Bluejay Diagnostics, Inc.: Form 10-Q for the period ended Sep 30, 2025

You should read the following discussion and analysis of our financial condition and results of operations in conjunction with the unaudited condensed consolidated financial statements and the related notes appearing elsewhere in this Form 10-Q. This discussion contains forward-looking statements reflecting our current expectations that involve risks and uncertainties. Actual results and the timing of events could differ materially from those discussed in our forward-looking statements as a result of many factors, including those set forth under “Risk Factors” and elsewhere in this Form 10-Q.

Overview

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, near-patient tests using whole blood on its Symphony technology platform (“Symphony”), which consists of an analyzer and single-use protein detection cartridges. 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”) before Symphony can be marketed as a diagnostic product in the United States. The Company has completed the pre-clinical development of the Symphony analyzer. The Company is redeveloping the manufacturing processes for cartridges through a third-party contractor who is managing such redevelopment. Such redevelopment is intended to address manufacturing 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 $20 million of capital between the date of this filing 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 by the end of 2026, with a goal of being in position to submit a 510(k) regulatory application to the FDA in 2027, with an objective of achieving FDA clearance thereafter.

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. The Symphony device candidate 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 with 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.

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 $1.6 million and $5.4 million for the three and nine months ended September 30, 2025, respectively. We had negative cash flow from operating activities of approximately $4.6 million and $6.4 million for the nine months ended September 30, 2025 and 2024, respectively, and had an accumulated deficit of approximately $40.1 million as of September 30, 2025.

As further described below under “Liquidity and Going Concern Uncertainty” as of September 30, 2025, the Company possessed cash and cash equivalents of approximately $3.1 million, while having current liabilities of approximately $1.1 million. The Company will need to raise a material amount of additional capital in the future to continue as a going concern.

Results of Operations

Comparison of the Three and Nine Months Ended September 30, 2025 and 2024

The following table sets forth our results of operations for the three and nine months ended September 30, 2025 and 2024:

Research and Development

Research and development expenses for the three months ended September 30, 2025 were approximately $0.8 million as compared to approximately $0.6 million for the same period in 2024. The increase in research and development expenses was primarily due to increased clinical trial expenses, partially offset by a reduction in technology transfer efforts. 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.

General and Administrative

General and administrative expenses for the three months ended September 30, 2025, were approximately $0.8 million as compared to approximately $0.8 million for the comparable period in 2024. We expect to monitor and continue to pare our general and administrative spend, as necessary, to optimize operational alignment.

Sales and Marketing

Sales and marketing expenses for the three months ended September 30, 2025 were zero, compared to approximately $753 for the comparable period in 2024. The decrease in sales and marketing expenses was due to a cessation in spending for all sales and marketing efforts.

Other Income (Expense), net

Total other income (expense), net for the three months ended September 30, 2025, was $19,315 of income as compared to $120,352 of expense for the same periods in 2024. The increase in other income (expense), net was primarily due to lower interest expense ($190,610) associated with our notes payable under the 2024 Bridge Note Financing.

Deemed dividend on warrant modification

Upon stockholder approval of the issuance of Class C Warrants and Class D 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 and the number of shares of common stock issuable upon exercise was proportionately increased to 1,372,586 shares. Concurrently, the number of shares of common stock issuable upon exercise of the Class D Warrants increased to four shares per warrant for the remaining unexercised warrants. In connection with the reset in the exercise price and number of shares issuable pursuant to exercise of the Class C Warrants and Class D Warrants, we recorded a deemed dividend of $13,223,053 based on the excess of the fair value of the modified Class C Warrants and Class D Warrants over the fair value of the Class C Warrants and 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 and nine-months ended September 30, 2024.

Summary Statement of Cash Flows

The following table sets forth the primary sources and uses of cash and cash equivalents for each of the periods presented.

Net cash used in operating activities

During the nine months ended September 30, 2025, we used approximately $4.6 million in cash for operating activities, a decrease of approximately $1.8 million as compared to the same period in 2024. The decrease is driven by a lower net loss, an increase in accrued expenses and other current liabilities and a decrease prepaid expenses when comparing the two periods.

Net cash used in investing activities

During the nine months ended September 30, 2025, we used no cash for investing activities, a decrease of $305,658 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.

Net cash provided by financing activities

During the nine months ended September 30, 2025, we raised approximately $3.4 million in cash through financing activities, a decrease of approximately $6.8 million as compared to the same period in 2024. The decrease in net cash generated by financing activities was due our private placement on April 8, 2025 as compared to our public offering on January 2, 2024, a Bridge Note Financing in June 2024 and our public offering on June 28, 2024.

Liquidity and Going Concern Uncertainty

The Company had cash and cash equivalents of $3,082,268 and current liabilities of $1,148,913 as of September 30, 2025. The Company has incurred net losses since its inception, has incurred negative cash flows from operations and had an accumulated deficit of $40,087,455 as of September 30, 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 manufacturing process for Symphony cartridges and conducts clinical trial work and, if such redevelopment and trials are successful, begins preparation of an FDA submission. These financial results and financial position, and the Company’s expected forward-looking outlook of significant negative cash flow in the future, raise substantial doubt with respect to its ability to continue as a going concern. The Company expects that it will not be in position to submit a 510(k) regulatory application to the FDA for Symphony until 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 sufficient future financing, its clinical trials and targeted FDA submission timeline could be delayed, 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, holders of shares of the Company’s common stock could recoup little, if any, value in such process. The Company currently estimates that the cash resources it possesses as of the date of this filing (which includes proceeds from a private placement transaction completed in October 2025) will be sufficient to fund its operations up to the third quarter of 2026.

The condensed consolidated financial statements for the three and nine months ended September 30, 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.

Recent Offerings

January 2024 Public 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 and (ii) prefunded warrants to purchase up to an aggregate 5,386 shares of common stock (the “January 2024 Prefunded Warrants”). The shares of common stock and January 2024 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 2024 Prefunded Warrant and related January 2024 Warrant.

As of December 31, 2024, all January 2024 Prefunded Warrants had been exercised in full. The January 2024 Warrants are exercisable for a period of five years following the date of issuance.

Pursuant to an engagement letter, dated as of August 7, 2023, as amended October 11, 2023, by and between the Company and H.C. Wainwright & Co., LLC (“H.C. Wainwright”), the Company paid H.C. Wainwright 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 H.C. Wainwright 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 H.C. Wainwright’s designees 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 January 2024 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 2024 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.

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 first 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%.

Under the terms of the SPA, the three additional 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%.

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.

June 2024 Public 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 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 “June 2024 Prefunded Warrant”), two Class C Warrants and one Class D Warrant to purchase Common Shares. Aegis Capital Corp. (“Aegis”) 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 June 2024 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.

April 2025 Private Placement

On April 7, 2025, the Company entered into inducement letter agreements with certain existing holders of the Company’s Class C Warrants, pursuant to which such holders agreed to purchase an aggregate of 1,085,106 shares of the Company’s common stock (or, to the extent the applicable holder would have exceeded a specified beneficial ownership limitation, prefunding the future exercise of such warrants, other than a remaining $0.0001 per share exercise price). The Class C Warrants were originally issued 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 applicable 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 pursuant to the inducement letters, and the exercise price of 402,903 of the Class C Warrants being amended to 0.0001 per share. As of September 30, 2025, all such reduced exercise price Class C Warrants had been exercised.

The gross proceeds to the Company from the exercise of the Class C Warrants and the sale of the new Class E Warrants were $3,846,692 million. The Company incurred total offering costs of $464,670, including a 10% financial advisory fee to Aegis Capital Corp. of $384,670.

The modification of the terms or conditions of the Class C Warrants in this transaction is treated as an exchange of the original instrument for a new instrument. Using the Black Scholes option pricing model, the fair value of the Series C Warrants immediately prior to the inducement transaction was $479,299 and immediately after the inducement transaction was $1,590,930. In addition, Series E Warrants with a fair value of $1,730,652 were provided as part of the inducement transaction for a purchase price of $135,638. The Company recorded additional equity issuance costs of $2,706,645 related to the modification of the Series C Warrants and issuance of Series E Warrants related to the inducement transaction. As this equity issuance cost was a non-cash transaction, the Company recorded an increase to additional paid-in capital to offset the expense.

October 2025 Private Placement

On October 9, 2025, the Company entered into a securities purchase agreement with two institutional investors pursuant to which the Company sold in a private placement (i) an aggregate of 175,000 shares of common stock and prefunded warrants to purchase up to 2,075,000 shares of common stock (the “October 2025 Prefunded Warrants”), and (ii) Series F warrants (the “Series F Warrants”) to purchase up to 4,500,000 shares of common stock. The combined price of the securities sold in the private placement was $2.00 per share of common stock (or prefunded warrant in lieu thereof, in which case such price was reduced by $0.0001) and accompanying Series F Warrants to acquire two shares of common stock. The October 2025 Prefunded Warrants are exercisable for shares of common stock at an exercise price of $0.0001 per share, are immediately exercisable and expire once exercised in full. The Series F Warrants are exercisable for shares of common stock at an exercise price of $1.75 per share, are immediately exercisable and expire five and one-half years from the date of issuance.

The transaction closed on October 10, 2025. The gross proceeds to the Company from the sale of the securities sold in the private placement were approximately $4.5 million. The Company incurred total offering costs of $542,650, including a 8% financial advisory fee to Rodman and Renshaw LLC (“Rodman”), the placement agent, of approximately $360,000. Under the terms of the Company’s engagement letter with Rodman, the Company issue Rodman’s designees warrants to purchase up to 180,000 of common stock at an exercise price of $2.50 per share, which expire 5.5 years from the date of issuance (the “October 2025 Placement Agent Warrants”).

In connection with the private placement, the Company entered into a registration rights agreement with the two institutional investors. Pursuant to which the Company agreed to register for resale, at the Company’s expense, the 175,000 shares of common stock sold in the private placement and the 6,755,000 shares of common stock collectively exercisable pursuant to the October 2025 Prefunded Warrants, the Series F Warrants and the October 2025 Placement Agent Warrants. The Company agreed to (i) file such a resale registration statement by October 24, 2025, (ii) use its best efforts to cause such registration statement to be declared effective by the Securities and Exchange Commission (the “SEC”) under the Securities Act of 1933, as amended (the “Securities Act”), as promptly as possible after filing (and in no event later than certain dates specified in the registration rights agreement, depending on the circumstances), and (iii) use its best efforts to keep such resale registration statement continuously effective under the Securities Act until the date that all shares of common stock registered thereunder have been sold or may be sold without registration under Rule 144. Failure by the Company to meet the filing deadlines and other requirements set forth in the registration rights agreement (including successfully registering the applicable shares) would subject the Company to liquidated damages amounts payable to the purchasers in the private placement. Such liquidated damages would generally be calculated as a monthly payment in the amount of 2% of the portion of the subscribed amount that has not been registered as of the applicable monthly calculation date, capped at an overall amount equal to 20% of the total $4,500,000 subscribed amount.

Pursuant to the terms of the purchase agreement, the Company generally may not, until the date that is 90 calendar days after the date that the resale registration statement has been declared effective by the SEC, issue or enter into agreements to issue shares of common stock or securities convertible into or exercisable for common stock. In addition, the purchase agreement provides that until the date that is one year following the date that the resale registration statement is declared effective by the SEC, the Company may not, without the prior written consent of investors who purchased a majority of the securities sold in the private placement, (i) engage in certain “variable rate transactions” (as defined in the purchase agreement) related to its securities, or (ii) undertake a reverse or forward stock split or recapitalization, other than in the good faith determination of the Company’s board of directors to maintain its listing on the Nasdaq Capital Market.

Recently Adopted Accounting Standards

See Note 2 to our condensed consolidated financial statements (under the caption “Recently Adopted Accounting Standards”).

Emerging Growth Company and Smaller Reporting Company Status

We are an emerging growth company, as defined in the Jumpstart Our Business Startups Act (the “JOBS Act”). Under the JOBS Act, emerging growth companies can delay adopting new or revised accounting standards issued subsequent to the enactment of the JOBS Act until such time as those standards apply to private companies. We elected to use this extended transition period for complying with new or revised accounting standards that have different effective dates for public and private companies until the earlier of the date that we (i) are no longer an emerging growth company or (ii) affirmatively and irrevocably opt out of the extended transition period provided in the JOBS Act. As a result, these condensed consolidated financial statements may not be comparable to companies that comply with the new or revised accounting pronouncements as of public company effective dates. We are using the extended transition period for any other new or revised accounting standards during the period in which we remain an emerging growth company.

We will remain an emerging growth company until the earliest of (i) the last day of our first fiscal year (a) following the fifth anniversary of the completion of IPO (November 2021), (b) in which we have total annual gross revenues of at least $1.07 billion or (c) in which we are deemed to be a large accelerated filer, which means the market value of our common stock that is held by non-affiliates exceeds $700 million as of the prior June 30th and (ii) the date on which we have issued more than $1 billion in non-convertible debt securities during the prior three-year period.

We are also a “smaller reporting company,” meaning that the market value of our stock held by non-affiliates is less than $700 million and our annual revenue is less than $100 million during the most recently completed fiscal year. We may continue to be a smaller reporting company if either (i) the market value of our stock held by non-affiliates is less than $250 million or (ii) our annual revenue is less than $100 million during the most recently completed fiscal year and the market value of our stock held by non-affiliates is less than $700 million. If we are a smaller reporting company at the time we cease to be an emerging growth company, we may continue to rely on exemptions from certain disclosure requirements that are available to smaller reporting companies. Specifically, as a smaller reporting company we may choose to present only the two most recent fiscal years of audited financial statements in our Annual Reports on Form 10-K and, similar to emerging growth companies, smaller reporting companies have reduced disclosure obligations regarding executive compensation.

JOBS Act Accounting Election

The JOBS Act provides that an “emerging growth company” can take advantage of the extended transition period provided in Section 7(a)(2)(B) of the Securities Act of 1933, as amended, for complying with new or revised accounting standards. In other words, an “emerging growth company” can delay the adoption of certain accounting standards until those standards would otherwise apply to private companies. We have irrevocably elected not to avail ourselves of this extended transition period and, as a result, we will adopt new or revised accounting standards on the relevant dates on which adoption of such standards is required for other public companies.

We have implemented all new accounting pronouncements that are in effect and may impact our financial statements and we do not believe that there are any other new accounting pronouncements that have been issued that might have a material impact on our financial position or results of operations.

We are a smaller reporting company as defined by Rule 12b-2 of the Securities Exchange Act of 1934, as Amended (the “Exchange Act”) and are not required to provide the information required under this item.

(a) Evaluation of Disclosure Controls and Procedures

We conducted an evaluation under the supervision and with the participation of our President and Chief Executive Officer (who serves as our principal executive officer and principal financial and accounting officer), regarding the effectiveness of our disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act) as of the end of the period covered by this report. Based on this evaluation, our President and Chief Executive Officer concluded that our disclosure controls and procedures were effective as of September 30, 2025. We continue to review our disclosure controls and procedures and may from time to time make changes aimed at enhancing their effectiveness and ensuring that our systems evolve with our Company’s business. A control system, no matter how well conceived and operated, can provide only reasonable, not absolute, assurance that the objectives of the control system are met.

(b) Changes in Internal Control Over Financial Reporting

There was no change in our internal control over financial reporting (as defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act) that occurred during the quarter ended September 30, 2025 that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.

For a discussion of potential risks or uncertainties, see “Risk Factors” in Part I, Item 1A of our Annual Report on Form 10-K for the fiscal year ended December 31, 2024, and in Part II, Item 1A of our Quarterly Reports on Form 10-Q for the fiscal quarters ended March 31, 2025 and June 30, 2025. The following disclosures supplement such Risk Factors, and should be read in conjunction therewith:

Additional Risks Related to Our Financial Condition and Capital Requirements

We expect to need to raise at least $20 million between the date of this filing and the end of the 2027 fiscal year, and failure to do so could require us to undertake a process of liquidation under U.S. bankruptcy laws, which could cause holders of our common stock to recoup little, if any, value for their shares.

As of September 30, 2025, we possessed cash and cash equivalents of approximately $3.1 million, while having current liabilities of approximately $1.1 million. We incurred net losses of approximately $7.7 million and $10.0 million for fiscal years 2024 and 2023, respectively, and $5.4 million for the nine months ended September 30, 2025. From our inception through September 30, 2025, we have an accumulated deficit of approximately $40.1 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 clearance as early as the third quarter of 2028, we expect to need to raise at least $20 million of capital between the date of this filing and the end of the 2027 fiscal year, which we hope to do in various tranches during this time period.

Our financial results and financial position, and our expected forward-looking outlook of significant negative cash flow in the future, raise substantial doubt with respect to our ability to continue as a going concern. We expect that we will not be in position to submit a 510(k) regulatory application to the FDA for Symphony until 2027, at the earliest, if we are even able to generate sufficient clinical trial results to support such a submission. If we fail to obtain sufficient future financing, our clinical trials and targeted FDA submission timeline could be delayed, and we could be forced to abandon such activities entirely and cease operations, with the possible loss of such properties or assets. If we are unable to obtain additional financing as we continue to generate negative cash flow, our board of directors could determine to cause us 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, holders of shares of our common stock could recoup little, if any, value in such process.

The number of shares of common stock underlying our outstanding warrants is several times greater than our currently outstanding common stock, which could have a negative effect on the market price of our common stock and make it more difficult for us to raise funds through future equity offerings. In addition, in connection with any merger, consolidation or sale of all or substantially all of our assets, holders of our outstanding warrants would be entitled to receive the Black Scholes value of such warrants, which may reduce the consideration otherwise available for payment to holders of our common stock.

As part of our public offerings and/or private placements of securities in October 2025, April 2025, June 2024, January 2024 and August 2023, we issued warrants to purchase shares of our common stock. As of the date of this filing, remaining warrants exercisable from these transactions included (i) October 2025 Prefunded Warrants to purchase up to 2,075,000 shares of common stock at an exercise price of $0.0001 per share, (ii) Series F Warrants issued in October 2025 to purchase up to 4,500,000 shares of common stock at an exercise price of $1.75 per share, (iii) October 2025 Placement Agent Warrants to purchase up to 180,000 shares of common stock at an exercise price of $2.50 per share, (iv) Class E Warrants issued in April 2025 to purchase up to 1,085,106 shares of common stock at an exercise price of $3.42 per share, (v) Class C Warrants issued in June 2024 to purchase up to 287,491 shares of common stock at an exercise price of $16.30 per share, (vi) January 2024 Warrants to purchase up to 6,730 shares of common stock at an exercise price of $520.00 per share, (vii) January 2024 Placement Agent Warrants to purchase up to 471 shares of common stock at an exercise price of $650.00 per share, and (viii) warrants issued in August 2023 to purchase up to an aggregate of 576 shares of common stock at exercise prices ranging from $2,896.00 to $3,684.00 per share. All of such warrants expire either five or five and one-half years from the date of issuance (except for the October 2025 Prefunded Warrants, which do not expire).

In general, holders of these warrants may not exercise any portion of such warrants if such holder, together with its affiliates, would beneficially own in excess of 4.99% or 9.99% (at the initial election of the holder) of the number of shares of the Company’s common stock outstanding immediately after giving effect to such exercise. The warrants include certain rights upon a “fundamental transaction” (as defined in such warrants), including the right of the holders thereof to receive from the Company or a successor entity cash or the same type or form of consideration (and in the same proportion) that is being offered and paid to the holders of common stock in such fundamental transaction in the amount of the Black Scholes value (as defined in such warrants) of the unexercised portion of the applicable warrants on the date of the consummation of such fundamental transaction.

Although these warrants are subject to beneficial ownership limitations, upon exercise in full of the warrants, the shares issuable upon exercise would represent a significant portion of our outstanding common stock. As a result, the holders of these warrants may be able to exert substantial influence over our business. The concentration of voting power resulting from the exercise of the warrants could delay, defer or prevent a change of control, or delay or prevent a merger, consolidation, takeover or other business combination involving us on terms that other stockholders may desire. In addition, conflicts of interest could arise in the future between us, on the one hand, and the holders of these warrants, concerning the issuance of additional securities and other matters. In addition, sales of these shares could cause the market price of our common stock to decline significantly.

We have registered the issuance of shares upon exercise of these warrants under registration statements (or are in the process of doing so). Sales of these shares into the public market in the future could cause the market price of our common stock to decline. Furthermore, if our stock price rises, the holders of these warrants may be more likely to exercise their warrants and sell a large number of shares, particularly if the price of our common stock substantially exceeds the exercise price of such warrants. Such exercises, particularly if followed up with subsequent sales by the holders receiving shares of common stock, could negatively affect the market price of our common stock and reduce or eliminate any appreciation in our stock price that might otherwise occur.

Given the amount and terms of these warrants, we may find it more difficult to raise additional equity capital on favorable terms or at all while these warrants are outstanding.

Our registration rights obligations in connection with the October 2025 private placement transaction could subject to us to liquidated damages provisions if we are unable to successfully register the applicable securities in accordance with the requirements of the registration rights agreement we entered into with the purchasers of the securities in such transaction.

In connection with the private placement we consummated in October 2025, we entered into a registration rights agreement with the two institutional investors who purchased the securities sold by us in such transaction. Under that registration right agreement, we agreed to register for resale, at our expense, the 175,000 shares of common stock sold in the private placement and the 6,755,000 shares of common stock collectively exercisable pursuant to the October 2025 Prefunded Warrants, the Series F Warrants and the October 2025 Placement Agent Warrants. Among other things, we agreed to (i) file such a resale registration statement by October 24, 2025, (ii) use our best efforts to cause such registration statement to be declared effective by the SEC under the Securities Act as promptly as possible after filing (and in no event later than certain dates specified in the registration rights agreement, depending on the circumstances), and (iii) use our best efforts to keep such resale registration statement continuously effective under the Securities Act until the date that all shares of common stock registered thereunder have been sold or may be sold without registration under Rule 144. Failure by us to meet the filing deadlines and other requirements set forth in the registration rights agreement (including successfully registering the applicable shares) would subject us to liquidated damages amounts payable to the purchasers in the private placement. Such liquidated damages would generally be calculated as a monthly payment in the amount of 2% of the portion of the subscribed amount that has not been registered as of the applicable monthly calculation date, capped at an overall amount equal to 20% of the total $4,500,000 subscribed amount. If the event that we are unable to successfully register the applicable securities in accordance with the requirements of the registration rights agreement, we could be required to pay these amounts, which could negatively affect our liquidity and results of operations.

Our obligations under the purchase agreement we entered into in connection with the October 2025 private placement transaction includes restrictions on our ability to engage in certain financing transactions in the near-term, which could make it more difficult for us to achieve the financing objectives that we expect to be necessary for us to successfully complete our commercialization and FDA clearance efforts.

Pursuant to the terms of the purchase agreement we entered into with the two institutional investor purchasers in the October 2025 private placement transaction, we may not, until the date that is 90 calendar days after the date that the resale registration statement has been declared effective by the SEC, issue or enter into agreements to issue shares of common stock or securities convertible into or exercisable for common stock. In addition, the purchase agreement provides that until the date that is one year following the date that the resale registration statement is declared effective by the SEC, we may not, without the prior written consent of investors who purchased a majority of the securities sold in the private placement, (i) engage in certain “variable rate transactions” (as defined in the purchase agreement) related to our securities, or (ii) undertake a reverse or forward stock split or recapitalization, other than in the good faith determination of our board of directors to maintain its listing on the Nasdaq Capital Market. These limitations, particular with respect to our ability to engage in financing transactions, could restrict our ability to raise capital in the near-term, making it more difficult for us to achieve the financing objectives that we expect to be necessary for us to successfully complete our commercialization and FDA clearance efforts.