CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS
This prospectus supplement, the accompanying prospectus and the documents incorporated herein or therein by reference contain forward-looking statements that are based on management’s beliefs and assumptions and on information currently available to management. All statements other than statements of historical facts contained in this report are forward-looking statements. In some cases, you can identify forward-looking statements by the following words: “may,” “will,” “might,” “could,” “would,” “should,” “expect,” “intend,” “plan,” “anticipate,” “believe,” “estimate,” “predict,” “project,” “aim,” “potential,” “continue,” “ongoing,” “goal,” “forecast,” “guidance,” “outlook,” or the negative of these terms or other similar expressions, although not all forward-looking statements contain these words.
These statements involve risks, uncertainties and other factors that may cause actual results, levels of activity, performance or achievements to be materially different from the information expressed or implied by these forward-looking statements. Although we believe that we have a reasonable basis for each forward-looking statement contained in this report, we caution you that these statements are based on a combination of facts and factors currently known by us and our projections of the future, about which we cannot be certain. Forward-looking statements in this prospectus supplement and the documents incorporated herein by reference include, but are not limited to, statements about:
•
the success, cost, enrollment, and timing of our clinical trials;
•
the success, cost, and timing of our product development activities;
•
the ability of us or our third-party contract manufacturers to continue to manufacture tumor infiltrating lymphocytes, or TIL, in accordance with our selected process;
•
our ability to design, construct, and staff our own manufacturing facility on a timely basis and within the estimated expenses;
•
the success of competing therapies that are or may become available;
•
regulatory developments in the United States of America, or U.S., and foreign countries;
•
the timing of and our ability to obtain and maintain U.S. Food and Drug Administration, or the FDA, European Commission, or other regulatory authority approval of, or other action with respect to, our products and/or product candidates;
•
our ability to attract and retain key scientific or management personnel;
•
the timing, execution and expected benefits of our restructuring plan announced in August 2025;
•
the accuracy of our estimates regarding expenses, future revenue, capital requirements, and needs for additional financing;
•
our ability to obtain funding for our operations, including funding necessary to complete further development of our product candidates and commercialization of our products;
•
our ability to successfully commercialize Amtagvi® (lifileucel) and Proleukin® (aldesleukin), and any other products and/or product candidates for which we obtain or have obtained FDA or other regulatory approvals, including by the European Commission in the European Union, or the EU;
•
the ability and willingness of our third-party research institution collaborators to continue research and development activities relating to our product candidates;
•
the potential of our other research and development and strategic collaborations;
•
our expectations regarding our ability to obtain and maintain intellectual property protection for our manufacturing methods and products and/or product candidates;
•
our plans to research, develop, and commercialize our products and/or product candidates;
•
the size and growth potential of the markets for our products and/or product candidates, and our ability to serve those markets;
•
our ability to contract with third-party suppliers and manufacturers and their ability to perform adequately;