bioAffinity Technologies (BIAF -8.86%), a biotechnology company focused on noninvasive diagnostics and cancer therapeutics, reported results for Q2 2025 on August 14, 2025. The most significant news from the release was that GAAP revenue came in well below analyst expectations, and GAAP EPS showed a wider loss than forecast. Net revenue was $1.27 million, short of the $1.51 million estimate and down from $2.4 million (GAAP) in Q2 2024. GAAP EPS was a loss of $(0.17), falling below the GAAP consensus of $(0.10) and slightly improved from $(0.19) per share (GAAP) in Q2 2024. The company highlighted cost-cutting progress and accelerating adoption of its main diagnostic test. However, overall financial performance remained pressured, and cash reserves declined further, making future liquidity a key concern.
| Metric | Q2 2025 | Q2 2025 Estimate | Q2 2024 | Y/Y Change |
|---|---|---|---|---|
| EPS (GAAP) | $(0.17) | $(0.10) | $(0.19) | -10.5 % |
| Revenue | N/A | $1.51 million | $2.40 million | (37.1 %) |
| Operating Expenses | N/A | $4.49 million | N/A | |
| Net Loss | $(4.06 million) | $(2.11 million) | (92.4 %) | |
| Cash and Cash Equivalents (period end) | $0.80 million | $1.11 million | (27.2 %) |
Source: Analyst estimates for the quarter provided by FactSet.
Company Overview and Strategic Focus
bioAffinity Technologies develops diagnostic tests and new drug therapies mostly aimed at lung cancer. Its main commercial product, CyPath® Lung, is a laboratory-developed test designed to detect lung cancer at an early stage using a noninvasive sputum sample.
The company shifted its commercial approach in Q2 2025, focusing on expanding CyPath® Lung adoption while exiting older pathology services that contributed little profit. Its main drivers of future success are building sales of its diagnostics and advancing its cancer therapy R&D pipeline. Rapid revenue growth in diagnostics, successful clinical studies, and efficient cash use are all vital for its outlook.
Quarterly Review: Sales, Products, Operations
GAAP revenue saw a sharp decline in Q2 2025 compared to Q2 2024 as the company discontinued most legacy pathology offerings and shifted focus to CyPath® Lung. This change led to lower reported GAAP revenues, as the newer diagnostic has so far generated much less revenue than the discontinued services. Operating expenses dropped 16% year over year, reflecting active cost-savings measures as management responded to lower revenue.
CyPath® Lung, the core product line, is a diagnostic test for early lung cancer detection. It saw strong momentum: year to date, sales rose 62% year-over-year for the six months ended June 30, 2025, reaching $323,000. The company raised the price of the test during Q2 2025 to $2,900 per use to improve margins, signaling confidence in payor acceptance and clinical support. In July, test volume increased 72% over the monthly average for the first six months of 2025, with consecutive record monthly sales in June and July 2025. Management highlighted new real-world case studies published showing that the test successfully detected early-stage cancers missed by other methods.
The company is also developing early-stage targeted cancer therapeutics. In Q2 2025, the company was granted new patents in the U.S. China, Canada, and Australia for both its diagnostics and new cancer therapy candidates, such as broad-spectrum treatments targeting CD320 and LRP2 cellular receptors. Research was presented showing progress in RNA-based (siRNA) therapeutics, a drug approach that kills cancer cells without harming healthy tissue. However, these programs remain pre-commercial, and Research and development (R&D) spending fell 23% year-over-year as resources shifted toward diagnostics. There was no reported revenue from the therapeutics pipeline.
No new regulatory approvals or submissions were reported this quarter. The company continued to grow its intellectual property estate, which lays the foundation for later commercialization and regulatory filings in more markets, but does not immediately impact results.
The company’s cash and financial health is a concern. Cash reserves at the end of Q2 2025 were $0.80 million, down from $1.11 million at December 31, 2024, even after completing a $3.25 million public equity offering in May 2025. Net loss (GAAP) widened to $4.06 million in Q2 2025 from $2.11 million in Q2 2024. Higher losses in Q2 2025 were attributed to non-cash expenses from warrant remeasurement and offering costs, after the share count nearly doubled to over 24 million due to capital raising.
Operationally, the company strengthened its logistics for CyPath® Lung with a partnership for better sample delivery and tracking. A new Chief Medical Officer was appointed to drive clinical strategy. However, The company’s liabilities now exceed its total assets, moving from positive equity at the end of last year to a deficit of $2.1 million as of June 30, 2025.
BIAF does not currently pay a dividend.
Looking Ahead: Guidance and Key Watch Points
Management did not provide detailed financial guidance for upcoming quarters or for fiscal 2025. Instead, leadership emphasized building on recent commercial gains, focusing on expanding CyPath® Lung access into new customer segments and regions, and continuing operational cost control.
Investors should monitor the pace of revenue growth in CyPath® Lung, as this product must quickly ramp up to offset the loss of legacy service income and meet the company’s near-term funding needs. For the six months ended June 30, 2025, CyPath® Lung testing revenue increased by approximately 62% year-over-year to $323,000. Other things to watch include plans to expand into government health systems and ongoing efforts in the development of next-generation cancer diagnostics and therapies. Cash burn and capital raising remain major risks to near-term stability unless diagnostic sales increase markedly.
Revenue and net income presented using U.S. generally accepted accounting principles (GAAP) unless otherwise noted.
