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Private company

Carisma Therapeutics Inc.

In its 2025 annual report the company says: “We are a biotechnology company focused on applying our industry leading expertise in macrophage engineering to develop transformative therapies to treat serious diseases including liver fibrosis and cancer. We have created a comprehensive set of platform technologies to enable the therapeutic use of engineered macrophages and monocytes, which belong to a subgroup of white blood cells called myeloid cells.”4 It is headquartered in Cambridge, United States.2

Last updated Oct 21, 2026.

Overview

  • IndustryPharmaceutical Preparations2
  • HeadquartersCambridge, United States2
  • Incorporated inDE3
  • Business address3675 Market Street, Suite 401, Philadelphia, Pa 191043
  • Filer categoryNon-accelerated filer, Smaller reporting company3
  • Legal formCorporation2
  • LEI549300DGKHONOZQIY1162
  • StatusActive2
  • LEI statusLapsed (not renewed)2
  • Registered addressC/O The Corporation Trust Company, 19801 Wilmington, United States2
  • Registered withDivision of Corporations, Department of State, 45090622

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We are a biotechnology company focused on applying our industry leading expertise in macrophage engineering to develop transformative therapies to treat serious diseases including liver fibrosis and cancer. We have created a comprehensive set of platform technologies to enable the therapeutic use of engineered macrophages and monocytes, which belong to a subgroup of white blood cells called myeloid cells. We seek to apply our ability to engineer macrophages and monocytes, either in vivo or ex vivo , using approaches and delivery systems most appropriate to each specific indication, to meaningfully alter the course of the disease. Our proprietary CAR-M platform uses chimeric antigen receptors, or CARs, to redirect macrophages or monocytes against specific tumor associated antigens with the goal of targeted anti-tumor immunity.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

-317.2%Operating margin5
-308.6%Net margin5
31.5%Revenue growth, 20245
-$60.0MFree cash flow5

Where the money goes

Where each dollar of revenue went, fiscal 2024

  • Research and development100¢$59.7M

Out of $19.6M in revenue.5 The company lost money this year.

Financial statements

Revenue67895$19.6M in 2024
0$10.0M$20.0M$30.0M2018: $0$020182019: $0$020192020: $11.2M$11.2M20202021: $26.5M$26.5M2021+136%2022: $9.8M$9.8M2022−63%2023: $14.9M$14.9M2023+52%2024: $19.6M$19.6M2024+32%
Operating income67895-$62.2M in 2024+80% since 2018
-$150.0M-$100.0M-$50.0M02018: -$34.5M-$34.5M20182019: -$108.5M-$108.5M2019+214%2020: -$21.1M-$21.1M2020−81%2021: -$8.5M-$8.5M2021−59%2022: -$56.2M-$56.2M2022+557%2023: -$88.7M-$88.7M2023+58%2024: -$62.2M-$62.2M2024−30%
Net income67895-$60.5M in 2024+79% since 2018
-$150.0M-$100.0M-$50.0M02018: -$33.7M-$33.7M20182019: -$107.5M-$107.5M2019+219%2020: -$22.4M-$22.4M2020−79%2021: -$336.0K-$336.0K2021−98%2022: -$61.2M-$61.2M2022+18122%2023: -$86.9M-$86.9M2023+42%2024: -$60.5M-$60.5M2024−30%
Fiscal year2018201920202021202220232024
Revenue$06$07$11.2M8$26.5M8$9.8M9$14.9M5$19.6M5
Research and development$14.1M6$24.7M7$29.2M8$25.3M8$56.6M9$74.1M5$59.7M5
Operating expenses$35.1M8$66.0M9$103.7M5$81.8M5
Operating income-$34.5M6-$108.5M7-$21.1M8-$8.5M8-$56.2M9-$88.7M5-$62.2M5
Income before tax-$8.6M8-$23.8M8
Income tax$06$07$1.4M8-$8.3M8-$3.9M8
Net income-$33.7M6-$107.5M7-$22.4M8-$336.0K8-$61.2M9-$86.9M5-$60.5M5
Earnings per share-$0.5512-$1.187-$0.198$0.008-$28.779-$2.595-$1.465
Earnings per share (diluted)-$0.5512-$1.187-$0.198$0.008-$28.779-$2.595-$1.465
Shares (weighted, basic)182.3M shares82.1M shares933.5M shares541.5M shares5
Shares (weighted, diluted)182.3M shares82.1M shares933.5M shares541.5M shares5

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Corporate structure

Carisma 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 Carisma Therapeutics Inc.

  • HealthCap VII, L.P. Filed SCHEDULE 13D/A on Carisma Therapeutics Inc., latest Sep 2, 2025 (7 filings since Mar 9, 2023)
  • AbbVie Biotechnology Ltd Filed SCHEDULE 13G/A on Carisma Therapeutics Inc., latest Apr 25, 2025 (2 filings since Mar 13, 2024)
  • VANGUARD GROUP INC Filed SC 13G/A on Carisma Therapeutics Inc., latest Feb 13, 2024 (3 filings since Feb 10, 2022)
  • Longview Innovation Corp. Filed SC 13G/A on Carisma Therapeutics Inc., latest Feb 2, 2024 (2 filings since Mar 16, 2023)
  • TRUSTEES OF THE UNIVERSITY OF PENNSYLVANIA Filed SC 13D/A on Carisma Therapeutics Inc., latest Jan 26, 2024 (2 filings since Mar 17, 2023)
  • ModernaTX, Inc. Filed SC 13G on Carisma Therapeutics Inc., latest Mar 13, 2023
  • Radoff Bradley Louis Filed SC 13D/A on Carisma Therapeutics Inc., latest Feb 15, 2023 (5 filings since Nov 18, 2022)
  • BlackRock Filed SC 13G on Carisma Therapeutics Inc., latest Jul 8, 2022 (2 filings since Feb 4, 2022)
  • Carisma Therapeutics Inc. Cambridge, Massachusetts, United States

Built from parent and subsidiary links from GLEIF, the Global Legal Entity Identifier Foundation (CC0); major holders from Schedules 13D and 13G. Each entity in the chart links to its source.

What it owns

What Carisma 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
Operating-lease assets (leased space)$2.0M5 Dec 31, 2024$2.2M5 Dec 31, 2023−6.1%

Investments

ItemLatestA year beforeChange
Cash and cash equivalents$17.9M5 Dec 31, 2024$77.6M5 Dec 31, 2023−76.9%
Marketable securities, current$09 Dec 31, 2023$27.8M9 Dec 31, 2022−100.0%
Debt securities available for sale$09 Dec 31, 2023$54.4M8 Dec 31, 2022−100.0%

Properties, in its own words

Our principal facilities consist of office and laboratory space in Philadelphia, Pennsylvania. We occupy approximately 4,369 square feet of office space under a lease that is expected to expire in October 2029 and laboratory space leases which expire in June 2025. We believe that our facilities are sufficient to meet our current needs.

Item 2 of the 10-K filed Mar 31, 2025.4

Leadership

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

Chief executive

  1. Abbie Celniker2014–2016
  2. Stephen A. Hurly2016–2018
  3. Thomas R. Cannell2018–2023

President

  1. Abbie Celniker2014–2016
  2. Stephen A. Hurly2016–2018
  3. Thomas R. Cannell2018–2023

Chief financial officer

  1. Gregory D. Perry2014–2015
  2. John J. McCabe2016–2017
  3. Richard F. Fitzgerald2017–2019
  4. Monica Forbes2019–2023
  5. Richard Steven Morris2023–now
201520202025
Board members and other officers (36)

Former names

  • Sesen Bio, Inc.Apr 2, 2018 to Mar 6, 20233
  • Eleven Biotherapeutics, Inc.Feb 24, 2010 to May 16, 20183

Timeline

  1. Dec 5, 20258-K Listing notice or transfer; Executive or director change55
  2. Oct 15, 20258-K Executive or director change56
  3. Oct 9, 20258-K Listing notice or transfer57
  4. Sep 18, 20258-K Entered a material agreement; Ended a material agreement; Other events58
  5. Aug 29, 20258-K Entered a material agreement; Unregistered sale of shares; Change in control59
  6. Aug 8, 20258-K Shareholder vote60
  7. Jul 15, 20258-K Listing notice or transfer61
  8. Jun 23, 20258-K Entered a material agreement; Regulation FD disclosure62
  9. Jun 12, 20258-K Other events63
  10. Apr 16, 20258-K Listing notice or transfer64
  11. Jan 13, 20258-K Other events65
  12. Jan 10, 20258-K Listing notice or transfer66
  13. Aug 9, 2018New chief executive Thomas R. Cannell becomes CEO14
  14. Sep 22, 2016New chief executive Stephen A. Hurly becomes CEO15
  15. Feb 5, 2014New chief executive Abbie Celniker becomes CEO16
  16. Feb 25, 2008Founded Carisma Therapeutics Inc. is founded2

Calendar

When it reported results

  1. Nov 7, 2024Reported quarterly or annual results67
  2. Aug 8, 2024Reported quarterly or annual results68
  3. May 9, 2024Reported quarterly or annual results69
  4. Apr 1, 2024Reported quarterly or annual results70
  5. Nov 9, 2023Reported quarterly or annual results71
  6. Aug 10, 2023Reported quarterly or annual results72
  7. May 12, 2023Reported quarterly or annual results73
  8. Apr 4, 2023Reported quarterly or annual results74

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

Filings

321 filings to the SEC since October 2021: 5 annual reports, 14 quarterly reports, 88 major events, 72 insider forms, 24 large holders, 118 other. The latest 20:

  1. Dec 29, 202515-12G EDGAR
  2. Dec 16, 2025EFFECT EDGAR
  3. Dec 16, 2025EFFECT EDGAR
  4. Dec 16, 2025EFFECT EDGAR
  5. Dec 16, 2025EFFECT EDGAR
  6. Dec 15, 2025S-8 POS EDGAR
  7. Dec 15, 2025S-8 POS EDGAR
  8. Dec 15, 2025S-8 POS EDGAR
  9. Dec 15, 2025S-8 POS EDGAR
  10. Dec 15, 2025S-8 POS EDGAR
  11. Dec 15, 2025S-8 POS EDGAR
  12. Dec 15, 2025S-8 POS EDGAR
  13. Dec 15, 2025S-8 POS EDGAR
  14. Dec 15, 2025S-8 POS EDGAR
  15. Dec 15, 2025S-8 POS EDGAR
  16. Dec 15, 2025S-8 POS EDGAR
  17. Dec 15, 2025S-8 POS EDGAR
  18. Dec 15, 2025S-8 POS EDGAR
  19. Dec 15, 2025POS AM EDGAR
  20. Dec 15, 2025POS AM EDGAR

The 321 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

14 open-market trades by officers, directors and large owners since October 2021: 0 buys and 14 sales. Grants, option exercises and gifts are left out.

DateWhoTradeSharesPriceValueFiling
Oct 7, 2025Klichinsky MichaelChief Scientific OfficerSale56,982$0.25$14.2KForm 4
Oct 3, 2025Klichinsky MichaelChief Scientific OfficerSale119,347$0.26$31.0KForm 4
Oct 2, 2025Klichinsky MichaelChief Scientific OfficerSale200,000$0.25$50.0KForm 4
Oct 1, 2025Klichinsky MichaelChief Scientific OfficerSale165,000$0.26$42.9KForm 4
Mar 2, 2023Sullivan MarkGeneral Counsel & SecretarySale219,218$0.59$129.3KForm 4
Mar 2, 2023MacDonald Glen CChief Technology OfficerSale170,372$0.59$100.5KForm 4
Mar 2, 2023Ryu EllyPrincipal Accounting OfficerSale17,289$0.59$10.2KForm 4
Mar 2, 2023Cannell Thomas RPresident and CEOSale487,487$0.59$287.6KForm 4
Mar 2, 2023Forbes MonicaChief Financial OfficerSale345,849$0.59$204.1KForm 4
Feb 21, 2023Sullivan MarkGeneral Counsel & SecretarySale39,831$0.59$23.5KForm 4
Feb 21, 2023Ryu EllyPrincipal Accounting OfficerSale7,159$0.59$4.2KForm 4
Feb 21, 2023Cannell Thomas RPresident and CEOSale53,727$0.59$31.7KForm 4
Feb 21, 2023Forbes MonicaChief Financial OfficerSale61,862$0.59$36.5KForm 4
Feb 21, 2023MacDonald Glen CChief Technology OfficerSale25,927$0.59$15.3KForm 4

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 Carisma 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 EDGARCarisma Therapeutics Inc.1
  • CIK0001485003
  • Employer ID (EIN)26-20256164
  • 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 address3675 Market Street, Suite 401, Philadelphia, PA 191041
  • Phone26749164221
  • Shares outstanding41,845,078 as of Nov 5, 202510
  • Public float$53.1M as of Jun 28, 20244
  • AuditorKPMG LLP, Philadelphia, Pennsylvania PCAOB ID 185; no auditor attestation of internal control over financial reporting4
  • On EDGAR sinceFeb 24, 20101
  • Filings853 in all: 8-K (256), 4 (190), 3 (53), 425 (42), 10-Q (36), SC 13G/A (26), SC 13G (19), CORRESP (18)1
    All 52 form types

    EFFECT (16), DEFA14A (15), UPLOAD (15), S-8 POS (14), S-8 (13), SC 13D/A (13), 10-K (12), 424B5 (11), DEF 14A (11), CT ORDER (8), 8-K/A (7), POS AM (6), PRE 14A (6), S-3 (6), SC 13D (6), S-4/A (5), D (4), S-1/A (4), SEC STAFF LETTER (4), 424B3 (3), S-1 (3), SCHEDULE 13D/A (3), 10-Q/A (2), 144 (2), 424B4 (2), ARS (2), FWP (2), S-4 (2), 10-K/A (1), 15-12G (1), 25 (1), 8-A12B (1), CERTNAS (1), D/A (1), DEFM14A (1), DRS (1), DRS/A (1), NT 10-Q (1), PREM14A (1), PRER14A (1), RW (1), S-3/A (1), S-4MEF (1), SCHEDULE 13G/A (1)

  • Latest filingsAnnual report (10-K) Mar 31, 2025
    Quarterly report (10-Q) Nov 12, 2025
    Proxy statement (DEF 14A) Jul 7, 2025
    Latest 8-K (8-K) Dec 5, 2025

Securities registered for trading

ClassSymbolExchange
Common Stock, $0.001 par value per shareCARMThe Nasdaq Stock Market LLC

From the cover page of the 10-K filed Mar 31, 2025 (Section 12(b) of the Exchange Act).4

Risk factors and legal proceedings

The risks Carisma Therapeutics Inc. names in Item 1A of its 10-K filed Mar 31, 2025: 73 risks under these headings, as written.4

  • Risks Related to Our Evaluation of Strategic Alternatives and Wind Down
  • Risks Related to Our Financial Position and Need for Additional Capital
  • Risks Related to Our Historical Discovery Programs and Research and Development of Our Product Candidates
  • Risks Related to the Commercialization of Our Product Candidates
  • Risks Related to Our Dependence on Third Parties
  • Risks Related to Our Intellectual Property
  • Risks Related to our Common Stock
  • Our exploration and pursuit of strategic alternatives may not be successful.
  • If we do not successfully identify a strategic alternative or, if such a strategic alternative is identified, consummate such a transaction, it is highly unlikely that there will be cash available for distribution to our stockholders.
  • Even if we do consummate a strategic alternative, the amount of cash available for distribution to our stockholders, if any, will depend heavily on the proceeds derived from the strategic transaction, the timing of any distribution to stockholders, whether as a dividend or through a liquidation and dissolution of our business, as well as the amount of cash that will need to be reserved for commitments and contingent liabilities.
  • We may elect to commence bankruptcy or liquidation and dissolution proceedings, and such proceedings may delay our wind down timeframe, increase our costs, and decrease the cash, if any, that may be available for stockholders.
  • We may experience difficulties, delays or unexpected costs and not achieve anticipated benefits and savings from our cash preservation plan, and our wind down activities may adversely affect our ability to consummate a strategic transaction that enhances stockholder value.
The other 67 risks
  • We will be substantially dependent on our remaining employees and consultants, along with any other advisors and consultants we may engage, to facilitate the consummation of a strategic transaction.
  • We may become involved in securities class action litigation that could divert management’s attention and harm our business, and insurance coverage may not be sufficient to cover all costs and damages.
  • Any future resumption of research and development activities would depend on completing a strategic transaction that would support our prior operating plans or otherwise obtaining significant additional funding. Significant additional financing may not be available to us on acceptable terms, or at all.
  • We have incurred significant losses since our inception. We have very limited cash resources remaining and a very short operating runway before we deplete our cash resources. We expect to continue to incur significant expenses and operating losses while we explore strategic alternatives and carry out the orderly wind down of our operations.
  • Our independent registered public accounting firm has included an explanatory paragraph relating to our ability to continue as a going concern in its report on our audited consolidated financial statements included in this Annual Report on Form 10-K.
  • We have never generated revenue from product sales and may never achieve or maintain profitability.
  • Our limited operating history and our cash preservation plan may make it difficult for you to evaluate the success of our business to date and to assess our future viability.
  • Changes in tax law may adversely affect us or our investors.
  • Our ability to use our net operating losses and research and development tax credit carryforwards to offset future taxable income may be subject to certain limitations.
  • We currently have no intention of resuming research and development activities independently or as a standalone company, and the following are risks primarily relating to our prior operations and historical activities, unless otherwise noted.
  • Cell therapy is a rapidly evolving area of science, and the approach we have taken to discover and develop product candidates by utilizing genetically modified macrophages and monocytes is novel and may never lead to approved or marketable products.
  • We are early in our development efforts. If we are unable to commercialize our product candidates or experience significant delays in doing so, our business will be materially harmed.
  • Drug development involves a lengthy and expensive process, with an uncertain outcome. The results of pre-clinical studies and early clinical trials may not be predictive of future results. We may incur additional costs or experience delays in completing, or ultimately be unable to complete, the development and commercialization of our product candidates.
  • We may conduct 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.
  • The results of early-stage clinical trials and pre-clinical studies may not be predictive of future results. Initial success in clinical trials may not be indicative of results obtained when these trials are completed or in later stage trials.
  • Interim and preliminary 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.
  • If we experience delays or difficulties in the enrollment of patients in our clinical trials for any of our product candidates, our receipt of necessary marketing approvals could be delayed or prevented.
  • If serious adverse events, undesirable side effects or unexpected characteristics are identified during the development of any of our product candidates, we may need to abandon or limit our further clinical development of those product candidates.
  • 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 may evaluate certain of our product candidates in combination with other drugs. If the FDA or similar regulatory authorities outside of the United States do not approve these other drugs, revoke their approval of such drugs, or if safety, efficacy, manufacturing or supply issues arise with the drugs we choose to evaluate in combination with our product candidates, we may be unable to obtain approval of our product candidates.
  • We may not be successful in our efforts to identify or discover additional potential product candidates.
  • Adverse public perception of genetic medicine, and gene therapy in particular, may negatively impact regulatory approval of, or demand for, our potential products.
  • Even if any of our product candidates receives marketing approval, we 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 our product candidates, if approved, may be smaller than we estimate.
  • 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 and when they are approved.
  • We face substantial competition, which may result in others discovering, developing or commercializing products before or more successfully than we do, thus rendering our products non-competitive, obsolete or reducing the size of the market for our products.
  • 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.
  • 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.
  • We currently have no intention of resuming research and development activities independently or as a standalone company. The following are risks primarily relating to our prior operations and historical activities, expect for the risks relating to our ongoing collaboration with Moderna or as other otherwise noted below.
  • We have relied on, and if we resume research and development activities expect to continue to rely on third-party CMOs for the manufacture of both drug substance and finished drug product of our product candidates for pre-clinical 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.
  • We currently, and may in the future, rely on single-source suppliers for certain materials and components used in the manufacturing of our product candidates.
  • We expect to depend on collaborations with third parties for the research, development and commercialization of certain of our product candidates, including our collaboration agreement with Moderna. If our collaborations are not successful, we may not be able to capitalize on the market potential of these product candidates and our business could be adversely affected.
  • If we are not able to establish or maintain additional collaborations, on commercially reasonable terms, we may have to alter our development and commercialization plans, and our business could be adversely affected.
  • We have a number of academic collaborations to supplement our internal discovery and product development programs. If any such collaborator decides to discontinue or devote less resources to such research, our discovery programs could be diminished.
  • Any acquisitions or in-license transactions that we complete could disrupt our business, cause dilution to our stockholders or reduce our financial resources.
  • The FDA, EMA, or other comparable foreign regulatory authorities could require the clearance or approval of a companion diagnostic device as a condition of approval for any product candidate that requires or would commercially benefit from such tests. Failure to successfully validate, develop and obtain regulatory clearance or approval for companion diagnostics on a timely basis or at all could harm our product development strategy and we may not realize the commercial potential of any such product candidate.
  • If we are unable to obtain, maintain and enforce patent protection for our 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 and we may not be able to compete effectively in our market.
  • Patent terms may be inadequate to protect our competitive position with respect to our current or future product candidates for an adequate amount of time.
  • 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.
  • If we do not obtain patent term extension 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 products.
  • Although we or our licensors are not currently involved in any intellectual property litigation, we may become involved in lawsuits to protect or enforce our patents, the patents of our licensors or other intellectual property rights, which could be expensive, time-consuming and unsuccessful.
  • We may need to license intellectual property from third parties, and such licenses may not be available or may not be available on commercially reasonable terms.
  • 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 have a material adverse effect on the success of our business.
  • 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 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.
  • If we fail to comply with our obligations in our current and future intellectual property licenses and funding 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.
  • We may not be able to protect our intellectual property and proprietary rights throughout the world.
  • We may be subject to claims challenging the inventorship or ownership of our patents and other intellectual property.
  • 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, including of their current or former employers or claims asserting we have misappropriated their intellectual property, or is 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.
  • Intellectual property rights do not necessarily address all potential threats to us.
  • If approved, our product candidates that are licensed and regulated as biologics may face competition from biosimilars approved through an abbreviated regulatory pathway.
  • Risks Related to Regulatory Approval and Other Legal Compliance Matters
  • The regulatory approval process of the FDA is lengthy, time-consuming and inherently unpredictable, and if we are ultimately unable to obtain marketing approval for our product candidates, our business will be substantially harmed.
  • Even if we complete the necessary pre-clinical 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 some or all 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.
  • 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.
  • Inadequate funding for the FDA, the SEC and other government agencies, including from government shutdowns, funding shortages, personnel losses, regulatory reform 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.
  • Regulatory requirements governing gene therapy products are periodically updated and may continue to change in the future.
  • Any product for which we obtain marketing approval in the future could be subject to post-marketing 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 any such product following approval.
  • Any regulatory approval to market our products will be limited by indication. If we fail to comply or are found to be in violation of FDA regulations restricting the promotion of our products for unapproved uses, we could be subject to criminal penalties, substantial fines or other sanctions and damage awards.
  • We may seek certain designations for our product candidates, including Breakthrough Therapy, Fast Track and Priority Review designations in the United States, 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 seek PRIME Designation in the European Union for our product candidates, 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.
  • If we are required by the FDA, EMA or comparable regulatory authority to obtain clearance or approval of a companion diagnostic test in connection with approval of any of our product candidates or a group of therapeutic products, and we do not obtain or we face delays in obtaining clearance or approval of a diagnostic test, we may not be able to commercialize the product candidate and our ability to generate revenue may be materially impaired.
  • 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 civil, criminal and administrative sanctions, contractual damages, reputational harm and diminished future profits and earnings.
  • Current and future legislation may increase the difficulty and cost for us and any of our collaborators to obtain marketing approval of and commercialize product candidates and affect the prices we, or any of our collaborators, may obtain.

Legal proceedings

We are currently not a party to any material legal proceedings.

The opening of Item 3, Legal Proceedings.4

Sources

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