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Century Therapeutics (United States)

In its 2026 annual report the company says: “We are a biotechnology company harnessing the power of allogeneic pluripotent stem cell therapies to develop potentially curative cell therapy products for autoimmune diseases, including type 1 diabetes, or T1D, and cancer. Our beta islet, T cell and NK cell programs are allogeneic, meaning they are derived from healthy donors for use in any patient, rather than being sourced from an individual for their own specific use, as is the case with autologous T cells.”5 It was founded in 2018.1 It is headquartered in Philadelphia, Pennsylvania.1 Its shares trade on Nasdaq under the symbol IPSC.1

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Last updated Oct 21, 2026.

Overview

2018Founded1

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  • TickerIPSC on Nasdaq1
  • IndustryBiological Products, (No Diagnostic Substances)1
  • HeadquartersPhiladelphia, Pennsylvania1
  • Websitewww.centurytx.com
  • Incorporated inDE3
  • Business address25 N 38Th Street, 12Th Floor, Philadelphia, Pa3
  • Filer category, Emerging growth company3

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We are a biotechnology company harnessing the power of allogeneic pluripotent stem cell therapies to develop potentially curative cell therapy products for autoimmune diseases, including type 1 diabetes, or T1D, and cancer. Our beta islet, T cell and NK cell programs are allogeneic, meaning they are derived from healthy donors for use in any patient, rather than being sourced from an individual for their own specific use, as is the case with autologous T cells. As a result, we believe such “off-the-shelf" therapies have the potential to overcome the limitations of first-generation cell therapies by providing readily available treatments more quickly, reliably, at greater scale, and to a broader patient population. What we believe further sets us apart from other allogeneic approaches is our focus on induced pluripotent stem cells, or iPSCs, which possess the unique ability to self-renew …5 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

-15.8%Operating margin6
-8.8%Net margin6
1556.8%Revenue growth, 20256
-6.0%Return on equity6
-$104.7MFree cash flow6

Where the money goes

Where each dollar of revenue went, fiscal 2025

  • Other costs100¢$109.1M
  • Income tax0¢$68.0K

Out of $109.2M in revenue.6 The company lost money this year.

Financial statements

Revenue786$109.2M in 2025+2000% since 2022
0$50.0M$100.0M$150.0M2022: $5.2M$5.2M20222023: $2.2M$2.2M2023−57%2024: $6.6M$6.6M2024+195%2025: $109.2M$109.2M2025+1557%
Operating income910786-$17.3M in 2025−68% since 2020
-$150.0M-$100.0M-$50.0M02020: -$53.9M-$53.9M20202021: -$94.9M-$94.9M2021+76%2022: -$133.8M-$133.8M2022+41%2023: -$146.5M-$146.5M2023+10%2024: -$138.1M-$138.1M2024−6%2025: -$17.3M-$17.3M2025−87%
Net income910786-$9.6M in 2025−82% since 2020
-$150.0M-$100.0M-$50.0M02020: -$53.6M-$53.6M20202021: -$95.8M-$95.8M2021+79%2022: -$130.9M-$130.9M2022+37%2023: -$136.7M-$136.7M2023+4%2024: -$126.6M-$126.6M2024−7%2025: -$9.6M-$9.6M2025−92%

Every line of the income statement as filed: the last 2 fiscal years, latest first.6

Period ending2025-12-312024-12-31
Collaboration revenue$109.2M$6.6M
Research and development$95.7M$107.2M
General and administrative$24.0M$33.2M
Impairment of long-lived assets$6.8M
Impairment of goodwill$4.3M
Total operating expenses$126.4M$144.7M
Loss from operations-$17.3M-$138.1M
Interest income$7.3M$13.0M
Other income$275.0K$354.0K
Total other income$7.6M$13.4M
Loss before provision for income taxes-$9.6M-$124.8M
(Benefit) provision for income taxes-$68.0K$1.8M
Net loss-$9.6M-$126.6M
Net loss per common share Basic (in dollars per share)-$0.14-$1.61
Net loss per common share Diluted (in dollars per share)-$0.14-$1.61
Weighted average common shares outstanding Basic (in shares)86.6M shares78.6M shares
Weighted average common shares outstanding Diluted (in shares)86.6M shares78.6M shares
Unrealized gain (loss) on investments-$294.0K$153.0K
Foreign currency translation gain$63.0K
Comprehensive loss-$9.9M-$126.3M

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Corporate structure

Century Therapeutics (United States) sits at the top of its group. 5 entities, 3 countries on record. Switch between the flow chart and the network, and select any entity to see its details.

Major holders of Century Therapeutics (United States)

  • Century Therapeutics (United States) Philadelphia, Pennsylvania
    • Century Therapeutics Canada ULC Subsidiary · British Columbia, Canada
    • Clade Therapeutics, Inc. Subsidiary · Delaware, United States
    • Clarent Intermediate Sub, Inc. Subsidiary · Delaware, United States
    • Gadeta B.V. Subsidiary · Netherlands

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 Century Therapeutics (United States) 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$98.6M6 Dec 31, 2025$98.2M6 Dec 31, 2024+0.4%
Accumulated depreciation$48.6M6 Dec 31, 2025$36.1M6 Dec 31, 2024+34.8%
Property and equipment, net$50.0M6 Dec 31, 2025$62.1M6 Dec 31, 2024−19.5%
Operating-lease assets (leased space)$16.1M6 Dec 31, 2025$28.7M6 Dec 31, 2024−43.8%

Investments

ItemLatestA year beforeChange
Cash and cash equivalents$61.9M6 Dec 31, 2025$58.4M6 Dec 31, 2024+5.8%
Marketable securities, current$55.3M6 Dec 31, 2025$130.9M6 Dec 31, 2024−57.8%
Long-term investments$30.8M6 Dec 31, 2024$89.1M8 Dec 31, 2023−65.4%

Intangibles and goodwill

ItemLatestA year beforeChange
Intangible assets, net (excluding goodwill)$34.2M6 Dec 31, 2025$34.2M6 Dec 31, 20240%

Properties, in its own words

Our principal executive offices are located in Philadelphia, Pennsylvania. We operate in two office and laboratory spaces in Philadelphia pursuant to leases that expire in October 2031 and March 2034. Additionally, we entered into the Watertown lease for office and laboratory space that commenced in February, 2026 and expires in January, 2031. We also have a 53,000 square foot cell therapy manufacturing facility in Branchburg, New Jersey pursuant to a lease expiring in February 2037.

We believe that our current facilities are adequate to meet our ongoing needs.

Item 2 of the 10-K filed Mar 12, 2026.5

Leadership

Who has led Century Therapeutics (United States), and when. Pick a name to see everywhere that person has worked.

Chief executive

  1. Osvaldo Flores2021–2023
  2. Brent Pfeiffenberger2023–now

President

  1. Hyam Levitsky2021–2024
  2. Brent Pfeiffenberger2023–now

Chief financial officer

  1. Michael Craig Diem2023
  2. Morgan Conn2024
20202025
Board members and other officers (20)

Subsidiaries and ownership

Subsidiaries (Exhibit 21)

  • Century Therapeutics Canada ULC British Columbia, Canada4
  • Clade Therapeutics, Inc. Delaware4
  • Clarent Intermediate Sub, Inc. Delaware4
  • Gadeta B.V. Netherlands4

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

Timeline

  1. Oct 2, 20268-K Regulation FD disclosure; Other events36
  2. Sep 9, 20268-K Executive or director change; Regulation FD disclosure37
  3. Aug 12, 20268-K Results of operations; Regulation FD disclosure38
  4. Jun 16, 20268-K Executive or director change39
  5. Jun 12, 20268-K Bylaws or fiscal year changed; Shareholder vote40
  6. Jun 8, 20268-K Other events41
  7. May 13, 20268-K Results of operations42
  8. Mar 26, 20268-K Other events43
  9. Mar 12, 20268-K Results of operations; Regulation FD disclosure44
  10. Jan 23, 20268-K Shareholder vote; Other events45
  11. Jan 12, 20268-K Regulation FD disclosure46
  12. Jan 8, 20268-K Entered a material agreement; Unregistered sale of shares; Regulation FD disclosure47
  13. Dec 6, 2023New chief executive Brent Pfeiffenberger becomes CEO13
  14. Jun 17, 2021New chief executive Osvaldo Flores becomes CEO14
  15. 2018Founded Founded1

Calendar

Coming up

  1. Nov 12, 2026Reports results for the quarter ending Sep/2026 A year earlier it reported ($0.32) a share, on Nov 13, 2025.48

When it reported results

  1. Aug 12, 2026Reported quarterly or annual results38
  2. May 13, 2026Reported quarterly or annual results42
  3. Mar 12, 2026Reported quarterly or annual results44
  4. Nov 13, 2025Reported quarterly or annual results49
  5. Aug 14, 2025Reported quarterly or annual results50
  6. May 15, 2025Reported quarterly or annual results51
  7. Mar 19, 2025Reported quarterly or annual results52
  8. Jan 13, 2025Reported quarterly or annual results53

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

Filings

388 filings to the SEC since October 2021: 5 annual reports, 15 quarterly reports, 74 major events, 161 insider forms, 32 large holders, 101 other. The latest 20:

  1. Oct 2, 20268-K EDGAR
  2. Sep 15, 20264 EDGAR
  3. Sep 15, 20264 EDGAR
  4. Sep 15, 20264 EDGAR
  5. Sep 14, 2026144 EDGAR
  6. Sep 14, 2026144 EDGAR
  7. Sep 10, 20264 EDGAR
  8. Sep 10, 20263 EDGAR
  9. Sep 9, 20264 EDGAR
  10. Sep 9, 20264 EDGAR
  11. Sep 9, 20264 EDGAR
  12. Sep 9, 20268-K EDGAR
  13. Sep 8, 2026144 EDGAR
  14. Aug 18, 20264 EDGAR
  15. Aug 12, 20268-K EDGAR
  16. Aug 12, 202610-Q EDGAR
  17. Aug 5, 20264 EDGAR
  18. Jun 16, 20268-K EDGAR
  19. Jun 15, 20264 EDGAR
  20. Jun 15, 20264 EDGAR

The 388 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

67 open-market trades by officers, directors and large owners since October 2021: 4 buys and 63 sales. Grants, option exercises and gifts are left out.

DateWhoTradeSharesPriceValueFiling
Sep 14, 2026Russotti GregorySee RemarksSale2,587$1.93$5.0KForm 4
Sep 14, 2026Carr DouglasSVP Finance & OperationsSale1,658$1.93$3.2KForm 4
Sep 8, 2026Russotti GregorySee RemarksSale534$2.05$1.1KForm 4
Sep 8, 2026Carr DouglasSVP Finance & OperationsSale254$2.05$521Form 4
Aug 3, 2026Carr DouglasSVP Finance & OperationsSale275$1.98$544Form 4
Jun 12, 2026Russotti GregorySee RemarksSale2,584$2.23$5.8KForm 4
Jun 12, 2026Carr DouglasSVP Finance & OperationsSale1,654$2.23$3.7KForm 4
Jun 8, 2026Russotti GregorySee RemarksSale524$2.11$1.1KForm 4
Jun 8, 2026Carr DouglasSVP Finance & OperationsSale249$2.11$525Form 4
May 4, 2026Carr DouglasSVP Finance & OperationsSale264$2.34$618Form 4
Mar 12, 2026Russotti GregorySee RemarksSale10,076$2.55$25.7KForm 4
Mar 12, 2026Carr DouglasSVP Finance & OperationsSale7,043$2.55$18.0KForm 4
Mar 9, 2026Russotti GregorySee RemarksSale479$2.54$1.2KForm 4
Mar 9, 2026Carr DouglasSVP Finance & OperationsSale247$2.54$627Form 4
Feb 3, 2026Carr DouglasSVP Finance & OperationsSale323$1.82$588Form 4
Dec 22, 2025Cowan ChadChief Scientific OfficerBuy58,060$0.85$49.4KForm 4
Dec 12, 2025Pfeiffenberger BrentPresident and CEOBuy52,000$0.58$30.2KForm 4
Dec 8, 2025Russotti GregorySee RemarksSale526$0.53$279Form 4
Dec 8, 2025Carr DouglasSVP Finance & OperationsSale257$0.53$136Form 4
Nov 20, 2025Cowan ChadChief Scientific OfficerSale5,462$0.50$2.7KForm 4

All 67 trades can be filtered by person here when JavaScript is on.

From Forms 4 filed with the SEC.

Major holders

Investors who own more than 5% of the shares must tell the SEC: a 13D if they may seek to influence the company, a 13G if they hold passively.

Executive pay

What the company paid its top executives, from the summary compensation table in its proxy statement. Total pay includes salary, bonus, stock and option awards and other pay, as the company valued them.

YearExecutiveAgeSalaryTotal pay
2025Brent Pfeiffenberger, Pharm.D.President, Chief Executive Officer and Chairman of the Board48$640.6K$2.4M69
2025Chad CowanPh.D. , Chief Scientific Officer$559.5K$1.2M69
2025Adrienne Farid, Ph.D.Former Chief Development Officer$333.3K$989.4K69
2025Gregory Russotti, Ph.D.Chief Technology and Manufacturing Officer and former Interim President and Chief Executive Officer59$559.6K$912.3K69
2024Brent Pfeiffenberger, Pharm.D.President, Chief Executive Officer and Chairman of the Board48$625.0K$2.2M69
2024Gregory Russotti, Ph.D.Chief Technology and Manufacturing Officer and former Interim President and Chief Executive Officer59$542.5K$1.5M69
2024Adrienne Farid, Ph.D.Former Chief Development Officer$513.0K$1.4M69

Held by these funds

The largest holders among investment managers' 13F reports for the quarter ending Jun 30, 2026, the top 25 of 98. Change is in shares since the quarter before.

FundSharesValueShare of the fundChange
Ra Capital Management, L.P.17,754,430$43.5M0.4%No change
TCG Crossover Management, LLC17,754,430$43.4M1.0%No change
Versant Venture Management, LLC12,166,109$29.8M18.3%No change
Deep Track Capital, LP9,462,645$23.2M0.3%−25,100
Rtw Investments, LP8,695,652$21.3M0.2%No change
Venrock Adviser, LLC8,695,652$21.3M0.6%No change
Commodore Capital LP8,695,652$21.3M1.3%No change
BlackRock, Inc.8,091,768$19.8M0.0%+6,567,346
Vanguard Capital Management LLC5,703,680$14.0M0.0%+17,476
Balyasny Asset Management L.P.5,522,944$13.5M0.0%+505,211
Point72 Asset Management, L.P.4,980,526$12.2M0.0%−984,152
Seven Fleet Capital Management LP4,347,826$10.7M1.8%+1,400,000
Woodline Partners LP4,257,530$10.4M0.0%+1,214,052
Millennium Management LLC4,194,981$10.3M0.0%−472,082
Trails Edge Capital Partners, LP4,134,969$10.1M1.6%+1,684,976
Spruce Street Capital LP4,059,054$9.9M2.0%No change
Adage Capital Partners Gp, L.l.c.3,789,538$9.3M0.0%No change
Geode Capital Management, LLC2,979,529$7.3M0.0%+1,677,865
Two Sigma Investments, LP2,699,013$6.6M0.0%+327,583
DAFNA Capital Management LLC2,400,458$5.9M1.1%−33,895
Stempoint Capital LP2,146,182$5.3M0.9%New
State Street Corp1,843,154$4.5M0.0%+1,456,431
Northern Trust Corp1,593,944$3.9M0.0%+1,363,124
DV Trading LLC1,400,000$3.4M0.3%No change
Rock Springs Capital Management LP1,304,347$3.2M0.2%No change

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

SEC filer profile

How Century Therapeutics (United States) is registered with the Securities and Exchange Commission, from its EDGAR record and the cover page of its latest annual report.

  • Name on EDGARCentury Therapeutics, Inc.2
  • CIK0001850119
  • Employer ID (EIN)84-20402955
  • Filer statusNon-accelerated filer an emerging growth company; a smaller reporting company; not a shell company5
  • Incorporated inDelaware5
  • Fiscal year endsDecember 312
  • Industry code (SIC)2836 Biological Products, (No Diagnostic Substances)2
  • SEC reviewing officeOffice of Life Sciences, Division of Corporation Finance2
  • Business address25 N 38Th Street, 12Th Floor, Philadelphia, PA2
  • Phone215-981-40002
  • Shares outstanding181,075,321 as of Aug 3, 202612
  • Public float$212.5M as of Jun 30, 20255
  • AuditorErnst & Young LLP, Philadelphia, Pennsylvania PCAOB ID 42; no auditor attestation of internal control over financial reporting5
  • On EDGAR sinceMar 15, 20212
  • Filings442 in all: 4 (162), 8-K (74), 144 (50), 3 (25), 10-Q (16), SC 13G/A (10), CORRESP (9), SC 13G (9)2
    All 37 form types

    SCHEDULE 13G (7), UPLOAD (7), DEF 14A (6), DEFA14A (6), EFFECT (6), S-8 (6), 10-K (5), S-3 (5), SCHEDULE 13G/A (5), ARS (4), CERT (3), PRE 14A (3), SEC STAFF LETTER (3), 144/A (2), 424B3 (2), 8-K/A (2), S-1/A (2), SC 13D/A (2), 424B4 (1), 424B5 (1), 424B7 (1), 8-A12B (1), D (1), DRS (1), DRS/A (1), DRSLTR (1), S-1 (1), S-3/A (1), SC 13D (1)

  • Latest filingsAnnual report (10-K) Mar 12, 2026
    Quarterly report (10-Q) Aug 12, 2026
    Proxy statement (DEF 14A) Apr 27, 2026
    Latest 8-K (8-K) Oct 2, 2026

Securities registered for trading

ClassSymbolExchange
Common Stock, $0.0001 par value per shareIPSCThe Nasdaq

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

Risk factors and legal proceedings

The risks Century Therapeutics (United States) names in Item 1A of its 10-K filed Mar 12, 2026: 74 risks under these headings, as written.5

  • Risks related to our financial position and capital requirements
  • We have incurred significant operating losses since our inception and expect to incur significant losses for the foreseeable future.
  • We have never generated revenue from product sales and may never achieve or maintain profitability.
  • We will require additional funding in order to finance operations. If we are unable to raise capital when needed, or on acceptable terms, we could be forced to delay, reduce, or eliminate our product development programs or commercialization efforts.
  • Raising additional capital may cause dilution to our stockholders, restrict our operations or require us to relinquish rights to our technologies or product candidates.
  • Our ability to utilize our net operating loss carryforwards and certain other tax attributes may be limited.
  • Changes in tax law may adversely affect us or our investors.
  • Unstable market and economic conditions may have serious adverse consequences on our business, financial condition, and stock price.
  • Adverse developments affecting the financial services industry, such as actual events or concerns involving liquidity, defaults or non-performance by financial institutions or transactional counterparties, could adversely affect our current and projected business operations and financial condition and results of operations.
  • Risks related to our business and industry
  • We are early in our development efforts. Our business is dependent on our ability to advance our current and future product candidates through preclinical studies and clinical trials, obtain marketing approval, and ultimately commercialize them.
  • Our business is highly dependent on the success of our lead product candidate, CNTY-813 and our other product candidates.
The other 64 risks
  • Our business depends upon the success of our iPSC-derived allogeneic cell therapy platforms.
  • Utilizing genetically engineered iPSC-derived immune cells and beta islet cells represents a novel therapeutic approach, and we must overcome significant challenges in order to develop, commercialize, and manufacture our product candidates.
  • We have not yet demonstrated long-term stability of cryopreserved iPSC-derived cell therapy products.
  • Gene-editing is a rapidly developing technology, and our success is dependent upon our ability to effectively utilize this technology in our product candidates and implement future technological advancements in gene-editing.
  • Our product candidates for which we intend to seek approval as biologic products may face competition sooner than anticipated.
  • Preclinical and clinical development involve a lengthy and expensive process with an uncertain outcome. We may incur additional costs or experience delays in completing, or ultimately be unable to complete, the development and commercialization of our current product candidates or any future product candidates.
  • As an organization, we have limited experience designing and implementing clinical trials. Failure to adequately design a trial, or incorrect assumptions about the design of the trial, could adversely affect the ability to initiate the trial, enroll patients, complete the trial, or obtain regulatory approval on the basis of the trial results, as well as lead to increased or unexpected costs.
  • Interim, topline, or preliminary data from our 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 file our INDs or CTAs to commence clinical trials on the timelines we expect, and even if we are able to, the FDA or other global health authorities may not permit us to proceed.
  • We are pursuing multiple programs and product candidates in our novel cell therapy development pipeline using an approach that is designed to enable rapid incorporation of new product features. If we elect to incorporate these new features into next-generation product candidates, this may render our existing product candidates obsolete, and we may devote our limited resources in pursuit of a particular program for which there is a greater potential for success and fail to capitalize on development opportunities or product candidates including those which may be more advanced in development.
  • We intend to study some of our product candidates in patient populations with significant comorbidities that may result in deaths or serious adverse events or unacceptable side effects and require us to abandon or limit our clinical development activities.
  • We may experience difficulties identifying and enrolling patients in our future clinical trials. Difficulty in enrolling patients could delay or prevent clinical trials of CNTY-813 or our other product candidates.
  • We may conduct clinical trials for programs at sites outside the United States, and the FDA may not accept data from trials conducted in such locations. Moreover, conducting clinical trials outside of the United Staes presents additional risks that may delay our trials.
  • CNTY-813 or our other product candidates may cause adverse events or undesirable side effects that could delay or prevent its regulatory approval, limit the commercial profile of an approved label, or result in significant negative consequences following marketing approval, if any.
  • Public opinion and scrutiny of cell-based and genetically engineered therapies for treating cancer, autoimmune or other serious diseases, or negative clinical trial results from our competitors, may impact public perception of our company and product candidates, or impair our ability to conduct our business.
  • Our research and development activities could be affected or delayed as a result of possible restrictions on animal testing.
  • If we do not achieve our projected development goals in the time frames we announce and expect, the commercialization of our product candidates, if approved, may be delayed.
  • Changes in regulatory requirements, guidance from the FDA and other regulatory authorities, or unanticipated events during our IND-enabling studies and future clinical trials of CNTY-813 or our other product candidates may result in changes to preclinical studies or clinical trials or additional preclinical or clinical trial requirements, which could result in increased costs to us and could delay our development timeline.
  • Disruptions at the FDA and other government agencies caused by funding shortages or global health concerns could hinder their ability to hire, retain, or deploy key leadership and other personnel, or otherwise prevent new or modified products from being advanced, developed, cleared or approved, or commercialized in a timely manner or at all, which could negatively impact our business.
  • We rely, and expect to continue to rely, on third parties to conduct, supervise, and monitor our preclinical studies and clinical trials for our product candidates.
  • 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 explore strategic collaborations that may never materialize or we may be required to relinquish important rights to and control over the development and commercialization of our product candidates to any future collaborators.
  • Risks related to manufacturing
  • The manufacture and distribution of our iPSC-derived cell product candidates is complex and subject to a multitude of risks. These risks could substantially increase our costs and limit the clinical and commercial supply of our product candidates.
  • Cell-based therapies depend on the availability of reagents and specialized materials and equipment which in each case are required to be acceptable to the FDA and foreign regulatory agencies, and such reagents, materials, and equipment may not be available to us on acceptable terms or at all. We rely on third-party suppliers for various components, materials, and equipment required for the manufacture of our product candidates and do not have supply arrangements for certain of these components.
  • There are operational and regulatory risks with manufacturing and releasing product for clinical trials and these could impact our ability to deliver product for trials and therefore impact development timelines.
  • Delays in commissioning and receiving regulatory approvals for our manufacturing facilities could delay our development plans and thereby limit our ability to generate revenues.
  • We cryogenically store our engineered cell therapy products, including CAR-iNK cells, CAR-iT cells and iPSC-derived beta islet cells, and master and working cell banks of the engineered iPSC cells at both our own manufacturing facility and at third-party facilities.
  • Risks related to commercialization of our product candidates
  • If we are unable to successfully commercialize CNTY-813 or any of our other product candidates for which we receive regulatory approval, or experience significant delays in doing so, our business will be materially harmed.
  • We face significant competition, and if our competitors develop product candidates more rapidly than we do or their product candidates are more effective, our ability to develop and successfully commercialize products may be adversely affected.
  • We expect to face uncertainty regarding the pricing of our existing product candidates and any other product candidates that we may develop, and for which we may receive approval.
  • The insurance coverage and reimbursement status of newly approved products is uncertain. Failure to obtain or maintain adequate coverage and reimbursement for new products could limit our product revenues.
  • Even if we obtain regulatory and marketing approval for a product candidate, our product candidates will remain subject to regulatory oversight.
  • Even if we receive marketing approval for CNTY-813 or our other product candidates, we may not achieve broad market acceptance.
  • Even if we receive marketing approval for CNTY-8131 or our other product candidates in the United States, we may never receive regulatory approval to market CNTY-813 or our other product candidates outside of the United States.
  • We may be unable to establish effective marketing, sales and distribution capabilities or enter into agreements with third parties to market and sell CNTY-813 or our other product candidates, if approved.
  • If the market opportunities for our product candidates for which we receive marketing approval are smaller than we believe they are, our revenue may be adversely affected, and our business may suffer.
  • Our operating results may fluctuate significantly, which makes our future operating results difficult to predict and could cause our operating results to fall below expectations or any guidance we may provide.
  • Risks related to employee matters, managing growth and other risks related to our business
  • We are dependent on the services of our management and other clinical and scientific personnel, and if we are not able to retain these individuals or recruit additional management or clinical and scientific personnel, our business will suffer.
  • We will need to increase the size and capabilities of our organization, and we may experience difficulties in managing our growth.
  • We are subject to various foreign, federal, and state healthcare and privacy laws and regulations, and our failure to comply with these laws and regulations could harm our results of operations and financial condition.
  • Healthcare legislation, including potentially unfavorable pricing regulations or other healthcare reform initiatives, may increase the difficulty and cost for us to obtain marketing approval of and commercialize our product candidates.
  • If we fail to maintain proper and effective internal controls over financial reporting our ability to produce accurate and timely financial statements could be impaired.
  • We, or our CMOs or suppliers, may use potent chemical agents and hazardous materials, and any claims relating to improper handling, storage or disposal of these materials could be time-consuming or costly.
  • If product liability lawsuits are brought against us, we may incur substantial liabilities and may be required to limit commercialization of our products.
  • We may be unable to adequately protect our or our vendors’ information systems from cyberattacks or other incidents, which could result in the disclosure of confidential or proprietary information, including personal data, damage our reputation, and subject us to significant financial and legal exposure.
  • Failure to comply with current or future federal, state, and foreign laws and regulations and industry standards relating to privacy and data protection laws could lead to government enforcement actions (which could include civil or criminal penalties), private litigation, and/or adverse publicity and could negatively affect our operating results and business.
  • Our employees and independent contractors, including principal investigators, CROs, consultants, and vendors, may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements.
  • Artificial intelligence presents risks and challenges that can impact our business including by posing security risks to our confidential information, proprietary information and personal data.
  • The increasing use of social media platforms presents new risks and challenges.
  • Risks related to our intellectual property
  • We do not currently own issued patents relating to some of our product candidates.
  • If any of our license agreements with FCDI are terminated, we could lose our rights to key components enabling our iPSC-derived allogeneic cell therapy platforms.
  • We may not be successful in obtaining or maintaining necessary intellectual property rights in the future for the development of CNTY-813 and our other product candidates.
  • Our success depends on our ability to obtain, maintain, protect, and enforce our intellectual property and our proprietary technologies.
  • If the scope of any patent protection we obtain is not sufficiently broad, or if we lose any of our patent protection, our ability to prevent our competitors from commercializing similar or identical product candidates would be adversely affected.
  • The patent protection and patent prosecution for some of our product candidates may be dependent on third parties.
  • Intellectual property rights do not necessarily address all potential threats to our competitive advantage.
  • Our commercial success depends significantly on our ability to operate without infringing, misappropriating, or otherwise violating the patents and other intellectual property and proprietary rights of third parties. Claims by third parties that we infringe, misappropriate, or violate their intellectual property or proprietary rights may result in liability for damages or prevent or delay our development and commercialization efforts.
  • The intellectual property landscape around gene-editing technology is highly dynamic, and third parties may initiate and prevail in legal proceedings alleging that we are infringing, misappropriating, or otherwise violating their intellectual property rights.
  • Changes in United States patent law, or laws in other countries, could diminish the value of patents in general, thereby impairing our ability to protect CNTY-813 and our other product candidates.
  • We may be subject to claims challenging the inventorship or ownership of our patents and other intellectual property.
  • Patent terms may be inadequate to protect our competitive position on CNTY-813 and our other product candidates for an adequate amount of time.
  • If we do not obtain patent term extension for CNTY-813 and our other product candidates, our business may be materially harmed.
  • We may not be able to protect our intellectual property rights throughout the world.
  • Obtaining and maintaining our patent protection depends on compliance with various procedural, documentary, fee payment, and other requirements imposed by regulations and governmental patent agencies, and our patent protection could be reduced or eliminated for noncompliance with these requirements.

Legal proceedings

We are not currently a party to any material legal proceedings. From time to time, we may become involved in other litigation or legal proceedings relating to claims arising from the ordinary course of business.

The opening of Item 3, Legal Proceedings.5

Sources

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