Inflarx N.v. · NASDAQ:IFRX
Inflarx — Investor Presentation (March 2021)
36 slides from Inflarx's investor presentation, Mar 9, 2021
Slide 1: Controlling Inflammation – Corporate Presentation March 2021
CONTROLLING INFLAMMATION CORPORATE PRESENTATION March 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 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 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 9: SHINE Study Baseline Study Characteristics (Day 1)
SHINE Study Baseline Study Characteristics (Day 1) Placebo 400mg q4w 800mg q4 800mg q2w 1200mg q2w (n= 36) (n= 34) (n= 35) (n= 36) (n= 36) Male gender (%) 41.7 52.9 48.6 44.4 36.1 Age (years, mean ± SD) 35.4 ± 11.3 39.6 ± 10.0 37.3 ± 12.5 38.3 ± 11.1 35.8 ± 12.3 Median years of HS 7.5 7.0 10.0 9.5 7
Slide 10: 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 11: 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 12: Week-16 Non-responder patients – IHS-4 score changes
Week-16 Non-responder patients – IHS-4 score changes RELATIVE CHANGE FROM BASELINE (MEAN) AT WEEK 16 AND WEEK 40* IHS-4 score change 30.0 20.6 IFX-1 800 mg q2w 20.0 9.0 10.0 0.0 -10.0 Treatment group: -20.0 -12.5 -10.9 placebo -19.9 -30.0 -25.3 -25.4 -25.6 minimum -26.6 -40.0 -32.7 low week 16 week
Slide 13: Week-16 Non-responder patients – AN, ANF & DF count changes
Week-16 Non-responder patients – AN, ANF & DF count changes RELATIVE CHANGE FROM BASELINE (MEAN) AT WEEK 16 AND WEEK 40* AN count change ANF count change DF count change 20.0 16.3 IFX-1 800 mg q2w 20.0 IFX-1 800 mg q2w 20.0 12.5 IFX-1 800 mg q2w 13.7 12.7 7.6 9.7 10.0 10.0 10.0 0.0 0.3 0.0 0.0 -10.0
Slide 14: Week-16 responder patients – IHS-4 score changes
Week-16 responder patients – IHS-4 score changes RELATIVE CHANGE FROM BASELINE (MEAN) AT WEEK 16 AND WEEK 40* IHS-4 score change 40.0 IFX-1 800 mg q4w 20.0 0.0 -20.0 Treatment group: -40.0 placebo -60.0 -59.4 -50.9 -61.3 minimum -80.0 -68.6 -69.1 -72.8 -79.0 -69.4 -68.4 -76.3 low -100.0 week 16 week
Slide 15: 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 16: Vilobelimab (IFX-1) for Severe COVID-19
VILOBELIMAB (IFX-1) FOR SEVERE COVID-19
Slide 17: 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 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 • 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 19: 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 20: 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 21: 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 22: 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 23: 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 24: Vilobelimab (IFX-1) for ANCA-Associated Vasculitis
VILOBELIMAB (IFX-1) FOR ANCA-ASSOCIATED VASCULITIS
Slide 25: 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 26: 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 27: 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 28: Vilobelimab (IFX-1) for Pyoderma Gangraenosum
VILOBELIMAB (IFX-1) FOR PYODERMA GANGRAENOSUM
Slide 29: Pyoderma Gangraenosum (PG) 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 30: 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 31: Vilobelimab (IFX-1) in Oncology
VILOBELIMAB (IFX-1) IN ONCOLOGY
Slide 32: 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 33: 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 34: Strategy and Outlook
2 a Ss CONTROLLING - _ ja INFLAMMATION in a lil oo 7 H . La eee P= = ; || == = aN # ii\\ ' STRATEGY AND OUTLOOK
Slide 35: Medium Term Deliverables and Strategic Objectives
Medium Term Deliverables and Strategic Objectives GOALS AND STRATEGY Advance vilobelimab in HS towards Phase III and ultimate approval based on regulatory guidance Complete Phase III development of lead program vilobelimab in Severe COVID-19; submit for approval if results positive Explore applicati
Slide 36: 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