CELU on Nasdaq

Celularity Inc

Celularity Inc is an American pharmaceutical preparations company based in Florham Park.1

$1.31 up 0.00 (0.00%)Price as of Oct 15, 2026 at 17:33 UTC

Last updated Oct 21, 2026.

Overview

Compare with Cue Biopharma, Inc., Entrada Therapeutics, Inc. or ALUMIS INC., or pick any stock.

  • TickerCELU on Nasdaq1
  • IndustryPharmaceutical Preparations1
  • HeadquartersFlorham Park, New Jersey1
  • Incorporated inDE3
  • Business address170 Park Ave, Florham Park, Nj 079323
  • Filer category, Emerging growth company3
  • Legal formCorporation

Biovance® human amniotic membrane allograft designed for use as a covering, barrier, or wrap to surgical sites.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

-230.9%Operating margin5
-345.4%Net margin5
-51.0%Revenue growth, 20255

What sells

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

Products and services

Product brought in 50% of the revenue Celularity Inc broke down this way in fiscal 2025.

  1. Product$13.2M550%down 63% from 2024
  2. License Royalty and Other$7.9M530%down 42% from 2024
  3. Service$5.4M520%up 6% from 2024
Products and services by year
Products and services20242025
Product$35.3M$13.2M
License Royalty and Other$13.7M$7.9M
Service$5.1M$5.4M

Business segments

Degenerative Disease brought in 65% of the revenue Celularity Inc broke down this way in fiscal 2025.

  1. Degenerative Disease$17.3M565%down 64% from 2024
  2. Biobanking$5.4M520%up 6% from 2024
  3. Cell Therapy$3.8M514%up 453% from 2024
Business segments by year
Business segments20242025
Degenerative Disease$48.4M$17.3M
Biobanking$5.1M$5.4M
Cell Therapy$688.0K$3.8M

Where the money goes

Where each dollar of revenue went, fiscal 2025

  • Cost of revenue23¢$20.1M
  • Research and development17¢$15.0M
  • Selling, general and admin59¢$51.3M
  • Income tax0¢$3.0K

Out of $26.6M in revenue.5 The company lost money this year.

Financial statements

Revenue67895$26.6M in 2025+86% since 2020
0$20.0M$40.0M$60.0M2020: $14.3M$14.3M20202021: $21.3M$21.3M2021+49%2022: $18.0M$18.0M2022−16%2023: $22.8M$22.8M2023+27%2024: $54.2M$54.2M2024+138%2025: $26.6M$26.6M2025−51%
Gross profit678$6.8M in 2023−28% since 2020
-$5.0M0$5.0M$10.0M$15.0M2020: $9.3M$9.3M20202021: $11.7M$11.7M2021+25%2022: -$1.7M-$1.7M20222023: $6.8M$6.8M2023
Operating income1067895-$61.3M in 2025+3542% since 2019
-$200.0M-$150.0M-$100.0M-$50.0M02019: -$1.7M-$1.7M20192020: -$151.9M-$151.9M2020+8924%2021: -$109.1M-$109.1M2021−28%2022: -$25.6M-$25.6M2022−77%2023: -$192.3M-$192.3M2023+651%2024: -$38.4M-$38.4M2024−80%2025: -$61.3M-$61.3M2025+60%
Net income1067895-$91.7M in 2025
-$300.0M-$200.0M-$100.0M0$100.0M2019: $5.9M$5.9M20192020: -$208.2M-$208.2M20202021: -$100.1M-$100.1M2021−52%2022: $14.2M$14.2M20222023: -$196.3M-$196.3M20232024: -$57.9M-$57.9M2024−71%2025: -$91.7M-$91.7M2025+58%

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

Period ending2025-12-312024-12-31
Total revenues$26.6M$54.2M
Cost of revenues$20.1M$15.0M
Research and development$15.0M$17.4M
Selling, general and administrative$51.3M$58.6M
Change in fair value of contingent consideration liability-$193.0K
Amortization of acquired intangible assets$1.5M$1.8M
Total operating expenses$87.9M$92.6M
Loss from operations-$61.3M-$38.4M
Interest income$262.0K$331.0K
Interest expense-$6.8M-$6.3M
Change in fair value of warrant liabilities-$3.3M$398.0K
Change in fair value of derivative liability$65.0K
Change in fair value of debt-$1.8M-$492.0K
Loss on debt extinguishment-$6.4M-$3.9M
Amortization of licensing obligation premium$1.9M
Loss on issuance of convertible notes with warrants-$2.3M
Impairment of preferred stock investment-$2.9M
Compliance fees and other expense, net-$9.2M-$9.6M
Total other expense-$30.4M-$19.5M
Loss before income taxes-$91.7M-$57.9M
Income tax expense (benefit)$3.0K
Net loss-$91.7M-$57.9M
Deemed dividend relating to inducement of Dragasac warrants-$64.0K
Paid-in kind preferred stock dividend-$20.0K
Net loss attributable to common shareholders-$91.8M-$57.9M
Net loss per share - basic-$3.59-$2.64
Net loss per share - diluted-$3.59-$2.64
Weighted average shares outstanding - basic25.6M shares21.9M shares
Weighted average shares outstanding - diluted25.6M shares21.9M shares
Change in fair value of debt due to change in credit risk$5.0K-$5.0K
Comprehensive loss-$91.7M-$57.9M

Compare Celularity Inc with another company

Corporate structure

Celularity 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 Celularity Inc

  • Celularity Inc Florham Park, New Jersey

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

What it owns

What Celularity 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$94.5M5 Dec 31, 2025$94.5M5 Dec 31, 20240%
Accumulated depreciation$38.7M5 Dec 31, 2025$32.9M5 Dec 31, 2024+17.7%
Property and equipment, net$55.8M5 Dec 31, 2025$61.6M5 Dec 31, 2024−9.4%
Operating-lease assets (leased space)$10.7M5 Dec 31, 2025$10.8M5 Dec 31, 2024−1.0%

Investments

ItemLatestA year beforeChange
Cash and cash equivalents$6.2M5 Dec 31, 2025$738.0K5 Dec 31, 2024+736.7%

Intangibles and goodwill

ItemLatestA year beforeChange
Goodwill$7.3M5 Dec 31, 2025$7.3M5 Dec 31, 20240%
Intangible assets, net (excluding goodwill)$7.8M5 Dec 31, 2025$9.2M5 Dec 31, 2024−16.1%
Indefinite-lived intangibles (excluding goodwill)$700.0K5 Dec 31, 2025$700.0K5 Dec 31, 20240%
Finite-lived intangibles, gross$24.0M5 Dec 31, 2025$24.0M5 Dec 31, 20240%
Accumulated amortization-$16.9M5 Dec 31, 2025-$15.4M5 Dec 31, 2024−9.7%
Finite-lived intangibles, net$7.1M5 Dec 31, 2025$8.5M5 Dec 31, 2024−17.5%

Inventory

ItemLatestA year beforeChange
Inventory, total$571.0K5 Dec 31, 2025$5.4M5 Dec 31, 2024−89.4%

Properties, in its own words

We occupy 147,215 square feet of office, laboratory and manufacturing space in Florham Park, New Jersey under a lease expiring in 2036, which we use as our principal place of business. We believe that our existing facilities will be sufficient for our needs for the foreseeable future.

Item 2 of the 10-K filed Apr 30, 2026.4

Leadership

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

Board members and other officers (22)

Named in SEC Form D filings

People the company listed in its private-offering notices.

  • Executive OfficerAnne R. Jones named May 27, 202241
  • DirectorPeter A. Diamandis named May 27, 2022 to Nov 3, 202542
  • DirectorAndrew C. von Eschenbach named May 27, 202241
  • DirectorLim Kok Thay named May 27, 202241
  • DirectorRobin L. Smith named May 27, 202241

Former names

  • GX Acquisition Corp.Nov 5, 2018 to Jul 19, 20213

Timeline

  1. Sep 29, 20268-K Executive or director change43
  2. Sep 28, 20268-K Entered a material agreement; New debt or obligation; Unregistered sale of shares44
  3. Sep 14, 20268-K Other events45
  4. Aug 7, 20268-K Executive or director change46
  5. Jul 29, 20268-K Listing notice or transfer47
  6. Jun 30, 20268-K Entered a material agreement; New debt or obligation; Executive or director change48
  7. Jun 25, 20268-K Executive or director change49
  8. Jun 12, 20268-K Listing notice or transfer50
  9. Jun 3, 20268-K Executive or director change; Regulation FD disclosure51
  10. May 28, 20268-K Entered a material agreement; New debt or obligation52
  11. Apr 21, 20268-K Entered a material agreement; New debt or obligation; Change to shareholders' rights53
  12. Mar 10, 20268-K Entered a material agreement; Other events54
  13. Jul 16, 2021New chief executive Robert J. Hariri becomes CEO13
  14. May 20, 2019New chief executive Jay R. Bloom becomes CEO15
  15. May 20, 2019New chief executive Dean C. Kehler becomes CEO14

Calendar

Coming up

  1. Nov 13, 2026Reports results for the quarter ending Sep/202655

When it reported results

  1. May 9, 2025Reported quarterly or annual results56
  2. Nov 7, 2024Reported quarterly or annual results57
  3. Oct 25, 2024Reported quarterly or annual results58
  4. May 21, 2024Reported quarterly or annual results59
  5. Jan 9, 2024Reported quarterly or annual results60
  6. Nov 10, 2022Reported quarterly or annual results61
  7. Aug 10, 2022Reported quarterly or annual results62
  8. May 16, 2022Reported quarterly or annual results63

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

Filings

372 filings to the SEC since October 2021: 7 annual reports, 14 quarterly reports, 101 major events, 132 insider forms, 21 large holders, 5 private raises, 92 other. The latest 20:

  1. Sep 29, 20268-K EDGAR
  2. Sep 29, 202610-Q EDGAR
  3. Sep 28, 20268-K EDGAR
  4. Sep 28, 2026SCHEDULE 13D/A EDGAR
  5. Sep 25, 20264 OWNERSHIP DOCUMENT EDGAR
  6. Sep 25, 20264 OWNERSHIP DOCUMENT EDGAR
  7. Sep 25, 20264 OWNERSHIP DOCUMENT EDGAR
  8. Sep 14, 20268-K EDGAR
  9. Aug 14, 2026NT 10-Q EDGAR
  10. Aug 7, 20268-K EDGAR
  11. Jul 29, 20268-K EDGAR
  12. Jul 22, 202625-NSE EDGAR
  13. Jun 30, 20268-K EDGAR
  14. Jun 25, 20268-K EDGAR
  15. Jun 23, 20264 OWNERSHIP DOCUMENT EDGAR
  16. Jun 23, 20264 OWNERSHIP DOCUMENT EDGAR
  17. Jun 23, 20264 OWNERSHIP DOCUMENT EDGAR
  18. Jun 23, 2026SCHEDULE 13D/A EDGAR
  19. Jun 12, 20268-K EDGAR
  20. Jun 3, 20268-K EDGAR

The 372 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

8 open-market trades by officers, directors and large owners since October 2021: 6 buys and 2 sales. Grants, option exercises and gifts are left out.

DateWhoTradeSharesPriceValueFiling
Jan 12, 2024Genting Berhad10% ownerBuy21,410,983$0.25$5.4MForm 4
Oct 5, 2023Sorrento Therapeutics, Inc.10% ownerSale6,307,158Form 4
Oct 5, 2023Hariri Robert JChief Executive OfficerBuy9,357,585$0.16$1.5MForm 4
Sep 29, 2023Sorrento Therapeutics, Inc.10% ownerSale9,064,539Form 4
Sep 29, 2023Hariri Robert JChief Executive OfficerBuy9,064,539$0.17$1.5MForm 4
Nov 30, 2022Hariri Robert JChief Executive OfficerBuy10,000$1.72$17.2KForm 4
Nov 29, 2022Hariri Robert JChief Executive OfficerBuy40,000$1.71$68.4KForm 4
Nov 28, 2022Hariri Robert JChief Executive OfficerBuy40,000$1.74$69.6KForm 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
2024Robert J. HaririM.D., Ph.D.$179.1K$849.0K74
2024John Haines67$434.4K$517.0K74
2024David Beers$369.2K$445.0K74
2023Chief Executive Officer$1.2M$1.2M74
2023Senior Executive Vice PresidentChief Administrative Officer and Corporate Secretary$500.0K$815.8K74
2023Chief Financial Officer$425.0K$635.6K74

Money raised

Private offerings the company reported to the SEC on Form D.

  1. Oct 24, 2025Raised $2 million in a private offering of equity Form D: $6.7 million offered in all Form D
  2. Jul 30, 2025Raised $2 million in a private offering of equity Form D: 1 investor so far Form D
  3. Jul 22, 2025Raised $1 million in a private offering of equity Form D: 14 investors so far Form D
  4. Jul 21, 2025Raised $6.8 million in a private offering of debt Form D: 1 investor so far Form D
  5. May 20, 2022Raised $30 million in a private offering of equity Form D: 1 investor so far Form D

Held by these funds

The largest holders among investment managers' 13F reports for the quarter ending Jun 30, 2026, the top 25 of 39. Change is in shares since the quarter before.

FundSharesValueShare of the fundChange
C V Starr & Co Inc764,069$1.6M0.8%No change
Vanguard Capital Management LLC621,105$371.4K0.0%No change
Geode Capital Management, LLC167,150$100.0K0.0%−23,926
Citadel Advisors LLC99,054$59.2K0.0%New
Vanguard Fiduciary Trust Co79,874$47.8K0.0%No change
BlackRock, Inc.76,359$45.7K0.0%−51,142
State Street Corp57,830$34.6K0.0%No change
Northern Trust Corp44,163$26.4K0.0%No change
Biltmore Family Office, LLC35,000$20.9K0.0%No change
HB Wealth Management, LLC31,915$19.1K0.0%−8,500
Keynote Financial Services LLC29,920$17.9K0.0%+600
Jane Street Group, LLC28,713$17.2K0.0%New
CenterStar Asset Management, LLC21,000$12.9K0.0%+3,150
Royal Bank Of Canada18,000$11.0K0.0%No change
IPG Investment Advisors LLC17,169$10.3K0.0%No change
IFP Advisors, Inc12,000$7.2K0.0%+4,000
Tower Research Capital LLC (TRC)5,111$3.1K0.0%+1,847
Group One Trading LLC3,595$2.1K0.0%+3,500
Wells Fargo & Company/mn2,500$1.5K0.0%No change
Vanguard Global Advisers, LLC2,315$1.4K0.0%No change
SBI Securities Co., Ltd.2,284$1.4K0.0%+461
Simplex Trading, LLC2,188$1.3K0.0%+2,133
UBS Group AG1,680$1.0K0.0%−2,849
Caldwell Sutter Capital, Inc.1,000$5980.0%No change
Weaver Capital Management LLC300$3990.0%No change

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

SEC filer profile

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

  • Name on EDGARCelularity Inc1
  • CIK0001752828
  • Employer ID (EIN)83-17025914
  • Filer statusNon-accelerated filer not an emerging growth company; a smaller reporting company; 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 address170 Park Ave, Florham Park, NJ 079321
  • Phone(908) 768-21701
  • Shares outstanding32,449,767 as of Sep 24, 202612
  • Public float$28.4M as of Jun 30, 20254
  • AuditorEisnerAmper LLP, Iselin, New Jersey PCAOB ID 274; no auditor attestation of internal control over financial reporting4
  • On EDGAR sinceNov 5, 20181
  • Filings556 in all: 4 (145), 8-K (119), 3 (36), 424B3 (33), 10-Q (21), 425 (20), SC 13G (18), CORRESP (16)1
    All 47 form types

    SC 13G/A (13), UPLOAD (13), EFFECT (12), 4/A (9), NT 10-Q (9), 10-K (7), DEF 14A (7), S-1 (7), SCHEDULE 13D/A (6), D (5), 424B5 (4), S-4/A (4), 10-K/A (3), 8-K/A (3), DEFA14A (3), NT 10-K (3), POS AM (3), PRE 14A (3), S-1/A (3), S-8 (3), SC 13D/A (3), 25-NSE (2), ARS (2), RW (2), S-3 (2), SC 13D (2), SCHEDULE 13G/A (2), SEC STAFF LETTER (2), 3/A (1), 424B4 (1), 8-A12B (1), CERT (1), DRS (1), DRS/A (1), DRSLTR (1), FWP (1), S-4 (1), SCHEDULE 13D (1), SCHEDULE 13G (1)

  • Latest filingsAnnual report (10-K) Apr 30, 2026
    Quarterly report (10-Q) Sep 29, 2026
    Proxy statement (DEF 14A) Nov 7, 2025
    Latest 8-K (8-K) Sep 29, 2026

Securities registered for trading

ClassSymbolExchange
Class A common stock, par value $0.0001 per shareCELUThe Nasdaq Stock Market LLC
Warrants, each exercisable for one share of Class A common stock at an exercise price of $115 per shareCELUWThe Nasdaq Stock Market LLC

From the cover page of the 10-K filed Apr 30, 2026 (Section 12(b) of the Exchange Act).4

Risk factors and legal proceedings

The risks Celularity Inc names in Item 1A of its 10-K filed Apr 30, 2026: 74 risks under these headings, as written.4

  • Risks Related to Business and Industry
  • Risks Related to Our Reliance on Third Parties
  • Risks Related to Government Regulation
  • Risks Related to Our Intellectual Property
  • Risks Related to Ownership of Our Class A Common Stock
  • We have minimal cash on hand, and we do not generate sufficient cash from operations to operate our business for the next twelve months. We need to raise additional cash through equity or debt sales to provide cash to continue operations. If we are not successful raising cash we will not be able to continue as a going concern.
  • We have incurred net losses in every period since our inception, and anticipate that we will incur substantial net losses in the future. Our historical operating results indicate substantial doubt exists related to our ability to continue as a going concern. In the first quarter of 2026 we reduced headcount and salaries to restructure our business in order to conserve cash and focus on our core sales strategies.
  • We will need substantial additional financing to develop our therapeutics and implement our operating plans. If we fail to obtain additional financing, we may be unable to complete the development and commercialization of our therapeutic candidates.
  • We may expend our limited resources to pursue product candidates that do not yield a successful product and fail to capitalize on development opportunities or therapeutic candidates that may be more profitable or for which there is a greater likelihood of success.
  • Our placental-derived cellular therapy candidates represent a novel approach to degenerative disease treatments that creates significant challenges.
  • We may rely on licensed gene editing technology for future cell therapy product candidates.
  • Our therapeutic candidates are based on novel technologies, which makes it difficult to predict the time and cost of therapeutic candidate development and obtaining regulatory approval.
The other 67 risks
  • Our therapeutic candidates may cause undesirable side effects or have other properties that could halt our clinical development, prevent our regulatory approval, limit our commercial potential or result in significant negative consequences.
  • Planned future clinical trials for our product candidates may fail to demonstrate the safety and efficacy of any of our therapeutic candidates, which would prevent or delay regulatory approval and commercialization.
  • Initial, interim and preliminary data from any clinical trials that we announce or publish from time to time may change as more patient data becomes available and are subject to audit and verification procedures that could result in material changes in the final data.
  • We may not be able to submit INDs to commence clinical trials on the timelines we expect, and even if we are able to, the FDA may not permit such trials to proceed.
  • Our HCT/P products are subject to extensive government regulation and our failure to comply with these requirements could cause our business to suffer.
  • We may encounter substantial delays in our planned clinical trials or may not be able to conduct our trials on the timelines we expect.
  • Our business could be materially adversely affected by the effects of health pandemics or epidemics in regions where we or third parties on which we rely have concentrations of clinical trial sites or other business operations.
  • Monitoring and managing toxicities in patients receiving therapeutic candidates is challenging, which could adversely affect our ability to obtain regulatory approval and commercialize our therapeutic candidates.
  • Clinical trials are expensive, time-consuming and difficult to design and implement.
  • If we fail to develop additional therapeutic candidates, our commercial opportunity will be limited.
  • Our organizational changes and cost cutting measures may not be successful.
  • We operate our own manufacturing and storage facility, which requires significant resources; manufacturing or other failures could adversely affect our clinical trials and the commercial viability of our therapeutic candidates and our biobanking and degenerative diseases businesses.
  • We currently have limited a cellular therapeutics marketing sales force. If we are unable to establish future marketing and sales capabilities or enter into agreements with third parties to market and sell our therapeutic candidates once approved, we may not be able to generate cell therapy product revenue.
  • A variety of risks associated with conducting research and clinical trials abroad and marketing our therapeutic candidates internationally could materially adversely affect our business.
  • We face significant competition from other biotechnology and pharmaceutical companies, and our operating results will suffer if we fail to compete effectively.
  • We are highly dependent on our key personnel, and if we are not successful in attracting and retaining highly qualified personnel, we may not be able to successfully implement our business strategy.
  • We may form or seek strategic alliances or enter additional licensing arrangements in the future, and we may not realize the benefits of such alliances or licensing arrangements.
  • We may not realize the benefits of acquired assets or other strategic transactions.
  • Our internal computer systems, or those used by our CROs, collaborators or other contractors or consultants, may fail or suffer security breaches.
  • Changes in funding for the FDA and other government agencies could hinder their ability to hire and retain key leadership and other personnel, prevent new therapeutics and services from being developed or commercialized in a timely manner or otherwise prevent those agencies from performing normal functions on which the operation of our business may rely, which could negatively impact our business.
  • Business disruptions could seriously harm our future revenue and financial condition and increase our costs and expenses.
  • If we do not obtain and maintain federal and state licenses and registrations required for our current and future operations, our ability to generate revenue will be limited.
  • Our relationships with customers, physicians, and third-party payors are subject to numerous laws and regulations. If we or our employees, independent contractors, consultants, commercial partners and vendors violate these laws, we could face substantial penalties.
  • Our collection, use, processing, and cross-border transfer of personal information, including individually identifiable health information, is governed by restrictive regulations.
  • If product liability lawsuits are brought against us, we may incur substantial liabilities and may be required to limit commercialization of our therapeutic candidates.
  • Our ability to utilize our net operating loss carryforwards and certain other tax attributes may be limited.
  • Changes in tax law could adversely affect our business and financial condition.
  • Fluctuations in the cost and availability of raw materials, equipment, labor, and transportation could cause manufacturing delays or increase our costs.
  • Failure to maintain effective internal controls could cause our investors to lose confidence in us and adversely affect the market price of our Class A common stock. If our internal controls are not effective, we may not be able to accurately report our financial results or prevent fraud.
  • 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 meet expected deadlines, we may not be able to obtain regulatory approval of, or commercialize, our therapeutic candidates.
  • We rely on donors of healthy human full-term placentas to manufacture our therapeutic candidates, and if we do not obtain an adequate supply of such placentas from qualified donors, development of our placental-derived allogeneic cells may be adversely impacted.
  • Cell-based therapies rely on the availability of specialty raw materials, which may not be available to us on acceptable terms or at all.
  • If we or third-party suppliers acting on our behalf use hazardous, non-hazardous, biological or other materials in a manner that causes injury or violates applicable law, we may be liable for damages.
  • The FDA regulatory approval process is lengthy and time-consuming, and we may experience significant delays in the clinical development and regulatory approval of our future therapeutic candidates.
  • To the extent a regulatory authority determines that any of our currently-marketed advanced biomaterials products do not qualify for regulation as human cells, tissues, and cellular and tissue based products, or HCT/P, solely under Section 361 of the Public Health Service Act, or PHSA, this could result in removal of these products from the market.
  • We expect the cell therapy therapeutic candidates we may develop will be regulated as biological products, or biologics, and they may be subject to competition sooner than anticipated.
  • The regulatory landscape that will govern our therapeutic candidates is uncertain; regulations relating to more established cellular therapy products are still developing, and changes in regulatory requirements could result in delays or discontinuation of development of our therapeutic candidates or unexpected costs in obtaining regulatory approval.
  • The FDA may disagree with our future regulatory plans, and we may fail to obtain regulatory approval of our cell therapeutic candidates.
  • We plan to seek orphan drug designation for some or all of our therapeutic candidates across various indications, but we may be unable to obtain such designations or to maintain the benefits associated with orphan drug designation, including market exclusivity, which may cause our revenue, if any, to be reduced.
  • We may not elect or be able to take advantage of any expedited development or regulatory review and approval processes available to therapeutic candidates granted breakthrough therapy or fast track designation by the FDA.
  • Obtaining and maintaining regulatory approval of our therapeutic candidates in one jurisdiction does not mean that we will be successful in obtaining regulatory approval of our therapeutic candidates in other jurisdictions.
  • Even if we receive regulatory approval of our therapeutic candidates, we will be subject to ongoing regulatory obligations and continued regulatory review, which may result in significant additional expense, and we may be subject to penalties if we fail to comply with regulatory requirements or experience unanticipated problems with our therapeutic candidates.
  • Negative public opinion and increased regulatory scrutiny of genetic research and therapies involving gene editing or modified cells may damage public perception of our therapeutic candidates or adversely affect our ability to conduct our business or obtain regulatory approvals for our therapeutic candidates.
  • Even if we obtain regulatory approval of our therapeutic candidates, the cell therapies may not gain market acceptance among physicians, patients, hospitals, cancer treatment centers and others in the medical community.
  • Coverage and reimbursement may be limited or unavailable in certain market segments for our therapeutic candidates, which could make it difficult for us to sell our cell therapies, if approved, profitably.
  • The advancement of healthcare reform may negatively impact our ability to sell our therapeutic candidates, if approved, profitably.
  • If our efforts to protect the proprietary nature of the intellectual property related to our technologies is not adequate, we may not be able to compete effectively in our market.
  • Confidentiality agreements with employees and third parties may not prevent unauthorized disclosure of trade secrets and other proprietary information.
  • We may be subject to claims that our employees, consultants or independent contractors have wrongfully used or disclosed confidential information of third parties.
  • Third-party claims of intellectual property infringement may prevent or delay our product discovery and development efforts and our ability to commercialize our therapeutic candidates.
  • We may not be successful in obtaining or maintaining necessary rights to product components and processes for our development pipeline through acquisitions and in-licenses.
  • We may be involved in lawsuits or other legal proceedings to protect or enforce our patents or the patents of our licensors, which could be expensive, time-consuming and unsuccessful.
  • Obtaining and maintaining our 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.
  • The lives of our patents may not be sufficient to effectively protect our products and business.
  • We or our licensors may be subject to claims challenging the inventorship of our patents and other intellectual property.
  • We may not be able to protect our intellectual property rights throughout the world.
  • Changes in patent law, including recent patent reform legislation, could increase the uncertainties and costs surrounding the prosecution of our patent applications and the enforcement or defense of our issued patents.
  • Intellectual property rights do not necessarily address all potential threats to our competitive advantage.
  • Risks Related Ownership of Our Securities
  • There may not be an active trading market for our securities, which may make it difficult to sell shares of Class A common stock.
  • The market price of our securities may be volatile, which could cause the value of an investment to decline.
  • We do not intend to pay cash dividends for the foreseeable future.
  • Our Class A common stock is currently listed on Nasdaq. If we are unable to maintain listing of our Class A common stock on Nasdaq or any stock exchange, our stock price could be adversely affected and the liquidity of our stock and our ability to obtain financing could be impaired and it may be more difficult for our stockholders to sell their securities.
  • Future sales and issuances of our Class A common stock or rights to purchase Class A common stock, including pursuant to our equity plans, could result in additional dilution of the percentage ownership of our stockholders and could cause our stock price to fall.
  • Anti-takeover provisions under our charter documents and Delaware law could delay or prevent a change of control, which could limit the market price of our Class A common stock and may prevent or frustrate attempts by our stockholders to replace or remove our current management.
  • Our certificate of incorporation provides that the Court of Chancery of the State of Delaware and the federal district courts of the United States of America will be the exclusive forums for substantially all disputes between us and our stockholders, which could limit our stockholders’ ability to obtain a favorable judicial forum for disputes with us or our directors, officers, or employees.
  • Sales of a substantial number of our shares of Class A common stock in the public market could cause our stock price to fall.
  • The exercise of our outstanding options and warrants and the vesting of outstanding restricted stock units will dilute stockholders and could decrease our stock price.

Legal proceedings

From time to time, we may become involved in litigation or other legal proceedings. Except as set forth below, we are not currently a party to any litigation or legal proceedings that, in the opinion of our management, are likely to have a material adverse effect on our business. Regardless of outcome, litigation can have an adverse impact because of defense and settlement costs, diversion of management resources and other factors.

Arbitration Demand from Palantir Technologies Inc.

The opening of Item 3, Legal Proceedings.4

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