공시 • May 17
20/20 Biolabs, Inc. announced delayed 10-Q filing On 05/15/2026, 20/20 Biolabs, Inc. announced that they will be unable to file their next 10-Q by the deadline required by the SEC. New Risk • Apr 04
New major risk - Negative shareholders equity The company has negative equity. Total equity: -US$19k This is considered a major risk. Being in negative equity means that the company's liabilities exceed its assets, meaning it owes more to creditors than it has in owned assets. While this doesn't mean the company is about to collapse, in the long-term, this is unsustainable. The company may have issues meeting financial obligations, is at risk of becoming insolvent and may have difficulty raising capital, especially more debt, if needed. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$1.9m free cash flow). Negative equity (-US$19k). Earnings have declined by 55% per year over the past 5 years. Minor Risks Revenue is less than US$5m (US$2.0m revenue). Market cap is less than US$100m (US$18.9m market cap). 공시 • Mar 13
20/20 Biolabs Highlights Advantages of Its Patented Protein Biomarker Technology for Multi-Cancer Early Detection 20/20 BioLabs provided an update on its patented protein tumor marker (PTM) based, machine learning (ML) derived multi-cancer early detection (MCED) methodology in the wake of several recent studies suggesting the expected value of this approach for earlier stage detection compared to stand-alone circulating tumor DNA (ctDNA) based MCEDs. Results reported in February 2026 from a large-scale ctDNA-based MCED study conducted in the U.K. has prompted broader discussion about the biological limitations of circulating tumor DNA as first-line screening tests for early-stage disease. Generally, for MCED tests to be clinically meaningful, they must detect cancer early enough to change outcomes. Among other things, this requires biomarkers that are present and detectable before tumors shed sufficient DNA into the bloodstream. Circulating tumor DNA (ctDNA)-based tests, while valuable in detecting advanced disease, face a fundamental biological constraint: in early-stage cancers, where tumor burden is low, DNA shedding is often intermittent or absent. As a result, ctDNA signals may only become reliably detectable after disease has progressed beyond the window of greatest clinical impact. Studies published by 20/20 Biolabs and several independent research groups in the U.S. and Asia over the past 10 months add to the growing body of evidence that company’s patented multi-cancer testing approach may help overcome many of the limitations of ctDNA for earlier stage detection: In May 2025 20/20 Biolabs presented data on the sensitivity of its OneTest for Cancer (Premium version) at the annual meeting of the U.S. National Cancer Institute’s (NCI) Early Detection Research Network (EDRN), demonstrating detection rates for early-stage cancers as high as 50% for some tumor types — including pancreatic and ovarian cancers — from a pre-diagnostic (asymptomatic) population using a blinded cohort supplied by the NCI. Additional support for using protein tumor markers comes from a large, multicenter validation study published in Nature’s Precision Oncology in October 2025, which evaluated an AI enhanced blood test integrating seven well established protein tumor markers (6 of which are part of OneTest) across more than 15,000 participants from seven centers in three countries (USA, China, and Brazil). The study demonstrated consistent cancer signal detection across diverse populations, with measurable sensitivity even in Stage I disease and progressively higher detection rates as cancers advanced. In a blinded validation study published in November 2025, investigators at MD Anderson Cancer Center reported that a protein based multicancer test—with most of the same biomarkers measured in OneTest (Standard version)—identified nearly 90% of early stage lung cancers and flagged multiple other cancers a median of 12–21 months prior to diagnosis, supporting the sensitivity of protein tumor markers during early oncogenesis. These recent reports build upon hundreds of studies over several decades showing the sensitivity of PTMs for early-stage detection of many different tumor types, especially following repeat (serial) testing. This evolving evidence reinforces the scientific and commercial rationale for large scale screening first with its protein biomarker-based OneTest for Cancer test prior to considering the more costly ctDNA tests or advanced imaging platforms. Given the higher sensitivity of protein-based tests for Stage I and II cancers, a tiered approach in which protein-based tests like OneTest serve as the initial screening step makes sense. Individuals identified by protein-based tests to be at mild risk can then be directed into ctDNA-based testing within a 3–6-month window, when ctDNA signals are more likely to be present. Those deemed at higher risk by protein–based tests are likely better served by moving directly to imaging studies. This tiered, or multi-step, approach is likely to yield the best outcomes and the lowest costs. Results from the ctDNA MCED trails in the U.K. come shortly after Congress passed legislation in February 2026 to create a pathway for Medicare coverage of MCEDs beginning in 2028. The reimbursement opportunity created by the new legislation is an important step forward for cancer screening access. As coverage decisions are made, the science supports a broader view of MCED — one that includes protein-based technologies that have demonstrated meaningful early-stage detection. 공시 • Feb 25
20/20 BioLabs Launches OneTest for Longevity Blood Test and Chronic Disease Risk Assessment and Management Solution Built with IBM AI Capabilities 20/20 BioLabs announced the launch and commercial availability of its OneTest for L longevity solution. The solution uses IBM w Watsonx.ai - an integrated AI application development studio - to analyze data, to help individuals track chronic inflammation associated with several major chronic diseases. The test is now available for purchase. The OneTest for L longevity solution uses IBM w Watsonx., an integrated AI application development studio to analyze data, to help individual track chronic inflammation associated with several large chronic diseases. The test is currently available for purchase. The One Test for L longevity solution uses IBM W Watsonx.ai to calculate and display an individual's risk of being diagnosed with chronic diseases such as diabetes, dementia, and cardiovascular disease. The product provides personalized, evidence-based dietary recommendations to help individuals better understand patterns in their biomarker levels and associated disease risks. The scientific publications being analyzed by the algorithms are curated by Dr. James R. Hebert and his team at the University of South Carolina, which developed the Dietary Inflammatory Index™? (DII®?). 20/20 BioLabs' OneTest has neither sought nor received FDA approval and is offered as a laboratory-developed test (LDT) in its CLIA-licensed and CAP-accredited labs. IBM is acting as an information technology provider only. IBM does not purport to be engaged in the practice of medicine or any other professional clinical or licensed activity. The company offers two families of lab tests under the OneTest brand. OneTest™? for Cancer is a multi-cancer early detection, or MCED, blood test, and OneTest for L longevity, which measures inflammatory biomarkers, expected to launch in the first half of 2026. OneTest's affordable, accurate, actionable tests can be conveniently accessed at home using new, upper arm collection devices that avoid painful needles. Tests are run in its College of American Pathologists (CAP) accredited, Clinical Laboratory Improvement Amendments (CLIA) licensed laboratory in Gaithersburg, MD. 20/20 BioLabs's pioneering Clinical Laboratory Innovation Accelerator, or CLIAx, is a shared CLIA laboratory for overseas diagnostics start-ups seeking to launch novel lab tests in the US without the expense of establishing and operating their own, independent lab. 
