Inflarx N.v. · NASDAQ:IFRX
Inflarx — Investor Presentation (January 2021)
31 slides from Inflarx's investor presentation, Jan 11, 2021
Slide 1: Controlling Inflammation Corporate Presentation
CONTROLLING INFLAMMATION CORPORATE PRESENTATIONJanuary 2021
Slide 2: Important Notice and Disclaimer
IMPORTANT NOTICE AND DISCLAIMERThis 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 solicit
Slide 3: Investment Highlights
Investment Highlights Page * Complete and selective blockade of the biological activity of C5a in vitro and in vivoStrong patent coverage on anti-C5a technology until end of 2030 / 2035 with extension Proven anti-inflammatory effect in multiple Phase II studies; favorable safety profile & excellent
Slide 4: Pipeline with Multiple Opportunities
Pipeline with Multiple Opportunities Page * PROPOSED INDICATIONS PREVALENCE PRE-CLINICAL PHASE I PHASE II PHASE III UPDATE Severe COVID-19 Currently unknown Phase II/III study: Phase II part: results published; Phase III part is enrolling Vilobelimab(IFX-1)C5a Inhibitor Hidradenitis Suppurativa Up t
Slide 5: The Terminal Complement Pathway
The Terminal Complement Pathway Page * Membrane Attack Complex (MAC)triggers lysis of pathogens strong amplifierof inflammation C5aR C5b-9 = MAC C5L2 C5b C5a C5 cell activationcytokine generation INFLAMMATION PKC-signaling HMGB-1 induction* (Inflammasome) C5a concentration in blood: 10 ~ 30 ng/ml (~
Slide 6: Vilobelimab (IFX-1) for Severe COVID-19
VILOBELIMAB (IFX-1) FOR SEVERE COVID-19
Slide 7: A Viral Pneumonia with a Broad Spectrum of Immune-Mediated Injury
A VIRAL PNEUMONIA WITH A BROAD SPECTRUM OF IMMUNE-MEDIATED INJURY Coronavirus Disease 2019 (COVID-19) Page * Source: https://www.chinalawtranslate.com/en/coronavirus-treatment-plan-7/; Rapkiewicz et all, EclinicalMedicine (2020) 100434; Goshua et al., Lancet Haematol 2020 June 30; Cugno et al., J Al
Slide 8: COVID-19 Induced Vascular Injury – Potential Role of C5a
Page * COVID-19 induced Vascular Injury – Potential Role of C5aModel 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 l
Slide 9: Design of Phase II/III Study with Vilobelimab in Severe COVID-19
STUDY DESIGNCritically ill intubated* patients with COVID-19 induced pneumoniaPhase III primary endpoint: 28-day all-cause mortalityOther key endpoints include assessments of organ support, assessment of disease improvement on the ordinal scaleSTATUSPhase 2 part completed:Encouraging Topline Results
Slide 10: Phase II Part Results: Overview
Phase II Part Results: Overview Page * Primary endpoint: no difference detected in improvements between groups in PaO2/FiO2 ratio: high variability between patients: conclusion: endpoint not suitable as response parameterKey secondary and other endpoints: Observed effects in vilobelimab treatment ar
Slide 11: Phase II Part Results: Lymphocyte Count Normalization
Phase II Part Results: Lymphocyte Count Normalization Page * * Shift Plot Lymphocytes – all randomized, n=15 per armVlaar, A et al. Lancet Rheumatol 2020. https://doi.org/10.1016/S2665-9913(20)30341-6 LYMPHOCYTES - BEST SUPPORTIVE CARE ONLY* Normal (1.5 to 4.0 x 109 per L) Low (0.75 to 1.5 x 109 per
Slide 12: Phase II Part Results: eGFR Level Stability
Phase II Part Results: eGFR Level Stability Page * eGFR* control At day 15, mean eGFR showed a 3% change from baseline in the vilobelimab group versus -14% in the best supportive care groupOnly 1 patient developed a kidney injury in the vilobelimab group vs 4 patients in the control group developed
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 Page * D-DIMER* control Vilobelimab treatment was associated with significant increase of D-dimer levels, suggesting potential pro-fibrinolytic activity of anti-C5a treatment Significant temporary D-dimer
Slide 14: Vilobelimab (IFX-1) for Hidradenitis Suppurativa
VILOBELIMAB (IFX-1) FOR HIDRADENITIS SUPPURATIVA
Slide 15: Phase IIb SHINE Study Details
Hidradenitis Suppurativa (HS)Phase IIb SHINE Study Details Page * Important Note: Patients entering the OLE were not unblinded to their initial therapy Test a dose-dependent effect of vilobelimab on HiSCR* response at week 16 (primary endpoint) Assess long-term safety of vilobelimabTest durability o
Slide 16: SHINE Study: Outcome at Week 16
SHINE Study: Outcome at Week 16 Page * HISCR RESPONSE RATE (%) WEEK 16* * Full analysis set AN COUNT SCORE CHANGE (MEAN %) WEEK 16* n = approx. 35/ group placebo minimum low medium high Treatment group: DRAINING FISTULA CHANGE (MEAN %)** IHS-4 SCORE CHANGE (MEAN %)** ** Full analysis set – baseline
Slide 17: LuNG [ad
LuNG [ad Rens /1//aRx
Slide 18: SHINE Study and Next Steps in HS Development
SHINE Study and Next Steps in HS Development Page * * Serious adverse events ** including aspects of the Ph III design, vilobelimab dosing, target study population, nonclinical & clinical pharmacology packages HiSCR is burdened by high variability (driven by AN count variability) and by a lack of ca
Slide 19: Vilobelimab (IFX-1) for ANCA-Associated Vasculitis
VILOBELIMAB (IFX-1) FOR ANCA-ASSOCIATED VASCULITIS
Slide 20: AAV: Clinical PoC for Role of C5a / C5aR Pathway
AAV, Life-threatening Autoimmune ConditionClinical PoC established for Role of C5a / C5aR Pathway in AAV Page * Rapid onset of action: intravenous administration with fast onset of action, inhibiting C5a signaling completely protecting from C5a induced priming and activation of neutrophils → potenti
Slide 21: Phase II Study in AAV in the US (IXPLORE) Study Design
Phase II Study in AAV in the US (IXPLORE)Study Design Page * TREATMENT: 16 WEEKS FOLLOW UP: 8 WEEKS Remission Induction Phase Maintenance Phase Maintenance Therapy:remain on SOC or transition to guideline maintenance therapy* Vilobelimab low dose + SOC Vilobelimab high dose + SOC Placebo + SOC A GRO
Slide 22: Phase II Study in AAV in Europe (IXCHANGE) Study Design
Phase II study in AAV in Europe (IXCHANGE)Study Design Page * Study (total enrolled: n=57**)Primary objective: Proof of Concept for efficacy of vilobelimab as replacement for glucocorticoid (GC) therapy in GPA and MPA Secondary objectives: To assess safety and tolerability of vilobelimab & compare t
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 Page * Assessing safety and efficacy of vilobelimab in PGRationale: Pyoderma Gangraenosum (PG) is a rare ulcerative skin disease with a high unmet medical need. PG is associated with a neutrophilic leukocytosis, which is likely to be t
Slide 25: Status and Next Steps
Status and Next Steps Page * PHASE IIA STUDY UPDATE C5A LEVELS AT BASELINE TREATMENTS Data reported on first 5 patients treated in Feb 20202 of 5 pts: complete closure of target ulcer; full disease remission; remained healed even after finishing the studyAdditional patient: initial wound healing act
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 Page * Inhibition of C5a signaling in the tumor microenvironment may decrease tumor growthCombination of C5a with PD-1 checkpoint inhibition could reverse resistance to PD-1 o
Slide 28: Study in Cutaneous Squamous Cell Carcinoma (cSCC)
Study in Cutaneous Squamous Cell Carcinoma (cSCC) Page * ARM A: VILOBELIMAB ALONE ARM B: VILOBELIMAB + PEMBROLIZUMAB N=7 Safety Analysis Safety run-in N=3 N=3 (+3) Regimen 1 N=3 (+3) Regimen 2 N=3 (+3) Regimen 3 N=4 or 7 Regimen 1,2 or 3 DLT Analysis DLT: Dose limiting toxicity; CR: complete respons
Slide 29: Strategy and Outlook
= CONTROLLING INFLAMMATION in a | STRATEGY AND OUTLOOK
Slide 30: Medium Term Deliverables and Strategic Objectives
Medium Term Deliverables and Strategic Objectives Page * Complete Phase III development of lead program vilobelimab in Severe COVID-19; submit for approval if results positiveAdvance vilobelimab in HS towards Phase III and ultimate approval based on regulatory guidanceExplore application of vilobeli
Slide 31: InflaRx N.V. Investor Relations
Winzerlaer Str. 207745 Jena, GermanyEmail: info@inflarx.comTel: +49-3641-508180Fax: +49-3641-508181www.inflarx.com Jordan ZwickChief Strategy OfficerEmail: jordan.zwick@inflarx.de INFLARX N.V. INVESTOR RELATIONS INFLARX N.V.