Bluejay Diagnostics(BJDX) - 2025 Q3 - Quarterly Report

Financial Performance - Total current assets decreased from $4,898,883 on December 31, 2024, to $3,352,859 on September 30, 2025, a decline of approximately 31.5%[18] - Operating expenses for the three months ended September 30, 2025, were $1,616,947, compared to $1,361,607 for the same period in 2024, representing an increase of about 18.7%[21] - The net loss applicable to common stockholders for the nine months ended September 30, 2025, was $5,418,671, compared to $19,508,857 for the same period in 2024, indicating a reduction of approximately 72.2%[21] - Cash and cash equivalents decreased from $4,301,945 at the beginning of the period to $3,082,268 at the end of September 30, 2025, a decrease of about 28.4%[27] - The total stockholders' equity decreased from $5,729,499 on December 31, 2024, to $3,692,782 on September 30, 2025, a decline of approximately 35.5%[18] - Interest income for the three months ended September 30, 2025, was $18,961, compared to $61,692 for the same period in 2024, a decrease of about 69.3%[21] - The Company had net cash used in operating activities of $4,598,705 for the nine months ended September 30, 2025, compared to $6,369,477 for the same period in 2024, a decrease of approximately 27.9%[27] - The Company incurred net losses of approximately $1.6 million and $5.4 million for the three and nine months ended September 30, 2025, respectively[112] - The Company had negative cash flow from operating activities of approximately $4.6 million for the nine months ended September 30, 2025, compared to $6.4 million for the same period in 2024[112] - As of September 30, 2025, the Company possessed cash and cash equivalents of approximately $3.1 million, with current liabilities of approximately $1.1 million[113] Research and Development - Research and development expenses for the nine months ended September 30, 2025, were $2,460,304, down from $2,917,674 in the same period of 2024, a decrease of approximately 15.7%[21] - Research and development expenses for Q3 2025 were approximately $0.8 million, up from $0.6 million in Q3 2024, primarily due to increased clinical trial expenses[115] - The Company is focused on developing the Symphony IL-6 test for monitoring disease progression in critical care settings, particularly for sepsis[110] - The Company has completed pre-clinical development of the Symphony analyzer and is redeveloping manufacturing processes for cartridges[108] Regulatory and Clinical Trials - The Symphony IL-6 test aims to provide laboratory-quality results in 20 minutes for critical care settings, focusing on monitoring disease progression in sepsis patients[2] - The SYMON-I pilot clinical study indicated that IL-6 levels within 24 hours of sepsis diagnosis may predict patient mortality up to 28 days[3] - The SYMON-II pivotal clinical study has enrolled approximately half of its targeted patient population as of the end of Q3 2025, with the goal of validating IL-6 as a predictor of 28-day all-cause mortality[4] - The Company expects to submit a 510(k) regulatory application to the FDA in 2027, contingent on successful clinical trial results[5] Capital and Financing - The Company plans to raise at least $20 million in capital between now and the end of the 2027 fiscal year to support the development of its Symphony technology platform[1] - The gross proceeds from the April 2025 private placement were $3,846,707, with total cash offering costs of $464,670 incurred[66] - The Company raised $8,569,075 in the June 2024 public offering, incurring offering costs of $1,133,419[69] - The January 2024 offering generated gross proceeds of $3,500,000, with offering costs amounting to $711,031[76] - The Company raised approximately $3.4 million in cash through financing activities during the nine months ended September 30, 2025, a decrease of $6.8 million compared to the same period in 2024[124] - The Company raised approximately $4.5 million from a private placement on October 10, 2025, incurring total offering costs of $542,650[142] Stock and Warrants - The company reported a weighted average common shares outstanding of 1,574,535 for the three months ended September 30, 2025, compared to 191,117 for the same period in 2024, reflecting a significant increase due to stock issuance[21] - As of September 30, 2025, there were 1,085,106 Class E warrants and 287,491 Class C warrants outstanding, with a significant number of potentially dilutive securities not included in the diluted net loss per share calculation[58] - The Company recorded a deemed dividend of $9,282,075 due to the modification of Class C Warrants, which adjusted the exercise price from $98.00 to $16.30, increasing the number of shares issuable to 1,372,586[80] - The Company has 287,491 Class C Warrants outstanding as of September 30, 2025, after all reduced exercise price Class C Warrants were exercised[80] - The Company issued various warrants in public offerings and private placements, including October 2025 Prefunded Warrants for up to 2,075,000 shares at an exercise price of $0.0001 per share[161] Legal and Compliance - The Company has no material legal proceedings currently pending[156] - The Company’s disclosure controls and procedures were deemed effective as of September 30, 2025[152] - The company may face liquidated damages of 2% per month on the unregistered subscribed amount, capped at 20% of the total $4,500,000 subscribed amount if it fails to meet registration requirements[166] Management and Governance - The base salary for the CEO has been increased to $400,000 per year, retroactively effective from October 1, 2025[172] - Non-management directors may receive restricted stock units for 200,000 shares annually, subject to a cap of $300,000 in combined value with cash fees[175] - The Company plans to amend the 2021 Stock Plan to increase the number of shares available for grant by 30,000,000 shares, with a decision deferred until 2026[174] Operational Updates - The Company has undergone multiple reverse stock splits, combining shares on a 1-for-8,000 aggregate basis since July 2023[8] - The Company has entered into agreements with Sanyoseiko Co. Ltd. for the manufacturing of analyzers and cartridges, which includes end-to-end support for the Symphony platform[9] - The Company is redeveloping the cartridge manufacturing process through Sanyoseiko, aiming to meet performance and quality requirements by October 2026[63] - The Company recorded additional equity issuance costs of $2,706,645 related to the modification of the Series C Warrants and issuance of Series E Warrants[67] - The Company transferred fixed assets with a net book value of $62,376 to a third party during the quarter ended September 30, 2025, as part of closing its internal lab[93]