RE: Another week of no news and even sellers at 1.2315 Dec 2022 13:10
The Company intends to use approximately £6 million of the received funds to achieve clinical proof of concept for HEMO-CAR-T for the treatment of acute myeloid leukemia (AML), including:
o approximately £0.5 million on completing IND-enabling preclinical studies that are needed in order to file an IND application requesting authorization from the FDA or other applicable regulatory body to initiate clinical trials and administer HEMO-CAR-T to humans. The Company anticipates completing these studies by September 2021;
o approximately £0.5 million on filing an IND; and
o approximately £5 million on completing Phase I/IIa clinical studies aimed at achieving clinical proof of concept and advancing HEMO-CAR-T towards later stages of clinical trials including Phase II and Phase III. The Company intends to initiate PhaseI/IIa clinical studies by the end of 2021/beginning of 2022.
The Company intends to use the remainder of the received funds from the Financing Facility for the development of its other product candidates. For example, the Company may use these funds to complete IND-enabling pre-clinical studies for its CDX antibody, if necessary, in the event that GlobalCo declines to exercise its option to license the intellectual property necessary to exploit the CDX antibody, as discussed above. If, in the alternative, these funds are not needed for CDX antibody development, the Company will deploy such funds for the development of its other product candidates, including the further development of its CBR Platform, as well as for general working capital purposes.