Inflarx N.v. · NASDAQ:IFRX
Inflarx — Investor Presentation (June 2023)
39 slides from Inflarx's investor presentation, June 2023
Slide 1: Corporate Presentation June 2023
CORPORATE PRESENTATION JUNE 2023
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: Pipeline and Company Status Development Update
Pipeline and Company Status Development Update marketed / AREA INDICATIONS PRECLIN. PHASE I PHASE II PHASE III authorized STATUS Acute organ dysfunction US EUA granted in April 2023, EU critical rapporteurs assigned, meeting held, MAA COVID-19 submission planned Phase III started - FPI expected in m
Slide 4: InflaRx N.V. Investment Highlights
InflaRx N.V. Targeting Complement to Control Inflammatory Diseases INVESTMENT HIGHLIGHTS Vilobelimab - first-in-class anti-C5a antibody • Critical COVID-19: US Emergency Use Authorization granted in April 2023 • Pyoderma gangrenosum: Positive Phase IIa data – Phase III study underway upon FDA feedba
Slide 5: Gohibic (vilobelimab) Critical COVID-19
Gohibic (vilobelimab) Critical COVID-19
Slide 6: Emergency Use Authorization (EUA) granted for Gohibic (vilobelimab)
Emergency Use Authorization (EUA) granted for Gohibic (vilobelimab) Authorized by the FDA for the treatment of coronavirus disease 19 (COVID-19) in hospitalized adults when initiated within 48 hours of receiving invasive mechanical ventilation (IMV) or extracorporeal membrane oxygenation (ECMO). Aut
Slide 7: COVID-19: Disease Progression and Therapeutic Interventions
COVID-19: Disease Progression and Therapeutic Interventions Vaccines Antiviral Treatments Anti-inflammatorische Anti-inflammatory Behandlung Treatments Versterben oder Death Heilung or Recovery Healthy Early Stage Intermediate to Severe Stage Critical Stage Recovery (pre- Incubation / asymptomatic o
Slide 8: 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 Placebo + SOC Day 28: 23.9 % relative reduction Kaplan-Meier point estimate: Placebo: 41.6.%
Slide 9: PANAMO Trial: Phase III – 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 10: PANAMO Trial: Phase III – Secondary Endpoint
PANAMO Trial: Phase III – Secondary 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/ S2213-260
Slide 11: Gohibic: Key Usage and Safety Facts
Gohibic: Key Usage and Safety Facts Administered as i.v. infusion over 30 - 60 minutes – in up to 6 doses of 800mg Gohibic over the course of 22 days. Important Safety Information: • There are limited clinical data available for GOHIBIC. Serious and unexpected adverse events (AEs) may occur that hav
Slide 12: Summary Gohibic (vilobelimab) in Critical COVID-19
Summary Gohibic (vilobelimab) in Critical COVID-19 EUA granted by FDA on April 5, 2023 / pre-submission meetings in EU held, submission planned in H2 2023 EUA based on a 28-day and 60-day survival improvement under vilobelimab treatment (p<0.05) on top of SOC (steroids and immunomodulators) PANAMO c
Slide 13: Vilobelimab Pyoderma Gangrenosum (PG)
Vilobelimab Pyoderma Gangrenosum (PG)
Slide 14: 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 • patients frequently suffer from other autoimmune disorders, e.g. ulcerative colitis, rheumatoid
Slide 15: 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 16: 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 17: PG Phase IIa Patient Case Studies
PG Phase IIa Patient Case Studies TARGET ULCER DEVELOPED WHILE ON ADALIMUMAB TARGET ULCER REAPPEARED 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, individual uptitration to 2400 mg a
Slide 18: PG Phase IIa Study Results Summary and Conclusion
PG Phase IIa Study Results Summary and Conclusion SAFETY CONCLUSION PHASE III IN • No infusion-related reactions observed PREPARATION • For 2 patients, related SAEs were reported: BASED ON − Erysipelas leading to hospitalization (judged as non-related by sponsor) FEEDBACK FROM − Rash due to delayed
Slide 19: PG Phase III Study Design
PG Phase III Study Design SCREENING TREATMENT: 26 WEEKS FOLLOW UP: 12 WEEKS Randomization Patient Level Stopping Criteria EOT (W 26) progression (any time) or no improvement at defined time points vilobelimab 2400 mg Q2W (13 doses) Safety Follow Up Arm 1 Prednisone tapered off placebo Q2W (13 doses)
Slide 20: Vilobelimab Oncology
Vilobelimab Oncology Cutaneous Squamous Cell Carcinoma (cSCC)
Slide 21: Cutaneous Squamous Cell Carcinoma (cSCC) Phase II Study Underway
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 22: cSCC: Phase II Study Underway
Cutaneous Squamous Cell Carcinoma (cSCC): Phase II Study Underway INCLUSION CRITERIA ARM B: VILOBELIMAB + ARM A: VILOBELIMAB ALONE PEMBROLIZUMAB • Locally advanced or metastatic cSCC N=3 • Refractory or resistant to PD-1 or PD-L1 inhibitor Stage 1 Safety Analysis • Locally advanced cSCC not amenable
Slide 23: INF904 Oral C5aR inhibitor
INF904 Oral C5aR inhibitor e
Slide 24: Properties of Currently Marketed Comparator Avacopan (CCX168)
Properties of Currently Marketed Comparator Avacopan (CCX168) Avacopan approved for ANCA Vasculitis • Chemistry: Crystalline solid (potentially low exposure) • 3 capsules 2x per day (10gm per capsule = 30mg/dose) ~35% inhibition ~50% inhibition Phase I data after dosing (30 mg; b.i.d) • Low trough l
Slide 25: Potential Improvements for a potential best-in-class anti-C5aR inhibitor
Potential Improvements for a potential “best-in-class” anti-C5aR inhibitor Properties of a hypothetical best-in-class C5aR antagonist • chemistry: Amorphous solid (high exposure potential) • improved toxicity profile especially with little impact on CYP3A4/5 liver enzymes • Improved PK properties wi
Slide 26: Allosteric Inhibitor INF904 (Oral Small Molecule)
Allosteric Inhibitor INF904 (Oral Small Molecule) Potential for Best-in-Class C5aR Inhibition INF904 Structure and MoA • INF904 binds to a well-known allosteric site in C5aR C5a • INF904 has a novel Markush structure Trp213 (human, • US patent was issued in October 2021 primate, hamster) PRE-CLINICA
Slide 27: Pre-clinical In Vivo Efficacy Comparison of INF904 to Avacopan
Allosteric Inhibitor INF904 (Oral Small Molecule) Potential for Best-in-Class C5aR Inhibition PRE-CLINICAL IN VIVO EFFICACY COMPARISON OF INF904 to AVACOPAN Inhibition of in vivo neutrophil activation by INF904 compared to Avacopan-like molecule 120 ✱✱ Avacopan-like Experiment: Challenge of rodents
Slide 28: INF904 Ongoing Phase I SAD / MAD Study
Allosteric Inhibitor INF904 (Oral Small Molecule) Potential for Best-in-Class C5aR Inhibition INF904 ONGOING PHASE I SAD / MAD STUDY • Single Ascending Dose (SAD) study will explore comparable and higher dosing compared to Avacopan dosing in the published Phase I study (Bekker et al. PLOS one 2016),
Slide 29: Role of C5a and vilobelimab MoA
Role of C5a and vilobelimab MoA
Slide 30: The Complement System and C5a Activation
The Complement System and C5a Activation Extrinsic “Pathway” Complement Pathways Enzymatic C5 Cleavage Classical Lectin Alternative Thrombin, Trypsin, Elastase, etc. Antibody binding Mannose binding Foreign surfaces C3 activation C5-convertases C5 C5 Scissile bonds Arg751/ Leu752 Terminal C5a C5b co
Slide 31: 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 32: 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 33: www.inflarx.com
www.inflarx.com INFLARX N.V. Winzerlaer Str. 2 07745 Jena, Germany Email: [email protected] Tel: +49-3641-508180 Fax: +49-3641-508181
Slide 34: Appendix
APPENDIX
Slide 35: Background to C5a as Key Player in the Development of Viral ARDS
Background to C5a as 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) 5
Slide 36: 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 37: 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 38: PANAMO Trial: Phase III Safety Results
PANAMO Trial: 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 relat
Slide 39: PANAMO Trial: Phase III Safety Results
PANAMO Trial: 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 patient Events per 100 patient Patients per 100