Item 1A. Risk Factors For a discussion of potential risks or uncertainties, see Risk Factors in the Companys 2024 annual report 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 file with Form 10-Q for the SEC. 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 To remain a going concern, we are in We expect to need of imminent material additional capital and absent our ability to raise such material capital in at least $20 million between the near-term, we may be required 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 we expect would limit could cause holders of our common stock from recouping any material to recoup little, if any, value for their shares. As of June September 30, 2025, we possessed cash and cash equivalents of approximately $4.4 $3.1 million, while having current liabilities of approximately $1.0 $1.1 million. We incurred net losses of approximately $7.7 million and $10.0 million for fiscal years 2024 and 2023, respectively, and $3.8 $5.4 million for the six nine months ended June September 30, 2025. From our inception through June September 30, 2025, we have an accumulated deficit of approximately $38.5 $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 approval thereafter, clearance as early as the third quarter of 2028, we expect to need to raise at least $30 $20 million of capital between the second quarter date of 2025 this filing and the end of the 2027 fiscal year, which we hope to do in various tranches during this time period. We are exploring potential pathways to Our financial results and financial position, and our expected forward-looking outlook of significant negative cash flow in the future, raise additional material capital, but there can be no assurance substantial doubt with respect to our ability to continue as a going concern. We expect that such additional capital we will not be available on in position to submit a timely basis or on terms that will 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 acceptable delayed, and we could be forced to us. abandon such activities entirely and cease operations, with the possible loss of such properties or assets. If we are ultimately unable to obtain the needed additional financing as we continue to implement generate negative cash flow, our business plans, our board of directors could determine to cause the Company 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, we do not currently expect that holders of shares of our common stock would could recoup any material little, if any, value in such process. 28 Additional Risks Related to Our Business To preserve cash resources, we The number of shares of common stock underlying our outstanding warrants is several times greater than our currently outstanding common stock, which could have downsized a negative effect on the market price of our organization, 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 business continuity, affect our ability to apply the consideration otherwise available for certain patents, and affect payment to holders of our product development and timelines, including common stock. As part of our previously disclosed plan public offerings and/or private placements of securities in October 2025, April 2025, June 2024, January 2024 and August 2023, we issued warrants to transfer underlying production purchase shares of our cartridges common stock. As of the date of this filing, remaining warrants exercisable from these transactions included (i) October 2025 Prefunded Warrants to a third-party contractor who 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). 29 In general, holders of these warrants may not exercise any portion of such warrants if such holder, together with its affiliates, would manage beneficially own in excess of 4.99% or 9.99% (at the initial election of the holder) of the number of shares of the Companys common stock outstanding immediately after giving effect to such redevelopment. To preserve cash resources, we have implemented exercise. The warrants include certain rights upon a series fundamental transaction (as defined in such warrants), including the right of recent cost savings measures the holders thereof to receive from the Company or a successor entity cash or the same type or form of consideration (and in our product development operations. As 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 this filing, we have reduced 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 overall Company-wide full-time employee headcount outstanding common stock. As a result, the holders of these warrants may be able to 5 persons, including recently separating with exert substantial influence over our Chief Technical Officer, who was also significantly involved 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 our ongoing SYMON-II clinical studies, analytical studies, the future between us, on the one hand, and certain intellectual property in connection with the prior development work holders of Symphony performed by Company, these warrants, concerning the issuance of additional securities and other matters. In addition, sales of these shares could cause the market price of our VP common stock to decline significantly. We have registered the issuance of Operations, who was overseeing shares upon exercise of these warrants under registration statements (or are in the process of redeveloping aspects doing so). Sales of these shares into the public market in the future could cause the market price of our Symphony cartridges. We are exploring pathways for redevelopment by outsourcing this work common stock to third parties. In addition, decline. Furthermore, if our stock price rises, the holders of these measures are expected warrants may be more likely to result in exercise their warrants and sell a loss large number of institutional knowledge 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 make our product redevelopment work 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 achieve. To register the extent applicable securities in accordance with the requirements of the registration rights agreement we obtain sufficient funding, entered into with the purchasers of the securities in such transaction. In connection with the private placement we may hire replacement personnel consummated in these areas 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 future, but there is 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 assurance 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 will are unable to successfully register the applicable securities in accordance with the requirements of the registration rights agreement, we could be able required to do so. These circumstances may 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 succeed in meeting achieve the technical challenges financing objectives that we expect to be necessary for us to bring successfully complete our Symphony product 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 level consistent 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 necessary performance and quality requirements respect to support an FDA submission and ultimately be able our ability to commercialize engage in financing transactions, could restrict our product, as well as ability to raise capital in the timeline near-term, making it more difficult for completing this work. us to achieve the financing objectives that we expect to be necessary for us to successfully complete our commercialization and FDA clearance efforts. 30