Core Insights - Bluejay Diagnostics, Inc. announced that an abstract related to its Symphony™ IL-6 Test has been accepted for presentation at the 2026 Society of Academic Emergency Medicine Annual Meeting [1] - The SYMON-I study evaluates the relationship between IL-6 levels in sepsis patients and organ dysfunction, measured by SOFA scores during the first three days of hospitalization [2][3] Study Details - SYMON-I is a multicenter pilot clinical study focusing on IL-6 levels in sepsis patients admitted to the ICU [2] - The study aims to determine if IL-6 levels can serve as a biomarker for early assessment of organ dysfunction in critically ill patients [3] Presentation Information - The presentation titled "Emergency Department Interleukin-6 Levels and Organ Dysfunction in Sepsis Across Multiple Centers" will be delivered by Dr. John H. Lee and Dr. Nathan Shapiro at the SAEM Annual Meeting in Atlanta, Georgia [4] Product Information - The Symphony™ IL-6 Test is designed for rapid assessment of patient acuity for sepsis triage and monitoring, providing results in approximately 20 minutes [8] - Bluejay's ongoing SYMON-II study aims to validate the findings of SYMON-I and support a 510(k) application to the FDA [6] Company Overview - Bluejay Diagnostics focuses on improving patient outcomes through its Symphony System, which is a cost-effective, rapid testing system for sepsis [8]

Core Viewpoint - NorthStrive Fund II LP recommends that Bluejay Diagnostics' Board of Directors evaluate a strategic acquisition opportunity that could significantly enhance long-term shareholder value [1][4][20]. Group 1: Shareholder Engagement - NorthStrive Fund is a significant shareholder of Bluejay, as disclosed in a Schedule 13G filed with the U.S. Securities and Exchange Commission [2]. - The Fund expresses support for the Board and management's progress on the SYMON™ II program while encouraging pipeline expansion [3][8]. Group 2: Proposed Acquisition - The letter suggests that Bluejay consider acquiring a Phase-1-ready therapeutic asset targeting refractory chronic cough, a condition affecting millions and representing a market opportunity exceeding $10 billion annually [4][14]. - The proposed asset is a small-molecule inhibitor of fatty acid amide hydrolase (FAAH), designed to increase levels of anandamide, potentially desensitizing hyperactive sensory neurons responsible for the cough reflex [14][15]. Group 3: Clinical and Financial Considerations - NorthStrive Fund believes that adding a differentiated clinical-stage program could diversify development risk and introduce multiple clinical catalysts, enhancing long-term market valuation [4][5]. - Financing for the potential acquisition has been arranged through a public-company financing structure, which could strengthen Bluejay's capital position [5][19]. Group 4: Market Context and Differentiation - Recent interest from larger pharmaceutical companies in the refractory chronic cough space has increased, highlighted by GSK's $2 billion acquisition of BELLUS Health in 2023 [17]. - The proposed program's mechanism is distinct from existing chronic cough treatments, potentially reducing the risk of side effects associated with current therapies [18]. Group 5: Strategic Recommendations - The letter emphasizes the importance of evaluating opportunities to add clinical-stage programs with clear competitive advantages and compelling risk-adjusted upside [11]. - It also highlights the need for programs capable of generating meaningful clinical milestones within the next 12–24 months to enhance investor visibility and valuation [12][13].

Funding and Financial Position - Bluejay Diagnostics aims to raise at least $20 million by the end of the 2027 fiscal year to support the commercialization of its Symphony platform[21]. - The company has incurred an accumulated deficit of approximately $41.5 million since inception, with operating losses of approximately $6.8 million for the fiscal year ended December 31, 2025[27]. - The company expects to need to raise at least $20 million by the end of the 2027 fiscal year to support its strategic plan, which includes submitting a 510(k) regulatory application to the FDA in 2027[81]. - The market price of the company's common stock has fallen by more than 99.9% since its initial public offering in November 2021, with declines exceeding 80% per year from 2022 to 2025[84]. - The company has conducted several public offerings and private placements to raise additional capital, resulting in further declines in the market price of its common stock[84]. - The company has incurred a net loss of approximately $6.8 million and $7.7 million for the years ended December 31, 2025 and 2024, respectively, with an accumulated deficit of approximately $41.5 million since inception[79]. - As of December 31, 2025, the company had cash and cash equivalents of approximately $5.2 million and current liabilities of approximately $1.1 million[81]. - The company has not generated any operating income and may not be able to commercialize its Symphony technology platform, impacting its ability to achieve profitability[80]. - The company has reduced its overall full-time employee headcount to 6 persons to preserve cash resources, which may affect business continuity and product development timelines[98]. - The company expects significant negative cash flow in the future, raising doubts about its ability to continue as a going concern[82]. Regulatory and Compliance - The FDA has determined that a 510(k) submission is the appropriate pathway for the Symphony IL-6 test, with specific data requested for the application[39]. - The company is subject to extensive FDA regulations governing the development, testing, and marketing of its medical devices[54]. - The company is required to obtain market approval for its products in the U.S. or EU by October 2026, or risk losing exclusivity under the license agreement with Toray[110]. - The company is subject to numerous post-marketing regulatory requirements, which may include labeling regulations and medical device reporting regulations[146]. - Failure to comply with regulatory requirements may result in enforcement actions, including fines, recalls, and production shutdowns[149]. - The regulatory clearance process for the Symphony platform is expected to be expensive and uncertain, with no assurance of obtaining necessary approvals[145]. - Delays in obtaining regulatory clearances or approvals could materially adversely affect the company's business and financial condition[152]. - The PMA process is typically more costly and lengthy than the 510(k) process, requiring valid scientific evidence from preclinical studies and human clinical trials[150]. - The company is required to establish a cartridge manufacturing site by October 2026, with modifications being managed by a third-party contractor, Sanyoseiko[105]. - The company is dependent on Sanyoseiko for compliance with FDA requirements and timely supply of Symphony analyzers and cartridges, which poses a risk to its viability[113]. Product Development and Market Strategy - The Symphony IL-6 test is designed to provide laboratory-quality results in approximately 20 minutes, targeting critical care settings such as ICUs and ERs[22]. - The Symphony platform is intended to address a significant market need in the U.S. IVD market, focusing on rapid tests for sepsis and potentially expanding to other diseases[30]. - Bluejay plans to submit a 510(k) regulatory application to the FDA in 2027, contingent upon successful completion of the SYMON-II clinical study[42]. - The company is conducting testing to demonstrate specimen stability from the SYMON-II clinical study, which is essential for proceeding to FDA clearance[107]. - The company has begun the cartridge manufacturing process through Sanyoseiko, a third-party contractor, to address manufacturing challenges[49]. - The company is working with Sanyoseiko to manufacture cartridges for the Symphony IL-6 test, with production and verification expected to be completed in 2026[143]. - The company has not yet launched any products and faces risks regarding market acceptance of its Symphony platform and test cartridges[115]. - The company is pursuing an exploratory initiative to integrate artificial intelligence capabilities into its Symphony platform, which remains in the evaluation stage[70]. - The company has undergone multiple reverse stock splits to maintain its Nasdaq listing, with a cumulative ratio of 1-for-32,000 since July 2023[72]. - Commercial sales must begin by October 2028, with potential extensions of up to 2 years if delays are not attributable to the company[110]. Intellectual Property and Competition - The company currently does not hold any granted patents and relies on a License Agreement with Toray for intellectual property protection, with key patents expiring between 2027 and 2030[51]. - The company relies on licensed intellectual property from Toray, which may not provide meaningful protection, and there are risks associated with potential patent expirations within the next five years[172][175]. - The company is subject to risks related to claims challenging the inventorship of the intellectual property licensed from Toray, which could result in loss of valuable rights[176]. - The company has the potential to face significant expenses and liabilities from litigation regarding intellectual property rights of others, which could delay product launches[173]. - Competition in the diagnostic testing market is intense, leading to potential price reductions, longer selling cycles, and lower product margins[179]. - There are currently no FDA cleared IL-6 tests on the market, providing Symphony with a competitive advantage[52]. Operational Challenges - The company is facing significant raw material shortages and supplier disruptions, which may adversely impact product sales and margins[130]. - Specific raw materials for the production of Symphony IL-6 cartridges are being discontinued, leading to potential delays and increased costs in finding suitable substitutes[131]. - The company is experiencing performance reproducibility issues with Symphony cartridges, which could delay the FDA clearance process[132]. - The company may incur significant additional costs and delays if the FDA requests further data or testing after application submission[112]. - The company faces challenges in obtaining coverage and reimbursement from third-party payors, which could negatively impact its business[117]. - Product liability claims could lead to costly litigation and increased insurance rates, adversely affecting the company's financial condition[128]. Corporate Governance and Compliance - The company has identified one or more material weaknesses in internal controls, which could adversely affect its stock price and market confidence[195]. - The company has no employees dedicated full-time to finance, accounting, legal, or compliance functions, increasing the likelihood of internal control failures[194]. - The company is classified as an "emerging growth company," allowing it to take advantage of reduced disclosure requirements, which may affect investor perception[185][187]. - The company is required to furnish a report on internal control over financial reporting in its Annual Reports on Form 10-K, which is both costly and challenging[195]. - The company has never declared or paid any cash dividends on its capital stock and does not expect to do so in the foreseeable future[216]. - The company’s common stock is subject to anti-takeover provisions that could discourage changes in control, potentially affecting stock price[189].

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): March 6, 2026 (Commission File No.) (I.R.S. Employer Identification No.) 360 Massachusetts Avenue, Suite 203 Acton, MA 01720 (Address of principal executive offices and zip code) (844) 327-7078 BLUEJAY DIAGNOSTICS, INC. (Exact Name of Registrant as Specified in its Charter) DELAWARE 001-41031 4 ...

Company Overview - Bluejay Diagnostics, Inc. is a medical diagnostics company focused on improving patient outcomes through its Symphony System, which is a cost-effective, rapid, near-patient testing system for sepsis triage and monitoring of disease progression [3] Recent Developments - As of February 19, 2026, all prefunded warrants issued in the October 2025 private placement have been fully exercised, resulting in approximately 972,000 shares of common stock outstanding [1] - The company has cash exercisable warrants outstanding for approximately 1.5 million shares, with a cash exercise price of $7.00 or greater per share [1] Stock Information - Recent Schedule 13G filings by investors do not reflect the 1-for-4 reverse stock split that occurred on January 29, 2026, which may lead to discrepancies in reported beneficial ownership share amounts [2]

Core Insights - Bluejay Diagnostics has successfully enrolled 545 patients in its SYMON™ II multicenter clinical study, exceeding initial expectations with a target of 750 patients [1][2] - The company is making significant progress in manufacturing readiness and technology transfer initiatives, marking a key transition from clinical enrollment to data analysis and commercialization [1][5] Clinical Study Progress - The SYMON™ II study focuses on IL-6 monitoring, with all patient enrollments conducted under approved IRB protocols [2] - The scale and diversity of the dataset are expected to enhance the company's regulatory positioning and facilitate discussions with future partners and stakeholders [3] Manufacturing Readiness - Manufacturing readiness activities are advancing across multiple workstreams, including antibodies, tooling, analytical validation, and commercial manufacturing infrastructure [4] - Key developments include the completion of monoclonal and polyclonal antibody production, which provides supply capacity for over 10 million test cartridges [8] - Technology transfer activities are progressing effectively, supported by strategies to mitigate timing and scale-up risks [4] Future Outlook - As Bluejay enters 2026, the company believes it is in a stronger execution position with reduced clinical risk and a heightened focus on value realization through data analysis and regulatory engagement [5]

ACTON, Mass., Jan. 27, 2026 (GLOBE NEWSWIRE) -- Bluejay Diagnostics, Inc. (NASDAQ: BJDX) (“Bluejay” or the “Company”), a medical technology company developing rapid diagnostics on its Symphony platform to improve patient outcomes in critical care settings, today announced that the Company’s Board of Directors has approved a reverse stock split of its shares of common stock at a ratio of 1-for-4 (the “Reverse Stock Split”). The Reverse Stock Split will become effective at 12:01 a.m. Eastern Time on January 2 ...

Core Insights - Bluejay Diagnostics, Inc. has completed commercial-scale production of polyclonal and monoclonal antibodies targeting interleukin-6 (IL-6), relevant for inflammatory and critical-care applications [1][2] Group 1: Antibody Production - Both polyclonal and monoclonal antibodies have met internal performance criteria for use in Symphony™ cartridge manufacturing intended for clinical and potential future commercial applications [2] - The company has generated polyclonal antibodies using both third-party and internally developed immunogens, intending to utilize antibodies from its proprietary immunogen for ongoing development activities [3] - Monoclonal antibodies produced by the company have demonstrated acceptable binding, specificity, and signal performance characteristics for their intended diagnostic use based on internal testing [3] Group 2: Production Capacity - Bluejay estimates sufficient material to support the production of over nine million Symphony cartridges for clinical and commercial manufacturing purposes [4] - The company has established the capability to produce additional antibodies as needed [4] Group 3: Product Development - The Symphony™ system remains under development and is subject to further validation, regulatory review, and clearance, with no assurance regarding the timing or success of these activities [5] - The Symphony System is designed for rapid, near-patient testing for sepsis triage and monitoring disease progression, with the first product candidate being an IL-6 Test for sepsis [6]

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]