PepGen Inc., a clinical-stage biotechnology company, reported a net loss of $89.7 million for the year ended December 31, 2025, compared to a net loss of $90.0 million for the previous year. The company's operating expenses totaled $93.6 million in 2025, a decrease from $97.7 million in 2024. Research and development expenses accounted for $71.0 million of the total operating expenses, while general and administrative expenses amounted to $22.6 million. The decrease in research and development expenses was primarily due to a $4.5 million decrease in preclinical costs as the two lead programs had both advanced into clinical trials, prior to the discontinuation of the DMD program in late May 2025.
The company's financial position included cash, cash equivalents, and marketable securities of $148.5 million as of December 31, 2025. Net cash used in operating activities was $81.6 million for 2025. Investing activities resulted in a net cash outflow of $15.2 million, primarily due to purchases of marketable securities. Financing activities provided $108.0 million in net cash, mainly from the 2025 Offering. The company believes its current financial resources will be sufficient to fund operations into the second half of 2027.
PepGen is primarily focused on advancing its lead product candidate, PGN-EDODM1, for the treatment of myotonic dystrophy type 1 (DM1). The company has initiated a Phase 2 clinical trial, FREEDOM2, in Canada and the U.K. and has concluded enrollment of the 5 mg/kg dose cohort. The company expects to report data from this cohort at the end of the first quarter of 2026. The study is currently dosing the 10 mg/kg dose cohort and the company expects to report data from this cohort in the second half of 2026. The FDA has placed a partial clinical hold on the FREEDOM2 study related to questions raised regarding previously submitted preclinical pharmacology and toxicology studies. The company is submitting additional analyses and is committed to working with the FDA to address these questions.
As a result of the company's early stage of development, it relies on third parties for manufacturing, research, and preclinical and clinical testing. The company also faces competition from other companies developing treatments for DM1, including Avidity Biosciences, Dyne Therapeutics, Entrada Therapeutics, and Sarepta Therapeutics. PepGen intends to continue to build and develop its Enhanced Delivery Oligonucleotide (EDO) platform and may opportunistically enter into strategic collaborations. The company's strategy includes advancing PGN-EDODM1 through clinical trials and potential regulatory approval, utilizing the modular nature of its EDO platform, and selectively exploring strategic collaborations to maximize the value of its EDO platform.
About PepGen Inc.
PepGen Inc. is a biotechnology company developing oligonucleotide therapeutics using its proprietary Enhanced Delivery Oligonucleotide (EDO) platform. Focused on neuromuscular and neurological diseases like Duchenne muscular dystrophy and myotonic dystrophy, it leverages cell-penetrating peptides to improve tissue delivery and efficacy. Its pipeline includes clinical-stage exon-skipping and splicing correction programs, aiming to address genetic root causes with enhanced safety, potency, and scalability.
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