Financial Performance - Net Loss was $21.4 million, or $(0.66) per share, for the three months ended September 30, 2024, compared to a net loss of $23.3 million, or $(0.98) per share, for the same period in 2023[8] - Total operating expenses for the three months ended September 30, 2024, were $23.2 million, compared to $24.8 million for the same period in 2023, a decrease of approximately 6.5%[14] Cash Position - Cash, Cash Equivalents, and Marketable Securities were $138.9 million as of September 30, 2024, expected to fund operations into 2026[8] Research and Development - Research and Development Expenses decreased to $17.7 million for the three months ended September 30, 2024, from $20.5 million in the same period in 2023, a reduction of approximately 13.9%[8] - The FREEDOM-DM1 study is evaluating PGN-EDODM1 in approximately 32 adult patients with DM1, with data from the 5 mg/kg and 10 mg/kg cohorts expected by the end of the first quarter of 2025[3] - The CONNECT1-EDO51 study has been optimized based on encouraging results from the 5 mg/kg cohort, with results from the expanded 10 mg/kg cohort expected before year-end 2025[5] - The Company expects to initiate dosing in the Phase 2 FREEDOM2-DM1 trial by year-end 2024, involving approximately 24 adult patients with DM1[4] - Paul Streck, MD, MBA, was appointed as the head of R&D, bringing over 20 years of experience in drug development[7] - The Company presented scientific and clinical data at various medical conferences, including the 29th Annual Congress of the World Muscle Society[7] Administrative Expenses - General and Administrative Expenses increased to $5.4 million for the three months ended September 30, 2024, compared to $4.2 million for the same period in 2023, an increase of approximately 28.6%[8]

Financial 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].

Financial Performance - As of June 30, 2024, cash, cash equivalents, and marketable securities totaled $161.3 million, expected to fund operations into 2026[9] - The net loss for the quarter was $28.3 million, or $(0.87) per share, compared to a net loss of $19.5 million, or $(0.82) per share, in the same quarter of 2023[9] - Total operating expenses for the quarter were $30.4 million, compared to $21.1 million in the same period of 2023, reflecting a 43.8% increase[15] Research and Development - Research and Development expenses for the quarter were $25.1 million, up from $16.9 million in the same period of 2023, representing a 48.5% increase[9] - Initial dosing for the FREEDOM2-DM1 clinical trial is expected in the second half of 2024 following regulatory clearance[6] - The company anticipates reporting clinical results from the FREEDOM-DM1 trial in the fourth quarter of 2024[5] - PGN-EDO51 achieved a mean exon skipping level of 2.15% and a mean muscle-adjusted dystrophin production increase of 0.70% from baseline after three months of dosing[3] - The Phase 2 CONNECT1-EDO51 trial reported that PGN-EDO51 was well tolerated with no discontinuations or dose interruptions[3] - The company plans to present additional results from the 5 mg/kg cohort at a medical meeting later in 2024[4] Administrative Expenses - General and Administrative expenses increased to $5.4 million from $4.2 million year-over-year, a rise of 28.6%[9]

Group 1 - PepGen, Inc. (PEPG) has experienced significant selling pressure, resulting in a 39.6% decline in stock price over the past four weeks, but analysts anticipate better earnings than previously predicted [1] - The stock is currently in oversold territory, indicated by a Relative Strength Index (RSI) reading of 23.57, suggesting that the heavy selling may be exhausting itself and a rebound could occur [3] - There has been a 2.2% increase in the consensus EPS estimate for PEPG over the last 30 days due to a strong agreement among sell-side analysts, which typically correlates with price appreciation [4] Group 2 - PEPG holds a Zacks Rank 2 (Buy), placing it in the top 20% of over 4,000 ranked stocks based on earnings estimate revisions and EPS surprises, indicating a potential turnaround in the near term [4]

Financial Performance - PepGen's net losses for Q1 2024 were $18.0 million, compared to $16.3 million for Q1 2023, indicating an increase in losses year-over-year[84]. - Net loss before income tax for the three months ended March 31, 2024, was $18.0 million, compared to a net loss of $16.3 million for the same period in 2023, reflecting an increase of $1.7 million[99]. - Total operating expenses increased by $1.8 million from $18.0 million for the three months ended March 31, 2023, to $19.8 million for the same period in 2024, primarily driven by increases in research and development and general and administrative expenses[99]. - Net cash used in operating activities was $22.5 million for the three months ended March 31, 2024, compared to $15.4 million for the same period in 2023[112]. - The company has not recorded a U.S. provision for federal or state income taxes due to no revenue and incurred losses since inception[98]. Cash and Funding - As of March 31, 2024, PepGen had cash, cash equivalents, and marketable securities totaling $175.2 million, with an accumulated deficit of $199.5 million[84]. - Cash, cash equivalents, and marketable securities totaled $175.2 million as of March 31, 2024, which is expected to fund operations into 2026[108]. - In February 2024, PepGen raised $9.9 million from an at-the-market offering and $76.4 million from a follow-on offering, totaling $86.3 million in net proceeds[82]. - The company issued and sold 7,530,000 shares of common stock in a Follow-on Offering at a price of $10.635 per share, resulting in net proceeds of $76.4 million[107]. - The company filed a shelf registration statement covering the offering of up to $300.0 million in aggregate of various securities, effective June 16, 2023[105]. Research and Development - Research and development expenses for Q1 2024 totaled $14.7 million, slightly up from $14.4 million in Q1 2023, with external expenses amounting to $7.4 million[90]. - Research and development expenses rose by $0.3 million to $14.7 million for the three months ended March 31, 2024, attributed to a $2.1 million increase in clinical trial costs and a $1.3 million increase in personnel-related costs[100]. - The company plans to increase research and development expenses in 2024 to support ongoing clinical trials and preclinical research programs[90]. Clinical Trials and Studies - The ongoing CONNECT1 Phase 2 study for PGN-EDO51 has fully enrolled its first cohort at a dose level of 5 mg/kg, with preliminary data expected in mid-2024[75]. - The CONNECT2 Phase 2 study for PGN-EDO51 received clearance from the MHRA and will evaluate multiple dose cohorts over six months, with participants dosed every four weeks[76]. - PGN-EDODM1 received Fast Track designation from the FDA for the treatment of DM1, with preliminary data from the FREEDOM study expected in the second half of 2024[77]. IPO and Historical Funding - PepGen completed its IPO in May 2022, raising approximately $122.9 million in gross proceeds, with net proceeds of $110.2 million after fees[80]. - PepGen has not generated any revenue from product sales since inception and expects to finance future operations through equity offerings and other capital sources[85].

– CONNECT1-EDO51 trial preliminary data from 5mg/kg dose cohort expected mid-2024 – – FREEDOM1-DM1 trial preliminary data from at least 5mg/kg dose cohort expected second half 2024 – Phase 2 CONNECT1-EDO51 Clinical Trial of PGN-EDO51: In March 2024, PepGen announced that the 5 mg/kg PGN-EDO51 dose cohort was fully enrolled. PepGen expects to report preliminary data from this cohort in mid-2024, including initial safety, exon 51 skipping, and dystrophin production data. CONNECT1-EDO51 is a Phase 2, open-labe ...

PepGen Reports First Quarter 2024 Financial Results and Recent Corporate Highlights potentially support a future accelerated approval pathway, subject to regulatory authority feedback. – CONNECT1-EDO51 trial preliminary data from 5mg/kg dose cohort expected mid-2024 – – FREEDOM1-DM1 trial preliminary data from at least 5mg/kg dose cohort expected second half 2024 – – Net proceeds of $86.3 million from common stock offerings extending cash runway into 2026 – BOSTON, May 14, 2024 (GLOBE NEWSWIRE) -- PepGen In ...

PepGen, Inc. (NASDAQ:PEPG) Q4 2023 Earnings Conference Call March 6, 2024 4:30 PM ET Company Participants Emiko Bryant - Chief of Staff James McArthur - President and CEO Michelle Mellion - SVP and Head, Clinical Development Noel Donnelly - CFO Conference Call Participants Jenny Gonzalez-Armenta - Leerink Partners James Condulis - Stifel Tazeen Ahmad - Bank of America Laura Chico - Wedbush Ananda Ghosh - H.C. Wainwright & Company Operator Good afternoon, and welcome to PepGen's Fourth Quarter and Full Year ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2023 OR (State or other jurisdiction of incorporation or organization) 321 Harrison Avenue Boston, MA 02118 (Address of principal executive offices) (Zip Code) (I.R.S. Employer Identification No.) ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR T ...

PepGen Reports Fourth Quarter and Full Year 2023 Financial Results and Recent Corporate Developments - FREEDOM-DM1 Phase 1 clinical trial enrolling DM1 patients with preliminary data for at least the 5 mg/kg dose cohort expected in the second half of 2024 - - Gross proceeds of approximately $80 million from February 2024 follow-on offering extends projected operating cash runway into 2026 - BOSTON, Mar. 6, 2024 -- PepGen Inc. (Nasdaq: PEPG), a clinical-stage biotechnology company advancing the next generati ...