Regulatory Approvals and Clinical Trials - The company has successfully achieved regulatory approval for Arakoda, a malaria preventative treatment, which has been on the market since late 2019[21]. - The FDA authorized the importation of Kodatef from Australia to cover potential disruptions of Arakoda in the U.S. market due to robust demand[47]. - An Investigational Review Board (IRB) approved a Phase II clinical study to evaluate the efficacy and safety of Tafenoquine for chronic babesiosis, with patient enrollment expected to begin in Q3 2025[48]. - The first patient has been enrolled in an expanded access clinical study for persistent babesiosis, confirming the activity of Tafenoquine in patients who have failed standard treatment[49]. - The company entered into a clinical trial agreement with Brigham and Women's Hospital to evaluate tafenoquine for hospitalized babesiosis patients, addressing a critical unmet medical need[51]. - The company is planning three clinical trials for Tafenoquine in babesiosis, with the first patient randomized on June 25, 2024, and interim analysis expected by January 31, 2026[99]. - The FDA has requested a new design for a pediatric malaria prophylaxis study, with an estimated cost of $2 million and a potential start date in Q2 2026[108]. - The FDA requires completion of preclinical laboratory tests and animal studies before human clinical trials can begin[134]. - An IND must be submitted to the FDA, which includes preclinical test results and plans for clinical trials, and there is a 30-day waiting period before trials can commence[137]. - Clinical trials are conducted in four phases, with Phase 1 focusing on safety and dosage, Phase 2 on efficacy and safety risks, Phase 3 on large-scale efficacy and safety evaluation, and Phase 4 on post-approval studies[146]. Financial Activities and Market Research - On February 5, 2025, the company sold 300,700 shares of common stock at a purchase price of $3.575 per share, raising net proceeds of $908,627[27][36]. - The company also sold 204,312 shares of common stock at a purchase price of $5.105 per share on January 28, 2025, raising net proceeds of approximately $804,346[37][46]. - In September 2024, the company entered into a securities purchase agreement for the sale of an aggregate of 1,739,133 shares of Common Stock through Pre-Funded Warrants and Series A and B Warrants[54][55]. - The company conducted market research indicating that the total U.S. market for malaria prevention therapies represents around 1.1 million prescriptions, with an accessible market for ARAKODA estimated at about 330,000 prescriptions[61]. - The company is repositioning tafenoquine for the treatment of chronic tick-borne disease (babesiosis), estimating a potential addressable market of 375,000 cases in the U.S.[62]. - The company is conducting market assessments for babesiosis, including qualitative interviews and plans for quantitative research in Q2 2025[92]. - The total operating expense for the development of Arakoda was less than $10 million, showcasing the company's ability to achieve clinical milestones cost-effectively[88]. Product Development and Pipeline - The company's pipeline includes development programs for vector-borne, fungal, and viral diseases, utilizing products such as Tafenoquine and Celgosivir[21]. - The company is evaluating tafenoquine for potential utility in fungal and viral diseases, including Dengue and RSV, which have significant global and U.S. hospitalization rates[70]. - The company has entered into a cooperative research and development agreement with the U.S. Army to complete the development of Arakoda (Tafenoquine) for malaria prevention, with a new drug application submitted to the FDA in 2018[78]. - Arakoda was approved by the FDA and Australia's Therapeutic Goods Administration in 2018 for malaria prevention, featuring convenient once-weekly dosing and good tolerability[80]. - Tafenoquine has shown potential in treating Candida infections, with 50,000 reported cases of candidiasis annually in the U.S., and could become a market-leading therapy for C. auris[74]. - The company is focused on developing treatments that utilize Tafenoquine, with multiple patents pending for its use in various infectious diseases[115]. Intellectual Property and Patents - The company holds exclusive worldwide licenses for Tafenoquine and has submitted patent applications for its use in various diseases, including COVID-19 and fungal infections[111]. - The company holds multiple patents related to the treatment of Dengue and Malaria, with several patents expiring in 2034 and 2035, indicating a strong pipeline in infectious disease therapeutics[112][114]. - The US patent for the treatment of human coronavirus infections is set to expire on February 19, 2041, showcasing the company's focus on addressing viral infections[115]. - The patent for the novel dosing regimens of Celgosivir for Dengue treatment has an estimated expiration in 2034, reflecting ongoing innovation in antiviral therapies[112]. - The patent portfolio includes treatments for Zika virus infections, with patents expiring in May 2037, indicating diversification in viral infection therapeutics[115]. - The anticipated expiration of several patents in 2041 suggests a long-term strategy for maintaining a competitive edge in the pharmaceutical market[116]. Sales and Marketing Strategies - A nine-month promotional pilot for ARAKODA® (tafenoquine) was launched to increase awareness and sales among healthcare providers and patients[52]. - The company plans to focus on increasing sales of Arakoda, conducting clinical trials for new indications, and repositioning small molecule therapeutics with good safety profiles[90]. - A new Chief Commercial Officer was hired in February 2024 to lead efforts in reintroducing Arakoda and planning new products for tick-borne diseases[92]. - The Arakoda commercial pilot program will start on March 17, 2025, aiming to increase awareness, drive trial and usage, and facilitate access and affordability[95]. - The company plans to relaunch Arakoda for malaria prevention in the United States in 2025[126]. Regulatory Compliance and FDA Processes - The FDA aims to review most NDAs within ten months and priority review applications within six months from the date of filing[150]. - Pre-approval inspections of manufacturing facilities are conducted by the FDA to ensure compliance with cGMP requirements before NDA approval[151]. - The FDA may require a Risk Evaluation and Mitigation Strategy (REMS) as a condition of approval to ensure the benefits of a product outweigh its risks[152]. - Fast-track, breakthrough therapy, and priority review designations are available for products addressing unmet medical needs, potentially expediting the review process[154]. - The FDA conducts a preliminary review of an NDA within 60 days and may request additional information before accepting it for substantive review[150]. - Companies must submit progress reports detailing clinical trial results at least annually to the FDA[147]. - The FDA may refer an application for a novel drug to an advisory committee for evaluation and recommendations[153]. Royalties and Financial Obligations - The company is obligated to pay royalties at a rate of 1.5% of gross sales under the 2014 NUS-SHS Agreement[119]. - The company will pay a minimum annual royalty of 3% of net sales for net sales under $35 million, and 5% for net sales exceeding $35 million under the U.S. Army Agreement[120]. - The company will pay Knight a royalty equal to 3.5% of net sales until July 12, 2033, or the conversion of all Series A Preferred Stock[124]. - The company is required to pay a sales-based milestone fee of $75,000 once cumulative net sales exceed $6 million under the U.S. Army Agreement[120]. - The company has a minimum annual royalty payment of $15,000 for the 2016 NUS-SHS Agreement in 2023[121].
60 Degrees Pharmaceuticals(SXTP) - 2024 Q4 - Annual Report