PepGen Inc. filings document the regulatory record of a clinical-stage biotechnology company developing Enhanced Delivery Oligonucleotide therapies for neuromuscular and neurological diseases. Its Form 8-K disclosures cover financial results, corporate presentations, clinical data updates for PGN-EDODM1, FDA-related regulatory matters involving FREEDOM2-DM1, and other business updates tied to its development pipeline.
The company’s proxy materials describe annual meeting matters, director elections, auditor ratification, board structure, executive compensation and stockholder voting mechanics. Other filings address officer appointments, inducement grants, stock-option plans, option repricing, common-stock compensation arrangements and related governance approvals. Together, the filings outline PepGen’s clinical-development disclosures, capital and equity incentive structure, risk-facing regulatory events and public-company governance practices.
PepGen Inc. reported first quarter 2026 results and development updates for its PGN-EDODM1 program in myotonic dystrophy type 1. The 5 mg/kg cohort of the FREEDOM2-DM1 multiple ascending dose trial showed favorable safety and promising biomarker data, and the 10 mg/kg cohort is fully enrolled with results expected in the second half of 2026.
The company held $132.3 million in cash, cash equivalents and marketable securities as of March 31, 2026, which it believes will fund operations into the second half of 2027. For the quarter, research and development expenses were $13.0 million and general and administrative expenses were $5.9 million, leading to a net loss of $17.8 million, or $(0.26) per share, compared with a net loss of $30.2 million in the prior-year period.
The U.S. FDA placed a partial clinical hold on the FREEDOM2 study related to preclinical pharmacology and toxicology questions; PepGen states the trial’s timing has not been impacted and it is working with the agency to address these questions.
PepGen Inc. reported another quarterly loss as it advances its neuromuscular disease pipeline. For the three months ended March 31, 2026, net loss was $17.8 million, improving from $30.2 million a year earlier, as research and development spending declined.
Research and development expense fell to $13.0 million from $25.4 million, mainly due to lower manufacturing and personnel costs following discontinuation of its DMD program, while general and administrative expense was flat at $5.9 million. Interest income of $1.3 million partially offset operating losses.
The company ended the quarter with $132.3 million in cash, cash equivalents and marketable securities and an accumulated deficit of $378.9 million. Management believes this liquidity will fund currently planned operations into the second half of 2027 while it continues Phase 2 development of lead candidate PGN-EDODM1 for DM1.
PepGen Inc. is holding its 2026 annual stockholders meeting virtually on June 18, 2026 at 12:00 p.m. Eastern via webcast at www.proxydocs.com/PEPG. Stockholders of record as of April 21, 2026, when 69,169,215 common shares were outstanding, may vote.
Investors are being asked to elect three Class I directors, each to serve until the 2029 annual meeting, and to ratify KPMG LLP as independent registered public accounting firm for the year ending December 31, 2026. The board recommends voting in favor of all nominees and the KPMG ratification.
PepGen Inc. reported topline results from the 5 mg/kg multiple-ascending-dose cohort of its Phase 2 FREEDOM2-DM1 trial of PGN-EDODM1 in myotonic dystrophy type 1. PGN-EDODM1 was generally well-tolerated, with all treatment-emergent adverse events mild or moderate, no serious adverse events and no kidney-related events or cumulative toxicity.
Patients treated at 5 mg/kg showed a mean splicing correction of 7.3% versus 6.8% on placebo; excluding one outlier, mean splicing correction reached 22.9%. Middle-finger vHOT results showed promising trends at this lowest dose, though no meaningful benefit appeared in 10-meter walk/run or handgrip strength. Mean muscle tissue concentration was 158 ng/g one week after the fourth dose.
The 10 mg/kg cohort in FREEDOM2 is more than halfway enrolled, with data expected in the second half of 2026. PepGen has 12 patients in the 5 mg/kg open-label extension and expects its cash runway to extend into the second half of 2027. PGN-EDODM1 holds Orphan Drug and Fast Track designations in the U.S. and Orphan designation in Europe.
PepGen Inc. ownership disclosure: Commodore Capital LP and related filers report beneficial ownership of 3,544,101 shares of common stock, representing 5.1% of the class. The filing is a Schedule 13G reporting holdings as of 03/04/2026, based on 69,115,292 shares outstanding as of February 26, 2026.
The report states the Firm is investment manager to Commodore Capital Master LP and that Michael Kramarz and Robert Egen Atkinson exercise investment discretion for the aggregated position.
PepGen Inc. executive Paul Streck, EVP and Head of R&D, had 1,879 shares of common stock sold on March 4, 2026 at prices between $6.23 and $6.29. The footnote explains these shares were automatically sold by the company under a mandatory sell-to-cover provision to satisfy minimum tax withholding due on vested restricted stock units, and the sale is described as non-discretionary under a Rule 10b5-1 "binding contract". After these transactions, Streck directly holds 76,226 common shares.
PepGen Inc. Chief Financial Officer Noel Donnelly had a total of 2,084 shares of common stock automatically sold on March 4, 2026 in open-market transactions at prices of $6.23 and $6.325 per share. According to the disclosure, these mandatory sell-to-cover trades were executed by the company to satisfy minimum statutory tax withholding due upon vesting and settlement of restricted stock units under a pre-existing Rule 10b5-1 compliant agreement, rather than as discretionary sales by the executive. Following these transactions, Donnelly directly holds 111,603 shares of PepGen common stock.
PepGen Inc. president and CEO James G. McArthur reported automatic sales of common stock tied to restricted stock units. On the transactions date, a total of 5,275 shares were sold at prices of $6.23 and $6.325 per share to cover minimum statutory tax withholding obligations, and he held 296,326 shares afterward. The filing states these sales were made under a mandatory sell-to-cover provision and did not represent discretionary trades.
PepGen Inc. updated its corporate presentation to spotlight PGN-EDODM1, an investigational therapy for myotonic dystrophy type 1 (DM1) built on its EDO oligonucleotide delivery platform. The company reports dose-dependent, single-dose splicing correction in a Phase 1 study, with mean improvements of 12.3% at 5 mg/kg, 29.1% at 10 mg/kg, and 53.7% at 15 mg/kg, alongside generally well-tolerated safety with mainly mild to moderate adverse events. A multinational Phase 2 multiple-ascending-dose FREEDOM2-DM1 trial is under way, though a partial clinical hold has recently been placed by the U.S. FDA. PepGen highlights upcoming clinical readouts in Q1 2026 for the 5 mg/kg cohort and in the second half of 2026 for the 10 mg/kg cohort, and states it has cash runway into the second half of 2027.
PepGen Inc. updated its corporate presentation to spotlight PGN-EDODM1, an investigational therapy for myotonic dystrophy type 1 (DM1) built on its EDO oligonucleotide delivery platform. The company reports dose-dependent, single-dose splicing correction in a Phase 1 study, with mean improvements of 12.3% at 5 mg/kg, 29.1% at 10 mg/kg, and 53.7% at 15 mg/kg, alongside generally well-tolerated safety with mainly mild to moderate adverse events. A multinational Phase 2 multiple-ascending-dose FREEDOM2-DM1 trial is under way, though a partial clinical hold has recently been placed by the U.S. FDA. PepGen highlights upcoming clinical readouts in Q1 2026 for the 5 mg/kg cohort and in the second half of 2026 for the 10 mg/kg cohort, and states it has cash runway into the second half of 2027.