Core Viewpoint - A class action lawsuit has been filed against PepGen Inc. and certain officers for alleged violations of federal securities laws during the Class Period from March 7, 2024, to March 3, 2025 [1][2]. Group 1: Lawsuit Details - The lawsuit seeks to recover damages for investors who purchased PepGen securities during the specified Class Period [2]. - The complaint alleges that Defendants made materially false and misleading statements regarding the effectiveness and safety of PGN-EDO51, the CONNECT2 study's suitability for FDA approval, and the overall clinical and commercial prospects of PepGen [3]. Group 2: Next Steps for Investors - Investors who suffered losses in PepGen have until August 8, 2025, to request appointment as lead plaintiff in the class action [4]. - A copy of the Complaint can be reviewed on the law firm's website [4]. Group 3: Legal Representation - The law firm operates on a contingency fee basis, meaning they will only seek reimbursement for expenses and attorneys' fees if successful in the case [5]. - Bronstein, Gewirtz & Grossman, LLC is recognized for representing investors in securities fraud class actions and has recovered significant amounts for investors nationwide [6].

Core Viewpoint - A securities class action lawsuit has been filed against PepGen Inc. for allegedly making false and misleading statements regarding its lead product candidate, PGN-EDO51, and its clinical trials [1][2]. Group 1: Lawsuit Details - The lawsuit covers all investors who purchased PepGen securities between March 7, 2024, and March 3, 2025 [1]. - Investors are encouraged to contact the law firm before the lead plaintiff motion deadline of August 8, 2025 [2]. Group 2: Allegations Against PepGen - The complaint alleges that PepGen misrepresented the efficacy and safety of PGN-EDO51, claiming it was less effective than publicly stated [8]. - The CONNECT2 study was described as dangerous or deficient for obtaining FDA approval, undermining the drug's clinical, regulatory, and commercial prospects [8]. - The truth about the drug's performance began to emerge on July 30, 2024, when PepGen reported "positive clinical data" that fell short of expectations, leading to a significant stock price drop of 32.69% [3][4].

Core Viewpoint - Faruqi & Faruqi, LLP is investigating potential claims against PepGen Inc. due to allegations of violations of federal securities laws related to misleading statements about the effectiveness and safety of its drug PGN-EDO51 and the CONNECT2 study [3][5]. Group 1: Allegations and Legal Actions - The complaint alleges that PepGen and its executives made false statements regarding the effectiveness and safety of PGN-EDO51, leading to an overstatement of its clinical and commercial prospects [5]. - Investors who suffered losses exceeding $50,000 in PepGen between March 7, 2024, and March 3, 2025, are encouraged to contact Faruqi & Faruqi to discuss their legal options [1][3]. - There is an August 11, 2025, deadline for investors to seek the role of lead plaintiff in the federal securities class action against PepGen [3]. Group 2: Clinical Study Results and Stock Performance - On July 30, 2024, PepGen reported "positive clinical data" from the CONNECT1 study, but analysts noted that the results were below expectations, leading to a 32.69% drop in stock price [6][7]. - A clinical hold notice from the FDA on December 16, 2024, raised concerns about the CONNECT2 study, resulting in a 3.63% decline in stock price [8][9]. - Following updates on safety concerns and a temporary pause of the CONNECT2 study on March 4, 2025, PepGen's stock fell by 18.86% [10][11]. - On May 28, 2025, PepGen announced the discontinuation of its DMD programs after PGN-EDO51 failed to achieve target dystrophin levels [12].

SAN DIEGO, June 10, 2025 /PRNewswire/ -- Robbins LLP informs stockholders that a class action was filed on behalf of investors who purchased or otherwise acquired PepGen Inc. (NASDAQ:PEPG) securities between March 7, 2024 and March 3, 2025. PepGen is a clinical-stage biotechnology company that focuses on the development of oligonucleotide therapeutics for use in the treatment of severe neuromuscular and neurologic diseases. The Company's lead product candidate was PGN-EDO51, a proprietary enhanced delivery ...

NEW YORK, June 10, 2025 /PRNewswire/ --Why: Rosen Law Firm, a global investor rights law firm, announces the filing of a class action lawsuit on behalf of purchasers of securities of PepGen Inc. (NASDAQ: PEPG) between March 7, 2024 and March 3, 2025, both dates inclusive (the "Class Period"). A class action lawsuit has already been filed. If you wish to serve as lead plaintiff, you must move the Court no later than August 8, 2025.So What: If you purchased PepGen securities during the Class Period you may be ...

Core Points - A shareholder class action lawsuit has been filed against PepGen Inc. alleging that the company made materially false and misleading statements regarding its business and operations [1] - The lawsuit specifically claims that PGN-EDO51 was less effective and safe than previously represented, and that the CONNECT2 study was inadequate for FDA approval [1] - As a result of these allegations, it is suggested that PepGen may halt the CONNECT2 study, leading to overstated clinical, regulatory, and commercial prospects for PGN-EDO51 [1] Legal Information - Shareholders who purchased PepGen shares between March 7, 2024, and March 3, 2025, and suffered significant losses are encouraged to discuss their legal rights [2] - The deadline to request to be appointed as lead plaintiff in the case is August 8, 2025 [3] - Holzer & Holzer, LLC is representing shareholders in this litigation and has a history of recovering significant amounts for investors affected by corporate misconduct [3]

Core Viewpoint - A securities class action lawsuit has been filed against PepGen Inc. for allegedly making false and misleading statements regarding the effectiveness and safety of its drug PGN-EDO51, as well as the CONNECT2 study's viability for FDA approval [1][2]. Group 1: Allegations and Impact - The lawsuit claims that PepGen misrepresented the effectiveness and safety of PGN-EDO51, leading investors to believe it was more promising than it actually was [2]. - It is alleged that the CONNECT2 study was either dangerous or deficient, which could result in PepGen halting the study, thereby overstating the drug's clinical, regulatory, and commercial prospects [2]. - Following the announcement of disappointing clinical data from the CONNECT1 study, PepGen's stock price dropped by $5.55, or 32.69%, closing at $11.43 per share [4]. Group 2: Clinical Data and Analyst Reactions - On July 30, 2024, PepGen reported "positive clinical data" from the CONNECT1 study, but analysts noted that the results were below expectations, with a dystrophin increase of only 0.61% of normal, which was disappointing [3]. - Analysts from Stifel and Leerink Partners expressed concerns that the results did not meet PepGen's anticipated threshold of 1% or greater dystrophin expression [3]. Group 3: Legal Proceedings - Investors who acquired shares of PepGen during the class period are encouraged to contact the law firm Gainey McKenna & Egleston before the lead plaintiff motion deadline on August 8, 2025 [5].

Core Viewpoint - A shareholder has filed a securities class action lawsuit against PepGen Inc. for alleged misrepresentations regarding the effectiveness and safety of its lead product candidate, PGN-EDO51, during the period from March 7, 2024, to March 3, 2025 [1][2]. Group 1 - The lawsuit is on behalf of investors who purchased or acquired PepGen's securities within the specified timeframe [1]. - Defendants are accused of making false statements about the lead product candidate's effectiveness and safety [2]. - Investors interested in serving as lead plaintiffs must file papers by August 8, 2025, and can remain absent class members if they choose not to take action [3]. Group 2 - Bernstein Liebhard LLP has a history of recovering over $3.5 billion for clients and has represented large public and private pension funds [4]. - The firm has been recognized multiple times for its success in litigating class actions, being named to The National Law Journal's "Plaintiffs' Hot List" and listed in The Legal 500 for several consecutive years [4].

Core Viewpoint - PepGen Inc. has decided to focus on its myotonic dystrophy type 1 (DM1) program while discontinuing its Duchenne muscular dystrophy (DMD) research due to unsatisfactory results in dystrophin levels from its clinical study [1][4]. Group 1: DMD Program Discontinuation - The company has voluntarily discontinued the development of PGN-EDO51 and plans to wind down all DMD-related research activities [1]. - In the CONNECT1 study's 10 mg/kg cohort, PGN-EDO51 showed a mean increase of 3.5% in exon 51 skipped transcripts, but total dystrophin only increased to 0.59% of normal levels, indicating limited efficacy [2]. - The safety profile of PGN-EDO51 was generally favorable, with all treatment-related adverse events being mild and no serious adverse events reported [3]. Group 2: Focus on DM1 Program - PepGen's investigational drug PGN-EDODM1 for DM1 has shown robust target engagement, achieving a mean mis-splicing correction of 29% after a single 10 mg/kg dose, with a favorable safety profile [5]. - The company anticipates reporting data from its FREEDOM-DM1 15 mg/kg cohort in the second half of 2025, which is a Phase 1 trial focusing on safety and splicing correction [5]. - Data from the 5 mg/kg cohort of the FREEDOM2-DM1 study is expected in the first quarter of 2026, which is a Phase 2 trial assessing multiple doses and their effects [6]. Group 3: Market Reaction - Following the announcement, PepGen's stock fell by 6.69%, trading at $1.47 during the premarket session [6].

[First Quarter 2025 Overview](index=1&type=section&id=First%20Quarter%202025%20Overview) PepGen's Q1 2025 overview highlights positive initial clinical data for PGN-EDODM1 and upcoming data readouts for DM1 and DMD programs [Headline Highlights](index=1&type=section&id=Headline%20Highlights) PepGen reported positive initial clinical data for PGN-EDODM1, showing significant splicing correction, and outlined upcoming data readouts for both its DM1 and DMD programs in the second half of 2025 and first quarter of 2026 - Reported positive DM1 patient data with mean splicing correction of **29.1%** following a single dose of PGN-EDODM1 at 10 mg/kg[1](index=1&type=chunk) - FREEDOM-DM1 data from the 15 mg/kg cohort is expected in the second half of 2025[1](index=1&type=chunk) - CONNECT1-EDO51 data from the 10 mg/kg cohort is expected in the third quarter of 2025[1](index=1&type=chunk) [CEO Commentary](index=1&type=section&id=CEO%20Commentary) The CEO highlighted the EDO platform's potential, emphasizing the promising clinical data from two programs and describing the next 12 months as pivotal for the DM1 and DMD clinical programs. The company also took steps to extend its cash runway - The EDO platform's unique ability to efficiently deliver oligonucleotides into cell nuclei is the foundation of a differentiated pipeline with promising clinical data[2](index=2&type=chunk) - The next 12 months are considered pivotal and catalyst-rich for PepGen and its DM1 and DMD clinical programs[2](index=2&type=chunk) - The company has undertaken various measures to extend its cash runway while prioritizing key clinical milestones[2](index=2&type=chunk) [Recent Program Updates](index=1&type=section&id=Recent%20Program%20Updates) This section details recent clinical trial progress and anticipated milestones for PepGen's PGN-EDODM1 and PGN-EDO51 programs [PGN-EDODM1: Myotonic Dystrophy Type 1 (DM1)](index=1&type=section&id=PGN-EDODM1%3A%20Myotonic%20Dystrophy%20Type%201%20(DM1)) PepGen reported positive initial data from its Phase 1 FREEDOM-DM1 trial, demonstrating a favorable safety profile and dose-dependent splicing correction. Further data from this program, including a Phase 2 trial, are anticipated in late 2025 and early 2026 [Phase 1 FREEDOM-DM1 Single Ascending Dose (SAD) Trial](index=1&type=section&id=Phase%201%20FREEDOM-DM1%20Single%20Ascending%20Dose%20(SAD)%20Randomized%2C%20Placebo-Controlled%20Clinical%20Trial%20of%20PGN-EDODM1) Initial Phase 1 FREEDOM-DM1 trial data showed a favorable safety profile and robust, dose-dependent splicing correction, with further 15 mg/kg cohort data expected in H2 2025 - Positive initial clinical data from the 5 mg/kg and 10 mg/kg dose cohorts were reported in February, showing a favorable emerging safety profile and robust, dose-dependent splicing correction at day 28 following a single dose[3](index=3&type=chunk) - PepGen expects to report safety, 28-day splicing, and functional benefit data from the 15 mg/kg cohort during the second half of 2025[3](index=3&type=chunk) [Phase 2 FREEDOM2-DM1 Multiple Ascending Dose (MAD) Trial](index=1&type=section&id=Phase%202%20FREEDOM2-DM1%20Multiple%20Ascending%20Dose%20(MAD)%20Randomized%2C%20Placebo-Controlled%20Clinical%20Trial%20of%20PGN-EDODM1) Results from the 5 mg/kg cohort of the Phase 2 FREEDOM2-DM1 trial are expected in the first quarter of 2026 - The Company expects to report results from the 5 mg/kg cohort of the FREEDOM2 trial in the first quarter of 2026[3](index=3&type=chunk) [PGN-EDO51: Duchenne Muscular Dystrophy (DMD)](index=2&type=section&id=PGN-EDO51%3A%20Duchenne%20Muscular%20Dystrophy%20(DMD)) The company anticipates reporting dystrophin production data from the CONNECT1 trial in Q3 2025. The CONNECT2 trial has been voluntarily paused pending review of CONNECT1 results [Phase 2 CONNECT1-EDO51 Open-Label MAD Clinical Trial](index=2&type=section&id=Phase%202%20CONNECT1-EDO51%20Open-Label%20MAD%20Clinical%20Trial%20of%20PGN-EDO51) PepGen expects to report additional safety and dystrophin production data from the 10 mg/kg cohort of the CONNECT1 trial in Q3 2025 - PepGen expects to report additional safety as well as dystrophin production data from the 10 mg/kg cohort of the CONNECT1 trial in DMD patients in the third quarter of 2025[7](index=7&type=chunk) [Phase 2 CONNECT2-EDO51 MAD Clinical Trial](index=2&type=section&id=Phase%202%20CONNECT2-EDO51%20MAD%20Clinical%20Trial%20of%20PGN-EDO51) The Phase 2 CONNECT2 trial for DMD has been voluntarily paused pending review of results from the CONNECT1 trial's 10 mg/kg cohort - In March 2025, the Company announced its voluntary decision to pause the Phase 2 CONNECT2 trial in DMD patients until it can review results from the 10 mg/kg cohort in the ongoing Phase 2 CONNECT1 trial[7](index=7&type=chunk) [Corporate Updates](index=2&type=section&id=Corporate%20Updates) This section covers recent corporate developments, including board appointments, conference presentations, and upcoming key milestones [Board of Directors Appointments](index=2&type=section&id=Board%20of%20Directors%20Appointments) PepGen strengthened its Board of Directors with the appointment of two industry veterans in March 2025 - In March 2025, Lisa Wyman and Mitchell H. Finer, PhD, joined the Company's Board of Directors, bringing decades of executive and operational experience in life sciences[7](index=7&type=chunk) [Conference Presentations](index=2&type=section&id=Conference%20Presentations) PepGen actively participated in key industry conferences, presenting data from its clinical trials and preclinical results for PGN-EDODM1 - In March 2025, the Company gave two oral presentations and presented five posters at the 2025 Muscular Dystrophy Association (MDA) Clinical & Scientific Conference, featuring data from CONNECT1 (DMD) and FREEDOM (DM1)[7](index=7&type=chunk) - In May 2025, the Company made an oral presentation and presented two posters at the 2025 Myotonic Dystrophy Foundation (MDF) Conference, highlighting recent FREEDOM clinical data in DM1 and preclinical results for PGN-EDODM1[7](index=7&type=chunk) [Upcoming Potential Milestones](index=2&type=section&id=Upcoming%20Potential%20Milestones) The company has several key data readouts anticipated in the coming quarters for its DM1 and DMD programs - Upcoming Milestones[7](index=7&type=chunk) - **3Q 2025**: CONNECT1-EDO51 data from 10 mg/kg cohort expected[7](index=7&type=chunk) - **2H 2025**: FREEDOM-DM1 data from 15 mg/kg cohort expected[7](index=7&type=chunk) - **1Q 2026**: FREEDOM2-DM1 data from the 5 mg/kg cohort expected[7](index=7&type=chunk) [Financial Results for the Three Months Ended March 31, 2025](index=2&type=section&id=Financial%20Results%20for%20the%20Three%20Months%20Ended%20March%2031%2C%202025) This section presents PepGen's financial performance for Q1 2025, including cash position, operating expenses, and net loss [Key Financial Highlights](index=2&type=section&id=Key%20Financial%20Highlights) PepGen reported a cash position of **$97.8 million** as of March 31, 2025, sufficient to fund operations for at least 12 months. The company experienced increased R&D and G&A expenses, leading to a higher net loss compared to the prior year - Cash, Cash Equivalents and Marketable Securities were **$97.8 million** as of March 31, 2025[7](index=7&type=chunk) - Existing cash, cash equivalents, and marketable securities are believed to be sufficient to fund operations for at least 12 months from the release date[7](index=7&type=chunk) Financial Performance (Q1 2025 vs Q1 2024) | Metric | Q1 2025 (USD) | Q1 2024 (USD) | Change (%) | | :-------------------------------- | :------ | :------ | :----- | | Research and Development Expenses | $25.4M | $14.7M | +72.8% | | General and Administrative Expenses | $5.9M | $5.1M | +15.7% | | Net Loss | $(30.2)M | $(18.0)M | +67.8% | | Net Loss per share (basic & diluted) | $(0.92) | $(0.63) | +46.0% | [Condensed Consolidated Statements of Operations](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) The condensed consolidated statements of operations detail the company's operating expenses, other income, and net loss for the three months ended March 31, 2025, compared to the same period in 2024 Condensed Consolidated Statements of Operations (unaudited, in thousands) | | | Three Months | Ended | | | --- | --- | --- | --- | --- | | | | March | 31, | | | | | 2025 | | 2024 | | Operating expenses: | | | | | | Research and development | $ | 25,378 | $ | 14,732 | | General and administrative | | 5,943 | | 5,066 | | Total operating expenses | $ | 31,321 | $ | 19,798 | | Operating loss | $ | (31,321) | $ | (19,798) | | Other income (expense) | | | | | | Interest income | | 1,122 | | 1,735 | | Other (expense) income, net | | (3) | | 43 | | Total other income, net | | 1,119 | | 1,778 | | Net loss before income tax | $ | (30,202) | $ | (18,020) | | Income tax expense | | — | | — | | Net loss | $ | (30,202) | $ | (18,020) | | Net loss per share, basic and diluted | $ | (0.92) | $ | (0.63) | | Weighted-average common stock outstanding, basic and diluted | | 32,674,720 | | 28,656,401 | [Condensed Consolidated Balance Sheets](index=6&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) The condensed consolidated balance sheets provide a snapshot of PepGen's financial position as of March 31, 2025, compared to December 31, 2024, showing changes in assets, liabilities, and stockholders' equity Condensed Consolidated Balance Sheets (unaudited, in thousands) | | March | 31, 2025 | | December 31, | | --- | --- | --- | --- | --- | | | | (unaudited) | | | | | | | | 2024 | | Assets | | | | | | Cash, cash equivalents and marketable securities | $ | 97,781 | $ | 120,191 | | Other assets | | 29,612 | | 30,692 | | Total assets | $ | 127,393 | $ | 150,883 | | Liabilities and stockholders' equity | | | | | | Liabilities | $ | 35,588 | $ | 32,263 | | Stockholders' equity | | 91,805 | | 118,620 | | Total liabilities and stockholders' equity | $ | 127,393 | $ | 150,883 | [About PepGen and Product Candidates](index=3&type=section&id=About%20PepGen%20and%20Product%20Candidates) This section provides an overview of PepGen, its proprietary EDO platform, and its investigational product candidates, PGN-EDODM1 and PGN-EDO51 [About PGN-EDODM1](index=3&type=section&id=About%20PGN-EDODM1) PGN-EDODM1 is PepGen's investigational candidate for Myotonic Dystrophy Type 1 (DM1), utilizing EDO technology to restore normal splicing function. It has received Orphan Drug and Fast Track Designations from the FDA - PGN-EDODM1 is an investigational candidate for DM1, utilizing PepGen's proprietary Enhanced Delivery Oligonucleotide (EDO) technology to restore the normal splicing function of MBNL1[8](index=8&type=chunk) - DM1 is a progressively disabling, life-shortening genetic disorder estimated to affect **40,000 people** in the United States and over **74,000** in Europe[8](index=8&type=chunk) - PGN-EDODM1 has been granted both Orphan Drug and Fast Track Designations by the U.S. FDA for the treatment of DM1[8](index=8&type=chunk) [About PGN-EDO51](index=3&type=section&id=About%20PGN-EDO51) PGN-EDO51 is PepGen's investigational candidate for Duchenne Muscular Dystrophy (DMD), designed to skip exon 51 using EDO technology to restore dystrophin production. It holds Orphan Drug and Rare Pediatric Disease Designations - PGN-EDO51 is an investigational candidate for DMD, utilizing EDO technology to target the root cause by skipping exon 51 of the dystrophin transcript[9](index=9&type=chunk) - It is designed to restore the open reading frame and enable the production of a truncated, yet functional dystrophin protein for approximately **13%** of DMD patients[9](index=9&type=chunk) - PGN-EDO51 has been granted both Orphan Drug and Rare Pediatric Disease Designations by the U.S. FDA for DMD amenable to an exon-51 skipping approach[9](index=9&type=chunk) [About PepGen](index=3&type=section&id=About%20PepGen) PepGen is a clinical-stage biotechnology company focused on developing next-generation oligonucleotide therapies for severe neuromuscular and neurological diseases, leveraging its proprietary EDO platform - PepGen is a clinical-stage biotechnology company advancing the next generation of oligonucleotide therapies to transform the treatment of severe neuromuscular and neurological diseases[10](index=10&type=chunk) - The company's EDO platform leverages cell-penetrating peptides to improve the uptake and activity of conjugated oligonucleotide therapeutics, forming the basis of its pipeline[10](index=10&type=chunk) [Legal Disclosures and Contact Information](index=3&type=section&id=Legal%20Disclosures%20and%20Contact%20Information) This section provides important legal disclaimers regarding forward-looking statements and investigational therapies, along with contact information [Forward-Looking Statements](index=3&type=section&id=Forward-Looking%20Statements) This section outlines the forward-looking nature of certain statements in the press release, emphasizing that they are based on current expectations and subject to various risks and uncertainties that could cause actual results to differ materially - The press release contains forward-looking statements regarding therapeutic potential, safety profile, expected timing for data reports, regulatory interactions, and financial resources[12](index=12&type=chunk) - These statements are based on current expectations and are subject to risks and uncertainties, including delays in development, patient enrollment, interpretation of results, safety/efficacy concerns, adverse regulatory outcomes, increased expenses, and dependence on third parties[13](index=13&type=chunk)[14](index=14&type=chunk) - PepGen explicitly disclaims any obligation to update forward-looking statements except as required by law[14](index=14&type=chunk) [Investigational Therapies Disclaimer](index=4&type=section&id=Investigational%20Therapies%20Disclaimer) A disclaimer stating that PGN-EDODM1 and PGN-EDO51 are investigational therapies not yet approved, and there is no guarantee of their successful clinical development or regulatory approval - PGN-EDODM1 and PGN-EDO51 are investigational therapies not approved for use in any country, and this release is not intended to convey conclusions about their efficacy or safety[15](index=15&type=chunk) - There is no guarantee that any investigational therapy will successfully complete clinical development or gain regulatory authority approval[15](index=15&type=chunk) [Investor and Media Contacts](index=4&type=section&id=Investor%20Contact) Contact information for investor and media inquiries - Investor Contact: Laurence Watts, New Street Investor Relations, laurence@newstreetir.com[15](index=15&type=chunk) - Media Contact: Julia Deutsch, Lyra Strategic Advisory, LLC, Jdeutsch@lyraadvisory.com[15](index=15&type=chunk)