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].

PART I - FINANCIAL INFORMATION [Item 1. Condensed Consolidated Financial Statements (Unaudited)](index=6&type=section&id=Item%201.%20Condensed%20Consolidated%20Financial%20Statements.) This section presents unaudited condensed consolidated financial statements, including balance sheets, statements of operations, equity changes, and cash flows, with detailed notes [Condensed Consolidated Balance Sheets](index=6&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) Balance Sheet Highlights | Metric | March 31, 2023 | December 31, 2022 | Change (Absolute) | Change (%) | | :--------------------------- | :------------- | :---------------- | :---------------- | :--------- | | Cash and cash equivalents | $6,781,911 | $10,114,990 | $(3,333,079) | -32.95% | | Total current assets | $8,901,923 | $11,788,470 | $(2,886,547) | -24.49% | | Total assets | $10,888,449 | $13,521,265 | $(2,632,816) | -19.47% | | Total current liabilities | $1,420,151 | $1,640,254 | $(220,103) | -13.42% | | Total liabilities | $1,725,031 | $1,979,992 | $(254,961) | -12.88% | | Total stockholders' equity | $9,163,418 | $11,541,273 | $(2,377,855) | -20.60% | | Accumulated deficit | $(19,536,945) | $(16,997,102) | $(2,539,843) | 14.94% | [Condensed Consolidated Statements of Operations](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) Statements of Operations Highlights | Metric | Three Months Ended March 31, 2023 | Three Months Ended March 31, 2022 | Change (Absolute) | Change (%) | | :--------------------------- | :-------------------------------- | :-------------------------------- | :---------------- | :--------- | | Research and development | $1,354,549 | $694,757 | $659,792 | 94.97% | | General and administrative | $1,176,977 | $1,319,819 | $(142,842) | -10.82% | | Sales and marketing | $148,046 | $53,685 | $94,361 | 175.78% | | Total operating expenses | $2,679,572 | $2,068,261 | $611,311 | 29.56% | | Operating loss | $(2,679,572) | $(2,068,261) | $(611,311) | 29.56% | | Other income, net | $139,729 | $54,858 | $84,871 | 154.71% | | Net loss | $(2,539,843) | $(2,013,403) | $(526,440) | 26.15% | | Net loss per share - Basic and diluted | $(0.12) | $(0.10) | $(0.02) | 20.00% | [Condensed Consolidated Statements of Changes in Stockholders' Equity](index=8&type=section&id=Condensed%20Consolidated%20Statements%20of%20Changes%20in%20Stockholders'%20Equity) - Total stockholders' equity decreased by **$2,377,855** from $11,541,273 at December 31, 2022, to $9,163,418 at March 31, 2023[73](index=73&type=chunk) - Net loss for the three months ended March 31, 2023, was **$(2,539,843)**[73](index=73&type=chunk) - Stock-based compensation expense contributed **$54,730** to additional paid-in capital, and grants of fully vested restricted stock units to settle accrued bonuses added **$107,234**[73](index=73&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=9&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Cash Flow Highlights | Cash Flow Activity | Three Months Ended March 31, 2023 | Three Months Ended March 31, 2022 | Change (Absolute) | Change (%) | | :--------------------------- | :-------------------------------- | :-------------------------------- | :---------------- | :--------- | | Net cash used in operating activities | $(2,933,607) | $(1,877,255) | $(1,056,352) | 56.27% | | Net cash used in investing activities | $(340,669) | $(46,346) | $(294,323) | 635.04% | | Net cash used in financing activities | $(58,803) | $0 | $(58,803) | N/A | | Net decrease in cash and cash equivalents | $(3,333,079) | $(1,923,601) | $(1,409,478) | 73.27% | | Cash and cash equivalents, end of period | $6,781,911 | $17,124,177 | $(10,342,266) | -60.39% | [Notes to Condensed Consolidated Financial Statements](index=10&type=section&id=Notes%20to%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) [Business](index=10&type=section&id=Business) - Bluejay Diagnostics is a clinical-stage medical diagnostics company developing rapid tests using its Symphony technology platform for critical care settings, aiming to provide laboratory-quality results in under 20 minutes[77](index=77&type=chunk) - The first product, Symphony IL-6 test, monitors disease progression and assesses infection/inflammation severity, particularly for sepsis[81](index=81&type=chunk) - Future plans include developing cardiac biomarkers (hsTNT and NT pro-BNP) and other tests on the Symphony platform, all requiring FDA clearance, authorization, or approval[82](index=82&type=chunk) [Risks and Uncertainties](index=10&type=section&id=Risks%20and%20Uncertainties) - The company faces risks such as rapid technological change, competition from larger biotechnology companies, dependence on key personnel, inflationary pressures, and global supply chain disruptions[84](index=84&type=chunk) - Nasdaq notified the company on October 25, 2022, of non-compliance with the minimum bid price requirement (below **$1.00** for 30 consecutive business days)[85](index=85&type=chunk) [Going Concern](index=11&type=section&id=Going%20Concern) - The company has incurred net losses and negative cash flows from operations since inception, raising substantial doubt about its ability to continue as a going concern[87](index=87&type=chunk) - Cash and cash equivalents of **$6.8 million** at March 31, 2023, are estimated to fund operations only into the fourth quarter of 2023, requiring additional capital for the next 12 months[88](index=88&type=chunk) - The company is seeking additional capital through various means (equity offerings, grants, debt, collaborations), but there is no assurance that adequate funds will be available on acceptable terms[89](index=89&type=chunk) [Basis of Presentation](index=11&type=section&id=Basis%20of%20Presentation) - The unaudited condensed consolidated financial statements are prepared in conformity with US GAAP, reflecting normal recurring adjustments, and consolidate Bluejay Diagnostics, Inc. and its wholly-owned subsidiary[90](index=90&type=chunk) - Results for the three months ended March 31, 2023, are not necessarily indicative of the results for the full fiscal year[91](index=91&type=chunk) [2. SIGNIFICANT ACCOUNTING POLICIES](index=11&type=section&id=2.%20SIGNIFICANT%20ACCOUNTING%20POLICIES) [Use of estimates](index=11&type=section&id=Use%20of%20estimates) - Management makes estimates and assumptions, particularly for stock-based compensation, accruals, and warrants, which could materially differ from actual results[93](index=93&type=chunk) [Stock-based compensation](index=12&type=section&id=Stock-based%20compensation) - Share-based compensation expense is measured based on the grant-date fair value of the award and recognized on a straight-line basis over the requisite service period[95](index=95&type=chunk)[96](index=96&type=chunk) - The Black-Scholes option pricing model is used to determine the fair value of options granted[96](index=96&type=chunk) [Research and development expenses](index=12&type=section&id=Research%20and%20development%20expenses) - Costs incurred in research and development, including personnel, supplies, professional services, and clinical trials, are expensed as incurred[98](index=98&type=chunk) - Future R&D expenses are expected to focus on clinical trial programs supporting regulatory strategy and manufacturing improvements[68](index=68&type=chunk) [Segment Reporting](index=12&type=section&id=Segment%20Reporting) - The company operates as a single operating segment, with all assets located in the United States as of March 31, 2023, and December 31, 2022[100](index=100&type=chunk) [Net Loss per Share](index=12&type=section&id=Net%20Loss%20per%20Share) - Basic and diluted net loss per share are computed by dividing net loss by the weighted-average common shares outstanding, with no difference between basic and diluted due to anti-dilutive securities[103](index=103&type=chunk) Potentially Dilutive Securities | Potentially Dilutive Securities | 2023 (Common Stock Equivalent Shares) | 2022 (Common Stock Equivalent Shares) | | :------------------------------ | :------------------------------------ | :------------------------------------ | | Options to purchase common stock | 739,835 | 806,065 | | Restricted stock units | 197,500 | - | | Warrants for common stock | 811,882 | 811,882 | | Class A warrants for common stock | 2,484,000 | 2,484,000 | | Class B warrants for common stock | 75,400 | 76,500 | [Recently Adopted Accounting Standards](index=12&type=section&id=Recently%20Adopted%20Accounting%20Standards) - The company adopted ASU No. 2021-08, Business Combinations (Topic 805), on January 1, 2023, which addresses the recognition and measurement of contract assets and liabilities acquired in a business combination[104](index=104&type=chunk) - The adoption of this new standard had no impact on the company's consolidated statements of operations or cash flows[104](index=104&type=chunk) [3. LICENSE AND SUPPLY AGREEMENT WITH TORAY INDUSTRIES](index=14&type=section&id=3.%20LICENSE%20AND%20SUPPLY%20AGREEMENT%20WITH%20TORAY%20INDUSTRIES) - Bluejay Diagnostics holds an exclusive license (outside Japan) from Toray Industries for protein detection cartridges[107](index=107&type=chunk) - Royalty payments of **15%** of net sales are due after regulatory approval and first sale, with minimum annual royalties of **$60,000** (first year) and **$100,000** (subsequent years) creditable against sales royalties[107](index=107&type=chunk) - No sales or revenues from these cartridges were recorded for the three months ended March 31, 2023, and 2022[107](index=107&type=chunk) [4. WARRANTS](index=14&type=section&id=4.%20WARRANTS) Warrant Summary | Warrant Type | Shares Outstanding (March 31, 2023) | Weighted Average Exercise Price | Weighted Average Remaining Life (Years) | | :------------------------ | :---------------------------------- | :------------------------------ | :-------------------------------------- | | Common Stock Warrants | 811,882 | $3.24 | 2.8 | | Class A Warrants | 2,484,000 | $7.00 | 3.6 | | Class B Warrants | 75,400 | $10.00 | 3.6 | - No warrants were issued during the three months ended March 31, 2023, and 2022[110](index=110&type=chunk) - **39,000** Class B Warrants were exercised on a cashless basis during the three months ended March 31, 2022, but none in 2023[113](index=113&type=chunk) [5. STOCK COMPENSATION](index=15&type=section&id=5.%20STOCK%20COMPENSATION) - The company has **262,269** shares available for grant under the 2018 Stock Incentive Plan and **807,541** shares available under the 2021 Stock Plan as of March 31, 2023[115](index=115&type=chunk)[116](index=116&type=chunk) - During Q1 2023, **512,180** restricted stock units were granted, and **374,680** vested, primarily to settle 2022 bonuses[119](index=119&type=chunk) Stock-Based Compensation Expense | Expense Category | Three Months Ended March 31, 2023 | Three Months Ended March 31, 2022 | Change (Absolute) | Change (%) | | :--------------------------- | :-------------------------------- | :-------------------------------- | :---------------- | :--------- | | Research and development | $44,845 | $17,311 | $27,534 | 159.05% | | General and administrative | $159,584 | $108,305 | $51,279 | 47.35% | | Sales and marketing | $15,160 | $470 | $14,690 | 3125.53% | | Total stock-based compensation | $219,589 | $126,086 | $93,503 | 74.16% | [6. RELATED PARTY TRANSACTIONS](index=16&type=section&id=6.%20RELATED%20PARTY%20TRANSACTIONS) - The company has an agreement with NanoHybrids, LLC, wholly owned by Bluejay's CTO, to utilize company R&D staff and lab facilities, billing at fully burdened personnel cost plus **10%**[123](index=123&type=chunk) Income from NanoHybrids | Metric | Three Months Ended March 31, 2023 | Three Months Ended March 31, 2022 | Change (Absolute) | Change (%) | | :------------------------- | :-------------------------------- | :-------------------------------- | :---------------- | :--------- | | Income from NanoHybrids | $95,798 | $40,886 | $54,912 | 134.32% | - Amounts receivable from NanoHybrids increased from **$19,731** at December 31, 2022, to **$95,798** at March 31, 2023[123](index=123&type=chunk) [7. PROPERTY AND EQUIPMENT](index=17&type=section&id=7.%20PROPERTY%20AND%20EQUIPMENT) Property and Equipment, Net | Asset Category | March 31, 2023 | December 31, 2022 | Change (Absolute) | Change (%) | | :------------------------- | :------------- | :---------------- | :---------------- | :--------- | | Construction-in-process | $768,850 | $375,466 | $393,384 | 104.77% | | Lab equipment | $1,275,958 | $1,268,380 | $7,578 | 0.60% | | Total property and equipment, net | $1,519,722 | $1,232,070 | $287,652 | 23.35% | - The company revised the useful life of certain lab equipment in Q1 2023, resulting in approximately **$45,000** of additional depreciation expense[125](index=125&type=chunk) [8. LEASES](index=17&type=section&id=8.%20LEASES) Lease Assets and Liabilities | Metric | March 31, 2023 | December 31, 2022 | | :------------------------------------------------------------------------------------------------ | :------------- | :---------------- | | Operating lease right-of-use asset | $433,361 | $465,514 | | Finance lease asset | $21,067 | $21,067 | | Total lease assets | $454,428 | $486,581 | | Current operating lease liability | $168,709 | $168,706 | | Current finance lease liability | $4,807 | $4,807 | | Non-current operating lease liabilities | $289,910 | $323,915 | | Non-current finance lease liabilities | $14,970 | $15,823 | | Total lease liabilities | $478,396 | $513,251 | - The weighted average remaining lease term for operating leases was **3.5 years** as of March 31, 2023[126](index=126&type=chunk) - Operating cash flows from operating leases increased to **$43,564** for the three months ended March 31, 2023, from **$29,248** in the prior year[126](index=126&type=chunk) [9. COMMITMENTS AND CONTINGENCIES](index=19&type=section&id=9.%20COMMITMENTS%20AND%20CONTINGENCIES) - The company has a non-cancelable purchase commitment of approximately **$800,000** with an international materials vendor, with **50%** prepaid in 2022[128](index=128&type=chunk) - Open non-cancelable commitments for the IL-6 cartridge manufacturing line buildout totaled approximately **$127,000** as of March 31, 2023[129](index=129&type=chunk) - Other non-cancelable purchase commitments, primarily for R&D supplies, prototypes, and advisory services, aggregate to approximately **$1.5 million**, all for less than one year[130](index=130&type=chunk) [10. SUPPLEMENTAL BALANCE SHEET INFORMATION](index=19&type=section&id=10.%20SUPPLEMENTAL%20BALANCE%20SHEET%20INFORMATION) Prepaid Expenses and Other Current Assets | Category | March 31, 2023 | December 31, 2022 | Change (Absolute) | Change (%) | | :------------------------------------------ | :------------- | :---------------- | :---------------- | :--------- | | Prepaid insurance | $564,361 | $751,979 | $(187,618) | -24.95% | | Vendor prepayments | $1,195,193 | $681,218 | $513,975 | 75.45% | | Prepaid other | $360,458 | $240,283 | $120,175 | 50.02% | | Total prepaid expenses and other current assets | $2,120,012 | $1,673,480 | $446,532 | 26.68% | Accrued Expenses and Other Current Liabilities | Category | March 31, 2023 | December 31, 2022 | Change (Absolute) | Change (%) | | :------------------------------------------------- | :------------- | :---------------- | :---------------- | :--------- | | Accrued personnel costs | $343,706 | $533,577 | $(189,871) | -35.59% | | Accrued good receipts | $281,054 | $10,077 | $270,977 | 2689.15% | | Accrued other | $238,637 | $292,076 | $(53,439) | -18.29% | | Total accrued expenses and other current liabilities | $863,397 | $835,730 | $27,667 | 3.31% | [11. SUBSEQUENT EVENTS](index=19&type=section&id=11.%20SUBSEQUENT%20EVENTS) - Nasdaq extended the compliance period for the minimum bid price requirement until October 23, 2023[134](index=134&type=chunk) - The company intends to monitor its stock price and may implement a reverse stock split, if approved by stockholders, to regain compliance[135](index=135&type=chunk) - Failure to regain compliance could lead to delisting, which the company would be entitled to appeal[135](index=135&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=21&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 results of operations, highlighting key performance drivers, liquidity challenges, and regulatory statuses, including its classification as an emerging growth and smaller reporting company [Overview](index=21&type=section&id=Overview) - Bluejay Diagnostics is a clinical-stage medical diagnostics company developing rapid tests on its Symphony platform for critical care settings[66](index=66&type=chunk) - The company has incurred net losses from operations each year since inception and expects this trend to continue, with net losses of approximately **$2.5 million** for Q1 2023 and **$2.0 million** for Q1 2022[67](index=67&type=chunk) - Negative cash flow from operating activities was approximately **$2.9 million** for Q1 2023 and **$1.9 million** for Q1 2022, leading to an accumulated deficit of approximately **$19.5 million** as of March 31, 2023[67](index=67&type=chunk) [Results of Operations](index=21&type=section&id=Results%20of%20Operations) [Research and Development](index=21&type=section&id=Research%20and%20Development) - Research and development expenses increased by approximately **95%** to **$1.4 million** for Q1 2023, up from **$695,000** in Q1 2022[68](index=68&type=chunk) - The increase was primarily due to higher personnel costs and clinical trial expenses[68](index=68&type=chunk) - Future R&D expenses will focus on clinical trial programs supporting regulatory strategy and manufacturing improvements[68](index=68&type=chunk) [General and Administrative](index=22&type=section&id=General%20and%20Administrative) - General and administrative expenses slightly decreased by **10.8%** to **$1.2 million** for Q1 2023, compared to **$1.3 million** in Q1 2022[71](index=71&type=chunk) - This decrease is attributed to ongoing efforts to preserve capital and limit infrastructure investment in line with the commercialization timeline[71](index=71&type=chunk) [Sales and Marketing](index=22&type=section&id=Sales%20and%20Marketing) - Sales and marketing expenses increased by approximately **174%** to **$148,000** for Q1 2023, up from **$54,000** in Q1 2022[56](index=56&type=chunk) - The increase was primarily due to increased personnel costs[56](index=56&type=chunk) [Other Income, net](index=22&type=section&id=Other%20Income,%20net) - Other income, net, significantly increased by **154.5%** to **$140,000** for Q1 2023, compared to **$55,000** in Q1 2022[57](index=57&type=chunk) - This increase was primarily driven by approximately **$28,000** higher interest income and an **$84,000** increase in related party income from NanoHybrids[57](index=57&type=chunk) [Liquidity and Going Concern](index=22&type=section&id=Liquidity%20and%20Going%20Concern) - The company had cash and cash equivalents of **$6.8 million** at March 31, 2023[58](index=58&type=chunk) - Current cash resources are insufficient to fund operations for the next twelve months, considering **$1.4 million** in current liabilities and **$2.5 million** in capital commitments, raising substantial doubt about the company's ability to continue as a going concern[58](index=58&type=chunk)[60](index=60&type=chunk) - The company is actively seeking additional capital through various means (equity offerings, grants, debt, collaborations) but cannot guarantee availability or acceptable terms[59](index=59&type=chunk) [Summary Statement of Cash Flows](index=23&type=section&id=Summary%20Statement%20of%20Cash%20Flows) - Net cash used in operating activities increased by approximately **$1.1 million** to **$2.9 million** in Q1 2023, primarily due to higher personnel and product development costs[78](index=78&type=chunk) - Net cash used in investing activities significantly increased by approximately **$294,000** to **$341,000** in Q1 2023, mainly due to capital purchases of manufacturing equipment[79](index=79&type=chunk) - Net cash used in financing activities was approximately **$59,000** in Q1 2023, an increase of **$59,000** from Q1 2022, primarily due to tax withholdings on vested restricted stock units[28](index=28&type=chunk) [Recently Adopted Accounting Standards](index=23&type=section&id=Recently%20Adopted%20Accounting%20Standards) - The company refers to Note 2 of its condensed consolidated financial statements for details on recently adopted accounting standards[29](index=29&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 is an "emerging growth company" (EGC) under the JOBS Act, allowing it to use an extended transition period for new accounting standards[30](index=30&type=chunk) - The company is also a "smaller reporting company" (SRC), which provides exemptions from certain disclosure requirements, such as presenting only two years of audited financial statements and reduced executive compensation disclosures[32](index=32&type=chunk) [JOBS Act Accounting Election](index=25&type=section&id=JOBS%20Act%20Accounting%20Election) - Despite its EGC status, the company has irrevocably elected not to use the extended transition period for new accounting standards, choosing to adopt them on the same dates as other public companies[34](index=34&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 quantitative and qualitative disclosures about market risk - The company is a smaller reporting company and is not required to provide information on quantitative and qualitative disclosures about market risk[36](index=36&type=chunk) [Item 4. Controls and Procedures](index=25&type=section&id=Item%204.%20Controls%20and%20Procedures) This section details the evaluation of the company's disclosure controls and procedures and confirms no material changes in internal control over financial reporting during the quarter [Evaluation of Disclosure Controls and Procedures and Changes in Internal Control over Financial Reporting](index=25&type=section&id=Evaluation%20of%20Disclosure%20Controls%20and%20Procedures%20and%20Changes%20in%20Internal%20Control%20over%20Financial%20Reporting) - Management, including the CEO and CFO, concluded that the company's disclosure controls and procedures were effective as of March 31, 2023[37](index=37&type=chunk) - The company continuously reviews and may make changes to enhance the effectiveness of its disclosure controls[37](index=37&type=chunk) [Changes in Internal Control Over Financial Reporting](index=25&type=section&id=Changes%20in%20Internal%20Control%20Over%20Financial%20Reporting) - There were no material changes in the company's internal control over financial reporting during the quarter ended March 31, 2023[38](index=38&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, though it may encounter litigation in the ordinary course of business and maintains insurance for potential losses - The company is not currently involved in any legal proceedings[42](index=42&type=chunk) - The results of litigation are inherently unpredictable, and any claims could be time-consuming and costly[41](index=41&type=chunk) - The company accrues for known indemnification issues when a loss is probable and estimable and has insurance policies covering potential losses where cost-effective[41](index=41&type=chunk) [Item 1A. Risk Factors](index=26&type=section&id=Item%201A.%20Risk%20Factors) For a comprehensive discussion of potential risks and uncertainties, the company refers to its 2022 annual report on Form 10-K, noting no material changes to those factors except as disclosed - For a discussion of potential risks or uncertainties, refer to the "Risk Factors" section in the company's 2022 annual report on Form 10-K[43](index=43&type=chunk) - There have been no material changes to the risk factors disclosed in the prior registration statement, except as set forth in this report[43](index=43&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=26&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 - None[44](index=44&type=chunk) [Item 3. Defaults Upon Senior Securities](index=26&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) There were no defaults upon senior securities to report for the period - None[44](index=44&type=chunk) [Item 4. Mine Safety Disclosures](index=26&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company's operations - Not applicable[45](index=45&type=chunk) [Item 5. Other Information](index=26&type=section&id=Item%205.%20Other%20Information) There is no other information to report under this item - None[46](index=46&type=chunk) [Item 6. Exhibits](index=27&type=section&id=Item%206.%20Exhibits) This section lists all exhibits filed with the Form 10-Q, including employment agreements, certifications from principal executive and financial officers, and various Inline XBRL documents - Exhibits include the First Amendment to Employment Agreement for Neil Dey, certifications of Principal Executive and Financial Officers (Rule 13a-14(a) and 18 U.S.C. Section 1350), and Inline XBRL documents[49](index=49&type=chunk) - The certifications on Exhibit 32 are not deemed "filed" for purposes of Section 18 of the Exchange Act[50](index=50&type=chunk) [Signatures](index=28&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 its Chief Financial Officer, Kenneth Fisher, on May 11, 2023 - The report is signed by Neil Dey, Chief Executive Officer and Director, and Kenneth Fisher, Chief Financial Officer, on May 11, 2023[55](index=55&type=chunk)

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 ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2022 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from __________ to__________ Commission file number: 001-41031 Bluejay Diagnostics, Inc. (Exact Name of Registrant as Specified in Its Charter) | --- | |------ ...

September 2022 00 DIAG 0 O OG O ● Disclaimer Forward-looking Statements CAUTIONARY STATEMENT CONCERNING FORWARD LOOKING STATEMENTS This document contains forward-looking statements. In addition, from time to time, we or our representatives may make forward-looking statements orally or in writing. We base these forward-looking statements on our expectations and projections about future events, which we derive from the information currently available to us. Such forward-looking statements relate to future eve ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Delaware 47-3552922 (State or Other Jurisdiction of Incorporation or Organization) (I.R.S. Employer Identification No.) Large Accelerated Filer ☐ Accelerated Filer ☐ Non-Accelerated Filer ☒ Smaller Reporting Company ☒ Emerging Growth Company ☒ Title of each class Trading Symbol(s) Name of each exchange on which registered Common Stock BJDX The Nasdaq Capital Market LLC FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15 ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2022 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ________ to__________ Commission file number: 001-41031 Bluejay Diagnostics, Inc. (Exact Name of Registrant as Specified in Its Charter) | --- | --- | |------ ...

| --- | --- | --- | --- | |---------------------------------------------------------------------------------------|-------|-------|-----------------------------------------------------| | | | | | | Delaware (State or Other Jurisdiction of Incorporation or Organization) | | | 47-3552922 (I.R.S. Employer Identification No.) | | 360 Massachusetts Avenue, Suite 203, Acton, MA | | | 01720 | | (Address of Principal Executive Offices) | | | (Zip Code) | UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2021 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ________ to__________ Commission file number: 001-41031 Bluejay Diagnostics, Inc. (Exact Name of Registrant as Specified in Its Charter) | --- | --- | |-- ...