PROK on Nasdaq

PROKIDNEY CORP.

In its 2026 annual report the company says: “We are a late-clinical-stage biotechnology company pioneering the development of a first-in-class, autologous cell therapy that is intended to preserve kidney function in patients with advanced chronic kidney disease and diabetes. Our lead product candidate, rilparencel, is the only cell therapy in Phase 3 clinical study for the treatment of advanced CKD and type 2 diabetes.”5 It is headquartered in Winston-Salem, North Carolina.1 Its shares trade on Nasdaq under the symbol PROK.1

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Last updated Oct 21, 2026.

Overview

$893.0KRevenue, fiscal 20252
-$69.0MNet income, fiscal 20252

Compare with Compass Therapeutics, Inc., ImageneBio, Inc. or Avalanche Biotechnologies, or pick any stock.

  • TickerPROK on Nasdaq1
  • IndustryBiological Products, (No Diagnostic Substances)1
  • HeadquartersWinston-Salem, North Carolina1
  • Incorporated inCayman Islands3
  • Business address2000 Frontis Plaza Blvd., Suite 250, Winston-Salem, Nc 271033
  • Filer category, Emerging growth company3

We are a late-clinical-stage biotechnology company pioneering the development of a first-in-class, autologous cell therapy that is intended to preserve kidney function in patients with advanced chronic kidney disease (“CKD”) and diabetes. Our approach seeks to redefine the treatment of CKD, shifting the emphasis away from management of kidney failure to the preservation of kidney function. Our lead product candidate, rilparencel, is the only cell therapy in Phase 3 clinical study for the treatment of advanced CKD and type 2 diabetes. Rilparencel is a product that includes autologous Selected Renal Cells (“SRC”) prepared from a patient’s own (autologous) kidney cells. The SRC are formulated as rilparencel for reinjection into the patient’s kidneys using a minimally invasive outpatient procedure. Because rilparencel is a personalized product composed of cells prepared from a patient’s own …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

-18477.8%Operating margin2
-7725.2%Net margin2
1075.0%Revenue growth, 20252
-$135.3MFree cash flow2

Where the money goes

Where each dollar of revenue went, fiscal 2025

  • Research and development100¢$114.1M
  • Interest0¢$4.0K
  • Income tax0¢$414.0K

Out of $893.0K in revenue.2 The company lost money this year.

Financial statements

Revenue62$893.0K in 2025
0$250.0K$500.0K$750.0K$1.0M2022: $0$020222023: $0$020232024: $76.0K$76.0K20242025: $893.0K$893.0K2025+1075%
Operating income7862-$165.0M in 2025+511% since 2020
-$200.0M-$150.0M-$100.0M-$50.0M02020: -$27.0M-$27.0M20202021: -$55.1M-$55.1M2021+104%2022: -$153.0M-$153.0M2022+178%2023: -$151.5M-$151.5M2023−1%2024: -$183.7M-$183.7M2024+21%2025: -$165.0M-$165.0M2025−10%
Net income7862-$69.0M in 2025+158% since 2020
-$150.0M-$100.0M-$50.0M02020: -$26.7M-$26.7M20202021: -$55.1M-$55.1M2021+106%2022: -$148.1M-$148.1M2022+169%2023: -$35.5M-$35.5M2023−76%2024: -$61.2M-$61.2M2024+73%2025: -$69.0M-$69.0M2025+13%

Every line of the income statement as filed: the last 3 fiscal years, latest first.2

Period ending2025-12-312024-12-312023-12-31
Revenue$893.0K$76.0K$0
Research and development$114.1M$127.7M$106.7M
General and administrative$51.8M$56.1M$44.8M
Total operating expenses$165.9M$183.8M$151.5M
Operating loss-$165.0M-$183.7M-$151.5M
Interest income$13.8M$19.8M$22.1M
Interest expense-$4.0K-$9.0K-$12.0K
Net loss before income taxes-$151.2M-$163.9M-$129.5M
Income tax (benefit) expense$414.0K-$598.0K$6.0M
Net loss before noncontrolling interest-$151.6M-$163.3M-$135.4M
Net loss attributable to noncontrolling interest-$82.6M-$102.1M-$100.0M
Net loss available to Class A ordinary shareholders-$69.0M-$61.2M-$35.5M

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Corporate structure

PROKIDNEY CORP. sits at the top of its group. 6 entities, 2 countries on record. Switch between the flow chart and the network, and select any entity to see its details.

Major holders of PROKIDNEY CORP.

  • Morgan Stanley Filed SCHEDULE 13G/A on PROKIDNEY CORP., latest Aug 12, 2026 (8 filings since Sep 12, 2022)
  • Control Empresarial de Capitales S.A. de C.V. Filed SCHEDULE 13D/A on PROKIDNEY CORP., latest Apr 30, 2026 (3 filings since Jul 22, 2022)
  • BlackRock Filed SCHEDULE 13G/A on PROKIDNEY CORP., latest Jul 17, 2025 (3 filings since Oct 18, 2024)
  • Tolerantia, LLC Filed SCHEDULE 13D/A on PROKIDNEY CORP., latest Jun 5, 2025 (6 filings since Jul 22, 2022)
  • MONTANOVA CAPITAL, LLC Filed SC 13G/A on PROKIDNEY CORP., latest Oct 22, 2024 (4 filings since Jul 22, 2022)
  • Chamath Palihapitiya Filed SC 13D/A on PROKIDNEY CORP., latest Nov 20, 2023 (6 filings since Jul 20, 2022)
  • Sculptor Capital LP Filed SC 13G/A on PROKIDNEY CORP., latest Feb 14, 2023 (2 filings since Dec 29, 2021)
  • INTEGRATED CORE STRATEGIES (US) LLC Filed SC 13G/A on PROKIDNEY CORP., latest Feb 10, 2023 (2 filings since Jan 25, 2022)
  • ADAGE CAPITAL PARTNERS GP, L.L.C. Filed SC 13G/A on PROKIDNEY CORP., latest Feb 9, 2023
  • SCS Sponsor III LLC Filed SC 13G/A on PROKIDNEY CORP., latest Jul 21, 2022 (2 filings since Feb 9, 2022)
  • PROKIDNEY CORP. Winston-Salem, North Carolina
    • ProKidney Acquisition Company II, LLC Subsidiary · Delaware, United States
    • ProKidney Acquisition Company, LLC Subsidiary · Delaware, United States
    • ProKidney Holdings, LLC Subsidiary · Delaware, United States
    • ProKidney Intermediate Holdings, LLC Subsidiary · Delaware, United States
    • ProKidney IPCo, 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 PROKIDNEY CORP. 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
Accumulated depreciation$16.6M2 Dec 31, 2025$11.0M2 Dec 31, 2024+50.0%
Property and equipment, net$51.2M2 Dec 31, 2025$42.2M2 Dec 31, 2024+21.3%
Finance-lease assets$74.0K2 Dec 31, 2025$97.0K2 Dec 31, 2024−23.7%
Operating-lease assets (leased space)$3.6M2 Dec 31, 2025$2.9M2 Dec 31, 2024+25.1%

Investments

ItemLatestA year beforeChange
Cash and cash equivalents$108.5M2 Dec 31, 2025$99.1M2 Dec 31, 2024+9.5%
Debt securities available for sale$202.0M2 Dec 31, 2025$315.1M6 Dec 31, 2024−35.9%

Properties, in its own words

We own two buildings in Winston-Salem, North Carolina, portions of which buildings we previously occupied pursuant to real estate leases. The two buildings represent total usable space of approximately 180,000 square feet. The portion of the buildings we currently occupy are used for office, manufacturing and research space. The remaining portion of these buildings are leased by us to third parties under lease agreements that expire between 2026 and 2029.

We have also leased approximately 14,700 square feet of office and warehouse space in Winston-Salem under leases that expire in 2027. Additionally, we have leased a total of approximately 16,300 square feet of office and laboratory space in the Research Triangle Park area of North Carolina under leases expiring in July 2027 and July 2031, respectively. Finally, we have leased approximately 7,400 square feet of office space in Boston, Massachusetts under a lease that expires in January 2029.

Item 2 of the 10-K filed Mar 18, 2026.5

Leadership

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

Board members and other officers (20)

Subsidiaries and ownership

Subsidiaries (Exhibit 21)

  • ProKidney Acquisition Company II, LLC Delaware4
  • ProKidney Acquisition Company, LLC Delaware4
  • ProKidney Holdings, LLC Delaware4
  • ProKidney IPCo, LLC Delaware4
  • ProKidney Intermediate Holdings, LLC Delaware4
  • ProKidney, LLC Delaware4

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

Former names

  • Social Capital Suvretta Holdings Corp. IIIApr 21, 2021 to Jul 11, 20223

Timeline

  1. Aug 10, 20268-K Results of operations35
  2. May 29, 20268-K Shareholder vote36
  3. May 15, 20268-K Results of operations; Regulation FD disclosure; Other events37
  4. Mar 18, 20268-K Results of operations38
  5. Feb 2, 20268-K Regulation FD disclosure; Other events39
  6. Jan 12, 20268-K Regulation FD disclosure40
  7. Nov 10, 20258-K Results of operations41
  8. Oct 17, 20258-K Entered a material agreement42
  9. Aug 12, 20258-K Results of operations43
  10. Jul 15, 20258-K Regulation FD disclosure; Other events44
  11. Jul 14, 20258-K Entered a material agreement; Ended a material agreement; Other events45
  12. Jul 8, 20258-K Regulation FD disclosure46
  13. Dec 5, 2023New chief executive Bruce Culleton becomes CEO13
  14. Jul 13, 2022New chief executive Timothy Bertram becomes CEO14

Calendar

Coming up

  1. Nov 9, 2026Reports results for the quarter ending Sep/2026 A year earlier it reported ($0.12) a share, on Nov 10, 2025.47

When it reported results

  1. Aug 10, 2026Reported quarterly or annual results35
  2. May 15, 2026Reported quarterly or annual results37
  3. Mar 18, 2026Reported quarterly or annual results38
  4. Nov 10, 2025Reported quarterly or annual results41
  5. Aug 12, 2025Reported quarterly or annual results43
  6. May 12, 2025Reported quarterly or annual results48
  7. Mar 17, 2025Reported quarterly or annual results49
  8. Nov 12, 2024Reported quarterly or annual results50

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

Filings

371 filings to the SEC since October 2021: 6 annual reports, 15 quarterly reports, 67 major events, 144 insider forms, 37 large holders, 102 other. The latest 20:

  1. Aug 20, 20264 EDGAR
  2. Aug 18, 2026144 EDGAR
  3. Aug 18, 2026144 EDGAR
  4. Aug 12, 2026SCHEDULE 13G/A EDGAR
  5. Aug 10, 20268-K EDGAR
  6. Aug 10, 202610-Q EDGAR
  7. Aug 6, 20264 EDGAR
  8. Jul 6, 20264 EDGAR
  9. Jun 15, 20264 EDGAR
  10. Jun 10, 20263 EDGAR
  11. May 29, 20264 EDGAR
  12. May 29, 20264 EDGAR
  13. May 29, 20264 EDGAR
  14. May 29, 20264 EDGAR
  15. May 29, 20264 EDGAR
  16. May 29, 20264 EDGAR
  17. May 29, 20264 EDGAR
  18. May 29, 20268-K EDGAR
  19. May 15, 20268-K EDGAR
  20. May 15, 202610-Q EDGAR

The 371 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

66 open-market trades by officers, directors and large owners since October 2021: 17 buys and 49 sales. Grants, option exercises and gifts are left out.

DateWhoTradeSharesPriceValueFiling
Aug 20, 2026Pereira Brian JGDirectorSale250,000$1.42$355.0KForm 4
Aug 19, 2026Pereira Brian JGDirectorSale250,000$1.44$360.0KForm 4
Aug 18, 2026Pereira Brian JGDirectorSale257,164$1.37$352.3KForm 4
Nov 13, 2025Pereira Brian JGDirectorSale502,136$2.37$1.2MForm 4
Nov 12, 2025Pereira Brian JGDirectorSale255,026$2.72$693.7KForm 4
Jul 8, 2025Weber Darin J.Chief Regulatory OfficerSale103,480$3.02$312.5KForm 4
Apr 22, 2025Control Empresarial de Capitales S.A. de C.V.10% ownerBuy387,393$0.71$275.0KForm 4
Apr 17, 2025Control Empresarial de Capitales S.A. de C.V.10% ownerBuy25,000$0.75$18.8KForm 4
Apr 16, 2025Control Empresarial de Capitales S.A. de C.V.10% ownerBuy100,000$0.75$75.0KForm 4
Apr 15, 2025Control Empresarial de Capitales S.A. de C.V.10% ownerBuy468,000$0.70$327.6KForm 4
Apr 14, 2025Control Empresarial de Capitales S.A. de C.V.10% ownerBuy268,105$0.73$195.7KForm 4
Apr 11, 2025Control Empresarial de Capitales S.A. de C.V.10% ownerBuy1,900$0.61$1.2KForm 4
Apr 10, 2025Control Empresarial de Capitales S.A. de C.V.10% ownerBuy1,032,218$0.61$629.7KForm 4
Sep 19, 2024Weber Darin J.Chief Regulatory OfficerSale16,412$2.50$41.0KForm 4
Jul 26, 2024Weber Darin J.Chief Regulatory OfficerSale826$2.50$2.1KForm 4
Jun 18, 2024Weber Darin J.Chief Regulatory OfficerSale17,238$2.82$48.6KForm 4
Jun 13, 2024Legorreta Pablo G.DirectorBuy22,617,909$2.42$54.7MForm 4
Jun 11, 2024Control Empresarial de Capitales S.A. de C.V.10% ownerBuy8,264,462$2.42$20.0MForm 4
May 20, 2024Weber Darin J.Chief Regulatory OfficerSale17,238$4.08$70.3KForm 4
Apr 22, 2024Weber Darin J.Chief Regulatory OfficerSale16,438$2.51$41.3KForm 4

All 66 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
2025Bruce Culleton, M.D.Chief Executive Officer58$687.7K$3.0M61
2025Todd C. GirolamoChief Legal Officer$466.2K$1.4M61
2025James CoulstonChief Financial Officer$465.9K$1.4M61
2024Todd C. GirolamoChief Legal Officer$425.0K$1.3M61
2024Bruce Culleton, M.D.Chief Executive Officer58$625.0K$1.0M61
2024James CoulstonChief Financial Officer$420.0K$950.1K61

Held by these funds

The largest holders among investment managers' 13F reports for the quarter ending Jun 30, 2026, the top 25 of 69. Change is in shares since the quarter before.

FundSharesValueShare of the fundChange
Montanova Capital, LLC12,341,266$25.2M0.5%No change
Morgan Stanley9,854,178$20.1M0.0%+898,211
BlackRock, Inc.5,197,227$10.6M0.0%+3,810,111
Geode Capital Management, LLC2,390,147$4.9M0.0%+1,159,738
Bleichroeder LP2,000,000$4.1M0.7%No change
Hennion & Walsh Asset Management, Inc.1,847,749$3.8M0.1%+236,056
Artia Global Partners LP1,806,939$3.7M0.7%No change
Vanguard Capital Management LLC1,175,257$2.4M0.0%+28,320
Renaissance Technologies LLC1,099,400$2.2M0.0%−151,394
Millennium Management LLC1,054,705$2.2M0.0%−1,216,872
State Street Corp1,045,945$2.1M0.0%+489,100
Charles Schwab Investment Management Inc781,729$1.6M0.0%+153,958
UBS Group AG671,447$1.4M0.0%+336,901
Northern Trust Corp664,827$1.4M0.0%+423,247
MYDA Advisors LLC640,775$1.3M0.3%+212,000
Vanguard Fiduciary Trust Co632,149$1.3M0.0%+93,778
Bank Of America Corp /de/545,158$1.1M0.0%−208,254
Vanguard Portfolio Management LLC517,082$1.1M0.0%New
Voleon Capital Management LP473,307$965.5K0.0%+370,609
Amundi304,151$620.5K0.0%+12,443
Two Sigma Investments, LP273,259$557.4K0.0%−73,123
Susquehanna International Group, Llp252,906$515.9K0.0%+48,418
Goldman Sachs Group Inc203,006$414.1K0.0%−218,896
Virtus Investment Advisers, LLC199,510$407.0K0.1%+76,122
Bank of New York Mellon Corp176,657$360.4K0.0%+165,465

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

SEC filer profile

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

  • Name on EDGARPROKIDNEY CORP.1
  • CIK0001850270
  • Employer ID (EIN)98-15865145
  • Filer statusNon-accelerated filer an emerging growth company; a smaller reporting company; not a shell company5
  • Incorporated inDelaware5
  • 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 address2000 Frontis Plaza Blvd., Suite 250, Winston-Salem, NC 271031
  • Phone336-999-70281
  • Shares outstanding141,942,905 Common Class A shares; 159,973,180 Common Class B shares as of Mar 18, 20265
  • Public float$58.9M as of Jun 30, 20255
  • AuditorErnst & Young LLP, Atlanta, Georgia, United States PCAOB ID 42; no auditor attestation of internal control over financial reporting5
  • On EDGAR sinceApr 21, 20211
  • Filings397 in all: 4 (124), 8-K (62), 3 (26), DEFA14A (22), 10-Q (16), 424B3 (15), 144 (11), SC 13G/A (11)1
    All 42 form types

    CORRESP (9), EFFECT (9), SC 13D/A (8), SC 13G (8), UPLOAD (7), 8-K/A (6), 10-K (5), POS AM (5), S-8 (5), 424B5 (4), ARS (4), S-8 POS (4), SC 13D (4), SCHEDULE 13G/A (4), DEF 14A (3), S-1/A (3), SCHEDULE 13D/A (3), PRER14A (2), S-1 (2), 10-K/A (1), 4/A (1), 424B4 (1), 8-A12B (1), 8-K12B (1), 8-K12B/A (1), CERT (1), DEFM14A (1), DEL AM (1), DRS (1), PREM14A (1), S-1MEF (1), S-3 (1), S-4 (1), SCHEDULE 13G (1)

  • Latest filingsAnnual report (10-K) Mar 18, 2026
    Quarterly report (10-Q) Aug 10, 2026
    Proxy statement (DEF 14A) Apr 17, 2026
    Latest 8-K (8-K) Aug 10, 2026

Securities registered for trading

ClassSymbolExchange
Class A common stock, $0.0001 par value per sharePROKNasdaq

From the cover page of the 10-K filed Mar 18, 2026 (Section 12(b) of the Exchange Act).5

Risk factors and legal proceedings

The risks PROKIDNEY CORP. names in Item 1A of its 10-K filed Mar 18, 2026: 72 risks under these headings, as written.5

  • Risks Related to Our Financial Position and Need for Additional Capital
  • We have incurred significant net losses since inception and we expect to continue to incur significant net losses for the foreseeable future.
  • We will continue to require substantial additional capital to finance our operations. If we are unable to raise such capital when needed, or on acceptable terms, we may be forced to delay, reduce and/or eliminate one or more of our research and product development programs, future commercialization efforts or other operations.
  • Risks Related to Research and Development of Rilparencel and Our Future Product Candidates
  • We have a limited operating history and have not generated any revenue to date, and may never become profitable.
  • The market for biologics and for the treatment of kidney disease is highly competitive. If we fail to effectively compete, our business, financial condition and operating results will suffer.
  • Our business is highly dependent on the success of our lead product candidate, rilparencel, as well as any other future product candidates that we may advance into clinical development. Rilparencel and our future product candidates will require significant additional clinical development and funding before we may be able to seek regulatory approval for and launch a product commercially.
  • Rilparencel is based on a novel technology, which makes it difficult to predict the time and cost of product development and of subsequently obtaining regulatory approval.
  • Clinical development involves a lengthy, complex and expensive process, with an uncertain outcome, and the results of nonclinical studies, previous clinical trials, or interim results of ongoing clinical trials of rilparencel and any of our future product candidates may not be predictive of future results. Further, we may encounter substantial delays in completing the development of rilparencel and any of our future product candidates.
  • Any topline data or interim analyses from our nonclinical studies and clinical trials that may be announced or published from time to time may change as more data becomes available and will remain subject to audit and verification procedures that could result in material changes in the final data.
  • The regulatory approval processes of the FDA and comparable foreign authorities are lengthy, time-consuming and inherently unpredictable. If we are not able to obtain required regulatory approval for rilparencel, our lead product candidate, or any of our future product candidates, our business may be materially and adversely affected.
  • Our nonclinical studies and clinical trials may fail to demonstrate substantial evidence of the safety and efficacy of rilparencel or our future product candidates, or serious adverse or unacceptable side effects may be identified during the development of rilparencel or any of our future product candidates, which could prevent, delay or limit the scope of regulatory approval of rilparencel or any of our future product candidates, limit their commercialization, increase our costs or necessitate the abandonment or limitation of the development of rilparencel or our future product candidates.
The other 62 risks
  • Negative public opinion and increased regulatory scrutiny of autologous cell therapy using rilparencel may adversely impact the development or commercial success of our current and future product candidates.
  • We are conducting our first Phase 3 clinical trial and may be unable to successfully complete it or any future clinical trials.
  • We have and may continue to encounter difficulties enrolling patients in our clinical trials, and our clinical development activities have been and may continue to be delayed or otherwise adversely affected.
  • The design or execution of our ongoing and future clinical trials may not support marketing approval.
  • We have obtained RMAT Designation from the FDA for rilparencel, but this may not lead to a faster development or regulatory review process, and such designation does not increase the likelihood that any of our product candidates will receive marketing approval in the United States and the FDA may withdraw such designation.
  • 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 have conducted and may in the future continue to conduct additional clinical trials for rilparencel outside the United States, and the FDA and similar foreign regulatory authorities may not accept data from such trials conducted in locations outside of their jurisdiction.
  • We may not be successful in our efforts to identify or discover additional product candidates in the future.
  • Due to our limited resources and access to capital, we must make decisions on the allocation of resources to certain programs and product candidates; these decisions may prove to be wrong and may adversely affect our business.
  • If we do not achieve our projected development goals in the time frames we announce and expect, the commercialization of our products may be delayed or never achieved.
  • Risks Related to the Manufacturing of Rilparencel and Our Future Product Candidates
  • Cell therapies are complex and difficult to manufacture, and we have experienced and may continue to experience manufacturing problems that result in delays in the development or commercialization of rilparencel, our lead product candidate, or otherwise harm our business.
  • We have our own manufacturing capabilities, which may result in increased costs being incurred by us.
  • Contract development and manufacturing organizations have a finite cell manufacturing capacity, which could inhibit the long-term growth prospects of our business.
  • Our autologous cell therapy products are patient-specific, and we need to ensure that the correct product is administered to the correct patient.
  • Delays in obtaining regulatory approval of the manufacturing process and facility to produce rilparencel or disruptions in the manufacturing process may delay or disrupt our commercialization efforts. Very few cGMP cell therapy manufacturing facilities in the United States have received approval from the FDA for the manufacture of an approved cell therapy product.
  • We do not have experience as a company managing a complex supply chain or satisfying manufacturing-related regulatory requirements.
  • Managing an autologous ex vivo cell therapy supply chain is highly complex. We must identify, engage, and coordinate with treatment centers where patients’ cellular source material must be collected, prepared and transported to the manufacturing facility and the cryopreserved therapeutic product must be returned to the treatment center for administration to the patient using vapor phase liquid nitrogen shipping containers. Additionally, we are dependent on highly specialized vendors to provide raw materials and components for our manufacturing process.
  • We depend on third-party suppliers for materials that are necessary for the conduct of clinical trials of rilparencel, our lead product candidate, and the loss of these third-party suppliers or their inability to supply us with sufficient quantities of adequate materials, or to do so at acceptable quality levels and on a timely basis, could harm our business.
  • Any microbial contamination in the manufacturing process for our cell-based product, shortages of raw materials or failure of any of our key suppliers to deliver necessary components could result in delays in our clinical development or marketing schedules.
  • Rilparencel requires cryopreservation with specific storage, handling and administration at the clinical sites.
  • Changes in methods of product candidate manufacturing or formulation may result in additional costs or delay.
  • Our current operations are concentrated in a number of locations, including a single manufacturing facility in North Carolina. We or the third parties upon whom we depend may be adversely affected by earthquakes, wildfires or other natural disasters, as well as epidemics, pandemics and other incidents, and our business continuity and disaster recovery plans may not adequately protect us from a serious disaster.
  • Risks Related to the Commercialization of Rilparencel and Our Future Product Candidates
  • Even if rilparencel or a future product candidate we develop receives marketing approval, it may fail to achieve the degree of market acceptance by physicians, patients, third-party payors and others in the medical community necessary for commercial success.
  • We currently have no marketing and sales organization and have no experience as a company in commercializing products, and we may have to invest significant resources to develop these capabilities. If we are unable to establish marketing and sales
  • capabilities or enter into agreements with third parties to market and sell any products for which we obtain regulatory approval, we may not be able to generate product revenue.
  • The affected populations for rilparencel or any of our future product candidates may be smaller than we or third parties currently project, which may affect the addressable markets for rilparencel or our future product candidates.
  • Obtaining and maintaining regulatory approval of rilparencel or any of our future product candidates in one jurisdiction does not mean that we will be successful in obtaining regulatory approval of rilparencel or future product candidates in other jurisdictions.
  • Off-label use or misuse of our products may harm our reputation in the marketplace, result in injuries that lead to costly product liability suits, and/or subject us to penalties if we fail to comply with regulatory requirements or experience unanticipated problems with any product.
  • Rilparencel and our future product candidates for which we intend to seek approval as biologic products may face competition sooner than anticipated, and our operating results will suffer if we fail to compete effectively.
  • Coverage and reimbursement may be limited or unavailable in certain market segments for rilparencel or our future product candidates, if approved, which could make it difficult for us to sell any product candidates profitably.
  • If product liability lawsuits are brought against us, we may incur substantial financial or other liabilities and may be required to limit commercialization of rilparencel or our future product candidates.
  • If we or any contract manufacturers and suppliers we engage, now or in the future, fail to comply with environmental, health, and safety laws and regulations, we could become subject to fines or penalties or incur costs that could substantially harm our business.
  • Risks Related to Our Reliance on Third Parties
  • We rely on third parties to conduct, supervise and monitor a certain portion of our research and nonclinical testing and clinical trials for rilparencel, and if those third parties do not successfully carry out their contractual duties, comply with regulatory requirements or otherwise perform satisfactorily, we may not be able to obtain regulatory approval or commercialize rilparencel, or such approval or commercialization may be delayed, and our business may be substantially harmed.
  • We rely on third parties for materials, including tissue samples, required for our research and development activities, and if we are unable to reach agreements with these third parties our research and development activities would be delayed.
  • We may in the future seek to enter into collaborations with third parties for the development and commercialization of rilparencel and/or our future product candidates, and our future collaborations will be important to our business. If we are unable to enter into collaborations, or if these collaborations are not successful, our business could be adversely affected.
  • Risks Related to Legal and Regulatory Compliance Matters
  • Our relationships with customers, health care providers, physicians, prescribers, purchasers, third-party payors, charitable organizations and patients will be subject to applicable anti-kickback, fraud and abuse and other health care laws and regulations, which could expose us to criminal sanctions, civil penalties, contractual damages, reputational harm and diminished profits and future earnings.
  • Even if we receive regulatory approval of any product candidates, we will be subject to ongoing regulatory oversight 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 rilparencel or any of our future product candidates.
  • Changes in health care policies, laws and regulations, including legislative measures aimed at reducing health care costs, may impact our ability to obtain approval for, or commercialize rilparencel or any of our future product candidates, if approved.
  • Disruptions and changes at the United States Food and Drug Administration (the “FDA”) and other government agencies from funding cuts, personnel losses and changes, regulatory reform, government shutdowns and other developments could hinder our ability to obtain guidance from the FDA regarding our clinical development program and develop and secure approval of our product candidates in a timely manner, which would negatively impact our business.
  • We may incur substantial costs in our efforts to comply with evolving global data protection laws and regulations, and any failure or perceived failure by us to comply with such laws and regulations may harm our business and operations.
  • Legal, political and economic uncertainty relating to our international operations could negatively impact or restrict our operations.
  • We are subject to certain U.S. and foreign anti-corruption, anti-money laundering, export control, sanctions, and other trade laws and regulations. We can face serious consequences for violations.
  • Our executive officers, directors, security holders and their respective affiliates may have competitive pecuniary interests that conflict with our interests.
  • Risks Related to Our Intellectual Property
  • Our success depends in part on our ability to protect our intellectual property. It is difficult and costly to protect our proprietary rights and technology, and we may not be able to ensure their protection.
  • We may enter into license or other collaboration agreements in the future that may impose certain obligations on us. If we fail to comply with our obligations under such future agreements with third parties, we could lose license rights that may be important to our future business.
  • If we are unable to protect the confidentiality of our trade secrets, the value of our technology could be negatively impacted, and our business and competitive position would be harmed.
  • The development and use of AI presents risks and challenges that can impact our business, including by posing security risks to our confidential information, proprietary information, and personal data and could give rise to legal and/or regulatory actions, damage our reputation, or otherwise materially harm our business.
  • Third-party claims of intellectual property infringement may be costly and time consuming to defend and could prevent or delay our product discovery, development and commercialization efforts.
  • Third parties may assert that we are employing their proprietary technology without authorization.
  • Third parties may assert that our employees or consultants have wrongfully used or disclosed confidential information or misappropriated trade secrets.
  • We may not identify relevant third-party patents or may incorrectly interpret the relevance, scope or expiration of a third-party patent which might adversely affect our ability to develop and market our products.
  • We may not be successful in obtaining or maintaining necessary intellectual property rights to develop any future product candidates on acceptable terms.
  • We may be involved in lawsuits to protect or enforce our patents or the patents of our licensors, or challenging the patent rights of others, 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.
  • Certain patents covering rilparencel could be found invalid or unenforceable if challenged in court or the USPTO.
  • Changes in patent law in the United States, changes in the administration’s interpretation of the law, or changes in the law in other jurisdictions could diminish the value of patents in general, thereby impairing our ability to protect our products.
  • We have limited foreign intellectual property rights and may not be able to protect and enforce our intellectual property rights throughout the world.
  • Patent terms may be inadequate to protect our competitive position on rilparencel or our future product candidates for an adequate amount of time, and if we do not obtain protection under the Hatch-Waxman Amendments and similar non-United States legislation for extending the term of patents covering rilparencel or our future product candidates, our business may be materially harmed.
  • Any trademarks we have obtained or may obtain may be infringed or otherwise violated, or successfully challenged, resulting in harm to our business.
  • Risks Related to Managing Our Business and Operations
  • We expect to expand our clinical development and research and regulatory capabilities, our manufacturing and administrative capacities, and potentially implement sales, marketing and distribution capabilities, and as a result, we may encounter difficulties in managing our growth, which could adversely affect our operations.
  • If we lose key management personnel, or if we fail to recruit additional highly skilled personnel, our ability to continue developing rilparencel or identify and develop new product candidates will be impaired, which could result in loss of markets or market share and could make us less competitive.

Legal proceedings

From time to time, we may become involved in litigation or other legal proceedings. 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 on us because of defense and settlement costs, diversion of management resources and other factors.

The opening of Item 3, Legal Proceedings.5

Sources

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