Earnings Releases·Nov 13, 2026, 4:05 PM ET

Bluejay Diagnostics — Third Quarter 2026 Earnings Summary

Cash and cash equivalents increased to $7.38 million as of September 30, 2026, from $5.16 million at year-end 2025, with net cash used in operating activities for the nine months ended September 30, 2026, totaling approximately $5.09 million.
The company targets an FDA 510(k) submission for the Symphony IL-6 test in the first half of 2027, contingent on successful validation, while current resources are projected to fund operations through the second quarter of 2027.
SYMON-II clinical enrollment was completed with 777 evaluable patients, and the company secured an alternative manufacturing site via Sanyoseiko ahead of the October 23, 2026 deadline while advancing U.S. manufacturing capabilities with ALURIS Sciences.
Strategic initiatives include a new distribution agreement with Lovell Government Services for U.S. government market access and an exploratory AI initiative for sepsis risk stratification, though additional financing remains necessary beyond Q2 2027.
The Symphony IL-6 test remains unapproved by the FDA and unavailable for commercial use, with preliminary data indicating an 18% mortality rate among the study cohort pending final analytical validation.