Inflarx N.v. · NASDAQ:IFRX
Inflarx — LifeSci Capital Alpha Series Conference 2020
32 slides from Inflarx's conference presentation, Apr 9, 2020
Slide 1: Controlling inflammation
Controlling inflammation LIFESCI CAPITAL ALPHA SERIES CONFERENCE 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 3 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 Statistically significant reduction of infl
Slide 4: Pipeline with Multiple Opportunities
Pipeline with Multiple Opportunities 4 Proposed Indications Prevalence Pre-Clinical Phase I Phase II Phase III Update IFX-1C5a Inhibitor Hidradenitis Suppurativa (HS) Up to 200,000patients in the USOver 200,000 patients in Europe Phase IIb completedPlanning for next steps ANCA-Associated Vasculitis
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: IFX-1 for COVID-19 Pneumonia
ifx-1 for COVID-19 Pneumonia
Slide 7: COVID-19 Disease Background and Clinical Features
7 Source: cdc.gov; Zhou et al. 2020, Lancet Infectious Disease Cause: severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) which likely uses ACE2 receptors for cell entryFirst identified in Wuhan, Hubei Province, China in December 2019 Disease Background Clinical features Long latency: Incub
Slide 8: COVID-19 Laboratory Findings and Diagnosis
8 Source: https://www.chinalawtranslate.com/en/coronavirus-treatment-plan-7/ Source: cdc.gov Systemic inflammation: lymphopenia (>80%) + elevated CRP (>60%) at admissionNeutrophil counts are positively correlated with disease severity and bad outcomePotential Prognostic Biomarker: NLR (neutrophil-to
Slide 9: COVID-19: White Blood Cell and Neutrophil Counts
Wang et al., Jama (2020) 1585 Gong et al., MedRXiv Preprint (2020) Feb.25 White blood cell counts and neutrophil counts increase in non-survivors from day 9 on 9 Neutrophils are strongly activated by C5a– this can damage host tissue COVID-19: White Blood Cell and Neutrophil Counts
Slide 10: Viral-induced Immune Injury in COVID-19 – Potential Role of C5a
IFN-Ƴ IP-10 IL-6 IL-1β IL-8 IL-14 IL-10TNF-α Tissue C5a DAMPs (e.g. O2-) NETosis Resolution:Lymphocyte recovery (IgG, IgM)Inflammation under controlEfferocytosis in lung Deterioration:Lymphocyte suppressionNeutrophil activation – tissue inflammation Organ damages (e.g., lung > heart, liver, vessel)C
Slide 11: IFX-1 Phase II/III Study in COVID-19 Pneumonia - Study Design
Overview of IFX-1 Phase II/III Study in COVID-19 Pneumonia - Study Design 11 Assessing safety and efficacy of IFX-1 in COVID-19 PneumoniaPrimary endpoint: Relative change (%) from baseline in Oxygenation Index (PaO2 / FiO2) to day 5Key secondary endpoints: Number of patients (%) achieving an Early R
Slide 12: IFX-1 for Hidradenitis Suppurativa
ifx-1 for Hidradenitis Suppurativa
Slide 13: Hidradenitis Suppurativa
Hidradenitis Suppurativa 13 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 Chroni
Slide 14: IFX-1 in Hidradenitis Suppurativa
IFX-1 in Hidradenitis Suppurativa 14 InflaRx established that HS patients have significant complement activation with elevated C5a levels C5a is key neutrophil activator in HS patient plasma HS patient plasma strongly provoked neutrophil activation in healthy donor blood; this effect could be comple
Slide 15: IFX-1 in HS: SHINE Study Details
IFX-1 in HS: SHINE Study Details 15 Important Note: Patients entering the OLE were not unblinded to their initial therapy 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
Slide 16: SHINE Study: Primary Outcome HiSCR versus AN Count Reduction
SHINE Study: Primary Outcome HiSCR at Week 16 versus AN Count Reduction 16 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 groups: Primary endpoint: HiSCR dose response signal not met but sig
Slide 17: SHINE Study: Draining Fistula and IHS-4 Score Reduction
SHINE Study: Outcome on Draining Fistula and IHS-4* Score Reduction – Week 16 17 Draining fistula change (mean %)** IHS-4 score change (mean %)*** placebo minimum low medium high Treatment groups: Statistically significant change in DF and in IHS-4 scores detected ** Full analysis set for patients w
Slide 18: Comparison of HiSCR for Responder versus Non-responder Groups
Comparison of HiSCR for Week 16 Responder versus Non-responder Groups (OLE) Over Time HISCR response rate (%) per visit® (OLE) — with 95% CI AIL OLE patients - 56.3 60 50 40 30 20 10 ° week16 week20- week24. «= week28 «= week32.—« week 36. «= week 40 HISCR responders 9 months = = 800 mgIFK-1q4w = ——
Slide 19: Inflammatory Lesion Reductions in All OLE Patients
Inflammatory Lesion Reductions in All OLE Patients at End of Treatment (Week 40) Compared to Placebo Group Performance in Main Period (Week 16) 19 of all OLE patients at week 40 (n=116) of placebo patients at week 16 Marked improvement of all inflammatory lesions over time – not explainable by place
Slide 20: SHINE Study and Next Steps in HS Development
SHINE Study and Next Steps in HS Development 20 HiSCR is burdened by high variability (driven by AN count variability) and by a lack of capturing reduction of draining fistula Our conclusions Evidence for a high C5a turnover rate in HS, leading to increased dose requirements of IFX-1 IFX-1 leads to
Slide 21: IFX-1 for ANCA-associated vasculitis
ifx-1 for ANCA-associated vasculitis
Slide 22: ANCA-Associated Vasculitis (AAV)
ANCA-Associated Vasculitis (AAV) 22 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
Slide 23: IFX-1 in AAV: Clinical PoC for C5a / C5aR Pathway
IFX-1 in AAVClinical PoC established for Role of C5a / C5aR Pathway in AAV 23 C5a is essential for development of MPA-ANCA crescentic glomerulonephritis in a mouse model Complement activation in active AAV patients is significant Evidence for role of C5a / C5aR pathway through recent Phase III succe
Slide 24: Phase II Study in AAV in the US (IXPLORE) Study Design
IFX-1 – P2.6 Phase II Study in AAV in the US (IXPLORE)Study Design 24 Treatment: 16 weeks 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 +
Slide 25: Phase II Study in AAV in Europe (IXCHANGE) Study Design
IFX-1 – P2.5 Phase II study in AAV in Europe (IXCHANGE)Study Design 25 Study objective (target: n=81)First patient dosed: May 2019Primary objective: Efficacy of IFX-1 treatment as replacement for glucocorticoid (GC) therapy in GPA and MPA Secondary objectives: To assess safety and tolerability of IF
Slide 26: IFX-1 for Pyoderma Gangraenosum
ifx-1 for Pyoderma Gangraenosum
Slide 27: Pyoderma Gangraenosum (PG)
Pyoderma Gangraenosum (PG) 27 Source: Demis.net PG 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 from other autoimmune disorders, including inflammatory bow
Slide 28: IFX-1 Phase IIa Study in PG - Study Design
Overview of IFX-1 Phase IIa Study in PG - Study Design 28 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 in
Slide 29: PG: Autoimmune Condition with High Unmet Need - Study Update
29 5 patients have been treated 2 out of the first 5 patients showed complete closure of the target ulcer with both patients in full disease remission. Both remained healed even after finishing the studyIn one additional patient, initial wound healing activity was detected in the first 2-3 weeks of
Slide 30: Two Patients Show Complete Wound Closure with IFX-1 Treatment
Female patient with extensive genital PG disease and target ulcer on lower extremity (no concomitant IBD)Various failed treatment attempts including high dose corticosteroids, etc.Significantly elevated baseline C5a levelsPatient completely healed of all PG lesions at the end of treatment and remain
Slide 31: Our Strategy
Our Strategy 31 Advance our lead program IFX-1 for HS towards Phase III / approval based on regulatory guidanceExplore application of IFX-1 for AAV, COVID-19, PG and oncology in clinical developmentExtend pipeline with initiation of clinical development of IFX-1 in other complement-mediated autoimmu
Slide 32: Winzerlaer Str. 207745 Jena, GermanyEmail: info@inflarx.comTel: +49-3641-508180Fax: +49-3641-508181www.inflarx.com Jo…
Winzerlaer Str. 207745 Jena, GermanyEmail: info@inflarx.comTel: +49-3641-508180Fax: +49-3641-508181www.inflarx.com Jordan ZwickGlobal Head of Business Development & Corporate StrategyEmail: jordan.zwick@inflarx.de InflaRx N.V. Investor Relations InflaRx N.V.
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