Inflarx N.v. · NASDAQ:IFRX
Inflarx — Investor Presentation (January 2024)
33 slides from Inflarx's investor presentation, January 2024
Slide 1: Corporate Presentation January 2024
CORPORATE PRESENTATION JANUARY 2024
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: Important Notice and Disclaimer
IMPORTANT NOTICE AND DISCLAIMER Information and Sources Certain information contained in this presentation relates to or is based on studies, publications, surveys and other data obtained from third-party sources and InflaRx’s own internal estimates and research. While InflaRx believes these third-p
Slide 4: Pipeline and Company Status Development Update
PIPELINE AND COMPANY STATUS DEVELOPMENT UPDATE AREA INDICATIONS PRECLIN. PHASE I PHASE II PHASE III MARKET STATUS US EUA granted in April 2023, EU MAA Acute organ dysfunction under review, possibility to develop critical COVID-19 towards broader ARDS label discussed broader ARDS vilobelimab with FDA
Slide 5: The Complement System and Our C5a Targeted Approach
THE COMPLEMENT SYSTEM AND OUR C5a TARGETED APPROACH
Slide 6: 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 C5a Terminal C5b co
Slide 7: Vilobelimab: A First-in-Class Anti-C5a Monoclonal Antibody
VILOBELIMAB: A FIRST-IN-CLASS ANTI-C5a MONOCLONAL ANTIBODY VILOBELIMAB (IFX-1) DEVELOPMENT AREAS IN ACUTE AND SUB-ACUTE INFLAMMATION Being a fast acting highly specific monoclonal antibody infused i.v., Cardiology Pulmonology vilobelimab therapy delivers: new • Strong and immediate C5a epitope inhib
Slide 8: INF904: Oral Inhibitor of the C5a-Receptor
INF904: ORAL INHIBITOR OF THE C5a-RECEPTOR INF904 POTENTIAL DEVELOPMENT AREAS IN CHRONIC INFLAMMATION C5a Trp213 (human, primate, hamster) Being a small molecule orally available C5aR inhibitor, INF904 Cardiology Pulmonology has the potential to deliver: INF904 binds to • Favorable tissue and plasma
Slide 9: INF904: Orally Administered, Highly Selective Low Molecular Weight C5aR Inhibitor
INF904: AN ORALLY ADMINISTERED, HIGHLY SELECTIVE LOW MOLECULAR WEIGHT C5aR INHIBITOR
Slide 10: Targeted Improvement of C5aR-Inhibition
TARGETED IMPROVEMENT OF C5aR-INHIBITION PROPERTIES OF A BEST-IN-CLASS C5aR ANTAGONIST • Improved PK properties with higher plasma trough level (>> 36 ng/mL) to achieve: • Improved blocking activity in vivo in humans (>> 50% blocking at 10 nM C5a) = significantly stronger inhibition of neutrophil act
Slide 11: INF904: Pre-Clinical Summary
INF904: PRE-CLINICAL SUMMARY C5a-binding site INF904 FACTS • INF904 binds to the well-defined allosteric site in C5aR transmembrane domain Trp213 (human, • INF904 has a novel and proprietary molecular structure primate, hamster) • US patent issued in October 2021; pending in other countries (PCT) IN
Slide 12: INF904: Potential for Becoming a Best-in-Class C5aR Inhibitor
INF904: POTENTIAL FOR BECOMING A BEST-IN-CLASS C5aR INHIBITOR PRE-CLINICAL IN VIVO EFFICACY COMPARISON OF INF904 to AVACOPAN* Inhibition of in vivo neutrophil activation by Experiment: Challenge of rodents with C5a leads to neutrophil INF904 compared to Avacopan-like molecule* activation and consequ
Slide 13: INF904: Phase I Study Design
INF904: PHASE I STUDY DESIGN 3mg Safety evaluation Single ascending dose (SAD) Multiple ascending dose (MAD): 14 days SAD (N=8, in 6:2 ratio) 10mg Safety evaluation SAD (N=8, in 6:2 ratio) 30mg QD Safety evaluation MAD 30mg Safety evaluation N=8 (in 6:2 ratio) SAD (N=8, in 6:2 ratio) 30mg BID Safety
Slide 14: INF904 Phase I Study: Safety Results Combined
INF904 PHASE I STUDY: SAFETY RESULTS COMBINED (SAD AND MAD PART) HIGHLIGHTS • INF904 was well tolerated in treated healthy volunteers and resulted in no safety signals of concern in single ascending doses ranging from 3mg to 240mg • Overall percentage of adverse events (AEs) in placebo group was hig
Slide 15: INF904: PK Results from Single Ascending Dose Phase I
INF904: PK RESULTS FROM SINGLE ASCENDING DOSE (SAD) PHASE I 1,400 Avacopan INF904 30mg 3mg Parameter Unit Dose INF904 Avacopan* INF904 3mg INF904 10mg AUCinf h.ng/ml 3 mg 285 25 1,200 INF904 10mg INF904 30mg INF904 30mg 10 mg 1264 130 INF904 60mg INF904 60mg 1,000 INF904 INF904 120mg 120mg 30 mg 595
Slide 16: INF904: PK Results from Multiple Ascending Dose Phase I
INF904: PK RESULTS FROM MULTIPLE ASCENDING DOSE (MAD) PHASE I AUC0-12hr (ng x hr/mL) ± Dose (Regimen) Day Cmax (ng/mL) ±SD SD 1 233 ± 79 1,615 ± 427 30 mg QD 14 284 ± 60 2,609 ± 792 1 236 ± 97 1,742 ± 648 30 mg BID 14 356 ± 84 3,331 ± 821 90 mg BID 1 653 ± 217 4,815 ± 1,993 14 1,028 ± 431 8,962 ± 4,
Slide 17: INF904 Phase I Study: PD Results from SAD Part
INF904 PHASE I STUDY: PD RESULTS FROM SAD PART C5a-mediated CD11b upregulation on neutrophils ex vivo at 24h post dosing rh C 5 a -C D 1 1 b R e s p o n s e , T = 2 4 h 120 • INF904: In response to 12.64 nM of C5a, ≥ 90% blocking activity was observed in the % C hange on C D 11b Level 100 P la c e b
Slide 18: INF904 Phase I Study: PD Results from MAD Part
INF904 PHASE I STUDY: PD RESULTS FROM MAD PART C5a-mediated CD11b upregulation on neutrophils ex vivo up to 14 day dosing INF904: 30 mg QD INF904: 30 mg BID INF904: 90 mg BID rh C 5 a -C D 1 1 b R e s p o n s e , 3 0 m g q .d ., 1 4 d o s e s r h C 5 a - C D 1 1 b R e s p o n s e , 3 0 m g b .i. d .
Slide 19: Summary: Topline Results from INF904 Phase I Study
SUMMARY Topline Results from INF904 Phase I Study KEY OUTCOMES INF904 was well tolerated in treated healthy volunteers and resulted in no safety signals of concerns over entire tested dose ranges and regimens. INF904 demonstrated a favorable PK profile with potential to achieve therapeutic exposures
Slide 20: Gohibic (Vilobelimab) Critical COVID-19
GOHIBIC (VILOBELIMAB) CRITICAL COVID-19
Slide 21: Emergency Use Authorization (EUA) Granted for Gohibic
EMERGENCY USE AUTHORIZATION (EUA) GRANTED FOR GOHIBIC (vilobelimab) Gohibic (vilobelimab) has not been approved, but has been authorized for emergency use by FDA under an EUA*, for the treatment of COVID-19 in hospitalized adults when initiated within 48 hours of receiving IMV**, or ECMO** Authoriza
Slide 22: COVID-19: Disease Progression and Therapeutic Interventions
COVID-19: DISEASE PROGRESSION AND THERAPEUTIC INTERVENTIONS Vaccines Antiviral Treatments Anti-inflammatorische Anti-inflammatory Behandlung Treatments Versterben Death oder or Recovery Heilung Healthy Early Stage Intermediate to Severe Stage Critical Stage Recovery (pre- Incubation / asymptomatic o
Slide 23: PANAMO Phase III Trial – Primary Endpoint
PANAMO PHASE III TRIAL – PRIMARY ENDPOINT 28 day all-cause mortality PANAMO Phase III trial: 1:1 randomized, double-blind, placebo-controlled, Placebo + SOC multi-national trial in (n=369) invasive mechanically Day 28: 23.9 % relative reduction Kaplan-Meier point estimate: ventilated COVID-19 patien
Slide 24: PANAMO Phase III Trial – Secondary Endpoint
PANAMO PHASE III TRIAL – 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/ S2213-2600
Slide 25: Vilobelimab for the Treatment of Ulcerative Pyoderma Gangrenosum (PG)
VILOBELIMAB FOR THE TREATMENT OF ULCERATIVE PYODERMA GANGRENOSUM (PG)
Slide 26: 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 27: 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 28: 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 29: 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 • Previous PG medication: None • Previous PG medication: Methylprednisolone only in Jun 2019, Dapsone Jun
Slide 30: PG Phase IIa Study Results Summary and Conclusion
PG PHASE IIA STUDY RESULTS Summary and Conclusion SAFETY CONCLUSION • No infusion-related reactions observed PHASE III INITIATED • For 2 patients, related SAEs were reported: BASED ON FEEDBACK FROM - Erysipelas leading to hospitalization (judged as non-related by sponsor) FDA - Rash due to delayed h
Slide 31: PG Phase III Study Design
PG PHASE III STUDY DESIGN Summary 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 (1
Slide 32: InflaRx – Summary
INFLARX – SUMMARY Targeting Complement to Control Inflammatory Diseases INVESTMENT HIGHLIGHTS InflaRx is a biotechnology company pioneering anti-inflammatory drug development in the terminal complement C5a / C5aR pathway and has developed highly active drug candidates for the target and the receptor
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