Heidelberg Pharma: Promising New Clinical Data on Lead ADC-Candidate HDP-101 to be Presented at ASH Annual Meeting 2024

PRESS RELEASE

Heidelberg Pharma: Promising New Clinical Data on Lead ADC-Candidate HDP-101 to be Presented at ASH Annual Meeting 2024

Ladenburg, Germany, 6 November 2024 – Heidelberg Pharma AG (FSE: HPHA), a clinical-stage developer of innovative Antibody Drug Conjugates (ADCs), today announces that new clinical data on its lead Amanitin-based ADC candidate, HDP-101, will be presented at the 66^th American Society of Hematology (ASH) Annual Meeting, taking place from 7-10 December 2024 in San Diego, California, USA.

Robert Z. Orlowski, MD, PhD, (Ad Interim) Director of Myeloma and Professor of Medicine in the Departments of Lymphoma/Myeloma and Experimental Therapeutics, University of Texas, Houston, Texas, and principal investigator at MD Anderson Cancer Center, Houston, Texas, USA, will report the latest developments from the ongoing Phase I/IIa study of HDP-101 for the treatment of relapsed or refractory multiple myeloma.

Currently advancing in its sixth cohort, the study has shown encouraging results, including complete remission in one patient from the fifth cohort who had been previously treated multiple times and had received several courses of HDP-101. In addition, several patients showed promising biological activity and objective improvements, underscoring the potential of HDP-101 as a treatment option for patients with this disease.

66th American Society of Hematology (ASH) Annual Meeting

In October, Robert Z. Orlowski, MD, PhD, along with Heidelberg Pharma's Chief Medical Officer, András Strassz, and another Key Opinion Leader (KOL) in the field of Myeloma, discussed the progress of the dose escalation study of HDP-101 during a R&D webinar.

Robert Z. Orlowski commented, “I would say that this should be considered a great drug for all relapsed or refractory myelomas.”

The recording of the R&D webinar can be found here: Virtual KOL Event on Multiple Myeloma and Updated Clinical Data from the IMS Oral Presentation of HDP-101, an Anti-BCMA ADC

About Heidelberg Pharma

Heidelberg Pharma is a biopharmaceutical company working on a new treatment approach in oncology and developing novel drugs based on its ADC technologies for the targeted and highly effective treatment of cancer. ADCs are antibody-drug conjugates that combine the specificity of antibodies with the efficacy of toxins to fight cancer. Selected antibodies are loaded with cytotoxic compounds, the so-called payloads, that are transported into diseased cells. Inside the cells, the toxins then unleash their effect and kill the diseased cells.

Heidelberg Pharma uses several compounds and has built up an ADC toolbox that overcomes tumor resistance via numerous pathways and addresses different types of cancer using various antibodies. The goal is to develop targeted and highly effective ADCs for the treatment of a variety of malignant hematologic and solid tumors. Heidelberg Pharma is the first company to use the compound Amanitin from the green death cap mushroom in cancer therapy. The biological mechanism of action of the toxin represents a new therapeutic modality and is used as a compound in the Amanitin-based ADC technology, the so-called ATAC technology. It offers the opportunity to overcome therapy resistance and also eliminate dormant tumor cells, which could lead to significant progress in cancer therapy - even for patients who no longer respond to other treatment.

The most advanced product candidate HDP-101 is a BCMA-ATAC for the indication multiple myeloma, which is currently in clinical development.

The first candidate that Heidelberg Pharma is developing with a toxin other than Amanitin is HDP-201, an Exatecan-based ADC. Exatecan is a topoisomerase I inhibitor that has proven itself in cancer therapy and is used in two already approved ADCs. It differs in its mode of action from that of Amanitin and thus expands the company's range of compounds.

The company is based in Ladenburg, Germany, and is listed on the Frankfurt Stock Exchange: ISIN DE000A11QVV0 / WKN A11QVV / Symbol HPHA. More information is available at www.heidelberg-pharma.com.

ATAC^® is a registered trademark of Heidelberg Pharma Research GmbH.

ITAC™, ETAC™ are pending trademark applications of Heidelberg Pharma Research GmbH.

This communication contains certain forward-looking statements relating to the Company's business, which can be identified by the use of forward-looking terminology such as "estimates", "believes", "expects", "may", "will”, "should”, "future", "potential" or similar expressions or by a general discussion of the Company's strategy, plans or intentions. Such forward-looking statements involve known and unknown risks, uncertainties and other factors, which may cause our actual results of operations, financial condition, performance, achievements, or industry results, to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Given these uncertainties, prospective investors and partners are cautioned not to place undue reliance on such forward-looking statements. We disclaim any obligation to update any such forward-looking statements to reflect future events or developments.