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bioAffinity Technologies, Inc.

CIK: 1712762 Filed: June 12, 2026 S-1

Offer Facts

Ticker
BIAF
Exchange
The Nasdaq Capital Market
Offer Price
$1.52
Shares Offered
2,631,579
Estimated Proceeds
$4.0M
Underwriters

Led by WallachBeth Capital LLC

Key Highlights

  • Pioneering non-invasive lung cancer detection via the CyPath® Lung test.
  • Scalable automated technology that identifies cancer cells in phlegm.
  • Transitioning from pre-revenue to commercialization with $9.4M in 2024 revenue.
  • Addresses a critical medical need to reduce reliance on invasive biopsies.

Risk Factors

  • Significant 'Going Concern' warning due to a $72M+ accumulated deficit.
  • High operational dependency on a single facility (PPLS) for all revenue.
  • Intense competition from well-funded, established healthcare corporations.
  • Limited sales experience and the challenge of securing widespread insurance coverage.

Financial Metrics

$9.4 million
Revenue (2024)
$6.2 million
Revenue (2025)
$1.4 million
Revenue ( Q1 2026)
>$72 million
Accumulated Deficit
$3.4 million
Capital Raise Goal ( June 2026)

IPO Analysis

bioAffinity Technologies, Inc. - What You Need to Know

Thinking about investing in bioAffinity Technologies (BIAF)? It is exciting to explore new biotech companies, but you should look past the technical jargon to understand the business. Here is a breakdown of what you need to know.

1. What does this company actually do?

In plain English, bioAffinity focuses on detecting lung cancer early. Their main product is a test called CyPath® Lung. Instead of just looking at a scan, the test uses automated technology to analyze a patient’s phlegm. They use a special compound that binds to cancer cells, making them "glow" under a microscope. This non-invasive tool helps doctors decide if a lung nodule is cancerous or harmless. It aims to spare patients from the risks and costs of invasive biopsies.

2. How do they make money and are they growing?

The company is currently in the "commercialization" phase. They generated no revenue before 2022, but they have started to scale operations. They reported approximately $9.4 million in revenue for 2024 and $6.2 million for 2025. In the first three months of 2026, they generated roughly $1.4 million.

However, they are not yet profitable. They spend much more on research, development, and daily operations than they earn from sales. Currently, they rely entirely on their own lab, Precision Pathology Laboratory Services (PPLS), to perform their tests. Because PPLS is the only provider of CyPath® Lung, any operational issues or loss of certification at this facility would stop the company from generating revenue.

3. What is this new offering about?

As of June 2026, the company plans to raise approximately $3.4 million by selling roughly 2.6 million new shares of stock.

They are also offering "pre-funded warrants." These act as placeholders for large investors. If an investor wants a large stake without immediately hitting ownership limits (like the 4.99% cap), they can buy these warrants and convert them into shares later. This process issues more shares, which reduces your ownership percentage in the company.

4. What are the main risks I should worry about?

Biotech investing is high-risk. Beyond standard challenges, keep these in mind:

  • The "Going Concern" Warning: The company states they must raise more cash to keep running. They have an accumulated deficit of over $72 million. This creates significant doubt about their ability to stay in business without more funding.
  • The "Sales" Hurdle: They have limited experience in sales. Success depends on convincing doctors to change their habits and adopt a new test. This is expensive and time-consuming. If they fail to secure insurance coverage, high out-of-pocket costs may deter doctors and patients.
  • Competition: They compete against large, well-funded corporations. These rivals have more money, stronger reputations, and better relationships with healthcare providers.
  • Key Person Risk: The company relies heavily on a small group of leaders, including CEO Maria Zannes. Losing these individuals could severely disrupt the company’s direction.

5. Where will it trade and who's running it?

You can find them on the Nasdaq stock exchange under the ticker symbol BIAF.

6. A final word of advice

Stock offerings are often volatile. There is no guarantee this offering will raise enough money to fund their long-term plan, so proceed with caution. Before you invest, ask yourself: "Am I comfortable with the risk that this company might need to raise even more money in the future?" Only invest what you can afford to lose, and do not feel pressured to buy immediately.

Disclaimer: I am an AI, not a financial advisor. This information is for educational purposes only and does not constitute financial advice. Always do your own research or talk to a professional before investing.

Company Profile

From the SEC filing

bioAffinity Technologies, Inc. is a biotechnology company focused on the early detection of lung cancer. Its primary commercial product, CyPath® Lung, is a non-invasive diagnostic test that utilizes automated technology to analyze a patient’s phlegm. By employing a proprietary compound that causes cancer cells to fluoresce under a microscope, the test provides a diagnostic tool to help physicians determine whether lung nodules are malignant or benign. This approach aims to provide a safer, more cost-effective alternative to traditional, invasive biopsy procedures. The company currently operates through its wholly-owned subsidiary, Precision Pathology Laboratory Services (PPLS), which serves as the exclusive provider for the CyPath® Lung test. While the company has moved into the commercialization phase, it remains in the early stages of scaling its operations and generating consistent revenue.

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Analysis Processed

June 19, 2026 at 03:20 AM

Important Disclaimer

This AI-generated analysis is for informational purposes only and does not constitute financial or investment advice. Always consult with qualified professionals and conduct your own research before making investment decisions.