Financial Performance - Total net revenue for the three months ended September 30, 2025, was $1,446,066, a decrease from $2,350,386 in the same period of 2024, representing a decline of approximately 38.4%[20] - Total net revenue for the nine months ended September 30, 2025, was $4,569,146, a decrease from $7,154,429 for the same period in 2024[48] - Patient service fees for the nine months ended September 30, 2025, were $3,685,397, compared to $6,259,806 for the same period in 2024[48] - The Company reported a total operating loss of $7,435,545 for the nine months ended September 30, 2025, compared to a loss of $6,006,892 for the same period in 2024[55] - The net loss for the three months ended September 30, 2025, was $5,051,084, compared to a net loss of $2,000,840 for the same period in 2024, indicating an increase in losses of approximately 152.5%[20] - For the nine months ended September 30, 2025, the net loss was $11,772,288, compared to a net loss of $6,072,934 for the same period in 2024, indicating an increase in losses of approximately 93% year-over-year[27]. Cash and Assets - Cash and cash equivalents increased significantly to $7,669,195 as of September 30, 2025, compared to $1,105,291 as of December 31, 2024, marking a growth of approximately 594.5%[17] - Total assets rose to $11,546,369 as of September 30, 2025, up from $6,513,667 as of December 31, 2024, representing an increase of about 77.6%[17] - Cash and cash equivalents at the end of the period were $7,669,195, a significant increase from $756,580 at the end of September 2024[27]. - The Company has significant cash balances that regularly exceed the federally insured limit of $250,000, posing a risk to its financial condition[41] Expenses - Total operating expenses for the three months ended September 30, 2025, were $3,738,912, compared to $4,324,250 for the same period in 2024, reflecting a decrease of about 13.5%[20] - Operating expenses for the nine months ended September 30, 2025, totaled $12.00 million, down from $13.16 million in the same period of 2024, indicating a reduction of approximately 9%[20] - Research and development expenses for the three months ended September 30, 2025, were $330,589, compared to $274,497 for the same period in 2024, an increase of about 20.5%[20] - Research and development expenses for the nine months ended September 30, 2025, were $1.01 million, slightly down from $1.07 million in the same period of 2024, a decrease of about 6%[20] - Stock-based compensation expense for the nine months ended September 30, 2025, was $605,355, compared to $755,594 for the same period in 2024, reflecting a decrease of approximately 20%[27] Equity and Liabilities - Total liabilities decreased to $2,644,171 as of September 30, 2025, from $3,911,631 as of December 31, 2024, a reduction of approximately 32.4%[17] - The total stockholders' equity as of September 30, 2025, was $8,902,198, compared to $3,121,025 as of September 30, 2024, representing an increase of approximately 185%[27] - The Company incurred an accumulated deficit of approximately $65.4 million as of September 30, 2025, and expects to continue incurring losses and negative cash flows for the foreseeable future[35] Shareholder Information - The company reported a weighted average of 1,066,350 common shares outstanding for the three months ended September 30, 2025, compared to 412,936 for the same period in 2024, reflecting an increase of approximately 158.5%[20] - The Company has authorized a total of 350,000,000 shares of Common Stock, increasing from 100,000,000 shares as of July 22, 2025[84] - As of September 30, 2025, the Company issued 3,473,065 shares of Common Stock, with 6,805 being unvested restricted stock awards[84] Future Operations and Concerns - The company anticipates increased expenses associated with being a public company and plans to utilize net proceeds from financings for future operations[13] - The Company raised an additional $13.4 million in gross proceeds during the third quarter of 2025, but will need further capital to support future operations if revenue does not significantly increase[35] - The Company expects to continue incurring losses and negative cash flows for the foreseeable future, raising substantial doubt about its ability to continue as a going concern[35] Product Development - The company is developing a noninvasive diagnostic test, CyPath Lung, for early detection of lung cancer, which is currently offered for sale to physicians[30] - The company is advancing research on therapeutic discoveries that could lead to broad-spectrum cancer treatments, starting with topical treatment for squamous cell skin cancer[30] - The company is developing a flow cytometry platform for noninvasive precision diagnostic tests for asthma and COPD[30] Acquisitions and Subsidiaries - The company formed a wholly owned subsidiary, Precision Pathology Laboratory Services, LLC, on August 14, 2023, to enhance its commercial operations and product development[31] - The acquisition of PPLS on September 18, 2023, added goodwill of $1,404,486 and intangible assets totaling $2,254,486 as of September 30, 2025[52] Legal and Compliance - The Company has no material pending legal proceedings as of the reporting date[83] - The Company has not recorded any impairment for its long-lived assets for the three and nine months ended September 30, 2025[49] - The Company is currently evaluating the impact of ASU 2024-03 on its related disclosures, which will be effective for annual periods beginning after December 15, 2026[53]
bioAffinity Technologies(BIAF) - 2025 Q3 - Quarterly Report