Bluejay Diagnostics — Third Quarter 2026 Earnings Summary

Financial Performance:

• Cash and cash equivalents totaled $7.38 million as of September 30, 2026, an increase from $5.16 million at December 31, 2025.
• Net cash used in operating activities for the nine months ended September 30, 2026, was approximately $5.09 million.
• No revenue, earnings, profit margins, or debt figures were disclosed in the press release.

Guidance and Future Outlook:

• The Company targets an FDA 510(k) submission for the Symphony IL-6 test during the first half of 2027, subject to successful validation.
• Existing cash resources are estimated to support operations through the second quarter of 2027.
• Additional financing will be required to support longer-term development and commercialization plans.
• Focus remains on completing SYMON-II clinical analysis, advancing analytical validation, and manufacturing qualification.

Business Segments and Product Lines:

• Completed enrollment in the SYMON-II clinical validation study, exceeding the original target of 750 patients with 777 evaluable patients.
• Preliminary baseline analysis of 777 patients identified 140 deaths within 28 days, representing approximately 18% mortality.
• Initiated preliminary sample testing and patient data analysis, with final analytical testing to follow cartridge verification and validation.
• Established an alternative Symphony cartridge manufacturing site through Sanyoseiko ahead of the October 23, 2026 contractual deadline under the agreement with Toray Industries.
• Advanced U.S. manufacturing capabilities through ALURIS Sciences (previously Argonaut Manufacturing) for cartridge production, quality activities, packaging, and distribution.
• Entered into a distribution agreement with Lovell Government Services to support potential access to U.S. government healthcare markets.
• Progressed an exploratory artificial intelligence initiative evaluating the integration of IL-6 measurements and clinical data for future sepsis risk stratification.

Market and Competitive Landscape:

• The Symphony™ Suite is designed as a rapid quantitative biomarker assay platform to provide results in approximately 20 minutes from sample-to-result for sepsis triage and monitoring.
• The Company aims to address unmet needs in critical care by bringing quantitative biomarker information closer to the patient.
• No specific market share, competitor names, or market size data were provided.

Risks and Challenges:

• The Symphony IL-6 Test has not been cleared or approved by the FDA and is not currently available for commercial clinical use in the United States.
• Preliminary baseline characteristics do not establish the prognostic performance, clinical utility, sensitivity, specificity, or regulatory acceptability of the test; conclusions depend on completion of planned analyses.
• Additional financing is required beyond the second quarter of 2027 to support long-term plans.
• Forward-looking statements involve known and unknown risks, uncertainties, and factors that could cause actual results to differ materially from expectations.

Management Commentary and Tone:

• Neil Dey, President and CEO, stated that the third quarter marked significant progress in advancing critical elements toward regulatory submission and commercialization.
• Management believes key development and operational risks have been meaningfully reduced following the completion of SYMON-II enrollment and manufacturing milestones.
• The Company remains committed to disciplined capital allocation, regulatory progress, and building a scalable diagnostic platform.

Other Key Points:

• The SYMON Clinical Study Program includes SYMON-I (pilot), SYMON-II (pivotal), and SYMON-III (pilot) studies, with SYMON-II intended to support the 510(k) application.
• The Company has no regulatory clearance for the Symphony™ System and requires FDA authorization before marketing the product in the U.S.
• The press release includes standard forward-looking statement disclaimers referencing risks detailed in the Company's Form 10-K and Form 10-Q filings.