PepGen Inc. Reports $30.2 Million Net Loss in Q1 2025, Increases R&D Spending

PepGen Inc. reported a net loss of $30.2 million for the first quarter of 2025, a significant increase from the $18.0 million loss recorded in the same period of the previous year. The company's total operating expenses rose to $31.3 million, up from $19.8 million in the first quarter of 2024, primarily driven by increased research and development costs associated with its clinical programs. Research and development expenses surged to $25.4 million, compared to $14.7 million in the prior year, reflecting heightened manufacturing costs and clinical trial expenses for its lead product candidates, PGN-EDO51 and PGN-EDODM1.

In terms of financial position, PepGen's total assets decreased to $127.4 million as of March 31, 2025, down from $150.9 million at the end of 2024. The decline was attributed to a reduction in cash and cash equivalents, which fell to $43.6 million from $49.4 million, alongside a decrease in marketable securities. The company's accumulated deficit also widened to $301.7 million, reflecting ongoing operational losses since its inception. As of the end of the first quarter, PepGen had cash, cash equivalents, and marketable securities totaling $97.8 million, which management believes will be sufficient to fund operations for at least the next 12 months.

Strategically, PepGen is advancing its clinical pipeline, focusing on oligonucleotide therapeutics for severe neuromuscular and neurologic diseases. The company is currently conducting two Phase 2 studies for PGN-EDO51, targeting Duchenne muscular dystrophy (DMD), and has initiated a Phase 1 study for PGN-EDODM1, aimed at myotonic dystrophy type 1 (DM1). The company has received orphan drug designation and Fast Track designation from the FDA for both candidates, underscoring their potential significance in addressing unmet medical needs.

Operationally, PepGen's workforce has expanded, contributing to increased personnel-related costs, which rose to $5.9 million in the first quarter of 2025 from $5.1 million in the prior year. The company is also actively managing its clinical trials, with ongoing studies in Canada and the UK, and plans to expand its research efforts into additional neuromuscular and neurologic indications. However, the company faces challenges, including a clinical hold from the FDA on one of its studies, which it is currently addressing.

Looking ahead, PepGen anticipates continued operational losses as it invests in the development of its product candidates. The company plans to finance its operations through equity offerings and other capital sources, while also exploring potential collaborations and licensing agreements. Despite the uncertainties inherent in clinical development, PepGen remains focused on advancing its pipeline and addressing the needs of patients with severe neuromuscular diseases.