CRBU on Nasdaq

Caribou Biosciences, Inc.

In its 2026 annual report the company says: “We are a clinical-stage C lustered R egularly I nterspaced S hort P alindromic R epeats genome-editing biopharmaceutical company dedicated to developing transformative therapies for patients with devastating diseases. Our genome-editing platform is based on our novel chRDNA ( C RISPR h ybrid R NA- DNA, or “chRDNA,” pronounced “chardonnay”) genome-editing technology, which enables more precise genome editing of allogeneic cell therapies.”4 It is headquartered in Berkeley, California.1 Its shares trade on Nasdaq under the symbol CRBU.1

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Last updated Oct 21, 2026.

Overview

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  • TickerCRBU on Nasdaq1
  • IndustryBiological Products, (No Diagnostic Substances)1
  • HeadquartersBerkeley, California1
  • Incorporated inDE2
  • Business address2929 7Th Street, Suite 105, Berkeley, Ca 947102
  • Filer category, Emerging growth company2

We are a clinical-stage C lustered R egularly I nterspaced S hort P alindromic R epeats (“CRISPR”) genome-editing biopharmaceutical company dedicated to developing transformative therapies for patients with devastating diseases. Our genome-editing platform is based on our novel chRDNA ( C RISPR h ybrid R NA- DNA , or “chRDNA,” pronounced “chardonnay”) genome-editing technology, which enables more precise genome editing of allogeneic cell therapies.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 2025

-1329.4%Operating margin5
-1327.4%Net margin5
11.7%Revenue growth, 20255
-121.2%Return on equity5
-$112.4MFree cash flow5

What sells

Revenue by product, business segment and region, as the company reports it to the SEC.

Regions

United States brought in 85% of the revenue Caribou Biosciences, Inc. broke down this way in fiscal 2025.

  1. United States$9.5M585%up 2% from 2024
  2. Outside the United States$1.7M515%up 132% from 2024
Regions by year
Regions20242025
United States$9.3M$9.5M
Outside the United States$724.0K$1.7M

Where the money goes

Where each dollar of revenue went, fiscal 2025

  • Research and development99¢$109.4M
  • Income tax1¢$550.0K

Out of $11.2M in revenue.5 The company lost money this year.

Financial statements

Revenue67895$11.2M in 2025+93% since 2019
0$10.0M$20.0M$30.0M$40.0M2019: $5.8M$5.8M20192020: $12.4M$12.4M2020+114%2021: $9.6M$9.6M2021−22%2022: $13.9M$13.9M2022+44%2023: $34.5M$34.5M2023+149%2024: $10.0M$10.0M2024−71%2025: $11.2M$11.2M2025+12%
Operating income67895-$148.3M in 2025+332% since 2019
-$200.0M-$150.0M-$100.0M-$50.0M02019: -$34.3M-$34.3M20192020: -$36.1M-$36.1M2020+5%2021: -$67.0M-$67.0M2021+85%2022: -$106.4M-$106.4M2022+59%2023: -$116.1M-$116.1M2023+9%2024: -$166.6M-$166.6M2024+44%2025: -$148.3M-$148.3M2025−11%
Net income67895-$148.1M in 2025+532% since 2019
-$150.0M-$100.0M-$50.0M02019: -$23.4M-$23.4M20192020: -$34.3M-$34.3M2020+46%2021: -$66.9M-$66.9M2021+95%2022: -$99.4M-$99.4M2022+49%2023: -$102.1M-$102.1M2023+3%2024: -$149.1M-$149.1M2024+46%2025: -$148.1M-$148.1M2025−1%

Every line of the income statement as filed: the last 2 fiscal years, latest first.5

Period ending2025-12-312024-12-31
Research and development$109.4M$130.2M
General and administrative$37.9M$46.5M
Total operating expenses$159.5M$176.6M
Loss from operations-$148.3M-$166.6M
Other income, net$8.8M$17.5M
Total other (expense) income-$331.0K$17.5M
Net loss before benefit from income taxes-$148.7M-$149.1M
Benefit from income taxes-$550.0K-$9.0K
Net loss-$148.1M-$149.1M
Net unrealized (loss) gain on available-for-sale marketable securities, net of tax-$152.0K$225.0K
Net comprehensive loss-$148.3M-$148.9M
Net loss per share, basic (in dollars per share)-$1.59-$1.65
Net loss per share, diluted (in dollars per share)-$1.59-$1.65
Weighted average common shares outstanding, basic (in shares)93.4M shares90.3M shares
Weighted average common shares outstanding, diluted (in shares)93.4M shares90.3M shares
Licensing and collaboration revenue (including $2,487 and $4,110 for years ended December 31, 2025, and December 31, 2024, respectively, from related parties)$11.2M$10.0M
Impairment charges$12.2M$0
Impairment Of Equity Method Investment-$9.2M$0

Compare Caribou Biosciences, Inc. with another company

Corporate structure

Caribou Biosciences, Inc. sits at the top of its group. 5 entities, 1 country on record. Switch between the flow chart and the network, and select any entity to see its details.

Major holders of Caribou Biosciences, Inc.

  • BlackRock Filed SCHEDULE 13G on Caribou Biosciences, Inc., latest Jul 27, 2026 (5 filings since Feb 3, 2023)
  • VANGUARD GROUP INC Filed SCHEDULE 13G/A on Caribou Biosciences, Inc., latest Apr 30, 2025 (3 filings since Nov 4, 2024)
  • Rachel E. Haurwitz Filed SCHEDULE 13D on Caribou Biosciences, Inc., latest Apr 25, 2025 (3 filings since Feb 4, 2022)
  • Bank of America Filed SCHEDULE 13G/A on Caribou Biosciences, Inc., latest Feb 14, 2025 (2 filings since Nov 14, 2024)
  • Avidity Partners Management LP Filed SC 13G/A on Caribou Biosciences, Inc., latest Nov 14, 2024 (2 filings since Jan 8, 2024)
  • PFM Health Sciences, LP Filed SC 13G/A on Caribou Biosciences, Inc., latest Nov 14, 2024 (4 filings since Feb 14, 2022)
  • Point72 Asset Management, L.P. Filed SC 13G/A on Caribou Biosciences, Inc., latest Nov 14, 2024 (4 filings since Jul 20, 2023)
  • State Street Corporation Filed SC 13G/A on Caribou Biosciences, Inc., latest Oct 17, 2024 (3 filings since Feb 3, 2023)
  • Pfizer Filed SC 13G on Caribou Biosciences, Inc., latest Jul 10, 2023
  • FMR LLC Filed SC 13G/A on Caribou Biosciences, Inc., latest Feb 9, 2023
  • EIDP Filed SC 13G/A on Caribou Biosciences, Inc., latest Jun 1, 2022 (2 filings since Mar 1, 2022)
  • FARALLON CAPITAL MANAGEMENT, L.L.C. Filed SC 13G/A on Caribou Biosciences, Inc., latest Feb 11, 2022
  • Caribou Biosciences, Inc. Berkeley, California
    • Antler Holdco, LLC Subsidiary · Delaware, United States
    • Arboreal Holdco, LLC Subsidiary · Delaware, United States
    • Biloba Holdco, LLC Subsidiary · Delaware, United States
    • Microbe Holdco, 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 Caribou Biosciences, 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$20.3M5 Dec 31, 2025$32.2M5 Dec 31, 2024−36.9%
Accumulated depreciation$13.5M5 Dec 31, 2025$12.9M5 Dec 31, 2024+5.0%
Property and equipment, net$6.8M5 Dec 31, 2025$19.3M5 Dec 31, 2024−64.9%
Operating-lease assets (leased space)$17.7M5 Dec 31, 2025$20.0M5 Dec 31, 2024−11.7%

Investments

ItemLatestA year beforeChange
Cash and cash equivalents$12.4M5 Dec 31, 2025$16.3M5 Dec 31, 2024−24.1%
Marketable securities, current$127.0M5 Dec 31, 2025$193.2M5 Dec 31, 2024−34.3%
Marketable securities, non-current$3.5M5 Dec 31, 2025$39.8M5 Dec 31, 2024−91.2%
Stakes in other companies (equity method)$05 Dec 31, 2025$9.3M5 Dec 31, 2024−100.0%

Properties, in its own words

Our corporate headquarters are located in Berkeley, California, where we lease approximately 71,735 square feet of laboratory and office space under two leases. These leases expire in July 2032 and March 2033. We have the ability to extend these leases for an additional five years each. See Note 8 to our consolidated financial statements included elsewhere in this Annual Report on Form 10-K for additional information.

We believe that our existing facilities are adequate for our near-term needs and that suitable additional facilities will be available in the future if and when needed.

Item 2 of the 10-K filed Mar 5, 2026.4

Leadership

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

Board members and other officers (18)

Subsidiaries and ownership

Subsidiaries (Exhibit 21)

  • Antler Holdco, LLC Delaware3
  • Arboreal Holdco, LLC Delaware3
  • Biloba Holdco, LLC Delaware3
  • Microbe Holdco, LLC Delaware3

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

Timeline

  1. Oct 6, 20268-K Exit or restructuring costs; Executive or director change; Regulation FD disclosure32
  2. Aug 13, 20268-K Results of operations33
  3. Jun 18, 20268-K Shareholder vote34
  4. Jun 11, 20268-K Regulation FD disclosure; Other events35
  5. May 7, 20268-K Results of operations36
  6. Mar 31, 20268-K Regulation FD disclosure; Other events37
  7. Mar 5, 20268-K Results of operations38
  8. Nov 12, 20258-K Results of operations39
  9. Nov 3, 20258-K Results of operations; Regulation FD disclosure; Other events40
  10. Aug 12, 20258-K Results of operations41
  11. Jun 23, 20258-K Other events42
  12. Jun 13, 20258-K Shareholder vote43
  13. Dec 21, 2021New chief executive Rachel E. Haurwitz becomes CEO12

Calendar

Coming up

  1. Nov 11, 2026Reports results for the quarter ending Sep/2026 A year earlier it reported ($0.30) a share, on Nov 12, 2025.44

When it reported results

  1. Aug 13, 2026Reported quarterly or annual results33
  2. May 7, 2026Reported quarterly or annual results36
  3. Mar 5, 2026Reported quarterly or annual results38
  4. Nov 12, 2025Reported quarterly or annual results39
  5. Nov 3, 2025Reported quarterly or annual results40
  6. Aug 12, 2025Reported quarterly or annual results41
  7. May 8, 2025Reported quarterly or annual results45
  8. Apr 24, 2025Reported quarterly or annual results46

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

Filings

270 filings to the SEC since October 2021: 5 annual reports, 17 quarterly reports, 71 major events, 108 insider forms, 31 large holders, 38 other. The latest 20:

  1. Oct 6, 20268-K EDGAR
  2. Aug 13, 202610-Q EDGAR
  3. Aug 13, 20268-K EDGAR
  4. Jul 27, 2026SCHEDULE 13G EDGAR
  5. Jun 18, 20268-K EDGAR
  6. Jun 11, 20268-K EDGAR
  7. Jun 5, 2026DEFA14A EDGAR
  8. May 7, 202610-Q EDGAR
  9. May 7, 20268-K EDGAR
  10. May 1, 2026DEFR14A EDGAR
  11. Apr 24, 2026ARS EDGAR
  12. Apr 24, 2026DEFA14A EDGAR
  13. Apr 24, 2026DEF 14A EDGAR
  14. Apr 10, 2026PRE 14A EDGAR
  15. Mar 31, 20268-K EDGAR
  16. Mar 5, 202610-K EDGAR
  17. Mar 5, 20268-K EDGAR
  18. Mar 5, 2026S-8 EDGAR
  19. Feb 27, 20264 EDGAR
  20. Feb 25, 2026144 EDGAR

The 270 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

19 open-market trades by officers, directors and large owners since October 2021: 8 buys and 11 sales. Grants, option exercises and gifts are left out.

DateWhoTradeSharesPriceValueFiling
Feb 25, 2026Kelly Timothy PChief Technology OfficerSale6,228$1.93$12.0KForm 4
Feb 24, 2026Albertson Tina M.Chief Medical OfficerSale1,066$1.96$2.1KForm 4
Feb 24, 2026Khan Ruhi AhmadChief Business OfficerSale6,938$1.96$13.6KForm 4
Feb 24, 2026Kelly Timothy PChief Technology OfficerSale3,147$1.96$6.2KForm 4
Feb 24, 2026MCCLUNG BARBARA GChief Legal OfficerSale6,938$1.96$13.6KForm 4
Mar 14, 2025Haurwitz Rachel E.President and CEOBuy20,000$1.02$20.4KForm 4
Feb 21, 2025Khan Ruhi AhmadChief Business OfficerSale3,564$1.35$4.8KForm 4
Feb 21, 2025Kanner StevenChief Scientific OfficerSale3,564$1.35$4.8KForm 4
Feb 21, 2025MCCLUNG BARBARA GChief Legal OfficerSale3,564$1.35$4.8KForm 4
Jan 29, 2025Ryali SriramChief Financial OfficerBuy17,360$1.42$24.7KForm 4
Jan 19, 2023Rizvi Syed Ali-aamirChief Medical OfficerSale5,627$6.31$35.5KForm 4
Oct 6, 2022Fischesser RyanVP of Finance and ControllerSale10,000$10.80$108.0KForm 4
Aug 25, 2022Kanner StevenChief Scientific OfficerSale43,248$11.22$485.2KForm 4
Jan 11, 2022Fischesser RyanVP of Finance and ControllerBuy7,387$4.00$29.6KForm 4
Dec 20, 2021Fischesser RyanVP of Finance and ControllerBuy1,136$2.69$3.1KForm 4
Dec 7, 2021MCCLUNG BARBARA GChief Legal OfficerBuy6,127$2.69$16.5KForm 4
Oct 20, 2021MCCLUNG BARBARA GChief Legal OfficerBuy9,219$2.69$24.8KForm 4
Oct 12, 2021Kanner StevenChief Scientific OfficerBuy114,860$1.92$220.8KForm 4
Oct 11, 2021Fischesser RyanVP of Finance and ControllerBuy1,746$2.69$4.7KForm 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.

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
2025Rachel HaurwitzPh.D.$667.5K$1.8M59
2025Sriram RyaliM.B.A.45$483.2K$1.0M59
2025Barbara McClungJ.D.71$502.0K$919.6K59
2024President and chief executive officer$508.7K$4.2M59
2024Chief legal officer$485.1K$1.6M59

Funding

Where the company's money came from, by calendar year: private offerings filed with the SEC, federal grants, loans, contracts and other assistance from USAspending.gov, and PPP loans from the SBA. Each bar links to the records below.

Money received by year$1.6M 2020–2020
Money received by yearMoney received by year, 2020–2020: $1.6M in all. PPP loans $1.6M.$0$500K$1M$1.5M$2M2020 · PPP loans: $1.6M2020
Figures by year
YearPPP loansTotal
2020$1.6M$1.6M

PPP loans

Paycheck Protection Program loans of $150,000 and up, approved April 2020 to July 2021, from the SBA60. Matched to this company by name and state.

  1. May 1, 2020$1.6M PPP loan (first draw) from WebBank60To CARIBOU BIOSCIENCES, INC., Berkeley CA; $1.6M forgiven May 21, 2021

Held by these funds

The largest holders among investment managers' 13F reports for the quarter ending Jun 30, 2026, the top 25 of 100. Change is in shares since the quarter before.

FundSharesValueShare of the fundChange
BlackRock, Inc.7,815,843$13.8M0.0%+5,672,758
Pfizer Inc4,690,431$7.9M4.6%No change
Vanguard Capital Management LLC4,208,568$7.4M0.0%+441,340
Mackenzie Financial Corp3,650,796$6.4M0.0%+2,708,010
Renaissance Technologies LLC2,773,545$4.9M0.0%+183,048
Kynam Capital Management, LP2,503,302$4.4M0.2%No change
Geode Capital Management, LLC2,374,894$4.2M0.0%+1,356,935
State Street Corp1,632,914$2.9M0.0%+1,209,651
Bank Of America Corp /de/1,410,958$2.5M0.0%+113,791
Two Sigma Investments, LP1,046,279$1.8M0.0%−713,655
Dimensional Fund Advisors LP975,327$1.7M0.0%+302,127
Charles Schwab Investment Management Inc775,809$1.4M0.0%+216,167
Fmr LLC727,115$1.3M0.0%+3,156
Northern Trust Corp712,965$1.3M0.0%+495,230
Maverick Capital Ltd652,542$1.1M0.0%No change
Vanguard Portfolio Management LLC613,801$1.1M0.0%New
Vanguard Fiduciary Trust Co606,388$1.1M0.0%+86,270
Qube Research & Technologies Ltd545,755$960.5K0.0%+369,058
UBS Group AG517,371$910.6K0.0%+258,202
72 Investment Holdings, LLC474,067$834.4K1.7%No change
Jacobs Levy Equity Management, Inc410,979$723.3K0.0%+52,038
Marshall Wace, Llp375,686$661.2K0.0%−829,982
Green Alpha Advisors, LLC364,324$641.2K0.4%−9,326
PFM Health Sciences, LP354,687$624.2K0.1%−603,100
Goldman Sachs Group Inc322,875$568.3K0.0%−53,714

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

SEC filer profile

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

  • Name on EDGARCaribou Biosciences, Inc.1
  • CIK0001619856
  • Employer ID (EIN)45-37282284
  • Filer statusNon-accelerated filer an emerging growth company; a smaller reporting company; not a shell company4
  • Incorporated inDelaware4
  • Fiscal year endsDecember 311
  • Industry code (SIC)2836 Biological Products, (No Diagnostic Substances)1
  • SEC reviewing officeOffice of Life Sciences, Division of Corporation Finance1
  • Business address2929 7Th Street, Suite 105, Berkeley, CA 947101
  • Phone510-982-60301
  • Shares outstanding107,207,513 as of Aug 7, 202611
  • Public float$112.5M as of Jun 30, 20254
  • AuditorDeloitte & Touche LLP, San Francisco, California PCAOB ID 34; no auditor attestation of internal control over financial reporting4
  • On EDGAR sinceSep 23, 20141
  • Filings324 in all: 4 (100), 8-K (71), 3 (21), SC 13G/A (18), 10-Q (16), SC 13G (12), DEFA14A (8), CORRESP (6)1
    All 42 form types

    S-8 (6), 10-K (5), DEF 14A (5), 8-K/A (4), ARS (4), SCHEDULE 13G/A (4), UPLOAD (4), 144 (3), D (3), EFFECT (3), 10-Q/A (2), 4/A (2), 424B5 (2), PRE 14A (2), S-1/A (2), S-3 (2), SEC STAFF LETTER (2), 3/A (1), 424B4 (1), 5 (1), 8-A12B (1), CERT (1), D/A (1), DEFR14A (1), DRS (1), DRS/A (1), DRSLTR (1), FWP (1), S-1 (1), S-1MEF (1), SC 13D (1), SC 13D/A (1), SCHEDULE 13D (1), SCHEDULE 13G (1)

  • Latest filingsAnnual report (10-K) Mar 5, 2026
    Quarterly report (10-Q) Aug 13, 2026
    Proxy statement (DEF 14A) Apr 24, 2026
    Latest 8-K (8-K) Oct 6, 2026

Securities registered for trading

ClassSymbolExchange
Common Stock, par value $0.0001 per shareCRBUThe Nasdaq Global Select Market

From the cover page of the 10-K filed Mar 5, 2026 (Section 12(b) of the Exchange Act).4

Risk factors and legal proceedings

The risks Caribou Biosciences, Inc. names in Item 1A of its 10-K filed Mar 5, 2026: 75 risks under these headings, as written.4

  • Risks Relating to our Financial Position and Need for Additional Capital
  • We have incurred significant operating losses since our inception and anticipate that we will incur continued operating losses for the foreseeable future and we may not be able to achieve or sustain profitability.
  • We will need substantial additional financing to conduct our planned pivotal clinical trial for vispa-cel and to implement our operating plans. If we fail to obtain additional financing, we will be unable to complete the development and commercialization of our vispa-cel and/or CB-011 product candidates.
  • Raising additional capital may cause dilution to our stockholders, restrict our operations, and/or require us to relinquish rights to our genome-editing technologies or product candidates.
  • We have a limited operating history, which may make it difficult to evaluate our technologies and product candidate development capabilities or to predict our future performance.
  • Risks Relating to our Business, Government Regulation, Technology, and Industry
  • Our CAR-T cell therapy product candidates are in clinical development and it will be many years before we commercialize a product candidate, if ever. If we are unable to advance our product candidates through clinical trials, obtain regulatory approval, and ultimately commercialize our product candidates, or if we experience significant delays in doing so, our business will be materially harmed.
  • Our product candidates are cell therapies generated by our novel CRISPR chRDNA genome-editing technology, which makes it difficult to predict the time and cost of developing these product candidates and obtaining regulatory approval. To date, no other products that use these chRDNA genome-editing technology have advanced into clinical trials or received marketing approval in the United States.
  • Manufacturing our product candidates is complex and we could experience manufacturing problems during our clinical trials, which could delay or limit development and/or commercialization of our product candidates.
  • Our business is highly dependent on the success of our product candidates, which will require significant additional human clinical trials before we can seek regulatory approval and potentially commercialize our product candidates. If we are unable to advance our clinical trials and obtain regulatory approval for, and successfully commercialize, our product candidates for the treatment of patients in approved indications, or if we are substantially delayed in doing so, our business will be materially harmed.
  • We are not currently researching and developing additional product candidates; if we choose to do so in the future, we may not be successful in our efforts to identify and successfully research and develop additional product candidates.
  • In the event that we are unable to continue to fund the clinical development of one or both of our product candidates, and/or if one or both of our clinical-stage product candidates is not clinically successful, does not receive regulatory approval, and/or is not commercially competitive, we currently do not have a research pipeline from which to generate new product candidates.
The other 65 risks
  • If we experience delays or difficulties enrolling patients in the clinical trials for our product candidates, our ability to advance our product candidates through clinical development and the regulatory process could be delayed or prevented.
  • Clinical trials are expensive, time-consuming, and subject to uncertainty. Our clinical trials may not be conducted as planned or completed on schedule, if at all completed. Issues may arise that could suspend or terminate our clinical trials. A failure of one or more of our clinical trials may occur at any stage of testing, and our future clinical trials may not be successful.
  • Our clinical trials may fail to adequately demonstrate the safety and efficacy of any of our product candidates and, if this happens, the development of our product candidates may be delayed or unsuccessful, which could prevent or delay regulatory approval and commercialization.
  • If our product candidates cause serious adverse events or undesirable side effects, including injury and death, or have other properties that could delay or prevent regulatory approval, our product candidates could have limited or no commercial potential.
  • The FDA or other regulatory agencies may disagree with our regulatory plans and we may fail to obtain regulatory approval of our CAR-T cell therapy product candidates.
  • Changes at the FDA may hinder the agency’s ability to hire and retain key leadership and other personnel, slow the time necessary for new product candidates to be reviewed and/or approved, or otherwise prevent these agencies from performing normal business functions on which our operations rely, which would adversely affect our business.
  • Even if we complete the necessary clinical trials, the regulatory approval process is expensive, time-consuming, and uncertain, and we may be unable to obtain the regulatory approvals necessary for the commercialization of our product candidates; furthermore, if there are delays in obtaining regulatory approvals, we may not be able to commercialize our products, may lose competitive lead time, and our ability to generate revenues will be materially impaired.
  • The regulatory landscape that will govern our product candidates is uncertain; regulations relating to more established gene therapy and cell therapy products are still developing, and changes in regulatory requirements could result in delays or discontinuation of development of our product candidates or unexpected costs in obtaining regulatory approval.
  • There is currently substantial uncertainty regarding governmental agencies, including the implementation of laws, regulations, policies, and guidance, and personnel. Such uncertainties could adversely affect our business.
  • If we are required by the FDA to obtain approval of a companion diagnostic in connection with approval of any of our product candidates, and we do not obtain, or face delays in obtaining, FDA approval of the companion diagnostic, we will not be able to commercialize our product candidates.
  • We may not receive additional designations for expedited programs, such as priority review, RMAT designation, breakthrough therapy designation, or fast track designation, by the FDA for our allogeneic CAR-T cell therapies.
  • We may continue to seek orphan drug designation for our allogeneic CAR-T cell therapy product candidates across various indications, but we may not be able to obtain such designations or to maintain the benefits associated with orphan drug designation, including potential exclusivity, which may cause our revenue, if any, to be reduced.
  • Our allogeneic CAR-T cell therapy product candidates will be regulated as biologics, and therefore may be subject to uncertainty regarding nonpatent regulatory exclusivity or maintaining regulatory approval.
  • We may never obtain approval to commercialize our product candidates outside the United States, which could limit our ability to recognize the full market potential of our product candidates and could materially impair our ability to generate revenues.
  • Negative public opinion and increased regulatory scrutiny of genetic research and therapies involving genome editing may damage public perception of our product candidates generated through genome editing or adversely affect our ability to conduct our business or obtain regulatory approvals for our product candidates.
  • We currently have no marketing and sales organization and as a company have no experience in marketing products. If we are unable to establish marketing and sales capabilities or enter into agreements with third parties to market and sell our product candidates, we may not be able to generate product revenue.
  • Our products may not gain market acceptance among physicians, patients, hospitals, cancer treatment centers, and others in the medical community, which could significantly harm our business, financial condition, results of operations, and prospects.
  • The market opportunities for our product candidates may be smaller than we currently believe and limited to those patients who are ineligible for or have failed prior treatment, which may adversely affect our business. Because the target patient populations of our product candidates are small, we must be able to successfully identify patients and capture a significant market share to achieve profitability and growth.
  • Even if we are able to commercialize our product candidates, such products may be subject to unfavorable pricing regulations, third-party reimbursement practices, or healthcare reform initiatives, which could harm our business.
  • Healthcare and other reform measures could hinder or prevent the commercial success of our product candidates, if approved.
  • We face significant competition from other biotechnology and pharmaceutical companies, which may result in other companies developing or commercializing products before, or more successfully than, we do, thus rendering our product candidates non-competitive or reducing the size of the market for our product candidates. Our operating results will suffer if we fail to compete effectively.
  • Our business operations and current and future relationships with clinical site investigators, healthcare professionals, consultants, third-party payors, patient organizations, and customers will be subject to applicable healthcare regulatory laws, which could expose us to penalties.
  • Our business activities will be subject to U.S. export control licensing requirements, as well as other U.S. and foreign trade regulations, sanctions laws, anti-corruption laws, and anti-money laundering laws and regulations including the Foreign Corrupt Practices Act, which could expose us to penalties.
  • We face potential liability related to the privacy of health information we may obtain from the patients in our clinical trials if we fail to comply with privacy laws.
  • 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 could have a material adverse effect on our business, financial condition, results of operations, or prospects.
  • Our use of artificial intelligence and challenges with properly managing its use could adversely affect our business.
  • Risks Relating to Intellectual Property
  • If we do not possess the necessary intellectual property rights covering our CRISPR chRDNA genome-editing technology, our product candidates, or other proprietary technologies, we may not be able to block competitors or to compete effectively in the market.
  • Third-party claims of intellectual property infringement may prevent or delay our ability to commercialize our product candidates.
  • We may not be able to protect our intellectual property rights throughout the world.
  • We may be subject to claims challenging the inventorship of our patents and other intellectual property.
  • The terms of our patents may not be sufficient to effectively protect our products and business, and the expiration of our patents may subject us to increased competition.
  • We may not obtain patent term extension for any product candidates we develop.
  • Changes to the patent law in the United States and other jurisdictions could diminish the value of patents in general, thereby impairing our ability to protect our genome-editing technologies and product candidates.
  • We may be involved in lawsuits or other proceedings to enforce or protect our patents, the patents of our licensors, or our other intellectual property rights, which could be expensive, time-consuming, and unsuccessful.
  • Our product candidates are biologics, and as such, we may enter into a settlement agreement with a biosimilar manufacturer seeking to market a product highly similar to our product; such a settlement agreement may be reviewed by the Federal Trade Commission and such review could result in a fine or penalty and substantial expense.
  • Our rights to develop and commercialize our product candidates are subject to the terms and conditions of our licenses and assignments with third parties. If we fail to comply with our obligations under these agreements, we could lose intellectual property rights and be subject to litigation from our licensors or assignors.
  • We may not be successful in obtaining or maintaining necessary rights to any future product candidates that we acquire through acquisitions or in-licenses.
  • Our ability to continue to receive licensing revenue and to enter into new licensing arrangements related to the foundational CRISPR-Cas9 intellectual property will be substantially impaired if such intellectual property is limited by administrative patent proceedings or other patent challenges.
  • If we are unable to protect the confidentiality of our trade secrets, our business and competitive position will be harmed.
  • Intellectual property rights do not necessarily address all potential competitive threats and may not adequately protect our business or permit us to maintain our competitive advantage.
  • If our trademarks 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.
  • Risks Relating to our Relationships with Third Parties
  • We rely on third parties to supply the materials for, and the manufacturing of, our clinical product candidates, and, if such product candidates receive regulatory approval, we may continue our reliance on third parties for manufacturing our commercial products. Our continued success is subject to the performance of these third parties.
  • For our allogeneic CAR-T product candidates, we rely on receiving safe and healthy donor material to manufacture our product candidates. Variation in quality of donor T cells, and potential challenges in procuring appropriate donor material, could impact the safety or efficacy of our product candidates, result in insufficient product supply, or cause us to be unable to initiate or continue clinical trials on the timelines we expect.
  • We rely and will continue to rely on third parties to conduct our clinical trials. If these third parties do not successfully carry out their contractual duties or do not meet deadlines, we may not be able to obtain regulatory approval of, or commercialize, our product candidates.
  • We may form or seek new strategic collaborations in the future for the development and commercialization of one or more of our product candidates or for new product candidates. We may not be successful in those efforts and, even if we do enter into any collaborations, they may not be successful.
  • We may not realize the benefits of acquired assets or other strategic transactions.
  • Risks Relating to Employee Matters, Managing Growth, and Other Risks Relating to our Business
  • Our future success depends on our ability to retain our executive officers and to attract, retain, and motivate qualified personnel.
  • We must continue developing and expanding our company, and we may encounter difficulties in managing this development and expansion, which could disrupt our operations.
  • Our internal computer systems, or those of third parties with which we interact, may fail or suffer security breaches, which could result in a material disruption of the development of our product candidates, 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 employees, clinical trial principal investigators, and consultants may engage in misconduct or other improper activities, including non-compliance with regulatory standards and requirements and insider trading.
  • We may be subject to claims that our employees, consultants, or third parties performing services for us have wrongfully used or disclosed confidential information of third parties.
  • If we fail to comply with environmental, health, and safety laws and regulations, we could become subject to fines or penalties or incur costs that could harm our business; additionally, our business could be shut down until we are in compliance with those laws and regulations.
  • Our insurance policies are expensive and only protect us from some business risks, which may leave us exposed to certain uninsured liabilities.
  • Product liability lawsuits against us could cause us to incur substantial liabilities and could limit commercialization of any product candidates that we may develop.
  • As a public company, we are obligated to develop and maintain proper and effective internal controls over financial reporting, and any failure to maintain the adequacy of these internal controls may adversely affect investor confidence in our company and, as a result, the value of our common stock.
  • Our effective tax rate may fluctuate, and we may incur obligations in tax jurisdictions in excess of amounts accrued on our financial statements.
  • Our ability to use our net operating loss (“NOL”) carryforwards and certain other tax attributes may be limited.
  • Pandemics or other public health crises may adversely impact our business, financial condition, and results of operations, including our clinical trials, and may cause substantial disruption in the financial markets and adversely impact economies worldwide.
  • Business disruptions could seriously harm our future revenue and financial condition and increase our costs and expenses.
  • Adverse developments affecting the financial services industry could adversely affect our current and projected business operations and our financial condition and results of operations.
  • We maintain our cash at financial institutions, often in balances that exceed federally insured limits.
  • Unfavorable global economic conditions could adversely affect our business, financial condition, or results of operations.
  • Risks Relating to Ownership of our Common Stock
  • The market price of our common stock has been, and may continue to be, volatile, and our investors may suffer substantial losses if the price of our common stock drops significantly.
  • We may not remain in compliance with the continued listing requirements of Nasdaq, and, if we are not able to remain in compliance, our common stock will be subject to delisting.

Legal proceedings

From time to time, we may become involved in litigation arising in the ordinary course of business. Regardless of the outcome, litigation can have a material adverse effect on us due to defense and settlement costs, diversion of our management resources, and other factors.

On December 24, 2024, a putative class action lawsuit was filed in the U.S. District Court for the Northern District of California against our company and certain of our current and former officers, Saylor v. Caribou Biosciences, Inc., et al., case number 3:24-cv-09413 (“Saylor Case”). The alleged class period was July 14, 2023, to July 16, 2024. The Saylor Case complaint challenged disclosures regarding our business, operations, and prospects, specifically with respect to the alleged safety, efficacy, and durability of vispa-cel, the clinical results and commercial prospects for vispa-cel, and our financial statements, in alleged violation of Sections 10(b) and 20(a) of the Securities Exchange Act of 1934, as amended (“Exchange Act”). On April 15, 2025, the lead plaintiff filed a motion to voluntarily dismiss the lawsuit and, on April 27, 2025, the court granted the motion, dismissing the lawsuit without prejudice.

The opening of Item 3, Legal Proceedings.4

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