InflaRx N.V. · NASDAQ:IFRX
InflaRx — Investor Presentation (September 2023)
39 slides from InflaRx's investor presentation, September 2023
Slide 1: Corporate Presentation September 2023
CORPORATE PRESENTATION SEPTEMBER 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: 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 marketed / AREA INDICATIONS PRECLIN. PHASE I PHASE II PHASE III authorized STATUS Acute organ dysfunction US EUA granted in April 2023, MAA critical submitted and validated for review, COVID-19 regulatory discussions for BLA ongoing vilobelimab pyoderma
Slide 5: The Complement System and Our Targets
The Complement System and Our Targets
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 Monoclonal Antibody directed against C5a
Vilobelimab a First-in-Class Monoclonal Antibody directed against C5a 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 ep
Slide 8: INF904 is a new Chemical Oral Inhibitor of C5aR
INF904 is a new Chemical Oral Inhibitor of C5aR 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 • Good tissue presence a
Slide 9: INF904 Orally Administered Low Molecular Weight C5aR Inhibitor
INF904 Orally Administered Low Molecular Weight C5aR Inhibitor
Slide 10: Improvement of C5aR Inhibition
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) hypothetical = significantly stronger inhibition of neutrophil
Slide 11: INF904: Pre-clinical Summary
INF904: Pre-clinical Summary C5a INF904 FACTS Trp213 (human, • INF904 binds to a well-defined allosteric site in C5aR primate, hamster) • INF904 has a novel molecular structure • US patent was issued in October 2021; national phases for other select countries (PCT) INF904 binds to allosteric binding
Slide 12: INF904: Potential Best-in-Class C5aR Inhibitor
INF904: Potential 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 consequent adherence (
Slide 13: INF904 Phase I Study Design
INF904 Phase I Study Design Single Ascending Dose (SAD) Multiple Ascending Dose (MAD) 3mg Safety evaluation • ongoing enrollment SAD • Total enrolled: n = 62 (N=8, in 6:2 ratio) 10mg Safety evaluation SAD (N=8, in 6:2 ratio) Dose 1 Safety evaluation MAD 30mg Safety evaluation N=8 (in 6:2 ratio) SAD
Slide 14: INF904 Phase I Study: Safety Results from SAD Part
INF904 Phase I Study: Safety Results from SAD 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 higher than in ac
Slide 15: INF904 Phase I Study: PK Results from SAD Part
INF904 Phase I Study: PK Results from SAD Part 1,400 Avacopan INF904 30mg 3mg Parameter Unit Dose INF904 Avacopan* INF904 3mg INF904 10mg 1,200 INF904 10mg AUCinf h.ng/ml 3 mg 285 25 INF904 30mg INF904 30mg 10 mg 1264 130 INF904 60mg INF904 60mg 1,000 INF904 INF904 120mg 120mg 30 mg 5956 628 INF904
Slide 16: 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, 100 ≥ 90% blocking activity was observed in the % C hange on C D 11b Level P la c e b
Slide 17: Summary: Topline Results from INF904 Phase I SAD Study
Summary Topline Results from INF904 Phase I SAD Study KEY OUTCOMES 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. INF904 demonstrated a favorable PK profile. INF904 demonstrated a strong C5a bl
Slide 18: Gohibic (vilobelimab) Critical COVID-19
Gohibic (vilobelimab) Critical COVID-19
Slide 19: Emergency Use Authorization (EUA) granted for Gohibic (vilobelimab)
Emergency Use Authorization (EUA) granted for Gohibic (vilobelimab) Gohibic 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** Authorization granted b
Slide 20: 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 21: 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 22: PANAMO Trial: Phase III – Secondary Endpoint
PANAMO Trial: Phase III – Secondary Endpoint Need for Renal Replacement Cause-specific Cox mode: HR: SECONDARY ENDPOINT: PROPORTION OF PATIENTS FREE OF RENAL REPLACEMENT WITHIN 28 DAYS 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 23: Vilobelimab Pyoderma Gangrenosum (PG)
Vilobelimab Pyoderma Gangrenosum (PG)
Slide 24: 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 25: 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 26: 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 27: 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 28: 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 29: 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 30: Vilobelimab Oncology: Cutaneous Squamous Cell Carcinoma (cSCC)
Vilobelimab Oncology Cutaneous Squamous Cell Carcinoma (cSCC)
Slide 31: 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 32: 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 33: cSCC: Interim Data from the Mono-Therapy Group in Arm A
cSCC: Interim Data from the Mono-Therapy Group in Arm A Summary SAFETY CONCLUSION • 10 patients enrolled in the monotherapy arm (1600 mg dose) • No major safety issues identified CLINICAL RESPONSE CONCLUSION • Initial signs of responses detected in 2/10 patients (who are elderly and refractory to pr
Slide 34: InflaRx N.V. - Summary
InflaRx N.V. - Summary Targeting Complement to Control Inflammatory Diseases INVESTMENT HIGHLIGHTS InflaRx aims to be the leading biotechnology company in the terminal complement C5a / C5aR pathway and has developed highly active drug candidates: • Vilobelimab is a first-in-class highly active fast
Slide 35: 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
Slide 36: Appendix
Appendix
Slide 37: 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 38: C5a / C5aR Signalling: A key Role in Inflammation
C5a / C5aR Signalling: A key Role in Inflammation Neutrophils (~200K C5aR per cell) Proinflam. Mediators • Chemotaxis • TNF-α, Interleukins .. • Adhesion • Chemokines, e.g. IL-8 • O2 Radicals • HMGB-1 • Enzyme release • Pyrogenic: PGE2 • NETosis (NETs) C5a Monocyte & Macrophage T-cells • ROS product
Slide 39: C5a / C5aR: Activation of Neutrophils as Major Tissue Damaging Event
C5a / C5aR: Activation of Neutrophils as Major Tissue Damaging Event C5A /C5AR MODE OF ACTION ON NEUTROPHILS • chemotaxis of neutrophils (Shin et al 1968, Science 162,361-3) • enzyme release (Goldstein et al 1974, J. Immunol. 113, 1583-8) • production of O2-radicals in neutrophils (Sacks et al 1978,