Bluejay Diagnostics(BJDX) - 2024 Q1 - Quarterly Report

Cover Page 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 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][23] - The registrant is a Non-Accelerated Filer and a Smaller Reporting Company[9][23][24] - As of May 1, 2024, the registrant had 2,904,448 shares of common stock outstanding[25] TABLE OF CONTENTS This section provides an organized listing of all chapters and sections within the quarterly report for easy navigation CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS 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 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][103] - 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][29] - 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] EXPLANATORY NOTE This section defines the terms used throughout the report to refer to Bluejay Diagnostics, Inc. and its subsidiary Company Reference Definition 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] PART I - FINANCIAL INFORMATION 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) 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 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 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 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][78] Condensed Consolidated Statements of Cash Flows 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] Notes to Condensed Consolidated Financial Statements 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 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][54] - 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] - The company plans to use SYMON-II validation study results to support a 510(k) application to the FDA, targeting submission in 2025[39][56] - 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][42][58][76][77] 2. SIGNIFICANT ACCOUNTING POLICIES 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][80] - The company has one operating segment and the majority of its assets are located in the United States[68] - 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][79][138] 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] 3. LICENSE AND SUPPLY AGREEMENT WITH TORAY INDUSTRIES 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] - 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] - 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] - There were no sales of or revenues from the cartridges during the three months ended March 31, 2024 and 2023[94][124] 4. WARRANTS 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] - 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] 5. STOCK COMPENSATION 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] - The 2021 Stock Plan has 40,377 shares available for grant at March 31, 2024[2] 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] 6. RELATED PARTY TRANSACTIONS 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] 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 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] 8. LEASES 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 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][135] - 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][148] 10. SUPPLEMENTAL BALANCE SHEET INFORMATION 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 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 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] - 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] - 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] - 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] Results of Operations 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 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 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] - Future R&D expenses are expected to focus on clinical trial programs, regulatory strategy, technology transfer, and manufacturing improvements[152] General and Administrative 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] - The decrease is attributed to capital preservation efforts, including limiting infrastructure investment and reducing professional services[154] Sales and Marketing 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] - This substantial reduction was due to a decrease in spending across all sales and marketing efforts[155] Other Income, net 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] - 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] Liquidity and Going Concern Uncertainty 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] - Net cash used in operating activities was approximately $2.3 million for the quarter ended March 31, 2024[140] - 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] - 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] - 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] Summary Statement of Cash Flows 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 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] - The decrease was primarily due to a reduction in personnel costs and product development costs[158] Net cash used in investing activities 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] - This decrease was primarily due to limited purchasing of manufacturing equipment[142] Net cash used in financing activities 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] - The increase was primarily due to the public offering completed on January 2, 2024[173] Recently Adopted Accounting Standards 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] - No other new accounting pronouncements are believed to have a material impact on the company's financial position or results of operations[145] Emerging Growth Company and Smaller Reporting Company Status 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] - 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] - 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] JOBS Act Accounting Election 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] - 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] Item 3. Quantitative and Qualitative Disclosures About Market Risk 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][176] Item 4. Controls and Procedures 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 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] (b) Changes in Internal Control Over Financial Reporting 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] PART II - OTHER INFORMATION This part provides additional information not covered in the financial statements, including legal proceedings, risk factors, and exhibits Item 1. Legal Proceedings 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] - 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] Item 1A. Risk Factors 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][178] - 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][180] Item 2. Unregistered Sales of Equity Securities and Use of Proceeds 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] Item 3. Defaults Upon Senior Securities There were no defaults upon senior securities to report for the period - No defaults upon senior securities to report[167] Item 4. Mine Safety Disclosures Mine safety disclosures are not applicable to the company's operations - Mine safety disclosures are not applicable[182] Item 5. Other Information There is no other information to report for the period - No other information to report[167][181] Item 6. Exhibits 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] SIGNATURES This section contains the official signatures attesting to the accuracy and completeness of the quarterly report Report Signatures 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]