Inflarx N.v. · NASDAQ:IFRX
Inflarx — JP Morgan Healthcare Conference 2020
35 slides from Inflarx's conference presentation, Jan 16, 2020
Slide 1: Controlling Inflammation - JP Morgan Corporate Presentation January 2020
CONTROLLING INFLAMMATION JP Morgan Corporate Presentation January 2020
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 principle 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 Proven anti-inflammatory effect in multiple Phase II studiesStatistically significant reduction of inflammatory lesions in Phase IIb Hidradenitis Suppurativa study and impressive long-term efficacyFull data set analysis warrants continued development towards Phase III despite m
Slide 4: Pipeline with Multiple Opportunities
Pipeline with Multiple Opportunities We have multiple ongoing Phase II studies with potential to expand into further indications These compounds and/or uses of approved products are investigational and have not been approved by the FDA or any other regulatory agency for the uses under investigation.
Slide 5: The Terminal Complement Pathway
The Terminal Complement Pathway Membrane Attack Complex (MAC) triggers lysis of pathogens strong amplifierof inflammation C5aR C5b-9 = MAC C5L2 C5b C5a C5 cell activationcytokine generation Inflammation C5a concentration in blood:10 ~ 30 ng/ml (~1-2.5 nM) C5 concentration in blood:~75 µg/ml (~400 nM
Slide 6: IFX-1 is a First-in-Class Anti-C5a Monoclonal Antibody
Blocks C5a biological effects up to 100% in human bloodLeaves MAC formation intactBinds with high affinity to the discovered epitope IFX-1 is a First-in-Class Anti-C5a Monoclonal Antibody KEY FEATURES C5b C5 new epitope Cleavage of C5 through:Complement pathway activation orDirectly through enzymes
Slide 7: The C5a Blocking Potential of IFX-1 in Plasma of HS Patients
The C5a Blocking Potential of IFX-1 in Plasma of Patients Suffering from Hidradenitis Suppurativa Data source: InflaRx GmbH in-house data Control heparin plasma HS patient heparin plasma5 nM IFX-1 highly effectively blocks HS-plasma / C5a-induced neutrophil activation in human blood CD11b FITC [MFI]
Slide 8: IFX-1 Specificity In Vitro and In Vivo
0 10 20 30 40 50 60 70 0h 24h 72h 8d concentration [U/ml] 5dTime placebolow dose medium dose high dose13d 28d 0 0.1 0.2 0.3 0.4 0.5 0.6 0.7 heat-inact. Plasma 0 µg/ml IFX-1 10 µg/ml IFX-120 µg/ml IFX-150 µg/ml IFX-1 0 30 40 50 60 70 80 90 100 110Plasma (1:10 dilution) [µl] OD (542 nm) IFX-1 Specific
Slide 9: IFX-1 for Hidradenitis Suppurativa
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Slide 10: Hidradenitis Suppurativa
Hidradenitis Suppurativa A chronic severely debilitating C5a-driven inflammatory skin condition with high unmet need * Combined Phase III trial data for Humira: response measured by HiSCR 50 and KOL quotes in LifeSci Capital initiation report 12/2018 HURLEY STAGING FOR HS CLINICAL FEATURES Chronic,
Slide 11: IFX-1 in Hidradenitis Suppurativa: Rationale for Targeting C5a
IFX-1 in Hidradenitis Suppurativa RATIONALE FOR TARGETING C5A InflaRx established that HS patients have significant complement activation with elevated C5a levelsC5a is involved in several key pathophysiological mechanisms in HSNeutrophil activation is driven by C5aVarious C5a dependent players pote
Slide 12: IFX-1 in Hidradenitis Suppurativa: HiSCR Endpoint
IFX-1 in Hidradenitis Suppurativa Humira was approved based on HiSCR response – providing a potential pathway to approval HiSCR defines3 types of lesions: HiSCR response defined as:At least 50% reduction in total AN countNo increase in the number of abscesses from baselineNo increase in the number o
Slide 13: IFX-1 Phase IIa Promising Results in HS
IFX-1 Phase IIa Promising Results in HS Clinical efficacy 0% 13 0% 50% 42% 67% 75% 83% 0% 40%20% 60% 80% HISCR response rate in HS patients100% Baseline Day 22 Day 50 Day 134 Day 29 Day 36 Day 43HiSCR response in HS patients DESIGN EFFICACY OUTCOME SAFETY / TOLERABILITY RESULTS Open label / single c
Slide 14: Phase IIb SHINE Study Snapshot Results
(= — Zoos PHASE IIB SHINE STUDY SNAPSHOT RESULTS
Slide 15: IFX-1 in HS: SHINE Study Details
IFX-1 in HS:SHINE Study Details Test a dose-dependent effect of IFX-1 on HiSCR response at week 16 (primary endpoint)Assess long-term safety of IFX-1Test durability of response with lower maintenance therapy in open label extension periodImportant Note: Patients entering the OLE were not unblinded t
Slide 16: SHINE Study: Primary Outcome HiSCR versus AN Count Reduction
SHINE Study:Primary Outcome HiSCR at Week 16 versus AN Count Reduction * Full analysis set HiSCR response rate (%) week 16* AN count score change (mean %) week 16*n = approx. 35/ group 100 0 90 -10 80 -20 70 -30 -26.5 605040 47.1 40.0 51.5 38.7 45.5 -40-50-60 -32.7 -54.6 -44.9 -47.7 30 -70 20 -80 10
Slide 17: SHINE Study: Draining Fistula and IHS-4 Score Reduction
-19.8 -24.6 -41.1 -38.4 -51.5 -80 -70 -60 -50 -40 -30 -20 -10 0 -18 -14.5 -15 -28 -63.2 -80 -70 -60 -50 -40 -30 -20 -10 0 SHINE Study:Outcome on Draining Fistula and IHS-4 Score Reduction – Week 16 Draining fistula change (mean %)* IHS-4 score change (mean %)** placebo minimum low medium high Treatm
Slide 18: IHS-4 Score: Includes and Weights All Inflammatory Lesions
IHS-4 Score:Includes and Weights All Inflammatory Lesions Developed by KOLs / physicians to establish a new severity scoring system, suitable for tracking treatment responseCaptures reduction of draining fistulas (unlike HiSCR)Weighs the most fluctuating lesions (infl. nodules) less than abscesses o
Slide 19: HiSCR Responder versus Non-responder Groups (OLE) Over Time
Comparison of HiSCR for Week 16 Responder versus Non-responder Groups (OLE) Over Time HiSCR response rate (%) per visit* (OLE) – with 95% CI All OLE patients Responders: 71% maintain HiSCR response with low dose IFX-1Non-responders: 42% become HiSCR responders with medium dose IFX-1 * Full analysis
Slide 20: Inflammatory Lesion Reductions in All OLE Patients at Week 40
Inflammatory Lesion Reductions in All OLE Patients at End of Treatment(Week 40) Compared to Placebo Group Performance in Main Period (Week 16) Marked improvement of all inflammatory lesions over time – not explainable by placebo effect * Full analysis set (unadjusted) Relative reduction (% mean) of
Slide 21: IHS-4 Scores Over Time in OLE
IHS-4 Scores Over Time in OLE: Non-responders versus Responders Non-responders improve under medium dose IFX-1 treatment during OLEResponders are relatively “stable” with their IHS-4 scores on low dose IFX-1 * Full analysis set 0 5 10 15 20 Change in IHS-4 scores between week 16 and week 40 in week
Slide 22: IHS-4 Scores in OLE Patients: Relative Change from Baseline
IHS-4 Scores in OLE Patients: Relative Change from Baseline (Day 1) HiSCR Non-responder Group (Week 16) Main period placebo and minimal dose patients show strongest improvement in IHS-4 scores when being treatedwith medium IFX-1 dose (for week 16 HiSCR non-responders) * Last observation carried forw
Slide 23: SHINE Study – Our Conclusions
SHINE Study – Our Conclusions OUR CONCLUSIONS HiSCR is burdened by high variability (driven by AN count variability) and by a lack of capturing reduction of draining fistulaEvidence for a high C5a turnover rate in HS, leading to increased dose requirements of IFX-1IFX-1 leads to a marked reduction o
Slide 24: HS – Next Steps
HS – Next Steps NEXT STEPS Request End-of-Phase II FDA Meeting in Q1 2020Discuss with FDA the path forward for regulatory approval towards a Phase III pivotal programDepending on meeting timing and feedback: define path forward by 2H 2020 24
Slide 25: IFX-1 for ANCA-Associated Vasculitis
= ££ = ved inf laRX | L 7 3 + | ae ly IN PHINN ' 4 IFX-1 FOR ANCA-ASSOCIATED VASCULITIS
Slide 26: ANCA-Associated Vasculitis (AAV)
ANCA-Associated Vasculitis (AAV) A life-threatening autoimmune condition Source: Chen, Jayne and Zhao. Complement in ANCA-associated vasculitis: mechanism and implication for management Rare, life-threatening autoimmune disease, characterized by necrotizing vasculitisLife-threatening flare phases af
Slide 27: IFX-1 in AAV: Clinical PoC for Role of C5a / C5aR Pathway
IFX-1 in AAVClinical PoC established for Role of C5a / C5aR Pathway in AAV C5a is essential for development of MPA-ANCA crescentic glomerulonephritis in a mouse modelComplement activation in active AAV patients is significantEvidence for role of C5a / C5aR pathway through recent Phase III success of
Slide 28: IFX-1 Phase II Study in AAV in the US (IXPLORE)
IFX-1 – P2.6 Phase II study in AAV in the US (IXPLORE) Study Design FOLLOW UP: 8 WEEKS Remission Induction Phase Maintenance Phase Maintenance Therapy:remain on SOC or transition to guideline maintenance therapy* IFX-1 low dose + SOC (n=12)IFX-1 high dose + SOC(n=12)Placebo + SOC (n=12) GROUPS: TREA
Slide 29: IFX-1 Phase II Study in AAV in Europe (IXCHANGE)
IFX-1 – P2.5 Phase II study in AAV in Europe (IXCHANGE) Study Design Study objective (target: n=81) May 2019 First patient dosed:Primary objective:Secondary objectives: Efficacy of IFX-1 treatment as replacement for glucocorticoid (GC) therapy in GPA and MPA To assess safety and tolerability of IFX-
Slide 30: IFX-1 for Pyoderma Gangraenosum
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Slide 31: Pyoderma Gangraenosum (PG)
Pyoderma Gangraenosum (PG) Source: Demis.net An autoimmune condition with high unmet needCLINICAL FEATURESPG is a rare ulcerative skin disorder that can lead to chronic painful and difficult-to-treat wounds / ulcers occurring predominantly in people in their 40s and 50sMany PG patients also suffer f
Slide 32: Overview of IFX-1 Phase IIa Study in PG
Overview of IFX-1 Phase IIa Study in PG Study Design Assessing safety and efficacy of IFX-1 in PGRationale:PG is associated with a neutrophilic leukocytosis, which is likely to be triggered by C5a. Pyoderma Gangraenosum lesions have pronounced neutrophilic infiltration and the expression of interleu
Slide 33: Strategic Long-Term Goals
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Slide 34: Our Strategy
Our Strategy Advance our lead program IFX-1 for HS towards Phase III / approval based on regulatory guidanceExplore application of IFX-1 for AAV, PG and within the oncology field in Phase II clinical developmentExtend pipeline with initiation of clinical development of IFX-1 in other complement-medi
Slide 35: InflaRx N.V. Investor Relations
Winzerlaer Str. 207745 Jena, Germany Email: info@inflarx.com Tel: +49-3641-508180Fax: +49-3641-508181www.inflarx.com Jordan ZwickGlobal Head of Business Development & Corporate Strategy Email: jordan.zwick@inflarx.de INFLARX N.V. INVESTOR RELATIONS INFLARX N.V.