Heidelberg Pharma Ag · XETR:HPHA
Heidelberg Pharma — Investor Presentation (July 2018)
31 slides from Heidelberg Pharma's investor presentation, July 2018
Slide 1: ATACs fighting Cancer
ATACs fighting Cancer July 2018
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 Project Outlook Platform Model HDP-101 © 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 WILEX AG becomes Heidelberg Improving efficacy New mode of action in cancer Pharma AG therapy - Antibody Targeted Overcoming resistance Amanitin Conjugates (ATACs)
Slide 5: 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 6: 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 7: ATAC Technology Platform
Corporate ATAC ATAC Proprietary Financials & Overview Technology Business ATAC Project Outlook Platform Model HDP-101 © Heidelberg Pharma AG 7
Slide 8: Innovative Potential First-in-humans Mode of Action with Compelling Clinical Potential
Innovative Potential First-in-humans Mode of Action with Compelling Clinical Potential Unique mode of action of Amanitin as toxic payload… • Amanitin kills dividing AND quiescent tumor cells by binding and inhibiting RNA polymerase II Death cap mushroom …results in potential clinical benefits by Che
Slide 9: 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 9
Slide 10: 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 11: 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 12: ATACs – Novel Approach to Cancer Therapy
ATACs – Novel Approach to Cancer Therapy Heidelberg Pharma is the first company using Amanitin for cancer treatment IP protection for ATACs World-class collaboration network includes (est. 2029 up to 2038) • Chemical synthesis of toxin • German Cancer Research Center (DKFZ) • Optimal linker attachme
Slide 13: ATAC Business Model
Corporate ATAC ATAC Proprietary Financials & Overview Technology Business ATAC Project Outlook Platform Model HDP-101 © Heidelberg Pharma AG 13
Slide 14: Early Validation and Cash Through Pharma Collaborations + Future High Value Potential with Proprietary Portfolio
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 15: 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 16: Magenta – Integrated Company Addressing all Aspects of Bone Marrow Transplant
Magenta – Integrated Company Addressing all Aspects of Bone Marrow Transplant Transplant conditioning: Precision approach to transplant via antibody drug conjugates Collaboration enables and accelerates Magenta’s research and development efforts across several targeted conditioning programs for bone
Slide 17: ATACs – Growing Pipeline of Proprietary and Partnered Programs
ATACs – Growing Pipeline of Proprietary and Partnered Programs Additional proprietary ATACs in research and preclinical development • Targets: PSMA, CD19, others • Excellent preclinical efficacy in mice and very good tolerability in cynomolgus monkeys Product Target Indication Research Preclinic Cli
Slide 18: Proprietary ATAC HDP-101
Corporate ATAC ATAC Proprietary Financials & Overview Technology Business ATAC Project Outlook Platform Model HDP-101 © Heidelberg Pharma AG 18
Slide 19: Lead Proprietary ATAC Candidate HDP-101 – Strong Case for Multiple Myeloma
Lead Proprietary ATAC Candidate HDP-101 – Strong Case for Multiple Myeloma • BCMA antibody selected under collaboration with Max Delbrück Center for Molecular Medicine in the Helmholtz Association • Amatoxin + Linker + BCMA antibody = HDP-101 • Ideal for multiple myeloma (MM) treatment • BCMA expre
Slide 20: BCMA Marker for Malignant Plasma Cells
BCMA Marker for Malignant Plasma Cells BCMA is expressed on mature but not on healthy earlier-stage plasma cells. BCMA is specifically expressed in multiple myeloma (MM), a mature B-cell neoplasm. © Heidelberg Pharma AG 20
Slide 21: 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 22: HDP-101: High Efficacy in Multiple Myeloma Xenograft; Long-lasting Remission after Single Treatment
HDP-101: High Efficacy in Multiple Myeloma Xenograft; Long-lasting Remission after Single Treatment Day 40 : Control Group Groups treated with ascending doses of HDP-101 0.1 mg/kg 0.3 mg/kg Disease progression monitored with bioimaging 1 0 11 P B S [ 1 0 m l/k g ] J 2 2 .9 - IS Y - D 2 6 5 C - 3 0 .
Slide 23: HDP-101 – Good Tolerability in Monkeys
HDP-101 – Good Tolerability in Monkeys No signs of liver toxicity in dose escalation and repeat dosing in cynomolgus monkeys 3 animals per group 3 week schedule * Scheduled sacrifice ---- min/mean/max/ values of untreated animals • No clinical side effects, LDH most sensitive parameter from clinical
Slide 24: HDP-101 – Results from Research Collaboration with Heidelberg University and the DKFZ Presented at ASH
HDP-101 – Results from Research Collaboration with Heidelberg University and the DKFZ Presented at ASH Comparison with MMAF (BCMA-Antibody Auristatin Conjugate as used by GSK) on MM Patient Cells • Green lines: Non-dividing (quiescent) cells isolated from multiple myeloma patient bone marrow biopsie
Slide 25: BCMA Validated Target – Therapy Overview
BCMA Validated Target – Therapy Overview ADCs targeting BCMA – small competitive environment − GSK: BCMA-MMAE ADC, Phase II data presented @ASH 12/2017: Overall response rate of 60% − HDP-101: IND in preparation, 1st patient-in H1/2019 − Celgene / Sutro collaboration: IND in preparation, undisclosed
Slide 26: Financials & Outlook
Corporate ATAC ATAC Proprietary Financials & Overview Technology Business ATAC Project Outlook Platform Model HDP-101 © Heidelberg Pharma AG 26
Slide 27: Financials
Financials in € m FY 2017 H1 2018 Guidance 2018 Sales revenue and other income 2.5 2.2 3.0 to 5.0 Operating expenses 13.2 6.9 16.0 to 20.0 Operating result (EBIT) -10.8 -4.7 -12.0 to -16.0 Funds required 8.6* 4.9* 13.0 to 17.0 Funds required per month 0.7* 0.8* 1.1 to 1.4 * Excluding capital increas
Slide 28: Heidelberg Pharma Shares
Heidelberg Pharma Shares Share performance 2018 Share ownership as of 30 June 2018 • High: €3.980 (15 January 2018) Corporate bodies * • Low: €2.580 (8 June 2018) 1% • Daily trading volume: 34,118 shares (2017: 14,049) Freefloat 20% • Shares outstanding: 28,129,782 (as of 30 May 2018) • Current mark
Slide 29: Next Steps and Potential Milestones: First Program Expected to Enter Clinic by End of 2018
Next Steps and Potential Milestones: First Program Expected to Enter Clinic by End of 2018 ATAC technology and proprietary pipeline Partnered legacy clinical programs • HDP-101 MESUPRON® • Biomarker development program matured to RUO status • Link Health: IND approval and start clinical development
Slide 30: 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 31: Contact us
Contact us Upcoming conferences & events H2 2018 Venue Date Herbstkonferenz Frankfurt 3 – 4 September 2018 Baader Investment Conference Munich 24 – 27 September 2018 Interim management statement on the first nine months of 2018 Heidelberg 11 October 2018 BIO Investor Forum San Francisco 17 – 18 Octo
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