Ladenburg - Heidelberg Pharma AG (FSE: HPHA) today published its financial report on the first six months of 2020 (1 December 2019 - 31 May 2020).
Dr. Jan Schmidt-Brand, CEO and CFO of Heidelberg Pharma AG, commented: 'At Heidelberg Pharma, we have been in the fortunate position that the coronavirus crisis has so far only had a minor impact on our day-to-day business processes. Our proprietary projects proceeded according to plan in the first half of the 2020 financial year. The final GLP toxicity study for our development candidate HDP-101 was started and is now nearing completion. At the same time, we have been working on the protocol for the Phase I trial for HDP-101 and on regulatory requirements. In this context, I am pleased to report that Dr. Andras Strassz, who joined Heidelberg Pharma in April as Senior Medical Officer, has been driving forward the work of our clinical team in his role as Senior Medical Officer since April. As soon as the final data package from the toxicology program is available, we will discuss the clinical trial protocol with the FDA and subsequently with the Paul Ehrlich Institute. We are confident that we will be able to submit the application for this trial during the second half of the year.
Our half-year financial results have developed in line with our planning. As expected, the development progress of our projects is reflected in increased research and development costs. We are particularly pleased to have successfully raised EUR 14.4 million through a capital increase, which will ensure the further development and commercialization of our ATAC technology until mid-2021.'
Key events in the first six months of 2020
HDP-101 program in multiple myeloma is progressing: The development of our proprietary candidate HDP-101 has been proceeding according to plan in recent months. The final GLP toxicity study has started and is well advanced. At the same time, the clinical development team has been working on the protocol of the Phase I trial for HDP-101 and on further preparations according to the regulatory requirements for the clinical trial. The next step is to discuss with the authorities on the study protocol and the start of the clinical trial.
Successful implementation of a corporate action: Heidelberg Pharma AG implemented a corporate action in April. There were 2,820,961 new shares issued from authorized capital, which corresponded to just under 10% of the share capital at that time. The shares were placed with dievini Hopp Biotech holding GmbH & Co. KG, Walldorf, (dievini), the majority shareholder, and with several new institutional investors at a price of EUR 5.10 per share. This measure increased the share capital to 31,030,572 shares and generated gross proceeds of EUR 14.4 million.
Partner MD Anderson Cancer Center is granted a US patent for diagnosis and treatment of patients with TP53/RNA polymerase II deletion: In March 2020, Heidelberg Pharma's partner University of Texas, MD Anderson Cancer Center, Houston, TX, USA, (MD Anderson) was granted a key patent by the US patent office for the diagnosis and treatment of select patient groups with TP53/RNA polymerase II deletion. The patent application entitled 'Methods of Treating Cancer Harbouring Hemizygous Loss of TP53' had been submitted with the US patent office by MD Anderson. Heidelberg Pharma holds the exclusive licensing rights to this patent.
Heidelberg Pharma is granted a European patent for amatoxin conjugates for tumor therapy: In late March, the European Patent Office granted Heidelberg Pharma an important patent for its proprietary ATAC technology for the production of Antibody Targeted Amanitin Conjugates. The patent is based on a 2009 patent application entitled 'Amatoxin armed therapeutic cell surface binding components designed for tumor therapy' that was submitted by Professor Heinz Faulstich and employees of the German Cancer Research Centre (DKFZ). Heidelberg Pharma exclusively in-licensed the patent in the same year.
Licensing partner Magenta announces MGTA-117 as the first ATAC candidate for clinical development: In January 2020, the Company's partner Magenta Therapeutics, Cambridge, MA, USA, (Magenta) (NASDAQ: MGTA) announced MGTA-117, which was developed within the partnership, as its first clinical ATAC candidate for the targeted preparation, or conditioning, of patients for stem cell transplants or gene therapy. Magenta presented preclinical data from its work with Heidelberg Pharma's ATAC technology at various scientific conferences. Magenta has indicated it will conduct further preclinical studies and prepare for MGTA-117 to enter clinical trials in 2021.
Report on post-balance sheet date events
Partner Telix is granted Breakthrough Therapy Designation for TLX250-CDx: On 1 July 2020, Heidelberg Pharma's partner Telix Pharmaceuticals Limited, Melbourne, Australia, (Telix) announced that it has been granted Breakthrough Therapy Designation (BT) from the FDA for the diagnostic candidate TLX250-CDx (89Zr-girentuximab). BT designation offers a number of significant benefits to Telix, including eligibility for fast track designation, more frequent and intensive interactions with the FDA, and the opportunity to submit a 'rolling' Biological License Application (BLA) for TLX250-CDx, where the application can be submitted in separate modules to streamline the FDA review process for approval. The criteria for BT designation require preliminary clinical evidence that demonstrates the product candidate may have substantial improvement on at least one clinically significant endpoint over available care.
Contact:
Sylvia Wimmer
Tel: +49 89 41 31 38-29
Email: investors[at]hdpharma.com
About Heidelberg Pharma
Heidelberg Pharma AG is a biopharmaceutical company based in Ladenburg, Germany. Heidelberg Pharma is an oncology specialist and the first company to develop the toxin Amanitin into cancer therapies. The proprietary technology platform is being applied to develop the Company's proprietary therapeutic ATACs as well as in third-party collaborations. The proprietary lead candidate HDP-101 is a BCMA ATAC for multiple myeloma.
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