Key Highlights

  • Net loss for the third quarter was USD 19.4 million, or USD 0.28 per share, compared with USD 18.0 million, or USD 0.52 per share, a year earlier on roughly double the weighted share count.
  • Research and development expense rose to USD 14.5 million from USD 13.4 million, including a USD 2.2 million increase in preclinical research, while general and administrative expense reached USD 5.9 million.
  • Cash, cash equivalents and marketable securities were USD 104.8 million at September 30, 2026, which management believes funds currently planned operations into 2028.
  • The 10 mg/kg cohort of the FREEDOM2 trial showed mean splicing correction of 46.5% at week 13 versus 6.8% for pooled placebo, though the study remains on partial clinical hold in the United States.

Quarterly Loss Edges Up as Preclinical Work Picks Up

PepGen (NASDAQ:PEPG) filed its Quarterly Report on November 10, 2026 for the period ended September 30, 2026. The company has no revenue, so the loss tracks spending. Research and Development expense rose USD 1.1 million, with a USD 2.2 million rise in preclinical research and USD 0.3 million more clinical trial expense offset by USD 2.0 million lower Manufacturing costs from the timing of campaigns. Interest income was USD 1.0 million. For nine months, net loss fell to USD 55.0 million, or USD 0.79 per share, from USD 71.3 million, or USD 2.14.

FREEDOM2 Data and the Partial Hold Question

The clinical-stage company is developing oligonucleotide therapies using cell-penetrating peptides, led by PGN-EDODM1 for myotonic dystrophy type 1. At the 10 mg/kg dose, the filing says the drug was generally well tolerated with no serious adverse events, and video hand opening time improved 4.3 seconds at week 13 versus 0.2 seconds for placebo at week 16. Patient-reported outcomes were inconclusive. In the open-label extension, 19 participants have enrolled with no serious adverse events or dose-limiting toxicities reported. FREEDOM2 remains on partial clinical hold in the United States while the company runs additional mouse studies to answer FDA feedback. No date for lifting the hold was given, though the company expects 12.5 mg/kg cohort results in the first half of 2027.

Runway Into 2028 and What Could Strain It

Net cash used in Operating Activities fell to USD 47.4 million for nine months from USD 65.8 million. The company announced in May 2025 that it would cease research in Duchenne muscular dystrophy. The accumulated Deficit is USD 416.1 million. Management expects cash to last into 2028 and an end-of-Phase 2 meeting with the FDA in the second half of 2027, pending removal of the hold. The company sold 237,500 shares under its at-the-market program in 2026 for USD 1.5 million. A prolonged hold, a weak 12.5 mg/kg readout or a need for new Equity could change that path.

Where Things Stand

Not on a known date, since the filing gives no timeline for lifting the hold. PepGen (NASDAQ:PEPG) has data showing 46.5% mean splicing correction at 10 mg/kg and a favorable tolerability profile so far, and USD 104.8 million of cash through 2028. Offsetting that, patient-reported outcomes were inconclusive, the hold persists in the United States and the company has no revenue. Next markers are the 12.5 mg/kg FREEDOM2 results in the first half of 2027, progress with FDA on the mouse studies and the planned end-of-Phase 2 meeting.