BJDX 10-K & 10-Q changes, risk factors and insider trading

Since our inception, we have engaged primarily in development activities, including planning and implementing clinical trials to support commercialization and FDA approvalclearance of our Symphony platform. We have funded our operations primarily through debt and equity financings, and have incurred losses since inception, including a net loss of approximately $7.7$6.8 million and approximately $10.0$7.7 million for the years ended December 31, 20242025 and 2023,2024, respectively, and from our inception through December 31, 2024, we had an accumulated deficit of approximately $34.7 $41.5 million.

We currently have no product revenue and we may not be able to commercialize our Symphony technology platform or achieve significant revenues or profitability. Our ability to generate revenue and achieve profitability depends upon our ability, alone or with others, to complete the development process of our product candidates, including regulatory approvals,clearances, and thereafter achieve substantial acceptance in the marketplace for our products. We may be unable to achieve any or all of these goals.

Absent furtherAs funding,of December 31, 2025, we currentlypossessed cash and cash equivalents of approximately $5.2 million, while having current liabilities of approximately $1.1 million. Consistent with prior years, we expect to runincur outa ofsignificant availableoperating cashloss resourcesin during2026 theand third2027 quartergiven ofthat 2025.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 approvalclearance as early as the third quarter of 2028,thereafter, we expect to need to raise at least $30$20 million of further capital between the second quarter of 2025 andthrough the end of the 2027 fiscal year, which we hope to do in various tranchestranches. duringIf thiswe timedo period.not raise additional capital, we expect to run out of available cash resources in the third quarter of 2026. There can be no assurance that such additional capital will be available on a timely basis or on terms that will be acceptable to us. We currently do not have any contracts or commitments for additional financing. In addition, any additional equity financing may involve substantial dilution to our existing stockholders, or provide that an equity or debt financing source obtains rights to control the membership of our board of directors.

As a result of our lack of cash resources, we have slowed the timeline of our clinical trial work to preserve cash resources in the near-term. If we fail to obtain additional financing, we likely will be forced to abandon suchoperational activities entirely and file for bankruptcy protection, with the possible loss of such properties or assets (including the license to our core technology). Based on our explorations to date, we do not expect that any other strategic alternatives, such as a potential sale of the Company or its assets or other restructuring efforts, will be available to us in the near-term. As a result, any inability to obtain additional financing in the near-term, including a material amount of financing over the next 2-32 years, would likely result in a material adverse effect on our business, results of operations, cash flow, financial condition and prospects and cause our stockholders to receive little or no return on their shares of common stock.

Since the initial public offering of our common stock in November 2021, the market price of our common stock has fallen by more than 99.9%, and we expect to need additional funding amounts substantially greater than the current market capitalization of our common stock, which may result in future dilution that coincides with further material declines in the trading price of our common stock beyond the substantial declines that have occurred in recent years.

Since the initial public offering of our common stock in November 2021, the market price of our common stock has fallen by more than 99.9%, including declines of greater than 80% per year in each of 2022,2025, 2024, 2023 and 2024.2022. During such period of time, we have conducted several public offerings and private placements of securities to raise additional capital, and in each case, the market price of our common stock has fallendeclined substantially after the consummation of such offerings. As described above, we expect to need to raise at least $30$20 million of funding over the next 2-3 2 years – an aggregate amount approximately 15several times the current market capitalization of our outstanding common stock, and we do not expect to be able to complete necessary product re-development, troubleshooting and clinical trial work absent such material funding. This may cause new investors to demand terms in future offerings that substantially dilute existing shareholders, orsuch resultas the inclusion of warrants with Black Scholes protections in suchthe holders obtainingevent orof beinga grantedsale shareholder voting or board governance control positions,transaction, which could cause our common stock to fall further from current levels on a per share basis.

The Classwarrants C Warrants, January 2024 Common Stock Warrants and August 2023 Common Stock Warrantsgenerally are generally only exercisable solely by means of a cash exercise. AIn holdergeneral, holders of these warrants (together with its affiliates) may not exercise any portion of thesuch warrants toif thesuch extentholder, thattogether with theits holderaffiliates, would beneficially own more than 4.99% (or, at the election of the holder, 9.99%) of our outstanding common stock immediately after exercise. The common stock warrants include certain rights upon a “fundamental transactionstransaction” (as describeddefined in thesuch warrants, warrants), including the right of the holders thereof to receive from us 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 describeddefined 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,us and the holders of these warrants,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.decline.

We have registered the issuance of shares upon exercise of these warrants under registration statements. As a result, the shares issuable upon exercise of these warrants can be freely sold in the public market upon issuance. Sales of these shares into the public market in the future could cause the market price of our common stock to decline significantly.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, whichparticularly 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 impact the market price of our common stock and reduce or eliminate any appreciation in our stock price that might otherwise occur.

We are effectively a new business with a plan to commercialize our licensed technology. Our limited operating history may not be adequate to enable you to fully assess our ability to develop and market our Symphony platform and test cartridges, assuming we receive regulatory clearances, for which there is no assurance, and respond to competition. Our efforts to date have related to the organization and formation of our Company, research and development and performing clinical trials. We have no approved products, have not yet generated sustainable revenue, and we cannot guarantee we will ever be able to generate future revenues. Therefore, we are, and expect for the foreseeable future to be, subject to all the risks and uncertainties, inherent in a new business focused on the development and sale of new medical devices. As a result, we may be unable to further develop, obtain regulatory approvalclearance for, manufacture, market, sell and derive revenues from our Symphony platform and test cartridges and the other product candidates in our pipeline, and our inability to do so would materially and adversely impact our viability. In addition, we still must optimize many functions necessary to operate a business, including expanding our managerial, personnel and administrative structure, continuing product research and development, and assessing and commencing our marketing activities.

Our license and supply agreements with Toray, which relate to the license of the core technology used in our Symphony Cartridgescartridges and the supply of cartridge intermediates from Toray to SanyoSeiko for SanyoSeikoSanyoseiko to manufacture cartridges for Bluejay, are subject to significant risks that may threaten our viability or otherwise have a material adverse effect on us and our business, assets and its prospects.

We have an exclusive license with Toray for the entire world, excluding Japan, to use their patents and know-how related to our Symphony test cartridges for the manufacturing, marketing and sale of such products. We also have a nonexclusive license for manufacturing purposes in Japan. We have a right to sublicense these Toray patents and know-how (upon either (a) obtaining consent from Toray prior to obtaining FDA approvalclearance or (b) giving notice to Toray after obtaining FDA approvalclearance), and for the purpose of obtaining FDA approval,clearance, we will need to exercise this sublicence to have the cartridges manufactured for Bluejay by a Japanese manufacturer, SanyoSeiko,Sanyoseiko, Inc. (“SanyoSeikoSanyoseiko”). We have no contractual rights to the intellectual property covered in the license agreement other than as expressly set forth therein. Our plans, business, prospects and viability are substantially dependent on that intellectual property and subject to the limitations relating thereto as set forth in the license agreement. Some of the risks this may give rise to are described below.

As an intermediate step to commercialregulatory viability, submission, we need to demonstrate that our IL-6collected clinical samples do not degrade over time, and our premise would be undermined if we fail to do so.time.

We are currently conducting testing to demonstrate specimen stability, which will be important to our future development efforts. Confirming stability of the samples collected from the SYMON-II clinical studystudy, which is one of the integral aspects that we will have to establish before we can proceed to FDA clearance. We plan to establish sample stability using standard plate ELISA technology.technology Once Symphonythat is accepted operational, weby planthe to perform a bridging study to demonstrate specimen stability commutability.FDA. If we fail to prove that IL-6 is stable over time, we might have to redesign our business plan.

There is a risk of our cartridges not passing analytical validation, one of the key requirements of FDA approval.clearance.

There is a risk that our cartridges, a core component of our Symphony system, will not pass analytical validation due to failures in performance. We are working on plans to redevelop the cartridges in order to reduce this risk, but we cannot be sure that our attempts will be successful until they have been tested and have successfully passed analytical validation themselves.

The Symphony analyzer has previously passed all safety validations required by the FDA. However, we plan to reperform some of the validations surrounding electromagnetic compatibility and safety standards due to a recent FDA requirement changes.changes Shouldshould other FDA standards change, we could need to perform those tests as well, incurring additional expenses and delays that are impossible to predict due to the uncertain nature of what standards the FDA might change in the future.

We depend on, and are liable for, SanyoSeiko Sanyoseiko as our Symphony analyzer and cartridge contract manufacturing organization (CMO), so its inability or failure to perform appropriately in that capacity may threaten our viability or have a material adverse effect on us and our business, assets and its prospects.

We are dependent on SanyoSeikoSanyoseiko to maintain compliance with the FDA requirements, and continuously manufacture and supply us with our Symphony analyzers. analyzers and cartridges. If SanyoSeikoSanyoseiko is unable to do so for any reason and we are unable to activate a new CMO to produce analyzers, we may be unable to obtain FDA approvalclearance and commence any commercial sales or unable to supply products to our customers in a timely manner or at all, either of which could threaten our viability.

We have not yet launched or received regulatory approvals clearances in any country or territory for our Symphony platform or test cartridges. Even if we receive regulatory approvals,clearances, we are faced with the risk that our Symphony platform will not be accepted over competing products and that we will be unable to enter the marketplace or compete effectively. We cannot assure you that our Symphony platform or test cartridges will gain market acceptance. If the market for our future products fails to develop or develops more slowly than expected, or if any of the technology and standards supported by us do not achieve or sustain market acceptance, our business and operating results would be materially and adversely affected.

We may be faced with lengthy and unpredictable customer evaluation and approval processes associated with our Symphony platform. Consequently, we may incur substantial expenses and devote significant management effort and expense in developing customer adoption of our Symphony platform, which may not result in revenue generation. We must also obtain regulatory clearances or approvals of our Symphony platform and test cartridges in jurisdictions in which we pursue approvals, which is subject to risk and potential delays. The same risks apply to other tests we may develop based on our Symphony platform. As such, we cannot accurately predict the volume, if any, or timing of any future sales.

In addition, we may utilize third party technology or components in our products, and we rely on those third parties to provide support services to us. The existence of errors, defects, or bugs in third party technology or components, or the failure of those third parties to provide necessary support services to us, could materially adversely impact on our business.

We believe that our management team must be able to act decisively to apply and adapt our business model in the markets in which we will compete. Our future performance depends to a large extent on the continued services of membersservice of our current management, including our President and Chief Executive Officer, Neil Dey, andwho is our Chiefsole Technologyexecutive Officer, Jason Cook.officer. In addition, we rely upon technical and scientific employees or third-party contractors to effectively establish, manage and grow our business. Consequently, we believe that our future viability will depend largely on our ability to attract and retain highly skilled managerial, sales, scientific and technical personnel.

In order to do so, we may need to pay higher compensation or fees to our employees or consultants than we currently expect, and such higher compensation payments would have a negative effect on our operating results. Competition for experienced, high-quality personnel is intense and we cannot assure that we will be able to recruit and retain such personnel, or that we will possess the cash resources to do so. For example, our limited cash resources have caused us to reduce our overall full-time employment headcount to 76 persons, and we could need to implement further personnel-related cost reductions in the near-term.future. As such, we may not be able to hire or retain the necessary personnel to implement our business strategy. For example, Mr. Dey is currently serving as our principal financial and accounting officer, in addition to serving as our principal executive officer. Our failure to hire and retain such personnel could impair our ability to develop new products and manage our business effectively. In the event that we lose the continued services of such key personnel for any reason, this could have a material adverse effect on our business, operations and prospects.

We do not have a meaningful amount of authorized shares remaining under our equity compensation plans and therefore cannot incentivize our directors and employees with non-cash compensation.compensation, and our cash compensation obligations for directors and officers are substantial relative to our market capitalization.

We have undergone a series of reverse stock splits at a cumulative ratio of 1-for-8,0001-for-32,000 oversince theour lastequity twoincentive years.plans were adopted. As a result, the authorized shares in our stock compensationsuch plans have been correspondingly reduced, and we only possess a de minimus amount of equity under our 2018these Stock Incentive Plan and our 2021 Stock Plan.plans. As a result, we currently cannot incentivize our directors and employees with non-cash compensation, and even if we possessed such available shares, the substantial declines in the value of our common stock in each of the prior three years may substantially depress the desired incentive effects of using such shares for compensatory purposes. We believe that stock incentive plans serve to closely align the interests of directors and officers with the interests of the Company’s shareholders, and without this tool we are left paying all compensation in cash. InGiving 2024,effect to compensation increases approved by our board of directors (and its compensation committee) in the fourth quarter of 2025, our anticipated cash compensation fees paidowed to non-employee directors werein $380,0002026 is expected to be $540,000 in the aggregateaggregate, and Mr. Dey receives annual base cash feescompensation paidof to our two executive officers were $526,000.$400,000. Given our lack of available equity incentives as a compensatory tool, we expect to continue incurring significant cash compensation expense relative to our overall market capitalization. We currently expect to seek stockholder approval at our 2026 annual meeting of stockholders to reload the shares available under our equity incentive plans, but there is no assurance that such proposal will be approved by stockholders.

Specific raw materials used in the production of Symphony IL-6 cartridges are being discontinued or are otherwise limited in supply and the process of finding a suitable substitute could be expensive, use important resources, reduce the efficacy of the platform, or lead to other delays and setbacks.

Several Certain raw materials used in production of Symphony IL-6 cartridges are being discontinued and we willmight need to be validate new materials to use as substitutes. These materials include hydrophobic coating solution, side film plastic laminate, and antibody. Testing new raw materials at themight same time that we are testing to discover the previously discussed instability in the product introduces additional variables that could make it more difficult for us to discover the source of the instability, addingadd extra expense and delay. We cannot currently predict what substitute materials will be found to work for the discontinued ones, whether they will perform as well, their availability, or their precise cost.

We might not be able to discoverresolve the underlying causecertain causes of a Symphony performance reproducibility issue, and if the issues are inherent in the design of the platformpersist we might have to redesigntake oura different approach.

We continue to face a performance reproducibility issue with the Symphony cartridges, and we have been unable to discover the cause to date. Our efforts to redevelop the cartridge might not adequatelybe able to resolve the issues if they are inherent to the design of the cartridge. If the issue lies in thesea ortimely similarlymanner, difficult-to-address areas, weand might need to redesign our approach, which would likely be expensive and significantly delay the FDA approvalclearance process.

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, settings.with a focus on sepsis. Our Symphony technology platform is an exclusively licensed, patented system that consists of aan mobile device analyzer and single-use testprotein detection cartridges that we believe, if cleared, authorized, or approved by the U.S. Food and Drug Administration (“FDA”), could provide a solution to a significant market need in the United States. Clinical trials indicateThe Symphony producesdevice candidate is designed to produce laboratory-quality results in less thanapproximately 20 minutes in critical care settings, including Intensive Care Units (“ICUs”) and and Emergency Rooms (“ERs”), where rapid and reliable results are required.

Research and development expenses decreased approximately $2.2 $0.4 million, or 39%,12%, for the year ended December 31, 2024,2025, as compared to 2023.2024. The decrease in research and development expenses was primarily due to a $0.5$0.2 million decrease in personnel related costs, a $0.8$0.1 million decrease in depreciationother expense,costs, and a $1.1$0.2 million decrease in product development costs, which was partially offset by a $0.5$0.1 million increase in clinical development costs.

General and administrative expenses decreased increased approximately $0.6$0.2 million, or 14%,6%, for the year ended December 31, 2024,2025, as compared to 2023. 2024. The decreaseincrease in general and administrative expenses is primarily due to thea $0.3 million increase in Delaware franchise tax cost reductionand effortsa focused$0.1 onmillion reducingincrease in personnel andrelated costs, otherwith administrativewas costs.partially offset by a $0.2 million decrease in consulting expenses.

Sales and marketing expenses decreased approximately $0.3 million, or 97%,100%, for year ended December 31, 2024,2025, as compared to 2023.2024. The low sales and marketing expenses in 20242025 are due to a reduction in spending in all sales and marketing efforts.

Total other income (expense) decreased approximately $0.9 $0.7 million for the year ended December 31, 20242025 as compared to 2023.2024. The decreases primarily related to the $0.8 million increase in interest expense associated with the 2024 Bridge Note Financing.

During 2024, 2025, we used approximately $0.3$0.2 million in cash forfrom investing activities, an approximately $0.4$0.1 million decrease from 2023.2024. The Company acquired laboratory equipment andless manufacturing equipment for the development of the Symphony devices in both 20242025 and 2023.2024.

During 2024,2025, we generated approximately $10.2$7.1 million million in cash from financing activities, as compared to $1.1$10.2 million in 2023.2024. The increasedecrease in net cash provided by financing activities was was primarily due to the proceeds from our private placements in April 2025 and October 2025 compared to our public offerings in January 2024 and June 2024 as compared to our private placement of common stock in August 2023.2024.

The Company expects that it will seek to raise such additional capital through public or private equity offerings, grant financing and support from governmental agencies, convertible debt, collaborations, strategic alliances and distribution arrangements.offerings. Additional funds may not be available when it needs them on terms that are acceptable to them, or at all. If adequate funds are not available, it may be required to delay its FDA regulatory strategy, and to delay or reduce the scope of its research or development programs, its commercialization efforts or its manufacturing commitments and capacity. In addition, if it raises additional funds through collaborations, strategic alliances or distribution arrangements with third parties, it may have to relinquish valuable rights to its technologies or future revenue streams.

January 2024 Public Offering

On January 2, 2024, the Company sold in a public offering (such transaction, the “January 2024 Offering”) (i) 1,344336 shares of the Company’s common stock, par value $0.0001 per sharestock and (ii) prefunded warrants to purchase up to an aggregate 5,3861,346 shares of Commoncommon Stockstock (the “January Prefunded Warrants”). The Shares and January Prefunded Warrants were sold together with warrants to purchase up to an aggregate of 6,7301,682 shares of Commoncommon Stockstock at an exercise price of $520.00$2,080.00 per share (the “January 2024 Warrants”). The combined public offering price was $520.00$2,080.00 per share of Common Stockcommon stock and related January 2024 Warrant and $519.96$2,079.84 per January Prefunded Warrant and related January 2024 Warrant.

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

To remain a going concern, we areexpect into need of imminentto materialraise additional capital and absentif we are unable to do so, we could become unable to finance our abilitybusiness plan, ultimately leading to raiseus such material capital in the near-term, we may be required to undertakeundertaking a process of liquidation under U.S. bankruptcy laws, which we expect would limit holders of our common stock from recouping any material value for their shares.laws.

As of MarchJune 31,30, 2026, we possessed cash and cash equivalents of approximately $3.7$9.6 million, while having current liabilities of approximately $1.4$2.1 million. We incurred losses of approximately $6.8 million and $7.7 million for fiscal years 2025 and 2024, respectively, and $1.9$4.2 million for the fiscalsix quartermonths ended MarchJune 31,30, 2026. From our inception through MarchJune 31,30, 2026, we have an accumulated deficit of approximately $43.4$45.8 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 first half of 2027 and achieve FDA approval thereafter. We expect to need to raise at least $20 million of capital between the second quarter of 2026 and the end of the 2027 fiscal year, whichthereafter, we hope to do in various tranches during this time period. We are exploring potential pathwaysexpect to raise additional materialcapital. capital, but thereThere can be no assurance that such additional capital will be available on a timely basis or on terms that will be acceptable to us. If we are ultimately unable to obtain the needed financing to implement our business plans, our board of directors could determine to cause the Company to undertake a process of liquidation under Chapter 7 of applicable U.S. bankruptcy laws. In such event, we do not currently expect that holders of shares of our common stock wouldmay not recoup any materialsignificant value in such process.value.

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.analyzer The Company has completed redevelopingand the manufacturing processes for cartridges through a third-party contractor.cartridges. To achieve its clinical and commercial plan, the Company expects to need to raise atbetween least$10.0 $20million and $14 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,plan is to begincomplete analytical and clinical testing of samples it is collecting as part of its ongoingthe SYMON-II clinical trial samples 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.

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 $4.2 million and $1.9$3.8 million for the threesix months ended MarchJune 31,30, 2026 and 2025, respectively. We had negative cash flow from operating activities of approximately $1.6$3.1 million and $1.2$3.2 million for the threesix months ended MarchJune 31,30, 2026 and 2025, respectively, and had an accumulated deficit of approximately $43.4$45.8 million as of MarchJune 31,30, 2026.

As further described below under “Liquidity and Going Concern Uncertainty” as of MarchJune 31,30, 2026, the Company possessed cash and cash equivalents of approximately $3.7$9.6 million, while having current liabilities of approximately $1.4$2.1 million. The Company will need to raise a material amount of additional capital in the future to continue as a going concern. 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.

Comparison of the Three and Six Months Ended March 31,June 30, 2026 and 2025

The following table sets forth our results of operations for the three and six months ended MarchJune 31,30, 2026 and 2025:

Research and development expenses for the three months ended MarchJune 31,30, 2026 were approximately $0.8$1.4 million as compared to approximately $0.8$0.9 million for the same period in 2025. The small increase in research and development expenses was primarily due to increaseda product$0.8 million increase in clinical development costs, which were largelysomewhat offset by decreasesa $0.3 million decrease in personnel costs. 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 expenses for the three months ended MarchJune 31,30, 2026, were approximately $1.1$0.9 million as compared to approximately $1.1 million for the comparable period in 2025. The small increasedecrease in general and administrative expenses is due to recognitionlower oflegal $0.1fees millionand ofaccounting 2025 bonus costsfees during the three months ended MarchJune 31,30, 2026,2026 compared to 2025, which was largelysomewhat offset by decreasesincreases in consulting, insurancepersonnel and other expense. The Company continues its 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.

Other Income,Income (expense), net

Other income (expense),income, net for the three months ended MarchJune 31,30, 2026 was approximately $19,590$25,111 as compared to $24,482$28,757 for the same periods in 2025. The decrease in other income (expense), net was primarily due to a decrease of approximately $7,000 in relatedinterest party income from NanoHybrids.income.

During the threesix months ended MarchJune 31,30, 2026, we used approximately $1.6$3.1 million in cash for operating activities, ana increasedecrease of approximately $0.4$0.1 million as compared to approximately $1.2 million for the same period in 2025. The increasedecrease in net cash used in operating activities was primarily due to an increase in working capital of approximately $362,000.$560,000 and largely offset by an increase in net loss of $422,000.

During the threesix months ended MarchJune 31,30, 2026, we used $15,314$158,087 in cash for investing activities, an increase of approximately $15,314$158,087 as compared to the same period in 2025. The increase in net cash used in investing activities was due to the acquisition of equipment necessary for the manufacture of cartridges in 2026, partially offset by proceeds from the sale of assets.

Net cash provided by (used in) financing activities

During the threesix months ended MarchJune 31,30, 2026, we generated $124,096$7.7 million of cash from financing activities, an increase from the cash usedprovided of approximately $985$4.3 million in the same period in 2025. The increase in 2026 is due to the June 2026 Private Placement net proceeds of $7.6 million and March 2026 Private Placement.Placement net proceeds of $125,000 when compared to the April 2025 private placement net proceeds of $3.4 million.

The Company had cash and cash equivalents of $3,684,457 $9,598,916 and current liabilities of $1,413,919$2,116,641 on its balance sheet as of MarchJune 31,30, 2026. The Company has incurred net losses since its inception, and has negative cash flows from operations and had an accumulated deficit of $43,436,508$45,760,521 as of MarchJune 31,30, 2026. The Company continues to develop its Symphony device and its first test for the measurement of IL-6. The Company remains committed to obtaining FDA clearance and hopes to conduct clinical trials to obtain sufficient data to support its FDA submission, while also continuing to build its manufacturing operations with its contract manufacturing organizations. Current cash resources and expected operating expenses are considered in determining its liquidity requirements. The Company estimates cash resources will be sufficient to fund its operations through the thirdsecond quarter of 2026. 2027. The Company will need additional capital to fund its planned operations for the next 1215 months.months for commercialization and manufacturing scale-up. These conditions raise substantial doubt about the Company’s ability to continue as a going concern within one year from the date these financial statements are issued.

The condensed consolidated financial statements for the three and six months ended MarchJune 31,30, 2026 and 2025 were prepared under the assumption that the Company will continue as a going concern, and do not include any adjustments relating 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.

The Company expects that it will seek to raise such additional capital through public or private equity offerings. Additional funds may not be available when it needs them on terms that are acceptable to them, or at all. If adequate funds are not available, it may be required to delay its FDA regulatory strategy, and to delay or reduce the scope of its research or development programs, its commercialization efforts or its manufacturing commitments and capacity. In addition, if it raises additional funds through collaborations, strategic alliances or distribution arrangements with third parties, it may have to relinquish valuable rights to its technologies or future revenue streams.

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.$3,846,692. The Company incurred total offering costs of $464,670, including a 10% financial advisory fee to Aegis Capital Corp. of $384,670.

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 43,750 shares of common stock and prefunded warrants to purchase up to 518,750 shares of common stock (the “October 2025 Prefunded Warrants”),stock, and (ii) Series F warrants (the “Series F Warrants”) to purchase up to 1,125,000 shares of common stock. The combined price of the securities sold in the private placement was $8.00 per share of common stock (or prefunded warrant in lieu thereof, in which case such price was reduced by $0.0004) and accompanying Series F Warrants to acquire two shares of common stock. The October 2025 Prefunded Warrants, were exercisable for shares of common stock at an exercise price of $0.0004 per share and have all been fully exercised as of the date hereof. The Series F Warrants are exercisable for shares of common stock at an exercise price of $7.00 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 $787,755, 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 45,000 of common stock at an exercise price of $10.00 per share, which expire 5.5 years from the date of issuance (the “October 2025 Placement Agent Warrants”).issuance.