Bluejay Diagnostics(BJDX) - 2024 Q2 - Quarterly Report

PART I - FINANCIAL INFORMATION Item 1. Condensed Consolidated Financial Statements (Unaudited) The company reported a $4.8 million net loss, with assets growing to $10.9 million from financing, raising going concern doubts Condensed Consolidated Balance Sheets Total assets significantly increased to $10.9 million due to financing-driven cash growth, with stockholders' equity reaching $8.6 million Condensed Consolidated Balance Sheet Highlights (Unaudited) | Account | June 30, 2024 ($) | Dec 31, 2023 ($) | | :--- | :--- | :--- | | Assets | | | | Cash and cash equivalents | $8,058,415 | $2,208,516 | | Total current assets | $9,018,408 | $3,220,860 | | Total assets | $10,859,211 | $4,868,531 | | Liabilities & Equity | | | | Total current liabilities | $2,056,882 | $1,771,375 | | Total liabilities | $2,218,136 | $1,973,683 | | Total stockholders' equity | $8,641,075 | $2,894,848 | | Total liabilities and stockholders' equity | $10,859,211 | $4,868,531 | - A 1-for-8 reverse stock split was effective on June 20, 2024, and all historical share and per-share information has been adjusted retroactively[10][27] Condensed Consolidated Statements of Operations Net loss improved to $4.8 million due to decreased operating expenses, partially offset by increased interest expense Condensed Consolidated Statements of Operations (Unaudited) | Metric | Six Months Ended June 30, 2024 ($) | Six Months Ended June 30, 2023 ($) | | :--- | :--- | :--- | | Research and development | $2,366,019 | $3,030,805 | | General and administrative | $1,950,618 | $2,250,080 | | Total operating expenses | $4,323,365 | $5,583,260 | | Operating loss | ($4,323,365) | ($5,583,260) | | Net loss | ($4,803,845) | ($5,353,148) | | Net Loss per share – Basic and diluted | ($12.35) | ($41.95) | Condensed Consolidated Statements of Cash Flows Operating cash outflow was $4.1 million, offset by $10.3 million from financing, leading to a $5.8 million net cash increase Summary of Cash Flows (Unaudited) | Activity | Six Months Ended June 30, 2024 ($) | Six Months Ended June 30, 2023 ($) | | :--- | :--- | :--- | | Net cash used in operating activities | ($4,149,682) | ($4,411,327) | | Net cash used in investing activities | ($305,431) | ($541,774) | | Net cash provided by (used in) financing activities | $10,305,012 | ($61,482) | | Increase (decrease) in cash | $5,849,899 | ($5,014,583) | Notes to Condensed Consolidated Financial Statements Notes detail Symphony platform development, regulatory shifts, significant financial risks including Nasdaq non-compliance and going concern, and recent financing - The company is developing the Symphony technology platform for rapid, whole-blood diagnostic tests in critical care settings. The first product is the Symphony IL-6 test for monitoring disease progression, particularly in sepsis patients[18][19] - The company's regulatory strategy has shifted from COVID-19 to sepsis. It completed the SYMON-I pilot study and plans to initiate the SYMON-II pivotal study in Q3 2024 to support a 510(k) FDA submission in 2025[22][25] - Management has concluded there is substantial doubt about the Company's ability to continue as a going concern, as current cash of approximately $8.1 million is only sufficient to fund operations through the first quarter of 2025[34][35] - The company received a Nasdaq non-compliance notice on February 28, 2024, for its stock price falling below the $1.00 minimum bid requirement. The company has until August 26, 2024, to regain compliance[28][29] - In June 2024, the company sold common units and pre-funded units in a public offering, which included shares/pre-funded warrants, Class C Warrants, and Class D Warrants, raising significant capital[55] Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations Management discusses significant net losses, negative cash flow, decreased operating expenses, and critical liquidity issues, with cash only through Q1 2025, necessitating capital Operating Expense Comparison (Three Months Ended June 30) | Expense Category | 2024 ($) | 2023 ($) | | :--- | :--- | :--- | | Research and development | $1,032,474 | $1,676,256 | | General and administrative | $862,482 | $1,073,103 | | Sales and marketing | $305 | $154,329 | - The decrease in R&D expenses was due to a reduction in technology transfer efforts, which offset increased clinical trial expenses[83] - The company's cash resources of $8.1 million as of June 30, 2024, are only sufficient to fund operations through the first quarter of 2025, raising substantial doubt about its ability to continue as a going concern[82][88] - Net cash provided by financing activities increased by approximately $10.4 million in the first six months of 2024 compared to the same period in 2023, due to public offerings in January and June 2024 and a Bridge Note Financing[94] Item 3. Quantitative and Qualitative Disclosures About Market Risk As a smaller reporting company, the company is not required to provide market risk disclosures - As a smaller reporting company, Bluejay Diagnostics is not required to provide quantitative and qualitative disclosures about market risk[101] Item 4. Controls and Procedures Management concluded disclosure controls were effective as of June 30, 2024, with no material changes to internal control over financial reporting - The President and CEO concluded that the company's disclosure controls and procedures were effective as of June 30, 2024[102] - No changes occurred during the quarter ended June 30, 2024, that materially affected, or are reasonably likely to materially affect, the company's internal control over financial reporting[103] PART II - OTHER INFORMATION Item 1. 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[104] Item 1A. Risk Factors This section highlights precarious financial condition, including losses and going concern uncertainty, product development risks, Nasdaq delisting risk, and potential stock dilution - Financial Risk: The company has a history of significant losses, an accumulated deficit of approximately $31.6 million, and expects to run out of cash in Q1 2025 without new funding, raising substantial doubt about its ability to continue as a going concern[106][108] - Product Development Risk: Ongoing materials, manufacturing, and quality control issues with its supplier, Toray, could negatively impact the timeline for the FDA submission of the Symphony device[111] - Stock & Listing Risk: The company is not in compliance with Nasdaq's $1.00 minimum bid price requirement and faces delisting if compliance is not regained. A 1-for-8 reverse split on June 20, 2024, has not resolved the issue[113][114][115] - Dilution Risk: The exercise of outstanding warrants, particularly the Class C and Class D warrants from the June 2024 offering, is expected to cause a substantial increase in outstanding shares and material dilution to existing stockholders[119][122] Item 2. Unregistered Sales of Equity Securities and Use of Proceeds No unregistered sales of equity securities were reported for the period - There were no unregistered sales of equity securities during the period[123] Item 5. Other Information No other information is reported for the period - There is no other information to report[124] Item 6. Exhibits This section lists all exhibits filed with the report, including certificates of incorporation, warrant agreements, purchase agreements, and officer certifications