ACTON, Mass., Aug. 07, 2025 (GLOBE NEWSWIRE) -- Bluejay Diagnostics, Inc. (NASDAQ: BJDX) (“Bluejay” or the “Company”), a medical diagnostics company developing near-patient solutions for critical care, today announced financial results for the quarter ended June 30, 2025, and provided an update on its Symphony IL-6 test program and key operational milestones. Second Quarter 2025 and Recent Corporate Highlights SYMON-II Pivotal Clinical Study Underway: Bluejay has initiated patient enrollment in the SYMON-II ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2025 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from __________ to__________ 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 ...

Core Insights - Bluejay Diagnostics, Inc. provided a mid-year business update for 2025, highlighting progress in its clinical programs and financial status [1][2] Business Highlights and Developments - The 2025 Annual Meeting of Stockholders is scheduled for June 18, 2025, with a proposal to reduce the Board of Directors from six to five members and to consider two reverse stock split proposals to meet Nasdaq listing requirements [3] - The SYMON-II clinical study has been initiated, following the successful SYMON-I pilot study, which indicated that IL-6 levels could predict sepsis patient mortality [4] - The company aims to submit a 510(k) application for its Symphony IL-6 test to the FDA in Q4 2027, with potential approval as early as Q3 2028 [4] - Bluejay is collaborating with SanyoSeiko for manufacturing the Symphony analyzer and is redeveloping Symphony cartridges to address technical challenges [4] Financial Results - As of April 30, 2025, Bluejay had cash and cash equivalents of approximately $5.7 million and current liabilities of about $1.0 million [4] - The company reported losses of approximately $7.7 million for the fiscal year ended December 31, 2024, and $1.9 million for the fiscal quarter ended March 31, 2025 [4] - In April 2025, Bluejay raised approximately $3.8 million through Class C warrant exercises and new Class E warrants, with a goal to raise at least $30 million by the end of the 2027 fiscal year [4] Product and Clinical Study Information - The Symphony IL-6 Test is designed for sepsis triage and monitoring, providing results in about 20 minutes [5][7] - The SYMON Clinical Study Program includes SYMON-I and SYMON-II, with SYMON-I focusing on IL-6 levels related to mortality outcomes [6]

PART I FINANCIAL INFORMATION [Condensed Consolidated Financial Statements (Unaudited)](index=6&type=section&id=Item%201.%20Condensed%20Consolidated%20Financial%20Statements%20(Unaudited)) The unaudited condensed consolidated financial statements for the quarter ended March 31, 2025, show a net loss of $1.9 million, a decrease from the $2.3 million loss in the same period of 2024. Total assets decreased to $5.3 million from $6.7 million at year-end 2024, primarily due to a reduction in cash. The company's financial position raises substantial doubt about its ability to continue as a going concern, with cash resources expected to fund operations only up to the third quarter of 2025. A key subsequent event was an April 2025 private placement that raised approximately $3.8 million in gross proceeds [Condensed Consolidated Balance Sheets](index=6&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) As of March 31, 2025, the company's total assets were $5.28 million, a decrease from $6.66 million at December 31, 2024. This was primarily driven by a decrease in cash and cash equivalents from $4.30 million to $3.12 million. Total liabilities increased from $0.93 million to $1.41 million, while total stockholders' equity decreased from $5.73 million to $3.87 million over the same period Condensed Consolidated Balance Sheet Highlights (in thousands) | Account | March 31, 2025 | December 31, 2024 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $3,116 | $4,302 | | Total current assets | $3,572 | $4,899 | | Total assets | $5,278 | $6,657 | | **Liabilities & Equity** | | | | Total current liabilities | $1,317 | $810 | | Total liabilities | $1,412 | $928 | | Total stockholders' equity | $3,866 | $5,729 | | Total liabilities and stockholders' equity | $5,278 | $6,657 | [Condensed Consolidated Statements of Operations](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) For the three months ended March 31, 2025, the company reported a net loss of $1.86 million, or ($3.37) per share. This is an improvement from the net loss of $2.33 million, or ($394.76) per share, for the same period in 2024. The reduced loss was primarily due to a decrease in research and development expenses Statement of Operations Summary (in thousands) | Metric | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :--- | :--- | :--- | | Research and development | $785 | $1,335 | | General and administrative | $1,104 | $1,087 | | Total operating expenses | $1,889 | $2,428 | | Operating loss | ($1,889) | ($2,428) | | Net loss | ($1,864) | ($2,328) | | Net loss per share | ($3.37) | ($394.76) | [Condensed Consolidated Statements of Cash Flows](index=9&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) For the three months ended March 31, 2025, net cash used in operating activities was $1.18 million, a significant reduction from $2.30 million in the prior year period. There were no investing activities in Q1 2025. Unlike Q1 2024, which saw $2.79 million in net cash from financing activities, Q1 2025 had negligible financing cash flow. This resulted in a net decrease in cash of $1.19 million for the quarter Cash Flow Summary (in thousands) | Activity | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | ($1,185) | ($2,300) | | Net cash used in investing activities | $0 | ($35) | | Net cash (used in) provided by financing activities | ($1) | $2,788 | | **Net increase (decrease) in cash** | **($1,186)** | **$453** | [Notes to Condensed Consolidated Financial Statements](index=10&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) The notes detail the company's focus on developing the Symphony IL-6 test for sepsis, with a goal for a 510(k) FDA submission in Q4 2027, contingent on raising at least $30 million. A significant 'Going Concern' uncertainty is disclosed, stating current cash will only fund operations into Q3 2025. The notes also cover the license agreement with Toray, various financing activities in 2024, outstanding warrants, and a subsequent event in April 2025 where a warrant inducement raised approximately $3.8 million in gross proceeds - The company is developing the Symphony IL-6 test for sepsis and plans to submit a 510(k) application to the FDA in Q4 2027, with potential approval in Q3 2028. This plan is contingent on raising at least **$30 million** in capital between Q2 2025 and the end of 2027[31](index=31&type=chunk) - There is substantial doubt about the Company's ability to continue as a going concern. As of March 31, 2025, the company had an accumulated deficit of **$36.5 million** and estimates its current cash will only be sufficient to fund operations up to the third quarter of 2025[50](index=50&type=chunk) - The company has an exclusive global license (excluding Japan) from Toray Industries for its Symphony detection cartridges. The royalty rate was reduced to **7.5%** of net sales. There is a risk Toray could terminate the license as early as November 2025 if the company does not establish a manufacturing facility[59](index=59&type=chunk)[60](index=60&type=chunk)[61](index=61&type=chunk) - In April 2025, the company entered into inducement agreements with holders of Class C warrants, resulting in the exercise of warrants for gross proceeds of approximately **$3.8 million**. The company issued new Class E warrants as part of the transaction[94](index=94&type=chunk)[97](index=97&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=23&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the company's focus on the Symphony IL-6 test and the significant financial challenges it faces. The net loss for Q1 2025 was $1.9 million, an improvement from $2.3 million in Q1 2024, due to lower R&D spending. A critical liquidity issue is highlighted, with a going concern uncertainty and an estimated cash runway only until Q3 2025. The company needs to raise at least $30 million by the end of 2027 to execute its strategic plan. Recent financing activities, including a $3.8 million private placement in April 2025, are noted as efforts to address the liquidity shortfall Operating Results Comparison (in millions) | Metric | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :--- | :--- | :--- | | Research and Development | $0.8 | $1.3 | | General and Administrative | $1.1 | $1.1 | | Net Loss | ($1.9) | ($2.3) | - The decrease in R&D expenses was primarily due to a reduction in technology transfer efforts, which offset increased clinical trial expenses[107](index=107&type=chunk) - The company has substantial doubt about its ability to continue as a going concern. It estimates current cash resources will only fund operations up to Q3 2025 and failure to obtain additional financing could lead to liquidation[116](index=116&type=chunk) - To execute its plan of achieving FDA approval by Q3 2028, the company estimates it needs to raise at least **$30 million** between Q2 2025 and the end of 2027[100](index=100&type=chunk) - In April 2025, the company raised approximately **$3.8 million** in gross proceeds through a private placement involving the exercise of existing Class C warrants and the issuance of new Class E warrants[127](index=127&type=chunk)[130](index=130&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=29&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company is a smaller reporting company and is not required to provide the information for this item - As a smaller reporting company, Bluejay Diagnostics, Inc. is not required to provide quantitative and qualitative disclosures about market risk[137](index=137&type=chunk) [Controls and Procedures](index=29&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that the company's disclosure controls and procedures were not effective as of March 31, 2025. This was due to a material weakness in internal control over financial reporting identified during the 2024 fiscal year-end audit. The weakness relates to the incorrect accounting and valuation of certain warrants with 'reset' features issued in June 2024. The company plans to remediate this by engaging outside accounting experts for complex financial instruments - The company's disclosure controls and procedures were determined to be not effective as of March 31, 2025[141](index=141&type=chunk) - A material weakness was identified related to the accounting and valuation of Class C and Class D warrants issued in June 2024, which had 'reset' features that were not properly accounted for as a 'deemed dividend on warrant modification'[139](index=139&type=chunk) - The remediation plan involves engaging outside accounting experts to review and document the appropriate accounting for complex financial instruments like warrants[140](index=140&type=chunk) PART II OTHER INFORMATION [Legal Proceedings](index=31&type=section&id=Item%201.%20Legal%20Proceedings) The company reports that it is not currently involved in any legal proceedings - As of the filing date, the company is not involved in any legal proceedings[145](index=145&type=chunk) [Risk Factors](index=31&type=section&id=Item%201A.%20Risk%20Factors) This section supplements existing risk factors, emphasizing the imminent need for additional capital to remain a going concern and the significant risk of liquidation, which would likely result in a total loss for common stockholders. It also highlights risks from recent downsizing to preserve cash, including the loss of key personnel (VP of Operations and CTO), which could negatively impact product redevelopment and timelines - The company is in need of imminent material capital to remain a going concern. Failure to raise funds may lead to liquidation under U.S. bankruptcy laws, where common stockholders are not expected to recoup any material value[146](index=146&type=chunk) - To preserve cash, the company has downsized its full-time employee headcount to **6 persons**, including separating with its VP of Operations and negotiating a separation with its Chief Technology Officer. This may reduce business continuity and negatively affect product development[147](index=147&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=32&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company reported no unregistered sales of equity securities during the period - None[148](index=148&type=chunk) [Other Information](index=32&type=section&id=Item%205.%20Other%20Information) On May 8, 2025, the company entered into a settlement and release agreement with Nanohybrids, terminating a services agreement and discussions of a potential acquisition. The company agreed to pay Nanohybrids $50,000 plus up to $30,000 in legal fees. Additionally, on May 10, 2025, the company informed its Chief Technology Officer, Jason Cook, of its intent to separate from employment and is currently discussing the terms - On May 8, 2025, the company entered into a settlement agreement with Nanohybrids, terminating a Sharing and Services Agreement and paying **$50,000** plus up to **$30,000** in legal fees[150](index=150&type=chunk) - On May 10, 2025, the company informed its Chief Technology Officer, Jason Cook, of an upcoming separation from employment and is currently discussing the terms[151](index=151&type=chunk) [Exhibits](index=33&type=section&id=Item%206.%20Exhibits) This section lists the exhibits filed with the Form 10-Q, including the settlement agreement with Nanohybrids, officer certifications (Rule 13a-14(a) and Section 906 of Sarbanes-Oxley), and Inline XBRL data files - Filed exhibits include the Settlement Agreement with Nanohybrids, Inc., CEO/CFO certifications, and XBRL data files[154](index=154&type=chunk)

Core Insights - Bluejay Diagnostics, Inc. announced the acceptance of an abstract for the Symphony IL-6 Test at the SAEM Annual Meeting, highlighting its potential in sepsis management [1][2] - The SYMON-I study results will be presented, focusing on IL-6 as a prognostic biomarker for mortality in sepsis patients [1][4] Company Overview - Bluejay Diagnostics is focused on developing rapid and accessible biomarker testing, with its lead product being the Symphony IL-6 Test for sepsis triage [5] - The Symphony IL-6 Test aims to provide results in approximately 20 minutes, assisting healthcare professionals in making timely treatment decisions [5] Clinical Study Details - The SYMON Clinical Study Program includes SYMON-I and SYMON-II, with SYMON-I being a pilot study assessing IL-6 levels related to various mortality endpoints [4] - SYMON-II is a pivotal study intended to validate SYMON-I outcomes and support a 510(k) application to the FDA [4] Presentation Information - The presentation titled "Multicenter Symphony IL-6 Monitoring Sepsis ICU Validation Study (SYMON I)" will take place on May 14, 2025, by presenters John H. Lee, M.D., Ph.D. and Nathan Shapiro, M.D. [3]

ACTON, Mass., April 07, 2025 (GLOBE NEWSWIRE) -- Bluejay Diagnostics, Inc. (NASDAQ:BJDX) ("Bluejay" or the "Company"), a medical technology company developing rapid diagnostics on its Symphony platform to improve patient outcomes in critical care settings, today announced that it has entered into an agreement with institutional investors that are existing holders of warrants to purchase shares of common stock of the Company for cash (the "Existing Warrants"), wherein the investors agreed to exercise the Exi ...

Part I [Item 1. Business](index=7&type=section&id=Item%201.%20Business) Bluejay Diagnostics is a pre-revenue medical diagnostics company developing the Symphony platform for critical care, targeting FDA clearance for its IL-6 sepsis test by Q4 2027, facing technical challenges and requiring substantial funding - Bluejay is a pre-revenue medical diagnostics company focused on its **Symphony platform** for critical care settings, with its primary product candidate being an **IL-6 test for sepsis**[21](index=21&type=chunk)[23](index=23&type=chunk) - The company faces significant technical and supply challenges with its Symphony cartridges, including performance reproducibility and discontinuation of key raw materials, necessitating a redevelopment process expected to last at least a year[19](index=19&type=chunk)[34](index=34&type=chunk)[135](index=135&type=chunk) - Bluejay's strategic plan requires raising at least **$30 million** in capital between Q2 2025 and the end of 2027 to fund operations, clinical trials, and achieve its goal of a 510(k) FDA submission in **Q4 2027**[21](index=21&type=chunk)[78](index=78&type=chunk) - The company is highly dependent on an exclusive license agreement with Toray Industries for its core cartridge technology, with a risk of termination if manufacturing capabilities are not established by **October 2025**[46](index=46&type=chunk)[48](index=48&type=chunk)[101](index=101&type=chunk) [Item 1A. Risk Factors](index=20&type=section&id=Item%201A.%20Risk%20Factors) The company faces extensive financial, operational, and regulatory risks, including a going concern warning, significant stock price decline, reliance on the Toray license, unresolved technical issues, and a material weakness in internal controls - The company has a history of significant losses, an accumulated deficit of **$34.7 million**, and substantial doubt about its ability to continue as a going concern, with cash expected to run out in **Q3 2025** without additional funding[75](index=75&type=chunk)[77](index=77&type=chunk) - The common stock market price has fallen by more than **99.9%** since the November 2021 IPO, and future funding needs are expected to lead to significant dilution[19](index=19&type=chunk)[80](index=80&type=chunk)[81](index=81&type=chunk) - A significant risk exists with the Toray license agreement, which could be terminated as early as **November 2025** if Bluejay fails to establish a cartridge manufacturing facility, jeopardizing company viability[101](index=101&type=chunk)[103](index=103&type=chunk) - The company faces ongoing performance reproducibility issues with its Symphony cartridges and lacks sufficient know-how from Toray to produce the critical capture antibody, requiring a lengthy and uncertain redevelopment process[19](index=19&type=chunk)[135](index=135&type=chunk)[136](index=136&type=chunk) - The company is at risk of delisting from the Nasdaq Capital Market due to potential failure to meet the minimum **$1.00** bid price and **$1 million** market value of publicly held shares requirements[93](index=93&type=chunk)[94](index=94&type=chunk) - A material weakness in internal control over financial reporting was identified due to a lack of sufficient internal accounting expertise, specifically related to complex accounting for warrants with reset features[203](index=203&type=chunk)[205](index=205&type=chunk) [Item 1B. Unresolved Staff Comments](index=52&type=section&id=Item%201B.%20Unresolved%20Staff%20Comments) The company reports no unresolved staff comments - There are no unresolved staff comments[212](index=212&type=chunk) [Item 1C. Cybersecurity](index=52&type=section&id=Item%201C.%20Cybersecurity) The company maintains cybersecurity processes overseen by the President and CEO with board oversight, integrated into its risk management framework, and is unaware of any material incidents - The Board of Directors oversees cybersecurity risk management, implemented by the President and CEO[215](index=215&type=chunk)[216](index=216&type=chunk) - The company is not aware of any material cybersecurity incidents that have impacted its operations[217](index=217&type=chunk) [Item 2. Properties](index=52&type=section&id=Item%202.%20Properties) The company leases two facilities in Acton, Massachusetts, and permits related and third-party entities, including one majority-owned by the CTO, to use its premises - The company leases two facilities in Acton, MA, with one lease expiring in **March 2027** and the other becoming month-to-month in **March 2025**[218](index=218&type=chunk) - A business entity majority-owned by the company's Chief Technology Officer is permitted to use the laboratory facility, with Bluejay billing for personnel time plus a **10%** facility use fee[219](index=219&type=chunk) [Item 3. Legal Proceedings](index=52&type=section&id=Item%203.%20Legal%20Proceedings) The company is not currently a party to any pending legal actions believed to have a material effect on its business - As of the filing date, the company is not involved in any material legal proceedings[220](index=220&type=chunk)[221](index=221&type=chunk) [Item 4. Mine Safety Disclosures](index=52&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company - No mine safety disclosures are applicable[222](index=222&type=chunk) Part II [Item 5. Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities](index=53&type=section&id=Item%205.%20Market%20for%20Registrant%27s%20Common%20Equity%2C%20Related%20Stockholder%20Matters%20and%20Issuer%20Purchases%20of%20Equity%20Securities) The company's common stock is listed on Nasdaq under "BJDX", has never paid dividends, and had 554,012 shares outstanding as of March 21, 2025 - The company's common stock trades on the Nasdaq Capital Market under the symbol **"BJDX"**[224](index=224&type=chunk) - As of **March 21, 2025**, there were **554,012** shares of common stock outstanding[226](index=226&type=chunk) - No cash dividends have ever been paid, and none are expected in the foreseeable future[225](index=225&type=chunk) [Item 7. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=53&type=section&id=Item%207.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) The company reported a net loss of **$7.7 million** for FY2024, a decrease from **$10.0 million** in FY2023, driven by reduced expenses, but faces substantial doubt about its going concern status with cash projected to last only into Q3 2025, necessitating further capital raises Financial Performance Summary (FY2024 vs. FY2023) | Metric | 2024 ($M) | 2023 ($M) | | :--- | :--- | :--- | | Research and Development | $3.5 | $5.7 | | General and Administrative | $3.7 | $4.3 | | **Operating Loss** | **($7.2)** | **($10.3)** | | **Net Loss** | **($7.7)** | **($10.0)** | | Accumulated Deficit | ($34.7) | ($27.0) | Cash Flow Summary (FY2024 vs. FY2023) | Activity | 2024 ($M) | 2023 ($M) | | :--- | :--- | :--- | | Net Cash Used in Operating | ($7.8) | ($8.3) | | Net Cash Used in Investing | ($0.3) | ($0.7) | | Net Cash Provided by Financing | $10.2 | $1.1 | - Management has expressed substantial doubt about the company's ability to continue as a going concern, with existing cash of **$4.3 million** only expected to fund operations into **Q3 2025**, necessitating additional capital raises[245](index=245&type=chunk)[339](index=339&type=chunk) - The company conducted multiple financing rounds in **2023** and **2024**, including registered direct offerings, public offerings, and bridge note financing, to sustain operations[248](index=248&type=chunk)[252](index=252&type=chunk)[256](index=256&type=chunk)[259](index=259&type=chunk) [Item 9A. Controls and Procedures](index=59&type=section&id=Item%209A.%20Controls%20and%20Procedures) As of December 31, 2024, management concluded that disclosure controls and internal control over financial reporting were ineffective due to a material weakness related to insufficient internal accounting expertise, particularly for complex warrant accounting, with a remediation plan in place - Both disclosure controls and internal control over financial reporting were deemed ineffective as of **December 31, 2024**[269](index=269&type=chunk)[270](index=270&type=chunk) - A material weakness was identified due to a lack of sufficient internal accounting expertise, highlighted by an error in accounting for a "deemed dividend on warrant modification" related to warrants issued in **June 2024**[270](index=270&type=chunk)[271](index=271&type=chunk) - The remediation plan involves enhancing review processes and, subject to funding, engaging additional qualified accounting resources, as the President and CEO, who is not a CPA, currently serves as the principal financial and accounting officer[274](index=274&type=chunk)[275](index=275&type=chunk) Part III [Item 10. Directors, Executive Officers and Corporate Governance](index=62&type=section&id=Item%2010.%20Directors%2C%20Executive%20Officers%20and%20Corporate%20Governance) Information for this item will be incorporated by reference from the company's definitive proxy statement for its 2025 annual meeting of stockholders [Item 11. Executive Compensation](index=62&type=section&id=Item%2011.%20Executive%20Compensation) Information for this item will be incorporated by reference from the company's definitive proxy statement for its 2025 annual meeting of stockholders [Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters](index=62&type=section&id=Item%2012.%20Security%20Ownership%20of%20Certain%20Beneficial%20Owners%20and%20Management%20and%20Related%20Stockholder%20Matters) Security ownership information will be incorporated by reference from the 2025 proxy statement, with **181** securities issuable under equity compensation plans and **136** remaining available as of December 31, 2024 Equity Compensation Plan Information as of December 31, 2024 | Plan Category | Securities to be Issued Upon Exercise (Units) | Weighted-Average Exercise Price ($) | Securities Remaining Available for Future Issuance (Units) | | :--- | :--- | :--- | :--- | | Equity compensation plans approved by security holders | 73 | $14,902.00 | 136 | | Equity compensation plans not approved by security holders | 108 | $7,180.00 | - | [Item 13. Certain Relationships and Related Transactions, and Director Independence](index=62&type=section&id=Item%2013.%20Certain%20Relationships%20and%20Related%20Transactions%2C%20and%20Director%20Independence) Information for this item will be incorporated by reference from the company's definitive proxy statement for its 2025 annual meeting of stockholders [Item 14. Principal Accountant Fees and Services](index=62&type=section&id=Item%2014.%20Principal%20Accountant%20Fees%20and%20Services) Information for this item will be incorporated by reference from the company's definitive proxy statement for its 2025 annual meeting of stockholders Part IV [Item 15. Exhibits and Financial Statement Schedules](index=63&type=section&id=Item%2015.%20Exhibits%20and%20Financial%20Statement%20Schedules) This section lists the financial statements, schedules, and exhibits filed as part of the Form 10-K, including articles of incorporation, bylaws, material contracts, and certifications [Item 16. Form 10-K Summary](index=65&type=section&id=Item%2016.%20Form%2010-K%20Summary) This item is not applicable - No Form 10-K summary was provided[297](index=297&type=chunk)[299](index=299&type=chunk) Financial Statements [Consolidated Financial Statements](index=68&type=section&id=Consolidated%20Financial%20Statements) The audited consolidated financial statements present the company's financial position and results, with the auditor's report highlighting substantial doubt about going concern due to recurring losses and negative cash flows, despite an increase in cash to **$4.3 million** driven by financing - The independent auditor's report expresses a fair presentation opinion but includes an "Emphasis of Matter" paragraph regarding the company's ability to continue as a going concern[307](index=307&type=chunk)[308](index=308&type=chunk) Consolidated Balance Sheet Data (As of December 31) | | 2024 ($) | 2023 ($) | | :--- | :--- | :--- | | Cash and cash equivalents | 4,301,945 | 2,208,516 | | Total Assets | 6,657,423 | 4,868,531 | | Total Liabilities | 927,924 | 1,973,683 | | Accumulated Deficit | (34,668,784) | (26,950,990) | | Total Stockholders' Equity | 5,729,499 | 2,894,848 | Consolidated Statement of Operations Data (For the Year Ended December 31) | | 2024 ($) | 2023 ($) | | :--- | :--- | :--- | | Operating Loss | (7,169,616) | (10,311,217) | | Net Loss | (7,717,794) | (9,953,888) | | Net Loss Per Share | (114.19) | (3,631.48) |

Part I [Part I - Financial Information](index=6&type=section&id=PART%20I%20-%20FINANCIAL%20INFORMATION) This section provides the company's unaudited condensed consolidated financial statements and related management discussion and analysis [Condensed Consolidated Financial Statements (Unaudited)](index=6&type=section&id=Item%201.%20Condensed%20Consolidated%20Financial%20Statements%20(Unaudited)) The unaudited condensed consolidated financial statements detail the company's financial position and performance, showing increased assets and reduced net loss, alongside significant changes in shares outstanding due to financing and a reverse stock split [Condensed Consolidated Balance Sheets](index=6&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) As of September 30, 2024, total assets increased to **$8.35 million** from **$4.87 million** at year-end 2023, driven by a significant rise in cash and cash equivalents to **$5.76 million**, while liabilities decreased and equity grew due to financing activities Condensed Consolidated Balance Sheet Highlights (Unaudited) | Account | Sep 30, 2024 ($) | Dec 31, 2023 ($) | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | 5,755,741 | 2,208,516 | | Total current assets | 6,567,686 | 3,220,860 | | Total assets | 8,353,410 | 4,868,531 | | **Liabilities & Equity** | | | | Total current liabilities | 1,049,247 | 1,771,375 | | Total liabilities | 1,188,976 | 1,973,683 | | Total stockholders' equity | 7,164,434 | 2,894,848 | | Total liabilities and stockholders' equity | 8,353,410 | 4,868,531 | - The number of common shares issued and outstanding increased significantly from **154,893** at the end of 2023 to **17,827,280** as of September 30, 2024, with all share data reflecting a 1-for-8 reverse stock split effective June 20, 2024[12](index=12&type=chunk) [Condensed Consolidated Statements of Operations](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) For the three months ended September 30, 2024, the company reported a net loss of **$1.48 million**, an improvement from **$2.30 million** in 2023, primarily due to reduced operating expenses, with the nine-month net loss also decreasing to **$6.29 million** from **$7.65 million** Operating Results Comparison (Unaudited) | Metric | Three Months Ended Sep 30, 2024 ($) | Three Months Ended Sep 30, 2023 ($) | Nine Months Ended Sep 30, 2024 ($) | Nine Months Ended Sep 30, 2023 ($) | | :--- | :--- | :--- | :--- | :--- | | Research and development | 551,655 | 1,397,318 | 2,917,674 | 4,428,123 | | General and administrative | 809,199 | 963,534 | 2,759,817 | 3,213,614 | | Operating loss | (1,361,607) | (2,341,233) | (5,684,972) | (7,924,493) | | Net loss | (1,481,959) | (2,297,998) | (6,285,804) | (7,651,146) | | Net loss per share | (0.16) | (16.67) | (1.82) | (58.38) | [Condensed Consolidated Statements of Cash Flows](index=9&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) For the nine months ended September 30, 2024, net cash used in operating activities was **$6.1 million**, offset by **$9.9 million** generated from financing activities, resulting in a net cash increase of **$3.5 million** and an ending cash balance of **$5.76 million** Cash Flow Summary (Unaudited, Nine Months Ended Sep 30) | Activity | 2024 ($) | 2023 ($) | | :--- | :--- | :--- | | Net cash used in operating activities | (6,081,083) | (5,536,393) | | Net cash used in investing activities | (305,658) | (616,272) | | Net cash provided by financing activities | 9,933,966 | 1,114,612 | | **Net increase (decrease) in cash** | **3,547,225** | **(5,038,053)** | | Cash and cash equivalents, end of period | 5,755,741 | 5,076,937 | - Financing activities in 2024 included **$12.1 million** from the issuance of common stock and prefunded warrants and **$2.0 million** from notes payable, offset by issuance costs and note repayments[16](index=16&type=chunk) [Notes to Condensed Consolidated Financial Statements](index=10&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) The notes detail the company's shift to a 510(k) FDA pathway for its sepsis test, significant delays due to technical challenges, substantial doubt about its going concern status with cash only through Q1 2025, and a Nasdaq non-compliance notice for its stock price - The company's regulatory strategy has shifted from COVID-19 to sepsis, with plans to use data from the SYMON-I and SYMON-II clinical studies to support a 510(k) application to the FDA[23](index=23&type=chunk)[29](index=29&type=chunk) - Technical challenges, including limited supply of critical materials and reliability issues with the Symphony Cartridge, are expected to delay the FDA submission by at least **18 months**[28](index=28&type=chunk)[30](index=30&type=chunk) - Management has concluded there is substantial doubt about the company's ability to continue as a going concern, as current cash is only sufficient to fund operations through the first quarter of 2025[43](index=43&type=chunk)[44](index=44&type=chunk) - The company received a Nasdaq non-compliance notice for its stock price being below **$1.00**, and has until February 24, 2025, to regain compliance, despite a 1-for-8 reverse stock split effected in June 2024 that did not maintain the price above **$1.00**[36](index=36&type=chunk)[37](index=37&type=chunk)[38](index=38&type=chunk) - In May 2024, the company raised **$2 million** through a Note Purchase Agreement and a Securities Purchase Agreement, which was subsequently repaid[62](index=62&type=chunk)[63](index=63&type=chunk)[64](index=64&type=chunk) - The company conducted public offerings in January and June 2024, issuing common stock, prefunded warrants, and various classes of warrants (Class C, Class D) to raise capital[67](index=67&type=chunk)[74](index=74&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=24&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the company's clinical-stage status, persistent net losses, and critical liquidity challenges, with cash projected to last only through Q1 2025, necessitating further dilutive financing despite reduced operating expenses Comparison of Operating Expenses (Three Months Ended Sep 30) | Expense Category | 2024 ($ millions) | 2023 ($ millions) | Change (%) | | :--- | :--- | :--- | :--- | | Research and development | 0.6 | 1.4 | -57 | | General and administrative | 0.8 | 1.0 | -20 | - The decrease in R&D expenses was primarily due to a reduction in technology transfer efforts, which offset increased clinical trial expenses[106](index=106&type=chunk) - The company's cash resources of **$5.8 million** are only sufficient to fund operations through the first quarter of 2025, raising substantial doubt about its ability to continue as a going concern[103](index=103&type=chunk)[110](index=110&type=chunk) - Net cash provided by financing activities increased by **$8.8 million** in the first nine months of 2024 compared to 2023, due to public offerings in January and June 2024[117](index=117&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=28&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) As a smaller reporting company, Bluejay Diagnostics, Inc. is not required to provide the information requested under this item - The company is a smaller reporting company as defined by Rule 12b-2 of the Exchange Act and is not required to provide quantitative and qualitative disclosures about market risk[126](index=126&type=chunk) [Controls and Procedures](index=28&type=section&id=Item%204.%20Controls%20and%20Procedures) Management, including the CEO, concluded the company's disclosure controls and procedures were effective as of September 30, 2024, with no material changes to internal control over financial reporting during the quarter - Based on an evaluation, the President and CEO concluded that the company's disclosure controls and procedures were effective as of September 30, 2024[127](index=127&type=chunk) - No changes in internal control over financial reporting occurred during the quarter ended September 30, 2024, that materially affected, or are reasonably likely to materially affect, internal controls[128](index=128&type=chunk) Part II [Part II - Other Information](index=28&type=section&id=PART%20II%20-%20OTHER%20INFORMATION) This section covers other required disclosures, including legal proceedings, risk factors, and exhibit listings [Legal Proceedings](index=28&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently involved in any legal proceedings - As of the filing date, the company is not involved in any legal proceedings[129](index=129&type=chunk) [Risk Factors](index=29&type=section&id=Item%201A.%20Risk%20Factors) This section supplements existing risk factors, emphasizing severe financial distress, an accumulated deficit of **$33.2 million**, and projected cash depletion by Q1 2025, alongside operational hurdles from material supply issues delaying FDA submission by at least **18 months**, and significant Nasdaq delisting risk - The company has incurred significant losses, has an accumulated deficit of approximately **$33.2 million**, and expects its current cash of **$5.8 million** to only fund operations through Q1 2025, raising substantial doubt about its ability to continue as a going concern[131](index=131&type=chunk) - The company is experiencing limited supply of critical materials and quality control issues for its test cartridges, which are expected to delay the FDA submission for Symphony by at least **18 months**[136](index=136&type=chunk) - The company is not in compliance with Nasdaq's minimum bid price requirement of **$1.00**, has until February 24, 2025, to regain compliance, and may need to effect another reverse stock split to avoid delisting[141](index=141&type=chunk)[142](index=142&type=chunk)[143](index=143&type=chunk) - The large number of outstanding warrants, particularly the Class C Warrants from the June 2024 offering, could cause significant dilution to existing stockholders and may make it more difficult to effect a future business combination[148](index=148&type=chunk)[149](index=149&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=33&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) None - There were no unregistered sales of equity securities during the period[149](index=149&type=chunk) [Defaults Upon Senior Securities](index=33&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) None - There were no defaults upon senior securities[149](index=149&type=chunk) [Mine Safety Disclosures](index=33&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) Not applicable - This item is not applicable to the company[149](index=149&type=chunk) [Other Information](index=33&type=section&id=Item%205.%20Other%20Information) None - There is no other information to report under this item[149](index=149&type=chunk) [Exhibits](index=34&type=section&id=Item%206.%20Exhibits) This section lists the exhibits filed with the Form 10-Q, including amendments to the Certificate of Incorporation and Bylaws, as well as officer certifications and XBRL data files - The report includes a list of filed exhibits, such as corporate governance documents, officer certifications required by the Sarbanes-Oxley Act, and Inline XBRL documents[150](index=150&type=chunk)

PART I - FINANCIAL INFORMATION [Item 1. Condensed Consolidated Financial Statements (Unaudited)](index=6&type=section&id=Item%201.%20Condensed%20Consolidated%20Financial%20Statements%20(Unaudited)) The company reported a **$4.8 million** net loss, with assets growing to **$10.9 million** from financing, raising going concern doubts [Condensed Consolidated Balance Sheets](index=6&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) Total assets significantly increased to **$10.9 million** due to financing-driven cash growth, with stockholders' equity reaching **$8.6 million** Condensed Consolidated Balance Sheet Highlights (Unaudited) | Account | June 30, 2024 ($) | Dec 31, 2023 ($) | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $8,058,415 | $2,208,516 | | Total current assets | $9,018,408 | $3,220,860 | | Total assets | $10,859,211 | $4,868,531 | | **Liabilities & Equity** | | | | Total current liabilities | $2,056,882 | $1,771,375 | | Total liabilities | $2,218,136 | $1,973,683 | | Total stockholders' equity | $8,641,075 | $2,894,848 | | Total liabilities and stockholders' equity | $10,859,211 | $4,868,531 | - A 1-for-8 reverse stock split was effective on June 20, 2024, and all historical share and per-share information has been adjusted retroactively[10](index=10&type=chunk)[27](index=27&type=chunk) [Condensed Consolidated Statements of Operations](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) Net loss improved to **$4.8 million** due to decreased operating expenses, partially offset by increased interest expense Condensed Consolidated Statements of Operations (Unaudited) | Metric | Six Months Ended June 30, 2024 ($) | Six Months Ended June 30, 2023 ($) | | :--- | :--- | :--- | | Research and development | $2,366,019 | $3,030,805 | | General and administrative | $1,950,618 | $2,250,080 | | Total operating expenses | $4,323,365 | $5,583,260 | | Operating loss | ($4,323,365) | ($5,583,260) | | Net loss | ($4,803,845) | ($5,353,148) | | Net Loss per share – Basic and diluted | ($12.35) | ($41.95) | [Condensed Consolidated Statements of Cash Flows](index=9&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Operating cash outflow was **$4.1 million**, offset by **$10.3 million** from financing, leading to a **$5.8 million** net cash increase Summary of Cash Flows (Unaudited) | Activity | Six Months Ended June 30, 2024 ($) | Six Months Ended June 30, 2023 ($) | | :--- | :--- | :--- | | Net cash used in operating activities | ($4,149,682) | ($4,411,327) | | Net cash used in investing activities | ($305,431) | ($541,774) | | Net cash provided by (used in) financing activities | $10,305,012 | ($61,482) | | **Increase (decrease) in cash** | **$5,849,899** | **($5,014,583)** | [Notes to Condensed Consolidated Financial Statements](index=10&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) Notes detail Symphony platform development, regulatory shifts, significant financial risks including Nasdaq non-compliance and going concern, and recent financing - The company is developing the Symphony technology platform for rapid, whole-blood diagnostic tests in critical care settings. The first product is the Symphony IL-6 test for monitoring disease progression, particularly in sepsis patients[18](index=18&type=chunk)[19](index=19&type=chunk) - The company's regulatory strategy has shifted from COVID-19 to sepsis. It completed the SYMON-I pilot study and plans to initiate the SYMON-II pivotal study in Q3 2024 to support a 510(k) FDA submission in 2025[22](index=22&type=chunk)[25](index=25&type=chunk) - Management has concluded there is substantial doubt about the Company's ability to continue as a going concern, as current cash of approximately **$8.1 million** is only sufficient to fund operations through the first quarter of 2025[34](index=34&type=chunk)[35](index=35&type=chunk) - The company received a Nasdaq non-compliance notice on February 28, 2024, for its stock price falling below the **$1.00** minimum bid requirement. The company has until August 26, 2024, to regain compliance[28](index=28&type=chunk)[29](index=29&type=chunk) - In June 2024, the company sold common units and pre-funded units in a public offering, which included shares/pre-funded warrants, Class C Warrants, and Class D Warrants, raising significant capital[55](index=55&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=24&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses significant net losses, negative cash flow, decreased operating expenses, and critical liquidity issues, with cash only through Q1 2025, necessitating capital Operating Expense Comparison (Three Months Ended June 30) | Expense Category | 2024 ($) | 2023 ($) | | :--- | :--- | :--- | | Research and development | $1,032,474 | $1,676,256 | | General and administrative | $862,482 | $1,073,103 | | Sales and marketing | $305 | $154,329 | - The decrease in R&D expenses was due to a reduction in technology transfer efforts, which offset increased clinical trial expenses[83](index=83&type=chunk) - The company's cash resources of **$8.1 million** as of June 30, 2024, are only sufficient to fund operations through the first quarter of 2025, raising substantial doubt about its ability to continue as a going concern[82](index=82&type=chunk)[88](index=88&type=chunk) - Net cash provided by financing activities increased by approximately **$10.4 million** in the first six months of 2024 compared to the same period in 2023, due to public offerings in January and June 2024 and a Bridge Note Financing[94](index=94&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=29&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) As a smaller reporting company, the company is not required to provide market risk disclosures - As a smaller reporting company, Bluejay Diagnostics is not required to provide quantitative and qualitative disclosures about market risk[101](index=101&type=chunk) [Item 4. Controls and Procedures](index=29&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded disclosure controls were effective as of June 30, 2024, with no material changes to internal control over financial reporting - The President and CEO concluded that the company's disclosure controls and procedures were effective as of June 30, 2024[102](index=102&type=chunk) - No changes occurred during the quarter ended June 30, 2024, that materially affected, or are reasonably likely to materially affect, the company's internal control over financial reporting[103](index=103&type=chunk) PART II - OTHER INFORMATION [Item 1. Legal Proceedings](index=29&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently involved in any legal proceedings - As of the filing date, the company is not involved in any legal proceedings[104](index=104&type=chunk) [Item 1A. Risk Factors](index=30&type=section&id=Item%201A.%20Risk%20Factors) This section highlights precarious financial condition, including losses and going concern uncertainty, product development risks, Nasdaq delisting risk, and potential stock dilution - **Financial Risk:** The company has a history of significant losses, an accumulated deficit of approximately **$31.6 million**, and expects to run out of cash in Q1 2025 without new funding, raising substantial doubt about its ability to continue as a going concern[106](index=106&type=chunk)[108](index=108&type=chunk) - **Product Development Risk:** Ongoing materials, manufacturing, and quality control issues with its supplier, Toray, could negatively impact the timeline for the FDA submission of the Symphony device[111](index=111&type=chunk) - **Stock & Listing Risk:** The company is not in compliance with Nasdaq's **$1.00** minimum bid price requirement and faces delisting if compliance is not regained. A 1-for-8 reverse split on June 20, 2024, has not resolved the issue[113](index=113&type=chunk)[114](index=114&type=chunk)[115](index=115&type=chunk) - **Dilution Risk:** The exercise of outstanding warrants, particularly the Class C and Class D warrants from the June 2024 offering, is expected to cause a substantial increase in outstanding shares and material dilution to existing stockholders[119](index=119&type=chunk)[122](index=122&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=34&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) No unregistered sales of equity securities were reported for the period - There were no unregistered sales of equity securities during the period[123](index=123&type=chunk) [Item 5. Other Information](index=35&type=section&id=Item%205.%20Other%20Information) No other information is reported for the period - There is no other information to report[124](index=124&type=chunk) [Item 6. Exhibits](index=35&type=section&id=Item%206.%20Exhibits) This section lists all exhibits filed with the report, including certificates of incorporation, warrant agreements, purchase agreements, and officer certifications

Company Overview - Bluejay Diagnostics, Inc. is a medical diagnostics company focused on improving patient outcomes through its Symphony System, which provides rapid, near-patient testing for sepsis triage and disease progression monitoring [3]. Offering Details - The company announced the closing of a public offering with gross proceeds expected to be approximately $8.75 million, before deducting underwriting discounts and estimated expenses [9]. - The offering consisted of 5,368,098 Common Units or Prefunded Units, with each unit comprising one share of common stock or one pre-funded warrant, two Class C warrants, and one Class D warrant [9]. - The purchase price for each Common Unit was set at $1.63, while the Prefunded Unit was priced at $1.6299 [9]. Use of Proceeds - The net proceeds from the offering will be utilized to repay $2.3 million in outstanding debt, fund FDA approval-related activities, and support research and development, as well as general working capital needs [5]. Underwriting and Legal Counsel - Aegis Capital Corp. acted as the underwriter for the offering, while Hogan Lovells US LLP served as counsel to the company [6].