bioAffinity Technologies, Inc.

SAN ANTONIO--(BUSINESS WIRE)--bioAffinity Technologies, Inc. (Nasdaq: BIAF; BIAFW), a biotechnology company focused on the need for accurate, noninvasive tests for the detection of early-stage lung cancer and other lung diseases, today reported financial results for the three months ended March 31, 2025. ...patient case studies continue to underscore the diagnostic power of CyPath® Lung in real-world settings — from avoiding unnecessary invasive procedures to identifying secondary or recurrent cancers. Key Highlights Generated revenue of $1.9 million in the first quarter of 2025. CyPath ® Lung sales up 276% year-over-year in the first quarter of 2025. Reported strong results from the Texas beta launch of CyPath ® Lung, with first-quarter test sales building on the momentum of more than 600 tests delivered in 2024. Announced strategic actions expected to reduce annual costs by approximately $3.8 million while expanding sales focus on high-margin diagnostics like CyPath ® Lung. Released multiple patient case studies highlighting CyPath ® Lung’s impact in real-world clinical settings, including early detection of second primary lung cancer and avoidance of unnecessary invasive procedures. Received acceptance of a new patent application from the Australian Patent Office, strengthening international IP protection for CyPath ® Lung and expanding global commercialization potential. Subsequent to the end of the first quarter, announced improvements to CyPath ® Lung processing that increased data acquisition throughput by 50% and reduced unit cost by more than 25%, enhancing efficiency without compromising test performance. Management Commentary “We began 2025 with strong momentum, delivering 276% year-over-year growth in CyPath® Lung sales and expanding our commercial footprint across the U.S.,” said Maria Zannes, President and Chief Executive Officer of bioAffinity Technologies. “Our first-quarter results reflect both the growing demand for our noninvasive lung cancer diagnostic and the successful execution of our strategy to focus on high-value services and operational efficiency. “During the quarter, we took decisive actions to streamline operations at our subsidiary lab by reducing labor costs, implementing operational efficiencies and discontinuing certain pathology services with suboptimal profit margins. These targeted actions will reduce costs approximately $3.8 million annually and accelerate the commercial growth of CyPath® Lung. These changes are already translating into margin improvements and enhanced resource allocation in support of our commercialization goals. “In parallel, patient case studies continue to underscore the diagnostic power of CyPath® Lung in real-world settings — from avoiding unnecessary invasive procedures to identifying secondary or recurrent cancers. As we move forward, we’re encouraged by the clinical and economic validation that supports our growth, including recent operational enhancements that have increased our test throughput by 50% and lowered per-test cost by over 25%. “We remain committed to expanding access to CyPath® Lung for patients at risk of lung cancer and advancing new diagnostics for diseases like COPD and asthma,” Zannes added. “With every test delivered, we’re improving outcomes for patients and delivering value to our shareholders.” First Quarter 2025 Financial Results Revenue for the quarter ended March 31, 2025, was $1.9 million. Revenue was primarily generated from patient service fees, histology services, and medical director fees. Operating expenses for the first quarter of 2025 were $4.5 million, compared with $4.4 million in the first quarter of 2024. Direct costs and expenses for the first quarter of 2025 were $1.4 million, down 13% from $1.6 million in the prior-year period, primarily due to targeted strategic actions implemented in March 2025. Research and development expenses decreased 7% year-over-year to $367,000, reflecting lower employee compensation and lab supply costs. Clinical development expenses rose to $138,000, driven by higher professional fees supporting the Company’s pivotal clinical trial strategy. Selling, general and administrative expenses were $2.5 million for the first quarter of 2025, up from $2.2 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® Lung. Net loss for the quarter ended March 31, 2025, was $2.7 million, or $0.16 per share, compared with a net loss of $2.0 million, or $0.20 per share, for the first quarter of 2024. Cash and cash equivalents as of March 31, 2025, were $0.4 million, compared with $1.1 million as of December 31, 2024. Subsequent to the end of 2024, bioAffinity Technologies raised gross proceeds of $1.4 million through the inducement of warrant exercises in February 2025 and $3.3 million in a public offering in May 2025. About bioAffinity Technologies, Inc. bioAffinity Technologies, Inc. addresses the need for noninvasive diagnosis of early-stage cancer and 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 announced strategic actions reducing annual costs by approximately $3.8 million 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; and expanding access to CyPath® Lung for patients at risk of lung cancer and advancing new diagnostics for diseases like COPD and asthma. 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 reduce costs while expanding sales of high-margin diagnostics; the Company’s ability to accelerate the commercial growth of CyPath® Lung; the Company’s ability to advance 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 March 31, 2025 December 31, 2024 (unaudited) ASSETS Current assets: Cash and cash equivalents $ 444,706 $ 1,105,291 Accounts and other receivables, net 963,744 1,139,204 Inventory 38,782 27,608 Prepaid expenses and other current assets 416,550 422,995 Total current assets 1,863,782 2,695,098 Non-current assets: Property and equipment, net 382,409 375,385 Operating lease right-of-use asset, net 431,746 463,011 Finance lease right-of-use asset, net 684,629 780,872 Goodwill 1,404,486 1,404,486 Intangible assets, net 760,556 775,139 Other assets 19,675 19,676 Total assets $ 5,547,283 $ 6,513,667 LIABILITIES AND STOCKHOLDERS’ EQUITY Current liabilities: Accounts payable $ 1,381,578 $ 987,311 Accrued expenses 1,370,735 1,398,722 Unearned revenue 24,404 24,404 Operating lease liability, current portion 130,342 127,498 Finance lease liability, current portion 403,584 395,301 Notes payable, current portion 104,766 171,669 Total current liabilities 3,415,409 3,104,905 Non-current liabilities Operating lease liability, net of current portion 308,415 342,098 Finance lease liability, net of current portion 335,899 444,448 Notes payable, net of current portion 48,156 20,180 Total liabilities 4,107,879 3,911,631 Commitments and contingencies Stockholders’ equity: Preferred stock, no shares issued or outstanding at March 31, 2025, and December 31, 2024, respectively — — Common stock, par value $0.007 per share; 100,000,000 shares authorized; 18,255,825 and 15,576,674 shares issued and outstanding as of March 31, 2025, and December 31, 2024, respectively 124,777 106,593 Additional paid-in capital 57,619,354 56,139,753 Accumulated deficit (56,304,727 ) (53,644,310 ) Total stockholders’ equity 1,439,404 2,602,036 Total liabilities, and stockholders’ equity $ 5,547,283 $ 6,513,667 bioAffinity Technologies, Inc. Unaudited Condensed Consolidated Statements of Operations Three Months Ended March 31, 2025 2024 Net Revenue $ 1,853,597 $ 2,406,391 Operating expenses: Direct costs and expenses 1,367,860 1,573,441 Research and development 367,386 393,639 Clinical development 138,353 48,960 Selling, general and administrative 2,452,549 2,185,944 Depreciation and amortization 154,588 149,637 Total operating expenses 4,480,736 4,351,621 Loss from operations (2,627,139 ) (1,945,230 ) Other income (expense): Interest income 542 6,127 Interest expense (15,485 ) (23,550 ) Other income 2 4,510 Other expense (9,642 ) — Total other expense (24,583 ) (12,913 ) Net loss before provision for income taxes (2,651,722 ) (1,958,143 ) Income tax expense (8,695 ) (3,672 ) Net loss $ (2,660,417 ) $ (1,961,815 ) Net loss per common share, basic and diluted $ (0.16 ) $ (0.20 ) Weighted average common shares outstanding, basic and diluted 16,257,456 9,915,426

SAN ANTONIO--(BUSINESS WIRE)--bioAffinity Technologies, Inc. (NASDAQ: BIAF, BIAFW) a biotechnology company focused on the need for noninvasive tests for the detection of early-stage cancer, today announced that it has closed its previously announced best efforts offering of securities as described below for aggregate gross proceeds to the Company of $3.25 million, before deducting agent fees and other estimated expenses payable by the company. The offering consisted of 10,156,250 shares (the “Shares”) of our Common Stock (or pre-funded warrants), together with warrants to purchase up to 15,234,375 shares of Common Stock, (the “May 2025 Warrants”). The combined public offering price for each share of common stock (or pre-funded warrant) and accompanying May 2025 Warrant is $0.32. WallachBeth Capital, LLC acted as sole placement agent for the offering. This press release does not constitute an offer to sell or the solicitation of an offer to buy, nor will there be any sales of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of such jurisdiction. The securities described above were offered by the Company pursuant to a registration statement on Form S-1 (File No. 333-286921), as amended, previously filed and declared effective by the Securities and Exchange Commission (the “SEC”). This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or jurisdiction. The offering was made only by means of a prospectus. A final prospectus relating to the offering was filed with the SEC and is available on the SEC’s website at www.sec.gov. Electronic copies of the prospectus supplements may be obtained, when available, from WallachBeth Capital, LLC, via email at cap-mkts@wallachbeth.com, by calling +1 (646) 237-8585, or by standard mail at WallachBeth Capital LLC, Attn: Capital Markets, 185 Hudson St., Suite 1410, Jersey City, NJ 07311, USA. 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. 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 risk factors discussed in the prospectus and 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.

JERSEY CITY, N.J., May 6, 2025 /PRNewswire/ -- WallachBeth Capital LLC, a leading provider of capital markets and institutional execution services, announced today that bioAffinity Technologies, Inc. (NASDAQ: BIAF and BIAFW) ) a biotechnology company focused on the need for noninvasive tests for the detection of early-stage cancer, priced a best efforts offering of securities as described below for aggregate gross proceeds to the Company of $3.25 million, before deducting agent fees and other estimated expenses payable by the company. The offering consists of 10,156,250 shares (the "Shares") of our Common Stock (or pre-funded warrants), together with warrants to initially purchase up to 15,234,375 shares of Common Stock, (the "May 2025 Warrants"). The combined public offering price for each share of common stock (or pre-funded warrants) and accompanying May 2025 Warrant is $0.32. The closing of the offering is expected to occur on or about May 7, 2025, subject to the satisfaction of customary closing conditions. WallachBeth Capital, LLC is acting as sole placement agent for the offering. This press release does not constitute an offer to sell or the solicitation of an offer to buy, nor will there be any sales of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of such jurisdiction. The securities described above are being offered by the Company pursuant to a registration statement on Form S-1 (File No. 333-286921), as amended, previously filed and declared effective by the Securities and Exchange Commission (the "SEC"). This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or jurisdiction. The offering is being made only by means of a preliminary prospectus and final prospectus that will form a part of the registration statement. A final prospectus relating to the offering will be filed with the SEC and will be available on the SEC's website at . Electronic copies of the prospectus supplements may be obtained, when available, from WallachBeth Capital, LLC, via email at [email protected], by calling +1 (646) 237-8585, or by standard mail at WallachBeth Capital LLC, Attn: Capital Markets, 185 Hudson St., Suite 1410, Jersey City, NJ 07311, USA. About WallachBeth Capital LLC WallachBeth Capital offers a robust range of capital markets and investment banking services to the healthcare community, connecting corporate clients with leading institutions, supporting issuers and investors in achieving their financial goals. The firm's experience includes initial public offerings, follow-on issues, PIPE offerings, and private transactions and ATM's. 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 closing of the offering on May 7, 2025. 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 ability to close the offering when anticipated and the risk 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. SOURCE WallachBeth Capital LLC WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED