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Inflammatory Biomarker Tracking Predicted to Enhance Response to 3-D Bio-Printed Therapies Expands OneTest for Longevity with Chronic Kidney Disease Risk Assessment GAITHERSBURG, Md., March 24, 2026 (GLOBE NEWSWIRE) -- 20/20 BioLabs, Inc. (“20/20”), 20/20 BioLabs (Nasdaq: AIDX), an early market entrant in cutting-edge, AI powered laboratory-based blood tests for the early detection and prevention of cancers and chronic diseases, today announced that it has entered into an exclusive U.S. technology license ...

Core Insights - HEALWELL AI Inc. reported record revenue of approximately $103.8 million for fiscal 2025, marking a 427% increase from $19.7 million in fiscal 2024, and achieved its first full year of positive Adjusted EBITDA of $2.3 million [4][5] Financial Performance - The company experienced a significant financial transformation, swinging from a $14.2 million Adjusted EBITDA loss in 2024 to a $2.3 million positive Adjusted EBITDA in 2025, reflecting a $16.5 million improvement [2][4] - HEALWELL ended 2025 with $18.6 million in cash, compared to $9.4 million at the end of 2024, indicating an improving balance sheet [4][5] - The company reported an IFRS net loss from continuing operations of $39.1 million in 2025, compared to a net loss of $24 million in 2024 [5] Operational Highlights - HEALWELL transitioned to a pure-play AI and software company, completing strategic divestments that generated approximately $9.7 million in cash proceeds [4][5] - The company achieved a gross profit of $57.3 million in 2025, with a gross margin percentage of 55%, consistent with the previous year [5] - In Q4 2025, HEALWELL reported quarterly revenue of $32.2 million, a 374% increase from $6.8 million in Q4 2024, and positive Adjusted EBITDA of $1.1 million [5][9] Strategic Initiatives - HEALWELL has established a competitive position with 47 peer-reviewed publications supporting its DARWEN AI engine and over 70 enterprise customers across 11 countries [2][4] - The company is focusing on global scaling, deepening AI adoption, and translating platform economics into sustained profitability in 2026 [2][4] - HEALWELL launched WELLTRUST™, a consent-first patient identification platform, and announced a multi-million dollar U.S. Health Information Exchange (HIE) contract, expanding its enterprise data interoperability footprint [9]

Core Insights - 20/20 BioLabs is advancing its patented protein tumor marker (PTM) based, machine learning derived multi-cancer early detection (MCED) methodology, which shows promise for earlier stage cancer detection compared to circulating tumor DNA (ctDNA) based methods [1][4][5] Group 1: MCED Methodology and Findings - Recent studies indicate that protein biomarkers may effectively identify early-stage cancers, addressing the limitations of ctDNA tests, which often fail to detect cancer until it has progressed [3][4] - A large-scale ctDNA-based MCED study in the U.K. has highlighted the biological constraints of ctDNA as a first-line screening tool for early-stage cancers, emphasizing the need for alternative approaches [2][4] - 20/20 BioLabs' OneTest for Cancer has demonstrated detection rates for early-stage cancers as high as 50% for certain tumor types, such as pancreatic and ovarian cancers, in asymptomatic populations [6] Group 2: Validation and Support for Protein Biomarkers - A multicenter validation study published in Nature's Precision Oncology showed consistent cancer signal detection across diverse populations, with measurable sensitivity even in Stage I disease [6] - A blinded validation study at MD Anderson Cancer Center reported that a protein-based multicancer test identified nearly 90% of early-stage lung cancers, indicating the effectiveness of protein tumor markers during early oncogenesis [6] Group 3: Strategic Approach and Future Directions - The company proposes a tiered approach to cancer screening, where protein-based tests like OneTest serve as the initial screening step, followed by ctDNA testing for individuals identified at mild risk [7] - The recent legislation passed by Congress to create a pathway for Medicare coverage of MCEDs starting in 2028 is seen as a significant advancement for cancer screening access [8] - 20/20 BioLabs is committed to building the evidence base for protein-based technologies and working with policymakers to ensure effective screening tools are available [8]

Core Insights - HEALWELL AI Inc. has provided a strategic update on its Software Business Unit, highlighting infrastructure expansion, renewal momentum, and AI integration across its global platform [1] Expansion and U.S. HIE Contract - The software division has secured a multi-million dollar contract for Health Information Exchange (HIE) software in the U.S., enhancing the company's data interoperability in the healthcare market [2][14] - This contract will facilitate the secure aggregation and exchange of healthcare data for millions of patients, improving care coordination and reducing duplication [2][3] AI Integration Across the Orion Amadeus Platform - HEALWELL has integrated AI capabilities such as SMART Identify, SMART Search, and SMART Summary into the Amadeus AI platform, enhancing patient identification and data retrieval [6][8] - The integration of clinically validated AI strengthens the company's competitive position and creates scalable pathways for enterprise AI commercialization [8] Integrated Bid Strategy and Enterprise-Scale Opportunities - The company is pursuing larger procurement opportunities through coordinated bids that leverage its software portfolio, reflecting increasing demand for integrated infrastructure and AI solutions [9][10] - HEALWELL is experiencing growing participation in multi-capability bids across North America and international markets [10][14] Leadership Commentary - The President of HEALWELL AI expressed excitement about the progress in the software division and the positive momentum driving demand in the software sector [5] - The Chief Commercial Officer emphasized the company's strategy to integrate interoperability infrastructure with clinically validated AI, showcasing its potential impact on Healthcare IT [11]

Core Insights - Premarket trading is showing notable activity with significant price movements indicating potential opportunities for traders [1] Premarket Gainers - Brand Engagement Network, Inc. (BNAI) is up 20% at $51.61 [3] - Latham Group, Inc. (SWIM) is up 20% at $7.79 [3] - Evolus, Inc. (EOLS) is up 14% at $4.74 [3] - Edesa Biotech, Inc. (EDSA) is up 11% at $4.86 [3] - 20/20 Biolabs, Inc. (AIDX) is up 11% at $3.28 [3] - DeFi Development Corp. (DFDV) is up 9% at $4.04 [3] - Accel Entertainment, Inc. (ACEL) is up 7% at $11.95 [3] - Solana Company (HSDT) is up 7% at $2.12 [3] - Nano-X Imaging Ltd. (NNOX) is up 6% at $2.76 [3] - Strive Asset Management, LLC (ASST) is up 5% at $8.81 [3] Premarket Losers - Battalion Oil Corporation (BATL) is down 28% at $19.67 [4] - TMD Energy Limited (TMDE) is down 24% at $3.03 [4] - Ascent Industries Co. (ACNT) is down 15% at $14.75 [4] - indie Semiconductor, Inc. (INDI) is down 14% at $2.71 [4] - WEBTOON Entertainment Inc. (WBTN) is down 13% at $9.98 [4] - STAAR Surgical Company (STAA) is down 10% at $17.00 [4] - Indonesia Energy Corporation Limited (INDO) is down 10% at $4.68 [4] - BiomX Inc. (PHGE) is down 7% at $4.52 [4] - Arbutus Biopharma Corporation (ABUS) is down 6% at $4.37 [4] - Global Interactive Technologies, Inc. (GITS) is down 6% at $2.43 [4]

Core Viewpoint - 20/20 BioLabs has launched its OneTest for Longevity, a blood test that integrates inflammatory biomarkers, dietary habits, and scientific research to provide personalized health insights, utilizing IBM's watsonx.ai technology [1][2][3] Group 1: Product Launch and Features - The OneTest for Longevity solution calculates and displays an individual's risk of chronic diseases such as diabetes, dementia, and cardiovascular disease, offering personalized dietary recommendations based on biomarker levels [2] - The platform leverages IBM's advanced AI capabilities, including the Granite 4.0 foundation models and the Docling toolkit, to analyze nutritional research and deliver evidence-based health insights [3][6] - The test is available for purchase and is conducted in CLIA-licensed and CAP-accredited labs, although it has not sought FDA approval [3][7] Group 2: Partnerships and Technology - 20/20 BioLabs has partnered with DAISource to enhance its AI-enabled health solutions, aiming to improve public health through scalable and secure technology [3] - IBM's role is as an information technology provider, focusing on supporting enterprises with secure workloads in various sectors, including healthcare [4] Group 3: Company Background and Market Position - 20/20 BioLabs is an early market leader in laboratory-based blood tests for early detection and prevention of cancers and chronic diseases, with its stock listed on Nasdaq under the ticker symbol "AIDX" since February 19, 2026 [5][6] - The company also operates a Clinical Laboratory Innovation Accelerator (CLIAx) to assist overseas diagnostics startups in launching lab tests in the U.S. [8]

Core Insights - 20/20 BioLabs, Inc. is an early market leader in AI-powered laboratory-based blood tests for early detection and prevention of cancers and chronic diseases [3][5] - The company will host a virtual investor webinar on February 26, 2026, to discuss its recent Nasdaq listing and product offerings [4][5] - The company offers two main products: OneTest™ for Cancer™, a multi-cancer early detection blood test, and OneTest for Longevity™, which measures inflammatory biomarkers [5][6] Company Overview - 20/20 BioLabs was listed on Nasdaq under the ticker symbol "AIDX" on February 19, 2026 [5] - The company operates a CAP-accredited and CLIA-licensed laboratory in Gaithersburg, MD, where tests are conducted [6] - The company also runs a Clinical Laboratory Innovation Accelerator (CLIAx) to support overseas diagnostics start-ups [7] Upcoming Initiatives - The OneTest for Longevity™ is expected to launch before the end of February 2026 [4] - The virtual investor webinar will include a question-and-answer session, allowing investors to engage directly with the company's leadership [4][5]

Core Viewpoint - 20/20 BioLabs, Inc. has launched its Class A ordinary shares on the Nasdaq Capital Market under the ticker symbol "AIDX," aiming to scale growth through AI-powered blood tests for cancer and chronic disease detection [1][6]. Financing and Growth Strategy - The company has entered a contingent financing agreement that could provide up to $40 million, with the first $5 million expected to close today [2]. - The CEO emphasized that the Nasdaq listing is a significant milestone that positions the company for substantial growth through both organic means and mergers and acquisitions [6][7]. Product Offerings - 20/20 BioLabs offers OneTest™ for Cancer, an AI-powered multi-cancer early detection blood test that analyzes tumor-associated protein biomarkers, allowing for earlier detection of multiple cancers at a lower price point than competing tests [4][11]. - The upcoming OneTest for Longevity™, expected to launch by the end of February, will track inflammatory biomarkers associated with chronic diseases, enabling consumers to make lifestyle changes to reduce disease risk [5][11]. Technological Innovation - The company's diagnostics leverage AI models built with real-world data, enhancing accuracy and clinical usefulness, and allowing for convenient home access through new blood collection devices [3][11]. - The OneTest for Cancer may be the first multi-cancer early detection test that can be self-collected at home, which is a significant advancement in the field [4]. Regulatory Environment - Recent legislation passed by Congress aims to facilitate Medicare reimbursement for multi-cancer early detection tests by 2028, which could positively impact the company's market potential [4]. Investor Relations - 20/20 BioLabs has launched an Investor Relations section on its website, providing various resources for investors, including press releases, current share prices, and SEC filings [8].

As filed with the U.S. Securities and Exchange Commission on January 26, 2026 Registration No. 333-292125 UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 Amendment No. 2 to FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 20/20 BIOLABS, INC. (Exact name of registrant as specified in its charter) | Delaware | | --- | Delaware 8734 57-2272107 (State or other jurisdiction of incorporation or organization) (Primary Standard Industrial Classification Code Number) (I.R.S. E ...