Heidelberg Pharma AG reported significant progress in its clinical development programs during the first quarter of fiscal year 2025, highlighting advancements in its Antibody-Drug Conjugate (ADC) pipeline based on the company's proprietary Amanitin-based technology platform.
HDP-101 Shows Promising Safety Profile in Multiple Myeloma Trial
The company's lead candidate, HDP-101, an Amanitin-based ADC targeting BCMA (B-cell maturation antigen), continues to demonstrate a favorable safety profile in its ongoing Phase I/IIa clinical trial for relapsed or refractory multiple myeloma. The Safety Review Committee has confirmed that the seventh cohort, treated at a dose of 112.50 µg/kg, showed the drug to be safe and well-tolerated.
"We are pleased that our lead ATAC candidate, HDP-101, has again proven to be safe and well tolerated in cohort 7 at a dose of 112.50 µg/kg. We have not yet reached the maximum tolerated dose and are continuing the dose escalation as planned," said Professor Andreas Pahl, Chief Executive Officer of Heidelberg Pharma AG. "This supports that we are developing an ATAC with an attractive therapeutic window."
The trial will now advance to cohort 8, where patients will receive an increased dose of 140 µg/kg. Notably, a patient from cohort 5 who achieved complete remission continues to maintain this response while receiving ongoing treatment with HDP-101. This patient had been heavily pretreated with various therapies before responding to HDP-101 monotherapy.
"Particularly encouraging is the persistently stable condition of a patient with complete remission," Professor Pahl added. The company plans to present new clinical data at the European Hematology Association (EHA) Congress in Milan, Italy, in mid-June.
HDP-102 Advances to Clinical Testing for Non-Hodgkin Lymphoma
In a significant pipeline milestone, Heidelberg Pharma has received all necessary regulatory approvals to initiate clinical testing of HDP-102, its second ATAC candidate. HDP-102 targets CD37, a protein expressed on B-cell lymphoma cells, and is being developed for non-Hodgkin lymphoma (NHL), which affects over 550,000 new patients worldwide annually.
The clinical trial will be conducted in the Republic of Moldova, Israel, and selected EU countries, with the first patient expected to be dosed in the coming weeks. Preclinical data presented at the American Association for Cancer Research (AACR) 2024 Annual Meeting demonstrated excellent anti-tumor efficacy and good tolerability after a single administration.
Financial Position Strengthened by HealthCare Royalty Agreement
Heidelberg Pharma's financial outlook has improved significantly following an amendment to its royalty purchase agreement with HealthCare Royalty (HCRx). The company received an immediate payment of USD 20 million in March 2025, extending its cash runway into 2027 based on current planning.
"Not only are our clinical projects making promising progress, but our financing activities have also been extremely successful," noted Walter Miller, Chief Financial Officer. "This and an expected payment of USD 70 million upon market approval of Telix' TLX250-CDx extend our cash reach into 2027 based on current planning."
The amendment modifies the original March 2024 agreement, adjusting the payment structure related to Telix Pharmaceuticals' diagnostic agent TLX250-CDx. The sales-related milestone of USD 15 million for 2025 no longer applies due to the later potential launch of TLX250-CDx, and the originally agreed payment upon FDA approval was reduced from USD 75 million to USD 70 million.
TLX250-CDx Progressing Toward Market Approval
Heidelberg Pharma's partner Telix Pharmaceuticals completed the submission of a revised Biologics License Application (BLA) for its PET imaging agent TLX250-CDx to the U.S. Food and Drug Administration (FDA) in December 2024. On February 26, 2025, Telix announced that the FDA had accepted the BLA, granted Priority Review, and provided a Prescription Drug User Fee Act (PDUFA) date of August 27, 2025.
Q1 2025 Financial Results
For the first three months of fiscal year 2025 (December 1, 2024 – February 28, 2025), Heidelberg Pharma reported:
- Total sales revenue and other income of EUR 2.9 million (previous year: EUR 1.9 million)
- Operating expenses of EUR 9.0 million (previous year: EUR 6.6 million)
- Research and development costs of EUR 6.6 million (previous year: EUR 5.1 million)
- Net loss of EUR 5.9 million (previous year: EUR 4.5 million)
- Cash and cash equivalents of EUR 20.7 million as of February 28, 2025 (November 30, 2024: EUR 29.4 million)
The increase in R&D expenses reflects the ongoing clinical study with HDP-101 and preparations for the clinical study with HDP-102, including external manufacturing costs for both ADC projects.
2025 Financial Outlook
For the full fiscal year 2025, Heidelberg Pharma expects:
- Sales revenue and other income between EUR 9.0 million and EUR 11.0 million
- Operating expenses between EUR 40.0 million and EUR 45.0 million
- Operating result between EUR -30.0 million and EUR -35.0 million
- Cash inflow between EUR 50.0 million and EUR 55.0 million due to the HCRx payment
About Heidelberg Pharma's ATAC Technology
Heidelberg Pharma is pioneering the use of Amanitin, a toxin derived from the death cap mushroom, in cancer therapy. The company's proprietary ATAC (Antibody Targeted Amanitin Conjugate) technology combines the specificity of antibodies with the potent cytotoxic effects of Amanitin to target and kill cancer cells.
The biological mechanism of action of Amanitin represents a new therapeutic modality in oncology. The company is developing a pipeline of ATACs for various hematologic and solid tumors, with the goal of creating targeted and highly effective treatments that can overcome tumor resistance through multiple pathways.
