Inflarx N.v. · NASDAQ:IFRX
Inflarx — Investor Presentation (November 2021)
39 slides from Inflarx's investor presentation, November 2021
Slide 1: Controlling Inflammation: Corporate Presentation
CONTROLLING INFLAMMATION CORPORATE PRESENTATION November 2021
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: Investment Highlights
Investment Highlights InflaRx’s Approach: Targeting Complement to Control Autoimmune Diseases Leading Proprietary Anti-C5a Technology • Complete and selective blockade of the biological activity of C5a in vitro and in vivo • Strong patent coverage on anti-C5a technology until end of 2030 / 2035 with
Slide 4: Pipeline with Multiple Opportunities
Pipeline with Multiple Opportunities FRANCHISE INDICATIONS PRE-CLINICAL PHASE I PHASE II PHASE III UPDATE • Phase IIb completed Hidradenitis • FDA supportive of new primary Suppurativa (HS) endpoint; Pivotal trial protocol to be submitted to the FDA in Q4 21 Immunodermatology Pyoderma • Positive Pha
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 (IFX-1) for Hidradenitis Suppurativa
VILOBELIMAB (IFX-1) FOR HIDRADENITIS SUPPURATIVA
Slide 7: Hidradenitis Suppurativa (HS)
Hidradenitis Suppurativa (HS) A chronic severely debilitating C5a-driven inflammatory skin condition with high unmet need HURLEY STAGING FOR HS Stage I CLINICAL FEATURES Single / multiple abscesses but • Chronic, inflammatory, recurrent, debilitating skin disease of the hair follicles no sinus tract
Slide 8: HS Phase IIb SHINE study details
Hidradenitis Suppurativa (HS) Phase IIb SHINE study details Main Period: n = 177 treated Open Label Extension Period (OLE): n = 156 Placebo Week 16 HiSCR Responders: Vilobelimab minimal dose (400 mg q4w) (800 mg q4w) Vilobelimab low dose Vilobelimab low dose (800 mg q4w) Week 16 HiSCR Non-Responders
Slide 9: SHINE Study and Next Steps in HS Development
SHINE Study and Next Steps in HS Development RESULTS CURRENT STATUS & NEXT STEPS • HiSCR primary endpoint and dose response signal not met but there • FDA Type A Meeting (August 2021) was a signal towards improved AN count • Received feedback from FDA within its Type A meeting • Statistically signif
Slide 10: Vilobelimab (IFX-1) for Pyoderma Gangraenosum
VILOBELIMAB (IFX-1) FOR PYODERMA GANGRAENOSUM
Slide 11: 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 ulce
Slide 12: PGA Score – Physician's Global Assessment Score
PGA Score – Physician‘s Global Assessment Score PGA SCORE IN THIS TRIAL PGA SCORE Completely except for possible residual hyperpigmentation • PGA classifies physician-assessed target ulcer 0 clear improvement compared to photography at Day 1 Almost clear very significant clearance (about 90%); howev
Slide 13: Phase IIa Study Design
Phase IIa Study Design • Sequential enrollment of 19 patients reached in April 2021 • Primary endpoint: Safety • Key secondary endpoints: Responder rate defined as PGA ≤3; Time to complete closure of target ulcer INITIATION MAINTENANCE INDIVIDUAL TITRATION OBSERVATION Day 1-8, 3 doses Day 15-43, 3 d
Slide 14: 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 15: 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 16: 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 17: Study Results – Group 1 and Group 2 C5a levels
Study Results – Group 1 and Group 2 C5a levels Group 1 Group 2 * * * 1* 2** 3* 4* 5** 6* 7* 11 8* 12 9 10** Patient Number Patient Number * Responder (PGA Score ≤ 3) Clinical observations ** Responder in remission (PGA ≤1) Values not available • Patient 10 in Group 2 reached clinical remission at Da
Slide 18: Study Results – Group 3 C5a levels
Study Results – Group 3 C5a levels Clinical observations • Six patients reached PGA≤1 • Patient 18 only showed minor improvement of target ulcer but no remission ** Responder in remission (PGA ≤1) 13 ** 14 ** 15 ** 16 ** 17 ** 18 19 ** Patient Number Values not available Page 18
Slide 19: Summary and Conclusion
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 • Observed AE profile in line with patients’ unde
Slide 20: Patient Case Studies in PG
I N N O VAT I O N TEAMWORK DISCOVERY COMPLEMENT Patient Case Studies in PG
Slide 21: Patient 10 Case Study
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 Jun 2019- Aug 2
Slide 22: Patient 14 Case Study
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 – September
Slide 23: Patient 13 Case Study
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. baseline TB t
Slide 24: Vilobelimab (IFX-1) for ANCA-Associated Vasculitis
VILOBELIMAB (IFX-1) FOR ANCA-ASSOCIATED VASCULITIS
Slide 25: ANCA-Associated Vasculitis (AAV)
ANCA-Associated Vasculitis (AAV) A LIFE-THREATENING AUTOIMMUNE CONDITION CLINICAL FEATURES • Rare, life-threatening autoimmune disease, characterized by necrotizing vasculitis • Life-threatening flare phases affect organs, leading to potentially fatal organ dysfunction and failure • Predominantly af
Slide 26: AAV, Life-threatening Autoimmune Condition: C5a/C5aR pathway PoC
AAV, Life-threatening Autoimmune Condition Clinical PoC established for role of C5a / C5aR pathway in AAV ROLE OF C5A IN AAV • Anti-neutrophil cytoplasmic auto-antibodies induce C5a activation leading to neutrophil-endothelial cell adherence and neutrophil activation --- causing neutrophil-driven va
Slide 27: Phase II Study in AAV in the US (IXPLORE)
Phase II Study in AAV in the US (IXPLORE) Results PHASE II TOPLINE RESULTS • Three-arm, placebo-controlled trial with 16 weeks of treatment 80% Patients with BVAS = 0 (%) and 8 weeks follow-up (n=19) • Primary endpoint met: safe and well-tolerated in patients with 60% AAV when added to SOC; • Observ
Slide 28: Phase II Study in AAV in EU (IXCHANGE) Study Design
Phase II Study in AAV in EU (IXCHANGE) Study Design TREATMENT: 16 WEEKS FOLLOW UP: 8 WEEKS Part A Vilobelimab + SOC with 1 reduced GC (n=15) Remission Induction Phase Maintenance Phase B placebo + SOC incl. GC Dosing scheme: (n=15) Safety analysis TREATMENT: 16 WEEKS FOLLOW UP: 8 WEEKS B placebo + S
Slide 29: Phase II Study in AAV in the EU (IXCHANGE) Results
Phase II Study in AAV in the EU (IXCHANGE) Results PHASE II TOPLINE RESULTS (IXCHANGE) BVAS Week 16 Endpoint Phase II IXCHANGE Trial BVAS 50% BVAS=0 • Study demonstrated proof of concept for the use of vilobelimab to reduce use Treatment (Clinical (Clinical of GC therapy in subjects with Granulomato
Slide 30: IXCHANGE: Use of GC and GC-induced toxicity
Phase II Study in AAV in the EU (IXCHANGE): Use of GC and GC-induced toxicity Cumulative Glucocorticoid intake (Day -28 to Day 1) Boxplot of GTI* composite score at week 16 Prednisone equivalent Vilobelimab (No GC) SDGC Vilobelimab + RDGC dose (mg) (N=18) (N=24) (N=15) 160 140 Subjects with no GC 1
Slide 31: Vilobelimab (IFX-1) for Severe COVID-19
VILOBELIMAB (IFX-1) FOR SEVERE COVID-19
Slide 32: 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 33: 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 wi
Slide 34: Vilobelimab (IFX-1) in Oncology
VILOBELIMAB (IFX-1) IN ONCOLOGY
Slide 35: Cutaneous Squamous Cell Carcinoma (cSCC)
Cutaneous Squamous Cell Carcinoma (cSCC) PD-1 or PD-L1 Inhibitor Resistant/Refractory Locally Advanced or Metastatic Patients POTENTIAL ROLE OF C5A IN ONCOLOGY & cSCC DISEASE INFORMATION cSCC • C5a induces an immunosuppressive tumor microenvironment • Risk factors include HS, cumulative UV radiation
Slide 36: cSCC: Phase II Study Underway
Cutaneous Squamous Cell Carcinoma (cSCC): Phase II Study Underway INCLUSION CRITERIA ARM B: VILOBELIMAB + ARM A: VILOBELIMAB ALONE PEMBROLIZUMAB • Locally advanced or metastatic cSCC N=3 • Refractory or resistant to PD-1 or PD-L1 inhibitor Stage 1 Safety Analysis • Locally advanced cSCC not amenable
Slide 37: Strategy and Outlook
2 a Ss CONTROLLING - _ ja INFLAMMATION in a lil oo 7 H . La eee P= = ; || == = aN # ii\\ ' STRATEGY AND OUTLOOK
Slide 38: Medium Term Deliverables and Strategic Objectives
Medium Term Deliverables and Strategic Objectives GOALS AND STRATEGY Advance vilobelimab in HS and PG towards Phase III and ultimate approval based on regulatory guidance Complete Phase III development of vilobelimab in Severe COVID-19; submit for approval if results positive Plan to discuss next st
Slide 39: 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: jordan.zwick@inflarx.de Tel: +49-3641-508180 Fax: +49-3641-508181 www.inflarx.com