Heidelberg Pharma AG has reported operational and financial updates for the first quarter of fiscal 2025, highlighting continued progress in its clinical programs and an extended financial outlook following an amended agreement with HealthCare Royalty.

The company’s lead ATAC (Antibody Targeted Amanitin Conjugate) candidate, HDP-101, continued to show a favorable safety profile in the Phase1/2a trial in relapsed or refractory multiple myeloma.

According to Heidelberg Pharma, cohort 7, dosed at 112.5 µg/kg, was deemed safe and well tolerated by the Safety Review Committee, supporting further dose escalation. Cohort 8 is expected to start shortly, with patients receiving 140 µg/kg. A complete remission in a heavily pretreated patient from cohort 5 has also been sustained, and updated clinical data are scheduled for presentation at the European Hematology Association Congress in June.

The company also announced the start of clinical development for its second ATAC candidate, HDP-102, which targets CD37 for the treatment of non-Hodgkin lymphoma. Dosing of the first patient is anticipated soon, with trial sites in Moldova, Israel, and selected European Union countries. Preclinical data presented at the AACR 2024 meeting showed strong anti-tumor activity and good tolerability following a single administration.

Separately, Heidelberg Pharma’s partnered program TLX250-CDx, an imaging agent developed by Telix Pharmaceuticals, reached a regulatory milestone with the FDA accepting its Biologics License Application and granting a Priority Review. A decision is expected by late August 2025.

On the financial side, Heidelberg Pharma secured an immediate payment of $20 million in March 2025 through an amendment to its agreement with HealthCare Royalty. The company expects a further $70 million payment upon potential FDA approval of TLX250-CDx, extending its cash runway into 2027 based on current planning.

For the first quarter ending 28 February 2025, Heidelberg Pharma reported total revenue and other income of €2.9 million, up from €1.9 million in the previous year. The net loss widened to €5.9 million from €4.5 million, reflecting increased research and development spending, primarily related to ongoing clinical trials and trial preparation. Cash holdings stood at €20.7 million at quarter-end, compared with €29.4 million at the end of fiscal 2024.

Looking ahead, the company forecasts full-year 2025 revenue and other income between €9 million and €11 million, with operating expenses expected to range between €40 million and € 45 million. An operating loss of €30 million to €35 million is anticipated for the year.