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PEPG on Nasdaq

PepGen Inc.

PepGen Inc. is an American pharmaceutical preparations company, incorporated in Delaware.1 It is headquartered in Boston, Massachusetts.1

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Last updated Oct 21, 2026.

Overview

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  • TickerPEPG on Nasdaq1
  • IndustryPharmaceutical Preparations1
  • HeadquartersBoston, Massachusetts1
  • Incorporated inDE2
  • Business address1 Marina Park Drive, Suite 900, Boston, Ma 022102
  • Filer category, Emerging growth company2

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PepGen Inc. (also referred to as “PepGen,” “we,” “our” or “us”) is a clinical-stage biotechnology company advancing the next generation of oligonucleotide therapeutics with the goal of transforming the treatment of severe neuromuscular and neurologic diseases. Our proprietary Enhanced Delivery Oligonucleotide, or EDO, platform is founded on over a decade of research and development and leverages cell-penetrating peptides, or CPPs, to improve the uptake and activity of conjugated oligonucleotide therapeutics. Our EDO peptides are engineered to optimize tissue penetration, cellular uptake and nuclear delivery, and in preclinical studies, we have observed their ability to transport oligonucleotides into a broad range of target tissues, including smooth, skeletal, and cardiac muscle. In our clinical trials to date, our investigational therapies have demonstrated robust delivery and activity …3 From its latest annual report

Financials

From the company’s reports to the SEC. Every number links to the filing it came from.

Financial statements

Operating income4567-$93.6M in 2025+245% since 2021
-$100.0M-$75.0M-$50.0M-$25.0M02021: -$27.1M-$27.1M20212022: -$68.3M-$68.3M2022+152%2023: -$84.8M-$84.8M2023+24%2024: -$97.7M-$97.7M2024+15%2025: -$93.6M-$93.6M2025−4%
Net income4567-$89.7M in 2025+229% since 2021
-$100.0M-$75.0M-$50.0M-$25.0M02021: -$27.3M-$27.3M20212022: -$69.1M-$69.1M2022+153%2023: -$78.6M-$78.6M2023+14%2024: -$90.0M-$90.0M2024+14%2025: -$89.7M-$89.7M2025−0%

Every line of the income statement as filed: the last 3 fiscal years, latest first.7

Period ending2025-12-312024-12-312022-12-31
Research and development$71.0M$76.5M
General and administrative$22.6M$21.3M
Total operating expenses$93.6M$97.7M
Operating loss-$93.6M-$97.7M
Interest income$4.0M$7.1M
Other (expense) income, net-$11.0K-$1.0K
Total other income, net$4.0M$7.1M
Net loss before income tax-$89.6M-$90.6M
Income tax (expense) benefit-$48.9K$617.0K-$3.7M
Net loss-$89.7M-$90.0M
Net loss per share, basic-$2.12-$2.85
Net loss per share, diluted-$2.12-$2.85
Weighted-average common shares outstanding, basic42.2M shares31.6M shares
Weighted-average common shares outstanding, diluted42.2M shares31.6M shares
Cumulative translation adjustment arising during the period$0-$50.0K
Unrealized (loss) gain on marketable securities-$12.0K$39.0K
Comprehensive loss-$89.7M-$90.0M

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Corporate structure

PepGen Inc. sits at the top of its group. 1 entity, 1 country on record. Switch between the flow chart and the network, and select any entity to see its details.

Major holders of PepGen Inc.

  • PepGen Inc. Boston, Massachusetts

Built from major holders from Schedules 13D and 13G. Each entity in the chart links to its source.

What it owns

What PepGen Inc. reports owning in its annual reports to the SEC: buildings, land and equipment, real estate and locations, investments, intangible assets and inventory, at the end of its latest fiscal year and a year before.

Property and equipment

ItemLatestA year beforeChange
Property and equipment, before depreciation$5.8M7 Dec 31, 2025$6.8M7 Dec 31, 2024−14.0%
Accumulated depreciation$3.9M7 Dec 31, 2025$3.0M7 Dec 31, 2024+28.4%
Property and equipment, net$1.9M7 Dec 31, 2025$3.7M7 Dec 31, 2024−48.8%
Operating-lease assets (leased space)$19.1M7 Dec 31, 2025$21.4M7 Dec 31, 2024−10.8%

Investments

ItemLatestA year beforeChange
Cash and cash equivalents$60.5M7 Dec 31, 2025$49.4M7 Dec 31, 2024+22.4%
Marketable securities, current$87.9M7 Dec 31, 2025$70.8M7 Dec 31, 2024+24.3%
Debt securities available for sale$87.9M7 Dec 31, 2025$70.8M7 Dec 31, 2024+24.3%

Properties, in its own words

Our principal facility is located at 321 Harrison Ave, Boston, Massachusetts, where we lease and occupy approximately 31,668 square feet of office and laboratory space. The lease was signed on December 1, 2021 and the lease term commenced on December 29, 2022. The current term of our lease expires in May 2032, with an option to extend the lease for one successive five-year term. We believe our facilities are adequate and suitable for our current needs and that should it be needed, suitable additional or alternative space will be available to accommodate our operations.

Item 2 of the 10-K filed Mar 4, 2026.3

Leadership

Who has led PepGen Inc., and when. Pick a name to see everywhere that person has worked.

Chief executive

  1. James G. McArthur2022–now

President

  1. James G. McArthur2022–now

Chief financial officer

  1. Noel Donnelly2022–now
2025
Board members and other officers (18)

Timeline

  1. Aug 6, 20268-K Results of operations; Regulation FD disclosure; Other events28
  2. Jun 22, 20268-K Shareholder vote29
  3. May 21, 20268-K Regulation FD disclosure30
  4. May 12, 20268-K Results of operations31
  5. Mar 30, 20268-K Regulation FD disclosure; Other events32
  6. Mar 4, 20268-K Results of operations; Other events33
  7. Mar 4, 20268-K Regulation FD disclosure34
  8. Dec 8, 20258-K Other events35
  9. Nov 12, 20258-K Results of operations36
  10. Nov 7, 20258-K Executive or director change37
  11. Oct 1, 20258-K Regulation FD disclosure38
  12. Sep 26, 20258-K Entered a material agreement; Other events39
  13. May 5, 2022New chief executive James G. McArthur becomes CEO10

Calendar

Coming up

  1. Nov 11, 2026Reports results for the quarter ending Sep/2026 A year earlier it reported ($0.52) a share, on Nov 12, 2025.40

When it reported results

  1. Aug 6, 2026Reported quarterly or annual results28
  2. May 12, 2026Reported quarterly or annual results31
  3. Mar 4, 2026Reported quarterly or annual results33
  4. Nov 12, 2025Reported quarterly or annual results36
  5. Aug 7, 2025Reported quarterly or annual results41
  6. May 8, 2025Reported quarterly or annual results42
  7. Feb 24, 2025Reported quarterly or annual results43
  8. Nov 7, 2024Reported quarterly or annual results44

Drug trials and FDA: coming up

  1. Mar 2027Phase 2 trial readout expected Phase 2 trial of PGN-EDODM1 in Myotonic Dystrophy 1: primary completion expected Mar 2027 (ClinicalTrials.gov NCT06667453).45

Upcoming dates from Nasdaq's calendar; past results from the company's 8-K filings (Item 2.02). Trials from ClinicalTrials.gov, as the sponsor registered them (expected dates are the sponsor's own and often move); approvals and advisory committee meetings from the FDA. The FDA does not publish its decision (PDUFA) dates. The full markets calendar

Filings

302 filings to the SEC since October 2021: 5 annual reports, 14 quarterly reports, 65 major events, 121 insider forms, 33 large holders, 64 other. The latest 20:

  1. Aug 6, 20268-K EDGAR
  2. Aug 6, 202610-Q EDGAR
  3. Jun 22, 20264 PRIMARY DOCUMENT EDGAR
  4. Jun 22, 20264 PRIMARY DOCUMENT EDGAR
  5. Jun 22, 20264 PRIMARY DOCUMENT EDGAR
  6. Jun 22, 20264 PRIMARY DOCUMENT EDGAR
  7. Jun 22, 20264 PRIMARY DOCUMENT EDGAR
  8. Jun 22, 20264 PRIMARY DOCUMENT EDGAR
  9. Jun 22, 20264 PRIMARY DOCUMENT EDGAR
  10. Jun 22, 20264 EDGAR
  11. Jun 22, 20268-K EDGAR
  12. May 26, 20264 EDGAR
  13. May 21, 2026EFFECT EDGAR
  14. May 21, 20268-K EDGAR
  15. May 19, 2026CORRESP EDGAR
  16. May 18, 2026S-3 EDGAR
  17. May 15, 2026SCHEDULE 13G/A EDGAR
  18. May 15, 2026SCHEDULE 13G/A EDGAR
  19. May 12, 20268-K EDGAR
  20. May 12, 202610-Q EDGAR

The 302 filings since October 2021 can be filtered by form type and year here when JavaScript is on.

Every filing from the last five years, summarized. The full record is on SEC EDGAR.

Insider trades

39 open-market trades by officers, directors and large owners since October 2021: 11 buys and 28 sales. Grants, option exercises and gifts are left out.

DateWhoTradeSharesPriceValueFiling
May 21, 2026Kasraian KasraChief Technical OfficerSale1,233$1.41$1.7KForm 4
Mar 4, 2026STRECK PAULEVP, Head of R&DSale1,879$6.23$11.7KForm 4
Mar 4, 2026Donnelly NoelChief Financial OfficerSale2,084$6.23$13.0KForm 4
Mar 4, 2026McArthur James GPresident and CEOSale5,275$6.23$32.9KForm 4
Sep 30, 2025Oxford Science Enterprises plcBuy200,000$3.20$640.0KForm 4
Sep 26, 2025RA Capital Healthcare Fund LPDirectorBuy9,375,000$3.20$30.0MForm 4
May 30, 2025STRECK PAULEVP, Head of R&DBuy8,375$1.24$10.4KForm 4
Apr 17, 2025McArthur James GPresident and CEOBuy10,000$1.36$13.6KForm 4
Apr 8, 2025McArthur James GPresident and CEOBuy41,500$1.15$47.7KForm 4
Feb 26, 2025DeLena Mary BethGeneral CounselSale1,432$1.68$2.4KForm 4
Feb 26, 2025Donnelly NoelChief Financial OfficerSale1,527$1.68$2.6KForm 4
Jul 25, 2024Mellion Michelle LChief Medical OfficerSale7,571$18.06$136.7KForm 4
Jul 24, 2024Mellion Michelle LChief Medical OfficerSale201$18.01$3.6KForm 4
Jul 18, 2024Mellion Michelle LChief Medical OfficerSale12,625$18.20$229.8KForm 4
Jul 16, 2024Mellion Michelle LChief Medical OfficerSale5,901$18.00$106.2KForm 4
Jul 12, 2024Mellion Michelle LChief Medical OfficerSale3,288$18.04$59.3KForm 4
Jul 2, 2024Mellion Michelle LChief Medical OfficerSale37$18.07$669Form 4
Jul 1, 2024Mellion Michelle LChief Medical OfficerSale875$18.01$15.8KForm 4
Jun 24, 2024Mellion Michelle LChief Medical OfficerSale9,260$18.19$168.4KForm 4
Jun 12, 2024Mellion Michelle LChief Medical OfficerSale1,086$18.06$19.6KForm 4

All 39 trades can be filtered by person here when JavaScript is on.

From Forms 4 filed with the SEC.

Major holders

Investors who own more than 5% of the shares must tell the SEC: a 13D if they may seek to influence the company, a 13G if they hold passively.

Executive pay

What the company paid its top executives, from the summary compensation table in its proxy statement. Total pay includes salary, bonus, stock and option awards and other pay, as the company valued them.

YearExecutiveAgeSalaryTotal pay
2025James McArthur, Ph.D.President and Chief Executive Officer64$619.0K$3.3M57
2025Noel P. Donnelly, M.B.A.Chief Financial Officer56$487.1K$1.8M57
2025Joseph D. Vittiglio, J.D.Chief Business and Legal Officer54$31.2K$1.3M57
2024James McArthur, Ph.D.President and Chief Executive Officer64$594.9K$4.4M57
2024Noel P. Donnelly, M.B.A.Chief Financial Officer56$468.4K$2.3M57

Held by these funds

The largest holders among investment managers' 13F reports for the quarter ending Jun 30, 2026, the top 25 of 72. Change is in shares since the quarter before.

FundSharesValueShare of the fundChange
Ra Capital Management, L.P.20,064,545$36.1M0.3%No change
Commodore Capital LP4,475,000$8.1M0.5%No change
Viking Global Investors LP3,482,434$6.3M0.0%No change
Laurion Capital Management LP2,750,855$5.0M0.4%No change
ADAR1 Capital Management, LLC2,591,085$4.7M0.2%+983,447
Vivo Capital, LLC2,325,000$4.2M0.4%No change
Vanguard Capital Management LLC1,935,920$3.5M0.0%−1,779
Millennium Management LLC1,786,765$3.2M0.0%−292,378
Renaissance Technologies LLC1,520,246$2.7M0.0%+1,463,446
BlackRock, Inc.1,304,262$2.3M0.0%+26,478
Marshall Wace, Llp866,992$1.6M0.0%+568,424
Citadel Advisors LLC658,381$1.2M0.0%+450,459
AWM Investment Company, Inc.600,000$1.1M0.1%−1,230,925
Monimus Capital Management, LP587,688$1.1M0.3%−10,975
Squarepoint Ops LLC529,083$952.3K0.0%+382,487
Geode Capital Management, LLC523,473$942.8K0.0%−12,526
Creek Drive Management Group LLC450,000$810.0K0.5%No change
Ikarian Capital, LLC447,165$804.9K0.1%No change
Diadema Partners LP373,284$671.9K0.3%+222,359
Boothbay Fund Management, LLC366,141$659.1K0.0%+14,767
Rosalind Advisors, Inc.350,000$630.0K0.2%New
Driehaus Capital Management LLC279,909$503.8K0.0%No change
Boxer Capital Management, LLC272,892$491.2K0.0%No change
Vanguard Fiduciary Trust Co261,476$470.7K0.0%+1,779
XTX Topco Ltd245,347$441.6K0.0%+114,196

13F reports cover disclosed long positions in U.S. stocks only.

SEC filer profile

How PepGen Inc. is registered with the Securities and Exchange Commission, from its EDGAR record and the cover page of its latest annual report.

  • Name on EDGARPepGen Inc.1
  • CIK0001835597
  • Employer ID (EIN)85-38198863
  • Filer statusNon-accelerated filer an emerging growth company; a smaller reporting company; not a shell company3
  • Incorporated inDelaware3
  • Fiscal year endsDecember 311
  • Industry code (SIC)2834 Pharmaceutical Preparations1
  • SEC reviewing officeOffice of Life Sciences, Division of Corporation Finance1
  • Business address1 Marina Park Drive, Suite 900, Boston, MA 022101
  • Phone703-456-80001
  • Shares outstanding69,259,517 as of Aug 2, 20269
  • Public float$16.9M as of Jun 30, 20253
  • AuditorKPMG LLP, San Diego, CA, USA PCAOB ID 185; no auditor attestation of internal control over financial reporting3
  • On EDGAR sinceDec 9, 20201
  • Filings304 in all: 4 (98), 8-K (65), 3 (21), 10-Q (14), SCHEDULE 13G/A (9), CORRESP (8), SC 13G (7), SC 13G/A (7)1
    All 37 form types

    UPLOAD (7), EFFECT (5), S-8 (5), SCHEDULE 13G (5), 10-K (4), 144 (4), 424B5 (4), ARS (4), DEF 14A (4), DEFA14A (4), S-3 (3), SC 13D/A (3), D (2), DRS (2), DRS/A (2), DRSLTR (2), S-1/A (2), SEC STAFF LETTER (2), 10-K/A (1), 3/A (1), 4/A (1), 424B4 (1), 8-A12B (1), CERT (1), POS AM (1), PRE 14A (1), S-1 (1), SC 13D (1), SCHEDULE 13D/A (1)

  • Latest filingsAnnual report (10-K) Mar 4, 2026
    Quarterly report (10-Q) Aug 6, 2026
    Proxy statement (DEF 14A) Apr 28, 2026
    Latest 8-K (8-K) Aug 6, 2026

Securities registered for trading

ClassSymbolExchange
Common stock, par value $0.0001 per sharePEPGNasdaq Global Select Market

From the cover page of the 10-K filed Mar 4, 2026 (Section 12(b) of the Exchange Act).3

Risk factors and legal proceedings

The risks PepGen Inc. names in Item 1A of its 10-K filed Mar 4, 2026: 73 risks under these headings, as written.3

  • Risks Related to Our Financial Position and Need for Additional Capital
  • We are substantially dependent on the success of our lead product candidate, PGN-EDODM1. If we are unable to complete development of, obtain approval for and commercialize PGN-EDODM1 in a timely manner or at all, our business will be harmed.
  • We have incurred significant losses since our inception, have no products approved for sale and we expect to incur losses for the foreseeable future.
  • We have never generated revenue from product sales and may never achieve or maintain profitability.
  • We will need to raise substantial additional funding. If we are unable to raise substantial additional funding when needed, we could be forced to delay, scale back or discontinue our product development programs or future commercialization efforts.
  • Our limited operating history may make it difficult for you to evaluate the success of our business to date and to assess our future viability.
  • Risks Related to Discovery, Development, Preclinical and Clinical Testing
  • We are early in our development efforts, having conducted only two Phase 1 and three Phase 2 clinical trials since our inception and as a result it will be years before we commercialize a product candidate, if ever. If we are unable to advance our product candidates through preclinical studies and clinical trials, obtain marketing approval and ultimately commercialize them, or experience significant delays in doing so, our business will be materially harmed.
  • If we experience delays or difficulties in the enrollment of patients in clinical trials, our ability to complete clinical trials may be adversely impacted.
  • Our approach to the discovery and development of product candidates based on our EDO platform is unproven, and we may not be successful in our efforts to identify, discover or develop potential product candidates.
  • Drug development is a lengthy and expensive process, and preclinical and clinical testing is uncertain as to the outcome. We may encounter substantial delays in the commencement, enrollment or completion of our clinical trials and may never advance to clinical trials, or we may fail to demonstrate safety and effectiveness to the satisfaction of applicable regulatory authorities, which could prevent us from advancing or commercializing our product candidates on a timely basis, if at all.
  • The outcome of preclinical studies and earlier-stage clinical trials may not be predictive of future results or the success of later preclinical studies and clinical trials.
The other 63 risks
  • Interim, initial, “topline”, and preliminary data from our preclinical studies or clinical trials that we announce or publish from time to time may change as more patient data become available and are subject to audit and verification procedures that could result in material changes in the final data.
  • If PGN-EDODM1, or any of our future product candidates, cause undesirable side effects or have other unexpected adverse properties, such side effects or properties could delay or prevent the initiation or completion of clinical trials prejudice regulatory
  • approval, limit the commercial potential of such candidate or result in significant negative consequences following any potential marketing approval.
  • We may expend our limited resources to pursue a particular program, product candidate or indication and fail to capitalize on programs, product candidates or indications that may be more profitable or for which there is a greater likelihood of success.
  • The increasing use of social media platforms presents new risks and challenges.
  • Clinical trial and product liability lawsuits against us could divert our resources, could cause us to incur substantial liabilities and could limit commercialization of our product candidates.
  • We conduct certain clinical trials for our product candidates outside of the U.S. However, the FDA and comparable foreign regulatory authorities may not accept data from such trials, in which case our development plans will be delayed, which could materially harm our business.
  • Risks Related to Our Dependence on Third Parties
  • We rely, and expect to continue to rely, on third parties to conduct some or all aspects of our product manufacturing, research and preclinical and clinical testing, and these third parties may not perform satisfactorily. If we need to replace one or more of these third parties, our development plans may be significantly delayed and we may expend more funds then currently planned.
  • We currently depend on a small number of third-party suppliers to supply the product candidates that we are evaluating in our research and development programs. The loss of these or future third-party suppliers, or their inability to provide us with sufficient supply, could harm our business.
  • We are dependent on single-source suppliers for some of the components and materials used in our product candidates.
  • We may enter into collaborations with third parties for the research, development and commercialization of certain of our product candidates. If any such collaborations are not successful, we may not be able to capitalize on the market potential of those product candidates.
  • If conflicts arise between us and our potential collaborators, these parties may act in a manner adverse to us and could limit our ability to implement our strategies.
  • If we are not able to establish collaborations on commercially reasonable terms, we may have to alter our development and commercialization plans.
  • We are dependent on third-party vendors to provide certain licenses, products and services and our business and operations, including clinical trials, could be disrupted by any problems with our significant third-party vendors.
  • Risks Related to Regulatory Approval and Other Regulatory and Legal Compliance Matters
  • As an organization, we have only completed or initiated a small number of clinical trials and may be unable to do so for any of our other product candidates nor carry out or complete further studies for our lead candidate.
  • We plan to seek approval from the FDA or comparable foreign regulatory authorities, where applicable, under the accelerated approval pathways. We may fail to obtain approval under such accelerated approval pathways. Moreover, these pathways may not lead to a faster development, regulatory review or approval process and do not increase the likelihood that our product candidates will receive marketing approval.
  • Even if we complete the necessary preclinical studies and clinical trials, the marketing approval process is expensive, time-consuming and uncertain and may prevent us from obtaining approvals for the commercialization of our product candidates. If we are not able to obtain, or if there are delays in obtaining, required regulatory approvals, we will not be able to commercialize, or will be delayed in commercializing, our product candidates, and our ability to generate revenue will be materially impaired.
  • Obtaining and maintaining marketing approval or commercialization of our product candidates in the U.S. does not mean that we will be successful in obtaining marketing approval of our product candidates in other jurisdictions. Failure to obtain marketing approval in foreign jurisdictions would prevent our product candidates from being marketed in such jurisdictions, which, in turn, would materially impair our ability to generate revenue.
  • We may seek one or more designations or expedited programs for one or more of our product candidates, but we might not receive such designations or be allowed to proceed on expedited program pathways, and even if we do and proceed on such expedited program pathways in the future, such designations or expedited programs may not lead to a faster development or regulatory review or approval process, and each designation does not increase the likelihood that any of our product candidates will receive marketing approval in the U.S.
  • We may pursue orphan drug designation for certain of our product candidates, and we may not be able to obtain such designation, or obtain or maintain the benefits of such designation including orphan drug exclusivity, and even if we do, that exclusivity may not prevent regulatory authorities from approving other competing products.
  • A marketing application for a product candidate with RPDD, if approved, may not meet the eligibility criteria for a Priority Review Voucher, or PRV, or the RPDD program may sunset before the FDA is able to consider eligibility for a voucher.
  • We may seek designation for our EDO platform as a designated platform technology, but we might not receive such designation, and even if we do, such designation may not lead to a faster regulatory review or approval process.
  • Even if we receive regulatory approval for any of our product candidates, we will be subject to ongoing regulatory obligations and continued regulatory review, which may result in significant additional expense. Additionally, our product candidates, if approved, could be subject to post-market study requirements, marketing and labeling restrictions, and even recall or market withdrawal if unanticipated safety issues are discovered following approval. In addition, we may be subject to penalties or other enforcement action if we fail to comply with regulatory requirements.
  • Any product candidate for which we obtain marketing approval will be subject to restrictions, such as the laws and regulations prohibiting the promotion of off-label uses, or may need to be withdrawn from the market, and we may be subject to substantial penalties if we fail to comply with regulatory requirements or if we experience unanticipated problems with our medicines, when and if any of them are approved.
  • We and our contract manufacturers are subject to significant regulation. The manufacturing facilities on which we rely may not continue to meet regulatory requirements, which could materially harm our business.
  • If we or any contract manufacturers and suppliers we engage fail to comply with environmental, health, and safety laws and regulations, we could become subject to fines or penalties or incur significant costs.
  • Shutdowns or disruptions at the FDA and other government agencies caused by funding shortages or global health concerns could hinder their ability to hire, retain or deploy key leadership and other personnel, or otherwise prevent new or modified products from being developed, approved or commercialized in a timely manner or at all, which could negatively impact our business.
  • Our relationships with healthcare providers, physicians and third-party payors will be subject to applicable anti-kickback, fraud and abuse, and other healthcare laws and regulations, which could expose us to criminal sanctions, civil penalties, contractual damages, reputational harm and diminished profits and future earnings.
  • Healthcare legislative reform discourse and potential or enacted measures may increase the difficulty and cost for us and any future collaborators to obtain marketing approval of and commercialize our product candidates and affect the prices we, or they, may obtain.
  • Our employees, principal investigators, consultants and commercial partners may engage in misconduct or other improper activities, including non-compliance with regulatory standards and requirements and insider trading.
  • Laws and regulations governing any international operations we may have in the future may preclude us from developing, manufacturing and selling certain product candidates outside of the U.S. and require us to develop and implement costly compliance programs.
  • We are subject to stringent data protection, privacy, and security laws, regulations, standards and contractual obligations and actual or perceived failure to comply with such requirements could have a material adverse effect on our business, financial condition, results of operations or prospects.
  • Our use of new and evolving technologies, such as artificial intelligence, may present risks and challenges that can impact our business, including by posing cybersecurity and other risks to our confidential and/or proprietary information, including personal information, and as a result we may be exposed to reputational harm and liability.
  • If any of our product candidates obtains regulatory approval and does not receive appropriate periods of non-patent exclusivity, competitors could enter the market with generic versions of such products more quickly than we expect, which may result in a material decline in sales of our products.
  • Risks Related to Commercialization
  • We face substantial competition, which may result in others discovering, developing or commercializing products before us or more successfully than we do.
  • Even if one or more of our product candidates receives marketing approval, it may fail to achieve the degree of market acceptance by physicians, patients, third-party payors and others in the medical community necessary for commercial success.
  • If the market opportunities for any product candidates we develop are smaller than we believe they are, our revenue may be adversely affected, and our business may suffer. Because the target patient populations of our programs are small, and the addressable patient population even smaller, we must be able to successfully identify patients and capture a significant market share to achieve profitability and growth.
  • The estimates of market opportunity and forecasts of market growth included in this Form 10-K, if any, may prove to be inaccurate, and even if the markets in which we compete achieve the forecasted growth, our business may not grow at similar rates, or at all.
  • The pricing and third-party payor coverage and reimbursement status of newly approved products are uncertain. Failure to obtain or maintain adequate coverage and reimbursement for our future product candidates, if approved, could limit our ability to market those products and decrease our ability to generate product revenue.
  • If we are unable to establish sales, marketing and distribution capabilities or enter into sales, marketing and distribution agreements with third parties, we may not be successful in commercializing our product candidates if any are approved.
  • Risks Related to Our Intellectual Property
  • If we or our licensors are unable to obtain, maintain, defend, and enforce patent and other intellectual property protection for any product candidates or technology, or if the scope of the patent or other intellectual property protection obtained is not sufficiently broad, our competitors could develop and commercialize products and technology similar or identical to ours, and our ability to successfully develop and commercialize our product candidates or our technology may be adversely affected due to such competition.
  • Our rights to develop and commercialize any product candidates are subject and may in the future be subject, in part, to the terms and conditions of licenses granted to us by third parties. If we fail to comply with our obligations under our current or future intellectual property license agreements, are not able to obtain adequate rights, or otherwise experience disruptions to our business relationships with our current or any future licensors, we could lose intellectual property rights that are important to our business.
  • We may not be able to protect our intellectual property rights throughout the world.
  • We may be involved in lawsuits to protect or enforce our patents or other intellectual property or the intellectual property of our licensors, which could be expensive, time-consuming, and unsuccessful.
  • Changes in patent law in the U.S. or worldwide could diminish the value of patents in general, thereby impairing our ability to protect our product candidates and our technology.
  • Obtaining and maintaining our patent protection depends on compliance with various procedural, document submission, fee payment and other requirements imposed by government patent agencies, and our patent protection could be reduced or eliminated for non-compliance with these requirements.
  • We may not be successful in obtaining necessary rights to our product candidates through acquisitions and in-licenses.
  • Issued patents covering our product candidates could be found invalid or unenforceable if challenged in court or before administrative bodies in the U.S. or abroad.
  • If we are unable to protect the confidentiality of our trade secrets, our business and competitive position would be harmed.
  • Third parties may initiate legal proceedings alleging that we are infringing, misappropriating or otherwise violating their intellectual property rights, the outcome of which would be uncertain and could harm our business.
  • Intellectual property litigation or other proceedings could cause us to spend substantial resources and distract our personnel from their normal responsibilities.
  • We may be subject to claims asserting that our employees, consultants or advisors have wrongfully used or disclosed alleged trade secrets of their current or former employers or claims asserting ownership of what we regard as our own intellectual property.
  • If we do not obtain patent term extension for our product candidates, our business may be harmed.
  • We may be subject to claims challenging the inventorship or ownership of our patent and other intellectual property rights.
  • If our trademarks and trade names are not adequately protected, then we may not be able to build name recognition in our markets of interest and our business may be adversely affected.
  • Intellectual property rights do not necessarily address all potential threats.
  • Our reliance on third parties requires us to share our trade secrets, which increases the possibility that a competitor or other third party will discover our trade secrets or that our trade secrets will be misappropriated or disclosed.
  • Risks Related to Employee Matters, Managing Growth and Other Operational Matters
  • Our future success depends on our ability to retain key executives and to attract, retain and motivate qualified personnel.
  • We may need to expand our headcount over time to support our development and regulatory capabilities and potentially implement sales, marketing and distribution capabilities, and as a result, we may encounter difficulties in managing our growth, which could disrupt our operations.
  • Our international activities subject us to various risks, and our failure to manage these risks could adversely affect our results of operations.
  • We face risks associated with tariffs and other trade restrictions, which may have a material adverse impact on our results of operations and financial condition.
  • Future acquisitions or strategic alliances could disrupt our business and harm our financial condition and results of operations.
  • Our operations or those of the third parties upon whom we depend might be affected by the occurrence of a natural disaster, pandemic or other catastrophic event.

Legal proceedings

From time to time, we may be a party to litigation or subject to claims incident to the ordinary course of business. On June 9, 2025, a putative shareholder class action captioned Johnny Karam v. PepGen Inc., et al. was filed in the United States District Court for the Eastern District of New York, naming the Company and our Chief Executive Officer and Chief Financial Officer as defendants. The lawsuit was filed by a stockholder who claimed to be suing on behalf of anyone who purchased or otherwise acquired our securities between March 7, 2024 and March 3, 2025. The lawsuit alleged that material misrepresentations and/or omissions of material fact were made in our public disclosures in violation of Sections 10(b) and 20(a) of the Exchange Act and Rule 10b-5 promulgated thereunder. The alleged improper disclosures related primarily to statements regarding PGN-EDO51. The plaintiff sought unspecified monetary damages on behalf of the putative class and an award of costs and expenses, including attorney’s fees. On July 15, 2025, the action was transferred to the United States District Court for the District of Massachusetts. On November 18, 2025, the parties filed a stipulation of voluntary dismissal of the action. Separately, by a letter received by us on September 29, 2025, a putative shareholder of the Company made a purported shareholder demand based on substantially the same allegations as those set forth in the above-mentioned putative class action suit. On December 1, 2025, the demanding shareholder withdrew the demand.

The opening of Item 3, Legal Proceedings.3

Sources

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