CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS AND SUMMARY RISK FACTORS
This Annual Report on Form 10-K (the “Annual Report”), contains “forward-looking statements,” which includes information relating to future events, future financial performance, financial projections, strategies, expectations, competitive environment and regulation. Words such as “may,” “should,” “could,” “would,” “predicts,” “potential,” “continue,” “expects,” “anticipates,” “future,” “intends,” “plans,” “believes,” “estimates,” and similar expressions, as well as statements in future tense, identify forward-looking statements. Forward-looking statements should not be read as a guarantee of future performance or results and may not be accurate indications of when such performance or results will be achieved. Forward-looking statements are based on information we have when those statements are made or management’s good faith belief as of that time with respect to future events, and are subject to significant risks and uncertainties that could cause actual performance or results to differ materially from those expressed in or suggested by the forward-looking statements. Important factors that could cause such differences include, but are not limited to:
| ● | our current and future capital requirements and our ability to satisfy our capital needs through financing transactions or otherwise; |
| ● | our ability to meet the requirements of our existing debt facility; |
| ● | our product launches and market penetration plans; |
| ● | the execution of agreements with various providers for our solution; |
| ● | our ability to maintain our relationships with key partners; |
| ● | our ability to maintain or protect the validity of our U.S. and other patents and other intellectual property; |
| ● | our ability to retain key executive members; |
| ● | our ability to internally develop new inventions and intellectual property; |
| ● | general market, political and economic conditions in the countries in which we operate, including those related to recent unrest and actual or potential armed conflict in Israel and other parts of the Middle East; |
| ● | our ability to effectuate a strategic transaction; |
| ● | interpretations of current laws and the passages of future laws; and |
| ● | acceptance of our business model by investors. |
The foregoing does not represent an exhaustive list of matters that may be covered by the forward-looking statements contained herein or risk factors that we are faced with that may cause our actual results to differ from those anticipated in our forward-looking statements. Please see “Risk Factors” for additional risks that could adversely impact our business and financial performance.
Moreover, new risks regularly emerge and it is not possible for our management to predict or articulate all the risks we face, nor can we assess the impact of all risks on our business or the extent to which any risk, or combination of risks, may cause actual results to differ from those contained in any forward-looking statements. All forward-looking statements included in this Annual Report are based on information available to us on the date of this Annual Report. Except to the extent required by applicable laws or rules, we undertake no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise. All subsequent written and oral forward-looking statements attributable to us or persons acting on our behalf are expressly qualified in their entirety by the cautionary statements contained above and throughout this Annual Report.
When used in this Annual Report, the terms “Dario,” “DarioHealth,” “the Company,” “we,” “our,” and “us” refer to DarioHealth Corp., a Delaware corporation and our subsidiary LabStyle Innovation Ltd., an Israeli company,
PsyInnovations Inc., a Delaware corporation, Twill, Inc., a Delaware corporation, and DarioHealth India Services Pvt. Ltd., an Indian company. Dario is registered as a trademark in the United States, China, Canada, Hong Kong, Australia, Brazil, the EU, and is also registered as a WO (WIPO registration). “DarioHealth” is registered as a trademark in the United States, Israel, China, Canada, Australia, India, Japan, the EU, and as a WO.
All information included herein relating to shares or price per share reflects the 20-for-1 reverse stock split effected by us on August 28, 2025.
Summary of Risk Factors
Our business is subject to several risks, including risks that may adversely affect our business, financial condition and results of operations. These risks are discussed more fully below and include, but are not limited to, risks related to:
| ● | our lack of positive cashflow and our future capital needs and their potential impact on our existing stockholders or our ability to operate; |
| ● | our history of losses and stockholder’s inability to rely upon our historical operating performance; |
| ● | our loan facility covenants and other restrictions and their impact on our financial condition; |
Risks Related to Our Business
| ● | the acceptance of our products in the market and our exposure to market trends; |
| ● | our risks of basing our business on the sale of our principal technology; |
| ● | our reliance on manufacturers and distributors; |
| ● | the impact of a failure of our digital marketing efforts; |
| ● | our reliance on the Apple App Store and Google Play Store; |
| ● | our dependence on a Software-as-a-Service (“SaaS”) business model; |
| ● | the risks associated with technological changes and conducting business internationally; |
| ● | potential errors in our business processes and product offerings; |
| ● | our exposure to fluctuations in currency exchange rates; |
| ● | our reliance on the performance of key members of our management team and our need to attract highly skilled personnel; |
| ● | our outcomes-based contracts and reimbursement arrangements may not achieve expected results and may expose us to financial and operational risks; |
| ● | the expense and time required to obtain regulatory clearance of our products; |
| ● | our limited clinical studies and the susceptibility to varying interpretations of such studies; |
| ● | the failure to comply with the U.S. Food and Drug Administration (“FDA”) Quality System Regulation, pre-market notifications, or any applicable state equivalent; |
| ● | the impact of legislation and federal, state and foreign laws on our business, including protecting the confidentiality of patient health information; |
| ● | the potential impact of product liability suits; |
| ● | our artificial intelligenc (“AI”) technologies may produce inaccurate or biased outputs and pose privacy, intellectual property, cybersecurity, regulatory, or reputational risks that could materially impact our business; |
Risks Related to Our Intellectual Property
| ● | the risks relating to obtaining or maintaining our intellectual property; |
| ● | potential litigation relating to the protection of our intellectual property; |
| ● | our limited foreign intellectual property rights; |
| ● | our reliance on confidentiality agreements and the difficulty in enforcing such agreements; |
Risks Related to Our Industry
| ● | the intense competition we face in the markets we operate; |
| ● | our need to respond quickly to technological developments; |
Risks Related to Our Operations in Israel
| ● | the risks relating to the political, economic and military instability that may exist in Israel; |
| ● | our principal executive offices and other significant operations are located in Israel, and, therefore, our results may be adversely affected by political, economic and military instability in Israel; |
| ● | the potential for operations to be disrupted as a result of obligations of Israeli citizens to perform military service; |
| ● | the difficulty in enforcing judgements against us or certain of our executive officers and directors; |
| ● | the potential lack of liquidity, or volatility, of our common stock; |
| ● | the impact of analysts not publishing research or reports about us; |
| ● | the expense relating to our requirements as a U.S. public company; |
| ● | the potential failure to maintain effective internal controls over financial reporting; |
| ● | the existence of anti-takeover provisions in our charter documents and Delaware law; and |
| ● | that we do not intend to pay dividends on our common stock. |
