Heidelberg Pharma Reports on First Half-Year 2025 and the Positive Course of Business

PRESS RELEASE

Heidelberg Pharma Reports on First Half-Year 2025 and the Positive Course of Business

• Clinical trial with ATAC candidate HDP-101 in multiple myeloma shows promising data
• Cohort 7 of the Phase I dose escalation study with HDP-101 safe and well tolerated; Cohort 8 started
• First patient in clinical study dosed with the second ATAC candidate HDP-102 in the non-Hodgkin lymphoma (NHL) indication
• Amendment of contract with HealthCare Royalty; payment of USD 20 million received
• A further payment of USD 70 million is expected upon approval of the TLX250-CDx diagnostic at the end of August 2025, which will significantly extend the current cash reach
• Dr. Karl Benedikt Biesinger and Dr. Klaus Schollmeier elected as new members of the Supervisory Board
• Financial figures in line with planning

Ladenburg, Germany, 10 July 2025 - Heidelberg Pharma AG (FSE: HPHA) published today its financial report on the first six months of 2025 (1 December 2024 - 31 May 2025) and reported about the course of business.

Professor Andreas Pahl, CEO of Heidelberg Pharma AG, commented: "We are very pleased that our second ATAC candidate, HDP-102, entered clinical development a few weeks ago and that the first patient has been dosed. HDP-102 is being developed for the treatment of various types of non-Hodgkin's lymphoma.

Clinical testing of our most advanced ATAC candidate, HDP-101, is also progressing well. We are now in the eighth cohort of the Phase I/IIa dose escalation study, with patients currently receiving HDP-101 as monotherapy at a dose of 140 µg/kg. Our ATAC candidate has so far proven safe and well tolerated in all cohorts, with no signs of serious side effects.

In addition to the scientific successes, Heidelberg Pharma's financial development in the first half of 2025 was also promising. In March, we amended the existing agreement with HealthCare Royalty dated March 2024 regarding the partial sale of license payments for the product TLX250-CDx from the partnership with Telix and received a payment of USD 20 million upon signing. Taking into account an expected payment of USD 70 million upon FDA approval of TLX250-CDx, we consider our financing to be secured until the beginning of 2027 based on our current medium-term planning.”

Key events in the first six months of 2025

Progress in the HDP-101 (BCMA-ATAC) program: The ATAC candidate HDP-101 is currently in a Phase I/IIa clinical trial for the treatment of relapsed or refractory multiple myeloma.

The first seven patient cohorts and dose levels have been completed. After completion of the seventh cohort, the Safety Review Committee (SRC) confirmed that the dose of 112.5 µg/kg used is safe and well tolerated and that the study can be continued with the eighth cohort and a dose of 140 µg/kg. Similar to the dosing regimen for the seventh cohort, patients in the eighth cohort will also be dosed in two different arms. As long as patients in the seventh cohort do not progress, they will continue to be treated at the current dose level.

In mid-June, new clinical data were presented at the EHA Congress, the annual meeting of the European Hematology Association, in Milan, Italy. The poster is available on the company's website.

Treatment with HDP-101 was well tolerated by patients in the seventh cohort. No pulmonary or ocular toxicities occurred. The adjusted dosing regimens significantly reduced the temporary decrease in platelet counts and the partial increases in liver enzymes.

The study has shown very encouraging results to date, including one patient from the fifth cohort in whom no tumor cells are detectable in blood and bone marrow since one year. She had been treated with multiple other therapies and is since then continuously being treated with HDP-101 alone. In addition, several patients from different cohorts showed promising anti-tumor activity and objective improvements, underscoring the potential of HDP-101 as a treatment option for patients with multiple myeloma.

Currently, five patients are still being treated. Patient recruitment for the eighth cohort is proceeding as planned.

HDP-102 (CD37-ATAC) development program: The ATAC HDP-102 targets CD37, a key antigen expressed on many B-cell lymphoma cells. HDP-102 is being developed for non-Hodgkin lymphoma (NHL).

At the end of May the company announced that the first patient has been dosed with HDP-102 in a Phase I study. 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. The trial will be conducted in Moldova, selected EU countries and Israel. The start of patient recruitment is proceeding according to plan.

New preclinical data from the ATAC technology platform presented at the AACR 2025 Annual Meeting: Heidelberg Pharma presented the latest research results and further developments of its Exatecan-based ADC technology platform (ETAC technology) at the American Association for Cancer Research (AACR) Annual Meeting in April 2025.

Preclinical results for HDP-201, Heidelberg Pharma's novel Exatecan-based multimer linker ADC, were presented. The results indicate targeted efficacy, strong antitumor activity, and high tolerability. The poster is available on the company's website.

In addition, Heidelberg Pharma scientists demonstrated the potential of computer-aided modeling to optimize NAMPT inhibitors (NAMPTi) developed in silico as payloads and as a mechanism of action in ADC technology. This novel technological approach has the potential to overcome the current limitations of cancer therapies by targeting both dividing and non-dividing cancer cells.

Amendment of the royalty purchase agreement with HealthCare Royalty secures USD 20 million: Heidelberg Pharma and Healthcare Royalty (HCRx) signed in March 2025 an amendment to the original license agreement dated March 2024. Heidelberg Pharma received an immediate payment of further USD 20 million upon signing of the agreement. In return, the sales-related milestone of USD 15 million for 2025 no longer applies due to the later potential launch of TLX250-CDx. The originally agreed payment of USD 75 million upon approval of TLX250-CDx by the FDA is reduced to USD 70 million - with further potential reductions if the approval occurs after the end of 2025.

Annual General Meeting elected new Supervisory Board: This year’s Annual General Meeting of Heidelberg Pharma took place in virtual format on 15 May. All management proposals have been approved with a large majority and a new Supervisory Board was elected. Dr. Georg F. Baur, Dr. Mathias Hothum, Dr. Birgit Kudlek, Dr. Dongzhou Jeffery Liu, and Dr. Yan Xia were re-elected. Professor Christof Hettich and Dr. Friedrich von Bohlen, who had been members of the Supervisory Board of Heidelberg Pharma AG since 2010 and 2005, respectively, did not stand for re-election. Dr. Karl Benedikt Biesinger and Dr. Klaus Schollmeier were elected to the Supervisory Board in their place. At the subsequent constituent meeting of the Supervisory Board, Dr. Biesinger was elected as the new Chairman and Dr. Baur and Dr. Hothum as Deputy Chairmen.

Events after the reporting period 

R&D Webinar after EHA took place
Following the EHA Congress, Heidelberg Pharma held an R&D webinar at the end of June to provide further insights into the ongoing clinical trial with its lead drug candidate HDP-101. The webinar, entitled “Pioneering New Treatment Options in Relapsed or Refractory Multiple Myeloma with a New Amanitin-based ADC,” featured presentations by the management team and key opinion leaders (KOLs) in the field of multiple myeloma.

Financial results for the first six months of fiscal year 2025

The Heidelberg Pharma Group, consisting of Heidelberg Pharma AG as well as its subsidiaries Heidelberg Pharma Research GmbH, HDP G250 AG & Co. KG and HDP G250 Beteiligungs GmbH, reports consolidated figures. The two latter companies are not operationally active and affiliated to the parent company, like Heidelberg Pharma Research GmbH.

The reporting period referred to below relates to the period from 1 December 2024 to the balance sheet date of 31 May 2025 (H1 2025).

The Heidelberg Pharma Group generated sales revenue and income of EUR 5.0 million in the first six months of the 2025 financial year (previous year: EUR 6.3 million).

Sales revenue totaling EUR 1.4 million (previous year: EUR 4.1 million) in both comparative periods and mainly comprised the group-wide cooperation agreements for ATAC technology. The revenue deferral from the license of HDP-103 to Huadong 2022 ended as planned at the end of the first fiscal quarter of 2025, meaning that no further revenue will be generated from this in the future.

At EUR 3.6 million, other income was significantly higher than the previous year's level of EUR 2.2 million and comprised foreign currency translations (EUR 1.9 million), a milestone payment in connection with the Emergence sale (EUR 1.4 million) and other items (EUR 0.3 million).

Operating expenses, including depreciation and amortization, amounted to EUR 18.0 million in the reporting period (previous year: EUR 15.6 million) and were thus in line with the previous year.

The cost of sales relates to the Group's costs directly related to sales revenue. They were significantly below the previous year's level, amounted to EUR 0.1 million (previous year: EUR 1.4 million) and corresponded to 1% of operating expenses. Research and development costs amounted to EUR 13.5 million, up from EUR 10.6 million in the previous year, as planned due to the start of the second clinical trial with HDP-102. This category continued to represent the largest cost item, accounting for 74% of operating expenses. Administrative expenses of EUR 3.4 million (previous year: EUR 3.0 million) amounted to 19% of operating expenses. Other expenses for business development, marketing and commercial market supply activities, which mainly comprise staff, travel and consulting costs, but also expenses from foreign currency valuation, amounted to EUR 1.0 million, up from the previous year (EUR 0.6 million) and corresponding to 6% of operating expenses.

The Heidelberg Pharma Group's net loss for the first six months of 2025 amounted to EUR 12.6 million (previous year: EUR 8.7 million). The increase in losses is attributable to both lower sales and higher expenses. Earnings per share amounted to EUR –0.27 and, taking into account the average number of shares in the comparative period, decreased in line with the net income for the period compared with the previous year (EUR –0.19).

At the end of the 2025 reporting period, Heidelberg Pharma had cash of EUR 33.3 million, which was above the year-end figure of EUR 29.4 million and below the half-year figure for the previous year as of 31 May 2024 (EUR 42.6 million). This represents an average monthly cash inflow of EUR 0.6 million for the first half of fiscal year 2025.

Total assets as of 31 May 2025 amounted to EUR 62.5 million, up from EUR 60.7 million as of the 30 November 2024 reporting date. Equity at the end of the reporting period amounted to EUR 18.5 million (30 November 2024: EUR 30.9 million) and corresponded to an equity ratio of 29.7% (30 November 2024: 50.8%).

The full-year financial guidance issued on 21 March 2025 for the Heidelberg Pharma Group is confirmed.

Based on the current budget,and taking into account an additional expected payment of USD 70.0 million (less transaction costs) from HealthCare Royalty, the Group would be funded into 2027.

¹ Not including any corporate actions

Key figures for the Heidelberg Pharma Group

1 The reporting period begins on 1 December and ends on 31 May
2 Equity / total assets
3 Including members of the Executive Management Board
Rounding of exact figures may result in differences.

The full half-yearly financial report including the consolidated financial statements prepared in accordance with International Financial Reporting Standards (IFRS) was published at http://heidelberg-pharma.com/en/press-and-investors/announcements/financial-reports. There will be no conference call on the half-year report.