Heidelberg Pharma Ag · XETR:HPHA
Heidelberg Pharma — German Spring Conference 2025
25 slides from Heidelberg Pharma's conference presentation, May 12, 2025
Slide 1: The Leader in Next Generation ADC Payloads
THE LEADER IN NEXT GENERATION ADC PAYLOADS Walter Miller, CFO • German Spring Conference • 12 May 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: Management Team with R&D and Pharma Experience
MANAGEMENT TEAM WITH R&D AND PHARMA EXPERIENCE András Strassz, MD Andreas Pahl, PhD Chief Medical Officer Chief Executive Officer More than 15 years experience in clinical drug development 25 years experience in drug including roles at Sandoz, Amgen and biotech companies development and academic res
Slide 4: Corporate Highlights
CORPORATE HIGHLIGHTS PROPRIETARY PAYLOADS, WHOLLY-OWNED ASSETS & PARTNERED ADCs Our Company Complete GMP Manufacturing Supply Chain • Clinical stage biotech • Heidelberg Pharma Group: 116 employees • Listed on Frankfurt Stock Exchange: HPHA Technology and Asset Partnerships Maximize Value of Pipelin
Slide 5: 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 5
Slide 6: The Journey of Many Cancer Patients
THE JOURNEY OF MANY CANCER PATIENTS BEFORE TREATMENT TREATMENT RESISTANCE & RELAPSE Wagle, N. et al, J Clin Oncol. 2011; 29(22): 3085–3096 © 2011 by American Society of Clinical Oncology We need new drugs with new mode of action (MOA) to overcome resistance © Heidelberg Pharma AG 6
Slide 7: Amanitin Fills the Gap in Cancer (Chemo)Therapy
AMANITIN FILLS THE GAP IN CANCER (CHEMO)THERAPY Amanitin is the only known specific Amatoxins are a Unique Class of Natural Toxins inhibitor of RNA polymerase II • Group of toxins from the poisonous Amanita phalloides Purines and pyrimidines • Completely novel MOA: 6-Mercaptopurine • Specific inhibi
Slide 8: 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 Cancer Stem Cells Increase (CSCs) survive CSCs survive Tumor bulk diminished Tumor Regrows Tumor ATAC Eradication Cure? Cancer Cell CSCs kil
Slide 9: The ATAC Platform Works Like a Guided Missile
THE ATAC PLATFORM WORKS LIKE A GUIDED MISSILE Enemy = Cancer Cells Missile's Warhead = Payload: α-Amanitin Targeting System = Antibody © Heidelberg Pharma AG 9
Slide 10: ADCs: A Cancer Therapy Powerhouse
ADCS: A CANCER THERAPY POWERHOUSE 15 Approved ADC drugs globally 50+ ADCs FIH clinical trials (2023) 200+ Active ADC clinical trial stage ADCs are drug candidates blockbusters 11 Newly approved ADC Enhertu (USD 2.3bn)* Kadcyla (USD 2.2bn)* 51 Out-licensing deals in 2023 Adcetris (USD 1.7bn)* 55.5 US
Slide 11: Strong IP Portfolio – HDP-101 Patent Estate
STRONG IP PORTFOLIO – HDP-101 PATENT ESTATE 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024 2025 2026 2027 2028 2029 2030 2031 2032 2033 2034 2035 2036 2037 2038 2039 2040 2041 2042 2043 2044 building blocks synthesis Payload humanized anti-BCMA mAbs, in-licensed ATAC Platform bioma
Slide 12: Lead Program: HDP-101 in Multiple Myeloma
LEAD PROGRAM: HDP-101 IN MULTIPLE MYELOMA MULTIPLE MYELOMA (MM) IS A TYPE OF BLOOD CANCER PHASE I/IIA CLINICAL TRIAL • … that develops from plasma cells in the bone marrow and can affect more than one part of the body. Phase I part: dose escalation (ongoing) • Cohorts of 2-6 patients are treated • I
Slide 13: HDP-101 – Phase I Preliminary Efficacy Data
HDP-101 – PHASE I PRELIMINARY EFFICACY DATA * 100 µg/kg Complete Response • 70-Year-old patient with myeloma since 2002 80 µg/kg • 9 prior lines of therapies • Started HDP-101 in Oct 2023 • No detectable M-protein in blood from day 60 µg/kg 225 of HDP-101 and sCR after 344 days * • Continues on trea
Slide 14: HDP-101 Phase I/IIa Trial Design
HDP-101 PHASE I/IIA TRIAL DESIGN CX RP2D tbc Phase I: Dose Escalation C8 Q1W split Key Eligibility Criteria dosing Q3W intravenous dosing, BLRM Design 140 µg/kg Split 1st dose & C8 premed*, then Q3W • Prior SCT or transplant ineligible Objectives Q1W split C7 dosing • Prior treatment with an Primary
Slide 15: HDP-101 Phase I/IIa: Preliminary Summary & Outlook
HDP-101 PHASE I/IIa: PRELIMINARY SUMMARY & OUTLOOK Multiple efficacy endpoints show dose-dependent and promising anti- cancer activity (Cohort 1-5): • 56% (10/18) of patients responded to treatment So far, 34 heavily treated patients • One patient with CR from day 225 of HDP-101 received HDP-101. HD
Slide 16: Listing Summary
LISTING SUMMARY PRIME STANDARD AT FRANKFURT STOCK EXCHANGE Current Market Cap EUR 130m – EUR 150m 52 Weeks - High/Low EUR 3.25 / 2.11 per share Number of Shares Outstanding EUR 46.6m Major Shareholders dievini & affiliated parties 44%, Huadong Medicine 35% 1.62% in stock options (fully diluted) Part
Slide 17: Stock Chart & Newsflow
STOCK CHART & NEWSFLOW 26.02.2025 Our partner Telix announces BLA by FDA for TLX250-CDx 3.20 27.03.2024 Orphan Drug Designation for 14.03.2025 3.10 HDP-101 granted by FDA Amendment of royalty financing 15.10.2024 24.10.2024 agreement with HealthCare Royalty to KOL R&D Webinar: Virtual KOL Event Anno
Slide 18: Amendment with HealthCare Royalty (March 2025)
AMENDMENT WITH HEALTHCARE ROYALTY (MARCH 2025) Partial monetization of royalty stream for TLX250-CDx in the field of diagnostic use Up to USD 115m Key terms of the amended agreement between Heidelberg Pharma and HealthCare Royalty: • $25 m upfront payment at closing, no repayment obligation in case
Slide 19: Strategic Partnership with Huadong Medicine
STRATEGIC PARTNERSHIP WITH HUADONG MEDICINE FEBRUARY/SEPTEMBER 2022 Exclusive licensing agreement for China and additional countries* • Exclusive development and commercialization rights for HDP-101 and HDP-103; deal value: up to USD 469m + royalties • Exclusive Option for other existing candidates;
Slide 20: Finances Summary
FINANCES SUMMARY AS OF FEBRUARY 28, 2025 Total Assets (including cash) EUR 52.8m Equity EUR 25.1m Cash Position EUR 20.7m (extra USD 20m secured on March 12, 2025) Cash Reach into 2027* Healthcare Royalty agreement additional USD 70m available upon drug approval* Cash as of February 28, 2025 - Expec
Slide 21: Profit and Loss Q1 2025 and FY 2024
PROFIT AND LOSS Q1 2025 AND FY 2024 In EUR m Guidance 2025 Q1 2025 FY 2024 Operating Expenses FY 2024 Sales revenue and other income 9.0 – 11.0 2.9 12.0 7% 5% Operating expenses (40.0) – (45.0) (9.0) (32.6) Cost of sales (0.05) (1.8) 21% R&D costs (6.6) (21.8) Administrative costs (1.6) (6.7) Other
Slide 22: ADC Program Pipeline: Multiple Potential Value Drivers
ADC PROGRAM PIPELINE: MULTIPLE POTENTIAL VALUE DRIVERS Product Target Indication Research Preclinic Phase I Phase II Phase III Approval Partner HDP-101 BCMA Multiple Myeloma ------------------------------------------------------------------------------------------ Huadong (China+) ATAC pipeline HDP-
Slide 23: Upcoming Catalysts: Multiple Value-Creating Milestones
UPCOMING CATALYSTS: MULTIPLE VALUE-CREATING MILESTONES 2024 2025 2026 2027 2028 Phase I Phase IIa Registrational Trial HDP-101 RP2D* Phase Ia HDP-102 CTA Submission First Patient In est. RDE* Phase I/IIa HDP-103 CTA Submission est. RP2D* Partnered programs: • Huadong Medicine HDP-101 IND in China ap
Slide 24: 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 25: Thank You for Your Attention!
THANK YOU FOR YOUR Heidelberg Pharma AG Ladenburg, Germany Tel.: +49 6203 10090 ATTENTION! investors@hdpharma.com investors@hdpharma.com www.heidelberg-pharma.com www.heidelberg-pharma.com