Bluejay Diagnostics provides Q3 corporate update

Third Quarter 2025 and Recent Corporate Highlights: SYMON-II Pivotal Clinical Study Continues: Bluejay continues patient enrollment in the SYMON-II pivotal clinical trial, designed to validate findings from its SYMON-I pilot study. The trial aims to assess the predictive performance of IL-6 levels in ICU patients for 28-day all-cause mortality. The Company’s goal is to use the Symphony IL-6 test to complete the testing in the SYMON-II clinical trial. Subject to receipt of further financing, the Company expects to complete sample testing by late 2026, positioning Symphony for a potential submission to the U.S. Food and Drug Administration in 2027. Strategic Partnerships and Supply-Chain Independence: Through an amended Master Service Agreement and the Master Supply Agreement with SanyoSeiko, a Japan-based contract manufacturer specializing in medical devices and precision engineering, Bluejay aims to strengthen its manufacturing process. The amended agreement was entered into in connection with Bluejay expanding SanyoSeiko’s role in helping to commercialize Bluejay’s Symphony platform. Cash Position and Recent Financings: As of September 30, 2025, the Company reported $3.08 million in cash and cash equivalents and $3.69 million in stockholders’ equity, following successful completion of a $3.85 million warrant-inducement financing in April and an additional $4.5 million PIPE financing in October. Future Outlook: Sepsis remains one of the leading causes of mortality worldwide, with over 1.7 million cases annually in the United States alone. The Symphony IL-6 test is designed to deliver actionable results in approximately 20 minutes, enabling faster triage in ICU and emergency settings. The global sepsis diagnostic market is projected to reach $1.8 billion by 2030, which the Company believes creates a compelling potential market opportunity for near-patient testing of sepsis biomarkers. To achieve its plan, the Company expects to need to raise at least $20 million of further capital by the end of the 2027 fiscal year, which the Company hopes to do in various tranches. The Company’s current plan, subject to achieving necessary financing, is to begin testing of samples it is collecting as part of its ongoing SYMON-II clinical trial by the end of 2026, with a goal of being in position to submit a 510(k) regulatory application to the FDA in 2027, with an objective of achieving FDA clearance thereafter.