BJDX

These risks include, but are not limited to, the following: ● We have incurred significant losses since our inception, do not currently generate any operating income, and will continue to incur losses as we work to obtain product approval, and thus we may never achieve or maintain profitability. ● We will require additional funding to finance our operations to continue as a going concern, which may not be available to us on acceptable terms, or at all, and our lack of cash resources could cause us to run out of cash resources in the near-term. ● 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. ● The number of shares of common stock underlying our outstanding warrants is several times greater than our currently outstanding common stock, which could have a negative effect on the market price of our common stock and make it more difficult for us to raise funds through future equity offerings.
In addition, in connection with any merger, consolidation or sale of all or substantially all of our assets, holders of our outstanding warrants would be entitled to receive the Black Scholes value of such warrants, which may reduce the consideration otherwise available for payment to holders of our common stock. ● Our common stock is currently listed for quotation on the Nasdaq Capital Market, but we may be unable to meet requirements for continued listing in the future, particularly if our common stock trades below $1.00 per share in the future.
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. ● Our license arrangements with Toray, which relate to the license of the core technology used in our Symphony Cartridges for Sanyoseiko Co., Ltd.
(“Sanyoseiko”) to manufacture cartridges for Bluejay, are subject to risks that may threaten our viability or otherwise have a material adverse effect on us and our business, assets and its prospects. ● Certain processes related to manufacturing have been the cause of prior performance and reproducibility issues with our cartridge product and we do not expect to be able to test our clinical trial samples until such manufacturing issues have been confirmed to be resolved. ● Our Symphony platform, including its software and systems, may contain undetected errors, which could limit our ability to provide our products and diminish the attractiveness of our offerings. ● If we or our manufacturers fail to comply with the regulatory quality system regulations or any applicable equivalent regulations, our proposed operations could be interrupted, and our operating results would suffer. ● If we are found to have violated laws protecting the confidentiality of patient health information, we could be subject to civil or criminal penalties, which could increase our liabilities and harm our reputation or our business. ● Significant raw material shortages, supplier capacity constraints, supplier disruptions, and sourcing issues may adversely impact or limit our products sales and or impact our product margins. iii ● The regulatory clearance process which we may be required to navigate may be expensive, time-consuming, and uncertain and may prevent us from obtaining clearance for our planned products. ● Clinical data obtained in the future may not meet the required objectives, which could delay, limit or prevent any regulatory clearance. ● We may be unable to complete required clinical evaluations, or we may experience significant delays in completing such clinical evaluations, which could prevent or significantly delay our targeted product launch timeframe and impair our viability and business plan. ● We and our suppliers may not meet regulatory quality standards applicable to our manufacturing processes, which could have an adverse effect on our business, financial condition, and results of operations. ● We may be liable if the FDA or another regulatory agency concludes that we have engaged in the off-label promotion of our products. ● Legislative or regulatory reforms may make it more difficult and costly for us to obtain regulatory clearance or approval of any future products and to manufacture, market and distribute our products after clearance or approval is obtained. ● We depend on intellectual property licensed from Toray, and any dispute over the license would significantly harm our business. ● We will depend primarily on Toray to file, prosecute, maintain, defend and enforce intellectual property that we license from it and that is material to our business. ● We and Toray may be unable to protect or enforce the intellectual property rights licensed to us, which could impair our competitive position. ● We and/or Toray may be subject to claims alleging the violation of the intellectual property rights of others. ● We and Toray may be subject to claims challenging the invention of the intellectual property that we license from Toray. ● Our analytical validation, required for FDA clearance, may take longer than expected. ● The FDA could request additional data or testing after our submission for application, requiring additional costs and delaying approval. ● We face intense competition in the diagnostic testing market, particularly in the IL-6 space, and as a result we may be unable to effectively compete in our industry. ● Sales of substantial amounts of our securities in the public market could depress the market price of our common stock. ● Failure to maintain effective internal controls in accordance with Section 404 of the Sarbanes-Oxley Act could have material adverse effect on our business and stock price.
(“Bluejay”) is a medical diagnostics company focused on improving patient outcomes in critical care settings, with a focus on sepsis.
We are working on developing rapid, near-patient tests using whole blood on our Symphony technology platform (“Symphony”), which consists of an analyzer and single-use protein detection cartridges.
Food and Drug Administration (the “FDA”) before Symphony can be marketed as a diagnostic product in the United States.
We have completed the pre-clinical development of the Symphony analyzer.
During 2026, we transferred the knowledge, technology and process 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.
We are 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 our plan, we expect to need to raise at least $20 million of further capital by the end of the 2027 fiscal year, which we hope to do in various tranches.
Our Symphony platform is a combination of Bluejay’s intellectual property (“IP”) and exclusively licensed and patented IP on the Symphony technology that we believe, 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.
A current challenge of healthcare professionals is the excessive time and cost associated with determining a patient’s level of severity at triage and we believe that our Symphony IL-6 test, if ultimately successful and approved, could have the ability to consistently monitor this critical care biomarker with rapid results.
We are currently enrolling patients in our SYMON-II pivotal clinical trial, which is designed to validate findings from our SYMON-I pilot study.
The trial aims to assess the predictive performance of IL-6 levels in ICU patients for 28-day all-cause mortality.
As of the date of this filing, we have enrolled approximately 583 hospital patients among a target of 750 patients, and we have collected, frozen and biobanked blood samples from the enrolled patients, while also obtaining all related patient data regarding their disease progression and outcomes.
We expect to complete patient enrollment in the study in the summer of 2026.
We are not yet testing the samples because we are 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.
Our goal is to produce and verify these cartridges during 2026 and be in position to analyze the blood samples using our Symphony IL-6 test in the third quarter 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.
If we succeed with the foregoing plan, in the future we hope 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.
Our operations to date have been funded primarily through the proceeds of (i) our initial public offering (the “IPO”) in November 2021, (ii) the registered direct offering of common stock and concurrent private placement of warrants that we completed in August 2023, (iii) the public offering of common stock and warrants that we completed in January 2024, (iv) the public offering of common stock and warrants that we completed in June 2024, (v) the warrant inducement and private placement transaction of common stock and warrants that we completed in April 2025 and (vi) the private placement of common stock and warrants that we completed in October 2025.
Since inception, our operations have resulted in accumulated deficit of approximately $41.5 million, and for the fiscal year ended December 31, 2025, we incurred operating losses of approximately $6.8 million.
Our planned business model, which is contingent on us ultimately obtaining market clearance and commercializing our Symphony platform, includes the following: ● Financing Model .
If we are able to achieve market clearance in the context of sepsis and then expand our test menu to other diseases and/or conditions, we hope to be able to increase our annual revenue per customer through the resulting increase in utilization.
Manufacturing We plan to manufacture our analyzers through Sanyoseiko as a contract manufacturing organizations (“CMO”), and we have entered into a master supply and service agreement governing these matters with Sanyoseiko.
Pursuant to statements of work that have begun providing 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.
Our license grants us exclusive global marketing, sales and manufacturing rights, with the exception of Japan.
FDA Regulatory Strategy The design, development, manufacture, testing and sale of our 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.
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.
Our current regulatory strategy is designed to support commercialization of Symphony in the United States if and when we receive marketing authorization from the FDA.
We 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).
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.
Our goal is to produce and verify these cartridges during 2026.
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.” We also plan 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 our cartridges that are described above, our plan is to begin testing of samples we are collecting as part of our 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.

and 172 more.

Gone since FY2024

These risks include, but are not limited to, the following: ● We have incurred significant losses since our inception, do not currently generate any operating income, and will continue to incur losses as we work to obtain product approval, and thus we may never achieve or maintain profitability. ● We will require material additional funding to finance our operations to continue as a going concern, which may not be available to us on acceptable terms, or at all, and our lack of cash resources has slowed the timeline of our clinical trial work and could cause us to run out of cash resources in the near-term. ● 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 material declines in the trading price of our common stock beyond the substantial declines that have occurred in recent years. ● The number of shares of common stock underlying our outstanding warrants is several times greater than our currently outstanding common stock, which could have a negative effect on the market price of our common stock and make it more difficult for us to raise funds through future equity offerings.
In addition, in connection with any merger, consolidation or sale of all or substantially all of our assets, holders of our outstanding warrants would be entitled to receive the Black Scholes value of such warrants, which may reduce the consideration otherwise available for payment to holders of our common stock. ● Our common stock is currently listed for quotation on the Nasdaq Capital Market, but we may be unable to meet requirements for continued listing in the future. ● We may be obligated to current and/or prior financial advisors under engagement letters that we enter into from time to time. ● Our license and supply arrangements with Toray, which relate to the license of the core technology used in our Symphony Cartridges and the supply of cartridge intermediates from Toray to SanyoSeiko 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. ● We do not currently have sufficient supply of, or know-how from Toray to produce the capture antibody for our cartridges that we currently depend on. ● We might not be able to discover the underlying cause of an ongoing performance reproducibility issue with our product, and if the issues are ultimately determined to be inherent in the design process of the platform, we might have to undertake a significant adjustment to our process and materials. ● Our Symphony platform, including its software and systems, may contain undetected errors, which could limit our ability to provide our products and diminish the attractiveness of our offerings. ● If we or our manufacturers fail to comply with the regulatory quality system regulations or any applicable equivalent regulations, our proposed operations could be interrupted, and our operating results would suffer. ● If we are found to have violated laws protecting the confidentiality of patient health information, we could be subject to civil or criminal penalties, which could increase our liabilities and harm our reputation or our business. ● Significant raw material shortages, supplier capacity constraints, supplier disruptions, and sourcing issues may adversely impact or limit our products sales and or impact our product margins. ● Our ability to solve ongoing issues with critical raw material supply, stability, and reliability of the Symphony Cartridge product may adversely impact our ability to complete clinical trial work and commercialize Symphony. iii ● The regulatory approval process which we may be required to navigate may be expensive, time-consuming, and uncertain and may prevent us from obtaining clearance for our planned products. ● Our Symphony platform may be sold as a research use only product.
The FDA could disagree with this strategy and subject the product to regulation as a regulated medical device, which could increase our costs and delay our commercialization efforts, thereby materially and adversely affecting our business and results of operations. ● Clinical data obtained in the future may not meet the required objectives, which could delay, limit or prevent any regulatory approval. ● We may be unable to complete required clinical evaluations, or we may experience significant delays in completing such clinical evaluations, which could prevent or significantly delay our targeted product launch timeframe and impair our viability and business plan. ● We and our suppliers may not meet regulatory quality standards applicable to our manufacturing processes, which could have an adverse effect on our business, financial condition, and results of operations. ● We may be liable if the FDA or another regulatory agency concludes that we have engaged in the off-label promotion of our products. ● Legislative or regulatory reforms may make it more difficult and costly for us to obtain regulatory clearance or approval of any future products and to manufacture, market and distribute our products after clearance or approval is obtained. ● We depend on intellectual property licensed from Toray, and any dispute over the license would significantly harm our business. ● We will depend primarily on Toray to file, prosecute, maintain, defend and enforce intellectual property that we license from it and that is material to our business. ● We and Toray may be unable to protect or enforce the intellectual property rights licensed to us, which could impair our competitive position. ● We and/or Toray may be subject to claims alleging the violation of the intellectual property rights of others. ● We and Toray may be subject to claims challenging the invention of the intellectual property that we license from Toray. ● We are currently only pursuing one aspect of analytical validation, one of three series of validation tests required for FDA clearance, and we cannot be certain how long the remaining tests will take us. ● The FDA could request additional data or testing after our submission for application, requiring additional costs and delaying approval. ● We face intense competition in the diagnostic testing market, particularly in the IL-6 space, and as a result we may be unable to effectively compete in our industry. ● Sales of substantial amounts of our securities in the public market could depress the market price of our common stock. ● Failure to maintain effective internal controls in accordance with Section 404 of the Sarbanes-Oxley Act could have material adverse effect on our business and stock price.
(“Bluejay”) is a medical diagnostics company focused on improving patient outcomes in critical care settings.
We are working on developing rapid tests using whole blood on our Symphony technology platform (“Symphony”), which consists of an analyzer and single-use cartridges.
Food and Drug Administration (the “FDA”) to be marketed as a diagnostic product in the United States.
We have completed the development of the Symphony analyzer.
We are currently preparing to transfer the intellectual property underlying the production of the Symphony cartridges from the original developer and outside supplier, Toray Industries, to an in-house facility.
We are also beginning the process of redeveloping aspects of the Symphony cartridges to address several technical challenges to bring Symphony to a level consistent with necessary performance and quality requirements.
After redevelopment, we plan to transfer manufacturing of the Symphony cartridges to a Contract Manufacturing Organization (“CMO”) to manufacture the Symphony cartridges.
To achieve our plan, we expect to need to raise at least $30 million of capital between the second quarter of 2025 and the end of the 2027 fiscal year, which we hope to do in various tranches during this time period.
Our current plan, subject to achieving necessary financing, is to begin testing of samples we are collecting as part of our ongoing SYMON-II clinical trial in mid-2027, with a goal of being in position to submit a 510(k) regulatory application to the FDA in the fourth quarter of 2027, with an objective of achieving FDA approval as early as the third quarter of 2028.
Our Symphony platform is a combination of Bluejay’s intellectual property (“IP”) and exclusively licensed and patented IP on the Symphony technology that we believe, if cleared, authorized, or approved by the FDA, can provide a solution to a significant market need in the United States.
The Symphony device is designed to produce laboratory-quality results in 20 minutes in critical care settings, including Intensive Care Units (“ICUs”) and Emergency Rooms (“ERs”), where rapid and reliable results are required.
A current challenge of healthcare professionals is the excessive time and cost associated determining a patient’s level of severity at triage and we believe that our Symphony IL-6 test, if ultimately successful and approved, could have the ability to consistently monitor this critical care biomarker with rapid results.
If we succeed with the foregoing plan, in the future we hope to develop additional tests for Symphony, including tests for myocardial infraction and congestive heart failure (cardiac biomarkers hsTNT and NT pro-BNP) as well as other tests using the Symphony platform.
Our operations to date have been funded primarily through the proceeds of (i) our initial public offering (the “IPO”) on November 2021 (the “IPO Date”), (ii) the registered direct offering of common stock and concurrent private placement of warrants that we completed on August 28, 2023, (iii) the public offering of common stock and warrants that we completed on January 2, 2024, and (iv) the public offering of common stock and warrants that we completed on June 20, 2024.
Since inception, our operations have resulted in accumulated deficit of approximately $34.7 million, and for the fiscal year ended December 31, 2024, we incurred operating losses of approximately $7.2 million.
On June 4, 2021, Bluejay formed Bluejay Spinco, LLC, a wholly owned subsidiary, for purposes of further development of our ALLEREYE diagnostic test.
ALLEREYE is a point-of-care device offering healthcare providers a solution for diagnosing Allergic Conjunctivitis.
Our planned business model, which is contingent on us ultimately obtaining market approval and commercializing our Symphony platform, includes the following: ● Financing Model .
If we are able to achieve market approval in the context of sepsis and then expand our test menu to other diseases and/or conditions, we hope to be able to increase our annual revenue per customer through the resulting increase in utilization.
Bluejay’s current supply agreement of Symphony cartridges from Toray Industries is valid through October 2025, at which point we expect the agreement to expire.
To date, Bluejay has relied on Toray’s development and manufacturing of the Symphony cartridges.
We have encountered several technical challenges in the performance and quality of the Symphony cartridges.
We are currently preparing to transfer the intellectual property underlying production of the cartridges from Toray to an in-house facility for redevelopment.
We are also beginning the process of redeveloping aspects of the cartridges to address several technical challenges to bring our product to a level consistent with the necessary performance and quality requirements.
To address the technical challenges related to the Symphony cartridges, we expect the redevelopment work will occur over at least the next year.
In particular, several individual components in the cartridges need to be replaced and/or validated due to limited supply or discontinuation (including the antibody used in the cartridge).
In addition, we are working to correct several reliability and stability issues with the cartridge product.
After the cartridge redevelopment is completed, we plan to transfer the manufacturing process to an FDA-registered CMO.
We expect that production lots for validation testing to support the FDA submission will be available once the transfer to an FDA registered CMO is completed.
At this time, we do not anticipate being able to perform analytical performance validation testing until mid-2027.
Manufacturing We plan to manufacture our analyzers through Sanyoseiko Co.
(“Sanyoseiko”), as a contract manufacturing organizations (“CMO”), and we have a contract with Sanyoseiko for this purpose.
Once redeveloped, we plan to transfer manufacturing of our cartridges to Sanyoseiko, or other suitable CMO.
We currently do not have a contract for the manufacture of the redeveloped cartridges.
Our license grants us exclusive global marketing rights, with the exception of Japan.
FDA Regulatory Strategy Our current regulatory strategy is designed to support commercialization of Symphony in the United States once we receive marketing authorization from the FDA.
We participated in a pre-submission meeting with the FDA on August 11, 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).

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Sentence-level comparison of Item 1A in the two most recent 10-Ks (FY2024 ↗, FY2025 ↗). A reworded sentence counts as one dropped and one added, so heavy edits read as low “kept”. Headings and page furniture are stripped; nothing is summarised by a model.

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