SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS
This prospectus supplement, the accompanying prospectus and the financial statements and other documents incorporated by reference in this prospectus supplement may contain forward-looking statements that are based on our current expectations, assumptions, estimates and projections about us and our industry. All statements other than statements of historical fact in this prospectus supplement, the accompanying prospectus and the financial statements and other documents that we incorporate by reference in this prospectus supplement are forward-looking statements.
These forward-looking statements are subject to known and unknown risks, uncertainties, assumptions and other factors that could cause our actual results of operations, financial condition, liquidity, performance, prospects, opportunities, achievements or industry results, as well as those of the markets we serve or intend to serve, to differ materially from those expressed in, or suggested by, these forward-looking statements. These forward-looking statements are based on assumptions regarding our present and future business strategies and the environment in which we expect to operate in the future. Important factors that could cause those differences include, but are not limited to:
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our ability to successfully advance our afami-cel (SPEARHEAD-1) and ADP-A2M4CD8 (MAGE- A4CD8) product candidates through clinical development and the timing within which we can recruit patients, launch trials and treat patients in all of our clinical trials;
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our ability to fund our operations;
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our ability to successfully and reproducibly manufacture cell therapies in order to meet patient demand;
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our ability to implement our strategy and continue with business operations as a result of the outbreak of coronavirus SARS-CoV-2 and the associated disease, or COVID-19;
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our ability to further develop our commercial manufacturing process for our cell therapies, transfer such commercial process to third party contract manufacturers, if required, and for such third party contract manufacturers or ourselves to manufacture cell therapies to the quality and on the timescales we require;
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our ability to successfully advance our cell therapies technology platform to improve the safety and effectiveness of our existing cell therapies product candidates, to identify and develop new cell therapies and to submit Investigational New Drug Applications, or INDs, for new cell therapies;
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the rate and degree of market acceptance of cell therapy generally and of our particular cell therapies;
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government regulation and approval;
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our ability to successfully commercialize any products and our ability to increase manufacturing capacity, set up processes and recruit employees required for such commercialization;
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the existence of any third party patents preventing further development of any of our cell therapies, including, any inability to obtain appropriate third party licenses, or enforcement of patents against us or our collaborators;
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our ability to obtain granted patents covering our cell therapies and to enforce such patents against third parties;
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volatility in equity markets in general and in the biopharmaceutical sector in particular;
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fluctuations in the price of materials and bought-in components;
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the scope and timing of performance of our ongoing collaborations with GSK, Genentech and with Universal Cells, a wholly-owned subsidiary of Astellas;
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our relationships with suppliers, contract manufacturing organizations or contract research organizations and other third-party providers;
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increased competition from other companies in the biotechnology and pharmaceutical industries including where such competition impacts our ability to recruit patients into clinical trials;
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claims for personal injury or death arising from the use of our cell therapies;
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our ability to attract and retain qualified personnel; and
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additional factors that are not known to us at this time.