\nPepGen Inc. (Nasdaq: PEPG), a clinical-stage biotechnology company advancing the next generation of oligonucleotide therapies with the goal of transforming the treatment of severe neuromuscular and neurological diseases, today reported financial results and recent corporate highlights for the quarter ended March 31, 2026, and recent corporate highlights.<\/p>\n
\n“We made encouraging progress during the first quarter of 2026 in our FREEDOM2-DM1 trial. The 5 mg\/kg cohort \u2014 the initial dose cohort \u2014 demonstrated a favorable tolerability profile and promising efficacy trends, reinforcing our confidence in PGN-EDODM1’s potential at higher doses,” said James McArthur, PhD, President and Chief Executive Officer of PepGen. “Enrollment in the 10 mg\/kg cohort is now complete and we remain on track to report data in the second half of this year. With funding in place through the 10 and 12.5 mg\/kg cohorts, we are well positioned to continue dose escalating and deliver on the promise of this program for the DM1 community.”<\/p>\n
Recent Program Updates<\/b><\/p>\n
PGN-EDODM1: Myotonic Dystrophy Type 1 (DM1)<\/span><\/b><\/p>\n Financial Results for the Three Months Ended March 31, 2026<\/span><\/b><\/p>\n About PGN-EDODM1<\/b><\/p>\n \nPGN-EDODM1, PepGen’s investigational candidate in development for the treatment of DM1, utilizes the Company’s proprietary EDO technology to deliver a therapeutic oligonucleotide that is designed to restore the normal splicing function of MBNL1, a key RNA splicing protein. PGN-EDODM1 addresses the deleterious effects of cytosine-uracil-guanine (CUG) repeat expansion in the dystrophia myotonica protein kinase (DMPK<\/i>) transcripts which sequester MBNL1, by binding to the pathogenic CUG trinucleotide repeat expansion present in the DMPK<\/i> transcripts, and disrupting the binding between the CUG repeat expansion and MBNL1. PepGen believes this innovative therapeutic approach may have considerable advantages over oligonucleotide modalities that rely on knockdown or degradation of the DMPK<\/i> transcripts as it will allow the DMPK<\/i> transcripts to continue to perform their normal function within the cell, while also liberating MBNL1 to correct downstream mis-splicing events. The U.S. Food and Drug Administration has granted PGN-EDODM1 both Orphan Drug and Fast Track Designations for the treatment of patients with DM1.<\/p>\n About Myotonic Dystrophy Type 1 (DM1)<\/b><\/p>\n \nMyotonic dystrophy type 1 (DM1) is a rare, progressive, and highly variable genetic neuromuscular disease caused by an abnormal expansion of cytosine-thymine-guanine (CTG) repeats in the dystrophia myotonica protein kinase (DMPK<\/i>) gene. DM1 affects over 115,000 individuals in the U.S. and EU and is characterized by widespread, multisystem symptoms that may include myotonia, progressive muscle weakness, fatigue, cardiac abnormalities, respiratory impairment, and cognitive dysfunction. The disease is driven by toxic RNA transcripts containing expanded cytosine-uracil-guanine (CUG) repeats that sequester muscleblind-like 1 (MBNL1), a key RNA splicing protein, leading to widespread mis-splicing across multiple tissues. There are currently no approved disease-modifying therapies for DM1, underscoring the significant unmet medical need for patients living with the disease.<\/p>\n About PepGen<\/b><\/p>\n \nPepGen Inc. is a clinical-stage biotechnology company developing the next generation of oligonucleotide therapies with the goal of transforming the treatment of severe neuromuscular and neurological diseases. PepGen\u2019s Enhanced Delivery Oligonucleotide (EDO) platform is founded on over a decade of research and development and leverages cell-penetrating peptides to improve the uptake and activity of conjugated oligonucleotide therapeutics. Using these EDO peptides, the Company is generating a pipeline of oligonucleotide therapeutic candidates designed to target the root cause of serious diseases.<\/p>\n \nFor more information, please visit PepGen.com<\/i><\/a>. Follow PepGen on LinkedIn <\/i><\/a>and X<\/i><\/a>.<\/p>\n Forward-Looking Statements \nAny forward-looking statements in this press release are based on current expectations, estimates and projections only as of the date of this release and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to risks related to: delays or failure to successfully initiate or complete our ongoing and planned development activities for our product candidates, including PGN-EDODM1; our ability to enroll patients in our clinical trials, including FREEDOM2; that our interpretation of clinical and preclinical study results may be incorrect, or that we may not observe the levels of therapeutic activity in clinical testing that we anticipate based on prior clinical or preclinical results, including for PGN-EDODM1; our product candidates, including PGN-EDODM1, may not be safe and effective or otherwise demonstrate safety and efficacy in our clinical trials; adverse outcomes from our regulatory interactions, including delays in regulatory review, clearance to proceed or approval by regulatory authorities with respect to our programs, including release of the partial clinical hold placed by the FDA and\/or clearance to commence planned clinical studies of our product candidates, or other regulatory feedback requiring modifications to our development programs, including in each case with respect to our FREEDOM2 program; changes in regulatory framework that are out of our control; unexpected increases in the expenses associated with our development activities or other events that adversely impact our financial resources and cash runway; and our dependence on third parties for some or all aspects of our product manufacturing, research and preclinical and clinical testing. Additional risks concerning PepGen\u2019s programs and operations are described in our most recent reports filed with the SEC. PepGen explicitly disclaims any obligation to update any forward-looking statements except to the extent required by law.<\/p>\n \nThis release discusses PGN-EDODM1, an investigational therapy that has not been approved for use in any country, and is not intended to convey conclusions about its efficacy or safety. There is no guarantee that PGN-EDODM1 or any other investigational therapy will successfully complete clinical development or gain regulatory authority approval.<\/p>\n Condensed Consolidated Statements of Operations<\/b><\/p>\n \n(unaudited, in thousands)<\/p>\n<\/td>\n<\/tr>\n Three Months Ended \n\u00a0<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n 2026<\/b><\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n 2025<\/b><\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n<\/tr>\n \nOperating expenses:<\/p>\n<\/td>\n \nResearch and development<\/p>\n<\/td>\n \n$<\/p>\n<\/td>\n \n13,004<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n$<\/p>\n<\/td>\n \n25,378<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n<\/tr>\n \nGeneral and administrative<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n5,938<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n5,943<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n<\/tr>\n \nTotal operating expenses<\/p>\n<\/td>\n \n$<\/p>\n<\/td>\n \n18,942<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n$<\/p>\n<\/td>\n \n31,321<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n<\/tr>\n \nOperating loss<\/p>\n<\/td>\n \n$<\/p>\n<\/td>\n \n(18,942<\/p>\n<\/td>\n \n)<\/p>\n<\/td>\n \n$<\/p>\n<\/td>\n \n(31,321<\/p>\n<\/td>\n \n)<\/p>\n<\/td>\n<\/tr>\n \nOther income (expense)<\/p>\n<\/td>\n \nInterest income<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n1,250<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n1,122<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n<\/tr>\n \nOther (expense) income, net<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n(56<\/p>\n<\/td>\n \n)<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n(3<\/p>\n<\/td>\n \n)<\/p>\n<\/td>\n<\/tr>\n \nTotal other income, net<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n1,194<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n1,119<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n<\/tr>\n \nNet loss before income tax<\/p>\n<\/td>\n \n$<\/p>\n<\/td>\n \n(17,748<\/p>\n<\/td>\n \n)<\/p>\n<\/td>\n \n$<\/p>\n<\/td>\n \n(30,202<\/p>\n<\/td>\n \n)<\/p>\n<\/td>\n<\/tr>\n \nIncome tax expense<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n(15<\/p>\n<\/td>\n \n)<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n\u2014<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n<\/tr>\n \nNet loss<\/p>\n<\/td>\n \n$<\/p>\n<\/td>\n \n(17,763<\/p>\n<\/td>\n \n)<\/p>\n<\/td>\n \n$<\/p>\n<\/td>\n \n(30,202<\/p>\n<\/td>\n \n)<\/p>\n<\/td>\n<\/tr>\n \nNet loss per share, basic and diluted<\/p>\n<\/td>\n \n$<\/p>\n<\/td>\n \n(0.26<\/p>\n<\/td>\n \n)<\/p>\n<\/td>\n \n$<\/p>\n<\/td>\n \n(0.92<\/p>\n<\/td>\n \n)<\/p>\n<\/td>\n<\/tr>\n \nWeighted-average common stock outstanding, basic and diluted<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n69,091,100<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n \n32,674,720<\/p>\n<\/td>\n \n\u00a0<\/p>\n<\/td>\n<\/tr>\n<\/table>\n\n
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<\/b>This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. These statements may be identified by words such as \u201caims,\u201d \u201canticipates,\u201d \u201cbelieves,\u201d \u201ccould,\u201d \u201cestimates,\u201d \u201cexpects,\u201d \u201cforecasts,\u201d \u201cgoal,\u201d \u201cintends,\u201d \u201cmay,\u201d \u201cplans,\u201d \u201cpossible,\u201d \u201cpotential,\u201d \u201cseeks,\u201d \u201cwill,\u201d and variations of these words or similar expressions that are intended to identify forward-looking statements. Any such statements in this press release that are not statements of historical fact may be deemed to be forward-looking statements. These forward-looking statements include, without limitation, statements regarding the therapeutic potential and safety profile of PGN-EDODM1 based on data from the 5, 10 and 15 mg\/kg cohorts of the single dose FREEDOM-DM1 study and data from 5 mg\/kg cohort of the multi-dose FREEDOM2-DM1 study, expected timelines for data reports from our FREEDOM2-DM1 trial, forecasts relating to PepGen\u2019s cash runway, and ongoing and planned regulatory interactions, including the potential timing and successful resolution of questions from the FDA relating to the partial clinical hold.<\/p>\n\n
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