The company was awaiting $70 million from HealthCare Royalty but missed an agreed-upon payment condition.
Ladenburg, Germany–based Heidelberg Pharma is laying off approximately 75% of its workforce in a bid to extend its cash runway after missing an expected royalty payment of $70 million.
Heidelberg is facing financial concerns after failing to meet the conditions of the payment outlined in a March 2024 financing agreement with HealthCare Royalty. The drastic cuts will give the company enough money in the coffers to last until mid-2026, according to an announcement Thursday.
While Heidelberg did not specify what payment condition it missed, under terms of the deal HealthCare Royalty would pay that sum to Heidelberg upon the FDA approval of the drug TLX250-CDx, Heidelberg’s radiolabeled version of the antibody girentuximab for clear cell renal cell carcinoma.
Heidelberg, along with its licensing partner Telix Pharmaceuticals, submitted a biological license application in December 2024, which was accepted under priority review with a target date of Aug. 27. On that date, the companies were informed that the FDA had identified issues related to the application’s chemistry, manufacturing and controls (CMC) package, as well as issues with third-party manufacturers and supply chain partners that would need “remediation” before the application could be resubmitted. At the time, Telix said that submission remediation “will begin immediately.”
Heidelberg instead is focusing on the development of its lead candidate, HDP-101, an antibody-drug conjugate (ADC) currently in a Phase I/IIa trial for multiple myeloma. HDP-101 is based on the compound amanitin, sourced from the green death cap mushroom. Heidelberg claims to be the first company to use the molecule in a cancer therapy.
Meanwhile, a different clinical program for another amanitin-based ADC, HDP-102, is being paused. Heidelberg does plan to submit a clinical trial application for another ADC, HDP-103 for castration-resistant prostate cancer, as planned, while exploring outlicensing opportunities for its other preclinical programs.
The company expects the layoffs to be complete by mid-2026. According to a May 31 press release, Heidelberg has 122 employees, meaning the layoffs could affect up to 92 people.
