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].
60 Degrees Pharmaceuticals(SXTP) - 2025 Q1 - Quarterly Report