Vicore Pharma Holding Ab · OMXSTO:VICO
Vicore Pharma Holding Ab — Investor Presentation (February 2023)
29 slides from Vicore Pharma Holding Ab's investor presentation, February 2023
Slide 1: Vicore Pharma
VICORE PHARMA Unlocking the potential of a new class of drugs – Angiotensin II type 2 receptor agonists (ATRAGs) February 2023
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
Vicore at a glance Unlocking the potential of a new drug class – ATRAGs Unprecedented data in IPF phase 2a Strong scientific rationale for disease modification in PAH MoA with wide therapeutic implications A clinical platform under development – capitalizing on lead 3
Slide 4: Company overview
Introduction AT2 receptor IPF/PAH New ATRAGs Company overview Background The company was founded in the early 2000s, based on the synthesis of the first small molecule AT2 receptor agonist C21 by Professor Anders Hallberg’s group at Uppsala University(1) Headquarters Stockholm Sweden, with Clin Ops
Slide 5: Market leadership opportunity in rare lung diseases
Introduction AT2 receptor 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 11.7 4.5 (1) • Still huge unmet medial need in IPF and PAH IPF – additional potential 2.9 (3) • C21 st
Slide 6: Strong leadership team with extensive industry experience
Introduction AT2 receptor IPF/PAH New ATRAGs Strong leadership team with extensive industry experience CARL-JOHAN DALSGAARD, MD, PhD HANS JEPPSSON, PhD MIKAEL NYGÅRD, PhD CHIEF EXECUTIVE OFFICER CHIEF FINANCIAL OFFICER VP BUSINESS DEVELOPMENT Ex AstraZeneca R&D: Head of Therapy Area Pain Control, Cr
Slide 7: Diversified pipeline with key readouts in the next year
Introduction AT2 receptor IPF/PAH New ATRAGs Diversified pipeline with key readouts in the next year Indication Compound Preclinical Phase 1 Phase 2 Phase 3 Comments Final data phase 2a, Q4 2023 IPF fibrosis C21 Phase 2b trial preparations during 2023 Proof-of principle study on endothelial PAH C21
Slide 8: The Angiotensin II type 2 (AT2) receptor is an attractive drug target
Introduction AT2 receptor IPF/PAH New ATRAGs The Angiotensin II type 2 (AT2) receptor is an attractive drug target ATRAGs (Angiotensin II type 2 receptor agonists) have a favorable pharmacological profile ATRAGs • Target is upregulated in diseased tissues • Selective stimulation of an endogenous rep
Slide 9: Multimodal action of AT2 receptor activation with broad therapeutic potential
Introduction AT2 receptor IPF/PAH New ATRAGs Multimodal action of AT2 receptor activation with broad therapeutic potential PDGF-BB FGF TGF-b1 ATRAG VEGF Cytokines Tyrosine TGF-bR AT2 Kinase R receptor Akt SMAD 2/3/4 Erk1/2 PP2A Jak/STAT SHP-1 eNOS → NO, cGMP MKP-1 IƘB NFƘB PPARγ Collagen/ECM MMP’s E
Slide 10: Rare lung disease – IPF and PAH
Rare lung disease – IPF and PAH
Slide 11: Idiopathic Pulmonary Fibrosis (IPF) – a significant unmet need
Introduction AT2 receptor 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 exp
Slide 12: The AT2 receptor is highly expressed in lung AEC2 cells
Introduction AT2 receptor IPF/PAH New ATRAGs The AT2 receptor is highly expressed in lung AEC2 cells Type 2 Alveolar epithelial cells (AEC2) Source: IPF cell atlas. Note: Single-cell RNA-sequencing (scRNA-seq) of single-cell suspensions generated from non-fibrotic control and PF lungs. N=30 12
Slide 13: AEC2 cell dysfunction is a key trigger for development of fibrosis in IPF
Introduction AT2 receptor IPF/PAH New ATRAGs AEC2 cell dysfunction is a key trigger for development of fibrosis in IPF Normal alveolus Lung fibrosis development Alveolar repair AEC1 cell AEC2 - Progenitor cell Proliferation & - Proliferation AEC2 dysfunction Differentiation - Differentiation and apo
Slide 14: Strong preclinical in-vivo data demonstrate multimodal effects of C21
Introduction AT2 receptor IPF/PAH New ATRAGs Strong preclinical in-vivo data demonstrate multimodal effects of C21 Significant and consistent effects of Bleomycin rat model C21 treatment across animal Collagen staining fibrosis models • Collagen content (Picro-sirius ↓ Lung fibrosis staining, Hydrox
Slide 15: C21 modulates gene expression in human lung tissue slices and primary cells
Introduction AT2 receptor IPF/PAH New ATRAGs C21 modulates gene expression in human lung tissue slices and primary cells Inhibition of profibrotic Collagen-1 and induction of anti-fibrotic MMP1 in primary lung cells Inhibition of TGFβ1 in human IPF lung tissue slices 100 TGFβ protein (% of Vehicle)
Slide 16: AIR Phase 2a trial in treatment-naïve IPF patients
Introduction AT2 receptor IPF/PAH New ATRAGs AIR Phase 2a trial in treatment-naïve IPF patients • Primary aim: To evaluate safety of C21 in patients with IPF • Secondary aim: To evaluate efficacy of C21 in IPF as measured by FVC change • N=60 treatment naïve IPF patients o Open label single arm Tria
Slide 17: AIR IPF Phase 2a data – Demography and baseline characteristics
Introduction AT2 receptor IPF/PAH New ATRAGs AIR IPF Phase 2a data – Demography and baseline characteristics Interim analysis October 2022 Patient characteristics Baseline pulmonary function tests All enrolled (N=45) All enrolled (N=45) Age (years) - Mean (SD) 67.0 (9.1) FVC (L) - Mean (SD) 2.41 (0.
Slide 18: AIR interim analysis shows disease stabilization with later increase in FVC
Introduction AT2 receptor IPF/PAH New ATRAGs AIR interim analysis shows disease stabilization with later increase in FVC Interim analysis October 2022 Mean change (±SEM) from baseline in FVC over time, observed values Increase 0,9 ** Stabilizes disease over 36 weeks 0,8 0,7 ** 10 C21 0,6 Increased F
Slide 19: PAH – a microvascular rare disease with poor prognosis
Introduction AT2 receptor IPF/PAH New ATRAGs PAH – a microvascular rare disease with poor prognosis PAH is a rare, fatal disease… …triggered by endothelial dysfunction • Orphan disease with ~67 000 patients in • Endothelial dysfunction and vascular remodeling leads to pulmonary arterial US and Europ
Slide 20: Strong preclinical data with C21 in disease-relevant animal model
Introduction AT2 receptor IPF/PAH New ATRAGs Strong preclinical data with C21 in disease-relevant animal model Sugen-Hypoxia rat model Effects of C21 treatment: Collagen ↓ Lung fibrosis ↓ Remodeling of pulmonary vessels ↓ Cardiac remodeling ↓ Pulmonary hypertension ↑ Cardiac output Vascular remodeli
Slide 21: Investigating effects on endothelial dysfunction in PAH
Introduction AT2 receptor IPF/PAH New ATRAGs Investigating effects on endothelial dysfunction in PAH Increase in forearm 80 Forearm blood flow in healthy volunteers blood flow (%) p=0.026 60 C21 increases local • Increase in blood flow (63%, p=0.026) at clinically relevant doses 40 blood flow • No s
Slide 22: Almee™ – Digital Therapy for Anxiety in Pulmonary Fibrosis
Introduction AT2 receptor IPF/PAH New ATRAGs Almee™ – Digital Therapy for Anxiety in Pulmonary Fibrosis ➢ Treat symptoms of anxiety and improve quality of life in adults with pulmonary fibrosis ➢ Reduce costs for overburdened hospital systems (nurse/psychologist resources, hospitalizations, ER visit
Slide 23: Inhaled thalidomide – targeted approach to address IPF cough
Introduction AT2 receptor 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 significant
Slide 24: New ATRAGs
New ATRAGs
Slide 25: Vicore has a platform of proprietary ATRAGs
Introduction AT2 receptor IPF/PAH New ATRAGs Vicore has a platform of proprietary 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 pending patents (fo
Slide 26: ATRAGs in development have confirmed potency, selectivity and efficacy
Introduction AT2 receptor IPF/PAH New ATRAGs ATRAGs in development have confirmed potency, selectivity and efficacy New ATRAGs compound characteristics Target engagement - autoradiography with human lung tissue - Displacement with cold ATRAGs at clinically relevant concentrations ➢ Small molecules ➢
Slide 27: ATRAG – a new class of drugs
Introduction AT2 receptor 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 AT2 receptor may be beneficial in a wide range of diseases ATRAG indications IPF PAH
Slide 28: Vicore at a glance
Vicore at a glance Unlocking the potential of a new drug class – ATRAGs Unprecedented data in IPF phase 2a Strong scientific rationale for disease modification in PAH MoA with wide therapeutic implications A clinical platform under development – capitalizing on lead 28
Slide 29: 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 Contact us Visiting addresses Business development and IR contacts www.vicorepharma.com [email protected] Stockholm Copenhagen MIKAEL NYGÅRD, VP BUSINESS DEVELOPMENT mikael.nygard@vicorep
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