PepGen(US:PEPG)2023-05-11 11:11Clinical Trials and Product Development - The company completed a Phase 1 clinical trial for its lead product candidate PGN-EDO51 in healthy volunteers, achieving over 70% exon 51 skipping in non-human primate studies[90] - The company plans to initiate two parallel Phase 2 studies for PGN-EDO51 in DMD patients in 2023, with initial data expected in 2024[90] - PGN-EDODM1 is anticipated to enter a Phase 1 clinical trial in DM1 patients in the first half of 2023, with results expected in 2024[92] - The company is developing additional EDO therapeutics targeting other DMD exon skipping populations and anticipates advancing more programs into clinical studies in 2024[93] Financial Performance - The company reported net losses of $16.3 million and $18.2 million for the three months ended March 31, 2023, and March 31, 2022, respectively[97] - Total operating expenses for Q1 2023 were $18.0 million, compared to $13.9 million in Q1 2022, reflecting an increase of $4.1 million[113] - Net loss for Q1 2023 was $16.3 million, a decrease of $1.9 million compared to a net loss of $18.2 million in Q1 2022[113] - Cash and cash equivalents as of March 31, 2023, were $165.4 million, with an accumulated deficit of $119.2 million[97] - Cash and cash equivalents as of March 31, 2023, amounted to $165.4 million, expected to fund operations into early 2025[119] - Net cash used in operating activities for Q1 2023 was $15.4 million, compared to $12.3 million in Q1 2022[123] Research and Development Expenses - Research and development expenses for the three months ended March 31, 2023, totaled $14.36 million, compared to $10.71 million for the same period in 2022, reflecting an increase in clinical trial activities[103] - Research and development expenses increased by $3.7 million from $10.7 million in Q1 2022 to $14.4 million in Q1 2023, driven by clinical program advancements and increased personnel costs[114] General and Administrative Expenses - General and administrative expenses rose by $0.5 million from $3.2 million in Q1 2022 to $3.7 million in Q1 2023, primarily due to higher personnel-related costs[115] Capital and Funding - The company raised approximately $122.9 million in gross proceeds from its IPO, with net proceeds of $110.2 million after deducting underwriting discounts and offering expenses[94] - The company has raised a total of $163.9 million from the sale of common and convertible preferred stock since inception[118] - Future capital requirements will depend on various factors, including the costs and timing of clinical trials and regulatory reviews[120] Revenue and Taxation - The company has not generated any revenue from product sales since inception and expects to continue incurring significant operating losses[96] - The company has not recorded a U.S. provision for federal or state income taxes due to no revenue and incurred losses since inception[112] - Interest income for Q1 2023 was $1.8 million, significantly up from $0.1 million in Q1 2022, primarily due to cash deposits and US Treasury-backed money market funds[116]