you hear about anecdotal cases of people who've traveled overseas and ended up contracting malaria while they were away.
For example, this anecdote from a local Fox News affiliate in the Washington, D.C. area, who contracted the symptoms of malaria while he was doing a barbecue on Labor Day and was subsequently hospitalized. Unfortunately, John's experience is increasing across the United States, and that's primarily for two reasons. One, there are no FDA-approved vaccines for malaria prevention. North Americans who've never been exposed to the illness before lack immunity. If you contract malaria while you're away or when you come back, it is a life-threatening situation and a medical emergency.
95% of these cases in returning travelers occur because people don't take the chemoprophylaxis meds that the CDC and other professional societies recommend you take. That's because, in part, picking the right medication is really complicated. There are all kinds of malaria with various differences in different parts of the world. The drugs that you use to treat the different kinds of malaria are different, and there's also drug resistance that you have to contend with. In the case of Plasmodium falciparum, which is the most deadly parasite, and the distribution is reflected on the right-hand side of the slide, in particular, the hotspot in sub-Saharan Africa.
Well, that geographic locality has no Plasmodium vivax, illustrated on the left-hand side, which is a type of malaria that relapses weeks or months after travel, and you need different drugs to treat these two illnesses. To maximize your pre-travel and post-travel prevention of malaria, you really need a triple combination to eliminate almost all the risk, according to standard of care, and that could be up to 53 pills for a one-month trip. If you take ARAKODA, which is our product, that pill burden is reduced to about 16, because while you travel, the drug is taken once a week as opposed to daily, like the existing medications. When you come back from travel, you don't have to take it for days or weeks, you just take one dose.
Before we started our relaunch or commercial pilot of ARAKODA for malaria last year, we did some market research which showed that, not surprisingly, brand recognition was slow, but patients and physicians liked the product profile. The barriers to entry were the lower out-of-pocket cost for the generic alternatives, which I mentioned, and a requirement for safety reasons to do a blood test for G6PD deficiency prior to travel. This is a barrier in travels with short planning horizons. For most of us who are thinking three-four weeks ahead, this is one of the routine pre-travel consultations that you have time to do before you travel. In 2026, we're expanding our commercial program, with programs to expand awareness through a Doximity surround sound effort.
We have increased the number of virtual sales representatives doing outreach to physicians, and we have new programs around access and affordability, including a partnership with GoodRx to provide a point-of-sales discount, and a newly announced consumer outreach program through Runway Health, which is the first telehealth platform for travel medicine. Now I'm going to switch gears to babesiosis. Babesiosis is a parasitic disease like malaria that is transmitted here in the United States by the ticks that transmit Lyme disease rather than mosquitoes like malaria is.
Once you're infected by a tick, the parasites get into your red blood cells and continue to cycle through amplifying, infecting new red blood cells, and building up the parasite burden, which leads to acute disease, which overlaps with the symptoms of malaria, such as fever, anemia, headache, and muscle aches and pains. In people with risk factors, it can lead to hospitalization. The other route of transmission in humans is through the blood donation system, and I'll share a little bit more about that on the next slide. Historically, there were a few hundred cases a year of blood-borne transmission of babesiosis until 2020, when the FDA licensed a new molecular test specifically for blood donation screening.
That screen is 1,000 times more sensitive than the routine PCR testing that's used for patient care of babesiosis. You can see the incidence of investigations into blood-borne transmission has declined sharply, almost to zero since this test was introduced. What this observation tells us is really enlightening. If you think about a blood donation or person who's giving blood, they are asymptomatic, so they don't know they're infected with babesiosis. Yet they're screened, and now we eliminate transmission. It tells you that there is a reservoir of asymptomatic folks with a biologically meaningful parasite burden, and they don't know it.
Now, if you're symptomatic with babesiosis, the approved standard of care does result in parasite clearance after about 90 days. The sensitivity of that test is 500- to 1,000-fold less than that blood bag test I mentioned. It's very unlikely that these approved drugs are actually resulting in parasite eradication at 90 days in the way that the old data with the old tests suggest. The question is in patients who are asymptomatic and infected or have been treated but perhaps not adequately, what are the residual parasites doing, and do they have biological importance? The medical dogma is very clear.
In an immunocompetent person who is infected and maybe has low or mild symptoms, the infection it clears on its own, and the guidance is not to treat those folks with medications. It's also clear that if you're a classically immunosuppressed person, so you may have had cancer or an immunosuppressive drug, or you have no spleen, the infection becomes persistent for many months or years, and continuing treatment can lead to the generation of resistance to existing treatments. Each new relapse is the potential for rehospitalization. The existence of these patients is not medically controversial.
What we don't know is what happens if your immune system falls in between those two extremes. You're not immunocompetent classically, you're not classically at risk. One of the theories about chronic disease is that in patients who have other diseases, for example, they might get COVID and then get Long COVID and a dysregulated immune system, then they're bitten by a tick, and now they're infected with babesiosis. The presence of that preexisting disease, plus a new infection, complicates their recovery leading to chronic illness. This is what physicians who treat chronic tick-borne disease believe to be true.
Our research program is designed in part to scientifically validate this patient and clinician experience and potentially open up the commercial market to treat chronic disease in a systematic way. We think tafenoquine, which is the active ingredient in ARAKODA, might be useful for this purpose based on the non-clinical literature and the early clinical experience in case reports. We know that tafenoquine kills Babesia parasites via the induction of oxidative stress, and you can see that here in the aberrant-looking forms of the parasites on microscopy films. It's similar between tafenoquine and hydrogen peroxide, which we all know induces oxidative stress.
We know that acute infections are cleared in animals by tafenoquine at similar doses, and this unique mechanism of action and the similarity led a Yale team, a couple of years ago, to publish a short case series in five patients where they added tafenoquine to background standard of care being used to treat immunosuppressed patients with relapsing illness. You can see from the colored bars in the bottom of this illustrative and representative patient example that for nine months, every known professional society-recommended medication was thrown at this patient's illness alone and in combination and did not result in successful treatment.
As soon as weekly tafenoquine was added to that background standard of care, we got to negative conventional PCRs, as you can see from the open boxes sequentially in the bottom right hand in the legend below the text. Whereas previously, the closed boxes indicating positive PCRs had shown that this patient was infected throughout the prior course of treatment. What was true for this patient was then true for four of five patients in this treatment series. That was taken by us as being pretty convincing evidence, albeit in a small group of patients, that tafenoquine could provide a benefit over standard of care. We've rolled out a targeted clinical program to show that tafenoquine added to standard of care can be beneficial with no new safety signal.
That program should also demonstrate that chronic babesiosis can be diagnostically confirmed. Once we've proved from those two things, it could potentially open up a commissioner's CBER route or simply a regulatory route through the usual sNDA process. With a goal of achieving the broadest possible labeling for treatment of babesiosis. If our interim analysis in our hospital study, which should happen in late September or October of this year, goes as we hope it will, that might open up the possibility of an NDA submission in the Q1 of 2027. Very briefly, we have three clinical trials underway, each in different populations of babesiosis, where the unmet medical need is particularly high.
The first one is a randomized placebo-controlled study where we're adding tafenoquine to the approved professional society standard of care. We've enrolled 19 patients in that study. We need to get to 24 before the interim analysis. We think if patient enrollment was like it was last year, that we should get to that goal at the end of July, triggering an interim analysis on the primary endpoint in late September or early October. We also have an expanded access open label study in those immunosuppressed patients. We've enrolled three patients so far, all who've been cured in the same way that Yale showed for four out of five of their patients. A third study in chronic disease, and these are patients with medically serious chronic fatigue and laboratory evidence of a Babesia infection.
That study, we think, will complete its enrollment later this year. As we reported recently, we think we're on track. We announced in December that a study we'd funded at North Carolina State University showed that in patients self-reporting symptoms of chronic fatigue, 24% of them had molecular evidence of Babesia infection. This study is small. It's not prospective or randomized, and it's not systematic. It does show in principle that the medical perspective that Babesia infection plays no role in chronic fatigue might not be correct. Then subsequently in March, we reported that those three patients in our expanded access study were cured. Importantly, we proved that using the blood bank test.
It validates the prior clinical experience at Yale with those sequentially but less sensitive conventional PCRs, that if you get to clinical resolution following tafenoquine treatment, monitored using the commercially available diagnostics, that our product combined with existing standard of care does seem to be providing some clinical benefit. Now we need to confirm that in the remainder of our clinical program, particularly the hospital study. I just briefly want to close with a short description of the chronic babesiosis study that we have enrolling patients at Mount Sinai.
These patients have severe disabling fatigue with functional impairment present for at least six months, and in that sense, based on clinical symptoms, represent the classic chronic fatigue kind of phenotype. Additionally, we also require that there's laboratory evidence of exposure to babesiosis in the last 12 months. Our goal is to enroll up to 100 patients until we reach an analysis population of 16 who complete the study. Those 16 are protocol-defined based on a positive blood bank test at baseline. Potentially 100 people will enter the study, and then potentially 16 will have infection confirmed at baseline, and that will enable us to validate that the clinical phenomenon of chronic babesiosis can be confirmed using an FDA licensed test.
In the course of the treatment of these patients with ARAKODA, we'll be monitoring their recovery from fatigue using a patient-reported endpoint. As we move forward over the next 12 months, we have a number of interesting catalysts. In Q1, we already announced that the folks enrolled in our expanded access study were cured, representing pretty compelling early clinical proof of concept. We hope in the coming months when it's appropriate to do so without biasing the study or sharing diagnostic results inappropriately, we'll be able to announce confirmation of chronic babesiosis using an FDA licensed test. In Q3, we hope to announce that we'll be meeting the minimum enrollment in our hospital study required for the interim analysis, which will be followed by the actual interim analysis in Q4.
Our initial expanded commercial access program will start to yield sales data, which we'll be able to use to guide the future of our commercial program. In Q4, we should have enough information to disclose our regulatory strategy for babesiosis rolling into 2027. That's it from me. Thank you very much for your attention, and hopefully I can answer any questions that may have cropped up.
Thank you, Geoffrey. As Geoffrey said, we are moving to your questions. As we can only take your written-in questions today, we ask that you use Zoom's way of doing it, which is to click on the Q&A button, a text box will appear, and then you can type in and submit your question. Geoffrey, we've already received some questions for you. ARAKODA is already on the market, but it still feels as if many investors mainly think of 60 Degrees as an early-stage story. How should investors think about the value of having an approved commercial product as the base of the company today?
There's kind of two barriers in biotech, two valleys of death. One of them is the end of phase I, as you're trying to get clinical proof of concept, and then the resources to go all the way to FDA. The other one is after you've gotten through the FDA process, and now you're in early commercialization. It allows us, having a commercial product, to road test many of the commercial strategies that we'll need to really grow sales before our larger indication is ready to go. That's the value. It does speak to a certain ambition as well to grow the company from the clinical phase into a truly sustainable organization.
Jeff, the recent babesiosis update looked very encouraging. Based on what you've seen so far, how much has that strengthened your confidence in tafenoquine's potential in this indication?
We were confident it should work based on the non-clinical literature and the case reports, but that's very different from doing your own prospective clinical study and generating your own data. Even though it's a small study, which is reflective of the rarity of these sort of patients, we think it's sort of qualitatively equivalent to a positive phase II outcome in a more traditional development plan. Because we already understand the drug safety profile, we're very confident that we're going to get the confirmatory data that we need to go to the FDA.
Geoffrey, if tafenoquine does move forward successfully in babesiosis, how meaningful could that be relative to the malaria prevention opportunity that investors already know?
We think the relative increase in sales could be 4x-5x higher than malaria. We don't know the ceilings, in reality yet on both indications. We still need more epidemiological and diagnostic evidence of chronic babesiosis before we'll know that. Directionally, it's substantially larger than the malaria opportunity.
Geoff, what are the biggest milestones investors should be watching for between now and a possible babesiosis NDA filing?
There are two main ones. The first is, can we prove diagnostically that chronic babesiosis is a real disease? Of course, patients and physicians already know it is, but that is not the same as the FDA being convinced of it using a diagnostic test that they believe is adequate. That's the first kind of proof of concept that we can take chronic babesiosis from a clinical phenomenon to a real regulatory pathway. The second important one is when we announce that we're doing the interim analysis in the hospital study, because that will tell us two things, whether we've reached statistical significance with the data we've got already, or whether we need to enroll more patients in 2027 before we go to the FDA.
Finally, Geoffrey, as we run out of time here, looking out over the next 12-24 months, what do you think has the best chance of changing investors' perceptions of your great company?
I think those two critical milestones that we talked about really change the value story. Our prior evidence of experience and competence kicks in because we've been to the FDA before, and we already have a commercial product with commercial infrastructure set up and ready to go.
Geoffrey, I really appreciate that. We're right up against 10:30 A.M. U.S. Eastern. Very much appreciated. It's Geoffrey Dow. He's the CEO of 60 Degrees Pharmaceuticals, trading on the Nasdaq under the ticker SXTP, and you can get more information about 60 Degrees Pharmaceuticals by writing us at sxtp@redchip. Thanks again, Geoffrey.
Thanks very much, Craig, and to everyone who listened in.