CervoMed (CRVO) investor relations material

Key scientific and clinical progress

• Achieved significant milestones in clinical, regulatory, and financing areas in the first half of the year, including a phase III-ready drug for dementia with Lewy bodies (DLB) and progress in frontotemporal dementia.

• Recent scientific advances highlight neuroinflammation and interleukin-1 beta/6 signaling as central to DLB pathology, aligning with the drug's mechanism.

• Presented new data showing potent inhibition of interleukin-1 beta and reduction of interleukin-6 in spinal fluid, supporting targeted therapy claims.

• Phase IIb trial results show clinically meaningful improvements in DLB patients, with higher drug concentrations yielding greater effects.

• MRI sub-study demonstrated stabilization or increase in basal forebrain volume with treatment, a unique and compelling finding.

Regulatory and partnership developments

• Submitted new placebo-controlled data to regulators, contributing to receiving the U.K. Innovation Passport (ILAP) designation.

• Ongoing discussions with potential partners, with flexibility on deal structure and timing to maximize value.

• ILAP designation seen as a strong indicator of transformative potential and commercial opportunity, with U.K. regulators and academic community leading in DLB.

• FDA and U.K. regulators aligned on trial design and endpoints, but U.K. process emphasizes access and broader value proposition.

Pipeline expansion and upcoming milestones

• Over-enrolled first targeted trial in non-fluent variant primary progressive aphasia (PPA), with initial biomarker data encouraging and further results to be presented at major conferences in October and November.

• Neurofilament light chain is the key biomarker in PPA, with 12- and 24-week data expected to be substantive catalysts.

• Product included in U.K.-funded EXPERTS-ALS trial for amyotrophic lateral sclerosis, with optimal dosing selected and study start planned by year-end.

• Mechanism validated across all major genetic subtypes of ALS and offers rationale for efficacy in sporadic ALS.