bioAffinity Technologies Reports Third Quarter 2026 Results and Continued Momentum in CyPath® Lung Commercialization
SAN ANTONIO--( BUSINESS WIRE)-- bioAffinity Technologies, Inc. (Nasdaq: BIAF; BIAFW), a biotechnology company developing noninvasive healthcare solutions for the early detection and monitoring of lung disease and topically delivered therapeutics for skin cancer, today reported financial results and business highlights for the third quarter (Q3) ended September 30, 2026.
"Our priorities remain disciplined execution, expanding commercial adoption (of CyPath Lung) and advancing our clinical and research programs."
Q3 2026 Highlights and Recent Events
Management Commentary
"Our third-quarter results reflect CyPath Lung’s continued momentum in addressing the critical need for early lung cancer detection, driven by both new physicians ordering the test and increased use by existing customers. We believe this growth reflects increasing physician engagement and recognition of the role CyPath Lung can play in managing care for patients at risk for lung cancer. We are also advancing its potential use in surveillance following curative-intent treatment, where CyPath Lung could complement imaging in monitoring for recurrence and new cancers," said Maria Zannes, President of CEO of bioAffinity Technologies. "Peer-to-peer education and growing clinical experience with the test remain important drivers of adoption, while our longitudinal study is designed to generate robust, real-world data across multiple sites to further evaluate how CyPath Lung may support risk assessment and clinical decision-making. Together, these efforts advance our objective of establishing CyPath Lung as a standard of care for evaluating patients at risk for lung cancer.
"We continue to build the foundation for long-term growth. Beyond lung cancer, we are advancing our platform to take advantage of precision medicine opportunities in asthma and COPD, where sputum-based analysis may help characterize lung inflammation and help physicians better match individual patients to available treatments, including Tezspire, Dupixent and Nucala. The tests we are developing are designed to meet a critical need for precision diagnostics in the multi-billion-dollar asthma and COPD therapeutic markets.
"Our patent portfolio now includes 22 awarded U.S. and foreign patents and 36 pending applications. The recent Hong Kong patent and the Japanese patent allowance, once awarded, are important additions to our patent portfolio. Our distribution agreement with AvMEDICAL is intended to expand our reach into government healthcare markets, including the VA, where the substantial burden of lung cancer underscores the need for more effective ways to evaluate pulmonary nodules and improve patient outcomes.
Ms. Zannes concluded, "Our priorities remain disciplined execution, expanding commercial adoption and advancing our clinical and research programs. We are also pursuing topical therapeutic approaches for squamous and basal cell skin cancers based on promising findings involving the CD320 and LRP2 receptors. We believe our expertise in flow cytometry, automated data analysis and siRNA technology provides a foundation for developing differentiated products across these markets. Together, these programs demonstrate our commitment to translating scientific innovation into meaningful new opportunities for patients and the Company."
Third Quarter 2026 Financial Results
Total revenue for the quarter ended September 30, 2026, was approximately $1.1 million, compared with approximately $1.4 million for the same period in 2025. The decrease is due primarily to a decrease in average reimbursement per CyPath Lung test and a slight decline in total cases completed at Precision Pathology Laboratory Services (PPLS) compared to the same period in 2025, in part due to internal business changes at three PPLS research clients. Multiple accounts previously serviced under these clients have since returned to PPLS. The Company is working to restore additional accounts and improve reimbursement levels.
Net loss for the quarter ended September 30, 2026, was approximately $5.3 million, compared with approximately $5.1 million for the third quarter of 2025. The increase in net loss is primarily due to the increase in loss from operations of approximately $3.5 million from approximately $2.3 million in the prior-year quarter, partially offset by a $1.2 million loss from the change in fair value of warrants, compared with a $2.7 million loss in the prior-year quarter.
Cash and cash equivalents were approximately $2.6 million as of September 30, 2026, compared with approximately $6.4 million at December 31, 2025. Subsequent to quarter-end, the Company completed a financing that generated approximately $4.0 million in gross proceeds.
Operating expenses for the third quarter of 2026 were approximately $4.6 million, compared with approximately $3.7 million in the third quarter of 2025.
About CyPath Lung
CyPath Lung by bioAffinity Technologies is a noninvasive test designed to improve the early detection of lung cancer in patients at high risk for the disease. CyPath Lung analyzes the lung microenvironment by using advanced flow cytometry and proprietary artificial intelligence (AI) to identify cell populations in patient sputum that indicate malignancy. The test incorporates a novel fluorescent porphyrin that is preferentially taken up by cancer and cancer-related cells. In a published clinical trial of high-risk patients, CyPath Lung demonstrated 92% sensitivity, 87% specificity, 88% accuracy and 99% negative predictive value (NPV) in detecting lung cancer in patients at high risk for the disease who had small indeterminate lung nodules less than 20 millimeters. The high NPV gives physicians greater confidence that a negative result is truly negative, potentially sparing patients from unnecessary invasive and costly procedures. CyPath Lung is marketed as a Laboratory Developed Test (LDT) and is not intended for use as a sole diagnostic tool and should be considered alongside other clinical findings. For more information, visit www.cypathlung.com.
About bioAffinity Technologies, Inc.
bioAffinity Technologies, Inc. addresses the need for noninvasive diagnosis of early-stage cancer and other diseases of the lung and broad-spectrum cancer treatments. The Company’s first product, CyPath Lung, is a noninvasive test that has shown high sensitivity, specificity and accuracy for the detection of early-stage lung cancer. CyPath Lung is marketed as a Laboratory Developed Test (LDT) by Precision Pathology Laboratory Services, a subsidiary of bioAffinity Technologies. LDTs are overseen under the Clinical Laboratory Improvement Amendments (CLIA), which are administered by the Centers for Medicare & Medicaid Services. For more information, visit www.bioaffinitytech.com.
Forward-Looking Statements
Certain statements in this press release constitute "forward-looking statements" within the meaning of the federal securities laws. Words such as "may," "might," "will," "should," "believe," "expect," "anticipate," "estimate," "continue," "predict," "forecast," "project," "plan," "intend" and similar expressions may identify forward-looking statements, although not all forward-looking statements contain these words. Actual results could differ materially from those expressed or implied because of risks and uncertainties, including the Company’s ability to expand the commercial adoption of CyPath Lung and capitalize on government healthcare market opportunities; the timing, cost, enrollment and outcome of clinical studies; the possibility that preliminary, in vitro or study-specific findings will not be replicated or translate into safe and effective therapies or commercial products for asthma, COPD or skin cancer; the need for further validation of new applications, including surveillance; the extent and timing of physician adoption, repeat utilization and customer retention; payer coverage, reimbursement rates and collections; and the Company’s ability to obtain, maintain and enforce intellectual property rights. Additional risks are discussed in the Company’s Annual Report on Form 10-K for the year ended December 31, 2025, and subsequent SEC filings, including its reports on Forms 10-Q and 8-K. Forward-looking statements reflect expectations and assumptions only as of the date of this release. Readers should not place undue reliance on them. The Company undertakes no obligation to update these statements, except as required by applicable law.
bioAffinity Technologies, Inc.
Condensed Consolidated Balance Sheets
September 30,
2026
December 31,
2025
(unaudited)
ASSETS
Current assets:
Cash and cash equivalents
$
2,550,034
$
6,449,782
Accounts and other receivables, net
742,144
541,962
Inventory
108,754
53,548
Prepaid expenses and other current assets
427,230
519,916
Total current assets
3,828,162
7,565,208
Non-current assets:
Property and equipment, net
362,359
265,593
Operating lease right-of-use asset, net
730,572
334,289
Finance lease right-of-use asset, net
538,326
661,575
Goodwill
1,404,486
1,404,486
Intangible assets, net
673,056
716,806
Other assets
16,710
12,815
Total assets
$
7,553,671
$
10,960,772
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities:
Accounts payable
$
949,018
$
761,901
Accrued expenses
1,143,227
1,717,989
Unearned revenue
48,874
42,405
Operating lease liability, current portion
168,534
139,220
Finance lease liability, current portion
78,926
139,490
Notes payable, current portion
144,715
105,161
Total current liabilities
2,533,294
2,906,166
Non-current liabilities:
Operating lease liability, net of current portion
596,086
202,878
Finance lease liability, net of current portion
475,772
532,759
Notes payable, net of current portion
33,958
41,313
Total liabilities
3,639,110
3,683,116
Stockholders’ equity:
Preferred Stock, par value $0.001 per share; 20,000,000 shares authorized; 150 shares and 700 shares issued and outstanding at September 30, 2026, and December 31, 2025, respectively
1
1
Common Stock, par value $0.007 per share; 350,000,000 shares authorized; 1,166,625 and 299,826 issued and outstanding at September 30, 2026, and December 31, 2025, respectively
8,166
2,097
Additional paid-in capital
84,734,173
75,829,622
Accumulated deficit
(80,827,779
)
(68,554,064
)
Total stockholders’ equity
3,914,561
7,277,656
Total liabilities and stockholders’ equity
$
7,553,671
$
10,960,772
bioAffinity Technologies, Inc.
Unaudited Condensed Consolidated Statements of Operations
Three Months Ended
September 30,
Nine Months Ended
September 30,
2026
2025
2026
2025
Net revenue
$
1,070,280
$
1,446,066
$
3,932,386
$
4,569,146
Operating expenses:
Direct costs and expenses
1,114,176
942,211
3,130,649
3,326,673
Research and development
389,122
330,589
1,100,404
1,009,347
Clinical development
251,043
143,311
1,060,968
410,943
Selling, general and administrative
2,759,769
2,209,441
8,859,961
6,876,551
Depreciation and amortization
66,842
113,360
242,916
381,177
Total operating expenses
4,580,952
3,738,912
14,394,898
12,004,691
Loss from operations
(3,510,672
)
(2,292,846
)
(10,462,512
)
(7,435,545
)
Other income (expense):
Interest income
4,734
1,088
18,118
3,655
Interest expense
(10,713
)
(5,358
)
(37,123
)
(31,303
)
Other income
3,144
513
6,516
38,568
Other expense
(13,072
)
(3,839
)
(48,270
)
(16,828
)
Offering costs allocated to warrant liability
(532,209
)
—
(532,209
)
(479,696
Loss on warrant liabilities
(1,218,235
)
(2,747,460
)
(1,218,235
)
(3,810,278
)
Total other income (expense), net
(1,766,351
)
(2,755,056
)
(1,811,203
)
(4,295,882
)
Net loss before provision for income tax expense
(5,277,023
)
(5,047,902
)
(12,273,715
)
(11,731,427
)
Income tax expense
—
3,182
—
40,861
Net loss
$
(5,277,023
)
$
(5,051,084
)
$
(12,273,715
)
$
(11,772,288
)
Net loss per common share, basic and diluted
$
(5.89
)
$
(71.05
)
$
(23.72
)
$
(219.47
)
Weighted average common shares outstanding
896,271
71,090
517,490
53,640