Hello, this is Craig Brelsford with RedChip Companies. Thank you for joining today's event with 60 Degrees Pharmaceuticals, which trades on the NASDAQ under the ticker SXTP. With us today, we have Geoff Dow, Chief Executive, President, and Director of 60 Degrees Pharmaceuticals. We will begin with a brief presentation in a moment, and then we will open the event to your questions. Welcome to everyone joining us today on X, YouTube, LinkedIn, and other social media platforms. To submit your question, we invite you to join us on Zoom. Use the posted event link. Once in Zoom, click the Q&A button at the bottom of your Zoom window and type your question into the text box. Before we begin, please allow me to read the safe harbor statement. This call 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. Forward-looking statements involve risks and uncertainties. Geoff, please go ahead.
Thank you, Craig, for the intro. I am Geoff Dow, CEO of 60 Degrees Pharma, and thank you to those who have joined us this evening. I am going to be focused on some updates around our core mission, which is to develop new therapies for vector-borne disease. Specifically at the moment, we are focused on repositioning our commercial product, ARAKODA, for malaria prevention to a new tick-borne disease called babesiosis, which is transmitted by the same ticks as transmit Lyme disease, which everyone will be familiar with. It has been a couple of months since we did a webinar, so I just wanted to start with updating some key facts which can be derived from public data, but are just easier to present in a simple way. The first thing is our common shares outstanding in the top left is 4.5 million. Our market cap is around $2.5 million.
This slide has also been updated for the recent round of warrant inducement that we did as well. The ARAKODA sales snapshot here are our Q2 results, so we will not be reporting the Q3 until that comes out in the next week or so. Similarly with the financing and runway, I will add there that we have recently done a warrant inducement this week and raised some more cash. The effects of the outstanding warrants are listed there in the bottom right-hand side of the slide. Essentially, what we are doing at 60 Degrees Pharma is taking our commercially available product, ARAKODA. We do a bunch of different clinical and non-clinical studies to generate evidence, and then we go back to FDA to seek additional regulatory labeling for our existing product to expand its use case.
We are using the exact same chemistry, packaging, and everything in our commercial product. The only thing we really need is additional efficacy data for the new disease state. Before we get into the weeds on babesiosis, it is worth just highlighting why we are interested in vector-borne disease overall. For those of you who are unfamiliar with ticks, they transmit an array of different diseases, parasitic, bacterial, viral, and of course, alpha-gal. The same ticks can transmit all these diseases on the right-hand side of this slide. Of course, this year, everyone is familiar with the fact that we have hit record emergency room visits for tick bites. Tick-borne disease is a growing issue in the U.S., and there are no specific FDA-approved products to treat any of these indications. We have a portfolio focused on these vector-borne diseases.
Obviously, ARAKODA, the molecular name for that product is tafenoquine, and I will be making reference to that throughout the presentation. That is commercially available. We have a vet re-indication for the same molecule that we are working on for tick-borne disease in dogs. Our main R&D program for clinical disease is repositioning that same package for the treatment of human babesiosis, of which we have several studies that I will be discussing in a moment. We recently signed a deal with the University of Southern Mississippi to look at our second product, castanospermine, for alpha-gal. Then we are in the process of working through IP and licensing agreements for two other products, which we hope to announce in the near future. Babesiosis is the main focus of this discussion, and just a brief reminder, this is a parasite of red blood cells that is transmitted by ticks.
You have a life cycle in rodents. The ticks bite the mice, then they bite us, and then we get a developing cycle of parasite amplification in our red blood cells. That infection and red cell destruction leads to flu-like acute symptoms. It can cause other symptoms like weakness, loss of appetite, nausea. The red blood cell destruction can trigger hemolytic anemia, and in older adults, individuals with no spleen or who are immunocompromised, that can lead to severe disease. Finally, in those same people, you get a lot of drug resistance and relapsing, which can lead to a long-term illness characterized by persistent fatigue and other problems. For the purposes of today's discussion, we will be focusing on two major disease areas within babesiosis. The first one is severe disease, and by that we mean individuals who are hospitalized for their illness.
The issue in hospitalized folks is that the mortality rate can be 1% or 2% in immunocompetent patients, but up to 20% in patients with risk factors. The anemia in particular can lead to organ dysfunction and long recovery times, and it is a clinical emergency in older and high-risk patients. The unmet medical need here is the desire to have reduced morbidity and faster recovery. On the right-hand side of this slide, we have relapsing disease, and this is in patients who are immunosuppressed for various reasons, and do not have antibodies to Babesia, or they do not have a spleen, and so they cannot clear the infection as fast. The illness in these folks can last months to years and be refractory to treatment.
In some of our modeling, we've shown that, based on the literature cases, any individual treatment course of the standard of care, atovaquone and azithromycin, might only be effective 35% of the time, and you need multiple cycles of treatment. There's a lot of drug resistance and other issues. The unmet medical need here is durable parasite clearance. ARAKODA, just a little bit of information about it. We're treating this as a marketed tafenoquine safety platform where we can embrace the safety evidence and the formulation platform we already have to expand into other disease areas. The product, you could see the box on the left-hand side, it was approved by FDA in 2018 for use in malaria prevention in travelers, for adults who are traveling to Africa and need to protect themselves from malaria while away.
There's a weekly maintenance schedule after a load, and that differentiates it from other drugs that are daily. It also has the benefit of being quite broad spectrum, so it works against all the different malaria parasites everywhere in the world, and that simplicity of dosing makes it quite a compelling product. It was commercially launched in 2019, and that safety package consisted of eight randomized clinical studies involving about 1,100 patients at the approved dose. In post-marketing studies, we showed it was safe out to a year of dosing with a very similar adverse event profile to placebo, and no increased risk of psychiatric events, which is one of the things that people worry about with malaria drugs.
That known dosing platform, supported by that long weekly half-life allowing weekly dosing, also confers some real advantages as we think about babesiosis, which is a disease where you need to administer a drug for a long period of time. We think that babesiosis could triple the value of ARAKODA as an asset between now and when the malaria patents expire at the end of 2035. You could see that conveyed here on the right-hand side of this slide. Why do we think tafenoquine might be useful for babesiosis? Now I'm going to walk you through some of the background literature leading up to some of our recent data that we've reported for expanded access patients, and then I'll give you an update on where we are with the hospital study and future plans.
A group of folks from Yale in 2024 did some pretty interesting non-clinical work where they treated lethal Babesia infections in immunosuppressed mice with atovaquone, and you can see that on the left there, the red and blue curves, all the mice relapsed. In tafenoquine, there was relapse in a high inoculum treatment group, two relapsed, four cured. When you combine the two drugs together, as evidenced by those circles along the horizontal axis on the right-hand side, at both high and low inoculums, all of the animals were cured. This provided the rationale for atovaquone being combined with tafenoquine in immunosuppressed patients. That and other interesting data in the literature led to the publication of the first tafenoquine case series in 2024.
You can see here on the left-hand side a representative case where tafenoquine combined with atovaquone therapy led to clinical success. The first thing to note is that graph is a longitudinal time shot between zero days and 350 days, so almost a year. The tafenoquine was added as that red horizontal bar at the bottom. That is the time course and timing. You could see that prior to that, there was a whole series of treatments given of various conventional medications, all of which failed. We know that because the closed circles show the level of or number of parasites in the blood, and then the boxes above the bars showing treatments, they are PCR results, and the negative ones represent clearance. You add tafenoquine to standard of care, and that is the first time this patient was cleared by PCR of parasitemia.
That was confirmed in four of five cases, using a regimen that is very similar to the malaria prevention dose, a loading dose of 600 followed by a weekly maintenance dose of 200 mg or 300 mg. This study also showed, based on other literature as well, that monotherapy was not sufficient, and where you saw the really strong clinical signal was when you combined tafenoquine with an atovaquone-containing regimen, mirroring what was seen in the prior animal studies. What I am showing here is a depiction of the treatment course of all the 45 cases of relapsing babesiosis that have been reported in the literature. You can see that it is really complicated, and you have periods of atovaquone therapy followed by treatment-free periods, and often those fail, and so you have to retreat.
It is a very complex picture of multiple different regimens, lots of failure, and hence the unmet medical need in this particular population. So we have been using AI to crunch through some of that data to kind of quantify what is qualitatively obvious, which is the existing regimens do not work very well, and if you add tafenoquine, it seems to improve things. What we found is that for every doubling of duration, you decrease the risk of retreatment hazard by 27%. That retreatment hazard just means within a defined window after therapy has ended, what is the risk of requiring treatment again, presumably for relapsing babesiosis? That duration is the strongest correlate of treatment success within the existing relapsing case series and conventional therapy.
Following that Yale study, recently there were a couple of additional treatment successes with tafenoquine reported in the literature, and those were a little bit different from the prior series because they intentionally used short treatment courses of atovaquone therapy at the start, followed by long weekly courses designed to end treatment when the patients had been PCR negative. That is negative by a molecular test for the period of time that red blood cells are present in your body. Basically, the idea was knock them down fast at the start, maintain drug pressure until you get clearance.
When we add these two cases to the existing five cases from the Krause study, and we match what we would have expected to see given the atovaquone regimens that were used compared to what we actually saw with combination treatment, you can see here that the treatment efficacy is 3.6 x better than what you would expect from monotherapy alone. This is pretty exciting. Even though we knew the existing literature was quite supportive, it was not until we started to crunch the numbers quantitatively that you get a sense for how impactful tafenoquine treatment may be. Of course, when we had initially seen the Yale data, we started up our own prospective study in relapsing patients in five different northeastern teaching hospitals. The goal here was to show prospectively confirm what had been seen in the literature.
With a focus on using a molecular test, which we believe if you test negative, it shows definitive cure, and so you can be confident that at that point, the patient requires no more treatment. What we have seen with the first five patients enrolled in this study, and these are all folks who had failed prior treatment and then combined tafenoquine with an atovaquone-containing regimen. We got clinical improvement and negative conventional PCR in all five patients, and then definitive cure using a NAT molecular test in 80% of them. We suspect if we had done longitudinal sampling that the fifth patient would also have been negative, but that was not part of the protocol. For now, it is 80% is the estimate.
We also have two more subjects enrolled, and so we will be updating these numbers when we get those data next year. Shifting gears to the hospital study.
This is in severe patients hospitalized with severe disease, and we have enrolled 30 subjects in this study, and we are going to unblind in early January, so we do not know what the outcome is yet. We did have a safety board meeting at the beginning of October and determined that there was no safety signal. This design is basically a randomized trial, tafenoquine plus standard of care, with standard of care being atovaquone combined with azithromycin, and we compare that to placebo, and then we look at time to sustained clinical resolution and time to molecular cure and other endpoints as the secondary and supportive endpoints. In January, when we unblind, we think there will be two regulatory pathways open to us, depending on what we see in the primary endpoint from the hospital study.
If it is positive, that will open up a regular sNDA pathway where we go to the agency with data from a randomized study, plus pretty strong supportive data, as I walked you through, and with a label and a conversation focused on the shorter time to sustained clinical resolution. The second possibility is to go through an accelerated approval route using the immunosuppressed patient data, where we propose that NAT test as a surrogate marker of cure. If you get NAT negative, you do not relapse, is the theory. This mechanism essentially involves a discussion with the agency about a post-marketing study to confirm clinical benefit, and that is the pathway we will be going down in the event that the hospital study misses its endpoint. As we move ahead into 2027, we have a number of pretty interesting catalysts which we are excited about.
We announced already the hospital study interim analysis in early October. We recently did an update for our expanded access patients that have been enrolled so far. in January, we will unblind the hospital data. That will allow us to file a request for an sNDA meeting in Q2, and if that is successful, that will lead to an sNDA filed and a potential PDUFA date with priority review in the fourth quarter of 2027, followed by launch in 2028. I also showed you some of the other projects we are working on in vector-borne disease, and there will be some interesting updates of various kinds through the year as we progress with our main program. That is it for today. I will stop there and see if there are questions. Thank you very much.
Thank you very much, Geoff. To submit your question, we invite you to join us on Zoom. Use the link provided. Once in Zoom, click the Q&A button at the bottom of your window and type your question into the text box. I am new to SXTP. Could you explain how the company's malaria business fits with its work on babesiosis?
Yeah. We cut our teeth scientifically securing regulatory approval for ARAKODA for malaria prevention. We have kind of been down that road before and are pretty confident that we can essentially repeat that effort for the same molecule for a new disease, that new disease being babesiosis. The reason why those two things are complementary is because it will be the same commercial product for both. Same safety platform, same pharmacology and formulation with an expansion of the existing label to encompass babesiosis, assuming that the FDA review and like the efficacy data sets that we are going to send them.
Thank you, Geoff. What are the main things you are doing to grow sales of ARAKODA?
On the malaria side, this is not public, so I can't share specifics, but we have moved to a commercial collaboration with an entity that has a commercial sales force in the travel medicine space. We're hopeful that that pilot program will allow us to put some more runs on the board as it relates to the malaria indication. As it relates to babesiosis, our main goal over the next 12 months is what we call kind of setting market expectations or pre-launch activities. That's centered around raising the profile of babesiosis as an important unmet medical need among prescribers. Then highlighting some of the treatment options and unmet medical need that we and others are trying to solve.
Then of course, those efforts are supported by the clinical trial program, which generates the actual data we need to secure marketing approval. Then in 2028, we'll be able to do a more formal market launch specifically for babesiosis directly to providers.
Geoff, what would you say is the biggest unmet need for babesiosis patients that tafenoquine could address?
For immunosuppressed patients, it's pretty straightforward that weekly dosing for a period of several months seems to significantly improve clinical recovery and reduce the requirement for retreatment. Assuming that the FDA agrees with the statement I just made, that's where I see probably the most impactful value of tafenoquine in the acute disease setting. Of course, what I haven't talked about today is the use already by physicians to treat chronic babesiosis, which is basically like a chronic fatigue presentation in patients that have also tested positive for babesiosis. We see the potential for a large unmet medical need there as well.
Thank you, Geoff. If the hospital study results are positive, what would the next steps with the FDA likely look like? Excuse me.
Typically what you do with a clinical trial is you go through the last subject, last visit, which for us will be Christmas Eve. Then your study team goes out to the sites and closes them out and makes sure all the data is entered into a database. That takes a couple weeks. Then you lock the database and unblind the study. We think all that will happen sort of towards mid-January. Then we take a look and see what we have, and sometimes you do not know what the whole package is going to look like until you have unblinded the data and kind of analyzed it all and thrown around some ideas. Sometimes towards the end of January, we will submit a pre-NDA meeting request. This is a standard regulatory meeting that is a requirement prior to submitting an NDA, which is just jargon for New Drug Application.
We think that if we get that paperwork in by January, then we might have that regulatory meeting in March, and how that goes will kind of determine the next steps in terms of the actual formal submission. That is more or less the process, and if we are successful in a simultaneous application for priority review, then the review of the data by the agency should be done and dusted by Thanksgiving next year, hopefully.
How could the expanded access results help support the company's regulatory plans?
If the hospital study is positive, then it is tricky because the hospitalized patients can benefit from a treatment that produces faster recovery. Most hospitalized folks who are immunocompetent will eventually recover from standard treatment. You cannot do a randomized study in immunosuppressed patients, and all you can really do is collect the literature cases and then do open-label studies like we have already done, where the unmet medical need is compelling and qualitatively obvious because all those patients have previously failed therapy. A randomized study where you have proven faster recovery from a short course of treatment, combined with strongly supportive data, where the unmet medical need is obvious and the effect of the drug is obvious, is really compelling supporting data in an application.
Immunosuppressed patients are kind of where it is at in terms of where traditional infectious disease experts believe the unmet medical need is. I think when folks take a look at all the data that we put together from the literature, the expanded access study, and then some of the patients from the hospital study as well who are immunosuppressed, that is all going to add up to a pretty compelling story as it relates to the potential value of tafenoquine in immunosuppressed patients by themselves. That is why we talk about two regulatory pathways to the same goal, and we are excited to unblind in January and nerd out on the numbers, and then the real work begins, turning a product into something useful for patients.
What are the most important milestones investors should be watching out for over the next year?
Those are pretty much outlined in the catalyst slide at the end of the presentation, but it is essentially the milestones related to our interaction with the FDA, because that really determines whether or not we can market the product for babesiosis. Specifically, those are when we file our pre-NDA meeting request, when we submit our dossier, and then when the FDA has had a chance to review it and makes a decision at the end of next year.
Thanks, Geoff. For more information on 60 Degrees Pharmaceuticals, reach us at 1-800-REDCHIP or email us at sxtp@redchip.com. Visit RedChip's investor information page for 60 Degrees Pharmaceuticals. It is sxtpinfo.com. There, you can view and download the investor presentation and fact sheet and sign up for news alerts on 60 Degrees Pharmaceuticals. Watch "Small Stocks, Big Money," RedChip's program featuring exciting small-cap companies, every Saturday night at 7:00 P.M. U.S. Eastern on Bloomberg USA, and every Sunday morning at 11:30 A.M. U.S. Eastern on CNBC. Join RedChip's next webinar with FibroBiologics, Thursday, November 19th at 4:15 P.M. U.S. Eastern. Register for all RedChip webinars at redchip.com/events. Thanks again to our many participants today, and thank you, Geoff.
Thanks, Craig, and thanks to everyone who was able to join us today. I appreciate the interest in SXTP, and if you want to know more about the company, just check out our website at www.60degreespharma.com. Thanks very much.