DGAP-News: Heidelberg Pharma AG / Key word(s): Interim Report
Heidelberg Pharma AG: Interim Management Statement on the First Three Months of 2021
2021-04-29 / 07:18
The issuer is solely responsible for the content of this announcement.
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Heidelberg Pharma AG: Interim Management Statement on the First Three Months of 2021
- Application to initiate clinical trial of HDP-101 green-lighted by the FDA in February 2021
- Management team expanded
- New financing commitment for up to EUR 30 million obtained from main shareholder dievini
- New preclinical data from the ATAC technology platform presented at the AACR 2021 Annual Meeting
Ladenburg, Germany, 29 April 2021 - Heidelberg Pharma AG (FSE: HPHA) today reported on the first three months of fiscal
year 2021 (1 December 2020 - 28 February 2021) and the Group's financial figures.
Dr. Jan Schmidt-Brand, CEO and CFO of Heidelberg Pharma AG, commented: "The FDA's approval of the study protocol for
the Phase I/IIa trial of our ATAC candidate HDP-101 in the first quarter was an outstanding milestone for Heidelberg
Pharma. We will start establishing the trial centers in the United States as soon as possible and plan to recruit the
first patients in the second quarter of 2021. We submitted an application to the Paul-Ehrlich-Institut in March to
conduct the clinical trial in Germany as well.
We also need to take appropriate financial measures to support the progress being made at an operating level and the
upcoming start of clinical development of our first ATAC candidate, which is why we signed a EUR 15 million loan
agreement with our main shareholder dievini back in mid-December. In March, we received a further financing commitment
from dievini in the amount of up to EUR 30 million. We would like to thank dievini for the trust it has placed in us
and for its excellent support. Our cash reach is now secured until mid-2022 and this will help us to expand our own
pipeline and technology, which is attracting increasing interest from institutional investors and partners worldwide."
Important operational developments and achievements
- HDP-101 (BCMA ATAC) development program: At the beginning of the year, Heidelberg Pharma submitted the study protocol
for HDP-101, a BCMA Antibody Targeted Amanitin Conjugate for treating multiple myeloma, to the US Food and Drug
Administration (FDA). On 4 February 2021, the FDA gave clearance to begin the Phase I/IIa trial for HDP-101. Heidelberg
Pharma also submitted the dossier to Germany's medical regulatory body, the Paul-Ehrlich-Institut, in March 2021. The
trial centers in the United States will be activated as soon as possible to initiate the trial and, once Heidelberg
Pharma gets the green light, a prompt start of the trial in Germany is planned as well. The first patients are set to
be included in the course of the second quarter of 2021.
- Results on HER2-ATAC for targeted immunotherapy of triple-negative breast cancer published in Science Translational
Medicine: In February, Heidelberg Pharma published new study results on Antibody Targeted Amanitin Conjugate (ATAC)
technology in the journal Science Translational Medicine in a joint report by a research group from the School of
Medicine, Indiana University, Indianapolis, IN, USA, and scientists from Heidelberg Pharma. The Trastuzumab-ATAC, which
consists of the antibody Trastuzumab targeting HER2 and the toxin Amanitin, demonstrated extraordinary efficacy in the
treatment of certain triple-negative breast cancers (TNBC). The preclinical data from this exploratory study shows that
the ATAC exhibits superior efficacy in treating aggressive tumors with a certain aggressive chromosomal change (17p
deletion) compared to other ADCs and that it also has immunostimulatory potential. In the trial conducted, the
Trastuzumab-ATAC induced an immunogenic cell death of the tumor cells, a type of cell death that elicits an immune
response. Consequently, the ATAC could be effectively combined with immune checkpoint blockade therapy, as also
demonstrated by data from the MD Anderson Cancer Center.
- Shareholder loan and financing commitment by main shareholder dievini: In December 2020, Heidelberg Pharma signed a
loan agreement with subordination with its main shareholder dievini in the amount of EUR 15 million. The
uncollateralized and indefinite loan bearing annual interest of 6% implements the financing commitment of 21 July 2020.
Heidelberg Pharma AG drew down an initial tranche of EUR 5 million in the quarter just ended. A further tranche of EUR
5 million was drawn down in March 2021 after the reporting date.
In March 2021, the company received a further financing commitment from dievini in the amount of up to EUR 30 million.
The details of the financing will be decided by the Executive Management Board and the Supervisory Board of Heidelberg
Pharma with dievini at a later date. The financing commitment is intended to enable the continuation of business
activities, without prejudice to potential alternative capital measures, in particular the implementation of the
clinical phase I/IIa of HDP-101 and the further development of the candidates HDP-102 and HDP-103. With this additional
commitment and based on current planning, the Company's cash reach is secured until mid-2022.
Events after the reporting period
- Heidelberg Pharma expands its management team: At the beginning of March, Dr. András Strassz, who had held the post
of Senior Medical Officer in the company since April 2020, was appointed Chief Medical Officer, while Dr. Mathias
Locher was named Chief Development Officer. Dr. Strassz has many years of experience in clinical development,
particularly in oncology, and will build up this area at Heidelberg Pharma. Dr. Strassz joined Heidelberg Pharma from
Affimed, where he had held the position of Medical Director. Prior to this, he had held roles in clinical development
at companies like Sandoz and Amgen. Along with a doctorate in medicine, Dr. Strassz has an MBA from the University of
Pécs, Hungary.
Dr. Mathias Locher has nearly 30 years of experience in drug development. He joins Heidelberg Pharma from Janssen
(Pharmaceutical Companies of Johnson & Johnson), where he worked as Senior Director - External Innovation for J&J
Innovation Centre, London. Prior to this, he had held executive positions at Covagen, Merck Serono, Micromet (now part
of Amgen) and ASTA Medica. Dr. Locher has a PhD in biochemistry from the University of Tübingen.
- New preclinical data from the ATAC technology platform presented at the AACR 2021 Annual Meeting: At the American
Association for Cancer Research (AACR) 2021 Annual Meeting, Heidelberg Pharma presented preclinical data on its novel
ATAC candidates HDP-102 and HDP-103 and, in another poster presentation, data on synergistic effects of ATACs with
checkpoint inhibitors. More information is available at https://heidelberg-pharma.com/en/research-and-development/
scientific-posters.
- Partner program updates: The partner Telix announced in mid-April that the Phase I/II 'ZIRDAC-JP' clinical study of
the renal cancer imaging product has reported results and met the study objectives, demonstrating safety and
tolerability of TLX250-CDx (89Zr-girentuximab) in Japanese patients. The results showed no difference between Japanese
and Caucasian patient populations for these endpoints as well as for pharmacology and dosing compared to previous
studies. Based on these results, Telix will consult with the Japanese regulator to confirm the design of the next stage
of development for TLX250-CDx in Japan, with the objective of bridging to Telix's Phase III ZIRCON study.
For the other partner projects by Magenta, Takeda, and RedHill, there are no significant changes compared to the
information already published.
Results of operations, financial position and net assets
The Heidelberg Pharma Group - as of the reporting date comprising Heidelberg Pharma AG and its subsidiary Heidelberg
Pharma Research GmbH - reports consolidated figures. The reporting period referred to below concerns the period from 1
December 2020 to 28 February 2021 (Q1 2021).
In the first three months of fiscal year 2021, the Group generated sales revenue and income totaling EUR 0.5 million
(previous year: EUR 1.8 million). This figure includes sales revenue of EUR 0.4 million (previous year: EUR 1.5
million) generated by the ATAC technology (EUR 0.3 million) and the service business (EUR 0.1 million). In the same
quarter of the previous year, sales were positively influenced by revenues from the supply of Amanitin linkers to
partners. Due to the higher yields achieved in the last production campaigns and the associated higher delivery
volumes, demand for Amanitin linker has been satisfied for the time being.
Other income amounted to EUR 0.1 million (previous year: EUR 0.3 million) and primarily consisted of government grants
and the reversal of unutilized accrued liabilities and provisions.
Operating expenses including depreciation and amortization totaled EUR 6.7 million in the reporting period (previous
year: EUR 6.3 million). Cost of sales amounted to EUR 1.1 million (previous year: EUR 1.5 million) and concern costs
directly related to sales revenue. These showed a disproportionate development in the short period under review of the
first fiscal quarter as a result of IFRS accounting policies and the fact that they also serve as a basis for sales
revenue generated at a later time. Research and development costs rose by EUR 1.0 million year-on-year to EUR 4.9
million (previous year: EUR 3.9 million) as planned due to the expansion of cost-intensive external good manufacturing
practice (GMP) production and preclinical and regulatory preparations for the clinical trial with HDP-101. At 72% of
operating expenses, R&D was the largest cost item. Administrative costs decreased to EUR 0.7 million in the first
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