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Bluejay Diagnostics, Inc.

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Business Summary

Bluejay Diagnostics, Inc. is a medical diagnostics company focused on developing rapid, near-patient tests for critical care settings, specifically targeting sepsis . The company's core offering is the Symphony technology platform, which comprises an analyzer and single-use protein detection cartridges . This platform is designed to deliver laboratory-quality results in approximately 20 minutes . The company's initial product candidate is the Symphony IL-6 test, an immunoassay for measuring interleukin-6 (IL-6) to monitor disease progression in critical care settings, particularly in the context of sepsis . Bluejay Diagnostics aims to address the challenge healthcare professionals face with the time and cost associated with determining patient severity at triage . The company's business model, contingent on regulatory clearance, involves offering various financing options for the Symphony device and generating recurring revenue from the sale of single-use diagnostic test cartridges . They intend for cartridge sales to be the primary source of revenue and gross profit .

The Symphony platform integrates sample preparation and reagents into disposable cartridges, requiring only a few drops of blood for measurement . The analyzer orchestrates sample processing, biomarker isolation, and immunoassay preparation using non-contact centrifugal force, measuring a fluorescence signature for biomarker quantitation . Each analyzer can run up to six cartridges simultaneously . The company plans to manufacture its analyzers and cartridges through Sanyoseiko, a contract manufacturing organization (CMO) located in Japan, which has FDA-recognized manufacturing and quality systems . Bluejay Diagnostics holds exclusive global marketing, sales, and manufacturing rights for the Symphony cartridges, excluding Japan, and also holds the rights to manufacture the analyzers .

For the fiscal year ended December 31, 2025, Bluejay Diagnostics reported an operating loss of approximately $6,952,972 , compared to an operating loss of approximately $7,169,616 for the year ended December 31, 2024. The net loss for 2025 was approximately $6,848,483 , an improvement from the net loss of approximately $7,717,794 in 2024. The net loss applicable to common shareholders was $6,848,483 in 2025, significantly lower than $20,940,847 in 2024, primarily due to a deemed dividend on warrant modification of $13,223,053 in 2024. Basic and diluted net loss per share to common stockholders was $(15.25) in 2025, compared to $(456.75) in 2024. The company had cash and cash equivalents of $5,164,875 as of December 31, 2025, up from $4,301,945 in 2024. Total current liabilities were $1,119,197 in 2025, and total liabilities were $1,143,948 . The accumulated deficit as of December 31, 2025, was approximately $41,517,267 . Net cash used in operating activities was approximately $6,053,575 in 2025, a decrease of approximately $1,767,247 from $7,820,822 in 2024.

Research and development expenses decreased by approximately $0.4 million , or 12% , to $3,046,448 in 2025 from $3,471,671 in 2024, mainly due to a $0.2 million decrease in personnel-related costs, a $0.1 million decrease in other costs, and a $0.2 million decrease in product development costs, partially offset by a $0.1 million increase in clinical development costs. General and administrative expenses increased by approximately $0.2 million , or 6% , to $3,906,524 in 2025 from $3,689,648 in 2024, primarily due to a $0.3 million increase in Delaware franchise tax cost and a $0.1 million increase in personnel-related costs, partially offset by a $0.2 million decrease in consulting expenses. Sales and marketing expenses decreased 100% in 2025 to $0 from $8,297 in 2024, reflecting a reduction in all sales and marketing efforts. Total other income (expense) improved by approximately $0.7 million in 2025 compared to 2024, mainly due to an $0.8 million decrease in interest expense associated with the 2024 Bridge Note Financing.

During 2025, the company transferred the knowledge, technology, and process for Symphony cartridge production from Toray Industries to Sanyoseiko . They are also working with Sanyoseiko to modify the manufacturing process to address technical issues and meet FDA performance and quality requirements . The company initiated the SYMON-II pivotal clinical study in the third quarter of 2024 and has enrolled approximately 583 hospital patients out of a target of 750 as of the filing date . Patient enrollment is expected to be completed in the summer of 2026 . The company is not yet testing samples due to ongoing cartridge manufacturing and verification efforts with Sanyoseiko, with a goal to produce and verify these cartridges during 2026 . In July 2025, an amendment to the New Toray License Agreement extended the deadline to establish an alternative manufacturing site for Symphony cartridges from October 23, 2025, to October 23, 2026 . The company also paid $71,212 to Toray for a final supply of certain chip components . The company is also pursuing an exploratory strategic initiative to evaluate the potential integration of artificial intelligence (AI) capabilities into its Symphony platform to enhance clinical interpretation of biomarker data and support sepsis risk stratification models .

Business Outlook

Bluejay Diagnostics expects to continue incurring losses for the foreseeable future, with significant operating losses anticipated in 2026 and 2027, as it currently generates no operating income . To execute its strategic plan, which includes submitting a 510(k) regulatory application to the FDA in 2027 and achieving FDA clearance thereafter, the company expects to need to raise at least $20 million of further capital by the end of the 2027 fiscal year, ideally in various tranches . Without this additional capital, the company anticipates running out of available cash resources in the third quarter of 2026 .

The company's primary growth area is the commercialization of its Symphony IL-6 test for sepsis, followed by the development of additional tests for the Symphony platform . Future tests are hoped to include those for myocardial infarction and congestive heart failure, utilizing cardiac biomarkers hsTNT and NT pro-BNP . The company also intends to explore strategic opportunities related to its pending intellectual property on IL-6 clinical utilities and the specimen biobanks from its SYMON I and SYMON II clinical studies . An exploratory strategic initiative is underway to evaluate integrating artificial intelligence (AI) capabilities into the Symphony platform to enhance clinical interpretation of biomarker data, including IL-6 measurements, and support sepsis risk stratification and patient outcome models . This AI initiative is in the evaluation stage, with no definitive agreements yet, and any development will be phased and disciplined, focusing on data integrity, clinical validation, regulatory considerations, and capital allocation .

Operationally, the company expects future research and development expenses to focus on costs associated with its clinical trial program supporting regulatory strategy, technology transfer efforts, and necessary manufacturing improvements . General and administrative expenses will be monitored and reduced as necessary to optimize operational alignment . The company is actively working with Sanyoseiko to modify the manufacturing process of the Symphony cartridges to address technical issues and meet FDA performance and quality requirements for regulatory submission . The goal is to produce and verify these cartridges during 2026 . All construction in process and manufacturing equipment, including $239,872 of manufacturing equipment placed into service in 2025, is held and operated by Sanyoseiko in Japan, with the remaining construction in process expected to be placed into service in 2026 to support the SYMON II clinical study .

The company's planned capital allocation includes seeking stockholder approval at its 2026 annual meeting to reload shares available under its equity incentive plans . As of December 31, 2025, there were only 9 shares available for grant under the 2018 Stock Incentive Plan and 25 shares available under the 2021 Stock Plan . The anticipated cash compensation fees owed to non-employee directors in 2026 are expected to be $540,000 in aggregate, and the President and Chief Executive Officer receives an annual base cash compensation of $400,000 .

Management has explicitly flagged several structural headwinds and execution risks. The company's ability to complete FDA submission activities is contingent upon raising sufficient capital, remaining a going concern, and producing products capable of meeting analytical and clinical validation requirements . There is a risk that the validation of the primary outcome measure of the SYMON-I study will not achieve statistical significance, potentially leading to redesigns and delays . Furthermore, there is a risk that the Symphony cartridges will not pass analytical validation due to performance failures . The company is required to use its best efforts to establish a cartridge manufacturing site by October 2026 , and failure to do so could lead to Toray terminating the license agreement as early as November 2026 , which would result in losing access to critical technology and materially adversely affecting commercialization efforts . The company will not obtain market approval in the United States or European Union by October 2026, which could lead to a loss of exclusivity in the license agreement territory with Toray . Additionally, the company is required to use reasonable efforts to start commercial sales by October 2028 , with potential extensions for up to two years if delays are not attributable to the company; failure to meet this deadline could result in Toray terminating the license agreement or making it non-exclusive .

Risk Factors

Bluejay Diagnostics faces substantial macroeconomic and operational risks, including the critical need to raise at least $20 million in additional capital by the end of the 2027 fiscal year to fund operations, as current cash resources are only sufficient until the third quarter of 2026 . The company has incurred significant losses since inception, with an accumulated deficit of approximately $41,517,267 as of December 31, 2025, and does not currently generate operating income, raising substantial doubt about its ability to continue as a going concern . The market price of its common stock has fallen by more than 99.9% since its IPO in November 2021, and future funding needs are substantially greater than its current market capitalization, potentially leading to further dilution . The company's Nasdaq listing is at risk if its common stock trades below $1.00 per share or if its market value of publicly held securities falls below $1 million , or if a recently proposed Nasdaq rule requiring a minimum market value of listed securities of $5 million is approved by the SEC, which the company currently does not satisfy . Operationally, the company is dependent on intellectual property licensed from Toray, and disputes or termination of this license could significantly harm the business . There are ongoing manufacturing challenges with Symphony cartridges that need to be resolved to meet FDA requirements , and there is a risk that cartridges will not pass analytical validation . The SYMON-II clinical study, which has enrolled approximately 583 out of a target of 750 patients, is not yet testing samples due to these manufacturing issues, potentially delaying FDA submission . The company's downsized organization, with only 6 full-time employees, may reduce business continuity and affect product development timelines .

Management Priorities

Management's message to shareholders conveys a determined but cautious tone, emphasizing the critical need for additional funding to advance the Symphony platform towards regulatory clearance and commercialization. The company explicitly states that it expects to need to raise at least $20 million of further capital by the end of the 2027 fiscal year to achieve its strategic plan, which includes submitting a 510(k) regulatory application to the FDA in 2027 and achieving FDA clearance thereafter . Without this funding, the company anticipates running out of available cash resources in the third quarter of 2026 . Key strategic priorities include successfully completing the SYMON-II pivotal clinical study, resolving manufacturing process challenges with the Symphony cartridges to meet FDA requirements, and securing the necessary capital to fund these activities . Management also highlights the exploratory initiative to integrate AI capabilities into the Symphony platform as a potential future enhancement for clinical interpretation and sepsis risk stratification .

View Source Annual Report on SEC.gov ↗

References

  1. [1] Item 1, Business — Overview
  2. [2] Item 7, MD&A — Results of Operations
  3. [3] Item 7, MD&A — Comparison of Years Ended December 31, 2025 and 2024
  4. [4] Item 7, MD&A — Results of Operations
  5. [5] Item 7, MD&A — Results of Operations
  6. [6] Item 7, MD&A — Results of Operations
  7. [7] Item 7, MD&A — Deemed dividend on warrant modification
  8. [8] Item 7, MD&A — Net loss per share to common stockholders - Basic and diluted
  9. [9] Item 7, MD&A — Liquidity and Going Concern
  10. [10] Item 7, MD&A — Liquidity and Going Concern
  11. [11] Item 8, Consolidated Balance Sheets
  12. [12] Item 7, MD&A — Liquidity and Going Concern
  13. [13] Item 7, MD&A — Summary Statement of Cash Flows
  14. [14] Item 7, MD&A — Net cash used in operating activities
  15. [15] Item 7, MD&A — Research and development
  16. [16] Item 7, MD&A — Research and development
  17. [17] Item 7, MD&A — Research and development
  18. [18] Item 7, MD&A — General and administrative
  19. [19] Item 7, MD&A — General and administrative
  20. [20] Item 7, MD&A — General and administrative
  21. [21] Item 7, MD&A — Sales and marketing
  22. [22] Item 7, MD&A — Sales and marketing
  23. [23] Item 7, MD&A — Other income (expense)
  24. [24] Item 7, MD&A — Other income (expense)
  25. [25] Item 1, Business — FDA Regulatory Strategy
  26. [26] Item 1, Business — License Agreement
  27. [27] Item 1, Business — License Agreement
  28. [28] Item 1A, Risk Factors — Risks Related to Our Financial Condition and Capital Requirements
  29. [29] Item 1A, Risk Factors — We expect to need to raise at least $20 million between the date of this filing and the end of the 2027 fiscal year, and failure to do so could require us to undertake a process of liquidation under U.S. bankruptcy laws, which could cause holders of our common stock to recoup little, if any, value for their shares.
  30. [30] Item 1A, Risk Factors — We expect to need to raise at least $20 million between the date of this filing and the end of the 2027 fiscal year, and failure to do so could require us to undertake a process of liquidation under U.S. bankruptcy laws, which could cause holders of our common stock to recoup little, if any, value for their shares.
  31. [31] Item 7, MD&A — Research and development
  32. [32] Item 7, MD&A — General and administrative
  33. [33] Item 8, Note 8 — Property and Equipment
  34. [34] Item 8, Note 8 — Property and Equipment
  35. [35] Item 1A, Risk Factors — We do not have a meaningful amount of authorized shares remaining under our equity compensation plans and therefore cannot incentivize our directors and employees with non-cash compensation, and our cash compensation obligations for directors and officers are substantial relative to our market capitalization.
  36. [36] Item 8, Note 6 — Stock Incentive Plans
  37. [37] Item 8, Note 6 — Stock Incentive Plans
  38. [38] Item 8, Note 6 — Stock Incentive Plans
  39. [39] Item 1A, Risk Factors — We do not have a meaningful amount of authorized shares remaining under our equity compensation plans and therefore cannot incentivize our directors and employees with non-cash compensation, and our cash compensation obligations for directors and officers are substantial relative to our market capitalization.
  40. [40] Item 1A, Risk Factors — We do not have a meaningful amount of authorized shares remaining under our equity compensation plans and therefore cannot incentivize our directors and employees with non-cash compensation, and our cash compensation obligations for directors and officers are substantial relative to our market capitalization.
  41. [41] Item 1A, Risk Factors — Our agreements with Toray, which relate to the license of the core technology used in our Symphony cartridges and for Sanyoseiko to manufacture cartridges for Bluejay, are subject to significant risks that may threaten our viability or otherwise have a material adverse effect on us and our business, assets and its prospects.
  42. [42] Item 1A, Risk Factors — Our agreements with Toray, which relate to the license of the core technology used in our Symphony cartridges and for Sanyoseiko to manufacture cartridges for Bluejay, are subject to significant risks that may threaten our viability or otherwise have a material adverse effect on us and our business, assets and its prospects.
  43. [43] Item 1A, Risk Factors — Our agreements with Toray, which relate to the license of the core technology used in our Symphony cartridges and for Sanyoseiko to manufacture cartridges for Bluejay, are subject to significant risks that may threaten our viability or otherwise have a material adverse effect on us and our business, assets and its prospects.
  44. [44] Item 1A, Risk Factors — Since the initial public offering of our common stock in November 2021, the market price of our common stock has fallen by more than 99.9%, and we expect to need additional funding amounts substantially greater than the current market capitalization of our common stock, which may result in future dilution that coincides with further declines in the trading price of our common stock beyond the substantial declines that have occurred in recent years.
  45. [45] Item 1A, Risk Factors — Since the initial public offering of our common stock in November 2021, the market price of our common stock has fallen by more than 99.9%, and we expect to need additional funding amounts substantially greater than the current market capitalization of our common stock, which may result in future dilution that coincides with further declines in the trading price of our common stock beyond the substantial declines that have occurred in recent years.
  46. [46] Item 1A, Risk Factors — Our common stock currently is listed for quotation on the Nasdaq Capital Market. We are required to meet specified financial requirements in order to maintain such listing, including a requirement that the bid price for our common stock remain above $1.00, and that the market value of our publicly held securities be at least $1 million. In addition, Nasdaq has recently proposed a new $5 million market value of listed securities requirement that we would not currently satisfy and therefore could cause our common stock be delisted by Nasdaq on an imminent basis, if approved by the SEC.
  47. [47] Item 1A, Risk Factors — Our common stock currently is listed for quotation on the Nasdaq Capital Market. We are required to meet specified financial requirements in order to maintain such listing, including a requirement that the bid price for our common stock remain above $1.00, and that the market value of our publicly held securities be at least $1 million. In addition, Nasdaq has recently proposed a new $5 million market value of listed securities requirement that we would not currently satisfy and therefore could cause our common stock be delisted by Nasdaq on an imminent basis, if approved by the SEC.
  48. [48] Item 1A, Risk Factors — Our common stock currently is listed for quotation on the Nasdaq Capital Market. We are required to meet specified financial requirements in order to maintain such listing, including a requirement that the bid price for our common stock remain above $1.00, and that the market value of our publicly held securities be at least $1 million. In addition, Nasdaq has recently proposed a new $5 million market value of listed securities requirement that we would not currently satisfy and therefore could cause our common stock be delisted by Nasdaq on an imminent basis, if approved by the SEC.
  49. [49] Item 1, Business — Employees
  50. [50] Item 1A, Risk Factors — To preserve cash resources, we downsized our organization in 2025, which may reduce business continuity, affect our ability to apply for certain patents, and affect our product development and timelines.

Analysis on 5/20/2026