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]

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 Insights - 60 Degrees Pharmaceuticals has entered a sponsored research agreement with Tulane University to study the effectiveness of tafenoquine against Borrelia and Bartonella, which are significant pathogens in Lyme disease [1][3] - The study aims to address the unmet need for effective treatments for tick-borne diseases, particularly in patients with co-infections [3] Company Overview - 60 Degrees Pharmaceuticals focuses on developing new medicines for infectious diseases and achieved FDA approval for its lead product, ARAKODA (tafenoquine), for malaria prevention in 2018 [16] - 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 [16] Product Information - Tafenoquine is an 8-aminoquinoline antimalarial drug approved for malaria prophylaxis, with a long terminal half-life of approximately 16 days, allowing for less frequent dosing [5] - ARAKODA is not approved for the treatment or prevention of babesiosis, Borrelia, or Bartonella [4][5] Research Significance - The study at Tulane University will further investigate tafenoquine's potential in treating co-infections in patients suffering from babesiosis [3] - Understanding the interactions between these pathogens is crucial for developing effective treatments for Lyme disease and related conditions [2][3]

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 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]