Heidelberg Pharma Ag · XETR:HPHA
Heidelberg Pharma — Investor Presentation (September 2025)
44 slides from Heidelberg Pharma's investor presentation, September 2025
Slide 1: The Leader in Next Generation ADC Payloads
THE LEADER IN NEXT GENERATION ADC PAYLOADS Company Presentation • September 2025
Slide 2: Safe Harbor: Forward Looking Statements
SAFE HARBOR FORWARD LOOKING STATEMENTS This communication contains certain forward-looking statements, competition from other biopharmaceutical, chemical and relating to the Company’s business, which can be identified by the pharmaceutical companies, environmental, health and safety matters, use of
Slide 3: Overview
OVERVIEW © Heidelberg Pharma AG 3
Slide 4: Corporate Highlights
CORPORATE HIGHLIGHTS PROPRIETARY PAYLOADS, WHOLLY-OWNED ASSETS & PARTNERED ADCs Lead ADC Program HDP-101 (BCMA-ATAC): Strong IP Portfolio Including Platform, Payload, • Proprietary Amanitin Payload (patent exclusivity) Assets, Method of Use and Predictive Biomarker • Overcome resistance due to new M
Slide 5: Management Team
MANAGEMENT TEAM Professor Andreas Pahl András Strassz, MD Chief Executive Officer Chief Medical Officer @ Heidelberg Pharma since 2012 @ Heidelberg Pharma since 2020 Professor of Pharmacology and Toxicology at the University of Erlangen-Nuremberg (FAU) with 25 years experience in research and higher
Slide 6: Our Mission
OUR MISSION Our vision is to become a fully integrated biotech company striving to eradicate cancer through a rich pipeline of ADCs driven by innovative payload technologies. Professor Andreas Pahl, CEO © Heidelberg Pharma AG 6
Slide 7: Strong In-House R&D Capabilities and Expertise
STRONG IN-HOUSE R&D CAPABILITIES AND EXPERTISE Synthetic chemistry Antibody generation & Preclinical testing bioconjugation CMC Bioanalytical sciences Clinical Development Best ADC candidate in the shortest time © Heidelberg Pharma AG 7
Slide 8: Value Creation Through Development of Best-in-Class ADC Assets
VALUE CREATION THROUGH DEVELOPMENT OF BEST-IN-CLASS ADC ASSETS DISCOVERY & DEVELOPMENT ENGINE Partnering at IND- ready, First clinical data, EOP1, Clinical POC Scouting Toolbox of proprietary Multiple targets payloads Partnering In-licensing Co-Development Development Upside: Retain Antibodies Exper
Slide 9: Next Generation ADC Payload Platform
NEXT GENERATION ADC PAYLOAD PLATFORM Developing an ADC toolbox and clinical product pipeline to overcome tumor resistance across cancer types Toolbox of proprietary payloads ATAC technology RNA polymerase II inhibitor Amanitin-based ETAC technology ITAC technology Topoisomerase I TLR7 agonist inhibi
Slide 10: Growing Pipeline of Proprietary Programs
GROWING PIPELINE OF PROPRIETARY PROGRAMS Product Target Indication Research Preclinic Phase I Phase II Phase III Approval Partner Huadong HDP-101 BCMA Multiple Myeloma --------------- --------------- ------------------------------------------------------------ (China+) ATAC pipeline HDP-102 CD37 NHL
Slide 11: Growing Pipeline of Partnered Programs
GROWING PIPELINE OF PARTNERED PROGRAMS Product Target Indication Research Preclinic Phase I Phase II Phase III Approval Partner Partners ATAC TAK-ATAC n/a Oncology ------------------------------------------------------------------------------------------ Takeda Product Target Indication Research Pre
Slide 12: ADC Technologies
ADC TECHNOLOGIES © Heidelberg Pharma AG 12
Slide 13: Resistance Is One of the Biggest Challenges in Oncology
RESISTANCE IS ONE OF THE BIGGEST CHALLENGES IN ONCOLOGY 1 in 2 > 90% people will be diagnosed with of cancer deaths are caused by cancer in their lifetime drug resistance © Heidelberg Pharma AG 13
Slide 14: The Payload MOA Is What Makes the Difference
THE PAYLOAD MOA IS WHAT MAKES THE DIFFERENCE! Enhertu® Payload: deruxtecan (Topo 1 inhibitor) Kadcyla® Payload: emtansine (Tubulin inhibitor) Source: Cortés, J. et al, N Engl J Med 2022; 386:1143-1154 Same target (HER2), same antibody (Trastuzumab), same patient population © Heidelberg Pharma AG 14
Slide 15: ATACs Are ADCs with Amanitin as a Payload
ATACs ARE ADCs WITH AMANITIN AS A PAYLOAD Antibody • Targeting tumor antigen Payload: α-Amanitin • Identified in Amanita phalloides mushroom • Completely novel MoA: • Inhibition of RNA Polymerase II • Kills dormant/non-dividing tumor cells • Circumvents resistance via new mechanism • Synthetic amani
Slide 16: ATACs Address the Limitations of Current Cancer Therapies
ATACs ADDRESS THE LIMITATIONS OF CURRENT CANCER THERAPIES Cancer Diagnosis Treatment Long Term Response Outcome Tumor Relapse Standard Minimal Survival Therapy Increase CSCs survive CSCs survive Tumor bulk diminished Tumor Regrows Tumor ATAC Eradication Cure? Cancer Cell CSCs killed CSCs Eliminated
Slide 17: ATACs Overcome Resistance
ATACs OVERCOME RESISTANCE BREAST CANCER MODEL (JIMT-1 XENOGRAFT) IS RESISTANT TO KADCYLA® AND ENHERTU® JIMT-1 Same antibody (Trastuzumab), different payload xenograft (amanitin vs. topoisomerase inhibitor) PBS (control) Mean tumor volume [mm3] Enhertu® (20 mg/kg) Control Enhertu® ATAC Trastuzumab AT
Slide 18: HDP-101 Overcomes Resistance in Multiple Myeloma
HDP-101 OVERCOMES RESISTANCE IN MULTIPLE MYELOMA Kills non-dividing tumor cells unlike Effectively kills cells from patients other ADC therapeutics multi-refractory to SOC Elotuzumab/Pom resistant Anti-BCMA-MMAF Daratumumab resistant No resistance From bone marrow of patients obtained primary MM cel
Slide 19: HDP-101 Overcomes Resistance in Multiple Myeloma
HDP-101 OVERCOMES RESISTANCE IN MULTIPLE MYELOMA Kills Non-Dividing Tumor Cells Effectively Kills Cells from Patients Kills cells with ultra-low antigen Multi-Refractory to SOC expression Patients derived 125 BCMA Anti-BCMA-MMAF density primary MM cells Pat 1 2262 Pat 2 3309 100 Pat 3 n.d Pat 4 587
Slide 20: Del(17p): Potential Predictive Biomarker
DEL(17p): POTENTIAL PREDICTIVE BIOMARKER Deletion of TP53 (tumor suppressor) • High incidence • More aggressive tumors resistant to SoC and poor prognosis Del(17p) ΔPOLR2A ΔTP53 Deletion of RNA Polymerase II (POLR2A is co-deleted) • Higher sensitivity to ATAC treatment Intracellular target of Tumor
Slide 21: Del(17p): Potential Predictive Biomarker, Xenograft Models
DEL(17p): POTENTIAL PREDICTIVE BIOMARKER HER2 1+ PATIENT-DERIVED XENOGRAFT MODELS Patient- Wild type - normal RNA Pol II levels del(17p) - reduced RNA Pol II levels derived cell inoculation Tumor volume [mm3] Tumor volume [mm3] PBS (control) PBS (control) 0.5/2 mg/kg Low-dose ATAC (0.5 mg/kg) Contro
Slide 22: Toxicity Mechanism of α-Amanitin in Humans
TOXICITY MECHANISM OF α-AMANITIN IN HUMANS α- Amanitin Ingestion Small Intestine Enterohepatic Cycle α-Ama OATP1B3 RNAP II inhibition Liver Urinary Excretion Hepatotoxicity Upon mushroom intoxication α-amanitin leads to hepatotoxicity by specific uptake of the toxin into hepatocytes via the OATP1B3
Slide 23: Multiple Myeloma and 17p Deletion
MULTIPLE MYELOMA AND 17p DELETION MULTIPLE MYELOMA (MM) • Malignancy characterized by clonal plasma cell expansion in the bone marrow • Despite substantial improvements in PF and OS, MM patients eventually relapse DEL(17p) IN MM • Deletion identified in app. 10% of newly Source: Source: Source: diag
Slide 24: HDP-101 – Phase I Preliminary Efficacy Data
HDP-101 – PHASE I PRELIMINARY EFFICACY DATA * Complete Response * * Readout: November 2024 Treatment duration (days) Progressive disease (PD) Partial response (PR) Very good partial remission (VGPR) End of treatment Minimal response (MR) Stable disease (SD) Complete response (CR) * Adverse Event, mo
Slide 25: HDP-101: Phase I Preliminary Efficacy Data (Cohort 5-7)
HDP-101: PHASE I PRELIMINARY EFFICACY DATA (COHORT 5-7) 10101_P30 B (112.5 µg/kg) 10101_P29 C Cohort 7 10101_P32 B Progressive disease (PD) 10101_P33 C Stable disease (SD) 10101_P34 C Minimal response (MR) 10101_P31 B Partial response (PR) Very good partial response (VGPR) Stringent complete respons
Slide 26: Dose-Dependent Efficacy of HDP-101 Treatment
DOSE-DEPENDENT EFFICACY OF HDP-101 TREATMENT M-protein Relative Change from Baseline M-protein % Change from Baseline 10101_P19 A 10101_P30 B 10101_P13 10101_P22 A 10101_P25 B 10101_P24 C 10101_P29 C 10101_P32 B 10101_P10 10101_P01 10101_P08 10101_P02 10101_P28 A 10101_P27 A 10101_P26 B 10101_P21 C
Slide 27: Case Summary: Complete Response in Cohort 5
CASE SUMMARY: IN COHORT 5 COMPLETE RESPONSE Female Patient with Stage II IgG-Ϗ Myeloma Since 2002 • 9 prior lines of therapies including transplant, IMiDs, PIs, and M-protein & IgG change over 11 cycles of HDP-101 Daratumumab 20 • Last 3 treatment regimens & response: 18 7th line: α-BCMA CAR-T (Aug-
Slide 28: Dose Optimization Strategies from Cohort 6
DOSE OPTIMIZATION STRATEGIES FROM COHORT 6 After Cohort 5, a detailed safety analysis was performed in January CX RP2D tbc 2025 Q1W split C8 dosing For cohort 6, the Safety Review Committee (SRC) recommended 140 µg/kg Split 1st dose & • to continue the clinical study and C8 premed*, then Q3W • mitig
Slide 29: Cohort 7 Summary and Cohort 8 Outlook
Cohort 7 Summary and Cohort 8 Outlook Cohort 7 has been completed • The dose level is at maximum escalation according to study protocol using dose distribution • Weekly dose (amendment planned to allow switch between weekly and 3 So far, 34 heavily treated patients weekly dosing) received HDP-101. •
Slide 30: HDP-101 Overview
HDP-101 OVERVIEW Unique preclinical features Potential clinical benefit Efficacious against dormant tumor cells Stronger & longer lasting tumor response Efficacious in ultra-low BCMA-expressing tumor cells Deeper responses and higher response rate Novel mechanism to which all patients will be naïve
Slide 31: Next ATAC Candidate: HDP-102 in Non-Hodgkin Lymphoma
NEXT ATAC CANDIDATE: HDP-102 IN NON-HODGKIN LYMPHOMA Non-Hodgkin lymphoma (NHL) is one of the more common types of cancer • Non-Hodgkin lymphoma covers an array of different malignant diseases of the lymphatic system that differ significantly in their histological structure, disease progression and
Slide 32: First-in-Human Clinical Trial with HDP-102 in Non-Hodgkin Lymphoma
FIRST-IN-HUMAN CLINICAL TRIAL WITH HDP-102 IN NON-HODGKIN LYMPHOMA Multicenter, multinational open-label Phase Ia/Ib PHASE Ia PHASE Ib • Dose escalation study • Dose expansion study • Up to 42 patients with relapsed / refractory B-cell Malignancies • 15 patients • Evaluate the safety, tolerability,
Slide 33: HDP-102 Started Enrollment of Patients in Spring 2025
HDP-102 STARTED ENROLLMENT OF PATIENTS IN SPRING 2025 Multicenter, multinational open-label Phase Ia/Ib trial for relapsed/refractory B-cell malignancies General information • Broad potential application in B-cell malignancies • Cohort 1 is completed (40 µg/kg) • 3 patients enrolled: 1 DLBCL, 1 MZL,
Slide 34: Next ATAC Candidate: HDP-103 in Prostate Cancer
NEXT ATAC CANDIDATE: HDP-103 IN PROSTATE CANCER Prostate cancer is the second most common cancer in men • Improved diagnostic methods combined with increasing life expectancy supports the forecast that the number of new cases each year will rise from 1.5 million to 2.6 million by 2045 • PSMA is over
Slide 35: Legacy Portfolio: Partner Telix Brings TLX250-CDx to the Patients
LEGACY PORTFOLIO: PARTNER TELIX BRINGS TLX250-CDx TO THE PATIENTS Imaging of kidney cancer to better Status distinguish benign or malignant lesions • Expanded Access Program in 30 centres in Europe and US • BLA submission accepted by the FDA, PDUFA date: 27 August 2025 (marketing approval) • Telix p
Slide 36: Strong IP Portfolio – From Payload to Patient Use
Strong IP Portfolio – From Payload to Patient Use 39 Patent families 400 Patents 30 thereof ATAC related 350 thereof ATAC related Payload ATAC Platform Antibodies & Products Patient & Tumor Amatoxin Synthesis & Cysteine-engineered mAbs HDP-101 (anti-BCMA ATAC) Biomarker for Stratification Derivative
Slide 37: Financials
FINANCIALS © Heidelberg Pharma AG 37
Slide 38: Finances – As of 31 May 2025
FINANCES – AS OF 31 MAY 2025 Total Assets (including cash) €62.5M Healthcare Royalty agreement $70M available upon approval* Equity €18.5M Common shares 46.8M Major Shareholders dievini & affiliated parties 44%, Huadong Medicine 35% Cash as of 31 May 2025 and expected payment from HCRx to fund opera
Slide 39: Financials and Shareholdings
FINANCIALS AND SHAREHOLDINGS In € m Guidance 2025 H1 2025 H1 2024 Sales revenue and other income 9.0 – 11.0 5.0 6.3 Operating expenses (40.0) – (45.0) (18.0) (15.6) Freefloat 21% Cost of sales (0.1) (1.4) dievini* R&D costs (13.5) (10.6) and affiliated Administrative costs (3.4) (3.0) parties 44% Ot
Slide 40: Balance Sheet as of 31 May 2025
BALANCE SHEET AS OF 31 MAY 2025 Assets (€ m) 31.05.2025 30.11.2024 Equity and liabilities (€ m) 31.05.2025 31.11.2024 Non-current assets 13.2 13.2 Non-current liabilities 37.6 21.8 Other current assets 16.0 18.1 Current liabilities 6.4 8.0 Cash 33.3 29.4 Equity 18.5 30.9 62.5 60.7 62.5 60.7 © Heidel
Slide 41: Outlook
OUTLOOK © Heidelberg Pharma AG 41
Slide 42: Leading ADC Pipeline in Liquid & Solid Tumor Indications
LEADING ADC PIPELINE IN LIQUID & SOLID TUMOR INDICATIONS HDP-101 HDP-102 HDP-103 HDP-104 BCMA-ATAC CD37-ATAC PSMA-ATAC GCC-ATAC for r/r Multiple Myeloma for Non-Hodgkin Lymphoma for mCR Prostate Cancer for colorectal cancer • Phase I/IIa Study dose • CTA approval Q4 2024 • First-in-Human enabling •
Slide 43: Good Reasons to Invest in Heidelberg Pharma
GOOD REASONS TO INVEST IN HEIDELBERG PHARMA HDP-101 positive efficacy data Highly dynamic ADC and good tolerability in RRMM environment with an are a validation of our Amanitin attractive global market that is based technology for future expected to grow indications to USD 34 billion in 20321 Mid- a
Slide 44: Heidelberg Pharma AG, Ladenburg, Germany
Heidelberg Pharma AG Ladenburg, Germany Tel.: +49 6203 10090 investors@hdpharma.com investors@hdpharma.com www.heidelberg-pharma.com www.heidelberg-pharma.com
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