UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
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TABLE OF CONTENTS
i
CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS
We make forward-looking statementsunder the “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and in other sectionsof this Quarterly Report on Form 10-Q (this “Form 10-Q”). In some cases, you can identify these statements by forward-lookingwords 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-lookingstatements, which are subject to known and unknown risks, uncertainties and assumptions about us, may include projections of our futurefinancial performance based on our growth strategies and anticipated trends in our business. These statements are only predictions basedon our current expectations and projections about future events. There are important factors that could cause our actual results, levelof activity, performance or achievements to differ materially from the results, level of activity, performance or achievements expressedor implied by the forward-looking statements.
While we believe we have identifiedmaterial risks, these risks and uncertainties are not exhaustive. Other sections of this Form 10-Q may describe additional factors thatcould 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 assessthe impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differmaterially from those contained in any forward-looking statements.
Although we believe the expectationsreflected 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-lookingstatements after the date of this Form 10-Q to conform our prior statements to actual results or revised expectations, and we do not intendto do so.
We caution you not to placeundue reliance on the forward-looking statements, which speak only as of the date of this Form 10-Q in the case of forward-looking statementscontained in this Form 10-Q.
You should not rely upon forward-lookingstatements as predictions of future events. Our actual results and financial condition may differ materially from those indicated in theforward-looking statements. We qualify all our forward-looking statements by these cautionary statements. Although we believe that theexpectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performanceor achievements. Therefore, you should not rely on any of the forward-looking statements. In addition, with respect to all our forward-lookingstatements, we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation ReformAct of 1995.
ii
EXPLANATORY NOTE
In this Form 10-Q, and unless the context otherwiserequires, the “Company,” “we,” “us,” and “our” refer to Bluejay Diagnostics, Inc. andits wholly owned subsidiary Bluejay SpinCo, LLC, taken as a whole.
iii
PART I - FINANCIAL INFORMATION
Item 1. Condensed Consolidated Financial Statements.
Bluejay Diagnostics, Inc.
Condensed Consolidated Balance Sheets
(Unaudited)
| June 30, 2025 | December 31, 2024 | |||||||
| ASSETS | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | $ | ||||||
| Prepaid expenses and other current assets | ||||||||
| Total current assets | ||||||||
| Property and equipment, net | ||||||||
| Operating lease right-of-use assets | ||||||||
| Other non-current assets | ||||||||
| Total assets | $ | $ | ||||||
| LIABILITIES AND STOCKHOLDERS’ EQUITY | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | $ | ||||||
| Operating lease liability, current | ||||||||
| Accrued expenses and other current liabilities | ||||||||
| Total current liabilities | ||||||||
| Operating lease liability, non-current | ||||||||
| Other non-current liabilities | ||||||||
| Total liabilities | ||||||||
| Commitments and Contingencies (See Note 10) | ||||||||
| Stockholders’ equity: | ||||||||
| Common stock, $ | ||||||||
| Additional paid-in capital | ||||||||
| Accumulated deficit | ( | ) | ( | ) | ||||
| Total stockholders’ equity | ||||||||
| Total liabilities and stockholders’ equity | $ | $ | ||||||
See accompanying notes to condensed consolidatedfinancial statements.
Reflects a 1-for-50 reverse stock split effectiveNovember 18, 2024 and 1-for-8 reverse stock split effective June 20, 2024.
1
Bluejay Diagnostics, Inc.
Condensed Consolidated Statements of Operations
(Unaudited)
Three Months Ended June 30, | Six Months Ended June 30, | |||||||||||||||
| 2025 | 2024 | 2025 | 2024 | |||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | $ | $ | $ | $ | ||||||||||||
| General and administrative | ||||||||||||||||
| Sales and marketing | ||||||||||||||||
| Total operating expenses | ||||||||||||||||
| Operating loss | ( | ) | ( | ) | ( | ) | ( | ) | ||||||||
| Other income (expense): | ||||||||||||||||
| Interest expense | ( | ) | ( | ) | ( | ) | ( | ) | ||||||||
| Interest income | ||||||||||||||||
| Other income, net | ( | ) | ||||||||||||||
| Total other income (expense), net | ( | ) | ( | ) | ||||||||||||
| Net loss | $ | ( | ) | $ | ( | ) | $ | ( | ) | $ | ( | ) | ||||
| Net Loss per share – Basic and diluted | $ | ( | ) | $ | ( | ) | $ | ( | ) | $ | ( | ) | ||||
| Weighted average common shares outstanding – Basic and diluted | ||||||||||||||||
See accompanying notes to condensed consolidatedfinancial statements.
Reflects a 1-for-50 reverse stock split effectiveNovember 18, 2024 and 1-for-8 reverse stock split effective June 20, 2024.
2
Bluejay Diagnostics, Inc.
Condensed Consolidated Statements of Changesin Stockholders’ Equity
(Unaudited)
| Stockholders’ Equity | ||||||||||||||||||||
| Common Stock | Additional Paid-In | Accumulated | Total Stockholders’ | |||||||||||||||||
| Shares | Amount | Capital | Deficit | Equity | ||||||||||||||||
| Balance at December 31, 2024 | $ | $ | $ | ( | ) | $ | ||||||||||||||
| Stock-based compensation expense | - | |||||||||||||||||||
| Net loss | - | ( | ) | ( | ) | |||||||||||||||
| Balance at March 31, 2025 | ( | ) | ||||||||||||||||||
| Stock-based compensation expense | - | ( | ) | ( | ) | |||||||||||||||
| Issuance of Common Stock for vested restricted stock units | ||||||||||||||||||||
| Issuance of Common Stock in connection with April 2025 Warrant Inducement, net of issuance costs of $ | ||||||||||||||||||||
| Warrant inducement cost | - | |||||||||||||||||||
| Net loss | - | ( | ) | ( | ) | |||||||||||||||
| Balance at June 30, 2025 | $ | $ | $ | ( | ) | $ | ||||||||||||||
| Stockholders’ Equity | ||||||||||||||||||||
| Common Stock | Additional Paid-In | Accumulated | Total Stockholders’ | |||||||||||||||||
| Shares | Amount | Capital | Deficit | Equity | ||||||||||||||||
| Balance at December 31, 2023 | $ | $ | $ | ( | ) | $ | ||||||||||||||
| Stock-based compensation expense | - | |||||||||||||||||||
| Issuance of common stock in connection with January 2024 Offering, net of issuance costs of $ | ||||||||||||||||||||
| Net loss | - | ( | ) | ( | ) | |||||||||||||||
| Balance at March 31, 2024 | ( | ) | ||||||||||||||||||
| Stock-based compensation expense | - | |||||||||||||||||||
| Issuance of common stock in connection with January 2024 Offering | ||||||||||||||||||||
| Issuance of Common Stock in connection with Bridge Note Financing | ||||||||||||||||||||
| Issuance of common stock in connection with June 2024 Offering, net of issuance costs of $ | ||||||||||||||||||||
| Net loss | - | ( | ) | ( | ) | |||||||||||||||
| Balance at June 30, 2024 | $ | $ | $ | ( | ) | $ | ||||||||||||||
See accompanying notes to condensed consolidatedfinancial statements.
Reflects a 1-for-50 reverse stock split effectiveNovember 18, 2024 and 1-for-8 reverse stock split effective June 20, 2024.
3
Bluejay Diagnostics, Inc.
Condensed Consolidated Statements of Cash Flows
(Unaudited)
| Six Months Ended June 30, | ||||||||
| 2025 | 2024 | |||||||
| CASH FLOWS FROM OPERATING ACTIVITIES: | ||||||||
| Net loss | $ | ( | ) | $ | ( | ) | ||
| Adjustments to reconcile net loss to net cash used in operating activities: | ||||||||
| Depreciation expense | ||||||||
| Stock-based compensation expense | ( | ) | ||||||
| Amortization of right-of-use asset | ||||||||
| Non-cash interest expense for notes payable | ||||||||
| Write-off of property and equipment | ||||||||
| Changes in operating assets and liabilities: | ||||||||
| Deferred offering costs | ||||||||
| Prepaid expenses and other current assets | ( | ) | ||||||
| Other non-current assets | ||||||||
| Accounts payable | ( | ) | ( | ) | ||||
| Accrued expenses and other current liabilities | ||||||||
| Net cash used in operating activities | ( | ) | ( | ) | ||||
| CASH FLOWS FROM INVESTING ACTIVITIES: | ||||||||
| Purchase of property and equipment | ( | ) | ||||||
| Net cash used in investing activities | ( | ) | ||||||
| CASH FLOWS FROM FINANCING ACTIVITIES: | ||||||||
| Proceeds from issuance of common stock and prefunded warrants | ||||||||
| Issuance costs related to issuance of common stock | ( | ) | ( | ) | ||||
| Proceeds from issuance of notes payable, net of discounts of $ | ||||||||
| Repayment of notes payable | ( | ) | ||||||
| Payment of finance lease | ( | ) | ( | ) | ||||
| Net cash provided by financing activities | ||||||||
| Increase in cash and cash equivalents | ||||||||
| Cash and cash equivalents, beginning of period | ||||||||
| Cash and cash equivalents, end of period | $ | $ | ||||||
| SUPPLEMENTAL DISCLOSURES OF CASH FLOW INFORMATION AND NON-CASH FINANCING ACTIVITIES | ||||||||
| Fair value of common stock issued in connection with notes payable | $ | $ | ||||||
See accompanying notes to condensed consolidatedfinancial statements.
4
Bluejay Diagnostics, Inc.
Notes to the Condensed Consolidated FinancialStatements
(Unaudited)
1. NATURE OF OPERATIONS AND BASIS OF PRESENTATION
Business
Bluejay Diagnostics, Inc. (“Bluejay” and/orthe “Company”) is a medical diagnostics company focused on improving patient outcomes in critical care settings. The Companyis working on developing rapid tests using whole blood on its Symphony technology platform (“Symphony”), which consists ofan analyzer and single-use protein detection cartridges that have a function of automatic stepwise feeding of reagent. The Company doesnot yet have regulatory clearance for Symphony, and it will need to receive regulatory authorization from the U.S. Food and Drug Administration(the “FDA”) to be marketed as a diagnostic product in the United States. The Company has completed the development of theSymphony analyzer. The Company is planning to begin cartridge redevelopment through a third-party contractor who would manage such redevelopment.Such redevelopment is intended to address several technical challenges to bring Symphony to a level consistent with necessary performanceand quality requirements. After redevelopment, the Company plans to have manufacturing of the Symphony cartridges occur at a ContractManufacturing Organization (“CMO”). To achieve its plan, the Company expects to need to raise at least $
The Company’s Symphony platform is a combinationof Bluejay’s intellectual property (“IP”) and exclusively licensed and patented IP on the Symphony technology that theCompany believes, 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 CareUnits (“ICUs”) and Emergency Rooms (“ERs”), where rapid and reliable results are required.
The Company’s first product candidate, theSymphony IL-6 test, is an immunoassay for the measurement of interleukin-6 (IL-6) to be used for the monitoring of disease progressionin critical care settings. The Company is currently focused on pursuing the Symphony IL-6 test in the context of sepsis. IL-6 is a clinicallyestablished inflammatory biomarker, and is considered a ‘first-responder,’ for assessment of severity of infection and inflammationacross many disease indications, including sepsis. A current challenge of healthcare professionals is the excessive time and cost associateddetermining a patient’s level of severity at triage and the Company believes that its Symphony IL-6 test, if ultimately successfuland approved, could have the ability to consistently monitor this critical care biomarker with rapid results.
If the Company succeeds with the foregoing plan,in the future it hopes to develop additional tests for Symphony, including tests for myocardial infarction and congestive heart failure(cardiac biomarkers hsTNT and NT pro-BNP) as well as other tests using the Symphony platform.
The Company was incorporated under the laws ofDelaware on March 20, 2015. Its headquarters are located in Acton, Massachusetts.
On June 4, 2021, the Company formed Bluejay Spinco,LLC, a wholly owned subsidiary of the Company, for purposes of further development of the Company’s ALLEREYE diagnostic test. ALLEREYEis a point-of-care device offering healthcare providers a solution for diagnosing Allergic Conjunctivitis. The Company currently is notactively pursuing development of the ALLEREYE diagnostic test.
5
FDA Regulatory Strategy
The Company’s current regulatory strategyis designed to support commercialization of Symphony in the United States pending marketing authorization from the FDA. In May 2023, theCompany submitted a pre-submission application to the FDA presenting study designs to validate Symphony IL-6 for use with hospitalizedsepsis patients. We participated in a pre-submission meeting with the FDA on August 11, 2023, and at the meeting the FDA provided feedbackon the new study design, determined that the submission of a 510(k) is the appropriate premarket submission pathway, and requested thatcertain data be provided in the 510(k). Based on this feedback, the Company determined to proceed on this basis, which considers the FDA’sfeedback.
In the second quarter of 2024, the Company completeda multicenter SYmphony IL-6 MONitoring Sepsis (“SYMON”) clinical study investigating the role of interleukin-6 (IL-6) in patientsdiagnosed with sepsis and septic shock. This prospective study assessed the performance of IL-6 upon initial presentation to the intensivecare unit (ICU). A primary analysis of the SYMON-I pilot clinical study (registered clinical trial number NCT06181604) highlighted thatIL-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 outcome of the SYMON-I study showed that IL-6 levels within 24 hours of sepsis or septic shock diagnosis andadmission to the ICU is a predictor of patient mortality during their hospitalization. Other secondary outcomes showed that lactate andSequential Organ Failure Assessment (SOFA), standard clinical tests used for sepsis and septic shock patients, were not predictors ofpatient mortality out to 28 days. We believe that the findings underscore the potential importance of IL-6 as a predictor and providenew insights into the potential pathways for improving sepsis outcomes. In the third quarter of 2024, we initiated the SYMON-II pivotalclinical study to validate the findings of the SYMON-I pilot clinical study.
Using the data analysis from the SYMON-I pilotclinical study, the Company initiated the SYMON-II pivotal clinical study in the third quarter of 2024. The SYMON II clinical study hasthree components: (1) collection, freezing, and biobanking of patient samples, (2) measuring IL-6 concentrations in the biobanked samplesnear the end of patient enrollment or after the patient enrollment has completed, and (3) analysis of the IL-6 data with the patient outcomesto see if the established IL-6 cutoff value has been validated for 28-day all-cause mortality. Patient enrollment started during the fourthquarter of 2024. The Company’s goal is to use the Symphony IL-6 test to complete the testing in the SYMON-II clinical trial.
If the Company is able to complete the SYMON-IIclinical study and the results are positive, the Company intends to use the data generated from SYMON-II to support a 510(k) applicationto the FDA. This application is currently expected to be based on the following intended use: “Symphony IL-6 is intended for useto determine the IL-6 concentration as an aid in assessing the cumulative 28-day risk of all-cause mortality in conjunction with otherlaboratory findings and clinical assessments for patients diagnosed with sepsis or septic shock in the ICU.” The Company also plansto present the SYMON-I and SYMON-II results at future national scientific meetings and publish them in peer-reviewed journals. Subjectto achieving needed funding and successfully addressing the technical challenges that are described above, the Company’s goal isto be in position to submit a 510(k) regulatory application to the FDA in 2027, with an objective of achieving FDA approval thereafter.
6
Product Manufacturing
The Company plans to manufacture its analyzers through Sanyoseiko Co.Ltd. (“Sanyoseiko”), as a contract manufacturing organizations (“CMO”), and the Company has a contract with Sanyoseikofor this purpose.
Once redeveloped, the Company also plans to manufacture its cartridgesthrough Sanyoseiko or another suitable CMO. The Company currently does not have a contract in place for the re-development or manufactureof the cartridges.
Sanyoseiko had been selected as the Company’s CMO for the analyzersdue to their core competencies in manufacturing and quality system recognized by the FDA. Sanyoseiko’s facilities are located inJapan. The Company currently licenses the technology for the Symphony cartridges from Toray Industries, Inc. (“Toray”). TheCompany’s license grants it exclusive global marketing rights, with the exception of Japan. Bluejay holds the rights to manufacturethe analyzers and the cartridges. The Company is evaluating the impact of tariffs on its operations.
Risks and Uncertainties
As noted above, Bluejay will be reliant upon CMOs to provide analyzersand, if and once redeveloped, cartridges, in sufficient quantity and quality to complete the validations for our FDA application. OurFDA application submission could be delayed if the Company encounters any material supply interruptions. In addition, there can be noassurance that we will be able to obtain necessary regulatory authorization for the manufacturing or marketing of the Symphony in theUnited States or elsewhere. There also can be no assurance that we will successfully complete any clinical evaluations necessary to receiveregulatory approvals, or that the clinical study will demonstrate sufficient safety and effectiveness of the Symphony IL-6 test. The failureto adequately demonstrate the clinical performance of the Symphony IL-6 test could delay or prevent regulatory approval, which could preventor result in delays to market launch and could materially harm our business.
In addition to the FDA regulatory strategy risks and uncertainties,the Company is subject to a number of risks similar to other companies in its industry, including rapid technological change, competitionfrom larger biotechnology companies and dependence on key personnel. The Company is also impacted by inflationary pressures and globalsupply chain disruptions currently impacting many companies. Additional risk and uncertainties regarding the Company are described in“Part I – Item 1A. Risk Factors” of the Company’s Annual Report on Form 10-K for the fiscal year ended December31, 2024 and in “Part II – Item 1A Risk Factors” of the Company’s subsequently filed Form 10-Qs.
7
Reverse Stock Splits and Increase to Authorized Capital
On July 21, 2023, the Company effected a reverse stock split of itsshares of common stock at a ratio of 1-for-20 (the “July 2023 Reverse Stock Split”). On June 20, 2024, the Company effecteda second reverse stock split of its shares of common stock at a ratio of
At our annual meeting of stockholders on June 18, 2025, our stockholdersprovided our Board of Directors with authority to implement a reverse stock split at a ratio of up to 1-for-20, as well as an additionalreverse stock split at a ratio of up to 1-for-20, and our Board of Directors is currently evaluating whether and when to implement anysuch reverse stock split.
On October 23, 2024, the stockholders of the Company approved and adoptedan amendment to the Company’s amended and restated certificate of incorporation, to increase the number of authorized shares ofthe Company’s Common Stock to
Basis of Presentation
The accompanying unaudited condensed consolidated financial statementsof the Company have been prepared in conformity with generally accepted accounting principles in the United States (“US GAAP”)consistent with those applied in, and should be read in conjunction with, the Company’s audited financial statements and relatedfootnotes for the year ended December 31, 2024 included in the Company’s Annual Report on Form 10-K. The unaudited condensed consolidatedfinancial statements reflect all adjustments, which include only normal recurring adjustments, necessary for the fair presentation ofthe Company’s financial position as of June 30, 2025, its results of operations and cash flows for the three and six months endedJune 30, 2025 and 2024, in accordance with US GAAP. The unaudited condensed consolidated financial statements do not include all of theinformation and footnotes required by US GAAP for complete financial statements, as allowed by the relevant U.S. Securities and ExchangeCommission (“SEC”) rules and regulations; however, the Company believes that its disclosures are adequate to ensure that theinformation presented is not misleading. The condensed consolidated financial statements include the accounts of the Company and its whollyowned subsidiary. All intercompany balances and transactions have been eliminated in consolidation.
The results for the three and six months ended June 30, 2025 are notnecessarily indicative of the results that may be expected for the fiscal year ending December 31, 2025, or any other interim period withinthis fiscal year.
8
Going Concern
The accompanying unaudited condensed consolidatedfinancial statements for the three and six months ended June 30, 2025 and 2024 were prepared under the assumption that the Company willcontinue as a going concern, which contemplates that the Company will be able to realize assets and discharge liabilities in the normalcourse of business.
The Company had cash and cash equivalents of $
These accompanying financial statements do notinclude any adjustments related to the recoverability and classification of recorded asset amounts or the amounts and classification ofliabilities that might result from the outcome of this uncertainty.
9
2. SIGNIFICANT ACCOUNTING POLICIES
During the six months ended June 30, 2025, therewere no changes to the significant accounting policies as described in the 2024 Audited Financial Statements. Certain 2024 financial statementbalances have been reclassified to correspond with current year presentation.
Use of Estimates
The preparation of financial statements in conformitywith US GAAP requires management to make estimates and assumptions that affect the amounts and disclosures reported in these condensedconsolidated financial statements and accompanying notes. Actual results could differ materially from those estimates. The Company believesjudgment is involved in accounting for the fair value-based measurement of stock-based compensation, accruals, and warrants. The Companyevaluates its estimates and assumptions as facts and circumstances dictate. As future events and their effects cannot be determined withprecision, actual results could differ from these estimates and assumptions, and those differences could be material to the condensedconsolidated financial statements.
Warrants
The Company accounts for warrants as either equity-classifiedor liability-classified instruments based on an assessment of the warrant’s specific terms and applicable authoritative guidancein the Financial Accounting Standards Board, or the FASB, ASC, 480, Distinguishing Liabilities from Equity, or ASC 480, and ASC 815, Derivativesand Hedging, or ASC 815. The assessment considers whether the warrants are freestanding financial instruments pursuant to ASC 480, meetthe definition of a liability pursuant to ASC 480, and whether the warrants meet all of the requirements for equity classification underASC 815, including whether the warrants are indexed to the Company’s own stock and whether the warrant holders could potentiallyrequire “net cash settlement” in a circumstance outside of the Company’s control, among other conditions for equityclassification. Finally, the Company determines if the warrants meet the definition of a derivative based on their contractual terms.This assessment, which requires the use of professional judgment, is conducted at the time of warrant issuance and as of each subsequentquarterly period end date while the warrants are outstanding.
For issued or modified warrants that meet allof the criteria for equity classification, the warrants are required to be recorded as a component of additional paid-in capital at thetime of issuance. For issued or modified warrants that do not meet all the criteria for equity classification, the warrants are requiredto be recorded at their initial fair value on the date of issuance, and at each balance sheet date thereafter. Changes in the estimatedfair value of liability-classified warrants are recognized as a non-cash gain or loss on the consolidated statements of operations. TheCompany also evaluates if changes in contractual terms or other considerations would result in the reclassification of outstanding warrantsfrom liabilities to stockholders’ equity (or vice versa).
Net Loss per Share
Basic net loss per share is computed by dividingthe net loss by the weighted-average number of shares of common stock outstanding for the period, without consideration for potentiallydilutive securities. Diluted net loss per share is computed by dividing the net loss by the weighted average number of shares of commonstock and dilutive common stock equivalents outstanding for the period determined using the treasury stock and if-converted methods. Dilutivecommon stock equivalents are comprised of convertible preferred stock, convertible notes, options outstanding under the Company’sstock option plan and warrants. For all periods presented, there is no difference in the number of shares used to calculate basic anddiluted shares outstanding as inclusion of the potentially dilutive securities would be antidilutive.
Potentially dilutive securities notincluded in the calculation of diluted net loss per share because to do so would be antidilutive are as follows (in common stock equivalentshares):
| June 30, | ||||||||
| Potentially Dilutive Securities Listing: | 2025 | 2024 | ||||||
| Options to purchase common stock | ||||||||
| Restricted stock units (RSUs) | ||||||||
| Warrants for common stock | ||||||||
| Class A warrants for common stock | ||||||||
| Class B warrants for common stock | ||||||||
| 5-Year warrants for common stock | ||||||||
| Prefunded warrants for common stock | ||||||||
| Class C warrants for common stock | ||||||||
| Class C pre-funded warrants for common stock | ||||||||
| Class D warrants for common stock | ||||||||
| Class E warrants for common stock | ||||||||
| Placement agent warrants | ||||||||
10
Recently Issued Accounting Standards
The Company does not believe that any recentlyissued but not yet effective accounting pronouncements will have a material effect on the accompanying unaudited condensed consolidatedfinancial statements.
3. LICENSE AND SUPPLY AGREEMENT WITH TORAYINDUSTRIES
The Company depends on Toray’s intellectualproperty for the Symphony cartridges upon which the Symphony platform relies. On October 6, 2020, the Company entered into a License andSupply Agreement (the “License Agreement”) with Toray, providing the Company with an exclusive global license with Toray,excluding Japan, to use Toray’s patents and know-how related to the Symphony detection cartridges for the manufacturing, marketingand sale of the products (as defined in the License Agreement). In exchange for the license, the Company committed to make two paymentsof $
On October 23, 2023, the Company and Toray enteredinto an Amended and Restated License Agreement (the “New Toray License Agreement”) and a Master Supply Agreement (the “NewToray Supply Agreement”). Under the New Toray License Agreement, the Company continues to license from Toray intellectual propertyrights needed to manufacture single-use test cartridges, and the Company has received the right to sublicense certain Toray intellectualproperty to Sanyoseiko in connection with Sanyoseiko’s ongoing agreement with the Company to manufacture the Company’s Symphonyanalyzers and cartridges (including in connection with the Company’s clinical trials). In addition, the New Toray License Agreementprovides for the transfer of certain technology related to the cartridges to Sanyoseiko. The royalty payment percentage payable by theCompany to Toray was reduced under the New Toray License Agreement from
On July 23, 2025, the Company entered into anamendment (the “Amendment”) to the New Toray License Agreement and the New Toray Supply Agreement with Toray. The Amendmentprovides that the deadline under the New Toray License Agreement for the Company to establish an alternative manufacturing site for theCompany’s Symphony cartridges will be extended from October 23, 2025 to October 23, 2026, and the Company has agreed to use itsbest efforts to establish the site by such date. The Amendment confirms that Toray has provided to the Company all applicable know-howrequired under the New Toray License Agreement and is not under any further obligation to provide know-how or technical assistance tothe Company. The Amendment also provides that the Company shall pay $
The Company is planning to begin cartridge redevelopmentthrough a third-party contractor who would manage such redevelopment, although a third-party contractor has not yet been contracted toperform the work. Such redevelopment is intended to address several technical challenges to bring Symphony to a level consistent withnecessary performance and quality requirements. After the cartridge redevelopment is completed, the Company plans to have the manufacturingprocess occur at an FDA-registered CMO, including for validation testing and commercial manufacturing. Under the Amendment, the Companywill use best efforts to have substantially completed the establishment of such cartridge redevelopment manufacturing site by October2026. The manufacturing sites, if any, will be established by Bluejay without Toray’s technical assistance. If Toray were to assertthat the Company has not done so, they could seek to terminate the license agreement as early as November 2026. If Toray were to be successfulin terminating the license agreement, the Company would lose access to certain technology required to produce the cartridges that theSymphony system relies on to function, which would likely result in a material adverse effect on the Company’s commercializationefforts. At June 30, 2025 and 2024, there were no amounts accrued related to the New Toray License Agreement or the License Agreement.
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4. FINANCINGS
April 2025 Private Placement
On April 7, 2025, the Company entered into inducementletter agreements (the “Inducement Letter Agreements”) with certain existing holders (the “Holders”) of the Company’sClass C warrants (the “Class C Warrants”), pursuant to which the Holders agreed to purchase an aggregate of
The transaction closed on April 8, 2025. The exerciseof the Class C Warrants resulted in the Company issuing
The gross proceeds to the Company from the exerciseof the Class C Warrants (or pre-funding of the future exercise thereof) and the sale of the new Class E Warrants were $
The modification of the terms or conditions ofthe warrants in this transaction is treated as an exchange of the original instrument for a new instrument. Using the Black Scholes optionpricing model, the fair value of the Series C warrants immediately prior to the inducement transaction was $
June 2024 Offering
On June 28, 2024, the Company sold in a publicoffering ( the “June 2024 Offering”), (i)
Pursuant to an engagement letter dated June 6,2024, by and between the Company and Aegis, the Company paid Aegis a total cash fee of $
The gross proceeds to the Company from the June2024 Offering were $
May 2024 Bridge Note Financing
On May 31, 2024, the Company entered into a NotePurchase Agreement with an accredited investor (the “NPA”), and a Securities Purchase Agreement with three accreditedinvestors (the “SPA”). This transaction closed on June 3, 2024. Debt issuance costs related to the NPA and SPA totaled $
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Under the terms of the SPA, the three investorsagreed to collectively provide the Company with a separate $
The interest expense recorded on the NPA and SPAswas $
January 2024 Offering
On January 2, 2024, the Company sold in a publicoffering (such transaction, the “January 2024 Offering”) (i)
As of December 31,2024, all Prefunded Warrants had been exercised in full. The January 2024 Warrants were exercisable immediately and remain exercisablefor a period of
Pursuant to an engagement letter, dated as ofAugust 7, 2023, as amended October 11, 2023 (the “Amended Engagement Letter”), by and between the Company and the PlacementAgent, the Company paid the Placement Agent a total cash fee of $
The gross proceeds to the Company from the January2024 Offering were $
5. WARRANTS
The following table summarizes informationwith regard to warrants outstanding at June 30, 2025:
| Shares | Exercisable for | Weighted Average Exercise Price | Weighted Average Remaining Life (in Years) | |||||||||||
| April 2025 Class E Warrants | $ | |||||||||||||
| April 2025 Pre-funded Class C Warrants | $ | |||||||||||||
| June 2024 Class C Warrants | $ | |||||||||||||
| January 2024 Common Stock Warrants | $ | |||||||||||||
| January 2024 Placement Agent Warrants | $ | |||||||||||||
| August 2023 Common Stock Warrants | $ | |||||||||||||
| August 2023 Placement Agent Warrants | $ | |||||||||||||
| Class A Warrants | $ | |||||||||||||
| Class B Warrants | $ | |||||||||||||
| Other Pre-2024 Common Stock Warrants | $ | |||||||||||||
April 2025 Private Placement Warrants
Pursuant to the April Private Placement, certainexisting holders of the Company’s Class C Warrants agreed to purchase an aggregate of
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June 2024 Common Stock Warrants and June2024 Underwriter Warrants
As a part of the June 2024 Offering, the Companyissued
Upon stockholderapproval of the issuance of Class C Warrants on August 21, 2024, the Class C Warrants, which had an initial exercise price of $
The Class D Warrants were immediately exercisableat an exercise price of $
During 2024, the Company issued
January 2024 Common Stock Warrants and January2024 Placement Agent Warrants
As part of the January 2024 Offering, the Companyissued
The Company’s warrants were accounted foras equity classified financial instruments as they meet the requirements for equity classification under ASC 815, Derivatives and Hedging.
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6. STOCK COMPENSATION
Stock Incentive Plans
In 2018, the Company adopted the 2018Stock Incentive Plan (the “2018 Plan”) for employees, consultants, and directors. The 2018 Plan, which is administered bythe Board of Directors, permits the Company to grant incentive and nonqualified stock options for the purchase of common stock, and restrictedstock awards. The maximum number of shares reserved for issuance under the 2018 Plan is
On July 6, 2021, the Company’s board ofdirectors and stockholders approved and adopted the Bluejay Diagnostics, Inc. 2021 Stock Plan (the “2021 Plan”). A total of
Stock Award Activity
The following table summarizes the status of theCompany’s non-vested restricted stock awards for the six months ended June 30, 2025:
| Non-vested Restricted Stock Awards | ||||||||
| Number of Shares | Weighted Average Grant Date Fair Value | |||||||
| Outstanding at December 31, 2024 | | $ | ||||||
| Granted | ||||||||
| Vested | ||||||||
| Forfeited | ||||||||
| Outstanding at June 30, 2025 | $ | |||||||
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The following is a summary of stock option activity for the six monthsended June 30, 2025:
| Number of Stock Options | Weighted Average Exercise Price Per Share | Weighted Average Remaining Contractual Life in Years | Aggregate Intrinsic Value | |||||||||||||
| Outstanding at December 31, 2024 | $ | $ | ||||||||||||||
| Granted | ||||||||||||||||
| Exercised | ||||||||||||||||
| Cancelled and forfeited | ||||||||||||||||
| Outstanding at June 30, 2025 | $ | $ | ||||||||||||||
| Exercisable at June 30, 2025 | $ | $ | ||||||||||||||
There were no stock options or restricted stock awards granted duringthe six months ended June 30, 2025.
Stock-Based Compensation Expense
For the three and six months endedJune 30, 2025, and 2024, the Company recorded stock-based compensation expense as follows:
| Three Months Ended June 30, | Six Months Ended June 30, | |||||||||||||||
| 2025 | 2024 | 2025 | 2024 | |||||||||||||
| Research and development | $ | ( | ) | $ | $ | ( | ) | $ | ||||||||
| General and administrative | ||||||||||||||||
| Total stock-based compensation | $ | ( | ) | $ | $ | ( | ) | $ | ||||||||
At June 30, 2025, there was approximately$
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7. RELATED PARTY TRANSACTIONS
NanoHybrids, LLC
In December 2021, the Company enteredinto an agreement with NanoHybrids, LLC (“NanoHybrids”), an entity in which the Company’s former Chief Technology Officer,Jason Cook, served as Chief Executive Officer of prior to joining Bluejay, to utilize the Company’s research and development staffand laboratory facility when available to perform work for NanoHybrids (the “Sharing and Services Agreement”). Any hours workedby Company employees for NanoHybrids are billed to NanoHybrids at a bill rate of the respective employee’s fully burdened personnelcost plus
| Three Months Ended June 30, | Six Months Ended June 30, | |||||||||||||||
| 2025 | 2024 | 2025 | 2024 | |||||||||||||
| Income from NanoHybrids included in other income | $ | $ | $ | $ | ||||||||||||
| Cash receipts from NanoHybrids | $ | $ | $ | $ | ||||||||||||
| As of | ||||||||
June 30, 2025 | December 31, 2024 | |||||||
| Amounts receivable from NanoHybrids included in Prepaid expenses and other current assets | $ | $ | ||||||
On May 8, 2025, the Company enteredinto a settlement and release agreement with Nanohybrids that terminated the respective parties’ obligations under the Sharing andServices Agreement, and memorialized that prior discussions between the parties regarding a potential sale of Nanohybrids to the Company(the “Strategic Transaction Discussions”) were terminated. Under the terms of such agreement, the Company agreed to make paymentof $
Each of the foregoing agreements wasapproved in advance by the Audit Committee of the Company’s Board of Directors.
8. PROPERTY AND EQUIPMENT
Property and equipment consisted ofthe following at June 30, 2025 and December 31, 2024:
| Depreciable lives | June 30, 2025 | December 31, 2024 | ||||||||
| Construction-in-process | $ | $ | ||||||||
| Furniture, fixtures, and equipment | ||||||||||
| Software | ||||||||||
| Lab equipment | ||||||||||
| Leasehold improvements | ||||||||||
| Less: accumulated depreciation | ( | ) | ( | ) | ||||||
| Property and equipment, net | $ | $ | ||||||||
Construction in process consists of symphony cartridgemanufacturing equipment. There are no commitments in place to complete construction in process as of June 30, 2025.
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9. LEASES
The Company has lease arrangements for office,laboratory space and copiers. A summary of supplemental lease information is as follows:
| Six Months Ended | ||||||||
| June 30, 2025 | June 30, 2024 | |||||||
| Weighted average remaining lease term – operating leases (in years) | ||||||||
| Weighted average remaining lease term – finance leases (in years) | ||||||||
| Weighted average discount rate – operating leases | % | % | ||||||
| Weighted average discount rate – finance leases | % | % | ||||||
| Operating cash flows from operating leases | $ | $ | ||||||
| Operating cash flows from finance leases | $ | $ | ||||||
A summary of the Company’s lease assets and liabilities are asfollows:
| June 30, 2025 | December 31, 2024 | |||||||
| Operating lease right-of-use asset | $ | $ | ||||||
| Finance lease asset – property & equipment, net | ||||||||
| Total lease assets | $ | $ | ||||||
| Current portion of operating lease liability | $ | $ | ||||||
| Current portion of finance lease liability included in accrued expenses | ||||||||
| Non-current portion of operating lease liabilities | ||||||||
| Non-current portion of finance lease liabilities included in other non-current liabilities | ||||||||
| Total lease liabilities | $ | $ | ||||||
A summary of the Company’s estimated operating lease paymentsare as follows:
| Year | ||||
| 2025 (1) | $ | |||
| 2026 | ||||
| 2027 | ||||
| Thereafter | ||||
| Total future lease payments | ||||
| Less: Imputed interest | ||||
| Present value of lease liability | $ | |||
| (1) |
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10. COMMITMENTS AND CONTINGENCIES
Separation Agreement
Under the terms of a separation agreementwith Mr. Jason Cook, the Company’s former Chief Technology Officer, the Company has agreed to compensate Mr. Cook $
The Company has paid Mr. Cook $
Minimum Royalties
As required under the License Agreement(see Note 3), following the first sale of Cartridges, the Company will make royalty payments to Toray equal to
Indemnification
The Company has certain agreementswith service providers with which it does business that contain indemnification provisions pursuant to which the Company typically agreesto indemnify the party against certain types of third-party claims. The Company accrues for known indemnification issues when a loss isprobable and can be reasonably estimated. The Company would also accrue for estimated incurred but unidentified indemnification issuesbased on historical activity. As the Company has not incurred any indemnification losses to date, there were no accruals for or expensesrelated to indemnification issues for any period presented.
11. SUPPLEMENTAL BALANCE SHEET INFORMATION
Prepaid expenses and other currentassets consist of the following:
| June 30, 2025 | December 31, 2024 | |||||||
| Prepaid insurance | $ | $ | ||||||
| Vendor prepayments | ||||||||
| Prepaid and other | ||||||||
| Total prepaid expenses and other current assets | $ | $ | ||||||
Accrued expenses and other currentliabilities consist of the following:
| June 30, 2025 | December 31, 2024 | |||||||
| Accrued personnel costs | $ | $ | ||||||
| Accrued legal fees | ||||||||
| Accrued clinical trial expenses | ||||||||
| Accrued board of director fees | ||||||||
| Accrued expenses for CTO separation agreement | ||||||||
| Accrued other | ||||||||
| Accrued Delaware franchise tax | ||||||||
| Total accrued expenses and other current liabilities | $ | $ | ||||||
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ITEM 2. MANAGEMENT’S DISCUSSION AND ANALYSISOF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
You should read the following discussion andanalysis of our financial condition and results of operations in conjunction with the unaudited condensed consolidated financial statementsand the related notes appearing elsewhere in this Form 10-Q. This discussion contains forward-looking statements reflecting our currentexpectations that involve risks and uncertainties. Actual results and the timing of events could differ materially from those discussedin our forward-looking statements as a result of many factors, including those set forth under “Risk Factors” and elsewherein this Form 10-Q.
Overview
Bluejay Diagnostics, Inc. (“Bluejay,”the “Company,” “we” and/or “us”)) is a medical diagnostics company focused on improving patient outcomesin critical care settings. The Company is working on developing rapid tests using whole blood on its Symphony technology platform (“Symphony”),which consists of an analyzer and single-use protein detection cartridges that have a function of automatic stepwise feeding of reagent.The Company does not yet have regulatory clearance for Symphony, and it will need to receive regulatory authorization from the U.S. Foodand Drug Administration (the “FDA”) to be marketed as a diagnostic product in the United States. The Company has completedthe development of the Symphony analyzer. The Company is planning to begin cartridge redevelopment through a third-party contractor whowould manage such redevelopment. Such redevelopment is intended to address several technical challenges to bring Symphony to a level consistentwith necessary performance and quality requirements. After redevelopment, the Company plans to have manufacturing of the Symphony cartridgesoccur at a Contract Manufacturing Organization (“CMO”). To achieve its plan, the Company expects to need to raise at least$30 million of capital between the third quarter of 2025 and the end of the 2027 fiscal year, which the Company hopes to do in varioustranches during this time period. The Company’s current plan, subject to achieving necessary financing, is to begin testing of samplesit is collecting as part of its ongoing 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, with an objective of achieving FDA approval thereafter.
The Company’s Symphony platform is a combinationof Bluejay’s intellectual property (“IP”) and exclusively licensed and patented IP on the Symphony technology that theCompany believes, 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 CareUnits (“ICUs”) and Emergency Rooms (“ERs”), where rapid and reliable results are required.
The Company’s first product candidate, theSymphony IL-6 test, is an immunoassay for the measurement of interleukin-6 (IL-6) to be used for the monitoring of disease progressionin critical care settings. The Company is currently focused on pursuing the Symphony IL-6 test in the context of sepsis. IL-6 is a clinicallyestablished inflammatory biomarker, and is considered a ‘first-responder,’ for assessment of severity of infection and inflammationacross many disease indications, including sepsis. A current challenge of healthcare professionals is the excessive time and cost associateddetermining a patient’s level of severity at triage and the Company believes that its Symphony IL-6 test, if ultimately successfuland approved, could have the ability to consistently monitor this critical care biomarker with rapid results.
If the Company succeeds with the foregoing plan,in the future it hopes to develop additional tests for Symphony, including tests for myocardial infarction and congestive heart failure(cardiac biomarkers hsTNT and NT pro-BNP) as well as other tests using the Symphony platform.
Since inception, we have incurred net losses fromoperations each year and we expect to continue to incur losses for the foreseeable future. We incurred net losses of approximately $2.0million and $3.8 million for the three and six months ended June 30, 2025, respectively. We had negative cash flow from operating activitiesof approximately $3.2 million and $4.2 million for the six months ended June 30, 2025 and 2024, respectively, and had an accumulated deficitof approximately $38.5 million as of June 30, 2025.
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As further described below under “Liquidityand Going Concern Uncertainty” as of June 30, 2025, the Company possessed cash and cash equivalents of approximately $4.4 million,while having current liabilities of approximately $1.0 million. The Company will need to raise a material amount of additional capitalin the imminent near-term to continue as a going concern, and that absent such near-term funding, it will likely run out of availablecash resources in the near-term. If we are unable to obtain financing in the near-term, or otherwise consummate strategic alternatives,we could determine to undertake a process of liquidation under U.S. bankruptcy laws.
Results of Operations
Comparison of the Three and Six Months EndedJune 30, 2025 and 2024
The following table sets forth our results ofoperations for the three and six months ended June 30, 2025 and 2024:
| Three Months Ended June 30 | Six Months Ended June 30 | |||||||||||||||
| 2025 | 2024 | 2025 | 2024 | |||||||||||||
| Operating expenses | ||||||||||||||||
| Research and development | $ | 889,896 | $ | 1,032,474 | $ | 1,674,696 | $ | 2,366,019 | ||||||||
| General and administrative | 1,095,465 | 862,482 | 2,199,582 | 1,950,618 | ||||||||||||
| Sales and marketing | - | 305 | - | 6,728 | ||||||||||||
| Total operating expenses | 1,985,361 | 1,895,261 | 3,874,278 | 4,323,365 | ||||||||||||
| Operating loss | (1,985,361 | ) | (1,895,261 | ) | (3,874,278 | ) | (4,323,365 | ) | ||||||||
| Other income (expense): | ||||||||||||||||
| Interest expense | (222 | ) | (626,471 | ) | (452 | ) | (631,689 | ) | ||||||||
| Interest income | 29,254 | 15,408 | 47,055 | 45,499 | ||||||||||||
| Other income, net | (275 | ) | 30,944 | 6,636 | 105,710 | |||||||||||
| Total other income (expense), net | 28,757 | (580,119 | ) | 53,239 | (480,480 | ) | ||||||||||
| Net loss | $ | (1,956,604 | ) | $ | (2,475,380 | ) | $ | (3,821,039 | ) | $ | (4,803,845 | ) | ||||
Research and Development
Research and development expenses for the threemonths ended June 30, 2025 were approximately $0.9 million as compared to approximately $1.0 million for the same period in 2024. Thedecrease in research and development expenses was primarily due to a reduction in technology transfer efforts which offset increased clinicaltrial expenses. We expect future research and development expenses to be focused on costs specifically associated with our clinical trialprogram supporting our regulatory strategy, technology transfer efforts and any necessary manufacturing improvements.
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General and Administrative
General and administrative expenses for the threemonths ended June 30, 2025, were approximately $1.1 million as compared to approximately $0.9 million for the comparable period in 2024.The increase in general and administrative expenses is due to continued efforts to raise capital and ongoing public company reportingrequirements. We expect to monitor and continue to pare our general and administrative spend, as necessary, to optimize operational alignment.
Sales and Marketing
Sales and marketing expenses for the three monthsended June 30, 2025 were zero, compared to approximately $305 for the comparable period in 2024. The decrease in sales and marketing expenseswas due to a cessation in spending for all sales and marketing efforts.
Other Income (Expense), net
Total other income (expense), net for the threemonths ended June 30, 2025, was approximately $29,000 of income as compared to $580,000 of expense for the same periods in 2024. The increasein other income (expense), net was primarily due to higher interest expense ($626,000) associated with our notes payable under the BridgeNote Financing.
Summary Statement of Cash Flows
The following table sets forth the primary sourcesand uses of cash and cash equivalents for each of the periods presented.
| Six Months Ended June 30, | ||||||||
| 2025 | 2024 | |||||||
| Cash proceeds (used in) provided by: | ||||||||
| Operating activities | $ | (3,238,912 | ) | $ | (4,214,891 | ) | ||
| Investing activities | - | (305,431 | ) | |||||
| Financing activities | 3,380,043 | 10,370,221 | ||||||
| Net increase in cash and cash equivalents | $ | 141,131 | $ | 5,849,899 | ||||
Net cash used in operating activities
During the six months ended June 30, 2025, weused approximately $3.2 million in cash for operating activities, a decrease of approximately $1.0 million as compared to the same periodin 2024. The decrease is primarily driven by a lower net loss when comparing the two periods.
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Net cash used in investing activities
During the six months ended June 30, 2025, weused no cash for investing activities, a decrease of approximately $305,000 as compared to the same period in 2024. The decrease in netcash used in investing activities was due to no purchasing of manufacturing equipment.
Net cash used in financing activities
During the six months ended June 30, 2025, weraised approximately $3.4 million in cash through financing activities, a decrease of approximately $7.0 million as compared to the sameperiod in 2024. The decrease in net cash generated by financing activities was due our private placement on April 8, 2025 as comparedto our public offering on January 2, 2024, a Bridge Note Financing in June 2024 and our public offering on June 28, 2024.
Liquidity and Going Concern Uncertainty
The Company had cash and cash equivalents of $4,443,076and current liabilities of $1,041,063 on its balance sheet as of June 30, 2025. The Company has incurred net losses since its inception,and has negative cash flows from operations and had an accumulated deficit of $38,489,823 as of June 30, 2025. The Company expects thatits net cash used in operating activities will continue to be negative over at least the next several years as it redevelops aspects ofthe Symphony cartridges and conducts clinical trial work and, if such redevelopment and trials are successful, begin preparation of anFDA submission. These financial results and financial position, and the Company’s expected forward-looking outwork of significantnegative cash flow in the future, raise substantial doubt with respect to its ability to continue as a going concern. As a result of theCompany’s lack of cash, it has slowed the timeline of its clinical trial work to preserve cash resources in the near-term, and theCompany expects that this will delay its Symphony platform regulatory submission timeline until 2027, at the earliest, if it is even ableto generate sufficient clinical trial results to support such a submission. If the Company fails to obtain additional material financingin the near-term, its clinical trials and targeted FDA submission timeline could be delayed further, and it could be forced to abandonsuch activities entirely and cease operations, with the possible loss of such properties or assets. If the Company is unable to obtainadditional financing as it continues to generate negative cash flow, its board of directors could determine to cause the Company to undertakea process of liquidation under Chapter 7 of applicable U.S. bankruptcy laws, or otherwise seek other protection under such laws. In suchevent, the Company expects that holders of shares of its common stock would recoup little if any material value in such process. The Companycurrently estimates that the cash resources it possesses as of the date of this filing will be sufficient to fund its operations up tothe fourth quarter of 2025.
The condensed consolidated financial statementsfor the three and six months ended June 30, 2025 and 2024 were prepared under the assumption that the Company will continue as a goingconcern, which contemplates that the Company will be able to realize assets and discharge liabilities in the normal course of business.
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Recent Offerings
January 2024 Offering
On January 2, 2024, the Company sold in a publicoffering (such transaction, the “January 2024 Offering”) (i) 1,344 shares of the Company’s common stock, par value $0.0001per share and (ii) prefunded warrants to purchase up to an aggregate 5,386 shares of Common Stock (the “January Prefunded Warrants”).The Shares and January Prefunded Warrants were sold together with warrants to purchase up to an aggregate of 6,730 shares of Common Stockat an exercise price of $520.00 per share (the “January 2024 Warrants”). The combined public offering price was $520.00 pershare of Common Stock and related January 2024 Warrant and $519.96 per January Prefunded Warrant and related January 2024 Warrant.
As of December 31, 2024, all January PrefundedWarrants had been exercised in full. The January 2024 Warrants are exercisable for a period of five years following the date of issuance.
Pursuant to an engagement letter, dated as ofAugust 7, 2023, as amended October 11, 2023, by and between the Company and the Placement Agent, the Company paid the Placement Agenta total cash fee of $245,000 equal to 7.0% of the gross proceeds received in the January 2024 Offering. The Company also paid the PlacementAgent in connection with the January Offering a management fee of $35,000 equal to 1.0% of the gross proceeds raised in the January 2024Offering and certain expenses incurred in connection with the January Offering. In addition, the Company issued to the Placement Agent,warrants to purchase up to an aggregate 471 shares of Common Stock (the “January 2024 Placement Agent Warrants”), which represents7.0% of the aggregate number of shares of Common Stock and Prefunded Warrants sold in the January 2024 Offering. The January 2024 PlacementAgent Warrants have substantially the same terms as the January 2024 Warrants, except that the January 2024 Placement Agent Warrants havean exercise price equal to $650.00, or 125% of the offering price per share of Common Stock and related January 2024 Warrant sold in theJanuary Offering and expire on the fifth anniversary from the date of the commencement of sales in the January 2024 Offering.
The gross proceeds to the Company from the January2024 Offering were $3,500,000. The Company incurred offering costs of $711,031.
May 2024 Bridge Note Financing
On May 31, 2024, the Company entered into a NotePurchase Agreement with an accredited investor (the “NPA”), and a Securities Purchase Agreement with three accredited investors(the “SPA”). This transaction closed on June 3, 2024. Debt issuance costs related to the NPA and SPA totaled $212,654. Underthe terms of the NPA, the investor provided the Company with a $1,000,000 cash subscription in exchange for the issuance of a senior securednote. As of December 31, 2024, a total of $1,176,470 was repaid to the NPA investors. The difference between such note and the subscriptionamount, initially recorded as a discount on the notes, was the result of the discount factor included in the NPA of approximately 17.6%.
Under the terms of the SPA, the three investorsagreed to collectively provide the Company with a separate $1,000,000 cash subscription in exchange for the issuance of senior securednotes ($333,333 each), and the collective issuance of 1,451 shares of the Company’s common stock. The fair value of the common stockissued in connection with the SPA was $307,563. As of December 31, 2024, a total of $1,111,110 was repaid to the SPA investors. The differencebetween such notes and the subscription amounts, initially recorded as a discount on the notes, was the result of the discount factorincluded in the SPA of 11.11%.
Interest expense recorded on the NPA and SPAswas $807,797 for the year ended December 31, 2024, including debt issuance costs related to the NPA and SPA totaling $212,654.
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June 2024 Offering
On June 28, 2024, the Company sold in a publicoffering ( the “June 2024 Offering”), (i) 11,541 common units (the “Common Units”), each consisting of one shareof common stock, two Class C Warrants and one Class D Warrant and (ii) 95,815 prefunded warrants (the “Prefunded Units”),each consisting of one prefunded warrant to purchase one share of common stock (each, a “Prefunded Warrant”), two Class CWarrants and one Class D Warrant to purchase Common Shares. Aegis Capital Corp. (“Aegis” or, the “Underwriter”)partially exercised its over-allotment option in respect to 13,573 Class C Warrants and 6,787 Class D Warrants (the “Over-AllotmentWarrants”). The Common Units were sold at a price of $81.50 per unit and the Prefunded Warrants were sold at a price of $81.495per unit. As of December 31, 2024, all Prefunded Warrants had been exercised in full.
Pursuant to an engagement letter dated June 6,2024, by and between the Company and Aegis, the Company paid Aegis a total cash fee of $743,750 equal to 8.5% of the gross proceeds receivedin the June 2024 Offering.
The gross proceeds to the Company from the June2024 Offering were $8,569,075. The Company incurred offering costs of $1,133,419.
April 2025 Private Placement
On April 7, 2025, the Company entered into inducementletter agreements (the “Inducement Letter Agreements”) with certain existing holders (the “Holders”) of the Company’sClass C Warrants, pursuant to which the Holders agreed to purchase an aggregate of 1,085,106 shares of the Company’s common stock.The Class C Warrants were originally issued to the Holders on June 28, 2024 for an exercise price of $98.00 per share and were subsequentlyreduced to $16.30 per share pursuant to stockholder approval on August 21, 2024. Pursuant to the Inducement Letter Agreements, the Holdersagreed to exercise their Series C warrants at a reduced exercise price of $3.42 per share, and to purchase an equivalent number of newClass E Warrants for an additional $0.125 per share. The Class E Warrants have an exercise price of $3.42 per share and expire on April8, 2030.
The transaction closed on April 8, 2025. The exerciseof the Class C Warrants resulted in the Company issuing 682,203 shares of Common Stock at closing and pre-funding of 402,903 shares ofCommon Stock.
The gross proceeds to the Company from the exerciseof the Class C Warrants and the sale of the new Class E Warrants were $3,846,692 million. The Company incurred total offering costs of$464,670, including a 10% financial advisory fee to Aegis Capital Corp. of $384,670.
The modification of the terms or conditions ofthe warrants in this transaction is treated as an exchange of the original instrument for a new instrument. Using the Black Scholes optionpricing model, the fair value of the Series C warrants immediately prior to the inducement transaction was $479,299 and immediately afterthe inducement transaction was $1,590,930. In addition, Series E warrants with a fair value of $1,730,652 were provided as part of theinducement transaction for a purchase price of $135,638. The Company recorded additional equity issuance costs of $2,706,645 related tothe modification of the Series C warrants and issuance of Series E warrants related to the inducement transaction. As this equity issuancecost was a non-cash transaction, the Company recorded an increase to additional paid-in capital to offset the expense.
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Recently Adopted Accounting Standards
See Note 2 to our condensed consolidated financialstatements (under the caption “Recently Adopted Accounting Standards”).
Emerging Growth Company and Smaller Reporting Company Status
We are an emerging growth company, as definedin the Jumpstart Our Business Startups Act (the “JOBS Act”). Under the JOBS Act, emerging growth companies can delay adoptingnew or revised accounting standards issued subsequent to the enactment of the JOBS Act until such time as those standards apply to privatecompanies. We elected to use this extended transition period for complying with new or revised accounting standards that have differenteffective dates for public and private companies until the earlier of the date that we (i) are no longer an emerging growth company or(ii) affirmatively and irrevocably opt out of the extended transition period provided in the JOBS Act. As a result, these condensed consolidatedfinancial statements may not be comparable to companies that comply with the new or revised accounting pronouncements as of public companyeffective dates. We are using the extended transition period for any other new or revised accounting standards during the period in whichwe remain an emerging growth company.
We will remain an emerging growth company untilthe earliest of (i) the last day of our first fiscal year (a) following the fifth anniversary of the completion of IPO (November2021), (b) in which we have total annual gross revenues of at least $1.07 billion or (c) in which we are deemed to be a large acceleratedfiler, which means the market value of our common stock that is held by non-affiliates exceeds $700 million as of the priorJune 30th and (ii) the date on which we have issued more than $1 billion in non-convertible debt securitiesduring the prior three-year period.
We are also a “smaller reporting company,”meaning that the market value of our stock held by non-affiliates is less than $700 million and our annual revenue is less than $100 millionduring the most recently completed fiscal year. We may continue to be a smaller reporting company if either (i) the market value of ourstock held by non-affiliates is less than $250 million or (ii) our annual revenue is less than $100 million during themost recently completed fiscal year and the market value of our stock held by non-affiliates is less than $700 million. If weare a smaller reporting company at the time we cease to be an emerging growth company, we may continue to rely on exemptions from certaindisclosure requirements that are available to smaller reporting companies. Specifically, as a smaller reporting company we may chooseto present only the two most recent fiscal years of audited financial statements in our Annual Reports on Form 10-K and, similarto emerging growth companies, smaller reporting companies have reduced disclosure obligations regarding executive compensation.
JOBS Act Accounting Election
The JOBS Act provides that an “emerginggrowth company” can take advantage of the extended transition period provided in Section 7(a)(2)(B) of the Securities Act of 1933,as amended, for complying with new or revised accounting standards. In other words, an “emerging growth company” can delaythe adoption of certain accounting standards until those standards would otherwise apply to private companies. We have irrevocably electednot to avail ourselves of this extended transition period and, as a result, we will adopt new or revised accounting standards on the relevantdates on which adoption of such standards is required for other public companies.
We have implemented all new accounting pronouncementsthat are in effect and may impact our financial statements and we do not believe that there are any other new accounting pronouncementsthat have been issued that might have a material impact on our financial position or results of operations.
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Item 3. Quantitative and Qualitative Disclosures About Market Risk
We are a smaller reporting company as definedby Rule 12b-2 of the Securities Exchange Act of 1934, as Amended (the “Exchange Act”) and are not required to provide theinformation required under this item.
Item 4. Controls and Procedures
(a) Evaluation of Disclosure Controls andProcedures
We conducted an evaluation under the supervisionand with the participation of our President and Chief Executive Officer (who serves as our principal executive officer and principal financialand accounting officer), regarding the effectiveness of our disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e)under the Exchange Act) as of the end of the period covered by this report. Based on this evaluation, our President and Chief ExecutiveOfficer concluded that our disclosure controls and procedures were effective as of June 30, 2025. We continue to review our disclosurecontrols and procedures and may from time to time make changes aimed at enhancing their effectiveness and ensuring that our systems evolvewith our Company’s business. A control system, no matter how well conceived and operated, can provide only reasonable, not absolute,assurance that the objectives of the control system are met.
Remediation of Previously Reported MaterialWeakness
As previously disclosed in the Company’sAnnual Report on Form 10-K for the year ended December 31, 2024, management identified a material weakness in the Company’s internalcontrol over financial reporting related to a lack of sufficient internal accounting expertise at the Company regarding the accountingfor complex equity transactions. Specifically, in June 2024, the Company issued Class C and Class D warrants that contained “reset”features that caused the exercise prices to decrease and number of shares of Company common stock issuable upon exercise of such warrantsto increase following stockholder approval of such reset in August 2024. Under applicable accounting guidance, upon reset, the Companyshould have recorded in its consolidated statement of operations a “deemed dividend on warrant modification” and “netloss applicable to common stockholders”.
During the quarter ended June 30, 2025, managementcompleted the implementation of its remediation plan, which included designing and implementing new controls over equity transaction reviewand approval, including the accounting for complex financial instruments upon their issuance, which included the engaging of externalconsultants to assist in technical accounting matters.
Management tested the newly implemented controlsand concluded that they were operating effectively as of June 30, 2025. As a result, management has concluded that the previously identifiedmaterial weakness has been remediated.
(b) Changes in Internal Control Over FinancialReporting
Other than the remediation activities describedabove, there was no change in our internal control over financial reporting (as defined in Rules 13a-15(f) and 15d-15(f) under the ExchangeAct) that occurred during the quarter ended June 30, 2025 that has materially affected, or is reasonably likely to materially affect,our internal control over financial reporting.
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PART II - OTHER INFORMATION
Item 1. Legal Proceedings
From time to time in the ordinary course of ourbusiness, we may be involved in legal proceedings, the outcomes of which may not be determinable. The results of litigation are inherentlyunpredictable. Any claims against us, whether meritorious or not, could be time consuming, result in costly litigation, require significantamounts of management time and result in diversion of significant resources. We are not able to estimate an aggregate amount or rangeof reasonably possible losses for those legal matters for which losses are not probable and estimable. We have insurance policies coveringpotential losses where such coverage is cost effective.
We are not at this time involved in any materiallegal proceedings.
Item 1A. Risk Factors
For a discussion of potential risks or uncertainties,see “Risk Factors” in the Company’s 2024 annual report on Form 10-K on file with the SEC. The following disclosuressupplement such Risk Factors, and should be read in conjunction therewith:
Additional Risks Related to Our Financial Conditionand Capital Requirements
To remain a going concern, we are in needof imminent material additional capital and absent our ability to raise such material capital in the near-term, we may be required toundertake a process of liquidation under U.S. bankruptcy laws, which we expect would limit holders of our common stock from recoupingany material value for their shares.
As of June 30, 2025, we possessed cash and cash equivalentsof approximately $4.4 million, while having current liabilities of approximately $1.0 million. We incurred losses of approximately $7.7million and $10.0 million for fiscal years 2024 and 2023, respectively, and $3.8 million for the six months ended June 30, 2025. Fromour inception through June 30, 2025, we have an accumulated deficit of approximately $38.5 million, and we do not currently generate anyoperating income. To achieve our current strategic plan, which strives to be in position to submit a 510(k) regulatory application tothe FDA in 2027 and achieve FDA approval thereafter, we expect to need to raise at least $30 million of capital between the second quarterof 2025 and the end of the 2027 fiscal year, which we hope to do in various tranches during this time period. We are exploring potentialpathways to raise additional material capital, but there can be no assurance that such additional capital will be available on a timelybasis or on terms that will be acceptable to us. If we are ultimately unable to obtain the needed financing to implement our businessplans, our board of directors could determine to cause the Company to undertake a process of liquidation under Chapter 7 of applicableU.S. bankruptcy laws. In such event, we do not currently expect that holders of shares of our common stock would recoup any material valuein such process.
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Additional Risks Related to Our Business
To preserve cash resources, we have downsizedour organization, which may reduce business continuity, affect our ability to apply for certain patents, and affect our product developmentand timelines, including our previously disclosed plan to transfer underlying production of our cartridges to a third-party contractorwho would manage such redevelopment.
To preserve cash resources, we have implementeda series of recent cost savings measures in our product development operations. As of the date of this filing, we have reduced our overallCompany-wide full-time employee headcount to 5 persons, including recently separating with our Chief Technical Officer, who was also significantlyinvolved in our ongoing SYMON-II clinical studies, analytical studies, and certain intellectual property in connection with the priordevelopment work of Symphony performed by Company, and our VP of Operations, who was overseeing the process of redeveloping aspects ofour Symphony cartridges. We are exploring pathways for redevelopment by outsourcing this work to third parties. In addition, these measuresare expected to result in a loss of institutional knowledge that may make our product redevelopment work more difficult to successfullyachieve. To the extent we obtain sufficient funding, we may hire replacement personnel in these areas in the future, but there is no assurancethat we will be able to do so. These circumstances may make it more difficult to succeed in meeting the technical challenges necessaryto bring our Symphony product to a level consistent with necessary performance and quality requirements to support an FDA submission andultimately be able to commercialize our product, as well as the timeline for completing this work.
Item 2. Unregistered Sales of Equity Securitiesand Use of Proceeds
April 2025 Private Placement
On April 8, 2025, pursuant to the April 7, 2025Inducement Letter Agreements with certain existing holders of the Company’s Class C Warrants, the Company sold 1,085,106 Class EWarrants to purchase unregistered shares of Common Stock for an immediate payment of $0.125 per Class E Warrant. Each Class E Warranthas an exercise price of $3.42 per share and expires on April 8, 2030. The sales proceeds were used for general corporate purposes.
Pursuant to the Inducement Letter Agreements,the Company agreed to file a registration statement providing for the resale by the purchasers of the shares of Common Stock issuableupon exercise of the Class E Warrants. On April 29, 2025, the Company filed Form S-3 with the Securities and Exchange Commission to registerthe sale of common stock issuable to the selling stockholders upon exercise of the Class E Warrants.
Item 3. Defaults Upon Senior Securities
None.
Item 4. Mine Safety Disclosures
Not applicable.
Item 5. Other Information
Insider Trading Arrangements and Policies
During the fiscal quarter ended June 30, 2025, none of our directorsor officers (as defined in Rule 16a-1(f) of the Exchange Act)
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Item 6. Exhibits
INDEX TO EXHIBITS
| * | Filed herewith. |
| (1) | The certifications on Exhibit 32 hereto are deemed not “filed” for purposes of Section 18 of the Exchange Act or otherwise subject to the liability of that Section. Such certifications will not be deemed incorporated by reference into any filing under the Securities Act or the Exchange Act. |
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SIGNATURES
Pursuant to the requirementsof the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereuntoduly authorized.
Bluejay Diagnostics, Inc.
| SIGNATURE | TITLE | DATE | ||
| /s/ Neil Dey | President, Chief Executive Officer and Director | August 7, 2025 | ||
| Neil Dey | (Principal Executive Officer, Principal Financial Officer and Principal Accounting Officer) |
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Exhibit 31.1
CERTIFICATION BY PRINCIPAL EXECUTIVE OFFICER
I, Neil Dey, certify that:
| 1. | I have reviewed this quarterly report on Form 10-Q of Bluejay Diagnostics, Inc.; |
| 2. | Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report; |
| 3. | Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report; |
| 4. | The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a–15(f) and 15d–15(f)) for the registrant and we have: |
| a. | designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared; |
| b. | designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles; |
| c. | evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and |
| d. | disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and |
| 5. | The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions): |
| a. | all significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and |
| b. | any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting. |
| Date: August 7, 2025 | ||
| By: | /s/ Neil Dey | |
| Neil Dey | ||
| President and Chief Executive Officer | ||
| (Principal executive officer) |
Exhibit 31.2
CERTIFICATION OF PRINCIPAL FINANCIAL OFFICER
I, Neil Dey, certify that:
| 1. | I have reviewed this quarterly report on Form 10-Q of Bluejay Diagnostics, Inc.; |
| 2. | Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report; |
| 3. | Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report; |
| 4. | The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a–15(f) and 15d–15(f)) for the registrant and we have: |
| a. | designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared; |
| b. | designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles; |
| c. | evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and |
| d. | disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and |
| 5. | The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions): |
| a. | all significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and |
| b. | any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting. |
| Date: August 7, 2025 | ||
| By: | /s/ Neil Dey | |
| Neil Dey | ||
| President and Chief Executive Officer | ||
| (Principal financial and accounting officer) |
Exhibit 32.1
CERTIFICATION OF PRINCIPAL EXECUTIVE OFFICER
Pursuant to section 906 ofthe Sarbanes-Oxley Act of 2002 (subsections (a) and (b) of section 1350, chapter 63 of title 18, United States Code), the undersignedofficer of Bluejay Diagnostics, Inc., a Delaware corporation (the “Company”), does hereby certify, to such officer’sknowledge, that:
The quarterly report on Form10-Q for the quarter ended June 30, 2025 (the “Form 10-Q”) of the Company fully complies with the requirements of section13(a) or 15(d) of the Securities Exchange Act of 1934, as amended and information contained in the Form 10-Q fairly presents, in all materialrespects, the financial condition and results of operations of the Company.
| Date: August 7, 2025 | ||
| By: | /s/ Neil Dey | |
| Neil Dey | ||
| President and Chief Executive Officer | ||
| (Principal executive officer) |
Exhibit 32.2
CERTIFICATION OF PRINCIPAL FINANCIAL OFFICER
Pursuant to section 906 ofthe Sarbanes-Oxley Act of 2002 (subsections (a) and (b) of section 1350, chapter 63 of title 18, United States Code), the undersignedofficer of Bluejay Diagnostics, Inc., a Delaware corporation (the “Company”), does hereby certify, to such officer’sknowledge, that:
The quarterly report on Form10-Q for the quarter ended June 30, 2025 (the “Form 10-Q”) of the Company fully complies with the requirements of section13(a) or 15(d) of the Securities Exchange Act of 1934, as amended and information contained in the Form 10-Q fairly presents, in all materialrespects, the financial condition and results of operations of the Company.
| Date: August 7, 2025 | ||
| By: | /s/ Neil Dey | |
| Neil Dey | ||
| President and Chief Executive Officer | ||
| (Principal financial and accounting officer) |