As filed with the Securities and Exchange Commission on August 29, 2025. Registration No. 333- UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM S-1 3300 Nacogdoches Road Suite 216 San Antonio, Texas 78217 (210) 698-5334 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) Delaware 8731 46-5211056 (Primary Standard Industrial Class ...

Core Viewpoint - bioAffinity Technologies, Inc. (BIAF) has experienced a significant decline in stock value following its second-quarter 2025 earnings release, with an 11% drop since the report and a 27.4% decline over the past month, contrasting with the S&P 500's performance [1][2]. Financial Performance - For Q2 2025, bioAffinity reported revenues of $1.3 million, a 47.1% decrease from $2.4 million in the same quarter last year, primarily due to the discontinuation of unprofitable pathology services [2]. - Testing revenue from the CyPath Lung diagnostic test increased by 62.3% year-over-year in the first half of 2025, reaching $323,000 from $199,000, indicating growing physician adoption [2]. - Operating expenses decreased by 15.6% to $3.8 million from $4.5 million a year earlier, but the net loss widened to $4.1 million, or $0.17 per share, compared to a loss of $2.1 million, or $0.19 per share, in Q2 2024 [3]. - The accumulated deficit increased to $60.4 million, with total stockholders' deficit at $2.1 million as of June 30, 2025 [5]. Cost Management - Direct costs fell by 27.8% year-over-year, and research and development spending decreased by 22.6% to $0.3 million [4]. - Clinical development expenses surged by 151.2% to $129,279, reflecting increased professional fees for advancing CyPath Lung toward pivotal trials [4]. - Selling, general, and administrative expenses were reduced by 10.4% to $2.2 million, aided by efficiencies from integrating Precision Pathology Laboratory Services [4]. Strategic Initiatives - CEO Maria Zannes highlighted the acceleration of the CyPath Lung commercialization strategy, supported by real-world case studies demonstrating its effectiveness in detecting early-stage lung cancers [6]. - A price increase for CyPath Lung to $2,900 was implemented to align with private payer reimbursement, and a logistics partnership with Cardinal Health OptiFreight was established to enhance sample delivery reliability [7]. - The company has expanded its intellectual property portfolio with new patents in the U.S., China, Canada, and Australia [7][10]. Market Positioning - The decline in revenue was attributed to a strategic exit from lower-margin pathology services, allowing a focus on high-margin diagnostics [8]. - CyPath Lung achieved record sales in June and July, indicating strong market traction [8]. - Management aims to broaden distribution into new regions and health systems while advancing next-generation diagnostic and therapeutic platforms [9].

PART I FINANCIAL INFORMATION [ITEM 1. CONDENSED CONSOLIDATED FINANCIAL STATEMENTS.](index=7&type=section&id=ITEM%201.%20CONDENSED%20CONSOLIDATED%20FINANCIAL%20STATEMENTS.) This section presents unaudited condensed consolidated financial statements and notes, detailing financial position, performance, and accounting policies - The financial statements include Condensed Consolidated Balance Sheets, Unaudited Condensed Consolidated Statements of Operations, Unaudited Condensed Consolidated Statements of Changes in Stockholders' Equity, Unaudited Condensed Consolidated Statements of Cash Flows, and Notes to Unaudited Condensed Consolidated Financial Statements[15](index=15&type=chunk)[16](index=16&type=chunk)[18](index=18&type=chunk) Key Financial Position Data (June 30, 2025 vs. December 31, 2024) | Metric | June 30, 2025 (unaudited) | December 31, 2024 | | :--------------------------------- | :------------------------ | :---------------- | | Total assets | $4,751,075 | $6,513,667 | | Total liabilities | $6,887,183 | $3,911,631 | | Total stockholders' equity (deficit) | $(2,136,108) | $2,602,036 | Key Operating Results (Six Months Ended June 30) | Metric | 2025 (USD) | 2024 (USD) | | :--------------------------------- | :--------- | :--------- | | Net revenue | $3,123,080 | $4,804,043 | | Net loss | $(6,721,204) | $(4,072,094) | | Net loss per common share, basic and diluted | $(0.20) | $(0.38) | Key Cash Flow Data (Six Months Ended June 30) | Activity | 2025 (USD) | 2024 (USD) | | :--------------------------------- | :--------- | :--------- | | Net cash used in operating activities | $(4,288,981) | $(3,878,400) | | Net cash provided by financing activities | $4,050,738 | $1,927,813 | | Cash and cash equivalents at end of period | $802,835 | $801,311 | [Condensed Consolidated Balance Sheets](index=7&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) Condensed Consolidated Balance Sheets (June 30, 2025 vs. December 31, 2024) | Metric | June 30, 2025 (unaudited) | December 31, 2024 | | :--------------------------------- | :------------------------ | :---------------- | | Cash and cash equivalents | $802,835 | $1,105,291 | | Accounts and other receivables, net | $421,869 | $1,139,204 | | Total current assets | $1,668,826 | $2,695,098 | | Total assets | $4,751,075 | $6,513,667 | | Accounts payable | $1,169,837 | $987,311 | | Accrued expenses | $1,048,034 | $1,398,722 | | Warrant liability | $3,974,911 | — | | Total liabilities | $6,887,183 | $3,911,631 | | Accumulated deficit | $(60,365,514) | $(53,644,310) | | Total stockholders' equity (deficit) | $(2,136,108) | $2,602,036 | [Unaudited Consolidated Statements of Operations](index=9&type=section&id=Unaudited%20Consolidated%20Statements%20of%20Operations) Unaudited Consolidated Statements of Operations (Three and Six Months Ended June 30) | Metric | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--------------------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Net revenue | $1,269,483 | $2,397,652 | $3,123,080 | $4,804,043 | | Total operating expenses | $3,785,043 | $4,485,450 | $8,265,779 | $8,837,071 | | Loss from operations | $(2,515,560) | $(2,087,798) | $(5,142,699) | $(4,033,028) | | Change in fair value of warrants issued | $(1,062,818) | — | $(1,062,818) | — | | Net loss | $(4,060,787) | $(2,110,279) | $(6,721,204) | $(4,072,094) | | Net loss per common share, basic and diluted | $(0.17) | $(0.19) | $(0.20) | $(0.38) | | Weighted average common shares outstanding | 24,021,546 | 11,389,308 | 20,148,211 | 10,655,483 | [Unaudited Consolidated Statements of Changes in Stockholders' Equity](index=10&type=section&id=Unaudited%20Consolidated%20Statements%20of%20Changes%20in%20Stockholders'%20Equity) Stockholders' Equity Changes (Six Months Ended June 30, 2025) | Item | Shares | Common Stock Amount | Additional Paid-in Capital | Accumulated Deficit | Stockholders' Equity (Deficit) | | :-------------------------- | :------- | :------------------ | :----------------------- | :-------------------- | :----------------------------- | | Balance at Dec 31, 2024 | 15,227,619 | $106,593 | $56,139,753 | $(53,644,310) | $2,602,036 | | Stock-based compensation expense | 294,068 | $2,059 | $536,164 | — | $538,223 | | Sale of common stock, net | 7,784,904 | $54,494 | $187,834 | — | $242,328 | | Exercise of stock warrants | 4,870,010 | $34,090 | $1,524,486 | — | $1,558,576 | | Offering costs | — | — | $(356,067) | — | $(356,067) | | Net loss | — | — | — | $(6,721,204) | $(6,721,204) | | Balance at June 30, 2025 | 28,176,601 | $197,236 | $58,032,170 | $(60,365,514) | $(2,136,108) | [Unaudited Consolidated Statements of Cash Flows](index=12&type=section&id=Unaudited%20Consolidated%20Statements%20of%20Cash%20Flows) Unaudited Consolidated Statements of Cash Flows (Six Months Ended June 30) | Activity | 2025 (USD) | 2024 (USD) | | :--------------------------------- | :--------- | :--------- | | Net cash used in operating activities | $(4,288,981) | $(3,878,400) | | Net cash used in investing activities | $(64,213) | $(69,672) | | Net cash provided by financing activities | $4,050,738 | $1,927,813 | | Net decrease in cash and cash equivalents | $(302,456) | $(2,020,259) | | Cash and cash equivalents at beginning of period | $1,105,291 | $2,821,570 | | Cash and cash equivalents at end of period | $802,835 | $801,311 | [Notes to Condensed Consolidated Financial Statements](index=13&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) - The notes provide detailed explanations and disclosures for the condensed consolidated financial statements, covering operations, significant accounting policies, financial instrument valuations, lease obligations, equity activities, and subsequent events[26](index=26&type=chunk) - bioAffinity Technologies develops noninvasive diagnostics for early-stage lung cancer (CyPath Lung) and other lung diseases using flow cytometry and AI, and is also developing therapeutic discoveries for broad-spectrum cancer treatments[27](index=27&type=chunk) - The company had an accumulated deficit of approximately **$60.4 million** at June 30, 2025, and cash and cash equivalents of approximately **$0.8 million**, raising substantial doubt about its ability to continue as a going concern for at least twelve months[31](index=31&type=chunk) Net Revenue by Source (Six Months Ended June 30) | Revenue Source | 2025 (USD) | 2024 (USD) | | :--------------------------------- | :--------- | :--------- | | Patient service fees | $2,512,449 | $4,209,955 | | Histology service fees | $572,358 | $530,053 | | Medical director fees | $33,897 | $33,193 | | Department of Defense observational studies | — | $6,923 | | Other revenues | $4,376 | $23,919 | | **Total net revenue** | **$3,123,080** | **$4,804,043** | - Direct billing for CyPath Lung diagnostic test was approximately **$323,000** for the six months ended June 30, 2025, an increase from **$199,000** in the prior year[43](index=43&type=chunk) - The company's outstanding warrants totaled **28,193,118** at June 30, 2025, with a weighted average exercise price of **$1.44**. A warrant liability of **$3,974,911** was recorded at June 30, 2025, primarily due to the May 2025 public offering and a **$1.1 million** change in fair value[81](index=81&type=chunk)[93](index=93&type=chunk)[65](index=65&type=chunk) - Subsequent events include stockholder approval for a reverse stock split and an increase in authorized common stock, a Nasdaq non-compliance notice regarding bid price and stockholders' equity, and further private placement and warrant inducement agreements in August 2025[96](index=96&type=chunk)[97](index=97&type=chunk)[99](index=99&type=chunk) [ITEM 2. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS.](index=30&type=section&id=ITEM%202.%20MANAGEMENT'S%20DISCUSSION%20AND%20ANALYSIS%20OF%20FINANCIAL%20CONDITION%20AND%20RESULTS%20OF%20OPERATIONS.) Management discusses the company's financial condition, operations, and liquidity, highlighting performance and going concern issues - The company's core business involves developing noninvasive diagnostics for early-stage lung cancer (CyPath Lung) and other lung diseases using flow cytometry and AI, alongside advancing novel cancer therapeutic approaches[104](index=104&type=chunk)[105](index=105&type=chunk)[107](index=107&type=chunk) - CyPath Lung testing revenue increased approximately **62%** to **$323,000** for the six months ended June 30, 2025, compared to **$199,000** for the same period in 2024[110](index=110&type=chunk) - Consolidated revenue decreased approximately **35%** to **$3.1 million** for the six months ended June 30, 2025, from **$4.8 million** in 2024, primarily due to strategic actions to discontinue certain unprofitable pathology services[110](index=110&type=chunk) - The net loss for the six months ended June 30, 2025, was approximately **$6.7 million**, an increase from **$4.1 million** in the prior year, largely due to a **$1.1 million** loss on remeasurement of warrant liability[143](index=143&type=chunk)[158](index=158&type=chunk) - The company faces substantial doubt about its ability to continue as a going concern, with cash and cash equivalents of **$0.8 million** at June 30, 2025, expected to support operations only through August 2025, necessitating further capital raises[127](index=127&type=chunk)[160](index=160&type=chunk) [Company Overview](index=30&type=section&id=Company%20Overview) - bioAffinity Technologies develops noninvasive diagnostics for early-stage lung cancer (CyPath Lung) and other lung diseases using flow cytometry and AI, and is advancing novel cancer therapeutic approaches[104](index=104&type=chunk)[105](index=105&type=chunk)[107](index=107&type=chunk) - CyPath Lung sales in July 2025 represented a **72% increase** over the previous monthly average for the first six months of 2025, with the company reaffirming a forecast of **3X year-over-year revenues** for CyPath Lung[111](index=111&type=chunk) - Recent patent awards include grants in China for a novel cancer-killing composition and method, and an allowance in Canada for lung disease detection via flow cytometry[117](index=117&type=chunk)[119](index=119&type=chunk)[120](index=120&type=chunk) - The company received a Nasdaq notice on August 7, 2025, for non-compliance with the minimum bid price (**$1**) and minimum stockholders' equity (**$2.5 million**) requirements, and has requested a hearing appeal[126](index=126&type=chunk) [Results of Operations (Three Months Ended June 30, 2025, Compared to Three Months Ended June 30, 2024)](index=34&type=section&id=Results%20of%20Operations%20(Three%20Months%20Ended%20June%2030,%202025,%20Compared%20to%20Three%20Months%20Ended%20June%2030,%202024)) - Net loss for the three months ended June 30, 2025, was approximately **$4.1 million**, compared to **$2.1 million** for the same period in 2024[130](index=130&type=chunk) - Consolidated revenue decreased by **$1.1 million** (**35%**) to **$1.3 million** in Q2 2025, from **$2.4 million** in Q2 2024, primarily due to discontinuing certain unprofitable pathology services[133](index=133&type=chunk) - CyPath Lung testing revenue decreased approximately **5%** to **$153,000** in Q2 2025, despite an increase in tests delivered, attributed to revised revenue estimation based on recent collection data[133](index=133&type=chunk) Operating Expense Changes (Three Months Ended June 30, YoY) | Expense Category | 2025 (USD) | 2024 (USD) | Change (USD) | Change (%) | | :-------------------------------- | :--------- | :--------- | :----------- | :--------- | | Direct costs and expenses | $1,016,602 | $1,407,710 | $(391,108) | (28)% | | Research and development | $311,372 | $402,433 | $(91,061) | (23)% | | Clinical development | $129,279 | $51,462 | $77,817 | 151% | | Selling, general and administrative | $2,214,561 | $2,472,775 | $(258,214) | (10)% | | Depreciation and amortization | $113,229 | $151,070 | $(37,841) | (25)% | | **Total operating expenses** | **$3,785,043** | **$4,485,450** | **$(700,407)** | **(16)%** | - Total other income (expense), net, was **$(1.5) million** in Q2 2025, a significant increase from **$(17,000)** in Q2 2024, primarily due to a **$1.1 million** loss on remeasurement of warrant liability[142](index=142&type=chunk) [Results of Operations (Six Months Ended June 30, 2025, Compared to Six Months Ended June 30, 2024)](index=35&type=section&id=Results%20of%20Operations%20(Six%20Months%20Ended%20June%2030,%202025,%20Compared%20to%20Six%20Months%20Ended%20June%2030,%202024)) - Net loss for the six months ended June 30, 2025, was approximately **$6.7 million**, compared to **$4.1 million** for the same period in 2024[143](index=143&type=chunk) - Consolidated revenue decreased by **$1.7 million** (**35%**) to **$3.1 million** for H1 2025, from **$4.8 million** for H1 2024, due to strategic actions to discontinue certain unprofitable pathology services[146](index=146&type=chunk) - CyPath Lung testing revenue increased approximately **56%** to **$323,000** for H1 2025, from **$207,000** for H1 2024, with **390 tests** delivered (vs **221**)[146](index=146&type=chunk) Operating Expense Changes (Six Months Ended June 30, YoY) | Expense Category | 2025 (USD) | 2024 (USD) | Change (USD) | Change (%) | | :-------------------------------- | :--------- | :--------- | :----------- | :--------- | | Direct costs and expenses | $2,384,462 | $2,981,151 | $(596,689) | (20)% | | Research and development | $678,758 | $796,072 | $(117,314) | (15)% | | Clinical development | $267,632 | $100,422 | $167,210 | 167% | | Selling, general and administrative | $4,667,110 | $4,658,719 | $8,391 | 0% | | Depreciation and amortization | $267,817 | $300,707 | $(32,890) | (11)% | | **Total operating expenses** | **$8,265,779** | **$8,837,071** | **$(571,292)** | **(6)%** | - Total other income (expense), net, was **$(1.5) million** for H1 2025, a significant increase from **$(30,000)** for H1 2024, primarily due to a **$1.1 million** loss on remeasurement of warrant liability[158](index=158&type=chunk) [Liquidity, Capital Resources, and Going Concern](index=38&type=section&id=Liquidity,%20Capital%20Resources,%20and%20Going%20Concern) - The company has funded operations primarily through equity sales, raising approximately **$46.0 million** gross proceeds since inception[159](index=159&type=chunk) - Net losses for the six months ended June 30, 2025, were **$6.7 million**, contributing to an accumulated deficit of approximately **$60.4 million**[160](index=160&type=chunk) - Cash and cash equivalents were **$0.8 million** at June 30, 2025, and **$0.3 million** as of August 14, 2025, which is expected to support operations only through August 2025[160](index=160&type=chunk) - Management concludes there is substantial doubt about the company's ability to continue as a going concern for at least twelve months, necessitating further capital raises through equity, debt, strategic relationships, or grants[160](index=160&type=chunk)[161](index=161&type=chunk) [Summary Statements of Cash Flows](index=38&type=section&id=Summary%20Statements%20of%20Cash%20Flows) Summary Statements of Cash Flows (Six Months Ended June 30) | Activity | 2025 (USD) | 2024 (USD) | | :--------------------------------- | :--------- | :--------- | | Net cash used in operating activities | $(4,288,981) | $(3,878,400) | | Net cash used in investing activities | $(64,213) | $(69,672) | | Net cash provided by financing activities | $4,050,738 | $1,927,813 | | Cash and cash equivalents at beginning of period | $1,105,291 | $2,821,570 | | Cash and cash equivalents at end of period | $802,835 | $801,311 | - The increase in cash used in operating activities for H1 2025 was primarily due to an increased loss from operations and a fair value adjustment to the warrant liability[164](index=164&type=chunk) - Cash provided by financing activities significantly increased in H1 2025, driven by **$4.4 million** in net proceeds from equity transactions[166](index=166&type=chunk) [Contractual Obligations and Commitments](index=40&type=section&id=Contractual%20Obligations%20and%20Commitments) - The company's contracts for clinical trials and R&D generally provide for termination with notice, resulting in non-cancellable obligations that are not material[167](index=167&type=chunk) [Critical Accounting Estimates](index=40&type=section&id=Critical%20Accounting%20Estimates) - Key estimates include patient fee revenues (contractual allowances, implicit price concessions), patient fee receivables and credit losses (portfolio risk, historical collection data), discount rates for finance leases (incremental borrowing rate), stock-based compensation (Black-Scholes model), and accounting for income taxes (deferred tax assets/liabilities, valuation allowance)[169](index=169&type=chunk)[170](index=170&type=chunk)[171](index=171&type=chunk)[172](index=172&type=chunk)[173](index=173&type=chunk) [Going Concern](index=42&type=section&id=Going%20Concern) - The evaluation of the company's ability to continue as a going concern requires assessing future cash sources and uses for one year from the financial statement issuance date, acknowledging the inherent uncertainty in R&D activities[174](index=174&type=chunk) [Off-Balance Sheet Arrangements](index=42&type=section&id=Off-Balance%20Sheet%20Arrangements) - The company does not engage in transactions with unconsolidated entities or financial partnerships and had no off-balance sheet arrangements during the periods presented[175](index=175&type=chunk) [Emerging Growth Company Status](index=42&type=section&id=Emerging%20Growth%20Company%20Status) - The company is classified as both an 'emerging growth company' and a 'smaller reporting company,' which allows for reduced public company reporting requirements[176](index=176&type=chunk) [ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK.](index=42&type=section&id=ITEM%203.%20QUANTITATIVE%20AND%20QUALITATIVE%20DISCLOSURES%20ABOUT%20MARKET%20RISK.) As a smaller reporting company, bioAffinity Technologies is not required to provide quantitative and qualitative disclosures about market risk - The company is exempt from providing market risk disclosures due to its status as a smaller reporting company[177](index=177&type=chunk) [ITEM 4. CONTROLS AND PROCEDURES.](index=42&type=section&id=ITEM%204.%20CONTROLS%20AND%20PROCEDURES.) This section details the company's disclosure controls and procedures, confirming their effectiveness and reporting no material changes in internal control - The Chief Executive Officer and Chief Financial Officer evaluated the effectiveness of the company's disclosure controls and procedures as of June 30, 2025, and concluded they are effective[178](index=178&type=chunk) - There were no material changes in internal control over financial reporting during the three months ended June 30, 2025[179](index=179&type=chunk) PART II OTHER INFORMATION [ITEM 1. LEGAL PROCEEDINGS.](index=43&type=section&id=ITEM%201.%20LEGAL%20PROCEEDINGS.) The company has no material pending legal proceedings expected to adversely impact its financial position or operations - The company has no material pending legal proceedings[181](index=181&type=chunk) [ITEM 1A. RISK FACTORS.](index=43&type=section&id=ITEM%201A.%20RISK%20FACTORS.) This section updates risk factors, focusing on financial position, capital needs, profitability, and Nasdaq listing compliance - The company's business plan relies heavily on obtaining additional capital and financing to fund operations and achieve profitability, with no guarantee of sufficient income generation[183](index=183&type=chunk)[184](index=184&type=chunk) - As of June 30, 2025, the company had an accumulated deficit of **$60.4 million** and **$0.8 million** cash on hand, with cash expected to last only through September 2025, raising substantial doubt about its ability to continue as a going concern[187](index=187&type=chunk) - The company received a Nasdaq notice for failing to meet the **$1.00** minimum bid price requirement and the **$2.5 million** stockholders' equity requirement, posing a risk of de-listing[190](index=190&type=chunk)[192](index=192&type=chunk) - Management collectively owns approximately **46.13%** of the company's voting power, which could influence corporate decisions and potentially affect the trading price of common stock[194](index=194&type=chunk) [ITEM 2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS.](index=46&type=section&id=ITEM%202.%20UNREGISTERED%20SALES%20OF%20EQUITY%20SECURITIES%20AND%20USE%20OF%20PROCEEDS.) This section states that there were no unregistered sales of equity securities or use of proceeds to report for the period - No unregistered sales of equity securities or use of proceeds were reported[196](index=196&type=chunk) [ITEM 3. DEFAULTS UPON SENIOR SECURITIES.](index=46&type=section&id=ITEM%203.%20DEFAULTS%20UPON%20SENIOR%20SECURITIES.) This section reports that there were no defaults upon senior securities for the period - No defaults upon senior securities were reported[197](index=197&type=chunk) [ITEM 4. MINE SAFETY DISCLOSURE.](index=46&type=section&id=ITEM%204.%20MINE%20SAFETY%20DISCLOSURE.) This section states that the disclosure item regarding mine safety is not applicable to the company - Mine safety disclosure is not applicable to the company[198](index=198&type=chunk) [ITEM 5. OTHER INFORMATION.](index=46&type=section&id=ITEM%205.%20OTHER%20INFORMATION.) This section provides other information, specifically regarding Rule 10b5-1 Trading Plans - None of the company's directors or executive officers adopted or terminated any Rule 10b5-1 trading plans during the fiscal quarter ended June 30, 2025[199](index=199&type=chunk) [ITEM 6. EXHIBITS.](index=47&type=section&id=ITEM%206.%20EXHIBITS.) This section lists the exhibits filed or furnished with the Quarterly Report on Form 10-Q, including various certifications and Inline XBRL documents - Exhibits include certifications (Section 302 and 906 of Sarbanes-Oxley Act), Inline XBRL Instance Document, Taxonomy Extension Schema, Calculation Linkbase, Definition Linkbase, Label Linkbase, Presentation Linkbase, and Cover Page Interactive Data File[200](index=200&type=chunk) [Signatures](index=48&type=section&id=Signatures) This section contains the official signatures of the registrant's authorized officers, certifying the filing of the report - The report was signed by Maria Zannes (Chief Executive Officer, President, Founder, and Director) and J. Michael Edwards (Vice President and Chief Financial Officer) on August 14, 2025[205](index=205&type=chunk)

[Executive Summary](index=1&type=section&id=Executive%20Summary) bioAffinity Technologies achieved significant Q2 2025 growth in CyPath Lung revenues and test volumes, alongside strategic milestones in product utility, pricing, logistics, capital raising, leadership, and intellectual property expansion [Q2 2025 Performance Overview](index=1&type=section&id=Q2%202025%20Performance%20Overview) bioAffinity Technologies reported significant growth in its CyPath Lung diagnostic product, with revenues increasing 62% year-over-year for the first six months of 2025, and test volumes also seeing a substantial rise, indicating growing clinical adoption - CyPath Lung revenues increased **62% year-over-year** for the six-month period ended June 30, 2025[3](index=3&type=chunk) - Completed CyPath Lung tests in July represented a **72% increase** over the previous monthly average for the first six months of 2025, including back-to-back record monthly sales in June and July[3](index=3&type=chunk) [Strategic and Operational Achievements](index=1&type=section&id=Strategic%20and%20Operational%20Achievements) The company achieved several strategic milestones, including demonstrating CyPath Lung's diagnostic utility through real-world case studies, increasing its list price, expanding logistics, completing a public offering, strengthening its leadership team, and expanding its global intellectual property portfolio - Released real-world case studies demonstrating the diagnostic utility of CyPath Lung, including successful detection of Stage 1A lung cancers[3](index=3&type=chunk) - Increased the list price of CyPath Lung to **$2,900**, aligning with private payer reimbursement strategies[3](index=3&type=chunk) - Expanded logistics capabilities through partnership with Cardinal Health™ OptiFreight Logistics, improving sample tracking and national delivery reliability[3](index=3&type=chunk) - Completed a **$3.25 million public offering** in May 2025 to provide working capital[3](index=3&type=chunk) - Appointed Dr. Gordon Downie, MD, PhD, as Chief Medical Officer, bringing over 30 years of clinical leadership[3](index=3&type=chunk) - Announced patent grants in the U.S., China, Canada, and Australia, expanding the global intellectual property portfolio for diagnostics and therapeutics[3](index=3&type=chunk) - Presented novel siRNA-based cancer therapy research at the 2025 RNA Therapeutics Conference[3](index=3&type=chunk) - President and CEO Maria Zannes appointed to the American Lung Association in Texas Leadership Board[3](index=3&type=chunk) [Management Discussion and Outlook](index=2&type=section&id=Management%20Commentary) Management commentary emphasizes the accelerated commercialization of CyPath Lung, strategic market expansion, strengthened financial and leadership foundations, and continued focus on product access and future innovation [CEO Commentary](index=2&type=section&id=CEO%20Commentary) CEO Maria Zannes highlighted the acceleration of CyPath Lung's commercialization, driven by increasing clinical adoption and validating real-world case studies, emphasizing the success of the Texas pilot marketing program, plans for expansion into new markets, and strategic steps taken to strengthen the financial foundation, leadership, and intellectual property, with a continued focus on expanding access, operational efficiency, and advancing next-generation diagnostics and therapeutics - Q2 results reflect continued acceleration of CyPath Lung commercialization strategy, with testing revenue up **62%** for the first half of the year, driven by increasing clinical adoption and physician-authored case studies[4](index=4&type=chunk) - The pilot marketing program in Texas demonstrated a sound and effective approach, preparing the company for expansion into additional key markets, including the Mid-Atlantic region and the Veterans Administration healthcare system[5](index=5&type=chunk) - Important steps were taken to strengthen the financial foundation, including a **$3.25 million public offering** and a strategic price adjustment for CyPath Lung, alongside enhanced national sample delivery capabilities through Cardinal Health OptiFreight® Logistics[6](index=6&type=chunk) - Expansion of the leadership team with Dr. Gordon Downie as Chief Medical Officer is shaping clinical direction, including advancement toward pivotal trials[7](index=7&type=chunk) - The intellectual property portfolio continues to grow with newly granted patents in the U.S., China, Canada, and Australia, strengthening diagnostic and therapeutic platforms globally[8](index=8&type=chunk) - Future focus remains on expanding access to CyPath Lung, delivering operational efficiency, and advancing next-generation diagnostics and therapeutics[9](index=9&type=chunk) [Second Quarter 2025 Financial Review](index=2&type=section&id=Second%20Quarter%202025%20Financial%20Review) The second quarter 2025 financial review details a decrease in total revenue due to discontinued services, a reduction in operating expenses, an increased net loss driven by non-cash items, and a decline in cash reserves despite a successful public offering [Revenue Analysis](index=2&type=section&id=Revenue%20Analysis) Total revenue for Q2 2025 decreased significantly to $1.3 million from $2.4 million in Q2 2024, primarily due to the strategic discontinuation of unprofitable pathology services, however, CyPath Lung testing revenue for the first six months of 2025 increased by 62% year-over-year to $323,000, reflecting growth in physician adoption Net Revenue (Three Months Ended June 30) | Metric | Q2 2025 | Q2 2024 | | :----- | :------ | :------ | | Net Revenue | $1,269,483 | $2,397,652 | Net Revenue (Six Months Ended June 30) | Metric | H1 2025 | H1 2024 | | :----- | :------ | :------ | | Net Revenue | $3,123,080 | $4,804,043 | | CyPath Lung Testing Revenue | $323,000 | N/A | - The decrease in total revenue was primarily attributable to the Company's strategic decision to discontinue unprofitable pathology services and reallocate resources toward the commercialization of CyPath Lung[9](index=9&type=chunk) - CyPath Lung testing revenue for the six months ended June 30, 2025, increased approximately **62% year-over-year**, reflecting growth in physician adoption and an increase in total test results delivered[9](index=9&type=chunk) [Operating Expenses Analysis](index=3&type=section&id=Operating%20Expenses%20Analysis) Operating expenses for Q2 2025 decreased by 16% to $3.8 million, mainly due to lower direct costs from laboratory operations and reduced research and development expenses, partially offset by increased clinical development spending in support of pivotal trials Operating Expenses (Three Months Ended June 30) | Expense Category | Q2 2025 | Q2 2024 | Change | | :--------------- | :------ | :------ | :----- | | Total Operating Expenses | $3,785,043 | $4,485,450 | -15.62% | | Direct costs and expenses | $1,016,602 | $1,407,710 | -27.78% | | Research and development | $311,372 | $402,433 | -22.63% | | Clinical development | $129,279 | $51,462 | +151.21% | | Selling, general and administrative | $2,214,561 | $2,472,775 | -10.44% | | Depreciation and amortization | $113,229 | $151,070 | -25.05% | - The decrease in operating expenses was primarily due to lower direct costs related to laboratory operations and reduced research and development expenses[10](index=10&type=chunk) - Increased clinical development spending was in support of the Company's pivotal trial strategy[10](index=10&type=chunk) [Net Loss and Earnings Per Share](index=3&type=section&id=Net%20Loss%20and%20Earnings%20Per%20Share) The net loss for Q2 2025 increased to $4.1 million ($0.17 per share) from $2.1 million ($0.19 per share) in Q2 2024, primarily driven by a $1.5 million rise in non-cash expenses related to warrant remeasurement and public offering costs Net Loss and EPS (Three Months Ended June 30) | Metric | Q2 2025 | Q2 2024 | | :----- | :------ | :------ | | Net Loss | $(4,060,787) | $(2,110,279) | | Net Loss per Common Share (basic and diluted) | $(0.17) | $(0.19) | - The increase in net loss was primarily driven by a **$1.5 million increase** in non-cash expenses related to warrant remeasurement and offering costs associated with the May 2025 public offering[11](index=11&type=chunk) [Liquidity and Capital Resources](index=3&type=section&id=Liquidity%20and%20Capital%20Resources) Cash and cash equivalents decreased to $0.8 million as of June 30, 2025, from $1.1 million at the end of 2024, with the company successfully raising $3.25 million through a public offering in May 2025 to provide working capital Cash and Cash Equivalents | Date | Amount | | :--- | :----- | | June 30, 2025 | $802,835 | | December 31, 2024 | $1,105,291 | - bioAffinity Technologies raised aggregate gross proceeds of **$3.25 million** through a public offering in May 2025[3](index=3&type=chunk)[12](index=12&type=chunk) [Company Profile](index=3&type=section&id=About%20bioAffinity%20Technologies%2C%20Inc.) This section outlines bioAffinity Technologies' core business as a biotechnology company specializing in noninvasive early-stage lung cancer diagnostics and broad-spectrum cancer treatments, featuring its flagship product, CyPath Lung [Business Description](index=3&type=section&id=Business%20Description) bioAffinity Technologies is a biotechnology company focused on noninvasive diagnosis of early-stage lung cancer and other lung diseases, as well as developing broad-spectrum cancer treatments, with its flagship product, CyPath Lung, a highly sensitive, specific, and accurate noninvasive test for early-stage lung cancer, marketed as a Laboratory Developed Test (LDT) by its subsidiary, Precision Pathology Laboratory Services - bioAffinity Technologies, Inc. addresses the need for noninvasive diagnosis of early-stage cancer and diseases of the lung and broad-spectrum cancer treatments[13](index=13&type=chunk) - The Company's first product, CyPath Lung, is a noninvasive test that has shown high sensitivity, specificity and accuracy for the detection of early-stage lung cancer[13](index=13&type=chunk) - CyPath Lung is marketed as a Laboratory Developed Test (LDT) by Precision Pathology Laboratory Services, a subsidiary of bioAffinity Technologies[13](index=13&type=chunk) [Condensed Consolidated Financial Statements](index=5&type=section&id=Condensed%20Consolidated%20Financial%20Statements) The condensed consolidated financial statements present a decrease in total assets, a significant increase in total liabilities due to warrant recognition, a shift to a stockholders' deficit, and an increased net loss for both the quarter and six-month periods, influenced by warrant fair value changes [Condensed Consolidated Balance Sheets](index=5&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) As of June 30, 2025, total assets decreased to $4.75 million from $6.51 million at December 31, 2024, total liabilities significantly increased to $6.89 million from $3.91 million, primarily due to the recognition of a warrant liability, and consequently, total stockholders' equity shifted from a positive $2.60 million to a deficit of $(2.14) million Balance Sheet Highlights | Metric | June 30, 2025 | December 31, 2024 | Change | | :-------------------------- | :------------ | :---------------- | :----- | | Total Assets | $4,751,075 | $6,513,667 | -27.06% | | Total Liabilities | $6,887,183 | $3,911,631 | +76.06% | | Total Stockholders' Equity (Deficit) | $(2,136,108) | $2,602,036 | -182.09% | | Warrant liability | $3,974,911 | — | N/A | - Cash and cash equivalents decreased from **$1,105,291** at December 31, 2024, to **$802,835** at June 30, 2025[18](index=18&type=chunk) [Unaudited Consolidated Statements of Operations](index=6&type=section&id=Unaudited%20Consolidated%20Statements%20of%20Operations) For the three months ended June 30, 2025, net revenue was $1.27 million, leading to a net loss of $4.06 million, and for the six months ended June 30, 2025, net revenue was $3.12 million, with a net loss of $6.72 million, where the significant increase in net loss for both periods was largely influenced by a $1.06 million change in the fair value of warrants Statements of Operations (Three Months Ended June 30) | Metric | 2025 | 2024 | Change | | :-------------------------------- | :----------- | :----------- | :----- | | Net Revenue | $1,269,483 | $2,397,652 | -47.05% | | Total Operating Expenses | $3,785,043 | $4,485,450 | -15.62% | | Loss from Operations | $(2,515,560) | $(2,087,798) | +20.49% | | Change in fair value of warrants issued | $(1,062,818) | — | N/A | | Net Loss | $(4,060,787) | $(2,110,279) | +92.43% | | Net Loss per Common Share | $(0.17) | $(0.19) | -10.53% | Statements of Operations (Six Months Ended June 30) | Metric | 2025 | 2024 | Change | | :-------------------------------- | :----------- | :----------- | :----- | | Net Revenue | $3,123,080 | $4,804,043 | -35.00% | | Total Operating Expenses | $8,265,779 | $8,837,071 | -6.50% | | Loss from Operations | $(5,142,699) | $(4,033,028) | +27.53% | | Change in fair value of warrants issued | $(1,062,818) | — | N/A | | Net Loss | $(6,721,204) | $(4,072,094) | +65.05% | | Net Loss per Common Share | $(0.20) | $(0.38) | -47.37% | [Additional Information](index=4&type=section&id=Additional%20Information) This section includes important disclaimers regarding forward-looking statements, highlighting inherent risks and the company's non-obligation to update them, along with essential contact information for communications and investor relations [Forward-Looking Statements](index=4&type=section&id=Forward-Looking%20Statements) This section contains forward-looking statements based on current estimates and assumptions, which are subject to various risks and uncertainties that could cause actual results to differ materially, with readers cautioned not to place undue reliance on these statements, and the company not undertaking any obligation to update them, except as required by applicable securities laws - Statements are based upon current estimates and assumptions and include statements regarding strategic actions, international patents, commercial growth, patient case studies, expanding access, and advancing new diagnostics[15](index=15&type=chunk) - These forward-looking statements are subject to various risks and uncertainties that could cause actual results to differ materially from current expectations[15](index=15&type=chunk) - The Company does not undertake any obligation to update any forward-looking statement relating to matters discussed in this press release, except as may be required by applicable securities laws[15](index=15&type=chunk) [Contacts](index=4&type=section&id=Contacts) Contact information is provided for bioAffinity Technologies' Director of Communications and for Investor Relations through RedChip Companies Inc - bioAffinity Technologies contact: Julie Anne Overton, Director of Communications (jao@bioaffinitytech.com)[16](index=16&type=chunk) - Investor Relations contact: Dave Gentry, RedChip Companies Inc. (1-800-RED-CHIP or 407-491-4498, BIAF@redchip.com)[16](index=16&type=chunk)

Core Insights - bioAffinity Technologies, Inc. (BIAF) reported a revenue decline of 22.9% year-over-year for Q1 2025, totaling $1.9 million, primarily due to changes in revenue contributions from various services [2] - Despite the revenue drop, the net loss per share improved to $0.16 from $0.20 in the previous year, although the absolute loss increased to $2.7 million from $1.9 million due to a higher share count [2] - The company's flagship diagnostic, CyPath Lung, experienced a significant sales increase of 276% year-over-year, indicating strong market acceptance and operational scaling [3] - Management is implementing strategic changes, including discontinuing low-margin services and cutting costs, expected to save approximately $3.8 million annually [4] - The company ended the quarter with $0.4 million in cash but has since raised $1.4 million through warrant exercises and $3.3 million via a public offering to support commercialization and clinical development [7] - bioAffinity received acceptance of a patent application for CyPath Lung from the Australian Patent Office, enhancing its international commercialization potential [9] Financial Performance - Revenues for Q1 2025 were $1.9 million, down from $2.4 million in Q1 2024 [2] - Operating expenses increased by 2.9% to $4.5 million, while direct costs declined by 13.1% to $1.4 million [2] - R&D expenses fell by 6.7% to $367,386, but clinical development expenses rose sharply from $48,960 to $138,353 [2] Strategic Initiatives - The company is focusing on commercial execution and operational changes to support CyPath Lung's growth [5] - Recent enhancements in test processing increased data acquisition throughput by 50% and reduced per-test costs by over 25% [6] - Management's strategic pivot aims to concentrate resources on high-margin diagnostics while improving overall profitability [4] Market Position and Future Outlook - The company did not provide forward-looking financial guidance but indicated a continued focus on expanding CyPath Lung's market presence [8] - The strong demand for CyPath Lung is supported by over 600 tests delivered in 2024, with continued momentum into 2025 [3]

[PART I FINANCIAL INFORMATION](index=7&type=section&id=PART%20I%20FINANCIAL%20INFORMATION) This section presents the Company's unaudited condensed consolidated financial statements and management's discussion and analysis for the quarter ended March 31, 2025 [ITEM 1. CONDENSED CONSOLIDATED FINANCIAL STATEMENTS.](index=7&type=section&id=ITEM%201.%20CONDENSED%20CONSOLIDATED%20FINANCIAL%20STATEMENTS.) This section presents the unaudited condensed consolidated financial statements, including the balance sheets, statements of operations, statements of stockholders' equity, and statements of cash flows, along with their accompanying notes, for the periods ended March 31, 2025, and December 31, 2024 [Condensed Consolidated Balance Sheets](index=7&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) This section provides a snapshot of the Company's financial position, detailing assets, liabilities, and equity as of March 31, 2025, and December 31, 2024 Condensed Consolidated Balance Sheet Highlights ($) | Metric | March 31, 2025 | December 31, 2024 | | :-------------------------- | :------------- | :---------------- | | Cash and cash equivalents | $444,706 | $1,105,291 | | Total current assets | $1,863,782 | $2,695,098 | | Total assets | $5,547,283 | $6,513,667 | | Total current liabilities | $3,415,409 | $3,104,905 | | Total liabilities | $4,107,879 | $3,911,631 | | Total stockholders' equity | $1,439,404 | $2,602,036 | - The company's cash and cash equivalents decreased by approximately **60%** from **$1.11 million** at December 31, 2024, to **$0.44 million** at March 31, 2025[17](index=17&type=chunk) - Total stockholders' equity decreased by approximately **44.7%** from **$2.60 million** at December 31, 2024, to **$1.44 million** at March 31, 2025[17](index=17&type=chunk) [Unaudited Consolidated Statements of Operations](index=9&type=section&id=Unaudited%20Consolidated%20Statements%20of%20Operations) This section outlines the Company's financial performance, presenting net revenue, operating expenses, and net loss for the three months ended March 31, 2025 and 2024 Unaudited Consolidated Statements of Operations Highlights (Three Months Ended March 31) ($) | Metric | 2025 | 2024 | Change ($) | Change (%) | | :------------------------- | :------------ | :------------ | :------------ | :--------- | | Net Revenue | $1,853,597 | $2,406,391 | $(552,794) | (23.0)% | | Total operating expenses | $4,480,736 | $4,351,621 | $129,115 | 3.0% | | Loss from operations | $(2,627,139) | $(1,945,230) | $(681,909) | 35.1% | | Net loss | $(2,660,417) | $(1,961,815) | $(698,602) | 35.6% | | Net loss per common share | $(0.16) | $(0.20) | $0.04 | (20.0)% | - Net revenue decreased by **23%** primarily due to strategic actions to discontinue unprofitable pathology services and focus on high-margin services like CyPath Lung[98](index=98&type=chunk)[109](index=109&type=chunk) - Net loss increased by **35.6%** to **$2.66 million** in Q1 2025, compared to **$1.96 million** in Q1 2024, driven by higher operating expenses and a decrease in net revenue[19](index=19&type=chunk)[106](index=106&type=chunk) [Unaudited Consolidated Statements of Changes in Stockholders' Equity](index=10&type=section&id=Unaudited%20Consolidated%20Statements%20of%20Changes%20in%20Stockholders%27%20Equity) This section details the changes in the Company's stockholders' equity, reflecting the impact of net loss, stock-based compensation, and warrant exercises for the three months ended March 31, 2025 Changes in Stockholders' Equity (Three Months Ended March 31, 2025) ($) | Item | Amount ($) | | :------------------------ | :--------- | | Balance at Dec 31, 2024 | 2,602,036 | | Stock-based compensation | 326,616 | | Exercise of stock warrants| 1,518,467 | | Offering costs | (347,298) | | Net loss | (2,660,417)| | Balance at Mar 31, 2025 | 1,439,404 | - Stockholders' equity decreased from **$2.60 million** at December 31, 2024, to **$1.44 million** at March 31, 2025, primarily due to a net loss of **$2.66 million**, partially offset by **$1.52 million** from warrant exercises and **$0.33 million** from stock-based compensation[21](index=21&type=chunk) [Unaudited Consolidated Statements of Cash Flows](index=11&type=section&id=Unaudited%20Consolidated%20Statements%20of%20Cash%20Flows) This section presents the Company's cash inflows and outflows from operating, investing, and financing activities for the three months ended March 31, 2025 and 2024 Unaudited Consolidated Statements of Cash Flows Highlights (Three Months Ended March 31) ($) | Cash Flow Activity | 2025 | 2024 | | :--------------------------- | :------------ | :------------ | | Net cash used in operating | $(1,641,775) | $(2,345,975) |\ | Net cash used in investing | $(50,786) | $(41,387) |\ | Net cash provided by financing | $1,031,976 | $2,018,957 |\ | Net decrease in cash | $(660,585) | $(368,405) |\ | Cash at end of period | $444,706 | $2,453,165 | - Net cash used in operating activities decreased by approximately **$0.7 million**, from **$2.35 million** in Q1 2024 to **$1.64 million** in Q1 2025, primarily due to changes in accounts receivables, accounts payable, and accrued expenses[23](index=23&type=chunk)[126](index=126&type=chunk) - Cash provided by financing activities decreased from **$2.02 million** in Q1 2024 to **$1.03 million** in Q1 2025, mainly due to lower net proceeds from financing activities compared to the prior year[23](index=23&type=chunk)[128](index=128&type=chunk) [Notes to Unaudited Condensed Consolidated Financial Statements](index=12&type=section&id=Notes%20to%20Unaudited%20Condensed%20Consolidated%20Financial%20Statements) This section provides detailed explanations and additional information supporting the unaudited condensed consolidated financial statements [Note 1. NATURE OF OPERATIONS, ORGANIZATION, AND BASIS OF PRESENTATION](index=12&type=section&id=Note%201.%20NATURE%20OF%20OPERATIONS%2C%20ORGANIZATION%2C%20AND%20BASIS%20OF%20PRESENTATION) This note describes the Company's business, its organizational structure, and the fundamental principles underlying the financial statement presentation - bioAffinity Technologies focuses on noninvasive diagnosis of early-stage lung cancer and other lung diseases using its proprietary platform, CyPath Lung, which utilizes flow cytometry and AI-driven automated data analysis[26](index=26&type=chunk) - The Company acquired Precision Pathology Laboratory Services, LLC (PPLS) in August 2023, which operates a CAP-accredited, CLIA-certified clinical pathology laboratory and offers CyPath Lung[27](index=27&type=chunk)[93](index=93&type=chunk) - Management has concluded there is substantial doubt about the Company's ability to continue as a going concern for at least 12 months due to significant losses and negative cash flows, with cash and cash equivalents of approximately **$0.4 million** at March 31, 2025[30](index=30&type=chunk) - A public offering completed on May 7, 2025, raised an additional **$3.25 million** in gross proceeds, but further capital will be needed to support future operations[30](index=30&type=chunk)[86](index=86&type=chunk) [Note 2. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES](index=12&type=section&id=Note%202.%20SUMMARY%20OF%20SIGNIFICANT%20ACCOUNTING%20POLICIES) This note outlines the key accounting principles and methods used in the preparation of the Company's financial statements - The Company's revenue streams include patient service fees, histology service fees, and medical director fees, recognized upon completion of testing or service rendering[42](index=42&type=chunk) Net Revenue by Source (Three Months Ended March 31) ($) | Revenue Source | 2025 | 2024 | | :---------------------------------- | :------------ | :------------ | | Patient service fees | $1,570,382 | $2,149,049 | | Histology service fees | $263,754 | $237,972 | | Medical director fees | $16,588 | $16,058 | | Department of Defense observational studies | $— | $2,885 | | Other revenues | $2,873 | $427 | | **Total net revenue** | **$1,853,597**| **$2,406,391**| - Direct billing for CyPath Lung diagnostic test increased significantly from **$45,000** in Q1 2024 to **$169,000** in Q1 2025[44](index=44&type=chunk) Intangible Assets, Net (as of) ($) | Asset Category | March 31, 2025 | December 31, 2024 | | :------------------------ | :------------- | :---------------- | | Goodwill | $1,404,486 | $1,404,486 | | Trade names and trademarks| $150,000 | $150,000 | | Customer relationships | $700,000 | $700,000 | | Accumulated amortization | $(89,444) | $(74,861) | | **Intangible assets, net**| **$2,165,042** | **$2,179,625** | Net Revenues and Operating Expenses by Segment (Three Months Ended March 31) ($) | Segment | 2025 Net Revenues | 2024 Net Revenues | 2025 Operating Expenses | 2024 Operating Expenses | | :------------------------ | :---------------- | :---------------- | :---------------------- | :---------------------- | | Diagnostic R&D | $— | $2,885 | $(505,739) | $(442,599) | | Laboratory services | $1,853,597 | $2,403,506 | $(2,267,656) | $(2,736,999) | | General corporate activities| N/A | N/A | $(1,707,341) | $(1,172,023) | [Note 3. ACCOUNTS AND OTHER RECEIVABLES, NET](index=18&type=section&id=Note%203.%20ACCOUNTS%20AND%20OTHER%20RECEIVABLES%2C%20NET) This note details the composition of the Company's accounts and other receivables, net of allowances, as of the reporting dates Accounts and Other Receivables, Net (as of) ($) | Receivable Type | March 31, 2025 | December 31, 2024 | | :------------------------ | :------------- | :---------------- | | Patient service fees | $744,859 | $915,488 | | Histology service fees | $189,904 | $190,648 | | Medical director fees | $11,600 | $5,194 | | Other receivables | $17,381 | $27,874 | | **Total receivables, net**| **$963,744** | **$1,139,204** | [Note 4. PREPAID EXPENSES AND OTHER CURRENT ASSETS](index=18&type=section&id=Note%204.%20PREPAID%20EXPENSES%20AND%20OTHER%20CURRENT%20ASSETS) This note provides a breakdown of the Company's prepaid expenses and other current assets as of the reporting dates Prepaid Expenses and Other Current Assets (as of) ($) | Asset Type | March 31, 2025 | December 31, 2024 | | :------------------------ | :------------- | :---------------- | | Prepaid insurance | $160,756 | $248,364 | | Legal and professional | $15,787 | $27,448 | | Other | $240,007 | $147,183 | | **Total prepaid assets** | **$416,550** | **$422,995** | [Note 5. PROPERTY AND EQUIPMENT, NET](index=19&type=section&id=Note%205.%20PROPERTY%20AND%20EQUIPMENT%2C%20NET) This note presents the Company's property and equipment, net of accumulated depreciation, as of the reporting dates Property and Equipment, Net (as of) ($) | Asset Category | March 31, 2025 | December 31, 2024 | | :------------------------------ | :------------- | :---------------- | | Lab equipment | $679,995 | $662,747 | | Computers and software | $81,433 | $81,433 | | Leasehold improvements | $19,353 | $19,353 | | Vehicles | $181,640 | $148,103 | | Less: accumulated depreciation | $(580,012) | $(536,251) | | **Total property and equipment**| **$382,409** | **$375,385** | - Depreciation expense for the three months ended March 31, 2025, was **$43,763**, an increase from **$38,811** in the same period of 2024[58](index=58&type=chunk) [Note 6. ACCRUED EXPENSES](index=19&type=section&id=Note%206.%20ACCRUED%20EXPENSES) This note details the composition of the Company's accrued expenses as of the reporting dates Accrued Expenses (as of) ($) | Expense Type | March 31, 2025 | December 31, 2024 | | :------------------------ | :------------- | :---------------- | | Compensation | $932,208 | $1,079,839 | | Legal and professional | $107,064 | $98,477 | | Clinical | $287,258 | $160,371 | | Other | $44,205 | $60,035 | | **Total accrued expenses**| **$1,370,735** | **$1,398,722** | [Note 7. UNEARNED REVENUE](index=19&type=section&id=Note%207.%20UNEARNED%20REVENUE) This note explains the Company's unearned revenue balance related to an observational study with the U.S. Department of Defense - The Company had an unearned revenue balance of **$24,404** as of March 31, 2025, and December 31, 2024, related to an observational study of CyPath Lung with the U.S. Department of Defense, where performance obligations for 30 units were not yet complete[60](index=60&type=chunk) [Note 8. FAIR VALUE MEASUREMENTS](index=19&type=section&id=Note%208.%20FAIR%20VALUE%20MEASUREMENTS) This note describes the Company's methodology for fair value measurements of financial instruments using a three-level hierarchy - The Company classifies financial instruments into a three-level hierarchy based on the observability of inputs used in fair value measurement, with most short-term instruments carried at historical cost approximating fair value[61](index=61&type=chunk)[62](index=62&type=chunk) [Note 9. LEASES](index=19&type=section&id=Note%209.%20LEASES) This note provides details on the Company's operating and finance leases, including their terms, liabilities, and discount rates - The Company holds operating leases for real estate and office space (**2.3 to 5.4 years remaining**) and finance leases for lab equipment (**1.1 to 2.8 years remaining**), with imputed interest rates ranging from **7.43% to 8.07%**[63](index=63&type=chunk)[64](index=64&type=chunk)[65](index=65&type=chunk) Lease Liabilities and Terms (as of March 31, 2025) | Lease Type | Right-of-Use Asset, Net ($) | Current Liability ($) | Non-Current Liability ($) | Remaining Term (years) | Weighted-Average Discount Rate (%) | | :---------------------- | :---------------------- | :---------------- | :-------------------- | :--------------------- | :----------------------------- | | Operating leases | $431,746 | $130,342 | $308,415 | 3.60 | 7.38% | | Finance leases | $684,629 | $403,584 | $335,899 | 2.28 | 8.04% | [Note 10. NOTES PAYABLE](index=22&type=section&id=Note%2010.%20NOTES%20PAYABLE) This note outlines the Company's notes payable, including vehicle loans and short-term financing for insurance policies - The Company has vehicle notes payable, including a new loan for **$33,517** at **11.65%** interest (January 2025) and an existing loan for **$23,815** at **5.99%** interest (March 2024)[70](index=70&type=chunk)[71](index=71&type=chunk) - Short-term financing of approximately **$260,000** was obtained in September 2024 for director and officer insurance policies, with a **6.7%** fixed annual rate[72](index=72&type=chunk) [Note 11. COMMITMENTS AND CONTINGENCIES](index=22&type=section&id=Note%2011.%20COMMITMENTS%20AND%20CONTINGENCIES) This note addresses the Company's commitments and contingencies, including any material legal proceedings - The Company is not involved in any material pending legal proceedings[73](index=73&type=chunk) [Note 12. COMMON STOCK](index=22&type=section&id=Note%2012.%20COMMON%20STOCK) This note provides information on the Company's authorized, issued, and outstanding common stock as of March 31, 2025 - The Company has **100,000,000** authorized shares of Common Stock (**$0.007** par value) and **18,255,825** shares issued and outstanding as of March 31, 2025, including **430,474** unvested restricted stock awards[74](index=74&type=chunk) [Note 13. STOCK-BASED COMPENSATION](index=22&type=section&id=Note%2013.%20STOCK-BASED%20COMPENSATION) This note details the stock-based compensation expense and restricted stock award activity for the three months ended March 31, 2025 Stock-Based Compensation Expense (Three Months Ended March 31) ($) | Expense Category | 2025 | 2024 | | :------------------------ | :-------- | :-------- | | Research and development | $21,250 | $21,882 | | General and administrative| $305,366 | $260,731 | | **Total expense** | **$326,616**| **$282,613**| Restricted Stock Award Activity (as of March 31, 2025) (Number of RSAs) | Item | Number of RSAs | | :------------------------ | :------------- | | Balance at Dec 31, 2024 | 1,326,861 | | Granted | 253,398 | | Forfeited | (10,289) | | **Balance at Mar 31, 2025**| **1,569,970** | - During Q1 2025, the Company issued **243,109** restricted stock awards to employees, non-employees, and the board of directors, with vesting terms up to three years[79](index=79&type=chunk) [Note 14. WARRANTS](index=24&type=section&id=Note%2014.%20WARRANTS) This note provides information on the Company's outstanding warrants, including exercise activity and new issuances - As of March 31, 2025, the Company had **12,873,602** warrants outstanding with a weighted average exercise price of **$2.74**, expiring through February 2030[80](index=80&type=chunk) - During Q1 2025, **2,438,473** warrants were exercised, generating **$1,414,314** in proceeds, compared to no exercises in Q1 2024[80](index=80&type=chunk) - On February 25, 2025, a warrant inducement agreement led to the exercise of **2,438,473** existing warrants at a reduced price of **$0.58** per share, generating approximately **$1.4 million**, and the issuance of **2,926,166** new unregistered warrants at an exercise price of **$0.85**[81](index=81&type=chunk)[82](index=82&type=chunk)[102](index=102&type=chunk) [Note 15. SUBSEQUENT EVENTS](index=25&type=section&id=Note%2015.%20SUBSEQUENT%20EVENTS) This note discloses significant events that occurred after the balance sheet date but before the financial statements were issued - On May 7, 2025, the Company completed a public offering, raising **$3.25 million** in gross proceeds through the sale of common stock (including pre-funded warrants) and accompanying warrants with an exercise price of **$0.352** per share[86](index=86&type=chunk)[99](index=99&type=chunk) [ITEM 2. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS.](index=26&type=section&id=ITEM%202.%20MANAGEMENT%27S%20DISCUSSION%20AND%20ANALYSIS%20OF%20FINANCIAL%20CONDITION%20AND%20RESULTS%20OF%20OPERATIONS.) This section provides management's perspective on the Company's financial condition and results of operations for the three months ended March 31, 2025, compared to the same period in 2024, including an overview of the business, financial highlights, recent developments, and a discussion of liquidity and critical accounting estimates [Company Overview](index=26&type=section&id=Company%20Overview) This section introduces the Company's core business, its diagnostic platform, and its research initiatives - The Company develops noninvasive diagnostics for early-stage lung cancer and other lung diseases, utilizing flow cytometry and AI-driven machine learning for automated analysis[91](index=91&type=chunk) - CyPath Lung, the Company's diagnostic test, is offered through its wholly-owned subsidiary PPLS, which operates a CAP-accredited and CLIA-certified commercial laboratory[92](index=92&type=chunk)[93](index=93&type=chunk) - Through OncoSelect Therapeutics, LLC, the Company also conducts research into novel cancer therapeutic approaches and intends to seek strategic partners for development[94](index=94&type=chunk) [Current Year Financial Highlights](index=26&type=section&id=Current%20Year%20Financial%20Highlights) This section summarizes key financial performance indicators and significant events for the three months ended March 31, 2025 - Consolidated revenue decreased by approximately **23%** to **$1.9 million** for the three months ended March 31, 2025, compared to **$2.4 million** in the prior year, primarily due to strategic actions to discontinue unprofitable pathology services[98](index=98&type=chunk) - CyPath Lung testing revenue increased by approximately **275%** to **$169,000** for the three months ended March 31, 2025, up from **$45,000** in the comparable period of 2024, driven by an increase of approximately **200** total test results delivered[98](index=98&type=chunk) - The Company raised approximately **$1.4 million** in gross proceeds from equity transactions to fund operating activities during the quarter[98](index=98&type=chunk) [Recent Developments](index=28&type=section&id=Recent%20Developments) This section outlines significant events and strategic initiatives undertaken by the Company recently, impacting its operations and financial outlook - On May 8, 2025, the Company released 'CyPath Lung In Practice,' highlighting its clinical utility in accelerating diagnosis and preventing unnecessary invasive procedures[99](index=99&type=chunk) - On May 7, 2025, a public offering of securities was completed, generating **$3.25 million** in gross proceeds, consisting of common stock and warrants[99](index=99&type=chunk) - Effective April 1, 2025, the list price of CyPath Lung was increased from **$1,900** to **$2,900** to optimize reimbursement terms[100](index=100&type=chunk) - On March 7, 2025, the Company announced strategic actions to achieve **$3 to $4 million** in annual cost savings at PPLS by reducing labor costs, enhancing operational efficiency, and discontinuing unprofitable pathology services, while increasing resources for CyPath Lung sales[101](index=101&type=chunk) - On February 26, 2025, a warrant inducement agreement resulted in the exercise of **2,438,473** existing warrants for approximately **$1.4 million** in gross proceeds and the issuance of new unregistered common warrants[102](index=102&type=chunk) [Financial](index=28&type=section&id=Financial) This section discusses the Company's historical funding, current financial position, and future capital requirements - The Company has historically funded operations through private and public equity sales, with approximately **$46.0 million** in gross proceeds since inception[121](index=121&type=chunk) - As of March 31, 2025, the Company had cash and cash equivalents of **$0.4 million**, an accumulated deficit of approximately **$56.3 million**, and a working capital deficit of approximately **$1.6 million**[103](index=103&type=chunk)[104](index=104&type=chunk) - Despite recent financings, current cash and anticipated revenue are expected to support operations only through August 2025, leading management to conclude there is substantial doubt about the Company's ability to continue as a going concern[103](index=103&type=chunk) - The Company anticipates needing to raise additional capital through equity or debt sales, collaborative arrangements, or grants to fund future operations and product development[105](index=105&type=chunk) [Results of Operations](index=29&type=section&id=Results%20of%20Operations) This section analyzes the Company's financial performance, detailing net loss, revenue, and operating expenses for the reporting periods [Net Loss](index=29&type=section&id=Net%20Loss) This section reports the Company's net loss for the three months ended March 31, 2025, compared to the prior year - Net loss for the three months ended March 31, 2025, was approximately **$2.7 million**, an increase from approximately **$2.0 million** for the same period in 2024[106](index=106&type=chunk) [Revenue](index=29&type=section&id=Revenue) This section provides a detailed breakdown and analysis of the Company's net revenue by source for the reporting periods Net Revenue Breakdown (Three Months Ended March 31) ($) | Revenue Source | 2025 | 2024 | Change ($) | Change (%) | | :---------------------------------- | :------------ | :------------ | :------------ | :--------- | | Patient service fees | $1,570,382 | $2,149,049 | $(578,667) | (26.9)% | | Histology service fees | $263,754 | $237,972 | $25,782 | 10.8% | | Medical director fees | $16,588 | $16,058 | $530 | 3.3% | | Department of Defense observational studies | $— | $2,885 | $(2,885) | (100.0)% | | Other revenues | $2,873 | $427 | $2,446 | 572.8% | | **Total net revenue** | **$1,853,597**| **$2,406,391**| **$(552,794)**| **(23.0)%**| - The decrease in total net revenue is primarily attributed to discontinuing certain unprofitable pathology services to focus on high-margin services like CyPath Lung[109](index=109&type=chunk) [Operating Expenses](index=29&type=section&id=Operating%20Expenses) This section analyzes the Company's operating expenses by category, highlighting changes and their underlying drivers Operating Expenses (Three Months Ended March 31) ($) | Expense Category | 2025 | 2024 | Change ($) | Change (%) | | :-------------------------------- | :------------ | :------------ | :------------ | :--------- | | Direct costs and expenses | $1,367,860 | $1,573,441 | $(205,581) | (13)% | | Research and development | $367,386 | $393,639 | $(26,253) | (7)% | | Clinical development | $138,353 | $48,960 | $89,393 | 183% | | Selling, general and administrative | $2,452,549 | $2,185,944 | $266,605 | 12% | | Depreciation and amortization | $154,588 | $149,637 | $4,951 | 3% | | **Total operating expenses** | **$4,480,736**| **$4,351,621**| **$129,115** | **3%** | - Direct costs and expenses decreased by **13%** due to strategic actions in March 2025 to streamline operations and reduce lab-related costs[111](index=111&type=chunk) - Clinical development expenses increased by **183%** due to higher professional fees related to managing the pivotal clinical trial strategy[114](index=114&type=chunk) - Selling, general and administrative expenses increased by **12%** due to additional personnel and support services to drive CyPath Lung sales growth[116](index=116&type=chunk) [Other Income (Expense)](index=30&type=section&id=Other%20Income%20%28Expense%29) This section details the Company's non-operating income and expenses, including interest and other miscellaneous items Other Income (Expense) (Three Months Ended March 31) ($) | Category | 2025 | 2024 | Change ($) | Change (%) | | :---------------------------- | :------------ | :------------ | :------------ | :--------- | | Interest (expense) income, net| $(14,493) | $(17,423) | $2,480 | (14)% | | Other income (expense), net | $(9,640) | $4,510 | $(14,150) | (314)% | | **Total other (expense) income**| **$(24,583)** | **$(12,913)** | **$(11,670)** | **90%** | - Total other expense increased by **90%** primarily due to a decrease in other income (expense) of **$14,150**, mainly attributable to property taxes[118](index=118&type=chunk)[120](index=120&type=chunk) [Liquidity, Capital Resources, and Going Concern](index=30&type=section&id=Liquidity%2C%20Capital%20Resources%2C%20and%20Going%20Concern) This section assesses the Company's ability to meet its short-term and long-term obligations, its capital-raising efforts, and its going concern status - The Company has incurred significant losses since its inception in 2014, with net losses of **$2.7 million** and **$2.0 million** for the three months ended March 31, 2025 and 2024, respectively, and an accumulated deficit of approximately **$56.3 million** as of March 31, 2025[122](index=122&type=chunk) - Despite recent financings totaling **$4.65 million** in gross proceeds (February and May 2025), the Company's cash and anticipated revenue are only expected to support operations through August 2025[122](index=122&type=chunk)[123](index=123&type=chunk) - Management concludes there is substantial doubt about the Company's ability to continue as a going concern for at least twelve months, necessitating further capital raises through equity, debt, or strategic relationships[123](index=123&type=chunk) [Summary Statements of Cash Flows](index=31&type=section&id=Summary%20Statements%20of%20Cash%20Flows) This section provides a summary of the Company's cash flow activities, categorized into operating, investing, and financing [Net Cash Used in Operating Activities](index=32&type=section&id=Net%20Cash%20Used%20in%20Operating%20Activities) This section analyzes the cash flows generated or used by the Company's primary business operations - Net cash used in operating activities decreased by approximately **$0.7 million** to **$1.6 million** for the three months ended March 31, 2025, compared to **$2.3 million** in the prior year, primarily due to a decrease in patient accounts receivables and an increase in accounts payable and accrued expenses[126](index=126&type=chunk) [Net Cash Used in Investing Activities](index=32&type=section&id=Net%20Cash%20Used%20in%20Investing%20Activities) This section details the cash flows related to the acquisition and disposal of long-term assets - Net cash used in investing activities was approximately **$0.05 million** for the three months ended March 31, 2025, mainly for the purchase of computer and laboratory equipment, a slight increase from **$0.04 million** in the prior year[127](index=127&type=chunk) [Net Cash Provided by Financing Activities](index=32&type=section&id=Net%20Cash%20Provided%20by%20Financing%20Activities) This section outlines the cash flows from debt and equity transactions, impacting the Company's capital structure - Net cash provided by financing activities decreased to approximately **$1.0 million** for the three months ended March 31, 2025, from **$2.0 million** in the prior year, primarily due to lower net proceeds from financing activities in February 2025 (**$1.4 million**) compared to March 2024 (**$2.5 million**)[128](index=128&type=chunk) [Contractual Obligations and Commitments](index=32&type=section&id=Contractual%20Obligations%20and%20Commitments) This section discusses the Company's contractual obligations and commitments, noting that non-cancelable obligations are not material - The Company's contracts with third-party organizations for clinical trials and other services generally include termination clauses, and thus, non-cancelable obligations are not considered material[129](index=129&type=chunk) [Critical Accounting Estimates](index=32&type=section&id=Critical%20Accounting%20Estimates) This section highlights the accounting estimates that require significant judgment and can materially impact the financial statements - Key accounting estimates include patient fee revenues (requiring judgment for contractual allowances and implicit price concessions), patient fee receivables and credit losses (assessing portfolio risk and historical collection data), discount rate for finance leased equipment (using a benchmarked incremental borrowing rate), stock-based compensation (using Black-Scholes model with management's best estimates), accounting for income taxes (asset and liability approach with valuation allowance assessment), and going concern evaluation (assessing future cash sources and uses)[130](index=130&type=chunk)[131](index=131&type=chunk)[132](index=132&type=chunk)[133](index=133&type=chunk)[134](index=134&type=chunk)[135](index=135&type=chunk)[137](index=137&type=chunk) [Off-Balance Sheet Arrangements](index=34&type=section&id=Off-Balance%20Sheet%20Arrangements) This section confirms the absence of off-balance sheet arrangements that could materially affect the Company's financial position - The Company does not engage in transactions that generate relationships with unconsolidated entities or financial partnerships, and therefore had no off-balance sheet arrangements during the periods presented[138](index=138&type=chunk) [Emerging Growth Company Status](index=34&type=section&id=Emerging%20Growth%20Company%20Status) This section clarifies the Company's status as an emerging growth and smaller reporting company, detailing its reduced reporting requirements - The Company is classified as both an 'emerging growth company' and a 'smaller reporting company,' which subjects it to reduced public company reporting requirements under the Exchange Act[139](index=139&type=chunk) [ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK.](index=34&type=section&id=ITEM%203.%20QUANTITATIVE%20AND%20QUALITATIVE%20DISCLOSURES%20ABOUT%20MARKET%20RISK.) As a smaller reporting company, bioAffinity Technologies is not required to provide quantitative and qualitative disclosures about market risk - The Company is exempt from providing market risk disclosures under Item 305(e) of Regulation S-K due to its status as a smaller reporting company[140](index=140&type=chunk) [ITEM 4. CONTROLS AND PROCEDURES.](index=34&type=section&id=ITEM%204.%20CONTROLS%20AND%20PROCEDURES.) This section details the evaluation of the Company's disclosure controls and procedures and reports on any changes in internal control over financial reporting [Evaluation of Disclosure Controls and Procedures](index=34&type=section&id=Evaluation%20of%20Disclosure%20Controls%20and%20Procedures) This section reports on the effectiveness of the Company's disclosure controls and procedures as assessed by management - As of March 31, 2025, the Chief Executive Officer and Chief Financial Officer concluded that the Company's disclosure controls and procedures were effective in ensuring timely and accurate reporting[141](index=141&type=chunk) [Changes in Internal Control over Financial Reporting](index=34&type=section&id=Changes%20in%20Internal%20Control%20over%20Financial%20Reporting) This section reports on any material changes in the Company's internal control over financial reporting during the quarter - There were no changes in the Company's internal control over financial reporting during the three months ended March 31, 2025, that materially affected or are reasonably likely to materially affect internal control over financial reporting[142](index=142&type=chunk) [PART II OTHER INFORMATION](index=35&type=section&id=PART%20II%20OTHER%20INFORMATION) This section provides additional information not covered in the financial statements, including legal proceedings, risk factors, and other disclosures [ITEM 1. LEGAL PROCEEDINGS.](index=35&type=section&id=ITEM%201.%20LEGAL%20PROCEEDINGS.) This section states that the Company is not currently involved in any material legal proceedings - The Company has no material pending legal proceedings that are expected to have a material adverse impact on its financial position or results of operations[144](index=144&type=chunk) [ITEM 1A. RISK FACTORS.](index=35&type=section&id=ITEM%201A.%20RISK%20FACTORS.) This section updates the risk factors previously disclosed in the 2024 Form 10-K, emphasizing risks related to the Company's financial position, ability to obtain additional capital, Nasdaq listing compliance, and the concentration of common stock ownership by management - The Company's business plan relies heavily on its ability to obtain additional capital and financing, and failure to do so could lead to curtailment or cessation of operations[146](index=146&type=chunk)[150](index=150&type=chunk) - There is substantial doubt about the Company's ability to continue as a going concern, requiring additional capital to fund operations beyond August 2025[150](index=150&type=chunk) - The Company is at risk of de-listing from The Nasdaq Capital Market due to not meeting the minimum bid price requirement and having stockholders' equity below the required **$2.5 million**[153](index=153&type=chunk)[155](index=155&type=chunk) - Management collectively owns approximately **26%** of the Company's voting power, which could influence corporate decisions and potentially deter changes of control[157](index=157&type=chunk) [ITEM 2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS.](index=38&type=section&id=ITEM%202.%20UNREGISTERED%20SALES%20OF%20EQUITY%20SECURITIES%20AND%20USE%20OF%20PROCEEDS.) This section confirms that the Company did not engage in any unregistered sales of equity securities during the quarter ended March 31, 2025, beyond what was previously disclosed - No unregistered sales of equity securities occurred during the quarter ended March 31, 2025, other than those previously disclosed[159](index=159&type=chunk) [ITEM 3. DEFAULTS UPON SENIOR SECURITIES.](index=38&type=section&id=ITEM%203.%20DEFAULTS%20UPON%20SENIOR%20SECURITIES.) This section states that there are no defaults upon senior securities to report - This item is not applicable to the Company for the reporting period[160](index=160&type=chunk) [ITEM 4. MINE SAFETY DISCLOSURE.](index=38&type=section&id=ITEM%204.%20MINE%20SAFETY%20DISCLOSURE.) This section indicates that mine safety disclosure is not applicable to the Company - This item is not applicable to the Company for the reporting period[161](index=161&type=chunk) [ITEM 5. OTHER INFORMATION.](index=38&type=section&id=ITEM%205.%20OTHER%20INFORMATION.) This section reports on Rule 10b5-1 trading arrangements by directors and officers - No director or officer adopted or terminated a 'Rule 10b5-1 trading arrangement' or 'non-Rule 10b5-1 trading arrangement' during the three months ended March 31, 2025[162](index=162&type=chunk) [ITEM 6. EXHIBITS.](index=39&type=section&id=ITEM%206.%20EXHIBITS.) This section provides a list of exhibits filed as part of this Quarterly Report on Form 10-Q - The report includes various exhibits such as the Certificate of Incorporation, Amended and Restated Bylaws, forms of warrants, employment agreements, and certifications under the Sarbanes-Oxley Act[164](index=164&type=chunk) [SIGNATURES](index=40&type=section&id=SIGNATURES) This section contains the signatures of the Company's authorized officers, certifying the report - The report is signed by Maria Zannes, Chief Executive Officer, President, Founder, and Director, and J. Michael Edwards, Vice President and Chief Financial Officer, on May 15, 2025[168](index=168&type=chunk)

[Executive Summary & Business Update](index=1&type=section&id=Executive%20Summary%20%26%20Business%20Update) [Company Overview](index=1&type=section&id=Company%20Overview) bioAffinity Technologies, Inc. is a biotechnology company focused on developing accurate, noninvasive tests for early-stage lung cancer and other lung diseases, with its primary product being CyPath Lung - bioAffinity Technologies, Inc. is a biotechnology company focused on noninvasive tests for early-stage lung cancer and other lung diseases, as well as broad-spectrum cancer treatments[2](index=2&type=chunk)[13](index=13&type=chunk) - The company's first product, CyPath Lung, is a noninvasive test for early-stage lung cancer, marketed as a Laboratory Developed Test (LDT) by its subsidiary, Precision Pathology Laboratory Services[13](index=13&type=chunk) [Key Highlights & Management Commentary](index=1&type=section&id=Key%20Highlights%20%26%20Management%20Commentary) The company reported strong momentum in Q1 2025, driven by significant year-over-year growth in CyPathLung sales and strategic actions to streamline operations and reduce costs, while also expanding its commercial footprint and intellectual property [Operational & Strategic Achievements](index=1&type=section&id=Operational%20%26%20Strategic%20Achievements) Key operational achievements include a substantial increase in CyPathLung sales, successful beta launch results, significant cost reduction initiatives, and advancements in intellectual property and processing efficiency CyPathLung Sales Growth (Q1 2025 vs. Q1 2024) | Metric | Q1 2025 | YoY Change | | :--------------- | :------ | :--------- | | CyPathLung Sales | N/A | **+276%** | - Strategic actions implemented in March 2025, including streamlining operations, reducing labor costs, and discontinuing suboptimal pathology services, are expected to reduce annual costs by approximately **$3.8 million**[5](index=5&type=chunk)[6](index=6&type=chunk) - The company received acceptance of a new patent application from the Australian Patent Office, enhancing international IP protection and global commercialization potential for CyPathLung[6](index=6&type=chunk) - Subsequent to the first quarter, improvements to CyPath Lung processing increased data acquisition throughput by **50%** and reduced unit cost by over **25%**[6](index=6&type=chunk)[7](index=7&type=chunk) [Management Outlook](index=1&type=section&id=Management%20Outlook) CEO Maria Zannes emphasized the growing demand for CyPathLung, the successful execution of the company's strategy focusing on high-value services and operational efficiency, and a commitment to expanding access and developing new diagnostics - CEO Maria Zannes highlighted strong momentum in Q1 2025, attributing it to growing demand for CyPathLung and successful execution of a strategy focused on high-value services and operational efficiency[4](index=4&type=chunk) - The company is committed to expanding access to CyPath Lung for patients at risk of lung cancer and advancing new diagnostics for diseases like COPD and asthma[8](index=8&type=chunk) [Financial Performance](index=2&type=section&id=Financial%20Performance) [First Quarter 2025 Financial Results Overview](index=2&type=section&id=First%20Quarter%202025%20Financial%20Results%20Overview) bioAffinity Technologies reported $1.9 million in revenue for Q1 2025, a decrease from the prior year, alongside an increase in operating expenses and a higher net loss. The company's cash position decreased, though subsequent financing activities raised additional capital Q1 2025 vs Q1 2024 Financial Summary | Metric | Q1 2025 | Q1 2024 | YoY Change | | :------------------------------------ | :------------- | :------------- | :--------- | | Net Revenue | **$1.9 million** | $2.4 million | **-20.8%** | | Operating Expenses | **$4.5 million** | $4.4 million | **+2.3%** | | Net Loss | **$(2.7) million** | $(2.0) million | **+35.0%** | | Net Loss Per Share (basic & diluted) | **$(0.16)** | $(0.20) | **-20.0%** | | Cash and Cash Equivalents (as of period end) | **$0.4 million** (Mar 31, 2025) | $1.1 million (Dec 31, 2024) | **-63.6%** | - Subsequent to the end of 2024, bioAffinity Technologies raised gross proceeds of **$1.4 million** through warrant exercises in February 2025 and **$3.3 million** in a public offering in May 2025[12](index=12&type=chunk) [Condensed Consolidated Balance Sheets](index=4&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) As of March 31, 2025, the company's total assets decreased to $5.5 million from $6.5 million at December 31, 2024, primarily driven by a reduction in cash and cash equivalents. Total liabilities increased, while total stockholders' equity decreased significantly Selected Balance Sheet Items (March 31, 2025 vs. December 31, 2024) | Item | March 31, 2025 | December 31, 2024 | | :------------------------ | :------------- | :---------------- | | Cash and cash equivalents | **$444,706** | $1,105,291 | | Total current assets | **$1,863,782** | $2,695,098 | | Total assets | **$5,547,283** | $6,513,667 | | Total current liabilities | **$3,415,409** | $3,104,905 | | Total liabilities | **$4,107,879** | $3,911,631 | | Total stockholders' equity| **$1,439,404** | $2,602,036 | [Unaudited Condensed Consolidated Statements of Operations](index=5&type=section&id=Unaudited%20Condensed%20Consolidated%20Statements%20of%20Operations) For Q1 2025, net revenue was $1.85 million, a decrease from Q1 2024. Operating expenses totaled $4.48 million, with direct costs decreasing due to strategic actions, while clinical development and selling, general and administrative expenses increased, leading to a net loss of $2.66 million Q1 2025 vs Q1 2024 Operating Expenses Breakdown | Expense Category | Q1 2025 | Q1 2024 | YoY Change | | :-------------------------------- | :----------- | :----------- | :--------- | | Direct costs and expenses | **$1,367,860** | $1,573,441 | **-13.0%** | | Research and development | **$367,386** | $393,639 | **-6.7%** | | Clinical development | **$138,353** | $48,960 | **+182.6%** | | Selling, general and administrative | **$2,452,549** | $2,185,944 | **+12.2%** | | Depreciation and amortization | **$154,588** | $149,637 | **+3.3%** | - Direct costs and expenses decreased **13%** year-over-year, primarily due to targeted strategic actions implemented in March 2025[10](index=10&type=chunk) - Selling, general and administrative expenses increased, mainly driven by higher employee compensation related to administrative and sales functions to scale the commercialization of CyPath Lung[11](index=11&type=chunk) [Additional Information](index=3&type=section&id=Additional%20Information) [Forward-Looking Statements](index=3&type=section&id=Forward-Looking%20Statements) This section provides a standard disclaimer regarding forward-looking statements, highlighting that future results may differ materially due to various risks and uncertainties - The press release contains forward-looking statements, which are based on current estimates and assumptions and are subject to various risks and uncertainties that could cause actual results to differ materially from current expectations[14](index=14&type=chunk) [Contacts](index=3&type=section&id=Contacts) Contact information for media and investor relations is provided for inquiries related to bioAffinity Technologies - Contact information for bioAffinity Technologies' Director of Communications (Julie Anne Overton) and Investor Relations (Dave Gentry of RedChip Companies Inc.) is provided[15](index=15&type=chunk)

Core Viewpoint - bioAffinity Technologies, Inc. has successfully closed a best efforts offering of securities, raising a total of $3.25 million before expenses [1]. Group 1: Offering Details - The offering included 10,156,250 shares of Common Stock and warrants to purchase up to 15,234,375 shares of Common Stock, with a combined public offering price of $0.32 per share or pre-funded warrant [2]. - WallachBeth Capital, LLC served as the sole placement agent for this offering [2]. Group 2: Company Background - WallachBeth Capital LLC provides a wide range of capital markets and investment banking services, particularly to the healthcare sector, facilitating connections between corporate clients and leading institutions [5].

Core Insights - bioAffinity Technologies, Inc. (BIAF) shares have increased by 160.9% since the financial results for the year ended December 31, 2024, contrasting with an 8.9% decline in the S&P 500 Index during the same period [1] - The company reported record revenues of $9.4 million for 2024, a 269.7% increase from $2.5 million in 2023, primarily due to the acquisition of Precision Pathology Laboratory Services [2] - Despite revenue growth, net loss widened to $9 million, or $0.75 per share, compared to a loss of $7.9 million, or $0.91 per share, in the previous year [3] Revenue Growth and Profitability Metrics - The significant revenue increase was largely attributed to a full year of operations from Precision Pathology, acquired in September 2023 [2] - Orders for the flagship test, CyPath Lung, surged by 1,400% over 2023, indicating strong adoption by physicians [2] Operating Expenses - Operating expenses rose by 74.3% to $18.3 million from $10.5 million, reflecting increased commercial activity and the full-year impact of PPLS operations [3] - Selling, general, and administrative expenses increased by 46.4% to $9.9 million, driven by higher personnel costs and commercialization efforts for CyPath Lung [4] - Direct costs and expenses surged by 243.7% to $5.9 million due to the expansion of pathology and lab operations [4] Cash Position and Liquidity - The company ended 2024 with $1.1 million in cash and equivalents, down from $2.8 million at the end of 2023, but raised $1.4 million in February 2025 through warrant exercises [4] Business Expansion - BIAF expanded its physician network by over 300% in 2024, establishing a broader footprint for future growth [5] - The test CyPath Lung has been reimbursed by Medicare and private insurers, and is listed on the U.S. Federal Supply Schedule, allowing access to 1,380 government healthcare facilities [6] Future Guidance - For 2025, bioAffinity anticipates revenues between $6 million and $8 million, including $1 million to $2 million from CyPath Lung sales, reflecting a planned discontinuation of unprofitable pathology services [9] - Management expects reductions in labor and overhead to offset the revenue dip, improving profitability at its subsidiary laboratory [10] Clinical Developments - BIAF submitted the pivotal study protocol to the Sterling Institutional Review Board, with the trial expected to enroll approximately 3,500 patients and launch in Q2 2025 [11] - The company has secured a Japanese patent for its proprietary method using flow cytometry for lung disease detection, enhancing its intellectual property portfolio [12]

Financial Performance - Consolidated revenue increased approximately 270% to $9.4 million compared to $2.5 million for the year ended December 31, 2023, primarily due to the acquisition of PPLS in September 2023[45] - The company generated revenue of approximately $9.4 million and $2.5 million for the years ended December 31, 2024, and December 31, 2023, respectively[155] - The company generated $2.5 million in revenue from PPLS in 2023 and $9.4 million in 2024, but does not expect to derive immediate profit from these services[169] - For the year 2024, cash used in operations was $7.1 million, and the net loss was $9.0 million[161] - As of December 31, 2024, the company had an accumulated deficit of $53.6 million and only $1.1 million in cash on hand[161] - The company anticipates needing to raise additional capital to support operations and may require further financing through equity or debt securities[166] Product Development and Clinical Trials - A pivotal clinical trial for CyPath Lung is expected to open in the second quarter of 2025, with 3,200 patients participating across multiple collection sites[40] - CyPath Lung achieved an overall 88% specificity and 82% sensitivity in a 150-patient validation trial, correctly detecting 80% of Stage I lung cancers[39] - The test demonstrated 92% sensitivity and 87% specificity for patients with lung nodules 20 millimeters or smaller, with a 99% negative predictive value[39] - The company plans to develop and commercialize its first diagnostic test, CyPath Lung, and aims to secure necessary regulatory approvals[164] - The company is in the preliminary phases of developing diagnostic tests and therapeutic products, which are critical for achieving profitability[156] - The company is conducting research to develop precision diagnostics for asthma and COPD, with patient studies expected to begin in 2026[84] - A pivotal clinical trial for the FDA-cleared FlowPath Lung test is expected to enroll approximately 3,400 patients over 18 months, with the first site opening in Q2 2025[70] Regulatory and Compliance - Medicare reimbursement code 0406U for CyPath Lung became effective on January 1, 2024, following regulatory approvals in 2023[61] - The FDA's final rule on Laboratory Developed Tests (LDTs) will require compliance with premarket review and quality system requirements for LDTs marketed after May 6, 2024[100] - The company has completed its certification as an LDT in accordance with CAP and CLIA regulations in 2023[100] - The FDA may order the temporary or permanent discontinuation of a clinical trial if it believes the trial is not compliant with regulations or poses unacceptable risks[120] - The company must maintain compliance with current good manufacturing practices (cGMP) post-approval to avoid product recalls or regulatory issues[142] - The company may face fines or withdrawal of regulatory approvals if it fails to comply with foreign regulatory requirements[146] Market Potential and Competitive Landscape - The global lung cancer diagnostic market is projected to grow from $15.1 billion in 2023 to $34.8 billion by 2034, with a CAGR of 7.9%[63] - The diagnostics market for COPD was valued at $5.6 billion in 2023 and is projected to reach $8.2 billion by 2029, indicating significant growth potential for the company's future products[84] - The company faces significant competition from larger diagnostic and pharmaceutical companies, which may have greater financial resources and established market presence[196] - The ability to achieve market acceptance for diagnostic tests and therapeutic products is contingent upon factors such as efficacy, safety, pricing, and physician willingness to adopt new tests[191] - The market for diagnostic tests and products is rapidly changing, with technological advancements potentially rendering the company's offerings noncompetitive[218] Financial Risks and Challenges - The company has limited operating history and faces significant risks in establishing its business and expanding its commercialization efforts[162] - The company’s future profitability is uncertain, and failure to generate sufficient revenue could lead to a decline in stockholder value[162] - The company may struggle to obtain adequate reimbursement from third-party payors, which could limit market acceptance and revenue generation[212] - The company relies on third parties for manufacturing and clinical trial management, which may reduce control over timelines and quality[204] - The evolving landscape of privacy regulations poses risks to the company's operations and could result in reputational harm if compliance is not maintained[210] Innovation and Intellectual Property - CyPath Lung is the first cancer diagnostic combining flow cytometry and automated analysis for lung cancer detection from sputum samples[62] - The company achieved a reduction of CD320 and LRP2 protein levels of up to 90% using siRNAs, which inhibited cell growth or killed cancer cells by up to 80%[87] - As of December 31, 2024, the company and its OncoSelect® subsidiary hold a patent estate that includes 17 issued U.S. and foreign counterpart patents, with expiration dates ranging from 2030 to 2039[92] - The diagnostic patent portfolio includes one issued U.S. patent and nine foreign counterpart patents, with applications directed at diagnosing lung health and proprietary compensation beads for flow cytometry[93] - The company plans to rely on regulatory protections such as orphan drug exclusivities and data exclusivities to maintain market position[98] Operational and Management Aspects - The company employs 57 employees, with 21 at bioAffinity and 36 at PPLS, emphasizing recruitment and retention of skilled professionals[147] - The Chief Science Officer has extensive experience in FDA approval processes, having previously worked at Genzyme Corporation and Ilex Products[148] - The loss of key executives could impede the company's ability to achieve its research and commercialization objectives[200] - The company has limited experience in sales and marketing of diagnostic tests, which may hinder its ability to commercialize products effectively[189] Economic and Environmental Factors - Increased inflation rates may result in higher operating costs, impacting demand and pricing for the company's drug candidates[229] - The global macroeconomic environment is affected by geopolitical instability, which could lead to uncertainty in local economies and financial markets[231] - Changes in U.S. trade policies, including tariffs, could adversely impact the company's business and financial condition[227]