PresentationI would now like to hand the conference call over to Laurence Watts of New Street Investor Relations. Please go ahead.Welcome to the PepGen conference call to discuss top line results from lowest dose MAD cohort in the Phase II FREEDOM2 study, demonstrating promising safety, splicing and vHOT data. [Operator Instructions] As a reminder, this call is being recorded today, Monday, March 30, 2026.Laurence Watts Thank you, operator. Joining us on the call today from PepGen are President and Chief Ex ...

Core Viewpoint - Johnson Fistel, PLLP is investigating potential claims on behalf of investors of PepGen Inc. regarding possible violations of federal securities laws by the company or its executives [1]. Group 1: Investigation Details - The investigation was initiated after PepGen disclosed that the FDA placed a partial clinical hold on its FREEDOM2-DM1 Phase 2 clinical trial due to concerns related to preclinical pharmacology and toxicology studies [3]. - Following the announcement of the clinical hold, PepGen's stock price experienced a sharp decline during intraday trading on March 5, 2026, indicating investor reaction to the regulatory development and uncertainty surrounding the clinical program [4]. Group 2: Investor Information - Investors who purchased PepGen securities and suffered losses are encouraged to join the investigation and can contact Johnson Fistel for more information [2][4]. - Johnson Fistel is a nationally recognized law firm that represents individual and institutional investors in securities class action lawsuits [5].

Core Viewpoint - The U.S. FDA has placed a partial clinical hold on PepGen's midstage trial for its muscle disease drug PGNEDODM1, leading to a significant drop in the company's shares by over 25% in extended trading [1]. Company Summary - PepGen is developing PGNEDODM1 for myotonic dystrophy type 1, a genetic condition that causes muscle weakness and tightening over time [1]. - The FDA's concerns are based on earlier laboratory and animal studies submitted by PepGen, but no safety issues were raised from patient data in an early-stage study [1]. - PepGen is collaborating with the FDA to address the concerns and plans to submit additional information, including new data from the earlier study [1]. - While the U.S. trial is on hold, PepGen has received approval to initiate the study in South Korea, Australia, and New Zealand [1]. - Patients in the UK and Canada are currently being treated at a 10 mg/kg dose, following a recommendation from an independent safety board for dose escalation [1]. - As of December 31, 2025, PepGen reported having $148.5 million in cash and investments, sufficient to fund operations into the second half of 2027 [1].

Financial Performance - The company reported net losses of $89.7 million and $90.0 million for the years ended December 31, 2025 and 2024, respectively, with an accumulated deficit of $361.1 million as of December 31, 2025[211]. - The company currently generates no revenue from product sales and does not expect to generate product revenue for many years, if ever[230]. - The company anticipates that its operating expenses will increase substantially as it continues research and development activities and seeks marketing approvals[218]. - The company may need to raise substantial additional funding to support its operations and product development programs, with potential risks if funding is not secured[223]. - Any delays or inability to obtain marketing approvals could restrict the company's ability to generate revenue and achieve profitability[332]. Clinical Trials and Development - The company has initiated a Phase 1 and a Phase 2 clinical trial for its lead product candidate PGN-EDODM1, with ongoing clinical trials including FREEDOM and FREEDOM2[209]. - The company has invested in developing its EDO platform and currently has two product candidates in clinical trials: PGN-EDODM1 for DM1 and PGN-EDO51 for DMD[229]. - The company has initiated Phase 1 and Phase 2 clinical trials for PGN-EDODM1, but the outcomes of these trials remain uncertain[247]. - The FREEDOM2 trial has concluded enrollment of the 5 mg/kg cohort and has begun dosing the 10 mg/kg cohort in Canada and the U.K.[229]. - The company has reported that the success of its product candidates will depend on timely completion of preclinical studies and obtaining regulatory approvals[232]. Regulatory and Compliance Challenges - The company has not received marketing approval for any product candidates from regulatory authorities in any jurisdiction[323]. - The FDA may require additional costly clinical trials or impose limitations on the approved indications for product candidates, which could adversely impact commercial viability[329]. - The company may face delays or denials in obtaining marketing approvals from the FDA or foreign regulatory authorities due to various factors, including trial design and safety profiles[329]. - Regulatory authorities impose stringent restrictions on the marketing and promotion of medicines, which could lead to product recalls or withdrawal from the market[347]. - The company is subject to numerous environmental, health, and safety laws, and non-compliance could result in significant fines or operational disruptions[357]. Manufacturing and Supply Chain Risks - The company is focused on establishing manufacturing sources and securing supply chain capacity for its product candidates[214]. - The company relies on third parties for manufacturing and clinical testing, which may lead to delays and increased expenses if replacements are needed[283]. - The company is dependent on a limited number of third-party suppliers for the manufacture of product candidates, which poses risks of supply disruptions and delays in clinical trials[289]. - The company does not currently have plans to develop its own manufacturing capabilities and relies entirely on third-party manufacturers for compliance with regulatory requirements[290]. - The company faces challenges in finding alternative suppliers for critical components, which could lead to significant delays and increased costs if current suppliers fail to meet contractual obligations[301]. Competition and Market Dynamics - The company faces significant competition in securing collaborations, which may limit its ability to implement strategies and develop product candidates[307]. - Competitors could file Abbreviated New Drug Applications (ANDAs) for generic versions of the company's products once approved, potentially impacting market share[407]. - The FDA's determination of exclusivity could significantly influence the timing of generic product approvals and market entry[406]. - The marketing approval process is expensive and time-consuming, with a small percentage of products successfully completing the FDA and EMA approval processes[325]. - The company may face competition from generic manufacturers if its product candidates are approved with only New Clinical Investigation (NCI) exclusivity[405]. Risks Related to Clinical Trials - The company may encounter significant delays in patient enrollment for clinical trials, which could adversely affect the completion of these trials[237]. - Conducting clinical trials in foreign countries presents risks that may delay completion, including adherence to clinical protocols and managing regulatory burdens[256]. - The company may face significant risks related to clinical trial and product liability exposure, which could divert resources and limit commercialization of product candidates[276]. - The company has faced challenges in transitioning from a research-focused entity to one capable of conducting multiple clinical development activities and supporting commercialization[228]. - The company acknowledges that drug development is a lengthy and expensive process, with high risks of failure in demonstrating safety and efficacy[245]. Data Privacy and Cybersecurity - Data protection and privacy laws are evolving, and non-compliance could result in fines up to 4% of global revenues or €20 million, adversely affecting the company's financial results[381]. - The use of artificial intelligence (AI) presents cybersecurity and data privacy risks, potentially exposing the company to reputational harm and liability[396]. - The FTC and state Attorneys General are actively reviewing privacy and data security protections, with potential penalties for failing to secure consumer personal information[387]. - Compliance with GDPR and similar laws requires significant resources and may interrupt or delay development and commercialization activities, potentially leading to increased costs and government enforcement actions[385]. - The introduction of new comprehensive privacy laws may require additional investment in compliance programs and could increase compliance costs and legal risks[390].

Financial Performance - The net loss for Q4 2025 was $18.3 million, or $(0.27) per share, compared to a net loss of $22.2 million, or $(0.68) per share in Q4 2024; total net loss for 2025 was $89.7 million, or $(2.12) per share, compared to $90.0 million, or $(2.85) per share in 2024[10] - Net loss for the twelve months ended December 31, 2025, was $89,655,000, compared to a net loss of $89,981,000 in 2024, indicating a slight improvement[20] - Net loss per share, basic and diluted, improved to $(2.12) in 2025 from $(2.85) in 2024[20] Cash and Assets - As of December 31, 2025, PepGen had $148.5 million in cash, sufficient to fund operations into the second half of 2027[10] - Cash, cash equivalents, and marketable securities increased to $148,456,000 as of December 31, 2025, up from $120,191,000 in 2024, representing a growth of 23.4%[22] - Total assets rose to $173,907,000 in 2025, compared to $150,883,000 in 2024, marking an increase of 15.3%[22] - Liabilities decreased to $26,463,000 in 2025 from $32,263,000 in 2024, a reduction of 17.9%[22] - Stockholders' equity increased to $147,444,000 in 2025, up from $118,620,000 in 2024, reflecting a growth of 24.3%[22] Expenses - Research and Development Expenses for Q4 2025 were $13.9 million, down from $19.0 million in Q4 2024; total R&D expenses for 2025 were $71.0 million, compared to $76.5 million in 2024[10] - General and Administrative Expenses for Q4 2025 were $5.9 million, compared to $5.4 million in Q4 2024; total G&A expenses for 2025 were $22.6 million, up from $21.3 million in 2024[10] - Total operating expenses for the twelve months ended December 31, 2025, were $93,612,000, a decrease of 4.3% from $97,739,000 in 2024[20] - Research and development expenses decreased to $71,043,000 from $76,478,000, reflecting a reduction of 7.1% year-over-year[20] Clinical Trials and Studies - The FREEDOM2 trial is currently dosing patients in the 10 mg/kg cohort, with four patients dosed so far; results from this cohort are expected in the second half of 2026[3] - The FREEDOM-DM1 study showed mean splicing correction levels of 12.3%, 29.1%, and 53.7% at doses of 5 mg/kg, 10 mg/kg, and 15 mg/kg, respectively[5] - The FDA has placed a partial clinical hold on the FREEDOM2 study, related to preclinical pharmacology and toxicology studies, but not on blinded clinical data[6] - PepGen has amended the FREEDOM2 protocol to allow dosing up to 12.5 mg/kg based on prior results[6] Leadership and Intellectual Property - The company appointed Joseph Vittiglio as Chief Business and Legal Officer in December 2025, bringing over two decades of experience in biotechnology[10] - A new composition of matter patent for PGN-EDODM1 was issued by the USPTO, expected to provide exclusivity until the second half of 2042[10] Income - Interest income for the twelve months ended December 31, 2025, was $4,017,000, down from $7,142,000 in 2024, a decline of 43.5%[20] - Total other income, net, decreased to $4,006,000 in 2025 from $7,141,000 in 2024, a decrease of 43.9%[20]

Company Presentation March 2026 Forward-Looking Statements This presentation 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 "aims," "anticipates," "believes," "could," "estimates," "expects," "forecasts," "goal," "intends," "may," "plans," "possible," "potential," "seeks," "will," and variations of these words or similar expressions that are intended to identify forward-looking st ...

Core Viewpoint - PepGen, Inc. (PEPG) has seen a 22.6% increase in share price over the past four weeks, closing at $5.7, with a mean price target of $10 indicating a potential upside of 75.4% according to Wall Street analysts [1] Price Targets and Analyst Estimates - The mean estimate consists of six short-term price targets with a standard deviation of $5.83, where the lowest estimate is $3.00 (47.4% decline) and the highest is $20.00 (250.9% increase) [2] - A low standard deviation suggests a high degree of agreement among analysts regarding the stock's price movement, which can serve as a starting point for further research [9] Earnings Estimates and Analyst Sentiment - Analysts have shown increasing optimism about PEPG's earnings prospects, with a strong consensus on higher EPS estimates, which correlates with potential stock price increases [11] - In the last 30 days, four earnings estimates have been revised upward, leading to an 11% increase in the Zacks Consensus Estimate for the current year [12] Zacks Rank and Investment Potential - PEPG holds a Zacks Rank 2 (Buy), placing it in the top 20% of over 4,000 ranked stocks based on earnings estimate factors, indicating strong potential for upside [13] - While consensus price targets may not be entirely reliable, the implied direction of price movement appears to be a useful guide for investors [14]

Market Overview - U.S. stock futures showed mixed results, with Dow futures decreasing approximately 0.1% on Monday [1] Company-Specific Movements - Meihua International Medical Technologies Co., Ltd. (NASDAQ:MHUA) announced its delisting from Nasdaq, leading to a significant pre-market decline of 32.9%, bringing shares down to $9.41 [1] - SMX (Security Matters) Public Limited Company (NASDAQ:SMX) shares fell 17.2% to $275.00 after a substantial increase of 135% on the previous Friday [3] - Gulf Resources, Inc. (NASDAQ:GURE) saw a decline of 16.1% to $6.87 following a 4% drop on Friday [3] - Wheeler Real Estate Investment Trust, Inc. (NASDAQ:WHLR) shares decreased by 16.1% to $5.35 after a notable surge of 98% on Friday [3] - Fly-E Group, Inc. (NASDAQ:FLYE) experienced a 14.4% drop to $7.08 after receiving a delinquency notice from Nasdaq regarding a delayed Form 10-Q [3] - Ecarx Holdings Inc. (NASDAQ:ECX) shares fell 9.1% to $1.91 after an 8% gain on Friday [3] - Arteris Inc (NASDAQ:AIP) saw a decline of 7.1% to $16.30 in pre-market trading [3] - Veracyte Inc (NASDAQ:VCYT) shares decreased by 5.7% to $42.06 after a 6% decline on Friday [3] - Chagee Holdings Ltd (NASDAQ:CHA) shares fell 4.6% to $13.91 in pre-market trading [3] - PureTech Health PLC (NASDAQ:PRTC) experienced a 4.2% decline to $17.30, despite announcing a successful end-of-Phase 2 meeting with the FDA for Deupirfenidone (LYT-100) in Idiopathic Pulmonary Fibrosis [3] - PepGen Inc (NASDAQ:PEPG) shares declined by 3.9% to $5.23 in pre-market trading [3]

Market Overview - U.S. stock futures showed mixed results, with Dow futures decreasing approximately 0.1% on Monday [1] Company-Specific Movements - Meihua International Medical Technologies Co., Ltd. (NASDAQ:MHUA) announced its delisting from Nasdaq, leading to a significant pre-market decline of 32.9%, bringing shares down to $9.41 [1] - SMX (Security Matters) Public Limited Company (NASDAQ:SMX) shares fell 17.2% to $275.00 after a substantial increase of 135% on the previous Friday [3] - Gulf Resources, Inc. (NASDAQ:GURE) saw a decline of 16.1% to $6.87 following a 4% drop on Friday [3] - Wheeler Real Estate Investment Trust, Inc. (NASDAQ:WHLR) shares decreased by 16.1% to $5.35 after surging 98% on Friday [3] - Fly-E Group, Inc. (NASDAQ:FLYE) experienced a 14.4% drop to $7.08 after receiving a delinquency notice from Nasdaq regarding a delayed Form 10-Q [3] - Ecarx Holdings Inc. (NASDAQ:ECX) shares fell 9.1% to $1.91 after an 8% gain on Friday [3] - Arteris Inc (NASDAQ:AIP) saw a decline of 7.1% to $16.30 in pre-market trading [3] - Veracyte Inc (NASDAQ:VCYT) shares decreased by 5.7% to $42.06 after a 6% decline on Friday [3] - Chagee Holdings Ltd (NASDAQ:CHA) shares fell 4.6% to $13.91 in pre-market trading [3] - PureTech Health PLC (NASDAQ:PRTC) declined 4.2% to $17.30 despite announcing a successful end-of-Phase 2 meeting with the FDA for Deupirfenidone (LYT-100) in Idiopathic Pulmonary Fibrosis [3] - PepGen Inc (NASDAQ:PEPG) shares decreased by 3.9% to $5.23 in pre-market trading [3]

Core Insights - Passage Bio and PepGen are small-cap medical companies being compared based on various financial and operational metrics to determine which stock is more favorable [1][3][4]. Institutional Ownership - Passage Bio has 53.5% of its shares owned by institutional investors, while PepGen has 58.0% [1]. - Insider ownership stands at 5.0% for Passage Bio and 5.2% for PepGen, indicating a similar level of insider investment [1]. Analyst Ratings - Passage Bio has a consensus target price of $42.67, suggesting a potential upside of 363.26% [3][4]. - PepGen's consensus target price is $10.00, indicating a potential upside of 83.82% [3][4]. - Passage Bio has a stronger consensus rating with a score of 2.50 compared to PepGen's score of 2.33 [3]. Earnings and Valuation - Passage Bio reported a net income of -$64.77 million with an earnings per share (EPS) of -$14.40 [5]. - PepGen's net income is -$89.98 million with an EPS of -$2.82 [5]. - Passage Bio has a higher price-to-earnings ratio compared to PepGen, which is currently trading at a lower valuation [5]. Profitability - Passage Bio has a net margin of -102.09% and a return on equity of -52.97% [6]. - PepGen's net margin is -84.15% with a return on equity of -65.59% [6]. Risk & Volatility - Passage Bio has a beta of 1.86, indicating it is 86% more volatile than the S&P 500 [7]. - PepGen has a beta of 1.91, meaning it is 91% more volatile than the S&P 500 [7]. Summary - PepGen outperforms Passage Bio in 6 out of 11 factors compared [8].