PepGen(PEPG) - 2024 Q3 - Quarterly Report

Financial Performance - As of September 30, 2024, PepGen reported a net loss of $67.7 million, compared to a net loss of $59.1 million for the same period in 2023, with an accumulated deficit of $249.2 million[64][65]. - Net loss for the three months ended September 30, 2024, was $21.4 million, compared to a net loss of $23.3 million for the same period in 2023, reflecting an improvement of $1.9 million[76]. - For the nine months ended September 30, 2024, net cash used in operating activities was $62.9 million, with a net loss of $67.7 million[95]. - The company had a net decrease in cash, cash equivalents, and restricted cash of $38.5 million for the nine months ended September 30, 2024[94]. Revenue and Funding - 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 fees[64]. - The company has raised a total of $286.8 million from the sale of common stock and convertible preferred stock since inception[85]. - The company filed a shelf registration statement covering the offering of up to $300.0 million in various securities, which was declared effective on June 16, 2023[86]. - The company issued and sold 7,530,000 shares of common stock at a price of $10.635 per share, resulting in net proceeds of $76.4 million after deducting fees[88]. - Net cash provided by financing activities was $88.6 million for the nine months ended September 30, 2024, driven by proceeds from the Follow-on Offering and sales under the Sales Agreement[99]. Research and Development - The ongoing CONNECT1 study for PGN-EDO51 showed 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[62]. - PGN-EDO51 has received orphan drug designation and rare pediatric disease designation from the FDA for treating DMD patients amenable to exon 51 skipping[63]. - The FREEDOM study for PGN-EDODM1 has been cleared by both the FDA and Health Canada, with patient dosing expected to begin in the U.S. in Q4 2024[63]. - PepGen plans to report data from the FREEDOM study by the end of Q1 2025, assessing safety and functional outcomes in DM1 patients[63]. - PepGen is developing additional EDO candidates targeting other DMD sub-populations, including exon 53, 45, and 44[63]. - The CONNECT2 study for PGN-EDO51 is set to evaluate multiple dose cohorts and is designed to support a potential accelerated approval pathway[62][63]. Expenses - Research and development expenses decreased by $2.8 million from $20.5 million for the three months ended September 30, 2023, to $17.7 million for the three months ended September 30, 2024[75]. - Total research and development expenses for the nine months ended September 30, 2024, increased by $5.7 million to $57.5 million compared to $51.8 million for the same period in 2023[81]. - General and administrative expenses increased by $1.2 million from $4.2 million for the three months ended September 30, 2023, to $5.4 million for the three months ended September 30, 2024[78]. - Total operating expenses for the three months ended September 30, 2024, were $23.2 million, a decrease of $1.6 million from $24.8 million for the same period in 2023[76]. - Total operating expenses for the nine months ended September 30, 2024, were $73.4 million, an increase of $9.4 million from $63.9 million for the same period in 2023[80]. - General and administrative expenses for the nine months ended September 30, 2024, increased by $3.7 million to $15.9 million compared to $12.1 million for the same period in 2023[82]. Cash and Marketable Securities - As of September 30, 2024, PepGen had cash, cash equivalents, and marketable securities totaling $138.9 million, expected to fund operations into 2026[65]. - The company’s primary exposure to market risk is interest income sensitivity, with $138.9 million in cash and marketable securities as of September 30, 2024[103]. - As of September 30, 2024, cash and money market accounts were held by three financial institutions, potentially exceeding insured limits[104]. Future Outlook - The company anticipates future capital requirements will depend on various factors, including the costs of clinical development and regulatory review[91]. - The company may finance cash needs through equity offerings or debt financings, which could dilute existing stockholders' ownership[93].