Vicore Pharma Holding Ab · OMXSTO:VICO
Vicore Pharma Holding Ab — Investor Presentation (November 2022)
30 slides from Vicore Pharma Holding Ab's investor presentation, November 2022
Slide 1: Vicore Pharma
VICORE PHARMA Developing a new class of drugs – Angiotensin II type 2 receptor agonists November 2022
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: Vicore at a glance
Introduction AT2R IPF/PAH New ATRAGs Vicore at a glance Establishing a portfolio in rare lung disease – IPF and PAH Unprecedented data in IPF phase 2 – increase of FVC at 9 months Pioneering a new drug class – Angiotensin II type 2 receptor agonists (ATRAGs) MoA is addressing regeneration with wide
Slide 4: Company overview
Introduction AT2R IPF/PAH New ATRAGs Company overview Company background and ambition Corporate Highlights • Vicore is an innovative Swedish clinical-stage Headquarters pharmaceutical company dedicated to creating life- changing treatments in diseases where the AT2 receptor Stockholm/Gothenburg Swed
Slide 5: Market leadership opportunity in rare lung diseases
Introduction AT2R IPF/PAH New ATRAGs Market leadership opportunity in rare lung diseases Possibility to expand the IPF market with more tolerable treatment Opportunity for market leadership 11.0 • Currently approved drugs in IPF highly unsatisfactory 4.5 (1) • New MoA; targets fibrosis and IPF – add
Slide 6: Vicore management team & board
Introduction AT2R IPF/PAH New ATRAGs Vicore management team & board CARL-JOHAN DALSGAARD, MD, PhD HANS JEPPSSON, PhD CHIEF EXECUTIVE OFFICER CHIEF FINANCIAL OFFICER Ex AstraZeneca R&D: Head of Therapy Area Pain Control, Cross-disciplinary background in finance and medicine. 10 years senior managemen
Slide 7: Vicore Pharma – pipeline
Introduction AT2R IPF/PAH New ATRAGs Vicore Pharma – pipeline Indication Compound Preclinical Phase 1 Phase 2 Phase 3 Next event IPF fibrosis C21 Interim analysis, Q4 2022 PAH C21 Phase 2a start, H1 2023 PF anxiety DTx Pivotal trial start, Q4 2022 IPF cough Inhaled IMID Toxicology study, H1 2023 Car
Slide 8: Pioneering the Angiotensin II type 2 receptor (AT2R)
Pioneering the Angiotensin II type 2 receptor (AT2R)
Slide 9: Angiotensin receptors as drug targets
Introduction AT2R IPF/PAH New ATRAGs Angiotensin receptors as drug targets • The Renin-Angiotensin System (RAS) is an AT1R evolutionarily well conserved system, crucial • Increase blood Antagonists for body and tissue pressure ACE and ARB’s homeostasis • The discovery of renin in the late 19th centu
Slide 10: Multimodal antifibrotic and vasoactive actions of AT2R activation
Introduction AT2R IPF/PAH New ATRAGs Multimodal antifibrotic and vasoactive actions of AT2R activation AT2R characteristics AT2R • 7TM domain receptor, crystal structure solved • Several tissue‐specific signaling mechanisms described • Activation of protein phosphatases (SHP‐1, Serine/ Threonine a
Slide 11: AT2R in disease – preclinical and clinical evidence
Introduction AT2R IPF/PAH New ATRAGs AT2R in disease – preclinical and clinical evidence C21 in preclinical C21 clinical Organ Cell/Tissue Disease targets Disease modifying effect models confirmation • Alveolar repair Alveolar epithelial • IPF progenitor cells • PAH • Remodeling • Prevent fibrosis
Slide 12: Rare lung disease – IPF and PAH
Rare lung disease – IPF and PAH
Slide 13: Idiopathic Pulmonary Fibrosis (IPF) – a significant unmet need
Introduction AT2R IPF/PAH New ATRAGs Idiopathic Pulmonary Fibrosis (IPF) – a significant unmet need A devastating interstitial lung disease… …with limited therapeutic options… • ~250 000 patients in the US and Europe • Only 2 approved IPF therapeutics to date with limited efficacy • Life expectancy
Slide 14: C21 in IPF (1) – mechanism of action
Introduction AT2R IPF/PAH New ATRAGs C21 in IPF (1) – mechanism of action Normal alveolus Lung Normal fibrosis development alveolus Alveolar repair AEC1 cell Proliferation & AEC2 - Progenitor cell AEC2 Differentiation - Proliferation dysfunction - Differentiation and apoptosis C21 TGFβ-1 O2 CO2 AEC2
Slide 15: C21 in IPF (2) – preclinical data
Introduction AT2R IPF/PAH New ATRAGs C21 in IPF (2) – preclinical data Significant and consistent effects of Bleomycin rat model C21 treatment in animal fibrosis Collagen staining models • Collagen content (Picro-sirius ↓ Lung fibrosis staining, Hydroxyproline, Collagen gene expression) Addera ngn g
Slide 16: C21 in IPF (3) – AT2R in human lung and target engagement
Introduction AT2R IPF/PAH New ATRAGs C21 in IPF (3) – AT2R in human lung and target engagement Abundant AT2R expression in human lung and specific C21 receptor binding C21 inhibits TGFβ1 in human IPF lung tissue Receptor autoradiography performed with human lung tissue slices Precision-cut human lun
Slide 17: C21 in IPF (4) – human AT2R lung expression and relevance
Introduction AT2R IPF/PAH New ATRAGs C21 in IPF (4) – human AT2R lung expression and relevance AT2R highly expressed in AEC2 cells in the lung(1) Clinical COVID-19 trial confirms alveolar AEC2 cell target • Critical disease due to alveolar # patients on supplemental O2 epithelial cell infection 39 3
Slide 18: C21 in IPF (5) – Phase 2 AIR trial design
Introduction AT2R IPF/PAH New ATRAGs C21 in IPF (5) – Phase 2 AIR trial design • Multicenter, open-label, single-arm trial Lung volume - FVC (L) • 60 subjects with IPF 4 Mild: • Central reader of HRCT to secure IPF diagnosis 80-100% normal Reduction by age 3 • Gold standard FVC measurement C21 Targe
Slide 19: C21 in IPF (6) – Interim analysis of AIR trial
Introduction AT2R IPF/PAH New ATRAGs C21 in IPF (6) – Interim analysis of AIR trial: stabilization and increased FVC FVC change from baseline over time (Mean ±SEM) vs expected change of untreated patients and SoC 1,2 • After an initial stabilization there is an increase in FVC 1 • At 24 weeks, FVC i
Slide 20: C21 in IPF (7) – IPF Phase 2 interim data in summary
Introduction AT2R IPF/PAH New ATRAGs C21 in IPF (7) – IPF Phase 2 interim data in summary Stabilizes disease in 12 weeks Increases lung function in 24-36 weeks Safe and well tolerated – no GI side effects Encouraging patient testimonies 20
Slide 21: C21 in PAH (1) – need for disease-modifying therapy
Introduction AT2R IPF/PAH COVID-19 C21 in PAH (1) – need for disease-modifying therapy PAH is a rare, fatal cardiopulmonary disease…. ….with significant unmet medical need • Orphan disease with ~67 000 patients in US and Europe(1,2) • Currently 14 approved PAH drugs (mainly • Disease is characterize
Slide 22: C21 in PAH (2) – preclinical data
Introduction AT2R IPF/PAH New ATRAGs C21 in PAH (2) – preclinical data Sugen-Hypoxia rat model Collagen staining Effects of C21 treatment: ↓ Lung fibrosis ↓ Remodeling of pulmonary vessels 35 ↓ Cardiac remodeling Diastolic Pulmonary Arterial 30 *** * Diastolic PAP (mmHg) Pressure (PAP) ↓ Pulmonary h
Slide 23: C21 in PAH (3) – PoC trial measuring Pulmonary Vascular Resistance
Introduction AT2R IPF/PAH New ATRAGs C21 in PAH (3) – PoC trial measuring Pulmonary Vascular Resistance (PVR) Background Screening Baseline and run-in • Increased PVR and Pulmonary Arterial Pressure (PAP) is caused <4 wks <6 wks Treatment period (24 wks) Follow-up (4 wks) by pulmonary arterial obstr
Slide 24: Digital Therapeutic for PF anxiety – COMPANION study
Introduction AT2R IPF/PAH New ATRAGs Digital Therapeutic (DTx) for Pulmonary Fibrosis (PF) anxiety – COMPANION study Background • Pulmonary Fibrosis (PF) is a deadly disease with poor QoL Screening Randomization Treatment period (8 weeks) Follow-up (3 weeks) dCBT-PF (125 pts) • 63% of patients have
Slide 25: Inhaled thalidomide – targeted approach to address IPF cough
Introduction AT2R IPF/PAH New ATRAGs Inhaled thalidomide – targeted approach to address IPF cough Background • Unlike other types of chronic cough, IPF cough does not respond to placebo treatment • No approved therapies today • In a double-blind cross-over study, oral thalidomide significantly impro
Slide 26: New ATRAGs
New ATRAGs Ras
Slide 27: Vicore’s proprietary Angiotensin II type 2 receptor agonists (ATRAGs)
Introduction AT2R IPF/PAH New ATRAGs Vicore’s proprietary Angiotensin II type 2 receptor agonists (ATRAGs) C21 – first in class – rare lung diseases • NCE patent expires 2024 • Market exclusivity (NCE) – US 5 years, Europe 10 years • Orphan drug status in IPF granted – US 7y, EU 10 years • Several p
Slide 28: ATRAG – a new class of drugs
Introduction AT2R IPF/PAH New ATRAGs ATRAG – a new class of drugs Based on the extensive preclinical documentation, the localization of the receptor in man as well as accumulating clinical data, stimulating AT2R may be beneficial in a wide range of diseases ATRAG indications IPF PAH Cardiorenal Wome
Slide 29: Vicore at a glance
Vicore at a glance Pioneering a new drug class – Angiotension II type 2 receptor agonists Unprecedented data in IPF phase 2 – increase of FVC at 9 months Establishing a portfolio in rare lung disease – IPF and PAH MoA is addressing regeneration with wide therapeutic implications A clinical platform
Slide 30: Vicore is well positioned to unlock the potential of a new class of drugs
Vicore is well positioned to unlock the potential of a new class of drugs - in rare lung diseases and beyond 30
Vicore Pharma — Investor Presentation (November 2022) on 6ix