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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Notes to Condensed Consolidated Financial Statements
Notes to the Condensed Consolidated Financial Statements
(Unaudited)
1. NATURE OF OPERATIONS AND BASIS OF PRESENTATION
Business
Bluejay Diagnostics, Inc. (“Bluejay” and/or the “Company”) 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.
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.
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.
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.
The Company was incorporated under the laws of Delaware on March 20, 2015. Its headquarters are located in Acton, Massachusetts.
On June 4, 2021, the Company formed Bluejay Spinco, LLC, a wholly owned subsidiary of the Company, for purposes of further development of the Company’s ALLEREYE diagnostic test. ALLEREYE is a point-of-care device offering healthcare providers a solution for diagnosing Allergic Conjunctivitis. The Company currently is not actively pursuing development of the ALLEREYE diagnostic test.
FDA Regulatory Strategy
The Company’s current regulatory strategy is designed to support commercialization of Symphony in the United States pending marketing authorization from the FDA. In May 2023, the Company submitted a pre-submission application to the FDA presenting study designs to validate Symphony IL-6 for use with hospitalized sepsis patients. We participated in a pre-submission meeting with the FDA on August 11, 2023, and at the meeting the FDA provided feedback on the new study design, determined that the submission of a 510(k) is the appropriate premarket submission pathway, and requested that certain data be provided in the 510(k). Based on this feedback, the Company determined to proceed on this basis, which considers the FDA’s feedback.
In the second quarter of 2024, the Company completed a multicenter SYmphony IL-6 MONitoring Sepsis (“SYMON”) clinical study investigating the role of interleukin-6 (IL-6) in patients diagnosed with sepsis and septic shock. This prospective study assessed the performance of IL-6 upon initial presentation to the intensive care unit (ICU). A primary analysis of the SYMON-I pilot clinical study (registered clinical trial number NCT06181604) highlighted that IL-6 levels within 24 hours of sepsis or septic shock diagnosis and admission to the ICU may predict patient mortality out to 28 days. Furthermore, a secondary outcome of the SYMON-I study showed that IL-6 levels within 24 hours of sepsis or septic shock diagnosis and admission to the ICU is a predictor of patient mortality during their hospitalization. Other secondary outcomes showed that lactate and Sequential Organ Failure Assessment (SOFA), standard clinical tests used for sepsis and septic shock patients, were not predictors of patient mortality out to 28 days. We believe that the findings underscore the potential importance of IL-6 as a predictor and provide new insights into the potential pathways for improving sepsis outcomes. In the third quarter of 2024, we initiated SYMON-II pivotal clinical study to validate the findings of the SYMON-I pilot clinical study.
Using the data analysis from the SYMON-I pilot clinical study, the Company initiated the SYMON-II pivotal clinical study in the third quarter of 2024. The SYMON II clinical study has three components: (1) collection, freezing, and biobanking of patient samples, (2) measuring IL-6 concentrations in the biobanked samples near the end of patient enrollment or after the patient enrollment has completed, and (3) analysis of the IL-6 data with the patient outcomes to see if the established IL-6 cutoff value has been validated for 28-day all-cause mortality. Patient enrollment started during the fourth quarter of 2024. The Company’s goal is to use the Symphony IL-6 test to complete the testing in the SYMON-II clinical trial.
If the Company is able to complete the SYMON-II clinical study and the results are positive, the Company intends to use the data generated from SYMON-II to support a 510(k) application to the FDA. This application is currently expected to be based on the following intended use: “Symphony IL-6 is intended for use to determine the IL-6 concentration as an aid in assessing the cumulative 28-day risk of all-cause mortality in conjunction with other laboratory findings and clinical assessments for patients diagnosed with sepsis or septic shock in the ICU.” The Company also plans to present the SYMON-I and SYMON-II results at future national scientific meetings and publish them in peer-reviewed journals. Subject to achieving needed funding and successfully addressing the technical challenges that are described above, the Company’s goal is to be 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.
Product Manufacturing
The Company plans to manufacture its analyzers through Sanyoseiko Co. Ltd. (“Sanyoseiko”), as a contract manufacturing organizations (“CMO”), and the Company has a contract with Sanyoseiko for this purpose.
Once redeveloped, the Company also plans to manufacture its cartridges through Sanyoseiko or another suitable CMO. The Company currently does not have a contract in place for the re-development or manufacture of the cartridges.
Sanyoseiko had been selected as the Company’s CMO for the analyzers due to their core competencies in manufacturing and quality system recognized by the FDA. Sanyoseiko’s facilities are located in Japan. The Company currently licenses the technology for the Symphony cartridges from Toray Industries, Inc. (“Toray”). The Company’s license grants it exclusive global marketing rights, with the exception of Japan. Bluejay holds the rights to manufacture the analyzers.
Risks and Uncertainties
As noted above, Bluejay will be reliant upon CMOs to provide analyzers and, if and once redeveloped, cartridges, in sufficient quantity and quality to complete the validations for our FDA application. Our FDA application submission could be delayed if the Company encounters any material supply interruptions. In addition, there can be no assurance that we will be able to obtain necessary regulatory authorization for the manufacturing or marketing of the Symphony in the United States or elsewhere. There also can be no assurance that we will successfully complete any clinical evaluations necessary to receive regulatory approvals, or that the clinical study will demonstrate sufficient safety and effectiveness of the Symphony IL-6 test. The failure to adequately demonstrate the clinical performance of the Symphony IL-6 test could delay or prevent regulatory approval, which could prevent or result in delays to market launch and could materially harm our business.
In addition to the FDA regulatory strategy risks and uncertainties, the Company is subject to a number of risks similar to other companies in its industry, including rapid technological change, competition from larger biotechnology companies and dependence on key personnel. The Company is also impacted by inflationary pressures and global supply chain disruptions currently impacting many companies. Additional risk and uncertainties regarding the Company are described in “Part I – Item 1A. Risk Factors” of the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2024.
Reverse Stock Splits and Increase to Authorized Capital
On July 21, 2023, the Company effected a reverse stock split of its shares of common stock at a ratio of 1-for-20 (the “July 2023 Reverse Stock Split”). On June 20, 2024, the Company effected a second reverse stock split of its shares of common stock at a ratio of 1-for-8 (the “June 2024 Reverse Stock Split”). On November 18, 2024, the Company effected a third reverse stock split of its shares of common stock at a ratio of 1-for-50 (the “November 2024 Reverse Stock Split” and, together with the July 2023 Reverse Stock Split and June 2024 Reverse Stock Split, the “Reverse Stock Splits”). As such, collectively, the Company’s common stock has undergone reverse stock splits that have combined the shares on a 1-for-8,000 aggregate basis since July 2023. All of the Company’s historical share and per share information related to issued and outstanding common stock and outstanding options and warrants exercisable for common stock in these financial statements have been adjusted, on a retroactive basis, to reflect these reverse stock splits.
On October 23, 2024, the stockholders of the Company approved and adopted an amendment to the Company’s amended and restated certificate of incorporation, to increase the number of authorized shares of the Company’s Common Stock to 250,000,000.
Basis of Presentation
The accompanying unaudited condensed consolidated financial statements of the Company have been prepared in conformity with generally accepted accounting principles in the United States (“US GAAP”) consistent with those applied in, and should be read in conjunction with, the Company’s audited financial statements and related footnotes for the year ended December 31, 2024 included in the Company’s Annual Report on Form 10-K. The unaudited condensed consolidated financial statements reflect all adjustments, which include only normal recurring adjustments, necessary for the fair presentation of the Company’s financial position as of March 31, 2025, its results of operations and cash flows for the three months ended March 31, 2025 and 2024, in accordance with US GAAP. The unaudited condensed consolidated financial statements do not include all of the information and footnotes required by US GAAP for complete financial statements, as allowed by the relevant U.S. Securities and Exchange Commission (“SEC”) rules and regulations; however, the Company believes that its disclosures are adequate to ensure that the information presented is not misleading. The condensed consolidated financial statements include the accounts of the Company and its wholly owned subsidiary. All intercompany balances and transactions have been eliminated in consolidation.
The results for the three months ended March 31, 2025 are not necessarily indicative of the results that may be expected for the fiscal year ending December 31, 2025, or any other interim period within this fiscal year.
Going Concern
The accompanying unaudited 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.
The Company had cash and cash equivalents of $3,116,103 and current liabilities of $1,316,677 as of March 31, 2025. The Company has incurred net losses since its inception, has incurred negative cash flows from operations and has 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 attempts to redevelop 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.
These accompanying financial statements do not include any adjustments related to the recoverability and classification of recorded asset amounts or the amounts and classification of liabilities that might result from the outcome of this uncertainty.
2.SIGNIFICANT ACCOUNTING POLICIES
During the three months ended March 31, 2025, there were no changes to the significant accounting policies as described in the 2024 Audited Financial Statements. Certain 2024 financial statement balances have been reclassified to correspond with current year presentation.
Use of estimates
The preparation of financial statements in conformity with US GAAP requires management to make estimates and assumptions that affect the amounts and disclosures reported in these condensed consolidated financial statements and accompanying notes. Actual results could differ materially from those estimates. The Company believes judgment is involved in accounting for the fair value-based measurement of stock-based compensation, accruals, and warrants. The Company evaluates its estimates and assumptions as facts and circumstances dictate. As future events and their effects cannot be determined with precision, actual results could differ from these estimates and assumptions, and those differences could be material to the condensed consolidated financial statements.
Warrants
The Company accounts for warrants as either equity-classified or liability-classified instruments based on an assessment of the warrant’s specific terms and applicable authoritative guidance in the Financial Accounting Standards Board, or the FASB, ASC, 480, Distinguishing Liabilities from Equity, or ASC 480, and ASC 815, Derivatives and Hedging, or ASC 815. The assessment considers whether the warrants are freestanding financial instruments pursuant to ASC 480, meet the definition of a liability pursuant to ASC 480, and whether the warrants meet all of the requirements for equity classification under ASC 815, including whether the warrants are indexed to the Company’s own stock and whether the warrant holders could potentially require “net cash settlement” in a circumstance outside of the Company’s control, among other conditions for equity classification. Finally, the Company determines if the warrants meet the definition of a derivative based on their contractual terms. This assessment, which requires the use of professional judgment, is conducted at the time of warrant issuance and as of each subsequent quarterly period end date while the warrants are outstanding.
For issued or modified warrants that meet all of the criteria for equity classification, the warrants are required to be recorded as a component of additional paid-in capital at the time of issuance. For issued or modified warrants that do not meet all the criteria for equity classification, the warrants are required to be recorded at their initial fair value on the date of issuance, and at each balance sheet date thereafter. Changes in the estimated fair value of liability-classified warrants are recognized as a non-cash gain or loss on the consolidated statements of operations. The Company also evaluates if changes in contractual terms or other considerations would result in the reclassification of outstanding warrants from liabilities to stockholders’ equity (or vice versa).
Net Loss per Share
Basic net loss per share is computed by dividing the net loss by the weighted-average number of shares of common stock outstanding for the period, without consideration for potentially dilutive securities. Diluted net loss per share is computed by dividing the net loss by the weighted average number of shares of common stock and dilutive common stock equivalents outstanding for the period determined using the treasury stock and if-converted methods. Dilutive common stock equivalents are comprised of options outstanding under the Company’s stock option plan, restricted stock units, and warrants. For all periods presented, there is no difference in the number of shares used to calculate basic and diluted shares outstanding as inclusion of the potentially dilutive securities would be antidilutive.
Potentially dilutive securities not included in the calculation of diluted net loss per share because to do so would be anti -dilutive are as follows (in common stock equivalent shares):
| March 31, | ||
|---|---|---|
| Potentially Dilutive Securities Listing: | 2025 | 2024 |
| Options to purchase common stock | 72 | 74 |
| Restricted stock units | 1 | 2 |
| Warrants for common stock | 660 | 679 |
| Class A warrants for common stock | 310 | 310 |
| Class B warrants for common stock | 9 | 9 |
| 5-Year warrants for common stock | 6,730 | 6,730 |
| Prefunded warrants for common stock | - | 3,107 |
| Class C warrants for common stock | 1,372,586 | - |
| Placement agent warrants | 471 | - |
Recently Issued Accounting Standards
The Company does not believe that any recently issued but not yet effective accounting pronouncements will have a material effect on the accompanying unaudited condensed consolidated financial statements.
3. LICENSE AND SUPPLY AGREEMENT WITH TORAY INDUSTRIES
The Company depends on Toray’s intellectual property for the Symphony cartridges upon which the Symphony platform relies. On October 6, 2020, the Company entered into a License and Supply Agreement (“License Agreement”) with Toray, providing the Company with an exclusive global license with Toray, excluding Japan, to use their patents and know-how related to the Symphony detection cartridges for the manufacturing, marketing and sale of the products (as defined in the License Agreement). In exchange for the license, the Company committed to make two payments of $120,000 each, both of which were made in 2021. In addition, following the first sale of the cartridges after regulatory approval, the Company is obligated make royalty payments to Toray based on the net sales of the cartridges for the period that any underlying patents exist or five years after the first sale. Following the first sale after obtaining regulatory approval, the Company will make minimum annual royalty payments of $60,000 for the first year and $100,000 for each year thereafter, which shall be creditable against any royalties owed to Toray in such calendar year.
On October 23, 2023, the Company and Toray entered into an Amended and Restated License Agreement (the “New Toray License Agreement”) and a Master Supply Agreement (the “New Toray Supply Agreement”). Under the New Toray License Agreement, the Company continues to license from Toray intellectual property rights needed to manufacture single-use test cartridges, and the Company has received the right to sublicense certain Toray intellectual property to Sanyoseiko in connection with Sanyoseiko’s ongoing agreement with the Company to manufacture the Company’s Symphony analyzers and cartridges (including in connection with the Company’s clinical trials). In addition, the New Toray License Agreement provides for the transfer of certain technology related to the cartridges to Sanyoseiko. The royalty payment percentage payable by the Company to Toray was reduced under the New Toray License Agreement from 15% to 7.5% (or less in certain circumstances) of net sales of certain cartridges for a term of 10 years. A 50% reduction in the royalty rate applies upon expiry of applicable Toray patents on a product-by-product and country-by-country basis. The New Toray License Agreement contemplates that applicable royalty payment obligations from the Company to Toray for other products will be determined separately by the parties in the future. There were no sales of or revenues from the cartridges during the three-month periods ended March 31, 2025 and 2024.
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 the cartridge redevelopment is completed, the Company plans to have the manufacturing process occur at an FDA-registered CMO, including for validation testing and commercial manufacturing. If Toray were to assert that the Company has not established a facility to manufacture the cartridges prior to the expiration of the supply agreement (which is currently expected to occur in October 2025), Toray could assert that the Company is in material breach of the license agreement and seek to terminate it as early as November 2025. If Toray sought to terminate the license, and was successful in doing so, the Company would lose access to certain technology required to produce the cartridges that the Symphony system relies on to function, which would likely result in a material adverse effect on the Company’s commercialization efforts. The Company is in the process of negotiating an agreement with Toray to, among other things, clarify that Toray will not seek to terminate the license agreement in connection with the expiration of the supply agreement.
At March 31, 2025 and 2024, there were no amounts accrued related to the New Toray License Agreement or the License Agreement.
4. FINANCINGS
June 2024 Offering
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 ofone share of common stock, two Class C Warrants andone Class D Warrant and (ii)95,815 prefunded units (the “Prefunded Units”), each consisting of one prefunded warrant to purchaseone share of common stock (each, a “Prefunded Warrant”), two Class C Warrants andone Class D Warrant. 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. 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”). As of December 31, 2024, all Prefunded Warrants had been exercised in full.
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.
The gross proceeds to the Company from the June 2024 Offering were $8,569,075. The Company incurred offering costs of $1,133,419.
May 2024 Bridge Note Financing
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”). This transaction closed on June 3, 2024. Debt issuance costs related to the NPA and SPA totaled $212,654. 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 (the “Bridge Note”). As of December 31, 2024, a total of $1,176,470 was repaid to the NPA investor in full satisfaction of the Bridge Note. The difference between the Bridge 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%.
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 (the “SPA Notes”), 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 had been repaid to the SPA investors, in full satisfaction of the SPA Notes. The difference between the SPA Notes and the subscription amounts, initially recorded as a discount on the SPA Notes, was the result of the discount factor included in the SPA of 11.11%.
The 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.
January 2024 Offering
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 “Prefunded Warrants”). The Shares and 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 Prefunded Warrant and related January 2024 Warrant.
As of December 31, 2024, all Prefunded Warrants had been exercised in full. The January 2024 Warrants were exercisable immediately and remain exercisable for a period offive years following the date of issuance.
Pursuant to an engagement letter, dated as of August 7, 2023, as amended October 11, 2023 (the “Amended Engagement Letter”), 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.
The gross proceeds to the Company from the January 2024 Offering were $3,500,000. The Company incurred offering costs of $711,031.
5. WARRANTS
The following table summarizes information with regard to warrants outstanding at March 31, 2025:
| Shares | Exercisable for | Weighted Average Exercise Price | Weighted Average Remaining Life (in Years) | |
|---|---|---|---|---|
| June 2024 Class C Warrants | 1,372,586 | Common Stock | $16.30 | 4.2 |
| January 2024 Common Stock Warrants | 6,730 | Common Stock | $520.00 | 3.8 |
| January 2024 Placement Agent Warrants | 471 | Common Stock | $650.00 | 3.8 |
| August 2023 Common Stock Warrants | 540 | Common Stock | $2,896.00 | 3.4 |
| August 2023 Placement Agent Warrants | 36 | Common Stock | $3,684.00 | 3.4 |
| Class A Warrants | 310 | Common Stock | $56,000.00 | 1.6 |
| Class B Warrants | 9 | Common Stock | $80,000.00 | 1.6 |
| Other Pre-2024 Common Stock Warrants | 84 | Common Stock | $27,327.00 | 1.1 |
June 2024 Common Stock Warrants and June 2024 Underwriter Warrants
As a part of the June 2024 Offering, the Company issued 214,724 Class C Warrants and 107,362 Class D Warrants. The Underwriter partially exercised its over-allotment option with respect to 13,573 Class C Warrants and 6,787 Class D Warrants (the “Over-Allotment Warrants”).
Upon stockholder approval of the issuance of Class C Warrants on August 21, 2024, the Class C Warrants, which had an initial exercise price of $98.00 per share of common stock, were adjusted to be exercisable at an exercise price of $16.30 per share (the “floor” price, which represented 20% of the “minimum price” under Nasdaq’s listing rules on the date of pricing of the June 2024 Offering), and the number of shares of common stock issuable upon exercise were proportionately increased to 1,372,586 shares. In connection with the reset in the exercise price and number of shares issuable pursuant to the Class C Warrants, we recorded a deemed dividend of $9,282,075 based on the excess of the fair value of the modified Class C Warrants over the fair value of the Class C Warrants before the modification, the effect of which was an increase in the net loss attributable to common shareholders in the statement of operations for the three-months ended September 30, 2024. The Class C Warrants may be exercised at any time for a period offive (5) years following the date of stockholder approval in August 2024.
The Class D Warrants were immediately exercisable at an exercise price of $0.0001 per share of common stock for a period offive (5) years following the date of issuance. Upon stockholder approval of the issuance of the Class D Warrants on August 21, 2024, the number of shares of common stock issuable upon exercise increased tofour shares per warrant for the remaining unexercised Class D Warrants as the weighted average price of our common stock over a rolling five (5)-trading day period fell below $16.30 per share (the “floor” price, which represented 20% of the “minimum price” under Nasdaq’s listing rules on the date of pricing of the June 2024 Offering) following the issuance date. In connection with the reset in the number of shares issuable pursuant to the Class D Warrants, we recorded a deemed dividend of $3,940,978 based on the excess of the fair value of the modified Class D Warrants over the fair value of the Class D Warrants before the modification, the effect of which was an increase in the net loss attributable to common shareholders in the statement of operations for the three months ended September 30, 2024. As of December 31, 2024, all Class D Warrants had been exercised andnone currently remain outstanding.
During 2024, the Company issued 435,377 shares of common stock upon exercise of the June 2024 Class D Warrants. The Class D Warrants were exercised on either a cash basis at $0.0001 per share exercise price or on a proportional cashless basis.
January 2024 Common Stock Warrants and January 2024 Placement Agent Warrants
As part of the January 2024 Offering, the Company issued 6,730 Common Stock Warrants with an exercise price of $520.00 per share and 471 Placement Agent Warrants with an exercise price of $650.00 per share. The January 2024 Warrants became exercisable immediately upon issuance for a period offive years following the date of issuance.
The Company’s warrants were accounted for as equity classified financial instruments as they meet the requirements for equity classification under ASC 815,Derivatives and Hedging.
6. STOCK COMPENSATION
Stock Incentive Plans
In 2018, the Company adopted the 2018 Stock Incentive Plan (the “2018 Plan”) for employees, consultants, and directors. The 2018 Plan, which is administered by the Board of Directors, permits the Company to grant incentive and nonqualified stock options for the purchase of common stock, and restricted stock awards. The maximum number of shares reserved for issuance under the 2018 Plan is 79. At March 31, 2025, there were 35 shares available for grant under the 2018 Plan.
On July 6, 2021, the Company’s board of directors and stockholders approved and adopted the Bluejay Diagnostics, Inc. 2021 Stock Plan (the “2021 Plan”). A total of 245 shares of common stock were approved to be initially reserved for issuance under the 2021 Stock Plan. At March 31, 2025, there were 101 shares available for grant under the 2021 Plan.
Stock Award Activity
The following table summarizes the status of the Company’s non-vested restricted stock awards for the three months ended March 31, 2025:
| Non-vested Restricted Stock Awards | ||
|---|---|---|
| Number of Shares | Weighted Average Grant Date Fair Value | |
| Outstanding at December 31, 2024 | 1 | $10,320 |
| Granted | - | - |
| Vested | - | - |
| Forfeited | - | - |
| Outstanding at March 31, 2025 | 1 | $10,320 |
The following is a summary of stock option activity for the three months ended March 31, 2025:
| Number of Stock Options · Weighted Average Exercise Price Per Share · Weighted Average Remaining Contractual Life in Years · Aggregate Intrinsic Value | |||||
|---|---|---|---|---|---|
| Outstanding at December 31, 2024 | 72 | $14,966 | 5.8 | $ | - |
| Granted | - | - | - | - | |
| Exercised | - | - | - | - | |
| Cancelled and forfeited | - | - | - | - | |
| Outstanding at March 31, 2025 | 72 | $14,966 | 5.5 | $ | - |
| Exercisable at March 31, 2025 | 67 | $14,966 | 5.4 | $ | - |
There were no options granted during the three months periods ended March 31, 2025 and 2024.
Stock-Based Compensation Expense
For the three months ended March 31, 2025 and 2024, the Company recorded stock-based compensation expense as follows:
| Three Months Ended March 31, | ||
|---|---|---|
| 2025 | 2024 | |
| Research and development | $1,113 | $4,845 |
| General and administrative | 199 | 7,029 |
| Total stock-based compensation | $1,312 | $11,874 |
At March 31, 2025, there was approximately $1,221 of unrecognized compensation expense related to non-vested stock option awards that are expected to be recognized over a weighted-average period of 0.65 years. At March 31, 2025, there was approximately $406 of unrecognized compensation expense related to non-vested restricted stock awards that are expected to be recognized over a weighted-average period of 0.44 years.
7. RELATED PARTY TRANSACTIONS
NanoHybrids, LLC
In December 2021, the Company entered into an agreement with NanoHybrids, LLC (“NanoHybrids”), an entity in which the Company’s Chief Technology Officer, Jason Cook, served as Chief Executive Officer of prior to joining Bluejay, to utilize the Company’s research and development staff and laboratory facility when available to perform work for NanoHybrids (the “Sharing and Services Agreement”). Any hours worked by Company employees for NanoHybrids are billed to NanoHybrids at a bill rate of the respective employee’s fully burdened personnel cost plus 10%. Additionally, the Company may purchase certain lab supplies for NanoHybrids and rebill these costs to NanoHybrids. Dr. Cook is the majority shareholder of NanoHybrids. The table below summarizes the amounts earned and due from NanoHybrids as of and for the three-month periods’ ended March 31, 2025 and 2024, and balances due as of March 31, 2025 and December 31, 2024:
| Three Months Ended March 31, | ||
|---|---|---|
| 2025 | 2024 | |
| Income from NanoHybrids included in Other Income | $6,873 | $73,591 |
| Cash receipts from NanoHybrids | $14,564 | $41,269 |
| As of | ||
|---|---|---|
| March 31, 2025 | December 31, 2024 | |
| Amounts receivable from NanoHybrids included in Prepaids and Other Current Assets | $6,873 | $14,564 |
On May 8, 2025, the Company entered into a settlement and release agreement with Nanohybrids that terminated the respective parties’ obligations under the Sharing and Services Agreement, and memorialized that prior discussions between the parties regarding a potential sale of Nanohybrids to the Company (the “Strategic Transaction Discussions”) were terminated. Under the terms of such agreement, the Company agreed to make payment of $50,000 to Nanohybrids and reimburse Nanohybrids for up to $30,000 in reasonable and documented attorneys’ fees that Nanohybrids had previously incurred in connection with the Strategic Transaction Discussions. The Company and Nanohybrids (including Dr. Cook for this limited purpose) each also provided the other with releases related to the Sharing and Services Agreement and the Strategic Transaction Discussions.
Each of the foregoing agreements was approved in advance by the Audit Committee of the Company’s Board of Directors.
8. PROPERTY AND EQUIPMENT
Property and equipment consisted of the following at March 31, 2025 and December 31, 2024:
| Depreciable lives | March 31, 2025 | December 31, 2024 | |
|---|---|---|---|
| Construction-in-process | $1,351,179 | $1,351,179 | |
| Furniture, fixtures, and equipment | 3-5 years | 135,785 | 136,312 |
| Software | 3-5 years | 4,457 | 4,457 |
| Lab equipment | 3-5 years | 173,268 | 173,268 |
| Leasehold improvements | Shorter of useful life or life of lease | 43,231 | 43,231 |
| 1,707,920 | 1,708,447 | ||
| Less: accumulated depreciation | (212,826) | (194,952) | |
| Property and equipment, net | $1,495,094 | $1,513,495 | |
Construction in process consists of symphony cartridge manufacturing equipment. There are no commitments in place to complete construction in process as of March 31, 2025.
9. LEASES
The Company has lease arrangements for office, laboratory space and copiers. A summary of supplemental lease information is as follows:
| Three Months Ended | ||
|---|---|---|
| March 31, 2025 | March 31, 2024 | |
| Weighted average remaining lease term – operating leases (in years) | 2.0 | 2.7 |
| Weighted average remaining lease term – finance leases (in years) | 2.8 | 3.9 |
| Weighted average discount rate – operating leases | 7.0% | 7.0% |
| Weighted average discount rate – finance leases | 7.0% | 7.0% |
| Operating cash flows from operating leases | $38,259 | $44,214 |
| Operating cash flows from finance leases | $217 | $288 |
A summary of the Company’s lease assets and liabilities are as follows:
| March 31, 2025 | December 31, 2024 | |
|---|---|---|
| Operating lease right-of-use asset | $176,296 | $209,788 |
| Finance lease asset – property & equipment, net | 9,238 | 10,421 |
| Total lease assets | $185,534 | $220,209 |
| Current portion of operating lease liability | $100,002 | $113,260 |
| Current portion of finance lease liability included in accrued expenses | 4,807 | 4,807 |
| Non-current portion of operating lease liabilities | 87,372 | 108,989 |
| Non-current portion of finance lease liabilities included in other non-current liabilities | 7,582 | 8,567 |
| Total lease liabilities | $199,763 | $235,623 |
A summary of the Company’s estimated operating lease payments are as follows:
| Year | Operating Lease |
|---|---|
| 2025 (1) | $75,000 |
| 2026 | 100,000 |
| 2027 | 25,000 |
| Thereafter | - |
| Total future lease payments | 200,000 |
| Less: Imputed interest | 12,626 |
| Present value of lease liability | $187,374 |
| (1) | Excludes the three months ended March 31, 2025 |
10. COMMITMENTS AND CONTINGENCIES
Minimum Royalties
As required under the License Agreement (see Note 3), following the first sale of cartridges, the Company will also make royalty payments to Toray equal to 7.5% of the net sales of the cartridges for a term of 10 years. A 50% reduction in the royalty rate applies upon expiry of applicable Toray patents on a product-by-product and country-by-country basis. There were no sales of or revenues from the cartridges through March 31, 2025.
Indemnification
The Company has certain agreements with service providers with which it does business that contain indemnification provisions pursuant to which the Company typically agrees to indemnify the party against certain types of third-party claims. The Company accrues for known indemnification issues when a loss is probable and can be reasonably estimated. The Company would also accrue for estimated incurred but unidentified indemnification issues based on historical activity. As the Company has not incurred any indemnification losses to date, there were no accruals for or expenses related to indemnification issues for any period presented.
11. SUPPLEMENTAL BALANCE SHEET INFORMATION
Prepaid expenses and other current assets consist of the following:
| March 31, 2025 | December 31, 2024 | |
|---|---|---|
| Prepaid insurance | $353,071 | $489,174 |
| Vendor prepayments | - | 21,946 |
| Prepaid and other | 103,008 | 85,818 |
| Total prepaid expenses and other current assets | $456,079 | $596,938 |
Accrued expenses and other current liabilities consist of the following:
| March 31, 2025 | December 31, 2024 | |
|---|---|---|
| Accrued personnel costs | $147,148 | $100,974 |
| Accrued legal fees | 143,350 | 48,860 |
| Accrued clinical trial expenses | 180,891 | 191,673 |
| Accrued board of director fees | - | 95,000 |
| Accrued other | 104,194 | 115,479 |
| Accrued Delaware franchise tax | 121,568 | - |
| Total accrued expenses and other current liabilities | $697,151 | $551,986 |
12. SUBSEQUENT EVENTS
April 2025 Private Placement
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.
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. As of May 13, 2025,144,951 of the shares subject to pre-funding have not been issued.
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.
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.
The text of this filing, as the company filed it with the SEC, without its images or exhibits. This is not investment advice.