UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-K
(Mark One)
☒ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the Fiscal Year Ended December 31,
2025
Or
☐TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
Commission file number: 001-41031
Bluejay Diagnostics, Inc.
(Exact Name of Registrant as Specified in
Its Charter)
(Address of Principal Executive Offices) (Zip Code)
(844)327-7078
(Registrant’s Telephone Number, Including
Area Code)
Securities registered pursuant to Section 12(b)
of the Act:
Title of each class Trading Symbol(s) Name of each exchange on which registered
Common Stock, par value $0.0001 per share BJDX The Nasdaq Stock Market LLC
Securities registered pursuant to section 12(g)
of the Act: None
Indicate by check mark if the registrant is a
well-known seasoned issuer, as defined in Rule 405 of the Securities Act. Yes ☐No☒
Indicate by check mark if the registrant is not
required to file reports pursuant to Section 13 or Section 15(d) of the Act. Yes ☐No☒
Indicate by check mark whether the registrant
(1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding
12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such
filing requirements for the past 90 days. Yes☒
No ☐
Indicate by check mark whether the registrant
has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§
232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such
files). Yes☒ No ☐
Indicate by check mark whether the registrant
is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company.
See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company”
and “emerging growth company” in Rule 12b-2 of the Exchange Act.
If an emerging growth company, indicate by check
mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting
standards provided pursuant to Section 13(a) of the Exchange Act. ☐
If securities are registered pursuant to Section
12(b) of the Act, indicate by check mark whether the financial statements of the registrant included in the filing reflect the correction
of an error to previously issued financial statements. ☐
Indicate by check mark whether any of those error
corrections are restatements that required a recovery analysis of incentive-based compensation received by any of the registrant’s
executive officers during the relevant recovery period pursuant to §240.10D-1(b). ☐
Indicate by check mark whether the registrant
has filed a report on and attestation to its management’s assessment of the effectiveness of its internal control over financial
reporting under Section 404(b) of the Sarbanes-Oxley Act (15 U.S.C. 7262(b)) by the registered public accounting firm that prepared or
issued its audit report. Yes ☐ No ☒
Indicate by check mark whether the registrant
is a shell company (as defined in Rule 12b-2 of the Act). Yes ☐
No ☒
The aggregate market value of the registrant’s
voting stock held by non-affiliates as of June 30, 2025, was approximately $2,570,000 based on the closing price of the common stock of
the registrant as reported on the Nasdaq Capital Market on such date. Shares of common stock held by each executive officer and director
and by each other person who may be deemed to be an affiliate of the registrant have been excluded from this computation. The determination
of affiliate status for this purpose is not necessarily a conclusive determination for other purposes. As of March 2, 2026, there were
972,215 shares of the registrant’s common stock, par value $0.0001 per share, outstanding.
DOCUMENTS INCORPORATED BY REFERENCE
The registrant intends to file a definitive proxy
statement relating to its Annual Meeting of Stockholders within 120 days of the fiscal year ended December 31, 2025. Portions of such
definitive proxy statement are incorporated by reference in Part III of the Form 10-K to the extent described therein.
TABLE OF CONTENTS
Page
CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS ii
SUMMARY OF RISK FACTORS iii
PART I 1
ITEM 1. BUSINESS 1
ITEM 1A. RISK FACTORS 9
ITEM 1B. UNRESOLVED STAFF COMMENTS 29
ITEM 1C. CYBERSECURITY 29
ITEM 2. PROPERTIES 30
ITEM 3. LEGAL PROCEEDINGS 30
ITEM 4. MINE SAFETY DISCLOSURES 30
ITEM 6. RESERVED 31
ITEM 7A. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK 36
ITEM 8. FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA 36
ITEM 9A. CONTROLS AND PROCEDURES 37
ITEM 9B. OTHER INFORMATION 37
ITEM 9C. DISCLOSURE REGARDING FOREIGN JURISDICTIONS THAT PREVENT INSPECTIONS 37
PART III 38
ITEM 10. DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE 38
ITEM 11. EXECUTIVE COMPENSATION 38
ITEM 14. PRINCIPAL ACCOUNTANT FEES AND SERVICES 38
ITEM 15. EXHIBITS AND FINANCIAL STATEMENT SCHEDULES 39
i
CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS
We make forward-looking statements in the “Business”,
“Management’s Discussion and Analysis of Financial Condition and Results of Operations” and other sections of this Annual
Report on Form 10-K (the “Form 10-K”). In some cases, you can identify these statements by forward-looking words such as “may,”
“might,” “should,” “would,” “could,” “expect,” “plan,” “anticipate,”
“intend,” “believe,” “estimate,” “predict,” “potential” or “continue,”
and the negative of these terms and other comparable terminology. These forward-looking statements, which are subject to known and unknown
risks, uncertainties and assumptions about us, may include projections of our future financial performance based on our growth strategies
and anticipated trends in our business. These statements are only predictions based on our current expectations and projections about
future events. There are important factors that could cause our actual results, level of activity, performance or achievements to differ
materially from the results, level of activity, performance or achievements expressed or implied by the forward-looking statements.
While we believe we have identified material risks,
these risks and uncertainties are not exhaustive. Other sections of this Form 10-K may describe additional factors that could adversely
impact our business and financial performance. Moreover, we operate in a very competitive and rapidly changing environment. New risks
and uncertainties emerge from time to time, and it is not possible to predict all risks and uncertainties, nor can we assess the impact
of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially
from those contained in any forward-looking statements.
Although we believe the expectations reflected
in the forward-looking statements are reasonable, we cannot guarantee future results, level of activity, performance or achievements.
Moreover, neither we nor any other person assumes responsibility for the accuracy or completeness of any of these forward-looking statements.
You should not rely upon forward-looking statements as predictions of future events. We are under no duty to update any of these forward-looking
statements after the date of this Form 10-K to conform our prior statements to actual results or revised expectations, and we do not intend
to do so.
We caution you not to place undue reliance on
the forward-looking statements, which speak only as of the date of this Form 10-K in the case of forward-looking statements contained
in this Form 10-K.
You should not rely upon forward-looking statements
as predictions of future events. Our actual results and financial condition may differ materially from those indicated in the forward-looking
statements. We qualify all of our forward-looking statements by these cautionary statements. Although we believe that the expectations
reflected in the forward looking-statements are reasonable, we cannot guarantee future results, levels of activity, performance or achievements.
Therefore, you should not rely on any of the forward-looking statements. In addition, with respect to all of our forward-looking statements,
we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of
1995.
SPECIAL NOTE REGARDING COMPANY REFERENCES
In this Form 10-K, and unless the context otherwise
requires, Bluejay Diagnostics, Inc. is referred to as the “Company,” “we,” “us” and “our”.
ii
SUMMARY OF RISK FACTORS
Our business is subject to a number of risks,
including risks that may prevent us from achieving our business objectives or may adversely affect our business, financial condition,
liquidity, results of operations and prospects. These risks are discussed more fully in Item 1A. Risk Factors. These risks include, but
are not limited to, the following:
iii
iv
PART I
ITEM 1. BUSINESS
Overview
Bluejay Diagnostics, Inc. (“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. We do not yet have regulatory clearance for Symphony, and we 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. 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.
Our 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. We are 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 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.
In the future, we also hope to explore new products
to support our biomarker detection program. Furthermore, we intend to explore strategic opportunities around our pending IP on clinical
utilities of IL-6 and the specimen biobanks generated from our SYMON I and SYMON II clinical studies.
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. As described above and elsewhere herein, we expect to need a material amount of additional funding to finance our operations
during the next several years and ultimately commercialize our products, and we do not currently expect to have any sources of revenue
during this period.
We were incorporated under the laws of Delaware
on March 20, 2015. Our headquarters is located in Acton, Massachusetts.
Our Market
The Symphony platform is designed to address a
subset of the global in vitro diagnostics devices (“IVDs”) market, with a focus on targeting critical care markets
where physicians must quickly determine patient acuity to identify optimal treatment regimens. We are currently focused on our initial
biomarker test, Symphony IL-6 test, in the context of the evaluation of the risk of mortality due to sepsis. We hope in the future to
also explore the potential for adding new biomarker tests to the Symphony platform to also be used in the context of cardio-metabolic
diseases, cancer and other diseases that require rapid tests.
1
Our Business Model
We do not currently have any revenue-generating
operations. Our goal is to become the first provider of rapid tests for critical care settings, including infectious, inflammatory and
metabolic diseases, by leveraging the strengths of our Symphony platform. We intend to target our sales and marketing of Symphony to the
largest critical care facilities in the United States. Our planned business model, which is contingent on us ultimately obtaining market
clearance and commercializing our Symphony platform, includes the following:
The Symphony Platform
The Symphony platform is a proprietary technology
platform that is designed to provide rapid and accurate measurements of key diagnostic biomarkers found in blood in a manner that we believe
is innovative in the market. Symphony is compact and is designed for the potential of it to be deployed in a manner that is more mobile
than current laboratory diagnostic platforms on the market. Symphony incorporates a user-friendly interface where all sample preparation
and reagents are integrated into the disposable Symphony cartridges. Symphony only requires a few drops of blood to provide a measurement
in approximately 20 minutes.
The Symphony analyzer is developed and is designed
to orchestrate sample processing (e.g. whole blood, plasma, serum, etc.), biomarker isolation, and immunoassay preparation using non-contact
centrifugal force. All necessary reagents and components are integrated into the Symphony cartridges. Utilizing precision microchannel
technology and high specificity antibodies, liquid samples are processed, and the biomarker is isolated within the Symphony cartridge.
Intermitted centrifugation cycles enable complex fluid movements, allowing sequential reagent additions and independent reaction steps
inside the Symphony cartridge. At the conclusion of the test, the Symphony analyzer measures the fluorescence signature correlating to
a highly sensitive quantitation of the biomarker.
To perform a Symphony test, the test operator
adds the sample (e.g. whole blood, plasma, serum, etc.) to the Symphony cartridge. After scanning the patient ID, the Symphony cartridge
is inserted into the Symphony analyzer and the operator initiates the fully automated test. Each analyzer can run up to six cartridges
simultaneously, either with six different patient samples or six different tests, providing quantitative measurements used for improved
patient management and clinical decision-making.
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.
2
Sanyoseiko had been selected as our CMO due to
their core competencies in manufacturing and quality system recognized by the FDA. Sanyoseiko’s facilities are located in Japan.
We currently license the technology for the Symphony cartridges from Toray. Our license grants us exclusive global marketing, sales and
manufacturing rights, with the exception of Japan. Bluejay holds the rights to manufacture the analyzers.
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. 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.
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. In May 2023, we
submitted a pre-submission application to the FDA presenting study designs to validate Symphony IL-6 for use with hospitalized sepsis
patients. 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). Based on this feedback, we determined to proceed on this basis, which considers the FDA’s feedback.
In the second quarter of 2024, we 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, we 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 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. Our goal is to use the
Symphony IL-6 test to complete the testing in the SYMON-II clinical trial. 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.
If we are able to complete the SYMON-II clinical
study and the results are positive, we intend 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.” 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.
Our ability to engage in and complete the activities
needed for an FDA submission will be contingent upon us addressing the various challenges described herein, 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.
Sales and Marketing
Until such time as Symphony products may be authorized
by the FDA, our sales and marketing efforts are intended to focus on brand awareness and market education to potential customers, emphasizing
the value of monitoring a critical care patient’s IL-6 levels to improve decision making and patient outcomes. If the device is
cleared by the FDA, we intend to target sales to ERs and ICUs at United States hospitals, as well as to long-term acute care facilities.
We hope to establish a market presence by selling Symphony devices and tests both directly and through various distribution channels to
maximize sales volume and market penetration. In addition to our hope to sell Symphony for eventual use in the patient care market, we
are also evaluating sales of Symphony devices for “research use only” purposes.
3
License Agreement
We depend on Toray’s intellectual property
to develop the Symphony cartridges upon which the Symphony platform relies. On October 6, 2020, we entered into a License and Supply Agreement,
as amended (the “License Agreement”), with Toray, providing us with an exclusive global license with Toray, excluding Japan,
to use their patents and know-how related to the Symphony detection cartridges for the manufacturing, marketing and sale of the products
(as defined in the License Agreement).
On October 23, 2023, we entered into an Amended
and Restated License Agreement (the “New Toray License Agreement”) and a Master Supply Agreement (the “New Toray Supply
Agreement”) with Toray. Under the New Toray License Agreement, we continue to license from Toray intellectual property rights needed
to manufacture single-use test cartridges, and we have received the right to sublicense certain Toray intellectual property to Sanyoseiko
in connection with our ongoing agreement with Sanyoseiko to manufacture our Symphony analyzers and cartridges (including in connection
with the Company’s clinical trials). In addition, the New Toray License Agreement provided for the transfer of certain technology
related to the cartridges to Sanyoseiko. The royalty payments we are required to pay Toray were reduced under the New Toray License Agreement
from 15% to 7.5% (or less in certain circumstances) of net sales of certain cartridges for a term of 10 years. A 50% reduction in the
royalty rate applies upon expiry of applicable Toray patents on a product-by-product and country-by-country basis. A 50% reduction in
the royalty rate applies upon expiry of applicable Toray patents on a product-by-product and country-by-country basis. The New Toray License
Agreement contemplates that applicable royalty payment obligations from us to Toray for other products will be determined separately in
the future.
On July 23, 2025, we entered into an amendment
(the “Amendment”) to the New Toray License Agreement and the New Toray Supply Agreement with Toray. The Amendment provided
that the deadline under the New Toray License Agreement for us to establish an alternative manufacturing site for our Symphony cartridges
would be extended from October 23, 2025 to October 23, 2026, and we have agreed to use our best efforts to establish the site by such
date. The Amendment confirms that Toray has provided to us all applicable know-how required under the New Toray License Agreement and
is not under any further obligation to provide know-how or technical assistance to us. Pursuant to the Amendment, we paid $71,212 to Toray
for a final supply of certain chip components prior to the expiration of the New Toray Supply Agreement, which occurred on October 23,
2025.
We have begun cartridge manufacturing process
through Sanyoseiko, a third-party contractor who is managing such process modifications. Such modifications are intended to address several
manufacturing challenges to bring Symphony to a level consistent with necessary performance and quality requirements for regulatory submission
and commercialization. After the cartridge manufacturing process modification is completed, we plan to have the manufacturing process
occur at Sanyoseiko, a FDA-registered CMO, including verification and validation testing and commercial manufacturing. The manufacturing
site will be established by us without Toray’s technical assistance. If Toray were to assert that we have not used our best efforts
to establish the cartridge manufacturing site by October 2026, they could seek to terminate the license agreement as early as November
2026. If Toray were to be successful in terminating the license agreement, we would lose access to certain technology required to produce
the cartridges that the Symphony system relies on to function, which would likely result in a material adverse effect on our commercialization
efforts.
Intellectual Property, Proprietary Technology
In the fourth quarter of 2024, the Company filed
a provisional patent application with the U.S. Patent and Trademark Office to establish a priority date related to certain utilizations
of interleukin-6 (IL-6) in sepsis patients. After further evaluation of the scope, patentability, and potential commercial relevance of
the subject matter, the Company determined that the provisional application was unlikely to result in patent protection that would be
material to its business. As a result, the Company has elected not to pursue conversion of the provisional application or to file a corresponding
Patent Cooperation Treaty (PCT) application. This decision reflects the Company’s disciplined approach to capital allocation and
its focus on deploying resources toward intellectual property and development activities that are expected to provide meaningful strategic
and commercial value.
We do not currently directly hold any granted
patents. We rely on a combination either directly or through the License Agreement with Toray of patent, copyright, trade secret, trademark,
confidentiality agreements, and contractual protection to establish and protect our proprietary rights. Of these patents we rely on, the
protections expire internationally in 2027 and 2028, while Toray patents in the U.S. expire on March 18, 2029 and February 22, 2030. As
described above, we are currently working toward a goal of being in position to submit a 510(k) regulatory application to the FDA in 2027
with an objective of achieving FDA clearance sometime thereafter, which means that even if meet our timeline, the period of time we will
have to commercialize our product under the protection of these patents is expected to be very narrow. See Part I, Item 1A. Risk Factors
– “We and Toray may be unable to protect or enforce the intellectual property rights licensed to us, which could impair
our competitive position.”
In connection with prior development work performed
by Bluejay, we plan to apply for patent protections related to certain design improvements made to the Symphony technology platform.
4
Competition
There are currently no FDA cleared or approved
IL-6 tests on the market. There are IL-6 tests granted under FDA Emergency Use Authorization (EUA) for use with only COVID-19 patients,
including the Roche Cobas®, Siemens ADVIA Centaur® and Beckman Coulter Access 2®, which are
central laboratory size equipment and require pre-processing of whole blood prior to performing their test. We believe that Symphony,
which is designed for many liquid sample types including whole blood, provides us with a substantial competitive advantage over the existing
competition that will sustain through commercialization, despite the major life science companies and consistent entry of innovative start-ups
that define our competitive landscape.
Government Regulation
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.
FDA Regulation
Medical Devices
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,
advertising and promotion, import and export, marketing and sales, and distribution of medical devices, including IVDs. IVDs are a type
of medical device and include reagents and instruments used in the diagnosis or detection of diseases, conditions or infections, including,
without limitation, the presence of certain chemicals or other biomarkers. Predictive, prognostic and screening tests can also be IVDs.
In the United States, medical devices are subject
to varying degrees of regulatory control and are classified in one of three classes depending on the extent of controls the FDA determines
are necessary to reasonably ensure their safety and effectiveness:
● Class III: special controls and requires a premarket approval (“PMA”).
FDA Premarket Clearance and Approval Requirements
Unless an exemption applies, each medical device
commercially distributed in the United States requires either FDA clearance of a 510(k) premarket notification, approval of a de novo
application, or approval of a premarket approval (PMA).
While most Class I devices are exempt from
the 510(k) premarket notification requirement, manufacturers of most Class II devices are required to submit to the FDA a premarket
notification under Section 510(k) of the FDCA requesting permission to commercially distribute the device. The FDA’s permission
to commercially distribute a device subject to a 510(k) premarket notification is generally known as 510(k) clearance. Devices deemed
by the FDA to pose the greatest risks, such as life sustaining, life supporting or some implantable devices, or devices that have a new
intended use, or use advanced technology that is not substantially equivalent to that of a legally marketed device, are placed in Class III,
requiring approval of a PMA. Some pre-amendment devices are unclassified, but are subject to FDA’s premarket notification and clearance
process in order to be commercially distributed. Our initial product is a Class II device subject to 510(k) clearance.
510(k) Clearance Marketing Pathway
To obtain 510(k) clearance, a company must submit
to the FDA a premarket notification submission demonstrating that the proposed device is “substantially equivalent” to a predicate
device already on the market. A predicate device is a legally marketed device that is not subject to PMA, i.e., a device that was legally
marketed prior to May 28, 1976 (pre-amendments device) and for which a PMA is not required, a device that has been reclassified from
Class III to Class II or I, or a device that was found substantially equivalent through the 510(k) process. The FDA’s
510(k) clearance process usually takes from three to twelve months, but often takes longer. The FDA may require additional information,
including clinical data, to make a determination regarding substantial equivalence. In addition, the FDA collects user fees for certain
medical device submissions and annual fees for medical device establishments.
After a device receives 510(k) marketing clearance,
any modification that could significantly affect its safety or effectiveness, or that would constitute a major change or modification
in its intended use, will require a new 510(k) clearance or, depending on the modification, PMA approval. The FDA requires each manufacturer
to determine whether the proposed change requires submission of a 510(k) or a PMA in the first instance, but the FDA can review any such
decision and disagree with a manufacturer’s determination. If the FDA disagrees with a manufacturer’s determination, the FDA
can require the manufacturer to cease marketing and/or request the recall of the modified device until 510(k) marketing clearance or PMA
approval is obtained. Also, in these circumstances, the manufacturer may be subject to significant regulatory fines or penalties.
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De Novo Classification
Devices of a new type that FDA has not previously
classified based on risk are automatically classified into Class III by operation of section 513(f)(1) of the FDCA, regardless of the
level of risk they pose. To avoid requiring PMA review of low- to moderate-risk devices classified in Class III by operation of law, Congress
enacted section 513(f)(2) of the FDCA. This provision allows FDA to classify a low- to moderate-risk device not previously classified
into Class I or II. After de novo authorization, an authorized device may be used as a predicate for future devices going through the
510(k) process.
The FDA has classified Symphony as de novo, a
device of a new type that the FDA has not previously classified. Once obtained, a de novo authorization may lead to Symphony’s use
as a predicate for future devices going through the 510(k) process.
Clinical Trials
Clinical trials are often required for a de novo
authorization. All clinical investigations of devices to determine safety and effectiveness must be conducted in accordance with the FDA’s
IDE regulations which govern investigational device labeling, prohibit promotion of the investigational device, and specify an array of
recordkeeping, reporting and monitoring responsibilities of study sponsors and study investigators. If the device presents a “significant
risk,” to human health, as defined by the FDA, the FDA requires the device sponsor to submit an IDE application to the FDA, which
must become effective prior to commencing human clinical trials. A significant risk device is one that presents a potential for serious
risk to the health, safety or welfare of a patient and either is implanted, used in supporting or sustaining human life, substantially
important in diagnosing, curing, mitigating or treating disease or otherwise preventing impairment of human health, or otherwise presents
a potential for serious risk to a subject. An IDE application must be supported by appropriate data, such as animal and laboratory test
results, showing that it is safe to test the device in humans and that the testing protocol is scientifically sound. The IDE will automatically
become effective 30 days after receipt by the FDA unless the FDA notifies the company that the investigation may not begin. If the FDA
determines that there are deficiencies or other concerns with an IDE for which it requires modification, the FDA may permit a clinical
trial to proceed under a conditional approval.
In addition, the study must be approved by, and
conducted under the oversight of, an Institutional Review Board (IRB) for each clinical site. The IRB is responsible for the initial and
continuing review of the IDE study and may pose additional requirements for the conduct of the study. If an IDE application is approved
by the FDA and one or more IRBs, human clinical trials may begin at a specific number of investigational sites with a specific number
of patients, as approved by the FDA. If the device presents a non-significant risk to the patient, a sponsor may begin the clinical trial
after obtaining approval for the trial by one or more IRBs without separate approval from the FDA, but must still follow abbreviated IDE
requirements, such as monitoring the investigation, ensuring that the investigators obtain informed consent, and labeling and record-keeping
requirements. Acceptance of an IDE application for review does not guarantee that the FDA will allow the IDE to become effective and,
if it does become effective, the FDA may or may not determine that the data derived from the trials support the safety and effectiveness
of the device or warrant the continuation of clinical trials. An IDE supplement must be submitted to, and approved by, the FDA before
a sponsor or investigator may make a change to the investigational plan that may affect its scientific soundness, study plan or the rights,
safety or welfare of human subjects.
During a study, the sponsor is required to comply
with the applicable FDA requirements, including, for example, trial monitoring, selecting clinical investigators and providing them with
the investigational plan, ensuring IRB review, adverse event reporting, record keeping and prohibitions on the promotion of investigational
devices or on making safety or effectiveness claims for them. The clinical investigators in the clinical study are also subject to FDA
regulations and must obtain patient informed consent, rigorously follow the investigational plan and study protocol, control the disposition
of the investigational device, and comply with all reporting and recordkeeping requirements. Additionally, after a trial begins, we, the
FDA or the IRB could suspend or terminate a clinical trial at any time for various reasons, including a belief that the risks to study
subjects outweigh the anticipated benefits.
Sponsors of applicable clinical trials of devices
also are required to register with www.clinicaltrials.gov, a public database of clinical trial information. Information related to
the device, patient population, phase of investigation, study sites and investigators and other aspects of the clinical trial is made
public as part of the registration. Although the FDA’s Quality System Regulation (QSR) does not fully apply to investigational devices,
the requirement for controls on design and development does apply.
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Post-market Regulation
After a device is cleared or approved for marketing,
numerous and pervasive regulatory requirements continue to apply. These include:
● establishment registration and device listing with the FDA;
● requirements related to promotional activities;
Once we have a commercialized product, our manufacturing
processes will be required to comply with the applicable portions of the QSR, which cover the methods and the facilities and controls
for the design, manufacture, testing, production, processes, controls, quality assurance, labeling, packaging, distribution, installation
and servicing of finished devices intended for human use. The QSR also requires, among other things, maintenance of a device master file,
device history file, and complaint files. As a manufacturer, we are subject to periodic scheduled or unscheduled inspections by the FDA.
Our failure to maintain compliance with the QSR requirements could result in the shut-down of, or restrictions on, our manufacturing operations
and the recall or seizure of our products, which would have a material adverse effect on our business. The discovery of previously unknown
problems with any of our products, including unanticipated adverse events or adverse events of increasing severity or frequency, whether
resulting from the use of the device within the scope of its clearance or off-label by a physician in the practice of medicine, could
result in restrictions on the device, including the removal of the product from the market or voluntary or mandatory device recalls.
The FDA has broad regulatory compliance and enforcement
powers. If the FDA determines that we failed to comply with applicable regulatory requirements, it can take a variety of compliance or
enforcement actions, which may result in any of the following sanctions:
● unanticipated expenditures to address or defend such actions;
● operating restrictions, partial suspension or total shutdown of production;
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● refusal to grant export approval for our products; or
● criminal prosecution.
Exploratory Artificial Intelligence Integration Initiative
The Company is pursuing an exploratory strategic initiative to evaluate
the potential integration of artificial intelligence (“AI”) capabilities into its SymphonyTM platform. This initiative
is intended to assess whether advanced analytics may enhance the clinical interpretation of biomarker data, including IL-6 measurements,
and support the development of models related to sepsis risk stratification and patient outcomes. This initiative remains in the evaluation
stage, and the Company has not entered into any definitive agreements related to AI integration. Any development activities are expected
to be conducted in a phased and disciplined manner, with attention to data integrity, clinical validation, regulatory considerations,
and capital allocation priorities. There can be no assurance that this exploratory initiative will result in a commercial product, regulatory
authorization, revenue generation, or strategic collaboration.
Employees
As of March 2, 2026, we have 6 full-time
employees, which includes one executive officer. We also contract with several consultants and contractors performing finance, accounting,
regulatory advisory, investor relations and manufacturing scale-up support. To conserve costs, our President and Chief Executive Officer
serves as our principal financial and accounting officer, in addition to being our principal executive officer. In addition, we do not
employ any internal legal personnel. None of our employees are represented by labor unions or covered by collective bargaining agreements.
Reverse Stock Splits and Increase to Authorized
Capital
On July 24, 2023, we effected the first reverse
stock split of our shares of common stock at a ratio of 1-for-20 (the “July 2023 Reverse Stock Split”). On June 20, 2024,
we effected a second reverse stock split of our shares of common stock at a ratio of 1-for-8 (the “June 2024 Reverse Stock Split”).
On November 18, 2024, we effected a third reverse stock split of our shares of common stock at a ratio of 1-for-50 (the “November
2024 Reverse Stock Split”). On January 29, 2026, we effected a fourth reverse stock split of our 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, the 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. Each
of the Reverse Stock Splits were undertaken because the trading price of our common stock had fallen below the $1.00 per share minimum
price that is required to maintain listing on Nasdaq, and the Company desired to maintain the common stock’s Nasdaq listing. The
Reverse Stock Splits became effective in the months noted above, when the Company’s common stock opened for trading on Nasdaq on
a post-split basis under the Company’s existing trading symbol, “BJDX.” All historical share and per share amounts reflected
throughout this Form 10-K have been adjusted to reflect the Reverse Stock Splits. However, our periodic and current reports, and all other
documents incorporated by reference into this Form 10-K that were filed prior to the dates noted above, do not give effect to the applicable
Reverse Stock Splits.
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.
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.
Available Information
Our principal executive offices are located at
360 Massachusetts Avenue, Suite 203, Acton, MA 01720 and our telephone number is (844) 327-7078. Our website address is www.bluejaydx.com.
Our Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and all amendments to those reports, proxy
statements and other information about us are made available, free of charge, through the Securities and Exchange Commission (“SEC”)
Filings section of our website at www.ir.bluejaydx.com/financial-information/sec-filings and at the SEC’s website at www.sec.gov
as soon as reasonably practicable after such material is electronically filed with or furnished to the SEC. We include our website address
in this report only as an inactive textual reference and do not intend it to be an active link to our website. The contents of our website
are not incorporated into this report.
In addition, our Board of Directors has adopted
a written Code of Business Conduct and Ethics applicable to all officers, directors and employees, which is available through the “Governance
Overview” section of our website at www.ir.bluejaydx.com/corporate-governance/governance-overview. We intend to satisfy the disclosure
requirement under Item 5.05 of Form 8-K regarding amendment to, or waiver from, a provision of the Code of Business Conduct and Ethics
and by posting such information on the website address and location specified above.
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ITEM 1A. RISK FACTORS
Investing in our securities carries a significant
degree of risk. You should carefully consider the risks described below, together with all of the other information in this Form 10-K,
including our consolidated financial statements and related notes included elsewhere in this Form 10-K, before deciding whether to invest
in our securities. If any or a combination of the following risks were to materialize, our results of operations, financial condition
and prospects could be materially adversely affected. If that were to be the case, the market price of our securities could decline, and
investors could lose all or part of their investment. The risks and uncertainties described below are not the only ones we face. Additional
risks and uncertainties not presently known to us or that we currently believe to be immaterial may also adversely affect our business.
Risks Related to Our Financial Condition and
Capital Requirements
We have incurred significant losses since
our inception, do not currently generate any operating income, and expect to continue incurring losses as we work to obtain product approval,
and thus we may never achieve or maintain profitability.
Since our inception, we have engaged primarily
in development activities, including planning and implementing clinical trials to support commercialization and FDA clearance of our Symphony
platform. We have funded our operations primarily through debt and equity financings, and have incurred losses since inception, including
a net loss of approximately $6.8 million and approximately $7.7 million for the years ended December 31, 2025 and 2024, respectively,
and from our inception through December 31, 2024, we had an accumulated deficit of approximately $41.5 million.
We currently have no product revenue and we may
not be able to commercialize our Symphony technology platform or achieve significant revenues or profitability. Our ability to generate
revenue and achieve profitability depends upon our ability, alone or with others, to complete the development process of our product candidates,
including regulatory clearances, and thereafter achieve substantial acceptance in the marketplace for our products. We may be unable to
achieve any or all of these goals.
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.
As of December 31, 2025, we possessed cash and
cash equivalents of approximately $5.2 million, while having current liabilities of approximately $1.1 million. Consistent with prior
years, we expect to incur a significant operating loss in 2026 and 2027 given that we do not currently generate any operating income.
To achieve our current strategic plan, which strives to be in position to submit a 510(k) regulatory application to the FDA in 2027 and
achieve FDA clearance thereafter, we expect to need to raise at least $20 million of further capital through the end of the 2027 fiscal
year, which we hope to do in various tranches. If we do not raise additional capital, we expect to run out of available cash resources
in the third quarter of 2026. There can be no assurance that such additional capital will be available on a timely basis or on terms that
will be acceptable to us. We currently do not have any contracts or commitments for additional financing. In addition, any additional
equity financing may involve substantial dilution to our existing stockholders, or provide that an equity or debt financing source obtains
rights to control the membership of our board of directors.
Our financial results and financial position,
and our expected forward-looking outlook of significant negative cash flow in the future, raise substantial doubt with respect to our
ability to continue as a going concern. We expect that we will not be in position to submit a 510(k) regulatory application to the FDA
for Symphony until 2027, at the earliest, if we are even able to generate sufficient clinical trial results to support such a submission.
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If we fail to obtain additional financing, we
likely will be forced to abandon operational activities entirely and file for bankruptcy protection, with the possible loss of properties
or assets (including the license to our core technology). Based on our explorations to date, we do not expect that any other strategic
alternatives, such as a potential sale of the Company or its assets or other restructuring efforts, will be available to us in the near-term.
As a result, any inability to obtain additional financing in the near-term, including a material amount of financing over the next 2 years,
would likely result in a material adverse effect on our business, results of operations, cash flow, financial condition and prospects
and cause our stockholders to receive little or no return on their shares of common stock.
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.
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%, including declines of greater than 80% per
year in each of 2025, 2024, 2023 and 2022. During such period of time, we have conducted several public offerings and private placements
of securities to raise additional capital, and in each case, the market price of our common stock has declined after the consummation
of such offerings. As described above, we expect to need to raise at least $20 million of funding over the next 2 years – an aggregate
amount several times the current market capitalization of our outstanding common stock, and we do not expect to be able to complete necessary
product re-development, troubleshooting and clinical trial work absent such material funding. This may cause new investors to demand terms
in future offerings that substantially dilute existing shareholders, such as the inclusion of warrants with Black Scholes protections
in the event of a sale transaction, which could cause our common stock to fall further from current levels on a per share basis.
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