InflaRx N.V. · NASDAQ:IFRX
InflaRx — Investor Presentation (May 2022)
34 slides from InflaRx's investor presentation, May 2022
Slide 1: Corporate Presentation May 2022
CORPORATE PRESENTATION MAY 2022
Slide 2: Important Notice and Disclaimer
IMPORTANT NOTICE AND DISCLAIMER This presentation has been prepared by InflaRx N.V. (“InflaRx” or the “Company”). This presentation is made for informational purposes only and does not constitute an offer to sell or a solicitation of an offer to buy securities. This presentation may not be relied up
Slide 3: InflaRx N.V.: Targeting Complement to Control Inflammatory Diseases
InflaRx N.V. Targeting Complement to Control Inflammatory Diseases Focused late-stage clinical development of lead asset and promising, earlier-stage development pipeline Vilobelimab - Efficacy Signals and Clean Safety Profile in Clinical Testing • Pyoderma gangrenosum: Positive Phase IIa data – see
Slide 4: Pipeline with Multiple Opportunities
Pipeline with Multiple Opportunities INDICATIONS PRECLINIC PHASE I PHASE II PHASE III STATUS Pyoderma Positive Phase IIa open label Gangrenosum (PG) results Vilobelimab Phase II results published; (IFX-1) Critical COVID-19 Phase III encouraging topline C5a Inhibitor data released in Q1 2022 Cutaneou
Slide 5: Important Expected Catalysts
Important Expected Catalysts H2 2021 H1 2022 H2 2022 H1 2023 Vilobelimab in Positive Data -Third End-of-Phase II Meeting PG Cohort in Phase IIa with FDA German Gov Grant Phase III Data Released Vilobelimab in COVID-19 Phase III Enrollment Discussions with Regulatory Authorities on Next Steps Complet
Slide 6: Vilobelimab Mode of Action
Vilobelimab Mode of Action C5 C5a Vilobelimab (IFX-1) Cleavage and New Conformational Change Epitope Cleavage of C5 through: C5a is a key chemo-attractant and a Key Features: • complement pathway activation; or strong activator of neutrophils leading • Blocks C5a biological effects • directly throug
Slide 7: Vilobelimab Key Clinical Data: Evidence for an Active Drug
Vilobelimab Key Clinical Data: Evidence for an Active Drug Pyoderma gangrenosum (PG) Hidradenitis suppurativa (HS) Phase IIa trial: Phase II SHINE trial: • High Dose Group shows highest rate of target ulcer closure and clinical • Significant difference between the total inflammatory lesion count rem
Slide 8: Leadership Team
Leadership Team NIELS RIEDEMANN, M.D., PH.D. KORINNA PILZ, M.D., M.SC. CHIEF EXECUTIVE OFFICER CHIEF CLINICAL DEVELOPMENT OFFICER • Founder of InflaRx • 20+ years in academia and industry • 15+ years in biotech industry • Innate Pharma, Boehringer Ingelheim, Roche, Merck • 20+ years in immunology re
Slide 9: Vilobelimab Pyoderma Gangrenosum (PG)
Vilobelimab Pyoderma Gangrenosum (PG)
Slide 10: Pyoderma Gangrenosum (PG)
Pyoderma Gangrenosum (PG) AN AUTOIMMUNE CONDITION WITH HIGH UNMET NEED Clinical Features • PG is a rare but potentially life-threatening skin disorder that can lead to chronic, difficult-to-treat wounds • Many PG patients also suffer from other autoimmune disorders, such as ulcerative colitis, rheum
Slide 11: PG Phase IIa Trial
PG Phase IIa Trial Study Design • 19 patients enrolled in the study • Primary endpoint: Safety • Key secondary endpoints: Responder rate defined as PGA ≤3 (PGA of ≤1 is considered clinical remission and closure of target ulcer); time to complete closure of target ulcer INITIATION MAINTENANCE INDIVID
Slide 12: Phase IIa Study Results – Group 1 & 2 (Low & Medium Dose)
Phase IIa Study Results – Group 1 & 2 (Low & Medium Dose) PGA Six evaluable 01 03 05 subjects: 02 04 06 score GROUP 1 RESULTS * • Two patients (02 and 05) achieved complete remission of target ulcer. • One patient (01) with initial response and fluctuating PGA. • Patients 02 and 05 stopped treatment
Slide 13: Phase IIa Study Results – Group 3 (High Dose)
Phase IIa Study Results – Group 3 (High Dose) PGA Seven evaluable 13 * 15 17 19 score patient: 14 16 18 GROUP 3 RESULTS • Six out of seven patients achieved PGA score of ≤ 1 (remission) • One patient (18) experienced target ulcer area decrease > 50%; however, new PG lesions developed • Patient 19 wi
Slide 14: C5a Plasma Concentration per Dosing Group
C5a Plasma Concentration per Dosing Group End of treatment visit CLINICAL OBSERVATION 120,0 • C5a sustained suppression for 26 weeks in 100,0 Group 3 • Six out of seven patients in the High Dose Group reached PGA ≤ 1 (clinical remission) 80,0 60,0 40,0 20,0 0,0 Baseline Day 15 Day 43 Day 99 Day 189
Slide 15: PG Phase IIa Patient Case Studies
PG Phase IIa Patient Case Studies TARGET ULCER OPENED (NOV 2020) WHILE ON STABLE TARGET ULCER REAPPEARED (AUG 2020) ADALIMUMAB MH: PG since August 2020, Psoriasis since 2017 MH: PG since 2019, Hypertension since 1998; Study Day 1: Feb 2021 Treatment Start: March 2021 Cohort 2: 1600 mg Q2W, individua
Slide 16: PG Phase IIa Study Results Summary and Conclusion
PG Phase IIa Study Results Summary and Conclusion SAFETY CONCLUSION • No infusion-related reactions observed • For 2 patients, related SAEs were reported: END-OF- • Erysipelas leading to hospitalization (judged as non-related by sponsor) PHASE II FDA • Rash due to delayed hypersensitivity reaction M
Slide 17: Vilobelimab Critical COVID-19
Vilobelimab Critical COVID-19
Slide 18: COVID-19 induced Vascular Injury – Potential Role of C5a
COVID-19 induced Vascular Injury – Potential Role of C5a Model for Proposed Mode of Action of C5a in COVID-19 induced vascular injury OUR HYPOTHESIS • Endothelial damage is induced by SARS-CoV-2 infection which also activates the complement system leading to C5a generation. • C5a activates neutrophi
Slide 19: Design of PANAMO Phase II/III Study with Vilobelimab in Severe COVID-19
Design of PANAMO Phase II/III Study with Vilobelimab in Severe COVID-19 Open-label 800mg i.v. STUDY DESIGN Phase II Vilobelimab + BSC • Critically ill intubated* patients with COVID-19 Part 28 days (n = 15) induced pneumonia Best supportive care Dosing scheme: • Phase III primary endpoint: (n = 15)
Slide 20: PANAMO Phase II/III Trial: Phase II Results
PANAMO Phase II/III Trial: Phase II Results PHASE II STUDY RESULTS Primary endpoint: • No difference detected in improvements between groups in PaO2/FiO2 ratio • High variability between patients • Conclusion: Endpoint not suitable as response parameter Key secondary and other endpoints – observed e
Slide 21: PANAMO Trial: Phase III Topline Results
PANAMO Trial: Phase III Topline Results MORTALITY – OVERALL & WESTERN EUROPE AT DAY 28 & 60 All-cause mortality: Overall All-cause mortality: Western Europe Day 28: 23.9 % relative reduction Day 28: 43.0 % relative reduction Kaplan-Meier point estimate: Kaplan-Meier point estimate: Vilobelimab: 31.7
Slide 22: PANAMO Trial: Analyzing the Primary Outcome (28-day Mortality)
PANAMO Trial: Analyzing the Primary Outcome (28-day Mortality) Cox Regression Analysis 55 patients from 17 sites with no events (death) are “lost” in this mathematical analysis = model only considers 313 patients instead of 368 All 368 treated patients are considered for these mathematical analyses
Slide 23: PANAMO Trial: Phase III Topline Results
PANAMO Trial: Phase III Topline Results PRE-SPECIFIED SUBGROUP ANALYSES BY REGION * ** *Belgium, France, Germany, Netherlands **Brazil, Mexico, Peru These subgroup analyses point towards a stronger treatment effect on 28-day all-cause mortality in more severe patients: Page 23
Slide 24: Phase III Part Top Line Results
Phase III Part Top Line Results SECONDARY ENDPOINT Proportion of patients free of any renal replacement therapy within 28 days of randomization Treatment: Fine and Gray model: sHR 0.578 (0.320 ; 1.045) p=0.0696 Placebo + SOC Cause-specific Cox mode: HR: Vilobelimab + SOC 0.539 (0.297 ; 0.978) p=0.04
Slide 25: Phase III Safety Results
Phase III Safety Results SAFETY OVERVIEW INFECTIONS Vilobelimab Placebo Vilobelimab Placebo Adverse event category MedDRA High Level Group Term (N=175) (N=189) (N=175) (N=189) Any TEAE in SOC infections and Any TEAE 159 (90.9%) 172 (91.0%) 110 (62.9%) 112 (59.3%) infestations Any related TEAE 20 (11
Slide 26: Phase III Safety Results
Phase III Safety Results INFECTIONS AND INFESTATIONS BY PATIENT DAYS IN HOSPITAL Vilobelimab (N=175) Placebo (N=189) n (%) n (%) Incidence Incidence MedDRA High Level Group Term (patient days = 2384) (patient days = 1736) Patients per 100 Events per 100 patient Patients per 100 Events per 100 patien
Slide 27: Summary
Summary KEY LEARNINGS FROM PHASE III RESULTS Primary endpoint of 28-day all-cause mortality – clinically meaningful benefit in vilobelimab arm but missed statistical significance using pre-specified analysis method Pre-specified and post-hoc analyses suggest robust reduction in mortality at day 28 a
Slide 28: Vilobelimab Oncology
Vilobelimab Oncology Cutaneous Squamous Cell Carcinoma (cSCC)
Slide 29: Cutaneous Squamous Cell Carcinoma (cSCC)
Cutaneous Squamous Cell Carcinoma (cSCC) Phase II Study Underway POTENTIAL ROLE OF C5A IN ONCOLOGY & cSCC DISEASE INFORMATION cSCC • C5a induces an immunosuppressive tumor microenvironment • Estimated incidence: 15-35 per 100,000 people; expected to • C5a promotes metastases increase 2-4% per year;
Slide 30: INF904 New Pipeline Program
INF904 New Pipeline Program E
Slide 31: Allosteric Inhibitor INF904
Allosteric Inhibitor INF904 Potential for Best-in-Class C5aR Inhibition Neutropenia in vivo Model RATIONALE 120 ✱✱ Avacopan-like (10mg/kg oral) • INF904 binds to a well-known allosteric site in C5aR 100 INF904 % Inhibition 80 (10mg/kg oral) • INF904 has a novel Markush structure 60 Vehicle • US pate
Slide 32: Strategy and Outlook
Strategy and Outlook
Slide 33: Strategy and Outlook
Strategy and Outlook Vilobelimab in • End-of-Phase II meeting with FDA in Q2 2022 PG Vilobelimab in • Discussions with regulatory authorities on next steps towards potential approval COVID-19 • Start of second cohort of combination arm in Phase II in H1 2022 Vilobelimab in • Topline data from monoth
Slide 34: www.inflarx.com
www.inflarx.com INFLARX N.V. INVESTOR RELATIONS INFLARX N.V. Winzerlaer Str. 2 Jordan Zwick 07745 Jena, Germany Chief Strategy Officer Email: info@inflarx.com Email: IR@inflarx.de Tel: +49-3641-508180 Fax: +49-3641-508181