Vicore Pharma Holding AB · OMXSTO:VICO
Vicore Pharma Holding AB — Investor Presentation (September 2019)
33 slides from Vicore Pharma Holding AB's investor presentation, September 2019
Slide 1: Vicore Pharma
VICORE PHARMA A Rare Disease Company with a Focus on Patients with Fibrotic Lung Disease
Slide 2: Forward Looking Statement
FORWARD LOOKING STATEMENT This presentation may contain certain forward-looking statements and forecasts based on uncertainty, since they relate to events and depend on circumstances that will occur in the future and which, by their nature, will have an impact on Vicore Pharma’s business, financial
Slide 3: Investment Case
INVESTMENT CASE Fibrotic lung diseases – devastating with need of better therapies Two complementary programs for treatment of fibrotic lung disease • VP01 – C21 (new modality) in phase II • VP02 – IMiD (reformulated) entering phase I Differentiated programs addressing fibrosis, vasculopathy a
Slide 4: Vicore is well positioned to develop novel therapies for fibrotic lung disease
Vicore is well positioned to develop novel therapies for fibrotic lung disease
Slide 5: The Team
THE TEAM First class drug development team
Slide 6: The Vicore Team
THE VICORE TEAM CARL-JOHAN DALSGAARD, CEO HANS JEPPSSON, CFO MD, PhD, Karolinska Institute with post-doc experience from Harvard PhD, Finance with post-doc research at UC Berkeley Former Head of Therapy Area Pain Control, AstraZeneca R&D Cross-disciplinary background in finance and medicine 10 years
Slide 7: Fibrotic Lung Disease
FIBROTIC LUNG DISEASE Rare diseases with large medical needs
Slide 8: Idiopathic Pulmonary Fibrosis (IPF)
IDIOPATHIC PULMONARY FIBROSIS (IPF) A rare interstitial pulmonary disease with unknown etiology High morbidity with shortness of breath and cough with a life expectancy of 3-5 years after diagnosis Prevalence US: 150,000 EU: 100,000 Male>female Two drugs on the market Esbriet and Ofev only slows dis
Slide 9: IPF Cough
IPF COUGH A dry persistent cough In IPF a severe debilitating cough correlates to disease progression, morbidity and mortality The pictures below shows a herniated diaphragm due to IPF cough Prevalence for IPF with severe dry cough US: 60,000 EU: 40,000 Male>female Severe dry cough is the symptom th
Slide 10: Systemic Sclerosis (SSc)
SYSTEMIC SCLEROSIS (SSc) A rare autoimmune disease with heterogeneous clinical manifestations The disease is chronic and has frequently a progressive course, can affect every organ with significant disability, disfigurement and mortality Prevalence for severe disseminated disease with ILD US: 36,000
Slide 11: Pipeline
PIPELINE Two phase II programs and one program with proven clinical efficacy
Slide 12: Vicore Pipeline
VICORE PIPELINE Exploratory Preclinical Phase I Phase II VP01 (C21) Idiopathic Pulmonary Fibrosis cv Systemic Sclerosis VP02 (IMiD) Idiopathic Pulmonary Fibrosis FOLLOW-ON MOLECULES (AT2R) Fibrosis 12
Slide 13: VP01 (C21)
VP01 (C21) First in class small molecule AT2R agonist
Slide 14: C21 Mode of Action
C21 MODE OF ACTION C21 is the first small molecule angiotensin II type 2 receptor (AT2R) agonist and also a low affinity thromboxane receptor (TP) antagonist Agonist Counterbalance C21 AT2R High affinity AT1R Antagonist Low affinity Vasodilation Antifibrotic TP Anti-inflammatory Reduced platelet act
Slide 15: AT2R Expression in Man
AT2R EXPRESSION IN MAN According to the Human Protein Atlas, AT2R is primarily expressed in lung in healthy individuals Total AT2r quantification In idiopathic systemic 10% sclerosis (IPF) and 8% systemic sclerosis (SSc), 6% AT2R is dramatically 4% upregulated suggesting a crucial role in 2% counter
Slide 16: C21 in the Bleomycin IPF Mouse Model
C21 IN THE BLEOMYCIN IPF MOUSE MODEL Reduction of fibrosis score (∆ compared with placebo) when drugs are given as prevention Esbriet Ofev Pamrevlumab PIRFENIDONE NINTEDANIB ANTI-CTGF Esbriet ROCHE Ofev B-I Pamrevlumab FIBROGEN C21 C21 50MG/KG 60MG/KG 30MG/KG 0.03MG/KG -23% -38% -41% -65% Wollin 201
Slide 17: C-21 in the Monocrotaline PH Mouse Model
C-21 IN THE MONOCROTALINE PH MOUSE MODEL Representative images of lung fibrosis % Interstitial Right Ventricular Relative AT2 Relative TGF-β Lung Fibrosis systolic pressure Receptor Expression Gene Expression 20 100 4 4 15 80 3 3 10 60 2 2 5 40 1 1 0 20 0 0 C21 reverses cardiopulmonary fibrosis and
Slide 18: C21 Is Also a TP-Receptor Antagonist
C21 IS ALSO A TP-RECEPTOR ANTAGONIST In addition to the NO-mediated vasodilation via AT2R C21 also exhibit an AT2R independent vasodilation in human resistance vessels via the thromboxane receptor Vicore, data on file C21 can address vasculopathy through both AT2R and TP receptor
Slide 19: VP01 – Status
VP01 – STATUS Preclinical Strong effects in models of IPF and pulmonary hypertension Efficacy Reduce expression of profibrotic growth factors Dilates small resistance vessels Safety 3 months toxicology data in mouse, dog and non human primate CMC Established production method for C21 Initially formu
Slide 20: VP02 (IMiD)
VP02 (IMiD) Effective therapy targeted directly to the lung
Slide 21: IMiDs
IMiDs • IMiDs belong to a well established drug class which includes thalidomide, lenalidomide and pomalidomide • Controlled studies and case reports confirm that systemic thalidomide resolves IPF cough • However, peripheral neuropathy and other systemic side effects have limited the use • IMiDs are
Slide 22: IMiDs in Bleomycine IPF Mouse Model
IMiDs IN BLEOMYCINE IPF MOUSE MODEL Reduction of fibrosis score (∆ compared with placebo) when drugs are given as treatment Esbriet Ofev Pamrevlumab C21 Thalidomide Esbriet Ofev Pamrevlumab C21 PIRFENIDONE NINTEDANIB ANTI-CTGF ROCHE B-I FIBROGEN 50MG/KG 60MG/KG 30MG/KG 0.03MG/KG 4MG/KG -1% -10% -41%
Slide 23: IMiDs in IPF – Clinical Evidence
IMiDs IN IPF – CLINICAL EVIDENCE Toby Maher Maureen Horton London Baltimore Treated individual cases Double blind placebo controlled cross over study Significant reduction of cough Improve quality if life Rebecca Haraf Toledo Lin Zhang Published case report Xi’an Open label placebo controlled study
Slide 24: IMiDs Improve Quality of Life in IPF
IMiDS IMPROVE QUALITY OF LIFE IN IPF Quality of life, as measured by the specific St George’s Respiratory Questionnaire (SGRQ), is improved by IMiD treatment 2012 An absolute change of 7 is considered clinically relevant Change in SGRQ scores Δ Improvement 10 No other approved or investigational dru
Slide 25: Drug Formulation for Direct Lung Delivery
DRUG FORMULATION FOR DIRECT LUNG DELIVERY IMiDs in amorphous form are loaded in nanopores of biodegradable microspheres After lung deposition there is an immediate release of 30% and a sustained release of the remaining 70% as the microspheres degrade Direct pulmonary delivery is expected to reduce
Slide 26: VP02 – Status
VP02 – STATUS Preclinical Strong effects in models of IPF Efficacy Reduction of TNF and other cytokine release Safety Systemic safety well known Local lung tolerability to be established CMC Established production method for API Inhalation presentation in nanoporous microspheres ongoing, evaluating
Slide 27: Market
MARKET vcore pharma
Slide 28: The Pulmonary Fibrosis Market
THE PULMONARY FIBROSIS MARKET Global IPF sales by brand $1 250 Combined global sales exceeded $2.3 billion in 2018 $1 000 $750 Price for one year’s treatment is close to $100,000 Million $500 75% of the sales are in the US $250 $0 Allied Market Research estimates annual sales of 2014 2015 2016 2017
Slide 29: Financial
FINANCIAL vcore pharma
Slide 30: Financial Information
FINANCIAL INFORMATION CASH SEK193 million (approx. €18 million) June 30, 2019 STOCK Listed on Nasdaq Stockholm main market on Sep 27, 2019 MARKET CAP SEK730 million (approx. €68 million) Sept 30, 2019 HealthCap VII L.P. 27.8% Göran Wessman 8.3% Swedbank Robur 6.3% Fourth Swedish National Pension Fun
Slide 31: Near Term Tentative Milestones
NEAR TERM TENTATIVE MILESTONES Filing of CTA* for mechanistic SSc phase II study with C21 – October 1 Capsule formulation of C21 – October 1 Filing of CTA for PoC** in IPF with C21 Filing of CTA for open label extension Selection of candidate formulation for VP02 Filing of CTA for phase
Slide 32: Summary
SUMMARY vcore pharma
Slide 33: Vicore is well positioned to develop novel therapies for fibrotic lung disease
Vicore is well positioned to develop novel therapies for fibrotic lung disease
Vicore Pharma — Investor Presentation (September 2019) on 6ix