60 Degrees Pharmaceuticals, Inc. Common Stock H.C. Wainwright 28th Annual Global Investment Conference

Geoff, please go ahead. Thanks, Matt, and hello to everyone who has dialed in.

It is my pleasure to present 60 Degrees Pharmaceuticals to you today. 60 Degrees Pharmaceuticals is unique. We are starting from a base of an already commercially approved and available product, ARAKODA, for malaria prevention. What I am going to share with you today is our plan to exploit some compatible and interesting biology with a new disease, babesiosis, to drive a clinical program to generate new evidence to support a label expansion for ARAKODA into a tick-borne disease with a specific disease, babesiosis. Before we get into the details on that, just a few highlights of our recent financials and our financial position. We are a small market cap company. Our valuation is about $4 million, which is unusual for a company with a commercially approved and available product for pharmaceutical RX. We do have some preferred shares.

The conversion of those is at the discretion of the company. We do have sales from our commercial product, ARAKODA, which is highlighted on the left-hand side. Those sales are growing, with relatively limited commercial promotional spend to date. We recently did a $1 million round in July, which provided enough runway to get us through to October, where there will be an important de-risking event, which I will share the details of. For folks who are in the Northeastern U.S. particularly, but increasingly all over the country, you would have seen in the press a lot of stuff about tick-borne disease, and in particular, the record levels of emergency room visits for tick bites. The reason why there are so many emergency room visits for tick bites is because ticks transmit a lot of nasty diseases for which the treatment situation is pretty poor.

We are focusing on three of those diseases as we move our pipeline forward. The first one is babesiosis, which I am going to tell you all about in a lot of detail. The second is post-treatment Lyme disease, which is a chronic sequelae to the failure to adequately eradicate the Lyme bacteria during the early phases of Lyme disease. Then the third is alpha-gal syndrome, which is an allergy to red meat that is transmitted by a tick bite. All of these diseases have in common the fact that there are no specific FDA-approved treatments and not a whole lot of pharma presence to date in terms of developing new therapies. We feel by focusing in this area, we are focusing on a high unmet medical need, as well as positioning the company in a competitive space that is attractive. This is our portfolio as of August.

We have ARAKODA, our malaria product, as I mentioned, that's commercially available. The active ingredient of ARAKODA is tafenoquine, and we're in the process of pursuing label expansions in two areas with that molecule. The first is for veterinary indications, and the second is the treatment of human babesiosis, for which we have a number of phase II and potentially pivotal trials underway, which I'll share the details of in a minute. The efforts in other areas, we're planning to do non-clinical bridging studies in 2027 to hopefully pave the way for clinical trials in the future. Babesiosis is a red blood cell parasite, a lot like malaria. It's transmitted to humans through a tick bite. Once it's in your body, it amplifies in red blood cells, increasing the parasite burden and causing anemia and other problems.

You can see some of the symptoms of babesiosis on the right-hand side. In its acute phase, it presents like the severe flu with fever, chills, and other symptoms. The cycling through red cells can cause hemolysis and other problems, and individuals who are older, who don't have a spleen, or who are immunocompromised, are at risk of severe disease and all the complications associated with that. It also causes severe chronic persistent fatigue, both in the infectious and post-infectious phases, an under-recognized and unmet patient population. In terms of treatment of babesiosis today, the first-line treatment is atovaquone and azithromycin, and that's expanded to a whole range of different drugs that replace the azithromycin component in treatment refractory disease.

What is a problem with this first-line treatment is that in immunosuppressed patients who relapse, any regimen of atovaquone combined with anything else has a less than 30% cure rate, and there are no specific FDA-approved regimens that might be more appropriate for managing the disease. For patients who are immunosuppressed, that's a problem because it means they require prolonged multi-drug therapy. The evidence base to help them is limited, and a repositioned small molecule could be really helpful, both in terms of systematizing a treatment pathway and also leading to FDA approval. That's what we'll be talking about in the rest of this presentation. With babesiosis itself, although there is an existing unapproved treatment, there is a persisting unmet medical need in three distinct disease segments.

The first is hospitalized patients for severe disease, where the mortality rate is quite high, particularly in high-risk patients, and there are long recovery times. Persistent disease in immunosuppressed patients, where the treatment course can be months or years, and the cure rate of that existing regimen is low, as I indicated. Then in chronic disease characterized by fatigue and other chronic symptoms, where babesia infection is hypothesized to prolong recovery from post-infectious illness. It's relatively poorly studied, and there are zero FDA-approved diagnostics for low-density parasite infections, which makes the study of that disease particularly challenging. I highlight these three patient segments because these are the three segments that we have clinical trials active in, which I'll highlight in a few minutes. We think that ARAKODA is potentially an interesting molecule to generate a label expansion for into babesiosis for a number of reasons.

Firstly, it is commercially available already, approved for malaria prevention. It has a broad spectrum of action, and it can be administered weekly, which is important for a regimen that you are giving to patients for a long period of time. It has a good safety profile. It has been well-characterized in 8 placebo-controlled clinical studies in more than 1,100 patients and had a comparable AE profile relative to placebo when given weekly for up to 52 weeks. That safety profile, commercial availability, and broad spectrum of action uniquely positions it to move into a potentially new babesia indication. There are some very encouraging non-clinical data generated independently of the company that show that tafenoquine has a unique mechanism of action that is different from the other drugs used to treat babesiosis, and that is specifically through an induction of intracellular oxidative stress.

The mouse studies show that atovaquone and tafenoquine combined are more effective than either drug alone, and in particular, more effective than atovaquone. What that set up subsequent to these studies was a series of case studies in the literature where tafenoquine was combined with atovaquone regimens in immunosuppressed patients with treatment-refractory babesiosis. This publication came out in 2024 and showed that in 4 patients treated with that combination regimen for at least 8 weeks, a cure was achieved in all of them. You can see how this operates in practice in the graph on the left-hand side, and I will draw your attention to the rows of colored bars which show the different treatments that were given prior to tafenoquine, which is the red bar. Above that, there are some boxes which indicate PCR results. PCR is a molecular test specific for babesia.

The closed boxes show that throughout the 9 months treatment period, this patient was positive by PCR, and then after tafenoquine, for the first time achieved negative sequential PCRs and was cured. What this data suggests is a human signal of efficacy. It shows the combination context where tafenoquine might be useful, and it is potentially supportive in regulatory applications, and it did support the company's rationale and motivation with a development plan for tafenoquine in babesiosis. The other thing that is important is that the addition of babesiosis to the list of indications for which ARAKODA might eventually be approved almost triples its value from an asset perspective, and that is because the treatment combination and the treatment length is longer than it is for malaria. Even though the patients are fewer, the value of the indication is higher from a strictly commercial perspective.

We have all that together, the prior supporting data, the potential value creation, and the scientific rationale led us to embark on a clinical development campaign in babesiosis. We have 3 studies currently enrolling patients, and they are targeted at each therapeutic areas or patient populations where there is a clear unmet medical need. From left to right, we have a randomized placebo-controlled study in hospitalized patients. Those are those patients with severe disease. This study is tafenoquine versus placebo in patients already receiving standard of care. Here we are focusing on the time to clinical recovery as the main endpoint and parasite clearance as the secondary endpoint. This study is testing a dose of tafenoquine, which is a loading dose of 200 milligrams for 4 days, 100 milligrams for 4 weeks.

In the relapsing patients, which is the panel in the middle, these are the folks who have all failed prior therapy treated with tafenoquine plus an atovaquone containing their regimen. What we are using to define cure in the study is clinical recovery plus the absence of evidence of any parasites on a NAT test. That NAT test is the same test that the Red Cross and American blood banks use to rule out babesiosis infection in blood donations. Here we are testing the same regimen as in the hospital study, but for as long as is required to achieve resolution of clinical symptoms before doing that NAT test. We reported earlier this year that our first three patients in that study were cured. We have two more enrolled, and those folks should later in the year.