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Private company

Generation Bio Co.

In its 2025 annual report the company says: “We are a biotechnology company working to change what’s possible for people living with T cell-driven autoimmune diseases.”4 It is headquartered in Cambridge, Massachusetts.1

Last updated Oct 21, 2026.

Overview

  • IndustryPharmaceutical Preparations1
  • HeadquartersCambridge, Massachusetts1
  • Business address301 Binney Street, Cambridge, Ma 021422
  • Filer categoryNon-accelerated filer, Smaller reporting company2

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We are a biotechnology company working to change what’s possible for people living with T cell-driven autoimmune diseases. Our strategy is to discover, develop, and commercialize redosable therapeutics that reprogram T cells in vivo to reduce or eliminate the production and persistence of autoreactive T cells, which erroneously recognize and attack the body’s own tissues, causing autoimmune disease. We are leveraging our cell-targeted lipid nanoparticle, or ctLNP, to selectively deliver small interfering RNA, or siRNA, to T cells, and we believe that the combination of selective delivery and an intracellular, genetically precise mechanism of target engagement unlocks a series of high-value historically undruggable disease-driving genes in autoimmunity.4 From its latest annual report

Financials

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

Key numbers, fiscal 2024

-715.8%Operating margin5
-661.9%Net margin5
236.9%Revenue growth, 20245
-152.7%Return on equity5
-$91.0MFree cash flow5

Where the money goes

Where each dollar of revenue went, fiscal 2024

  • Research and development100¢$61.3M

Out of $19.9M in revenue.5 The company lost money this year.

Financial statements

Revenue65$19.9M in 2024
0$5.0M$10.0M$15.0M$20.0M2021: $0$020212022: $0$020222023: $5.9M$5.9M20232024: $19.9M$19.9M2024+237%
Operating income7865-$142.4M in 2024+129% since 2019
-$150.0M-$100.0M-$50.0M02019: -$62.3M-$62.3M20192020: -$81.1M-$81.1M2020+30%2021: -$119.1M-$119.1M2021+47%2022: -$141.2M-$141.2M2022+19%2023: -$138.6M-$138.6M2023−2%2024: -$142.4M-$142.4M2024+3%
Net income7865-$131.7M in 2024+115% since 2019
-$150.0M-$100.0M-$50.0M02019: -$61.3M-$61.3M20192020: -$80.5M-$80.5M2020+31%2021: -$119.2M-$119.2M2021+48%2022: -$136.6M-$136.6M2022+15%2023: -$126.6M-$126.6M2023−7%2024: -$131.7M-$131.7M2024+4%
Fiscal year2018201920202021202220232024
Revenue$06$06$5.9M5$19.9M5
Research and development$50.1M7$58.5M8$85.2M6$96.7M5$93.6M5$61.3M5
Operating expenses$119.1M6$141.2M5$144.5M5$162.3M5
Operating income-$62.3M7-$81.1M8-$119.1M6-$141.2M5-$138.6M5-$142.4M5
Income tax$07$08$06$05$05$05
Net income-$61.3M7-$80.5M8-$119.2M6-$136.6M5-$126.6M5-$131.7M5
Earnings per share-$12.967-$2.958-$2.126-$2.355-$1.965-$1.985
Earnings per share (diluted)-$12.967-$2.958-$2.126-$2.355-$1.965-$1.985
Shares (weighted, basic)56.3M shares658.1M shares564.5M shares566.6M shares5
Shares (weighted, diluted)56.3M shares658.1M shares564.5M shares566.6M shares5

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Corporate structure

Generation Bio Co. is part of a group headed by XOMA Royalty Corp. 14 entities, 5 countries on record. Switch between the flow chart and the network, and select any entity to see its details.

Major holders of Generation Bio Co.

  • XOMA Royalty Corp Emeryville, California
    • Generation Bio Co. Cambridge, Massachusetts
    • Generation Bio Securities Corp. Subsidiary · Massachusetts, United States
    • HilleVax, Inc. Subsidiary · Delaware, United States
    • Kinnate Biopharma Inc. Subsidiary · Delaware, United States
    • LAVA Therapeutics New Topco B.V. Subsidiary · Netherlands
    • Mural Oncology plc Subsidiary · Ireland
    • Pulmokine, Inc. Subsidiary · Delaware, United States
    • Turnstone Biologics Corp. Subsidiary · Delaware, United States
    • XOMA (US) LLC Subsidiary · Delaware, United States
    • XOMA Technology Ltd. Subsidiary · Bermuda
    • XOMA UK Limited Subsidiary · United Kingdom
    • XRA 5 Corp. Subsidiary · Delaware, United States
    • XRL 1 LLC Subsidiary · Delaware, United States

Built from subsidiaries listed in Exhibit 21 of annual reports filed with the SEC; major holders from Schedules 13D and 13G. Each entity in the chart links to its source.

What it owns

What Generation Bio Co. 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$38.2M5 Dec 31, 2024$45.5M5 Dec 31, 2023−16.0%
Accumulated depreciation$22.9M5 Dec 31, 2024$19.7M5 Dec 31, 2023+16.3%
Property and equipment, net$15.3M5 Dec 31, 2024$25.8M5 Dec 31, 2023−40.7%
Operating-lease assets (leased space)$20.3M5 Dec 31, 2024$69.9M5 Dec 31, 2023−70.9%

Investments

ItemLatestA year beforeChange
Cash and cash equivalents$76.3M5 Dec 31, 2024$66.4M5 Dec 31, 2023+14.8%
Marketable securities, current$108.9M5 Dec 31, 2024$197.9M5 Dec 31, 2023−45.0%

Properties, in its own words

Our headquarters are located at 301 Binney Street, Cambridge, Massachusetts, where we occupy approximately 71,562 square feet of research and development, laboratory and office space. This lease expires in 2029. In July 2021, we entered into the Seyon Lease. On January 31, 2024, we notified the Landlord of termination of the Seyon Lease due to the Landlord’s breach of its obligations to us under the Seyon Lease and returned possession of the premises to the Landlord, effective January 31, 2024. On February 14, 2024, the Landlord sent us a notice of the termination of the Seyon Lease due to our non-payment of rent. On February 20, 2024, the Landlord served us with a complaint, filed in the Court, with respect to the Seyon Lease. The complaint sought declaratory judgment that we unlawfully terminated the Seyon Lease and also asserted a claim for breach of contract damages. Following receipt of the complaint, we filed a counterclaim against the Landlord asserting breach of contract and violation of Massachusetts General Law Chapter 93A. On October 29, 2024, the Court determined that although we did not have the right to terminate the Seyon Lease, the Landlord’s subsequent termination was effective, and that we had alleged sufficient facts to state a claim for breach of contract and violation of Massachusetts General Law Chapter 93A by the Landlord. On January 21, 2025, the Court granted the Landlord’s motion for preliminary injunction and ordered us to pay, until further notice, monthly amounts equal to the rent and other charges that would have been due to the Landlord under the Seyon Lease had it not been terminated. On February 14, 2025, we filed a notice of appeal of the Court’s preliminary injunction ruling. We are continuing to make monthly payments under the Seyon Lease during the pendency of the appeal. We will continue to vigorously defend the action and prosecute our counterclaims against the Landlord with respect to this matter. For additional information, refer to Note 7, Leases. In the future, we may lease, operate, purchase or construct additional facilities in which to conduct expanded research, development and manufacturing activities and support future commercial operations. We believe that the total space available to us under our current leases is sufficient to meet our needs for the foreseeable future and that suitable additional space will be available as and when needed.

Item 2 of the 10-K filed Mar 13, 2025.4

Leadership

Who has led Generation Bio Co., and when. Pick a name to see everywhere that person has worked.

Chief executive

  1. Geoff McDonough2021–2026
  2. Yalonda Howze2026–now

President

  1. Geoff McDonough2021–2026
  2. Yalonda Howze2026–now

Chief financial officer

  1. Matthew Norkunas2020–now

Chief operating officer

  1. Mark D. Angelino2020–2021
  2. Antoinette Paone2022–now
2025
Board members and other officers (16)

Subsidiaries and ownership

Subsidiaries (Exhibit 21)

  • Generation Bio Securities Corporation Massachusetts3

The subsidiaries the company lists in Exhibit 21 of its annual report, as filed.

Timeline

  1. Feb 9, 20268-K Entered a material agreement; Ended a material agreement; Completed an acquisition or sale33
  2. Feb 4, 2026New chief executive Yalonda Howze becomes CEO13
  3. Dec 15, 20258-K Entered a material agreement; Other events34
  4. Nov 5, 20258-K Results of operations35
  5. Oct 22, 20258-K Executive or director change36
  6. Aug 12, 20258-K Results of operations37
  7. Jul 18, 20258-K Change to shareholders' rights; Bylaws or fiscal year changed38
  8. Jun 5, 20258-K Shareholder vote39
  9. May 7, 20258-K Results of operations40
  10. Mar 13, 20258-K Results of operations41
  11. Feb 28, 20258-K Listing notice or transfer42
  12. Jan 6, 20258-K Executive or director change; Regulation FD disclosure; Other events43
  13. Nov 6, 20248-K Results of operations44
  14. Jan 13, 2021New chief executive Geoff McDonough becomes CEO14

Calendar

When it reported results

  1. Nov 5, 2025Reported quarterly or annual results35
  2. Aug 12, 2025Reported quarterly or annual results37
  3. May 7, 2025Reported quarterly or annual results40
  4. Mar 13, 2025Reported quarterly or annual results41
  5. Nov 6, 2024Reported quarterly or annual results44
  6. Aug 7, 2024Reported quarterly or annual results45
  7. May 13, 2024Reported quarterly or annual results46
  8. Mar 6, 2024Reported quarterly or annual results47

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

Filings

348 filings to the SEC since October 2021: 4 annual reports, 13 quarterly reports, 42 major events, 207 insider forms, 41 large holders, 41 other. The latest 20:

  1. May 14, 2026SCHEDULE 13G/A EDGAR
  2. Feb 19, 202615-12G EDGAR
  3. Feb 17, 2026SCHEDULE 13G/A EDGAR
  4. Feb 12, 2026SCHEDULE 13G/A EDGAR
  5. Feb 11, 2026SCHEDULE 13G/A EDGAR
  6. Feb 10, 2026EFFECT EDGAR
  7. Feb 9, 20264 EDGAR
  8. Feb 9, 20264 OWNERSHIP DOCUMENT EDGAR
  9. Feb 9, 20264 OWNERSHIP DOCUMENT EDGAR
  10. Feb 9, 20264 OWNERSHIP DOCUMENT EDGAR
  11. Feb 9, 20264 OWNERSHIP DOCUMENT EDGAR
  12. Feb 9, 20264 OWNERSHIP DOCUMENT EDGAR
  13. Feb 9, 20264 OWNERSHIP DOCUMENT EDGAR
  14. Feb 9, 20264 OWNERSHIP DOCUMENT EDGAR
  15. Feb 9, 20264 OWNERSHIP DOCUMENT EDGAR
  16. Feb 9, 20264 OWNERSHIP DOCUMENT EDGAR
  17. Feb 9, 20264 OWNERSHIP DOCUMENT EDGAR
  18. Feb 9, 20264 OWNERSHIP DOCUMENT EDGAR
  19. Feb 9, 20264 OWNERSHIP DOCUMENT EDGAR
  20. Feb 9, 2026POS AM EDGAR

The 348 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

27 open-market trades by officers, directors and large owners since October 2021: 15 buys and 12 sales. Grants, option exercises and gifts are left out.

DateWhoTradeSharesPriceValueFiling
Jan 13, 2025Quinn Anthony G.DirectorBuy85,000$0.97$82.5KForm 4
Jan 10, 2025Quinn Anthony G.DirectorBuy125,791$0.96$120.8KForm 4
Jul 1, 2024Paone AntoinetteCHIEF OPERATING OFFICERSale6,719$2.74$18.4KForm 4
Jan 2, 2024Samayoa PhillipCHIEF SCIENTIFIC OFFICERSale2,445$1.62$4.0KForm 4
Jan 2, 2024Paone AntoinetteCHIEF OPERATING OFFICERSale2,445$1.62$4.0KForm 4
Dec 8, 2023Appelhans DannielleDirectorBuy8,000$1.79$14.3KForm 4
Dec 4, 2023Appelhans DannielleDirectorBuy12,000$1.50$18.0KForm 4
Dec 4, 2023Rowland Charles A JrDirectorBuy150,000$1.50$225.0KForm 4
Dec 1, 2023Rowland Charles A JrDirectorBuy192,960$1.31$252.8KForm 4
Dec 1, 2023Quinn Anthony G.DirectorBuy88,495$1.41$124.8KForm 4
Dec 1, 2023Nicholson Donald WilliamDirectorBuy100,000$1.44$144.0KForm 4
Aug 23, 2023Paone AntoinetteCHIEF OPERATING OFFICERSale3,116$4.93$15.4KForm 4
Jul 3, 2023Samayoa PhillipCHIEF SCIENTIFIC OFFICERSale3,116$5.29$16.5KForm 4
Apr 25, 2023Paone AntoinetteCHIEF OPERATING OFFICERSale2,914$4.61$13.4KForm 4
Jan 26, 2023Paone AntoinetteCHIEF OPERATING OFFICERSale2,695$5.56$15.0KForm 4
Jan 10, 2023Paone AntoinetteCHIEF OPERATING OFFICERSale1,865$4.57$8.5KForm 4
Jan 9, 2023Samayoa PhillipCHIEF SCIENTIFIC OFFICERSale1,865$5.11$9.5KForm 4
Oct 27, 2022Paone AntoinetteCHIEF OPERATING OFFICERSale2,914$5.03$14.7KForm 4
Sep 29, 2022Paone AntoinetteCHIEF OPERATING OFFICERSale2,828$5.24$14.8KForm 4
Sep 19, 2022Rowland Charles A JrDirectorBuy15,750$5.26$82.8KForm 4

All 27 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.

SEC filer profile

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

  • Name on EDGARGeneration Bio Co.1
  • CIK0001733294
  • Employer ID (EIN)81-43012844
  • Filer statusNon-accelerated filer not an emerging growth company; a smaller reporting company; not a shell company4
  • Incorporated inDelaware4
  • Fiscal year endsDecember 311
  • Industry code (SIC)2834 Pharmaceutical Preparations1
  • SEC reviewing officeOffice of Life Sciences, Division of Corporation Finance1
  • Business address301 Binney Street, Cambridge, MA 021421
  • Phone857-529-59081
  • Shares outstanding6,737,899 as of Oct 31, 202511
  • Public float$155.2M as of Jun 28, 20244
  • AuditorErnst & Young LLP, Boston, Massachusetts PCAOB ID 42; no auditor attestation of internal control over financial reporting4
  • On EDGAR sinceMar 5, 20181
  • Filings526 in all: 4 (291), 8-K (53), 3 (27), SC 13G/A (25), 10-Q (17), SC 13G (15), SCHEDULE 13G/A (10), S-8 (7)1
    All 42 form types

    S-8 POS (7), CORRESP (6), 10-K (5), DEF 14A (5), DEFA14A (5), EFFECT (5), UPLOAD (4), ARS (3), SC TO-T/A (3), SCHEDULE 13G (3), 144 (2), 3/A (2), 424B4 (2), D (2), DRS (2), POS AM (2), PRE 14A (2), S-1 (2), S-1/A (2), S-1MEF (2), SC 14D9/A (2), 15-12G (1), 25-NSE (1), 8-A12B (1), CERT (1), DRS/A (1), DRSLTR (1), POSASR (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) Mar 13, 2025
    Quarterly report (10-Q) Nov 5, 2025
    Proxy statement (DEF 14A) Apr 23, 2025
    Latest 8-K (8-K) Feb 9, 2026

Securities registered for trading

ClassSymbolExchange
Common Stock, $0.0001 Par ValueGBIONasdaq Global Select Market

From the cover page of the 10-K filed Mar 13, 2025 (Section 12(b) of the Exchange Act).4

Risk factors and legal proceedings

The risks Generation Bio Co. names in Item 1A of its 10-K filed Mar 13, 2025: 71 risks under these headings, as written.4

  • Risks related to our financial position and need for additional capital
  • We have incurred significant losses since our inception, have no products approved for sale and we expect to incur losses over the next several years.
  • 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 to evaluate the success of our business to date and to assess our future viability.
  • Our ability to utilize our net operating loss carryforwards may be subject to limitations.
  • Risks related to discovery and development
  • We are very early in our development efforts. We have not identified any product candidates for Investigational New Drug, or IND, -enabling studies or clinical development, and as a result it will be years before we commercialize a product candidate, if ever. If we are unable to identify and advance 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.
  • We may encounter substantial delays in commencement, enrollment or completion of our clinical trials or we may fail to demonstrate purity, potency and safety to the satisfaction of applicable regulatory authorities, which could prevent us from commercializing any product candidates we determine to develop on a timely basis, if at all.
  • Nucleic acid therapies are an emerging area of drug development that poses many scientific and other risks. We have only limited prior experience in nucleic acid therapies and manufacturing and no prior experience in clinical development of nucleic acid therapies. Our lack of experience for our nucleic acid therapies may limit our ability to be successful or may delay our development efforts.
  • Our technologies are unproven clinically, which makes it difficult to predict the time and cost of development and of subsequently obtaining regulatory approval, if at all.
The other 61 risks
  • If any product candidates we may develop cause undesirable side effects or have other unexpected adverse properties, such side effects or properties could delay or prevent regulatory approval, limit the commercial potential or result in significant negative consequences following any potential marketing approval.
  • 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 not be successful in our efforts to identify, discover or develop potential product candidates.
  • 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.
  • Clinical trial and product liability lawsuits against us could divert our resources, could cause us to incur substantial liabilities and could limit commercialization of any product candidates we may develop.
  • Risks related to manufacturing
  • We intend to manufacture any product candidate we may develop using CMOs, which will require significant resources. If we fail to successfully execute this strategy, our business will be materially harmed.
  • The manufacture of any product candidates we may develop will be subject to a number of scientific and technical risks, some of which are common to the manufacture of drugs and biologics and others of which may be unique to the manufacture of any product candidate we may develop. We could experience manufacturing problems that result in delays in our development or commercialization programs.
  • Testing of and changes to methods of product candidate manufacturing or formulation may result in additional costs or delay.
  • We and our contract manufacturers are subject to significant regulation with respect to manufacturing our products. The manufacturing facilities on which we rely may not continue to meet regulatory requirements and have limited capacity.
  • Risks related to our dependence on third parties
  • We currently depend on a small number of third-party suppliers for our research materials, and we expect to continue to depend on third-party suppliers for materials used in the manufacture of any product candidates we may develop, and the loss of these third-party suppliers or their inability to supply us with adequate materials, particularly those raw materials that are in short supply, could harm our business.
  • 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.
  • We may from time to time be dependent on single-source suppliers for some of the components and materials used in, and the space and processes required to develop, our future development candidates and investigational medicines.
  • We expect to rely on third parties to conduct, supervise and monitor IND-enabling studies and clinical studies, and if these third parties perform in an unsatisfactory manner, it may harm our business.
  • We have entered into, and may continue to enter into, collaborations with third parties for the research, development and commercialization of certain of the product candidates we may develop. 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 collaborators or strategic partners, 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.
  • If we breach, or a counterparty breaches, our agreements with third parties or if there is a dispute concerning any of our agreements with third parties, our business could be materially harmed.
  • 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 any product candidate that we may develop receives marketing approval, it may fail to achieve the degree of market acceptance by physicians, patients, third-party payers and others in the medical community necessary for commercial success.
  • The pricing, insurance coverage and reimbursement status of newly approved products is 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 any product candidates we may develop if and when they are approved.
  • Any product candidates for which we intend to seek approval as biologic products may face competition sooner than anticipated.
  • Risks related to our intellectual property
  • If we or our licensors are unable to obtain, maintain and defend patent and other intellectual property protection for our product candidates and 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 any product candidates we may develop or our technology may be adversely affected due to such competition.
  • Our rights to develop and commercialize any product candidates are 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 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.
  • 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 product candidates we may develop through acquisitions and in-licenses.
  • Issued patents covering any product candidates we may develop could be found invalid or unenforceable if challenged in court or before administrative bodies in the United States 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.
  • Changes in patent law in the United States or worldwide could diminish the value of patents in general, thereby impairing our ability to protect any product candidates we may develop and our technology.
  • If we do not obtain patent term extension and regulatory exclusivity for any product candidates we may develop, 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 regulatory approval and other legal compliance matters
  • We may continue to incur costs related to the Seyon Lease.
  • 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 costs that could have a material adverse effect on the success of our business.
  • 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 may 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 may develop, and our ability to generate revenue will be materially impaired.
  • Failure to obtain marketing approval in foreign jurisdictions would prevent any product candidates we may 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, RMAT and Priority Review designations in the United States, 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 complete the necessary preclinical studies and clinical trials, we cannot predict when or if we will obtain regulatory approval to commercialize a product candidate we may develop or the approval may be for a more narrow indication than we expect.
  • Even if we, or any collaborators we may have, obtain marketing approvals for any product candidates we may 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.
  • The FDA, EMA and other regulatory authorities actively enforce the laws and regulations prohibiting the promotion of off-label uses.
  • Disruptions in the FDA and other government agencies caused by funding shortages or global health concerns could hinder their ability to hire and retain key leadership and other personnel, or otherwise prevent new product candidates and services from being developed or commercialized in a timely manner, which could negatively impact our business.
  • Our relationships with healthcare providers, physicians and third-party payers 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.
  • Recently enacted and future legislation 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.
  • The prices of prescription pharmaceuticals in the United States and foreign jurisdictions are subject to considerable legislative and executive actions and could impact the prices we obtain for our products, if and when licensed.
  • 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.
  • We are subject to stringent privacy laws, information security laws, regulations, policies and contractual obligations related to data privacy and security and changes in such laws, regulations, policies, contractual obligations and 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.
  • Risks related to employee matters and managing growth
  • Our future success depends on our ability 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 achieving and managing our future growth, which could disrupt our operations.
  • Our current collaboration with Moderna and future acquisitions or strategic alliances could disrupt our business and harm our financial condition and results of operations.
  • Our internal information technology systems, or those of our third-party vendors, collaborators or other contractors or consultants, may fail or suffer security breaches, loss or leakage of data and other disruptions, which could result in a material disruption of our product development programs, compromise sensitive information related to our business or prevent us from accessing critical information, potentially exposing us to liability or otherwise adversely affecting our business.
  • 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.
  • Risks related to ownership of our common stock and our status as a public company
  • We do not know whether a market will continue to develop or be sustained for our common stock, and, as a result, it may be difficult for our stockholders to sell their shares of our common stock.
  • The price of our common stock is volatile and fluctuates substantially, which could result in substantial losses for purchasers of our common stock.

Legal proceedings

We, from time to time, may be party to litigation arising in the ordinary course of business. On February 20, 2024, the Landlord served us with a complaint, filed in the Court with respect to the Seyon Lease. The complaint sought declaratory judgment that we unlawfully terminated the Seyon Lease and also asserted a claim for breach of contract damages. Following receipt of the complaint, we filed a counterclaim against the Landlord asserting breach of contract and violation of Massachusetts General Law Chapter 93A. On October 29, 2024, the Court determined that although we did not have

the right to terminate the Seyon Lease, the Landlord’s subsequent termination was effective, and that we had alleged sufficient facts to state a claim for breach of contract and violation of Massachusetts General Law Chapter 93A by the Landlord. On January 21, 2025, the Court granted the Landlord’s motion for preliminary injunction and ordered us to pay, until further notice, monthly amounts equal to the rent and other charges that would have been due to the Landlord under the Seyon Lease had it not been terminated. On February 14, 2025, we filed a notice of appeal of the Court’s preliminary injunction ruling. We are continuing to make monthly payments under the Seyon Lease during the pendency of the appeal. We will continue to vigorously defend the action and prosecute our counterclaims against the Landlord with respect to this matter. As a result, we may continue to incur costs and expenses relating to this facility, and we may remain responsible for payments under the Seyon Lease, which may have a material adverse effect on our business, results of operations or financial condition.

The opening of Item 3, Legal Proceedings.4

Sources

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