Bluejay Diagnostics, Inc.
For the period ended Mar 31, 2025. Filed May 13, 2025.
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Mar 31, 2025 · Filed May 13, 2025
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Item 1A. Risk Factors
For a discussion of potential risks or uncertainties, see “Risk Factors” in the Company’s 2024 annual report on Form 10-K on file with the SEC. The following disclosures supplement such Risk Factors, and should be read in conjunction therewith:
Additional Risks Related to Our Financial Condition and Capital Requirements
To remain a going concern, we are in need of imminent material additional capital and absent our ability to raise such material capital in the near-term, we may be required to undertake a process of liquidation under U.S. bankruptcy laws, which we expect would limit holders of our common stock from recouping any material value for their shares.
As of March 31, 2025, we possessed cash and cash equivalents of approximately $3.1 million, while having current liabilities of approximately $1.3 million. We incurred losses of approximately $7.7 million and $10.0 million for fiscal years 2024 and 2023, respectively, and $1.9 million for the fiscal quarter ended March 31, 2025. From our inception through March 31, 2025, we have an accumulated deficit of approximately $36.5 million, and we do not currently generate any operating income. To achieve our current strategic plan, which strives to be in position to submit a 510(k) regulatory application to the FDA in the fourth quarter of 2027 and achieve FDA approval as early as the third quarter of 2028, we expect to need to raise at least $30 million of capital between the second quarter of 2025 and the end of the 2027 fiscal year, which we hope to do in various tranches during this time period. In April 2025, we entered into a warrant inducement transaction with certain existing warrant holders that raised approximately $3.8 million of gross proceeds (less total offering costs of approximately $465,000, including a 10% financial advisory fee to Aegis Capital Corp. of approximately $385,000). We are exploring potential pathways to raise additional material capital, but there can be no assurance that such additional capital will be available on a timely basis or on terms that will be acceptable to us. If we are ultimately unable to obtain the needed financing to implement our business plans, our board of directors could determine to cause the Company to undertake a process of liquidation under Chapter 7 of applicable U.S. bankruptcy laws. In such event, we do not currently expect that holders of shares of our common stock would recoup any material value in such process.
Additional Risks Related to Our Business
To preserve cash resources, we have downsized our organization, which may reduce business continuity, affect our ability to apply for certain patents, and affect our product development and timelines, including our previously disclosed plan to transfer underlying production of our cartridges to an in-house facility for redevelopment.
To preserve cash resources, we have implemented a series of recent cost savings measures in our product development operations. As of the date of this filing, we have reduced our overall Company-wide full-time employee headcount to 6 persons, including recently separating with our VP of Operations, who was overseeing the process of redeveloping aspects of our Symphony cartridges. We are also currently negotiating an upcoming separation with our Chief Technology Officer, who is also significantly involved in these matters, our ongoing SYMON-II clinical studies, analytical studies, and certain intellectual property in connection with the prior development work of Symphony performed by Company. While we continue to explore conducting cartridge redevelopment at an in-house facility, we are now exploring other alternative pathways for how to pursue such redevelopment, including by outsourcing this work to third parties. In addition, these measures are expected to result in a loss of institutional knowledge that may make our product redevelopment work more difficult to successfully achieve, whether we ultimately attempt to undertake such work in-house or through a third party. To the extent we obtain sufficient funding, we may hire replacement personnel in these areas in the future, but there is no assurance that we will be able to do so. These circumstances may make it more difficult to succeed in meeting the technical challenges necessary to bring our Symphony product to a level consistent with necessary performance and quality requirements to support an FDA submission and ultimately be able to commercialize our product, as well as the timeline for completing this work.
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