Slide 1: INF904 Topline Phase 2a Data in HS & CSU
INF904 Topline Phase 2a Data Hidradenitis suppurativa (HS) & chronic spontaneous urticaria (CSU) NOVEMBER 10, 2025 1
Slide 2: Speakers
Speakers 2 Niels Riedemann, M.D., Ph.D. Chief Executive Officer, Founder, InflaRx Camilla Chong, M.D. Chief Medical Officer, InflaRx Prof. John Ingram Clinical Professor & Consultant Dermatologist, Cardiff University & Specialty Lead for Dermatology, Health and Care Research Wales Thomas Taapken, Ph
Slide 3: Important Notice and Disclaimer
Important Notice and Disclaimer This presentation has been prepared by InflaRx N.V. (“InflaRx” or “we”). 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 in any jurisdiction in which such offer or solic
Slide 4: Important Notice and Disclaimer: InflaRx data presented
Important Notice and Disclaimer InflaRx data presented The data presented herein are topline results based on the number of patients indicated and are subject to final data review and quality checks. Data from patients still completing treatment are not included in the current analysis and may resul
Slide 5: C5a/C5aR signaling inhibition: INF904 prevents binding of C5a to C5aR
C5a/C5aR signaling inhibition: INF904 prevents binding of C5a to C5aR Advantages of blocking C5aR with INF904 A small molecule oral compound is predicted to have good tissue penetration and to control C5a/C5aR signaling at the site of inflammation C5aR is selectively expressed on various immune and
Slide 6: INF904: An oral C5aR antagonist with best-in-class potential
*InflaRx data on file: PK Results From Single Ascending Dose (SAD) Phase 1 study – note: Avacopan data (Becker et al, 2016, PLoS One) are superimposed in graph for orientation. Avacopan was not included as a comparator in INF904 Phase I study. **InflaRx data on file: PD Results from multiple ascendi
Slide 7: INF904 therapeutic exposure reached within the first week
INF904 therapeutic exposure reached within the first week Page 7 Lower dose of 60 mg bid projected to result in complete signal control based on Phase 1 data Explore efficacy at the high end by adding 90 mg bid (HS) and 120 mg bid (HS and CSU) Preliminary PK results* * Preliminary PK results of pool
Slide 8: INF904 Phase 2a data show no signals of safety concern
* Preliminary safety reporting at topline data release, final and full QC checked results will be reported after completion of the study at the end of observation period (week 8) for all patients INF904 Phase 2a data show no signals of safety concern Safety results in HS* No signals of safety concer
Slide 9: INF904 Phase 2a in Hidradenitis Suppurativa
INF904 Phase 2a in Hidradenitis Suppurativa 9 All data presented herein for end of treatment (EOT) at week 4 show results for n=29 evaluable patients All data presented herein for end of study (EOS) at week 8 (after 4-week follow-up period) show results for n=25 evaluable patients Data from two addi
Slide 10: HS: Phase 2a trial design
HS: Phase 2a trial design Arm 1 Arm 2 Arm 3 4 weeks treatment n=10 per arm 4 weeks follow-up INF904 60 mg BID INF904 90 mg BID INF904 120 mg BID R 1:1:1 Baseline EOT EOS Primary & secondary objectives Safety & PK Exploratory objectives Clinical endpoints AN, dT, ANdT, HiSCR, NRS-Skin Pain, DLQI 10 I
Slide 11: HS: Phase 2a baseline characteristics
HS: Phase 2a baseline characteristics 11 n AN-count mean dT-count mean ANdT-count mean IHS4-score mean Pain Score mean DLQI mean Hurley III (%) mean HS diagnosis (years) mean age (years) % pts with ≥ 1 dT prior biologic use mean BMI % female 60 mg bid 10 12.5 4.2 16.7 33.7 7.1 12.4 50% 14.6 42.2 70%
Slide 12: INF904 drives meaningful and consistent AN count reductions
INF904 drives meaningful and consistent AN count reductions 12 A N AN A N AN A N AN A N AN
Slide 13: Comparison to reported Phase 2 and Phase 3 drug data
13 Comparison to average of reported successfully completed Phase 2 (moved into Phase 3) and all available completed Phase 3 drug data* * Data are derived from different completed Phase 3 clinical trials and averages were created using the data available at each timepoint: Adalimumab Phase 3 PIONEER
Slide 14: INF904 drives draining tunnel (dT) count reductions
INF904 drives draining tunnel (dT) count reductions 14 All n=21 All
Slide 15: INF904 dT reductions compared to reported successful Phase trials
INF904 dT reductions compared to reported successful Phase 3 trials * Data are derived from different completed Phase 3 clinical trials and averages were created using the data available at each timepoint: Adalimumab PIONEER I & II: week 12 data for tested dose and placebo as reported by Kimball et
Slide 16: INF904 drives early improvements in HiSCR
INF904 drives early improvements in HiSCR 16 44% EOS (w8) n=25 63 % n=8 44% n=9 25% n=8
Slide 17: INF904 HiSCR compared to successful Phase trials
INF904 HiSCR compared to successful Phase 3 trials 17 * Data are derived from different completed Phase 3 clinical trials and averages were created using the data available at each timepoint: Adalimumab PIONEER I & II : week 2, 4, 8, and 12 data for tested dose and placebo as reported by Kimball et
Slide 18: INF904 drives high pain score reduction (NRS30)
INF904 drives high pain score reduction (NRS30) NRS30 response is defined as >30% reduction from baseline and at least 2 point reduction When applying the NRS 3 points reduction (in analogy to sonelokimab VELA data), the curve is identical 18 * Data are derived from different completed Phase 3 clini
Slide 19: INF904 comparison with reported avacopan data
INF904 comparison with reported avacopan data* 19 * Data from avacopan Phase 2 AURORA trial reported at clinicaltrials.gov (NCT03852472). NRS30 definition used in AURORA reported data: ≥30% reduction and ≥1 point reduction from baseline for patients with baseline NRS ≥3 Placebo INF904 120mg INF904 p
Slide 20: Highlights of INF904 in HS
Highlights of INF904 in HS 20 INF904 shows biologic-like efficacy in the first 4 weeks with AN count reduction and HiSCR in line with successful Phase 3 comparators Preliminary week 8 data indicate that HiSCR response further deepens in the 4 weeks after end of treatment INF904 shows a fast and deep
Slide 21: INF904 Phase 2a in Chronic Spontaneous Urticaria
INF904 Phase 2a in Chronic Spontaneous Urticaria 21 All data presented herein for end of treatment (EOT) at week 4 show results for n=30 evaluable patients All data presented herein for end of study (EOS) at week 8 (after 4-week follow-up period) show results for n=23 evaluable patients Data from on
Slide 22: CSU: Phase 2a trial design
Arm 1 Arm 2 Arm 3 CSU 4 weeks treatment n=15 per arm 4 weeks follow-up INF904 60 mg BID INF904 60 mg BID n=10 R 1:1 Baseline EOT EOS INF904 120 mg BID Anti-IgE experienced* INF904 120 mg BID CSU: Phase 2a trial design Primary & secondary objectives Safety & PK Exploratory objectives Clinical endpoin
Slide 23: CSU: Baseline characteristics
23 CSU: Baseline characteristics mean age (years) % female mean CSU duration (years) mean UAS7 mean UCT7 IgE (IU/L) anti IgE experienced 60 mg BID n=14 41.3 86% 3.6 33.5 5.0 283.4 7% 120 mg BID n=16 47.8 81% 3.3 29.5 4.3 178.0 19% All n=30 44.8 83% 3.5 31.4 4.6 230.7 13% Anti IgE Naive n=25 43.7 80%
Slide 24: CSU: Effect on UAS7 at W4 continues to end of study (W8)
24 CSU: Effect on UAS7 at W4 continues to end of study (W8) after end of treatment -16.3 n=10 EOS (w8) n=23 -7.1 n=13 -11.1 n=23
Slide 25: CSU: Phase 2 UAS7 data at W4 from competition
CSU: Phase 2 UAS7 data at W4 from competition(products progressed to Phase 3*) Omalizumab Phase 2: Saini S et al J Allergy Clin Immunol. 2011 Sep;128(3):567-73 Remibrutinib Phase 2: Maurer M, et al. J Allergy Clin Immunol. 2022 Dec;150(6):1498-1506 Barzolvolima Phase 2: EAACI2025 Rilzabrutinib Phase
Slide 26: Phase 3 UAS7 data at W4 from competition
Phase 3 UAS7 data at W4 from competition Omalizumab Phase 3 ASTERIA II: Maurer M N Engl J Med. 2013 Omalizumab Phase 3 ASTERIA I: Saini SS,. J Invest Dermatol. 2015. Remibrutinib Phase 3: Metz M et al. N Engl J Med. 2025 Mar 6;392(10):984-994 Dupilumab Phase 3: Maurer M et al J Allergy Clin Immunol.
Slide 27: CSU: UAS7 reduction in severe disease and angioedema sub-populations
27 CSU: INF904 achieves substantial reduction in UAS7 in sub-populations with severe disease and those with angioedema
Slide 28: CSU: UAS7 reduced in patients with low IgE levels at baseline
28 CSU: UAS7 reduced in patients with low IgE levels at baseline * Dotted line represents the placebo average UAS7 CFB at Week 12 of remibrutinib and barzolvolimab Phase 2 data for IgE low patients ( -1.6 and 6.1) Remibrutinib Research Abstract / Ann Allergy Asthma Immunol 129 (2022) S15−S81 Barzovo
Slide 29: CSU: Disease control with improvement in UCT7
All doses achieved more than 4-point improvement in UCT7 score by W4 29 CSU: Disease control with improvement in UCT7
Slide 30: Highlights of INF904 Phase 2a in CSU
Highlights of INF904 Phase 2a in CSU INF904 drives reduction in disease activity (UAS7 reduction) within a range indicative of clinical activity (as observed from Phase 2 & 3 comparators) 60mg dose achieved the highest reduction of UAS7 –13.7 In those with "most severe" CSU (defined as UAS7 of 28 -4
Slide 31: HS Appendix
HS Appendix
Slide 32: HS & CSU: Safety in patients taking at least one dose
HS & CSU: Safety in patients taking at least 1 dose of study drug AE term CTCAEgrade relationship tostudy drug Headache Mild = Grade I Unrelated Nausea Mild = Grade I Unrelated Left Hand Swelling Moderate = Grade II Unrelated Right Middle Finger Swelling Mild = Grade I Unrelated Abdominal Cramping M
Slide 33: Hidradenitis suppurativa and HiSCR
Hidradenitis suppurativa and HiSCR There are 3 inflammatory lesions: inflammatory nodules (N), abscesses (A) and draining tunnels (dT) ANdT = total inflammatory burden (TIB) A and N are present in all disease stages, can fluctuate strongly week to week which can drive placebo responses dT are presen
Slide 34: Baseline AN count impact on HiSCR placebo response rates
extracted from EMA Assessment Report: Humira - No. EMEA/H/C/000481/II/0137 – page 82 Changing the cutoff of baseline AN count to ≥ 11 in the pooled PIONEER data set was reported to result in a reduction of the placebo response rate by absolute 15.2% Comparing baseline means between placebo and treat
Slide 35: INF904 drives draining tunnel (dT) count reductions
INF904 drives draining tunnel (dT) count reductions 35 All n=21
Slide 36: INF904 drives reduction in total inflammatory burden (TIB)
Comparison to average of reported successfully completed povorcitinib Phase 2 data* INF904 drives reduction in total inflammatory burden (TIB)TIB = ANdT count 36 * Data from Povorcitinib Phase 2 trial for week 2, 4, 6, 8, 12, and 16 as reported on Clinicaltrials.gov (NCT04476043). Average of data fr
Slide 37: INF904 drives reductions in IHS4 score
INF904 drives reductions in IHS4 score 37 * Data are derived from different completed Phase 3 clinical trials and averages were created using the data available at each timepoint: Adalimumab PIONEER I & II : week 12 data from tested dose groups and placebo as reported in post hoc analysis by Frew et
Slide 38: INF904 drives DLQI improvements
INF904 drives Dermatology Life Quality Index (DLQI) improvements 38 * Data are derived from different completed Phase 3 clinical trials and averages were created using the data available at each timepoint: Adalimumab PIONEER I & II : week 12 data from tested dose groups and placebo as reported by Ki
Slide 39: CSU Appendix
CSU Appendix
Slide 40: CSU: INF904 achieved UAS7 reduction at W4
CSU: INF904 achieved UAS7 reduction at W4 40
Slide 41: CSU: INF904 reduces UAS7 in anti-IgE naive and experienced patients
41 CSU: INF904 reduces UAS7 in both anti-IgE naïve and experienced patients * 1 anti-IgE experienced patient had history of unexplained urticaria exacerbations from (stress and mental health shifts) which resulted in a dramatic increase in UAS7 at W4 but this was subsequently reduced after end of tr
Slide 42: CSU: INF904 improves angioedema
No episodes: 0 Low: 1 to 6 Moderate: 7 to 18 Severe: 19 to 105 42 CSU: INF904 improves angioedema consistently up to W4
Slide 43: Responders of disease activity (UAS7) and disease control (UCT7) at W4
Responders of disease activity (UAS7) and disease control (UCT7) at W4 43 UAS7 mean absolute CFB W4 responders UAS7 = 0 at W4 UAS7 ≤ 6 at W4 UCT7 ≥ 12 at W4 All n=30 -10.4 7% 11% 29% 60 mg BID n=14 -13.7 0% 8% 31% 120 mg BID n=16 -7.9 13% 13% 25%