Core Viewpoint - 60 Degrees Pharmaceuticals, Inc. is initiating the regulatory process to gain access to the U.S. market for Australian Chestnut Extract as a botanical product for non-prescription uses [1][5]. Group 1: Company Developments - The company has exercised its option with Florida State University to negotiate an exclusive license for large-scale purification techniques to extract castanospermine from Australian Chestnut seeds [1]. - Since signing the option agreement in April 2025, the company has conducted safety testing on Australian Chestnut Extract and developed various prototype capsule formulations for oral delivery [5]. - 60 Degrees Pharmaceuticals specializes in developing new medicines for vector-borne diseases and received FDA approval for its lead product, ARAKODA, in 2018 [6]. Group 2: Product Information - Castanospermum australe, the source of castanospermine, is primarily found in Queensland and New South Wales, Australia, as well as in Florida, Hawaii, and California [2]. - Castanospermine has been shown to modulate carbohydrate metabolism and impact disease outcomes in animal models through immunomodulation [3]. - It is also a metabolite of celgosivir, which has been evaluated in clinical trials against HIV and Hepatitis C, suggesting castanospermine's safety and activity against similar pharmacological targets [4].

Core Insights - 60 Degrees Pharmaceuticals, Inc. has announced a partnership with Runway Health to enhance access to ARAKODA (tafenoquine) for malaria prevention among international travelers [1][4] - ARAKODA is the only broad-spectrum, once-weekly prescription malaria prevention medication available in the U.S. market [2][9] - The partnership will commence on April 2, 2026, and aims to provide a personalized medical treatment plan for travelers [4] Company Overview - 60 Degrees Pharmaceuticals, Inc. specializes in developing new medicines for vector-borne diseases and received FDA approval for ARAKODA in 2018 [18] - The company is headquartered in Washington, D.C., and has a subsidiary in Australia, with ARAKODA commercially available in both countries [18] Product Information - ARAKODA (tafenoquine) is indicated for malaria prophylaxis in adults aged 18 and older and has been assessed for safety in multiple clinical trials [5][8] - The drug has a long terminal half-life of approximately 16 days, allowing for less frequent dosing [7] - ARAKODA is prescribed in 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 [7] Partnership Details - The collaboration with Runway Health will utilize a telehealth platform to facilitate online consultations and home delivery of ARAKODA before travel [2][4] - This partnership adds a consumer-focused approach to the marketing strategy of ARAKODA, targeting individuals planning to travel to malaria-endemic regions [9]

Core Viewpoint - 60 Degree Pharmaceuticals, Inc. will implement a one-for-four (1:4) reverse stock split to comply with Nasdaq's minimum bid price requirement, effective January 20, 2026 [1][2] Group 1: Reverse Stock Split Details - The reverse stock split will reduce the number of outstanding shares from approximately 5,148,767 to about 1,287,192 [5] - All issued and outstanding shares, options, restricted stock awards, warrants, and other securities will be adjusted accordingly, with no fractional shares issued [4] - The par value of the Common Stock will remain unchanged at $0.0001 per share, and the authorized number of shares will not change [4] Group 2: Approval Process - Stockholders approved the reverse split proposal at a special meeting on October 8, 2025, allowing the board to file an amendment to effect the split [3] - The board officially approved the reverse split on December 17, 2025, and the amendment has been filed with the Secretary of State of Delaware [3] Group 3: Company Overview - 60 Degrees Pharmaceuticals, Inc. specializes in developing new medicines for vector-borne diseases and received FDA approval for its lead product, ARAKODA, in 2018 [6] - The company is headquartered in Washington, D.C., with a subsidiary in Australia and collaborates with prominent research organizations [6]

Core Insights - 60 Degrees Pharmaceuticals, Inc. announced a study revealing that 24% of 50 patients with chronic fatigue were infected with Babesia, a parasite linked to babesiosis, suggesting a potential connection between Babesia infection and prolonged recovery times in chronic fatigue patients [1][2][9] Group 1: Study Findings - The study conducted by North Carolina State University involved 50 participants who reported chronic diseases and potential exposure to arthropod vectors, with all participants experiencing fatigue for at least six months [5] - The findings support the hypothesis that Babesia infection may be associated with chronic diseases, particularly in prolonging recovery times for patients suffering from chronic fatigue [2][4] Group 2: Ongoing Research - The B-Free Chronic Babesiosis Study is currently evaluating the efficacy and safety of the ARAKODA regimen (tafenoquine) over 90 days for resolving severe fatigue in chronic babesiosis patients, with enrollment taking place at the Icahn School of Medicine at Mount Sinai in New York [3][9] - The study's results highlight the need for further prospective controlled studies to better understand the relationship between Babesia infection and chronic diseases [4] Group 3: Babesiosis Overview - Babesiosis is a tick-borne illness caused by Babesia parasites, leading to symptoms such as fevers, chills, and fatigue, with severe cases posing life-threatening risks, especially to the elderly and immunosuppressed [7] - The incidence of babesiosis is rapidly increasing, particularly in the Northeast, with an estimated minimum annual incidence of at least 25,000 cases in the U.S., although the actual number may be significantly higher [7][8] Group 4: Company Background - 60 Degrees Pharmaceuticals, Inc. specializes in developing new medicines for vector-borne diseases and received FDA approval for its lead product, ARAKODA (tafenoquine), for malaria prevention in 2018 [10] - The company collaborates with prominent research and academic organizations in the U.S. and Australia, and is headquartered in Washington, D.C. [10]

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]