WASHINGTON, Aug. 21, 2025 (GLOBE NEWSWIRE) -- 60 Degrees Pharmaceuticals, Inc. (NASDAQ: SXTP; SXTPW) (“60 Degrees Pharma” or the “Company”), a pharmaceutical company focused on developing new medicines for vector-borne diseases, announced today it will participate in the H.C. Wainwright (HCW) 27th Annual Global Investment Conference at the Lotte New York Palace Hotel, September 8-10, 2025. Dr. Geoff Dow, CEO, will be presenting live on Wednesday, September 10, at 2:30 ET, and Company management will be cond ...

WASHINGTON, Aug. 21, 2025 (GLOBE NEWSWIRE) -- 60 Degrees Pharmaceuticals, Inc. (NASDAQ: SXTP; SXTPW) (“60 Degrees Pharma” or the “Company”), a pharmaceutical company focused on developing new medicines for vector-borne diseases, announced today it will participate in the H.C. Wainwright (HCW) 27th Annual Global Investment Conference at the Lotte New York Palace Hotel, September 8-10, 2025. Dr. Geoff Dow, CEO, will be presenting live on Wednesday, September 10, at 2:30 ET, and Company management will be cond ...

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]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM _________ to __________ COMMISSION FILE NUMBER 001-41719 60 DEGREES PHARMACEUTICALS, INC. (Exact name of registrant as specified in its charter) | Delaware | 45-2406880 | | --- | --- | | (State or other jurisdiction of | (I.R.S. Employer | | incorporation or organization) | Identification No.) | Form 10-Q (Mark On ...

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 successfully closed a public offering of 2,631,578 shares of common stock at a price of $1.90 per share, raising total gross proceeds of $5 million, which will be used for working capital and general corporate purposes [1][3]. Group 1: Offering Details - The public offering included Series A-1 warrants and short-term Series A-2 warrants, both with an exercise price of $1.90 per share [2]. - The Series A-1 warrants are exercisable upon issuance and expire five years thereafter, while the Series A-2 warrants expire in 18 months [2]. - The potential additional gross proceeds from the Series A-2 warrants, if fully exercised, could amount to approximately $5 million [3]. Group 2: Company Background - 60 Degrees Pharmaceuticals, Inc. specializes in developing new medicines for infectious diseases and achieved FDA approval for its lead product, ARAKODA® (tafenoquine), in 2018 [6]. - 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 institutional investors [6]. - The company is headquartered in Washington D.C. and has a majority-owned subsidiary in Australia [6].

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]

Data from three independent clinical studies demonstrate utility of tafenoquine to treat acute canine babesiosis WASHINGTON, July 14, 2025 (GLOBE NEWSWIRE) -- 60 Degrees Pharmaceuticals, Inc. (NASDAQ: SXTP; SXTPW) (“60 Degrees” or the “Company”), a pharmaceutical company focused on developing new medicines for infectious diseases, today announced that the Company will conduct a gap analysis of its existing data prior to submitting a Minor Use Minor Species (MUMS) designation request to the United States Foo ...