Item 1A. RISK FACTORS There have been no material changes to the risk factors disclosed in Item 1A, entitled Risk Factors, in the Company's Annual Report on Form 10-K for the year ended December 31, 2024 filed with the SEC on March 7, 2025, other than as set forth below. Adding the following new risk factors: Share Repurchases Could Increase the Volatility of the Trading Price of Our Common Stock and Diminish Our Cash Reserves, and We Cannot Guarantee That Our Stock Repurchase Program Will Enhance Long-Term Stockholder Value. On March 21, 2025, our Board authorized the repurchase of up to $40.0 million factor: Changes in shares of our common stock pursuant to a stock repurchase program (the Repurchase Program). The Repurchase Program does not obligate us to repurchase any 28 Table of Contents minimum dollar amount tax laws or number of shares, and can be modified, terminated in their implementation or suspended at any time. Repurchases of shares of our common stock could interpretation may adversely affect the trading price of our common stock and increase volatility of such securities. Similarly, the future announcement of the modification, suspension us or termination of the Repurchase Program, or our decision not to utilize investors. The rules dealing with the full authorized repurchase amount U.S. federal, state and local income taxation are constantly under the Repurchase Program, could result review by persons involved in a decrease in the trading price of our common stock. In addition, legislative process and by the Repurchase Program could have the impact of reducing our cash reserves, which may impact our ability to finance our growth, fund working capital, strategic acquisitions Internal Revenue Service, or business opportunities, IRS, and other general corporate purposes and execute our strategic plan. Although the Repurchase Program is intended U.S. Treasury Department. Changes to enhance long-term stockholder value, there can be no assurance that it will do so because the trading price of our common stock tax laws (which changes may decline below the levels at which we repurchased our shares and short-term stock price fluctuations could reduce the effectiveness of the Repurchase Program. Disruptions at the FDA and Other Government Agencies Caused By Reduction in Staffing or Funding Shortages Could Hinder Their Ability have retroactive application), including with respect to Hire net operating losses and Retain Key Leadership research and Other Personnel, Prevent New Products and Services From Being Developed development tax credits, could adversely affect us or Commercialized holders of our common stock. In A Timely Manner, or Otherwise Prevent Those Agencies From Performing Normal Business Functions, Which Could Negatively Impact Our Business recent years, many changes have been made and Our Timelines. Currently, federal agencies changes are likely to continue to occur in the United States are operating under a continuing resolution future. For example, recent legislation that is set to expire was signed into law on September 30, 2025. Without appropriation of additional funding July 4, 2025 made significant changes to federal agencies, our business operations related to our product development for the U.S. market could federal tax law. It cannot be impacted. Inadequate funding for the FDA, the SEC and other government agencies, including from government shut downs, or other disruptions to these agencies operations, could hinder their ability to hire and retain key leadership and other personnel, prevent new products and services from being developed or commercialized predicted whether, when, in a timely manner what form, or otherwise prevent those agencies from performing normal business functions on which the operation of our business may rely, which could negatively impact our business. The Trump administration has issued executive orders seeking to greatly reduce the size of the federal workforce, including through layoffs and severance packages offered to employees of federal agencies within the executive branch and independent agencies, including the FDA. Any such reduction in personnel may result in longer review times by the FDA, the SEC and other agencies. The ability of the FDA to review and approve with what effective dates, new products can be affected by a variety of factors, including government budget and funding levels, ability to hire and retain key personnel and accept the payment of user fees, shifting policy priorities as a result of changes in the Presidential administration and political appointees tasked to oversee the agency, and statutory, regulatory, and policy changes. Average review times at the agency have fluctuated in recent years as a result. In addition, government funding of other government agencies on which our operations tax laws may rely is subject to the impacts of political events, which are inherently fluid and unpredictable. Disruptions and personnel turnover, as a result of leadership changes, staff reductions be enacted, or otherwise, at the FDA regulations and other agencies rulings may slow the time necessary for new drugs to be reviewed and/or approved by necessary government agencies, which could adversely affect our business. For example, over the last several years, the U.S. government has shut down several times and certain regulatory agencies, such as the FDA and the SEC, have had to furlough critical FDA, SEC and other government employees and stop critical activities. If a prolonged government shutdown occurs, enacted, promulgated or if staffing changes prevent the FDA, the SEC issued under existing or other regulatory authorities from conducting their regular inspections, reviews, or other regulatory activities, including formal and informal interactions with product developers, it could significantly impact the ability of the FDA, the SEC or other regulatory authority to timely review and process our regulatory submissions, which could have a material adverse effect on our business and our timelines. Supplementing the following risk factor: Increasing Geopolitical and Economic Risk and Tariffs Could Negatively Affect Our Ability to Maintain Sales at Existing Levels. The imposition of tariffs, non-tariff barriers, and other import and export restrictions have contributed to increased global economic uncertainty. For example, on April 2, 2025, the United States imposed substantial tariffs on most countries throughout the world. The new U.S. administration has indicated that it is considering broadly imposing tariffs, tax laws, which could lead to corresponding punitive actions by countries with which the United States trades. These actions could make it more difficult for us to attract new customers, retain existing customers, continue to produce and source result in an optimal manner, maintain increase in our supply chain, or maintain sales at existing levels, both in the United States and in other countries. Geopolitical and economic risks, together with trade protectionism have increased over the past few years in many regions of the world, including in the United States. Any of these risks, ensuing retaliation, or the further deterioration of trade 29 Table of Contents relations between countries could make our offerings more expensive stockholders tax liability or non-competitive require changes in the affected countries. Growing tensions, protectionist trade policies, and tariffs may also lead to a fragmentation of the global economy, a general reduction of international trade manner in goods and services, and a reduction which we operate in the integration of financial markets, order to minimize or mitigate any adverse effects of which could materially and adversely affect our business results, cash flows, financial condition, changes in tax law or prospects. in the interpretation thereof. 32