Vivoryon Therapeutics N.V. · EURONEXT:VVY
Vivoryon Therapeutics — Probiodrug — H1 2017 Earnings Presentation
35 slides from Vivoryon Therapeutics's earnings presentation, Aug 31, 2017
Slide 1: Interim Report H1 2017
Interim Report H1 2017 Reporting period January – June 2017 Halle (Saale), 31 August 2017 Konrad Glund Hendrik Liebers Inge Lues Frank Weber CEO CFO CDO CMO
Slide 2: Important notice and disclaimer
Important notice and disclaimer This Presentation has been prepared and issued by Probiodrug AG (the “Company”) and has not been independently verified by any third party. No representation or warranty is given as to the achievement or reasonableness of, and no reliance should be placed on, any proj
Slide 3: Content
Content 1. Corporate introduction 2. Results January – June 2017 3. Outlook 4. Q & A 3
Slide 4: At a glance
At a glance Alzheimer’s disease – a worldwide health crisis New concept for treatment – target pGlu-Abeta (N3pG), involved in initiation and progression of disease Glutaminyl Cyclase (QC) catalyzes formation of N-terminal pGlu-Abeta from N-terminal Glutamate Products under development PQ91
Slide 5: Longstanding track-record and renowned investor base
Longstanding track-record and renowned investor base Brief history Major investors (> 3%) 1997: Foundation, pioneered a new class of anti-diabetics (gliptins) – partnerships with Merck & Co, Ferring and Novartis 2004: Sold diabetes franchise to OSI Pharmaceuticals – proceeds partially returned t
Slide 6: Alzheimer's Disease: growing burden, no cure
Alzheimer's Disease: growing burden, no cure Worldwide dementia population will triple Alzheimer's Disease introduction in the next 30 years* Leading cause of dementia, ultimately CAGR leading to death +3% 131 Large burden on families 47 Growing cost for society Available treatments marginal
Slide 7: Original Abeta approach
Original Abeta approach Probiodrug targets toxic structures in Alzheimer's Disease Considerations* Most new drug treatments Most new drugs have focused on Abeta formation or Abeta/plaque clearance have targeted Abeta or plaques Therapies have focused on: 1. Reduction of Abeta formation 2. Cleara
Slide 8: Probiodrug's differentiated approach
Probiodrug’s differentiated approach Probiodrug targets toxic structures in Alzheimer's Disease Considerations* Probiodrug and others Most new drugs have focused on Abeta formation or Abeta/plaque clearance have progressed insights on Abeta and its role in AD Abeta has a physiological function
Slide 9: pGlu-Abeta - N-modified Abeta
pGlu-Abeta - N-modified Abeta Jawhar, S., Wirths, O., Bayer, T.A. JBC 286, 45, 2011 9
Slide 10: Target pGlu-Abeta: small molecule approach (QC inhibitor)
Target pGlu-Abeta: small molecule approach (QC inhibitor) Probiodrug was first to discover the role of QC and has full ownership of broad target IP Jawhar, S., Wirths, O., Bayer, T.A. JBC 286, 45, 2011; modified 10
Slide 11: Target pGlu-Abeta: antibody approach
Target pGlu-Abeta: antibody approach Probiodrug’s complementary approach with a pGlu-Abeta specific antibody Jawhar, S., Wirths, O., Bayer, T.A. JBC 286, 45, 2011; modified 11
Slide 12: Anti pGlu-Abeta strategies– the emerging new field in AD treatment
Anti pGlu-Abeta strategies– the emerging new field in AD treatment pGlu-Abeta (N3pG) - preclinically validated target critical to the formation of toxic oligomers involved in the initiation and progression of AD, pGlu-Abeta (N3pG) – first positive clinical data in AD patients accomplished Two
Slide 13: Focused proprietary pipeline
Focused proprietary pipeline Pre- Product Phase 1 Phase 2 clinical PQ912 Small molecule QC inhibitor SAPHIR trial results announced 11 June 2017 PBD-C06 pGlu-Abeta specific monoclonal antibody PQ1565 Small molecule QC inhibitor Clinical proof of concept 13
Slide 14: The Probiodrug Share
The Probiodrug Share KEY INFORMATION SHAREHOLDER (> 3%)* ISIN: DE0007921835 WKN: 792183 Ticker Symbol: PBD Type of shares: Bearer shares Number of shares: 8,186,735 Stock exchange: Euronext Amsterdam Liquidity Provider: Kempen & Co. Listing Agent: Kempen & Co. First trading day: 27
Slide 15: Content
Content 1. Corporate introduction 2. Results January – June 2017 3. Outlook 4. Q & A 15
Slide 16: Key Highlights January to June 2017
Key Highlights January to June 2017 PQ912 delivers positive pharmacodynamic and efficacy results in a Phase-2a-study in early stage AD patients Successful settlement of the longpending potential tax liability PQ912 demonstrates efficacy in preclinical Huntington`s disease model Publication o
Slide 17: Key financial figures January – June 2017 (according to IFRS)
Key financial figures January – June 2017 (according to IFRS) In EUR k, unless otherwise stated Jan - June 2017 Jan - June 2016 Jan - Dec 2016 Earnings, Financial and Net Assets Position Operating loss -6,262 -5,987 -13,777 Income from release of tax provision 1,956 0 0 Net loss for the period -4,30
Slide 18: Details of the Financial Results January – June 2017
Details of the Financial Results January – June 2017 (according to IFRS) Net loss Operating loss Operating loss in line with expectations kEUR 6,262 primarily driven by R&D expenses for the SAPHIR study Release of tax provision Income from release of tax provision after kEUR 1,956 successful set
Slide 19: Operational Review (1)
Operational Review (1) PQ912 - SAPHIR Phase-2a trial design Objectives and read-outs Trial ongoing in 7 EU countries Primary objective: To assess safety and Study chair: Philip Scheltens, Amsterdam tolerability of PQ912 compared with placebo Total: 120 patients Early stage Alzheimer's Diseas
Slide 20: Operational Review (2)
Operational Review (2) Update PQ912 SAPHIR trial used a high dose of PQ912 (which showed 90% QC-enzyme inhibition in CSF in Phase-1) in order to find both: early-on tolerability signs and first signals on various sensitive secondary exploratory outcome measures in a relatively short time. Ju
Slide 21: Operational Review (3)
Operational Review (3) Update PQ912 - Results of the Phase-2a SAPHIR Study in early stage AD patients Safety No statistically significant differences of PQ912 vs placebo between number of patients experiencing an adverse event (PQ912 n=49, placebo n=45) or number of patients with a serious adver
Slide 22: Operational Review (4)
Operational Review (4) Update PQ912 - Results of the Phase 2a SAPHIR Study in early stage AD patients Pharmacodynamics and efficacy Very strong target engagement (QC inhibition), confirming the finding in Phase-1 in elderly healthy volunteers of more than 90% Reduction of numbers of patients w
Slide 23: Operational Review (5)
Operational Review (5) Update PQ912 - Results of the Phase 2a SAPHIR Study in early stage AD patients Overall conclusion: SAPHIR revealed a positive benefit risk ratio of PQ912 and provides important guidance how to move forward in the development pf PQ912 as a disease-modifying drug for AD. R
Slide 24: Operational Review (6)
Operational Review (6) Update PBD-C06 Monoclonal antibody targeting pGlu-Abeta, while leaving non-toxic forms of Abeta untouched Currently in preclinical stage IgG isotype modified to eliminate complement activation (assumed to be involved in ARIAs) while keeping phagocytosis competency For
Slide 25: Operational Review (7)
Operational Review (7) Publications/ Presentations March 2017: poster/ presentation at Alzheimer’s and Parkinson’s Diseases Congress (AD/PDTM 2017) QC- enzyme/CSF Biomarker Cerebrospinal fluid glutaminyl cyclase (QC) activity correlates with Alzheimer’s disease biomarkers and inflammation mole
Slide 26: Operational Review (8)
Operational Review (8) Publications/ Presentations April 2017: Oral presentation at the 12th Annual HD Therapeutics Conference of the CHDI Foundation The Glutaminyl Cyclase (QC) inhibitor PQ912 demonstrates beneficial effects in a preclinical Huntington´s disease model HD is the most common in
Slide 27: Operational Review (9)
Operational Review (9) Publications/ Presentations May 2017: Acceptance of PQ912 Pharmacology Paper by Peer Reviewed Journal of Pharmacology and Experimental Therapeutics Glutaminyl Cyclase Inhibitor PQ912 improves cognition in mouse models of Alzheimer’s disease – studies on relation to effecti
Slide 28: Corporate Review (1)
Corporate Review (1) Settlement of the potential tax liability resulting from the financial year 2004 Agreement reached with the relevant authorities of Saxony-Anhalt about the corporate income and trade tax claim for the assessment period 2004. Following a tax audit in 2008, tax authorities ret
Slide 29: Corporate Review (2)
Corporate Review (2) Annual Shareholders’ Meeting 2017 on 13 June 2017 All resolutions proposed by the Company’s Management and Supervisory Board were approved at the meeting including: Adoption of a resolution on the approval of the actions of the management board members for the financial year
Slide 30: Content
Content 1. Corporate introduction 2. Results January – June 2017 3. Outlook 4. Q & A 30
Slide 31: Outlook
Outlook Continuing the clinical development of PQ912 with a focus on dose dependency and a longer treatment period, Exploring partnering options, Continuing the development of PBD-C06, Further scientific analysis of potential additional indications for the use of QC inhibitors, Further inc
Slide 32: Anticipated news flow (selection)
Anticipated news flow (selection) 2014 2015 2016 2017 First patient enrolled in PQ912 Phase- PQ912 results of long term tox PQ912 Preclinical ✔ ✔ ✔ assessment of 2a “SAPHIR” study at leading studies Alzheimer Center in Amsterdam potential in Huntington Disease Additional data on Glutaminyl Cyc
Slide 33: Financial Calendar
Financial Calendar May 12th, 2017 Interim Management Statement Q1 2017 June 13th , 2017 Annual General Meeting of Shareholders in Berlin August 31st, 2017 Interim Report, half year results 2017 November 30th, 2017 Interim Management Statement Q3 2017 33
Slide 34: Content
Content 1. Corporate introduction 2. Results January – June 2017 3. Outlook 4. Q & A 34
Slide 35: Q&A
probtodrug O&A probtodrug