Risk Factors.
−Removed: Our business is subject to risks and events that, if they occur, could adversely affect our financial condition and results of operations and the trading price of our securities.
−Removed: Our risk factors have not changed materially from those described in “Risk Factors” in Exhibit 99.1 of the Form 10.
−Removed: For a further discussion of risks that could materially affect our business, financial condition or results of operations, we refer you to our Registration Statement on Form S-1 (File No.
−Removed: 333-280127), which was filed with the SEC on June 11, 2024 and declared effective on June 18, 2024, or the S-1.
−Removed: In addition to the information set forth in this Quarterly Report, you should carefully consider the risk factors described in “Risk Factors” of the S-1.
−Removed: The risks disclosed in the S-1 and information provided elsewhere in this Quarterly Report could materially affect our business, financial condition or results of operations.
−Removed: Additional risks and uncertainties not currently known or we currently deem to be immaterial may materially adversely affect our business, financial condition or results of operations.
−Removed: Except for such additional information and the risk factors set forth below, we believe there have been no other material changes in our risk factors from those disclosed in the S-1.
+Added: Except for the risk factor set forth below, there have been no material changes to the risk factors set forth in Part I, Item 1A of our 2024 Annual Report.
+Added: Unfavorable global economic conditions and an uncertain geopolitical environment could have an adverse effect on our business, financial condition, results of operations and prospects.
+Added: Our and our third-party partners’ and service providers’ ability to continue operations and advance our therapeutic candidates could be adversely affected by general conditions in the global economy or disruption of global financial markets, including the impacts of uncertain trade policy and inflation.
+Added: The current federal government administration has increased, and may continue to increase, the use of tariffs by the United States to accomplish certain policy goals.
+Added: For example, on April 2, 2025, the United States imposed substantial tariffs on most countries throughout the world.
+Added: Such tariffs and any countermeasures by the United States’ trading partners could increase the cost of raw materials for the manufacture of drug product and may impact our ability to import drug product and cause uncertainty in our ability to supply drug product for our clinical trials.
+Added: Such conditions may increase the costs for us to run our business, disrupt global supply chains, create additional operational challenges and cause widespread uncertainty in the financial markets.
+Added: Further, it is possible the administration may implement trade policy directly impacting the biopharmaceutical industry, which, along with related uncertainty about such policy changes, could reduce our ability to access capital and could increase volatility in the market valuation of companies in the healthcare industry.
+Added: Because of such uncertainty, we cannot predict the impact of any future changes to international trading relationships or the ultimate impact recently adopted tariff policies will have on our business.
+Added: Such changes in tariffs and trade regulations could have a material adverse effect on our business, financial condition, results of operations and prospects.
Unregistered Sales of Equity Securities and Use of Proceeds.
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