PepGen (PEPG) Company Report

PepGen reported significant efficacy in its FREEDOM-DM1 clinical study, achieving 54% splicing improvement at a 15 mg/kg single dose in DM1 patients, exceeding previous benchmarks.
The company has secured financing that extends its cash runway into the second half of 2027, supporting upcoming clinical readouts.
Key upcoming data readouts include 5 mg/kg multiple ascending dose (MAD) data in Q1 next year and 10 mg/kg MAD data in the second half of next year, with expectations for functional benefit translation.
The DM1 program demonstrates a larger therapeutic window and a cleaner safety profile compared to the DMD program, with no kidney-related treatment-emergent adverse events observed at 5 or 10 mg/kg single doses in DM1 patients.

Nov 13, 2025, 9:00 PM

Transcript

PepGen Reports Q3 2025 Financial Results and Clinical Highlights

PEPG

Earnings

Guidance Update

New Projects/Investments

PepGen Inc. reported a net loss of $18.0 million, or $(0.52) basic and diluted net loss per share, for the three months ended September 30, 2025.
As of September 30, 2025, cash, cash equivalents, and marketable securities totaled $163.7 million.
The FREEDOM Phase 1 study for PGN-EDODM1 demonstrated a mean splicing correction of 53.7% following a single 15 mg/kg dose in DM1 patients.
The company anticipates reporting results from the 5 mg/kg cohort of the FREEDOM2 trial in the first quarter of 2026.
A $115 million financing closed in September 2025 has extended the company's cash runway into the second half of 2027.

Nov 12, 2025, 1:02 PM

8-K

PepGen Secures U.S. Patent for PGN-EDODM1 Molecule

PEPG

New Projects/Investments

PepGen Inc. announced the issuance of U.S. Patent No. 12,465,646 for its proprietary PGN-EDODM1 molecule.
This patent is expected to provide exclusivity for PGN-EDODM1 in the United States into the second half of 2042, with the possibility of patent term extension following FDA approval.
PGN-EDODM1 is an investigational candidate designed to address myotonic dystrophy type 1 (DM1), a severe neuromuscular disease for which there are no approved therapies targeting its underlying cause.
The U.S. Food and Drug Administration (FDA) has granted PGN-EDODM1 both Orphan Drug and Fast Track Designations for the treatment of DM1.

Nov 12, 2025, 12:05 PM

Press Release

PepGen Reports Q3 2025 Financial Results and Clinical Trial Progress

PEPG

Earnings

Guidance Update

New Projects/Investments

PepGen reported a net loss of $(18.0) million, or $(0.52) per share, for the three months ended September 30, 2025, compared to a net loss of $(21.4) million, or $(0.66) per share, for the same period in 2024.
As of September 30, 2025, cash, cash equivalents, and marketable securities totaled $163.7 million. A $115 million financing closed in September 2025 is expected to extend the company's cash runway into the second half of 2027.
The FREEDOM-DM1 15 mg/kg cohort demonstrated a mean splicing correction of 53.7%. Results from the FREEDOM2-DM1 5 mg/kg cohort are anticipated in Q1 2026.

Nov 12, 2025, 12:00 PM

Press Release

PepGen Reports Strong DM1 Clinical Data and Outlines 2026 Milestones

PEPG

New Projects/Investments

Guidance Update

PepGen's EDO platform for neuromuscular diseases, specifically DM1, demonstrated 54% splicing improvement at its top 15 mg/kg single dose, more than double previous therapies, with a generally safe and well-tolerated profile.
The company has secured capital to fund operations into the second half of 2027.
Key upcoming milestones include reporting results from the 5 mg/kg multiple ascending dose study in Q1 2026, and data from the 10 mg/kg cohort in the second half of 2026.
PepGen aims to address the DM1 market, which is five times larger than SMA and currently lacks approved therapies, leveraging its EDO platform's 100-fold higher nuclear delivery.

Nov 10, 2025, 4:30 PM

Transcript

PepGen Inc. Furnishes Updated Corporate Presentation

PEPG

New Projects/Investments

Guidance Update

PepGen Inc. furnished an updated Corporate Presentation on October 1, 2025, outlining its EDO platform and clinical development programs.
The presentation highlights that the investigational therapy PGN-EDODM1 for Myotonic Dystrophy Type 1 (DM1) demonstrated a favorable emerging safety profile and achieved a mean splicing correction of 53.7% at the 15 mg/kg dose in the FREEDOM Phase 1 study.
The company projects a cash runway into the second half of 2027.
Key upcoming clinical milestones include the release of FREEDOM2 5 mg/kg clinical results in Q1 2026 and FREEDOM2 10 mg/kg clinical results in H2 2026.

Oct 1, 2025, 8:05 PM

8-K

PepGen Inc. announces pricing of underwritten public offering

PEPG

New Projects/Investments

PepGen Inc. priced an underwritten offering of 31,250,000 shares of common stock at $3.20 per share, with expected gross proceeds of $100 million.
The underwriters fully exercised their option to purchase an additional 4,687,500 shares, increasing the estimated net proceeds to $107.6 million.
The company intends to use the net proceeds to fund ongoing research and clinical development efforts, including the FREEDOM-DM1 and FREEDOM2-DM1 clinical trials, as well as for working capital and other general corporate purposes.
The offering is expected to close on or about September 26, 2025.

Sep 26, 2025, 11:00 AM

8-K

PepGen Announces $100 Million Public Stock Offering

PEPG

New Projects/Investments

PepGen Inc. announced a $100 million underwritten public offering of 31.25 million shares at $3.20 each.
The proceeds from the offering are intended to fund ongoing research and clinical trials, including the FREEDOM-DM1 and FREEDOM2-DM1 projects, as well as for working capital and general corporate purposes.
Following the announcement, PepGen's shares surged by 33.8% in after-hours trading.
The company is a clinical-stage biotechnology firm that currently has no revenue and negative earnings.

Sep 24, 2025, 10:49 PM

Morningstar

PepGen Announces Positive PGN-EDODM1 Clinical Trial Results

PEPG

New Projects/Investments

PepGen Inc. announced positive clinical data from the 15 mg/kg dose cohort of its FREEDOM-DM1 Phase 1 study for myotonic dystrophy type 1 (DM1).
The study demonstrated a mean splicing correction of 53.7% in DM1 patients following a single 15 mg/kg dose of PGN-EDODM1, which is the highest reported to date.
All patients (100%) in the 15 mg/kg cohort showed improved splicing correction, and PGN-EDODM1 was generally well-tolerated with mild or moderate drug-related adverse events.
PepGen anticipates reporting results from the FREEDOM2-DM1 MAD study 5 mg/kg cohort in the first quarter of 2026.