Inflarx N.v. · NASDAQ:IFRX
Inflarx — Investor Presentation (September 2022)
33 slides from Inflarx's investor presentation, September 2022
Slide 1: Corporate Presentation September 2022
CORPORATE PRESENTATION SEPTEMBER 2022
Slide 2: Important Notice and Disclaimer
IMPORTANT NOTICE AND DISCLAIMER This presentation has been prepared by InflaRx N.V. (“InflaRx” or the “Company”). This presentation is made for informational purposes only and does not constitute an offer to sell or a solicitation of an offer to buy securities. This presentation may not be relied up
Slide 3: InflaRx N.V. Targeting Complement to Control Inflammatory Diseases
InflaRx N.V. Targeting Complement to Control Inflammatory Diseases Focused late-stage clinical development of lead asset and promising, earlier-stage development pipeline Vilobelimab - Efficacy Signals and Clean Safety Profile in Clinical Testing • Pyoderma gangrenosum: Positive Phase IIa data – pre
Slide 4: Pipeline and Company Status Development Update
Pipeline and Company Status Development Update INDICATIONS PRECLINIC PHASE I PHASE II PHASE III STATUS Phase II and III results published, US EUA Critical submission in prep., EU Rapporteurs assigned, COVID-19 Positive Phase IIa open label results Vilobelimab Pyoderma Phase III trial design submitte
Slide 5: Vilobelimab Mode of Action
Vilobelimab Mode of Action C5 C5a Vilobelimab (IFX-1) Cleavage and New Conformational Change Epitope Cleavage of C5 through: C5a is a key chemo-attractant and a Key Features: • complement pathway activation; or strong activator of neutrophils leading • Blocks C5a biological effects • directly throug
Slide 6: Vilobelimab Key Clinical Data: Evidence for an Active Drug
Vilobelimab Key Clinical Data: Evidence for an Active Drug Pyoderma gangrenosum (PG) Hidradenitis suppurativa (HS) Phase IIa trial: Phase II SHINE trial: • High Dose Group shows highest rate of target ulcer closure and clinical • Significant difference between the total inflammatory lesion count rem
Slide 7: Vilobelimab Critical COVID-19
Vilobelimab Critical COVID-19
Slide 8: C5a: A Key Player in the Development of Viral ARDS
C5a: A Key Player in the Development of Viral ARDS C5A INHIBITION IMPROVED OUTCOME IN VIRAL ARDS MODELS ❑ In a monkey model of H7N9-induced viral pneumonia, Vilobelimab (IFX-1) InflaRx PANAMO trial (Phase II) markedly improved lung injury and reduced viral load (Sun et al, CID, 2015) 500 ❑ In a mous
Slide 9: 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 OUR HYPOTHESIS • Endothelial damage is induced by SARS-CoV-2 infection which also activates the complement system leading to C5a generation. • C5a activates neutrophi
Slide 10: PANAMO Trial: Phase III – Primary Endpoint
PANAMO Trial: Phase III – Primary Endpoint -- 1:1 randomized, double-blind, placebo- controlled, multi-national trial in (n=369) invasive mechanically ventilated COVID-19 patients All-cause mortality: Overall Day 28: 23.9 % relative reduction Placebo + SOC Kaplan-Meier point estimate: Placebo: 41.6.
Slide 11: PANAMO Trial: Phase III – Primary Endpoint 28-day Mortality Analyses
PANAMO Trial: Phase III – Primary Endpoint 28-day Mortality Analyses FOREST PLOT OF DIFFERENT COX REGRESSION APPROACHES FOR PRIMARY ENDPOINT 61 patients from 23 sites with no events (no death) or from single patient sites (regardless off outcome) are effectively ignored for the analysis output (p-va
Slide 12: PANAMO Trial: Phase III – Sec. Endpoint 60-day Mortality Analysis
PANAMO Trial: Phase III – Sec. Endpoint 60-day Mortality Analysis FOREST PLOT OF DIFFERENT COX REGRESSION APPROACHES FOR 60-DAY MORTALITY 43 patients from 20 sites with no events (no death) or from single patient sites (regardless off outcome) are effectively ignored for the analysis output (p-value
Slide 13: PANAMO Trial: Phase III – Outcome of pre-specified Western EU Region
PANAMO Trial: Phase III – Outcome of pre-specified Western EU Region All-cause mortality: Western Europe (n=209) Day 28: 43.0 % relative reduction Kaplan-Meier point estimate: Placebo + SOC Placebo: 37.2.% Vilobelimab: 21.2%, Hazard ratio: 0.5 (0.3; 0.9) p = 0.0142 Vilobelimab + SOC Day 60: 31.6 % r
Slide 14: PANAMO Trial: Phase III – Survival Outcome of pre-specified Regions
PANAMO Trial: Phase III – Survival Outcome of pre-specified Regions PRE-SPECIFIED SUBGROUP ANALYSES BY REGION (28-DAY ALL-CAUSE MORTALITY) * ** *Belgium, France, Germany, Netherlands **Brazil, Mexico, Peru Signal in South American Region is mainly driven by Brazil In Brazil, placebo group was statis
Slide 15: PANAMO Trial: Phase III – Patient Distribution and Death in Brazil
PANAMO Trial: Phase III – Patient Distribution and Death in Brazil Baseline Age Distribution and Day 60 Death Rate in Brazil (total n = 74) Placebo (n) Vilobelimab (n) 5 > 60 5 60% 57% median 9 51 - 60 14 53.5 yr. 67% 50% median 44.5 yr. 10 41 - 50 7 30% 29% 11 31 - 40 5 9% 0% 5 < = 30 1 0% 0% 70% 6
Slide 16: PANAMO Trial: Phase III – Survival Outcome of pre-specified Subgroups
PANAMO Trial: Phase III – Survival Outcome of pre-specified Subgroups PRE-SPECIFIED SUBGROUP ANALYSES (28-DAY ALL-CAUSE MORTALITY) All three pre-specified subgroup analyses for more severe patients suggest a significant survival benefit for the vilobelimab treatment arm when compared to placebo Page
Slide 17: PANAMO Trial: Phase III – Sec. Endpoint Need for Renal Replacement
PANAMO Trial: Phase III – Sec. Endpoint Need for Renal Replacement SECONDARY ENDPOINT: PROPORTION OF PATIENTS FREE OF RENAL REPLACEMENT WITHIN 28 DAYS Cause-specific Cox mode: HR: 0.539 (0.297 ; 0.978) p=0.0422 Figure from Vlaar, A et al. Lancet Resp Med 2022. https://doi.org/10.1016/ S2213-2600(22)
Slide 18: Phase III Safety Results
Phase III Safety Results SAFETY OVERVIEW INFECTIONS Vilobelimab Placebo Vilobelimab Placebo Adverse event category MedDRA High Level Group Term (N=175) (N=189) (N=175) (N=189) Any TEAE in SOC infections and Any TEAE 159 (90.9%) 172 (91.0%) 110 (62.9%) 112 (59.3%) infestations Any related TEAE 20 (11
Slide 19: Phase III Safety Results
Phase III Safety Results INFECTIONS AND INFESTATIONS BY PATIENT DAYS IN HOSPITAL Vilobelimab (N=175) Placebo (N=189) n (%) n (%) Incidence Incidence MedDRA High Level Group Term (patient days = 2384) (patient days = 1736) Patients per 100 Events per 100 patient Patients per 100 Events per 100 patien
Slide 20: Summary
Summary KEY LEARNINGS FROM PHASE III RESULTS Vilobelimab treatment led to a robust 28-day and 60-day survival improvement on top of SOC (23.9% relative reduction of 28-day mortality) Significant treatment benefit (p=0.014) in pre-defined analysis of Western European patient population (n=209) with 4
Slide 21: Vilobelimab Pyoderma Gangrenosum (PG)
Vilobelimab Pyoderma Gangrenosum (PG)
Slide 22: Pyoderma Gangrenosum (PG)
Pyoderma Gangrenosum (PG) AN AUTOIMMUNE CONDITION WITH HIGH UNMET NEED Clinical Features • PG is a rare but potentially life-threatening skin disorder that can lead to chronic, difficult-to-treat wounds • Many PG patients also suffer from other autoimmune disorders, such as ulcerative colitis, rheum
Slide 23: PG Phase IIa Trial
PG Phase IIa Trial Study Design • 19 patients enrolled in the study • Primary endpoint: Safety • Key secondary endpoints: Responder rate defined as PGA ≤3 (PGA of ≤1 is considered clinical remission and closure of target ulcer); time to complete closure of target ulcer INITIATION MAINTENANCE INDIVID
Slide 24: Phase IIa Study Results – Group 3 (High Dose)
Phase IIa Study Results – Group 3 (High Dose) PGA Seven evaluable 13 * 15 17 19 score patient: 14 16 18 GROUP 3 RESULTS • Six out of seven patients achieved PGA score of ≤ 1 (remission) • One patient (18) experienced target ulcer area decrease > 50%; however, new PG lesions developed • Patient 19 wi
Slide 25: PG Phase IIa Patient Case Studies
PG Phase IIa Patient Case Studies TARGET ULCER DEVELOPED (NOV 2020) WHILE ON STABLE TARGET ULCER REAPPEARED (AUG 2020) ADALIMUMAB MH: PG since August 2020, Psoriasis since 2017 MH: PG since 2019, Hypertension since 1998; Study Day 1: Feb 2021 Treatment Start: March 2021 Cohort 2: 1600 mg Q2W, indivi
Slide 26: PG Phase IIa Study Results
PG Phase IIa Study Results Summary and Conclusion SAFETY CONCLUSION PHASE III IN PREPARATION • No infusion-related reactions observed BASED ON • For 2 patients, related SAEs were reported: FEEDBACK FROM • Erysipelas leading to hospitalization (judged as non-related by sponsor) • Rash due to delayed
Slide 27: Vilobelimab Oncology
Vilobelimab Oncology Cutaneous Squamous Cell Carcinoma (cSCC)
Slide 28: Cutaneous Squamous Cell Carcinoma (cSCC)
Cutaneous Squamous Cell Carcinoma (cSCC) Phase II Study Underway POTENTIAL ROLE OF C5A IN ONCOLOGY & cSCC DISEASE INFORMATION cSCC • C5a induces an immunosuppressive tumor microenvironment • Estimated incidence: 15-35 per 100,000 people; expected to • C5a promotes metastases increase 2-4% per year;
Slide 29: INF904 New Pipeline Program
INF904 New Pipeline Program E
Slide 30: Allosteric Inhibitor INF904 (Oral Small Molecule)
Allosteric Inhibitor INF904 (Oral Small Molecule) Potential for Best-in-Class C5aR Inhibition C5a RATIONALE Trp213 (human, primate, hamster) • INF904 binds to a well-known allosteric site in C5aR • INF904 has a novel Markush structure • US patent was issued in October 2021 INF904 binds to allosteric
Slide 31: Strategy and Outlook
Strategy and Outlook
Slide 32: Strategy and Outlook
Strategy and Outlook Vilobelimab in • EUA submission planned for end of Q3 2022 Critical COVID • EMA discussions ongoing Vilobelimab in • Phase III design feedback awaited PG • Phase III study preparation ongoing • Opened third cohort of combination arm in Phase II in Q3 2022 Vilobelimab in • Toplin
Slide 33: www.inflarx.com
www.inflarx.com INFLARX N.V. Winzerlaer Str. 2 07745 Jena, Germany Email: IR@inflarx.com Tel: +49-3641-508180 Fax: +49-3641-508181