Full Press Release Details
Technologies Announces Targeted Actions to Cut $4 Million in Costs and Drive CyPath Lung Sales Growth
| Proactive steps reinforce bioAffinity Technologies' laser focus on accelerating CyPath Lung sales growth in strategic national markets | ||
| Decreases labor and overhead costs, including 38% workforce reduction in non-CyPath Lung personnel at Company's subsidiary laboratory |
ANTONIO, Texas (March 6, 2025) - bioAffinity Technologies, Inc. (Nasdaq: BIAF; BIAFW), a biotechnology company focused
on the need for noninvasive tests for the detection of early-stage lung cancer and other lung diseases, today announced targeted strategic
actions to improve financial performance and accelerate the commercial growth of CyPath Lung, the Company's noninvasive
test for early-stage lung cancer. The Company expects these measures to deliver approximately $4 million in annual cost savings at its
subsidiary Precision Pathology Laboratory Services (PPLS), while increasing resources to expand CyPath Lung sales in high-potential
our acquisition of PPLS, we embarked on a deliberate and strategic review as part of our commitment to optimizing operations and accelerating
CyPath Lung sales. We believe our changes at PPLS support and enhance bioAffinity's commercial strategy to fast-track market
expansion and sales of CyPath Lung while continuing to provide PPLS clients with exceptional anatomical pathology services as it
has done for more than 25 years," bioAffinity President and CEO Maria Zannes said. "We will continue to rely on the combined
innovation and expertise of both bioAffinity and PPLS employees to achieve our planned 2025 milestones, including starting enrollment
for the FDA pivotal trial for CyPath Lung and development of additional noninvasive diagnostics, including tests for COPD and asthma."
bioAffinity Technologies expects to achieve the majority of the $4 million in cost savings on an annual run rate through:
| Labor cost reductions, including an approximately 38% workforce reduction at PPLS; | ||
| Operational efficiency enhancements, such as reduced direct costs for purchased services and supplies; and, | ||
| A focus on high-margin services by discontinuing certain pathology services with suboptimal profit margins. |
year-over-year sales growth, CyPath Lung remains the focal point of bioAffinity's commercial strategy. "Although these
actions are expected to result in a decrease in revenue, they are also expected to improve profitability at our PPLS subsidiary by focusing
on CyPath Lung and other high-value service lines," bioAffinity Chief Financial Officer Michael Edwards said.
strategic adjustments today enhance our readiness to serve the market for noninvasive lung cancer detection in both civilian and military
healthcare systems, and we continue to see increasing sales as more and more physicians incorporate CyPath Lung into their protocol
for patients at high risk for lung cancer," Maria Zannes, President and Chief Executive Officer, said. "With CyPath
Lung now available for purchase through the Federal Supply Schedule, we intend to launch a focused government marketing program next
quarter to introduce the test to Veterans Administration and Department of Defense medical centers."
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 92% sensitivity,
87% specificity and 88% accuracy in detecting lung cancer in patients at high risk for the disease who had small lung nodules less
than 20 millimeters. Diagnosing and treating early-stage lung cancer can improve outcomes and increase patient survival. For more
information, visit www.cypathlung.com.
bioAffinity Technologies, Inc.
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.
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 based upon current estimates and assumptions and include statements
regarding the measures to deliver approximately $4 million in cost savings at Precision Pathology Laboratory Services (PPLS), while increasing
resources to expand CyPath Lung sales in high-potential national markets; changes at PPLS supporting and enhancing bioAffinity's
commercial strategy to fast-track market expansion and sales of CyPath Lung while continuing to provide PPLS clients with exceptional
anatomical pathology services as it has done for more than 25 years; continuing to rely on the combined innovation and expertise of both
bioAffinity and PPLS employees to achieve planned 2025 milestones, including starting enrollment for the FDA pivotal trial for CyPath
Lung and development of additional noninvasive diagnostics, including tests for COPD and asthma; achieving the $4 million in cost savings
on an annual run rate through labor cost reductions, operational efficiency enhancements and focus on high margin services; the actions
resulting in a decrease in revenue and improvement in profitability; the continued increase in sales; and launching a focused government
marketing program next quarter to introduce the test to Veterans Administration and Department of Defense medical centers. 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 targeted actions having
the desired results, including a $4 million cost savings and improvement in profitability, the ability to increase market expansion;
the ability to start enrollment for the FDA pivotal trial for CyPath Lung and development of additional noninvasive diagnostics
in 2025; and the other factors discussed in the Company's Annual Report on Form 10-K for the year ended December 31, 2023, 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.
(733-2447) or 407-491-4498