Shares of bioAffinity Technologies, Inc. BIAF have surged 160.9% since the company reported its financial results for the year ended Dec. 31, 2024. In stark contrast, the S&P 500 Index declined 8.9% during the same period. Over the past month, BIAF stock notched an impressive gain of 89.3%, outperforming the S&P 500’s 9.7% slide.

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Revenue Growth and Profitability Metrics

bioAffinity reported record revenues of $9.4 million for 2024, marking an increase of 269.7% from $2.5 million in 2023. The top-line growth was attributed largely to a full year of consolidated operations from its subsidiary Precision Pathology Laboratory Services (PPLS), which was acquired in September 2023. The company’s flagship test, CyPath Lung, saw a 1,400% surge in orders over 2023, indicating strong physician adoption.

Despite higher revenues, net loss widened to $9 million, or $0.75 per share, from a loss of $7.9 million, or $0.91 per share, in the prior year. Operating expenses rose 74.3% to $18.3 million from $10.5 million, reflecting increased commercial activity and the full-year impact of PPLS operations.

Other Key Business Metrics

Selling, general, and administrative expenses climbed 46.4% to $9.9 million from $6.8 million, driven by higher personnel costs and commercialization efforts for CyPath Lung. Direct costs and expenses increased 243.7% to $5.9 million from $1.7 million due to the expansion of pathology and lab operations. Research and development (R&D) expenses remained flat at approximately $1.5 million, while clinical development costs increased 25.3% to $0.32 million from $0.26 million. The company ended 2024 with $1.1 million in cash and equivalents, a decrease from $2.8 million at the end of 2023. However, it raised $1.4 million in February 2025 through warrant exercises, bolstering its liquidity position.

BIAF also expanded its physician network by more than 300% in 2024, establishing a broader footprint that sets the stage for future growth.

Management Commentary

President and CEO Maria Zannes emphasized that the record-breaking year validated the company’s growth strategy, especially through the integration of Precision Pathology and accelerated adoption of CyPath Lung. Zannes highlighted the test’s reimbursement by Medicare and private insurers, as well as its listing on the U.S. Federal Supply Schedule, enabling access to 1,380 government healthcare facilities. According to her, these developments lay the groundwork for sustained nationwide expansion beyond Texas. Looking ahead, Zannes outlined priorities, including commercial scaling of CyPath Lung, execution of an FDA pivotal trial and advancement of the diagnostic pipeline using AI and flow cytometry.

Factors Influencing the Headline Numbers

BIAF’s top-line expansion was primarily driven by Precision Pathology’s full-year contribution and CyPath Lung’s growing adoption among physicians and healthcare systems. The unique economic value of CyPath Lung was underscored by an independent study, which concluded that adding the test to Medicare’s standard of care could have saved an average of $2,773 per patient in 2022, amounting to $379 million in total savings. For patients with private insurance, the estimated savings were even higher at $6,460 per patient, totaling $895 million if all eligible individuals were covered.

Operating costs rose in line with revenue growth, driven by expansion-related expenses, including higher labor and overhead costs associated with Precision Pathology and intensified marketing efforts for CyPath Lung. Notably, R&D, as well as clinical development expenses, remained stable year over year, although management anticipates a rise in clinical costs in 2025 with the launch of the pivotal FDA study.

Guidance

For 2025, bioAffinity anticipates revenues in the range of $6 million to $8 million, including $1 million to $2 million from CyPath Lung sales. The projected decline compared to 2024 is due to the planned discontinuation of certain unprofitable pathology services.

However, management expects corresponding reductions in labor and overhead to offset the revenue dip, ultimately improving profitability at its subsidiary laboratory. Additionally, the company is preparing for increased clinical spending as it advances the pivotal trial for CyPath Lung.

Other Developments

BIAF announced its submission of the pivotal study protocol to the Sterling Institutional Review Board, with the trial expected to enroll approximately 3,500 patients and launch in the second quarter of 2025. bioAffinity also released a series of patient case studies in collaboration with Gordon Downie, MD, PhD, illustrating CyPath Lung’s role in earlier cancer detection and avoidance of unnecessary invasive procedures.

Internationally, bioAffinity has secured a Japanese patent for its proprietary method, which utilizes flow cytometry for the detection of lung disease, further strengthening its intellectual property portfolio. BIAF also advanced R&D efforts targeting diagnostics for chronic obstructive pulmonary disease and asthma, supported by recent international patent recognition in Japan.

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