8-K: bioAffinity Technologies Reports Record $9.4 Million Revenue for 2024 Driven by Increased Demand and Expanded Insurance Coverage

bioAffinity Technologies announces a 270% increase in revenue to $9.4 million for 2024, driven by increased demand for CyPath Lung and expanded insurance coverage.

Summary

• bioAffinity Technologies reported its financial results for the year ended December 31, 2024.
• The company achieved record revenue of $9.4 million, a 270% increase compared to $2.5 million in 2023.
• CyPath Lung orders grew by approximately 1,400% over the full year 2023.
• The unique CPT code for CyPath Lung was added to the Centers for Medicare and Medicaid Services (CMS) 2024 clinical laboratory schedule effective January 1, leading to reimbursement of the test by both Medicare and private insurers.
• The number of physician offices signed increased by over 300% in 2024.
• CyPath Lung was added to the U.S. Federal Supply Schedule in October 2024.
• A study concluded that adding CyPath Lung to the standard of care for Medicare patients with a positive lung cancer screening could have saved an average of $2,773 per patient, amounting to $379 million in total cost savings in 2022.
• The savings for private insurance patients would have been even greater, an average of $6,460 per patient, an estimated total savings of $895 million if all individuals screened in 2022 were covered by private insurance.
• The company appointed J. Michael Edwards as Chief Financial Officer and William Bauta as Chief Science Officer.
• The company received a Certificate of Grant of Patent from the Japan Patent Office.
• The company anticipates generating between $6 million to $8 million in total revenue in 2025, including $1 to $2 million from sales of CyPath lung tests.
• The reduction in revenue for the 2025 financial outlook as compared to 2024 is a result of discontinuing certain unprofitable pathology services.
• The company submitted a protocol for a pivotal clinical trial to the Sterling Institutional Review Board (IRB) expected to open in the second quarter of 2025.
• Operating expenses for 2024 totaled $18.3 million, compared with $10.5 million in 2023.
• Net loss for the year ended December 31, 2024, was $9.0 million, or $0.75 per share, compared with a net loss of $7.9 million, or $0.91 per share, for the prior year.
• Cash and cash equivalents as of December 31, 2024, were $1.1 million, compared with $2.8 million as of December 31, 2023.
• Subsequent to the end of 2024, bioAffinity Technologies raised aggregate gross proceeds of $1.4 million through warrant exercises in February 2025.

Sentiment

Score: 7

Explanation: The document presents a positive outlook with strong revenue growth and expanded market access for CyPath Lung. However, the net loss and decrease in cash reserves temper the overall sentiment.

Positives

• The company experienced significant revenue growth, driven by increased demand for CyPath Lung.
• Expanded insurance coverage for CyPath Lung enhances accessibility for patients.
• The addition of CyPath Lung to the U.S. Federal Supply Schedule provides access to Veterans and military personnel.
• Economic validation suggests significant cost savings associated with CyPath Lung.
• The company is progressing with its FDA pivotal study.
• The company raised $1.4 million through warrant exercises in February 2025.

Negatives

• The company experienced a net loss of $9.0 million in 2024, compared to a net loss of $7.9 million in the prior year.
• Cash and cash equivalents decreased from $2.8 million to $1.1 million year-over-year.
• The company anticipates lower revenue in 2025 ($6 million to $8 million) compared to 2024 ($9.4 million) due to discontinuing certain unprofitable pathology services.

Risks

• The company's ability to achieve its revenue projections for 2025 is subject to various factors, including market adoption of CyPath Lung.
• The company's success depends on the outcome of its FDA pivotal study.
• The company's financial performance is subject to risks and uncertainties, including those discussed in its filings with the SEC.

Future Outlook

The company anticipates generating between $6 million to $8 million in total revenue in 2025, including $1 to $2 million from sales of CyPath lung tests. The reduction in revenue for the 2025 financial outlook as compared to 2024 is a result of discontinuing certain unprofitable pathology services, which will be more than offset by corresponding cost reductions from lower labor and overhead costs at our subsidiary laboratory.

Management Comments

• We are proud of the tremendous strides bioAffinity Technologies made in 2024, achieving record revenue and laying the groundwork for continued growth, said bioAffinity President and Chief Executive Officer Maria Zannes.
• The full-year integration of our pathology lab, Precision Pathology, and the growing adoption of CyPath Lung reflect the success of our strategy to build a scalable, high-impact business focused on early lung cancer detection.
• Our inclusion on the U.S. Federal Supply Schedule marks a major milestone, ensuring Veterans and military personnel across the country have easy access to CyPath Lung, Zannes continued.
• Physician adoption is accelerating, driven by the clinical value and noninvasive nature of our test.
• Referrals and word-of-mouth continue to fuel our expansion beyond Texas, positioning us for sustained growth.
• As we look to 2025, our focus remains on expanding commercial adoption of CyPath Lung, strengthening our relationships with key opinion leaders, starting our FDA pivotal study, and advancing our pipeline of diagnostics powered by artificial intelligence and flow cytometry, Zannes added.
• With the recent streamlining of operations that will increase profitability at our laboratory, we are building a company with the science, strategy and leadership to shape the future of lung cancer diagnostics and with every test ordered, were unlocking value for both patients and shareholders.

Industry Context

The announcement reflects the growing demand for non-invasive diagnostic tests in the early detection of lung cancer. The addition of CyPath Lung to the U.S. Federal Supply Schedule and its reimbursement by Medicare and private insurers are significant milestones that could drive further adoption and market penetration.

Comparison to Industry Standards

• It's difficult to directly compare bioAffinity's results to industry standards without knowing the specific benchmarks for early-stage lung cancer diagnostics.
• However, the 270% revenue growth suggests strong market traction compared to peers in the diagnostics space.
• Companies like Exact Sciences (EXAS) with its Cologuard test, and Guardant Health (GH) with its liquid biopsy tests, have demonstrated the potential for significant growth in the diagnostic market.
• bioAffinity's focus on non-invasive testing aligns with the industry trend towards less invasive and more patient-friendly diagnostic solutions.
• The reported cost savings per patient are significant and could be a key differentiator compared to other lung cancer screening methods.

Management Changes

Stakeholder Impact

• Shareholders: The record revenue and potential for future growth are positive for shareholders.
• Patients: Expanded access to CyPath Lung provides a non-invasive option for early lung cancer detection.
• Employees: The company's growth may lead to increased job opportunities.
• Veterans and Military Personnel: Streamlined access to CyPath Lung through the U.S. Federal Supply Schedule.

Next Steps

• Expanding commercial adoption of CyPath Lung.
• Strengthening relationships with key opinion leaders.
• Starting the FDA pivotal study.
• Advancing the pipeline of diagnostics powered by artificial intelligence and flow cytometry.

Key Dates

Keywords

CyPath Lung, lung cancer, bioAffinity Technologies, revenue, financial results, diagnostics, Medicare, insurance coverage, Federal Supply Schedule