PepGen Announces Q3 2024 Financial Results and Corporate Updates

PepGen Inc. (Nasdaq: PEPG), a biotechnology firm in the clinical-stage, has unveiled its financial outcomes and recent corporate activities for the quarter ending September 30, 2024. The company, known for advancing oligonucleotide therapies, aims to revolutionize treatments for severe neuromuscular and neurological diseases.

James McArthur, PhD, President and CEO, highlighted the company’s progress, particularly in their lead clinical programs. The addition of Paul Streck as Head of Research and Clinical Development has been pivotal. Streck has been influential in the development strategy for both myotonic dystrophy type 1 (DM1) and Duchenne muscular dystrophy (DMD). Streck informed that the FREEDOM-DM1 study's 10 mg/kg cohort is fully enrolled, showing promising results in both 5 mg/kg and 10 mg/kg groups. Comprehensive updates for these cohorts are expected by the end of Q1 2025, with further data anticipated throughout 2025 for both DM1 and DMD programs.

McArthur continued, stating that the positive results from the 5 mg/kg cohort of the CONNECT1-EDO51 study for DMD have allowed for optimization of both CONNECT1 and CONNECT2-EDO51 study designs. With protocol enhancements, data from the expanded 10 mg/kg cohort of CONNECT1 are expected by the end of 2025. PepGen's commitment to advancing treatments for severe neuromuscular and neurological diseases remains strong.

In terms of program updates, the PGN-EDODM1 for Myotonic Dystrophy Type 1 continues with the Phase 1 FREEDOM-DM1 Clinical Trial. This study evaluates PGN-EDODM1 in around 32 adults with DM1 across the United States, Canada, and the United Kingdom. Results from the 15 mg/kg cohort are anticipated in the latter half of 2025. The Phase 2 FREEDOM2-DM1 Clinical Trial is set to start dosing by year-end, involving approximately 24 adult patients in Canada, the UK, and potentially the U.S., pending regulatory approval.

For the PGN-EDO51 aimed at treating Duchenne Muscular Dystrophy, the Phase 2 CONNECT1-EDO51 Clinical Trial is progressing with encouraging data from the 5 mg/kg cohort. The study protocol has been amended to improve outcomes, and the 10 mg/kg cohort has been expanded. Results from this cohort are expected by year-end 2025. The Phase 2 CONNECT2-EDO51 Clinical Trial is also being optimized, leveraging the safety profile data from CONNECT1. This trial is open in the UK, with plans to expand to the U.S. and other regions, subject to regulatory clearance.

On the corporate front, PepGen appointed Paul Streck as Executive Vice President and Head of R&D in August, bringing over two decades of experience in drug development and regulatory affairs. The company also showcased its scientific and clinical data at various medical conferences, including the World Muscle Society's Annual Congress.

Financially, PepGen reported $138.9 million in cash, cash equivalents, and marketable securities as of September 30, 2024. This is expected to support planned operations into 2026. Research and Development expenses for the quarter were $17.7 million, a decrease from $20.5 million in the same quarter of 2023. General and Administrative expenses increased to $5.4 million from $4.2 million in the previous year. The net loss for the quarter stood at $21.4 million, down from $23.3 million in the same period last year. As of September 30, 2024, PepGen had approximately 32.6 million shares outstanding.

PGN-EDODM1, PepGen’s investigational therapy for DM1, employs the company's Enhanced Delivery Oligonucleotide (EDO) technology to correct RNA splicing function. DM1 affects approximately 40,000 individuals in the U.S. and over 74,000 in Europe. PGN-EDODM1 has received Orphan Drug and Fast Track Designations from the U.S. FDA.

PGN-EDO51, aimed at DMD treatment, uses EDO technology to deliver a therapeutic phosphorodiamidate morpholino oligomer (PMO) targeting the disease's root cause. It aims to skip exon 51 of the dystrophin transcript, beneficial for about 13% of DMD patients. PGN-EDO51 has been granted Orphan Drug and Rare Pediatric Disease Designations by the U.S. FDA.

PepGen is dedicated to advancing oligonucleotide therapies, leveraging over a decade of research and development to enhance the treatment of severe diseases.