Bluejay Diagnostics advances sepsis test, plans FDA filing

ACTON, Mass. - Bluejay Diagnostics, Inc. (NASDAQ: BJDX), a medical diagnostics company with a market capitalization of $2.63 million and a stock price that has declined 99% over the past year according to InvestingPro data, announced today that it has initiated the SYMON-II clinical study, a pivotal trial aimed at validating the use of interleukin-6 (IL-6) levels to predict mortality in sepsis patients. This follows the completion of the SYMON-I pilot study, which suggested that IL-6 levels within the first 24 hours of ICU admission could be indicative of patient outcomes up to 28 days later.

The company is currently biobanking samples for IL-6 measurement after patient enrollment concludes. Bluejay aims to use the Symphony IL-6 test for this purpose, following redevelopment of the test cartridges. The patient enrollment for the SYMON-II study began in the last quarter of 2024 and is ongoing.

In preparation for a U.S. Food and Drug Administration (FDA) submission, the company is planning to file a 510(k) regulatory application in the fourth quarter of 2027, with hopes of obtaining FDA approval by the third quarter of 2028.

Manufacturing developments include a continued partnership with SanyoSeiko for the Symphony analyzer and a search for a third-party contract manufacturing organization to potentially oversee the redevelopment of the Symphony cartridges.

Financially, as of April 30, 2025, Bluejay reported cash and cash equivalents of approximately $5.7 million against current liabilities of $1.0 million. The company raised approximately $3.8 million in April 2025 through warrant exercises and issuances, contributing to its near-term financial stability. InvestingPro analysis shows the company maintains a healthy current ratio of 2.71, though it’s quickly burning through cash with an EBITDA of -$6.56 million in the last twelve months. The company experienced losses of $7.7 million for the fiscal year ended December 31, 2024, and $1.9 million for the quarter ended March 31, 2025. Bluejay aims to secure at least $30 million in financing through the end of fiscal 2027.

To extend its cash runway, Bluejay has downsized its workforce to five full-time employees and has recently lost its Chief Technology Officer. The company’s 2025 annual meeting of stockholders is scheduled for June 18, 2025, where it will propose two reverse stock split proposals to help maintain NASDAQ listing compliance. According to InvestingPro, the stock shows high price volatility and currently trades below its Fair Value, with an overall financial health score rated as ’WEAK’. Subscribers to InvestingPro can access 12 additional key insights about Bluejay’s financial position and market performance.

Bluejay’s Symphony IL-6 Test is designed to provide rapid, near-patient testing results in about 20 minutes for sepsis triage and monitoring, potentially aiding in quicker and more effective patient management.

This update is based on a press release statement from Bluejay Diagnostics, Inc.

In other recent news, Bluejay Diagnostics has announced the departure of its Chief Technology Officer, Jason Cook. The separation agreement was mutually entered into on May 28, 2025, and will be effective as of June 4, 2025, with Dr. Cook’s employment officially ceasing on May 30, 2025. According to the terms of the agreement, Dr. Cook will receive severance payments, including a six-month base salary and a pro-rated target bonus for the 2025 calendar year. These payments are contingent upon his adherence to ongoing confidentiality and cooperation covenants. The agreement also allows for the possibility of Dr. Cook serving as a paid consultant post-employment, subject to future agreement on terms by both parties. This development was disclosed in an 8-K filing with the Securities and Exchange Commission, which includes the full text of the Separation Agreement. The company’s quarterly report for the period ending March 31, 2025, previously discussed the departure.

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