Heidelberg Pharma Announces Major Restructuring Following FDA Setback

Heidelberg Pharma, a German biotech company, has announced a significant restructuring plan following a regulatory setback that has delayed a crucial milestone payment. The company will reduce its workforce by 75% and narrow its research focus in an effort to extend its cash runway into mid-2026.

FDA Rejection Triggers Financial Strain

The restructuring comes in the wake of the U.S. Food and Drug Administration's (FDA) rejection of Telix Pharmaceuticals' imaging agent TLX250-CDX. This regulatory decision has postponed a $70 million milestone payment that Heidelberg was expecting to receive at the end of August 2025. The delay has put considerable strain on the company's finances, with Heidelberg reporting only enough cash to fund operations into the first quarter of 2026.

Workforce Reduction and R&D Refocus

In response to the financial challenge, Heidelberg has outlined plans to significantly reduce its workforce. The company, which had 122 employees as of mid-2025, will cut approximately 75% of its staff by the middle of next year. This drastic measure is part of a broader strategy to narrow the company's R&D focus and conserve resources.

Heidelberg will continue work on its lead antibody-drug conjugate (ADC) HDP-101, which is currently in clinical trials for multiple myeloma. The company aims to establish the maximum dose for HDP-101 this year, paving the way for the phase 2 portion of the study. HDP-101 is distinguished by its anti-BCMA antibody conjugated to an amanitin payload, setting it apart from other ADCs targeting BCMA, such as GSK's Blenrep.

However, development of HDP-102, another ADC that recently entered clinical trials, will be paused. The company will proceed with creating and submitting a clinical trial application for a third candidate, HDP-103, as originally planned.

Strategic Decisions and Future Outlook

Heidelberg will halt early research activities and explore out-licensing opportunities for its preclinical programs, including two that target GCC for gastrointestinal tumors such as colorectal cancer. The company is also continuing to explore financing options to secure its long-term future.

While the $70 million milestone payment from Telix Pharmaceuticals remains a possibility, the timeline for its receipt is uncertain. Telix has stated that the FDA's concerns are "readily addressable" and has begun submission remediation work, but has not committed to a specific timeline for refiling for approval.

As Heidelberg navigates this challenging period, the company's focus on advancing HDP-101 and streamlining operations underscores its determination to weather the current storm and position itself for future success in the competitive landscape of antibody-drug conjugates and targeted cancer therapies.