Heidelberg Pharma AG · XETR:HPHA
Heidelberg Pharma — Inv€$tival Showcase 2022
19 slides from Heidelberg Pharma's conference presentation, Nov 14, 2022
Slide 1: ATACs®: a Unique New Mode of Action to Fight Cancer
ATACs®: a Unique New Mode of Action to Fight Cancer Inv€$tival Showcase - 14th November 2022
Slide 2: Safe Harbor
Safe Harbor Forward looking statements This communication contains certain forward-looking statements, limitations of insurance, limitations of supplies, competition from other relating to the Company’s business, which can be identified by the use of biopharmaceutical, chemical and pharmaceutical co
Slide 3: Heidelberg Pharma – a Clinical Stage Company
Heidelberg Pharma – a Clinical Stage Company Our Our Approach Company Inhibition of RNA Polymerase II ~ 110 employees Targeted delivery via antibodies (ADC technology) Use Amanitin as toxic payload (ATAC® technology) Headquarters in Heidelberg area, Germany Listed on Frankfurt Stock Exchange: HPHA O
Slide 4: Growing Pipeline of Proprietary and Partnered Programs
Growing Pipeline of Proprietary and Partnered Programs Product Target Indication Research Preclinic Phase I Phase II Phase III Partner HDP-101 BCMA Multiple Myeloma (DBCL/CLL) Huadong (Asia) ATAC® pipeline HDP-102 CD37 NHL Huadong (Asia, option) HDP-103 PSMA Prostate cancer Huadong (Asia) HDP-104 GC
Slide 5: ATAC® Technology & Proprietary Projects
ATAC® Technology & Proprietary Projects 5
Slide 6: ATACs: ADCs with Amanitin as a Payload
ATACs: ADCs with Amanitin as a Payload Antibody • Targeting tumor antigen Amanitin as Warhead • Differentiated mechanism of action: inhibition of RNA Polymerase • Kills dormant tumor cells • Overcomes resistance • Predictive biomarker • Synthetic amanitin derivatives with improved properties • GMP m
Slide 7: The Payload Makes The Difference!
The Payload Makes The Difference! Amatoxins – a novel mode of action in oncology Group of toxins from the poisonous Amanita phalloides Murine breast cancer xenograft model green death cap mushroom 1000 (Amanita phalloides) Mean tumore volume [mm3] • Same antibody (Trastuzumab), different 500 payload
Slide 8: ATACs promise higher efficacy in certain aggressive tumors
ATACs promise higher efficacy in certain aggressive tumors del(17p) as a potential biomarker for higher ATAC sensitivity • Chromosomal deletion that eliminates p53 (higher-risk tumor) Collaboration with MD Anderson: and frequently POL2RA gene: Higher ATAC® sensitivity of del(17p) myeloma cells lower
Slide 9: First-in-Human Clinical Trial with an ATAC
First-in-Human Clinical Trial with an ATAC HDP-101: anti-BCMA-ATAC for multiple myeloma Clinical trial designed to determine safe dose and assess preliminary efficacy Two-part, Open-label, Multicenter Phase I/IIa Study 2022 2023 2024 2025 Expansion cohorts Assess accelerated approval option BCMA naï
Slide 10: ATACs Promise Significant Clinical Benefits
ATACs Promise Significant Clinical Benefits Unique preclinical features of HDP-101 Potential clinical benefit Efficacious against dormant tumor cells Longer PFS and MRD negativity Efficacious in ultra-low target-expressing tumor cells Deeper responses and higher ORR Novel MoA to which all patients w
Slide 11: Strategic partnership with Huadong
Strategic partnership with Huadong 11
Slide 12: Strategic Partnership With Huadong Medicine
Strategic Partnership With Huadong Medicine Building a robust ADC product pipeline with best-in-class potential Investment 80 m EUR Shareholding 35% 2 seats in Supervisory Board Commercial Agreements • Exclusive development and commercialization rights for HDP-101 and HDP-103, • Deal value: up to 46
Slide 13: A Transformative Deal with a Strong Partner
A Transformative Deal with a Strong Partner: Supporting our Strategy to Become a Global ADC Player Immediate strengthening Dedicated, long-term investor Accelerated development Potential expansion of cash position and broadening of pipeline of the collaboration Success-based milestones and royalties
Slide 14: Partner Projects & Next steps
Partner Projects & Next steps 14
Slide 15: ATAC® Technology Partnerships
ATAC® Technology Partnerships Targeted conditioning programs with ATACs®: License agreement for an ATAC®: selectively eliminate stem cells and/or immune cells from a patient Worldwide exclusive license for an ATAC targeting a previously prior to transplant or gene therapy. selected target molecule (
Slide 16: Partner Telix: Progressing towards Filing for Market Approval
Partner Telix: Progressing towards Filing for Market Approval Pivotal Phase III ZIRCON reported Positive topline results with imaging agent TLX250-CDx in November 2022 Accurate diagnosis of clear cell renal cell carcinoma (ccRCC) with TLX250-CDx (89Zr-DFO-girentuximab) • Global multicenter Ph III tr
Slide 17: Next Steps Proprietary ATAC Pipeline
Next Steps Proprietary ATAC Pipeline HDP-101 HDP-102 Phase I/IIa study in RRMM CD37-ATAC for NHL • Dose escalation ongoing • On track to IND 2024 • First safety data expected 2022 • Phase I completion in 2023 HDP-103 PSMA-ATAC for prostate cancer • On track to IND 2023 HDP-104 Guanylyl cyclase C (GC
Slide 18: Investment Summary
Investment Summary A clinical-stage company with the goal of becoming a global ADC player Disruptive first-in-humans mode of action provides high Validated by international efficacy and potential for unique high-quality partnerships clinical advantages Clinical lead program with Increased efficacy a
Slide 19: Thank you for your attention and please get in touch with us!
Thank you for your attention and please get in touch with us! Dr. Jan Schmidt-Brand, CEO, CFO Dr. András Strassz, @ Heidelberg Pharma since 2001 CMO 30 years experience in commercial and financial leadership positions in @ Heidelberg Pharma since 2020 pharma and chemical companies, including BASF LL