PepGen Inc.

PepGen reported fourth-quarter 2023 net loss of $19.5 million and full-year 2023 net loss of $78.6 million. Research and development expense was $16.3 million in the fourth quarter and $68.1 million for the full year; general and administrative expense was $4.5 million in the quarter and $16.6 million for the year. Cash and cash equivalents were $110.4 million at December 31, 2023 versus $181.8 million at December 31, 2022. The company also completed an underwritten stock offering on February 9, 2024 for gross proceeds of approximately $80 million, and said current cash plus offering proceeds are expected to fund operations into 2026. Looking ahead, PepGen expects preliminary CONNECT1-EDO51 data in mid-2024 and preliminary FREEDOM-DM1 data in the second half of 2024; it also expects to open FREEDOM2-DM1 in the second half of 2024.

James McArthur emphasized 2023 as a year of meaningful progress, pointing to the start of inpatient clinical trials in DMD and DM1 and saying the company is moving with urgency toward potentially disease-modifying medicines. He highlighted the EDO platform as the foundation of the company’s long-term strategy and repeatedly framed the upcoming data as important proof points for the platform. His tone was confident, especially around the company’s modeling for dystrophin output in DMD and splicing correction in DM1, while still tying key milestones to upcoming clinical readouts and regulatory discussions.

Noel Donnelly focused on the balance sheet and operating spend. He said PepGen ended 2023 with $110.4 million in cash and cash equivalents, and that the February 2024 offering brought in about $80 million in gross proceeds, extending runway into 2026. He also laid out the quarter and full-year losses and expense base: net loss of $19.5 million in Q4 and $78.6 million for 2023, R&D of $16.3 million in Q4 and $68.1 million for the year, and G&A of $4.5 million in Q4 and $16.6 million for the year. He attributed higher R&D to advancement of PGN-ED051 and PGN-EDODM1 and higher G&A mainly to personnel costs.

Analysts pressed on how PepGen’s DM1 mechanism differs from DMPK-degrading approaches, whether selective targeting could improve safety, and what level of splicing correction might be meaningful. Management said EDODM1 targets the CUG repeat/toxic RNA species rather than degrading both pathogenic and normal DMPK, and argued that preclinical data support robust splicing correction and potential myotonia improvement at well-tolerated doses. Questions also focused on the DMD readout, including whether dystrophin figures are adjusted and how much early signal is needed to support a higher-dose outcome; management said it expects to report dystrophin above background and believes the 5 mg/kg cohort can inform confidence in the 10 mg/kg dose. On DM1, management said endpoint discussions with regulators are ongoing and suggested a package of vHoT, strength, grip and functional measures will be important over time.