PepGen(PEPG)

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PepGen(PEPG) - 2024 Q1 - Quarterly Report
2024-05-14 20:05
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].
PepGen Reports First Quarter 2024 Financial Results and Recent Corporate Highlights
Newsfilter· 2024-05-14 20:02
– 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(PEPG) - 2024 Q1 - Quarterly Results
2024-05-14 20:01
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(PEPG) - 2023 Q4 - Earnings Call Transcript
2024-03-07 22:10
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 ...
PepGen(PEPG) - 2023 Q4 - Annual Report
2024-03-06 21:23
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(PEPG) - 2023 Q4 - Annual Results
2024-03-06 21:00
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 ...
PepGen(PEPG) - 2023 Q3 - Quarterly Report
2023-11-08 13:30
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ___________________ to ___________________ Commission File Number: 001-41374 PEPGEN INC. (Exact Name of Registrant as Specified in its Charter) Delaware 85- ...
PepGen(PEPG) - 2023 Q2 - Quarterly Report
2023-08-08 12:17
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ___________________ to ___________________ Commission File Number: 001-41374 PEPGEN INC. (Exact Name of Registrant as Specified in its Charter) Delaware 85-38198 ...
PepGen(PEPG) - 2023 Q1 - Quarterly Report
2023-05-11 11:11
Clinical 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]
PepGen(PEPG) - 2022 Q4 - Earnings Call Transcript
2023-03-25 14:58
PepGen Inc (NASDAQ:PEPG) Q4 2022 Earnings Conference Call March 23, 2023 4:30 PM ET Company Participants Noel Donnelly - Chief Financial Officer James McArthur - President and Chief Executive Officer Jaya Goyal - Executive Vice President, Research and Preclinical Development Michelle Mellion - Senior Vice President and Head, Clinical Development Conference Call Participants Laura Chico - Wedbush Operator Good afternoon and welcome to the PepGen Conference Call to discuss PepGen’s Fourth Quarter and Full Yea ...