CyPath$(R)$ Lung cancer diagnostic unit sales rise 146% year-over-year
Growth expected to accelerate throughout 2026 as planned commercial initiatives seek to drive increasing awareness of CyPath(R) Lung benefits
SAN ANTONIO--(BUSINESS WIRE)--May 08, 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 first quarter ended March 31, 2026.
Q1 2026 Highlights
-- CyPath(R) Lung unit sales increased 146% year-over-year in the first
quarter of 2026, reflecting accelerating physician adoption and expanding
clinical use of the Company's noninvasive lung cancer diagnostic.
-- CyPath(R) Lung testing revenue increased approximately 114% to
$361,000, compared to $169,000 in the first quarter of 2025.
-- Total consolidated revenue decreased approximately 27% to $1.4 million,
compared to $1.9 million for the first quarter of 2025, resulting from
the discontinuation of certain unprofitable pathology services in March
2025 to focus on higher margin services, including CyPath(R) Lung
testing.
-- The number of physician offices and clinics ordering CyPath(R) Lung
increased 69% from first quarter 2025 to the same period in 2026,
reflecting continued productivity and expansion of the Company' sales
force and focus on additional strategic markets. The Company expects
growth to accelerate throughout 2026, as a result of these commercial
initiatives and increasing awareness of the benefits of CyPath(R) Lung.
-- The Company launched a large-scale longitudinal clinical trial
partially funded by the U.S. Department of Defense to further validate
CyPath(R) Lung performance and support establishing the noninvasive test
as a standard of care for military and Veterans Administration (VA)
medical centers. The trial is expected to include up to 20 clinical sites,
including multiple Department of Veterans Affairs medical centers and
leading U.S. military hospitals. The John P. Murtha Cancer Center
Research Program is providing support and funding for the study at
several federal facilities.
-- As part of the Company's commercial strategy to develop companion tests
using its diagnostic platform to more precisely target drugs that treat
asthma and COPD, bioAffinity Technologies announced that Brooke Army
Medical Center, the military's largest healthcare institution, was
conducting a 40-patient collaborative study. The study will use
bioAffinity Technologies' flow cytometry+AI technology to evaluate
whether its proprietary platform can detect biologic drug receptors in
sputum, including those for dupilumab and benralizumab, to guide
personalized therapy selection and monitor patient response over time.
The Company presented findings from its early pipeline development
activities at the American Academy of Allergy, Asthma and Immunology
(AAAAI) 2026 annual meeting.
-- Nationally recognized pulmonary and lung cancer experts joined the
Company's Medical and Scientific Advisory Board (MSAB) to provide
independent guidance on strategic priorities, including clinical
implementation and broader adoption of CyPath(R) Lung. David Ost, MD, MPH,
University of Texas MD Anderson Cancer Center, Daniel Sterman, MD, New
York University Langone Medical Center, and J. Scott Ferguson, MD,
University of Wisconsin School of Medicine and Public Health, were named
to the Company's panel of experts.
-- The Company released three additional patient case studies in first
quarter 2026 in which CyPath(R) Lung results of "Unlikely Malignancy"
helped avoid unnecessary invasive and costly biopsies when other tests
suggested the presence of lung cancer in patients at high risk. CyPath(R)
Lung test results were confirmed by follow-up imaging that showed stable
or resolved lung nodules.
Management Commentary
"Our first quarter results demonstrate continued momentum for CyPath(R) Lung in the marketplace. As more and more physicians adopt CyPath(R) Lung and share their experiences with peers, we see the opportunity to expand our commercial reach and bridge the diagnostic gap between imaging and invasive procedures, especially when dealing with indeterminate nodules in high-risk patients," said Maria Zannes, President and CEO of bioAffinity Technologies. "We are accelerating our marketing strategy to expand access to CyPath(R) Lung and educate healthcare practitioners and patients alike about the need for accurate, objective information to better stratify risk and improve patient outcomes. On April 8, we hosted our first webinar featuring a panel of pulmonologists who shared how they use CyPath(R) Lung in their diverse practices."
Ms. Zannes continued, "Physicians continue to share their case studies in which CyPath(R) Lung has identified lung cancer as early as Stage 1A when it is most treatable and conversely in which a negative CyPath(R) Lung result helped avoid unnecessary invasive procedures. We believe the growing number of case studies and our longitudinal clinical trial, supported by leading military and VA institutions, will lead to broader adoption of CyPath(R) Lung as part of the standard of care."
Ms. Zannes concluded, "We are uniquely positioned to fulfill the need for an accurate, noninvasive diagnostic for lung cancer, particularly when imaging and risk models are inconclusive or turn out to be wrong. The remainder of 2026 will be focused on scaling commercial execution, expanding into new geographic markets, and driving increased utilization of CyPath(R) Lung through continued physician engagement while also leveraging our flow cytometry and AI platform to advance our pipeline of diagnostics for serious or life-threatening lung diseases."
First Quarter 2026 Financial Results
Revenue for the quarter ended March 31, 2026, was $1.4 million. Revenue was primarily generated from patient service fees, histology services, and medical director fees.
Operating expenses for the first quarter of 2026 were $5.0 million, compared with $4.5 million in the first quarter of 2025.
Direct costs and expenses for the first quarter of 2026 were $0.9 million, down 32% from $1.4 million in the prior-year period, primarily due to targeted strategic actions implemented in March 2025. Research and development expenses decreased 5% year-over-year to $350,000, reflecting lower employee compensation and lab supply costs. Clinical development expenses rose to $334,000, driven by higher professional fees supporting the Company's longitudinal clinical trial strategy.
Selling, general and administrative expenses were $3.2 million for the first quarter of 2026, up from $2.5 million in the same period last year. The increase was primarily driven by higher employee compensation related to administrative and sales functions, reflecting the addition of personnel and support services to scale the commercialization of CyPath(R) Lung.
Net loss for the quarter ended March 31, 2026, was $3.6 million, or $(0.81) per share, compared with a net loss of $2.7 million, or $(4.80) per share, for the first quarter of 2025.
Cash and cash equivalents as of March 31, 2026, were $3.1 million, compared with $6.4 million as of December 31, 2025.
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. In a clinical trial of high-risk patients, CyPath(R) 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(R) 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.
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. LDTs are overseen under the Clinical Laboratory Improvement Amendments $(CLIA)$, 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" 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 obtain additional financing to fund operations, the Company's limited operating history and history of net losses, the Company's ability to achieve broader market acceptance of CyPath(R) Lung, the Company's dependence on key personnel, risks related to the regulatory environment for laboratory developed tests, the Company's ability to maintain and protect its intellectual property, and the other factors discussed in the Company's Annual Report on Form 10-K for the year ended December 31, 2025, 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
March 31, 2026 December 31, 2025
---------------- -------------------
(unaudited)
ASSETS
Current assets:
Cash and cash equivalents $ 3,098,366 $ 6,449,782
Accounts and other
receivables, net 685,235 541,962
Inventory 77,887 53,548
Prepaid expenses and other
current assets 479,913 519,916
------------ ---------------
Total current assets 4,341,401 7,565,208
Non-current assets:
Property and equipment, net 246,849 265,593
Operating lease
right-of-use asset, net 651,430 334,289
Finance lease right-of-use
asset, net 586,048 661,575
Goodwill 1,404,486 1,404,486
Intangible assets, net 702,222 716,806
Other assets 12,816 12,815
------------ ---------------
Total assets $ 7,945,252 $ 10,960,772
============ ===============
LIABILITIES AND
STOCKHOLDERS' EQUITY
Current liabilities:
Accounts payable $ 836,211 $ 761,901
Accrued expenses 2,033,924 1,717,989
Unearned revenue 31,140 42,405
Operating lease liability,
current portion 142,303 139,220
Finance lease liability,
current portion 80,241 139,490
Notes payable, current
portion 61,141 105,161
------------ ---------------
Total current liabilities 3,184,960 2,906,166
Non-current liabilities
Operating lease
liability, net of
current portion 545,157 202,878
Finance lease liability,
net of current portion 514,834 532,759
Notes payable, net of
current portion 38,915 41,313
------------ ---------------
Total liabilities 4,283,866 3,683,116
------------ ---------------
Commitments and
contingencies (See Note 11)
Stockholders' equity:
Preferred stock, par value
$0.001 per share;
20,000,000 shares
authorized; 700 shares
issued or outstanding at
March 31, 2026, and
December 31, 2025,
respectively 1 1
Common stock, par value
$0.007 per share;
350,000,000 shares
authorized; 4,498,675
shares issued and
outstanding as of March
31, 2026, and December 31,
2025 31,464 31,461
Additional paid-in capital 75,814,595 75,800,258
Accumulated deficit (72,184,674) (68,554,064)
------------ ---------------
Total stockholders' equity 3,661,386 7,277,656
------------ ---------------
Total liabilities, and
stockholders' equity $ 7,945,252 $ 10,960,772
============ ===============
bioAffinity Technologies, Inc.
Unaudited Consolidated Statements of Operations
Three Months Ended
March 31,
-------------------------
2026 2025
----------- -----------
Net Revenue $ 1,351,527 $ 1,853,597
---------- ----------
Operating expenses:
Direct costs and expenses 928,636 1,367,860
Research and development 349,707 367,386
Clinical development 334,040 138,353
Selling, general and administrative 3,241,602 2,452,549
Depreciation and amortization 114,518 154,588
---------- ----------
Total operating expenses 4,968,503 4,480,736
---------- ----------
Loss from operations (3,616,976) (2,627,139)
Other income (expense):
Interest income 10,026 542
Interest expense (14,722) (15,485)
Other income -- 2
Other expense (8,938) (9,642)
---------- ----------
Total other expense (13,634) (24,583)
---------- ----------
Net loss before provision for income
taxes (3,630,610) (2,651,722)
Income tax expense -- (8,695)
---------- ----------
Net loss $(3,630,610) $(2,660,417)
========== ==========
Net loss per common share, basic and
diluted $ (0.81) $ (4.80)
Weighted average common shares
outstanding, basic and diluted 4,494,752 541,841
View source version on businesswire.com: https://www.businesswire.com/news/home/20260508460240/en/
CONTACT: bioAffinity Technologies
Julie Anne Overton
Director of Communications
investors@bioaffinitytech.com
(END) Dow Jones Newswires
May 08, 2026 08:30 ET (12:30 GMT)
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