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].

Revenue Performance - Product revenues for the three months ended September 30, 2025, were $437,602, compared to $135,293 for the same period in 2024, representing an increase of 224%[175] - For the nine months ended September 30, 2025, product revenues reached $702,086, up from $365,939 in 2024, indicating a growth of 92%[175] - Research revenues increased to $90,960 for the three months ended September 30, 2025, from $12,818 in 2024, marking a 609.63% increase[184] - Product revenues for the nine months ended September 30, 2025, reached $702,086, a 91.86% increase from $365,939 in the same period of 2024[195] - Research revenues surged to $390,630 for the nine months ended September 30, 2025, an increase of 804.72% from $43,177 in 2024, primarily due to a new USAMMDA contract[202] Financial Position - As of September 30, 2025, the company had cash and cash equivalents of $4,115,779, a decrease from $1,659,353 as of December 31, 2024[160] - The company raised approximately $4,281,300 in net proceeds from the July 2025 Offering, which closed on July 16, 2025[156] - Cash and cash equivalents increased by 112.09% to $2,456,426 for the nine months ended September 30, 2025, compared to $1,158,203 in 2024[212] Operating Expenses - Total operating expenses for the three months ended September 30, 2025, were $2,316,397, a 7.48% increase from $2,155,116 in 2024[186] - General and administrative expenses rose by 24.00% to $1,506,620 for the three months ended September 30, 2025, from $1,215,053 in 2024[189] - Operating expenses decreased by 19.50% to $6,272,931 for the nine months ended September 30, 2025, compared to $7,792,318 in 2024[203] Profitability and Loss - The cost of revenues for the three months ended September 30, 2025, was $537,690, compared to $111,687 in 2024, resulting in a gross loss of $100,088[175] - Gross profit for the nine months ended September 30, 2025, was $41,073, down 58.62% from $99,251 in 2024, resulting in a gross margin decrease from 27.12% to 5.85%[195][201] - The company recognized a loss of $156,445 on the change in fair value of derivative liabilities for the nine months ended September 30, 2025, compared to a gain of $1,683,034 in 2024[210] Cash Flow - Net cash used in operating activities increased by 28.60% to $(5,156,566) for the nine months ended September 30, 2025, compared to $(4,009,871) in 2024[212] - Net cash provided by investing activities was $1,625,347 for the nine months ended September 30, 2025, compared to net cash used of $1,887,016 for the same period in 2024, with proceeds of $1,708,000 from short-term investments[215] - Net cash provided by financing activities decreased to $5,979,077 for the nine months ended September 30, 2025, from $7,052,598 in the same period of 2024, mainly due to lower net proceeds from stock offerings[216] Debt and Obligations - Contractual obligations as of September 30, 2025, total $1,639,415, with $1,400,119 due within one year[168] - The company has accumulated losses to date and has not generated enough revenues to cover operating expenses, raising concerns about its ability to continue as a going concern[161] - The company plans to fund operations through third-party debt, private placements, and stock issuance until achieving profitability[164] Research and Development - Research and development expenses decreased by 13.86% to $809,777 for the three months ended September 30, 2025, compared to $940,063 in 2024[186] - The company capitalized research and development costs for its babesiosis trial at $1,109,279 for the nine months ended September 30, 2025, up from $846,323 in the same period of 2024[214] Accounting and Standards - The company recognized revenue in accordance with FASB ASC Topic No. 606, with revenue recognized when control is transferred to customers[220] - The company has elected to take advantage of the JOBS Act accounting election, allowing it to delay the adoption of certain accounting standards[233] - The company adopted ASU 2023-07 on a retrospective basis for the 2024 annual period, impacting financial statement disclosures[235]

Summary of 60 Degrees Pharmaceuticals Webinar Company Overview - **Company**: 60 Degrees Pharmaceuticals (NasdaqCM: SXTP) - **Product**: ARAKODA® (FDA-approved for malaria prevention) - **Market Cap**: Currently does not reflect historical achievements and success [15][18] Key Points and Arguments Sales Performance - ARAKODA® sales were impacted by the COVID-19 pandemic, limiting travel and thus demand [16] - Sales have increased over time, primarily driven by off-label use for chronic babesiosis [17] - Annualized gross sales are currently between $1 million and $2 million, with potential to exceed $200 million by 2035 [18] Market Potential - Malaria prevention is estimated to represent about 25% of the market potential, while chronic babesiosis could account for the majority [18] - The company aims to prove the economic opportunity and meet unmet medical needs associated with chronic babesiosis [19] Commercial Strategy - A commercial pilot program was initiated in July 2024 to increase awareness and differentiate ARAKODA® through electronic media and virtual sales representatives [22] - The pilot program includes a copay opportunity to reduce out-of-pocket costs for insured patients [22] - The company is focused on increasing awareness and managing reimbursement and market access [37][38] Research and Development - The company is conducting three clinical trials targeting different populations of babesiosis patients, with results expected in the second half of 2026 [30] - A breakthrough therapy designation request is planned for submission, with feedback expected in December [33][42] Market Valuation - The potential market for tafenoquine in babesiosis is estimated at $245 million annually, contingent on proving chronic babesiosis as a clinically significant condition [44] - The total market potential for ARAKODA® is projected to be over $200 million, with chronic babesiosis accounting for approximately 75% of that [48] Financial Outlook - The company reported a cash runway through March 2026, with updates expected in mid-November [49] - Positive cash flow timeline will be reassessed based on the outcomes of the commercial pilot data [50] Additional Important Information - ARAKODA® requires fewer pills compared to generic alternatives, which may enhance patient compliance [22] - The company is exploring the potential of tafenoquine for treating chronic Lyme disease in collaboration with Tulane University [35] - The incidence of malaria in returning travelers has been increasing, highlighting the ongoing relevance of malaria prevention [20] This summary encapsulates the critical insights from the 60 Degrees Pharmaceuticals webinar, focusing on the company's product, market potential, commercial strategies, and research initiatives.

Core Insights - 60 Degrees Pharmaceuticals has announced that the first patient in its trial for relapsing babesiosis has tested negative for the disease, indicating potential efficacy of ARAKODA (tafenoquine) in immunosuppressed patients [1][7] Company Developments - The company is conducting an expanded access study of ARAKODA in combination with conventional treatments for relapsing babesiosis, with the trial expected to confirm a high cure rate as reported by Yale in a 2024 publication [5][9] - A Breakthrough Therapy Designation request has been submitted to the FDA for tafenoquine, and the company plans to request a Type B meeting with the FDA in early 2026 to discuss the requirements for a supplementary New Drug Application (sNDA) [4][8] Clinical Study Details - The study is an open-label, multi-site trial evaluating the safety and efficacy of tafenoquine in patients with risk factors for severe disease who have previously failed conventional treatments [5][9] - The first patient tested negative for babesiosis using both the Mayo Clinic RT-PCR and an FDA-approved RNA amplification test, which is significantly more sensitive than standard tests [6][7] Disease Context - Babesiosis is a tick-borne illness that can be life-threatening, especially in elderly and immunosuppressed patients, with a rising incidence particularly in the Northeast [2] - The disease may relapse in patients with certain risk factors, and Babesia parasites can develop resistance to conventional drugs [2]

Core Insights - 60 Degrees Pharmaceuticals, Inc. has announced the B-FREE Chronic Babesiosis Study, the first trial globally to evaluate a potential new treatment for chronic babesiosis [1][2] - The study will assess the efficacy and safety of the ARAKODA regimen of tafenoquine over a 90-day period for patients suffering from chronic babesiosis [2][6] - Currently, there are no FDA-approved treatments for chronic babesiosis, highlighting the significance of this study [3][10] Company Overview - 60 Degrees Pharmaceuticals specializes in developing new medicines for vector-borne diseases and received FDA approval for its lead product, ARAKODA, in 2018 [24] - The company is headquartered in Washington, D.C., and collaborates with research and academic organizations in the U.S. and Australia [24] Study Details - The B-FREE study is a Phase 2 open-label trial expected to last approximately 12 months, enrolling up to 100 patients diagnosed with chronic babesiosis [2][7] - The primary endpoint is the resolution of fatigue, measured at Day 90 compared to baseline, with participants having experienced significant functional impairment for at least six months [6][7] - Tafenoquine, the active ingredient in ARAKODA, is currently approved for malaria prophylaxis but has not been proven effective for babesiosis treatment [5][12] Patient Engagement - The naming of the B-FREE study involved direct engagement with the tick-borne disease patient community, reflecting the company's commitment to patient involvement in research [4][5] - A total of $5,000 was donated to the Global Lyme Alliance and the International Lyme and Associated Diseases Education Foundation as part of this initiative [4] Public Health Context - Chronic babesiosis is a growing public health concern, particularly for vulnerable populations such as the elderly and immunocompromised individuals [5][10] - The incidence of babesiosis is rising, with an estimated minimum of 25,000 cases annually in the U.S., although the actual number may be significantly higher [10]

Summary of 60 Degrees Pharmaceuticals FY Conference Call Company Overview - **Company**: 60 Degrees Pharmaceuticals (NasdaqCM:SXTP) - **Focus**: Development and commercialization of small molecule therapeutics for vector-borne diseases, specifically malaria and babesiosis [1][2] Core Product - **Product**: Aracoda, approved for malaria prevention in 2018 - **Sales History**: Entered the US supply chain in September 2019; sales initially impacted by the COVID-19 pandemic but have since increased, with a significant portion attributed to chronic babesiosis [2][3][4] Sales and Market Potential - **Sales Growth**: Sales have stabilized with a gross margin of approximately 50% [4][5] - **Future Sales Potential**: Projected sales could exceed $200 million by 2035, with contributions from malaria prevention (20%), acute babesiosis, and chronic babesiosis [5][6] - **Market Research**: Identified a growing need for malaria prevention due to increasing cases among travelers and the complexity of existing treatment regimens [6][7][8] Commercial Strategy - **Commercial Pilot Program**: Launched to increase brand awareness and sales, including electronic outreach, direct physician contact, and co-pay assistance [10][11] - **Data Expectations**: Anticipated data from the pilot program by the end of 2025, which will inform future scaling decisions [12] Babesiosis Program - **Disease Overview**: Babesiosis is transmitted by ticks and shares similarities with malaria, including symptoms and treatment challenges [12][13] - **Diagnostic Challenges**: The introduction of a new FDA-approved diagnostic test has significantly reduced blood-borne infections, indicating a hidden reservoir of undiagnosed cases [14][15] - **Clinical Trials**: Three trials are underway to explore the efficacy of Tefaniquin for chronic babesiosis, with the goal of enrolling 100 patients [22][24] Research and Development - **Tefaniquin's Efficacy**: Promising results from animal studies and a case series from Yale University suggest Tefaniquin may effectively treat chronic babesiosis [20][21] - **Trial Design**: Trials are designed to confirm chronic babesiosis diagnoses and assess the drug's impact on patient-reported outcomes [25][26] Market Outlook - **Sales Growth**: Increased sales reported in the first half of the year, with expectations for continued growth following the resolution of supply chain issues [26][27] - **Future Catalysts**: Upcoming data releases and regulatory decisions regarding new labeling for babesiosis are expected to drive investor interest [27] Conclusion - **Investor Engagement**: The company is focused on leveraging market research and clinical trial data to enhance its product offerings and expand its market presence in the vector-borne disease space [27][28]

Company Overview - 60 Degrees Pharmaceuticals, Inc. specializes in developing and commercializing new medicines for vector-borne diseases [2] - The company was founded in 2010 and is headquartered in Washington, D.C., with a subsidiary in Australia [2] - 60 Degrees Pharma achieved FDA approval for its lead product, ARAKODA (tafenoquine), for malaria prevention in 2018, which is commercially available in the U.S. and Australia [2] Upcoming Event - The company will present live at the H.C. Wainwright 27th Annual Global Investment Conference on September 9, 2025, at 3:30 PM ET [1][2] - Dr. Geoff Dow, the CEO of 60 Degrees Pharma, will conduct one-on-one meetings during the conference [2] - The event will take place at the Lotte New York Palace Hotel, and a webcast link is available for registration [1][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 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].