Inflarx N.v. · NASDAQ:IFRX
Inflarx — Investor Presentation (September 2020)
32 slides from Inflarx's investor presentation, September 2020
Slide 1: Controlling Inflammation – Corporate Presentation
CONTROLLING INFLAMMATION CORPORATE PRESENTATION September 2020
Slide 2: Important Notice and Disclaimer
IMPORTANT NOTICE AND DISCLAIMER This 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 solici
Slide 3: Investment Highlights
Investment Highlights LEADING PROPRIETARY ANTI-C5A TECHNOLOGY • Complete and selective blockade of the biological activity of C5a in vitro and in vivo • Strong patent coverage on anti-C5a technology until end of 2030 / 2035 with extension ESTABLISHED CLINICAL EFFICACY FOR LEAD DRUG IFX-1 • Proven an
Slide 4: Pipeline with Multiple Opportunities
Pipeline with Multiple Opportunities PROPOSED INDICATIONS PREVALENCE PRE-CLINICAL PHASE I PHASE II PHASE III UPDATE COVID-19 Pneumonia • Currently unknown • Phase II/III study: Phase II part: enrollment completed; Phase III part is open for enrollment IFX-1 Hidradenitis • Up to 200,000 • Phase IIb c
Slide 5: The Terminal Complement Pathway
The Terminal Complement Pathway C5 C5 concentration in blood: ~75 µg/ml (~400 nM) C5a concentration C5a C5b in blood: other ligands: 10 ~ 30 ng/ml C3a, ASP, C4a etc Membrane Attack Complex (MAC) (~1-2.5 nM) strong amplifier triggers lysis of pathogens of inflammation C5b-9 = MAC C5aR C5L2 C5L2 has a
Slide 6: IFX-1 for COVID-19 Pneumonia
IFX-1 FOR COVID-19 PNEUMONIA
Slide 7: Coronavirus Disease 2019 (COVID-19)
Coronavirus Disease 2019 (COVID-19) A VIRAL PNEUMONIA WITH A BROAD SPECTRUM OF IMMUNE-MEDIATED INJURY CLINICAL & PATHOLOGY FEATURES • Death is typically caused by respiratory failure and viral sepsis in presence of immune-response induced multiple organ dysfunction • Pathology in lung: extensive inf
Slide 8: COVID-19 induced Vascular Injury – Potential Role of C5a
COVID-19 induced Vascular Injury – Potential Role of C5a Model for Proposed Mode of Action of C5a in COVID-19 induced vascular injury Proposed Potential Role of C5a in COVID-19- induced Vascular Injury • Endothelial damage is induced by SARS- CoV-2 infection which also activates the complement syste
Slide 9: IFX-1 Phase II/III Study in COVID-19 Pneumonia
IFX-1 Phase II/III Study in COVID-19 Pneumonia PHASE II PART DESIGN (EXPLORATORY) PHASE II STUDY RESULTS* • Exploratory, adaptive, open-label, randomized, multicenter trial • Primary endpoint: no difference detected between groups in in EU PaO2/FiO2 ratio: high variability between patients: conclusi
Slide 10: Phase III Part Initiated in COVID-19 Pneumonia
Phase III Part Initiated in COVID-19 Pneumonia MOVING INTO PHASE III FOLLOWING ENCOURAGING TOPLINE RESULTS FROM PHASE II STUDY DESIGN • Double-blinded, randomized, placebo-controlled trial – Adequately powered for statistical analyses • ~360 early intubated, critically ill patients with COVID-19 ind
Slide 11: IFX-1 for Hidradenitis Suppurativa
IFX-1 FOR HIDRADENITIS SUPPURATIVA
Slide 12: Hidradenitis Suppurativa
Hidradenitis Suppurativa A chronic severely debilitating C5a-driven inflammatory skin condition with high unmet need HURLEY STAGING FOR HS Stage I CLINICAL FEATURES Single / multiple abscesses but • Chronic, inflammatory, recurrent, debilitating skin disease of the hair follicles no sinus tracts or
Slide 13: IFX-1 in Hidradenitis Suppurativa
IFX-1 in Hidradenitis Suppurativa RATIONALE FOR TARGETING C5A InflaRx established that HS patients have significant complement activation with elevated C5a levels C5a is involved in several key pathophysiological mechanisms in HS • Neutrophil activation is driven by C5a • Various C5a dependent playe
Slide 14: IFX-1 in HS: Phase IIb SHINE Study Details
IFX-1 in HS: PH IIb SHINE Study Details Main Period: n = 177 treated Open Label Extension Period (OLE): n = 156 Placebo Week 16 HiSCR Responders: IFX-1 minimal dose (400 mg q4w) (800 mg q4w) IFX-1 low dose IFX-1 low dose (800 mg q4w) Week 16 HiSCR Non-Responders: IFX-1 medium dose (800 mg q2w) (800
Slide 15: SHINE Study: Primary Outcome HiSCR at Week 16 versus AN Count Reduction
SHINE Study: Primary Outcome HiSCR at Week 16 versus AN Count Reduction HISCR RESPONSE RATE (%) WEEK 16* AN COUNT SCORE CHANGE (MEAN %) WEEK 16* n = approx. 35/ group 51.5 47.1 45.5 40.0 38.7 -26.5 -32.7 -44.9 -47.7 -54.6 Spalte4 Spalte4 Treatment group: placebo minimum low medium high Primary Endpo
Slide 16: SHINE Study: Draining Fistula and IHS-4 Score Reduction – Week 16
SHINE Study: Outcome on Draining Fistula and IHS-4* Score Reduction – Week 16 DRAINING FISTULA CHANGE (MEAN %)** IHS-4 SCORE CHANGE (MEAN %)*** -14.5 -15 -18 -19.8 -24.6 -28 -41.1 -38.4 -51.5 -63.2 p= 0.0359 p= 0.0202 Spalte4 Spalte4 Treatment group: placebo minimum low medium high Statistically sig
Slide 17: Comparison of HiSCR for Week 16 Responder versus Non-responder Groups
Comparison of HiSCR for Week 16 Responder versus Non-responder Groups (OLE) Over Time during Open Label Long Term Extension Study HISCR RESPONSE RATE (%) PER VISIT* (OLE) – WITH 95% CI ALL OLE PATIENTS 100 90 80 56.3 70 Responders 60 (n = 72) 50 40 Non-Responders 30 (n = 84) 20 10 0 week 16 week 20
Slide 18: Inflammatory Lesion Reductions in all OLE Patients at End of Treatment
Inflammatory Lesion Reductions in all OLE Patients at End of Treatment (week 40) Compared to Placebo Group Performance in Main Period (week 16) RELATIVE REDUCTION (% MEAN) OF COUNTS / SCORES COMPARED TO RESPECTIVE BASELINE (DAY1)* OF ALL OLE PATIENTS ON WEEK 40 (N=116) OF PLACEBO PATIENTS ON WEEK 16
Slide 19: SHINE Study and Next Steps in HS Development
SHINE Study and Next Steps in HS Development OUR CONCLUSIONS CURRENT STATUS & NEXT STEPS • HiSCR is burdened by high variability (driven by AN count variability) • Scientific Advice received from EMA in July 2020 and by a lack of capturing reduction of draining fistula • EMA agreed to key proposals
Slide 20: IFX-1 for ANCA-Associated Vasculitis
IFX-1 FOR ANCA-ASSOCIATED VASCULITIS
Slide 21: ANCA-Associated Vasculitis (AAV)
ANCA-Associated Vasculitis (AAV) A LIFE-THREATENING AUTOIMMUNE CONDITION CLINICAL FEATURES • Rare, life-threatening autoimmune disease, characterized by necrotizing vasculitis • Life-threatening flare phases affect organs, leading to potentially fatal organ dysfunction and failure • Predominantly af
Slide 22: IFX-1 in AAV: Clinical PoC for Role of C5a / C5aR Pathway
IFX-1 in AAV Clinical PoC established for Role of C5a / C5aR Pathway in AAV LEADING PROPRIETARY ANTI-C5A TECHNOLOGY • 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 /
Slide 23: IFX-1 Phase II Study in AAV in the US (IXPLORE)
IFX-1 – Phase II Study in AAV in the US (IXPLORE) Study Design GROUPS: TREATMENT: 16 WEEKS FOLLOW UP: 8 WEEKS IFX-1 low dose + SOC A (n=12) Remission Induction Phase Maintenance Phase IFX-1 high dose + SOC B (n=12) Placebo + SOC C (n=12) Day 1 Week 16 Week 24 Randomization 1:1:1 SOC = Rituximab or C
Slide 24: IFX-1 Phase II Study in AAV in Europe (IXCHANGE)
IFX-1 – Phase II study in AAV in Europe (IXCHANGE) Study Design TREATMENT: 16 WEEKS FOLLOW UP: 8 WEEKS Part IFX-1 + SOC with reduced GC A (n=15) 1 Remission Induction Phase Maintenance Phase placebo + SOC incl. GC (n=15) Dosing scheme: B Safety analysis TREATMENT: 16 WEEKS FOLLOW UP: 8 WEEKS placebo
Slide 25: IFX-1 for Pyoderma Gangraenosum
IFX-1 FOR PYODERMA GANGRAENOSUM
Slide 26: Pyoderma Gangraenosum (PG)
Pyoderma Gangraenosum (PG) AN AUTOIMMUNE CONDITION WITH HIGH UNMET NEED CLINICAL FEATURES • 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 50s • Many PG patients also suffer from other a
Slide 27: Overview of IFX-1 Phase IIa Study in PG - Study Design
Overview of IFX-1 Phase IIa Study in PG - Study Design STUDY OBJECTIVE STUDY DESIGN TREATMENTS • Assessing safety and efficacy of IFX-1 in PG • Open label • Trial started with 1 dose • Rationale: • Multicenter group: amendment approved PG is associated with a neutrophilic leukocytosis, which is to i
Slide 28: Pyoderma Gangraenosum: Study Update and C5a Levels at Baseline
Pyoderma Gangraenosum (PG) Autoimmune Condition with High Unmet Need STUDY UPDATE C5A LEVELS AT BASELINE C 5 a le v e l in P G p a tie n ts Data reported on first 5 patients treated in February 2020 responder • 2 of the first 5 patients showed complete closure of target ulcer 80 0 1 -0 0 2 with both
Slide 29: Two Patients Show Complete Wound Closure with IFX-1 Treatment
Pyoderma Gangraenosum (PG) Two Patients Show Complete Wound Closure with IFX-1 Treatment PATIENT EXAMPLE 1 (UPDATE FEB. 2020) • Female patient with extensive genital PG disease and target ulcer on lower extremity (no concomitant IBD) • Various failed treatment attempts including high dose corticoste
Slide 30: Strategy and Outlook
2 a Ss CONTROLLING - _ ja INFLAMMATION in a lil oo 7 H . La eee P= = ; || == = aN # ii\\ ' STRATEGY AND OUTLOOK
Slide 31: Our Strategy
Our Strategy GOALS AND STRATEGY Plan to enter Phase III development of lead program IFX-1 in COVID-19 pneumonia following encouraging results from Phase II part of study Advance IFX-1 in HS towards Phase III / approval based on regulatory guidance Explore application of IFX-1 for AAV, PG and oncolog
Slide 32: InflaRx N.V. Investor Relations
INFLARX N.V. INVESTOR RELATIONS INFLARX N.V. Winzerlaer Str. 2 Jordan Zwick 07745 Jena, Germany Global Head of Business Development & Corporate Strategy Email: info@inflarx.com Email: jordan.zwick@inflarx.de Tel: +49-3641-508180 Fax: +49-3641-508181 www.inflarx.com