In an autologous transplant, the patient's own stem cells are used. Arrows indicate timing and dose of the in vivo selection agent, O6BG/BCNU. Initial data from the study are expected in mid-2021. 8226; C300: targets only immune cells. 8226; G100: targets alloreactive T cells implicated in GvHD. This was comparable to historical data with multiple doses of busulfan conditioning. However, GvHD can occur even with proper matching. Bars represent median and each symbol represents an individual mouse (n=eight). Statistics were determined by a one-tailed Student's t-test. The Novartis Agreement led to the establishment of MGTA-456 as one of our programs. We refer to this agreement, as amended, as the Heidelberg Agreement. We may obtain such exclusive target-specific rights to up to four targets. 50 Table of Contents The FDA and the sponsor must reach an agreement on the PSP. The FDA will not approve the NDA or BLA without an approved REMS, if required. It is unclear what impact these rulings will have on our business. A separate application will, however, still be required. This final rule codified CMS's policy change that was effective January 1, 2019. It is unknown how long these pauses or disruptions could continue. As of December 31, 2020, we had an accumulated deficit of $254.4 million. We were founded and commenced operations in June 2015. We may not generate revenues from product sales for the next several years, if ever. In addition, ADCs may have other adverse side effects including fatalities. Heidelberg Pharma has filed an IND with the FDA that has been accepted. Designation as a breakthrough therapy is within the discretion of the FDA. For additional information regarding our competition, see "Item 1. As a result, we could lose our trade secrets. As a result, our revenue from applicable products could be reduced. Litigation may be necessary to defend against these claims. We cannot predict the success of any collaboration that we enter into. We face significant competition in seeking appropriate collaborators. Collaborations are complex and time-consuming to negotiate and document.