Announcement • Apr 30
PepGen Inc., Annual General Meeting, Jun 18, 2026 PepGen Inc., Annual General Meeting, Jun 18, 2026. New Risk • Mar 31
New major risk - Share price stability The company's share price has been highly volatile over the past 3 months. It is more volatile than 90% of American stocks, typically moving 23% a week. This is considered a major risk. Share price volatility increases the risk of potential losses in the short-term as the stock tends to have larger drops in price more frequently than other stocks. It may also indicate the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (23% average weekly change). Shareholders have been substantially diluted in the past year (111% increase in shares outstanding). Revenue is less than US$1m. Minor Risk Currently unprofitable and not forecast to become profitable over next 3 years (US$96m net loss in 3 years). Announcement • Mar 06
PepGen Inc Announces Regulatory Updates On Freedom2 Trial PepGen Inc. announced regulatory updates related to the FREEDOM2 trial. The U.S. Food and Drug Administration (FDA) has placed a partial clinical hold on the FREEDOM2-DM1 Phase 2 multiple ascending dose (MAD), randomized, placebo-controlled clinical trial of PGN-EDODM1 in patients with myotonic dystrophy type 1 (DM1). The partial clinical hold questions raised by FDA relate to previously submitted preclinical pharmacology and toxicology studies. The partial clinical hold did not cite any questions regarding blinded clinical data from the Phase 1 FREEDOM study previously submitted to the FDA in order to initiate the FREEDOM2 study in the U.S. As part of its ongoing dialogue with the FDA, the Company is submitting additional analyses, including the recently unblinded FREEDOM data. PepGen was recently cleared to open the FREEDOM2 study in New Zealand, Australia, and South Korea. Following the Data Safety Monitoring Board’s recommendation to dose escalate, the FREEDOM2 trial is dosing patients at 10 mg/kg in Canada and the UK. No U.S. patients have been enrolled in FREEDOM2. Patients from the FREEDOM and FREEDOM2 studies in Canada are continuing into the Open Label Extension (OLE) study. The Company has received regulatory clearance for the OLE study in the UK and intends to open the OLE study in all geographies where FREEDOM2 is open. The Company expects to report data from the 5 mg/kg cohort of FREEDOM2 in the first quarter of 2026, and from the 10 mg/kg cohort in the second half of 2026. PGN-EDODM1, PepGen's investigational candidate in development for the treatment of DM1, utilizes the Company's proprietary EDO technology to deliver a therapeutic oligonucleotide that is designed to restore the normal splicing function of MBNL1, a key RNA splicing protein. PGN-EDODM1 addresses the deleterious effects of cytosine-uracil-guanine (CUG) repeat expansion in the dystrophia myotonica protein kinase (DMPK) transcripts which sequester MBNL1, by binding to the pathogenic CUG trinucleotide repeat expansion present in the DMPK transcripts, and disrupting the binding between the CUG repeat expansion and MBNL1. The U.S. Food and Drug Administration has granted PGN-EDODM1 both Orphan Drug and Fast Track Designations for the treatment of patients with DM1. The European Medicines Agency (EMA) has recently granted Orphan Designation for PGN-EDODM1.