Bluejay Diagnostics(US:BJDX)2025-03-31 20:18Part I Item 1. Business Bluejay Diagnostics is a pre-revenue medical diagnostics company developing the Symphony platform for critical care, targeting FDA clearance for its IL-6 sepsis test by Q4 2027, facing technical challenges and requiring substantial funding - Bluejay is a pre-revenue medical diagnostics company focused on its Symphony platform for critical care settings, with its primary product candidate being an IL-6 test for sepsis2123 - The company faces significant technical and supply challenges with its Symphony cartridges, including performance reproducibility and discontinuation of key raw materials, necessitating a redevelopment process expected to last at least a year1934135 - Bluejay's strategic plan requires raising at least $30 million in capital between Q2 2025 and the end of 2027 to fund operations, clinical trials, and achieve its goal of a 510(k) FDA submission in Q4 20272178 - The company is highly dependent on an exclusive license agreement with Toray Industries for its core cartridge technology, with a risk of termination if manufacturing capabilities are not established by October 20254648101 Item 1A. Risk Factors The company faces extensive financial, operational, and regulatory risks, including a going concern warning, significant stock price decline, reliance on the Toray license, unresolved technical issues, and a material weakness in internal controls - The company has a history of significant losses, an accumulated deficit of $34.7 million, and substantial doubt about its ability to continue as a going concern, with cash expected to run out in Q3 2025 without additional funding7577 - The common stock market price has fallen by more than 99.9% since the November 2021 IPO, and future funding needs are expected to lead to significant dilution198081 - A significant risk exists with the Toray license agreement, which could be terminated as early as November 2025 if Bluejay fails to establish a cartridge manufacturing facility, jeopardizing company viability101103 - The company faces ongoing performance reproducibility issues with its Symphony cartridges and lacks sufficient know-how from Toray to produce the critical capture antibody, requiring a lengthy and uncertain redevelopment process19135136 - The company is at risk of delisting from the Nasdaq Capital Market due to potential failure to meet the minimum $1.00 bid price and $1 million market value of publicly held shares requirements9394 - A material weakness in internal control over financial reporting was identified due to a lack of sufficient internal accounting expertise, specifically related to complex accounting for warrants with reset features203205 Item 1B. Unresolved Staff Comments The company reports no unresolved staff comments - There are no unresolved staff comments212 Item 1C. Cybersecurity The company maintains cybersecurity processes overseen by the President and CEO with board oversight, integrated into its risk management framework, and is unaware of any material incidents - The Board of Directors oversees cybersecurity risk management, implemented by the President and CEO215216 - The company is not aware of any material cybersecurity incidents that have impacted its operations217 Item 2. Properties The company leases two facilities in Acton, Massachusetts, and permits related and third-party entities, including one majority-owned by the CTO, to use its premises - The company leases two facilities in Acton, MA, with one lease expiring in March 2027 and the other becoming month-to-month in March 2025218 - A business entity majority-owned by the company's Chief Technology Officer is permitted to use the laboratory facility, with Bluejay billing for personnel time plus a 10% facility use fee219 Item 3. Legal Proceedings The company is not currently a party to any pending legal actions believed to have a material effect on its business - As of the filing date, the company is not involved in any material legal proceedings220221 Item 4. Mine Safety Disclosures This item is not applicable to the company - No mine safety disclosures are applicable222 Part II Item 5. Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities The company's common stock is listed on Nasdaq under "BJDX", has never paid dividends, and had 554,012 shares outstanding as of March 21, 2025 - The company's common stock trades on the Nasdaq Capital Market under the symbol "BJDX"224 - As of March 21, 2025, there were 554,012 shares of common stock outstanding226 - No cash dividends have ever been paid, and none are expected in the foreseeable future225 Item 7. Management's Discussion and Analysis of Financial Condition and Results of Operations The company reported a net loss of $7.7 million for FY2024, a decrease from $10.0 million in FY2023, driven by reduced expenses, but faces substantial doubt about its going concern status with cash projected to last only into Q3 2025, necessitating further capital raises Financial Performance Summary (FY2024 vs. FY2023) | Metric | 2024 ($M) | 2023 ($M) | | :--- | :--- | :--- | | Research and Development | $3.5 | $5.7 | | General and Administrative | $3.7 | $4.3 | | Operating Loss | ($7.2) | ($10.3) | | Net Loss | ($7.7) | ($10.0) | | Accumulated Deficit | ($34.7) | ($27.0) | Cash Flow Summary (FY2024 vs. FY2023) | Activity | 2024 ($M) | 2023 ($M) | | :--- | :--- | :--- | | Net Cash Used in Operating | ($7.8) | ($8.3) | | Net Cash Used in Investing | ($0.3) | ($0.7) | | Net Cash Provided by Financing | $10.2 | $1.1 | - Management has expressed substantial doubt about the company's ability to continue as a going concern, with existing cash of $4.3 million only expected to fund operations into Q3 2025, necessitating additional capital raises245339 - The company conducted multiple financing rounds in 2023 and 2024, including registered direct offerings, public offerings, and bridge note financing, to sustain operations248252256259 Item 9A. Controls and Procedures As of December 31, 2024, management concluded that disclosure controls and internal control over financial reporting were ineffective due to a material weakness related to insufficient internal accounting expertise, particularly for complex warrant accounting, with a remediation plan in place - Both disclosure controls and internal control over financial reporting were deemed ineffective as of December 31, 2024269270 - A material weakness was identified due to a lack of sufficient internal accounting expertise, highlighted by an error in accounting for a "deemed dividend on warrant modification" related to warrants issued in June 2024270271 - The remediation plan involves enhancing review processes and, subject to funding, engaging additional qualified accounting resources, as the President and CEO, who is not a CPA, currently serves as the principal financial and accounting officer274275 Part III Item 10. Directors, Executive Officers and Corporate Governance Information for this item will be incorporated by reference from the company's definitive proxy statement for its 2025 annual meeting of stockholders Item 11. Executive Compensation Information for this item will be incorporated by reference from the company's definitive proxy statement for its 2025 annual meeting of stockholders Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters Security ownership information will be incorporated by reference from the 2025 proxy statement, with 181 securities issuable under equity compensation plans and 136 remaining available as of December 31, 2024 Equity Compensation Plan Information as of December 31, 2024 | Plan Category | Securities to be Issued Upon Exercise (Units) | Weighted-Average Exercise Price ($) | Securities Remaining Available for Future Issuance (Units) | | :--- | :--- | :--- | :--- | | Equity compensation plans approved by security holders | 73 | $14,902.00 | 136 | | Equity compensation plans not approved by security holders | 108 | $7,180.00 | - | Item 13. Certain Relationships and Related Transactions, and Director Independence Information for this item will be incorporated by reference from the company's definitive proxy statement for its 2025 annual meeting of stockholders Item 14. Principal Accountant Fees and Services Information for this item will be incorporated by reference from the company's definitive proxy statement for its 2025 annual meeting of stockholders Part IV Item 15. Exhibits and Financial Statement Schedules This section lists the financial statements, schedules, and exhibits filed as part of the Form 10-K, including articles of incorporation, bylaws, material contracts, and certifications Item 16. Form 10-K Summary This item is not applicable - No Form 10-K summary was provided297299 Financial Statements Consolidated Financial Statements The audited consolidated financial statements present the company's financial position and results, with the auditor's report highlighting substantial doubt about going concern due to recurring losses and negative cash flows, despite an increase in cash to $4.3 million driven by financing - The independent auditor's report expresses a fair presentation opinion but includes an "Emphasis of Matter" paragraph regarding the company's ability to continue as a going concern307308 Consolidated Balance Sheet Data (As of December 31) | | 2024 ($) | 2023 ($) | | :--- | :--- | :--- | | Cash and cash equivalents | 4,301,945 | 2,208,516 | | Total Assets | 6,657,423 | 4,868,531 | | Total Liabilities | 927,924 | 1,973,683 | | Accumulated Deficit | (34,668,784) | (26,950,990) | | Total Stockholders' Equity | 5,729,499 | 2,894,848 | Consolidated Statement of Operations Data (For the Year Ended December 31) | | 2024 ($) | 2023 ($) | | :--- | :--- | :--- | | Operating Loss | (7,169,616) | (10,311,217) | | Net Loss | (7,717,794) | (9,953,888) | | Net Loss Per Share | (114.19) | (3,631.48) |