We plan to initiate additional studies in combination with leading anti-cancer agents. These trials will be conducted in collaboration with Merck. Existing anti-cancer therapeutics can increase "eat me" signals on cancer cells. Overlapping toxicities of these agents dictate which agents can and cannot be combined. Moreover, many combinations are precluded entirely due to overlapping toxicity. The ORR reported in the lower dose 10 mg/kg QW cohort was 40.9% (9/22). & & Single-agent azacitidine is one of the few FDA-approved agents for patients with MDS. Treatment goals for patients with lower-risk MDS are different. Preliminary data for this cohort was also presented at SITC 2020. Subject response was evaluated based on RECIST version 1.1. As of October 1, 2020, five subjects had been dosed and four were response evaluable. Outcomes The primary objective of the trial was to assess safety. Notes: Data Cutoff October 1, 2020. The first part of the trial will evaluate the safety of the combination treatment. SIRPα TRAAC is complementary to our CD47 blocker approach. However, we believe that we do not infringe claims listed in this U.S. patent. These so-called Phase 4 trials may be made a condition to approval of the BLA. As of December 31, 2020, we had an accumulated deficit of $118.5 million. A failure of one or more clinical trials can occur at any stage of the process. Clinical trials can take many years to complete, and their ultimate outcome is uncertain. The development and commercialization of new product candidates is highly competitive. If they are unable to do so, it could have a material adverse impact on our business. For example, these third parties may be adversely impacted by the COVID-19 pandemic. We may face difficulties from changes to current regulations and future legislation. Other states are beginning to consider and pass similar laws. Litigation may be necessary to defend against these claims. Such license may not be available on commercially reasonable terms or at all. We currently have no products that have been approved for commercial sale. Collaborations are complex and time-consuming to negotiate and document. Therefore, these provisions could adversely affect the price of our common stock.
