EQS-News: Heidelberg Pharma Announces First Patient Dosed in Phase I Study of Amanitin-based ADC Candidate HDP-102 for Non-Hodgkin Lymphoma

PRESS RELEASE

Heidelberg Pharma Announces First Patient Dosed in Phase I Study of Amanitin-based ADC Candidate HDP-102 for Non-Hodgkin Lymphoma

Ladenburg, Germany, 27 May 2025 – Heidelberg Pharma AG (FSE: HPHA), a clinical-stage biotech company developing innovative Antibody Drug Conjugates (ADCs), today announced that the first patient has been dosed in a Phase I clinical study evaluating HDP-102 for the treatment of non-Hodgkin lymphoma (NHL).

HDP-102 is Heidelberg Pharma’s second drug candidate from its proprietary Amanitin-based ADC technology (ATAC technology) platform to enter clinical development. The ATAC targets CD37, a key antigen expressed on many B-cell lymphoma cells and has the potential to successfully treat patients across multiple NHL indications.

Dr András Strassz, Chief Medical Officer of Heidelberg Pharma, said: “Moving our second ATAC program, HDP-102, into clinical development in patients with non-Hodgkin lymphoma is a significant milestone. Building on the encouraging safety and efficacy data we have seen with HDP-101 in multiple myeloma, we are optimistic that HDP-102 will deliver similarly promising results. Our goal is to bring new therapies with favorable safety profiles to patients facing these devastating and challenging cancers.”

The first patient has been dosed with HDP-102 in a study center in the Republic of Moldova. This multicenter, multinational, open-label study is designed to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of HDP-102 in patients with relapsed or refractory B-cell malignancies, and to determine the recommended dose for future studies. In addition to Moldova, the trial will be conducted in Israel, and selected EU countries. Following the initial dose escalation phase, the study is planned to enter an expansion phase to further evaluate the safety and potential efficacy of HDP-102 at the optimal dose.

Heidelberg Pharma presented preclinical data for HDP-102 at the American Association for Cancer Research (AACR) 2024 Annual Meeting. The data demonstrated strong anti-tumor efficacy and favorable tolerability following a single administration.

About non-Hodgkin lymphoma (NHL)

Non-Hodgkin lymphoma (NHL) is one of the more common types of cancer, with more than 550,000 new cases diagnosed each year. The disease leads to the death of two to three patients per 100,000 people annually. NHL includes various malignant diseases of the lymphatic system, which differ in histological structure, disease progression, and response to treatment. Among the various types of non-Hodgkin lymphoma (NHL), diffuse large B-cell lymphoma (DLBCL) is the most aggressive and accounts for approximately 32% of cases. Other common B-cell lymphoma subtypes include follicular lymphoma (17%), marginal zone lymphoma (8%), and mantle cell lymphoma (4%). Despite treatment advances over the last three decades with the use of combination immunotherapies, a significant proportion of NHL patients either relapse or fail to respond to current treatments. While conventional chemotherapy achieves response rates of over 50%, relapse remains common, highlighting the urgent need for more durable and effective treatment options.

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.

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.

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