Laboratory business streamlined in 2025 to focus on profitable diagnostic testing services including the Company's high-value CyPath$(R)$ Lung test
Number of CyPath(R) Lung tests performed in 2025 increased by 99% compared to 2024
Orders for CyPath(R) Lung by physicians and clinics rose 67% YoY due to peer-to-peer marketing, positive real-world experiences and growing test awareness
SAN ANTONIO--(BUSINESS WIRE)--March 13, 2026--
bioAffinity Technologies, Inc. (Nasdaq: BIAF; BIAFW), a biotechnology company focused on the need for noninvasive, accurate tests for the detection of early-stage lung cancer and other lung diseases, today reported financial results for the year ended December 31, 2025.
2025 Highlights
-- Record CyPath(R) Lung Revenue and Unit Sales. Revenue from our
noninvasive diagnostic for lung cancer increased 87% over 2024 with the
number of tests performed rising 99% year over year, reflecting growing
clinical utilization and validating the first phase of our
commercialization strategy. The Company's strategic decision to
discontinue unprofitable pathology services and reallocate resources to
the commercialization of CyPath(R) Lung led to a 34% decrease in total
revenue and a 9% decrease in operating expenses compared to 2024,
respectively.
-- Expanded Physician Network. The number of physician offices and clinics
ordering CyPath(R) Lung for their patients increased 67% over 2024. We
expect the trend to accelerate in 2026 as we expand our sales force into
new markets. Peer-to-peer physician engagement remains a key driver of
growth. Compelling patient case studies and key opinion leaders (KOLs)
who are sharing their clinical experience are building awareness and
clinical adoption of CyPath(R) Lung.
-- Leadership Appointments. Gordon Downie, MD, PhD, joined bioAffinity
Technologies as Chief Medical Officer, bringing more than three decades
of experience in pulmonary medicine, clinical research, medical
innovation, and interventional pulmonology to the role. Roberto Rios, CPA,
and John J. Oppenheimer, MD, were appointed to the Board of Directors in
2025. Mr. Rios has more than four decades of executive leadership
experience in corporate finance and governance across industries
including biotechnology and medical devices. Dr. Oppenheimer is a
recognized leader in the diagnosis and treatment of asthma and COPD and
directs clinical research in lung health while also teaching at the
University of Medicine and Dentistry of New Jersey-Rutgers.
-- Successful Financings. The Company raised approximately $16.9 million
in gross proceeds during 2025 from equity transactions to fund CyPath(R)
Lung clinical development, commercialization, and operational expansion.
-- CyPath(R) Lung-Centered Performance. Through targeted operational
streamlining and the discontinuation of certain unprofitable pathology
services at our laboratory, Precision Pathology Laboratory Services
(PPLS), we positioned CyPath(R) Lung as the core driver of long-term
shareholder value. While these actions contributed to lower consolidated
revenue in the short term, they improved operating focus and cost
structure and are intended to position our noninvasive lung cancer
diagnostic for scalable growth and improved long-term margin potential.
-- Innovation Pipeline Progress. Research and development continued on
diagnostic tests for chronic obstructive pulmonary disease (COPD) and
asthma that build on our expertise in using sputum as a sample for flow
cytometric analysis. Research is focused on detecting specific receptors
in sputum to guide personalized treatment and identify patients likely to
benefit from emerging targeted therapies. Asthma and COPD impact
approximately 650 million children and adults globally.1 We expect to
begin patient studies in 2026.
-- Expanded Global Intellectual Property Portfolio. During 2025, we
strengthened our intellectual property portfolio supporting CyPath(R)
Lung and our broader flow cytometry platform through multiple patent
allowances and acceptances. These included notification of allowance from
the U.S. Patent and Trademark Office for our diagnostic algorithm and
test method, patent allowances in Canada and China covering flow
cytometry-based lung cancer detection methods, and acceptance of patent
applications in Australia related to early-stage lung cancer detection
and multi-disease lung health assessment. These developments further
expand international protection of our diagnostic technology and support
our long-term commercialization strategy.
Management Commentary
"2025 was a transformational year for bioAffinity Technologies. We took deliberate actions to streamline operations at PPLS and align our resources behind the national expansion of CyPath(R) Lung," said Maria Zannes, bioAffinity President and Chief Executive Officer. "While these actions contributed to a decrease in consolidated revenue, we believe that the Company is now better positioned to leverage revenue generated from the profitable testing services performed in our lab. Importantly, revenue for our core value driver, CyPath(R) Lung, increased 87% year over year, reflecting continued physician adoption and growing clinical utilization.
"The work we accomplished in 2025 was intentional and strategic. We strengthened our capital base, removed unprofitable legacy services from PPLS services and concentrated on high-value diagnostics. The launch of our longitudinal trial and our ongoing integration into the military healthcare system are both significant milestones that support our strategy of establishing CyPath(R) Lung as a standard of care for indeterminate pulmonary nodules and a tool for surveillance after cancer treatment.
"Every day, we hear from practitioners who confirm the need for noninvasive, accurate lung cancer diagnostics, particularly when imaging and risk models are inconclusive or turn out to be wrong. CyPath(R) Lung remains our first priority. It is a gamechanger that provides clinical confidence for physicians and better outcomes for patients. We believe our focus on improving care for patients at risk for lung cancer and other pulmonary diseases will create long-term value for our shareholders."
2026 Outlook
-- Financial Outlook. bioAffinity entered 2026 with strong momentum,
building on a year of increased sales and revenue growth and positioning
the Company for continued expansion in the lung cancer diagnostics
market. Our forecast for unit sales of CyPath(R) Lung reflects an
increase of greater than 100% over 2025, with a corresponding increase in
revenues for our noninvasive lung cancer diagnostic. We will continue to
expand our market both geographically and by the number of physicians and
medical facilities adding CyPath(R) Lung to the diagnostic pathway for
patients with indeterminate pulmonary nodules and to post-treatment care
for surveillance of lung cancer survivors.
-- Market Opportunity. Consistent with estimates from the US Preventive
Services Task Force, the number of indeterminate pulmonary nodules
detected in the U.S. through lung cancer screening and incidental imaging
is projected to grow 62% from 2.9 million in 2025 to 4.7 million in 2030,
representing an estimated market opportunity exceeding $4.7 billion for
CyPath(R) Lung. The forecast assumes 10% compound annual growth from
2024--2030, driven by increased lung cancer screening adoption, improved
adherence to screening guidelines, and enhanced detection through
AI-enabled imaging tools. Another market opportunity opening up for
CyPath(R) Lung is its potential to improve post-treatment surveillance
for lung cancer survivors. The number of Americans living with lung
cancer is projected to increase 28% from 680,450 in 2025 to 871,580 in
20352, representing an estimated $870 million market opportunity over the
next decade.
-- CyPath(R) Lung Longitudinal Trial. In March 2026, we enrolled the first
patient in our longitudinal study evaluating CyPath(R) Lung as a
noninvasive diagnostic for high-risk patients with indeterminate
pulmonary nodules. The trial plans to enroll up to 2,000 patients across
17 Veterans Administration (VA), military, academic, and private medical
centers and will assess the sensitivity and specificity of the test over
a follow-up period of up to two years. The John P. Murtha Cancer Center
Research Program (MCCRP), a research program within the Department of
Surgery at the Uniformed Services University of the Health Sciences in
Bethesda, Maryland, is providing support and funding associated with the
trial at several federal facilities. This study is intended to provide
additional clinical validation to support broader adoption in federal and
commercial markets.
-- Military Research Collaboration to Expand Sample Collection Options for
CyPath(R) Lung. In February 2026, we announced a collaboration with
Brooke Army Medical Center (BAMC) to evaluate the use of CyPath(R) Lung
on sputum samples obtained via tracheal and bronchial suctioning during
bronchoscopy. This study is designed to assess the clinical utility of
CyPath(R) Lung for earlier detection of lung cancer in patients
undergoing standard bronchoscopy procedures, potentially expanding the
test's applicability to a larger patient population and increasing
integration into pulmonology workflows.
-- Real-World Case Studies Validate CyPath(R) Lung. The Company released
10 patient case studies in 2025 including multiple cases in which
CyPath(R) Lung detected curative Stage 1A lung cancer. In February 2026,
we released two new real-world clinical cases in which a negative
CyPath(R) Lung test result supported the physician's decision to continue
monitoring high-risk patients with indeterminate nodules through
noninvasive surveillance. CyPath(R) Lung guided physician decision-making
and reduced the burden on the patients by easing anxiety and helping them
avoid additional invasive, costly and often risky procedures. The body of
clinical evidence behind CyPath(R) Lung and real-world case studies
continues to grow.
-- Positive Findings Presented at AAAAI on Expansion of Platform
Technology to Asthma. In February 2026, the Company presented research on
the ability of our innovative diagnostic platform to identify antibody
drug receptors in sputum, including receptors for dupilumab, a leading
therapy for asthma and chronic obstructive pulmonary disease (COPD), and
benralizumab, another asthma therapy. The research supports advancement
of the Company's pipeline tests aimed at guiding personalized treatment
decisions and improving disease monitoring for asthma and COPD
sufferers.
2025 Financial Results
-- Revenue was $6.2 million, compared with $9.4 million for 2024. The
decrease reflects targeted strategic actions to discontinue certain
unprofitable services and reallocate resources toward CyPath(R) Lung.
Testing revenue for CyPath(R) Lung increased 87% year-over-year, driven
by increased adoption by physicians and clinics, including the VA.
-- Operating expenses decreased 9% to $16.7 million in 2025, primarily due
to strategic actions aimed at streamlining and reducing lab operation
costs.
-- Research and development expenses were $1.4 million in 2025, slightly
lower than the prior year, reflecting ongoing investment in lab
operations and preclinical development.
-- Selling, general and administrative expenses remained flat at $9.9
million.
-- Net loss for the year ended December 31, 2025, was $14.9 million,
compared to $9.0 million for 2024. The increase was primarily
attributable to changes in the fair value of warrants, expanded sales
activities and increased clinical development.
-- Cash and cash equivalents as of December 31, 2025, were $6.5 million,
compared with $1.1 million at the end of 2024. The Company raised $16.9
million in multiple financings in 2025 to support ongoing operations.
__________________________
(1) https://academic.oup.com/ajrccm/article/212/2/297/8444672?login=false&utm
(2) *Wagel, et al. Cancer treatment and survivorship statistics, 2025 CA
Cancer J Clin. 2025 Sep 13;75(6):683.
About CyPath(R) Lung
CyPath(R) 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(R) Lung uses advanced flow cytometry and proprietary artificial intelligence (AI) to identify cell populations in patient sputum that indicate malignancy. CyPath(R) Lung incorporates a fluorescent porphyrin that is preferentially taken up by cancer and cancer-related cells. Clinical study results demonstrated 92% sensitivity, 87% specificity and 88% accuracy in detecting lung cancer in patients at high risk for the disease who had small indeterminate lung nodules less than 20 millimeters.
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(R) Lung, is a noninvasive test that has shown high sensitivity, specificity and accuracy for the detection of early-stage lung cancer. CyPath(R) 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, the Company's ability to successfully commercialize and achieve market acceptance of CyPath(R) Lung; the Company's ability to raise additional capital to fund operations; the Company's history of losses and ability to achieve profitability; the Company's reliance on CyPath(R) Lung as its primary revenue-generating product; changes in the regulatory landscape for laboratory developed tests, including potential FDA oversight; the Company's ability to obtain and maintain adequate reimbursement from third-party payors; the outcome of the Company's clinical trials and studies; the Company's ability to attract and retain qualified personnel; competition from existing and new diagnostic techniques; the Company's ability to protect its intellectual property; the Company's ability to maintain its Nasdaq listing; general economic, political, and market conditions; and the other factors discussed in the Company's Annual Report on Form 10-K for the year ended December 31, 2025 to be filed with the Securities and Exchange Commission today, 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.
Consolidated Balance Sheets
As of December 31, 2025 and 2024
December 31,
------------------------------
2025 2024
------------- ---------------
ASSETS
Current assets:
Cash and cash equivalents $ 6,449,782 $ 1,105,291
Accounts and other receivables,
net 541,962 1,139,204
Inventory 53,548 27,608
Prepaid expenses and other
current assets 519,916 422,995
----------- -----------
Total current assets 7,565,208 2,695,098
Non-current assets:
Property and equipment, net 265,593 375,385
Operating lease right-of-use
asset, net 334,289 463,011
Finance lease right-of-use
asset, net 661,575 780,872
Goodwill 1,404,486 1,404,486
Intangible assets, net 716,806 775,139
Other assets 12,815 19,676
----------- -----------
Total assets $ 10,960,772 $ 6,513,667
=========== ===========
LIABILITIES AND STOCKHOLDERS'
EQUITY
Current liabilities:
Accounts payable $ 761,901 $ 987,311
Accrued expenses 1,717,989 1,398,722
Unearned revenue 42,405 24,404
Operating lease liability,
current portion 139,220 127,498
Finance lease liability, current
portion 139,490 395,301
Notes payable, current portion 105,161 171,669
----------- -----------
Total current liabilities 2,906,166 3,104,905
Non-current liabilities
Operating lease liability, net
of current portion 202,878 342,098
Finance lease liability, net
of current portion 532,759 444,448
Notes payable, net of current
portion 41,313 20,180
----------- -----------
Total liabilities 3,683,116 3,911,631
=========== ===========
Stockholders' equity:
Preferred stock, $0.001 per
share; 20,000,000 shares
authorized; 700 and 0 shares
issued and outstanding at
December 31, 2025 and 2024,
respectively 1 --
Common Stock, par value $0.007
per share; 350,000,000 shares
authorized; 4,498,675 and
519,158 issued and
outstanding at December 31,
2025 and 2024,
respectively(1) 31,461 106,593
Additional paid-in capital(1) 75,800,258 56,139,753
Accumulated deficit (68,554,064) (53,644,310)
----------- -----------
Total stockholders' equity 7,277,656 2,602,036
----------- -----------
Total liabilities and stockholders'
equity $ 10,960,772 $ 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.
Consolidated Statements of Operations
For the Years Ended December 31, 2025 and 2024
2025 2024
------------- --------------
Net Revenue $ 6,161,959 $ 9,362,022
----------- ----------
Operating expenses:
Direct costs and expenses 4,226,799 5,983,475
Research and development 1,383,359 1,461,227
Clinical development 705,744 321,655
Selling, general and
administrative 9,913,729 9,943,473
Depreciation and amortization 504,836 605,637
----------- ----------
Total operating expenses 16,734,467 18,315,467
----------- ----------
Loss from operations (10,572,508) (8,953,445)
Other income (expense):
Interest income 23,385 17,610
Interest expense (44,372) (92,475)
Other income 40,490 10,323
Other expense (502,429) (10,194)
Change in fair value of warrants
issued (3,810,278) --
----------- ----------
Loss before income tax expense (14,865,712) (9,028,181)
Income tax expense (44,042) (11,650)
----------- ----------
Net loss $(14,909,754) $(9,039,831)
=========== ==========
Net loss per common share, basic and
diluted(2) $ (8.66) $ (22.50)
Weighted average common shares
outstanding(2) 1,721,082 404,167
(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/20260313834345/en/
CONTACT: bioAffinity Technologies
Julie Anne Overton
Director of Communications
investors@bioaffinitytech.com
(END) Dow Jones Newswires
March 13, 2026 08:00 ET (12:00 GMT)