エドガーで原本を確認する
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): March 6, 2025
bioAffinity Technologies, Inc.
(Exact name of registrant as specified in its charter)
| Delaware | 001-41463 | 46-5211056 | ||
|
(State or other jurisdiction of incorporation) |
(Commission File Number) |
(I.R.S. Employer Identification Number) |
3300 Nacogdoches Road, Suite 216
San Antonio, Texas 78217
(Address of principal executive offices, including zip code)
(210) 698-5334
(Registrant’s telephone number, including area code)
(Former name or former address, if changed since last report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):
| ☐ | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
| ☐ | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| ☐ | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| ☐ | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e- 4(c)) |
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
| Title of each class | Trading Symbols | Name of each exchange on which registered | ||
|
Common Stock, par value $0.007 per share
|
|
BIAF
|
The Nasdaq Stock Market LLC (Nasdaq Capital Market) |
|
| Warrants to purchase Common Stock | BIAFW |
The Nasdaq Stock Market LLC (Nasdaq Capital Market) |
Indicate by check mark whether the registrant is an emerging growth company as defined in in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company ☒
If an emerging growth company, indicate by checkmark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Item 7.01. Regulation FD Disclosure.
On March 6, 2025, bioAffinity Technologies, Inc. (the “Company”) issued a press release announcing that it was implementing targeted actions to deliver approximately $4.0 million in cost savings at its subsidiary, Precision Pathology Laboratory Services (“PPLS”), while increasing resources that support continued sales growth for CyPath® Lung, the Company’s noninvasive test for early-stage lung cancer.
The Company expects to achieve the majority of the cost savings on an annual run-rate through: (i) decreased labor cost reductions, including an approximately 38% workforce reduction at PPLS; (ii) operational efficiency enhancements, such as reduced direct costs for purchased services and supplies; and (iii) a focus on high-margin services by discontinuing certain pathology services with suboptimal profit margins.
The information in this Item 7.01 and in the press release furnished as Exhibit 99.1 to this Current Report on Form 8-K shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that section or Sections 11 and 12(a)(2) of the Securities Act of 1933, as amended and shall not be incorporated by reference into any filing with the U.S. Securities and Exchange Commission made by the Company, whether made before or after the date hereof, regardless of any general incorporation language in such filing. The press release furnished as Exhibit 99.1 to this Current Report on Form 8-K includes “safe harbor” language pursuant to the Private Securities Litigation Reform Act of 1995, as amended, indicating that certain statements contained therein are “forward-looking” rather than historical.
Item 8.01. Other Events.
On March 6, 2025, the Company issued a press release announcing that it was implementing targeted actions to deliver approximately $4.0 million in cost savings at its subsidiary, PPLS, while increasing resources that support continued sales growth for CyPath® Lung, the Company’s noninvasive test for early-stage lung cancer.
The Company expects to achieve the majority of the cost savings on an annual run-rate through: (i) decreased cost reductions, including an almost 38% workforce reduction at PPLS; (ii) operational efficiency enhancements, such as reduced direct costs for purchased services and supplies; and (iii) a focus on high-margin services by discontinuing certain pathology services with suboptimal profit margins.
Item 9.01. Financial Statements and Exhibits.
| (d) | Exhibits. |
| Exhibit Number |
Description | |
| 99.1 | Press Release issued by bioAffinity Technologies, Inc., dated March 6, 2025 | |
| 104 | Cover Page Interactive Data File (embedded within the XBRL document) |
| - |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this Current Report on Form 8-K to be signed on its behalf by the undersigned hereunto duly authorized.
| Date: March 7, 2025 | BIOAFFINITY TECHNOLOGIES, INC. | |
| (Registrant) | ||
| By: | /s/ Maria Zannes | |
| Name: | Maria Zannes | |
| Title: | President and Chief Executive Officer | |
| - |
Exhibit 99.1
 |
News Release |
bioAffinity 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 |
SAN 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 national markets.
“Following 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.”
Specifically, 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. |
With 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.
“Our 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.”
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 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.
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 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.
Contacts
bioAffinity Technologies
Julie Anne Overton
Director of Communications
jao@bioaffinitytech.com
Investor Relations
Dave Gentry
RedChip Companies Inc.
1-800-RED-CHIP (733-2447) or 407-491-4498
BIAF@redchip.com