IBRX on Nasdaq

ImmunityBio, Inc.

ImmunityBio, Inc. is an American biological products company based in San Diego.2 Its shares trade on Nasdaq under the symbol IBRX.2

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Last updated Oct 20, 2026.

Overview

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  • TickerIBRX on Nasdaq2
  • IndustryBiological Products, (No Diagnostic Substances)2
  • HeadquartersWashington, DC, United States2
  • Incorporated inDE3
  • Business address3530 John Hopkins Court, San Diego, Ca 921213
  • Filer categoryLarge accelerated filer3
  • Legal formCorporation2
  • LEI529900J9XLBR4HFL4B832
  • StatusActive2
  • LEI statusLapsed (not renewed)2
  • Registered addressc/o National Registered Agents, Inc., 160 Greentree DR STE 101, 19904 Dover, United States2
  • Registered withDivision of Corporations, Department of State, 54970722

Financials

From the company’s reports to the SEC. Every number links to the filing it came from.

Key numbers, fiscal 2025

-226.0%Operating margin5
-310.2%Net margin5
668.3%Revenue growth, 20255
-$308.8MFree cash flow5

What sells

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

Products and services

Product brought in 100% of the revenue ImmunityBio, Inc. broke down this way in fiscal 2025.

  1. Product$113.0M5100%up 698% from 2024
  2. Product and Service, Other$306.0K50%down 49% from 2024
Products and services by year
Products and services202320242025
Product$0$14.2M$113.0M
Product and Service, Other$622.0K$595.0K$306.0K

Regions

United States brought in 100% of the revenue ImmunityBio, Inc. broke down this way in fiscal 2025.

  1. United States$113.0M5100%up 695% from 2024
  2. Europe$278.0K50%down 48% from 2024
Regions by year
Regions202320242025
United States$31.0K$14.2M$113.0M
Europe$591.0K$531.0K$278.0K

Where the money goes

Where each dollar of revenue went, fiscal 2025

  • Cost of revenue1¢$753.0K
  • Other costs45¢$51.5M
  • Interest54¢$60.9M
  • Income tax0¢$135.0K

Out of $113.3M in revenue.5 The company lost money this year.

Financial statements

Revenue67895$113.3M in 2025+5045% since 2019
0$50.0M$100.0M$150.0M2019: $2.2M$2.2M20192020: $605.0K$605.0K2020−73%2021: $934.0K$934.0K2021+54%2022: $240.0K$240.0K2022−74%2023: $622.0K$622.0K2023+159%2024: $14.7M$14.7M2024+2271%2025: $113.3M$113.3M2025+668%
Operating income67895-$256.0M in 2025+64% since 2019
-$400.0M-$300.0M-$200.0M-$100.0M02019: -$156.3M-$156.3M20192020: -$220.9M-$220.9M2020+41%2021: -$330.3M-$330.3M2021+50%2022: -$351.3M-$351.3M2022+6%2023: -$362.2M-$362.2M2023+3%2024: -$344.2M-$344.2M2024−5%2025: -$256.0M-$256.0M2025−26%
Net income67895-$351.4M in 2025+123% since 2019
-$600.0M-$400.0M-$200.0M02019: -$157.8M-$157.8M20192020: -$221.9M-$221.9M2020+41%2021: -$346.8M-$346.8M2021+56%2022: -$416.6M-$416.6M2022+20%2023: -$583.2M-$583.2M2023+40%2024: -$413.6M-$413.6M2024−29%2025: -$351.4M-$351.4M2025−15%

Every line of the income statement as filed: the last 3 fiscal years, latest first.5

Period ending2025-12-312024-12-312023-12-31
Total revenue$113.3M$14.7M$622.0K
Cost of sales$753.0K$0$0
Impairment of intangible assets$0$0$886.0K
Total operating costs and expenses$369.3M$358.9M$362.9M
Loss from operations-$256.0M-$344.2M-$362.2M
Interest and investment income, net$6.4M$8.0M$1.1M
Interest expense related to revenue interest liability-$51.5M-$39.7M-$264.0K
Change in fair value of warrant liabilities$49.1M$20.0M-$47.6M
Change in fair value of related-party convertible note-$42.8M$43.5M-$36.2M
Change in fair value of derivative liabilities$6.4M$13.5M$0
Loss on equity method investment$0$0-$7.5M
Other expense, net-$2.2M-$15.0K-$2.2M
Total other expense, net-$95.6M-$69.5M-$221.6M
Loss before income taxes and noncontrolling interests-$351.6M-$413.6M-$583.9M
Income tax benefit$135.0K$0$40.0K
Net loss-$351.5M-$413.6M-$583.9M
Net loss attributable to noncontrolling interests, net of tax-$74.0K-$81.0K-$656.0K
Net loss attributable to ImmunityBio common stockholders-$351.4M-$413.6M-$583.2M
Net loss per ImmunityBio common share - basic (in dollars per share)-$0.38-$0.59-$1.15
Net loss per ImmunityBio common share - diluted (in dollars per share)-$0.38-$0.62-$1.15
Weighted-average number of common shares used in computing net loss per share basic (in shares)919.9M shares697.3M shares508.6M shares
Weighted-average number of common shares used in computing net loss per share diluted (in shares)919.9M shares700.4M shares508.6M shares

Compare ImmunityBio, Inc. with another company

Corporate structure

ImmunityBio, Inc. sits at the top of its group. 19 entities, 4 countries on record. Switch between the flow chart and the network, and select any entity to see its details.

Major holders of ImmunityBio, Inc.

  • Cambridge Equities, LP Filed SCHEDULE 13D/A on ImmunityBio, Inc., latest Aug 6, 2026 (7 filings since Dec 7, 2022)
  • ImmunityBio, Inc. Washington, DC, California, United States
    • AccessBio LLC Subsidiary · Delaware, United States
    • Altor BioScience Manufacturing Company LLC Subsidiary · Delaware, United States
    • Altor BioScience, LLC Subsidiary · Delaware, United States
    • Etubics Corporation Subsidiary · Delaware, United States
    • GlobeImmune, Inc. Subsidiary · Delaware, United States
    • IgDraSol, Inc. Subsidiary · Delaware, United States
    • ImmunityBio Ireland Ltd. Subsidiary · Ireland
    • Immunotherapy NANTibody, LLC Subsidiary · Delaware, United States
    • Inex Bio, Inc. Subsidiary · South Korea
    • Infacell Therapeutics, Inc. Subsidiary · Delaware, United States
    • Mariposa Clinic Co LLC Subsidiary · Delaware, United States
    • Mariposa Lab Co LLC Subsidiary · Delaware, United States
    • Mariposa Radiology Co LLC Subsidiary · Delaware, United States
    • MCLR Parent LLC Subsidiary · Delaware, United States
    • NantCell, Inc. Subsidiary · Delaware, United States
    • Receptome, Inc. Subsidiary · Delaware, United States
    • VBC Holdings LLC Subsidiary · Delaware, United States
    • VivaBioCell, S.p.A. Subsidiary · Italy

Built from parent and subsidiary links from GLEIF, the Global Legal Entity Identifier Foundation (CC0); 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 ImmunityBio, 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$226.7M5 Dec 31, 2025$236.7M5 Dec 31, 2024−4.2%
Accumulated depreciation$112.5M5 Dec 31, 2025$99.6M5 Dec 31, 2024+12.9%
Property and equipment, net$114.3M5 Dec 31, 2025$137.1M5 Dec 31, 2024−16.7%
Finance-lease assets$271.0K5 Dec 31, 2025$05 Dec 31, 2024
Operating-lease assets (leased space)$33.0M5 Dec 31, 2025$33.4M5 Dec 31, 2024−1.1%

Investments

ItemLatestA year beforeChange
Cash and cash equivalents$88.3M5 Dec 31, 2025$143.4M5 Dec 31, 2024−38.4%
Marketable securities, current$154.5M5 Dec 31, 2025$6.4M5 Dec 31, 2024+2321.0%
Marketable securities, non-current$09 Dec 31, 2024$891.0K9 Dec 31, 2023−100.0%

Intangibles and goodwill

ItemLatestA year beforeChange
Goodwill$910.0K5 Dec 31, 2025$910.0K5 Dec 31, 20240%
Indefinite-lived intangibles (excluding goodwill)$52.0K5 Dec 31, 2025$489.0K5 Dec 31, 2024−89.4%
Finite-lived intangibles, gross$21.0M5 Dec 31, 2025$21.2M8 Dec 31, 2022−1.3%
Accumulated amortization$8.0M5 Dec 31, 2025$5.9M5 Dec 31, 2024+35.7%
Finite-lived intangibles, net$13.0M5 Dec 31, 2025$14.5M9 Dec 31, 2024−10.6%

Inventory

ItemLatestA year beforeChange
Inventory, total$910.0K5 Dec 31, 2025$8.3M5 Dec 31, 2024−89.0%
Raw materials$09 Dec 31, 2024$09 Dec 31, 2023
Work in process$12.5M5 Dec 31, 2025$7.5M5 Dec 31, 2024+66.9%
Finished goods$1.9M5 Dec 31, 2025$767.0K5 Dec 31, 2024+146.9%

Properties, in its own words

We lease property in multiple facilities across the U.S. and Italy, including facilities located in El Segundo and Culver City, CA that are leased from related parties. See Note 15 “Related-Party Agreements” of the “Notes to Consolidated Financial Statements” that appears in Part II, Item 8. “Financial Statements and Supplementary Data” of this Annual Report for more information about our related-party leases.

The following table summarizes our principal properties under lease as of December 31, 2025:

The rest of Item 2

Location · Expiration Year (1) · ApproximateRentableSquare Feet (2), (3) · Primary Function(s)

United States

Dunkirk, NY · 2028 · 409,000 · Future Manufacturing Facility

El Segundo, CA · 2026 – 2029 · 132,136 · Laboratory – Research & Manufacturing

Louisville, CO · 2030 · 50,838 · Laboratory – Research

Culver City, CA · Month to Month · 46,330 · Laboratory – Research & Manufacturing

San Diego, CA · 2030 · 44,681 · Laboratory – Research & Corporate Office

Summit, NJ · 2028 · 11,256 · Office – Regulatory Affairs

International

Italy · 2027 – 2030 · 15,748 · Laboratory – Research & Office

(1) · Expiration years shown are per the lease agreements in effect as of December 31, 2025 and do not reflect contractual options to extend the term of the lease available to us under the lease agreements. For locations with multiple leases, the first and last expiration year are shown.

(2) · Amounts shown represent the total approximate rentable square feet for all buildings located in each city.

(3) · Previous lease for laboratory and research space in Seattle, WA expired in 2025. We will occupy space in 2026 under a new lease.

We believe that our existing facilities are adequate to meet our current and future needs and that we will be able to renew existing leases and obtain additional commercial space as needed.

Item 2 of the 10-K filed Feb 23, 2026.13

Leadership

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

Board members and other officers (19)

Named in SEC Form D filings

People the company listed in its private-offering notices.

  • Executive Officer, DirectorPatrick Soon-Shiong named Jul 22, 2022 to Sep 22, 202340
  • DirectorJohn Brennan named Jul 22, 2022 to Sep 22, 202340

Subsidiaries and ownership

Subsidiaries (Exhibit 21)

  • AccessBio LLC Delaware4
  • Altor BioScience Manufacturing Company LLC Delaware4
  • Altor BioScience, LLC Delaware4
  • Etubics Corporation Delaware4
  • GlobeImmune, Inc. Delaware4
  • IgDraSol, Inc. Delaware4
  • ImmunityBio Ireland Ltd. Ireland4
  • Immunotherapy NANTibody, LLC Delaware4
  • Inex Bio, Inc. Republic of Korea4
  • Infacell Therapeutics, Inc. Delaware4
  • MCLR Parent LLC Delaware4
  • Mariposa Clinic Co LLC Delaware4
  • Mariposa Lab Co LLC Delaware4
  • Mariposa Radiology Co LLC Delaware4
  • NantCell, Inc. Delaware4
  • Receptome, Inc. Delaware4
  • VBC Holdings LLC Delaware4
  • VivaBioCell, S.p.A. Italy4

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

Former names

  • NantKwest, Inc.Jun 10, 2015 to Mar 8, 20213
  • Conkwest, Inc.Apr 17, 2014 to Jul 13, 20153
  • ZelleRx CorpApr 29, 2005 to Oct 9, 20093

Timeline

  1. Oct 14, 20268-K Regulation FD disclosure41
  2. Aug 4, 20268-K Results of operations42
  3. Jul 30, 20268-K Regulation FD disclosure43
  4. Jun 10, 20268-K Shareholder vote44
  5. May 18, 20268-K Entered a material agreement; Regulation FD disclosure45
  6. May 7, 20268-K Results of operations46
  7. Apr 9, 20268-K Results of operations47
  8. Apr 6, 20268-K Regulation FD disclosure48
  9. Mar 31, 20268-K Entered a material agreement; New debt or obligation; Regulation FD disclosure49
  10. Feb 23, 20268-K Results of operations50
  11. Feb 18, 20268-K Other events51
  12. Jan 26, 20268-K Entered a material agreement52
  13. Oct 29, 2020New chief executive Richard Adcock becomes CEO14
  14. Jul 27, 2015New chief executive Shiong Patrick Soon becomes CEO15

Calendar

Coming up

  1. Nov 3, 2026Reports results for the quarter ending Sep/2026 A year earlier it reported ($0.07) a share, on Nov 4, 2025.53

When it reported results

  1. Aug 4, 2026Reported quarterly or annual results42
  2. May 7, 2026Reported quarterly or annual results46
  3. Apr 9, 2026Reported quarterly or annual results47
  4. Feb 23, 2026Reported quarterly or annual results50
  5. Jan 15, 2026Reported quarterly or annual results54
  6. Nov 5, 2025Reported quarterly or annual results55
  7. Aug 5, 2025Reported quarterly or annual results56
  8. Jul 25, 2025Reported quarterly or annual results57

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

Filings

265 filings to the SEC since October 2021: 5 annual reports, 15 quarterly reports, 60 major events, 111 insider forms, 7 large holders, 2 private raises, 65 other. The latest 20:

  1. Oct 14, 20268-K EDGAR
  2. Oct 6, 20264 EDGAR
  3. Oct 6, 20264 EDGAR
  4. Oct 5, 2026144 EDGAR
  5. Oct 2, 2026144 EDGAR
  6. Aug 6, 2026SCHEDULE 13D/A EDGAR
  7. Aug 4, 202610-Q EDGAR
  8. Aug 4, 20268-K EDGAR
  9. Jul 30, 20268-K EDGAR
  10. Jul 6, 20264 EDGAR
  11. Jul 6, 20264 EDGAR
  12. Jul 2, 2026144 EDGAR
  13. Jul 1, 2026144 EDGAR
  14. Jul 1, 20264 EDGAR
  15. Jun 30, 2026144 EDGAR
  16. Jun 29, 2026144 EDGAR
  17. Jun 26, 20264 EDGAR
  18. Jun 10, 20264 EDGAR
  19. Jun 10, 20264 EDGAR
  20. Jun 10, 20264 EDGAR

The 265 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

17 open-market trades by officers, directors and large owners since October 2021: 4 buys and 13 sales. Grants, option exercises and gifts are left out.

DateWhoTradeSharesPriceValueFiling
Jul 2, 2026Cohen CherylDirectorSale131,210$9.50$1.2MForm 4
Jul 1, 2026Selecky ChristobelDirectorSale159,478$9.02$1.4MForm 4
Jun 30, 2026Selecky ChristobelDirectorSale1,000$9.00$9.0KForm 4
Jun 29, 2026Selecky ChristobelDirectorSale95,722$9.01$862.5KForm 4
Jun 24, 2026Simon Barry J.DirectorSale25,000$7.88$197.0KForm 4
Jun 4, 2026Simon Barry J.DirectorSale23,033$7.18$165.4KForm 4
Feb 24, 2026Simon Barry J.DirectorSale75,000$12.01$900.8KForm 4
Feb 23, 2026Selecky ChristobelDirectorSale25,000$10.00$250.0KForm 4
Feb 23, 2026Simon Barry J.DirectorSale165,000$10.25$1.7MForm 4
Feb 20, 2026Simon Barry J.DirectorSale10,000$9.25$92.5KForm 4
Jan 20, 2026Selecky ChristobelDirectorSale25,000$7.51$187.8KForm 4
Jan 20, 2026Simon Barry J.DirectorSale151,967$7.20$1.1MForm 4
Jan 16, 2026Selecky ChristobelDirectorSale50,000$5.00$250.0KForm 4
Jun 5, 2023BLASZYK MICHAEL DDirectorBuy71,915$2.75$198.0KForm 4
Jun 2, 2023Brennan John OwenDirectorBuy25,000$2.83$70.7KForm 4
Jun 1, 2023Clark WesleyDirectorBuy7,000$2.91$20.4KForm 4
Oct 8, 2021Adcock RichardCEO & PresidentBuy1,930$8.81$17.0KForm 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
2025Richard Adcock57$831.7K$12.7M59
2025Patrick Soon-ShiongM.D.$648.8K$12.3M59
2025David Sachs48$591.7K$4.2M59
2025Regan Lauer56$338.8K$745.3K59
2024President andCEO$802.1K$11.0M59
2024Global ChiefScientific and Medical Officer$625.8K$8.2M59
2024CFO$574.5K$3.4M59
2023President andCEO$796.0K$1.2M59
2023CFO$537.5K$1.1M59
2023Global ChiefScientific and Medical Officer$621.0K$865.3K59

Money raised

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

  1. Sep 11, 2023Raised $470 million in a private offering of securities Form D: 3 investors so far Form D
  2. Jul 9, 2022Raised $10.7 million in a private offering of equity Form D: 6 investors 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 100. Change is in shares since the quarter before.

FundSharesValueShare of the fundChange
BlackRock, Inc.34,083,262$298.4M0.0%+7,736,819
State Street Corp21,398,438$187.3M0.0%+3,690,335
Vanguard Portfolio Management LLC17,863,911$156.4M0.0%+1,541,067
Vanguard Capital Management LLC15,691,579$137.4M0.0%+563,865
D. E. Shaw & Co., Inc.11,551,019$101.1M0.1%−1,020,578
Two Sigma Investments, LP11,097,106$97.2M0.1%+6,711,606
Geode Capital Management, LLC9,847,896$86.2M0.0%+1,815,975
Millennium Management LLC5,579,793$48.9M0.0%+4,159,549
Northern Trust Corp3,565,248$31.2M0.0%+1,060,467
Morgan Stanley3,432,678$30.1M0.0%−586,191
Goldman Sachs Group Inc3,234,277$28.3M0.0%−2,801
UBS Group AG3,195,728$28.0M0.0%+250,840
Charles Schwab Investment Management Inc2,888,607$25.3M0.0%+410,666
Woodline Partners LP2,500,189$21.9M0.1%−947,157
SEB Asset Management AB2,447,150$21.4M0.1%No change
Vanguard Fiduciary Trust Co2,412,338$21.1M0.0%+289,210
Bank Of America Corp /de/2,184,489$19.1M0.0%−263,354
Voloridge Investment Management, LLC1,721,902$15.1M0.1%−1,205,650
Federated Hermes, Inc.1,713,200$15.0M0.0%+326,609
Royal Bank Of Canada1,542,717$13.5M0.0%+56,668
Jpmorgan Chase & Co1,450,180$12.9M0.0%−39,329
Bank of New York Mellon Corp1,314,760$11.5M0.0%+483,330
First Trust Advisors LP1,214,667$10.6M0.0%New
Cetera Investment Advisers1,140,476$10.0M0.0%+193,767
Sound Capital Solutions LLC1,120,808$9.8M2.3%New

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

Members of Congress who traded it

3 trades disclosed by members of Congress. “Vs S&P since” is the stock’s change since the trade minus the S&P 500’s.

DateMemberTradeAmountVs S&P sinceFiling
Sep 30, 2026Lisa C. McClainRepublican, HouseBuy$1,001 - $15,000+4.7%Report
Sep 28, 2026Lisa C. McClainRepublican, HouseBuy$1,001 - $15,000+16.6%Report
Mar 6, 2023Daniel S. GoldmanDemocratic, HouseSale$1,001 - $15,000−377.4%Report

Members report amounts as ranges, not exact figures. Returns are price-only (no dividends).

SEC filer profile

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

  • Name on EDGARImmunityBio, Inc.1
  • CIK0001326110
  • Employer ID (EIN)43-197975413
  • Filer statusLarge accelerated filer not an emerging growth company; not a smaller reporting company; not a shell company13
  • Incorporated inDelaware13
  • 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 address3530 John Hopkins Court, San Diego, CA 921211
  • Phone(844) 696-52351
  • Shares outstanding1,059,836,273 as of Jul 31, 202611
  • Public float$690.2M as of Jun 30, 202513
  • AuditorDeloitte & Touche LLP, San Diego, California PCAOB ID 34; it also attests to the company’s internal control over financial reporting13
  • On EDGAR sinceApr 29, 20051
  • Filings554 in all: 4 (217), 8-K (99), 10-Q (34), 3 (23), 424B5 (14), CORRESP (13), 10-K (11), 144 (11)1
    All 50 form types

    425 (11), DEF 14A (11), SC 13D/A (10), UPLOAD (9), D (8), EFFECT (8), 5 (6), S-1/A (6), S-8 (6), DEFA14A (5), ARS (4), S-3 (4), 3/A (3), DEF 14C (3), PRE 14C (3), SC 13G (3), SCHEDULE 13D/A (3), 4/A (2), POS AM (2), S-3ASR (2), SC 13G/A (2), 424B3 (1), 424B4 (1), 8-A12B (1), 8-K/A (1), AW (1), CERTNAS (1), CT ORDER (1), D/A (1), DEFM14A (1), DRS (1), POS EX (1), POSASR (1), REGDEX (1), S-1 (1), S-1MEF (1), S-3/A (1), S-3MEF (1), S-4 (1), S-4/A (1), S-8 POS (1), SC 13D (1)

  • Latest filingsAnnual report (10-K) Feb 23, 2026
    Quarterly report (10-Q) Aug 4, 2026
    Proxy statement (DEF 14A) Apr 30, 2026
    Latest 8-K (8-K) Oct 14, 2026

Securities registered for trading

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

From the cover page of the 10-K filed Feb 23, 2026 (Section 12(b) of the Exchange Act).13

Risk factors and legal proceedings

The risks ImmunityBio, Inc. names in Item 1A of its 10-K filed Feb 23, 2026: 75 risks under these headings, as written.13

  • Risks Related to Our Financial Condition and Capital Requirements
  • Risks Related to the Discovery, Development and Commercialization of our Approved Product and our Other Product Candidates
  • Risks Related to Reliance on Third Parties
  • Risks Related to Healthcare and Other Government Regulations
  • Risks Related to Intellectual Property
  • Risks Related to Our Common Stock
  • We are a biotechnology company with a single approved product and a limited operating history as a commercial company and have many other product candidates at the clinical stage. We have a history of operating losses, and we expect to continue to incur losses and may never be profitable, which, together with our limited operating history, makes it difficult to assess our future viability.
  • Our payment obligations under the RIPA may adversely affect our financial position and results of operations and our ability to raise additional capital, which in turn may increase our vulnerability to adverse regulatory developments or economic or business downturns.
  • The RIPA contains affirmative and negative operational covenants and events of default, which may prevent us from capitalizing on business opportunities and taking some corporate actions and give rise to a Put Option in favor of Oberland, which could have a material adverse effect on our financial condition and business operations.
  • Our debt and revenue interest liability could adversely affect our cash flows and limit our flexibility to raise additional capital.
  • The value of our warrants outstanding and the revenue interest liability are subject to potentially material increases and decreases based on fluctuations in the price of our common stock or projected sales and the probability of specific events, which may affect our results of operations and financial position and could adversely affect our stock price.
  • Changes in the fair value of our convertible promissory note could have a material effect on our reported financial results.
The other 68 risks
  • We invest our cash on hand in various financial instruments which are subject to risks that could adversely affect our business, results of operations, liquidity and financial condition.
  • Our ability to use NOLs and research and development credits to offset future taxable income may be subject to certain limitations.
  • Our transfer pricing policies may be subject to challenge by the Internal Revenue Service or other taxing authorities.
  • Unanticipated changes in effective tax rates or adverse outcomes resulting from new tax statutes or regulations, examination of our income or other tax returns could expose us to greater than anticipated tax liabilities.
  • We are substantially dependent on the successful commercialization of our approved product and the success and regulatory approval of our other product candidates. If we are unable to successfully commercialize our approved product or successfully complete clinical development of, obtain regulatory approval for, or commercialize, our other product candidates, or if we experience delays in doing so, our business will be materially harmed.
  • We have limited experience as a commercial company and the sales, marketing, and distribution of our approved product or any future approved products may be unsuccessful or less successful than anticipated.
  • We have developed an approved product and are developing other product candidates in combination with other therapies, which expose us to additional risks.
  • Our clinical trials may fail to adequately demonstrate the safety and efficacy of our product candidates, which would prevent or delay regulatory approval and commercialization of other product candidates.
  • The ongoing shortage of TICE BCG in the U.S. may adversely impact market uptake of our approved product, ANKTIVA, and it may also delay our ability to execute our clinical trials or seek new approvals.
  • We may choose to expend our limited resources on programs that do not yield successful product candidates or additional indications and may fail to capitalize on other indications and product candidates that may ultimately have been more profitable or had a greater likelihood of success.
  • Our projections regarding the market opportunities for our approved product and our other product candidates may not be accurate, and the actual market for our approved product and other product candidates, may be smaller than we estimate.
  • There can be no assurance that we will complete strategic partnerships on acceptable terms, or at all.
  • Interim, initial, top-line and preliminary data from our clinical trials that we announce or publish from time to time may change as more patient data become available and are subject to audit and verification procedures that could result in material changes in the final data.
  • Our clinical trials may not be initiated or completed when we expect, or at all, may take longer and cost more to complete than we project, and may have higher costs than more conventional therapeutic technologies or drug products. We may be required to conduct additional clinical trials or modify current or future clinical trials based on feedback we receive from the FDA.
  • Even if more of our product candidates are approved and commercialized, we may not become profitable.
  • If we encounter delays or difficulties enrolling and/or maintaining patients in our clinical trials, our clinical development activities, and receipt of necessary marketing approvals could be delayed or otherwise adversely affected.
  • Our approved product and other product candidates may cause undesirable side effects, adverse events, or have other properties or safety risks that could halt their clinical development, delay or prevent their regulatory approval, result in regulatory warning letters, product recalls, regulatory and manufacturing holds, or limit their commercial potential or result in other significant negative consequences.
  • We may not be successful in managing the build-out of our manufacturing facilities and associated costs or satisfying manufacturing-related regulatory requirements.
  • Cell-based therapies and biologics rely on the availability of reagents, specialized equipment, and other specialty materials, which may not be available to us on acceptable terms or at all. For some of these reagents, equipment, and materials, we rely or may rely on sole source vendors or a limited number of vendors, which could impair our ability to manufacture and supply our approved product and any future products, if approved.
  • Because our approved product and other product candidates represent, and our other potential product candidates will represent, novel approaches to the treatment of disease, there are many uncertainties regarding the development, market acceptance, public opinion, third-party reimbursement coverage, and the commercial potential of our approved product and other product candidates, which may impact public perception of us and our approved product and other product candidates and which may adversely affect our ability to conduct our business and implement our business plans.
  • If product liability lawsuits are brought against us, we may incur substantial liabilities and may be required to limit commercialization of our approved product or other product candidates.
  • We will face significant competition from other biotechnology and pharmaceutical companies and from non-profit institutions.
  • As a condition of approval, the FDA may require that we implement various post-marketing requirements and conduct post-marketing studies, any of which would require a substantial investment of time, effort, and money, and which may limit our commercial prospects.
  • We have never commercialized a product candidate before our approved product, and we may lack the necessary expertise, personnel and resources to successfully commercialize any products on our own or together with suitable collaborators. We may be unable to establish effective marketing and sales capabilities or enter into agreements with third parties or related parties to market and sell our other product candidates, if they are approved, and as a result, we may be unable to generate product revenues.
  • If our approved product or any of our other product candidates do not achieve broad market acceptance, the revenues that we generate from their sales will be limited.
  • Our approved product and our product candidates may face competition sooner than anticipated.
  • We will need to obtain FDA approval of any proposed branded product names, and any failure or delay associated with such approval may adversely affect our business.
  • Our systems, infrastructure or data, or those used by our CROs, CMOs, clinical sites or other contractors or consultants, may or may be perceived to fail or suffer a cyberattack, security breach or other incident, including a breakdown or compromise of the confidentiality, integrity and availability of our systems, networks or data, which could adversely affect the operation of our business and reputation.
  • A pandemic, epidemic or outbreak of an infectious disease, such as COVID-19, or the perception of its effects, may materially and adversely affect our business, operations and financial condition.
  • If third-party manufacturers, wholesalers, and distributors fail to perform as expected, or fail to devote sufficient time and resources to our approved product or other product candidates, our clinical development may be delayed, our costs may be higher than expected or our other product candidates may fail to be approved, or we may fail to commercialize our approved product or any other product candidates, if approved.
  • We use the Clinic, a related party, in some of our clinical trials which may expose us to significant regulatory risks. If our data for this site is not sufficiently robust or if there are any data integrity issues, we may be required to repeat such studies or contract with other clinical trial sites, which could delay and/or increase the cost of our development plans.
  • We have formed, and may in the future form or seek, strategic alliances or enter into collaborations with third parties or additional licensing arrangements, and we may not realize the benefits of such alliances or licensing arrangements. Conflicts may arise between us and our collaborators or strategic partners, and such strategic alliances, collaborations or licensing arrangements may not be successful.
  • If conflicts arise between us and our collaborators or strategic partners, these parties may act in a manner adverse to us and could limit our ability to implement our strategies.
  • Our use of joint ventures, strategic partnerships, and alliances may expose us to risks associated with jointly owned investments.
  • We are heavily dependent on our senior management, particularly Dr. Soon-Shiong, our Founder, Executive Chairman and Global Chief Scientific and Medical Officer, and a loss of a member of our senior management team in the future, even if only temporary, could harm our business.
  • We will need to grow the size and capabilities of our organization, and we may experience difficulties in achieving and managing this growth.
  • If we engage in future acquisitions or strategic partnerships, this may increase our capital requirements, dilute our stockholders, cause us to incur debt or assume contingent liabilities, and subject us to other risks.
  • A variety of risks associated with marketing our approved product and other product candidates internationally could materially adversely affect our business.
  • We are party to a public-private partnership regarding our manufacturing facility in Dunkirk, New York, and our failure to meet the obligations of those agreements could materially impact our development, operations and prospects.
  • Our contractors and subcontractors may place liens on our projects, and if they then successfully foreclose on such projects, we may not be able to use such assets for our business.
  • While we have one product approved by the FDA, MHRA and SFDA and we have received conditional marketing authorization from the EC (EMA) for the EU, we may be unable to obtain additional U.S. or foreign regulatory approval and, as a result, may be unable to commercialize our other product candidates. We are, and will continue to be subject to ongoing extensive regulation, regulatory obligations and continued regulatory review, which may result in significant additional expense.
  • Obtaining and maintaining regulatory approval of our approved product or other product candidates in one jurisdiction does not mean that we will be successful in obtaining or maintaining regulatory approval in other jurisdictions.
  • Failure to obtain regulatory approval in any targeted jurisdiction would prevent us from marketing our products to a larger patient population and reduce our commercial opportunities.
  • Even though we have received regulatory approval for our approved product, we will continue to be subject to ongoing regulatory requirements concerning it and our other product candidates, which may result in significant additional expenses. Additionally, our other product candidates, if approved, could be subject to labeling and other restrictions, and we may be subject to penalties if we fail to comply with regulatory requirements or experience unanticipated problems with our approved product or other product candidates.
  • If we are unable to establish sales, marketing and distribution capabilities, we may not be successful commercializing our approved product or our other product candidates, including in international markets, if and when they are approved.
  • Problems related to large-scale commercial manufacturing could cause delays in product launches, an increase in product costs, product recalls or product shortages.
  • If we fail to comply with U.S. and foreign regulatory requirements, regulatory authorities could limit or withdraw any marketing or commercialization approvals we have or may receive and subject us to other penalties that could materially harm our business. For example, our GMP-in-a-Box may be regulated by the FDA as a medical device, and regulatory compliance for medical devices is expensive, complex and uncertain, and a failure to comply could lead to enforcement actions against us and other negative consequences for our business.
  • The FDA and other regulatory agencies actively enforce the laws and regulations prohibiting pre-approval promotion and the promotion of off-label uses. If we or our sales and marketing partners violate these laws and regulations, we could face civil liability or encounter regulatory investigations and significant regulatory penalties and sanctions.
  • Inappropriate assumptions may be drawn based on results for patients who receive access to any of our non-approved product candidates through compassionate use, EAPs, or right to try access, which should not be viewed as representative of how the product candidate will perform in a well-controlled clinical trial.
  • We are subject to U.S. and certain foreign export and import controls, sanctions, embargoes, anti-corruption, anti-money laundering, data export, and foreign investment laws and regulations. Compliance with these legal standards could impair our ability to compete in domestic and international markets. We can face criminal and/or civil liability and other serious consequences for violations, which can harm our business.
  • Recent and further changes in the tariff and trade policies of the U.S. or of other countries could increase manufacturing and sourcing costs, decrease demand for our offerings, disrupt supply chains, or otherwise adversely affect our business and financial condition.
  • Our failure to comply with state, national and/or international privacy and security laws and regulations could lead to government enforcement actions and significant penalties against us and adversely impact our operating results.
  • We and our third-party contractors must comply with environmental, health and safety laws and regulations. A failure to comply with these laws and regulations could expose us to significant costs or liabilities.
  • Coverage and reimbursement may be limited or unavailable in certain market segments for our approved product or other product candidates, which could make it difficult for us to sell our approved product or other product candidates profitably.
  • We may face difficulties from changes to current regulations and future legislation.
  • Governments outside the U.S. tend to impose strict price controls, which may adversely affect our revenues, if any.
  • Our employees, independent contractors, consultants, commercial partners, principal investigators, CROs, CMOs, suppliers and vendors may engage in misconduct or other improper activities, including non-compliance with regulatory standards and requirements.
  • Our relationships with health care professionals, institutional providers, principal investigators, consultants, potential customers and third-party payors are, and will continue to be, subject, directly and indirectly, to federal and state health care fraud and abuse, false claims, marketing expenditure tracking and disclosure, government price reporting, and privacy and security laws. If we are unable to comply, or have not fully complied, with such laws, we could face significant penalties and liabilities.
  • Personnel changes, disruptions at the FDA, the SEC and other government agencies caused by layoffs, agency reorganizations, funding cuts or shortages could hinder their ability to hire and retain key leadership and other personnel, prevent new products from being developed or commercialized in a timely manner, or otherwise prevent those agencies from performing normal business functions, which could negatively impact our business and the approval of our future BLA submissions, as well as adversely affect the U.S. and global economy and our liquidity, financial condition and earnings.
  • If we are unable to obtain, maintain, protect and enforce patent protection and other proprietary rights for our approved product, other product candidates, and other technologies in development, we may not be able to compete effectively or operate profitably, and our ability to prevent our competitors from commercializing similar or identical technology would be adversely affected.
  • If any of our owned or in-licensed patent applications do not issue as patents in any jurisdiction, we may not be able to compete effectively.
  • The use of our technology and product or our other product candidates could potentially conflict with the rights of others, and third-party claims of intellectual property infringement, misappropriation or other violation against us, our licensors or our collaborators may prevent or delay the development and commercialization of our product, product candidates and technologies.
  • Changes in U.S. patent law could diminish the value of patents in general, thereby impairing our ability to protect our approved product and other product candidates.
  • Obtaining and maintaining our patent protection depends on compliance with various procedural, document submission, fee payment, and other requirements imposed by government patent agencies, and our patent protection could be reduced or eliminated for non-compliance with these requirements.
  • Our rights to develop and commercialize our product candidates and technologies are subject, in part, to the terms and conditions of licenses granted to us by others.
  • If we fail to comply with our obligations in the agreements under which we license intellectual property rights from third parties or otherwise experience disruptions to our business relationships with our licensors, we may be required to pay damages and we could lose license rights that are important to our business.
  • We have limited foreign intellectual property rights and may not be able to protect our intellectual property rights in various jurisdictions throughout the world.
  • We may be subject to claims that our employees, consultants or independent contractors have wrongfully used or disclosed trade secrets or other confidential information of third parties or claims asserting ownership of what we regard as our own intellectual property.

Legal proceedings

From time to time, we may be involved in various claims and legal proceedings relating to claims arising out of our operations. We are not currently a party to any legal proceedings that, in the opinion of our management, are likely to have a material adverse effect on our business. If we are served with any such complaints, we will assess at that time any contingencies for which we may need to reserve. Regardless of the outcome, litigation can have an adverse impact on us because of defense and settlement costs, diversion of management resources, and other factors.

Shenzhen Beike Biotechnology Co. Ltd. Arbitration

In 2020, we received a Request for Arbitration before the International Chamber of Commerce, International Court of Arbitration. The arbitration relates to a license, development, and commercialization agreement that Altor entered into with Beike in 2014, which was amended and restated in 2017, pursuant to which Altor granted to Beike an exclusive license to use, research, develop and commercialize products based on ANKTIVA in China for human therapeutic uses. In the arbitration, Beike is asserting a claim for breach of contract under the license agreement. Among other things, Beike alleges that we failed to use commercially reasonable efforts to deliver to Beike materials and data related to ANKTIVA. Beike is seeking specific performance and declaratory relief for the alleged breaches. On September 25, 2020, the parties entered into a standstill and tolling agreement (standstill agreement) under which, among other things, the parties affirmed they will perform certain of their obligations under the license agreement by specified dates and agreed that all deadlines in the arbitration are indefinitely extended. The standstill agreement could be terminated by any party on ten calendar days’ notice, and upon termination, the parties had the right to pursue claims arising from the license agreement in any appropriate tribunal. On March 20, 2023, we

The opening of Item 3, Legal Proceedings.13

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