424B3 1 ea0286113-424b3_2020bio.htm PROSPECTUS

Filed Pursuant to Rule 424(b)(3)

Registration No. 333-294903

PROSPECTUS

20/20 Biolabs, Inc.

10,105,000 Shares of Common Stock

This prospectus relates to 10,105,000 shares of common stock that may be sold from time to time by the selling stockholder named in this prospectus, which includes:

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475,000 shares of common stock previously issued to the selling stockholder;

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62,500 shares of common stock issuable to the selling stockholder upon the exercise of a warrant issued to the selling stockholder;

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up to 42,500 shares of common stock issuable to the selling stockholder upon the conversion of a secured convertible promissory note in the principal amount of $275,000 issued to the selling stockholder; and

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up to 9,525,000 shares of common stock that may be issued to the selling stockholder upon the conversion of shares of series E convertible preferred stock that may be issued to the selling stockholder.

We will not receive any proceeds from sales of the common stock held by the selling stockholder or from the conversion of the shares of series E convertible preferred stock or the secured convertible promissory note, but we will receive funds from the exercise of the warrant held by the selling stockholder.

Our common stock is listed on The Nasdaq Capital Market under the symbol “AIDX.” On April 9, 2026, the last reported sale price of our common stock on The Nasdaq Capital Market was $1.84.

The selling stockholder may offer and sell the shares being offered by this prospectus from time to time in public or private transactions, or both. These sales may occur at fixed prices, at market prices prevailing at the time of sale, at prices related to prevailing market prices, or at negotiated prices. The selling stockholder may sell shares to or through underwriters, broker-dealers or agents, who may receive compensation in the form of discounts, concessions or commissions from the selling stockholder, the purchasers of the shares, or both. Any participating broker-dealers and any selling stockholder who is an affiliate of broker-dealers may be deemed to be “underwriters” within the meaning of the Securities Act of 1933, as amended, or the Securities Act, and any commissions or discounts given to any such broker-dealer or affiliates of a broker-dealer may be regarded as underwriting commissions or discounts under the Securities Act. The selling stockholder has informed us that it does not have any agreement or understanding, directly or indirectly, with any person to distribute its shares. See “Plan of Distribution” for a more complete description of the ways in which the shares may be sold.

We are an “emerging growth company,” as that term is used in the Jumpstart Our Business Startups Act of 2012, and as such, have elected to comply with certain reduced public company reporting requirements for this prospectus and future filings. See “Prospectus Summary—Implications of Being an Emerging Growth Company” and “Risk Factors—Risks Related to Ownership of Our Common Stock.”

Investing in our securities involves a high degree of risk. Before buying any securities, you should carefully read the discussion of the material risks of investing in our securities under the heading “Risk Factors” beginning on page 9 of this prospectus.

Neither the Securities and Exchange Commission nor any state securities commission has approved or disapproved of these securities or determined if this prospectus is truthful or complete. Any representation to the contrary is a criminal offense.

Prospectus dated April 10, 2026

TABLE OF CONTENTS

	Page

Prospectus Summary	1
Risk Factors	9
Cautionary Statement Regarding Forward-Looking Statements	26
Use of Proceeds	27
Dividend Policy	27
Management’s Discussion and Analysis of Financial Condition and Results of Operations	28
Business	39
Management	62
Executive Compensation	68
Certain Relationships and Related Party Transactions	72
Principal and Selling Stockholders	73
Description of Capital Stock	75
Shares Eligible for Future Sale	80
Material U.S. Federal Income Tax Considerations for Non-U.S. Holders	81
Plan of Distribution	85
Legal Matters	86
Experts	86
Where You Can Find More Information	86
Financial Statements	F-1

You should rely only on the information that we have provided in this prospectus and any related free writing prospectus that we may authorize to be provided to you. We have not authorized anyone to provide you with different information. No dealer, salesperson or other person is authorized to give any information or to represent anything not contained in this prospectus or any related free writing prospectus that we may authorize to be provided to you. You must not rely on any unauthorized information or representation. This prospectus is an offer to sell only the securities offered hereby, but only under circumstances and in jurisdictions where it is lawful to do so. You should assume that the information in this prospectus or any related free writing prospectus is accurate only as of the date on the front of this prospectus or any such related free writing prospectus, regardless of the time of delivery of this prospectus or any related free writing prospectus, or any sale of a security.

INDUSTRY AND MARKET DATA

We are responsible for the disclosure in this prospectus. However, this prospectus includes industry data that we obtained from market research, publicly available information and industry publications. We did not fund and are not otherwise affiliated with any of the sources cited in this prospectus. The market research, publicly available information and industry publications that we use generally state that the information contained therein has been obtained from sources believed to be reliable. The information therein represents the most recently available data from the relevant sources and publications and we believe remains reliable. However, this data involves a number of assumptions and limitations regarding our industry which are necessarily subject to a high degree of uncertainty and risk due to a variety of factors, including those described in the section titled “Risk Factors.” Forward-looking information obtained from these sources is also subject to the same qualifications and additional uncertainties regarding the other forward-looking statements in this prospectus.

TRADEMARKS, TRADE NAMES AND SERVICE MARKS

We own or have rights to various trademarks, service marks and trade names that we use in connection with the operation of our business. This prospectus may also contain trademarks, service marks and trade names of third parties, which are the property of their respective owners. Our use or display of third parties’ trademarks, service marks and trade names or products in this prospectus is not intended to, and does not imply a relationship with, or endorsement or sponsorship by us. Solely for convenience, the trademarks, service marks and trade names referred to in this prospectus may appear without the ®, TM or SM symbols, but the omission of such references is not intended to indicate, in any way, that we will not assert, to the fullest extent under applicable law, our rights or the right of the applicable owner of these trademarks, service marks and trade names.

PROSPECTUS SUMMARY

This summary highlights selected information contained elsewhere in this prospectus. This summary is not complete and does not contain all of the information that you should consider before deciding whether to invest in our securities. You should carefully read the entire prospectus, including the risks associated with an investment in our company discussed in the “Risk Factors” section of this prospectus, before making an investment decision. Some of the statements in this prospectus are forward-looking statements. See the section titled “Cautionary Statement Regarding Forward-Looking Statements.”

Unless otherwise indicated by the context, reference in this prospectus to “we,” “us,” “our,” “our company” and similar references are to 20/20 Biolabs, Inc.

Our Company

Overview

We develop and commercialize AI-powered, laboratory-based blood tests for the early detection and prevention of cancers and chronic diseases.

We offer two families of lab tests, both under our OneTest brand: (i) OneTest for Cancer, a multi-cancer early detection, or MCED, test and (ii) OneTest for Longevity, which measures inflammatory biomarkers, that was launched in February 2026 (the Longevity test is also being branded “OneTest for Workplace Wellness” when marketed to self-insured employers). Both tests are run in our CAP (College of American Pathologists) accredited, CLIA (Clinical Laboratory Improvement Amendments) licensed laboratory in Gaithersburg, MD. This laboratory also hosts our Clinical Laboratory Innovation Accelerator, or CLIAx, which we believe is the country’s first shared CLIA laboratory for overseas diagnostics start-ups seeking to launch novel lab tests in the U.S. without the expense of establishing and operating their own independent lab.

Our legacy business also includes a pioneering field test kit for screening suspicious powders for bioterror agents known as BioCheck.

For the years ended December 31, 2025 and 2024, sales of OneTest for Cancer accounted for approximately 88% and 85% of our revenues respectively, while sales of BioCheck accounted for approximately 8% and 10% of our revenues, respectively, and our CLIAx accounted for approximately 4% and 5% of our revenues, respectively.

Our Products

OneTest for Cancer

The Problem: Screening is not widely available in the U.S. for most of the leading cancer killers, such as those of the lungs, pancreas, ovaries, and liver. To address this void, a class of blood testing MCEDs have entered the market in recent years and are generating significant enthusiasm among many medical practitioners, policymakers, employers, and consumers. Most of these MCEDs, such as the Galleri test developed by Grail Inc., or Grail, analyze circulating tumor DNA, or ctDNA, which is expensive, hard to access, and misses most cancers at their earlier stages when they can often be effectively treated.

Our Solution: OneTest measures a panel of protein tumor markers, or PTMs, that have been extensively validated and are widely utilized in certain regions of the world for cancer screening (the Premium version of OneTest also includes inflammatory and metabolic biomarkers). PTMs are specific proteins produced by cancer cells or by the body in response to cancer, which can be detected and measured in the blood to help identify the presence of certain types of cancer. These markers, such as alpha-fetoprotein, or AFP, carcinoembryonic antigen, or CEA, and carbohydrate antigen, or CA, 19.9, are commonly used in cancer screening and recurrence monitoring.

Our patented approach improves upon the use of these biomarkers with various algorithms and is powered by AI. We believe that ours is the first and only MCED on the market in the U.S. that (i) is available at a starting price of under $200, (ii) can be accessed at home without painful needles, and (iii) has been demonstrated in studies conducted in 2024 by National Cancer Institute, or the NCI, to correctly identify significant numbers of otherwise deadly cancers at early stages. These cancers include those of the lung, pancreas, and ovaries, which, when detected at an earlier stage, give the best chance of survival. Please see “Business” below for additional data.

Key Competitive Advantages: Our patented MCED approach, based on PTMs (a/k/a “tumor antigens”) versus ctDNA, provides the following advantages (we refer to these advantages as our Straight A’s), which are described in more detail under “Business” below:

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Affordability. Since the analyzers and reagents we utilize in our lab are individually approved by the U.S. Food and Drug Administration, or the FDA, and widely used around the world, and feature “walk-away” automation and robotics, the costs to run these tests are quite low compared to DNA sequencing. In most cases, follow-up testing of high biomarkers is covered by insurance.

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Accuracy for Earlier Stage Cancers. Evidence suggests that tumor antigens (proteins) are more readily detectable in the blood at earlier stages than ctDNA. Some experts suggest PTMs as a first screening and then refer positive cases to ctDNA testing.

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Accessibility. The small quantities of blood required permits capillary (upper arm) blood collection that can be easily self-administered at home, at retail outlets including pharmacies, and at workplaces (e.g., fire stations), avoiding the need for special appointments with phlebotomists and painful needles. Ease of access boosts compliance with follow-up testing which aids in the earlier detection of more cancers.

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Acceleration Over Time. Many studies suggest that annual screening with PTMs boosts sensitivity for many cancer types (lung, pancreatic, liver, etc.) and repeat testing of slightly high biomarkers at ~2-month intervals substantially lowers false positive rates.

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AI Compatible. We believe that analyzing well established biomarkers like tumor proteins and inflammatory biomarkers permits AI to be meaningfully leveraged both in test development and in the interpretation of results by end users. Our algorithms use data from large real world data sets, while no such other data is easily obtainable for competing ctDNA approaches. State-of-the-art machine learning and other AI based programs require large amounts of data. Because PTMs are widely used for screening and early used in East Asia there is much published and unpublished data that can be leveraged without the burden and expense of running our own large scale clinical trials.

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Assists Imaging. Published studies conclude that PTMs like AFP, CEA, and CA 19.9 can help resolve ambiguous findings on an ultrasound or CT scan to aid in the early detection of liver, testicular, lung, and pancreatic cancers.

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Advisory Expertise. Unlike novel ctDNA targets, PTMs have been used clinically and in research studies for decades. This allows us to offer expert medical consultants who have vast experience in using these biomarkers over many years to help advise patients and their doctors.

OneTest for Longevity

The Problem: According to the U.S. Centers for Disease Control and Prevention, or the CDC, chronic diseases are the leading cause of premature death in America, responsible for eight out of the ten most common causes of mortality. These diseases, including cancer, type 2 diabetes, cardiovascular ailments, and dementia, are closely linked to chronic inflammation. A significant contributor to this inflammation is the consumption of processed foods, which are often high in sugars, unhealthy fats, and additives. We believe that new tools to measure and track chronic inflammation to inform and encourage better food and lifestyle choices are urgently needed.

Our Solution: In February 2026, we introduced and began promoting OneTest for Longevity, an AI powered blood test to measure and track biomarkers associated with chronic inflammation which, according to the CDC, is associated with 8 of 10 leading causes of death in America. We expect to maintain the Longevity test brand when marketing directly to consumers but will use OneTest for Workplace Wellness when marketing to self-insured employers (although we might also adopt other names when offering the test in conjunction with particular pharmaceuticals or medical devices). The test offers specific and personalized diet and exercise changes proven to lower inflammation associated biomarker levels and the associated risk of type 2 diabetes, cancer, cardiovascular disease, dementia, mental health, and diseases associated with aging.

For this product, we are partnering with James R. Hébert, Ph.D. and his colleagues from the University of South Carolina. Hébert, a nutritional epidemiologist for over 30 years, is the author of Diet, Inflammation, and Health and the developer of the Dietary Inflammatory Index, or the DII, a numerical score that assesses a diet for its effect on several biomarkers linked to inflammation. The DII has been utilized in over 1,300 peer reviewed studies and validated in studies involving over 187,000 subjects. An AI avatar of Dr. Hébert is being developed, which is intended to permit users of this test to ask questions about improving their diet to lower levels of inflammation and improve health outcomes. Since he is an author of hundreds of peer-reviewed publications, this offers a corpus of published work which can be a rich training and reference dataset to train AI algorithms and create an authentic and scientifically accurate avatar for purposes of Q&A. On February 14, 2025, we obtained exclusive rights to utilize, incorporate and report the DII score together with inflammatory biomarkers measured in a lab.

In addition to providing biomarker levels and specific dietary recommendations, we also plan to offer electronic coupons for discounts for those suggested healthy food items. This has the dual benefit of motivating consumers to make better food selections while providing an ancillary revenue stream for both us and the participating supermarket (food manufacturers commonly remunerate distributors of redeemed coupons).

Key Competitive Advantages: Longevity tests on the market, such as those that measure telomere length or assess dozens of biomarkers or genetic mutations, tend to be expensive and rarely provide simple to understand, evidence based, practical and specific guidance for lifestyle changes proven to improve lifespan and health span. Microbiome testing has a further disadvantage in that it requires collecting stool specimens, which is unpopular with many consumers. Many of the labs that offer these tests also promote and sell dietary supplements, the safety and efficacy of which is often questionable.

We believe that OneTest for Longevity fills a compelling unmet need for an affordable, easily accessible test with actionable, evidence-based recommendations to reduce inflammation and the risk of most major chronic diseases. Our exclusive access to the DII for use with clinical lab test reporting, a unique food-frequency questionnaire, as well as the AI avatar from the developer of the DII, provides another level of distinctiveness.

Clinical Laboratory Innovation Accelerator (CLIAx)

To increase our menu of innovative tests faster and at a lower cost and risk than through internal development, in 2021 we established our CLIAx, which permits diagnostics start-up companies from around the world to launch their laboratory developed tests in our CLIA licensed laboratory using shared equipment and laboratory personnel. To date, we have enrolled the first company in our CLIAx, Minomic International, or Minomic, and helped it validate and launch its blood test to help determine whether prostate specific antigen, or PSA, levels should be followed up with a biopsy. Our CLIAx, which we believe to be the first such shared CLIA laboratory facility in the U.S., reduces the costs and expense for start-up companies to launch their novel tests in the American market while providing us with sales and marketing rights to additional products. In 2022, it earned an “Honorable Mention” in Fast Company magazine’s list of “World Changing Ideas.”

We plan to expand our capacity associated with our CLIAx. This would enable us to invest in, acquire, or transact with companies or academic medical centers that have tests that could add to our menu or technologies, products, testing components or intellectual property that strengthen our core business. We have identified a few companies that could be candidates for this CLIAx fund, but have no agreements, or letters of intent with any of them. Thus, there is no guarantee that we can identify or reach agreement in the near term with any such companies to meaningfully contribute to inorganic growth.

Field Tests for Screening Suspicious Powders

We have a longstanding business that makes and sells a proprietary test kit for screening suspicious powders called BioCheck. These kits are widely used by fire departments and other emergency responders to quickly screen unknown suspicious powders for compounds such as ricin, anthrax, and other bioweapon agents and to identify false alarms in minutes at the site of a suspected bioterror threat.

Growth Strategies and Path to Profitability

We will strive to increase stockholder value by pursuing the following growth strategies:

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Exploit our compelling advantage of at-home and retail collections. We believe that COVID-19 testing caused a paradigm shift in the way Americans seek access to testing. Previously, most testing was done at doctor’s offices and at specialty patient service centers maintained by the large national lab chains. During the pandemic, testing was conducted at retail establishments and at home. OneTest for Cancer utilizes small volume, capillary collected blood specimens that can easily be accessed at home and at retail venues such as pharmacies, health clubs, etc. This is a big advantage over most known competitors which need to utilize traditional venipuncture to obtain sufficient blood volumes to permit DNA sequencing. Requiring an in-person visit to a specimen collection site is a potential barrier for a person who needs testing. Our at-home specimen collection option may help eliminate these barriers. OneTest for Longevity also can utilize capillary collection. To date, we have demonstrated that this collection approach works well both at home and in retail environments (we are now offering our tests at pharmacies within Giant Food, the largest supermarket chain in the Washington, D.C. area). We also have a telemedicine provider available to authorize the test and be available to consult with the patient in the event of a high-risk score. We plan to expand direct-to-consumer marketing and build additional retail channel partnerships (supermarkets, pharmacies, health clubs, etc.) at which blood collection is not yet commonplace.

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Strategic partnerships and cooperative advertising. To facilitate scale while mitigating expenses, we have initiated an ambitious plan of marketing alliances and partnerships with an array of other companies, large and small, including suppliers, other clinical labs, and organizations that offer wellness and screening tests. In many cases we seek to introduce the cooperative advertising model where marketing expenses are shared pro rata based on revenue allotments.

SEC Form 424B3 filed by 20/20 Biolabs Inc.