InflaRx N.V. · NASDAQ:IFRX
InflaRx — Investor Presentation (January 2021)
31 slides from InflaRx's investor presentation, January 2021
Slide 1: Controlling Inflammation – Corporate Presentation
CONTROLLING INFLAMMATION CORPORATE PRESENTATION January 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 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 extension ESTABLISHED CLINICAL EFFICACY FOR VILOBELIMAB (IFX-1): • Prov
Slide 4: Pipeline with Multiple Opportunities
Pipeline with Multiple Opportunities PROPOSED PREVALENCE PRE-CLINICAL PHASE I PHASE II PHASE III UPDATE INDICATIONS Severe COVID-19 • Currently unknown • Phase II/III study: Phase II part: results published; Phase III part is enrolling Hidradenitis • Up to 200,000 • Phase IIb completed Vilobelimab S
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 Severe COVID-19
VILOBELIMAB (IFX-1) FOR SEVERE COVID-19
Slide 7: Coronavirus Disease 2019 (COVID-19)
Coronavirus Disease 2019 (COVID-19) A VIRAL PNEUMONIA WITH A BROAD SPECTRUM OF IMMUNE-MEDIATED INJURY CLINICAL & PATHOLOGY FEATURES • Death is typically caused by respiratory failure and viral sepsis in presence of immune-response induced multiple organ dysfunction • Pathology in lung: extensive inf
Slide 8: 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 • Endothelial damage is induced by SARS-CoV-2 infection which also activates the complement system leading to C5a generation. • C5a activates neutrophils via C5aR lea
Slide 9: Design of Phase II/III study with Vilobelimab in Severe COVID-19
Design of Phase II/III study with Vilobelimab in Severe COVID-19 COMPLETED STUDY DESIGN Open-label 800mg i.v. 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: 28-day a
Slide 10: 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 in vi
Slide 11: Phase II Part Results: Lymphocyte Count Normalization
Phase II Part Results: Lymphocyte Count Normalization LYMPHOCYTES - VILOBELIMAB+BEST SUPPORTIVE CARE* LYMPHOCYTES - BEST SUPPORTIVE CARE ONLY* vilobelimab control Patients (%) Patients (%) Time since randomization (days) Time since randomization (days) Normal (1.5 to 4.0 x 109 per L) Low (0.75 to 1.
Slide 12: Phase II Part Results: eGFR Level Stability
Phase II Part Results: eGFR Level Stability eGFR LEVEL eGFR* • At day 15, mean eGFR showed a 3% change from baseline in the Least squares mean percentage change control vilobelimab group versus -14% in the best supportive care group • Only 1 patient developed a kidney injury in the vilobelimab group
Slide 13: Phase II Part Results: Significant Increase in D-dimer Levels
Phase II Part Results: Vilobelimab Treatment Associated Significant Increase in D-dimer Levels LEVELS OF D-DIMER D-DIMER* • Significant temporary D-dimer increase observed directly upon Least squares mean percentage change control initiation of vilobelimab therapy (day 2) • Possible sign of inductio
Slide 14: Vilobelimab (IFX-1) for Hidradenitis Suppurativa
VILOBELIMAB (IFX-1) FOR HIDRADENITIS SUPPURATIVA
Slide 15: Hidradenitis Suppurativa Phase IIb SHINE Study Details
Hidradenitis Suppurativa (HS) Phase IIb SHINE Study Details HS: A chronic severely debilitating C5a-driven inflammatory skin condition with high unmet need Main Period: n = 177 treated Open Label Extension Period (OLE): n = 156 Placebo Week 16 HiSCR Responders: Vilobelimab minimal dose (400 mg q4w)
Slide 16: SHINE Study: Outcome at Week 16
SHINE Study: Outcome at Week 16 HISCR RESPONSE RATE (%) WEEK 16* AN COUNT SCORE CHANGE (MEAN %) WEEK 16* n = approx. 35/ group 47,1 51,5 40,0 45,5 38,7 -26,5 -32,7 -44,9 -47,7 -54,6 Spalte4 Spalte4 Treatment group: DRAINING FISTULA CHANGE (MEAN %)** IHS-4 SCORE CHANGE (MEAN %)** placebo minimum -18
Slide 17: Responder versus Non-responder Inflammatory Lesion Reductions: OLE
Responder versus Non-responder Inflammatory Lesion Reductions: OLE OLE Week 16 to Week 40 Patients (w40) Compared to Placebo HISCR RESPONSE RATE (%) PER VISIT* (OLE) WITH 95% CI (w16) RELATIVE REDUCTION (% MEAN) COMPARED TO RESPECTIVE BASELINE (DAY1)* 100 90 AN count DF count IHS-4 score ANF count 8
Slide 18: SHINE Study and Next Steps in HS Development
SHINE Study and Next Steps in HS Development OUR CONCLUSIONS CURRENT STATUS & NEXT STEPS • HiSCR is burdened by high variability (driven by AN count variability) • Scientific Advice received from EMA in July 2020 and by a lack of capturing reduction of draining fistulas • EMA agreed to key proposals
Slide 19: Vilobelimab (IFX-1) for ANCA-Associated Vasculitis
VILOBELIMAB (IFX-1) FOR ANCA-ASSOCIATED VASCULITIS
Slide 20: AAV, Life-threatening Autoimmune Condition
AAV, Life-threatening Autoimmune Condition Clinical PoC established for Role of C5a / C5aR Pathway in AAV LEADING PROPRIETARY ANTI-C5A TECHNOLOGY • C5a is essential for development of MPA-ANCA crescentic glomerulonephritis in a mouse model • Complement activation in active AAV patients is significan
Slide 21: Phase II Study in AAV in the US (IXPLORE)
Phase II Study in AAV in the US (IXPLORE) Study Design GROUPS: TREATMENT: 16 WEEKS FOLLOW UP: 8 WEEKS A Vilobelimab low dose + SOC Remission Induction Phase Maintenance Phase B Vilobelimab high dose + SOC C Placebo + SOC Day 1 Week 16 Week 24 Randomization 1:1:1 SOC = Rituximab or Cyclophosphamide +
Slide 22: Phase II Study in AAV in Europe (IXCHANGE)
Phase II study in AAV in Europe (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
Slide 23: Vilobelimab (IFX-1) for Pyoderma Gangraenosum
VILOBELIMAB (IFX-1) FOR PYODERMA GANGRAENOSUM
Slide 24: Pyoderma Gangraenosum Rationale and Phase IIa Study Overview
Pyoderma Gangraenosum (PG) Rationale and Phase IIa Study Overview STUDY OBJECTIVE STUDY DESIGN TREATMENT • Assessing safety and efficacy of vilobelimab in PG • Open label • The first 5 patients were • Rationale: • Multicenter dosed at 800mg biweekly Pyoderma Gangraenosum (PG) is a rare ulcerative sk
Slide 25: Status and Next Steps
Status and Next Steps PHASE IIA STUDY UPDATE C5A LEVELS AT BASELINE TREATMENTS Data reported on first 5 patients treated in Feb 2020 Two Patients Show Complete Wound responder • 2 of 5 pts: complete closure of target ulcer; full Closure with Vilobelimab Treatment 70 disease remission; remained heale
Slide 26: Vilobelimab (IFX-1) in Oncology
VILOBELIMAB (IFX-1) IN ONCOLOGY
Slide 27: 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 Hidradenitis Suppurativa, c
Slide 28: Study in Cutaneous Squamous Cell Carcinoma (cSCC)
Study in Cutaneous Squamous Cell Carcinoma (cSCC) 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 for curative tr
Slide 29: Strategy and Outlook
2 a Ss CONTROLLING - _ ja INFLAMMATION in a lil oo 7 H . La eee P= = ; || == = aN # ii\\ ' STRATEGY AND OUTLOOK
Slide 30: Medium Term Deliverables and Strategic Objectives
Medium Term Deliverables and Strategic Objectives GOALS AND STRATEGY Complete Phase III development of lead program vilobelimab in Severe COVID-19; submit for approval if results positive Advance vilobelimab in HS towards Phase III and ultimate approval based on regulatory guidance Explore applicati
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: jordan.zwick@inflarx.de Tel: +49-3641-508180 Fax: +49-3641-508181 www.inflarx.com