PepGen Inc SEC Filings

PepGen Inc. furnished an updated corporate presentation outlining clinical progress for its investigational DM1 therapy PGN-EDODM1 and its cash runway. The company highlights its EDO delivery platform, which has shown up to a 98-fold increase in nuclear uptake of oligonucleotides in preclinical models and high levels of splicing correction and myotonia improvement with multiple doses. Early clinical data from the single-ascending-dose study show dose-dependent splicing correction, with 83% of patients at 15 mg/kg achieving more than 20% splicing improvement at Day 28 and robust muscle drug concentrations. Initial multiple-ascending-dose data at 5 mg/kg in the FREEDOM2 trial indicate a favorable safety profile, mean splicing correction of 22.9% excluding one outlier, and promising functional trends, supporting ongoing 10 mg/kg and planned 12.5 mg/kg cohorts. The company states it has a strong cash runway into the second half of 2027 through the FREEDOM2 12.5 mg/kg readout.

PepGen Inc. has filed a shelf registration that permits offers of up to $400,000,000 of common stock, preferred stock, debt securities, warrants and units. Separately, PepGen entered into an at-the-market Sales Agreement with Stifel dated to sell up to $100,000,000 of common stock under the prospectus. The Sales Agreement replaces a prior agreement and terminates the prior sales prospectus; $88,474,029.98 remained available under the prior agreement prior to this filing. The prospectus states proceeds are intended for general corporate purposes, including research and development and clinical programs, with timing and specific allocations to be described in future prospectus supplements.

PepGen Inc. ownership update: Viking Global Investors and related entities report beneficial ownership of 3,482,434 shares of Common Stock, equal to 5.03% of the class based on 69,167,958 shares outstanding as of March 31, 2026.

This Amendment No. 1 removes David C. Ott as a Reporting Person effective March 31, 2026, and confirms the filing parties and their shared voting and dispositive powers over the disclosed shares.

PepGen Inc. reporting persons Commodore Capital LP, Commodore Capital Master LP, Robert Egen Atkinson and Michael Kramarz state beneficial ownership of 4,475,000 shares of Common Stock, representing 6.5%, as of March 31, 2026.

Shares outstanding were reported as 69,167,958 Common Stock as of March 31, 2026 in the Issuer's Form 10-Q. The filing is an amendment to a Schedule 13G/A and is signed on May 15, 2026.

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.