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Bluejay Diagnostics Announces All Prefunded Warrants Now Exercised
Globenewswire· 2026-02-20 11:30
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]
Bluejay Diagnostics Successfully Enrolls 545 Patients in SYMON™ II Study and Advances Manufacturing Readiness into 2026
Globenewswire· 2026-02-17 11:30
ACTON, Mass., Feb. 17, 2026 (GLOBE NEWSWIRE) -- Bluejay Diagnostics (NASDAQ: BJDX) today announced that it has successfully enrolled 545 patients in its SYMON™ II multicenter clinical study and has made substantial progress in advancing manufacturing readiness and technology transfer initiatives into 2026, representing a key execution milestone as the Company transitions from clinical enrollment toward data analysis, regulatory engagement, and commercialization readiness. SYMON-II Clinical trialsBluejay is ...
Bluejay Diagnostics Announces 1-for-4 Reverse Stock Split
Globenewswire· 2026-01-27 13:00
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 ...
Bluejay Diagnostics Announces Completion of Commercial-Scale IL-6 Antibody Production
Globenewswire· 2025-12-29 12:00
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]
Bluejay Diagnostics Corporate Update: Advancing Clinical Milestones and Strategic Partnerships
Globenewswire· 2025-11-10 12:30
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]
Bluejay Diagnostics(BJDX) - 2025 Q3 - Quarterly Report
2025-11-07 21:01
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]
Bluejay Diagnostics Announces Closing of $4.5 Million Private Placement Priced At-The-Market Under Nasdaq Rules
Globenewswire· 2025-10-10 21:16
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]
Recent Stock Market Gains Highlight Sector Diversity
Financial Modeling Prep· 2025-10-09 22:00
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]
Bluejay Diagnostics Announces $4.5 Million Private Placement Priced At-the-Market Under Nasdaq Rules
Globenewswire· 2025-10-09 19:15
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].
Bluejay Diagnostics and SanyoSeiko Expand Strategic Partnership to Advance Commercialization of Symphony Platform
Globenewswire· 2025-10-09 10:30
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]