Bluejay Diagnostics(BJDX) - 2024 Q3 - Quarterly Report

Part I Part I - Financial Information This section provides the company's unaudited condensed consolidated financial statements and related management discussion and analysis Condensed Consolidated Financial Statements (Unaudited) The unaudited condensed consolidated financial statements detail the company's financial position and performance, showing increased assets and reduced net loss, alongside significant changes in shares outstanding due to financing and a reverse stock split Condensed Consolidated Balance Sheets As of September 30, 2024, total assets increased to $8.35 million from $4.87 million at year-end 2023, driven by a significant rise in cash and cash equivalents to $5.76 million, while liabilities decreased and equity grew due to financing activities Condensed Consolidated Balance Sheet Highlights (Unaudited) | Account | Sep 30, 2024 ($) | Dec 31, 2023 ($) | | :--- | :--- | :--- | | Assets | | | | Cash and cash equivalents | 5,755,741 | 2,208,516 | | Total current assets | 6,567,686 | 3,220,860 | | Total assets | 8,353,410 | 4,868,531 | | Liabilities & Equity | | | | Total current liabilities | 1,049,247 | 1,771,375 | | Total liabilities | 1,188,976 | 1,973,683 | | Total stockholders' equity | 7,164,434 | 2,894,848 | | Total liabilities and stockholders' equity | 8,353,410 | 4,868,531 | - The number of common shares issued and outstanding increased significantly from 154,893 at the end of 2023 to 17,827,280 as of September 30, 2024, with all share data reflecting a 1-for-8 reverse stock split effective June 20, 2024[12] Condensed Consolidated Statements of Operations For the three months ended September 30, 2024, the company reported a net loss of $1.48 million, an improvement from $2.30 million in 2023, primarily due to reduced operating expenses, with the nine-month net loss also decreasing to $6.29 million from $7.65 million Operating Results Comparison (Unaudited) | Metric | Three Months Ended Sep 30, 2024 ($) | Three Months Ended Sep 30, 2023 ($) | Nine Months Ended Sep 30, 2024 ($) | Nine Months Ended Sep 30, 2023 ($) | | :--- | :--- | :--- | :--- | :--- | | Research and development | 551,655 | 1,397,318 | 2,917,674 | 4,428,123 | | General and administrative | 809,199 | 963,534 | 2,759,817 | 3,213,614 | | Operating loss | (1,361,607) | (2,341,233) | (5,684,972) | (7,924,493) | | Net loss | (1,481,959) | (2,297,998) | (6,285,804) | (7,651,146) | | Net loss per share | (0.16) | (16.67) | (1.82) | (58.38) | Condensed Consolidated Statements of Cash Flows For the nine months ended September 30, 2024, net cash used in operating activities was $6.1 million, offset by $9.9 million generated from financing activities, resulting in a net cash increase of $3.5 million and an ending cash balance of $5.76 million Cash Flow Summary (Unaudited, Nine Months Ended Sep 30) | Activity | 2024 ($) | 2023 ($) | | :--- | :--- | :--- | | Net cash used in operating activities | (6,081,083) | (5,536,393) | | Net cash used in investing activities | (305,658) | (616,272) | | Net cash provided by financing activities | 9,933,966 | 1,114,612 | | Net increase (decrease) in cash | 3,547,225 | (5,038,053) | | Cash and cash equivalents, end of period | 5,755,741 | 5,076,937 | - Financing activities in 2024 included $12.1 million from the issuance of common stock and prefunded warrants and $2.0 million from notes payable, offset by issuance costs and note repayments[16] Notes to Condensed Consolidated Financial Statements The notes detail the company's shift to a 510(k) FDA pathway for its sepsis test, significant delays due to technical challenges, substantial doubt about its going concern status with cash only through Q1 2025, and a Nasdaq non-compliance notice for its stock price - The company's regulatory strategy has shifted from COVID-19 to sepsis, with plans to use data from the SYMON-I and SYMON-II clinical studies to support a 510(k) application to the FDA[23][29] - Technical challenges, including limited supply of critical materials and reliability issues with the Symphony Cartridge, are expected to delay the FDA submission by at least 18 months[28][30] - Management has concluded there is substantial doubt about the company's ability to continue as a going concern, as current cash is only sufficient to fund operations through the first quarter of 2025[43][44] - The company received a Nasdaq non-compliance notice for its stock price being below $1.00, and has until February 24, 2025, to regain compliance, despite a 1-for-8 reverse stock split effected in June 2024 that did not maintain the price above $1.00[36][37][38] - In May 2024, the company raised $2 million through a Note Purchase Agreement and a Securities Purchase Agreement, which was subsequently repaid[62][63][64] - The company conducted public offerings in January and June 2024, issuing common stock, prefunded warrants, and various classes of warrants (Class C, Class D) to raise capital[67][74] Management's Discussion and Analysis of Financial Condition and Results of Operations Management discusses the company's clinical-stage status, persistent net losses, and critical liquidity challenges, with cash projected to last only through Q1 2025, necessitating further dilutive financing despite reduced operating expenses Comparison of Operating Expenses (Three Months Ended Sep 30) | Expense Category | 2024 ($ millions) | 2023 ($ millions) | Change (%) | | :--- | :--- | :--- | :--- | | Research and development | 0.6 | 1.4 | -57 | | General and administrative | 0.8 | 1.0 | -20 | - The decrease in R&D expenses was primarily due to a reduction in technology transfer efforts, which offset increased clinical trial expenses[106] - The company's cash resources of $5.8 million are only sufficient to fund operations through the first quarter of 2025, raising substantial doubt about its ability to continue as a going concern[103][110] - Net cash provided by financing activities increased by $8.8 million in the first nine months of 2024 compared to 2023, due to public offerings in January and June 2024[117] Quantitative and Qualitative Disclosures About Market Risk As a smaller reporting company, Bluejay Diagnostics, Inc. is not required to provide the information requested under this item - The company is a smaller reporting company as defined by Rule 12b-2 of the Exchange Act and is not required to provide quantitative and qualitative disclosures about market risk[126] Controls and Procedures Management, including the CEO, concluded the company's disclosure controls and procedures were effective as of September 30, 2024, with no material changes to internal control over financial reporting during the quarter - Based on an evaluation, the President and CEO concluded that the company's disclosure controls and procedures were effective as of September 30, 2024[127] - No changes in internal control over financial reporting occurred during the quarter ended September 30, 2024, that materially affected, or are reasonably likely to materially affect, internal controls[128] Part II Part II - Other Information This section covers other required disclosures, including legal proceedings, risk factors, and exhibit listings Legal Proceedings The company is not currently involved in any legal proceedings - As of the filing date, the company is not involved in any legal proceedings[129] Risk Factors This section supplements existing risk factors, emphasizing severe financial distress, an accumulated deficit of $33.2 million, and projected cash depletion by Q1 2025, alongside operational hurdles from material supply issues delaying FDA submission by at least 18 months, and significant Nasdaq delisting risk - The company has incurred significant losses, has an accumulated deficit of approximately $33.2 million, and expects its current cash of $5.8 million to only fund operations through Q1 2025, raising substantial doubt about its ability to continue as a going concern[131] - The company is experiencing limited supply of critical materials and quality control issues for its test cartridges, which are expected to delay the FDA submission for Symphony by at least 18 months[136] - The company is not in compliance with Nasdaq's minimum bid price requirement of $1.00, has until February 24, 2025, to regain compliance, and may need to effect another reverse stock split to avoid delisting[141][142][143] - The large number of outstanding warrants, particularly the Class C Warrants from the June 2024 offering, could cause significant dilution to existing stockholders and may make it more difficult to effect a future business combination[148][149] Unregistered Sales of Equity Securities and Use of Proceeds None - There were no unregistered sales of equity securities during the period[149] Defaults Upon Senior Securities None - There were no defaults upon senior securities[149] Mine Safety Disclosures Not applicable - This item is not applicable to the company[149] Other Information None - There is no other information to report under this item[149] Exhibits This section lists the exhibits filed with the Form 10-Q, including amendments to the Certificate of Incorporation and Bylaws, as well as officer certifications and XBRL data files - The report includes a list of filed exhibits, such as corporate governance documents, officer certifications required by the Sarbanes-Oxley Act, and Inline XBRL documents[150]