Bluejay Diagnostics Reports $7.7 Million Net Loss for Fiscal Year 2024

Bluejay Diagnostics, Inc. reported a net loss of approximately $7.7 million for the fiscal year ending December 31, 2024, a decrease from a net loss of $10.0 million in 2023. The company has accumulated a deficit of about $34.7 million since its inception. Total operating expenses for 2024 were approximately $7.2 million, down from $10.3 million in the previous year, primarily due to reduced research and development costs. The decrease in expenses was attributed to a reduction in personnel-related costs and product development expenses, although clinical development costs increased.

In terms of strategic developments, Bluejay is focused on its Symphony platform, which aims to provide rapid diagnostic tests for critical care settings. The company is currently preparing to transfer the intellectual property for its Symphony cartridges from Toray Industries to an in-house facility, with plans to redevelop the cartridges to address technical challenges. Bluejay has also initiated the SYMON-II pivotal clinical study, which aims to validate the Symphony IL-6 test for assessing the risk of mortality in sepsis patients. The company anticipates submitting a 510(k) regulatory application to the FDA in the fourth quarter of 2027, with a goal of achieving FDA approval by the third quarter of 2028.

Operationally, Bluejay's workforce has been reduced to seven full-time employees, including two executive officers. The company has relied on external consultants for various functions, including finance and regulatory advisory. As of December 31, 2024, Bluejay had cash and cash equivalents of approximately $4.3 million, which it expects will be sufficient to fund operations until the third quarter of 2025. The company plans to raise at least $30 million in capital to support its operations and product development through various financing methods.

The company has faced significant challenges, including a decline in the market price of its common stock, which has fallen by over 99.9% since its initial public offering in November 2021. Bluejay's stock is currently listed on the Nasdaq Capital Market, but it faces risks related to maintaining compliance with listing requirements. The company has also undergone multiple reverse stock splits to manage its stock price and market capitalization. Looking ahead, Bluejay's ability to continue as a going concern is contingent upon securing additional funding and successfully navigating the regulatory landscape for its products.