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].

This press release contains statements that the Company believes are "forward-looking statements" within the meaning of the Private Litigation Reform Act. Forward-looking statements in this press release include, without limitation, statements pertaining to the completion of the offering, the satisfaction of customary closing conditions related to the offering and the intended use of proceeds from the offering. Forward-looking statements may be identified by words such as "anticipates," "believes," "estimat ...

Core Insights - The SYMON-I study indicates that IL-6 levels measured within 24 hours of sepsis or septic shock diagnosis can predict patient mortality up to 28 days [1][11] - Secondary outcomes of the study reveal that IL-6 is a more reliable predictor of mortality than traditional clinical tests like lactate and SOFA [2] - The SYMON clinical study program aims to enhance understanding of IL-6 as a key biomarker for managing sepsis, potentially improving patient survival rates [3][5] Company Overview - Bluejay Diagnostics is focused on developing rapid and accessible biomarker testing, with its lead product candidate being the Symphony IL-6 Test for sepsis triage [13][14] - The company plans to initiate the SYMON-II pivotal clinical study in Q3 2024, with the intention of using the results to support a 510(k) application to the FDA in 2025 [12] - Bluejay Diagnostics aims to improve clinical outcomes through timely and precise diagnostic tests, with results from the SYMON studies expected to be presented at national scientific meetings and published in peer-reviewed journals [12][14]

ACTON, Mass., June 26, 2024 (GLOBE NEWSWIRE) -- Bluejay Diagnostics, Inc. (NASDAQ: BJDX), today announced results from the primary analysis of SYMON-I, a multicenter pilot clinical study investigating the role of interleukin-6 (IL-6) in patients diagnosed with sepsis and septic shock. This prospective study assessed the utility of IL-6 upon initial presentation to the intensive care unit (ICU). The primary analysis of the SYMON-I study (registered clinical trial number NCT06181604) highlighted that IL-6 lev ...

This press release contains statements that the Company believes are "forward-looking statements" within the meaning of the Private Litigation Reform Act. Forward-looking statements in this press release include, without limitation, the expected nature and timing of the Company's planned FDA submission and related plans for clinical study amendment, whether the Company's cash position will be sufficient to fund operations needed to achieve regulatory approval and initial commercialization of the Symphony IL ...

January 2024 Common Stock Warrants, January 2024 Placement Agent Warrants and January 2024 Prefunded Warrants On July 6, 2021, the Company's board of directors and stockholders approved and adopted the Bluejay Diagnostics, Inc. 2021 Stock Plan (the "2021 Plan"). A total of 98,000 shares of common stock were approved to be initially reserved for issuance under the 2021 Stock Plan. At March 31, 2024, there were 40,377 shares available for grant under the 2021 Plan. Basic net loss per share is computed by divi ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the Fiscal Year Ended December 31, 2023 Or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Commission file number: 001-41031 Bluejay Diagnostics, Inc. (Exact Name of Registrant as Specified in Its Charter) Delaware 47-3552922 (State or Other Jurisdiction of (I.R.S. Employer Incorporat ...

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 million during the most recently completed fiscal year. We may continue to be a smaller reporting company if either (i) the market value of our stock held by non-affiliates is less than $250 million or (ii) our annual revenue is less than $100 million during the most recently completed fiscal year and the market value of our stock hel ...