Core Viewpoint - 60 Degrees Pharmaceuticals, Inc. has announced a public offering of common stock and warrants, aiming to raise approximately $5 million in gross proceeds, with potential additional proceeds of up to $5 million from short-term warrants [1][4]. Group 1: Offering Details - The public offering includes 2,631,578 shares of common stock or pre-funded warrants, along with Series A-1 and short-term Series A-2 warrants, priced at $1.90 per share [1][2]. - The Series A-1 warrants will have an exercise price of $1.90, exercisable upon issuance and expiring in five years, while the Series A-2 warrants will also have an exercise price of $1.90, expiring in 18 months [2]. - The closing of the offering is expected on or about July 16, 2025, pending customary closing conditions [2]. Group 2: Financial Implications - The gross proceeds from the offering are expected to be approximately $5 million before deducting fees and expenses, with an additional potential of $5 million from the exercise of Series A-2 warrants [4]. - The net proceeds from the offering will be utilized for working capital and general corporate purposes [4]. Group 3: Company Background - 60 Degrees Pharmaceuticals, Inc. specializes in developing new medicines for infectious diseases, having achieved FDA approval for its lead product, ARAKODA, in 2018 [7]. - The company collaborates with prominent research organizations in the U.S., Australia, and Singapore, and has received support from the U.S. Department of Defense and private investors [7].

Core Insights - 60 Degrees Pharmaceuticals has identified a total addressable market (TAM) for ARAKODA (tafenoquine) in treating human babesiosis, estimating it at 380,000 patients and $245 million in annual sales, with a cumulative TAM of 1.17 million patients and $1.1 billion through patent expiration in 2035 [1][2][8] - The company is advancing clinical research for tafenoquine to address the unmet medical need for babesiosis, a serious tick-borne illness, with no FDA-approved treatments currently available [1][3] Market Research - The TAM calculations were based on a nationwide survey of 6,000 patients and a quantitative research survey of 300 healthcare professionals conducted by Format Analytics [2][8] Clinical Trials - Three clinical trials sponsored by 60 Degrees Pharmaceuticals are underway to evaluate the safety and efficacy of tafenoquine for treating babesiosis, with data expected in the first half of 2026 [4][8] - A New Drug Application (NDA) submission to the U.S. FDA for babesiosis is anticipated in 2026, contingent on positive trial results [4][8] Product Information - ARAKODA (tafenoquine) was approved for malaria prophylaxis in the U.S. in 2018 and launched commercially in 2019, with a long terminal half-life of approximately 16 days allowing for less frequent dosing [5][6] - Tafenoquine is not currently approved for the treatment or prevention of babesiosis [6] Company Overview - 60 Degrees Pharmaceuticals, founded in 2010, focuses on developing new medicines for infectious diseases and has received FDA approval for ARAKODA for malaria prevention [17]

Core Insights - 60 Degrees Pharmaceuticals is conducting a gap analysis of existing data to submit a Minor Use Minor Species (MUMS) designation request to the FDA for tafenoquine to treat acute canine babesiosis [1] - Tafenoquine, marketed as ARAKODA, has shown positive results in three clinical efficacy studies for treating canine babesiosis, indicating it is well tolerated and may facilitate recovery from acute infection [2][4] - Canine babesiosis is an emerging tick-borne illness with no FDA-approved oral treatment currently available, highlighting a significant market opportunity for tafenoquine [3] Company Overview - 60 Degrees Pharmaceuticals focuses on developing new medicines for infectious diseases and achieved FDA approval for ARAKODA for malaria prophylaxis in 2018 [16] - Tafenoquine was discovered by the Walter Reed Army Institute of Research and has a long terminal half-life of approximately 16 days, allowing for less frequent dosing [4][16] - The company collaborates with prominent research organizations and has received support from the U.S. Department of Defense and private investors [16] Clinical Studies - The clinical efficacy studies involved both experimental and naturally acquired Babesia infections in dogs, with one study conducted at North Carolina State University [2] - The studies collectively demonstrated the potential of tafenoquine in treating canine babesiosis, aligning with earlier findings of its effectiveness against babesiosis in humans [4] Market Context - Canine babesiosis cases in the U.S. range from several hundred to several thousand annually, indicating a growing need for effective treatments [3] - Current treatments for canine babesiosis carry significant toxicity risks and the potential for drug resistance, creating a gap in the market that tafenoquine could fill [3]

Core Points - 60 Degrees Pharmaceuticals, Inc. has introduced a new 8-count bottle format for ARAKODA® (tafenoquine), aimed at patients traveling to malaria-endemic areas for shorter durations [1][2] - The new packaging option enhances accessibility for healthcare professionals prescribing ARAKODA for malaria prevention during trips of one week or less [2] - ARAKODA is the only weekly prophylactic therapy that protects against all stages of malaria for individuals aged 18 and older [3][4] Product Information - Tafenoquine, the active ingredient in ARAKODA, was discovered by the Walter Reed Army Institute of Research and received FDA approval for malaria prophylaxis in 2018 [4] - ARAKODA is available as a prescription-only medication and is distributed through pharmaceutical wholesaler networks in the U.S. and Australia [4] - The dosing regimen includes a loading phase of 2 x 100 mg tablets once daily for three days before travel, followed by 2 x 100 mg tablets weekly during travel, and 2 x 100 mg in the week following travel [4] Safety Information - ARAKODA is contraindicated in patients with G6PD deficiency, a history of psychotic disorders, or known hypersensitivity to tafenoquine [6][9] - The drug may cause serious adverse reactions, including hemolytic anemia and methemoglobinemia, necessitating monitoring and appropriate therapy [8][11] - Common adverse reactions reported include headache, dizziness, and gastrointestinal issues, with a notable incidence of psychiatric effects in susceptible individuals [11] Company Overview - 60 Degrees Pharmaceuticals, Inc. specializes in developing and marketing new medicines for infectious diseases, with a focus on malaria prevention [14] - The company was founded in 2010 and has received support from the U.S. Department of Defense and private investors [14] - The headquarters is located in Washington D.C., with a majority-owned subsidiary in Australia [14]

Core Insights - 60 Degrees Pharmaceuticals, Inc. announced results from an insurance claims analysis indicating a significant discrepancy between the number of Americans seeking reimbursement for babesiosis-related medical costs and CDC estimates of actual cases [1][2][10] - The company is investigating the true burden of babesiosis, particularly its association with chronic fatigue, through ongoing clinical trials and studies [6][8][10] Claims Analysis - Approximately 25,000 Americans seek reimbursement for babesiosis-related medical costs annually, while CDC estimates only 2,000 cases in 2020 [2][10] - Claims data revealed that about 31% of babesiosis cases persist longer than 30 days, with nearly half of these cases associated with chronic fatigue lasting over six months [4][10] Chronic Fatigue Insights - Babesia infections can last at least 12 months in 14% of patients, with potential relapses occurring up to 27 months later [3] - Over three years, more than 12 million U.S. adults experienced chronic fatigue lasting more than six months, yet current guidelines do not mandate babesiosis as a differential diagnosis for such fatigue [5][10] Clinical Development - The company is conducting clinical trials to evaluate the safety and efficacy of tafenoquine in treating babesiosis, with data expected in the first half of 2026 [8][10] - A new drug application (NDA) for babesiosis is anticipated to be submitted to the FDA in 2026 [8][10] Product Information - Tafenoquine, marketed as ARAKODA, was approved for malaria prophylaxis in 2018 and is available as a prescription-only medication [9][10] - The drug has a long terminal half-life of approximately 16 days, allowing for less frequent dosing [9]

Core Viewpoint - 60 Degrees Pharmaceuticals, Inc. reported significant growth in net product revenues and gross profit for Q1 2025, driven primarily by domestic sales of its lead product ARAKODA® [5][6]. Financial Highlights - Net product revenues for Q1 2025 increased by approximately 55% year-over-year, reaching about $163.6 thousand, up from $105.7 thousand in Q1 2024 [6]. - Gross profit for Q1 2025 was approximately $90.3 thousand, representing a 124% increase from approximately $40.2 thousand in Q1 2024 [5][6]. - Operating expenses rose to approximately $2.09 million in Q1 2025, compared to approximately $1.41 million in Q1 2024, with increased expenditures in sales and investor-related services contributing to this rise [6]. - The net loss attributable to common shareholders for Q1 2025 was approximately $2.01 million, or ($1.56) per share, contrasting with a net income of approximately $308.7 thousand, or $1.83 per share in Q1 2024 [6].

Financial Performance - Product revenues for the three months ended March 31, 2025, were $163,552, a 54.77% increase from $105,674 in the same period of 2024[181]. - Gross profit for the three months ended March 31, 2025, was $90,280, representing a 124.37% increase from $40,237 in the same period of 2024[180]. - Research revenues increased to $92,731 for the three months ended March 31, 2025, up 212.95% from $29,631 in the same period of 2024, driven by a new contract with USAMMDA[187]. - The gross margin percentage improved to 55.20% for the three months ended March 31, 2025, up from 38.08% in the same period of 2024[186]. - The company reported a net loss of $1,876,549 for the three months ended March 31, 2025, compared to a net income of $430,470 in the same period of 2024[179]. Cash Flow and Liquidity - The company had cash and cash equivalents of $3,451,500 as of March 31, 2025, compared to $1,659,353 as of December 31, 2024, indicating a significant increase in liquidity[163]. - Net cash used in operating activities for the three months ended March 31, 2025, was $1,597,366, up from $1,140,438 in the same period of 2024, reflecting increased operational costs[163]. - The net increase in cash and cash equivalents was $1,792,147 for the three months ended March 31, 2025, representing an increase of $1,039,932, or 138.25%, from $752,215 in 2024[195]. - Net cash provided by investing activities was $1,702,518 for the three months ended March 31, 2025, compared to a net cash used of $9,814 in the same period in 2024, marking a significant change of 17,447.85%[197]. - Net cash provided by financing activities decreased by $206,392, or 10.84%, to $1,696,899 for the three months ended March 31, 2025, compared to $1,903,291 in 2024[198]. Operational Highlights - The company suspended a Phase IIB study for the Arakoda regimen of Tafenoquine due to FDA guidance, pivoting back to focus on the commercialization of Arakoda for malaria[145]. - The company plans to increase sales of Arakoda, conduct clinical trials for new indications of Tafenoquine, and reposition small molecule therapeutics for new uses as part of its strategy for profitability[146]. - The FDA authorized the importation of Kodatef from Australia to mitigate potential shortages of Arakoda in the U.S. market due to high demand[155]. - The company enrolled the first patient in a clinical study for tafenoquine in treating persistent babesiosis, with patient enrollment expected to begin in Q3 2025[149]. - Arakoda sales volume increased by 55% to 1,579 boxes sold for the three months ended March 31, 2025, compared to 1,022 boxes in the same period of 2024[183]. - Kodatef sales to the Australian distributor were $12,066 for the three months ended March 31, 2025, compared to $1,004 in the same period of 2024, indicating a significant increase[184]. Expenses and Costs - Total operating expenses for the three months ended March 31, 2025, were $2,093,886, compared to $1,412,316 for the same period in 2024, reflecting increased R&D and administrative costs[179]. - Research and development costs increased by $70,440, or 20.89%, to $407,622 for the three months ended March 31, 2025, compared to $337,182 for the same period in 2024[188]. - General and administrative expenses rose by $611,130, or 56.84%, to $1,686,264 for the three months ended March 31, 2025, driven by higher sales, advertising, and promotion expenses[190]. - Total operating expenses increased by $681,570, or 48.26%, to $2,093,886 for the three months ended March 31, 2025, compared to $1,412,316 for the same period in 2024[188]. - Interest expense for the three months ended March 31, 2025, was $1,790, up from $1,402 in the same period in 2024, reflecting a 27.67% increase[191]. Auditor Concerns - The auditors expressed substantial doubt about the company's ability to continue as a going concern due to recurring operating losses and the need for additional capital[165]. - The company’s contractual obligations as of March 31, 2025, totaled $1,410,583, with $1,166,751 due within one year[171]. Accounting Standards and Regulations - The company has elected to take advantage of the JOBS Act exemption, delaying the adoption of certain accounting standards until they apply to private companies[213]. - The FASB issued ASU 2023-07, which expands disclosure requirements for reportable segments, effective for the 2024 annual period and interim periods beginning in 2025[215]. - ASU 2023-09 requires disaggregated information about effective tax rate reconciliation and income taxes paid, effective for annual periods beginning after December 15, 2024[216]. - ASU 2024-03 mandates public business entities to disclose disaggregated information about certain income statement expenses, effective for fiscal years beginning after December 15, 2026[217]. - The company is classified as a smaller reporting company and is electing scaled disclosure reporting obligations, thus not required to provide certain market risk information[218].

Core Insights - 60 Degrees Pharmaceuticals, Inc. has revealed that the actual burden of babesiosis in the U.S. may be significantly higher than CDC statistics indicate, with nearly 3 million Americans potentially diagnosed with the disease [1][2][9] - The survey conducted by the company suggests that babesiosis is underdiagnosed or underreported, indicating a greater demand for effective treatment than current CDC statistics suggest [2][5] - The company is developing treatment candidates for babesiosis and aims to define the commercial market size for these treatments [5][12] Survey Findings - The survey included 6,000 participants and found that 1.26% of respondents reported a diagnosis of babesiosis, equating to approximately 3 million Americans [6][9] - About 17% of those diagnosed with babesiosis reported experiencing illness for six months or more, suggesting at least 570,000 adults may have chronic disease [6][9] - Approximately 3.7% of respondents reported experiencing chronic fatigue lasting longer than six months, which may be related to babesiosis [7][9] Medical Implications - Babesiosis is a serious tick-borne disease that can co-occur with Lyme disease and may be life-threatening for immunocompromised and elderly individuals [3][10] - There is a hypothesis that persistent Babesia infection may contribute to chronic fatigue, potentially affecting millions of Americans who are undiagnosed [4][8] - The company is conducting clinical trials to test the efficacy of ARAKODA (tafenoquine) in treating babesiosis, although it is currently only approved for malaria prophylaxis [12][13] Company Background - 60 Degrees Pharmaceuticals, Inc. was founded in 2010 and specializes in developing new medicines for infectious diseases [14] - The company achieved FDA approval for its lead product, ARAKODA, in 2018 for malaria prevention and collaborates with research organizations in multiple countries [14]

Core Insights - 60 Degrees Pharmaceuticals is addressing the rising threat of babesiosis, a tick-borne disease, through participation in the Healing Lyme Summit [1][2][4] - The company is conducting two active clinical trials to evaluate the efficacy and safety of tafenoquine for treating severe babesiosis [3][6] Company Overview - 60 Degrees Pharmaceuticals, founded in 2010, focuses on developing treatments for infectious diseases and achieved FDA approval for its lead product, ARAKODA® (tafenoquine), in 2018 [6] - The company collaborates with research organizations in the U.S., Australia, and Singapore, and has received support from the U.S. Department of Defense and private investors [6] Industry Context - Babesiosis is increasingly recognized as a significant public health threat, often co-occurring with Lyme disease, yet awareness and clinical recognition remain limited [2][4] - The Healing Lyme Summit, taking place from April 15–21, 2025, aims to enhance understanding and response to tick-borne illnesses through scientific discussions and educational content [4]

Core Viewpoint - 60 Degrees Pharmaceuticals has signed a Patent License Agreement with Yale School of Medicine and Yale School of Public Health to develop and commercialize tafenoquine for treating and preventing babesiosis, a tick-borne disease [1][2][3] Company Overview - 60 Degrees Pharmaceuticals, Inc. specializes in developing new medicines for infectious diseases and achieved FDA approval for its lead product, ARAKODA® (tafenoquine), for malaria prevention in 2018 [18] - The company collaborates with prominent research organizations in the U.S., Australia, and Singapore, and is headquartered in Washington D.C. [18] Tafenoquine Development - Tafenoquine is currently not approved by the FDA for babesiosis treatment or prevention, but the agreement with Yale aims to advance its development [2][6] - The drug has shown promise as a next-generation therapeutic for babesiosis, which has limited treatment options for patients with advanced symptoms [3][4] - The clinical trial (NCT06207370) sponsored by 60 Degrees is evaluating tafenoquine's efficacy and safety in treating severe babesiosis, with enrollment ongoing at multiple U.S. sites [5] Babesiosis Context - Babesiosis is caused by the Babesia parasite and transmitted by black-legged ticks, with a significant risk for elderly and immunocompromised patients [4] - An estimated 10% of Lyme disease patients may be coinfected with Babesia, indicating a substantial patient population that could benefit from tafenoquine if approved [4] Clinical Trial Details - The clinical trial is randomized, double-blind, and placebo-controlled, focusing on the time to sustained clinical resolution and molecular cure as primary endpoints [5] - The trial aims to recruit between 24 to 33 patients before conducting an interim analysis [5]