There have been no approved exosome-based therapeutics to date. Our current pipeline of engEx product candidates and discovery programs is shown below. In September 2020, we initiated our Phase 1 clinical trial of exoIL-12. As part of the agreement, Jazz paid us an upfront payment of $56.0 million. Results also confirmed the desired prolonged retention of IL-12 at the injection site. 8226; High degree of scalability. We believe there are approximately 90,000 patients annually in the US with these cancers. Primary tumor growth (left panel) of the subcutaneous tumor was measured. See panel A in the figure below. During Cycle 2, exoSTING will be dosed on Days 1 and 15. Emerging data with a FSA in combination with CPI has shown activity in ATC. Levels of rIL-12 or IFNY were evaluated and plotted (n=3). The IP-10 production is durable through Day 8 -15. EM pictures illustrate the difference between engEx-AAV and free AAV. exoASO-NLPR3 is a discovery stage product candidate. Either party may also terminate the agreement upon 30 days' prior written notice. We hope to integrate the HIV antigens identified by Drs. The engEx product candidate patent applications described below are owned by us. We have one issued US patent in this area, which will expire in 2038. & &# These include marketed products and those that are currently in clinical development. FDA approval of a BLA must be obtained before a biologic may be marketed in the US. Orphan drug designation for a biologic must be requested before submitting a BLA. Private payors tend to follow CMS to a substantial degree. Remuneration" has been interpreted broadly to include anything of value. Infringement of these laws could result in substantial fines and imprisonment. Payments made to physicians in certain EU member states must be publicly disclosed. Among our employees, 50% identify as female and 50% as male. Investing in our common stock involves a high degree of risk. As of December 31, 2020, we had $88.9 million of cash and cash equivalents. We may not be successful in such a transition. & Further, new studies may change the estimated incidence or prevalence of these diseases. We rely on third-party manufacturers to produce and process our product candidates. In the future regulatory agencies may require the development and approval of such tests. This final rule codified CMS's policy change that was effective January 1, 2019. In-licenses from third parties for patent rights may also be co-exclusive. Trade secrets and know-how can be difficult to protect. In addition, there is a natural transition period when a new CRO begins work. We have not paid any dividends since our incorporation. We also expect our non-US activities to increase in time. We also cannot predict the prices at which our shares of common stock will trade.
