PepGen (NASDAQ:PEPG) Issues Quarterly Earnings Results, Misses Expectations By $0.01 EPS

Key Points

• PepGen reported quarterly EPS of -$0.28, missing the consensus estimate of -$0.27 by $0.01.
• In a small DM1 study cohort, four doses of PGN-EDODM1 produced a 46.5% mean improvement in splicing, alongside early gains in some functional measures. The treatment was generally well tolerated, though patient-reported outcomes showed no clear signal.
• The U.S. multiple-ascending-dose study remains under a partial FDA clinical hold over questions about prior mouse toxicology findings; PepGen is conducting additional studies to address the concerns.

PepGen (NASDAQ:PEPG - Get Free Report) announced its quarterly earnings results on Tuesday. The company reported ($0.28) earnings per share (EPS) for the quarter, missing the consensus estimate of ($0.27) by ($0.01), FiscalAI reports.

Here are the key takeaways from PepGen's conference call:

• PepGen reported a 46.5% mean improvement in splicing after four doses of PGN-EDODM1 at 10 mg/kg, with four of six treated participants exceeding 50% improvement. The company said this was the highest mean splicing correction reported to date in a multiple-dose DM1 study.
• The company also reported improvements across several functional measures: myotonia improved by 4.3 seconds at week 13, while hand grip strength improved 16% at week 16, alongside favorable changes in timed mobility tests. These results come from a small cohort and are early; patient-reported outcomes did not yet show a clear signal.
• Management described the treatment as generally well tolerated, with no serious adverse events, dose-limiting toxicities, or discontinuations. Four mild kidney-related events were reported; albuminuria was transient, and the company said it saw no meaningful changes in eGFR or serum creatinine.
• The U.S. multiple-ascending-dose study remains under a partial FDA clinical hold related to questions about prior mouse toxicology findings. PepGen said it is conducting additional mouse studies to address the agency’s concerns, although the hold has not stopped the ongoing study in other countries.
• PepGen expects to report longer-term safety data at 10 mg/kg and additional data from the open-label extension in January 2027, with results from the 12.5 mg/kg cohort expected in the first half of 2027. The company said these data will inform dose selection and discussions with regulators about a pivotal trial.

PepGen Price Performance

Shares of NASDAQ:PEPG traded up $3.04 during mid-day trading on Tuesday, hitting $5.43. The company had a trading volume of 73,945,673 shares, compared to its average volume of 1,354,017. The firm has a fifty day moving average price of $2.66 and a 200 day moving average price of $2.98. The company has a market capitalization of $376.15 million, a PE ratio of -4.16 and a beta of 2.02. PepGen has a one year low of $1.31 and a one year high of $7.80.

Analyst Ratings Changes

A number of equities analysts recently weighed in on PEPG shares. Weiss Ratings raised shares of PepGen from a "sell (e+)" rating to a "sell (d-)" rating in a research note on Tuesday, September 22nd. HC Wainwright reaffirmed a "buy" rating on shares of PepGen in a research report on Wednesday, September 9th. Finally, Wall Street Zen upgraded PepGen from a "sell" rating to a "hold" rating in a report on Saturday. Five analysts have rated the stock with a Buy rating and one has assigned a Sell rating to the company's stock. According to data from MarketBeat, the stock presently has a consensus rating of "Moderate Buy" and a consensus target price of $11.40.

About PepGen

PepGen Inc is a clinical-stage biotechnology company developing genetic medicines for serious neuromuscular diseases. The company's technology is designed to improve the delivery of oligonucleotide therapeutics into skeletal and cardiac muscle, with the goal of addressing diseases caused by genetic mutations or abnormal RNA processing.

PepGen's platform, known as Enhanced Delivery Oligonucleotides (EDO), combines therapeutic oligonucleotides with proprietary peptides intended to facilitate their distribution into muscle tissue.

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