Completed Oversubscribed Financing
Closed an oversubscribed public offering in April with $225.0M gross proceeds; pro forma cash of ~$535.0M as of April 30 (up from $332.0M at March 31, a ~61% increase), providing runway through the pro forma Phase III MASH 52-week data readout expected in 2029.
Advance to Late-Stage Development — PERFORMA Phase III
Finalized Phase III (PERFORMA) protocol for MASH, submitted to FDA and aligned with EMA; CRO partner engaged and global start-up activities underway with study initiation planned for H2 2026.
Regulatory Recognition — Breakthrough Therapy Designation
Pemvidutide received FDA Breakthrough Therapy Designation in MASH, underscoring regulatory recognition of potential clinical benefit.
Strong Phase II Efficacy and Tolerability Signals
Phase II IMPACT showed strong efficacy at 24 and 48 weeks, particularly at 1.8 mg; low discontinuation rates (fewer AE-related discontinuations in pemvidutide arms versus placebo) and improved adherence reported; 2.4 mg to be introduced in Phase III based on additional weight-loss signal.
Scientific Validation at EASL
48-week Phase II IMPACT results selected as an oral 'Best of EASL' presentation; additional posters planned (cardiovascular risk factors, weight loss, NIT, Q-fibrosis), increasing scientific visibility and KOL engagement ahead of Phase III.
Multiple Near-Term Clinical Milestones
Topline data from the Phase II RECLAIM trial in Alcohol Use Disorder expected next quarter (Q3 2026 referenced as 'next quarter' in call); RESTORE (ALD) enrollment expected to complete in Q3 2026.
Focused Clinical & Operational Execution
Company has strengthened executive team and prioritizes execution for Phase III start-up, global site activation, clinical supply chain readiness and CRO collaboration.
Detailed R&D Spending on Pemvidutide
Q1 2026 R&D expense of $16.2M included $9.5M of direct pemvidutide development costs (MASH $3.7M; AUD/ALD $4.2M; CMC $1.6M), indicating continued investment in core programs.