NanoVibronix, Inc.

Item 1A. Risk Factors

The following description of risk factors includes any material changes to, and supersedes the description of, the risk factors addressed below associated with our business, financial condition and results of operations previously disclosed in Item 1A. Risk Factors of our Annual Report on Form 10-K for the fiscal year ended December 31, 2024, as filed with the SEC on March 31, 2025. Our business, financial condition, and operating results can be affected by a number of factors, whether currently known or unknown, including but not limited to those described below, any one or more of which could, directly or indirectly, cause our actual financial condition and operating results to vary materially from past, or from anticipated future, financial condition and operating results. Any of these factors, in whole or in part, could materially and adversely affect our business, financial condition, operating results, and stock price.

The following discussion of risk factors contains forward-looking statements. These risk factors may be important to understanding other statements in this Form 10-Q. The following information should be read in conjunction with the condensed consolidated financial statements and related notes in Part I, Item 1, Financial Statements and Part I, Item 2, Managements Discussion and Analysis of Financial Condition and Results of Operations of this Quarterly Report.

If we fail to comply with the continued listing requirements of Nasdaq, our common stock may be delisted and the price of our common stock and our ability to access the capital markets could be negatively impacted.

Our common stock is currently listed for trading on Nasdaq. We must satisfy Nasdaqs continued listing requirements, including, among other things, a minimum stockholders equity of$2.5 million and a minimum closing bid price of $1.00 per share or risk delisting, which would have a material adverse effect on our business. A delisting of our common stock from Nasdaq could materially reduce the liquidity of our common stock and result in a corresponding material reduction in the price of our common stock. In addition, delisting could harm our ability to raise capital through alternative financing sources on terms acceptable to us, or at all, and may result in the potential loss of confidence by investors, suppliers, customers and employees and fewer business development opportunities.

We have in the past, and may in the future, be unable to comply with certain of the listing standards that we are required to meet to maintain the listing of our common shares on Nasdaq. For example, On April 10, 2024, we received the Letter from the Staff indicating that, based upon the closing bid price of our common stock for the 30 consecutive business days between February 27, 2024, and April 9, 2024, we did not meet the minimum bid price of $1.00 per share required for continued listing on Nasdaq pursuant to the Bid Price Rule. The Letter also indicated that we were provided with a compliance period of 180 calendar days, or until October 7, 2024, in which to regain compliance with the Bid Price Rule pursuant to Nasdaq Listing Rule 5810(c)(3)(A). We did not regain compliance with the Bid Price Rule by October 7, 2024, and on October 8, 2024, Nasdaq notified us that our securities were subject to delisting from Nasdaq unless we timely requested a hearing before the Panel. We subsequently timely requested a hearing before the Panel, which was held on December 5, 2024.

On November 19, 2024, we received an additional deficiency notice from the Staff indicating that we no longer satisfied the $2.5 million stockholders equity requirement set forth in the Equity Rule for continued listing on Nasdaq. The Staff indicated that our non-compliance with the Equity Rule would be considered by the Panel at the Hearing and could serve as an additional basis for delisting of our securities from Nasdaq.

On December 26, 2024, we received the Decision Letter from the Panel granting a limited extension of time for us to demonstrate compliance with the Bid Price Rule and the Equity Rule for continued listing on Nasdaq, subject to the following conditions: (i) on or before February 27, 2025, we will have obtained stockholder approval to effect a reverse stock split of our common stock; (ii) on or before March 31, 2025, we shall have effected a reverse stock split and, thereafter, maintain a $1.00 closing bid price of our common stock for a minimum of ten consecutive trading days; (iii) on or before March 31, 2025, we are required to demonstrate compliance with the Equity Rule by filing public disclosure with the SEC and demonstrate long-term compliance with the Equity Rule; and (iv) on or before March 31, 2025, we are required to demonstrate compliance with all continued listing requirements for Nasdaq. On February 24, 2025, we obtained approval from our stockholders to file a certificate of amendment to our Certificate of Incorporation to effectuate the 2025 Reverse Stock Split, among others, and on March 13, 2025, the 2025 Reverse Stock Split became effective.

On April 9, 2025, we received the April Letter from the Staff notifying us that we had demonstrated compliance with the Bid Price Rule and the Equity Rule as required by the Panel pursuant to the Decision Letter.

Pursuant to the April Letter, we will be subject to a mandatory panel monitor for a period of one year from the date of the April Letter. If, within that one-year monitoring period, Staff finds us again out of compliance with the Equity Rule that was subject of the exception, notwithstanding Rule 5810(c)(2), we will not be permitted to provide the Staff with a plan of compliance with respect to that deficiency and Staff will not be permitted to grant additional time for us to regain compliance with respect to that deficiency, nor will the company be afforded an applicable cure or compliance period pursuant to Rule 5810(c)(3). Instead, Staff will issue a Delist Determination Letter and we will have an opportunity to request a new hearing with the Panel or a newly convened Hearings Panel if the initial Panel is unavailable.

There is no assurance that we will maintain compliance with the minimum listing requirements with all applicable requirements for continued listing on Nasdaq. If our common stock were delisted from Nasdaq, trading of our common stock would most likely take place on an over-the-counter market established for unlisted securities, such as the OTCQB or the Pink Market maintained by OTC Markets Group Inc. An investor would likely find it less convenient to sell, or to obtain accurate quotations in seeking to buy, our common stock on an over-the-counter market, and many investors would likely not buy or sell our common stock due to difficulty in accessing over-the-counter markets, policies preventing them from trading in securities not listed on a national exchange or other reasons. In addition, as a delisted security, our common stock would be subject to SEC rules as a penny stock, which impose additional disclosure requirements on broker-dealers. The regulations relating to penny stocks, coupled with the typically higher cost per trade to the investor of penny stocks due to factors such as broker commissions generally representing a higher percentage of the price of a penny stock than of a higher-priced stock, would further limit the ability of investors to trade in our common stock. In addition, delisting could harm our ability to raise capital through alternative financing sources on terms acceptable to us, or at all, and may result in the potential loss of confidence by investors, suppliers, customers and employees and fewer business development opportunities. For these reasons and others, delisting would adversely affect the liquidity, trading volume and price of our common stock, causing the value of an investment in us to decrease and having an adverse effect on our business, financial condition and results of operations, including our ability to attract and retain qualified employees and to raise capital.

Risks Related to our Preferred Stock

The Series X Certificate of Designations, as amended by the Series X Certificate of Amendment, containthe Series G Certificate of Designations and the Series H Certificate of Designations contain certain provisions that may result in the reduction of the conversion price of the Series X Preferred Stock as a , the Series G Preferred Stock and the Series H Preferred Stock as a result of thisfuture offerings and issuances of our equity securities. Thisese feature may increase the number of shares of common stock being issuable upon conversion of the Series X Preferred Stock, the Series G Preferred Stock and the Series H Preferred Stock.

The Series X Certificate of Designations, as amended by the Series X Certificate of Amendment, contains cthe Series G Certificate of Designations and the Series H Certificate of Designations each contain certain provisions, which include, but are not limited to, provisions that require the lowering of the applicable conversion price of the Series X Preferred Stock to the conversion pricesuch shares of the Ppreferred Sstock upon the closing of this offering. Upon the closing of this offering, which in turn, weould will be required, subject to certaresult in limitations and adjustments as provided in the Certificatea greater number of shares of Designations, to reduce the Series X Ccommon stock being issuable upon conversion Price toof the conversion price of the Series X Preferred Stock, which such adjustment will result in a greater number of shares of common sthe Series G Preferred Stock being issuable upon conversion of and the Series XH Preferred Stock, which in turn will increase the dilutive effect of such conversions on existing holders of our common stock.

The Series G Certificate of Designations for the Series G Preferred Stock contaiand the Series H Certificate of Designations ancontain anti-dilution provisions that may result in the reduction of the conversion price for the Series G Preferred Stock iand the Series H Preferred Stock in the future. This feature may result in an indeterminate number of shares of common stock being issued upon conversion or exercise, as applicable.

The Series G Certificate of Designations for our Series G Preferred Stock contaiand the Series H Certificate of Designations anfor our Series H Preferred Stock contain anti-dilution provisions, which such provisions require the lowering of the conversion price to the purchase price of future offerings. If in the future we issue securities for less than the conversion price of our Series G Preferred Stock or the Series H Preferred Stock, we will be required to further reduce the relevant conversion price, which will result in a greater number of shares of common stock being issuable upon conversion, which in turn will have a greater dilutive effect on our shareholders, provided, however, that the conversion price shall in no event be less than the applicable Floor Price (as defined in the Series G Certificate of Designations and the Series H Preferred Stock). As such, it is possible that we will not have sufficient available shares to satisfy the conversion of the Series G Preferred Stock if and the Series H Preferred Stock if we enter into a future transaction that lowers the conversion price. If we do not have sufficient available shares for any Series G Preferred Stock cor Series H Preferred Stock conversions, we will be required to increase our authorized shares, which may not be possible and will be time consuming and expensive. The potential for such issuances may depress the price of our common stock regardless of our business performance. We may find it more difficult to raise additional equity capital while the Series G Preferred Stock is oand the Series H Stock are outstanding.

The Series G Preferred Stock provides for the payment of dividends in cash or in shares of our common stock, and we may not be permitted to pay such dividends in cash, and the Series H Preferred Stock provides for the payment of dividends in shares of our common stock, each which will require us to have shares of common stock available to pay the dividends. 

Each share of Series G Preferred Stock will be entitled to receive cumulative dividends at the rate per share of 9% per annum of the state value per share, until the fifth anniversary of the date of issuance of the Preferred Stock. The dividholder of Series G Preferred Stock will receive the same pay-in-kind (PIK) dividends a amount regardless of when they choose to convert. Each share paof Series H Preferred Stock will be entitled to receive cumulative dividends at a rate of 9% per annum, payable, a on each conversion date (as defined in the Series H Certificate of Designations). As related to the Series G Preferred Stock, such dividends are payable, at our discretion, in cash, out of any funds legally available for such purpose, or in pay-in-kind shares of common stock calculated based on the conversion price, subject to adjustment as provided in the Series G Certificate of Designations and the Floor Price. As related to the Series H Preferred Stock, such dividends are payable in shares of common stock. The conversion price is sof each of the Series G Preferred Stock and Series H Preferred Stock is subject to reduction if in the future we issue securities for less than the conversion price of our Series G Preferred Stock, p and the Series H Preferred Stock, as applicable, provided, however, that the conversion price shall in no event be less than the applicable Floor Price. As such, it is possible that we will not have sufficient available shares to pay the dividends in common stock, which , in the case of the Series G Preferred Stock, would require the payment of the dividend in cash. We wAs related to the Series G Preferred Stock, we will not be permitted to pay the dividend in cash unless we are legally permitted to do so under Delaware law, which requires cash to be available from surplus or net profits neither of which we currently have available. AS related to the Series H Preferred Stock, if we are unable to pay the dividend in shares of our common stock shall accrue and entail a late fee, which must be paid in cash, at the rate of 15% per annum, or the lesser rate permitted by applicable law and as further set forth in the Series H Certificate of Designations, which could materially affect our financial condition and operations.

Risk Related to the August 2025 Reverse Stock Split

The August 2025 Reverse Stock Split may not increase the price of our common stock over the long-term and our common stock may be delisted.

The principal purpose of the August 2025 Reverse Stock Split was to increase the trading price of our common stock to maintain the minimum stock price standards of Nasdaq. However, the effect of a reverse stock split on the market price of our common stock cannot be predicted with any certainty, and we cannot assure you that a reverse stock split will accomplish this objective for any meaningful period of time, or at all. While we expect that the reduction in the number of outstanding shares of common stock will proportionally increase the market price of our common stock, we cannot assure you that a reverse stock split will increase the market price of our common stock by a multiple of any reverse stock split ratio, or result in any permanent or sustained increase in the market price of our common stock sufficient to maintain compliance with the continued listing requirements of the Nasdaq Capital Market. The market price of our common stock may be affected by other factors which may be unrelated to the number of shares outstanding, including our business and financial performance, general market conditions, and prospects for future success.

There can be no assurance that we will ultimately maintain compliance with all applicable requirements for continued listing on Nasdaq and maintain the listing of our common stock.

If we are delisted from Nasdaq, among other things, it will increase the difficulty in our ability to raise money through the sale of our securities. A delisting of our common stock from Nasdaq could materially reduce the liquidity of our common stock and result in a corresponding material reduction in the price of our common stock. In addition, delisting could harm our ability to raise capital through alternative financing sources on terms acceptable to us, or at all, and may result in the potential loss of confidence by investors, suppliers, customers and employees and fewer business development opportunities.

The August 2025 Reverse Stock Split may decrease the liquidity of our common stock.

The August 2025 Reverse Stock Split reduced the total number of outstanding shares of common stock, which may lead to reduced trading and a smaller number of market makers for our common stock, particularly if the price per share of our common stock does not increase as a result of a reverse stock split.

The August 2025 Reverse Stock Split may result in some stockholders owning odd lots that may be more difficult to sell or require greater transaction costs per share to sell.

The August 2025 Reverse Stock Split had the effect of increasing the number of stockholders who own odd lots of less than 100 shares of common stock. A purchase or sale of less than 100 shares of common stock (an odd lot transaction) may result in incrementally higher trading costs through certain brokers, particularly full service brokers. Therefore, those stockholders who own fewer than 100 shares of common stock following a reverse stock split may be required to pay higher transaction costs if they sell their common stock.

The August 2025 Reverse Stock Split may lead to a decrease in our overall market capitalization.

A reverse stock split, including the August 2025 Reverse Stock Split, may be viewed negatively by the market and, consequently, could lead to a decrease in our overall market capitalization. If the per share market price of our common stock does not increase in proportion to the reverse stock split ratio, or following such increase does not maintain or exceed such price, then our value, as measured by our market capitalization, will be reduced. Additionally, any reduction in our market capitalization may be magnified as a result of the smaller number of total shares of common stock outstanding following a reverse stock split.