PepGen DSMB backs advance of PGN-EDODM1 to top dose in FREEDOM2-DM1

PepGen Inc. said on August 6, 2026 that an independent Data and Safety Monitoring Board had reviewed safety data from the 10 mg/kg multiple ascending dose cohort and the open-label extension (OLE) study of PGN-EDODM1 and recommended advancing the FREEDOM2 trial into the third and highest dose cohort, 12.5 mg/kg.¹ The board also approved dose escalation in the OLE study from 5 mg/kg to 10 mg/kg.¹ Per the company's 8-K, the DSMB's recommendation on the 12.5 mg/kg cohort came with no recommended changes to the study protocol.¹

On the trial itself, the 10 mg/kg cohort of FREEDOM2 is now fully enrolled, and 7 of 8 participants have completed dosing¹, with data from this cohort on track to be reported in November.¹ Looking further out, the 12.5 mg/kg cohort results are anticipated in the first half of 2027.¹ An OLE update is expected by early January, and six of the eight participants from the 5 mg/kg FREEDOM2 cohort have opted into the OLE, bringing total OLE enrollment to 16 participants.¹

On finances, PepGen reported cash, cash equivalents and marketable securities of $117.2 million as of June 30, 2026, which the company said should fund operations into the fourth quarter of 2027.¹ Research and development spending was $12.5 million for the quarter, versus $18.4 million a year earlier.¹ Net loss was $17.8 million, or $(0.26) per share, compared with $23.1 million, or $(0.70) per share, in the same period of 2025, with about 69.3 million shares outstanding as of June 30, 2026.¹