PEPG · PepGen Inc.

PepGen Inc. announced first quarter 2026 financial results and key clinical progress in the FREEDOM2 Phase 2 trial for PGN-EDODM1 in myotonic dystrophy type 1 (DM1). The 5 mg/kg multiple ascending dose (MAD) cohort delivered promising topline results, including favorable safety and tolerability, alongside positive splicing and vHOT efficacy data. CEO James McArthur highlighted the encouraging trends reinforcing confidence in higher doses. The 10 mg/kg cohort is now fully enrolled, with data anticipated in the second half of 2026, and the 12.5 mg/kg cohort readout expected in 2027. Enrollment continues in the open-label extension with 13 patients at 5 mg/kg and no discontinuations. Sites are active in multiple countries, with recent regulatory clearance in South Korea, Australia, and New Zealand. An FDA partial clinical hold relates to prior preclinical studies but has not delayed the ongoing study, and PepGen is addressing FDA questions promptly.

Financially, the net loss narrowed to $17.8 million or $(0.26) per share from $30.2 million or $(0.92) per share in Q1 2025, driven by a 49% reduction in R&D expenses to $13.0 million, reflecting optimized spending amid clinical advancement. G&A expenses remained steady at $5.9 million. Cash, cash equivalents, and marketable securities stood at $132.3 million as of March 31, 2026, down from $148.5 million at year-end 2025 but sufficient to fund operations through the FREEDOM2 12.5 mg/kg readout and into the second half of 2027. With approximately 69.2 million shares outstanding, the company maintains a solid financial position to execute on its DM1 program, which has Orphan Drug and Fast Track designations from the FDA.