Inflarx N.v. · NASDAQ:IFRX
Inflarx — Investor Presentation (March 2024)
42 slides from Inflarx's investor presentation, Mar 21, 2024
Slide 1: Corporate Presentation March 2024
CORPORATE PRESENTATION MARCH 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: 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: InflaRx Highlights
Harnessing C5a/C5aR for Controlling Inflammation in the I&I Space InflaRx Highlights Uniquely targeting complement C5a/C5aR, a validated mechanism and critical part of the inflammation cascade with: First-in-class and highly potent anti-C5a monoclonal antibody (vilobelimab + second generation IFX-2)
Slide 5: Significant Opportunity in Immuno-Dermatology
Significant Opportunity in Immuno-Dermatology Page 5 Potential to target several attractive, billion-dollar+ commercial markets InflaRx has identified unmet medical needs that INF904 could strongly address Strong rationale for the role of C5a/C5aR based on mechanism of action, pre-clinical and clini
Slide 6: Focus INF904 on Immuno-Dermatology: I&I Pipeline-in-a-Drug Potential
Key initial development focus and area to demonstrate potential of INF904 Potential for future development or development in collaboration with a partner Immuno-dermatology Neurology Nephrology & Hematology Chronic spontaneous urticaria (CSU) Hidradenitis suppurativa (HS) others Chronic inflammatory
Slide 7: Late-Stage Pipeline Targets Multiple Sizable Markets
Page 7 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 antic
Slide 8: C5a/C5aR: A Strategic Position in the Inflammatory Cascade
Vilobelimab [C5a monoclonal antibody] INF904 [oral C5aR inhibitor] C5a/C5aR: A Strategic Position in the Inflammatory Cascade
Slide 9: C5a/C5aR are Validated Targets Promoting Inflammation
Anaphylatoxin C5a is upstream of the cytokine network Boosting effect on various pro-inflammatory cytokines IL-17, IL-6, IL-8, IL-1 and others Strong activator of neutrophils and macrophages Chemotaxis of neutrophils O2 radical generation + granular enzyme release NETosis (neutrophil extracellular t
Slide 10: Vilobelimab for Ulcerative Pyoderma Gangrenosum (PG)
Vilobelimab for Ulcerative Pyoderma Gangrenosum (PG)
Slide 11: Vilobelimab: A First-in-Class Anti-C5a Monoclonal Antibody
Highly selective anti-C5a mAB Blocks C5a biological effects up to 100% in human blood Leaves MAC formation intact Fast binding / high affinity to the newly discovered epitope Commercially validated / available under Emergency Use Authorization in certain severely ill COVID-19 patients Vilobelimab: A
Slide 12: PG: An Autoimmune Condition With High Unmet Need
PG: An Autoimmune Condition With High Unmet Need Page 12 PG Overview and 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, r
Slide 13: PG Pathogenesis: Potential Role of the C5a/C5aR Axis
C5a Levels in PG Wound Fluid Correlate With NETosis The etiology of PG is believed to be linked to the dysregulation of the immune system, specifically, altered neutrophil function Evidence suggest that complement activation and C5a play an important role in the disease development: High C5a levels
Slide 14: PG Phase IIa Showed No Safety or Tolerability Concerns and Dose-Dependent Drug Activity
PG Phase IIa Showed No Safety or Tolerability Concerns and Dose-Dependent Drug Activity Page 14 Clinical Response High-dose group showed highest rate of target ulcer closure and clinical remission (86%) Out of 17 evaluable patients at end of treatment visit or day of last drug administration Clinica
Slide 15: PG Study Phase IIa – Treatment Examples
PG Study Phase IIa – Treatment Examples Patient Case Studies Page 15 Target Ulcer Developed While on Adalimumab MH: PG since August 2020, Psoriasis since 2017 Previous PG medication: None Cohort 3: 2400 mg Q2W up to Day 85 -> exclusion after 9 doses due to delayed availability of pos. baseline TB te
Slide 16: PG Phase III Study Design: Interim Analysis Expected in 2025
PG Phase III Study Design: Interim Analysis Expected in 2025 Page 16 Treatment: 26 Weeks Follow up: 12 Weeks Safety Follow Up Prednisone tapered off Prednisone tapered off Randomization vilobelimab 2400 mg Q2W (13 doses) EOT (W 26) Safety Follow Up Patient Level Stopping Criteria progression (any ti
Slide 17: INF904: An Oral Highly Selective C5aR Inhibitor With Best-in-Class Potential
INF904: An Oral Highly Selective C5aR Inhibitor With Best-in-Class Potential
Slide 18: INF904: Oral C5aR Antagonist With Best-in-Class Potential
INF904: Oral C5aR Antagonist With Best-in-Class Potential Page 18 INF904 Key Features Focusing on Immuno-Derm, Other Options Possible Favorable drug profile supported by preclinical studies and data reported from InflaRx’s Phase I SAD and MAD trials Phase I PK/PD profile that could open significant
Slide 19: INF904 Has Double the Inhibitory Effect in Vivo Compared to Avacopan
INF904: Oral C5aR Antagonist With Best-in-Class PotentialINF904 Has Double the Inhibitory Effect in Vivo in a Pre-clinical Model Compared to Avacopan Page 19 Inhibition of in vivo neutrophil activation by INF904 compared to avacopan-like molecule* Experiment: Challenge of rodents with C5a leads to n
Slide 20: PK Results From Single Ascending Dose (SAD) Phase 1
INF904: Oral C5aR Antagonist With Best-in-Class PotentialPK Results From Single Ascending Dose (SAD) Phase 1 Page 20 Parameter Unit Dose INF904 Avacopan* AUCinf h.ng/ml 3 mg 285 25 10 mg 1264 130 30 mg 5956 628 AUClast h.ng/ml 3 mg 254 23 10 mg 1117 122 30 mg 5197 557 Cmax ng/ml 3 mg 21.5 9 10 mg 74
Slide 21: C5a-Mediated CD11b Upregulation on Neutrophils Ex Vivo up to 14-day Dosing
PD MAD results confirm strong >90% C5a inhibition at C5a levels found in human diseases – this is clearly differentiated from reported avacopan results which have shown approximately 50% inhibition at a lower challenge of 10nM C5a (7 day dosing – trough)** Upon stimulation with 12.6 nM rhC5a (levels
Slide 22: Investing Into INF904 Development: Phase IIa Expected to Begin by EOY 2024
Page 22 Investing Into INF904 Development Phase IIa Expected to Begin by EOY 2024 Initial Phase IIa – demonstrating pipeline-in-a-drug potential of INF904 Open-label PK / PD “basket study” to explore initial efficacy signals 4-week treatment period in 2 immuno-derm indications CSU and HS with establ
Slide 23: INF904 for Chronic Spontaneous Urticaria (CSU)
INF904 for Chronic Spontaneous Urticaria (CSU)
Slide 24: A Strong Rationale for Developing INF904 in CSU
A Strong Rationale for Developing INF904 in CSU C5aR Signaling is Involved in Histamine Release in an IgE Independent Manner Increasing scientific evidence suggests that C5aR signaling is involved in histamine release from mast cells and basophils in CSU in an IgE independent manner. This mechanism
Slide 25: 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 26: CSU Endotypes - Type I Auto-Allergens and Type IIb Autoimmunity
CSU Endotypes - Type 1 Auto-Allergens and Type IIb Autoimmunity Two major endotypes of CSU described as activation of mast cells include: Maurer et al. Clinical reviews in allergy and clinical immunology. 2022. 1 2 Type I autoallergens (IgE mediated) Type IIb autoimmunity (IgG mediated; ~30% of CSU)
Slide 27: C5a in CSU and its Role in IgE-Independent Histamine Release
C5a in CSU and its Role in IgE-Independent Histamine Release Page 27 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 release from basophils in
Slide 28: C5a-Induced Histamine Release is Important for Both IgE Dependent and Independent Pathways
C5a-Induced Histamine Release is Important for Both, IgE Dependent Pathway and IgE Independent Pathway C5a/C5aR Contributes to Histamine Release in an IgE Independent Manner Anti-IgE Stimulus pos. (>20% HR) Anti-IgE Stimulus neg. C5a generation in CSU may be amplified by the activation of the coagul
Slide 29: INF904 Development in CSU
INF904 Development in CSU Page 29 Conclusion: C5aR signaling is involved in histamine release from mast cells / basophils 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 inhibition represents a novel mech
Slide 30: INF904 for Hidradenitis Suppurativa (HS)
INF904 for Hidradenitis Suppurativa (HS)
Slide 31: A Strong Rationale for Developing INF904 in HS
A Strong Rationale for Developing INF904 in HS New Mechanisms are Needed New mechanisms are needed to address the disease more completely E.g. moderate to severe patients with active draining disease currently have limited approved treatment options which have proven to be effective for them and res
Slide 32: HS Overview and Unmet Need
Hidradenitis Suppurativa (HS) HS Overview and Unmet Need Clinical features A chronic, recurring, debilitating neutrophil-driven inflammatory disease, that can persist for years Characterized by abscesses, nodules and draining tunnels (dTs) with purulent or bloodstained discharge, that can flare and
Slide 33: An Important Role for C5a/C5aR is Recognized in HS Pathogenesis
An Important Role for C5a/C5aR is Recognized in HS Pathogenesis van Straalen KR Front. Immunol. 13:953674.doi: 10.3389/fimmu.2022.953674 Mechanism in HS development: Follicular occlusion of the folliculo-pilosebaceous unit, followed by follicular rupture, leading to immune responses which involve co
Slide 34: Strong Rationale for Developing an Anti-C5a/C5aR in HS
Page 34 Strong Rationale for Developing an Anti-C5a/C5aR in HS HS Patients Have Elevated C5a, a Major Neutrophil Activator That Can Be Blocked by an Anti-C5a/C5aR Kanni et al, 2018 HS patients have significant complement activation with elevated C5a levels C5a/C5aR activation is a key neutrophil act
Slide 35: Enhanced C5aR Staining in Biopsies From HS Patients at All Disease Stages
Enhanced C5aR Staining in Biopsies From HS Patients at All Disease Stages Page 35 C5aR1 Staining HF: Hair follicles S: Suppurative Hurley stage I patient with extensive deep dermal and subcutaneous suppurative abscessing inflammation, surrounding hair follicles with hyperkeratosis. C5aR1 staining po
Slide 36: Clinical Evidence for the Role of C5a/C5aR Signaling in HS
Clinical Evidence for the Role of C5a/C5aR Signaling in HS Page 36 Vilobelimab (anti-C5a mAb) SHINE Phase IIb study in moderate-severe HS patients resulted in various signals of efficacy for high dose treatment group (1200mg EOW) including an overall inflammatory lesion reduction * In SHINE, dT redu
Slide 37: Avacopan Data in Phase II Trial Shows Efficacy Emerging Only at W12
Avacopan Data in Phase II Clinical Trial Shows Efficacy Emerging Only at W12 Page 37 Results From Avacopan in HS Patients (Hurley III)* Avacopan’s efficacy (separation from placebo group) in HS only starts to emerge at W12 – please note: steady state reported from ANCA patients was only reached at a
Slide 38: Avacopan Data in ANCA Patients Shows Steady State Reached by 13 Weeks
Avacopan Data in ANCA Patients Shows Steady State Reached by 13 Weeks Page 38 Avacopan reported plasma trough PK data in ANCA Patients* Steady state plasma levels of avacopan 30mg BID are reached by 13 weeks and the accumulation is approximately 4-fold Mean steady state plasma exposure estimates of
Slide 39: Vilobelimab and Avacopan Provide Evidence for Efficacy in HS Patients
Vilobelimab* and Avacopan** Provide Evidence for Efficacy in HS Patients Page 39 Conclusion: There is a strong scientific rationale for the role of C5aR in HS C5a/C5aR signaling inhibition has resulted in signals of efficacy in HS patients Tight control over C5aR signaling is required to achieve opt
Slide 40: Gohibic (vilobelimab) Critical COVID-19 & ARDS
Gohibic (vilobelimab) Critical COVID-19 & ARDS
Slide 41: Emergency Use Authorization (EUA) Granted for Gohibic
Emergency Use Authorization (EUA) Granted for Gohibic Page 41 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** MAA under revie
Slide 42: Email: IR@inflarx.com Tel: +49-3641-508180 Fax: +49-3641-508181 www.inflarx.com InflaRx N.V. Winzerlaer Str. 207745 J…
Email: IR@inflarx.com Tel: +49-3641-508180 Fax: +49-3641-508181 www.inflarx.com InflaRx N.V. Winzerlaer Str. 207745 Jena, Germany