Phio Pharmaceuticals(PHIO) - 2025 Q3 - Quarterly Report

Financial Performance - Total current assets increased to $11,493,000 as of September 30, 2025, compared to $5,736,000 on December 31, 2024, representing a growth of 100%[10] - The net loss for the nine months ended September 30, 2025, was $6,327,000, compared to a net loss of $5,524,000 for the same period in 2024, indicating a 15% increase in losses[13] - The company reported total operating expenses of $6,686,000 for the nine months ended September 30, 2025, a 17% increase from $5,713,000 in the same period of 2024[13] - The Company reported a net loss of $2.392 million for the three months ended September 30, 2025, compared to a net loss of $1.524 million for the same period in 2024, representing a 57% increase in net loss year-over-year[74] - Total operating expenses for the nine months ended September 30, 2025, were $6.686 million, up from $5.713 million in the same period of 2024, indicating an increase of 17%[74] Cash and Financing Activities - Cash and cash equivalents at the end of the period were $10,705,000, up from $5,390,000 at the end of September 30, 2024, reflecting a 98% increase[16] - The Company raised approximately $900,000 from the December 19, 2024 Offerings after deducting placement agent fees and offering expenses[45] - The net proceeds from the July 2025 Financing were approximately $2.1 million after deducting fees and expenses[57] - Net cash used in operating activities for the nine months ended September 30, 2025, was $5,900,000, slightly higher than $5,741,000 for the same period in 2024[16] - Net cash provided by financing activities for the nine months ended September 30, 2025, was $11.2 million, an increase from $2.6 million in 2024, mainly due to the issuance and exercise of common stock and warrants[117] Research and Development - Research and development expenses for the three months ended September 30, 2025, were $1,181,000, up 83% from $644,000 in the same period of 2024[13] - Research and development expenses for the nine months ended September 30, 2025, totaled $3.141 million, compared to $2.658 million for the same period in 2024, reflecting a 18% increase[74] - The ongoing Phase 1b clinical trial for PH-762 has shown promising results, with 100% tumor clearance in one of three patients and over 90% clearance in another at Day 36[87] - A total of 18 patients with cutaneous carcinomas completed treatment in the Phase 1b trial, with 6 achieving a complete response (100% clearance) and 2 showing near complete response (>90% clearance) [88] - Preclinical data indicated that PH-762 treated DP TIL increased tumor killing activity by two-fold in collaboration with AgonOx [90] Stock and Equity - Total stockholders' equity rose to $9,839,000 as of September 30, 2025, compared to $4,723,000 at the end of 2024, marking a 108% increase[10] - The weighted average number of common shares outstanding increased to 5,468,584 for the three months ended September 30, 2025, compared to 990,033 in the same period of 2024[13] - The Company issued 2,507,005 shares of common stock and warrants, net of offering costs of $1,028,000, during the reporting period[14] - The Company completed a 1-for-9 reverse stock split effective July 5, 2024, adjusting all share and per share amounts accordingly[25] Operational Challenges - The Company has reported recurring losses from operations since inception and expects to continue negative cash flows for the foreseeable future[27] - The Company has not yet recognized any product revenues, raising doubts about its ability to continue as a going concern[28] - The Company anticipates incurring substantial additional operating losses for several years as it continues to develop product candidates and seek marketing approval[119] - Future funding requirements may be influenced by various factors, including investments in research and development, clinical trial expenses, and potential strategic acquisitions[121] - The company may seek additional funding to sustain future operations, but there is no assurance that such funding will be available on favorable terms[122] Compliance and Regulatory Risks - The company is currently in compliance with Nasdaq listing requirements, but there is no guarantee of maintaining compliance in the future[132] - Changes in U.S. and international trade policies may adversely impact the company's business and operating results, particularly regarding supply chain disruptions and increased costs[134]