Good day, and thank you for standing by. Welcome to the next steps in the development of tafenoquine for babesiosis webinar. Before we begin, please note that today's presentation and Q&A may include forward-looking statements under the Safe Harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These include expectations about tafenoquine's potential in babesiosis, clinical development, regulatory approval, and commercialization. These statements reflect current assumptions and expectations, involve risks and uncertainties, and do not guarantee future outcomes. Actual results can differ materially. Risks include substantial doubt about the company's ability to continue as a going concern, eligibility for Australian research and development tax rebates, difficulties completing clinical trials or obtaining FDA approval for additional indications of tafenoquine or Celecoxib, and manufacturing delays arising from the company's lack of manufacturing capacity. Please review the risks factors in the company's annual report on Form 10-K filed March 30th, 2026, and subsequent SEC filings available at www.sec.gov. You should not place undue reliance on forward-looking statements. They speak only as of today, and the company undertakes no obligation to update them except as required by law. Finally, tafenoquine is FDA approved for malaria prevention under the brand name ARAKODA, but is not FDA approved to treat or prevent babesiosis. Leading today's call is Dr. Geoff Dow, Chief Executive Officer of 60 Degrees Pharmaceuticals, who is joined by Dr. Edouard Vannier, Assistant Professor of Medicine at Tufts Medical Center and Tufts University School of Medicine, and Dr. Peter Krause, Senior Research Scientist at Yale School of Public Health and Yale School of Medicine. Doctors Vannier and Krause are leading experts in babesiosis and will share their perspectives on the clinical data and current treatment challenges. Dr. Dow, I will now turn the webinar over to you. Thank you very much. Thanks everyone for dialing into this interesting webinar today. This morning, 60 Degrees Pharma disclosed the outcome of a DSMB interim analysis of its severe babesiosis study in hospitalized patients. The DSMB essentially recommended to complete the study as planned. The good news is that preserves our optimistic timeline for launch of ARAKODA for babesiosis in Q1 2028, assuming everything goes okay with the interactions with FDA next year. It also preserves the near-term catalysts of an additional data disclosure around our expanded access study in immunosuppressed patients and, of course, the unblinding of the data for the hospital study in January of 2027. I'll be giving a short presentation that will outline the background to everything I just covered, and then we'll get into a Q&A with our KOLs, and then there'll be a little bit of time at the end of the webinar to address some investor questions. You all know that ticks are nasty bugs that can transmit a variety of different diseases. You may be used to thinking about tick-borne disease in the context of Lyme disease, but the whole variety of other infections and syndromes that ticks can cause, including alpha-gal and babesiosis, and today we'll be discussing babesiosis in some detail. The other thing is, the number of tick bites seems to be increasing. This year, we hit a record level of emergency room visits, so ticks are on everybody's minds. Broadly, we have a portfolio focused on addressing tick-borne disease with a variety of new products. What we'll be focusing on today is ARAKODA, which is an antimalarial approved for malaria prevention in the U.S. market, and its active ingredient is a molecule called tafenoquine. For most of the presentation, I'll be referring to the research and development of tafenoquine for babesiosis. Babesiosis is transmitted by ticks. There is a cycle in wildlife. Once it gets into your body from a tick bite, it invades and replicates and destroys your red blood cells, accumulating a parasite burden over time. The acute symptoms are a lot like flu and overlap with a variety of other illnesses. The thing that really characterizes the disease is the red cell destruction, which can lead to anemia, and that it also triggers a persistent fatigue, which can be quite severe in some patients and prolong recovery from illness. 25 years ago, a randomized trial was conducted which established the utility of atovaquone/azithromycin as standard of care. One of our experts today, Dr. Peter Krause, was the lead investigator on that study, and will share a little bit more about it. atovaquone/azithromycin was shown to be better tolerated than the prior treatment with equivalent efficacy, and so there'll be a lot of reference, particularly to atovaquone in the discussion today. There are two major unmet needs or populations that we'll be addressing today and that are the focus of two of 60 Degrees Pharma's clinical trials. On the left-hand side, we have severe disease. These are hospitalized patients, and they have a mortality risk of up to 21% in folks with comorbidities. The unmet medical need there is the desire to have new therapeutics with reduced morbidity that result in faster recovery. Then on the right-hand side, we have relapsing disease in patients who are immunosuppressed. They may have illness that goes on for months or years with a lot of recurring episodes of parasite burden and symptoms. There are drugs to treat relapsing babesiosis, but on an individual regimen basis have a relatively poor cure rate. This slide here captures what we know about relapsing babesiosis from the literature. Each of the horizontal bars represents a case. The purple segments show a course of atovaquone therapy, followed in some cases by treatment-free periods, which are highlighted in yellow. What you'll notice is it's very heterogeneous. Lots of patients get treated in different ways, and many require multiple rounds of treatment before you get clinical success, and even then, the overall cure rate is about 80% on a total drug-administered basis. We know from doing some analyses of these cases that atovaquone regimens are successful about 30% of the time, and we will be referencing that further in the discussion. We know from the literature that tafenoquine added to background therapy, and what we mean by that is an atovaquone regimen, shows additive activity in animal models. These are relapsing parasitemia curves from a severe disease model of babesiosis. On the left, you can see that all six animals in this study in blue relapsed. That is the blue curve, which looks like the control curve, but delayed. In the middle, you can see that two animals relapsed following tafenoquine treatment, so it did a little bit better. But it took both drugs combined to flatline the parasitemia curve on that horizontal axis, where you never saw a relapse at all. This supported the further study of tafenoquine and atovaquone combinations in immunosuppressed patients, and Peter and Ed will discuss that in more detail. What I am showing here is a representative case from a series of five immunosuppressed patients who were treated with tafenoquine combined with atovaquone regimens. The graph there essentially shows your about eight months of prior therapy, which all failed until tafenoquine was added. Then you started to see a drop in parasitemia, a recovery from symptoms, and negative PCRs for the first time. That study involved a loading dose of tafenoquine over three days with weekly tafenoquine administered until recovery, and it did establish that combination therapy with atovaquone was important, and Ed and Peter will elaborate on that in a bit more detail. Apart from those five original cases, there have been a couple of others which I am conveying here. The purple segments here show prior atovaquone therapy. The tafenoquine administered at the end of the treatment course is illustrated as either green or red, depending on the success. And you can see here that six out of seven of these patients were successfully treated with tafenoquine, which is a pretty promising outcome so far. ARAKODA, of course, which I mentioned earlier in this presentation, is the brand name of tafenoquine. It was approved in 2018 by the FDA for malaria prevention. It became commercially available in 2019, and it has a number of features that make it pretty interesting as a potential babesia drug. The first is it has a well-established safety profile. The second is it is a weekly dose because it has a long half-life, and as a follow-on treatment for babesiosis, that is really useful because now you can give a drug once a week. The other thing it has that is useful is a broad spectrum of action against parasites that target red blood cells. And their malaria has a commonality with babesiosis because it is also a parasite that destroys red cells and has a similar symptom and acute manifestation profile as babesiosis. Now we get into the status of our clinical studies. I mentioned that we have two clinical trials that are actively enrolling patients. The first is the randomized placebo-controlled study, which we disclosed the interim outcome for this morning. That study has enrolled 30 patients as of the 1st of October, when we did the interim analysis. It involved a comparison of tafenoquine to placebo in patients also receiving atovaquone and azithromycin, and its primary endpoint is the time to sustain clinical recovery. On the right-hand side is our open-label expanded access study in relapsing immunosuppressed patients. We reported earlier in the year that the first three patients in that study, which is a follow-on from the case series that I mentioned earlier. In that prospective study, three patients were cured. Then we have another two patients that will complete the study by the end of this month, and we should have some results to disclose in early November. Very briefly, this was the mandate that the DSMB had when they did the interim analysis for the hospital study. We, as the sponsor, are told what to do next. We don't have any insight into the actual statistics that the DSMB reviewed. That potential recommendation is in column two of this table. The DSMB could have concluded, based on the data, that we'd already met the endpoint and directed us to terminate the study. They could have said that in order to get enough statistical power to see a successful outcome, eventually, we would need to enroll more patients than we originally intended or to complete the study as originally planned. That is, of course, the advice that we received, complete the study as originally planned. They also said there was no safety signal associated with the data. It's important to know that the study remains blinded, and we won't know the outcome until it's unblinded early next year. I mentioned that we'd enrolled 30 patients as of the 1st of October, and that the recommendation from the DSMB was to complete the enrollment of the full original 33 subjects. Unfortunately, enrolling an additional three subjects would require us waiting a year, and it wouldn't add any or marginal value in terms of additional statistical power. The company has made the decision to complete the follow-up visits of the 30 patients enrolled to date and to unblind the study in early 2027, when that's complete. At that point, we're confident we'll have two potential regulatory pathways to secure regulatory approval for babesiosis for tafenoquine. The first is what we call our default pathway, and that involves compiling the literature case evidence, the five or six cases that will result prospectively from our expanded access study, supported by additional non-clinical literature, and file an accelerated approval and propose a confirmatory study as a post-marketing requirement. There is regulatory precedent for that based on the leucovorin example from March of 2026. The de-risk path, which is the pathway we hope we'll be on, is when we unblind the hospital study database in early 2027. Then we'll be adding a randomized trial to that core default data set, and we'll proceed down a regular sNDA pathway. That opens up a lot of interesting catalysts for investors in the next 15 months. We've just, of course, reported the outcome of the hospital study interim analysis. That's going to be followed by a disclosure of the outcome of treatment in the fourth and fifth patients in expanded access study in early November. Unblinding of the hospital data in early 2027. A pre-sNDA meeting back and forth with the FDA in Q2 of next year. Hopefully following that, if that all goes well, the filing of an sNDA and a launch in the first quarter of 2028. At this point, that ends my opening slides, and we're going to transition to just follow up with a few questions for Ed and Peter, who have been waiting patiently in the data room. Michelle, if we could switch over, please. May I just have confirmation from the control room that we're all set? All right. Looks like we're all set. I guess I'm going to start with Peter and Ed. You guys co-authored the first series of patients treated with tafenoquine and atovaquone in a study that came out in 2024, and I was hoping you could just share briefly the background to that study and why you did it and what you think the important findings from it are. Maybe if we start with Peter and then Ed, you can follow on. Thanks, Geoff. I'll give a little background information to the case series that we wrote. Relapsing babesiosis in immunosuppressed patients was described in a paper that we wrote back in 2008 with a multi-center group. It was very difficult to achieve cure in these patients, and it required months or even years of standard antibiotics and other antibiotic combinations for cure. Treatment was not always successful, and in this case series of relapsing babesiosis, we found there was a 20% mortality rate. When we talk about immunosuppression, there are a number of conditions that lead to this, including cancer, no spleen, HIV, AIDS, immunosuppressive drugs, and advanced age over 60. The relapsing babesiosis patients usually have two or more of these immunosuppressive factors, so they're really quite immunosuppressed. About five years ago, Dr. Ralph Rogers at Brown called me about a relapsing babesiosis patient he had, and this patient had received multiple bouts or multiple treatment courses with standard therapy, and it still was not working. We decided to try tafenoquine on a compassionate use basis in this patient. Why did we choose to do that? Tafenoquine had been shown to be effective in curing relapsing babesiosis in an immunosuppressed mouse model. It is successful in treating Plasmodium vivax malaria, and malaria is related to babesia. This also suggested that this might be effective. Another impetus to try tafenoquine was the discovery by Dr. Vannier of antibiotic resistance to standard babesia antibiotics. We added tafenoquine and the relapsing fever patient was cured, and that was very encouraging. We then identified five more relapsing babesiosis patients and treated them with tafenoquine plus standard antibiotic therapy with good success, with an 85% cure rate. We treated with tafenoquine and additional antibiotics, and there was no relapse in these patients. They basically, after that initial treatment with tafenoquine, were cured in 85% of the cases. This represented the first case series of tafenoquine therapy in babesiosis patients. Ed, did you want to add anything to that? Were you surprised by the initial promising performance of tafenoquine given the literature? Thank you for your question. I would add to Peter's comment that indeed, tafenoquine was quite amazing in achieving rapid resolution of symptoms and eventually clearance of the parasite, which was very good in such difficult cases. Were we surprised? Actually, quite no. For one, tafenoquine works by inducing oxidative stress, and such mechanism of action would predict efficacy against a variety of resistant parasites. We were quite confident it would work. We combined tafenoquine with atovaquone or atovaquone-proguanil, and we achieved resolution, which was also expected because atovaquone works against the mitochondria of the parasite, therefore providing a complementary approach to the activity of tafenoquine. Okay. Just maybe, Peter, you could elaborate a little more on how important it is for us to develop, as a community, new therapies in immunosuppressed patients. Right. We have touched on relapsing disease in highly immunocompromised patients, but there is an array of immune suppression. These patients who are immunosuppressed may be not so sick that they get relapsing disease but still are immunosuppressed. They often develop severe acute disease with anemia, sometimes cardiac, neurologic, pulmonary, or renal complications. Death has been reported in 7%-21% in this group using standard therapy, in part because of this antibiotic resistance. This is a real challenge for us, and I think was the major challenge in the field of babesiosis to date. Today we reported the outcome of the interim analysis in the company's hospital study that is being done at a few of the teaching hospitals in the northeast of the United States. Just wondering if you could elaborate a little more on what the data output or advice so far means, and what are the next steps? Well, as you mentioned, the Data Safety Monitoring Board have met, and they reviewed the data to date. They stated that there was no reason, based on conditional power, to increase the study sample size or to terminate the study early. There were no safety signals. This is all good news. On the other hand, the results of our current study are still blinded, and we are going to need to wait until January for the unblinding to decide what to do next. Ed, do you have anything to add to that? I would just restate the fact that the study is going well. We're going to see the last six patients being completed by January, and we are going to get a result. That's very exciting, we think. Awesome. Of course, the other data output we've disclosed as a catalyst that's coming very soon in November is we'll know the outcome of patient four and patient five in expanded access study. You recall, earlier in the year, we reported that the first three patients in expanded access study were cured, which is an outcome we expected based on the case series that you guys had already published. I guess I'm going to express my personal opinion. I think that the unmet medical need in immunosuppressed relapsing patients, in particular, is quite compelling. From my perspective, if we're able to confirm those additional cures in the patients next month, it's a pretty compelling learn and confirm model with respect to tafenoquine's performance in the literature, and then prospectively evaluating a series of five new cases. I'm pretty optimistic, and I'm just wondering if you guys feel, based on those data and the direction we're heading in, whether tafenoquine should be approved for use in babesiosis patients in the coming months. I totally agree. Yeah, I would add by stating that what is quite interesting in these five patients that were enrolled in the expanded access study is the use of the highly sensitive nucleic acid test for monitoring infection. Thus far, we had used real-time PCR, which is sensitive, but not as sensitive as the highly sensitive nucleic acid test. Essentially, use of these nucleic acid test will provide confidence that the infection is really clear, and that speaks to the power and the efficacy of tafenoquine in doing so. Yeah. Just as a reminder, the NAT test is an FDA-licensed RNA amplification test, which is used in blood donation screening, to prevent transmission of babesiosis through the blood donor system. Since it was introduced by the Red Cross and other blood donation centers, the rate of blood transmitted babesiosis has dropped off precipitously. So it's a pretty sensitive and validated test, and that's the marker that we use for cure in the expanded access program. If we end up going down an accelerated approval pathway, would be what we were proposing as a surrogate marker for the lack of relapse in a confirmatory study. So, that's kind of the end of the planned questions I had. But I'd like to ask both of you if you had any other thoughts about tafenoquine, about the direction the company's going in, anything else you'd like to share with our folks on the call today. We'll start with you, Ed. Yes, I think that we are delighted to see that tafenoquine is moving forward in the field of babesiosis. Definitely, it's comforting that you guys have a lot of experience with tafenoquine in the field of malaria, so that bodes well for the ability to push that drug for babesiosis. It's a drug that is, as we discussed, needed for the improved treatment of relapsing babesiosis or severe babesiosis in the immunocompromised population. Yeah, I agree with you, Geoff, and Ed. This is, I think, a very important work. I think it's going to have great benefit for immunocompromised patients who have babesiosis. I think even beyond that, someday it may be used in patients who are immunocompetent. We may find ultimately that that will serve them well. It's when you see these patients in the ICU or just in the hospital with the suffering that they experience, and of course, especially with the relapsing babesiosis patients, it would really be wonderful if this is successful, which we believe it will be. I think the study designs have been excellent and are excellent, and the studies have been well carried out. It has been a pleasure to work with you, Geoff, and with Edouard, of course, and with the team. Awesome. Thank you both. We have a few questions in the chat from investors, so I'm just going to briefly go through a few of those before we wrap things up. One of the questions is, following the FDA, hopefully the FDA approval of ARAKODA for babesiosis, will you need to do a separate costly product formulation or some sort of unique process that will involve a huge monetary spend? The nice thing about our program is we have intentionally used the existing weekly dosing regimen followed by a load of ARAKODA for malaria prevention in all our clinical studies. So the safety database that was developed through the U.S. Army malaria program for years will be a really good support for the dosing regimen that we're going to roll out. Of course, ARAKODA is commercially available through retail pharmacies. There's an established supply chain already in place in the U.S. market, and so we don't anticipate major changes. The thing that hopefully will follow a label is better access to the drug, more insurance coverage, and a bit more confidence in which dosing regimens to use. We have a second question related to runway. There's always a question related to runway. It's the nature of a small growing company that's using funds very frugally and cost effectively, and of course, that's what we've been doing recently. We did report transparently that our runway after our last financing was into mid-October. We see a number of interesting catalysts ahead of us over the next few months and opportunities to raise more financing to get us all the way through to FDA approval, hopefully, if things work out well. Then we have a question here related to the Commissioner's National Priority Review Voucher. Just give me a sec while I- Okay. You submitted interest in a Commissioner's National Priority Review Voucher. What does that award mean for the company and its plan for supplemental NDA? For those folks who are not familiar with this, last year the FDA introduced a Commissioner's National Priority Review Voucher Program, which in some cases for eligible programs allows the usual even priority review of six months to be accelerated to one to two months. We have expressed interest through the FDA's website in that program. What it would mean for patients if we were fortunate enough to be considered eligible is we could potentially get ARAKODA approved and available for babesiosis ahead of the next tick season. That's what we'd really love to do if there's interest in the FDA's part in being involved with us in that project. Then there was a fourth question, the duration and dose in expanded access study. It's essentially a loading dose followed by weekly dosing using the same 100 mg tablets that are already in the approved packaging at the same weekly dose. If there were other questions from the webinar participants that we missed, we'll be following up individually with those comments by email following the call. I'm just checking to see if we've got a late-breaking question here. Hold on. We have a couple of analyst questions, which I'm going to do with the third one first. What are your largest safety concerns in this patient population treated with tafenoquine? The short answer to that question is, as long as the G6PD test performed, which is not an inconvenience in a relapsing or patient with a persistent disease, or in an institutionalized setting. As long as that important step of doing a G6PD test is followed, the data we've seen so far from the clinical trials don't indicate a safety signal that's beyond what's already disclosed in the label. I'm pretty confident that safety is not going to be the issue that holds us back. There's a question here about diagnosis and how diagnosing babesiosis has changed over the years, and I might actually turn that question over to Peter and Ed just to briefly address that particular issue, if you'd like to. Sure. The diagnosis is based certainly on epidemiologic information. That is, a patient needs to live or travel through an area that's endemic for the disease. The history is there are typical symptoms, which you mentioned, are a flu-like illness that can be confused with other diseases. But in areas where physicians practice where there's a fair amount or a lot of babesiosis, this will be in their differential diagnosis, and they would generally order a blood smear and/or a PCR test to confirm the diagnosis, and that's readily done, and generally is both sensitive and specific. How has that changed over the years? Well, initially it was just blood smear, then PCR was introduced. Now we have the NAT testing, which is even more sensitive. There's been increased sensitivity and specificity of these tests for diagnosis. Again, the key factor is the physician knowing or being aware of babesiosis. But again, in endemic areas, physicians are quite aware of this potential or quite aware of the disease, and will go ahead and confirm the diagnosis and then treat. Ed, do you want to add to that? I think part of the question was related to treatment over the years. I would just say that the key study by Dr. Krause, published in 2000, was a turning point. Before that, as Geoff, you stated in your presentation, treatment was consisting when administered of clindamycin plus quinine. After Peter's study, the first-line therapy became azithromycin, atovaquone. Of course, as we covered during the call, treatment of immunocompromised patients, especially when they relapse, is complex and usually involves combination of the first-line regimen plus clindamycin and/or quinine. It's very complex. It's on a case-by-case basis. The other part of Matt's question was, what sort of improvement in recovery time in hospitalizations would be meaningful? My answer to that is going to be pretty straightforward. The kind of hazard ratio in the endpoint is a two to two and a half fold improvement in the recovery time. So if the study hits that endpoint, it will be very meaningful for patients. I'll just check to see if there's any other questions. So I think we'll leave the questions there. If we missed any, we'll follow up by email, as I indicated. I'm very grateful for the folks' attendance and time that managed to dial into this presentation today. I think speaking for 60 Degrees Pharma, and the board, and the team of physicians and healthcare professionals who've helped us put the data together that we're collecting, we're very proud to be a pioneering company in tick-borne disease, and in particular in babesiosis specifically. This is the first kind of industrial effort to put a sponsored drug development program behind babesiosis. We're very optimistic about the data outputs, particularly around immunosuppressed patients, and that there's a viable pathway forward to a regulatory approval. It's been a long road, and we hope that the community and investors will stick with us for another year while we bring this exciting program to fruition. Finally, I just thank Peter and Ed for your time, and for the technical folks who put this presentation together behind the scenes. Thanks very much, and talk to you again soon. This concludes today's webinar. Thank you for participating, and you may now disconnect. Everyone, have a great day.