bioAffinity Technologies Reports Third Quarter 2025 Financial Results
Company achieves
Key Highlights
-
CyPath® Lung revenues increased
86% year over year for the first nine months of 2025, driven by higher test volumes and growing clinical adoption, including the Veterans Administration (VA). -
Sales of CyPath® Lung reached a record high in the third quarter of 2025, representing a
92% increase over the previous quarter. The increase reflects growing adoption by VA hospitals and market expansion in the mid-Atlantic region. -
In the first nine months of 2025, the number of CyPath® Lung tests processed increased by
97% over the same period in 2024. -
Total revenues decreased from
$2.4 million $1.5 million -
Raised approximately
$10.4 million - Released details of four patient case studies in which CyPath® Lung was the critical factor in clinical decision making, including patients whose lung cancer was detected at Stage 1A.
- Appointed Roberto Rios, CPA, and John J. Oppenheimer, M.D., to the Board of Directors. Mr. Rios brings executive leadership in corporate finance. Dr. Oppenheimer is a recognized leader in the diagnosis and treatment of asthma and COPD and also serves as an advisor to pharmaceutical companies focused on lung health.
- Regained full Nasdaq Capital Market compliance for continued listing of the Company’s common stock (BIAF) and warrants (BIAFW), subject to a mandatory panel monitor for a period of one year.
-
Expanded patent portfolio with a new
U.S. patent protecting the diagnostic algorithm and test method used to detect lung cancer.
Management Commentary
“In the third quarter of 2025, our primary focus was on driving the adoption of CyPath® Lung while maintaining fiscal discipline,” said Maria Zannes, President and Chief Executive Officer of bioAffinity Technologies. “The strong increase in CyPath® Lung testing revenue reflects growing confidence among physicians who are recognizing our test’s ability to detect early-stage lung cancer when it is most treatable. The continued publication of case studies in which patients have benefited from Stage 1A lung cancer detection and others have been spared unnecessary and costly biopsies is particularly impactful.
“Our marketing program to the VA is showing results in terms of both sales and interest in participating in our upcoming longitudinal study. Our work with the VA is especially meaningful since we know veterans are at higher risk for lung cancer due to environmental and occupational exposures during their service. Now VA clinicians have access to a powerful tool to detect lung cancer early when treatment can save lives.
“We raised approximately
“We expanded our intellectual property portfolio for the second quarter in a row with an important
“And we were delighted to welcome two new members to our board. Mr. Rios’ business and financial expertise combined with Dr. Oppenheimer’s clinical and strategic leadership will be invaluable as we increase sales of CyPath® Lung, develop companion diagnostics for asthma and COPD, and continue to build shareholder value,” Ms. Zannes said.
Financial Results
For the quarter ended September 30, 2025, bioAffinity reported total revenue of
Operating expenses for the third quarter of 2025 were
-
Direct costs and expenses were
$0.9 million 38% decrease from the prior-year period, driven by cost-saving initiatives implemented in March 2025. -
Research and development expenses increased
20% year-over-year to$330,000 -
Clinical development expenses increased to
$143,000 $94,000 -
Selling, general and administrative expenses decreased
7% to$2.2 million -
Depreciation and amortization expense declined
25% year-over-year to$113,000
Net loss for the three months ended September 30, 2025, was
Cash and cash equivalents as of September 30, 2025, were
About CyPath® Lung
CyPath® Lung uses proprietary advanced flow cytometry and artificial intelligence (AI) to identify cell populations in patient sputum that indicate malignancy. Automated data analysis helps determine if cancer is present or if the patient is cancer-free. CyPath® Lung incorporates a fluorescent porphyrin that is preferentially taken up by cancer and cancer-related cells. Clinical study results demonstrated that CyPath® Lung had
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. 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" or similar expressions, or statements regarding intent, belief, or current expectations, are forward-looking statements. These forward-looking statements are subject to various risks and uncertainties, many of which are difficult to predict, that could cause actual results to differ materially from current expectations and assumptions from those set forth or implied by any forward-looking statements. Important factors that could cause actual results to differ materially from current expectations include, among others, clinical adoption of CyPath® Lung; strategic actions reducing costs while expanding sales focus on high-margin diagnostics like CyPath® Lung; international patents expanding CyPath® Lung’s global commercialization potential; the targeted actions accelerating the commercial growth of CyPath® Lung; patient case studies continuing to underscore the diagnostic power of CyPath® Lung in real-world settings; expanding access to CyPath® Lung for patients at risk of lung cancer; and advancing new diagnostics for diseases like COPD and asthma; and the other factors discussed in the Company’s Annual Report on Form 10-K for the year ended December 31, 2024, and its subsequent filings with the SEC, including subsequent periodic reports on Forms 10-Q and 8-K. Such forward-looking statements are based on facts and conditions as they exist at the time such statements are made and predictions as to future facts and conditions. While the Company believes these forward-looking statements are reasonable, readers of this press release are cautioned not to place undue reliance on any forward-looking statements. The information in this release is provided only as of the date of this release, and the Company does not undertake any obligation to update any forward-looking statement relating to matters discussed in this press release, except as may be required by applicable securities laws.
bioAffinity Technologies, Inc. Condensed Consolidated Balance Sheets |
||||||||
|
||||||||
|
|
September 30, 2025 |
|
December 31, 2024 |
||||
|
|
(unaudited) |
|
|
||||
ASSETS |
|
|
|
|
|
|
||
Current assets: |
|
|
|
|
|
|
||
Cash and cash equivalents |
|
$ |
7,669,195 |
|
|
$ |
1,105,291 |
|
Accounts and other receivables, net |
|
|
448,990 |
|
|
|
1,139,204 |
|
Inventory |
|
|
35,234 |
|
|
|
27,608 |
|
Prepaid expenses and other current assets |
|
|
460,187 |
|
|
|
422,995 |
|
Total current assets |
|
|
8,613,606 |
|
|
|
2,695,098 |
|
|
|
|
|
|
|
|
||
Non-current assets: |
|
|
|
|
|
|
||
Property and equipment, net |
|
|
303,122 |
|
|
|
375,385 |
|
Operating lease right-of-use asset, net |
|
|
367,398 |
|
|
|
463,011 |
|
Finance lease right-of-use asset, net |
|
|
113,553 |
|
|
|
780,872 |
|
Goodwill |
|
|
1,404,486 |
|
|
|
1,404,486 |
|
Intangible assets, net |
|
|
731,389 |
|
|
|
775,139 |
|
Other assets |
|
|
12,815 |
|
|
|
19,676 |
|
|
|
|
|
|
|
|
||
Total assets |
|
$ |
11,546,369 |
|
|
$ |
6,513,667 |
|
|
|
|
|
|
|
|
||
LIABILITIES AND STOCKHOLDERS’ EQUITY (DEFICIT) |
|
|
|
|
|
|
||
|
|
|
|
|
|
|
||
Current liabilities: |
|
|
|
|
|
|
||
Accounts payable |
|
$ |
940,761 |
|
|
$ |
987,311 |
|
Accrued expenses |
|
|
984,547 |
|
|
|
1,398,722 |
|
Unearned revenue |
|
|
37,915 |
|
|
|
24,404 |
|
Operating lease liability, current portion |
|
|
136,197 |
|
|
|
127,498 |
|
Finance lease liability, current portion |
|
|
123,757 |
|
|
|
395,301 |
|
Notes payable, current portion |
|
|
136,396 |
|
|
|
171,669 |
|
Total current liabilities |
|
|
2,359,573 |
|
|
|
3,104,905 |
|
|
|
|
|
|
|
|
||
Non-current liabilities: |
|
|
|
|
|
|
||
Operating lease liability, net of current portion |
|
|
238,942 |
|
|
|
342,098 |
|
Finance lease liability, net of current portion |
|
|
1,998 |
|
|
|
444,448 |
|
Notes payable, net of current portion |
|
|
43,658 |
|
|
|
20,180 |
|
|
|
|
|
|
|
|
||
Total liabilities |
|
|
2,644,171 |
|
|
|
3,911,631 |
|
|
|
|
|
|
|
|
||
Commitments and contingencies (Note 11) |
|
|
|
|
||||
|
|
|
|
|
|
|
||
Stockholders’ equity: |
|
|
|
|
|
|
||
Preferred stock, par value |
|
|
1 |
|
|
|
— |
|
Common Stock, par value |
|
|
24,264 |
|
|
|
3,553 |
|
Additional paid-in capital(1) |
|
|
74,294,531 |
|
|
|
56,242,793 |
|
Accumulated deficit |
|
|
(65,416,598 |
) |
|
|
(53,644,310 |
) |
|
|
|
|
|
|
|
||
Total stockholders’ equity |
|
|
8,902,198 |
|
|
|
2,602,036 |
|
|
|
|
|
|
|
|
||
Total liabilities and stockholders’ equity |
|
$ |
11,546,369 |
|
|
$ |
6,513,667 |
|
(1) |
The values of Common Stock and paid-in capital, as well as the number of shares issued and outstanding, have been retroactively adjusted in order to give effect to the Company’s 1-for-30 reverse stock split. |
bioAffinity Technologies, Inc. Unaudited Condensed Consolidated Statements of Operations |
||||||||||||||||
|
||||||||||||||||
|
|
Three Months Ended
|
|
Nine Months Ended
|
||||||||||||
|
|
2025 |
|
2024 |
|
2025 |
|
2024 |
||||||||
|
|
|
|
|
|
|
|
|
||||||||
Net revenue |
|
$ |
1,446,066 |
|
|
$ |
2,350,386 |
|
|
$ |
4,569,146 |
|
|
$ |
7,154,429 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Direct costs and expenses |
|
|
942,211 |
|
|
|
1,440,158 |
|
|
|
3,326,673 |
|
|
|
4,421,309 |
|
Research and development |
|
|
330,589 |
|
|
|
274,497 |
|
|
|
1,009,347 |
|
|
|
1,070,569 |
|
Clinical development |
|
|
143,311 |
|
|
|
93,705 |
|
|
|
410,943 |
|
|
|
194,127 |
|
Selling, general and administrative |
|
|
2,209,441 |
|
|
|
2,364,592 |
|
|
|
6,876,551 |
|
|
|
7,023,311 |
|
Depreciation and amortization |
|
|
113,360 |
|
|
|
151,298 |
|
|
|
381,177 |
|
|
|
452,005 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Total operating expenses |
|
|
3,738,912 |
|
|
|
4,324,250 |
|
|
|
12,004,691 |
|
|
|
13,161,321 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Loss from operations |
|
|
(2,292,846 |
) |
|
|
(1,973,864 |
) |
|
|
(7,435,545 |
) |
|
|
(6,006,892 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Other income (expense): |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Interest income |
|
|
1,088 |
|
|
|
2,228 |
|
|
|
3,655 |
|
|
|
13,541 |
|
Interest expense |
|
|
(5,358 |
) |
|
|
(21,631 |
) |
|
|
(31,303 |
) |
|
|
(67,430 |
) |
Other income |
|
|
513 |
|
|
|
9,683 |
|
|
|
38,568 |
|
|
|
9,683 |
|
Other expense |
|
|
(3,839 |
) |
|
|
(14,697 |
) |
|
|
(496,524 |
) |
|
|
(10,186 |
) |
Change in fair value of warrants issued |
|
|
(2,747,460 |
) |
|
|
— |
|
|
|
(3,810,278 |
) |
|
|
— |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Total other income (expense), net |
|
|
(2,755,056 |
) |
|
|
(24,417 |
) |
|
|
(4,295,882 |
) |
|
|
(54,392 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Net loss before provision for income tax expense |
|
|
(5,047,902 |
) |
|
|
(1,998,281 |
) |
|
|
(11,731,427 |
) |
|
|
(6,061,284 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Provision for income tax expense |
|
|
3,182 |
|
|
|
2,559 |
|
|
|
40,861 |
|
|
|
11,650 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Net loss |
|
$ |
(5,051,084 |
) |
|
$ |
(2,000,840 |
) |
|
$ |
(11,772,288 |
) |
|
$ |
(6,072,934 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Net loss per common share, basic and diluted(2) |
|
$ |
(4.74 |
) |
|
$ |
(4.84 |
) |
|
$ |
(7.55 |
) |
|
$ |
(16.22 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Weighted average common shares outstanding(2) |
|
|
1,066,350 |
|
|
|
412,936 |
|
|
|
804,604 |
|
|
|
374,445 |
|
| (2) | The values of Common Stock and paid-in capital, as well as the number of shares issued and outstanding, have been retroactively adjusted in order to give effect to the Company’s 1-for-30 reverse stock split. |
View source version on businesswire.com: https://www.businesswire.com/news/home/20251114274995/en/
bioAffinity Technologies
Julie Anne Overton
Director of Communications
jao@bioaffinitytech.com
Source: bioAffinity Technologies, Inc.
