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PART I
Forward‑Looking Statements
This Annual Report on Form 10‑K or this Annual Report, may contain “forward‑looking statements” within the meaning of the federal securities laws made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. We have based these forward‑looking statements largely on our current expectations and projections about future events and financial trends affecting the financial condition of our business. Forward‑looking statements should not be read as a guarantee of future performance or results, and will not necessarily be accurate indications of the times at, or by, which such performance or results will be achieved. Forward‑looking statements are based on information available at the time those statements are made and/or management’s good faith belief as of that time with respect to future events, and are subject to risks and uncertainties that could cause actual performance or results to differ materially from those expressed in or suggested by the forward‑looking statements. Our actual results could differ materially from those anticipated in these forward‑looking statements as a result of various factors, including those set forth below under Part I, Item 1A, “Risk Factors” in this Annual Report. These statements, which represent our current expectations or beliefs concerning various future events, may contain words such as “may,” “will,” “expect,” “anticipate,” “intend,” “plan,” “believe,” “estimate” or other words indicating future results. Such statements may include, but are not limited to, statements concerning the following:
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the initiation, cost, timing, progress and results of our research and development activities, preclinical studies and future clinical trials; |
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our ability to obtain and maintain regulatory approval of our future product candidates, and any related restrictions, limitations, and/or warnings in the label of an approved product candidate; |
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our ability to obtain funding for our operations; |
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our plans to research, develop and commercialize our future product candidates; |
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our strategic alliance partners’ election to pursue development and commercialization; |
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our ability to attract collaborators with development, regulatory and commercialization expertise; |
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our ability to obtain and maintain intellectual property protection for our future product candidates; |
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the size and growth potential of the markets for our future product candidates, and our ability to serve those markets; |
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our ability to successfully commercialize our future product candidates; |
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the rate and degree of market acceptance of our future product candidates; |
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our ability to develop sales and marketing capabilities, whether alone or with potential future collaborators; |
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regulatory developments in the United States and foreign countries; |
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the performance of our third‑party suppliers and manufacturers; |
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the success of competing therapies that are or become available; |
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the loss of key scientific or management personnel; |
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our expectations regarding the time during which we will be an emerging growth company under the JOBS Act; |
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our use of the proceeds from our recently completed initial public offering and private placement; and |
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the accuracy of our estimates regarding expenses, future revenues, capital requirements and need for additional financing. |
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Given these uncertainties, you should not place undue reliance on these forward‑looking statements. These forward‑looking statements represent our estimates and assumptions only as of the date of this Annual Report on Form 10‑K and, except as required by law, we undertake no obligation to update or revise publicly any forward‑looking statements, whether as a result of new information, future events or otherwise after the date of this Annual Report on Form 10‑K. We qualify all of our forward‑looking statements by these cautionary statements.
Item 1. Business.
Our Business
We are a clinical‑stage biopharmaceutical company focused on discovering and developing engineered monoclonal antibodies to treat severe and life‑ threatening diseases with unmet medical needs. We use our proprietary XmAb technology platform to create next‑generation antibody product candidates designed to treat autoimmune and allergic diseases, cancer and other conditions. In contrast to conventional approaches to antibody design, which focus on the portion of antibodies that interact with target antigens, we focus on the portion of the antibody that interacts with multiple segments of the immune system. This portion, referred to as the Fc domain, is constant and interchangeable among antibodies. Our engineered Fc domains, the XmAb technology, can be readily substituted for natural Fc domains. We believe our Fc domains enhance antibody performance by, for example, increasing immune inhibitory activity, improving cytotoxicity, extending circulating half‑ life or stabilizing novel antibody structures, while maintaining 99.5% identity in structure and sequence to natural antibodies. By improving over natural antibody function, we believe that our XmAb‑engineered antibodies offer innovative approaches to treating disease and potential clinical advantages over other treatments.
Our business strategy is based on the plug‑and‑play nature of the XmAb technology platform to modify features of natural antibodies and create numerous differentiated antibody product candidates. We have internally generated a pipeline that has allowed us to selectively partner certain development programs while maintaining full ownership of other programs. We also have a number of technology licenses under which we have licensed the XmAb technology platform to pharmaceutical and biotechnology companies for use in a limited number of programs, providing multiple revenue streams that require no further resources from Xencor. There are currently eight antibody product candidates in clinical trials that have been engineered with XmAb technology, including six candidates being advanced by licensees and development partners.
Our internally‑generated pipeline includes the following three lead XmAb‑ engineered antibodies that are currently in development:
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