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Nature of Operations and Basis of Presentation | 12 Months Ended
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Dec. 31, 2025
Nature of Operations and Basis of Presentation [Abstract] |
NATURE OF OPERATIONS AND BASIS OF PRESENTATION | 1. NATURE OF OPERATIONS AND BASIS OF PRESENTATION Business Bluejay Diagnostics, Inc. (“Bluejay” and/or the “Company”) is a medical diagnostics company focused on improving patient outcomes in critical care settings, with a focus on sepsis. The Company is working on developing rapid, near-patient tests using whole blood on its Symphony technology platform (“Symphony”), which consists of an analyzer and single-use protein detection cartridges. The Company does not yet have regulatory clearance for Symphony, and it will need to receive regulatory authorization from the U.S. Food and Drug Administration (the “FDA”) before Symphony can be marketed as a diagnostic product in the United States. The Company has completed the pre-clinical development of the Symphony analyzer. During 2025, the Company transferred the intellectual property underlying the production of the Symphony cartridges from the original developer and outside supplier, Toray Industries, to a contract manufacturing facility with FDA certification run by Sanyoseiko. The Company is also working with Sanyoseiko to modify the manufacturing process of the Symphony cartridges to address certain technical issues to bring Symphony to a level consistent with necessary performance and quality requirements for regulatory submission. To achieve its plan, the Company expects to need to raise at least $20 million of further capital by the end of the 2027 fiscal year, which the Company hopes to do in various tranches. The Company’s Symphony platform is a combination of Bluejay’s intellectual property (“IP”) and exclusively licensed and patented IP on the Symphony technology that the Company believes if cleared, authorized, or approved by the FDA, could provide a solution to a significant market need in the United States. The Symphony device candidate is designed to produce laboratory-quality results in approximately 20 minutes in critical care settings, including Intensive Care Units (“ICUs”) and Emergency Rooms (“ERs”), where rapid and reliable results are required. The Company’s first product candidate, the Symphony IL-6 test, is an immunoassay for the measurement of interleukin-6 (IL-6) to be used for the monitoring of disease progression in critical care settings. The Company is currently focused on pursuing the Symphony IL-6 test in the context of sepsis. IL-6 is a clinically established inflammatory biomarker, and is considered a ‘first-responder,’ for assessment of severity of infection and inflammation across many disease indications, including sepsis. A current challenge of healthcare professionals is the excessive time and cost associated with determining a patient’s level of severity at triage and the Company believes that its Symphony IL-6 test, if ultimately successful and approved, could have the ability to consistently monitor this critical care biomarker with rapid results. If the Company succeeds with the foregoing plan, in the future it hopes to develop additional tests for Symphony, including tests for myocardial infarction and congestive heart failure (cardiac biomarkers hsTNT and NT pro-BNP) as well as other tests using the Symphony platform. The Company was incorporated under the laws of Delaware on March 20, 2015. Its headquarters are located in Acton, Massachusetts. On June 4, 2021, the Company formed Bluejay Spinco, LLC, a wholly-owned subsidiary of the Company, for purposes of further development of the Company’s ALLEREYE diagnostic test. ALLEREYE is a point-of-care device offering healthcare providers a solution for diagnosing Allergic Conjunctivitis. The Company currently is not actively pursuing development of the ALLEREYE diagnostic test. FDA Regulatory Strategy The design, development, manufacture, testing and sale of the Company’s products in the U.S. are subject to regulation by numerous governmental authorities, principally the FDA, and corresponding state and local regulatory agencies. Generally, the products we develop must be cleared by the FDA before they are marketed in the United States. Before and after approval, authorization, or clearance in the United States, our products are subject to extensive regulation by the FDA, as well as by other regulatory bodies. FDA regulations govern, among other things, the development, testing, manufacturing, labeling, safety, storage, recordkeeping, market clearance, authorization or approval, labeling and promotion, import and export, marketing and sales, and distribution of medical devices. The Company’s current regulatory strategy is designed to support commercialization of Symphony in the United States if and when the Company receives marketing authorization from the FDA. In May 2023, the Company submitted a pre-submission application to the FDA presenting study designs to validate Symphony IL-6 for use with hospitalized sepsis patients. The Company participated in a pre-submission meeting with the FDA in August 2023, and at the meeting the FDA provided feedback on the study design, determined that the submission of a 510(k) is the appropriate premarket submission pathway, and requested that certain data be provided in the 510(k). Based on this feedback, the Company determined to proceed on this basis, which considers the FDA’s feedback. In the second quarter of 2024, the Company completed a multicenter SYmphony IL-6 MONitoring Sepsis (“SYMON”) clinical study investigating the role of interleukin-6 (IL-6) in patients diagnosed with sepsis and septic shock. This prospective study assessed the performance of IL-6 upon initial presentation to the intensive care unit (ICU). A primary endpoint of the SYMON-I pilot clinical study (registered clinical trial number NCT06181604) suggested that IL-6 levels within 24 hours of sepsis or septic shock diagnosis and admission to the ICU may predict patient mortality out to 28 days. Furthermore, a secondary endpoint of the SYMON-I study suggested that IL-6 levels within 24 hours of sepsis or septic shock diagnosis and admission to the ICU is a predictor of patient mortality during their hospitalization. Other secondary endpoints suggested that lactate and Sequential Organ Failure Assessment (SOFA), standard clinical tests used for sepsis and septic shock patients, were not predictors of patient mortality out to 28 days. We believe that the findings underscore the potential importance of IL-6 as a predictor and provide new insights into the potential pathways for improving sepsis outcomes. Using the data analysis from the SYMON-I pilot clinical study, the Company initiated the SYMON-II pivotal clinical study in the third quarter of 2024. The SYMON II clinical study has three components: (1) collection, freezing, and biobanking of patient samples, (2) measuring IL-6 concentrations in the biobanked samples near the end of patient enrollment or after the patient enrollment has completed, and (3) analysis of the IL-6 data with the patient outcomes to see if the established IL-6 cutoff value has been validated for 28-day all-cause mortality. Patient enrollment started during the fourth quarter of 2024. As of March 2, 2026, the Company has enrolled approximately 583 hospital patients among a target of 750 patients, and it has collected, frozen and biobanked blood samples from the enrolled patients, while also obtaining all related patient data regarding their disease progression and outcomes. The Company expects to complete patient enrollment in the study in the summer of 2026. The Company’s goal is to use the Symphony IL-6 test to complete the testing in the SYMON-II clinical trial. The Company is not yet testing the samples because it is simultaneously working with Sanyoseiko to manufacture the cartridges that will be used in the test, and these cartridges are still being manufactured and verified to ensure that they meet FDA requirements for submission and commercial production. The Company’s goal is to produce and verify these cartridges during 2026. If the Company is able to complete the SYMON-II clinical study and the results are positive, the Company intends to use the data generated from SYMON-II to support a 510(k) application to the FDA. This application is currently expected to be based on the following intended use: “Symphony IL-6 is intended for use to determine the IL-6 concentration as an aid in assessing the cumulative 28-day risk of all-cause mortality in conjunction with other laboratory findings and clinical assessments for patients diagnosed with sepsis or septic shock in the ICU.” The Company also plans to present the SYMON-I and SYMON-II results at future national scientific meetings and publish them in peer-reviewed journals, subject to future completion of the SYMON-II study and the results being positive. Subject to achieving needed funding and successfully addressing the manufacturing process challenges with its cartridges, the Company’s plan is to begin testing of samples it is collecting as part of the SYMON-II clinical trial by the end of 2026, with a goal of being in position to submit a 510(k) regulatory application to the FDA in 2027, and an objective of achieving FDA clearance thereafter. The Company’s ability to engage in and complete the activities needed for an FDA submission will be contingent upon it addressing these and other challenges, including possessing and/or raising sufficient capital, remaining a going concern, and producing product capable of supporting our product requirements and meeting analytical validation and clinical validation. Product Manufacturing The Company plans to manufacture its analyzers and cartridges through Sanyoseiko Co. Ltd. (“Sanyoseiko”), as a contract manufacturing organization (“CMO”), and the Company has entered into master supply and master service agreements with Sanyoseiko governing these matters. Pursuant to statements of work that the Company will provide to Sanyoseiko under these agreements, Sanyoseiko will provide end-to-end support for the Symphony platform, including supporting the manufacturing redevelopment process for analyzers and cartridges (with hardware, software, and design updates), managing raw material sourcing and vendor compliance, and serving as the Company’s contract manufacturing organization for analyzers, cartridges, and related components. In this capacity, Sanyoseiko will oversee fulfillment, kit assembly, labeling, packaging, shipping, and quality control of manufactured products, while also providing regulatory and quality management support, and equipment storage and maintenance. Sanyoseiko had been selected as the Company’s CMO due to their core competencies in manufacturing and quality systems recognized by the FDA. Sanyoseiko’s facilities are located in Japan. The Company currently licenses the technology for the Symphony cartridges from Toray Industries, Inc. (“Toray”). The Company’s license grants it exclusive global marketing rights, with the exception of Japan. The Company holds the rights to manufacture the analyzers and the cartridges. Risks and Uncertainties As noted above, the Company will be reliant upon its CMO, Sanyoseiko to provide analyzers and, once manufacturing processes have been redeveloped, cartridges, in sufficient quantity and quality to complete the validations for its FDA application. The Company’s FDA application submission could be delayed if the Company encounters any material supply interruptions. In addition, there can be no assurance that the Company will be able to obtain necessary regulatory authorization for the manufacturing or marketing of the Symphony in the United States or elsewhere. There also can be no assurance that the Company will successfully complete any clinical evaluations necessary to receive regulatory clearances, or that the clinical study will demonstrate sufficient safety and effectiveness of the Symphony IL-6 test. The failure to adequately demonstrate the clinical performance of the Symphony IL-6 test could delay or prevent regulatory clearance, which could prevent or result in delays to market launch and could materially harm the Company’s business. In addition to the FDA regulatory strategy risks and uncertainties, the Company is subject to a number of risks similar to other companies in its industry, including rapid technological change, competition from larger biotechnology companies and dependence on key personnel. Additional risk and uncertainties regarding the Company are described in “Part I – Item 1A. Risk Factors” of this Annual Report on Form 10-K. Reverse Stock Splits and Increase to Authorized Capital On July 24, 2023, the Company effected the first reverse stock split of its shares of common stock at a ratio of 1-for-20 (the “July 2023 Reverse Stock Split”). On June 20, 2024, the Company effected a second reverse stock split of its shares of common stock at a ratio of 1-for-8 (the “June 2024 Reverse Stock Split”). On November 18, 2024, the Company effected a third reverse stock split of its shares of common stock at a ratio of 1-for-50 (the “November 2024 Reverse Stock Split”). On January 29, 2026, the Company effected a fourth reverse stock split of its shares of common stock at a ratio of 1-for-4 (the “January 2026 Reverse Stock Split” and, together with the July 2023 Reverse Stock Split, June 2024 Reverse Stock Split, and the November 2024 Reverse Stock Split, the “Reverse Stock Splits”). As such, collectively, the Company’s common stock has undergone reverse stock splits that have combined the shares on a 1-for-32,000 aggregate basis since July 2023. All of the Company’s historical share and per share information related to issued and outstanding common stock and outstanding options and warrants exercisable for common stock in these financial statements have been adjusted, on a retroactive basis, to reflect these reverse stock splits. At the Company’s annual meeting of stockholders on June 18, 2025, the Company’s stockholders provided the Company’s board of directors with authority to implement the January 2026 Reverse Stock Split, as well as an additional reverse stock split at a ratio of up to 1-for-20 (the “Additional Reverse Stock Split”). The Additional Reverse Stock Split may not be implemented if it would reduce the number of publicly held shares of the Company’s common stock to less than 500,000. The Board’s authority to implement the Additional Reverse Stock expires on June 18, 2026. On October 23, 2024, the stockholders of the Company approved and adopted an amendment to the Company’s amended and restated certificate of incorporation, to increase the number of authorized shares of the Company’s common stock to 250,000,000. Basis of Presentation The accompanying consolidated financial statements have been prepared in accordance with generally accepted accounting principles in the United States (“US GAAP”) and include all adjustments necessary for the presentation of the Company’s consolidated financial position, results of operations and cash flows for the periods presented. The consolidated financial statements include the accounts of the Company and its wholly owned subsidiary. All intercompany balances and transactions have been eliminated in consolidation. Going Concern The consolidated financial statements for the years ended December 31, 2025 and 2024 were prepared under the assumption that the Company will continue as a going concern, which contemplates that the Company will be able to realize assets and discharge liabilities in the normal course of business. The Company had cash and cash equivalents of $5,164,875 and current liabilities of $1,119,197 as of December 31, 2025. The Company has incurred net losses since its inception, has incurred negative cash flows from operations and has an accumulated deficit of $41,517,267 as of December 31, 2025. The Company expects that its net cash used in operating activities will continue to be negative over at least the next several years as it attempts to redevelop aspects of the manufacturing process for Symphony cartridges and conducts clinical trial work and, if such redevelopment and trials are successful, begins preparation of an FDA submission. These financial results and financial position, and the Company’s expected forward-looking outlook of significant negative cash flow in the future, raise substantial doubt with respect to its ability to continue as a going concern. The Company expects that it will not be in position to submit a 510(k) regulatory application to the FDA for Symphony until 2027, at the earliest, if it is even able to generate sufficient clinical trial results to support such a submission. If the Company fails to obtain sufficient future financing, its clinical trials and targeted FDA submission timeline could be delayed, and it could be forced to abandon such activities entirely and cease operations, with the possible loss of such properties or assets. If the Company is unable to obtain additional financing as it continues to generate negative cash flow, its board of directors could determine to cause the Company to undertake a process of liquidation under Chapter 7 of applicable U.S. bankruptcy laws, or otherwise seek other protection under such laws. In such event, holders of shares of the Company’s common stock could recoup little, if any, value in such process. The Company currently estimates cash resources will be sufficient to fund its operations up to the third quarter of 2026. These accompanying financial statements do not include any adjustments related to the recoverability and classification of recorded asset amounts or the amounts and classification of liabilities that might result from the outcome of this uncertainty.

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