PepGen(PEPG)2024-08-08 12:05Financial Performance - For the six months ended June 30, 2024, PepGen reported a net loss of $46.4 million, compared to a net loss of $35.8 million for the same period in 2023[60]. - The net loss for the three months ended June 30, 2024, was $28.3 million, compared to a net loss of $19.5 million for the same period in 2023, reflecting an increase of $8.8 million[70]. - For the six months ended June 30, 2024, net cash used in operating activities was $38.9 million, resulting from a net loss of $46.4 million[86]. - For the six months ended June 30, 2023, net cash used in operating activities was $33.1 million, resulting from a net loss of $35.8 million[87]. Cash and Securities - As of June 30, 2024, PepGen had cash, cash equivalents, and marketable securities totaling $161.3 million, with an accumulated deficit of $227.8 million[60]. - Cash, cash equivalents, and marketable securities as of June 30, 2024, totaled $161.3 million, which is expected to fund operations into 2026[82]. - The net decrease in cash, cash equivalents, and restricted cash for the six months ended June 30, 2024, was $14.7 million[85]. - The company’s cash and money market accounts are held by three financial institutions in the U.S. and one in the U.K., potentially exceeding insured limits[94]. Research and Development - PepGen is advancing PGN-EDODM1 for DM1, with preliminary data from the FREEDOM study expected in Q4 2024[59]. - The FREEDOM2 study for PGN-EDODM1 is set to initiate patient dosing in the second half of 2024, following regulatory clearances[59]. - PepGen's research and development expenses primarily consist of external costs related to clinical trials and personnel-related costs[63]. - Research and development expenses increased by $8.1 million from $16.9 million for the three months ended June 30, 2023, to $25.1 million for the three months ended June 30, 2024[71]. - Research and development expenses for the six months ended June 30, 2024, increased by $8.5 million to $39.8 million from $31.3 million for the same period in 2023[75]. - The company anticipates an increase in research and development expenses for the remainder of 2024 due to ongoing clinical trials and increased headcount[71]. Clinical Trials and Designations - The Phase 1 clinical trial of PGN-EDO51 demonstrated a mean exon skipping of 2.15% in biceps tissue at week 13, with a mean muscle-adjusted dystrophin level of 1.49% of normal[58]. - The CONNECT1 study of PGN-EDO51 reported no discontinuations or dose interruptions, indicating a well-tolerated treatment profile[58]. - The FDA granted orphan drug designation and rare pediatric disease designation for PGN-EDO51, supporting its development for DMD patients[58]. Capital and Financing - PepGen's IPO in May 2022 raised gross proceeds of $108.0 million from the sale of 9,000,000 shares at $12.00 per share, with net proceeds of approximately $110.2 million after underwriters' fees[60]. - The company plans to raise substantial additional capital in the future to support ongoing and new development programs[66]. - The company has filed a shelf registration statement covering the offering of up to $300.0 million in various securities, effective June 16, 2023[79]. - Net cash provided by financing activities was $88.3 million, driven by $76.9 million from a Follow-on Offering[90]. - The company may face dilution of stockholder ownership if additional capital is raised through equity or convertible debt securities[84]. Operating Expenses - Total operating expenses for the three months ended June 30, 2024, were $30.4 million, an increase of $9.3 million compared to $21.1 million for the same period in 2023[70]. - General and administrative expenses rose by $1.1 million from $4.2 million for the three months ended June 30, 2023, to $5.3 million for the three months ended June 30, 2024[73]. - Interest income for the three months ended June 30, 2024, was $2.1 million, an increase from $1.7 million for the same period in 2023[73].