Bluejay Diagnostics, Inc.
For the period ended Mar 31, 2025. Filed May 13, 2025.
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A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Mar 31, 2025 · Filed May 13, 2025
BJDX$2.35+7.3%Stored close · as of Nov 6, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2024-09-30; filed 2024-11-07.
0001213900-24-095388
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2025-03-31; filed 2025-05-13.
0001213900-25-042633
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
Compared 38 previous paragraphs and 59 current paragraphs.
22 unchanged; 11 reworded; 26 added; 5 removed; 0 previous and 0 current paragraphs rearranged.
Tables are not compared: 2 previous and 2 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
Added paragraphs (26)
Current report
Bluejay Diagnostics, Inc. (“Bluejay,” the “Company,” “we” and/or “us”)) is a medical diagnostics company focused on improving patient outcomes in critical care settings. The Company is working on developing rapid tests using whole blood on its Symphony technology platform (“Symphony”), which consists of an analyzer and single-use protein detection cartridges that have a function of automatic stepwise feeding of reagent. The Company does not yet have regulatory clearance for Symphony, and it will need to receive regulatory authorization from the U.S. Food and Drug Administration (the “FDA”) to be marketed as a diagnostic product in the United States. The Company has completed the development of the Symphony analyzer. The Company is planning to begin cartridge redevelopment either at an in-house facility or through a third-party contractor who would manage such redevelopment. Such redevelopment is intended to address several technical challenges to bring Symphony to a level consistent with necessary performance and quality requirements. After redevelopment, the Company plans to have manufacturing of the Symphony cartridges occur at a Contract Manufacturing Organization (“CMO”). To achieve its plan, the Company expects 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 the Company hopes to do in various tranches during this time period. The Company’s current plan, subject to achieving necessary financing, is to begin testing of samples it is collecting as part of its ongoing SYMON-II clinical trial in mid-2027, with a goal of being in position to submit a 510(k) regulatory application to the FDA in the fourth quarter of 2027, with an objective of achieving FDA approval as early as the third quarter of 2028.
Current report
The Company’s first product candidate, the Symphony IL-6 test, is an immunoassay for the measurement of interleukin-6 (IL-6) to be used for the monitoring of disease progression in critical care settings. The Company is currently focused on pursuing the Symphony IL-6 test in the context of sepsis. IL-6 is a clinically established inflammatory biomarker, and is considered a ‘first-responder,’ for assessment of severity of infection and inflammation across many disease indications, including sepsis. A current challenge of healthcare professionals is the excessive time and cost associated determining a patient’s level of severity at triage and the Company believes that its Symphony IL-6 test, if ultimately successful and approved, could have the ability to consistently monitor this critical care biomarker with rapid results.
Current report
If the Company succeeds with the foregoing plan, in the future it hopes to develop additional tests for Symphony, including tests for myocardial infarction and congestive heart failure (cardiac biomarkers hsTNT and NT pro-BNP) as well as other tests using the Symphony platform.
Current report
During the three months ended March 31, 2025, we used approximately $1.2 million in cash for operating activities, a decrease of approximately $1.1 million as compared to approximately $2.3 million for the same period in 2024. The decrease in net cash used in operating activities was primarily due to a decrease in working capital of approximately $664,000 and decreases in personnel and product development costs.
Current report
Net cash used in financing activities
Current report
The Company had cash and cash equivalents of $3,116,103 and current liabilities of $1,316,677 on its balance sheet as of March 31, 2025. The Company has incurred net losses since its inception, and has negative cash flows from operations and had an accumulated deficit of $36,533,219 as of March 31, 2025. The Company expects that its net cash used in operating activities will continue to be negative over at least the next several years as it redevelops aspects of the Symphony cartridges and conducts clinical trial work and, if such redevelopment and trials are successful, begin preparation of an FDA submission. These financial results and financial position, and the Company’s expected forward-looking outwork of significant negative cash flow in the future, raise substantial doubt with respect to its ability to continue as a going concern. As a result of the Company’s lack of cash, it has slowed the timeline of its clinical trial work to preserve cash resources in the near-term, and the Company expects that this will delay its Symphony platform regulatory submission timeline until the fourth quarter of 2027, at the earliest, if it is even able to generate sufficient clinical trial results to support such a submission. If the Company fails to obtain additional material financing in the near-term, its clinical trials and targeted FDA submission timeline could be delayed further, and it could be forced to abandon such activities entirely and cease operations, with the possible loss of such properties or assets. If the Company is unable to obtain additional financing as it continues to generate negative cash flow, its board of directors could determine to cause the Company to undertake a process of liquidation under Chapter 7 of applicable U.S. bankruptcy laws, or otherwise seek other protection under such laws. In such event, the Company expects that holders of shares of its common stock would recoup little if any material value in such process. The Company currently estimates that the cash resources it possesses as of the date of this filing will be sufficient to fund its operations up to the third quarter of 2025.
Current report
The condensed consolidated financial statements for the three months ended March 31, 2025 and 2024 were prepared under the assumption that the Company will continue as a going concern, which contemplates that the Company will be able to realize assets and discharge liabilities in the normal course of business.
Current report
Recent Offerings
Current report
January 2024 Offering
Current report
On January 2, 2024, the Company sold in a public offering (such transaction, the “January 2024 Offering”) (i) 1,344 shares of the Company’s common stock, par value $0.0001 per share and (ii) prefunded warrants to purchase up to an aggregate 5,386 shares of Common Stock (the “January Prefunded Warrants”). The Shares and January Prefunded Warrants were sold together with warrants to purchase up to an aggregate of 6,730 shares of Common Stock at an exercise price of $520.00 per share (the “January 2024 Warrants”). The combined public offering price was $520.00 per share of Common Stock and related January 2024 Warrant and $519.96 per January Prefunded Warrant and related January 2024 Warrant.
Current report
As of December 31, 2024, all January Prefunded Warrants had been exercised in full. The January 2024 Warrants are exercisable for a period of five years following the date of issuance.
Current report
Pursuant to an engagement letter, dated as of August 7, 2023, as amended October 11, 2023, by and between the Company and the Placement Agent, the Company paid the Placement Agent a total cash fee of $245,000 equal to 7.0% of the gross proceeds received in the January 2024 Offering. The Company also paid the Placement Agent in connection with the January Offering a management fee of $35,000 equal to 1.0% of the gross proceeds raised in the January 2024 Offering and certain expenses incurred in connection with the January Offering. In addition, the Company issued to the Placement Agent, warrants to purchase up to an aggregate 471 shares of Common Stock (the “January 2024 Placement Agent Warrants”), which represents 7.0% of the aggregate number of shares of Common Stock and Prefunded Warrants sold in the January 2024 Offering. The January 2024 Placement Agent Warrants have substantially the same terms as the January 2024 Warrants, except that the January 2024 Placement Agent Warrants have an exercise price equal to $650.00, or 125% of the offering price per share of Common Stock and related January 2024 Warrant sold in the January Offering and expire on the fifth anniversary from the date of the commencement of sales in the January 2024 Offering.
Current report
The gross proceeds to the Company from the January 2024 Offering were $3,500,000. The Company incurred offering costs of $711,031.
Current report
May 2024 Bridge Note Financing
Current report
On May 31, 2024, the Company entered into a Note Purchase Agreement with an accredited investor (the “NPA”), and a Securities Purchase Agreement with three accredited investors (the “SPA”). Under the terms of the NPA, the investor provided the Company with a $1,000,000 cash subscription in exchange for the issuance of a senior secured note. As of December 31, 2024, a total of $1,176,470 was repaid to the NPA investors. The difference between such note and the subscription amount, initially recorded as a discount on the notes, was the result of the discount factor included in the NPA of approximately 17.6%.
Current report
Under the terms of the SPA, the three investors agreed to collectively provide the Company with a separate $1,000,000 cash subscription in exchange for the issuance of senior secured notes ($333,333 each), and the collective issuance of 1,451 shares of the Company’s common stock. The fair value of the common stock issued in connection with the SPA was $307,563. As of December 31, 2024, a total of $1,111,110 was repaid to the SPA investors. The difference between such notes and the subscription amounts, initially recorded as a discount on the notes, was the result of the discount factor included in the SPA of 11.11%.
Current report
Interest expense recorded on the NPA and SPAs was $807,797 for the year ended December 31, 2024, including debt issuance costs related to the NPA and SPA totaling $212,654.
Current report
June 2024 Offering
Current report
On June 28, 2024, the Company sold in a public offering ( the “June 2024 Offering”), (i) 11,541 common units (the “Common Units”), each consisting of one share of common stock, two Class C Warrants and one Class D Warrant and (ii) 95,815 prefunded warrants (the “Prefunded Units”), each consisting of one prefunded warrant to purchase one share of common stock (each, a “Prefunded Warrant”), two Class C Warrants and one Class D Warrant to purchase Common Shares. Aegis Capital Corp. (“Aegis” or, the “Underwriter”) partially exercised its over-allotment option in respect to 13,573 Class C Warrants and 6,787 Class D Warrants (the “Over-Allotment Warrants”). The Common Units were sold at a price of $81.50 per unit and the Prefunded Warrants were sold at a price of $81.495 per unit. As of December 31, 2024, all Prefunded Warrants had been exercised in full.
Current report
Pursuant to an engagement letter dated June 6, 2024, by and between the Company and Aegis, the Company paid Aegis a total cash fee of $743,750 equal to 8.5% of the gross proceeds received in the June 2024 Offering.
Current report
The gross proceeds to the Company from the June 2024 Offering were $8,569,075. The Company incurred offering costs of $1,133,419.
Current report
April 2025 Private Placement
Current report
On April 7, 2025, the Company entered into inducement letter agreements (the “Inducement Letter Agreements”) with certain existing holders (the “Holders”) of the Company’s Class C warrants, pursuant to which the Holders agreed to purchase an aggregate of 1,085,106 shares of the Company’s common stock. The Class C warrants were originally issued to the Holders on June 28, 2024 for an exercise price of $98.00 per share and were subsequently reduced to $16.30 per share pursuant to stockholder approval on August 21, 2024. Pursuant to the Inducement Letter Agreements, the Holders agreed to exercise their Series C warrants at a reduced exercise price of $3.42 per share, and to purchase an equivalent number of new Class E warrants for an additional $0.125 per share. The Class E warrants have an exercise price of $3.42 per share and expire on April 8, 2030.
Current report
The transaction closed on April 8, 2025. The exercise of the Class C warrants resulted in the Company issuing 682,203 shares of Common Stock at closing and pre-funding of 402,903 shares of Common Stock.
Current report
The New Warrants were issued and sold in a private placement pursuant to Section 4(a)(2) of the Securities Act of 1993, as amended (the “Securities Act”), and/or Rule 506 of Regulation D as promulgated by the Securities and Exchange Commission under the Securities Act. Pursuant to the Inducement Letter Agreements, the Company agreed to file a registration statement providing for the resale by the purchasers of the shares of Common Stock issuable upon exercise of the New Warrants. Such registration statement was filed on April 29, 2025 and became effective on May 7, 2025.
Current report
The gross proceeds to the Company from the exercise of the Class C Warrants and the sale of the new Class E warrants were approximately $3.8 million. The Company incurred total offering costs of approximately $465,000, including a 10% financial advisory fee to Aegis Capital Corp. of approximately $385,000.
Removed paragraphs (5)
Previous report
Our operations to date have been funded primarily through equity financings. As of September 30, 2024, the Company had cash and cash equivalents of approximately $5.8 million and current liabilities of approximately $1.0 million. During the nine-month period ended September 30, 2024, the Company’s net cash used in operating activities was approximately $6.1 million. The future viability of the Company is largely dependent on its ability to raise additional capital to finance its operations. The Company expects that it will need to raise additional capital within the next twelve months to continue its operations as the current, cash resources will be sufficient to fund its operations through the first quarter of 2025. Although the Company has been able to raise capital in the past, there is no assurance that it will be successful in obtaining additional financing on terms acceptable to the Company, if at all. In addition, recent fundraising by the Company has resulted in very high ownership dilution to shareholders, and given the Company’s current market capitalization and financing needs, it is likely that future fundraising may also be highly dilutive. If the Company is unable to obtain funding, the Company could be forced to delay, reduce or eliminate its research and development program, product development or commercialization efforts, which could adversely affect its business prospects.
Previous report
We continue to develop the Symphony device and its first test for the measurement of IL-6, including conducting clinical trials to obtain additional data to support a submission to obtain FDA clearance of the Symphony device. However, our ability to continue these activities and continue operations (over the next twelve months) is dependent on the Company obtaining additional capital. If we fail to obtain additional financing within twelve months, we could be forced to abandon such activities entirely, with the possible loss of such properties or assets.
Previous report
There can be no assurance that such additional capital will be available on a timely basis or on acceptable terms. We currently do not have any contracts or commitments for additional financing. In addition, any additional equity financing may involve substantial dilution to the Company’s existing stockholders.
Previous report
During the nine months ended September 30, 2024, we used approximately $6.1 million in cash for operating activities, an increase of approximately $545,000 as compared to the same period in 2023. The increase is primarily driven by the timing of payments made by the Company to their vendors when comparing the two periods.
Previous report
Net cash provided by financing activities
Reworded paragraphs (11)
Previous wording
We are a clinical-stage medical diagnostics company developing rapid tests using whole blood on our Symphony platform (“Symphony”) to improve patient outcomes in critical care settings. Our Symphony technology platform is an exclusively licensed, patented system that consists of a mobile device and single-use test cartridges that if cleared, authorized, or approved by the U.S. Food and Drug Administration (“FDA”), can provide a solution to a significant market need in the United States. Clinical trials indicate Symphony produces results in less than 20 minutes for intensive care units and emergency rooms, where rapid and reliable results are required.
Current wording
The Company’s Symphony platform is a combination of Bluejay’s intellectual property (“IP”) and exclusively licensed and patented IP on the Symphony technology that the Company believes, if cleared, authorized, or approved by the FDA, can provide a solution to a significant market need in the United States. The Symphony device is designed to produce laboratory-quality results in 20 minutes in critical care settings, including Intensive Care Units (“ICUs”) and Emergency Rooms (“ERs”), where rapid and reliable results are required.
Previous wording
Since inception we have incurred net losses from operations each year and we expect to continue to incur losses for the foreseeable future. We incurred net losses of approximately $1.5 million and $6.3 million for the three and nine months ended September 30, 2024. We had an accumulated deficit of approximately $33.2 million as of September 30, 2024.
Current wording
Since inception, we have incurred net losses from operations each year and we expect to continue to incur losses for the foreseeable future. We incurred net losses of approximately $1.9 million and $2.3 million for the three months ended March 31, 2025 and 2024, respectively. We had negative cash flow from operating activities of approximately $1.2 million and $2.3 million for the three months ended March 31, 2025 and 2024, respectively, and had an accumulated deficit of approximately $36.5 million as of March 31, 2025.
Previous wording
As further described below under “Liquidity and Going Concern Uncertainty” as of September 30, 2024, the Company possessed cash and cash equivalents of approximately $5.8 million, while having current liabilities of approximately $1.0 million. During the nine months ended September 30, 2024, the Company’s net cash used in operating activities was approximately $6.1 million. The Company expects that it will need to raise additional capital in the next twelve months to continue as a going concern, and absent such funding, cash resources will be sufficient to fund its operations only through the first quarter of 2025.
Current wording
As further described below under “Liquidity and Going Concern Uncertainty” as of March 31, 2025, the Company possessed cash and cash equivalents of approximately $3.1 million, while having current liabilities of approximately $1.3 million. The Company will need to raise a material amount of additional capital in the imminent near-term to continue as a going concern, and that absent such near-term funding, it will likely run out of available cash resources in the near-term. If we are unable to obtain financing in the near-term, or otherwise consummate strategic alternatives, we could determine to undertake a process of liquidation under U.S. bankruptcy laws.
Previous wording
Comparison of the Three and Nine Months Ended September 30, 2024 and 2023
Current wording
Comparison of the Three Months Ended March 31, 2025 and 2024
Previous wording
The following table sets forth our results of operations for the three and nine months ended September 30, 2024 and 2023:
Current wording
The following table sets forth our results of operations for the three months ended March 31, 2025 and 2024:
Previous wording
Research and development expenses for the three months ended September 30, 2024 were approximately $0.6 million as compared to approximately $1.4 million for the same period in 2023. The decrease in research and development expenses was primarily due to a reduction in technology transfer efforts which offset increased clinical trial expenses. We expect future research and development expenses to be focused on costs specifically associated with our clinical trial program supporting our regulatory strategy, technology transfer efforts and any necessary manufacturing improvements.
Current wording
Research and development expenses for the three months ended March 31, 2025 were approximately $0.8 million as compared to approximately $1.3 million for the same period in 2024. The decrease in research and development expenses was primarily due to a reduction in technology transfer efforts which offset increased clinical trial expenses. We expect future research and development expenses to be focused on costs specifically associated with our clinical trial program supporting our regulatory strategy, technology transfer efforts and any necessary manufacturing improvements.
Previous wording
General and administrative expenses for the three months ended September 30, 2024, were approximately $0.8 million as compared to approximately $1.0 million for the comparable period in 2023. The minor decrease in general and administrative expenses is due to continued efforts to preserve capital by limiting our investment in infrastructure and reducing professional services commensurate with our commercialization timeline. We expect to monitor and continue to pare our general and administrative spend, as necessary, to optimize operational alignment.
Current wording
General and administrative expenses for the three months ended March 31, 2025, were approximately $1.1 million as compared to approximately $1.1 million for the comparable period in 2024. The increase in general and administrative expenses is due to an increase in Delaware franchise tax expense of $0.1 million and largely offset by continued efforts to preserve capital by limiting our investment in infrastructure and reducing professional services commensurate with our commercialization timeline. We expect to monitor and continue to pare our general and administrative spend, as necessary, to optimize operational alignment.
Previous wording
Sales and marketing expenses for the three months ended September 30, 2024 were $753 as compared to $(19,619) for the comparable period in 2023. The low sales and marketing expenses in 2024 are due to a reduction in spending in all sales and marketing efforts and the negative 2023 amount is related to the cancellation and forfeiture of equity awards by terminated personnel.
Current wording
Sales and marketing expenses for the three months ended March 31, 2025 were nil as compared to approximately $6,400 for the comparable period in 2024. The decrease in sales and marketing expenses was due to a reduction in spending in all sales and marketing efforts.
Previous wording
Other income (expense), net for the three months ended September 30, 2024, was $(120,352) of expense as compared to $43,235 of income for the same periods in 2023. The decrease in other income (expense), was primarily due to higher interest expense incurred associated with our notes payable under the Bridge Note Financing.
Current wording
Other income (expense), net for the three months ended March 31, 2025 was approximately $24,482 as compared to $99,640 for the same periods in 2024. The decrease in net other income (expense) was primarily due to lower interest income due to a reduction in our cash balance resulting in a decrease of approximately $12,000 and a decrease of approximately $67,000 in related party income from NanoHybrids.
Previous wording
During the nine months ended September 30, 2024, we used approximately $306,000 in cash for investing activities, a decrease of approximately $311,000 as compared to the same period in 2023. The decrease in net cash used in investing activities was due to limited purchasing of manufacturing equipment.
Current wording
During the three months ended March 31, 2025, we used no cash for investing activities, a decrease of approximately $35,000 as compared to the same period in 2024. The decrease in net cash used in investing activities was due to no purchasing of manufacturing equipment in 2025.
Previous wording
During the nine months ended September 30, 2024, we raised approximately $9.9 million in cash through financing activities, an increase of approximately $8.8 million as compared to the same period in 2023. The increase in net cash generated by financing activities was due our public offering on January 2, 2024, the Bridge Note Financing in June 2024 and our public offering on June 28, 2024 as compared to our private placement of common stock in August 2023.
Current wording
During the three months ended March 31, 2025, we used $985 of cash in financing activities, a decrease of approximately $2.8 million as compared to the same period in 2024. The decrease in net cash generated by financing activities was due no fund raising in the first quarter of 2025 as compared to our public offering on January 2, 2024.