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Bluejay Diagnostics Provides Mid-Year Business and Corporate Update
Globenewswireยท 2025-06-03 20:05
Core Insights - Bluejay Diagnostics, Inc. provided a mid-year business update for 2025, highlighting progress in its clinical programs and financial status [1][2] Business Highlights and Developments - The 2025 Annual Meeting of Stockholders is scheduled for June 18, 2025, with a proposal to reduce the Board of Directors from six to five members and to consider two reverse stock split proposals to meet Nasdaq listing requirements [3] - The SYMON-II clinical study has been initiated, following the successful SYMON-I pilot study, which indicated that IL-6 levels could predict sepsis patient mortality [4] - The company aims to submit a 510(k) application for its Symphony IL-6 test to the FDA in Q4 2027, with potential approval as early as Q3 2028 [4] - Bluejay is collaborating with SanyoSeiko for manufacturing the Symphony analyzer and is redeveloping Symphony cartridges to address technical challenges [4] Financial Results - As of April 30, 2025, Bluejay had cash and cash equivalents of approximately $5.7 million and current liabilities of about $1.0 million [4] - The company reported losses of approximately $7.7 million for the fiscal year ended December 31, 2024, and $1.9 million for the fiscal quarter ended March 31, 2025 [4] - In April 2025, Bluejay raised approximately $3.8 million through Class C warrant exercises and new Class E warrants, with a goal to raise at least $30 million by the end of the 2027 fiscal year [4] Product and Clinical Study Information - The Symphony IL-6 Test is designed for sepsis triage and monitoring, providing results in about 20 minutes [5][7] - The SYMON Clinical Study Program includes SYMON-I and SYMON-II, with SYMON-I focusing on IL-6 levels related to mortality outcomes [6]