BJDX

SYMON-II pivotal clinical study completes targeted enrollment of 750 patients Company advances toward planned 510(k) submission and commercialization with US manufacturing contract signed to mitigate supply-chain risk Company ends second quarter with approximately $9.6 million in cash following significant financing ACTON, Mass., Aug. 13, 2026 (GLOBE NEWSWIRE) -- Bluejay Diagnostics, Inc. (NASDAQ: BJDX) (“Bluejay” or the “Company”), a medical diagnostics company focused on improving patient outcomes in critical care settings, today reported financial results for the quarter ended June 30, 2026 and provided an update on the Company’s clinical, regulatory and manufacturing progress. During the first half of 2026, Bluejay continued to advance several key elements of its development strategy for the Symphony™ platform and its lead product candidate, the Symphony IL-6 test. The Company completed the targeted enrollment of 750 hospital patients in its SYMON-II pivotal clinical validation study and is progressing toward analytical and clinical validation activities intended to support a future FDA 510(k) submission. At June 30, 2026, Bluejay had approximately $9.6 million in cash and cash equivalents, compared with approximately $5.2 million at December 31, 2025. During the first six months of 2026, the Company generated approximately $7.7 million of net cash from financing activities, including approximately $7.6 million of net proceeds from its June 2026 private placement. “We believe the second quarter represented an important period of execution for Bluejay as we strengthened our financial position while continuing to advance the clinical, regulatory and manufacturing infrastructure required for Symphony,” said Neil Dey, President and Chief Executive Officer of Bluejay Diagnostics. “With targeted enrollment of 750 patients in SYMON-II now completed, our focus is increasingly shifting towards manufacturing readiness and the activities necessary to support our planned regulatory submission and commercialization.” Dey continued, “Importantly, we believe our recent financing provides us with additional resources to execute these near-term priorities. We ended the quarter with approximately $9.6 million in cash, and our current cash resources are estimated to fund operations through the second quarter of 2027. We recognize that disciplined capital allocation remains critical, and our objective is to concentrate our resources on activities that we believe can advance Symphony toward regulatory clearance and commercial readiness.” Note: The Company's Symphony™ rapid diagnostic platform is an investigational device and is limited by United States law to investigational use. About the SYMON Clinical Study Program: The SYMON Clinical Study Program includes SYMON-I (clinicaltrials.gov ID NCT06181604), SYMON-II (NCT06654895), and SYMON-III (NCT07425587). SYMON-I is a pilot study to determine IL-6 levels associated with various endpoints, including, but not limited to 28-day all-cause mortality and in-hospital mortality. The SYMON-II study is the pivotal study to validate the outcomes of the SYMON-I study, which the Company plans to use to support a 510(k) application to the FDA. The SYMON-III study is a pilot study to determine IL-6 levels associated with patients presenting with increasing severity of infection in the emergency department and risk of developing sepsis. About Bluejay Diagnostics: Bluejay Diagnostics, Inc. is a medical diagnostics company focused on improving patient outcomes using its Symphony System, a cost-effective, rapid, near-patient testing system for sepsis triage and monitoring of disease progression. Bluejay does not yet have regulatory clearance for the Symphony System, and we will need to receive regulatory authorization from the U.S. Food and Drug Administration before Symphony can be marketed as a diagnostic product in the United States. Bluejay’s first product candidate, an IL-6 Test for sepsis, is designed to provide accurate, reliable results in approximately 20 minutes from ’sample-to-result’ to help medical professionals make earlier and better triage/treatment decisions. More information is available at www.bluejaydx.com. Forward-Looking Statements: This press release contains statements that the Company believes are “forward-looking statements” within the meaning of the Private Litigation Reform Act. Forward-looking statements may be identified by words such as “anticipates,” “believes,” “estimates,” “expects,” “intends,” “may,” “plans,” “projects,” “seeks,” “should,” “suggest,” “will,” and similar expressions. The Company has based these forward-looking statements on its current expectations and projections about future events, nevertheless, actual results or events could differ materially from the plans, intentions and expectations disclosed in, or implied by, the forward-looking statements the Company makes. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, including market and other conditions and those discussed under item 1A. “Risk Factors” in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2025, and in Part II, Item 1A, “Risk Factors” in its Quarterly Reports on Form 10-Q for the fiscal quarters ended March 31, 2026 and June 30, 2026. You should not place undue reliance on these forward-looking statements, as they are subject to risks and uncertainties, and actual results and performance in future periods may not occur or may be materially different from any future results or performance suggested by the forward-looking statements in this release. This press release speaks as of the date indicated above. The Company undertakes no obligation to update any forward-looking statements, whether as a result of new information, future events, or otherwise, except as required by law. The Company expressly disclaims any obligation to update or revise any forward-looking statements found herein to reflect any future changes in the Company’s expectations of results or any future change in events, except as required by law. Investor Contact: Neil DeyBluejay Diagnostics, [email protected]: www.bluejaydx.com

ACTON, Mass., May 07, 2026 (GLOBE NEWSWIRE) -- Bluejay Diagnostics, Inc. (“Bluejay” or the “Company”), a medical diagnostics company focused on improving patient outcomes in critical care settings, today provided a corporate update highlighting progress achieved during the first quarter of 2026 and recent operational developments related to its Symphony™ near-patient diagnostic platform. During the first quarter of 2026, Bluejay continued advancing the clinical, manufacturing, and regulatory activities supporting the development of its Symphony IL-6 test for sepsis patient monitoring and risk assessment in critical care settings. Q1 2026 and Recent Highlights • Continued enrollment progress in the ongoing SYMON-II pivotal clinical study evaluating the role of IL-6 in sepsis and septic shock patients. As of May 5, 2026, approximately 680 patients have been enrolled toward the target enrollment of 750 patients across participating clinical sites. • Advanced manufacturing readiness activities for Symphony cartridges in collaboration with Sanyoseiko Co. Ltd., Bluejay’s contract manufacturing organization. The Company successfully resolved technical issues related to the Symphony cartridge manufacturing process and is progressing toward analytical and clinical validation activities intended to support future regulatory submission. • Continued execution of Bluejay’s FDA-focused regulatory strategy for Symphony IL-6, with the Company maintaining its objective of preparing for a future 510(k) submission following completion of required analytical and clinical validation activities. • Continued development activities related to Bluejay’s broader Symphony platform strategy, which includes future potential applications in additional critical care biomarkers and cardiovascular disease monitoring. Neil Dey, President and Chief Executive Officer of Bluejay Diagnostics, commented, “We believe the first quarter of 2026 represented meaningful operational progress across several key areas of our Symphony program. Most importantly, we continued strong enrollment momentum in our SYMON-II pivotal study while also advancing manufacturing readiness activities intended to support future analytical and clinical validation. We are encouraged by the progress our team and partners have made in positioning Symphony toward the next phase of development.” Mr. Dey continued, “We believe Symphony has the potential to address an important unmet need in critical care by enabling rapid, near-patient biomarker testing where time-sensitive clinical decisions are essential. As we continue executing our clinical and manufacturing roadmap, we remain focused on progressing toward regulatory readiness and future commercialization opportunities.” Financial Highlights As of March 31, 2026, Bluejay reported cash and cash equivalents of approximately $3.7 million. The Company reported a net loss of approximately $1.9 million for the first quarter of 2026, compared to approximately $1.9 million for the same period in 2025. The Company believes it has continued to manage operating expenses with financial discipline while prioritizing critical clinical, manufacturing, and regulatory activities supporting the Symphony program. About the Symphony IL-6 Test: The SymphonyTM Test platform is designed to determine patient acuity for triage and monitoring based on the measurement of a specific biomarker. The SymphonyTM IL-6 Test to determine patient acuity for sepsis triage and monitoring (“SymphonyTM IL-6 Test”) is currently Bluejay’s lead product candidate. Note: Investigational device. Limited by United States law to investigational use. About the SYMON Clinical Study Program: The SYMON Clinical Study Program includes SYMON-I (clinicaltrials.gov ID NCT06181604), SYMON-II (NCT06654895), and SYMON-III (NCT07425587). SYMON-I is a pilot study to determine IL-6 levels associated with various endpoints, including, but not limited to 28-day all-cause mortality and in-hospital mortality. The SYMON-II study is the pivotal study to validate the outcomes of the SYMON-I study, which the Company plans to use to support a 510(k) application to the FDA. The SYMON-III study is a pilot study to determine IL-6 levels associated with patients presenting with increasing severity of infection in the emergency department and risk of developing sepsis. About Bluejay Diagnostics: Bluejay Diagnostics, Inc. is a medical diagnostics company focused on improving patient outcomes using its Symphony System, a cost-effective, rapid, near-patient testing system for sepsis triage and monitoring of disease progression. Bluejay does not yet have regulatory clearance for the Symphony System, and we will need to receive regulatory authorization from the U.S. Food and Drug Administration before Symphony can be marketed as a diagnostic product in the United States. Bluejay’s first product candidate, an IL-6 Test for sepsis, is designed to provide accurate, reliable results in approximately 20 minutes from ’sample-to-result’ to help medical professionals make earlier and better triage/treatment decisions. More information is available at www.bluejaydx.com. Forward-Looking Statements: This press release contains statements that the Company believes are “forward-looking statements” within the meaning of the Private Litigation Reform Act. Forward-looking statements may be identified by words such as “anticipates,” “believes,” “estimates,” “expects,” “intends,” “may,” “plans,” “projects,” “seeks,” “should,” “suggest,” “will,” and similar expressions. The Company has based these forward-looking statements on its current expectations and projections about future events, nevertheless, actual results or events could differ materially from the plans, intentions and expectations disclosed in, or implied by, the forward-looking statements the Company makes. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, including market and other conditions and those discussed under item 1A. “Risk Factors” in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2025, and in Part II, Item 1A, “Risk Factors” in its Quarterly Report on Form 10-Q for the fiscal quarter ended March 31, 2026. You should not place undue reliance on these forward-looking statements, as they are subject to risks and uncertainties, and actual results and performance in future periods may not occur or may be materially different from any future results or performance suggested by the forward-looking statements in this release. This press release speaks as of the date indicated above. The Company undertakes no obligation to update any forward-looking statements, whether as a result of new information, future events, or otherwise, except as required by law. The Company expressly disclaims any obligation to update or revise any forward-looking statements found herein to reflect any future changes in the Company’s expectations of results or any future change in events, except as required by law. Investor Contact: Neil Dey Bluejay Diagnostics, Inc. [email protected] 978-631-0310 Website: www.bluejaydx.com

ACTON, Mass., Aug. 07, 2025 (GLOBE NEWSWIRE) -- Bluejay Diagnostics, Inc. (NASDAQ: BJDX) (“Bluejay” or the “Company”), a medical diagnostics company developing near-patient solutions for critical care, today announced financial results for the quarter ended June 30, 2025, and provided an update on its Symphony IL-6 test program and key operational milestones. Second Quarter 2025 and Recent Corporate Highlights SYMON-II Pivotal Clinical Study Underway: Bluejay has initiated patient enrollment in the SYMON-II pivotal clinical trial, designed to validate findings from the successful SYMON-I pilot study. Early indicators show continued clinical momentum. The trial aims to assess the predictive performance of IL-6 levels in ICU patients for 28-day all-cause mortality. Symphony IL-6 Development and Regulatory Pathway: Bluejay remains on track to complete SYMON-II sample testing by the end of 2026, with a target 510(k) submission to the FDA in 2027. Strategic Manufacturing Alignment with SanyoSeiko: Bluejay continues to work closely with SanyoSeiko Co., Ltd. as its contract manufacturing organization (CMO) for the Symphony analyzer. In parallel, the Company is advancing plans to secure cartridge redevelopment and validation manufacturing through a qualified FDA-registered CMO. These steps aim to ensure regulatory-grade supply chain readiness for clinical validation and commercialization. Amended License & Supply Agreement with Toray Industries: On July 23, 2025, Bluejay entered into an amendment with Toray Industries, extending the timeline to establish alternate cartridge manufacturing to October 2026. The amendment also confirms completion of Toray’s know-how transfer and final supply obligations—strengthening Bluejay’s independence in future manufacturing. Financing Progress and Outlook: In April 2025, Bluejay raised gross proceeds of $3.85 million through a warrant inducement financing. The Company anticipates requiring additional capital through 2027 to support manufacturing readiness, clinical trials, and regulatory activities. The Company is actively exploring strategic and institutional financing avenues to meet these milestones. Upcoming Catalysts Manufacturing Site Selection and Onboarding for Cartridge Redevelopment Completion of Cartridge Redevelopment Specifications and Validation Readiness Patient Enrollment Acceleration and Interim Data Review from SYMON-II Initiation of Analytical Validation Studies Ongoing Partnership and Financing Discussions to Support Regulatory Strategy “We continue to make focused progress on multiple fronts—clinically, operationally, and financially. Our continued and timely progress of SYMON-II clinical studies marks a major step toward demonstrating Symphony IL-6’s predictive value in sepsis care,” said Neil Dey, Chief Executive Officer of Bluejay Diagnostics. “With updated licensing terms from Toray and manufacturing alignment through SanyoSeiko, we are positioning the Symphony platform for scalable development. We are actively engaging with strategic partners and capital providers to support this mission.” About the Symphony IL-6 Test: The Symphony Test platform is designed to determine patient acuity for triage and monitoring based on the measurement of a specific biomarker. The Symphony IL-6 Test to determine patient acuity for sepsis triage and monitoring (“Symphony IL-6 Test”) is currently Bluejay’s lead product candidate. About the SYMON Clinical Study Program: The SYMON Clinical Study Program includes SYMON-I I (clinicaltrials.gov ID NCT06181604) and SYMON-II (NCT06654895). SYMON-I is a pilot study to determine IL-6 levels associated with various endpoints, including, but not limited to 28-day all-cause mortality and in-hospital mortality. The SYMON-II study is the pivotal study to validate the outcomes of the SYMON-I study, which the Company plans to use to support a 510(k) application to the FDA. About Bluejay Diagnostics: Bluejay Diagnostics, Inc. is a medical diagnostics company focused on improving patient outcomes using its Symphony System, a cost-effective, rapid, near-patient testing system for sepsis triage and monitoring of disease progression. Bluejay’s first product candidate, an IL-6 Test for sepsis, is designed to provide accurate, reliable results in approximately 20 minutes from ‘sample-to-result’ to help medical professionals make earlier and better triage/treatment decisions. More information is available at www.bluejaydx.com. Symphony is a registered trademark of Bluejay Diagnostics, Inc. Forward Looking Statements: This press release contains statements that the Company believes are “forward-looking statements” within the meaning of the Private Litigation Reform Act. Forward-looking statements in this press release include, without limitation, statements about the ongoing SYMON-II clinical trial, plans to redevelop the cartridges used in the Company’s Symphony system, including the potential for working with a third-party contract manufacturing organization in connection with such redevelopment, the expected nature and timing of the Company’s planned FDA submission and related plans for clinical study completion, whether the Company’s cash position will be sufficient to fund operations needed to achieve regulatory approval and initial commercialization of the Symphony IL-6 Test, whether such regulatory approval will actually occur, the Company’s plans for future fundraising, and the continuation of the Company as a going concern. Forward-looking statements may be identified by words such as “anticipates,” “believes,” “estimates,” “expects,” “intends,” “may,” “plans,” “projects,” “seeks,” “should,” “suggest,” “will,” and similar expressions. The Company has based these forward-looking statements on its current expectations and projections about future events, nevertheless, actual results or events could differ materially from the plans, intentions and expectations disclosed in, or implied by, the forward-looking statements the Company makes. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, including market and other conditions and those discussed under Part I, Item 1A, “Risk Factors” in its Annual Report on Form 10-K for the fiscal year ended December 31, 2024, filed with the SEC on March 31, 2025, and in Part II, Item 1A, “Risk Factors” in its Quarterly Report on Form 10-Q for the fiscal quarter ended March 31, 2025, filed with the SEC on May 13, 2025, and in its Quarterly Report on Form 10-Q for the fiscal quarter ended June 30, 2025, filed with the SEC on August7th , 2025. You should not place undue reliance on these forward-looking statements, as they are subject to risks and uncertainties, and actual results and performance in future periods may not occur or may be materially different from any future results or performance suggested by the forward-looking statements in this release. This press release speaks as of the date indicated above. The Company undertakes no obligation to update any forward-looking statements, whether as a result of new information, future events, or otherwise, except as required by law. The Company expressly disclaims any obligation to update or revise any forward-looking statements found herein to reflect any future changes in the Company’s expectations of results or any future change in events, except as required by law. Investor Contact: Investor Relations Bluejay Diagnostics, Inc. [email protected] Website: www.bluejaydx.com