Cormedix Inc. · NASDAQ:CRMD
Cormedix — Technical Presentation (October 2026)
16 slides from Cormedix's technical presentation, October 2026
Slide 1: Rezafungin (Once Weekly) versus Standard Antimicrobial Regimen for Antifungal Prophylaxis in Allo-HSCT
Rezafungin (Once Weekly) versus Standard Antimicrobial Regimen (Daily) for Antifungal Prophylaxis in Allogeneic Hematopoietic Stem Cell Transplantation: ReSPECT, a Multicenter, Randomized, Double-Blind, Phase 3 Study (LB-2201.3) Johan Maertens1; Drew Winston2; Shariq Haider3; Francisco Javier López-
Slide 2: Disclosures
Disclosures Shariq Haider reports: • Research / clinical trial funding from AVIR Pharmaceuticals and Cidara Therapeutics • Consulting fees from Merck • Honoraria from AVIR Pharmaceuticals All relevant financial disclosures have been mitigated 2
Slide 3: Background
Background • Antifungal prophylaxis is standard of care for allo-HSCT recipients to prevent life-threatening IFD • Daily azole + TMP/SMX is the cornerstone of current antifungal prophylaxis – Complicated by drug toxicities, DDIs, TDM, antifungal resistance, and challenges of daily oral administratio
Slide 4: ReSPECT overview
ReSPECT overview • ReSPECT is a Phase 3, multicenter, double-blind, double-dummy RCT (NCT 04368559) Aim: evaluate the efficacy and safety of antifungal prophylaxis with once-weekly IV rezafungin vs daily oral SAR (azole + TMP/SMX) in allo-HSCT recipients • Adults undergoing allo-HSCT received once-w
Slide 5: ReSPECT Study Design
ReSPECT Study Design Allo-HSCT Primary Endpoint: Fungal-free survival at Day 90 Follow up Week Rezafungin (n=400) Screening 1 2 3 4 5 12 13 17 Rezafungin QW (IV)a Azole placebo QD (capsule) TMP/SMX placebo QDc Day 1 90 120 Permanent Randomization (2:1) stratified by baseline data: switch of FLZ to •
Slide 6: ReSPECT Study endpoints
ReSPECT Study endpoints Endpointsb Primary endpoint Composite endpoint: 1o Fungal-free survival at Day 90a • Survival, and • No proven or probable IFD Key secondary endpoints (per 2020 modification of 2o • Discontinuation due to toxicity or intolerance at Day 90a EORTC-MSGERC criteria), and • Incide
Slide 7: ReSPECT: Key enrolment criteria
ReSPECT: Key enrolment criteria Key inclusion criteriaa Key exclusion criteriaa • ≥18 years of age • AML not in morphological remission • Scheduled for allo-HSCTb • Chemotherapy-resistant lymphoma • Receiving myeloablative or reduced intensity • Suspected / diagnosed IFD ≤4 weeks of conditioning ran
Slide 8: Baseline characteristics
Baseline characteristics Rezafungin QW SARb QD • FLZ n=172, PCZ n=25a ITT population (N=402) (N=200) • Permanent switch from Age in years, mean (SD) 55.0 (14.1) 54.4 (14.5) FLZ to PCZ permitted for Male, n (%) 259 (64.4) 117 (58.5) significant, acute GvHDd: n=20 Normal renal function (eCrCl ≥90 mL/m
Slide 9: Primary endpoint: FFS (Day 90)
Primary endpoint: FFS (Day 90) Primary endpoint was met: FFS (Day 90) with rezafungin was non-inferior to SAR (ITT population) 1.0 Rezafungin SARa QD QW (N=200) (N=402) 0.9 60.7% 59.0% FFS probability Difference 1.6% (95% CI -6.2, 9.3)b 0.8 Non-inferiority P=0.0002 • Non-inferiority margin for 0.7 r
Slide 10: FFS (Day 90): key drivers
FFS (Day 90): key drivers • Most FFS ‘failures’ at Day 90 were due to use of non-study systemic antifungal drugs for >10 days (cumulative) – Numerically lower with rezafungin 27.4% vs SARa 32.5% • Other FFS failures (rezafungin, SAR) were due to death (4.5%, 5.5%), proven/probable IFD (3.5%, 4.5%),
Slide 11: Safety overview (safety population)
Safety overview (safety population) Rezafungin QW SARa QD Safety population (N=397) (N=197) n (%) TEAE 396 (99.7) 197 (100) Study drug-relatedb TEAE 62 (15.6) 37 (18.8) TEAE leading to study 37 (9.3) 29 (14.7) discontinuation Acute kidney injuryc was the most frequent of these TEAE leading to study
Slide 12: Frequent TEAEs (safety population)
Frequent TEAEsa (safety population) Rezafungin QW SARb QD n (%) (N=397) (N=197) Diarrhea 230 (57.9) 117 (59.4) Pyrexia 188 (47.4) 90 (45.7) Liver enzyme elevations Mucosal inflammation 148 (37.3) 65 (33.0) were comparable across Nausea 137 (34.5) 57 (28.9) treatment groups (no confirmed Hy’s Law Feb
Slide 13: Conclusions
Conclusions ReSPECT supports using rezafungin for antifungal prophylaxis in allo-HSCT recipients • FFS (Day 90) was non-inferior with once-weekly rezafungin (IV) vs daily SAR (oral azole + TMP/SMX) for IFD prophylaxis: 60.7% vs 59.0% (difference 1.6% [95% CI -6.2, 9.3], P=0.0002a) – Incidence of bIF
Slide 14: Acknowledgements
Acknowledgements • The authors thank the patients, study investigators, and study site personnel who participated in ReSPECT • ReSPECT was sponsored by Mundipharma Research Ltd • Statistical analysis was performed by MMS Holdings, Inc., funded by Mundipharma Research Ltd • Medical writing support (S
Slide 15: BACK-UP (to support Q on indeterminant FFS & other sensitivity analyses)
BACK-UP (to support Q on indeterminant FFS & other sensitivity analyses) 15
Slide 16: Pre-planned sensitivity analyses of Day 90 FFS (ITT population)
Pre-planned sensitivity analyses of Day 90 FFS (ITT population) Participants with FFS, Rezafungin QW SARa QD Difference P valueb n (%) N=402 N=200 %, 95% CI ITT population (primary analysis) 244 (60.7) 118 (59.0) 1.6 (-6.2, 9.3) 0.0002 Pre-planned sensitivity analyses Multiple imputation for indeter