Core Insights - Bluejay Diagnostics, Inc. announced results from the SYMON-I study, which investigates the role of interleukin-6 (IL-6) in patients with sepsis and septic shock [1][2] Study Findings - The primary analysis of 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 [2] - Secondary outcomes revealed that IL-6 levels are also predictive of in-hospital mortality, while traditional clinical tests like lactate and SOFA scores did not predict 28-day mortality [3] Future Directions - Bluejay Diagnostics plans to initiate the SYMON-II pivotal study in Q3 2024 to validate SYMON-I findings, with the intention to support a 510(k) application to the FDA in 2025 [4][8] - The Symphony IL-6 Test aims to assist in assessing the cumulative 28-day risk of all-cause mortality for sepsis patients in the ICU [4] Company Overview - Bluejay Diagnostics is focused on developing rapid and accessible biomarker testing, with the Symphony IL-6 Test being its lead product candidate designed for sepsis triage [9]

As filed with the Securities and Exchange Commission on June 24, 2024 Registration Statement No. 333-280253 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 AMENDMENT NO. 1 TO FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 Bluejay Diagnostics, Inc. (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorporation or organization) Delaware 3841 47-3552922 (Primary Standard Industrial Classification Code Number) (I.R.S. Employer Ident ...

Core Viewpoint - Bluejay Diagnostics, Inc. has announced a reverse stock split of its common stock at a ratio of 1-for-8, effective June 20, 2024, to improve its stock price and market perception [3][6]. Company Overview - Bluejay Diagnostics, Inc. is a medical technology company focused on developing rapid diagnostics through its Symphony platform, aimed at enhancing patient outcomes in critical care settings [3][5]. - The company's first product candidate is an IL-6 Test for sepsis triage, designed to deliver accurate results in approximately 20 minutes, facilitating timely medical decisions [5]. Reverse Stock Split Details - The reverse stock split will consolidate every eight shares of common stock into one share, reducing the total outstanding shares from approximately 4,511,756 to about 563,969 [6]. - The par value of the shares will remain unchanged at $0.0001 per share, and no fractional shares will be issued; instead, cash payments will be provided for any fractional shares [6]. - The reverse stock split will not affect stockholders' percentage interest in the company, except for adjustments related to fractional shares [6]. Stockholder Instructions - The company has appointed Continental Stock Transfer & Trust Company as the exchange agent for the reverse stock split, providing instructions to stockholders with certificate shares [4]. - Stockholders holding shares in book-entry form or brokerage accounts will see the effects of the reverse stock split reflected automatically in their accounts [4].

As filed with the Securities and Exchange Commission on June 17, 2024 Registration Statement No. 333- UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 Bluejay Diagnostics, Inc. (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorporation or organization) Delaware 3841 47-3552922 (Primary Standard Industrial Classification Code Number) (I.R.S. Employer Identification Number) 360 Mas ...

[Cover Page](index=1&type=section&id=Cover%20Page) This section provides the official cover page for the Quarterly Report on Form 10-Q, detailing key filing information for Bluejay Diagnostics, Inc [Form 10-Q Filing Information](index=1&type=section&id=Form%2010-Q%20Filing%20Information) This document is a Quarterly Report on Form 10-Q for the period ended March 31, 2024, filed by Bluejay Diagnostics, Inc. The company is a non-accelerated filer and a smaller reporting company, indicating its size and reporting obligations - The registrant is filing a Quarterly Report on Form 10-Q for the period ended March 31, 2024[7](index=7&type=chunk)[23](index=23&type=chunk) - The registrant is a Non-Accelerated Filer and a Smaller Reporting Company[9](index=9&type=chunk)[23](index=23&type=chunk)[24](index=24&type=chunk) - As of May 1, 2024, the registrant had **2,904,448 shares of common stock** outstanding[25](index=25&type=chunk) [TABLE OF CONTENTS](index=3&type=section&id=TABLE%20OF%20CONTENTS) This section provides an organized listing of all chapters and sections within the quarterly report for easy navigation [CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS](index=4&type=section&id=CAUTIONARY%20NOTE%20REGARDING%20FORWARD-LOOKING%20STATEMENTS) This section warns readers that the report contains forward-looking statements subject to risks and uncertainties, and actual results may differ [Forward-Looking Statements Disclaimer](index=4&type=section&id=Forward-Looking%20Statements%20Disclaimer) The report contains forward-looking statements that are subject to known and unknown risks, uncertainties, and assumptions. Readers are cautioned not to place undue reliance on these statements, as actual results may differ materially, and the company is under no duty to update them - Forward-looking statements are subject to known and unknown risks, uncertainties, and assumptions, and actual results may differ materially[13](index=13&type=chunk)[103](index=103&type=chunk) - The company cannot guarantee future results, level of activity, performance, or achievements and is under no duty to update these statements after the filing date[14](index=14&type=chunk)[29](index=29&type=chunk) - All forward-looking statements are qualified by cautionary statements, and the company claims the protection of the safe harbor provision of the Private Securities Litigation Reform Act of 1995[29](index=29&type=chunk) [EXPLANATORY NOTE](index=5&type=section&id=EXPLANATORY%20NOTE) This section defines the terms used throughout the report to refer to Bluejay Diagnostics, Inc. and its subsidiary [Company Reference Definition](index=5&type=section&id=Company%20Reference%20Definition) In this Form 10-Q, 'the Company,' 'we,' 'us,' and 'our' refer to Bluejay Diagnostics, Inc. and its wholly owned subsidiary Bluejay SpinCo, LLC, taken as a whole - The terms 'Company,' 'we,' 'us,' and 'our' refer to Bluejay Diagnostics, Inc. and its wholly owned subsidiary Bluejay SpinCo, LLC[30](index=30&type=chunk) [PART I - FINANCIAL INFORMATION](index=6&type=section&id=PART%20I%20FINANCIAL%20INFORMATION) This part presents the unaudited condensed consolidated financial statements and management's discussion and analysis of financial condition and results of operations [Item 1. Condensed Consolidated Financial Statements (Unaudited)](index=6&type=section&id=Item%201.%20Condensed%20Consolidated%20Financial%20Statements%20%28Unaudited%29) This section presents the unaudited condensed consolidated financial statements, including the Balance Sheets, Statements of Operations, Statements of Changes in Stockholders' Equity, and Statements of Cash Flows for the periods ended March 31, 2024, and December 31, 2023 (for balance sheet) or March 31, 2023 (for income statement and cash flow) [Condensed Consolidated Balance Sheets](index=6&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) The company's total assets increased slightly from $4.87 million at December 31, 2023, to $5.08 million at March 31, 2024. Total liabilities decreased from $1.97 million to $1.71 million, while total stockholders' equity increased from $2.89 million to $3.37 million | Metric | March 31, 2024 | December 31, 2023 | Change (Absolute) | Change (%) | | :------------------------- | :------------- | :---------------- | :---------------- | :--------- | | Cash and cash equivalents | $2,661,169 | $2,208,516 | $452,653 | 20.50% | | Total current assets | $3,449,747 | $3,220,860 | $228,887 | 7.11% | | Total assets | $5,075,077 | $4,868,531 | $206,546 | 4.24% | | Total current liabilities | $1,525,741 | $1,771,375 | $(245,634) | -13.87% | | Total liabilities | $1,707,851 | $1,973,683 | $(265,832) | -13.47% | | Total stockholders' equity | $3,367,226 | $2,894,848 | $472,378 | 16.32% | [Condensed Consolidated Statements of Operations](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) The company reported a net loss of $2.33 million for the three months ended March 31, 2024, an improvement from a $2.54 million net loss in the same period of 2023. This was primarily driven by a reduction in total operating expenses and other income | Metric | Three Months Ended March 31, 2024 | Three Months Ended March 31, 2023 | Change (Absolute) | Change (%) | | :------------------------- | :-------------------------------- | :-------------------------------- | :---------------- | :--------- | | Research and development | $1,334,797 | $1,354,549 | $(19,752) | -1.46% | | General and administrative | $1,086,884 | $1,176,977 | $(90,093) | -7.65% | | Sales and marketing | $6,424 | $148,046 | $(141,622) | -95.66% | | Total operating expenses | $2,428,105 | $2,679,572 | $(251,467) | -9.38% | | Operating loss | $(2,428,105) | $(2,679,572) | $251,467 | -9.38% | | Other income, net | $99,640 | $139,729 | $(40,089) | -28.69% | | Net loss | $(2,328,465) | $(2,539,843) | $211,378 | -8.32% | | Basic net loss per share | $(0.99) | $(2.49) | $1.50 | -60.24% | | Weighted-average shares | 2,359,376 | 1,018,755 | 1,340,621 | 131.59% | [Condensed Consolidated Statements of Changes in Stockholders' Equity](index=8&type=section&id=Condensed%20Consolidated%20Statements%20of%20Changes%20in%20Stockholders'%20Equity) Stockholders' equity increased from $2.89 million at December 31, 2023, to $3.37 million at March 31, 2024. This increase was primarily due to the issuance of common stock and prefunded warrants, net of issuance costs, totaling $2.79 million, partially offset by a net loss of $2.33 million Warrants Outstanding at March 31, 2024 | Metric | December 31, 2023 | March 31, 2024 | | :------------------------------------------------------------------ | :---------------- | :------------- | | Common Shares | 1,239,140 | 2,688,448 | | Stock Amount | $124 | $269 | | Additional Paid-In Capital | $29,845,714 | $32,646,412 | | Accumulated Deficit | $(26,950,990) | $(29,279,455) | | Total Stockholders' Equity | $2,894,848 | $3,367,226 | | **Changes during Q1 2024:** | | | | Stock-based compensation expense | | $11,874 | | Issuance of Common Stock and PreFunded Warrants net of costs | | $2,788,969 | | Exercise of PreFunded Warrants | | $0 | | Net loss | | $(2,328,465) | - A **1-for-20 reverse stock split** was effective July 24, 2023, retroactively adjusting historical share and per share information[48](index=48&type=chunk)[78](index=78&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=9&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Net cash provided by financing activities significantly increased to $2.78 million in Q1 2024, compared to a net cash use of $58,803 in Q1 2023, primarily due to proceeds from a public offering. This led to a positive net increase in cash and cash equivalents of $452,653 in Q1 2024, a substantial improvement from a decrease of $3.33 million in Q1 2023 | Cash Flow Activity | Three Months Ended March 31, 2024 | Three Months Ended March 31, 2023 | | :----------------------------- | :-------------------------------- | :-------------------------------- | | Operating activities | $(2,296,076) | $(2,933,607) | | Investing activities | $(35,433) | $(340,669) | | Financing activities | $2,784,162 | $(58,803) | | Net increase (decrease) in cash | $452,653 | $(3,333,079) | | Cash, beginning of period | $2,208,516 | $10,114,990 | | Cash, end of period | $2,661,169 | $6,781,911 | - Proceeds from the issuance of common stock, gross, amounted to **$3,500,000 in Q1 2024**, significantly boosting financing cash flow[51](index=51&type=chunk) [Notes to Condensed Consolidated Financial Statements](index=10&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) The notes provide detailed information on the company's operations, significant accounting policies, agreements, equity instruments, related party transactions, and financial commitments, offering context to the condensed financial statements [1. NATURE OF OPERATIONS AND BASIS OF PRESENTATION](index=10&type=section&id=1.%20NATURE%20OF%20OPERATIONS%20AND%20BASIS%20OF%20PRESENTATION) Bluejay Diagnostics is a medical diagnostics company developing rapid tests on its Symphony platform, with its first product being the Symphony IL-6 test for sepsis monitoring. The company is conducting SYMON clinical studies and aims for FDA 510(k) submission in 2025. It faces a Nasdaq minimum bid price non-compliance and potential delisting, which could severely impact its ability to raise capital and stock liquidity - Bluejay Diagnostics is developing rapid tests using its Symphony technology platform for critical care settings, with the Symphony IL-6 test targeting sepsis monitoring[53](index=53&type=chunk)[54](index=54&type=chunk) - The company initiated multicenter SYMON clinical studies in Q1 2024, investigating IL-6's role in sepsis, with preliminary SYMON-I pilot study results showing a strong association between baseline IL-6 levels and in-hospital/28-day mortality[37](index=37&type=chunk) - The company plans to use SYMON-II validation study results to support a 510(k) application to the FDA, targeting submission in 2025[39](index=39&type=chunk)[56](index=56&type=chunk) - Bluejay received a Nasdaq notification on February 28, 2024, for non-compliance with the **$1.00 minimum bid price requirement** and has 180 days to regain compliance. Failure to do so could lead to delisting, impacting stock liquidity and ability to raise capital[41](index=41&type=chunk)[42](index=42&type=chunk)[58](index=58&type=chunk)[76](index=76&type=chunk)[77](index=77&type=chunk) [2. SIGNIFICANT ACCOUNTING POLICIES](index=13&type=section&id=2.%20SIGNIFICANT%20ACCOUNTING%20POLICIES) The company's financial statements are prepared under US GAAP, with no material changes to significant accounting policies in Q1 2024. It operates as one segment and faces a going concern uncertainty due to insufficient cash, requiring additional capital in the near-term to avoid potential liquidation. The company adopted ASU No. 2020-06 on January 1, 2024, with no material impact - The company's financial statements are prepared in conformity with US GAAP, and there were no changes to significant accounting policies during the three months ended March 31, 2024[63](index=63&type=chunk)[80](index=80&type=chunk) - The company has one operating segment and the majority of its assets are located in the United States[68](index=68&type=chunk) - The company faces a going concern uncertainty, expecting to run out of available cash resources in the near-term without material additional capital, potentially leading to liquidation[61](index=61&type=chunk)[79](index=79&type=chunk)[138](index=138&type=chunk) Potentially Dilutive Securities (Common Stock Equivalent Shares) | Security Type | 2024 | 2023 | | :-------------------------------- | :---------- | :------ | | Options to purchase common stock | 29,770 | 36,992 | | Restricted stock units (RSUs) | 1,000 | 9,875 | | Warrants for common stock | 271,714 | 40,594 | | Class A warrants for common stock | 124,200 | 124,200 | | Class B warrants for common stock | 3,770 | 3,770 | | 5-Year warrants for common stock | 2,692,308 | - | | Prefunded warrants for common stock | 1,243,000 | - | - The company adopted ASU No. 2020-06 on January 1, 2024, which had no material impact on its condensed consolidated financial statements[88](index=88&type=chunk) [3. LICENSE AND SUPPLY AGREEMENT WITH TORAY INDUSTRIES](index=16&type=section&id=3.%20LICENSE%20AND%20SUPPLY%20AGREEMENT%20WITH%20TORAY%20INDUSTRIES) Bluejay Diagnostics entered into new agreements with Toray Industries on October 23, 2023, including an Amended and Restated License Agreement and a Master Supply Agreement. The New Toray License Agreement reduced royalty payments from 15% to 7.5% of net sales of certain cartridges, and the New Toray Supply Agreement involves Toray manufacturing intermediate components for FDA approval cartridges, not for commercial sale - On October 23, 2023, Bluejay and Toray entered into a New Toray License Agreement and a New Toray Supply Agreement[94](index=94&type=chunk) - The New Toray License Agreement reduced royalty payments from **15% to 7.5%** (or less in certain circumstances) of net sales of certain cartridges for a term of 10 years[94](index=94&type=chunk) - Under the New Toray Supply Agreement, Toray manufactures product intermediate components for cartridges used for FDA approval, not for commercial sale, with the term ending October 23, 2025, or upon FDA approval[4](index=4&type=chunk) - There were no sales of or revenues from the cartridges during the three months ended March 31, 2024 and 2023[94](index=94&type=chunk)[124](index=124&type=chunk) [4. WARRANTS](index=16&type=section&id=4.%20WARRANTS) As of March 31, 2024, Bluejay Diagnostics had various warrants outstanding, including 2,692,308 January 2024 Common Stock Warrants and 1,243,000 January 2024 Prefunded Warrants. The company completed a public offering on January 2, 2024, selling common stock and prefunded warrants, along with January 2024 Warrants. A significant portion of Prefunded Warrants have been exercised Warrants Outstanding at March 31, 2024 | Warrant Type | Shares | Exercisable For | Weighted Average Exercise Price | Average Remaining Life (Years) | | :-------------------------------- | :---------- | :-------------- | :------------------------------ | :----------------------------- | | January 2024 Common Stock Warrants | 2,692,308 | Common Stock | $1.30 | 4.8 | | January 2024 Placement Agent Warrants | 188,462 | Common Stock | $1.625 | 4.8 | | January 2024 Prefunded Warrants | 1,243,000 | Common Stock | $0.0001 | – | | August 2023 Common Stock Warrants | 216,000 | Common Stock | $7.365 | 4.4 | | August 2023 Placement Agent Warrants | 15,120 | Common Stock | $9.2063 | 4.4 | | Class A Warrants | 124,200 | Common Stock | $140.00 | 2.6 | | Class B Warrants | 3,770 | Common Stock | $200.00 | 2.6 | | Other Pre-2024 Common Stock Warrants | 40,594 | Common Stock | $64.73 | 1.9 | - On January 2, 2024, the company completed a public offering, selling **537,768 shares of common stock** and prefunded warrants to purchase up to **2,154,540 shares**, along with warrants to purchase up to **2,692,308 shares**[89](index=89&type=chunk) - As of March 31, 2024, **911,540 Prefunded Warrants** had been exercised, with an additional **216,000** exercised between March 31, 2024, and May 15, 2024[5](index=5&type=chunk) [5. STOCK COMPENSATION](index=17&type=section&id=5.%20STOCK%20COMPENSATION) Bluejay Diagnostics has two stock incentive plans (2018 Plan and 2021 Plan) for employees, consultants, and directors. As of March 31, 2024, 13,113 shares were available for grant under the 2018 Plan and 40,377 shares under the 2021 Plan. The company recorded $11,874 in stock-based compensation expense for Q1 2024, a significant decrease from $219,589 in Q1 2023, and has unrecognized compensation expense for non-vested awards - The 2018 Stock Incentive Plan has **13,113 shares** available for grant at March 31, 2024[91](index=91&type=chunk) - The 2021 Stock Plan has **40,377 shares** available for grant at March 31, 2024[2](index=2&type=chunk) Stock-Based Compensation Expense | Expense Category | Three Months Ended March 31, 2024 | Three Months Ended March 31, 2023 | | :------------------------- | :-------------------------------- | :-------------------------------- | | Research and development | $4,845 | $44,845 | | General and administrative | $7,029 | $159,584 | | Sales and marketing | $0 | $15,160 | | Total | $11,874 | $219,589 | - As of March 31, 2024, there was approximately **$12,609 of unrecognized compensation expense** for non-vested stock options (0.91 years weighted-average period) and **$6,331** for non-vested restricted stock awards (0.50 years weighted-average period)[127](index=127&type=chunk) [6. RELATED PARTY TRANSACTIONS](index=19&type=section&id=6.%20RELATED%20PARTY%20TRANSACTIONS) Bluejay Diagnostics has an agreement with NanoHybrids, LLC, a company majority-owned by Bluejay's Chief Technology Officer, to provide research and development staff and laboratory facilities. Income from NanoHybrids decreased from $95,798 in Q1 2023 to $73,591 in Q1 2024, while amounts receivable increased - The company has an agreement with NanoHybrids, LLC, majority-owned by its CTO, to utilize company staff and facilities for R&D work[119](index=119&type=chunk) NanoHybrids Related Party Transactions | Metric | Three Months Ended March 31, 2024 | Three Months Ended March 31, 2023 | | :-------------------------------------- | :-------------------------------- | :-------------------------------- | | Income from NanoHybrids | $73,591 | $95,798 | | Cash receipts from NanoHybrids | $0 | $19,731 | | **Balance Sheet (As of):** | March 31, 2024 | December 31, 2023 | | Amounts receivable from NanoHybrids | $73,591 | $41,269 | [7. PROPERTY AND EQUIPMENT](index=20&type=section&id=7.%20PROPERTY%20AND%20EQUIPMENT) Net property and equipment increased slightly to $1.30 million at March 31, 2024, from $1.29 million at December 31, 2023. Construction-in-process is the largest component, and the company revised the useful life of certain lab equipment in Q1 2023, resulting in additional depreciation Property and Equipment, Net | Category | March 31, 2024 | December 31, 2023 | | :----------------------------- | :------------- | :---------------- | | Construction-in-process | $1,088,255 | $1,052,822 | | Furniture, fixtures, equipment | $141,164 | $141,164 | | Software | $4,457 | $4,457 | | Lab equipment | $1,287,783 | $1,287,783 | | Leasehold improvements | $43,231 | $43,231 | | Total gross P&E | $2,564,890 | $2,529,457 | | Less: accumulated depreciation | $(1,263,430) | $(1,243,716) | | Property and equipment, net | $1,301,460 | $1,285,741 | - In Q1 2023, the company revised the useful life of certain lab equipment, resulting in approximately **$45,000 of additional depreciation**[132](index=132&type=chunk) [8. LEASES](index=20&type=section&id=8.%20LEASES) The company has lease arrangements for office, laboratory space, and copiers. Total lease assets decreased to $312,625 at March 31, 2024, from $348,419 at December 31, 2023, and total lease liabilities also decreased to $332,728 from $370,105. The weighted average remaining lease term for operating leases is 2.7 years, with a discount rate of 7.0% Lease Assets and Liabilities | Category | March 31, 2024 | December 31, 2023 | | :------------------------------------- | :------------- | :---------------- | | Operating lease right-of-use asset | $298,655 | $333,267 | | Finance lease asset | $13,970 | $15,152 | | Total lease assets | $312,625 | $348,419 | | Current operating lease liability | $145,811 | $162,990 | | Current finance lease liability | $4,807 | $4,807 | | Non-current operating lease liabilities | $170,703 | $189,987 | | Non-current finance lease liabilities | $11,407 | $12,321 | | Total lease liabilities | $332,728 | $370,105 | Supplemental Lease Information (Q1 2024) | Metric | Value | | :-------------------------------------------- | :-------- | | Weighted average remaining lease term (operating) | 2.7 years | | Weighted average remaining lease term (finance) | 3.9 years | | Weighted average discount rate | 7.0% | | Operating cash flows from operating leases | $44,214 | | Operating cash flows from finance leases | $4,807 | Estimated Operating Lease Payments | Year | Amount | | :--------- | :---------- | | 2024 | $120,812 | | 2025 | $100,000 | | 2026 | $100,000 | | 2027 | $25,000 | | Total | $345,812 | | Less: Imputed interest | $29,298 | | Present value of lease liability | $316,514 | [9. COMMITMENTS AND CONTINGENCIES](index=22&type=section&id=9.%20COMMITMENTS%20AND%20CONTINGENCIES) The company has indemnification provisions in agreements with service providers but has not incurred any losses to date. It is also committed to royalty payments to Toray of 7.5% of net sales of cartridges following the first sale, with no sales recorded through March 31, 2024 - The company has indemnification provisions in agreements but has not incurred any indemnification losses to date[105](index=105&type=chunk)[135](index=135&type=chunk) - Royalty payments of **7.5% of net sales** are due to Toray following the first sale of cartridges, with no sales recorded through March 31, 2024[124](index=124&type=chunk)[148](index=148&type=chunk) [10. SUPPLEMENTAL BALANCE SHEET INFORMATION](index=22&type=section&id=10.%20SUPPLEMENTAL%20BALANCE%20SHEET%20INFORMATION) Supplemental balance sheet information details prepaid expenses and other current assets, which increased to $788,578 at March 31, 2024, from $747,263 at December 31, 2023. Accrued expenses and other current liabilities slightly decreased to $1,108,105 from $1,116,911, with a notable decrease in accrued CFO separation agreement expenses Prepaid Expenses and Other Current Assets | Category | March 31, 2024 | December 31, 2023 | | :---------------------------- | :------------- | :---------------- | | Prepaid insurance | $37,090 | $136,342 | | Vendor prepayments | $538,019 | $558,959 | | Prepaid other | $213,469 | $51,962 | | Total prepaid expenses and other current assets | $788,578 | $747,263 | Accrued Expenses and Other Current Liabilities | Category | March 31, 2024 | December 31, 2023 | | :---------------------------------------- | :------------- | :---------------- | | Accrued personnel costs | $519,377 | $566,087 | | Goods received but unpaid | $8,066 | $78,579 | | Accrued expenses for CFO separation agreement | $20,000 | $160,000 | | Accrued legal fees | $107,570 | $157,670 | | Accrued clinical trial expenses | $350,620 | $0 | | Accrued other | $102,472 | $154,575 | | Total accrued expenses and other current liabilities | $1,108,105 | $1,116,911 | [Item 2. 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) This section provides management's perspective on the company's financial condition and operational results, highlighting the ongoing net losses, significant cash burn from operations, and the critical need for additional capital to continue as a going concern. It also details changes in operating expenses and cash flow activities [Overview](index=23&type=section&id=Overview) Bluejay Diagnostics is a clinical-stage medical diagnostics company developing rapid tests on its Symphony platform. The company has consistently incurred net losses and negative cash flow from operations, leading to a significant accumulated deficit and a critical need for imminent additional capital to avoid potential liquidation - Bluejay Diagnostics is a clinical-stage medical diagnostics company developing rapid tests using its Symphony platform for critical care settings[106](index=106&type=chunk) - The company has incurred net losses and negative cash flow from operations since inception, with an accumulated deficit of approximately **$29.2 million** as of March 31, 2024[126](index=126&type=chunk) - As of March 31, 2024, the company had **$2.7 million in cash and cash equivalents** and **$1.5 million in current liabilities**, with net cash used in operating activities of **$2.3 million** for the quarter[138](index=138&type=chunk) - The company requires a material amount of additional capital in the imminent near-term to continue operations and avoid potential liquidation under U.S. bankruptcy laws, which would likely result in no material value for common stockholders[138](index=138&type=chunk) [Results of Operations](index=23&type=section&id=Results%20of%20Operations) For the three months ended March 31, 2024, the company's net loss improved to $2.33 million from $2.54 million in the prior year, primarily due to reduced operating expenses. Research and development, general and administrative, and sales and marketing expenses all decreased, while other income also saw a decline | Metric | Three Months Ended March 31, 2024 | Three Months Ended March 31, 2023 | Change (Absolute) | Change (%) | | :------------------------- | :-------------------------------- | :-------------------------------- | :---------------- | :--------- | | Research and development | $1,334,796 | $1,354,549 | $(19,753) | -1.46% | | General and administrative | $1,086,884 | $1,176,977 | $(90,093) | -7.65% | | Sales and marketing | $6,426 | $148,046 | $(141,620) | -95.66% | | Total operating expenses | $2,428,105 | $2,679,572 | $(251,467) | -9.38% | | Operating loss | $(2,428,105) | $(2,679,572) | $251,467 | -9.38% | | Other income, net | $99,460 | $139,729 | $(40,269) | -28.82% | | Net loss | $(2,328,465) | $(2,539,843) | $211,378 | -8.32% | [Comparison of the Three Months Ended March 31, 2024 and 2023](index=23&type=section&id=Comparison%20of%20the%20Three%20Months%20Ended%20March%2031%2C%202024%20and%202023) Operating expenses decreased by 9.38% year-over-year, driven by reductions across all categories. Net loss improved by 8.32% due to these expense controls, despite a decrease in other income [Research and Development](index=23&type=section&id=Research%20and%20Development) Research and development expenses slightly decreased by 1.46% to $1.3 million in Q1 2024, primarily due to reduced technology transfer efforts, partially offset by increased clinical trial expenses. Future R&D will focus on clinical trials, technology transfer, and manufacturing improvements - Research and development expenses decreased by approximately **$19,753 (1.46%) to $1.33 million** in Q1 2024, mainly due to reduced technology transfer efforts offsetting increased clinical trial expenses[152](index=152&type=chunk) - Future R&D expenses are expected to focus on clinical trial programs, regulatory strategy, technology transfer, and manufacturing improvements[152](index=152&type=chunk) [General and Administrative](index=25&type=section&id=General%20and%20Administrative) General and administrative expenses decreased by 7.65% to $1.1 million in Q1 2024, reflecting ongoing efforts to preserve capital by limiting infrastructure investment and reducing professional services in line with the commercialization timeline - General and administrative expenses decreased by approximately **$90,093 (7.65%) to $1.09 million** in Q1 2024[154](index=154&type=chunk) - The decrease is attributed to capital preservation efforts, including limiting infrastructure investment and reducing professional services[154](index=154&type=chunk) [Sales and Marketing](index=25&type=section&id=Sales%20and%20Marketing) Sales and marketing expenses saw a drastic reduction of 95.66% to approximately $6,500 in Q1 2024, down from $148,000 in Q1 2023, due to a significant cut in all sales and marketing efforts - Sales and marketing expenses decreased by approximately **$141,620 (95.66%) to $6,426** in Q1 2024[155](index=155&type=chunk) - This substantial reduction was due to a decrease in spending across all sales and marketing efforts[155](index=155&type=chunk) [Other Income, net](index=25&type=section&id=Other%20Income%2C%20net) Other income, net, decreased by 28.82% to approximately $100,000 in Q1 2024, compared to $140,000 in Q1 2023. This decline was primarily due to lower interest income from a reduced cash balance and decreased related party income from NanoHybrids - Other income, net, decreased by approximately **$40,269 (28.82%) to $99,460** in Q1 2024[139](index=139&type=chunk) - The decrease was primarily due to lower interest income (approx. **$12,000 reduction**) and decreased related party income from NanoHybrids (approx. **$22,000 reduction**)[139](index=139&type=chunk) [Liquidity and Going Concern Uncertainty](index=25&type=section&id=Liquidity%20and%20Going%20Concern%20Ucertainty) Bluejay Diagnostics faces significant liquidity challenges and a going concern uncertainty, with only $2.7 million in cash and cash equivalents against $1.5 million in current liabilities as of March 31, 2024. The company used $2.3 million in operating cash in Q1 2024 and urgently needs to raise substantial additional capital to continue operations, as its board has not yet identified viable financing or strategic alternatives, raising the risk of liquidation - As of March 31, 2024, the company had approximately **$2.7 million in cash and cash equivalents** and **$1.5 million in current liabilities**[140](index=140&type=chunk) - Net cash used in operating activities was approximately **$2.3 million** for the quarter ended March 31, 2024[140](index=140&type=chunk) - The company expects to need a material amount of additional capital in the imminent near-term to continue operations and will likely run out of cash resources without it[140](index=140&type=chunk) - The board of directors has not yet identified viable financing or strategic alternatives, and inability to obtain financing could lead to liquidation under Chapter 7 bankruptcy, with no material value expected for common stockholders[156](index=156&type=chunk) - Due to lack of cash, the company has slowed its clinical trial timeline, delaying Symphony platform regulatory submission until 2025, with further delays or cessation of activities possible if financing is not secured[140](index=140&type=chunk) [Summary Statement of Cash Flows](index=26&type=section&id=Summary%20Statement%20of%20Cash%20Flows) Cash flows from operating activities decreased by $0.6 million in Q1 2024, while investing activities decreased by $306,000. Financing activities significantly increased cash by $2.8 million due to a public offering, resulting in a net increase in cash and cash equivalents for the quarter | Cash Flow Activity | Three Months Ended March 31, 2024 | Three Months Ended March 31, 2023 | Net Change (Absolute) | | :----------------------------- | :-------------------------------- | :-------------------------------- | :-------------------- | | Operating activities | $(2,296,076) | $(2,933,607) | $637,531 | | Investing activities | $(35,433) | $(340,669) | $305,236 | | Financing activities | $2,784,162 | $(58,803) | $2,842,965 | | Net increase (decrease) in cash | $452,653 | $(3,333,079) | $3,785,732 | [Net cash used in operating activities](index=26&type=section&id=Net%20cash%20used%20in%20operating%20activities) Net cash used in operating activities decreased by approximately $0.6 million to $2.3 million in Q1 2024, primarily due to reduced personnel and product development costs - Net cash used in operating activities decreased by approximately **$0.6 million to $2.3 million** in Q1 2024, compared to $2.9 million in Q1 2023[158](index=158&type=chunk) - The decrease was primarily due to a reduction in personnel costs and product development costs[158](index=158&type=chunk) [Net cash used in investing activities](index=26&type=section&id=Net%20cash%20used%20in%20investing%20activities) Net cash used in investing activities decreased by approximately $306,000 to $35,000 in Q1 2024, compared to $340,669 in Q1 2023, mainly due to limited purchasing of manufacturing equipment - Net cash used in investing activities decreased by approximately **$306,000 to $35,433** in Q1 2024, compared to $340,669 in Q1 2023[142](index=142&type=chunk) - This decrease was primarily due to limited purchasing of manufacturing equipment[142](index=142&type=chunk) [Net cash used in financing activities](index=26&type=section&id=Net%20cash%20used%20in%20financing%20activities) Net cash provided by financing activities increased by approximately $2.8 million to $2.8 million in Q1 2024, compared to a net use of $58,803 in Q1 2023, driven by proceeds from the January 2, 2024 public offering - Net cash provided by financing activities increased by approximately **$2.8 million to $2.78 million** in Q1 2024, compared to a net use of $58,803 in Q1 2023[173](index=173&type=chunk) - The increase was primarily due to the public offering completed on January 2, 2024[173](index=173&type=chunk) [Recently Adopted Accounting Standards](index=26&type=section&id=Recently%20Adopted%20Accounting%20Standards) The company has implemented all new accounting pronouncements in effect that may impact its financial statements and does not anticipate any material impact from other recently issued but not yet effective standards - The company has implemented all new accounting pronouncements that are in effect and may impact its financial statements[145](index=145&type=chunk) - No other new accounting pronouncements are believed to have a material impact on the company's financial position or results of operations[145](index=145&type=chunk) [Emerging Growth Company and Smaller Reporting Company Status](index=26&type=section&id=Emerging%20Growth%20Company%20and%20Smaller%20Reporting%20Company%20Status) Bluejay Diagnostics is an 'emerging growth company' and a 'smaller reporting company,' which allows it to take advantage of reduced disclosure obligations. The company will remain an emerging growth company until certain revenue or market capitalization thresholds are met or five years post-IPO - The company is an 'emerging growth company' as defined by the JOBS Act[143](index=143&type=chunk) - The company is also a 'smaller reporting company,' allowing it to present only two years of audited financial statements and have reduced executive compensation disclosure obligations[161](index=161&type=chunk) - The company will remain an emerging growth company until the earliest of specific conditions related to fiscal year, annual gross revenues (**$1.07 billion**), large accelerated filer status (**$700 million market value**), or non-convertible debt issuance (**$1 billion**)[160](index=160&type=chunk) [JOBS Act Accounting Election](index=27&type=section&id=JOBS%20Act%20Accounting%20Election) While the JOBS Act allows emerging growth companies to delay adopting new accounting standards, Bluejay Diagnostics has irrevocably elected not to use this extended transition period and will adopt new or revised accounting standards on the same dates as other public companies - The JOBS Act allows emerging growth companies to delay adopting new or revised accounting standards[175](index=175&type=chunk) - Bluejay Diagnostics has irrevocably elected not to avail itself of this extended transition period and will adopt new or revised accounting standards on the relevant dates required for other public companies[175](index=175&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=27&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) As a smaller reporting company, Bluejay Diagnostics is not required to provide the information typically required under this item regarding quantitative and qualitative disclosures about market risk - As a smaller reporting company, Bluejay Diagnostics is not required to provide quantitative and qualitative disclosures about market risk[146](index=146&type=chunk)[176](index=176&type=chunk) [Item 4. Controls and Procedures](index=27&type=section&id=Item%204.%20Controls%20and%20Procedures) Management, including the CEO, evaluated the effectiveness of disclosure controls and procedures as of March 31, 2024, and concluded they were effective. There were no material changes in internal control over financial reporting during the quarter [(a) Evaluation of Disclosure Controls and Procedures and Changes in Internal Control over Financial Reporting](index=27&type=section&id=%28a%29%20Evaluation%20of%20Disclosure%20Controls%20and%20Procedures%20and%20Changes%20in%20Internal%20Control%20over%20Financial%20Reporting) The company's management, including the CEO, concluded that disclosure controls and procedures were effective as of March 31, 2024, following an evaluation - Management, including the President and CEO, concluded that disclosure controls and procedures were effective as of March 31, 2024[147](index=147&type=chunk) [(b) Changes in Internal Control Over Financial Reporting](index=27&type=section&id=%28b%29%20Changes%20in%20Internal%20Control%20Over%20Financial%20Reporting) There were no changes in internal control over financial reporting during the quarter ended March 31, 2024, that materially affected or are reasonably likely to materially affect the company's internal control over financial reporting - No material changes in internal control over financial reporting occurred during the quarter ended March 31, 2024[163](index=163&type=chunk) [PART II - OTHER INFORMATION](index=28&type=section&id=PART%20II%20OTHER%20INFORMATION) This part provides additional information not covered in the financial statements, including legal proceedings, risk factors, and exhibits [Item 1. Legal Proceedings](index=28&type=section&id=Item%201.%20Legal%20Proceedings) Bluejay Diagnostics is not currently involved in any legal proceedings. While the company may face litigation in the ordinary course of business, it accrues for known issues when probable and estimable, and has not incurred any indemnification losses to date - The company is not currently involved in any legal proceedings[177](index=177&type=chunk) - The company accrues for known indemnification issues when a loss is probable and can be reasonably estimated, but has not incurred any indemnification losses to date[105](index=105&type=chunk) [Item 1A. Risk Factors](index=28&type=section&id=Item%201A.%20Risk%20Factors) The company faces severe financial risks, including an imminent need for material additional capital to avoid liquidation, which would likely result in no material value for common stockholders. Additionally, the company is non-compliant with Nasdaq's minimum bid price requirement and could face delisting if its market value falls below $1 million - The company needs imminent material additional capital to remain a going concern; absent this, it may be forced into liquidation under U.S. bankruptcy laws, with common stockholders likely recouping no material value[166](index=166&type=chunk)[178](index=178&type=chunk) - The company is non-compliant with Nasdaq's **$1.00 minimum bid price requirement** and could be delisted if its common stock price further declines or if the market value of its publicly held securities falls below **$1 million** (currently **$1.25 million** as of May 9, 2024)[179](index=179&type=chunk)[180](index=180&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=28&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) There were no unregistered sales of equity securities or use of proceeds to report for the period - No unregistered sales of equity securities and use of proceeds to report[167](index=167&type=chunk) [Item 3. Defaults Upon Senior Securities](index=28&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) There were no defaults upon senior securities to report for the period - No defaults upon senior securities to report[167](index=167&type=chunk) [Item 4. Mine Safety Disclosures](index=28&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) Mine safety disclosures are not applicable to the company's operations - Mine safety disclosures are not applicable[182](index=182&type=chunk) [Item 5. Other Information](index=28&type=section&id=Item%205.%20Other%20Information) There is no other information to report for the period - No other information to report[167](index=167&type=chunk)[181](index=181&type=chunk) [Item 6. Exhibits](index=29&type=section&id=Item%206.%20Exhibits) This section lists the exhibits filed with the Form 10-Q, including certifications from the Principal Executive Officer and Principal Financial Officer, as well as Inline XBRL documents List of Exhibits | Number | Description | | :------- | :------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | | 31.1* | Certification of the Principal Executive Officer pursuant to Rule 13a-14(a) or 15d-14(a) of the Securities Exchange Act of 1934. | | 31.2* | Certification of the Principal Financial Officer pursuant to Rule 13a-14(a) or 15d-14(a) of the Securities Exchange Act of 1934. | | 32.1*(1) | Certification of the Principal Executive Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. | | 32.2*(1) | Certification of the Principal Financial Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. | | 101.INS* | Inline XBRL Instance Document. | | 101.SCH* | Inline XBRL Taxonomy Extension Schema Document. | | 101.CAL* | Inline XBRL Taxonomy Extension Calculation Linkbase Document. | | 101.DEF* | Inline XBRL Taxonomy Extension Definition Linkbase Document. | | 101.LAB* | Inline XBRL Taxonomy Extension Label Linkbase Document. | | 101.PRE* | Inline XBRL Taxonomy Extension Presentation Linkbase Document. | | 104* | Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101). | - Certifications on Exhibit 32 are deemed not 'filed' for purposes of Section 18 of the Exchange Act and are not incorporated by reference into any filing[184](index=184&type=chunk) [SIGNATURES](index=30&type=section&id=SIGNATURES) This section contains the official signatures attesting to the accuracy and completeness of the quarterly report [Report Signatures](index=30&type=section&id=Report%20Signatures) The report is duly signed on behalf of Bluejay Diagnostics, Inc. by Neil Dey, President, Chief Executive Officer, Principal Financial Officer, and Principal Accounting Officer, on May 15, 2024 - The report was signed by Neil Dey, President, Chief Executive Officer, Principal Financial Officer, and Principal Accounting Officer, on May 15, 2024[186](index=186&type=chunk)

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 ...

As filed with the Securities and Exchange Commission on December 27, 2023 Registration Statement No. 333-275697 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 AMENDMENT NO. 2 TO FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 Bluejay Diagnostics, Inc. (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorporation or organization) (Primary Standard Industrial Classification Code Number) Delaware 3841 47-3552922 (I.R.S. Employer I ...

(Exact name of registrant as specified in its charter) (State or other jurisdiction of incorporation or organization) (Primary Standard Industrial Classification Code Number) As filed with the Securities and Exchange Commission on December 21, 2023 Registration Statement No. 333-275697 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 AMENDMENT NO. 1 TO FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 Bluejay Diagnostics, Inc. Washington, DC 20004 (212) 659-7300 (202) 6 ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 As filed with the Securities and Exchange Commission on November 21, 2023 Registration Statement No. 333- FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 Bluejay Diagnostics, Inc. (Exact name of registrant as specified in its charter) Delaware 3841 47-3552922 (State or other jurisdiction of incorporation or organization) (Primary Standard Industrial Classification Code Number) (I.R.S. Employer Identification Number) 360 ...

PART I - FINANCIAL INFORMATION [Item 1. Condensed Consolidated Financial Statements (Unaudited)](index=6&type=section&id=Item%201.%20Condensed%20Consolidated%20Financial%20Statements%20(Unaudited)) This section presents the unaudited condensed consolidated financial statements, including balance sheets, statements of operations, changes in stockholders' equity, and cash flows, along with detailed notes on the company's operations, significant accounting policies, and financial instruments. Key updates include the **August 2023 offering**, a revised FDA regulatory strategy focusing on sepsis, and the company's going concern status due to continued net losses and need for additional capital [Condensed Consolidated Balance Sheets](index=6&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) Condensed Consolidated Balance Sheets | Metric | September 30, 2023 | December 31, 2022 | | :----------------------------------- | :------------------- | :------------------ | | **ASSETS** | | | | Cash and cash equivalents | $5,076,937 | $10,114,990 | | Total current assets | $6,527,742 | $11,788,470 | | Total assets | $8,246,608 | $13,521,265 | | **LIABILITIES AND STOCKHOLDERS' EQUITY** | | | | Total current liabilities | $2,800,140 | $1,640,254 | | Total liabilities | $3,033,453 | $1,979,992 | | Total stockholders' equity | $5,213,155 | $11,541,273 | | Total liabilities and stockholders' equity | $8,246,608 | $13,521,265 | [Condensed Consolidated Statements of Operations](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) Condensed Consolidated Statements of Operations | Metric | Three Months Ended Sep 30, 2023 | Three Months Ended Sep 30, 2022 | Nine Months Ended Sep 30, 2023 | Nine Months Ended Sep 30, 2022 | | :----------------------------------- | :------------------------------ | :------------------------------ | :----------------------------- | :----------------------------- | | Revenue | $ - | $ - | $ - | $ 249,040 | | Gross profit | $ - | $ - | $ - | $ 48,911 | | Research and development | $ 1,397,318 | $ 1,379,665 | $ 4,428,123 | $ 2,830,705 | | General and administrative | $ 963,534 | $ 1,284,411 | $ 3,213,614 | $ 3,801,226 | | Sales and marketing | $ (19,619) | $ 146,102 | $ 282,756 | $ 281,144 | | Total operating expenses | $ 2,341,233 | $ 2,810,178 | $ 7,924,493 | $ 6,913,075 | | Operating loss | $ (2,341,233) | $ (2,810,178) | $ (7,924,493) | $ (6,864,164) | | Total other income (expense), net | $ 43,235 | $ (149,711) | $ 273,347 | $ (46,530) | | Net loss | $ (2,297,998) | $ (2,959,889) | $ (7,651,146) | $ (6,910,694) | | Net loss per share - Basic and diluted | $ (2.08) | $ (2.94) | $ (7.30) | $ (6.86) | | Weighted average common shares outstanding: Basic and diluted | $ 1,102,966 | $ 1,007,617 | $ 1,048,430 | $ 1,007,445 | [Condensed Consolidated Statements of Changes in Stockholders' Equity](index=8&type=section&id=Condensed%20Consolidated%20Statements%20of%20Changes%20in%20Stockholders%27%20Equity) Condensed Consolidated Statements of Changes in Stockholders' Equity | Metric | Common Shares (Sep 30, 2023) | Common Stock Amount (Sep 30, 2023) | Additional Paid-In Capital (Sep 30, 2023) | Accumulated Deficit (Sep 30, 2023) | Total Stockholders' Equity (Sep 30, 2023) | | :--------------------------------------------------------------------------------------------------- | :--------------------------- | :------------------------- | :---------------------------------------- | :--------------------------------- | :-------------------------------------- | | Balance as of December 31, 2022 | 1,010,560 | $ 101 | $ 28,538,274 | $ (16,997,102) | $ 11,541,273 | | Stock-based compensation expense | - | - | 54,730 | - | 54,730 | | Grants of fully vested restricted stock units to settled accrued bonus, net of shares withheld | 12,188 | 1 | 107,234 | - | 107,235 | | Net loss | - | - | - | (2,539,843) | (2,539,843) | | Balance as of March 31, 2023 | 1,022,748 | 102 | 28,700,238 | (19,536,945) | 9,163,395 | | Stock-based compensation expense | - | - | 27,702 | - | 27,702 | | Issuance of common stock | 750 | - | - | - | - | | RSU tax withholding | (358) | - | (1,453) | - | (1,453) | | Net loss | - | - | - | (2,813,305) | (2,813,305) | | Balance as of June 30, 2023 | 1,023,140 | 102 | 28,726,487 | (22,350,250) | 6,376,339 | | Stock-based compensation expense | - | - | (42,482) | - | (42,482) | | Issuance of common stock, net of issuance costs of $413,544 | 216,000 | 22 | 1,177,274 | - | 1,177,296 | | Net loss | - | - | - | (2,297,998) | (2,297,998) | | Balance as of September 30, 2023 | 1,239,140 | $ 124 | $ 29,861,279 | $ (24,648,248) | $ 5,213,155 | [Condensed Consolidated Statements of Cash Flows](index=9&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Condensed Consolidated Statements of Cash Flows | Metric | Nine Months Ended Sep 30, 2023 | Nine Months Ended Sep 30, 2022 | | :----------------------------------- | :----------------------------- | :----------------------------- | | Net cash used in operating activities | $ (5,536,393) | $ (4,797,350) | | Net cash used in investing activities | $ (616,272) | $ (961,063) | | Net cash provided by financing activities | $ 1,114,612 | $ - | | Net decrease in cash and cash equivalents | $ (5,038,053) | $ (5,758,413) | | Cash and cash equivalents, end of period | $ 5,076,937 | $ 13,289,365 | [Notes to the Condensed Consolidated Financial Statements](index=10&type=section&id=Notes%20to%20the%20Condensed%20Consolidated%20Financial%20Statements) [1. NATURE OF OPERATIONS AND BASIS OF PRESENTATION](index=10&type=section&id=1.%20NATURE%20OF%20OPERATIONS%20AND%20BASIS%20OF%20PRESENTATION) Bluejay Diagnostics is a medical diagnostics company developing rapid tests on its Symphony platform for critical care settings, with its first product being the Symphony IL-6 test for sepsis risk stratification. The company has shifted its FDA regulatory focus from COVID-19 to sepsis and plans a **510(k)** submission in **H1 2024**. Operations are funded by IPO proceeds and a recent **August 2023 offering**. The company executed a **1-for-20 reverse stock split** in **July 2023** and faces a going concern risk due to continued net losses and the need for additional capital to fund operations beyond **Q1 2024** - Bluejay's primary product is the Symphony IL-6 test, designed for rapid monitoring of disease progression in critical care, particularly for sepsis patients[48](index=48&type=chunk)[72](index=72&type=chunk) - The company's FDA regulatory strategy has shifted from COVID-19 to an initial indication for risk stratification of hospitalized sepsis patients, with a **510(k)** submission planned for the **first half of 2024**[52](index=52&type=chunk)[100](index=100&type=chunk) - In **August 2023**, the company completed a registered direct offering of **216,000** shares of common stock at **$7.365** per share, raising **$1,590,840** in gross proceeds, and issued warrants[75](index=75&type=chunk)[50](index=50&type=chunk)[99](index=99&type=chunk) - A **1-for-20 reverse stock split** was effective **July 24, 2023**, reducing authorized shares from **100,000,000** to **7,500,000** and regaining Nasdaq compliance[80](index=80&type=chunk)[103](index=103&type=chunk)[55](index=55&type=chunk) - The company has incurred net losses since inception, has negative cash flows from operations, and requires additional funding beyond **Q1 2024**, raising substantial doubt about its ability to continue as a going concern[104](index=104&type=chunk)[82](index=82&type=chunk)[56](index=56&type=chunk) [2. SIGNIFICANT ACCOUNTING POLICIES](index=13&type=section&id=2.%20SIGNIFICANT%20ACCOUNTING%20POLICIES) The company's financial statements are prepared using US GAAP, requiring management estimates for areas like stock-based compensation and accruals. No material changes to significant accounting policies were made during the nine months ended **September 30, 2023**. The company operates as a single segment and calculates basic and diluted net loss per share, noting that potentially dilutive securities were anti-dilutive for all periods presented - No changes to significant accounting policies were made during the nine months ended **September 30, 2023**, as described in the **2022** Audited Financial Statements[107](index=107&type=chunk) - The company uses the Black-Scholes option pricing model for stock-based compensation, recognizing expense on a straight-line basis over the service period[84](index=84&type=chunk)[109](index=109&type=chunk) - Research and development costs, including salaries, supplies, and clinical trial expenses, are expensed as incurred[85](index=85&type=chunk)[111](index=111&type=chunk) - The company has one operating segment. Diluted net loss per share is the same as basic due to anti-dilutive securities[113](index=113&type=chunk)[114](index=114&type=chunk) Potentially Dilutive Securities (Common Stock Equivalent Shares) | Security Type | September 30, 2023 | September 30, 2022 | | :----------------------------------- | :------------------- | :------------------- | | Options to purchase common stock | 31,361 | 39,389 | | Restricted stock units | 7,875 | - | | Warrants for common stock | 271,714 | 40,594 | | Class A warrants for common stock | 124,200 | 124,200 | | Class B warrants for common stock | 3,770 | 3,770 | [3. LICENSE AND SUPPLY AGREEMENT WITH TORAY INDUSTRIES](index=14&type=section&id=3.%20LICENSE%20AND%20SUPPLY%20AGREEMENT%20WITH%20TORAY%20INDUSTRIES) The company previously held an exclusive license with Toray for protein detection cartridges, with royalty payments contingent on regulatory approval and sales. As of **September 30, 2023**, no sales or revenues from these cartridges had occurred. This agreement was superseded by new agreements in **October 2023** - The original License and Supply Agreement with Toray Industries granted an exclusive license (outside Japan) for protein detection cartridges, with **15%** royalties on net sales after regulatory approval and minimum annual royalties of **$60,000** (first year) and **$100,000** (thereafter)[117](index=117&type=chunk) - No sales or revenues from the cartridges occurred during the nine-month periods ended **September 30, 2023** and **2022**[117](index=117&type=chunk) - The original agreement was superseded by the New Toray License Agreement and Master Supply Agreement on **October 23, 2023**[118](index=118&type=chunk)[228](index=228&type=chunk) [4. WARRANTS](index=15&type=section&id=4.%20WARRANTS) As of **September 30, 2023**, the company had various warrants outstanding, including Common Stock Warrants, Class A Warrants, and Class B Warrants, with different exercise prices and remaining lives. The **August 2023 offering** included the issuance of **216,000** Common Stock Warrants and **15,120** Placement Agent Warrants Warrants Outstanding as of September 30, 2023 | Warrant Type | Shares Exercisable | Weighted Average Exercise Price | Weighted Average Remaining Life (in Years) | | :------------------- | :----------------- | :------------------------------ | :----------------------------------------- | | Common Stock Warrants | 271,714 | $15.94 | 4.5 | | Class A Warrants | 124,200 | $140.00 | 3.1 | | Class B Warrants | 3,770 | $200.00 | 3.1 | - During the three and nine months ended **September 30, 2023**, the company issued **216,000** Warrants and **15,120** Placement Agent Warrants as part of the **August 2023 offering**[91](index=91&type=chunk) - No Class B Warrants were exercised during the nine months ended **September 30, 2023**, compared to **40,100** exercised on a cashless basis in the same period of **2022**[121](index=121&type=chunk) [5. STOCK COMPENSATION](index=15&type=section&id=5.%20STOCK%20COMPENSATION) The company operates under the **2021** Stock Plan and the **2018** Stock Incentive Plan, with shares available for grant. Stock-based compensation expense was recorded for both stock options and restricted stock units, with a decrease in total expense for the nine months ended **September 30, 2023**, compared to **2022** - As of **September 30, 2023**, there were **40,377** shares available for grant under the **2021** Plan and **13,113** shares under the **2018** Plan[93](index=93&type=chunk)[122](index=122&type=chunk) Stock-Based Compensation Expense | Expense Category | Three Months Ended Sep 30, 2023 | Three Months Ended Sep 30, 2022 | Nine Months Ended Sep 30, 2023 | Nine Months Ended Sep 30, 2022 | | :----------------------------------- | :------------------------------ | :------------------------------ | :----------------------------- | :----------------------------- | | Research and development | $ 9,393 | $ 20,528 | $ 54,389 | $ 54,231 | | General and administrative | $ (30,275) | $ 92,531 | $ 157,971 | $ 290,397 | | Sales and marketing | $ (21,600) | $ 160 | $ (7,550) | $ 790 | | Total stock-based compensation | $ (42,482) | $ 113,219 | $ 204,810 | $ 345,418 | - The weighted average grant date fair value of options granted decreased from **$29.00** per share in **2022** to **$8.80** per share in **2023**[125](index=125&type=chunk) - As of **September 30, 2023**, unrecognized compensation expense was **$46,083** for stock options (over **8.56 years**) and **$31,872** for restricted stock units (over **9.11 years**)[151](index=151&type=chunk) [6. RELATED PARTY TRANSACTIONS](index=17&type=section&id=6.%20RELATED%20PARTY%20TRANSACTIONS) The company has an agreement with NanoHybrids, Inc., where company staff and facilities are used to perform work for NanoHybrids, billed at cost plus **10%**. The company's Chief Technology Officer is the majority shareholder of NanoHybrids - The company provides research and development services to NanoHybrids, Inc., billing at fully burdened personnel cost plus **10%**, and rebills lab supplies[152](index=152&type=chunk) - The company's Chief Technology Officer is the majority shareholder of NanoHybrids[152](index=152&type=chunk) Related Party Transactions with NanoHybrids | Metric | Three Months Ended Sep 30, 2023 | Three Months Ended Sep 30, 2022 | Nine Months Ended Sep 30, 2023 | Nine Months Ended Sep 30, 2022 | | :----------------------------------- | :------------------------------ | :------------------------------ | :----------------------------- | :----------------------------- | | Income from NanoHybrids | $ - | $ 42,649 | $ 136,773 | $ 118,575 | | Cash receipts from NanoHybrids | $ - | $ 35,040 | $ 156,504 | $ 75,926 | | Amounts receivable from NanoHybrids (Sep 30, 2023) | $ - | | | | | Amounts receivable from NanoHybrids (Dec 31, 2022) | | | | $ 19,731 | [7. PROPERTY AND EQUIPMENT, NET](index=18&type=section&id=7.%20PROPERTY%20AND%20EQUIPMENT%2C%20NET) Property and equipment, net, increased from **$1,232,070** at **December 31, 2022**, to **$1,321,711** at **September 30, 2023**, primarily due to an increase in construction-in-process. The company revised the useful life of certain lab equipment in **Q1 2023**, resulting in additional depreciation Property and Equipment, Net | Category | September 30, 2023 | December 31, 2022 | | :----------------------------------- | :------------------- | :------------------ | | Construction-in-process | $1,067,149 | $375,466 | | Furniture, fixtures, and equipment | $141,164 | $136,942 | | Software | $4,457 | $4,457 | | Lab equipment | $1,287,783 | $1,268,380 | | Leasehold improvements | $43,231 | $43,231 | | Total | $2,543,784 | $1,828,476 | | Less: accumulated depreciation | $(1,222,073) | $(596,406) | | Property and equipment, net | $1,321,711 | $1,232,070 | - The company revised the useful life of certain lab equipment in the **first quarter of 2023**, leading to approximately **$431,740** of additional depreciation for the nine months ended **September 30, 2023**[154](index=154&type=chunk) [8. LEASES](index=18&type=section&id=8.%20LEASES) The company primarily leases office and laboratory space, with weighted average remaining lease terms of **3.1 years** for operating leases and **4.3 years** for finance leases as of **September 30, 2023**. Total lease assets and liabilities decreased compared to **December 31, 2022** Lease Information | Metric | September 30, 2023 | December 31, 2022 | | :----------------------------------- | :------------------- | :------------------ | | Weighted average remaining lease term - operating leases (in years) | 3.1 | 3.9 | | Weighted average remaining lease term - finance leases (in years) | 4.3 | 5.3 | | Weighted average discount rate | 7.0% | 7.0% | | Operating lease right-of-use asset | $367,248 | $465,514 | | Finance leases in Property and Equipment | $21,067 | $21,067 | | Total lease assets | $388,315 | $486,581 | | Total lease liabilities | $406,836 | $513,251 | Estimated Lease Payments (Excludes 9 months ended Sep 30, 2023) | Year | Finance Leases | Operating Leases | | :--- | :------------- | :--------------- | | 2023* | $1,202 | $42,177 | | 2024 | $4,807 | $162,991 | | 2025 | $4,807 | $100,000 | | 2026 | $4,807 | $100,000 | | 2027 | $5,207 | $25,000 | | Thereafter | $ - | $ - | | Total future lease payments | $20,830 | $430,168 | | Less: Imputed interest | $2,803 | $41,359 | | Present value of lease liability | $18,027 | $388,809 | [9. COMMITMENTS AND CONTINGENCIES](index=19&type=section&id=9.%20COMMITMENTS%20AND%20CONTINGENCIES) The company recorded a **$240,000** severance liability for its former CFO, Kenneth Fisher, following his departure in **September 2023**. Royalty payments to Toray are contingent on product sales, with minimum annual royalties of **$60,000** (first year) and **$100,000** (thereafter) after regulatory approval, but no sales have occurred to date. The company has not incurred any indemnification losses - A severance liability of **$240,000** was recorded for former CFO Kenneth Fisher, included in accrued expenses as of **September 30, 2023**[130](index=130&type=chunk) - Minimum royalty payments to Toray of **$60,000** (first year) and **$100,000** (subsequent years) are required after the first sale of cartridges following regulatory approval, creditable against actual royalties[131](index=131&type=chunk) - No sales or revenues from cartridges have occurred through **September 30, 2023**[131](index=131&type=chunk) - The company has not incurred any indemnification losses to date and thus has no accruals for such issues[158](index=158&type=chunk) [10. SUBSEQUENT EVENTS](index=20&type=section&id=10.%20SUBSEQUENT%20EVENTS) On **October 23, 2023**, the company entered into new agreements with Toray, the New Toray License Agreement and New Toray Supply Agreement, which supersede previous agreements. The new license agreement reduces royalty payments to Toray from **15%** to **7.5%** (or less) of net sales for a **10-year term** and facilitates technology transfer to Sanyoseiko for cartridge manufacturing for FDA approval purposes - The New Toray License Agreement and New Toray Supply Agreement, effective **October 23, 2023**, supersede prior agreements[228](index=228&type=chunk) - The New Toray License Agreement reduces royalty payments to Toray from **15%** to **7.5%** (or less in certain circumstances) of net sales for a **10-year term**[159](index=159&type=chunk) - The new agreements provide for the transfer of certain cartridge technology to Sanyoseiko and outline Toray's near-term manufacturing of intermediate components for FDA approval purposes, with Sanyoseiko taking over after approval[159](index=159&type=chunk)[134](index=134&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=21&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) This section provides an overview of the company's financial performance, highlighting continued net losses and negative cash flows. It details changes in revenue, operating expenses (R&D, G&A, S&M), and other income, and discusses the company's liquidity, going concern status, and its classification as an emerging growth and smaller reporting company [Overview](index=21&type=section&id=Overview) - The company is a clinical-stage medical diagnostics company developing rapid tests on its Symphony platform for critical care settings[162](index=162&type=chunk) - The company incurred net losses of approximately **$7.7 million** and **$6.9 million** for the nine months ended **September 30, 2023** and **2022**, respectively, with an accumulated deficit of approximately **$24.6 million** as of **September 30, 2023**[135](index=135&type=chunk) - Negative cash flow from operating activities was approximately **$5.5 million** and **$4.8 million** for the nine months ended **September 30, 2023** and **2022**, respectively[135](index=135&type=chunk) [Results of Operations](index=21&type=section&id=Results%20of%20Operations) - Revenue and gross profit were zero for the three-month period ended **September 30, 2023**, and decreased by approximately **$0.2 million** and **$0.1 million**, respectively, for the nine-month period due to a minor sale to Toray in **2022** that was not anticipated to recur[137](index=137&type=chunk) - Research and development expenses increased to **$4.4 million** for the nine months ended **September 30, 2023**, from **$2.8 million** in **2022**, primarily due to higher personnel and product development costs, with further increases expected for clinical trials and manufacturing[193](index=193&type=chunk) - General and administrative expenses decreased to **$3.2 million** for the nine months ended **September 30, 2023**, from **$3.8 million** in **2022**, reflecting efforts to preserve capital and workforce reductions[140](index=140&type=chunk) - Sales and marketing expenses decreased for the three months ended **September 30, 2023**, primarily due to the cancellation and forfeiture of equity awards by terminated personnel and cost savings efforts[167](index=167&type=chunk) - Other income, net, increased for the nine months ended **September 30, 2023**, to **$0.3 million** from **$0.2 million** in **2022**, driven by higher interest rates and increased related party income from NanoHybrids[195](index=195&type=chunk) [Liquidity and Going Concern](index=22&type=section&id=Liquidity%20and%20Going%20Concern) - As of **September 30, 2023**, the company had approximately **$5.1 million** in cash and cash equivalents and **$2.8 million** in current liabilities[168](index=168&type=chunk) - Current capital is not sufficient to fund operations for the next twelve months, necessitating additional capital through equity offerings, grants, debt, or strategic alliances, which raises substantial doubt about the company's ability to continue as a going concern[168](index=168&type=chunk)[169](index=169&type=chunk)[142](index=142&type=chunk) [Summary Statement of Cash Flows](index=23&type=section&id=Summary%20Statement%20of%20Cash%20Flows) Cash Flow Summary (Nine Months Ended September 30) | Activity | 2023 | 2022 | | :----------------------------------- | :------------- | :------------- | | Operating activities | $(5,536,393) | $(4,797,350) | | Investing activities | $(616,272) | $(961,063) | | Financing activities | $1,114,612 | $ - | | Net decrease in cash and cash equivalents | $(5,038,053) | $(5,758,413) | - Net cash used in operating activities increased by approximately **$0.7 million** in **2023** compared to **2022**, primarily due to higher personnel and product development costs, partially offset by non-cash items[198](index=198&type=chunk) - Net cash used in investing activities decreased by approximately **$0.3 million** in **2023**, mainly due to a reduced need for equipment purchases following a shift away from COVID-19 patient focus[145](index=145&type=chunk) - Net cash provided by financing activities increased significantly in **2023** due to proceeds from the **August 2023 offering**[171](index=171&type=chunk) [Emerging Growth Company and Smaller Reporting Company Status](index=23&type=section&id=Emerging%20Growth%20Company%20and%20Smaller%20Reporting%20Company%20Status) - The company qualifies as an 'emerging growth company' under the JOBS Act, allowing it to delay adoption of new accounting standards and benefit from reduced disclosure obligations regarding executive compensation and auditor attestation[172](index=172&type=chunk)[174](index=174&type=chunk)[175](index=175&type=chunk)[2](index=2&type=chunk) - The company also qualifies as a 'smaller reporting company,' which permits presenting only two most recent fiscal years of audited financial statements and reduced executive compensation disclosures[1](index=1&type=chunk)[3](index=3&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=25&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) As a smaller reporting company, Bluejay Diagnostics is not required to provide the information typically mandated under this item - The company is a smaller reporting company and is not required to provide information regarding quantitative and qualitative disclosures about market risk[3](index=3&type=chunk)[176](index=176&type=chunk) [Item 4. Controls and Procedures](index=25&type=section&id=Item%204.%20Controls%20and%20Procedures) Management, including the CEO and Interim CFO, concluded that the company's disclosure controls and procedures were effective as of **September 30, 2023**. No material changes to internal control over financial reporting occurred during the quarter - The Chief Executive Officer and Interim Chief Financial Officer concluded that the company's disclosure controls and procedures were effective as of **September 30, 2023**[4](index=4&type=chunk) - There were no material changes in the company's internal control over financial reporting during the quarter ended **September 30, 2023**[177](index=177&type=chunk) PART II - OTHER INFORMATION [Item 1. Legal Proceedings](index=26&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently involved in any legal proceedings. However, it acknowledges that litigation outcomes are unpredictable and could be costly and time-consuming if claims arise - The company is not currently involved in any legal proceedings[207](index=207&type=chunk) - Legal proceedings are inherently unpredictable, and any claims could be time-consuming, costly, and divert significant management resources[6](index=6&type=chunk) [Item 1A. Risk Factors](index=26&type=section&id=Item%201A.%20Risk%20Factors) This section outlines significant risks, particularly those related to the company's new license and supply agreements with Toray and its dependence on licensed intellectual property and contract manufacturing. These risks include supply limitations, regulatory approval challenges, warranty disclaimers, potential termination of agreements, and the complexities and costs associated with protecting and enforcing intellectual property rights [Risks Related to Our Business](index=26&type=section&id=Risks%20Related%20to%20Our%20Business) - The New License Agreement with Toray and New Supply Agreement contain significant risks that may threaten the company's viability, including minimum royalty payments regardless of sales (**$60,000** initial, **$100,000** thereafter)[179](index=179&type=chunk)[209](index=209&type=chunk) - Toray is only required to supply cartridge intermediates until **October 2025**, with a maximum **six-month extension**, posing a risk of future supply interruption if Sanyoseiko cannot manufacture within that period[9](index=9&type=chunk) - The company must bear the sole expense and responsibility for obtaining all regulatory approvals (e.g., FDA) and legal permits, a process that is expensive, time-consuming, and without assurance of success[10](index=10&type=chunk) - Toray disclaims most representations, warranties, or covenants relating to the licensed intellectual property, including fitness for purpose or against third-party infringement, limiting the company's recourse for IP flaws[11](index=11&type=chunk) - Toray has the right to terminate the New License Agreement or make it non-exclusive if the company fails to generate commercial sales by **October 2028** (or **October 2030** if due to company-controlled events)[182](index=182&type=chunk) - The company is dependent on SanyoSeiko as its primary contract manufacturing organization (CMO), and any failure by SanyoSeiko could threaten the company's viability or ability to obtain FDA approval and commercialize products[213](index=213&type=chunk)[232](index=232&type=chunk) [Risks Related to Our Intellectual Property](index=28&type=section&id=Risks%20Related%20to%20Our%20Intellectual%20Property) - The company is substantially dependent on intellectual property licensed from Toray, and disputes over this license or Toray's failure to adequately protect it could significantly harm the business[185](index=185&type=chunk)[214](index=214&type=chunk) - Toray generally controls the filing, prosecution, maintenance, defense, and enforcement of the licensed intellectual property; if Toray fails to do so, the company's ability to develop and launch products may be adversely affected[14](index=14&type=chunk)[215](index=215&type=chunk) - Risks to IP protection include competitors developing similar technologies, pending applications not being approved or taking longer, and the complexity and expense of enforcing IP rights[16](index=16&type=chunk)[20](index=20&type=chunk)[216](index=216&type=chunk)[217](index=217&type=chunk) - The company and/or Toray may face significant expense and liability from litigation or other proceedings related to third-party intellectual property rights, including claims challenging invention or ownership[16](index=16&type=chunk)[21](index=21&type=chunk)[188](index=188&type=chunk)[222](index=222&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=30&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) This item is not applicable to the company for the reporting period - This item is not applicable[17](index=17&type=chunk) [Item 3. Defaults Upon Senior Securities](index=30&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) There were no defaults upon senior securities during the reporting period - None[22](index=22&type=chunk) [Item 4. Mine Safety Disclosures](index=30&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company for the reporting period - None[223](index=223&type=chunk) [Item 5. Other Information](index=30&type=section&id=Item%205.%20Other%20Information) There is no other information to report under this item - None[218](index=218&type=chunk) [Item 6. Exhibits](index=31&type=section&id=Item%206.%20Exhibits) This section lists all exhibits filed with the Form 10-Q, including corporate documents, warrant forms, securities purchase agreements, the separation agreement for the former CFO, the Amended and Restated License Agreement and Master Supply Agreement with Toray, and various certifications Key Exhibits Filed | Number | Description | | :----- | :---------- | | 3.2 | Certificate of Amendment to the Amended and Restated Certificate of Incorporation, filed **July 21, 2023**. | | 4.1 | Form of Warrant, dated **August 28, 2023**. | | 10.1 | Form of Securities Purchase Agreement, dated **August 24, 2023**. | | 10.2* | Separation Agreement and General Release, dated **October 6, 2023**, with Kenneth Fisher. | | 10.3 | Amended and Restated License Agreement, entered into on **October 23, 2023**, by and between Bluejay Diagnostics, Inc. and Toray Industries, Inc. | | 10.4 | Master Supply Agreement, entered into on **October 23, 2023**, by and between Bluejay Diagnostics, Inc. and Toray Industries, Inc. | | 31.1* | Certification of the Principal Executive Officer. | | 31.2* | Certification of the Principal Financial Officer. | | 32.1* | Certification of the Principal Executive Officer pursuant to 18 U.S.C. Section 1350. | | 32.2* | Certification of the Principal Financial Officer pursuant to 18 U.S.C. Section 1350. | [Signatures](index=32&type=section&id=Signatures) The report is duly signed on behalf of Bluejay Diagnostics, Inc. by its Chief Executive Officer and Director, Neil Dey, and Interim Chief Financial Officer, Frances Scally, on **November 9, 2023** - The report was signed by Neil Dey, Chief Executive Officer and Director, and Frances Scally, Interim Chief Financial Officer, on **November 9, 2023**[192](index=192&type=chunk)