• Like a Guardant Health focused on non-invasive, early lung cancer detection using sputum.
• Like an early-stage Alnylam Pharmaceuticals developing RNAi therapies, but for cancer.

• CyPath® Lung: A noninvasive diagnostic test for the early detection of lung cancer, which analyzes sputum samples using flow cytometry.
• Targeted Cancer Therapeutics (RNAi platform): A development program focused on creating novel cancer treatments utilizing RNA interference (RNAi) to selectively kill cancer cells.

bioAffinity Technologies (BIAF) sells its diagnostic tests primarily to other companies within the healthcare sector rather than directly to individuals. The company's first diagnostic test, CyPath® Lung, is designed to be ordered by physicians to assist in the assessment of lung cancer in patients.

Based on the provided information, the major customers of bioAffinity Technologies are:

• Healthcare providers, such as hospitals and clinics.
• Physician practices that order diagnostic tests for their patients.
• Diagnostic laboratories that would process the CyPath® Lung samples and generate patient reports for ordering physicians.

The company description does not list specific names of customer companies, nor does it provide their stock symbols, as it describes the intended market for its product rather than current, named commercial partnerships or direct sales. Therefore, no specific customer company names or symbols can be provided.

Maria Zannes

President and Chief Executive Officer

Ms. Zannes brings over 30 years of executive-level management experience. She founded bioAffinity Technologies in 2014. Prior to that, she founded The Zannes Firm, focusing on strategic solutions for private industry in the medical, environmental, and energy sectors. Ms. Zannes also served as President of the Energy Recovery Council and General Manager of ECOS Corporation, a subsidiary of Burlington Environmental. Earlier in her career, she was a project manager at Wheelabrator Technologies, Inc. and began her career as a journalist, later serving as a legislative aide. She is also a co-founder of two engineering research centers at Columbia University.

J. Michael Edwards, MBA, CPA

Chief Financial Officer

Mr. Edwards has more than three decades of experience in financial management and business strategy. He rejoined bioAffinity Technologies as Chief Financial Officer in October 2024, having previously served as the company's consulting CFO from 2014 to 2023 and interim CFO since September 2024. In these roles, he oversaw the company's initial public offering in 2022. Previously, Mr. Edwards held CFO positions at CytoBioscience Inc. and OncoVista Innovative Therapies, Inc. His career also includes finance roles at BioNumerik Pharmaceuticals, Inc. and Ilex Oncology, Inc. He began his career at PricewaterhouseCoopers LLP.

Steven Girgenti

Executive Chairman

Mr. Girgenti is a veteran healthcare executive with expertise in healthcare marketing strategies, financing, and mergers and acquisitions. He has served as Executive Chairman of bioAffinity Technologies, Inc. since November 2014. He is currently the Managing Partner of Medi-Pharm Consulting, LLC. Previously, he was the CEO and co-founder of DermWorx Incorporated, a dermatology company.

Timothy P. Zannes, J.D.

Executive Vice President, Secretary, and General Counsel

Mr. Zannes is responsible for corporate compliance and directs Human Resources at bioAffinity Technologies. Before receiving his J.D., he worked as a court bailiff and managed his own private investigation firm after serving as an investigator for the Albuquerque City Attorney.

Xavier T. Reveles, M.S.

Chief Operating Officer

Mr. Reveles, who holds a Master of Science degree, is responsible for overseeing the day-to-day operations of bioAffinity Technologies. His duties include ensuring efficiency and driving the successful execution of strategic initiatives, managing research and development processes, manufacturing, supply chain, and the overall operational infrastructure.

Key Risks to bioAffinity Technologies (BIAF)

1. Regulatory Approval and Clinical Development Success: bioAffinity Technologies' core business relies on the successful development, clinical validation, and regulatory approval of its diagnostic test, CyPath® Lung, and its therapeutic candidates. The therapeutic platform, currently showing promise in "petri dishes," faces a lengthy, expensive, and uncertain path through preclinical research, clinical trials, and ultimately, regulatory hurdles. Failure to achieve regulatory approvals for CyPath® Lung or demonstrate the safety and efficacy of its therapeutic pipeline in clinical trials would severely impede the company's ability to commercialize its products and generate revenue.
2. Market Adoption, Commercialization, and Competition: Even with regulatory approval, the commercial success of CyPath® Lung depends on its widespread adoption by physicians, acceptance by patients, and favorable reimbursement from payers. CyPath® Lung enters a market with established diagnostic protocols, including various imaging techniques, lab tests, and biopsies. The company will need to overcome existing practices and clearly demonstrate the superior value and benefits of its noninvasive test over current methods, including low-dose computed tomography (LDCT) screening. Failure to gain significant market traction or secure adequate reimbursement could limit its commercial potential.
3. Intellectual Property Protection: bioAffinity Technologies' value proposition is rooted in its "proprietary noninvasive diagnostic tests" and "broad platform technologies." The company's competitive advantage and ability to exclude others from using its innovations are critically dependent on its ability to obtain, maintain, and enforce robust intellectual property (IP) protection, such as patents, particularly around its synthetic porphyrin (TCPP) and siRNA-driven therapies. Challenges to its IP, or the inability to secure and defend its patents, could significantly erode its market position and potential profitability.

Here are the expected drivers of future revenue growth for bioAffinity Technologies (BIAF) over the next 2-3 years:

1. Accelerated Sales and Market Penetration of CyPath® Lung: bioAffinity Technologies anticipates continued rapid growth in the sales and adoption of its noninvasive CyPath® Lung test for early detection of lung cancer. The company projects over 100% unit sales growth for CyPath® Lung in 2026, building on an 87% increase in testing revenue and a 99% rise in test volumes in 2025. This growth is driven by increasing clinical utilization and validation of its commercialization strategy.
2. Expansion into National and Federal Healthcare Markets: The company is strategically expanding the availability of CyPath® Lung into national markets and has secured inclusion in the U.S. Federal Supply Schedule. This provides streamlined access to the Veterans Health Administration (VHA) and the Military Health System, opening up significant new customer bases for the diagnostic test.
3. Development and Commercialization of New Diagnostic Tests for Other Lung Diseases: Leveraging its platform technology, bioAffinity Technologies is actively developing noninvasive diagnostic tests for chronic obstructive pulmonary disease (COPD) and asthma. Patient studies for these new pipeline tests are expected to commence in 2026, which could introduce new revenue streams beyond lung cancer detection.
4. Enhanced Clinical Evidence and Expanded Indications for CyPath® Lung: A large-scale longitudinal clinical trial involving up to 2,000 high-risk patients across 17 centers began in 2026 to further evaluate CyPath® Lung. Additionally, collaborations, such as with Brooke Army Medical Center, aim to expand sample collection methods and broaden the test's utility. This ongoing clinical development and validation are expected to deepen clinical evidence, leading to broader physician adoption, potential new indications like post-treatment surveillance for lung cancer survivors, and use in indeterminate pulmonary nodule evaluation.

Share Issuance

• In September 2022, bioAffinity Technologies completed its initial public offering (IPO) of 1,282,600 units, which, along with subsequent warrant exercises, generated approximately $15.6 million in total gross proceeds by September 28, 2022.
• The company raised approximately $16.9 million through various financings in 2025, which contributed to an increase in cash and cash equivalents.
• In October 2025, bioAffinity Technologies entered into definitive agreements for a registered direct offering of 720,000 shares of common stock at $2.50 per share, with expected gross proceeds of approximately $1.8 million.

Inbound Investments

• bioAffinity Technologies received approximately $15.6 million in total gross proceeds from its initial public offering and the exercise of associated warrants in September 2022.
• The company secured approximately $16.9 million in gross proceeds from equity financings during 2025.

Outbound Investments

• bioAffinity Technologies acquired Precision Pathology Laboratory Services (PPLS) in September 2023.

Capital Expenditures

• Capital expenditures for bioAffinity Technologies were approximately -$60,568 in the last 12 months.
• Research and development expenses, primarily focused on advancing its diagnostic platform and therapeutic discoveries, amounted to $1.4 million in 2025.