Inflarx N.v. · NASDAQ:IFRX
Inflarx — Investor Presentation (November 2021)
39 slides from Inflarx's investor presentation, Nov 15, 2021
Slide 1: Controlling inflammation – Corporate Presentation November 2021
Controlling inflammation CORPORATE PRESENTATIONNovember 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 3 Leading Proprietary Anti-C5a Technology 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 extensionEstablished Clinical Efficacy for Vilobelimab (IFX-1):Proven anti
Slide 4: Pipeline with Multiple Opportunities
Pipeline with Multiple Opportunities 4 Franchise Indications Pre-Clinical Phase I Phase II Phase III Update Vilobelimab(IFX-1)C5a Inhibitor Hidradenitis Suppurativa (HS) Phase IIb completedFDA supportive of new primary endpoint; Pivotal trial protocol to be submitted to the FDA in Q4 21 Pyoderma Gan
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 (IFX-1) for Hidradenitis Suppurativa
Vilobelimab (IFX-1) for Hidradenitis Suppurativa
Slide 7: Hidradenitis Suppurativa (HS)
Hidradenitis Suppurativa (HS) 7 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 featuresChr
Slide 8: HS Phase IIb SHINE study details
Hidradenitis Suppurativa (HS)Phase IIb SHINE study details 8 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 of res
Slide 9: SHINE Study and Next Steps in HS Development
HiSCR is burdened by high variability (driven by AN count variability) and does not capture reduction of draining tunnelsEvidence for a high C5a turnover rate in HS, leading to increased dose requirements of vilobelimabVilobelimab leads to marked reduction in all inflammatory lesions, with a durable
Slide 10: Vilobelimab (IFX-1) for Pyoderma Gangraenosum
Vilobelimab (IFX-1) for Pyoderma Gangraenosum
Slide 11: Pyoderma Gangraenosum (PG)
Pyoderma Gangraenosum (PG) 11 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 12: PGA Score – Physician's Global Assessment Score
PGA Score – Physician‘s Global Assessment Score 12 PGA score Description 0 Completely clear except for possible residual hyperpigmentation 1 Almost clear very significant clearance (about 90%); however, patchy remnants of dusky erythema and/or very small ulceration 2 Marked improvement significant i
Slide 13: Phase IIa Study Design
Phase IIa Study Design 13 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 80
Slide 14: 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) 14 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 15: 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) 15 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 16: 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) 16 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 17: Study Results – Group 1 and Group 2 C5a levels
Study Results – Group 1 and Group 2C5a levels 17 Patient 10 in Group 2 reached clinical remission at Day 99 after uptitration to 2400mg at Day 57 Clinical observations Group 1 Group 2 1* 2** 3* 4* 5** 6* 7* 11 8* 12 9 10** Patient Number Patient Number Patients 6, 9, and 10 were uptitrated on day 57
Slide 18: Study Results – Group 3 C5a levels
18 Clinical observations Six patients reached PGA≤1Patient 18 only showed minor improvement of target ulcer but no remission 13 ** 14 ** 15 ** 16 ** 17 ** 18 19 ** Patient Number Study Results – Group 3C5a levels ** Responder in remission (PGA ≤1) Values not available
Slide 19: Summary and Conclusion
Summary and Conclusion 19 Vilobelimab Q2W shows good safety and tolerabilityEvidence for 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 sponsor) Rash due to delayed hy
Slide 20: Patient Case Studies in PG
Patient Case Studies in PG
Slide 21: Patient Case Study
Patient 10 Case Study 21 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 2019- Aug 2020
Slide 22: Patient Case Study
Patient 14 Case Study 22 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 September 2020 – Nov
Slide 23: Patient Case Study
Patient 13 Case Study 23 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 Medication: Adali
Slide 24: Vilobelimab (IFX-1) for ANCA-associated vasculitis
Vilobelimab (IFX-1) for ANCA-associated vasculitis
Slide 25: ANCA-Associated Vasculitis (AAV)
ANCA-Associated Vasculitis (AAV) 25 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 26: AAV, Life-threatening Autoimmune Condition: Role of C5a
AAV, Life-threatening Autoimmune ConditionClinical PoC established for role of C5a / C5aR pathway in AAV 26 Halbwachs et al. J Am Soc Nephrol. 2012 23(9):1449Chen et al. Nat Rev Nephrol. 2017 13(6):359Schreiber et al. J Am Soc Nephrol. 2009 20(2): 289Hao et al. Plos One. 2013 8(6):e66305 Anti-neutro
Slide 27: Phase II Study in AAV in the US (IXPLORE) Results
Phase II Study in AAV in the US (IXPLORE)Results 27 Phase II Topline RESULTS Three-arm, placebo-controlled trial with 16 weeks of treatment and 8 weeks follow-up (n=19)Primary endpoint met: safe and well-tolerated in patients with AAV when added to SOC; Observed TEAEs are reflective of the disease a
Slide 28: Phase II Study in AAV in EU (IXCHANGE) Study Design
Phase II Study in AAV in EU (IXCHANGE)Study Design 28 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 toxicity
Slide 29: Phase II Study in AAV in the EU (IXCHANGE) Results
Phase II Study in AAV in the EU (IXCHANGE)Results 29 Phase II Topline RESULTS (IXCHANGE) Study demonstrated proof of concept for the use of vilobelimab to reduce use of GC therapy in subjects with Granulomatosis with Polyangiitis (GPA) and Microscopic Polyangiitis (MPA); achieved comparable efficacy
Slide 30: IXCHANGE: Use of GC and GC-induced toxicity
Phase II Study in AAV in the EU (IXCHANGE): Use of GC and GC-induced toxicity 30 Cumulative Glucocorticoid intake (Day -28 to Day 1) Cumulative GC intake (-28 to day 1 mg) Prednisone equivalent dose (mg) Vilobelimab (No GC)(N=18) SDGC(N=24) Vilobelimab + RDGC(N=15) Subjects with no GC intake within
Slide 31: Vilobelimab (IFX-1) for Severe COVID-19
Vilobelimab (IFX-1) for Severe COVID-19
Slide 32: Design of Phase II/III study 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 2 part completed:Encouraging topline results publishedPhase 3 part fully enrolle
Slide 33: Phase II Part Results: Overview
Phase II Part Results: Overview 33 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
Slide 34: Vilobelimab (IFX-1) in Oncology
Vilobelimab (IFX-1) in Oncology
Slide 35: Cutaneous Squamous Cell Carcinoma (cSCC)
Cutaneous Squamous Cell Carcinoma (cSCC)PD-1 or PD-L1 Inhibitor Resistant/Refractory Locally Advanced or Metastatic Patients 35 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
Slide 36: cSCC: Phase II Study Underway
Cutaneous Squamous Cell Carcinoma (cSCC): Phase II Study Underway 36 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: comp
Slide 37: Strategy and Outlook
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Slide 38: Medium Term Deliverables and Strategic Objectives
Medium Term Deliverables and Strategic Objectives 38 Advance vilobelimab in HS and PG towards Phase III and ultimate approval based on regulatory guidanceComplete Phase III development of vilobelimab in Severe COVID-19; submit for approval if results positivePlan to discuss next steps for the AAV pr
Slide 39: InflaRx N.V. Contact and 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.