PepGen Extends Cash Runway Into 2028 After FREEDOM2 Data

The Tip Desk · November 10, 2026 · 3 min read

Cash, cash equivalents and marketable securities were $104.8 million as of September 30, 2026, and the company said that balance will fund operations into 2028.

PepGen Inc. (PEPG), a clinical-stage biotechnology company developing oligonucleotide therapies for rare genetic diseases, reported that cash, cash equivalents and marketable securities were $104.8 million as of September 30, 2026, and that the balance is sufficient to fund operations into 2028.

The company had said in August that $117.2 million of cash as of June 30 would fund operations into the fourth quarter of 2027. The later runway statement now extends that horizon.

The quarter’s defining clinical update was topline data from the 10 mg/kg multiple ascending dose cohort of the Phase 2 FREEDOM2-DM1 trial of PGN-EDODM1 in myotonic dystrophy type 1. Mean splicing correction in muscle reached 46.5% at Week 13, which the company said was the highest reported to date in a multiple-dose study. Five of six treated participants showed greater than 20% splicing improvement and four showed greater than 50%. The pooled placebo group from earlier cohorts showed mean splicing correction of 6.8% at Week 13.

Functional measures moved with the splicing signal. Video Hand Opening Time, an objective measure of myotonia, improved 3.9 seconds at Week 16, an approximately 52.7% improvement; placebo improved 0.2 seconds. Hand grip strength improved about 16.2% at Week 16, or 6.3 points in maximum predicted percent normal, versus 0.9 points in placebo. Timed Up and Go improved 8.5%, or 0.6 seconds, and the 10-Meter Walk/Run Test improved 6.8%, or 0.4 seconds. Patient-reported outcomes were inconclusive at Week 16.

PGN-EDODM1 was generally well tolerated at 10 mg/kg, with no serious or severe adverse events, no dose-limiting toxicities and no treatment discontinuations. All treatment-emergent adverse events were mild or moderate; the most common was nausea. Four renal treatment-emergent adverse events were reported, all mild, with transient albuminuria after the first dose that decreased with later doses.

An independent Data and Safety Monitoring Board recommended advancing FREEDOM2 into the third and highest dose cohort, 12.5 mg/kg. That cohort is now fully enrolled, with participants having received up to three doses, and results are expected in the first half of 2027. The DSMB also approved dose escalation in the open-label extension from 5 mg/kg to 10 mg/kg. OLE enrollment rose to 19 participants, with more than 35 doses at 10 mg/kg and 100 doses at 5 mg/kg delivered. Interim 10 mg/kg OLE safety and 5 mg/kg OLE clinical data are expected in January 2027. PepGen said it plans to initiate an expansion cohort running in parallel to Cohort 3 to generate longer-term data of up to 9 months.

The study remains subject to a partial clinical hold in the United States, which the company said was issued in March 2026 citing nonclinical findings in mice. PepGen said it is conducting nonclinical mouse studies and remains engaged with the FDA. Data from FREEDOM2 and FREEDOM-OLE are expected to support an end-of-Phase 2 meeting in the second half of 2027 pending removal of the hold. In October 2026, the FDA selected PGN-EDODM1 for its CMC Development and Readiness Pilot program under the currently open U.S. IND.

Research and development expenses were $14.5 million for the three months ended September 30, 2026, compared with $12.5 million in the three months ended June 30. General and administrative expenses were $5.9 million. Net loss was $19.4 million, or $(0.28) a share, versus $17.8 million, or $(0.26) a share, in the three months ended March 31. Weighted-average shares outstanding were 69.3 million.

The company said it is conducting nonclinical mouse studies and remains actively engaged with the FDA about additional studies designed to respond to the agency’s questions on the partial clinical hold.