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.
−Removed: Adding the following new risk factors:
−Removed: 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.
−Removed: On March 21, 2025, our Board authorized the repurchase of up to $40.0 million in shares of our common stock pursuant to a stock repurchase program (the “Repurchase Program”).
−Removed: The Repurchase Program does not obligate us to repurchase any
−Removed: minimum dollar amount or number of shares, and can be modified, terminated or suspended at any time.
−Removed: Repurchases of shares of our common stock could affect the trading price of our common stock and increase volatility of such securities.
−Removed: Similarly, the future announcement of the modification, suspension or termination of the Repurchase Program, or our decision not to utilize the full authorized repurchase amount under the Repurchase Program, could result in a decrease in the trading price of our common stock.
−Removed: In addition, 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 or business opportunities, and other general corporate purposes and execute our strategic plan.
−Removed: Although the Repurchase Program is intended to enhance long-term stockholder value, there can be no assurance that it will do so because the trading price of our common stock 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.
−Removed: Disruptions at the FDA and Other Government Agencies Caused By Reduction in Staffing or Funding Shortages Could Hinder Their Ability to Hire and Retain Key Leadership and Other Personnel, Prevent New Products and Services From Being Developed or Commercialized In A Timely Manner, or Otherwise Prevent Those Agencies From Performing Normal Business Functions, Which Could Negatively Impact Our Business and Our Timelines.
−Removed: Currently, federal agencies in the United States are operating under a continuing resolution that is set to expire on September 30, 2025.
−Removed: Without appropriation of additional funding to federal agencies, our business operations related to our product development for the U.S.
−Removed: market could be impacted.
−Removed: 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 in a timely manner 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.
−Removed: 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.
−Removed: Any such reduction in personnel may result in longer review times by the FDA, the SEC and other agencies.
−Removed: The ability of the FDA to review and approve 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.
−Removed: Average review times at the agency have fluctuated in recent years as a result.
−Removed: In addition, government funding of other government agencies on which our operations may rely is subject to the impacts of political events, which are inherently fluid and unpredictable.
−Removed: Disruptions and personnel turnover, as a result of leadership changes, staff reductions or otherwise, at the FDA and other agencies may slow the time necessary for new drugs to be reviewed and/or approved by necessary government agencies, which could adversely affect our business.
−Removed: For example, over the last several years, the U.S.
−Removed: 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.
−Removed: If a prolonged government shutdown occurs, or if staffing changes prevent the FDA, the SEC 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.
−Removed: Supplementing the following risk factor:
−Removed: Increasing Geopolitical and Economic Risk and Tariffs Could Negatively Affect Our Ability to Maintain Sales at Existing Levels.
−Removed: The imposition of tariffs, non-tariff barriers, and other import and export restrictions have contributed to increased global economic uncertainty.
−Removed: For example, on April 2, 2025, the United States imposed substantial tariffs on most countries throughout the world.
−Removed: administration has indicated that it is considering broadly imposing tariffs, which could lead to corresponding punitive actions by countries with which the United States trades.
−Removed: These actions could make it more difficult for us to attract new customers, retain existing customers, continue to produce and source in an optimal manner, maintain our supply chain, or maintain sales at existing levels, both in the United States and in other countries.
−Removed: 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.
−Removed: Any of these risks, ensuing retaliation, or the further deterioration of trade
−Removed: relations between countries could make our offerings more expensive or non-competitive in the affected countries.
−Removed: Growing tensions, protectionist trade policies, and tariffs may also lead to a fragmentation of the global economy, a general reduction of international trade in goods and services, and a reduction in the integration of financial markets, any of which could materially and adversely affect our business results, cash flows, financial condition, or prospects.
+Added: Adding the following new risk factor:
+Added: Changes in tax laws or in their implementation or interpretation may adversely affect us or our investors.
+Added: The rules dealing with the U.S.
+Added: federal, state and local income taxation are constantly under review by persons involved in the legislative process and by the Internal Revenue Service, or IRS, and the U.S.
+Added: Treasury Department.
+Added: Changes to tax laws (which changes may have retroactive application), including with respect to net operating losses and research and development tax credits, could adversely affect us or holders of our common stock.
+Added: In recent years, many changes have been made and changes are likely to continue to occur in the future.
+Added: For example, recent legislation that was signed into law on July 4, 2025 made significant changes to U.S.
+Added: federal tax law.
+Added: It cannot be predicted whether, when, in what form, or with what effective dates, new tax laws may be enacted, or regulations and rulings may be enacted, promulgated or issued under existing or new tax laws, which could result in an increase in our or our stockholders’ tax liability or require changes in the manner in which we operate in order to minimize or mitigate any adverse effects of changes in tax law or in the interpretation thereof.
Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.