Vicore Pharma Holding AB · OMXSTO:VICO
Vicore Pharma Holding AB — Investor Presentation (January 2024)
25 slides from Vicore Pharma Holding AB's investor presentation, Jan 9, 2024
Slide 1: Vicore Pharma
VICORE PHARMA Unlocking the potential of a new class of drugs – Angiotensin II type 2 receptor agonists (ATRAGs) January 2024
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 A powerful, upstream mechanism for IPF Unprecedented data in IPF phase 2a A clinical platform under development – capitalizing on lead 3
Slide 4: Company overview
Company overview Vision Transform the lives of patients where modulation of the AT2 (angiotensin II type 2) receptor can play a central role in halting and reversing disease pathology Locations Stockholm, Sweden, Cambridge, Massachusetts & Copenhagen, Denmark Financials Publicly listed (Nasdaq Stock
Slide 5: Advancing a diversified pipeline
Advancing a diversified pipeline Indication Compound Preclinical Phase 1 Phase 2 Phase 3 Comments Final data phase 2a, H1 2024 IPF C21 Phase 2b trial start H1 2024 PAH C21 Anxiety in pulmonary Almee DTx Pivotal study completed fibrosis Not disclosed C103, C111, C112 Preclinical studies / IND-enablin
Slide 6: IPF - a large and growing commercial opportunity
IPF - a large and growing commercial opportunity Strong market growth despite SoC shortcomings Majority of the market is not adequately addressed Population in US and Europe Healthy lung Lung with fibrosis $4.3Bn ~250.000 $2.0Bn Only ~26% of U.S patients High discontinuation rate and initiate treatm
Slide 7: AT2R agonism is an upstream intervention driving tissue repair
AT2R agonism is an upstream intervention driving tissue repair • The Angiotensin II pathway is highly conserved with similar components across species • Angiotensin II activates AT1R and AT2R with similar potency • AT1R is widely expressed, while AT2R is ATRAGs expressed in few tissues such as the l
Slide 8: AT2R is highly expressed in human lungs and specifically on AEC2s
AT2R is highly expressed in human lungs and specifically on AEC2s AT2R is selectively expressed on Alveolar epithelial cells AT2R—but not AT1R—is expressed in the human lung type 2 (AEC2) (AT1R blocker) Single cell analysis shows AT2 AT2R expression receptor selectively on AEC2 in the lung AEC2 Ang
Slide 9: Healthy alveolus and function of alveolar epithelial cells type 1 and 2
Healthy alveolus and function of alveolar epithelial cells type 1 and 2 Healthy alveolus • The alveolar epithelium is constantly exposed to damaging irritants in inhaled air AEC2 • AEC1 is the predominant alveolar cell type and is responsible for gas exchange Proliferation • AEC2 is a progenitor cel
Slide 10: Damage to AEC2 in IPF drives disease progression
Damage to AEC2 in IPF drives disease progression Key processes in IPF development Micro-injury • Loss of functional AEC2 • Reduces surfactant production AEC2 dysfunction • No generation of AEC1 • Alveolar collapse and dysfunction AT2R activation with C21 • TGFβ1 is released from injured AEC2 and FMT
Slide 11: C21 reduces TGFβ1 and Collagen in human IPF lung slices
C21 reduces TGFβ1 and Collagen in human IPF lung slices TGFβ1 protein levels in PCLuS Collagen protein levels in PCLuS Human precision cut lung slices (PCLuS) ✱✱ 150 4000 ✱ ✱✱ Collagen-1a1 (pg/ml) 3000 TGF-β 1(pg/mL) 100 2000 -44% -61% 50 1000 0 0 • IPF tissue collected from IPF patients undergoing
Slide 12: C21 reduces TGFβ1 in IPF patients
C21 reduces TGFβ1 in IPF patients Plasma TGFβ1 at baseline and 24-week C21 treatment in IPF patients (AIR Interim analysis) -57% 80 25 20 60 TGF-β1 (ng/ml) TGF-β1 (ng/ml) 15 40 10 20 5 0 0 Baseline Week 24 Baseline Week 24 • 7 patients with most elevated TGFβ1 (total) at baseline all showed marked r
Slide 13: Strong preclinical evidence for C21 in pulmonary fibrosis
Strong preclinical evidence for C21 in pulmonary fibrosis Bleomycin Monocrotaline Sugen-Hypoxia 6 15 * * 7 ** ** * * * Hydroxy proline (nM) 6 4 10 Fibrosis (%) Fibrosis (%) 5 2 5 4 0 0 3 Control BLEO C21 C21 Control MCT MCT + C21 Control SuHx C21 Prevention Treatement vehicle 20 mg/kg Lung collagen
Slide 14: AIR - demonstrating safety and efficacy of C21 in treatment naïve IPF patients
AIR - demonstrating safety and efficacy of C21 in treatment naïve IPF patients • Primary aim: To evaluate safety of C21, an Angiotensin II type 2 receptor agonist (ATRAG), in patients with IPF • Secondary aim: To evaluate efficacy of C21 in IPF as measured by FVC change • N=52 treatment naïve IPF pa
Slide 15: Better tolerability than SoC
Better tolerability than SoC AIR interim analysis May 2023 AIR analysis INPULSIS 1; 52-week treatment(1) May 2023 Nintedanib Placebo C21 n=309 n=204 n=51 Any AE 96% 89% 63% Common AEs (Non-exhaustive) Diarrhea 62% 19% 6% Nausea 23% 6% 4% Good GI side effect profile Progression of IPF 10% 10% 6% Coug
Slide 16: Outstanding efficacy data – stabilized FVC over weeks
Outstanding efficacy data – stabilized FVC over 36 weeks AIR interim analysis May 2023 0,6 0,5 *** 0,4 C21 ** FVC change (L) 0,3 19 ** mean ±SEM 0,2 ** 23 * 23 0,1 29 30 27 0 37 31 30 N=46 41 46 35 -0,1 SoC -0,2 Untreated 0 4 8 12 16 20 24 28 32 36 Week 17 of 19 patients have an FVC change above the
Slide 17: All subgroups show stabilization over baseline
All subgroups show stabilization over baseline at 36 weeks AIR interim analysis May 2023 Mean FVC change at week 36 vs baseline 0,6 Subgroup (# patients); ∆L 0,5 Probable (n=12); 0,49 India (n=13); 0,47 0,4 Female (n=4); 0,36 Male (n=15); 0,35 FVC change (L) 19 0,3 Observed mean (n=19); 0,35 mean ±S
Slide 18: 3D-reconstruction of HRCTs confirm diagnosis and FVC quality
3D-reconstruction of HRCTs confirm diagnosis and FVC quality AIR interim analysis May 2023 Fibrosis pattern typical for IPF patients Strong FVC and total lung volume correlation p<0.001 Pearson = 0.73 p < 0.001 • Fibrosis predominant in the lower lobes • Additional confirmation of IPF diagnosis in A
Slide 19: C21 in IPF: Phase 2b ASPIRE trial design
C21 in IPF: Phase 2b ASPIRE trial design • A randomized, double-blind, placebo-controlled, parallel-group multicenter, dose-finding trial • IPF patients on stable nintedanib/SoC or not on SoC (no access, refused, intolerant or failed) • 52-week treatment duration; N=270 (90 per arm) Study • Assessm
Slide 20: The AIR trial updated interim analysis in summary
The AIR trial updated interim analysis in summary IPF diagnosis and FVC quality confirmed by 3D reconstruction of HRCT Continued unprecedented efficacy data Good safety and tolerability profile – no GI signals Supportive biomarker data 20
Slide 21: Almee – Digital Therapy for Anxiety in Pulmonary Fibrosis
Almee – Digital Therapy for Anxiety in Pulmonary Fibrosis Almee Integrated digital • Disease management in pulmonary fibrosis (PF essentials) product for patients • Treatment of anxiety for eligible PF patients (dCBT-PF) with PF 250.000 Pulmonary • 63% of patients with treatable levels of anxiety1 F
Slide 22: Almee can unlock the potential of molecular assets
Almee can unlock the potential of molecular assets Treating the psychological impact of living with PF Moving an RCT confirmed clinical endpoint True patient engagement – creating trust and empowerment Increased adherence New Revenue IP Extension Data access and initiation Streams Custom build for s
Slide 23: Vicore has a platform of proprietary ATRAGs
Vicore has a platform of proprietary ATRAGs C21 – first in class – rare lung diseases • Market exclusivity (NCE) – US 5 years, Europe 10 years • Orphan drug status in IPF granted – US 7y, EU 10 years • Several granted and pending patents (formulation, manufacturing, use) covering C21, projected expi
Slide 24: Strong leadership team with extensive industry experience
Strong leadership team with extensive industry experience AHMED MOUSA HANS JEPPSSON, PhD MIKAEL NYGÅRD, PhD CHIEF EXECUTIVE OFFICER CHIEF FINANCIAL OFFICER VP OPERATIONS AND CORPORATE STRATEGY Experienced biotech executive with a multi-disciplinary background Cross-disciplinary background in finance
Slide 25: 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 IR contacts www.vicorepharma.com Stockholm Copenhagen Boston AHMED MOUSA, CEO ahmed.mousa@vicorepharma.com Kornhamnstorg 53 Agern Allé 5A Cambridge Innovation Ce