InflaRx N.V. · NASDAQ:IFRX
InflaRx — Investor Presentation (January 2022)
31 slides from InflaRx's investor presentation, January 2022
Slide 1: Controlling Inflammation – Corporate Presentation January 2022
CONTROLLING INFLAMMATION CORPORATE PRESENTATION January 2022
Slide 2: Important Notice and Disclaimer
IMPORTANT NOTICE AND DISCLAIMER This presentation has been prepared by InflaRx N.V. (“InflaRx”), a US-Nasdaq publicly listed Dutch company having its principal place of business in Germany. This presentation is made for informational purposes only and does not constitute an offer to sell or a solici
Slide 3: InflaRx N.V. – Targeting Complement to Control Inflammatory Diseases
InflaRx N.V. Targeting Complement to Control Inflammatory Diseases LEAD PRODUCT CANDIDATE WITH PIVOTAL PROGRAM FOCUS ON IMMUNODERMATOLOGICAL DISEASES Clinical Efficacy and Clean Safety Profile enabling Vilobelimab to Advance in Multiple Indications • Hidradenitis Suppurativa (HS): Initiated pivotal
Slide 4: Pipeline with Multiple Opportunities
Pipeline with Multiple Opportunities FRANCHISE INDICATIONS PRE-CLINICAL PHASE I PHASE II PHASE III UPDATE Hidradenitis Pivotal trial initiated with new Suppurativa (HS) primary endpoint Immunodermatology Pyoderma Positive preliminary Phase IIa open Gangraenosum (PG) label results Phase II/III study:
Slide 5: The Terminal Complement Pathway
The Terminal Complement Pathway C5 C5 concentration in blood: ~75 µg/ml (~400 nM) C5a concentration C5a C5b in blood: other ligands: 10 ~ 30 ng/ml C3a, ASP, C4a etc Membrane Attack Complex (MAC) (~1-2.5 nM) strong amplifier triggers lysis of pathogens of inflammation C5b-9 = MAC C5aR C5L2 C5L2 has a
Slide 6: Vilobelimab Immunodermatology Focus
I N N O VAT I O N TEAMWORK DISCOVERY COMPLEMENT Vilobelimab Immunodermatology Focus • Hidradenitis Suppurativa (HS) • Pyoderma Gangraenosum (PG)
Slide 7: Hidradenitis Suppurativa (HS)
Hidradenitis Suppurativa (HS) Debilitating C5a-driven inflammatory skin condition with high unmet need HURLEY STAGING FOR HS Stage I Clinical Features Single / multiple • Chronic, inflammatory, recurrent, debilitating skin disease of the hair follicles abscesses but no sinus • Most commonly in the a
Slide 8: SHINE Phase II Study
SHINE Phase II Study Results and Conclusions RESULTS • HiSCR primary endpoint and dose response signal not met but signal towards improved AN count for the highest dose cohort • Statistically significant change in draining tunnels (dTs) and in ANdT count detected for the highest dose cohort • Pharma
Slide 9: HS Phase III Development
HS Phase III Development Study Initiation FDA MEETINGS & NEXT STEPS FDA Type A meeting (August 2021) • Received feedback from FDA supportive of a new primary endpoint measuring reductions in all three inflammatory HS lesions, including Draining Tunnels • FDA had previously agreed to the Phase III do
Slide 10: Pyoderma Gangraenosum (PG)
Pyoderma Gangraenosum (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, highly painful and difficult-to-treat wounds • Many PG patients also suffer from other autoimmune disorders, such as ulcer
Slide 11: PG Phase IIa Study Design
PG Phase IIa 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 INDIVIDUAL TI
Slide 12: Study Results – Group 1 (Low Dose)
Study Results – Group 1 (Low Dose) PGA-line plot of absolute values over time by patient (Actual days displayed acc. to visit windows) PGA Six evaluable 01 03 05 score subjects: 02 04 06 GROUP 1 RESULTS • Two patients (02 and 05) achieved complete remission of target ulcer * • One patient (01) with
Slide 13: Study Results – Group 2 (Medium Dose)
Study Results – Group 2 (Medium Dose) PGA-line plot of absolute values over time by patient (Actual days displayed acc. to visit windows) PGA Four evaluable 07 09 11 score patients: 08 10 12 GROUP 2 RESULTS • One patient (10) out of four healed upon up-titration to ** 2400mg group on day 57 with PGA
Slide 14: Study Results – Group 3 (High Dose)
Study Results – Group 3 (High Dose) PGA-line plot of absolute values over time by patient (Actual days displayed acc. to visit windows) PGA Seven evaluable 13 * 15 17 19 score patient: 14 16 18 GROUP 3 RESULTS • Six patients out of 7 achieved PGA score of ≤ 1 (remission) • One patient (18) experienc
Slide 15: PG Phase IIa Patient Case Study
PG Phase IIa Patient 10 Case Study TARGET ULCER REAPPEARED IN AUGUST 2020 MH: PG since Jun 2019, Hypertension since 1998; Study Day 1: Feb 2021 Cohort 2: 1600 mg Q2W, individual uptitration to 2400 mg at D57, treatment completed Previous PG medication: Methylprednisolone only in Jun 2019, Dapsone Ju
Slide 16: PG Phase IIa Patient Case Study
PG Phase IIa Patient 14 Case Study PG TREATMENT HISTORY: CICLOSPORIN, DAPSONE MH: PG since October 2018, Obesity since longer time (no exact day available) Treatment Start: February 2021 Cohort 3: 2400 mg Q2W treatment completed Previous PG medication: Ciclosporin and methylprednisolone October 2018
Slide 17: PG Phase IIa Patient Case Study
PG Phase IIa Patient 13 Case Study TARGET ULCER OPENED IN NOVEMBER 2020 WHILE ON STABLE ADALIMUMAB MH: PG since August 2020, Psoriasis since 2017 Treatment Start: March 2021 Previous PG medication: None Cohort 3: 2400 mg Q2W up to Day 85 → exclusion after 9 doses due to delayed availability of pos.
Slide 18: 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: • Erysipelas leading to hospitalization (judged as non-related by sponsor) • Rash due to delayed hypersensitivity reaction WE WILL MEET • Observe
Slide 19: Vilobelimab Life-threatening Inflammatory Diseases
I N N O VAT I O N TEAMWORK DISCOVERY COMPLEMENT Vilobelimab Life-threatening Inflammatory Diseases • COVID-19 • ANCA Associated Vasculitis (AAV)
Slide 20: 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 21: Phase II Part Results Overview
Phase II Part Results Overview 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 effects with
Slide 22: Design of Phase II/III Study with Vilobelimab in Severe COVID-19
Design of 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 COMPLETED Best supportive care Dosing scheme: • Phase III primary endpoint: 28-day a
Slide 23: Phase II Studies in AAV – Results
Phase II Studies in AAV Results EU PHASE II TOPLINE RESULTS (N=57 TOTAL) • Demonstrated Proof of concept for vilobelimab to reduce use of glucocorticoid (GC) therapy in AAV • Achieved comparable efficacy to standard of care GC therapy • Use of vilobelimab instead of GC led to a substantially lower o
Slide 24: Vilobelimab Oncology
I N N O VAT I O N TEAMWORK DISCOVERY COMPLEMENT Vilobelimab Oncology • Cutaneous Squamous Cell Carcinoma (cSCC)
Slide 25: Cutaneous Squamous Cell Carcinoma (cSCC) – Phase II Study Underway
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 26: INF904 New Pipeline Program
I N N O VAT I O N TEAMWORK DISCOVERY COMPLEMENT INF904 New Pipeline Program
Slide 27: Background: C5aR and its allosteric inhibitor INF904
Background C5aR and its allosteric inhibitor INF904 C5a and INF904 Nathan Robertson, 2018 Nature • C5a receptor (C5aR): Heng Liu, 2018, Nat. Struct. Mol. Biol • a 7-transmembrane G-protein-coupled-receptor C5a expressed primarily on granulocytes, mediates the major pathophysiological effects of C5a
Slide 28: INF904 Potential for Best in Class C5aR Inhibition
INF904 Potential for Best in Class C5aR Inhibition Neutropenia in vivo Model PROGRAM DETAILS ✱✱ Avacopan-like 120 (10mg/kg oral) • INF904 shows no obvious toxicological findings even in the highest dose 100 INF904 % Inhibition 80 (10mg/kg oral) groups in required GLP toxicity analyses Vehicle 60 • I
Slide 29: Strategy and Outlook
I N N O VAT I O N TEAMWORK DISCOVERY COMPLEMENT Strategy and Outlook
Slide 30: Strategic Objectives
Strategic Objectives Immuno- • HS: Initiate Phase III program with vilobelimab, incorporating novel endpoint dermatology • PG: Advance vilobelimab towards Phase III based on regulatory guidance Focus • Severe COVID-19: Complete Phase III with vilobelimab; Submit for approval if results are positive
Slide 31: InflaRx N.V. Investor Relations
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 www.inflarx.com