Core Viewpoint - bioAffinity Technologies, Inc. (BIAF) has experienced a significant decline in stock value following its third-quarter 2025 results, with shares dropping 21.8% since the earnings release, compared to a 2.2% loss in the S&P 500 Index during the same period [1] Financial Performance - In Q3 2025, bioAffinity reported total revenues of $1.4 million, a decrease of 38.5% from $2.4 million in the same quarter last year, due to a strategic exit from unprofitable pathology services and a focus on CyPath Lung commercialization [2] - CyPath Lung testing revenue increased by 122% year-over-year, driven by higher case volumes and increased physician adoption, particularly within Veterans Administration (VA) medical centers [2] - Operating expenses fell by 13.5% to $3.7 million from $4.3 million, primarily due to lower laboratory-related costs, but the net loss widened to $5.1 million from $2 million a year ago, largely due to non-cash expenses related to warrant revaluations [3] - Loss per share slightly narrowed to $4.74 from $4.84 [3] Operational Metrics - Direct costs decreased by 34.6% year-over-year to $0.9 million from $1.4 million, reflecting efficiency initiatives [4] - Selling, general, and administrative expenses decreased by 6.6%, while depreciation and amortization expenses dropped by 25.1% [4] - Research and development (R&D) spending rose by 20.4%, and clinical development costs increased by 52.9% due to expanded preclinical and clinical work [4] Growth and Adoption - Test volumes for CyPath Lung increased by 97% in the first nine months of 2025 compared to the prior year, with a record quarterly sales level in Q3 2025, climbing 92% from the previous quarter [5] - Management emphasized the importance of marketing initiatives targeting the VA health system, which have shown positive traction [7] Balance Sheet and Cash Position - Cash and equivalents improved significantly to $7.7 million from $1.1 million at year-end 2024, supported by $10.4 million in gross proceeds from equity transactions during the quarter [6] Strategic Focus and Future Plans - Management outlined strategic objectives for 2025, including expanding the sales team, engaging with major VA medical centers, and increasing marketing efforts [11] - The company is advancing companion diagnostic candidates for asthma and chronic obstructive pulmonary disease (COPD), targeting an estimated $26 billion global market [12] Governance and Intellectual Property - bioAffinity strengthened its governance with new board appointments and regained full Nasdaq Capital Market compliance [13] - The company added another U.S. patent protecting its proprietary algorithm used in CyPath Lung, marking its second consecutive quarter of patent portfolio expansion [13]

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]

Revenue Performance - CyPath Lung testing revenue increased by 86% year over year for the first nine months of 2025, driven by higher test volumes and growing clinical adoption[3] - CyPath Lung testing revenue for Q3 2025 increased approximately 122% year over year, reflecting growth in physician adoption and total test results delivered[9] - 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%[21] Operating Expenses - Operating expenses for Q3 2025 were $3.7 million, down 16% from $4.3 million in Q3 2024, due to lower direct costs related to laboratory operations[10] - Total operating expenses for the three months ended September 30, 2025, were $3,738,912, down from $4,324,250 in 2024, reflecting a reduction of about 13.5%[21] Net Loss - Net loss for Q3 2025 was $5.1 million, or $4.74 per share, compared to a net loss of $2.0 million, or $4.84 per share, for Q3 2024[11] - The net loss for the three months ended September 30, 2025, was $5,051,084, compared to a net loss of $2,000,840 in the same period of 2024, indicating an increase in losses of approximately 152.5%[21] - Net loss per common share, basic and diluted, was $(4.74) for the three months ended September 30, 2025, compared to $(4.84) in 2024, showing a minor improvement of approximately 2.1%[21] Cash Position - Cash and cash equivalents as of September 30, 2025, were $7.7 million, up from $1.1 million as of December 31, 2024[12] - The company raised approximately $10.4 million in gross proceeds from equity transactions in Q3 2025 to fund ongoing operations and growth initiatives[6] Research and Development - Research and development expenses increased by 20% year-over-year to $330,000, primarily due to expenditures for lab supplies and preclinical studies[16] - Research and development expenses increased to $330,589 for the three months ended September 30, 2025, compared to $274,497 in 2024, marking a rise of about 20.5%[21] Test Volume - The number of CyPath Lung tests processed increased by 97% in the first nine months of 2025 compared to the same period in 2024[3] Patent Portfolio - The company expanded its patent portfolio with a new U.S. patent protecting the diagnostic algorithm and test method used to detect lung cancer[3] Other Financial Metrics - Interest income for the three months ended September 30, 2025, was $1,088, down from $2,228 in 2024, a decrease of approximately 51.1%[21] - The change in fair value of warrants issued resulted in a loss of $(2,747,460) for the three months ended September 30, 2025, with no comparable figure in 2024[21] - The provision for income tax expense for the three months ended September 30, 2025, was $3,182, compared to $2,559 in 2024, indicating a slight increase of about 24.4%[21] - The weighted average common shares outstanding increased to 1,066,350 for the three months ended September 30, 2025, compared to 412,936 in 2024, reflecting a significant increase of approximately 158.5%[21] - The loss from operations for the three months ended September 30, 2025, was $(2,292,846), compared to $(1,973,864) in 2024, representing an increase in operational losses of about 16.2%[21]

Core Insights - bioAffinity Technologies has successfully closed a public offering, raising $4.8 million [1] Company Summary - The public offering was part of bioAffinity Technologies' strategy to enhance its financial position and support future growth initiatives [1] - The funds raised will be utilized for the development of the company's proprietary technologies and to expand its market presence [1]

Company Overview - bioAffinity Technologies, Inc. is a biotechnology company focused on developing noninvasive tests for early-stage cancer detection [1] - The company has announced a public offering of securities to raise capital [1] Offering Details - The offering consists of 1,921,799 shares of Common Stock priced at $2.50 per share, or pre-funded warrants at $2.493 each [2] - Each pre-funded warrant is immediately exercisable for one share of Common Stock and will expire when fully exercised [2] - The closing of the offering is expected to occur on or about September 30, 2025, pending customary closing conditions [3] Financial Aspects - The aggregate gross proceeds from the offering are expected to be significant, although the exact amount is not specified in the provided text [1] - WallachBeth Capital, LLC is acting as the sole placement agent for this offering [3]

Core Points - bioAffinity Technologies has announced the pricing of a public offering amounting to $4.8 million [1] Company Summary - The public offering is part of bioAffinity Technologies' strategy to raise capital for its operations and growth initiatives [1]

As filed with the Securities and Exchange Commission on September 25, 2025. Registration No. 333-290480 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 AMENDMENT NO. 1 TO 3300 Nacogdoches Road Suite 216 San Antonio, Texas 78217 (210) 698-5334 (Address, including zip code, and telephone number, including area code, of registrant's principal executive offices) FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 bioAffinity Technologies, Inc. (Exact name of registrant as sp ...

As filed with the Securities and Exchange Commission on September 24, 2025. Registration No. 333- UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 bioAffinity Technologies, Inc. (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorporation or organization) (Primary Standard Industrial Classification Code Number) Delaware 8731 46-5211056 (I.R.S. Employer Identification Number) 3300 N ...

Core Point - bioAffinity Technologies announced a 1-for-30 reverse stock split effective at the opening of trading on September 19, 2025 [1] Company Summary - The reverse stock split will reduce the number of outstanding shares by a factor of 30, which may impact the stock price and market perception [1]

Core Insights - CyPath® Lung technology identifies incidentally found ground-glass lung nodules, facilitating early diagnosis and timely treatment [1] Group 1 - The technology enhances the detection of lung nodules, which can lead to improved patient outcomes [1] - Early diagnosis through CyPath® Lung can potentially reduce the progression of lung diseases [1] - The innovation represents a significant advancement in lung cancer screening and management [1]