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We are a pre-clinical biopharmaceutical company focused on harnessing our licensed proprietary technologies to create novel cell-based immunotherapies for the treatment of human cancers. The development of our novel technologies has been inspired by the clinical success of existing CAR-T in treating hematological malignancies as well as the current clinical limitations and commercial challenges in extrapolating the CAR-T principle into treatment of solid tumors. We believe that the current development of CD19-targeting CAR-T cells in treating B-cell malignancies signifies that cellular immunotherapy is becoming one of the pillars in cancer care. However, we believe that it remains challenging to apply the current CAR-T principle into treatments of other type of cancers, in particular solid tumors, due to a variety of reasons, including (i) the reliance on the limited cell quality and quantity of patients, (ii) the lack of suitable surface cancer antigens and their recognition system, and (iii) the ability of cancer to escape because of a single antigen-targeting strategy. To this end, we have established two novel patient blood cell-independent platform technologies to manufacture “off-the-shelf” cell-based cancer immunotherapies, meaning the manufacturing of the stated cell therapies in quantities, which utilizes either donor blood cells or iPSCs as starting materials, but not the limited patient’s own blood cells and no matching is required between such donor and recipient of the product. Our two novel platforms depend on healthy donor blood cells and induced pluripotent stem cells as starting material. Such platform technologies and the resulting product candidates exploit the multiple antigen recognition systems of NK cells and gamma delta T cells in the human body and so as to recognize and treat a broad range of cancers. Built on proprietary platform technologies, we are developing three product candidates: CTM-N2D, iPSC-gdNKT and CTM-GDT. CTM-N2D is our lead product candidate and it consists of expanded gamma delta T cells grafted with NKG2DL-targeting CAR to enhance anti-cancer cytotoxicity. We submitted a CTA application for Phase I clinical trial to HSA, Singapore in December 2021 and, in July 2022, were granted a CTA relating to the use of our CTM-N2D for the ANGELICA Trial to be conducted with the National University Hospital Singapore, subject to conditions specified by the HSA. On January 6, 2023, the HSA acknowledged that we had submitted the relevant documents to meet the approval conditions and no further action was required. On March 10, 2023, we entered into the Clinical Study Agreement pursuant to which the ANGELICA Trial will be conducted by the National University Hospital Singapore to evaluate the safety of CTM-N2D in human subjects. We expect to expand our pipeline further in Phase II trials of CTM-N2D therapy for specific cancer indications. Our second product candidate, iPSC-gdNKT, utilizes iPSC as a starting material to generate gdNKT, which is a synthetic hybrid of a gamma delta T cell and a NK cell. The hybrid cell express receptors of both cells which potentially allow the gdNKT cells to recognize and treat a broad range of cancers. This product is currently undergoing pre-clinical development. Our third product candidate, CTM-GDT, consists of expanded allogeneic gamma delta T cells and exploits the potential of these cells to recognize and treat a broad range of cancers. We are looking to submit a CTX application for Phase I clinical trial to NPRA, Malaysia after 2023. We have also appointed an agent in the United States to prepare a Drug Master File for a potential research collaboration in the United States. As of the date of this Prospectus, we are a holding company incorporated in Singapore which oversees our operations in Malaysia. We conduct our business activities primarily through our direct wholly-owned subsidiary in Malaysia, CytoMed Malaysia, but may be commencing more research and clinical trial activities in Singapore through CytoMed moving forward. Other than CytoMed Malaysia, our other subsidiaries have minimal operations as of the date of this Prospectus. We have an operating cGMP Facility in Johor, Malaysia (which is near Singapore) which has been built in accordance with the international PIC/S GMP standards for the manufacture of cell therapy products and clinical trials. In addition, we have a well-trained operations team who conducts all essential cGMP activities including manufacture, quality control, quality assurance and documentation. We manufacture our product candidates in our cGMP Facility instead of engaging and relying on an external CMO. As of the date of this Prospectus, the registrant is a public company limited by shares known as CytoMed Therapeutics Limited. On January 19, 2023, the registrant converted from a private company limited by shares incorporated in Singapore, known as CytoMed Therapeutics Pte. Ltd. to a public company limited by shares pursuant to the provisions of the Singapore Companies Act. Our principal executive office in Singapore is located at 1 Commonwealth Lane, #08-22, Singapore.
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