PepGen Q2 2024 Financial Results and Corporate Highlights

PepGen Inc. (Nasdaq: PEPG), a biotechnology company focused on developing advanced oligonucleotide therapies, has recently shared its financial results and corporate developments for the quarter ending June 30, 2024. The company's key focus remains on treating severe neuromuscular and neurological diseases.

The most notable achievement in the period was the July data readout from the CONNECT1 clinical trial for Duchenne muscular dystrophy (DMD). According to James McArthur, Ph.D., President and CEO of PepGen, their investigational therapy PGN-EDO51 produced notable results. It demonstrated higher mean levels of exon-skipped transcripts at lower doses and in a shorter time compared to other exon 51 therapies, both approved and in development. This underscores the efficiency of their Enhanced Delivery Oligonucleotide (EDO) technology, which appears to be effective in delivering higher levels of oligonucleotides to cell nuclei. Importantly, PGN-EDO51 was well tolerated by patients and increased dystrophin production in all participants.

Program Highlights

PGN-EDO51: Duchenne Muscular Dystrophy (DMD)

CONNECT1 Clinical Trial: 
The CONNECT1 trial, a Phase 2, open-label, multiple ascending dose study, evaluated PGN-EDO51 in approximately 10 male patients aged 8 years and above in Canada. At the 5 mg/kg dose level:

- PGN-EDO51 was well tolerated through week 13 with no discontinuations or dose interruptions.
- Achieved a mean exon skipping level of 2.15% in biceps tissue by week 13.
- Produced a mean muscle-adjusted dystrophin level of 1.49% of normal, representing a 0.70% increase from baseline after four doses.
- Achieved a mean absolute dystrophin level of 0.61% of normal by Western blot analysis.

PepGen plans to present additional results from this dose cohort at an upcoming medical meeting and expects initial results from the 10 mg/kg cohort by early 2025.

CONNECT2 Clinical Trial: 
Building on the data from CONNECT1, PepGen is optimizing the design of the CONNECT2 trial, a multinational Phase 2 double-blind, placebo-controlled, 25-week study. The trial is currently open in the United Kingdom, with plans to expand to the European Union and the United States by year-end, pending regulatory approval.

PGN-EDODM1: Myotonic Dystrophy Type 1 (DM1)

FREEDOM-DM1 Clinical Trial:
PepGen expects to report clinical results from the FREEDOM trial in the fourth quarter of 2024. This Phase 1 single ascending dose trial evaluates PGN-EDODM1 in about 24 adult patients in the United States, Canada, and the United Kingdom.

FREEDOM2-DM1 Clinical Trial: 
Health Canada and the UK's Medicines and Healthcare products Regulatory Agency have approved PepGen's applications for the FREEDOM2 trial. This Phase 2 randomized, double-blind, placebo-controlled study will evaluate PGN-EDODM1 in approximately 24 adult DM1 patients, with dosing expected to begin in the second half of 2024.

Financial Highlights

As of June 30, 2024, PepGen had $161.3 million in cash, cash equivalents, and marketable securities, which is expected to fund operations through 2026. Research and development expenses were $25.1 million for the quarter, compared to $16.9 million for the same period in 2023. General and administrative expenses were $5.4 million, up from $4.2 million in the previous year. The net loss was $28.3 million, or $0.87 per share, compared to a net loss of $19.5 million, or $0.82 per share, in the same period in 2023. As of June 30, 2024, PepGen had approximately 32.6 million shares outstanding.

About PepGen

PepGen Inc. is dedicated to developing next-generation oligonucleotide therapies for severe neuromuscular and neurological diseases. Their EDO platform, built on over a decade of research, employs cell-penetrating peptides to enhance the delivery and efficacy of oligonucleotide therapeutics. The company's pipeline aims to address the root causes of these serious conditions, offering hope for transformative treatments.

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