Private company

Verve Therapeutics, Inc.

In its 2025 annual report the company says: “We are a clinical-stage company developing a new class of genetic medicines for cardiovascular disease, or CVD, with the potential to transform treatment from chronic therapies to single-course gene editing medicines. We are developing a pipeline of gene editing programs targeting the three lipoprotein pathways that drive atherosclerotic cardiovascular disease, or ASCVD, the most common form of CVD: low-density lipoprotein, or LDL, triglyceride-rich lipoproteins, and lipoprotein(a), or Lp(a).”3 It is headquartered in Boston, Massachusetts.1

Last updated Oct 20, 2026.

Overview

  • IndustryPharmaceutical Preparations1
  • HeadquartersBoston, Massachusetts1
  • Incorporated inDE2
  • Business address201 Brookline Avenue, Suite 601, Boston, Ma 022152
  • Filer categoryNon-accelerated filer, Smaller reporting company2

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We are a clinical-stage company developing a new class of genetic medicines for cardiovascular disease, or CVD, with the potential to transform treatment from chronic therapies to single-course gene editing medicines. Despite advances in treatment over the last 50 years, CVD remains the leading cause of death worldwide. The current paradigm of chronic care is fragile—requiring rigorous patient adherence, extensive healthcare infrastructure and regular healthcare access—and leaves many patients without adequate care. We are developing a pipeline of gene editing programs targeting the three lipoprotein pathways that drive atherosclerotic cardiovascular disease, or ASCVD, the most common form of CVD: low-density lipoprotein, or LDL, triglyceride-rich lipoproteins, and lipoprotein(a), or Lp(a). Our lead, clinical-stage programs target the PCSK9 and ANGPTL3 genes which have been extensively v…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-$228.7M in 2024+1576% since 2019
-$300.0M-$200.0M-$100.0M02019: -$13.6M-$13.6M20192020: -$40.6M-$40.6M2020+198%2021: -$87.1M-$87.1M2021+114%2022: -$165.7M-$165.7M2022+90%2023: -$223.1M-$223.1M2023+35%2024: -$228.7M-$228.7M2024+2%
Net income467-$198.7M in 2024+930% since 2019
-$300.0M-$200.0M-$100.0M02019: -$19.3M-$19.3M20192020: -$200.1M-$200.1M2020+937%2021: -$120.3M-$120.3M2021−40%2022: -$157.4M-$157.4M2022+31%2023: -$200.1M-$200.1M2023+27%2024: -$198.7M-$198.7M2024−1%
Fiscal year20182019202020212022202320242025
Research and development$11.1M4$35.4M5$68.2M6$130.1M7$184.9M7$204.3M7
Operating expenses$87.1M6$167.6M7$234.9M7$261.0M7
Operating income-$13.6M4-$40.6M5-$87.1M6-$165.7M7-$223.1M7-$228.7M7
Income before tax-$120.3M6-$157.3M7-$199.8M7-$198.4M7
Income tax$05$06$53.0K7$275.0K7$349.0K7
Net income-$19.3M4-$200.1M6-$120.3M6-$157.4M7-$200.1M7-$198.7M7
Earnings per share-$20.315-$4.486-$2.917-$3.127-$2.357
Earnings per share (diluted)-$20.315-$4.486-$2.917-$3.127-$2.357
Shares (weighted, basic)26.9M shares654.0M shares764.2M shares784.7M shares7
Shares (weighted, diluted)26.9M shares654.0M shares764.2M shares784.7M shares7

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Corporate structure

Verve Therapeutics, 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 Verve Therapeutics, Inc.

  • BIOTECHNOLOGY VALUE FUND L P Filed SCHEDULE 13G/A on Verve Therapeutics, Inc., latest Aug 14, 2025 (2 filings since Nov 18, 2024)
  • Pentwater Capital Management LP Filed SCHEDULE 13G on Verve Therapeutics, Inc., latest Aug 14, 2025
  • GV 2017, L.P. Filed SCHEDULE 13G/A on Verve Therapeutics, Inc., latest Jul 28, 2025 (4 filings since Feb 14, 2022)
  • MILLENNIUM MANAGEMENT LLC Filed SCHEDULE 13G on Verve Therapeutics, Inc., latest Apr 29, 2025 (4 filings since Jun 27, 2024)
  • State Street Corporation Filed SCHEDULE 13G on Verve Therapeutics, Inc., latest Feb 5, 2025 (4 filings since Feb 7, 2023)
  • ARK Investment Management LLC Filed SCHEDULE 13G/A on Verve Therapeutics, Inc., latest Jan 10, 2025 (3 filings since Feb 10, 2023)
  • VANGUARD GROUP INC Filed SC 13G/A on Verve Therapeutics, Inc., latest Nov 12, 2024 (4 filings since Feb 9, 2023)
  • BlackRock Filed SC 13G/A on Verve Therapeutics, Inc., latest Nov 8, 2024 (2 filings since Oct 22, 2024)
  • James R. Singer Filed SCHEDULE 13G/A on Verve Therapeutics, Inc., latest Jan 16, 2024 (3 filings since Jan 24, 2022)
  • FMR LLC Filed SC 13G/A on Verve Therapeutics, Inc., latest Dec 11, 2023 (5 filings since Dec 28, 2021)
  • Casdin Capital, LLC Filed SC 13G/A on Verve Therapeutics, Inc., latest Feb 14, 2023 (2 filings since Feb 14, 2022)
  • ARCH Venture Fund X, L.P. Filed SC 13G/A on Verve Therapeutics, Inc., latest Feb 13, 2023 (2 filings since Feb 9, 2022)
  • Verve Therapeutics, 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 Verve Therapeutics, 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$35.8M7 Dec 31, 2024$32.9M7 Dec 31, 2023+8.7%
Accumulated depreciation$17.1M7 Dec 31, 2024$10.4M7 Dec 31, 2023+64.6%
Property and equipment, net$18.6M7 Dec 31, 2024$22.5M7 Dec 31, 2023−17.2%
Operating-lease assets (leased space)$78.1M7 Dec 31, 2024$85.3M7 Dec 31, 2023−8.5%

Investments

ItemLatestA year beforeChange
Cash and cash equivalents$172.6M7 Dec 31, 2024$206.2M7 Dec 31, 2023−16.3%
Marketable securities, current$351.7M7 Dec 31, 2024$417.8M7 Dec 31, 2023−15.8%

Properties, in its own words

We currently lease 105,182 square feet of office and laboratory space in Boston, Massachusetts under a lease that expires in December 2032 with an option to extend for an additional five years.

We believe that our facilities are sufficient to meet our current needs and that suitable additional space will be available as and when needed.

Item 2 of the 10-K filed Feb 27, 2025.3

Leadership

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

Chief executive

  1. Sekar Kathiresan2021–now

Chief financial officer

  1. Allison Dorval2021–now
2025
Board members and other officers (18)

Timeline

  1. Jul 25, 20258-K Ended a material agreement; Completed an acquisition or sale; Listing notice or transfer30
  2. Jul 15, 20258-K Executive or director change31
  3. Jun 17, 20258-K Entered a material agreement; Other events32
  4. Jun 10, 20258-K Shareholder vote33
  5. May 14, 20258-K Results of operations34
  6. Apr 14, 20258-K Other events35
  7. Feb 27, 20258-K Results of operations36
  8. Nov 5, 20248-K Results of operations37
  9. Aug 8, 20248-K Results of operations38
  10. Jun 28, 20248-K Shareholder vote39
  11. Jun 28, 20248-K Executive or director change40
  12. Jun 7, 20248-K Shareholder vote41
  13. Jun 16, 2021New chief executive Sekar Kathiresan becomes CEO11

Calendar

When it reported results

  1. May 14, 2025Reported quarterly or annual results34
  2. Feb 27, 2025Reported quarterly or annual results36
  3. Nov 5, 2024Reported quarterly or annual results37
  4. Aug 8, 2024Reported quarterly or annual results38
  5. May 8, 2024Reported quarterly or annual results42
  6. Feb 27, 2024Reported quarterly or annual results43
  7. Nov 7, 2023Reported quarterly or annual results44
  8. Aug 10, 2023Reported quarterly or annual results45

Upcoming dates from Nasdaq's calendar; past results from the company's 8-K filings (Item 2.02). The full markets calendar

Filings

258 filings to the SEC since October 2021: 4 annual reports, 11 quarterly reports, 39 major events, 124 insider forms, 39 large holders, 41 other. The latest 20:

  1. Aug 14, 2025SCHEDULE 13G/A EDGAR
  2. Aug 14, 2025SCHEDULE 13G EDGAR
  3. Aug 4, 202515-12G EDGAR
  4. Jul 28, 2025EFFECT EDGAR
  5. Jul 28, 2025SCHEDULE 13G/A EDGAR
  6. Jul 28, 20254 EDGAR
  7. Jul 28, 20254 EDGAR
  8. Jul 28, 20254 EDGAR
  9. Jul 28, 20254 EDGAR
  10. Jul 28, 20254 EDGAR
  11. Jul 28, 20254 EDGAR
  12. Jul 28, 20254 EDGAR
  13. Jul 28, 20254 EDGAR
  14. Jul 28, 20254 EDGAR
  15. Jul 28, 20254 EDGAR
  16. Jul 28, 20254 EDGAR
  17. Jul 28, 20254 EDGAR
  18. Jul 28, 20254 EDGAR
  19. Jul 28, 20254 EDGAR
  20. Jul 25, 2025POS AM EDGAR

The 258 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

49 open-market trades by officers, directors and large owners since October 2021: 6 buys and 43 sales. Grants, option exercises and gifts are left out.

DateWhoTradeSharesPriceValueFiling
Apr 2, 2025Kathiresan SekarChief Executive OfficerSale9,822$4.15$40.8KForm 4
Apr 2, 2025Nickerson JoanChief Administrative OfficerSale2,777$4.15$11.5KForm 4
Apr 2, 2025Ashe Andrew D.See RemarksSale2,681$4.15$11.1KForm 4
Apr 2, 2025Politi JasonChief Technical Ops. Off.Sale3,235$4.15$13.4KForm 4
Apr 2, 2025Dorval AllisonChief Financial OfficerSale3,350$4.15$13.9KForm 4
Apr 2, 2025Lister TroyChief Scientific OfficerSale2,189$4.15$9.1KForm 4
Dec 2, 2024Dorval AllisonChief Financial OfficerSale555$5.64$3.1KForm 4
May 14, 2024Ashe Andrew D.See RemarksBuy76,000$6.26$475.8KForm 4
Apr 2, 2024Nickerson JoanChief Administrative OfficerSale1,514$8.24$12.5KForm 4
Dec 1, 2023Yeshwant KrishnaDirectorBuy1,800,000$10.00$18.0MForm 4
Nov 29, 2023Dorval AllisonChief Financial OfficerSale554$11.45$6.3KForm 4
Dec 1, 2022Bellinger AndrewChief Scientific OfficerSale865$22.95$19.9KForm 4
Nov 29, 2022Dorval AllisonChief Financial OfficerSale554$22.10$12.2KForm 4
Nov 4, 2022Alphabet Inc.Sale97,166$31.14$3.0MForm 4
Nov 4, 2022Yeshwant KrishnaDirectorSale48,583$31.14$1.5MForm 4
Nov 3, 2022GV 2017, L.P.10% ownerSale99,137$32.80$3.3MForm 4
Nov 3, 2022Yeshwant KrishnaDirectorSale49,568$32.80$1.6MForm 4
Nov 2, 2022GV 2017, L.P.10% ownerSale57,303$35.95$2.1MForm 4
Nov 2, 2022Yeshwant KrishnaDirectorSale28,652$35.95$1.0MForm 4
Nov 1, 2022GV 2019 GP, L.P.10% ownerSale63,926$36.79$2.4MForm 4

All 49 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
2024Sekar KathiresanM.D.$639.2K$7.4M60
2024Andrew BellingerM.D., Ph.D.$243.8K$3.4M60
2024Allison Dorval$469.4K$2.9M60
2024Andrew Ashe$389.1K$2.4M60
2023Chief Executive Officer$596.8K$9.3M60
2023Former Chief Scientific Officer$497.3K$3.5M60
2023Chief Financial Officer$465.6K$3.5M60

SEC filer profile

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

  • Name on EDGARVerve Therapeutics, Inc.1
  • CIK0001840574
  • Employer ID (EIN)82-48001323
  • Filer statusNon-accelerated filer not 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 address201 Brookline Avenue, Suite 601, Boston, MA 022151
  • Phone(978) 501-30261
  • Shares outstanding89,143,237 as of May 7, 202510
  • Public float$345.2M as of Jun 28, 20243
  • AuditorErnst & Young LLP, Boston, Massachusetts PCAOB ID 42; no auditor attestation of internal control over financial reporting3
  • On EDGAR sinceJan 22, 20211
  • Filings344 in all: 4 (137), 8-K (41), 3 (38), SC 13G/A (21), SC 13G (15), 10-Q (12), SCHEDULE 13G/A (6), CORRESP (5)1
    All 42 form types

    S-8 (5), S-8 POS (5), 10-K (4), 424B5 (4), DEF 14A (4), DEFA14A (4), EFFECT (4), ARS (3), SC 14D9/A (3), SC TO-T/A (3), SCHEDULE 13G (3), POS AM (2), POSASR (2), SEC STAFF LETTER (2), UPLOAD (2), 10-Q/A (1), 15-12G (1), 25-NSE (1), 424B4 (1), 5 (1), 8-A12B (1), 8-K/A (1), CERT (1), D (1), DRS (1), S-1 (1), S-1/A (1), S-1MEF (1), S-3 (1), S-3ASR (1), SC 14D9 (1), SC TO-C (1), SC TO-T (1), SC14D9C (1)

  • Latest filingsAnnual report (10-K) Feb 27, 2025
    Quarterly report (10-Q) May 14, 2025
    Proxy statement (DEF 14A) Apr 25, 2025
    Latest 8-K (8-K) Jul 25, 2025

Securities registered for trading

ClassSymbolExchange
Common stock, par value $0.001 per shareVERVNasdaq Global Select Market

From the cover page of the 10-K filed Feb 27, 2025 (Section 12(b) of the Exchange Act).3

Risk factors and legal proceedings

The risks Verve Therapeutics, Inc. names in Item 1A of its 10-K filed Feb 27, 2025: 73 risks under these headings, as written.3

  • Risks related to our financial position and need for additional capital
  • We have incurred significant losses since our inception and have no products approved for sale. We expect to incur losses for the foreseeable future and may never achieve or maintain profitability.
  • We have never generated revenue from product sales and may never achieve or maintain profitability.
  • We will need substantial additional funding. If we are unable to raise capital when needed, we could be forced to delay, reduce or eliminate our product development programs or commercialization efforts.
  • Raising additional capital may cause dilution to our stockholders, restrict our operations or require us to relinquish rights to our technologies or product candidates.
  • Our limited operating history may make it difficult for stockholders to evaluate the success of our business to date and to assess our future viability.
  • Our ability to use our net operating losses and research and development tax credit carryforwards to offset future taxable income or taxes may be subject to certain limitations.
  • Risks related to discovery and development
  • We are early in our clinical development efforts, and we have not yet completed a clinical trial of any product candidate. As a result, we expect it will be many years before we commercialize any product candidate, if ever. If we are unable to advance our current or future product candidates through clinical trials, obtain marketing approval and ultimately commercialize our product candidates or experience significant delays in doing so, our business will be materially harmed.
  • In vivo gene editing, including base editing, is a novel technology that is not yet clinically validated as being safe and efficacious for human therapeutic use. The approaches we are taking to discover and develop novel therapeutics are unproven and may never lead to marketable products.
  • The gene editing field is relatively new and is evolving rapidly. We have focused our research and development efforts for our clinical-stage programs on gene editing using base editing technology, but other gene editing technologies may be discovered that provide significant advantages over base editing, which could materially harm our business.
  • We may not be successful in our efforts to identify and develop potential product candidates. If these efforts are unsuccessful, we may never become a commercial stage company or generate any revenues.
The other 63 risks
  • Clinical drug development involves a lengthy and expensive process, with an uncertain outcome. If we are ultimately unable to obtain regulatory approval for our product candidates, our business will be substantially harmed.
  • 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.
  • We may incur unexpected costs or experience delays in completing, or ultimately be unable to complete, the development and commercialization of our product candidates.
  • Preclinical drug development is uncertain. Some or all of our preclinical programs may experience delays or may never advance to clinical trials, which would adversely affect our ability to obtain marketing approvals or commercialize these product candidates on a timely basis or at all, which would have an adverse effect on our business.
  • If we experience delays or difficulties in the enrollment of patients in clinical trials, our receipt of necessary regulatory approvals could be delayed or prevented.
  • If any of the product candidates we develop, or the delivery modes we rely on to administer them, cause serious adverse events, undesirable side effects or unexpected characteristics, such adverse events, side effects or characteristics could delay or prevent regulatory approval of the product candidates, limit the commercial potential or result in significant negative consequences following any potential marketing approval.
  • Adverse public perception of genetic medicines, and gene editing and base editing in particular, may negatively impact demand for our potential products and increased regulatory scrutiny of genetic medicines may adversely affect our ability to obtain regulatory approval for our product candidates.
  • Interim, preliminary or top-line results from our clinical trials that we announce or publish from time to time may change as more participant data become available and are subject to audit and verification procedures, which could result in material changes in the final data.
  • Genetic medicines are complex and difficult to manufacture. We could experience delays in satisfying regulatory authorities or production problems that result in delays in our development programs, limit the supply of our product candidates we may develop, or otherwise harm our business.
  • If any of our product candidates receives marketing approval and we, or others, later discover that the drug is less effective than previously believed or causes undesirable side effects that were not previously identified, our ability to market the drug could be compromised.
  • We may expend our limited resources to pursue a particular product candidate or indication and fail to capitalize on product candidates or indications that may be more profitable or for which there is a greater likelihood of success.
  • We have been conducting clinical trials, and plan to conduct additional clinical trials, at sites outside the United States. The FDA may not accept data from trials conducted in such locations, and the conduct of trials outside the United States could subject us to additional delays and expense.
  • 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.
  • Manufacturing biologic products is complex and subject to product loss for a variety of reasons. We contract with third parties for the manufacture of our product candidates for preclinical and clinical testing and expect to continue to do so for commercialization. This reliance on third parties increases the risk that we will not have sufficient quantities of our product candidates or products or such quantities at an acceptable cost or quality, which could delay, prevent or impair our development or commercialization efforts.
  • If any third-party manufacturer of our product candidates is unable to increase the scale of its production of our product candidates, and/or increase the product yield of its manufacturing, then our costs to manufacture the product candidate may increase and commercialization may be delayed.
  • We have entered into collaborations, and may enter into additional collaborations, with third parties for the research, development, manufacture and commercialization of programs or product candidates. If these collaborations are not successful, our business could be adversely affected.
  • If we are not able to establish or maintain collaborations on commercially reasonable terms, we may have to alter our development and commercialization plans and our business could be adversely affected.
  • We depend on single-source suppliers for some of the components and materials used in our product candidates.
  • Changes in U.S. and international trade policies, particularly with respect to China, may adversely impact our business and operating results.
  • Risks related to our intellectual property
  • If we or our licensors are unable to obtain, maintain, defend and enforce patent rights that cover our gene editing technology and product candidates or if the scope of the patent protection obtained is not sufficiently broad, our competitors could develop and commercialize technology and products similar or identical to ours, and our ability to successfully develop and commercialize our technology and product candidates may be adversely affected.
  • Our rights to develop and commercialize our gene editing technology and product candidates are subject, in part, to the terms and conditions of licenses granted to us by others.
  • Our owned and in-licensed patents and patent applications and other intellectual property may be subject to priority or inventorship disputes, interferences and similar proceedings. If we or our licensors are unsuccessful in any of these proceedings, we may be required to obtain licenses from third parties, which may not be available on commercially reasonable terms or at all, or to cease the development, manufacture, and commercialization of one or more of the product candidates we may develop, which could have a material adverse impact on our business.
  • If we fail to comply with our obligations in our intellectual property licensing arrangements with third parties, or otherwise experience disruptions to our business relationships with our licensors, we could lose intellectual property rights that are important to our business.
  • If we are unable to obtain licenses from third parties on commercially reasonable terms or fail to comply with our obligations under such agreements, our business could be harmed.
  • The intellectual property landscape around genome editing technology, including base editing and delivery, is highly dynamic, and 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 may prevent, delay or otherwise interfere with our product discovery and development efforts.
  • Patent terms may be inadequate to protect our competitive position on our product candidates for an adequate amount of time.
  • Our product candidates may face competition from biosimilars approved through an abbreviated regulatory pathway.
  • If we do not obtain patent term extension in the United States under the Hatch-Waxman Act and in foreign countries under similar legislation, thereby potentially extending the term of our marketing exclusivity for any product candidates we may develop, our business may be materially harmed.
  • Changes to patent laws in the United States and other jurisdictions could diminish the value of patents in general, thereby impairing our ability to protect our gene editing platform technology and product candidates.
  • Issued patents covering our product candidates could be found invalid or unenforceable if challenged in court. We may not be able to protect our trade secrets in court.
  • Intellectual property litigation or other legal proceedings relating to intellectual property could cause us to spend substantial resources and distract our personnel from their normal responsibilities.
  • Obtaining and maintaining patent protection depends on compliance with various procedural, document submission, fee payment and other requirements imposed by governmental patent agencies, and our patent protection could be reduced or eliminated for non-compliance with these requirements.
  • We have limited foreign intellectual property rights and may not be able to protect our intellectual property and proprietary rights throughout the world.
  • We may be subject to claims by third parties asserting that our employees, consultants or contractors have wrongfully used or disclosed confidential information of third parties, or we have wrongfully used or disclosed alleged trade secrets of their current or former employers or claims asserting we have misappropriated their intellectual property, or claiming ownership of what we regard as our own intellectual property.
  • If we are unable to protect the confidentiality of our trade secrets, our business and competitive position would be harmed.
  • 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.
  • Risks related to commercialization
  • Even if any of our current or future 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, and the market opportunity for any of such product candidates, if approved, may be smaller than we estimate.
  • We face substantial competition, which may result in others discovering, developing or commercializing products before us or more successfully than we do.
  • 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 current and future product candidates if and when they are approved.
  • We currently rely, and expect to continue to rely, on CMOs to manufacture our product candidates. If we are unable to enter into such arrangements as expected or if such organizations do not meet our supply requirements, development and/or commercialization of our product candidates may be delayed.
  • Even if we are able to commercialize any product candidates, the products may become subject to unfavorable pricing regulations, third-party coverage or reimbursement practices or healthcare reform initiatives, which could harm our business.
  • Our future growth depends, in part, on our ability to penetrate foreign markets, where we would be subject to additional regulatory burdens and other risks and uncertainties that, if they materialize, could harm our business.
  • Clinical trial and product liability lawsuits against us could divert our resources and could cause us to incur substantial liabilities and to limit commercialization of any products that we may develop.
  • Risks related to regulatory approval and other legal compliance matters
  • Gene editing is novel and the regulatory landscape that will govern any product candidates we may develop is uncertain and may change. As a result, we cannot predict the time and cost of obtaining regulatory approval, if we receive it at all, for any product candidates we may develop.
  • Because we are developing product candidates in the field of genetic medicines, a field that includes gene therapy and gene editing, in which there is little clinical experience, there is increased risk that the FDA, the EMA, or other regulatory authorities may not consider the endpoints of our clinical trials to provide clinically meaningful results and that these results may be difficult to analyze.
  • 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 any product candidates we develop. 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, product candidates we develop, and our ability to generate revenue will be materially impaired.
  • Obtaining and maintaining marketing approval or commercialization of our product candidates in the United States 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 any product candidates we develop from being marketed in such jurisdictions, which, in turn, would materially impair our ability to generate revenue.
  • We may seek certain designations for our product candidates, including Fast Track, Breakthrough Therapy, Regenerative Medicine Advanced Therapy and Priority Review designations in the United States, Innovative Licensing and Access Pathway designation in the United Kingdom, and PRIME Designation in the European Union, but we might not receive such designations, and even if we do, such designations may not lead to a faster development or regulatory review or approval process.
  • We may not be able to obtain orphan drug exclusivity for any product candidates we may develop, and even if we do, that exclusivity may not prevent the FDA or the EMA from approving other competing products.
  • Even if we, or any collaborators we may have, obtain marketing approvals for any product candidates we develop, the terms of approvals and ongoing regulation of our products could require the substantial expenditure of resources and may limit how we, or they, manufacture and market our products, which could materially impair our ability to generate revenue.
  • Any product candidate for which we obtain marketing approval could be subject to restrictions or withdrawal 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 products, when and if any of them are approved.
  • Inadequate funding for the FDA, the SEC and other government agencies, including from government shut downs, or other disruptions to these agencies’ operations, could hinder their ability to hire and retain key leadership and other personnel, prevent new products and services from being developed or commercialized in a timely manner or otherwise prevent those agencies from performing normal business functions on which the operation of our business may rely, which could negatively impact our business.
  • Any relationships we may have with customers, healthcare providers and professionals, and third-party payors, among others, will be subject to applicable anti-kickback, fraud and abuse and other healthcare laws and regulations, which could expose us to penalties, including criminal sanctions, civil penalties, contractual damages, reputational harm, fines, disgorgement, exclusion from participation in government healthcare programs, curtailment or restricting of our operations, and diminished profits and future earnings.
  • Current and future legislation may increase the difficulty and cost for us and any collaborators to obtain marketing approval and commercialize our product candidates and affect the prices we, or they, may obtain.
  • The prices of prescription pharmaceuticals in the United States and foreign jurisdictions are subject to considerable legislative and executive actions and such actions could impact the prices we obtain for our products, if and when licensed.
  • Compliance with global privacy and data security requirements could result in additional costs and liabilities to us or inhibit our ability to collect and process data globally, and the failure to comply with such requirements could subject us to significant fines and penalties, which may have a material adverse effect on our business, financial condition or results of operations.
  • 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 United States and require us to develop and implement costly compliance programs.
  • If we or any third-party manufacturer we engage now or in the future fail to comply with environmental, health and safety laws and regulations, we could become subject to fines or penalties or incur costs or liabilities that could have a material adverse effect on our business.
  • Risks related to employee matters and managing growth
  • Our future success depends on our ability to retain key executives and to attract, retain and motivate qualified personnel.
  • We expect to expand 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.
  • Future acquisitions or strategic alliances could disrupt our business and harm our financial condition and results of operations.

Legal proceedings

As of the date of this Annual Report on Form 10-K, we were not party to any material legal matters or claims. In the future, we may become involved in litigation or other legal proceedings arising in the ordinary course of our business. Regardless of outcome, litigation can have an adverse impact on our business, financial condition, results of operations and prospects because of defense and settlement costs, diversion of management resources and other factors.

On August 27, 2024, a putative securities class action lawsuit captioned Oldroyd v. Verve Therapeutics, Inc., et. al., Case No. 1:24-CV-12218, was filed against us and certain of our officers in the U.S. District Court for the District of Massachusetts. The complaint alleged violations of Sections 10(b) and 20(a) of the Exchange Act and Rule 10b-5 promulgated thereunder on the basis of purportedly materially false and misleading statements and omissions concerning the Company's pause in enrollment of the Heart-1 trial. The complaint sought, among other things, unspecified damages, interest, attorneys’ fees, expert fees, and other costs. In December 2024, the court appointed the lead plaintiff for the action. On February 4, 2025, the lead plaintiff voluntarily dismissed the action without prejudice against all defendants and as to all claims.

The opening of Item 3, Legal Proceedings.3

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