Cinclus Pharma Holding Ab · OMXSTO:CINPHA
Cinclus Pharma Holding Ab — Q3 2024 Earnings Presentation
29 slides from Cinclus Pharma Holding Ab's earnings presentation, Nov 14, 2024
Slide 1: Cinclus Pharma Q3 Report 2024
Cinclus Pharma Q3 Report 2024 Webcast November 14, 2024, 10:00 Presenters: Christer Ahlberg, CEO Maria Engström, CFO 1
Slide 2: Disclaimer
Disclaimer IMPORTANT: You must read the following before continuing. The following applies to this and Markets Act 2000 (Financial Promotion) Order 2005 as amended (the “Order”), a “qualified document, the oral presentation of the information in this document by Cinclus Pharma Holding investors” fal
Slide 3: Linaprazan Glurate: the next gold-standard in healing of severe erosive GERD
Linaprazan Glurate: the next gold-standard in healing of severe erosive GERD 1 Next generation PCAB targeting healing in severe eGERD, the area of high unmet medical need 2 Superior acid control profile delivering fastest onset of action & time to steady state(1), crucial for healing of severe eGERD
Slide 4: Strategic roadmap with dense upcoming news flow
Strategic roadmap with dense upcoming news flow Description 2024 2025E 2026E 2027E 2028E 2029E 1st Phase III 1st Phase III Healing Read-out eGERD 2nd Phase III 2nd Phase III Healing Read-out Phase I / III H. pylori Undisclosed ILLUSTRATIVE indications First patient in, study NDA/MAA and first regula
Slide 5: The significant need for new alternatives to PPIs is evident as PCABs are making great progress
“The significant need for new alternatives to PPIs is evident as PCABs are making great progress worldwide” • Japan – vonoprazan is market leader • Other markets where PCABs are launched: • South Korea – Increasing significant sales LATAM: APAC: • India – Many different vonoprazan labels Mexico Japa
Slide 6: Summary of key events Q3, 2024
Summary of key events Q3, 2024 • PSI CRO was selected as the clinical research organization (CRO) for the phase III program. • The PK/PD study was elected to be presented at UEGW, a scientific congress within the gastroenterology area. • The manufacturing of the Investigational Medicinal Product (IM
Slide 7: Summary of key events Q3, 2024
Summary of key events Q3, 2024 • PSI CRO was selected as the clinical research organization (CRO) for the phase III program. • The PK/PD study was elected to be presented at UEGW, a scientific congress within the gastroenterology area. • The manufacturing of the Investigational Medicinal Product (IM
Slide 8: Pharmacokinetics and pharmacodynamics of linaprazan glurate after multiple oral doses up to 14 days
PHARMACOKINETICS AND PHARMACODYNAMICS OF LINAPRAZAN GLURATE AFTER MULTIPLE ORAL DOSES UP TO 14 DAYS IN HEALTHY SUBJECTS Matjaz Fležar 1 , Kajsa Larsson 2 , Kjell Andersson 2 , Gunilla Huledal 2 , Kristofer Katkits 2 , Elham Yektaei 2, Peter Unge 2 1. University of Ljubljana, Ljubljana, Slovenia and
Slide 9: Linaprazan glurate
Linaprazan glurate • Prodrug of linaprazan. • Treatment of acid related disease. • Studied in 6 phase I and 1 phase II clinical trials. • Safe and well tolerated in ≈ 500 individuals. • Promising healing results in patients with erosive esophagitis. 9
Slide 10: Phase I SAD/MAD Study
Phase I SAD/MAD Study • Holding time ratio pH>4 is a biomarker for healing of erosive esophagitis. • Linaprazan glurate provides fast onset & full pH control. 2 mg/kg linaprazan glurate: Fast onset and close to 24 hours pH>4 (>90%). 1 mg/kg linaprazan glurate: Fast onset and 11 to 13 hours pH>4 (~45
Slide 11: Primary Endpoints and Study Objective
Primary Endpoints • Percentage of time with gastric pH >4 at Day 1 Study Objective and Day 14, following linaprazan glurate administration. To study the pH control and PK • Linaprazan glurate and linaprazan PK properties of a linaprazan parameters after single and repeated after once glurate tablet
Slide 12: Dose Response with pH>4 HTR on Day 1 and Day 14
Dose Response with pH>4 HTR on Day 1 and Day 14 Percentage of time with intragastric pH >4, based on 10-minute medians of pH. 25 mg LG 50 mg LG 75 mg LG 25 mg LG 50 mg LG 75 mg LG Day Statistics QD QD QD BID BID BID (N=12) (N=12) (N=13) (N=9) (N=11) (N=10) n 12 12 12 9 11 9 Day 1 64.6 68.1 76.0 87.4
Slide 13: Summary of key events Q3, 2024
Summary of key events Q3, 2024 • PSI CRO was selected as the clinical research organization (CRO) for the phase III program. • The PK/PD study was elected to be presented at UEGW, a scientific congress within the gastroenterology area. • The manufacturing of the Investigational Medicinal Product (IM
Slide 14: Strong global IP protection and market exclusivity
4. IP, TIMEPLAN, UOP AND SUMMARY Strong global IP protection and market exclusivity 2024 2025 2026 2027 2028 2029 2030 2031 2032 2033 2034 2035 2036 2037 2038 2039 2040 2041 2042 2043 2044 2045 2046 NCE1 GAIN2 Composition of Matter Patent Patent Term Extension Polymorph Patent Additional patents inc
Slide 15: Summary of key events Q3, 2024
Summary of key events Q3, 2024 • PSI CRO was selected as the clinical research organization (CRO) for the phase III program. • The PK/PD study was elected to be presented at UEGW, a scientific congress within the gastroenterology area. • The manufacturing of the Investigational Medicinal Product (IM
Slide 16: Cinclus Pharma are in agreement with EMA regarding the paediatric study plan for eGERD
Cinclus Pharma are in agreement with EMA regarding the paediatric study plan for eGERD. • Cinclus Pharma, has reached an agreement with the European Medicines Agency’s (EMA) Paediatric Committee (PDCO) on the company’s Pediatric Investigation Plan (PIP). • A regulatory agreement of a PIP must be obt
Slide 17: Summary of key events Q3, 2024
Summary of key events Q3, 2024 • PSI CRO was selected as the clinical research organization (CRO) for the phase III program. • The PK/PD study was elected to be presented at UEGW, a scientific congress within the gastroenterology area. • The manufacturing of the Investigational Medicinal Product (IM
Slide 18: Team with proven track-record within drug discovery and commercialization
1. INTRODUCTION TO CINCLUS PHARMA Team with proven track-record within drug discovery and commercialization… CHRISTER MARIA MARGIT JESPER WIKLUND AHLBERG ENGSTRÖM MAHLAPUU Director of Corporate KAJSA LARSSON Executive R&D PETER WALLICH and Business CEO CFO CMO Director Commercial Director Developmen
Slide 19: Supported by an experienced international advisory board
1. INTRODUCTION TO CINCLUS PHARMA … supported by an experienced international advisory board Professor Emeritus Richard Hunt, MD, Ph.D. McMaster University, Hamilton, Canada ▪ Member of the Editorial Boards of 20 scientific journals, including Gastroenterology. Author of over 600 papers and abstract
Slide 20: Key figures
Key figures Q3 Q2 FY-23 Cash 644 685 88 MSEK MSEK MSEK Co-workers 29 26 29 R&D spending of total OPEX 81% 56% 81% 20
Slide 21: Financial overview
Financial overview SEKm Q3-24 Q3-23 YoY Q2-24 Q1-24 Jan-Dec-23 • Net sales – awaiting approval in China which will generate smaller Net sales – – – – – 6,0 milestone payment. G&A -7,3 -8,5 1,2 -16,7 -5,6 -39,6 R&D -32,0 -54,5 22,5 -20,8 -30,5 -166,7 • The operating expenses were lower than last year
Slide 22: Largest shareholders end of September 2024
Largest shareholders end of September 2024 Number of shares Share (%) IPO Cornerstone investors: Trill Impact Ventures 3 721 221 8,0% Fjärde AP-fonden 3 686 568 7,9% Linc AB 2 318 322 5,0% - Trill Impact Ventures Peter Unge genom bolag 2 050 015 4,4% - 4th AP fund Kjell Andersson genom bolag 1 908 0
Slide 23: Calendar
QA Calendar Year-End Report 2024, February 20, 2025 Annual report 2024, April 17, 2025 Q1 interim report, May 20, 2025 Annual General Meeting, May 22, 2025 IR contact ir@cincluspharma.com 23
Slide 24: Indication aspiration
Indication aspiration … Accomplished 24hr pH control in clinical studies …Aiming to show superior Healing in severe eGERD (C&D) Treatment of erosive With focus on … Aiming to show superior Gastro- esophageal healing of symptom control with focus on reflux disease severe eGERD night time symptoms (eG
Slide 25: Focus on the unmet medical need, where 24 hr acid control is most important
Focus on the unmet medical need, where 24 hr acid control is most important Focus on Healing of Severe Linaprazan glurate Patients, the Unmet Potential to become best in Medical Need in eGERD class and the first innovative Enables Specialty Commercial Focus HQ: Stockholm, MoA 1) in gastric acid rela
Slide 26: Appendix
Appendix 26
Slide 27: Blockbuster market potential in severe eGERD in USA & EU
Blockbuster market potential in severe eGERD in USA & EU GERD 705m – USA and EU-30 approachable population1) 133m – GERD population (~19% of general population) 92.5m – Proportion seeking treatment (70%) eGERD 27.7m 30% Proportion of eGERD patients seeking treatment patients 10m 36% All eGERD C/D -
Slide 28: Linaprazan glurate: Potential to be best in class 2nd generation PCAB
Linaprazan glurate: Potential to be best in class 2nd generation PCAB PHARMACOLOGICAL (PRODRUG) ADVANTAGES PROVIDES… … CLINICAL ADVANTAGES AND SUPERIORITY PROFILE HEALING EFFECT SUPERIOR DAY- SUPERIOR NIGHT- DOSING TIME TO DIFFERENCE TIIME TO SUPERIORITY IN TIME SYMPTOM TIME SYMPTOM INDEPENDENT TIME
Slide 29: Specialist GI targeted commercialization approach maximizes optionality post-data
Specialist GI targeted commercialization approach maximizes Cinclus Pharma optionality post-data Severe eGERD Effective go-to-market approach Specialist GI approach (LA Grade C/D patients) Effective market entr y ▪ Specialist GI approach… Accessible with a highly focused sales & The concentrated Spe
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