Financial Performance - The company incurred net losses of $90.0 million and $78.6 million for the years ended December 31, 2024, and December 31, 2023, respectively, with an accumulated deficit of $271.5 million as of December 31, 2024[266]. - The company has never generated revenue from product sales and expects it will be many years before a product candidate is ready for commercialization[268]. - As of December 31, 2024, the company had cash, cash equivalents, and marketable securities of $120.2 million, with additional net proceeds of $86.3 million from recent equity offerings[274][276]. - The company anticipates significant increases in operating expenses as it continues research and development, clinical trials, and seeks marketing approvals for its product candidates[273]. - Future capital requirements will depend on various factors, including the costs of clinical trials, regulatory reviews, and commercialization activities[278]. - The company has no committed source of additional capital and may need to seek funding sooner than planned if capital resources deplete faster than expected[279]. - The company is still in the early stages of development and may never achieve profitability or generate significant revenue from product sales[270]. Clinical Trials and Development - The company completed a Phase 1 clinical trial for PGN-EDO51 and initiated two Phase 2 clinical trials for PGN-EDO51, along with a Phase 1 and a Phase 2 clinical trial for PGN-EDODM1[281]. - The FDA issued a clinical hold on the initiation of the Phase 2 CONNECT2 trial of PGN-EDO51 in December 2024, and Health Canada has requested additional information regarding safety concerns[269][281]. - Initial data from the low dose cohort (5 mg/kg) of the Phase 2 CONNECT1 trial for PGN-EDO51 was reported in July 2024, leading to protocol amendments[283]. - The FDA issued a clinical hold on the initiation of the Phase 2 CONNECT2 trial in the U.S. in December 2024, and a clinical hold was previously placed on the Phase 1 FREEDOM trial in May 2023[285][286]. - The company has initiated a Phase 1 clinical trial for its second product candidate PGN-EDODM1, with initial single-dose data reported on February 24, 2025[283]. - The success of the company's product candidates depends on various factors, including timely completion of preclinical studies and regulatory approvals[287]. - The company is evaluating additional product candidates in preclinical studies but has not advanced any into clinical trials[284]. - Regulatory authorities may request additional preclinical studies or impose stricter approval conditions, which could delay clinical trials[286]. - The lengthy and expensive drug development process may encounter substantial delays, impacting the ability to commercialize product candidates[293]. - The company has successfully completed a Phase 1 clinical trial for its lead product candidate, PGN-EDO51, and reported early data from the low dose cohort of its first Phase 2 trial in DMD patients[308]. - Initial results from the Phase 1 FREEDOM study showed a robust and dose-dependent mean splicing correction of 29.1% at the 10 mg/kg dose level[308]. - The company faces challenges in patient recruitment for clinical trials due to the rarity of DMD amenable to exon 51 skipping and competition from other therapies[311]. - Delays in clinical trials may result from regulatory holds, patient recruitment difficulties, and the need for additional studies due to inconclusive results[303][306]. - Preliminary data from clinical trials may change as more patient data become available, and final results could differ significantly from initial reports[313]. Regulatory Challenges - The company must navigate complex regulatory environments and potential conflicts of interest related to principal investigators in clinical trials[302]. - Regulatory authorities may impose restrictions or require additional trials based on safety concerns or adverse events observed during clinical trials[306]. - The company may need to conduct additional studies if manufacturing or formulation changes are made to its product candidates[303]. - The company intends to conduct clinical trials outside the U.S., which may face acceptance issues from the FDA[329]. - The company may face regulatory changes that could adversely impact its business, particularly regarding orphan drug regulations[383]. - The FDA may require additional clinical trials for marketing approval, which could delay commercialization of product candidates[371]. - The FDA's accelerated approval pathways do not guarantee faster development or approval processes for product candidates[374]. - The FDA may withdraw orphan drug designation if it believes the designation is no longer supported by clinical data[377]. - The FDA requires pre-approval of promotional materials for products receiving accelerated approval, potentially impacting commercial launch timing[375]. - The company will be subject to ongoing regulatory obligations if it receives regulatory approval for its product candidates, which may result in significant additional expenses[386]. - The FDA and other regulatory authorities may impose extensive and ongoing regulatory requirements on approved product candidates, including post-marketing studies and compliance with cGMPs and GCPs[387]. Competition and Market Dynamics - The company faces significant competition from major pharmaceutical and biotechnology companies, which may hinder its ability to develop and commercialize products successfully[440]. - The company’s commercial opportunity could be significantly reduced if competitors develop safer, more effective, or less expensive products[441]. - The company is currently competing with several FDA-approved drugs for the treatment of DMD, including EMFLAZA and exon skipping drugs like EXONDYS 51 and VYONDYS 53[442]. - The competitive landscape includes companies with significantly greater financial resources and expertise, which may affect the company’s market position[448]. - The company faces significant uncertainty regarding insurance coverage and reimbursement for newly approved products, particularly under the Medicare program, which is influenced by the Centers for Medicare & Medicaid Services (CMS)[457]. - International operations are subject to extensive governmental price controls, which may delay or prevent commercial launches of products in various countries, particularly in the EU[458]. Intellectual Property and Compliance - The company's patent portfolio is at an early stage, with only two issued patents, and the success of its product candidates depends on obtaining and maintaining adequate intellectual property protection[462]. - The patent prosecution process is complex and expensive, and the company may not be able to secure necessary patent protections in a timely manner[464]. - The company may be required to provide predetermined discounts to third-party payors, impacting net prices and overall revenue potential[457]. - The company faces risks related to recruiting and retaining effective sales and marketing personnel, which could affect the ability to educate physicians and negotiate reimbursement arrangements[463]. Data Privacy and Regulatory Compliance - The company must adhere to stringent data protection laws, with potential fines up to 4% of global revenues for non-compliance with GDPR[419]. - The evolving regulatory landscape for data privacy requires the company to implement robust compliance programs, which can be resource-intensive[418]. - Non-compliance with data transfer regulations could lead to substantial fines and restrictions on clinical trial activities, affecting collaborations and increasing data processing costs[421]. - The U.K. adequacy decision for data transfers may expire in June 2025, potentially increasing compliance costs and regulatory risks for the company[420]. - The California Consumer Privacy Act (CCPA) and the California Privacy Rights Act (CPRA) impose new operational requirements and could impact business activities, especially regarding sensitive personal information[424]. - The company may incur additional compliance costs due to evolving state and federal privacy laws, which could complicate compliance obligations and increase legal risks[425]. - HIPAA regulations impose privacy and security obligations that could lead to substantial penalties if the company inadvertently receives non-compliant health information[426]. Operational Risks - The company relies on third parties for manufacturing and clinical testing, which may impact product development timelines[331]. - The company may need to establish its own manufacturing facility in the future, which would require substantial resources and expertise[340]. - The reliance on third-party manufacturers for compliance with cGMP requirements is critical, as any failure could lead to sanctions and operational disruptions[341]. - The company faces significant liabilities if it fails to manage the promotion of its product candidates effectively, which could adversely affect its financial condition[389]. - Disruptions at the FDA and other government agencies due to funding shortages or global health concerns could hinder timely product development and approval processes[402].

Core Viewpoint - Pomerantz LLP is investigating claims of potential securities fraud or unlawful business practices involving PepGen Inc. and its officers or directors [1] Group 1: Company Overview - PepGen Inc. is a company listed on NASDAQ under the ticker PEPG [1] - The company is currently facing scrutiny due to a clinical hold notice received from the FDA regarding its IND application for a clinical trial related to Duchenne muscular dystrophy [2] Group 2: Recent Developments - On December 16, 2024, PepGen announced it received a clinical hold notice from the FDA, which will provide an official letter within 30 days [2] - Following this announcement, PepGen's stock price decreased by $0.17, or 3.63%, closing at $4.51 per share on the same day [2] Group 3: Legal Context - Pomerantz LLP is recognized for its expertise in corporate, securities, and antitrust class litigation, having a long history of fighting for victims of securities fraud and corporate misconduct [3]

Core Viewpoint - PepGen, Inc. (PEPG) has received an upgrade to a Zacks Rank 2 (Buy), indicating a positive trend in earnings estimates which is a significant factor influencing stock prices [1][3]. Earnings Estimates and Stock Price Impact - The Zacks rating system reflects changes in earnings estimates, which are strongly correlated with near-term stock price movements [4][6]. - Rising earnings estimates for PepGen suggest an improvement in the company's underlying business, likely leading to an increase in stock price [5]. Zacks Rating System - The Zacks Rank system classifies stocks into five groups based on earnings estimates, with a strong historical performance, particularly for Zacks Rank 1 stocks which have averaged a +25% annual return since 1988 [7]. - The upgrade of PepGen to a Zacks Rank 2 places it in the top 20% of Zacks-covered stocks, indicating a strong potential for market-beating returns in the near term [10]. Earnings Estimate Revisions for PepGen - For the fiscal year ending December 2024, PepGen is expected to earn -$2.73 per share, reflecting a year-over-year change of 17.3% [8]. - Over the past three months, the Zacks Consensus Estimate for PepGen has increased by 9%, indicating a positive trend in analyst expectations [8].

Core Viewpoint - Pomerantz LLP is investigating potential securities fraud or unlawful business practices involving PepGen Inc. and its officers or directors [1] Group 1: Company Developments - On December 16, 2024, PepGen announced it received a clinical hold notice from the FDA regarding its IND application for the CONNECT2-EDO51 clinical trial in patients with Duchenne muscular dystrophy [2] - Following the announcement of the clinical hold, PepGen's stock price decreased by $0.17 per share, or 3.63%, closing at $4.51 per share on the same day [2] Group 2: Legal Context - Pomerantz LLP is recognized for its expertise in corporate, securities, and antitrust class litigation, having a long history of fighting for victims of securities fraud and corporate misconduct [3]

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].

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].