Core Insights - Bluejay Diagnostics, Inc. reported financial results for Q3 2025, highlighting progress in clinical, operational, and financial initiatives [1][2] Financial Performance - As of September 30, 2025, the company had $3.08 million in cash and cash equivalents and $3.69 million in stockholders' equity [3] - The company completed a $3.85 million warrant-inducement financing in April and a $4.5 million PIPE financing in October [3] Market Opportunity - Sepsis is a leading cause of mortality, with over 1.7 million cases annually in the U.S. [3] - The global sepsis diagnostic market is projected to reach $1.8 billion by 2030, presenting a significant opportunity for near-patient testing of sepsis biomarkers [3] Clinical Development - The SYMON-II clinical trial is approximately 50% completed, aiming to validate findings from the SYMON-I pilot study [5][6] - The trial assesses the predictive performance of IL-6 levels in ICU patients for 28-day all-cause mortality [6] - The company plans to begin testing samples collected in the SYMON-II trial by late 2026, with a goal to submit a 510(k) regulatory application to the FDA in 2027 [3][6] Strategic Partnerships - Bluejay has amended agreements with SanyoSeiko Co., Ltd. to enhance its manufacturing process and support the commercialization of the Symphony platform [6]

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]

Core Points - Bluejay Diagnostics, Inc. has completed a private placement of 2,250,000 shares of common stock and Series F warrants to purchase up to 4,500,000 shares at a price of $2.00 per share, with Series F warrants having an exercise price of $1.75 and expiring in five and a half years [1][2] - The gross proceeds from this offering amounted to $4.5 million, which will be used for FDA approval processes, clinical studies, research and development, and general working capital needs [2] - The securities were offered under Section 4(a)(2) of the Securities Act and have not been registered, meaning they cannot be sold in the U.S. without an effective registration statement or applicable exemption [3] Company Overview - Bluejay Diagnostics focuses on improving patient outcomes through its Symphony System, a rapid near-patient testing system for sepsis triage and disease monitoring [5] - The company's first product candidate is an IL-6 Test for sepsis, designed to deliver accurate results in approximately 20 minutes, aiding medical professionals in making timely treatment decisions [5]

Group 1: Market Overview - The stock market has seen notable gains across various sectors, including technology, healthcare, and energy [1][6] - Recent movements highlight the dynamic nature of the stock market, driven by technological advancements, healthcare innovations, and strategic corporate activities [6] Group 2: Company Highlights - New Era Energy & Digital, Inc. (NASDAQ:NUAI) leads with an 88.96% increase, reaching $2.91, driven by its innovative approach in helium, oil, and natural gas exploration [1][7] - Bluejay Diagnostics, Inc. (NASDAQ:BJDX) follows with an 86.64% rise to $3.49, fueled by its Symphony platform and diagnostic tests, along with an expanded partnership with SanyoSeiko Co., Ltd. [2][7] - Lakeshore Acquisition III Corp. Rights (NASDAQ:LCCCR) saw an 81.82% increase to $0.4, reflecting speculative trading often associated with shell companies and potential upcoming acquisitions [3][7] - Turn Therapeutics Inc. (NASDAQ:TTRX) experienced a 56.39% rise to $10.94, focusing on dermatology and wound care, with an upcoming Nasdaq listing indicating positive developments [4][7] - AtlasClear Holdings, Inc. (NASDAQ:ATCH) saw a 50.59% increase to $0.54, supported by a recent $20 million financing, reflecting market optimism about its future prospects [5][7]

Core Viewpoint - Bluejay Diagnostics, Inc. has announced a private placement of common stock and Series F warrants to raise approximately $4.5 million to fund FDA approval processes and other R&D activities [1][2]. Group 1: Offering Details - The company will sell 2,250,000 shares of common stock at a price of $2.00 per share, along with Series F warrants to purchase up to 4,500,000 additional shares at an exercise price of $1.75 [1]. - The Series F warrants will be exercisable immediately and will expire 5.5 years from the issuance date [1]. - The private placement is expected to close on or about October 10, 2025, pending customary closing conditions [1]. Group 2: Use of Proceeds - The net proceeds from the offering will be used for obtaining FDA approval, including related clinical studies, as well as for general working capital and other research and development activities [2]. Group 3: Company Overview - Bluejay Diagnostics focuses on improving patient outcomes with its Symphony System, a rapid near-patient testing system for sepsis triage and disease monitoring [5]. - The company's first product candidate is an IL-6 Test for sepsis, designed to deliver results in approximately 20 minutes, aiding medical professionals in making timely treatment decisions [5].

Core Insights - Bluejay Diagnostics, Inc. has entered into an amended agreement with SanyoSeiko Co., Ltd. to enhance the commercialization of its Symphony platform, a near-patient testing system for critical care diagnostics [1][2][4] Company Overview - Bluejay Diagnostics focuses on developing rapid near-patient testing solutions aimed at improving patient outcomes, particularly in sepsis management [5] - The Symphony System is designed to provide accurate results for key biomarkers, such as IL-6, in approximately 20 minutes from sample to result [5] Partnership Details - The amended agreement expands SanyoSeiko's role to provide end-to-end support for the Symphony platform, including manufacturing redevelopment, raw material sourcing, and quality control [3] - SanyoSeiko will manage the fulfillment, kit assembly, labeling, packaging, shipping, and regulatory support for Bluejay's products [3][4] Strategic Importance - This partnership is seen as a key milestone in Bluejay's commercialization strategy, enhancing supply chain resilience and production capacity for the Symphony platform [4] - Both companies express optimism about the potential impact of the Symphony platform in critical care diagnostics globally [4]

Core Insights - Bluejay Diagnostics, Inc. reported financial results for Q2 2025 and provided updates on its Symphony IL-6 test program and operational milestones [1][2] Financial Results - The company raised gross proceeds of $3.85 million through warrant inducement financing in April 2025 [5] - Additional capital is anticipated to be required through 2027 to support manufacturing readiness, clinical trials, and regulatory activities [5] Symphony IL-6 Test Program - The Symphony IL-6 Test is designed for sepsis triage and monitoring, providing results in approximately 20 minutes [6] - The SYMON-II pivotal clinical trial has commenced patient enrollment, aiming to validate findings from the SYMON-I pilot study [5] - The SYMON-II study will assess the predictive performance of IL-6 levels in ICU patients for 28-day all-cause mortality [5] Strategic Partnerships and Manufacturing - Bluejay has amended its licensing agreement with Toray Industries, extending the timeline for alternate cartridge manufacturing to October 2026 [5] - The company is collaborating with SanyoSeiko as its contract manufacturing organization to ensure regulatory-grade supply chain readiness [5] Upcoming Catalysts - The company is focused on accelerating patient enrollment and interim data review from SYMON-II [5] - Plans for cartridge redevelopment and validation manufacturing are underway, with ongoing discussions for strategic and institutional financing [5]

[PART I FINANCIAL INFORMATION](index=6&type=section&id=PART%20I%20FINANCIAL%20INFORMATION) [Item 1. Condensed Consolidated Financial Statements (Unaudited)](index=6&type=section&id=Item%201.%20Condensed%20Consolidated%20Financial%20Statements%20(Unaudited)) Presents the company's unaudited condensed consolidated financial statements, including balance sheets, operations, equity changes, cash flows, and explanatory notes [Condensed Consolidated Balance Sheets](index=6&type=section&id=Condensed%20Consolidated%20Balance%20Sheets%20as%20of%20June%2030%2C%202025%20and%20December%2031%2C%202024) Presents the company's financial position, detailing assets, liabilities, and stockholders' equity as of June 30, 2025, and December 31, 2024 Condensed Consolidated Balance Sheets (Unaudited) | Item | June 30, 2025 ($) | December 31, 2024 ($) | | :--- | :--- | :--- | | ASSETS | | | | **Current assets:** | | | | Cash and cash equivalents | $4,443,076 | $4,301,945 | | Prepaid expenses and other current assets | $305,478 | $596,938 | | **Total current assets** | **$4,748,554** | **$4,898,883** | | Property and equipment, net | $1,476,857 | $1,513,495 | | Operating lease right-of-use assets | $155,683 | $209,788 | | Other non-current assets | $22,164 | $35,257 | | **Total assets** | **$6,403,258** | **$6,657,423** | | LIABILITIES AND STOCKHOLDERS' EQUITY | | | | **Current liabilities:** | | | | Accounts payable | $108,817 | $145,122 | | Operating lease liability, current | $100,002 | $113,260 | | Accrued expenses and other current liabilities | $832,244 | $551,986 | | **Total current liabilities** | **$1,041,063** | **$810,368** | | Operating lease liability, non-current | $65,375 | $108,989 | | Other non-current liabilities | $6,589 | $8,567 | | **Total liabilities** | **$1,113,027** | **$927,924** | | **Stockholders' equity:** | | | | Common stock | $149 | $55 | | Additional paid-in capital | $43,779,905 | $40,398,228 | | Accumulated deficit | $(38,489,823) | $(34,668,784) | | **Total stockholders' equity** | **$5,290,231** | **$5,729,499** | | **Total liabilities and stockholders' equity** | **$6,403,258** | **$6,657,423** | - Total assets **decreased by** approximately **$254,165** from **$6,657,423** at December 31, 2024, to **$6,403,258** at June 30, 2025[20](index=20&type=chunk) - Total current liabilities **increased by** approximately **$230,695** from **$810,368** at December 31, 2024, to **$1,041,063** at June 30, 2025[20](index=20&type=chunk) - Accumulated deficit **increased by** approximately **$3.82 million** from **$(34,668,784)** at December 31, 2024, to **$(38,489,823)** at June 30, 2025[20](index=20&type=chunk) [Condensed Consolidated Statements of Operations](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20for%20the%20Three%20and%20Six%20Months%20Ended%20June%2030%2C%202025%20and%202024) Summarizes the company's financial performance, including operating expenses, other income/expense, and net loss for the periods Condensed Consolidated Statements of Operations (Unaudited) | Category | Three Months Ended June 30, 2025 ($) | Three Months Ended June 30, 2024 ($) | Six Months Ended June 30, 2025 ($) | Six Months Ended June 30, 2024 ($) | | :--- | :--- | :--- | :--- | :--- | | Research and development | $889,896 | $1,032,474 | $1,674,696 | $2,366,019 | | General and administrative | $1,095,465 | $862,482 | $2,199,582 | $1,950,618 | | Sales and marketing | - | $305 | - | $6,728 | | **Total operating expenses** | **$1,985,361** | **$1,895,261** | **$3,874,278** | **$4,323,365** | | **Operating loss** | **$(1,985,361)** | **$(1,895,261)** | **$(3,874,278)** | **$(4,323,365)** | | Other income (expense), net | $28,757 | $(580,119) | $53,239 | $(480,480) | | **Net loss** | **$(1,956,604)** | **$(2,475,380)** | **$(3,821,039)** | **$(4,803,845)** | | Net Loss per share – Basic and diluted | $(1.41) | $(256.16) | $(3.94) | $(617.39) | | Weighted average common shares outstanding – Basic and diluted | 1,387,118 | 9,663 | 970,565 | 7,781 | - Net loss **decreased by** **$518,776** (**20.9%**) for the three months ended June 30, 2025, compared to the same period in 2024, and by **$982,806** (**20.5%**) for the six months ended June 30, 2025, compared to the same period in 2024[23](index=23&type=chunk) - Net loss per share **significantly decreased** from **$(256.16)** to **$(1.41)** for the three months ended June 30, 2025, and from **$(617.39)** to **$(3.94)** for the six months ended June 30, 2025, **primarily due to** a substantial increase in weighted average common shares outstanding[23](index=23&type=chunk) [Condensed Consolidated Statements of Changes in Stockholders' Equity](index=8&type=section&id=Condensed%20Consolidated%20Statements%20of%20Changes%20in%20Stockholders'%20Equity%20for%20the%20Three%20and%20Six%20Months%20Ended%20June%2030%2C%202025%20and%202024) Details changes in stockholders' equity, including common stock, additional paid-in capital, and accumulated deficit Condensed Consolidated Statements of Changes in Stockholders' Equity (Unaudited) | Item | Shares | Common Stock Amount ($) | Additional Paid-In Capital ($) | Accumulated Deficit ($) | Total Stockholders' Equity ($) | | :--- | :--- | :--- | :--- | :--- | :--- | | Balance at December 31, 2024 | 554,012 | $55 | $40,398,228 | $(34,668,784) | $5,729,499 | | Stock-based compensation expense | - | - | $1,312 | - | $1,312 | | Net loss | - | - | - | $(1,864,435) | $(1,864,435) | | Balance at March 31, 2025 | 554,012 | $55 | $40,399,540 | $(36,533,219) | $3,866,376 | | Stock-based compensation expense | - | - | $(1,563) | - | $(1,563) | | Issuance of Common Stock for vested restricted stock units | 15 | - | - | - | - | | Issuance of Common Stock in connection with April 2025 Warrant Inducement, net | 940,155 | $94 | $675,283 | - | $675,377 | | Warrant inducement cost | - | - | $2,706,645 | - | $2,706,645 | | Net loss | - | - | - | $(1,956,604) | $(1,956,604) | | **Balance at June 30, 2025** | **1,494,182** | **$149** | **$43,779,905** | **$(38,489,823)** | **$5,290,231** | - Total stockholders' equity **decreased by** **$439,268** from **$5,729,499** at December 31, 2024, to **$5,290,231** at June 30, 2025, **primarily due to** net losses and stock-based compensation, partially offset by capital raised from warrant inducements[26](index=26&type=chunk) - The issuance of common stock in connection with the April 2025 Warrant Inducement added **$675,377** to total stockholders' equity, and a **warrant inducement cost** of **$2,706,645** was recorded as an increase to additional paid-in capital[26](index=26&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=9&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows%20for%20the%20Six%20Months%20Ended%20June%2030%2C%202025%20and%202024) Summarizes cash flows from operating, investing, and financing activities for the six months ended June 30, 2025 and 2024 Condensed Consolidated Statements of Cash Flows (Unaudited) | Item | Six Months Ended June 30, 2025 ($) | Six Months Ended June 30, 2024 ($) | | :--- | :--- | :--- | | Net loss | $(3,821,039) | $(4,803,845) | | **Net cash used in operating activities** | **$(3,238,912)** | **$(4,214,891)** | | **Net cash used in investing activities** | **-** | **$(305,431)** | | Proceeds from issuance of common stock and prefunded warrants | $3,846,692 | $12,069,075 | | Issuance costs related to issuance of common stock | $(464,670) | $(1,844,450) | | Proceeds from issuance of notes payable, net | - | $2,000,000 | | Repayment of notes payable | - | $(1,852,560) | | **Net cash provided by financing activities** | **$3,380,043** | **$10,370,221** | | **Increase in cash and cash equivalents** | **$141,131** | **$5,849,899** | | Cash and cash equivalents, end of period | $4,443,076 | $8,058,415 | - Net cash used in operating activities **decreased by** approximately **$1.0 million** (**23.2%**) to **$3.2 million** for the six months ended June 30, 2025, compared to **$4.2 million** in the prior year[29](index=29&type=chunk)[119](index=119&type=chunk) - Net cash provided by financing activities **significantly decreased by** approximately **$7.0 million** (**67.5%**) to **$3.4 million** for the six months ended June 30, 2025, compared to **$10.4 million** in the prior year[29](index=29&type=chunk)[121](index=121&type=chunk) [Notes to Condensed Consolidated Financial Statements](index=10&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) [Note 1. Nature of Operations and Basis of Presentation](index=10&type=section&id=1.%20NATURE%20OF%20OPERATIONS%20AND%20BASIS%20OF%20PRESENTATION) Details the company's business as a medical diagnostics firm developing the Symphony platform for rapid critical care tests - The company is developing the Symphony technology platform, a rapid test system for critical care settings, with its first product candidate being the Symphony IL-6 test for sepsis. The company aims for FDA 510(k) submission in **2027**[31](index=31&type=chunk)[32](index=32&type=chunk)[33](index=33&type=chunk)[40](index=40&type=chunk) - The company **requires at least** **$30 million** in capital between Q3 2025 and end of FY2027 to execute its plan, including cartridge redevelopment and clinical trials[31](index=31&type=chunk)[52](index=52&type=chunk) - The SYMON-I pilot clinical study showed IL-6 levels within 24 hours of sepsis diagnosis predict 28-day mortality, leading to the initiation of the SYMON-II pivotal clinical study in Q3 2024 to validate these findings[38](index=38&type=chunk)[39](index=39&type=chunk) - The company plans to manufacture analyzers through Sanyoseiko Co. Ltd. and redevelop/manufacture cartridges through a third-party contractor and CMO, leveraging licensed technology from Toray Industries, Inc[31](index=31&type=chunk)[42](index=42&type=chunk)[43](index=43&type=chunk) - The company has undergone multiple reverse stock splits (1-for-20 in July 2023, 1-for-8 in June 2024, 1-for-50 in November 2024), totaling a **1-for-8,000** aggregate basis since July 2023[46](index=46&type=chunk) - The company's financial condition raises **substantial doubt** about its ability to continue as a going concern, with cash resources estimated to **only fund operations until Q4 2025**, necessitating additional material financing[51](index=51&type=chunk)[52](index=52&type=chunk) [Note 2. Significant Accounting Policies](index=15&type=section&id=2.%20SIGNIFICANT%20ACCOUNTING%20POLICIES) Outlines significant accounting policies, warrant classification, net loss per share calculation, and recent accounting standards - The company accounts for warrants as either equity-classified or liability-classified based on specific terms and FASB ASC guidance, with changes in fair value for liability-classified warrants recognized in the statements of operations[57](index=57&type=chunk)[58](index=58&type=chunk) - Basic and diluted net loss per share are calculated based on weighted-average common shares outstanding; potentially dilutive securities are excluded if antidilutive[59](index=59&type=chunk) Potentially Dilutive Securities Listing | Item | June 30, 2025 (shares) | December 31, 2024 (shares) | | :--- | :--- | :--- | | Options to purchase common stock | 43 | 74 | | Restricted stock units (RSUs) | - | 2 | | Warrants for common stock | 660 | 664 | | Class A warrants for common stock | 310 | 310 | | Class B warrants for common stock | 9 | 9 | | 5-Year warrants for common stock | 6,730 | 6,730 | | Prefunded warrants for common stock | - | 66,960 | | Class C warrants for common stock | 287,491 | 228,297 | | Class C pre-funded warrants for common stock | 144,951 | - | | Class D warrants for common stock | - | 114,149 | | Class E warrants for common stock | 1,085,106 | - | | Placement agent warrants | 471 | 471 | - **No material changes** to significant accounting policies during the six months ended June 30, 2025, and no material effect expected from recently issued but not yet effective accounting pronouncements[55](index=55&type=chunk)[61](index=61&type=chunk) [Note 3. License and Supply Agreement with Toray Industries](index=17&type=section&id=3.%20LICENSE%20AND%20SUPPLY%20AGREEMENT%20WITH%20TORAY%20INDUSTRIES) Details the exclusive global license with Toray Industries for Symphony detection cartridges, including royalties and amendments - The company holds an exclusive global license (excluding Japan) from Toray Industries for Symphony detection cartridges, with royalty payments of **7.5%** of net sales after regulatory approval[62](index=62&type=chunk)[63](index=63&type=chunk) - An amendment on July 23, 2025, extended the deadline for the company to establish an alternative cartridge manufacturing site to October 23, 2026, and confirmed Toray has provided all required know-how[64](index=64&type=chunk)[65](index=65&type=chunk) - Failure to establish the manufacturing site by October 2026 could lead to termination of the license agreement, **materially impacting** commercialization efforts[65](index=65&type=chunk) [Note 4. Financings](index=18&type=section&id=4.%20FINANCINGS) Provides a detailed account of recent financing activities, including private placements, offerings, and bridge note financing Financing Event Summary | Financing Event | Gross Proceeds ($) | Offering Costs ($) | | :---------------------- | :------------- | :------------- | | April 2025 Private Placement | $3,846,692 | $464,670 | | June 2024 Offering | $8,569,075 | $1,133,419 | | May 2024 Bridge Note Financing | $2,000,000 | $212,654 | | January 2024 Offering | $3,500,000 | $711,031 | - The April 2025 Private Placement involved existing Class C warrant holders exercising warrants at a reduced price (**$3.42**/share) and purchasing new Class E warrants, generating **$3.85 million** in gross proceeds[66](index=66&type=chunk)[68](index=68&type=chunk) - The modification of Class C warrants and issuance of Class E warrants in April 2025 resulted in a **non-cash equity issuance cost** of **$2,706,645**, recorded as an increase to additional paid-in capital[69](index=69&type=chunk) [Note 5. Warrants](index=19&type=section&id=5.%20WARRANTS) Summarizes outstanding warrants as of June 30, 2025, detailing types, exercise prices, remaining lives, and 2024 adjustments Outstanding Warrants Summary | Warrant Type | Shares Exercisable for | Exercise Price ($) | Weighted Average Remaining Life (in Years) | | :--- | :--- | :--- | :--- | | April 2025 Class E Warrants | 1,085,106 | $3.42 | 4.8 | | April 2025 Pre-funded Class C Warrants | 144,951 | $0.0001 | 4.8 | | June 2024 Class C Warrants | 287,491 | $16.30 | 3.9 | | January 2024 Common Stock Warrants | 6,730 | $520.00 | 3.5 | | January 2024 Placement Agent Warrants | 471 | $650.00 | 3.5 | | August 2023 Common Stock Warrants | 540 | $2,896.00 | 3.2 | | August 2023 Placement Agent Warrants | 36 | $3,684.00 | 3.2 | | Class A Warrants | 310 | $56,000.00 | 1.3 | | Class B Warrants | 9 | $80,000.00 | 1.3 | | Other Pre-2024 Common Stock Warrants | 84 | $27,327.00 | 0.7 | - Class C Warrants were adjusted from **$98.00** to **$16.30** per share and the number of issuable shares increased to **1,372,586** following stockholder approval in August 2024, resulting in a deemed dividend of **$9,282,075**[83](index=83&type=chunk) - Class D Warrants' issuable shares increased to four shares per warrant after the stock price fell below **$16.30**, leading to a deemed dividend of **$3,940,978**. All Class D Warrants were exercised by December 31, 2024[84](index=84&type=chunk) [Note 6. Stock Compensation](index=22&type=section&id=6.%20STOCK%20COMPENSATION) Details stock incentive plans, award activity for non-vested restricted stock and options, and compensation expense recognized - The company has two stock incentive plans (2018 and 2021 Plans) with **35** and **129** shares available for grant, respectively, as of June 30, 2025[89](index=89&type=chunk)[90](index=90&type=chunk) Stock-Based Compensation Expense (Unaudited) | Category | Three Months Ended June 30, 2025 ($) | Three Months Ended June 30, 2024 ($) | Six Months Ended June 30, 2025 ($) | Six Months Ended June 30, 2024 ($) | | :--- | :--- | :--- | :--- | :--- | | Research and development | $(1,563) | $4,520 | $(450) | $9,365 | | General and administrative | - | $1,490 | $199 | $8,519 | | **Total stock-based compensation** | **$(1,563)** | **$6,010** | **$(251)** | **$17,884** | - As of June 30, 2025, there was approximately **$257** of unrecognized compensation expense related to non-vested stock option awards, expected to be recognized over **0.3 years**[93](index=93&type=chunk) [Note 7. Related Party Transactions](index=24&type=section&id=7.%20RELATED%20PARTY%20TRANSACTIONS) Describes the past agreement with NanoHybrids, LLC for sharing services and facilities, and its settlement and termination - The company had a Sharing and Services Agreement with NanoHybrids, LLC (an entity where the former CTO was majority shareholder) for R&D staff and facility use, billing at burdened cost plus **10%**[95](index=95&type=chunk) Income from NanoHybrids and Cash Receipts (Unaudited) | Category | Three Months Ended June 30, 2025 ($) | Three Months Ended June 30, 2024 ($) | Six Months Ended June 30, 2025 ($) | Six Months Ended June 30, 2024 ($) | | :--- | :--- | :--- | :--- | :--- | | Income from NanoHybrids (Other Income) | $0 | $30,609 | $6,873 | $104,200 | | Cash receipts from NanoHybrids | $6,873 | $73,591 | $21,437 | $114,860 | - On May 8, 2025, the Sharing and Services Agreement with NanoHybrids was terminated via a settlement agreement, which included a **$50,000** payment to NanoHybrids and reimbursement of up to **$30,000** in legal fees[95](index=95&type=chunk) [Note 8. Property and Equipment](index=24&type=section&id=8.%20PROPERTY%20AND%20EQUIPMENT) Provides a breakdown of the company's property and equipment, net of accumulated depreciation, as of June 30, 2025 and 2024 Property and Equipment, Net (Unaudited) | Asset Category | June 30, 2025 ($) | December 31, 2024 ($) | | :--- | :--- | :--- | | Construction-in-process | $1,351,179 | $1,351,179 | | Furniture, fixtures, and equipment | $128,452 | $136,312 | | Software | $0 | $4,457 | | Lab equipment | $173,268 | $173,268 | | Leasehold improvements | $43,231 | $43,231 | | Total | $1,696,130 | $1,708,447 | | Less: Accumulated depreciation | $(219,273) | $(194,952) | | **Property and equipment, net** | **$1,476,857** | **$1,513,495** | - Construction-in-process, primarily Symphony cartridge manufacturing equipment, remained unchanged at **$1,351,179**, with no commitments to complete as of June 30, 2025[97](index=97&type=chunk) [Note 9. Leases](index=25&type=section&id=9.%20LEASES) Summarizes lease arrangements for office, laboratory space, and copiers, including terms, discount rates, assets, and liabilities Lease Information Summary | Metric | June 30, 2025 | June 30, 2024 | | :--- | :--- | :--- | | Weighted average remaining lease term – operating leases (in years) | 1.8 | 2.4 | | Weighted average remaining lease term – finance leases (in years) | 2.6 | 3.6 | | Weighted average discount rate – operating leases | 7.0% | 7.0% | | Weighted average discount rate – finance leases | 7.0% | 7.0% | | Operating cash flows from operating leases | $63,259 | $88,428 | | Operating cash flows from finance leases | $424 | $559 | Lease Assets and Liabilities (Unaudited) | Category | June 30, 2025 ($) | December 31, 2024 ($) | | :--- | :--- | :--- | | Operating lease right-of-use asset | $155,683 | $209,788 | | Finance lease asset – property & equipment, net | $8,055 | $10,421 | | **Total lease assets** | **$163,738** | **$220,209** | | Current portion of operating lease liability | $100,002 | $113,260 | | Current portion of finance lease liability (accrued expenses) | $4,807 | $4,807 | | Non-current portion of operating lease liabilities | $65,375 | $108,989 | | Non-current portion of finance lease liabilities (other non-current) | $6,589 | $8,567 | | **Total lease liabilities** | **$176,773** | **$235,623** | [Note 10. Commitments and Contingencies](index=26&type=section&id=10.%20COMMITMENTS%20AND%20CONTINGENCIES) Outlines commitments, including a CTO separation agreement, minimum royalty obligations, and general indemnification provisions - The company has a severance liability of **$193,440** for its former CTO, Jason Cook, who departed on May 30, 2025, with **$178,560** remaining accrued as of June 30, 2025[99](index=99&type=chunk)[100](index=100&type=chunk) - Minimum annual royalty payments to Toray of **$60,000** (first year) and **$100,000** (thereafter) will commence after the first sale of cartridges following regulatory approval. No sales or revenues from cartridges have occurred through June 30, 2025[62](index=62&type=chunk)[101](index=101&type=chunk) - The company accrues for known indemnification issues when probable and estimable but has not incurred any losses to date, thus no accruals or expenses for indemnification[102](index=102&type=chunk) [Note 11. Supplemental Balance Sheet Information](index=26&type=section&id=11.%20SUPPLEMENTAL%20BALANCE%20SHEET%20INFORMATION) Provides detailed breakdown of prepaid expenses, other current assets, accrued expenses, and other current liabilities Prepaid Expenses and Other Current Assets (Unaudited) | Category | June 30, 2025 ($) | December 31, 2024 ($) | | :--- | :--- | :--- | | Prepaid insurance | $210,864 | $489,174 | | Vendor prepayments | $600 | $21,946 | | Prepaid and other | $94,014 | $85,818 | | **Total** | **$305,478** | **$596,938** | Accrued Expenses and Other Current Liabilities (Unaudited) | Category | June 30, 2025 ($) | December 31, 2024 ($) | | :--- | :--- | :--- | | Accrued personnel costs | $107,279 | $100,974 | | Accrued legal fees | $58,444 | $48,860 | | Accrued clinical trial expenses | $164,631 | $191,673 | | Accrued board of director fees | $95,000 | $95,000 | | Accrued expenses for CTO separation agreement | $178,560 | $0 | | Accrued other | $160,256 | $115,479 | | Accrued Delaware franchise tax | $68,074 | $0 | | **Total** | **$832,244** | **$551,986** | [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=27&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Provides management's perspective on the company's financial condition and results of operations for the three and six months ended June 30, 2025, compared to 2024 [Overview](index=27&type=section&id=Overview) The company is a medical diagnostics company focused on developing the Symphony platform for rapid critical care tests - The company is developing the Symphony technology platform, a rapid test system for critical care settings, with its first product candidate being the Symphony IL-6 test for sepsis. The company aims for FDA 510(k) submission in **2027**[105](index=105&type=chunk)[106](index=106&type=chunk)[107](index=107&type=chunk) - The company incurred net losses of **$2.0 million** (Q2 2025) and **$3.8 million** (H1 2025), with an accumulated deficit of **$38.5 million** as of June 30, 2025[109](index=109&type=chunk) - The company had **$4.4 million** in cash and cash equivalents and **$1.0 million** in current liabilities as of June 30, 2025, and **requires significant additional capital** to continue operations beyond Q4 2025[111](index=111&type=chunk)[122](index=122&type=chunk) [Results of Operations](index=28&type=section&id=Results%20of%20Operations) Analyzes changes in operating expenses and other income/expense, highlighting R&D, sales & marketing, and other income shifts Condensed Consolidated Statements of Operations (Unaudited) | Metric | Three Months Ended June 30, 2025 ($) | Three Months Ended June 30, 2024 ($) | Six Months Ended June 30, 2025 ($) | Six Months Ended June 30, 2024 ($) | | :--- | :--- | :--- | :--- | :--- | | Research and development | $889,896 | $1,032,474 | $1,674,696 | $2,366,019 | | General and administrative | $1,095,465 | $862,482 | $2,199,582 | $1,950,618 | | Sales and marketing | $0 | $305 | $0 | $6,728 | | Total operating expenses | $1,985,361 | $1,895,261 | $3,874,278 | $4,323,365 | | Operating loss | $(1,985,361) | $(1,895,261) | $(3,874,278) | $(4,323,365) | | Total other income (expense), net | $28,757 | $(580,119) | $53,239 | $(480,480) | | Net loss | $(1,956,604) | $(2,475,380) | $(3,821,039) | $(4,803,845) | [Research and Development](index=28&type=section&id=Research%20and%20Development) - R&D expenses **decreased by** approximately **$0.14 million** (**13.8%**) for Q2 2025 and **$0.69 million** (**29.2%**) for H1 2025, **primarily due to** reduced technology transfer efforts, partially offset by increased clinical trial expenses[113](index=113&type=chunk) [General and Administrative](index=29&type=section&id=General%20and%20Administrative) - G&A expenses **increased by** approximately **$0.23 million** (**26.9%**) for Q2 2025 and **$0.25 million** (**12.8%**) for H1 2025, driven by capital raising efforts and public company reporting requirements[114](index=114&type=chunk) [Sales and Marketing](index=29&type=section&id=Sales%20and%20Marketing) - Sales and marketing expenses were zero for Q2 and H1 2025, a **significant decrease** from **$305** (Q2 2024) and **$6,728** (H1 2024), **due to a cessation of all sales and marketing efforts**[115](index=115&type=chunk) [Other Income (Expense), net](index=29&type=section&id=Other%20Income%20(Expense)%2C%20net) - Total other income (expense), net, shifted from an expense of **$580,000** in Q2 2024 to an income of **$29,000** in Q2 2025, **primarily due to** higher interest expense (**$626,000**) in 2024 related to Bridge Note Financing[116](index=116&type=chunk) [Summary Statement of Cash Flows](index=29&type=section&id=Summary%20Statement%20of%20Cash%20Flows) Summarizes cash flows from operating, investing, and financing activities, highlighting changes and their primary drivers Condensed Consolidated Statements of Cash Flows (Unaudited) | Cash proceeds (used in) provided by: | Six Months Ended June 30, 2025 ($) | Six Months Ended June 30, 2024 ($) | | :--- | :--- | :--- | | Operating activities | $(3,238,912) | $(4,214,891) | | Investing activities | - | $(305,431) | | Financing activities | $3,380,043 | $10,370,221 | | **Net increase in cash and cash equivalents** | **$141,131** | **$5,849,899** | [Net cash used in operating activities](index=29&type=section&id=Net%20cash%20used%20in%20operating%20activities) - Net cash used in operating activities **decreased by** approximately **$1.0 million** (**23.2%**) to **$3.2 million** for H1 2025, **primarily due to** a lower net loss compared to H1 2024[119](index=119&type=chunk) [Net cash used in investing activities](index=30&type=section&id=Net%20cash%20used%20in%20investing%20activities) - Net cash used in investing activities **decreased by** approximately **$305,000** to zero for H1 2025, as there were no purchases of manufacturing equipment, compared to H1 2024[120](index=120&type=chunk) [Net cash used in financing activities](index=30&type=section&id=Net%20cash%20used%20in%20financing%20activities) - Net cash provided by financing activities **decreased by** approximately **$7.0 million** (**67.5%**) to **$3.4 million** for H1 2025, **primarily due to** the smaller scale of the April 2025 private placement compared to the larger public offerings and bridge note financing in H1 2024[121](index=121&type=chunk) [Liquidity and Going Concern Uncertainty](index=30&type=section&id=Liquidity%20and%20Going%20Concern%20Uncertainty) Reaffirms **substantial doubt** about going concern due to losses, negative cash flows, and need for **$30M** additional capital - As of June 30, 2025, the company had **$4.4 million** in cash and **$1.0 million** in current liabilities, with an accumulated deficit of **$38.5 million**[122](index=122&type=chunk) - The company expects negative operating cash flows for several years and estimates current cash resources will **only fund operations until Q4 2025**[122](index=122&type=chunk) - The company **needs to raise at least** **$30 million** between Q3 2025 and the end of FY2027 to fund cartridge redevelopment, clinical trials, and FDA submission, with failure potentially leading to liquidation[122](index=122&type=chunk) [Recent Offerings](index=31&type=section&id=Recent%20Offerings) Recaps details of recent offerings and private placements, focusing on capital raised, associated costs, and warrant terms - The January 2024 Offering raised **$3.5 million** gross, involving common stock, prefunded warrants, and January 2024 Warrants, with **$711,031** in offering costs[124](index=124&type=chunk)[127](index=127&type=chunk) - The May 2024 Bridge Note Financing provided **$2 million** in cash through senior secured notes and common stock issuance, incurring **$212,654** in debt issuance costs[128](index=128&type=chunk)[129](index=129&type=chunk) - The June 2024 Offering generated **$8.57 million** gross from common and prefunded units, including Class C and Class D Warrants, with **$1,133,419** in offering costs[131](index=131&type=chunk)[132](index=132&type=chunk) - The April 2025 Private Placement raised **$3.85 million** gross by inducing Class C warrant exercises and selling new Class E warrants, with **$464,670** in offering costs and a **non-cash equity issuance cost** of **$2,706,645**[133](index=133&type=chunk)[134](index=134&type=chunk)[135](index=135&type=chunk) [Emerging Growth Company and Smaller Reporting Company Status](index=33&type=section&id=Emerging%20Growth%20Company%20and%20Smaller%20Reporting%20Company%20Status) States the company's status as an 'emerging growth company' and 'smaller reporting company' under JOBS Act and Exchange Act - The company is an '**emerging growth company**' and '**smaller reporting company**,' allowing for certain exemptions from disclosure requirements[137](index=137&type=chunk)[139](index=139&type=chunk) - The company has **irrevocably elected not to use the extended transition period** for complying with new or revised accounting standards, adopting them on public company effective dates[137](index=137&type=chunk)[140](index=140&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=34&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) As a smaller reporting company, the company is not required to provide quantitative and qualitative disclosures about market risk - The company is a smaller reporting company and is **not required to provide quantitative and qualitative disclosures about market risk**[142](index=142&type=chunk) [Item 4. Controls and Procedures](index=34&type=section&id=Item%204.%20Controls%20and%20Procedures) Discusses effectiveness of disclosure controls, remediation of material weakness, and absence of other internal control changes [Evaluation of Disclosure Controls and Procedures](index=34&type=section&id=(a)%20Evaluation%20of%20Disclosure%20Controls%20and%20Procedures) - The President and CEO concluded that the company's disclosure controls and procedures were **effective as of June 30, 2025**[143](index=143&type=chunk) [Remediation of Previously Reported Material Weakness](index=34&type=section&id=Remediation%20of%20Previously%20Reported%20Material%20Weakness) - A **material weakness** in internal control over financial reporting related to accounting for complex equity transactions (specifically warrant reset features) was identified in the 2024 Annual Report on Form 10-K[144](index=144&type=chunk) - Management remediated the material weakness by implementing new controls over equity transaction review and approval, including engaging external consultants, and concluded these controls were **operating effectively as of June 30, 2025**[145](index=145&type=chunk)[146](index=146&type=chunk) [Changes in Internal Control Over Financial Reporting](index=34&type=section&id=(b)%20Changes%20in%20Internal%20Control%20Over%20Financial%20Reporting) - Other than the remediation activities, there were **no material changes** in internal control over financial reporting during the quarter ended June 30, 2025[147](index=147&type=chunk) [PART II OTHER INFORMATION](index=35&type=section&id=PART%20II%20OTHER%20INFORMATION) [Item 1. Legal Proceedings](index=35&type=section&id=Item%201.%20Legal%20Proceedings) States that the company is not currently involved in any material legal proceedings, though it may be subject to litigation - The company is **not currently involved in any material legal proceedings**[150](index=150&type=chunk) [Item 1A. Risk Factors](index=35&type=section&id=Item%201A.%20Risk%20Factors) Supplements previously disclosed risk factors, emphasizing capital need and impact of downsizing on product development [Additional Risks Related to Our Financial Condition and Capital Requirements](index=35&type=section&id=Additional%20Risks%20Related%20to%20Our%20Financial%20Condition%20and%20Capital%20Requirements) - The company has an accumulated deficit of **$38.5 million** and **requires at least** **$30 million** in additional capital by the end of 2027 to execute its strategic plan[151](index=151&type=chunk) - Failure to raise imminent material capital could force the company into liquidation under U.S. bankruptcy laws, **likely resulting in little to no value** for common stockholders[151](index=151&type=chunk) [Additional Risks Related to Our Business](index=36&type=section&id=Additional%20Risks%20Related%20to%20Our%20Business) - To preserve cash, the company has reduced its full-time employee headcount to **5** persons, including the departure of the CTO and VP of Operations, which **may hinder business continuity**, patent applications, and product development timelines[152](index=152&type=chunk)[153](index=153&type=chunk) - The downsizing and loss of institutional knowledge are expected to make it more difficult to meet technical challenges for Symphony product development and FDA submission[153](index=153&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=36&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) Details the April 2025 Private Placement, where Class E Warrants were sold for unregistered shares, with proceeds for general purposes - In April 2025, the company sold **1,085,106** Class E Warrants to purchase unregistered shares of Common Stock at **$0.125** per warrant, with an exercise price of **$3.42** per share, expiring April 8, 2030[154](index=154&type=chunk) - The proceeds from the Class E Warrants sale were used for general corporate purposes, and the company filed a Form S-3 to register the resale of shares issuable upon exercise[154](index=154&type=chunk)[155](index=155&type=chunk) [Item 3. Defaults Upon Senior Securities](index=36&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) States that there are no defaults upon senior securities - There were **no defaults upon senior securities**[156](index=156&type=chunk) [Item 4. Mine Safety Disclosures](index=36&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) Not applicable for the company - Mine Safety Disclosures are **not applicable** to the company[157](index=157&type=chunk) [Item 5. Other Information](index=36&type=section&id=Item%205.%20Other%20Information) Reports that no directors or officers adopted, modified, or terminated any Rule 10b5-1 trading arrangements during the quarter - **No directors or officers adopted, modified, or terminated any Rule 10b5-1 trading arrangements** during the quarter ended June 30, 2025[158](index=158&type=chunk) [Item 6. Exhibits](index=37&type=section&id=Item%206.%20Exhibits) Provides an index of exhibits filed with the Form 10-Q, including forms of warrants, settlement agreements, and certifications - The report includes an index of exhibits, such as Form of Class E Common Stock Purchase Warrant, Settlement Agreement and Release with Nanohybrids, and Separation and Release Agreement with Jason Cook[160](index=160&type=chunk) [Signatures](index=38&type=section&id=Signatures) Contains the required signatures for the Form 10-Q, confirming its submission by authorized personnel - The report is signed by Neil Dey, President, Chief Executive Officer, Principal Financial Officer, and Principal Accounting Officer, on August 7, 2025[164](index=164&type=chunk)

Core Insights - Bluejay Diagnostics, Inc. provided a mid-year business update for 2025, highlighting progress in its clinical programs and financial status [1][2] Business Highlights and Developments - The 2025 Annual Meeting of Stockholders is scheduled for June 18, 2025, with a proposal to reduce the Board of Directors from six to five members and to consider two reverse stock split proposals to meet Nasdaq listing requirements [3] - The SYMON-II clinical study has been initiated, following the successful SYMON-I pilot study, which indicated that IL-6 levels could predict sepsis patient mortality [4] - The company aims to submit a 510(k) application for its Symphony IL-6 test to the FDA in Q4 2027, with potential approval as early as Q3 2028 [4] - Bluejay is collaborating with SanyoSeiko for manufacturing the Symphony analyzer and is redeveloping Symphony cartridges to address technical challenges [4] Financial Results - As of April 30, 2025, Bluejay had cash and cash equivalents of approximately $5.7 million and current liabilities of about $1.0 million [4] - The company reported losses of approximately $7.7 million for the fiscal year ended December 31, 2024, and $1.9 million for the fiscal quarter ended March 31, 2025 [4] - In April 2025, Bluejay raised approximately $3.8 million through Class C warrant exercises and new Class E warrants, with a goal to raise at least $30 million by the end of the 2027 fiscal year [4] Product and Clinical Study Information - The Symphony IL-6 Test is designed for sepsis triage and monitoring, providing results in about 20 minutes [5][7] - The SYMON Clinical Study Program includes SYMON-I and SYMON-II, with SYMON-I focusing on IL-6 levels related to mortality outcomes [6]

PART I FINANCIAL INFORMATION [Condensed Consolidated Financial Statements (Unaudited)](index=6&type=section&id=Item%201.%20Condensed%20Consolidated%20Financial%20Statements%20(Unaudited)) The unaudited condensed consolidated financial statements for the quarter ended March 31, 2025, show a net loss of $1.9 million, a decrease from the $2.3 million loss in the same period of 2024. Total assets decreased to $5.3 million from $6.7 million at year-end 2024, primarily due to a reduction in cash. The company's financial position raises substantial doubt about its ability to continue as a going concern, with cash resources expected to fund operations only up to the third quarter of 2025. A key subsequent event was an April 2025 private placement that raised approximately $3.8 million in gross proceeds [Condensed Consolidated Balance Sheets](index=6&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) As of March 31, 2025, the company's total assets were $5.28 million, a decrease from $6.66 million at December 31, 2024. This was primarily driven by a decrease in cash and cash equivalents from $4.30 million to $3.12 million. Total liabilities increased from $0.93 million to $1.41 million, while total stockholders' equity decreased from $5.73 million to $3.87 million over the same period Condensed Consolidated Balance Sheet Highlights (in thousands) | Account | March 31, 2025 | December 31, 2024 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $3,116 | $4,302 | | Total current assets | $3,572 | $4,899 | | Total assets | $5,278 | $6,657 | | **Liabilities & Equity** | | | | Total current liabilities | $1,317 | $810 | | Total liabilities | $1,412 | $928 | | Total stockholders' equity | $3,866 | $5,729 | | Total liabilities and stockholders' equity | $5,278 | $6,657 | [Condensed Consolidated Statements of Operations](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) For the three months ended March 31, 2025, the company reported a net loss of $1.86 million, or ($3.37) per share. This is an improvement from the net loss of $2.33 million, or ($394.76) per share, for the same period in 2024. The reduced loss was primarily due to a decrease in research and development expenses Statement of Operations Summary (in thousands) | Metric | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :--- | :--- | :--- | | Research and development | $785 | $1,335 | | General and administrative | $1,104 | $1,087 | | Total operating expenses | $1,889 | $2,428 | | Operating loss | ($1,889) | ($2,428) | | Net loss | ($1,864) | ($2,328) | | Net loss per share | ($3.37) | ($394.76) | [Condensed Consolidated Statements of Cash Flows](index=9&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) For the three months ended March 31, 2025, net cash used in operating activities was $1.18 million, a significant reduction from $2.30 million in the prior year period. There were no investing activities in Q1 2025. Unlike Q1 2024, which saw $2.79 million in net cash from financing activities, Q1 2025 had negligible financing cash flow. This resulted in a net decrease in cash of $1.19 million for the quarter Cash Flow Summary (in thousands) | Activity | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | ($1,185) | ($2,300) | | Net cash used in investing activities | $0 | ($35) | | Net cash (used in) provided by financing activities | ($1) | $2,788 | | **Net increase (decrease) in cash** | **($1,186)** | **$453** | [Notes to Condensed Consolidated Financial Statements](index=10&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) The notes detail the company's focus on developing the Symphony IL-6 test for sepsis, with a goal for a 510(k) FDA submission in Q4 2027, contingent on raising at least $30 million. A significant 'Going Concern' uncertainty is disclosed, stating current cash will only fund operations into Q3 2025. The notes also cover the license agreement with Toray, various financing activities in 2024, outstanding warrants, and a subsequent event in April 2025 where a warrant inducement raised approximately $3.8 million in gross proceeds - The company is developing the Symphony IL-6 test for sepsis and plans to submit a 510(k) application to the FDA in Q4 2027, with potential approval in Q3 2028. This plan is contingent on raising at least **$30 million** in capital between Q2 2025 and the end of 2027[31](index=31&type=chunk) - There is substantial doubt about the Company's ability to continue as a going concern. As of March 31, 2025, the company had an accumulated deficit of **$36.5 million** and estimates its current cash will only be sufficient to fund operations up to the third quarter of 2025[50](index=50&type=chunk) - The company has an exclusive global license (excluding Japan) from Toray Industries for its Symphony detection cartridges. The royalty rate was reduced to **7.5%** of net sales. There is a risk Toray could terminate the license as early as November 2025 if the company does not establish a manufacturing facility[59](index=59&type=chunk)[60](index=60&type=chunk)[61](index=61&type=chunk) - In April 2025, the company entered into inducement agreements with holders of Class C warrants, resulting in the exercise of warrants for gross proceeds of approximately **$3.8 million**. The company issued new Class E warrants as part of the transaction[94](index=94&type=chunk)[97](index=97&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=23&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the company's focus on the Symphony IL-6 test and the significant financial challenges it faces. The net loss for Q1 2025 was $1.9 million, an improvement from $2.3 million in Q1 2024, due to lower R&D spending. A critical liquidity issue is highlighted, with a going concern uncertainty and an estimated cash runway only until Q3 2025. The company needs to raise at least $30 million by the end of 2027 to execute its strategic plan. Recent financing activities, including a $3.8 million private placement in April 2025, are noted as efforts to address the liquidity shortfall Operating Results Comparison (in millions) | Metric | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :--- | :--- | :--- | | Research and Development | $0.8 | $1.3 | | General and Administrative | $1.1 | $1.1 | | Net Loss | ($1.9) | ($2.3) | - The decrease in R&D expenses was primarily due to a reduction in technology transfer efforts, which offset increased clinical trial expenses[107](index=107&type=chunk) - The company has substantial doubt about its ability to continue as a going concern. It estimates current cash resources will only fund operations up to Q3 2025 and failure to obtain additional financing could lead to liquidation[116](index=116&type=chunk) - To execute its plan of achieving FDA approval by Q3 2028, the company estimates it needs to raise at least **$30 million** between Q2 2025 and the end of 2027[100](index=100&type=chunk) - In April 2025, the company raised approximately **$3.8 million** in gross proceeds through a private placement involving the exercise of existing Class C warrants and the issuance of new Class E warrants[127](index=127&type=chunk)[130](index=130&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=29&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company is a smaller reporting company and is not required to provide the information for this item - As a smaller reporting company, Bluejay Diagnostics, Inc. is not required to provide quantitative and qualitative disclosures about market risk[137](index=137&type=chunk) [Controls and Procedures](index=29&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that the company's disclosure controls and procedures were not effective as of March 31, 2025. This was due to a material weakness in internal control over financial reporting identified during the 2024 fiscal year-end audit. The weakness relates to the incorrect accounting and valuation of certain warrants with 'reset' features issued in June 2024. The company plans to remediate this by engaging outside accounting experts for complex financial instruments - The company's disclosure controls and procedures were determined to be not effective as of March 31, 2025[141](index=141&type=chunk) - A material weakness was identified related to the accounting and valuation of Class C and Class D warrants issued in June 2024, which had 'reset' features that were not properly accounted for as a 'deemed dividend on warrant modification'[139](index=139&type=chunk) - The remediation plan involves engaging outside accounting experts to review and document the appropriate accounting for complex financial instruments like warrants[140](index=140&type=chunk) PART II OTHER INFORMATION [Legal Proceedings](index=31&type=section&id=Item%201.%20Legal%20Proceedings) The company reports that it is not currently involved in any legal proceedings - As of the filing date, the company is not involved in any legal proceedings[145](index=145&type=chunk) [Risk Factors](index=31&type=section&id=Item%201A.%20Risk%20Factors) This section supplements existing risk factors, emphasizing the imminent need for additional capital to remain a going concern and the significant risk of liquidation, which would likely result in a total loss for common stockholders. It also highlights risks from recent downsizing to preserve cash, including the loss of key personnel (VP of Operations and CTO), which could negatively impact product redevelopment and timelines - The company is in need of imminent material capital to remain a going concern. Failure to raise funds may lead to liquidation under U.S. bankruptcy laws, where common stockholders are not expected to recoup any material value[146](index=146&type=chunk) - To preserve cash, the company has downsized its full-time employee headcount to **6 persons**, including separating with its VP of Operations and negotiating a separation with its Chief Technology Officer. This may reduce business continuity and negatively affect product development[147](index=147&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=32&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company reported no unregistered sales of equity securities during the period - None[148](index=148&type=chunk) [Other Information](index=32&type=section&id=Item%205.%20Other%20Information) On May 8, 2025, the company entered into a settlement and release agreement with Nanohybrids, terminating a services agreement and discussions of a potential acquisition. The company agreed to pay Nanohybrids $50,000 plus up to $30,000 in legal fees. Additionally, on May 10, 2025, the company informed its Chief Technology Officer, Jason Cook, of its intent to separate from employment and is currently discussing the terms - On May 8, 2025, the company entered into a settlement agreement with Nanohybrids, terminating a Sharing and Services Agreement and paying **$50,000** plus up to **$30,000** in legal fees[150](index=150&type=chunk) - On May 10, 2025, the company informed its Chief Technology Officer, Jason Cook, of an upcoming separation from employment and is currently discussing the terms[151](index=151&type=chunk) [Exhibits](index=33&type=section&id=Item%206.%20Exhibits) This section lists the exhibits filed with the Form 10-Q, including the settlement agreement with Nanohybrids, officer certifications (Rule 13a-14(a) and Section 906 of Sarbanes-Oxley), and Inline XBRL data files - Filed exhibits include the Settlement Agreement with Nanohybrids, Inc., CEO/CFO certifications, and XBRL data files[154](index=154&type=chunk)