bioAffinity Q3 Revenue Falls to $1.1M as CyPath Sales Double

# bioAffinity Q3 Revenue Falls to $1.1M as CyPath Sales Double

bioAffinity Technologies, Inc. (Nasdaq: BIAF; BIAFW) reported third-quarter 2026 net revenue of approximately $1.1 million, down from approximately $1.4 million a year earlier, even as CyPath Lung test unit sales doubled through the first nine months of 2026 versus the same 2025 stretch, the company announced on November 6, 2026. Net loss widened to approximately $5.3 million from $5.1 million. Cash and cash equivalents stood at $2.55 million on September 30, 2026, versus $6.45 million at December 31, 2025.

Context — why the revenue decline matters now

The quarter captures a divergence the company itself frames: commercial traction is rising while reported revenue falls. CyPath Lung testing revenue for the first nine months of 2026 rose 79% to approximately $1.1 million, yet total net revenue for the nine months slipped to $3.93 million from $4.57 million a year earlier.

The gap traces to the company's laboratory subsidiary, Precision Pathology Laboratory Services. bioAffinity attributed the quarterly revenue decline primarily to a lower average reimbursement per CyPath Lung test and a slight drop in total cases completed at PPLS, partly from internal business changes at three PPLS research clients. The company said multiple accounts previously serviced under those clients have since returned to PPLS, and it is working to restore additional accounts and improve reimbursement levels.

That mix shift matters because it separates volume from price. Doubling unit sales while revenue falls implies reimbursement pressure is doing the damage, not demand. For a diagnostics company marketing a Laboratory Developed Test under CLIA oversight, the reimbursement line is the lever that converts physician interest into cash.

The company also raised capital twice in the period — an $8.0 million gross private placement in August 2026 and a registered direct offering with concurrent private placement in October 2026 — explicitly to fund CyPath Lung commercialization. Subsequent to quarter-end, that October financing generated approximately $4.0 million in gross proceeds, the company said.

Operating expenses climbed to approximately $4.6 million from $3.7 million, led by selling, general and administrative costs that rose 28% to approximately $2.8 million on added sales and marketing personnel.

Data — what the numbers show

The headline tension sits in two lines of the income statement moving in opposite directions.

Metric	Q3 2026	Q3 2025
Net revenue	$1,070,280	$1,446,066
Net loss	$5,277,023	$5,051,084
Loss from operations	$3,510,672	$2,292,846
Total operating expenses	$4,580,952	$3,738,912

Clinical development spending rose 75% to approximately $251,000 from approximately $143,000, reflecting the launch of trial sites and patient enrollment in the longitudinal study. Research and development rose 18% to approximately $389,000, tied to laboratory supplies and a June 2026 facility relocation.

On the operating side, the company said the number of ordering physicians increased 89% in Q3 2026 versus Q3 2025, and physicians already ordering CyPath Lung raised their volume 48% year over year. In July 2026, bioAffinity surpassed the total CyPath Lung test reports delivered to physicians during all of 2025.

Balance-sheet detail: total stockholders' equity fell to $3.91 million from $7.28 million at year-end 2025, with accumulated deficit widening to $80.83 million from $68.55 million. Net loss per common share was $5.89, against $71.05 a year earlier, reflecting a much larger share count — weighted average shares outstanding rose to 896,271 from 71,090.

Analysis — what it means for markets and sectors

bioAffinity sits in the crowded lung-cancer screening space, where liquid-biopsy and imaging-adjunct developers compete for pulmonologist attention and payer coverage. The company's own positioning leans on a published trial showing 92% sensitivity, 87% specificity and a 99% negative predictive value in high-risk patients with small indeterminate nodules under 20 millimeters — the kind of statistic designed to win over physicians deciding whether a negative result can spare an invasive biopsy.

Distribution is the second front. An agreement with AvMEDICAL, a Service-Disabled Veteran-Owned Small Business distributor to government agencies including the Department of Veterans Affairs, extends reach into a channel where the company says lung cancer burden is substantial. Eleven clinical sites were active as of September 30, 2026, including nine VA and military medical centers enrolling patients.

The counter-argument is cash. With $2.55 million on the balance sheet at quarter-end plus roughly $4.0 million gross from the October financing, the company's runway depends on how quickly reimbursement improves and how far operating expenses keep climbing. The share count roughly tripled year over year, diluting existing holders even as the per-share loss narrowed.

Beyond lung cancer, bioAffinity is pushing sputum-based inflammation testing into asthma and COPD, where it named Tezspire, Dupixent and Nucala as therapies physicians might better match to patients. A collaboration with Pictor, Inc. supports that work. Preliminary in vitro findings on self-delivering siRNAs that selectively kill squamous and basal carcinoma cells remain early-stage.

Outlook — what to watch next

Three catalysts dominate. First, reimbursement: the company said it is working to restore PPLS accounts and improve average reimbursement per test, the single variable separating unit growth from revenue growth. Second, the longitudinal clinical trial, which the company says is designed to generate real-world data across sites; enrollment pace and any protocol updates are the markers.

Third, capital. After the October 2026 financing, the next disclosure on cash position and burn rate will indicate how much runway the commercialization push has. The company did not disclose terms beyond gross proceeds for either offering.

On intellectual property, the portfolio now includes 22 awarded U.S. and foreign patents and 36 pending applications, following a September 2026 Hong Kong patent grant and an October Notice of Allowance from the Japan Patent Office. No specific revenue targets or timeline for profitability were provided.

Frequently Asked Questions

Why did bioAffinity's revenue fall while CyPath Lung unit sales doubled?

The company attributed the decline primarily to a lower average reimbursement per CyPath Lung test and a slight drop in total cases at Precision Pathology Laboratory Services, partly from internal changes at three PPLS research clients. Unit volume and revenue moved apart because price per test fell. bioAffinity said some accounts have returned and it is working to restore others.

How much cash does bioAffinity have after its October 2026 financing?

bioAffinity reported approximately $2.55 million in cash and cash equivalents as of September 30, 2026, down from $6.45 million at December 31, 2025. Subsequent to quarter-end, the company completed a financing generating approximately $4.0 million in gross proceeds. Combined, that suggests a pro-forma cash position near $6.5 million before any post-quarter operating spend.

What is the CyPath Lung longitudinal clinical trial testing?

The trial is designed to evaluate the clinical performance of CyPath Lung. As of September 30, 2026, 11 clinical sites were active, including nine VA and military medical centers enrolling patients. The John P. Murtha Cancer Center Research Program at the Uniformed Services University of the Health Sciences is providing support and funding. The company did not disclose enrollment numbers or a completion date.

Bottom Line

bioAffinity's CyPath Lung demand is doubling, but reimbursement pressure and a widening net loss mean the commercialization story still hinges on converting volume into cash.

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