Slide 1: InflaRx virtual R&D event: INF904 oral C5aR inhibitor
InflaRx - virtual R&D event INF904: oral C5aR inhibitor with best-in-class potential in the immuno-dermatology and broader I&I space June 5, 2024 – 12 p.m. EST (US) / 6pm CET (EU)
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: Information and Sources
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: Content Page
Content Page 4 Presentation of today’s speakers and company introduction Current understanding of the C5a/C5aR1 biology Prof. Dr. med. Jörg Köhl The Role of C5aR in chronic spontaneous urticaria (CSU) Prof. Dr. med. Marcus Maurer The Role of C5aR in hidradenitis suppurativa (HS) Prof. Chris Sayed, M
Slide 5: Today's presenters
Today’s presenters Prof. Niels RiedemannFounder and CEO Camilla Chong, MDCMO Prof. Renfeng GuoFounder and CSO Dr. Thomas TaapkenCFO Jan MedinaVP Investor Relations Prof. Dr. med. Marcus Maurer Managing Director, Institute for Allergy Research, Charité University Hospital, Berlin, Germany Prof. Dr. m
Slide 6: Late-stage pipeline targets multiple sizable markets
Late-stage pipeline targets multiple sizable markets vilobelimab C5a Inhibitor IFX002 C5a Inhibitor INF904 Oral C5aR Inhibitor IMMUNO-DERMATOLOGY vilobelimab C5a Inhibitor OTHER INF904 Oral C5aR Inhibitor chronic spontaneous urticaria Phase IIa “basket study” anticipated by YE 2024 Data anticipated
Slide 7: IFRX strategic focus: why immuno-dermatology
IFRX strategic focus: why immuno-dermatology Strong rationale for the role of C5a/C5aR based on mechanism of action, pre-clinical and clinical data Potential to target several attractive, billion-dollar+ commercial markets with an attractive new MoA which is not currently addressed by any other drug
Slide 8: INF904 – highly selective C5aR1 inhibitor with best in class potential
INF904 – highly selective C5aR1 inhibitor with “best in class” potential Favorable drug safety profile supported by preclinical studies and data reported from InflaRx’s Phase I SAD and MAD trials Other favorable features compared to avacopan: Higher drug strength with potential for reduced capsule i
Slide 9: Current understanding of the C5a/C5aR1 biology
Current understanding of the C5a/C5aR1 biology Prof. Dr. Jörg Köhl Why target C5aR1 in the immuno-dermatologic space?
Slide 10: Complement translates danger signals into cellular responses
Zhang and Köhl Expert Rev Clin Immunol 2010 Complement translates danger signals into a broad range of cellular responses High/ Moderate Laumonnier et al Mol Immunol 2017 Low Mast cell C5L2/C5aR2 C5a C5adesArg C5aR1 G-protein ßarrs G-protein ßarrs Prof. Dr. Jörg Köhl – Current understanding of the C
Slide 11: Multiple sources of C5/C5a and its functions
Local immune cell activation and function The multiple sources of C5 / C5a and its systemic and cellular functions Gosh and Rana Int. Immunopharmacol 2023 C5 Singh and Kemper Eur. J. Immunol.2023 Prof. Dr. Jörg Köhl – Current understanding of the C5a/C5aR1 biology Page 11
Slide 12: Multi-functional roles of C5a in myeloid cells via C5aR1
Gosh and Rana Int. Immunopharmacol 2023 Multi-functional roles of C5a in distinct myeloid cells via C5aR1 activation Wang et al. J. Invest. Dermatol. 2024 / C5aR1 drives NETosis Neutrophil Critical driver of inflammation in Neutrophilic Skin Diseases (Hidradenitis suppurativa, Pyoderma gangrenosum)
Slide 13: C5a/C5aR1 axis synergizes with innate immune receptors
The C5a/C5aR1 axis synergizes with other innate immune receptors to promote a pro-inflammatory environment TLR Synergistic effects on Inflammation Autoimmunity Infection Prof. Dr. Jörg Köhl – Current understanding of the C5a/C5aR1 biology Page 13
Slide 14: C5aR1 signaling induces pro-inflammatory patterns in myeloid cells
Monocyte LPS PGE2 IL-6, TNF-a, IFN-g C5aR1 C5aR1 Myeloid cell C5aR1 signaling induces pro-inflammatory patterns in myeloid immune cells Prof. Dr. Jörg Köhl – Current understanding of the C5a/C5aR1 biology Page 14
Slide 15: C5a/C5aR1 axis activation in macrophages drives Th17 development
C5a/C5aR1 axis activation in macrophages drives Th17 development Hashimoto et al. J. Exp. Med. 2010 HS = Hidradenitis suppurativa; PG = Pyoderma gangrenosum Th17 responses are frequently found in neutrophilic skin diseases such as HS and PG. IL-17 promotes neutrophil migration into affected skin are
Slide 16: C5aR1 in disease areas
Infectious Diseases Cardiovascular Diseases Neoplastic Diseases Allergic Diseases Neurodegenerative Diseases C5aR1 C5a Kidney Disease Autoimmune Diseases Prof. Dr. Jörg Köhl – Current understanding of the C5a/C5aR1 biology Page 16
Slide 17: C5aR1 As a Target in the Complement System
C5aR1 As a Target in the Complement System Prof. Dr. Jörg Köhl
Slide 18: Key mediator of inflammation upstream of the cytokine network
Key Mediator of Inflammation involved in many inflammatory pathways and upstream of the cytokine network scissile bond C5a/C5aR1 signaling inhibition: the importance of a targeted approach MG7 domain C5a C5aR1 1.) through C5 convertases (complement mediated) 2.) through enzymatic cleavage at scissil
Slide 19: C5aR1 in disease areas
Autoimmune Diseases Infectious Diseases Cardiovascular Diseases Neoplastic Diseases Allergic Diseases Neurodegenerative Diseases C5aR1 C5a Kidney Disease Prof. Dr. Jörg Köhl – Current understanding of the C5a/C5aR1 biology Page 19
Slide 20: C5ar1-/- mice are protected from anaphylaxis
Ahrens et al., Am J Pathol 2012 C5ar1-/- mice are protected from the development of anaphylaxis Kordowski et al. Allergy 2019 Ovalbumin induced allergic / anaphylactic gut permeability increase leading to diarrhea Prof. Dr. Jörg Köhl – Current understanding of the C5a/C5aR1 biology Page 20
Slide 21: C5aR1-mediated induction of anaphylaxis via mast cell activation
Activation of the C5a/C5aR1 axis drives the development of anaphylaxis at several levels: The regulation of the B cell response in male mice that leads to the production of antigen-specific IgE. 1 2 3 The enhancement of FcR1-dependent degranulation of MCs. The sensitization of the vascular system t
Slide 22: Mast cell activation and its role in CSU
Yanase et al. Cells 2021 Mast cell activation and its role in chronic spontaneous urticaria (CSU) addressed by Prof. Maurer Prof. Dr. Jörg Köhl – Current understanding of the C5a/C5aR1 biology Page 22
Slide 23: C5aR1 in disease areas
Autoimmune Diseases Infectious Diseases Cardiovascular Diseases Neoplastic Diseases Allergic Diseases Neurodegenerative Diseases C5aR1 C5a Kidney Disease Prof. Dr. Jörg Köhl – Current understanding of the C5a/C5aR1 biology Page 23
Slide 24: Neutrophilic skin diseases are associated with activation of C5aR1
Neutrophilic skin diseases are associated with activation of C5aR1 Hidradenitis suppurativa* Pyoderma gangraenosum** Pemphigoid diseases*** Increased systemic C5a levels Increased local C5aR1 expression Skin microbiota expressing C5-cleaving enzyme High levels of local C5a in wound fluid C5a drives
Slide 25: Bacterial-induced C5aR1/TLR cross-talk driving skin inflammation
The hypothesis of bacterial-induced C5aR1 / TLR cross-talk driving skin inflammation The bacterium Porphyromonas in the oral cavity cleaves C5 into C5a and activates TLR2 to subvert complement/TLR-driven anti-microbial responses. This leads to a dysbiotic microbial community activating complement an
Slide 26: Neutrophilic skin diseases are associated with activation of C5aR1
Neutrophilic skin diseases are associated with activation of C5aR1 Hidradenitis suppurativa* Pyoderma gangraenosum** Pemphigoid diseases*** Increased systemic C5a levels Increased local C5aR1 expression Skin microbiota expressing C5-cleaving enzyme High levels of local C5a in wound fluid C5a drives
Slide 27: Neutrophilic skin diseases are associated with activation of C5aR1
Neutrophilic skin diseases are associated with activation of C5aR1 Hidradenitis suppurativa* Pyoderma gangraenosum** Pemphigoid diseases*** Increased systemic C5a levels Increased local C5aR1 expression Skin microbiota expressing C5-cleaving enzyme High levels of local C5a in wound fluid C5a drives
Slide 28: Neutrophilic skin diseases are associated with activation of C5aR1
Neutrophilic skin diseases are associated with activation of C5aR1 Hidradenitis suppurativa* Pyoderma gangraenosum** Pemphigoid diseases*** Increased systemic C5a levels Increased local C5aR1 expression Skin microbiota expressing C5-cleaving enzyme High levels of local C5a in wound fluid C5a drives
Slide 29: Role of the C5a/C5aR1 axis in pemphigoid disease
Pathophysiologic role of the C5a/C5aR1 axis in pemphigoid disease Structural proteins of the dermal/epidermal junction (DEJ) as targets of auto-antibody formation in Pemphigoid Disease Schmidt and Zillikens, Lancet, 2013 Role of C5a/C5aR1 in blister formation and skin inflammation Epidermolysis Bull
Slide 30: C5a/C5aR1 axis controls neutrophil migration into the skin
The C5a/C5aR1 axis controls neutrophil migration into the skin B6.s C5ar1-/- Week-2 Week-4 Week-6 Week-8 B6.s C5ar1-/- Ly6G Kenno et al. (unpublished work from the Köhl lab) Immunization-induced „active“ model of EBA C5aR1 controls neutrophil migration into the skin Prof. Dr. Jörg Köhl – Current und
Slide 31: C5aR1 controls early generation of auto-antigen-specific IgG
C5aR1 controls the early generation of auto-antigen-specific IgG Abs and their inflammatory potential IgM AAbs IgG1 AAbs Reduced switch from IgM to IgG auto-antibodies in C5ar1-/- mice Kenno et al. (unpublished work from the Köhl lab ) / Verghese et al. JCI Insight 2018 / Cumpelik et al. Nat Immunol
Slide 32: C5aR1 drives disease development in experimental EBA
C5aR1 drives disease development in experimental EBA at several levels The recruitment of neutrophils into the skin. The early generation of Type VII collagen-specific IgG Aabs. The inflammatory potential (ROS) of Type VII collagen-specific IgG Aabs. Prof. Dr. Jörg Köhl – Current understanding of th
Slide 33: Summary
Summary
Slide 34: Key Messages: why target C5aR1 in immuno-dermatology
Key Messages Why target C5aR1 in the immuno-dermatologic space? Key Message 1 Evidence for local C5a and C5aR1 expression in disease Key Message 2 C5aR1 activates and controls key effector cells (neutrophils, eosinophils, basophils, MCs), the B cell response and Th17 development Key Message 4 Tailor
Slide 35: Thank you for your attention
35 Thank you for your attention
Slide 36: The role of C5aR in chronic spontaneous urticaria (CSU)
The role of C5aR in chronic spontaneous urticaria (CSU) Prof. Dr. Marcus Maurer
Slide 37: Objectives for CSU session
Page 37 Objectives for CSU session Introduction to CSU disease, epidemiology and current unmet medical needs Pathophysiology of the disease : Type I & IIb endotypes The role of C5a/C5aR signaling : IgE dependent and independent pathways The potential role of INF904 in the future treatment landscape
Slide 38: CSU Overview and Unmet Need
Chronic Spontaneous Urticaria (CSU) CSU Overview and Unmet Need Clinical features An immune-mediated chronic inflammatory skin disorder, with dysregulated inflammatory cascades that leave patients predisposed to symptom development: debilitating and intensely itchy hives / wheals for > 6 weeks and o
Slide 39: CSU endotypes: type I auto-allergens and type IIb autoimmunity
CSU Endotypes : type I auto-allergens and type IIb autoimmunity C5aR signaling is suggested to be involved in both Type I and Type IIb endotypes Page 39 Activated Coagulation Factors II and X generate C5a from C5 Modified from Kaplan AP et al Clin Exp Allergy 2009 and Yanase Y, J Allergy Clin Immuno
Slide 40: C5aR is upregulated in the skin of CSU patients
Page 40 ** CSU healthy controls Munoz M. Charite Berlin Data on file C5aR is upregulated in the skin of CSU patients Prof. Dr. Marcus Maurer – The role of C5aR in chronic spontaneous urticaria (CSU)
Slide 41: C5a levels are increased in CSU
C5a levels are increased in CSU: an important new mechanism for histamine releases Page 41 CSU patients show evidence of complement activation in the skin CSU patients have elevated C5a levels 46.9 ng/ml 20.1 ng/ml N=95 N=42 p = 0.004 C4d staining in skin biopsy C5a (ng/mL) C5a induces histamine rel
Slide 42: INF904 can block C5a-mediated histamine release
Page 42 INF904 can effectively block C5a-mediated histamine releases (IgE-independent) InflaRx Data on file C5a-mediated histamine release from human basophils can be effectively inhibited by INF904 Prof. Dr. Marcus Maurer – The role of C5aR in chronic spontaneous urticaria (CSU)
Slide 43: C5a drives mast cell attraction, activation and degranulation
C5a drives mast cell attraction, activation and degranulation Page 43 Elieh-Ali-Komi D, Metz M, Kolkhir P, Kocatürk E, Scheffel J, Frischbutter S, Terhorst-Molawi D, Fox L, Maurer M. Chronic urticaria and the pathogenic role of mast cells. Allergol Int. 2023 Jul;72(3):359-368 The chemoattractant nat
Slide 44: Current treatment landscape including Phase 3 compounds
Current treatment landscape including Phase 3 clinical compounds Page 44 Therapy MoA Efficacy: 12 weeks Limitations Xolair® (omalizumab) marketed Anti-IgE mAb 300 mg Q4w Placebo UAS7 (CFB) ~-21 ~-8 UAS7=0 36% 9% Black box warning 1 SC injection > 30 % remain symptomatic 5 Dupixent® (dupilumab) Phase
Slide 45: Opportunities for another novel MoA such as anti-C5aR with INF904
There are opportunities for another novel MoA such as anti-C5aR with INF-904 Page 45 Opportunities Ease of administration to address patient preference and adherence: Oral capsules (BD or QD dosing) New mechanism of action to treat all affected CSU patient populations: Type I IgE mediated and Type I
Slide 46: Predictor of efficacy from Phase 2 UAS7 data
Predictor of efficacy from Phase 2 UAS7 data change from baseline (CFB) at 4 weeks Page 46 Historical UAS7 placebo rates at 4 weeks have ranged from -5.4 to – 9.6 (with an average of -7) UAS7 efficacy results at 4 weeks show that those who did not achieve a min. CFB vs placebo of -9 have not succeed
Slide 47: A strong rationale for developing INF904 in CSU
A strong rationale for developing INF904 in CSU Page 47 Conclusion: C5aR signaling is involved in histamine release and mast cell/basophil activation in CSU This C5a-mediated histamine release is independent of the IgE pathway and has been suggested to play a role in both subtypes of CSU C5aR inhibi
Slide 48: Charité Berlin Team
Charité Berlin Team Page 48 Prof. Dr. Marcus Maurer – The role of C5aR in chronic spontaneous urticaria (CSU)
Slide 49: The Role of C5aR in Hidradenitis Suppurativa
The Role of C5aR in Hidradenitis Suppurativa Dr. Chris Sayed, MD Prof. of Dermatology
Slide 50: Disease background
Disease background Dr. Chris Sayed, MD Prof. of Dermatology
Slide 51: HS Overview and Unmet Need
Hidradenitis Suppurativa (HS) HS Overview and Unmet Need Clinical features A chronic inflammatory disease characterized by abscesses, nodules and draining tunnels (dTs) with purulent and bloody drainage in sites such as axillae, groin, buttocks, and breasts Flares are unpredictable and cause permane
Slide 52: Pathophysiology – what's new
PATHOPHYSIOLOGY – what’s new Chris Sayed, MD Prof. of Dermatology
Slide 53: C5a is elevated in HS and has a role in pathogenesis
C5a is elevated in HS and has a role in HS pathogenesis van Straalen KR Front. Immunol. 13:953674.doi: 10.3389/fimmu.2022.953674 Mechanism in HS development: Follicular inflammation and an altered microbiome trigger complement activation including C5a/C5aR engagement Inflammation and dysregulated wo
Slide 54: Neutrophils play a critical role in HS pathogenesis
Neutrophils play a critical role in HS pathogenesis especially in draining tunnels (DTs) Neutrophils infiltrate inflammatory lesions in HS, including within tunnels and the surrounding tissue T: Tunnel G: Granuloma F: Fibrosis Hurley stage III patient with tunnel formation and surrounding granulomat
Slide 55: What have we learned from C5a/C5aR signaling inhibition in HS
What have we learned from C5a/C5aR signaling inhibition in HS Dr. Chris Sayed, MD Prof. of Dermatology
Slide 56: Phase 2a open label study vilobelimab in HS: HiSCR results
Phase 2a open label study vilobelimab in HS : HiSCR results 0% 0% 50% 42% 67% 75% 83% 0% 40% 20% 60% 80% Baseline Day 22 Day 29 Day 36 Day 43 HiSCR response in HS patients Day 50* Day 134 DESIGN EFFICACY OUTCOME SAFETY / TOLERABILITY RESULTS Open label / single center / 12 patients / 1 dose group wi
Slide 57: Phase 2a vilobelimab in HS: visual result examples
Day 1 Day 22 Hypogastrium Day 1 Day 22 Left axilla Phase 2a open label study vilobelimab in HS: visual result examples Dr. Chris Sayed, M.D. Prof. of Dermatology – The Role of C5aR in Hidradenitis Suppurativa InflaRx data on file Page 57
Slide 58: Phase 2a vilobelimab in HS: visual result examples
Day 1 Day 134 Gluteal fold Right inguiinal Day 1 Day 134 Phase 2a open label study vilobelimab in HS: visual result examples Day 1 Day 134 Scrotum Dr. Chris Sayed, M.D. Prof. of Dermatology – The Role of C5aR in Hidradenitis Suppurativa InflaRx data on file Page 58
Slide 59: Vilobelimab in HS: Phase 2b SHINE study details
Vilobelimab in HS: Phase 2b SHINE study details Important Note: Patients entering the OLE remained blinded to their initial therapy Test a dose-dependent effect of vilobelimab on HiSCR* response at week 16 (primary endpoint) Assess long-term safety of vilobelimab Test durability of response with low
Slide 60: SHINE study: primary endpoint not achieved, high placebo response
SHINE STUDY: primary endpoint HiSCR response not achieved with unusually high placebo response rate (week 16) An unusually high placebo response rate Secukinumab (anti-IL17A) 2 x phase 3 placebo n=180 -183 (mean in graph) / Kimball et al, Lancet 2023 Bimekizumab (anti-IL17A&17F) 2 x phase 3 placebo
Slide 61: HiSCR50 comparison from reported positive studies
Secukinumab (anti-IL17A) phase 3 Sunshine n=180 / Kimball et al, Lancet 2023 Secukinumab (anti-IL17A) phase 3 Sunrise n=180 / Kimball et al, Lancet 2023 Bimekizumab (anti-IL17A&17F) phase 2 n=44 / Glatt et al, JAMA Dermatol. 2021 Bimekizumab (anti-IL17A&17F) q2w phase 3 n=289 / Kimball et al, Lancet
Slide 62: HiSCR 50% response in the OLE
HiSCR 50% response in the OLE suggests that non-responders gain response (42%) on vilo and that 71% keep response on low dose vilo maintenance treatment HiSCR response rate (%) per visit* (OLE) – with 95% CI * Full analysis set Responders (n = 72) Non-responders (n = 84) sub-optimal doses (low or me
Slide 63: SHINE: inflammatory lesion reductions after OLE phase
SHINE Study: Patients who completed the OLE phase (w 40) showed substantial inflammatory lesion reductions when compared to observed placebo count reductions from the double-blind main period (w 16) * Full analysis set (unadjusted) Relative reduction (% mean) of counts / scores compared to respectiv
Slide 64: SHINE study: ANdT count and IHS4 score
SHINE STUDY: outcome of ANdT count and IHS4 score (week 16) * Full analysis set baseline adjusted p= 0.0279 Relative Change % n = 32-36 patients/group ANdT Count Change (LS means)* p= 0.0202 Relative Change % Dr. Chris Sayed, M.D. Prof. of Dermatology – The Role of C5aR in Hidradenitis Suppurativa I
Slide 65: SHINE study: inflammatory lesion reduction under C5a inhibition
SHINE STUDY: evidence of inflammatory lesion reduction under C5a inhibition (w 16) * Full analysis set baseline adjusted, LS Means % Reduction in Number of Draining Tunnels DT Count Change Week 16 (LS means)* p= 0.0359 Placebo 400 Q4W 800 Q4W 800 Q2W 1200 Q2W % patients with DT 100 response Complete
Slide 66: Evidence for efficacy of C5aR inhibition in HS: Avacopan data
Evidence for efficacy of C5aR inhibition in HS: Avacopan data * Reported outcome results at clinicaltrials.gov, Chemocentryx, Avacopan HS phase II trial (AURORA) ** Data from Chemocentryx presentation on Avacopan HS phase II trial (AURORA) results, October 28, 2020: note: overall results were not st
Slide 67: What have we learned from C5a/C5aR inhibition in HS
What have we learned from C5a/C5aR inhibition in HS Dr. Chris Sayed, MD Prof. of Dermatology
Slide 68: Rationale for developing INF904 as oral C5aR inhibitor in HS
Summary and rationale for developing INF904 as potent oral C5aR inhibitor in HS Learnings: Both C5a as well as C5aR signaling inhibition have resulted in clear signals of efficacy (reduction of inflammatory lesions + established scores) in moderate to severe HS patients Both treatment attempts (vilo
Slide 69: Experts panel Q&A
Q&A Experts panel InFlaRx
Slide 70: Next clinical development steps for INF904
Next clinical development steps for INF904 Dr. Camilla Chong, MD CMO
Slide 71: Phase 2a open label basket study in CSU and HS
Phase 2a open label basket study in CSU and HS Page 71 To determine the appropriate dosing regimen in CSU & HS with safety, PK and efficacy measurements in order to progress to a larger placebo-controlled Phase 2b clinical program. Basket study approach has been agreed with FDA for a single IND subm
Slide 72: Phase 2a open label basket study concept
Phase 2a open label basket study concept Page 72 Primary and Secondary endpoints are the same in determination of safety and PK measurements in CSU and HS study population Exploratory clinical endpoints including PROs will be specific to each disease Arm 1 Arm 2 Arm 3 HS 4 weeks treatment (n=10 per
Slide 73: Exploratory endpoints and study design for CSU
Page 73 Exploratory Endpoints Change of the weekly Urticaria Activity Score 7 (UAS7) , Hives Severity Score (HSS7) and Itch Severity Score (ISS7) Biomarkers : Tryptase, IgE, IgG, anti-TPO Patient Reported Outcome (PRO) Endpoints: Urticaria Control Test (UCT7) Angioedema Activity Score (AAS 7) Chroni
Slide 74: Main inclusion criteria for CSU
Page 74 Main inclusion criteria for CSU Patients diagnosed with moderate to severe CSU and inadequately controlled by second generation H1-antihistamines at the time of randomization as defined in the following: The presence of itch and hives for ≥6 consecutive weeks prior to screening in spite of u
Slide 75: Exploratory endpoints and study design for HS
Page 75 Exploratory Endpoints (all change from baseline, CFB): Total Abscess (A), Inflammatory Nodule (N) and draining tunnels (dT) Count (ANdT, AN and separate counts for each lesion), HS lesions related scores (HiSCR –various, modified-HiSCR, IHS-4) Clinician’s Global Impression of Change (CGI-C)
Slide 76: Main inclusion criteria for HS
Main inclusion criteria for HS Page 76 Moderate or severe hidradenitis suppurativa (with Hurley Stage II or III), and an Abscess and Nodule (AN) count ≥ 5. Inflammatory lesions should affect at least 2 distinct anatomic areas Diagnosis of HS based on clinical history and physical examination for at
Slide 77: Commercial Opportunity
Commercial Opportunity Dr. Thomas Taapken CFO
Slide 78: Immuno-dermatology: attractive, rapidly growing market
Focus on immuno-dermatology – attractive and rapidly growing market opportunity Page 78 The immuno-dermatology market is witnessing robust growth, driven by the increased incidence of disease, emerging targeted therapeutics and improved diagnostic capabilities Market growth rates are attracting seve
Slide 79: Strong commercial potential based on differentiated profile of INF904
Strong commercial potential based on differentiated profile of INF904 Oral availability provides for ease of administration and patient acceptance Favorable drug metabolism, PK and toxicology profile positions INF904 as a potential strong alternative to other drug classes INF904 could address areas
Slide 80: CSU market dynamic and INF904 commercial opportunity
CSU market dynamic and INF904 commercial opportunity Overall CSU US market size* estimated to be US$ 1.1 Bn in 2024 and growing at 10% CAGR to US$ 3.1 Bn by 2035, mainly driven by new therapies for severe disease entering the market incidence approx. 400k patients p.a. (US) anti-histamine refractory
Slide 81: HS market dynamic and INF904 commercial opportunity
HS market dynamic and INF904 commercial opportunity Overall HS US market size* estimated to be US$ 1.3 Bn in 2024 and growing at 15% CAGR to US$ 6 Bn by 2035, mainly driven by new therapies for severe disease entering the market incidence approx. 320k patients p.a. (US) 2nd line treatment options be
Slide 82: Role of C5aR inhibition spans beyond immuno-dermatology
Role of C5aR inhibition spans well beyond immuno-dermatology “Pipeline in a drug” potential of INF904 C5aR inhibition could be developed broadly in different I&I indications Initial focus on HS and CSU but other indications (e.g., renal diseases) are likely areas for development This opportunity cou
Slide 83: Conclusions and next steps
Conclusions and next steps Page 83 InflaRx has sufficient resources to complete Phase 2a basket study in HS and CSU Cash position as of Q1 2024 was EUR 85.8M (~$93M) – a runway into 2026 Expected start of Phase 2a open label study by year-end 2024, with data in summer 2025 Goal is to generate additi
Slide 84: Summary
Summary Prof. Dr. Niels C. Riedemann CEO
Slide 85: Summary and conclusions from today's presentation
Summary and conclusions from today’s presentation Page 85 Thank you for your attention! The new oral C5aR inhibitor INF904 has best-in-class potential and has been developed to become a pipeline-in-a-drug in the immuno-dermatology space and broader I&I space Supported by cutting-edge science, there
Slide 86: Q&A
Q&A all presenters InFlaRx
Slide 87: Contact details
Email: IR@inflarx.com Tel: +49-3641-508180 Fax: +49-3641-508181 www.inflarx.com InflaRx N.V. Winzerlaer Str. 207745 Jena, Germany