Cervomed Inc. · NASDAQ:CRVO
Cervomed — AD/PD 2026
18 slides from Cervomed's conference presentation, March 2026
Slide 1: Neflamapimod Treatment Effects in Patients with DLB without Concomitant AD Pathology
Neflamapimod Treatment Effects in Patients with Dementia with Lewy Bodies without Concomitant AD Pathology in the RewinD-LB Clinical Study (NCT05869669) John-Paul Taylor1, Stephen N Gomperts2, Lawrence S Honig3, Niels D Prins4, Amanda Gardner5, Kelly Blackburn5, John Alam5, James E Galvin6 1Newcastl
Slide 2: Disclosures
Disclosures • Neflamapimod is an investigational drug • J. Alam, A. Gardner, and K. Blackburn are employees of CervoMed Inc, the company developing neflamapimod • S.N. Gomperts and J-P Taylor each have acted as a consultant for CervoMed Inc. • The other co-authors have no disclosures to declare 2
Slide 3: Neflamapimod is an oral, small molecule drug that selectively inhibits p38α
Neflamapimod is an oral, small molecule drug that selectively inhibits p38α, a key synaptic dysfunction in the basal forebrain cholinergic system Clinical proof-of-concept achieved in DLB* Safety profile well defined 4 • Positive Phase 2a and 2b results Target engagement demonstrated in 3 • Phase 3
Slide 4: Today's objectives
Today’s objectives 1. To review the primary analyses of the RewinD-LB study 2. Present new secondary analyses that inform on an optimal plasma pTau181 cutoff point to enrich for DLB patients without AD co-pathology 4
Slide 5: RewinD-LB Phase 2b study in DLB: A two-part study design
RewinD-LB Phase 2b study in DLB: A two-part study design PATIENTS • 159 patients with dementia with Lewy bodies by consensus clinical criteria Part A Part B • CDR global score of 0.5 or 1.0 at baseline PLACEBO-CONTROLLED NEFLAMAPIMOD-ONLY EXTENSION PHASE1 • Baseline plasma PHASE OF STUDY (32 weeks)
Slide 6: DP Batch A failed to achieve target plasma drug concentrations; DP Batch B achieved 5.0 ng/mL target
DP Batch A failed to achieve target plasma drug concentrations, effectively underdosing participants; in contrast, DP Batch B achieved 5.0 ng/mL target DP Batch A DP Batch B Use in Randomized Phase (Part A) and Extension Phase (Part B) only RewinD-LB Extension Phase (Part B) Target for Date of Octob
Slide 7: Pre-planned introduction of DP Batch B enabled robust Extension Phase analyses
Pre-planned introduction of DP Batch B, which achieved target plasma drug concentrations enabled a robust Extension Phase analyses NEFLAMAPIMOD ONLY EXTENSION PHASE (32 Number of Participants weeks) at Start of Extension N=12 Treatment in Extension Phase was N=33 open-label; capsule batch identity (
Slide 8: No significant differences between placebo and neflamapimod (DP Batch A) during Randomized Phase
No significant differences between placebo and neflamapimod (DP Batch A) in mean change in CDR-SB or ADCS-CGIC during Randomized Phase Randomized Phase (16 Weeks), Randomized Phase (Week 8), Mean Change in CDR-SB Mean ADCS-CGIC Score Placebo NFMD (DP Batch A) Placebo DP Batch A 4.8 1.4 Mean (SE) Cha
Slide 9: Significant improvement on CDR-SB and ADCS-CGIC in Extension Phase with DP Batch B
Significant improvement demonstrated on mean change in CDR-SB and ADCS-CGIC, during first 16 weeks of the Extension Phase with DP Batch B Extension Phase (Week 8 and Extension Phase (Week 8), Week 16), Mean Change in CDR-SB Mean ADCS-CGIC Score DP Batch A Batch-B Mean (SE) Change in CDR-SB p=0.007DP
Slide 10: Summary of other key results from the Phase 2b RewinD-LB study
Summary of other key results from the Phase 2b RewinD-LB study (full results presented at CTAD 2025) • The effects on CDR-SB were durable out 32 weeks of treatment as assessed by both mean change in CDR-SB or risk of significant progression (≥ 1.5-point increase in CDR-SB) • Neflamapimod significant
Slide 11: AD co-pathology determines severity of disease and response to basal forebrain-directed treatment
AD co-pathology determines severity of disease and whether targeting the basal forebrain cholinergic system can slow clinical progression in DLB DLB Without AD Co-Pathology = Low Levels DLB With AD Co-Pathology = Elevated Levels of Plasma pTau181 of Plasma pTau181 + = + = VS Basal Forebrain Medial R
Slide 12: Lowering plasma pTau181 cut-off progressively enriches for patients without AD co-pathology
Lowering plasma pTau181 cut-off progressively enriches for patients without AD co-pathology Participants in Estimated % of Participants Without AD Co-Pathology by Plasma pTau181 Cut-off Stricter cut-off → purer DLB population Efficacy Analysis (N) 50% 60% 70% 80% 90% 100% < 27.2 pg/mL Placebo=79 60–
Slide 13: Primary outcome results in patients treated with DP Batch A by plasma pTau181 cutoff
Primary outcome results in patients treated with DP Batch A during Randomized Phase by plasma pTau181 cutoff Neflamapimod (DP Batch A) Effect on Change in CDR- Change in CDR-SB During Placebo Controlled Phase by SB by Plasma pTau181 Cutoff Trough Plasma Drug Concentration in <21 pTau181 Subset 0.4 1
Slide 14: Within subject analysis by pTau181 subset of mean change in CDR-SB
Within subject analysis by pTau181 subset of mean change in CDR-SB in participants who received placebo and then DP Batch B during Extension Phase1 1.9 CDR-SB over 16 Weeks Placebo DP Batch B Mean (SE) Change in 1.4 0.9 0.95 0.90 0.77 0.61 0.4 0.53 0.21 0.19 -0.1 -0.17 -0.6 <27.2 <25.2 <23 <21 <27.2
Slide 15: Risk of clinically meaningful progression by pTau181 subset
Risk of clinically meaningful progression (≥ 1.5-point increase in CDR-SB) by pTau181 subset Hazard Ratio DP Batch B vs. DP Batch A Participants with Screening Plasma pTau181 < 21 pg/mL DP Batch B DP Batch A Placebo <27.2 <25.2 <23 <21 Hazard Ratio DP Batch B vs. Placebo Pp=0.00013 favoring DP Batch
Slide 16: Reached alignment with the FDA on registration path for DLB
Reached alignment with the FDA on registration path for potential approval in dementia with Lewy bodies Planned Phase 3 Placebo-Controlled Study of Neflamapimod in Patients with DLB KEY PARAMETERS (32 weeks) • DLB by consensus criteria, enriched for patients without AD co- RANDOMIZATION pathology (p
Slide 17: Summary and conclusions
Summary and conclusions Findings From Randomized Phase Consistent with Inadequate Drug Exposure In contrast, analysis by plasma pTau181 subset and plasma trough drug concentrations demonstrate clinical effect in patients with pure DLB who reach target drug concentrations in Randomized Phase Patient
Slide 18: Acknowledgements
Acknowledgements • Patients, caregivers, study investigators, and clinical site staff involved with the RewinD-LB study • Clinical project teams at Worldwide Clinical Trials and CervoMed, Inc. • Members of the Data Safety Monitoring Board (DSMB) for the RewinD-LB study: Kenneth Rockwood MD, FRCPC, F