Heidelberg Pharma Ag · XETR:HPHA
Heidelberg Pharma — Investor Presentation (August 2019)
32 slides from Heidelberg Pharma's investor presentation, August 2019
Slide 1: ATACs fighting Cancer
ATACs fighting Cancer July / August 2019
Slide 2: Safe Harbor
Safe Harbor Forward looking statements This communication contains certain forward-looking additional funding, risks of product liability and limitations of statements, relating to the Company’s business, which can be insurance, limitations of supplies, competition from other identified by the use o
Slide 3: Corporate Overview
Corporate ATAC ATAC Proprietary Financials & Overview Technology Business ATAC Projects Outlook Platform Model © Heidelberg Pharma AG 3
Slide 4: Heidelberg Pharma at a Glance
Heidelberg Pharma at a Glance Developing new options to address major challenges in cancer therapy Our Company Our Mission Our Approach Listed as Heidelberg Pharma AG Improve efficacy New mode of action in cancer Frankfurt Stock Exchange: WL6 therapy Overcome resistance Shares outstanding: 28.16 mil
Slide 5: Management Team with Strong Pharma and R&D Experience
Management Team with Strong Pharma and R&D Experience Dr. Jan Prof. Dr. Schmidt- Andreas Brand Pahl CEO / CFO CSO @ Heidelberg Pharma since 2001 @ Heidelberg Pharma since 2012 20 years’ experience in commercial and financial 20 years’ experience in research and higher education leadership positions
Slide 6: Strategic Cornerstones
Strategic Cornerstones Additional upside potential Build proprietary ATAC Sign technology licensing with partnered non-ATAC pipeline collaborations legacy clinical assets Proprietary lead candidate ATAC technology partnering HDP-101 with pharma and biotech ATAC Lead ATAC technology HDP-101 partner A
Slide 7: ATACs – Growing Pipeline of Proprietary and Partnered Programs
ATACs – Growing Pipeline of Proprietary and Partnered Programs Additional proprietary ATACs in research and preclinical development • Excellent preclinical efficacy in mice and very good tolerability Product Target Indication Research Preclinic Clinic Partner Proprietary I II III HDP-101 BCMA Multip
Slide 8: Achievements – Last 12 Months
Achievements – Last 12 Months Proprietary lead candidate HDP-101 ATAC technology partnering • Core milestones of GMP • Magenta Therapeutics manufacturing achieved ✓ 1st licensing option exercised • Preclinical GLP tox studies – first part (10/2018) completed ✓ 3 poster presentations: ASH HDP and Mag
Slide 9: ATAC Technology Platform
Corporate ATAC ATAC Proprietary Financials & Overview Technology Business ATAC Projects Outlook Platform Model © Heidelberg Pharma AG 9
Slide 10: Amanitin – Innovative Cell Toxin with High Clinical Potential
Amanitin – Innovative Cell Toxin with High Clinical Potential Amanitin From nature to lab Unique mode of action of Amanitin as toxic payload… • Amanitin kills dividing AND quiescent tumor cells by binding and inhibiting RNA polymerase II → results in potential clinical benefits by Antibody Targeted
Slide 11: Antibody Drug Conjugate Technology – Proven & Established Technology
Antibody Drug Conjugate Technology – Proven & Established Technology ADC: Combining the best of two therapeutic modalities Antibody specificity + toxin efficacy → improved therapeutic window and fewer side effects © Heidelberg Pharma AG 11
Slide 12: Amanitin Compared Favorably to Approved ADC Toxins
Amanitin Compared Favorably to Approved ADC Toxins Calicheamicin Auristatin Maytansinoids Amanitin Target DNA Tubulin Tubulin RNA Pol II Target concentration ? 10-5 M 10-5 M 10-8 - 10-9 M Structure hydrophobic hydrophobic hydrophobic hydrophilic Activity on low low low high non-dividing cells Activi
Slide 13: ATACs – Highly Potent Payload, Superior to Existing Payloads
ATACs – Highly Potent Payload, Superior to Existing Payloads Complete remissions in JIMT-1 xenograft models after single dose application of 2.9mg/kg Her2-ATAC Clinical dose of T-DM1 ineffective (FDA approved Kadcyla®) Equivalent dose of HER2-ATAC shows complete remission Kadcyla could not achieve r
Slide 14: ATAC Business Model
Corporate ATAC ATAC Proprietary Financials & Overview Technology Business ATAC Projects Outlook Platform Model © Heidelberg Pharma AG 14
Slide 15: Early Validation and Cash Through Pharma Collaborations
Early Validation and Cash Through Pharma Collaborations + Future High Value Potential with Proprietary Portfolio Partnering target by target Antibodies from partners, license to the partner, development by the partner A A A A Defined payload ATAC toolbox: Linker variations customized and target-opti
Slide 16: Multi-Target Research and Option Agreements with Takeda and Magenta
Multi-Target Research and Option Agreements with Takeda and Magenta Research & Option Agreements Financials • Synthesis of ATACs using antibodies from the • Upfront technology access fees and R&D support Takeda/Magenta portfolio • Option fee for each option exercised • Both companies have exclusive
Slide 17: Magenta – Integrated Company Addressing all Aspects of Bone Marrow Transplant
Magenta – Integrated Company Addressing all Aspects of Bone Marrow Transplant Copyright: Magenta 2018 Collaboration enables and accelerates Magenta’s research and development efforts across 17 several targeted conditioning programs for bone marrow transplant with ATACs
Slide 18: Proprietary ATAC Projects
Corporate ATAC ATAC Proprietary Financials & Overview Technology Business ATAC Outlook Platform Model Projects © Heidelberg Pharma AG 18
Slide 19: Multiple Myeloma – Major Unmet Medical Need
Multiple Myeloma – Major Unmet Medical Need • Second most prevalent hematopoietic malignancy* • MM represents about 0.8-1% of all cancers worldwide, with 70,000 deaths annually; median age at diagnosis is 65-70 years • Malignancy characterized by the proliferation of single clone of plasma cells der
Slide 20: BCMA Validated Target – Pipeline Overview
BCMA Validated Target – Pipeline Overview ADCs targeting BCMA – small competitive environment − GSK: BCMA-MMAE ADC, Phase II data presented @ASH 12/2017: Overall response rate of 60% − Medimmune: Start Phase I Q2 2018 − HDP-101: IND and CTD in preparation for filing in Q4 2019 − Celgene / Sutro coll
Slide 21: HDP-101 – Results from Research Collaboration with Heidelberg University and the DKFZ
HDP-101 – Results from Research Collaboration with Heidelberg University and the DKFZ Presented at ASH Comparison with MMAF (Auristatin Conjugate as used by GSK) on MM Patient Cells • Green lines: Non-dividing (quiescent) cells isolated from multiple myeloma patient bone marrow biopsies • Black line
Slide 22: 17p Deletion – Loss of TP53/POL2RA on Chromosome 17
17p Deletion – Loss of TP53/POL2RA on Chromosome 17 23 human chromosome pairs p q Tumorsuppressor • TP53 gene on chromosome 17 is frequently mutated (> 50%) in human cancer cells • POLR2A gene frequently co-deleted with TP53 → higher sensitivity to treatment with ATACs Quelle: https://en.wikipedia.o
Slide 23: 17p Deletion – Loss of TP53/POL2RA on Chromosome 17
17p Deletion – Loss of TP53/POL2RA on Chromosome 17 • NATURE Publication: 10 x increased susceptibility to Amanitin in the case of loss of POLR2A • POLR2A potential biomarker to increase therapeutic window Target of amanitin POLR2A close to TP53 on Chr 17 → Passenger deletion © Heidelberg Pharma AG
Slide 24: Literature Confirms Very Bad Prognosis of MM Patients with 17p Deletion
Literature Confirms Very Bad Prognosis of MM Patients with 17p Deletion Overall survival with and without 17p deletion Without 17p Deletion 17p Deletion Blood 2009, Jul 16;114 (3): 522-525 © Heidelberg Pharma AG 24
Slide 25: PSMA-ATAC – Metastatic Castration-Resistant Prostate Cancer (mCRPC)
PSMA-ATAC – Metastatic Castration-Resistant Prostate Cancer (mCRPC) 2500 • PSMA is a clinically validated target, e.g. 177Lu-PSMA-617, a radio-ligand therapy for mCRPC T u m o r V o lu m e [m m ] 3 2000 • PSMA is a commercially attractive target: Novartis acquired Endocyte for that program for USD 2
Slide 26: Clinical Hypothesis Around 17p Deletion
Clinical Hypothesis Around 17p Deletion • Multiple Myeloma and prostate cancer patients FDA programs to enhance with 17p deleted tumors have a very high medical innovative therapies need for new treatment options • HDP-101 has a preferential activity on 17p deleted tumor cells derived from Multiple
Slide 27: Financials & Outlook
Corporate ATAC ATAC Proprietary Financials & Overview Technology Business ATAC Projects Outlook Platform Model © Heidelberg Pharma AG 27
Slide 28: Financials
Financials Guidance in € m FY 2018 6M 2019 2019 Sales revenue and other income 4.4 4.1 5.0 to 7.0 Operating expenses 16.0 8.4 14.0 to 18.0 Operating result (EBIT) -11.7 -4.3 -8.0 to -12.0 Funds required 10.9 6.3 10.0 to 14.0 Funds required per month 0.9 1.1 0.9 to 1.2 Financing • Mixed non-cash and
Slide 29: Heidelberg Pharma Shares
Heidelberg Pharma Shares Share performance 2019 ytd Share ownership unchanged as of 30 June 2019 • High: €3.390 (17 April 2019) Corporate bodies * • Low: €2.350 (2 January 2019) 1% • Ave. daily trading volume: 9,095 shares Freefloat (2018: 34,118) 20% • Shares outstanding: 28,155,630 (as of 30 June
Slide 30: Next Steps and Potential Milestones
Next Steps and Potential Milestones ATAC technology and proprietary pipeline Partnered legacy clinical programs • HDP-101 REDECTANE® (Telix) • Complete GLP toxicity study TLX250-CDx – imaging agent • ZIRCON Phase III trial: Add new • Prepare study protocol, sign up study centers sites in the US and
Slide 31: Investment Summary
Investment Summary Developing new options to address major challenges in cancer therapy • Heidelberg Pharma is developing new treatment options with Amanitin for different cancer indications, also validated by high quality collaborations • The innovative first in humans mode of action provides high
Slide 32: Meet Us
Meet Us Upcoming conferences & events Venue Date Pareto Securities' 10th Annual Health Care Conference Stockholm 5 September 2019 Baader Investment Conference Munich 23 – 26 September 2019 World ADC Congress San Diego 8 – 11 October 2019 European Antibody Congress Basel 15 – 17 October 2019 BIO-Euro
Heidelberg Pharma — Investor Presentation (August 2019) on 6ix