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 ...

Financial Performance - The company reported a net loss of $2.81 million for the three months ended June 30, 2023, compared to a net loss of $1.94 million for the same period in 2022, reflecting an increase in operating expenses[32]. - Revenue for the six months ended June 30, 2023, was $249,040 million, unchanged from the same period in 2022[40]. - Net loss for the six months ended June 30, 2023, was $5,252,148 million, compared to a net loss of $3,950,805 million in the same period of 2022, indicating a 33% increase in losses[40]. - Other income for the six months ended June 30, 2023, was $230,112 million, compared to $103,181 million in 2022, showing a significant increase of 123%[40]. Operating Expenses - Total operating expenses for the three months ended June 30, 2023, were $2.90 million, up from $2.03 million in the same period of 2022, with research and development costs increasing to $1.68 million from $0.76 million[32]. - Total operating expenses for the six months ended June 30, 2023, increased to $5,583,260 million from $4,102,897 million in 2022, representing a 36% increase[40]. - Research and development expenses for the six months ended June 30, 2023, were $3,030,805 million, up from $1,451,040 million in 2022, reflecting a 108% increase[40]. - General and administrative expenses decreased to $2,250,080 million for the six months ended June 30, 2023, from $2,516,815 million in 2022, a reduction of 11%[40]. Cash and Liabilities - As of June 30, 2023, the company had cash and cash equivalents of $5.1 million and estimated that these resources would be sufficient to fund operations into the fourth quarter of 2023[18]. - The company incurred approximately $1.8 million in current liabilities and commitments of about $1.9 million as of June 30, 2023[18]. - Total lease liabilities decreased to $442,928 million as of June 30, 2023, from $513,251 million as of December 31, 2022, a decline of 14%[54]. - The company has a minimum royalty payment obligation of $100,000 per year to Toray Industries following the first sale of Cartridges, which has not yet occurred as of June 30, 2023[56]. Stock and Shares - The company executed a reverse stock split at a ratio of 1-for-20 on July 24, 2023, reducing the number of authorized outstanding shares from 100 million to 7.5 million[17]. - The company’s weighted average common shares outstanding for the three months ended June 30, 2023, were 1,023,052, reflecting a 1-for-20 reverse stock split[32]. Clinical Development - The company plans to conduct a clinical study to support an FDA regulatory submission for the Symphony IL-6 test, with a timeline for submission in the first half of 2024[36]. - The company is developing the Symphony device for measuring IL-6, which is intended for monitoring disease progression in critical care settings[35]. - The company is reliant on Toray and Sanyoseiko for cartridges necessary for clinical trials, with potential supply interruptions posing risks to trial timelines[37]. Reporting Classification - The company is classified as a smaller reporting company, with a market value of stock held by non-affiliates below $700 million and annual revenue under $100 million[61].

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q OR Commission file number: 001-41031 47-3552922 (I.R.S. Employer Identification No.) If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐ (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT ...

For the Fiscal Year Ended December 31, 2022 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) TABLE OF CONTENTS | --- | --- | --- | |------------|----------------------------------------------------------------------------------------------|-------| | | | Page | | CAUTIONARY | NOTE REGARDING FORWARD-LOOKING STATEMENTS | ii | | SUMMARY | OF RISK FACTOR ...