Captor Therapeutics, a biopharmaceutical company, specialized in the development of drugs based on Targeted Protein Degradation (TPD), published its financial report for the first half of 2023.

• In view of the rapid progress of its research work, Captor Therapeutics presented in May this year its development strategy for 2023-25, aimed - in step one - at initiating clinical trials for the most advanced research projects: CT-01 (including hepatocellular carcinoma) and CT-03 (including hematological malignancies) in 2023 and 2024, respectively. The company expects the clinical trial license application for CT-01 to be submitted this year.

 

• The company has received shareholders’ approval for a share issue, which will take place at the most favorable time for the company. Captor Therapeutics is currently working with Wedbush investment bank to choose the optimal timing for the transaction.

 

• At the end of June 2023, the company had cash resources in the amount of PLN 58.7 million. Despite increased development expenditure, Captor Therapeutics' financial situation is stable. The company allocated PLN 35.3 million for R&D activities, including advance payments for studies that are in progress and are required to apply for consent to conduct clinical trials.

 

• In July 2023, the company signed an agreement with the Medical Research Agency (ABM) for a PLN 52.2 million grant for a project related to developing a selective and effective degrader of a new molecular target as a new form of immunotherapy for colorectal cancer (CRC). The company has already received a prepayment from ABM in the amount of PLN 7.8 million, strengthening its cash position.

- The CT-01 research project is progressing towards the clinic, and we are finalizing the next key steps: the selection of a Clinical Research Organization partner (CRO) And the submission of our clinical trial application. The moment when Captor becomes a clinical stage biotechnology company  opens up completely new opportunities for us in the capital market. Thereby, we are proving our ability to achieve milestones and to implement objectives outlined in our 2023-25 strategy - commented Dr. Tom Shepherd, CEO of Captor Therapeutics.

- A very important point in the strategy is to raise capital for further development. We have already obtained shareholders’ approval for a share issue. In the medium term, our priority remains to attract an investor from the United States. However, observing the macroeconomic situation in the US we remain flexible and do not exclude investors from other parts of the world, including Poland, in order to secure a stable functioning of the company in the horizon of at least next 24 months. We are currently working with Wedbush investment bank to select the optimal timing of the transaction. As we know, the market environment is currently challenging – added Dr. Shepherd.

CT-O1: Milestones implementation and clinical phase commencement

During the reviewed period, a preliminary toxicological evaluation was conducted. Based on the results, a 4-week toxicological study (with a 2-week recovery phase) was designed in GLP standard (Good Laboratory Practice) on two selected animal species. The animal phase of this study has now been completed and toxicokinetic and histopathological analysis are underway. The GLP standard toxicology study package is a key part of the documentation required for clinical trial approval.

In addition, a large-scale synthesis of the clinical candidate CPT-6281 has been optimized to achieve high purity and performance, and the compound has been produced in the amount needed for toxicology studies. A GMP campaign (Good Manufacturing Practice) has also been initiated to produce the active ingredient (compound CPT-6281) in accordance with quality requirements for use in the clinical trial, which is being carried out on schedule. The company has also entered into an agreement with Contract Development and Manufacturing Organization (CDMO), which has been entrusted with the work and development of the drug formulation and production of the first batch of the drug to be administered to patients during the clinical trial.

- Current work is focused on preparation of the reports and documentation necessary for application for a clinical trial permit, manufacture of an active substance in GMP standard, development of the final form of the drug and research methods, which will be used to analyze patient samples (pharmacokinetic and pharmacodynamic studies) - stressed Dr. Michał Walczak, CSO and Member of the Management Board at Captor Therapeutics.

Cooperation with Ono Pharmaceutical on schedule

The research and development work carried out in cooperation with Ono Pharmaceutical is proceeding according to schedule. Meetings were held in January and April 2023 to review its results to date and plan research for the coming months. In July 2023, top representatives of Ono Pharmaceutical visited Captor to discuss current cooperation and learn about the company's full operational potential. Both parties are satisfied with the progress of the project. Captor Therapeutics is being reimbursed for the R&D tasks performed.

Cash position further strengthened by the prepayment from ABM

In July 2023, the company signed an agreement with the Medical Research Agency (ABM) for a funding of PLN 52.2 million for a project titled "Development and clinical development of a first-in-class small-molecule drug candidate for the treatment of colorectal cancer, based on stimulation of immune cells to enhanced anti-cancer activity through induced protein degradation." The total cost of the project is PLN 74.3 million.

The main objective of the project is to develop a selective and effective degrader of a novel molecular target as a new form of immunotherapy for colorectal cancer (CRC). Analysis of clinical CRC samples has shown that increased expression of an unnamed molecular target in tumor-infiltrating T cells is associated with their impaired proliferation and activity. Studies in preclinical models confirmed that genetic inactivation of the molecular target in T cells resulted in enhanced anti-tumor activity and tumor growth inhibition.

- At the end of June 2023, the company had cash resources of PLN 58.7 million. In August, we had already received the first prepayment from ABM in the amount of more than PLN 7.8 million for this project, which further strengthened the company's cash position. Despite increased expenditures on development, including advance payments for research in progress, especially visible in the second quarter and mainly related to the  expenses for toxicological studies in the CT-01 and CT-03 research projects, the company's financial situation is stable. In the period from January to June this year, we spent 35.3 million PLN on R&D activities - concluded Radosław Krawczyk, CFO and Member of the Management Board at Captor Therapeutics.