bioAffinity Technologies, Inc.’s BIAF investors have been experiencing some short-term losses. Shares of the San Antonio, TX-based biotechnology company have lost 77% in the past three months against the industry’s 4.5% rise. It has also underperformed the sector and the S&P 500’s gain of 8.2% and 10.1%, respectively, in the same time frame.
Two major recent developments of BIAF are the announcement of continued acceleration in commercial sales for CyPath Lung, with more than 200% growth year over year (in July) and the preclinical findings for a novel therapeutic approach that uses small interfering RNAs (siRNAs) that kill squamous and basal skin cancer cells in vitro while leaving non-cancerous skin cells unharmed (in June).
bioAffinity also announced its first-quarter 2026 results in May. In the quarter, the company reported mixed financial results as strong growth in its CyPath Lung business was offset by the strategic discontinuation of certain lower-margin pathology services. Total revenues declined year over year, while BIAF posted a wider net loss as commercialization and clinical development investments increased.
Management attributed the quarter’s progress to accelerating physician adoption of CyPath Lung, reflected in higher unit sales, testing revenues and an expanding base of ordering physician offices. bioAffinity also advanced its long-term growth strategy by launching a Department of Defense-supported clinical trial, expanding its scientific advisory board and increasing physician outreach, while expecting commercial initiatives and broader awareness to drive faster adoption through the remainder of 2026.
BIAF Three Months Price Comparison
Image Source: Zacks Investment Research
Over the past three months, the stock’s performance has remained weak, underperforming its peers like ALX Oncology Holdings Inc. ALXO and ADMA Biologics, Inc. ADMA. ALX Oncology and ADMA Biologics’ shares have gained 35.3% and lost 4.6%, respectively, in the same time frame.
bioAffinity is a diagnostics company focused on developing noninvasive tests for early-stage lung cancer and other pulmonary diseases. Its first product, CyPath Lung, is a non-invasive test that has shown high sensitivity, specificity and accuracy for the detection of early-stage lung cancer.
bioAffinity’s Commercialization Execution Challenges
While CyPath Lung adoption continues to improve, BIAF is still in the early stages of commercialization. Management remains focused on expanding its sales footprint, increasing physician awareness, adding new ordering sites and integrating the test into routine clinical workflows, suggesting that broader market penetration is still developing.
bioAffinity continues to operate at a loss despite rapid growth in CyPath Lung testing. Higher selling, administrative and clinical development expenses associated with commercialization widened the quarterly loss, while cash reserves declined during the first quarter of 2026, underscoring the financial burden of scaling the business.
BIAF continues to rely on equity financing to support operations, as reflected by its June 2026 public offering. The need to periodically raise capital before achieving sustainable profitability increases the risk of shareholder dilution and highlights the business’s ongoing funding requirements.
BIAF’s Business Concentration & Regulatory Risks
CyPath Lung remains bioAffinity’s only commercial product, making the company’s growth highly dependent on its continued physician adoption, reimbursement expansion and commercial success. Although BIAF is advancing additional diagnostic and therapeutic programs, most remain in the research or clinical development stage.
CyPath Lung is marketed as a Laboratory Developed Test (LDT), exposing the company to potential changes in the regulatory framework governing LDTs. At the same time, bioAffinity continues to conduct large-scale clinical studies to generate additional validation data and support broader clinical acceptance, meaning future adoption remains dependent on both regulatory developments and successful study outcomes.
Fundamentals to Drive bioAffinity
Accelerating adoption of CyPath Lung remains bioAffinity’s biggest growth driver, with expanding physician utilization, a growing base of ordering sites and deeper integration into clinical workflows expected to support higher test volumes through 2026. Another key catalyst is the continued expansion and validation of its diagnostic platform. Large-scale clinical studies, Department of Defense-backed collaborations and development of companion diagnostics for asthma and chronic obstructive pulmonary disease (COPD) are expected to strengthen clinical evidence, broaden the platform’s applications and support wider physician acceptance over the long term.
BIAF Stock’s Valuation
bioAffinity’s trailing 12-month P/B of 1.02X is lower than the industry’s average of 3.65X and its six-month median of 1.59X.
Image Source: Zacks Investment Research
ALX Oncology and ADMA Biologics’ trailing 12-month P/B currently stand at 2.07X and 5.44X, respectively, in the same time frame.
Our Final Take on bioAffinity
BIAF’s long-term growth story continues to be centered on the commercial expansion of CyPath Lung, which is witnessing increasing physician adoption and stronger integration into clinical practice. The company’s ongoing clinical validation studies, Department of Defense-backed collaborations and efforts to expand its diagnostic platform into asthma and COPD further strengthen its long-term growth prospects and could support broader market acceptance over time.
However, bioAffinity is still navigating the challenges associated with an early-stage commercialization business. Continued operating losses, reliance on external financing, dependence on a single commercial product and regulatory uncertainties surrounding LDTs remain key risks that could pressure the stock until BIAF demonstrates more consistent financial improvement.
From a valuation perspective, the stock appears inexpensive relative to both its industry peers and its own historical trading levels. While this may indicate an attractive entry point for long-term investors, it also reflects the market’s cautious stance toward bioAffinity’s execution, funding needs and path to sustainable profitability.
For existing shareholders, the recent sharp decline appears to reflect near-term execution and financing concerns rather than a deterioration in bioAffinity’s long-term commercial opportunity. Investors with a higher risk tolerance may consider holding the stock as commercial adoption continues to improve. Prospective investors, meanwhile, may benefit from waiting for clearer evidence of sustained revenue growth, improving profitability and reduced dependence on external capital before initiating a position.
Radical New Technology Could Hand Investors Huge Gains
Quantum Computing is the next technological revolution, and it could be even more advanced than AI.
While some believed the technology was years away, it is already present and moving fast. Large hyperscalers, such as Microsoft, Google, Amazon, Oracle, and even Meta and Tesla, are scrambling to integrate quantum computing into their infrastructure.
Senior Stock Strategist Kevin Cook reveals 7 carefully selected stocks poised to dominate the quantum computing landscape in his report, Beyond AI: The Quantum Leap in Computing Power.
Kevin was among the early experts who recognized NVIDIA’s enormous potential back in 2016. Now, he has keyed in on what could be “the next big thing” in quantum computing supremacy. Today, you have a rare chance to position your portfolio at the forefront of this opportunity.
bioAffinity Technologies, Inc. (BIAF): Free Stock Analysis Report
ADMA Biologics Inc (ADMA) : Free Stock Analysis Report
ALX Oncology Holdings Inc. (ALXO) : Free Stock Analysis Report
This article originally published on Zacks Investment Research (zacks.com).
5 Stocks Our Experts Predict Could Double In the Next Year
By submitting your email, you'll also get a free pivot & flow membership. A free daily market overview. You can unsubscribe at any time.