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Latest 10-Q filed 11/14/2025 · Compared against 8/14/2025
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ITEM 1A. RISK FACTORS
Except as set forth below, and as disclosed in our Quarterly Report on Form 10-Q for the period ended March 31, 2025, there hand our Quarterly Report on Form 10-Q for the period ended June 30, 2025, there have been no material changes to our risk factors from those disclosed in Part I, Item 1A. Risk Factors of our 2024 Form 10-K:
Risks Related to Our Business and Our Industry
We do not satisfy all listing requirements for the Nasdaq Capital Market. We can provide no assurance that we will be ab.
If we are unable to comply with the continurepay the Secured listing requirements over time and that our common stock will continue to be listed onPromissory Note, the ownership of the Nasdaq Capital Market.
As previously disclosed, on August 5, 2025, we received a notification letter (secured assets held as collateral for the BiSecured Price Letter) from The Nasdaq Stock Market LLC (Nasdaq) indicating that we did not satisfy the requirement for continued listing on The Nasdaq Capital Market under Nasdaq Listing Rule 5550(a) (Rule 5550(a)) omissory Note could be transferred to Oramed.
We entered into maintain a minimum bid price of $1 per share. We beca Secured Promissory Note with Orame deficient with Rule 5550(a) ad, dated as of August November 14, 2025 as our closing bid price was less than $1 per share for 30 consecutive business days. As in the past, the Bid Price Letter i(the Note), pursuant to which Oramed has a notice of deficiency, not delisting, and does not currently affect tgreed to make a loan (the listing or trading of our ordinary shares on The Nasdaq Capital Market. We have 180 calendar days, or Loan) to us in an aggregate amountil February 2, 2026, to regain compliance with Rule 5550(a)(2). If at any time before February 2, 2026, the bid price of of $3.0 million. The Loan is secured by a lien on our ordinary shares closes at $1.00 per share or more for a minimum of 10 consecutive business days, Nasdaq will provide written confirmation that cash and accounts receivable, and if we have regained compliance. Additionally, we may be eligible for a second 180-dare unable repay period to satisfy Rule 5550(a)s minimum bid price requirement, if, as the Loan, the ownership of February 2, 2026, we continue to have a market value of publicly the secured assets held shares of at least $1 million, meet all other initias collateral listing standards of the Nasdaq Capital Market (with the exception of the bid price requirement) and provide written notice of our intention to curecould be transferred to Oramed.
If we default under the deficiency during such second compliance period. We intend to monitor closely the closing bid price oNote, Oramed may accelerate all of our ordinary shares and to consider plans for regaining compliance with Rule 5550(a). While we plan to review all available options, there can be no assurance that we wirepayment obligations and exercise all be able to regain compliance with the applicable rules during the 180-day compliance period, any subsequent extension period, or at all.
If we do not regain compliance with Rule 5550(a) during the of their rights and remedies under the Note and applicable cure period, Nasdaq will notify us that our ordinary shares are subject to delistlaw, potentially requiring. We would then be permitted to appeal any delisting determination to a Nasdaq Hearings Panel, and us to renegotiate our ordinary shares would remain listedagreement on the Nasdaq Capital Market pending the panels decision after the hearing. If we do not appeal the delisting determination or do not succeed in such an appeal, our ordinary shares would be removed from trading on the Nasdaq Capital Market. Any delisting determination cerms less favorable to us. Further, Orameds right to repayment would seriously decrease be senior eliminateto the value of an investment in our ordinary shares and orights of ther securities linked to holders of our ordinary shares. While an alternative listing on an over-the-Oramed counter exchange could maintain some degree of a market in our ordinary shares, we could fald declare a default upon the occurrence substantial material adverse consequencesof customary events of default, including, but not limited to, events that the following: limited availability for marky interpret quotations for our ordinary shares; reduced liquidity with respect to our ordinary shares; aas a material adverse change as determinatiolineated in that our ordinary shares are penny stock under SEC rules, subjecting brokers trading our ordinary share Note, payment defaults or breaches to more stringent rules on disclosure and the class of investors to which the broker may sellof certain affirmative or negative covenants, the ordinary shares; limited news and analyst coverage, in part duereby requiring us to the penny stock rules; decreased ability to issue additional securities or obtain additional financing in the future; and potential breaches under or terminations of our agreements with current or prospective large srepay the loan immediately. Any declaration by Oramed of an event of default could significantly hareholders, strategic investorm our business and banks. The perception among investors that we are at heightened risk of delisting prospects and could also negatively affect tcause the market price of our securities and trading volume of our orordinary shares. In the event of a delisting, to decline. Additionally, if we can provide no assurance that araise any acddition taken by us to restore complial debt finance with listing requirements would allow our common stock to become listed again, stabilize the market price or improve the liquidity of our common stock, prevent our common stock from dropping, the terms of such additional debt could further restrict our operating below the Nasdaq minimum bid price requirement, or prevent future non-compliand finance with Nasdaqs listing requirementsial flexibility.
We may encounter dinot have sufficulties in transitioning the manufacturing of our ReWalk products to our in-house manufacturer.
In the second quarter of 2025, we transient funds or may be unable to arrange for additioned the manufactural financing of our ReWalk products to outo repay our in-house manufacturer in an effort to reduce costs and provide us with more control over product quality. As a result, we termindebtedness under the Loan or to make any accelerated our agreement with Sanmina Corporation, an interr redemption payments, make the $500,000 terminational contract manufacturer that manufactur fee payment and Oramed our ReWalk products at could seek to enforce its facilisecurity in Israel since 2013 and sourced terests in the components and raw mallaterials necessary for manufactual securing.
However, to fully establish our manufacturing operations, we will need such indebtedness or other remedies available to identify, recruit and build experienced teams, and there are can be no assurance that we will be successful in doing soOramed or as provided by applicable law. Additionally, Sanima previously contracted directny failure by us to comply with third-party suppliers to supply certain components of our products. We cannot guaranteee obligations under that we will be able to establish similar agreements to source sufficient quantities or obtain components at commercially e Loan could cause our stock price to decreasonable costs.
If we are unable to manufacture products that consistently meet specificae significantly, result in substantial dilutions, are produced in necessary quantities, comply with regulatory requirements and quality control standards and are delivered at commercially acceptable costs and on a timely basis, it will or cause us to be unable to raise additional capital, which could have a material adversenegative effect on our business, financial condition and results of operations. The process of moving our manufacturing operations in house is time consuming, costly and may disrupt our operations. There can be no assurance that we will fully realize the anticipated benefits from such transition.
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