Core Viewpoint - 60 Degrees Pharmaceuticals, Inc. reported significant growth in net product revenues and improvements in net loss for the fiscal year 2025, driven by increased sales and strategic partnerships [5][4]. Financial Highlights - FY 2025 net product revenues increased by 65% to $1.005 million, up from $607.6 thousand in 2024, attributed to rising sales, price increases, and fewer returns [5]. - Gross profit for 2025 was approximately $223.8 thousand, slightly up from $222.8 thousand in 2024, despite inventory write-offs related to short-dated products [5]. - Operating expenses decreased to approximately $8.4 million in 2025 from $10.0 million in 2024, with a notable reduction in R&D costs [5]. - Net loss attributable to common shareholders improved to approximately $7.37 million, or $11.73 per share, compared to a net loss of approximately $7.96 million, or $74.17 per share, in 2024 [5]. Recent Business Highlights - In March 2026, the company announced successful outcomes in its expanded access study for relapsing babesiosis, leading to calls for revised treatment guidelines [5]. - A partnership with GoodRx was established in February 2026 to offer savings on ARAKODA®, expanding its sales footprint to over 70,000 pharmacies [5]. - The company exercised its Florida State University license option for large-scale purification of castanospermine in January 2026, indicating readiness to begin regulatory processes for Australian Chestnut Extract [5]. - A Phase 2 B-FREE Chronic Babesiosis Study commenced in November 2025, aiming to enroll up to 100 patients [5]. - A sponsored research agreement with Tulane University was signed in July 2025 to evaluate tafenoquine's activity against Lyme and Bartonella bacteria [5].

Core Viewpoint - 60 Degrees Pharmaceuticals, Inc. has submitted a New Dietary Ingredient Notification for Australian Chestnut Extract to the FDA, with a marketing opportunity expected post-May 25, 2026, if no objections arise [1][9] Group 1: Company Developments - The company has signed an option agreement with Florida State University (FSU) to license rights related to new capsule formulation methods for Australian Chestnut Extract, building on a previous license for large-scale purification of Castanospermine [2][9] - 60 Degrees Pharmaceuticals specializes in developing medicines for vector-borne diseases and received FDA approval for its lead product, ARAKODA® (tafenoquine), in 2018, which is available in the U.S. and Australia [6] Group 2: Product Information - Australian Chestnut Extract is derived from the seeds of Castanospermum australe, with castanospermine as its dominant molecular constituent [3] - Scientific literature indicates that castanospermine can modulate carbohydrate metabolism at low doses and has shown potential in impacting disease outcomes through immunomodulation in animal models [4] - Castanospermine is a metabolite of celgosivir, previously evaluated in clinical trials for HIV and Hepatitis C, suggesting its safety and efficacy at achievable doses in humans [5]

Core Insights - 60 Degrees Pharmaceuticals, Inc. has announced a partnership with GoodRx to provide savings of up to 30% on ARAKODA (tafenoquine) for eligible consumers [1][10] - ARAKODA is the only FDA-approved, once-weekly malaria prevention medication available in the U.S. market, making it a preferred choice for travelers to malaria-endemic regions [2][6] Company Overview - 60 Degrees Pharmaceuticals, Inc. specializes in developing new medicines for vector-borne diseases and received FDA approval for ARAKODA in 2018 [19] - The company is headquartered in Washington, D.C., and has a subsidiary in Australia, with ARAKODA commercially available in both countries [19] Product Information - ARAKODA (tafenoquine) is indicated for malaria prophylaxis in patients aged 18 and older and has a long terminal half-life of approximately 16 days, allowing for less frequent dosing [7][8] - The medication was discovered by the Walter Reed Army Institute of Research and has undergone extensive safety assessments in clinical trials [5][6] Partnership Details - The collaboration with GoodRx aims to lower out-of-pocket costs for patients and expand the marketing reach of ARAKODA, making it accessible at over 70,000 pharmacies nationwide [10][4] - Eligible patients can access a low self-pay price for ARAKODA through GoodRx starting February 2, 2026 [4][10]

Core Insights - 60 Degrees Pharmaceuticals, Inc. plans to expand its sales and marketing initiatives for ARAKODA® following positive results from a 6-month commercial pilot that indicated increased market demand among prescribers [1][2][3] Sales and Marketing Initiatives - The company will enhance its integrated digital marketing campaign to improve awareness and engagement with prescribers [2] - The number of inside sales representatives will be increased to strengthen outreach and provider relationships [8] - A partnership with GoodRx will be established to provide broader visibility of ARAKODA offers, facilitating access to savings information for patients and prescribers [8] Clinical Development - The company will add at least two clinical sites for ongoing studies related to babesiosis treatment, responding to FDA feedback regarding its Breakthrough Therapy Designation request [3][4] - The FDA acknowledged that babesiosis meets the criteria for being classified as a serious disease, suggesting the company resubmit its request with data from ongoing clinical trials [3] Product Information - ARAKODA® (tafenoquine) is approved for malaria prophylaxis in the U.S. and has been assessed for safety in five randomized trials lasting up to six months [5][6][20] - Tafenoquine offers potential advantages in less-frequent dosing for malaria prophylaxis due to its long terminal half-life of approximately 16 days [10]

Core Insights - 60 Degrees Pharmaceuticals, Inc. has initiated patient enrollment for the B-FREE Chronic Babesiosis Study, the first of its kind to evaluate a therapeutic for chronic babesiosis, which is expected to run for approximately 12 months [1][5][7] Study Overview - The B-FREE Chronic Babesiosis Study (NCT06656351) is a Phase 2 open-label study assessing the efficacy and safety of the ARAKODA® regimen of tafenoquine over 90 days for patients with chronic babesiosis [2][6] - Chronic babesiosis is characterized by disabling fatigue lasting at least six months, with laboratory confirmation of Babesia parasite exposure within the last year [3][4] - The study aims to confirm Babesia infection using validated molecular tests, potentially revealing a patient population size that could range from 4,400 to 190,000 cases annually in the U.S. [4][7] Treatment Details - The primary endpoint of the study is the resolution of fatigue, measured at Day 90 compared to baseline, using a patient-reported outcome measure [6][7] - The treatment regimen involves self-administering tafenoquine (2 x 100 mg tablets) orally with food for a total of 12 weeks [6][7] Market Need - There is currently no FDA-approved treatment for babesiosis, highlighting a significant unmet medical need [4][15] - The incidence of babesiosis is rising, particularly in the Northeast U.S., with estimates suggesting at least 25,000 cases annually, though the true number may be much higher [15][30] Company Background - 60 Degrees Pharmaceuticals, Inc. specializes in developing new medicines for vector-borne diseases and achieved FDA approval for ARAKODA® (tafenoquine) for malaria prevention in 2018 [30][18] - The company collaborates with research and academic organizations in the U.S. and Australia, and is headquartered in Washington, D.C. [30]

Core Viewpoint - 60 Degrees Pharmaceuticals, Inc. reported significant growth in net product revenue for Q3 2025, alongside challenges in gross profit due to inventory write-offs and increased operating expenses [6][7]. Financial Highlights for Q3 2025 - Net product revenue increased by 223% year-over-year to $438 thousand [6]. - Gross profit decreased from $24 thousand to a loss of $100 thousand due to a one-time inventory write-off [6][7]. - Operating expenses rose to approximately $2.32 million, up from $2.16 million in Q3 2024, primarily due to increased advertising and sales promotion costs [7]. - Net loss attributable to common shareholders was approximately $2.44 million, or ($0.66) per share, compared to a net loss of approximately $2.27 million, or ($4.65) per share in Q3 2024 [7]. Business Highlights for Q3 2025 - ARAKODA® pharmacy deliveries increased by 14% from 1,319 boxes in Q3 2024 to 1,505 boxes in Q3 2025 [7]. - The company announced its intention to seek a Minor Use Minor Species (MUMS) designation from the FDA for treating acute canine babesiosis [7]. - A nationwide survey determined the total addressable market (TAM) for Babesiosis treatment to be up to $1.1 billion through patent expiration in 2035 [7]. - The company entered a sponsored research agreement with Tulane University to evaluate tafenoquine's activity against Borrelia and Bartonella bacteria [7]. - A partnership was established with the Icahn School of Medicine at Mount Sinai for a planned Phase II clinical study of tafenoquine in treating chronic babesiosis [7].

Core Viewpoint - 60 Degrees Pharmaceuticals, Inc. will participate in the H.C. Wainwright 27th Annual Global Investment Conference from September 8-10, 2025, showcasing its focus on developing new medicines for vector-borne diseases [1][2]. Company Overview - 60 Degrees Pharmaceuticals, Inc. specializes in developing and commercializing new medicines for the treatment and prevention of vector-borne diseases, with its lead product ARAKODA® (tafenoquine) approved by the U.S. FDA for malaria prevention in 2018 [3]. - ARAKODA is commercially available in the U.S. and Australia, and the company collaborates with prominent research and academic organizations in both countries [3]. Conference Details - Dr. Geoff Dow, CEO of 60 Degrees Pharmaceuticals, will present live on September 10 at 2:30 ET, and management will conduct one-on-one meetings during the conference [2]. - Attendees can request meetings with management through the conference portal or directly with the company [2].

Core Viewpoint - 60 Degrees Pharmaceuticals, Inc. will participate in the H.C. Wainwright 27th Annual Global Investment Conference from September 8-10, 2025, showcasing its focus on developing new medicines for vector-borne diseases [1][2]. Company Overview - 60 Degrees Pharmaceuticals, Inc. specializes in developing and commercializing new medicines for the treatment and prevention of vector-borne diseases, with its lead product ARAKODA® (tafenoquine) approved by the U.S. FDA for malaria prevention in 2018 [3]. - ARAKODA is commercially available in the U.S. and Australia, and the company collaborates with prominent research and academic organizations in both countries [3]. Conference Participation - Dr. Geoff Dow, CEO of 60 Degrees Pharmaceuticals, will present live on September 10 at 2:30 ET, and the company management will conduct one-on-one meetings during the conference [2]. - Attendees can request meetings with management through the conference portal or directly with the company [2]. Webcast Information - A live webcast of the presentation will be available, with a replay accessible for approximately 90 days on the company's investor page [3].

Core Viewpoint - 60 Degrees Pharmaceuticals, Inc. has initiated a Phase II clinical trial for tafenoquine (ARAKODA®) to treat chronic babesiosis, collaborating with the Icahn School of Medicine at Mount Sinai [1][5]. Company Overview - 60 Degrees Pharmaceuticals specializes in developing new medicines for vector-borne diseases and received FDA approval for ARAKODA® for malaria prevention in 2018 [21]. - The company is headquartered in Washington, D.C., and has a subsidiary in Australia, focusing on novel therapies for unmet medical needs [21]. Clinical Trial Details - The Phase II open-label study (NCT06656351) will assess the efficacy and safety of tafenoquine over a 90-day period in patients with chronic babesiosis, defined by disabling fatigue lasting at least six months [2][3]. - The primary endpoint is the resolution of fatigue, measured at Day 90 using a patient-reported outcome measure [3]. - Enrollment for the trial is expected to begin in Q4 2025, with completion anticipated by Q2 2026 [9]. Background on Babesiosis - Babesiosis is a tick-borne illness caused by Babesia parasites, leading to symptoms such as fever, chills, and debilitating fatigue, particularly affecting the elderly and immunosuppressed [6]. - The incidence of babesiosis is rising, especially in the Northeast United States, and there are currently no FDA-approved treatments for chronic babesiosis [6][9]. Tafenoquine (ARAKODA®) Information - Tafenoquine is currently approved for malaria prophylaxis but has not been proven effective for treating babesiosis [4][7]. - The drug was discovered by the Walter Reed Army Institute of Research and was approved in the U.S. in 2018, with commercial availability starting in 2019 [8].

Core Viewpoint - 60 Degrees Pharmaceuticals, Inc. reported a decline in net product revenues for Q2 2025 but achieved increased profitability due to a shift in distribution strategy and cash-pay patients utilizing KODATEF® [2][6] Financial Highlights - Q2 2025 net product revenues decreased by 19% year-over-year, from $125 thousand in Q2 2024 to $101 thousand in Q2 2025, attributed to a 17% decrease in ARAKODA pharmacy deliveries [7] - Gross profit for Q2 2025 was approximately $51 thousand, up from $35 thousand in Q2 2024, primarily due to lower overall cost of sales and sales of KODATEF 16-count boxes [7] - Operating expenses were approximately $1.86 million in Q2 2025, significantly lower than $4.22 million in Q2 2024, due to the absence of one-off, non-cash R&D costs [7] - Net loss attributable to common shareholders in Q2 2025 was approximately $1.84 million, or ($1.25) per share, compared to a net loss of approximately $4.29 million, or ($21.12) per share in Q2 2024, representing a $2.45 million decrease in loss [7] - The company had $1.97 million in cash on hand as of June 30, 2025, and expects to remain financially viable through March 31, 2026, assuming no additional capital is raised [7] Business Highlights - The company specializes in developing and marketing new medicines for infectious diseases, with FDA approval for its lead product, ARAKODA® (tafenoquine), for malaria prevention achieved in 2018 [5] - A new 8-count bottle format of ARAKODA was introduced to reduce costs for short-term travelers to malaria-endemic regions [7] - The total addressable U.S. market for ARAKODA for human babesiosis may approach $1.1 billion over the remaining 10-year patent life, with annual incidence of babesiosis estimated between 25,000 and 380,000 cases [7] - The company is conducting a hospitalized babesiosis study and aims to complete interim analysis before the end of the 2025 tick season [3][7]