Strategy

Heidelberg Pharma is working on developing a completely new treatment approach for cancer therapy. This approach is based on the inhibition of RNA polymerase II by the toxin Amanitin and has the potential to address current challenges in cancer therapy such as the development of resistance, the destruction of non-dividing tumor cells and the improvement of efficacy in particularly aggressive tumors. The toxin is specifically introduced into cancer cells via antibodies using so-called ADC technology. For this purpose, the drug is bound to the antibody via a suitable chemical linker. After absorption into the cancer cells, the toxin is released there and destroys the cancer cell.

The Company focuses on the development and marketing of its proprietary ATAC technology (Antibody Targeted Amanitin Conjugates – ATACs). Its core elements are the expansion of the Company's own project pipeline, the initiation of research and option agreements and their extension to include long-term license agreements, as well as the broadening of the technology base.

Based on in-licensed antibodies, own ATAC molecules are produced, tested as R&D candidates and build up a proprietary pipeline. Therefor suitable antibodies have been in-licensed, selected and optimized in comprehensive processes in recent years. The currently most advanced proprietary ATAC candidate HDP-101 will be tested in patients with multiple myeloma for the first time. According to the clinical development strategy, applications for the Phase I (dose escalation) and Phase IIa (dose expansion) will be submitted simultaneously in the USA and Germany. The clinical trial program is not expected to start until 2020 at the earliest.

At the same time, additional proprietary ATAC candidates are undergoing preclinical testing to determine their efficacy and tolerability. The aim is to identify another development candidate from the ATAC portfolio as a follow-up project.

In addition, Heidelberg Pharma signs research/option and license agreements for the development and commercialization of ATAC candidates with biopharmaceutical companies to test and transfer the therapeutic potential to their antibodies. To this end, Heidelberg Pharma is supplying the toxin Amanitin in GMP quality as well as the Amanitin linker technology.

As part of further development of the ATAC technology, new target molecules, antibodies and alternative conjugation processes are currently being evaluated with academic groups and biotechnology companies. This work is to be systematically continued in order to identify additional project candidates or offer our license partners further product optimization opportunities.

Heidelberg Pharma also runs a preclinical service business that conducts pharmacological studies for other research companies and for its own use of the ATAC technology.

In addition to the ATAC technology, Heidelberg Pharma also has a more mature clinical portfolio that is to be further developed and exploited by licensing partners. Former product candidates REDECTANE® and MESUPRON® have already been out-licensed to partners. Heidelberg Pharma will receive milestone payments if the candidates are approved and marketed.

The Company is not yet in a position to fully finance its own R&D activities using its own funds in the short to medium term. Stable revenue from the services business and increased payments from Heidelberg Pharma Research GmbH’s technology partnerships or from license agreements are expected to help finance the Company’s own development work. Depending on the development plan, the Company still needs to raise funds for product development via the capital markets.

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