PepGen — Third Quarter 2026 Earnings Summary

Financial Performance:

• Cash, cash equivalents, and marketable securities totaled $104.8 million as of September 30, 2026, down from $148.5 million as of December 31, 2025.
• Research and development expenses were $14.5 million for the three months ended September 30, 2026, compared to $13.4 million in the same period of 2025.
• General and administrative expenses were $5.9 million for the three months ended September 30, 2026, compared to $5.2 million in the same period of 2025.
• Net loss was $19.4 million ($0.28 per share) for the three months ended September 30, 2026, compared to $18.0 million ($0.52 per share) in the same period of 2025.
• Total operating expenses were $20.4 million for the three months ended September 30, 2026, compared to $18.7 million in the same period of 2025.
• Interest income was $1.0 million for the three months ended September 30, 2026, compared to $0.6 million in the same period of 2025.
• Weighted-average common stock outstanding was 69.3 million for the three months ended September 30, 2026, compared to 34.4 million in the same period of 2025.

Guidance and Future Outlook:

• The company expects to fund operations into 2028 based on current cash positions and planned operations.
• Results for the fully enrolled 12.5 mg/kg FREEDOM2-DM1 cohort are expected in the first half of 2027.
• Interim 10 mg/kg FREEDOM-OLE safety and 5 mg/kg FREEDOM-OLE clinical data are expected in January 2027.
• An end-of-Phase 2 (EOP2) meeting is expected in the second half of 2027, pending the removal of the partial clinical hold.
• PepGen plans to initiate an expansion cohort running in parallel to Cohort 3 to generate longer-term data (up to 9 months).

Business Segments and Product Lines:

• PGN-EDODM1 is the company's sole clinical candidate, an investigational Enhanced Delivery Oligonucleotide (EDO) for myotonic dystrophy type 1 (DM1).
• The 10 mg/kg cohort of the Phase 2 FREEDOM2-DM1 trial demonstrated a mean splicing correction of 46.5%, the highest reported to date in a multiple dose study.
• In the 10 mg/kg FREEDOM2 cohort, five of six participants demonstrated greater than 20% splicing improvement, and four participants had greater than 50% splicing improvement at Week 13.
• The 10 mg/kg cohort showed improvements in functional measures including video Hand Opening Time (vHOT), hand grip strength, 10-Meter Walk/Run Test (10MWRT), and Timed Up and Go (TUG).
• The 12.5 mg/kg FREEDOM2-DM1 cohort is fully enrolled with participants having received up to three doses.
• The FREEDOM-OLE study has delivered over 35 doses at 10 mg/kg and 100 doses at 5 mg/kg, with 19 participants currently enrolled.
• The Data and Safety Monitoring Board (DSMB) recommended advancing the FREEDOM2 trial to the third and highest dose cohort (12.5 mg/kg) and approved dose escalation in the OLE from 5 mg/kg to 10 mg/kg.
• PGN-EDODM1 has received Orphan Drug and Fast Track designations from the U.S. FDA and Orphan Designation from the European Medicines Agency.
• In October 2026, the FDA selected PGN-EDODM1 for its CMC Development and Readiness Pilot (CDRP) program.

Market and Competitive Landscape:

• DM1 is estimated to affect more than 110,000 people across the United States and the European Union.
• No approved therapies currently address the underlying cause of DM1.
• The FREEDOM2-DM1 study is conducted in Canada, the United Kingdom, New Zealand, Australia, and South Korea.

Risks and Challenges:

• The FREEDOM2 study is subject to a partial clinical hold in the United States issued in March 2026 citing nonclinical findings in mice.
• The company is conducting additional nonclinical mouse studies to respond to FDA questions regarding the partial clinical hold.
• Forward-looking statements highlight risks related to delays or failure to complete development activities, patient enrollment challenges, incorrect interpretation of results, and potential safety or efficacy failures.
• Risks include adverse regulatory outcomes, such as delays in review or clearance to proceed, and the potential for the partial clinical hold to remain unresolved.
• The company faces risks related to unexpected increases in development expenses and dependence on third parties for manufacturing and testing.

Management Commentary and Tone:

• James McArthur, Ph.D., President and CEO, stated the team's focused execution made the positive 10 mg/kg cohort results possible.
• Management expressed strong confidence in PGN-EDODM1's potential to deliver meaningful benefit to the DM1 community.
• Management noted the company ended the quarter in a strong position to advance the program to the third and highest dose cohort.

Other Key Points:

• The FREEDOM2-DM1 trial is a multinational, randomized, double-blind, placebo-controlled Phase 2 multiple ascending dose study evaluating PGN-EDODM1 in people living with DM1.
• Participants in the FREEDOM2 study receive four intravenous doses every four weeks over 12 weeks.
• The 10 mg/kg dose cohort in FREEDOM2 was generally well tolerated with no treatment discontinuations, no serious or severe adverse events (SAE), and no dose-limiting toxicities (DLT) reported.
• In the FREEDOM-OLE study, there have been no SAEs or DLTs, with one discontinuation occurring due to a hypersensitivity reaction.
• PepGen presented PGN-EDODM1 data at the 27th Annual Neuromuscular Study Group Scientific Meeting and the 31st Annual Congress of the World Muscle Society in September 2026.
• The company has approximately 69.3 million shares outstanding as of September 30, 2026.