Press Release: Bioaffinity Technologies' Noninvasive Cypath(R) Lung Test To Be Highlighted At American Cancer Society National Lung Cancer Roundtable

Shares of bioAffinity Technologies, Inc. BIAF have lost sharply since the company reported third-quarter 2025 results. The stock has plunged 21.8% since the earnings release compared with the S&P 500 Index’s 2.2% loss during the same period. Over the past month, bioAffinity shares have dipped 48.9%, significantly underperforming the broader market, which slipped 2%.

BIAF’s Earnings Snapshot

In the third quarter of 2025, bioAffinity generated $1.4 million in total revenues, down 38.5% from $2.4 million a year earlier, reflecting its strategic exit from unprofitable pathology services and renewed emphasis on CyPath Lung commercialization. Despite the top-line decline, the company reported strong momentum in its flagship diagnostic product. CyPath Lung testing revenue rose 122% year over year, supported by higher case volumes and increased physician adoption — including growing usage across Veterans Administration (VA) medical centers.

Operating expenses fell 13.5% to $3.7 million from $4.3 million, driven mainly by lower laboratory-related costs. Still, BIAF’s net loss widened to $5.1 million from $2 million a year ago, primarily due to a non-cash expense tied to warrant revaluations. Loss per share narrowed slightly to $4.74 from $4.84.

bioAffinity’s Operational and Financial Metrics

Beyond revenue and operating costs, BIAF reported notable reductions across several expense lines. Direct costs declined 34.6% year over year to $0.9 million from $1.4 million, reflecting March 2025 efficiency initiatives. Selling, general and administrative expenses decreased 6.6%, aided by operational streamlining at Precision Pathology Laboratory Services. Depreciation and amortization expenses dropped 25.1% from the prior year. However, research and development (R&D) spending rose 20.4% and clinical development costs increased 52.9% due to expanded preclinical and clinical work ahead of an upcoming longitudinal study.

In addition, bioAffinity highlighted robust operational momentum for CyPath Lung, noting that test volumes for the first nine months of 2025 increased 97% over the prior-year period. The test also reached a record quarterly sales level in the third quarter of 2025, climbing 92% from the preceding quarter. These gains were driven by expanded adoption, particularly within the VA system and in new regional markets.

Balance sheet strength improved meaningfully, with cash and equivalents rising to $7.7 million from $1.1 million at year-end 2024, supported by $10.4 million in gross proceeds from equity transactions completed during the quarter.

bioAffinity Technologies, Inc. Price, Consensus and EPS Surprise

bioAffinity Technologies, Inc. price-consensus-eps-surprise-chart | bioAffinity Technologies, Inc. Quote

BIAF’s Management Commentary

Management emphasized that third-quarter 2025 efforts centered on advancing CyPath Lung adoption while maintaining cost discipline. CEO Maria Zannes highlighted the value of recently published patient case studies, which showcased the test’s ability to detect malignancy at Stage 1A and in cases where other diagnostic tools were inconclusive or contraindicated. Additionally, marketing initiatives targeting the VA health system continued to yield traction, with further interest emerging in the company’s upcoming longitudinal trial.

Leadership also underscored the importance of the newly awarded U.S. patent protecting CyPath Lung’s diagnostic algorithm, strengthening the test’s competitive moat.

Factors Influencing bioAffinity’s Results

The quarter’s revenue decline reflects bioAffinity’s pivot away from low-margin pathology services in favor of its higher-value diagnostic platform. The transition has temporarily reduced overall revenue but improved mix quality, as CyPath Lung testing becomes a larger share of total sales. Accelerated spending tied to clinical development and research investments also contributed to the quarterly loss, though these expenditures support BIAF’s broader diagnostic pipeline — including emerging asthma and chronic obstructive pulmonary disease (COPD) companion diagnostics.

Non-cash warrant valuation changes further widened the bottom-line loss, but do not reflect core business performance. Meanwhile, bioAffinity’s cost-reduction efforts materially lowered direct expenses, offsetting some of the pressures from increased R&D and clinical development activities.

BIAF’s Guidance

bioAffinity did not issue formal financial guidance, but management outlined strategic objectives for 2025. These include continued expansion of the sales team into national markets, broader engagement with major VA medical centers, increased multi-media marketing and the opening of clinical trial collection sites under a newly approved protocol. bioAffinity also plans ongoing publication of case studies demonstrating clinical impact.

On the pipeline front, BIAF is advancing companion diagnostic candidates for asthma and COPD, an estimated $26 billion global market.

bioAffinity’s Other Developments

During the quarter, bioAffinity strengthened its governance and strategic capabilities with the appointments of Roberto Rios, CPA, and John J. Oppenheimer, M.D., to its board of directors. It also regained full Nasdaq Capital Market compliance, subject to a one-year panel monitor.

On the intellectual property front, BIAF added another U.S. patent that protects its proprietary algorithm used in CyPath Lung — marking its second consecutive quarter of patent portfolio expansion.

This article originally published on Zacks Investment Research (zacks.com).

Zacks Investment Research

CyPath® Lung sales surged 97% year-over-year, driving a record quarter, but overall revenue fell 36% due to discontinued services. The company raised $13.4 million in new capital but faces substantial doubt about its ability to continue as a going concern beyond May 2026 without further funding.

Original document: bioAffinity Technologies, Inc. [BIAF] SEC 10-Q Quarterly Report — Nov. 14 2025

CyPath® Lung testing revenue grew 86% year-over-year, with a 92% sequential increase in Q3 2025, while total revenue declined due to discontinued pathology services. Net loss widened to $5.1 million, but $10.4 million was raised to support growth and operations.

Original document: bioAffinity Technologies, Inc. [BIAF] SEC 8-K Current Report — Nov. 14 2025