ATOS — what changed in the latest 10-Q

Text added vs the prior filing · source: 10-Q · 2026-05-08

• our ability to shorten our clinical development timelines and reduce future clinical development costs through an accelerated path to filing a New Drug Application, which is dependent on the timing and outcomes of submissions to and other interactions with the U.S. Food and Drug Administration (FDA)…

• the impact of general macroeconomic conditions, including the impact of inflation, high interest rates, general economic slowdown or a recession, the availability of credit, foreign exchange rate volatility, financial institution instability, changes in monetary policy, changes in trade policies, in…

• our ability to pursue a Duchenne muscular dystrophy (DMD) indication, McCune-Albright Syndrome (MAS) indication, or other indications for our lead program, (Z)-endoxifen;

• our eligibility for, and any expected benefits of, any FDA programs or special designations, such as the Rare Pediatric Disease Priority Review Voucher (PRV) program and the orphan drug exclusivity designation;

• our ability to receive orphan-drug exclusivity for (Z)-endoxifen for DMD;

Text removed vs the prior filing · source: 10-Q · 2025-11-12

• our ability to successfully execute our strategy to pursue a metastatic breast cancer indication for our lead program, (Z)-endoxifen, and to develop in parallel low dose (Z)-endoxifen for breast cancer reduction;

• our ability to shorten our clinical development timelines and reduce future clinical development costs through an accelerated path to filing a New Drug Application (NDA), which is dependent on the timing and outcomes of submissions to and other interactions with the U.S. Food and Drug Administration…

• the impact of general macroeconomic conditions, including the impact of inflation, high interest rates, general economic slowdown or a recession, foreign exchange rate volatility, changes in monetary policy, changes in trade policies, including tariffs or other trade restrictions or the threat of su…

• our ability to regain and maintain compliance with the continued listing requirements of the Nasdaq Capital Market (Nasdaq);

• This Quarterly Report also contains estimates and other statistical data provided by third parties and by us relating to market size and growth, and other industry data. These and other forward-looking statements made in this Quarterly Report, unless otherwise indicated, are presented as of the date…

Text added vs the prior filing · source: 10-Q · 2026-05-08

• Rare pediatric disease designation for any of our product candidates does not guarantee that the NDA for the product will qualify for a priority review voucher upon approval, and it does not lead to a faster development or regulatory review process, or increase the likelihood that our product candid…

• We may not enjoy the market exclusivity benefits of our orphan drug designations.

• In evaluating our business, you should carefully consider the following discussion of material risks, events and uncertainties that make an investment in us speculative or risky in addition to the other information included in this Quarterly

• Report. A manifestation of any of the following risks and uncertainties could, in circumstances we may or may not be able to accurately predict, materially and adversely affect our business and operations, growth, reputation, prospects, operating and financial results, financial condition, cash flow…

• If we do not raise additional capital, we anticipate liquidity issues within the next twelve months and we may not continue as a going concern.

Text removed vs the prior filing · source: 10-Q · 2025-11-12

• In evaluating our business, you should carefully consider the following discussion of material risks, events and uncertainties that make an investment in us speculative or risky in addition to the other information included in this Quarterly Report. A manifestation of any of the following risks and …

• Although we believe we have sufficient capital resources to fund our operations for at least the next 12 months based on our current business plan, our business plan may change and may require greater expenditures of capital than currently anticipated, in particular, due to expenditures relating to …

• For example, the United States has announced tariffs on imports from most countries, including significant tariffs on imports from Canada, Mexico and China, leading to increasing trade and political tensions. In response to tariffs, other countries have implemented retaliatory tariffs on U.S. goods.…

• companies, licensing, development and commercialization efforts, and our ability to continue our operations, generate revenues, and achieve or sustain profitability may be substantially harmed.

• For example, our ability to raise capital in the public capital markets, including through “at the market” offerings pursuant to our Open Market Sale AgreementSM (the Sale Agreement) with Jefferies LLC (Jefferies), may be limited by, among other things, SEC rules and regulations impacting the eligib…