Inflarx N.v. · NASDAQ:IFRX
Inflarx — Investor Presentation (January 2022)
31 slides from Inflarx's investor presentation, Jan 10, 2022
Slide 1: Controlling inflammation – Corporate Presentation January 2022
Controlling inflammation CORPORATE PRESENTATIONJanuary 2022
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: Targeting Complement to Control Inflammatory Diseases
InflaRx N.V.Targeting Complement to Control Inflammatory Diseases 3 Clinical Efficacy and Clean Safety Profile enabling Vilobelimab to Advance in Multiple IndicationsHidradenitis Suppurativa (HS): Initiated pivotal study program in Q1 2022 after receiving no comments from the FDA in the 30-day revie
Slide 4: Pipeline with Multiple Opportunities
Pipeline with Multiple Opportunities 4 Franchise Indications Pre-Clinical Phase I Phase II Phase III Update VilobelimabC5a Inhibitor Immunodermatology Hidradenitis Suppurativa (HS) Pivotal trial initiated with new primary endpoint Pyoderma Gangraenosum (PG) Positive preliminary Phase IIa open label
Slide 5: The Terminal Complement Pathway
The Terminal Complement Pathway 5 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 (~1-2.5
Slide 6: Vilobelimab Immunodermatology Focus
VilobelimabImmunodermatology Focus Hidradenitis Suppurativa (HS)Pyoderma Gangraenosum (PG)
Slide 7: Hidradenitis Suppurativa disease background and medical need
7 * Combined Phase III trial data for Humira: response measured by HiSCR 50 and KOL quotes in Sam Slutsky’s LifeSci Capital InflaRx initiation report 12/2018 Hurley staging for hs Clinical FeaturesChronic, inflammatory, recurrent, debilitating skin disease of the hair follicles Most commonly in the
Slide 8: HS Phase IIb results
HiSCR is burdened by high variability (driven by AN count variability) and does not capture reduction of dTsIncreased dose required for full vilobelimab efficacyReduction in all inflammatory lesions achieved with vilobelimab high-dose with a durable long-term effect detected even at sub-optimal dose
Slide 9: HS Phase III Development
HS Phase III DevelopmentStudy Initiation 9 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 TunnelsFDA had previously agreed to the Phase III dosing regimen, a higher dose tha
Slide 10: Pyoderma Gangraenosum (PG): high unmet need
Pyoderma Gangraenosum (PG) 10 An autoimmune condition with high unmet need Clinical FeaturesPG 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 ulcerat
Slide 11: PG Phase IIa Study Design
PG Phase IIa Study Design 11 800mg Group 1 N= 6 Initiation Day 1-8, 3 doses Maintenance Day 15-43, 3 doses PGA ≤ 4 PGA > 4 800mg Q2W Individual titration Day 57-189, 9 doses 1600mg Q2W 800mg Completed Observation Day 219 & 249 800mg Group 2 N= 6 PGA ≤ 4 PGA > 4 1600mg Q2W 2400mg Q2W 1600mg Completed
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) 12 Two patients (02 and 05) achieved complete remission of target ulcerOne patient (01) with initial response and fluctuating PGAPatients 02 and 05 stopped treatment
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) 13 One patient (10) out of four healed upon up-titration to 2400mg group on day 57 with PGA = 0 since visit 12 (closure of large target ulcer area)Two patients (08
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) 14 Six patients out of 7 achieved PGA score of ≤ 1 (remission)One patient (18) experienced target ulcer area decrease >50%; however, new PG lesions developedPatient
Slide 15: PG Phase IIa Patient Case Study
PG Phase IIa Patient 10 Case Study 15 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 completedPrevious PG medication: Methylprednisolone only in Jun 2019, Dapsone Jun 2019- Aug 2020, Cyclosporine Oct 20
Slide 16: PG Phase IIa Patient Case Study
PG Phase IIa Patient 14 Case Study 16 MH: PG since October 2018, Obesity since longer time (no exact day available)Treatment Start: February 2021 Cohort 3: 2400 mg Q2W treatment completedPrevious PG medication: Ciclosporin and methylprednisolone October 2018 – September 2019, failed. Dapsone Septemb
Slide 17: PG Phase IIa Patient Case Study
PG Phase IIa Patient 13 Case Study 17 MH: PG since August 2020, Psoriasis since 2017Treatment Start: March 2021Previous PG medication: None Cohort 3: 2400 mg Q2W up to Day 85 exclusion after 9 doses due to delayed availability of pos. baseline TB testing result (no TB activation!) Concomitant Medi
Slide 18: PG Phase IIa Study Results Summary and Conclusion
PG Phase IIa Study ResultsSummary and Conclusion 18 Vilobelimab Q2W shows good safety and tolerabilityEvidence of dose-dependent drug activity in PG No infusion-related reactions observedFor 2 patients, related SAEs were reported:Erysipelas leading to hospitalization (judged as non-related by sponso
Slide 19: Vilobelimab Life-threatening Inflammatory Diseases
Vilobelimab Life-threatening Inflammatory Diseases COVID-19ANCA Associated Vasculitis (AAV)
Slide 20: COVID-19 induced Vascular Injury – Potential Role of C5a
20 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, lead
Slide 21: Phase II Part Results Overview
Phase II Part ResultsOverview 21 Primary endpoint: No difference detected in improvements between groups in PaO2/FiO2 ratio High variability between patientsConclusion: Endpoint not suitable as response parameterKey secondary and other endpoints - Observed effects with vilobelimab compared to best s
Slide 22: Design of Phase II/III Study with Vilobelimab in Severe COVID-19
Critically ill intubated* patients with COVID-19 induced pneumoniaPhase III primary endpoint: 28-day all-cause mortalityOther key endpoints include assessments of organ support, disease improvement on ordinal scalePhase II part completed:Topline results publishedPhase III part fully enrolled: 369 pa
Slide 23: Phase II Studies in AAV Results
Phase II Studies in AAV Results 23 US Phase II Topline RESULTS (n=19) Primary endpoint met; safe and well-tolerated in patients with AAV Observed TEAEs are reflective of the disease and SOC treatmentAll three treatment groups showed a strong clinical response (50% reduction in BVAS) at week 16Clinic
Slide 24: Vilobelimab Oncology: Cutaneous Squamous Cell Carcinoma
VilobelimabOncology Cutaneous Squamous Cell Carcinoma (cSCC)
Slide 25: cSCC Phase II Study Underway
Cutaneous Squamous Cell Carcinoma (cSCC)Phase II Study Underway 25 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 or PD-L1 inhibitor therapy POTENTIAL ROLE OF C5A IN ONCOLOGY & cSC
Slide 26: INF904 New Pipeline Program
INF904New Pipeline Program
Slide 27: Background: C5aR and its allosteric inhibitor INF904
BackgroundC5aR and its allosteric inhibitor INF904 27 Nathan Robertson, 2018 NatureHeng Liu, 2018, Nat. Struct. Mol. Biol Trp213 C5a receptor (C5aR):a 7-transmembrane G-protein-coupled-receptor expressed primarily on granulocytes, mediates the major pathophysiological effects of C5aC5aR proven to be
Slide 28: INF904 Potential for Best in Class C5aR Inhibition
INF904Potential for Best in Class C5aR Inhibition INF904 shows no obvious toxicological findings even in the highest dose groups in required GLP toxicity analyses INF904 shows a high in vitro potency with a desired IC50 (<1nM) in calcium mobilization assayIn vitro analysis of INF904’s effect on CYP3
Slide 29: Strategy and Outlook
Strategy and Outlook
Slide 30: Strategic Objectives
Strategic Objectives 30 HS: Initiate Phase III program with vilobelimab, incorporating novel endpointPG: Advance vilobelimab towards Phase III based on regulatory guidance Severe COVID-19: Complete Phase III with vilobelimab; Submit for approval if results are positiveAAV: Discuss next steps for vil
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: IR@inflarx.de InflaRx N.V. Investor Relations InflaRx N.V.