ibrx-20260630
Table of Contents
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-Q
(Mark One)
þ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the quarterly period ended June 30, 2026
or
¨
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the transition period from to
Commission File Number: 001-37507
_____________________________________
IMMUNITYBIO, INC.
(Exact name of registrant as specified in its charter)
_____________________________________
Delaware 43-1979754
(State or other jurisdiction of
incorporation or organization) (I.R.S. Employer
Identification No.)
3530 John Hopkins Court
San Diego , California
92121
(Address of principal executive offices) (Zip Code)
Registrant’s telephone number, including area code: ( 844 ) 696-5235
_____________________________________
Securities registered pursuant to Section 12(b) of the Act:
Title of each class Trading Symbol(s) Name of each exchange on which registered
Common Stock, par value $0.0001 per share IBRX The Nasdaq Global Select Market
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes þ No ¨
Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes þ No ¨
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
Large accelerated filer þ
Accelerated filer ¨
Non-accelerated filer ¨ Smaller reporting company ¨
Emerging growth company ¨
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ¨
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ¨ No þ
The number of shares of the Registrant’s common stock outstanding as of July 31, 2026 was 1,059,836,273 (excluding 163,800 shares held by a majority owned subsidiary of ours which are treated as treasury shares for accounting purposes).
IMMUNITYBIO, INC. AND SUBSIDIARIES
QUARTERLY REPORT ON FORM 10-Q
FOR THE QUARTER ENDED JUNE 30, 2026
TABLE OF CONTENTS
Page
PART I—FINANCIAL INFORMATION
Item 1.
Financial Statements
Condensed Consolidated Balance Sheets –
As of June 30, 2026 and December 31, 2025
1
Condensed Consolidated Statements of Operations –
For the three and six months ended June 30, 2026 and 2025
3
Condensed Consolidated Statements of Comprehensive Loss –
For the three and six months ended June 30, 2026 and 2025
4
Condensed Consolidated Statements of Stockholders’ Deficit –
For the three and six months ended June 30, 2026 and 2025
5
Condensed Consolidated Statements of Cash Flows –
For the six months ended June 30, 2026 and 2025
7
Notes to Unaudited Condensed Consolidated Financial Statements
10
Item 2.
Management’s Discussion and Analysis of Financial Condition and Results of Operations
38
Item 3.
Quantitative and Qualitative Disclosures about Market Risk
63
Item 4.
Controls and Procedures
63
PART II—OTHER INFORMATION
Item 1.
Legal Proceedings
64
Item 1A.
Risk Factors
66
Item 2.
Unregistered Sales of Equity Securities and Use of Proceeds
141
Item 3.
Defaults Upon Senior Securities
141
Item 4.
Mine Safety Disclosures
141
Item 5.
Other Information
141
Item 6.
Exhibits
142
Signatures
143
i
DEFINED TERMS
Unless expressly indicated or the context required otherwise, the terms “ImmunityBio,” “the company,” “we,” “us,” and “our” in this Quarterly Report refer to ImmunityBio, Inc., a Delaware corporation, and, where appropriate, its subsidiaries. We have also used several other terms in this Quarterly Report, the unaudited condensed consolidated financial statements and accompanying notes included herein, most of which are defined below:
Term Definition
2015 Plan ImmunityBio, Inc. 2015 Equity Incentive Plan
2015 Share Repurchase Plan Board of Directors-approved share repurchase program
2025 Plan ImmunityBio, Inc. 2025 Equity Incentive Plan
3M IPC 3M Innovative Properties Company
AAHI Access to Advanced Health Institute
ACA Affordable Care Act
ALC absolute lymphocyte count
AI artificial intelligence
Altor Altor BioScience, LLC
America Invents Act Leahy-Smith America Invents Act
ANKTIVA ®
Proprietary name for N-803 (formerly ALT-803), our novel IL-15 receptor superagonist
complex (nogapendekin alfa inbakicept)
Annual Report Annual Report on Form 10-K for the year ended December 31, 2025
Approved product ANKTIVA
ASC Accounting Standards Codification
ASC 270 FASB ASC Topic 270, Interim Reporting
ASC 321 FASB ASC Topic 321, Investments—Equity Securities
ASC 470-50 FASB ASC Topic 470-50, Debt—Modifications and Extinguishment
ASC 815 FASB ASC Topic 815, Derivatives and Hedging
ASC 825 FASB ASC Topic 825, Financial Instruments
ASU Accounting Standards Update
Athenex Athenex, Inc.
ATM “at-the-market” sales agreement, as amended
BCG Bacillus Calmette-Guérin (TICE ® BCG approved for use in the U.S.)
Beike Shenzhen Beike Biotechnology Co. Ltd.
BIS U.S. Department of Commerce, Bureau of Industry and Security
BLA Biologics License Application
BPCIA Biologics Price Competition and Innovation Act of 2009
Cambridge Cambridge Equities, LP
Cancer BioShield ™
our first-in-class immunotherapy strategy designed to restore immune competence by
reversing lymphopenia—the loss of functional immune cells caused by cancer itself
and by conventional treatments such as chemotherapy, radiation and immunotherapy.
CAR chimeric antigen receptor
CCPA California Consumer Privacy Act of 2018
CEO chief executive officer
CFO chief financial officer
cGMP current Good Manufacturing Practice
China when used in connection with the RIPA, People’s Republic of China, Hong Kong and
any territories controlled by the People’s Republic of China
ii
Term Definition
CIS carcinoma in situ
Clinic Immuno-Oncology Clinic, Inc.
Closing Date when used in connection with the RIPA, December 29, 2023
CMO contract manufacturing organization
CMS Centers for Medicare & Medicaid Services
Code Internal Revenue Code of 1986, as amended
CODM chief operating decision maker
CPI checkpoint inhibitor
CPRA California Privacy Rights Act
CRL complete response letter
CRO contract research organization
CVR contingent value right
DGCL Delaware General Corporation Law
December 2024 Convertible
Promissory Note Related-party convertible note due December 31, 2027 between ImmunityBio, Inc.
and Nant Capital
Dunkirk Facility a leasehold interest in a cGMP ISO Class 5 pharmaceutical manufacturing space in
western New York
EAP Expanded Access Program
EDE Emirates Drug Establishment of the UAE
EMA European Medicines Agency
EU European Union
Exchange Act Securities Exchange Act of 1934, as amended
Exyte Exyte U.S., Inc.
FASB Financial Accounting Standards Board
FCA False Claims Act
FCPA U.S. Foreign Corrupt Practices Act
FD&C Act Federal Food, Drug, and Cosmetic Act
FDA U.S. Food and Drug Administration (or the Agency)
FSMC Fort Schuyler Management Corporation, a not-for-profit corporation affiliated with the
State of New York
FTO freedom-to-operate
FVO fair value option
GBM glioblastoma
GCP Good Clinical Practice
GDPR General Data Protection Regulation
GMP Good Manufacturing Practice
hAd5 human adenovirus serotype 5
haNK high-affinity NK
Hatch-Waxman Act Drug Price Competition and Patent Term Restoration Act of 1984
HCPCS Healthcare Common Procedure Coding System, a set of standardized codes used in the
U.S. to describe specific medical procedures, services, equipment, medications,
and supplies.
HIPAA Health Insurance Portability and Accountability Act of 1996
iii
Term Definition
HIV human immunodeficiency virus
HPV human papillomavirus
IEEPA International Emergency Economic Powers Act
IL-15 novel interleukin 15
Infinity Infinity SA LLC, as purchaser agent for affiliates of Oberland
IRA Inflation Reduction Act of 2022
J-code a part of the HCPCS used to designate non-oral medications and other medical devices
JAMS Judicial Arbitration and Mediation Services
JBL Japan BCG Laboratory
M-ceNK memory-like cytokine-enhanced NK
MHRA UK Medicines and Healthcare products Regulatory Agency
Nant Capital Nant Capital, LLC
NantCell NantCell, Inc., a subsidiary of the company
NANTibody Immunotherapy NANTibody, LLC, a subsidiary of the company
NantKwest NantKwest, Inc.
NantWorks NantWorks, LLC, a related-party
NCI National Cancer Institute
NDA New Drug Application
NHL non-Hodgkin lymphoma
NK natural killer
NMIBC non-muscle invasive bladder cancer
NOL net operating loss
NSCLC non-small cell lung cancer
Oberland Oberland Capital Management LLC and its affiliates (including Purchasers as
defined in the RIPA)
OBBB Act One Big Beautiful Bill Act
OPDP FDA Office of Prescription Drug Promotion
PD-L1 programmed death receptor ligand
PDUFA Prescription Drug User Fee Act
PHI Protected Health Information
PMA premarket approval
Quarterly Report Quarterly Report on Form 10-Q for the three and six months ended June 30, 2026
QUILT QUantum Integrative Lifelong Trial
rBCG recombinant BCG
RCT randomized controlled trial
RDO registered direct offering
REMS Risk Evaluation and Mitigation Strategy
Revenue Interest Payments with respect to each calendar quarter during the revenue interest period, the amount payable
by the company to Oberland equal to the net sales in the covered territory for such calendar
quarter multiplied by the applicable percentage, subject to the terms and conditions set forth
in the RIPA; provided that, with respect to any calendar quarter, that the total revenue interest
payments will not exceed the cap amount applicable at such time
iv
Term Definition
Revenue Interests all of the company’s right, title and interest in and to that portion of the accounts and payment
intangibles arising out of sales and licenses of the included products and the product assets
equal to the Revenue Interest Payments for each calendar quarter (or portion thereof) during
the revenue interest period
RIPA Revenue Interest Purchase Agreement
RMAT regenerative medicine advanced therapy
RSU restricted stock unit
RTF Refuse to File
Sarbanes-Oxley Sarbanes-Oxley Act of 2002
SARS-CoV-2 novel strain of the coronavirus (COVID-19)
sBLA supplemental Biologics License Application
SEC U.S. Securities and Exchange Commission
Section 404 Section 404 of the Sarbanes-Oxley Act of 2002
Securities Act Securities Act of 1933, as amended
Serum Institute Serum Institute of India
SFDA Saudi Food and Drug Authority
SPC Supplementary Protection Certificate
SPOA Stock Purchase and Option Agreement
TCJA Tax Cuts and Jobs Act of 2017
Term SOFR Term Secured Overnight Financing Rate
Test Date when used in connection with the RIPA, December 31, 2029
t-haNK targeted high-affinity NK
TLR toll-like receptor
Tokyo-172 BCG Tokyo strain of BCG developed and manufactured by JBL
UAE United Arab Emirates
UK United Kingdom
UK GDPR UK Data Protection Act of 2018
U.S. United States of America
U.S. GAAP accounting principles generally accepted in the U.S.
USPTO U.S. Patent and Trademark Office
VBC Holdings VBC Holdings, LLC, a subsidiary of the company
VivaBioCell VivaBioCell, S.p.A., a wholly-owned subsidiary of VBC Holdings
v
Table of Contents
PART I—FINANCIAL INFORMATION
ITEM 1. FINANCIAL STATEMENTS.
ImmunityBio, Inc. and Subsidiaries
Condensed Consolidated Balance Sheets
(Unaudited; in thousands, except share and per share amounts)
June 30,
2026 December 31,
2025
ASSETS
Current assets:
Cash and cash equivalents $ 75,670 $ 88,334
Marketable securities 281,701 154,484
Accounts receivable, net 53,472 42,571
Inventories 1,940 910
Due from related parties 27 46
Prepaid expenses and other current assets 24,822 27,761
Prepaid expenses – related parties 1,348 769
Total current assets 438,980 314,875
Property, plant and equipment, net 114,223 114,264
Goodwill and intangible assets, net 11,836 13,953
Long-term inventories, net 16,421 13,508
Convertible note receivable — 7,380
Operating lease right-of-use assets, net 19,575 19,808
Operating lease right-of-use assets, net – related parties 11,696 13,202
Other assets 15,395 4,530
Other assets – related parties 378 378
Total assets $ 628,504 $ 501,898
LIABILITIES AND STOCKHOLDERS’ DEFICIT
Current liabilities:
Accounts payable $ 11,999 $ 6,978
Accrued expenses and other liabilities 55,671 46,838
Operating lease liabilities 4,885 4,291
Operating lease liabilities – related parties 2,623 3,244
Due to related parties 1,549 403
Total current liabilities 76,727 61,754
Related-party convertible note payable, at fair value ( Note 11 )
774,350 477,093
Revenue interest liability ( Note 10 )
415,086 324,615
Operating lease liabilities, less current portion 18,783 19,732
Operating lease liabilities, less current portion – related parties 12,420 13,715
Derivative liabilities ( Note 10 )
24,006 19,722
Warrant liabilities ( Note 13 )
352,383 84,417
Other liabilities 510 424
Total liabilities 1,674,265 1,001,472
The accompanying notes are an integral part of these condensed consolidated financial statements.
1
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ImmunityBio, Inc. and Subsidiaries
Condensed Consolidated Balance Sheets (Continued)
(Unaudited; in thousands, except share and per share amounts)
June 30,
2026 December 31,
2025
Commitments and contingencies ( Note 8 )
Stockholders’ deficit:
Common Stock, $ 0.0001 par value; 1,650,000,000 shares authorized
as of June 30, 2026 and December 31, 2025; 1,053,221,645 and
1,011,800,008 shares issued and outstanding as of June 30, 2026 and
December 31, 2025, respectively; excluding treasury stock, 163,800 shares
outstanding as of June 30, 2026 and December 31, 2025
$ 105 $ 101
Additional paid-in capital 3,515,788 3,197,120
Accumulated deficit ( 4,589,806 ) ( 3,726,646 )
Accumulated other comprehensive income 27,284 28,956
Total ImmunityBio stockholders’ deficit ( 1,046,629 ) ( 500,469 )
Noncontrolling interests 868 895
Total stockholders’ deficit ( 1,045,761 ) ( 499,574 )
Total liabilities and stockholders’ deficit $ 628,504 $ 501,898
The accompanying notes are an integral part of these condensed consolidated financial statements.
2
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ImmunityBio, Inc. and Subsidiaries
Condensed Consolidated Statements of Operations
(Unaudited; in thousands, except per share amounts)
Three Months Ended
June 30, Six Months Ended
June 30,
2026 2025 2026 2025
Revenue
Product revenue, net $ 50,672 $ 26,421 $ 94,839 $ 42,930
Other revenues 568 4 607 12
Total revenue 51,240 26,425 95,446 42,942
Operating costs and expenses
Cost of sales 298 136 536 194
Research and development 57,690 52,430 122,460 98,406
Research and development – related parties
3,126 2,806 6,345 5,064
Selling, general and administrative 50,626 41,862 95,087 73,839
Selling, general and administrative – related parties
1,197 476 2,506 1,153
Total operating costs and expenses 112,937 97,710 226,934 178,656
Loss from operations ( 61,697 ) ( 71,285 ) ( 131,488 ) ( 135,714 )
Other income (expense), net
Interest and investment income, net 3,155 1,153 5,469 2,040
Change in fair value of related-party convertible note ( 95,964 ) 1,169 ( 332,589 ) ( 41,413 )
Change in fair value of warrant liabilities ( 44,190 ) 3,889 ( 339,603 ) 3,441
Interest expense related to revenue interest liability ( 17,192 ) ( 13,405 ) ( 31,063 ) ( 26,939 )
Interest expense – related party ( 14,032 ) ( 15,474 ) ( 28,591 ) ( 30,787 )
Change in fair value of derivative liabilities ( 692 ) 1,931 416 7,509
Interest expense ( 20 ) ( 5 ) ( 54 ) ( 23 )
Other income (expense), net 242 ( 278 ) ( 5,675 ) ( 319 )
Total other expense, net ( 168,693 ) ( 21,020 ) ( 731,690 ) ( 86,491 )
Loss before income taxes and noncontrolling interest ( 230,390 ) ( 92,305 ) ( 863,178 ) ( 222,205 )
Income tax expense — ( 269 ) ( 9 ) ( 35 )
Net loss ( 230,390 ) ( 92,574 ) ( 863,187 ) ( 222,240 )
Net loss attributable to noncontrolling interests, net of tax ( 12 ) ( 19 ) ( 27 ) ( 39 )
Net loss attributable to ImmunityBio common stockholders $ ( 230,378 ) $ ( 92,555 ) $ ( 863,160 ) $ ( 222,201 )
Net loss per ImmunityBio common share – basic and diluted $ ( 0.22 ) $ ( 0.10 ) $ ( 0.83 ) $ ( 0.26 )
Weighted-average number of common shares used in computing
net loss per share – basic and diluted 1,050,070 888,216 1,038,536 870,786
The accompanying notes are an integral part of these condensed consolidated financial statements.
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ImmunityBio, Inc. and Subsidiaries
Condensed Consolidated Statements of Comprehensive Loss
(Unaudited; in thousands)
Three Months Ended
June 30, Six Months Ended
June 30,
2026 2025 2026 2025
Net loss $ ( 230,390 ) $ ( 92,574 ) $ ( 863,187 ) $ ( 222,240 )
Other comprehensive (loss) income, net of income taxes:
Reclassification of realized gain on instrument-specific credit risk — — ( 1,425 ) —
Net unrealized losses on available-for-sale securities ( 191 ) ( 5 ) ( 379 ) ( 269 )
Reclassification of net realized gains on available-for-sale
securities included in net loss 35 1 43 254
Change in fair value of related-party convertible note related to
instrument-specific credit risk — ( 7,536 ) — 11,206
Foreign currency translation adjustments ( 13 ) 152 89 179
Total other comprehensive (loss) income ( 169 ) ( 7,388 ) ( 1,672 ) 11,370
Comprehensive loss ( 230,559 ) ( 99,962 ) ( 864,859 ) ( 210,870 )
Less: Comprehensive loss attributable to noncontrolling interests 12 19 27 39
Comprehensive loss attributable to ImmunityBio
common stockholders $ ( 230,547 ) $ ( 99,943 ) $ ( 864,832 ) $ ( 210,831 )
The accompanying notes are an integral part of these condensed consolidated financial statements.
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ImmunityBio, Inc. and Subsidiaries
Condensed Consolidated Statements of Stockholders’ Deficit
(Unaudited; in thousands, except share amounts)
Six Months Ended June 30, 2026
Common Stock Additional
Paid-in
Capital Accumulated
Deficit Accumulated
Other
Comprehensive
Income Total
ImmunityBio
Stockholders’
Deficit Noncontrolling
Interests Total
Stockholders’
Deficit
Shares Amount
Balance as of December 31, 2025 1,011,800,008 $ 101 $ 3,197,120 $ ( 3,726,646 ) $ 28,956 $ ( 500,469 ) $ 895 $ ( 499,574 )
Issuance of common stock “at-the-market” offering,
net of commissions of $ 2,353 and offering costs of $ 148
12,280,637 1 102,090 — — 102,091 — 102,091
Conversion of related-party convertible note 4,606,596 — 35,332 — — 35,332 — 35,332
Stock-based compensation expense — — 8,169 — — 8,169 — 8,169
Exercise of stock options 233,749 — 971 — — 971 — 971
Vesting of RSUs 2,144,738 — — — — — — —
Net share settlement for RSUs vesting ( 916,017 ) — ( 6,994 ) — — ( 6,994 ) — ( 6,994 )
Exercise of warrants 17,191,435 2 125,177 — — 125,179 — 125,179
Other comprehensive loss, net of tax — — — — ( 1,503 ) ( 1,503 ) — ( 1,503 )
Net loss — — — ( 632,782 ) — ( 632,782 ) ( 15 ) ( 632,797 )
Balance as of March 31, 2026 1,047,341,146 104 3,461,865 ( 4,359,428 ) 27,453 ( 870,006 ) 880 ( 869,126 )
Issuance of common stock “at-the-market” offering,
net of commissions of $ 1,040 and offering costs of $ 137
5,624,053 1 45,058 — — 45,059 — 45,059
Stock-based compensation expense — — 8,518 — — 8,518 — 8,518
Exercise of stock options 175,527 — 666 — — 666 — 666
Vesting of RSUs 126,325 — — — — — — —
Net share settlement for RSUs vesting ( 45,406 ) — ( 319 ) — — ( 319 ) — ( 319 )
Other comprehensive loss, net of tax — — — — ( 169 ) ( 169 ) — ( 169 )
Net loss — — — ( 230,378 ) — ( 230,378 ) ( 12 ) ( 230,390 )
Balance as of June 30, 2026 1,053,221,645 $ 105 $ 3,515,788 $ ( 4,589,806 ) $ 27,284 $ ( 1,046,629 ) $ 868 $ ( 1,045,761 )
The accompanying notes are an integral part of these condensed consolidated financial statements.
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ImmunityBio, Inc. and Subsidiaries
Condensed Consolidated Statements of Stockholders’ Deficit (Continued)
(Unaudited; in thousands, except share amounts)
Six Months Ended June 30, 2025
Common Stock Additional
Paid-in
Capital Accumulated
Deficit Accumulated
Other
Comprehensive
Income Total
ImmunityBio
Stockholders’
Deficit Noncontrolling
Interests Total
Stockholders’
Deficit
Shares Amount
Balance as of December 31, 2024 852,904,340 $ 85 $ 2,884,867 $ ( 3,375,248 ) $ 1,198 $ ( 489,098 ) $ 969 $ ( 488,129 )
Stock-based compensation expense — — 9,537 — — 9,537 — 9,537
Exercise of stock options 110,020 — 220 — — 220 — 220
Vesting of RSUs 901,713 — — — — — — —
Net share settlement for RSUs vesting ( 359,880 ) — ( 1,202 ) — — ( 1,202 ) — ( 1,202 )
Other comprehensive income, net of tax — — — — 18,758 18,758 — 18,758
Net loss — — — ( 129,646 ) — ( 129,646 ) ( 20 ) ( 129,666 )
Balance as of March 31, 2025 853,556,193 85 2,893,422 ( 3,504,894 ) 19,956 ( 591,431 ) 949 ( 590,482 )
Issuance of common stock “at-the-market” offering, net of
commissions and offering costs of $ 2,403
32,854,486 3 98,245 — — 98,248 — 98,248
Issuance of shares in an equity offering, net of
offering costs of $ 127 and value ascribed to
associated warrants
29,024,768 3 13,048 — — 13,051 — 13,051
Stock-based compensation expense — — 9,648 — — 9,648 — 9,648
Vesting of RSUs 297,223 — — — — — — —
Net share settlement for RSUs vesting ( 107,617 ) — ( 322 ) — — ( 322 ) — ( 322 )
Other comprehensive loss, net of tax — — — — ( 7,388 ) ( 7,388 ) — ( 7,388 )
Net loss — — — ( 92,555 ) — ( 92,555 ) ( 19 ) ( 92,574 )
Balance as of June 30, 2025 915,625,053 $ 91 $ 3,014,041 $ ( 3,597,449 ) $ 12,568 $ ( 570,749 ) $ 930 $ ( 569,819 )
The accompanying notes are an integral part of these condensed consolidated financial statements.
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ImmunityBio, Inc. and Subsidiaries
Condensed Consolidated Statements of Cash Flows
(Unaudited; in thousands)
Six Months Ended
June 30,
2026 2025
Operating activities:
Net loss $ ( 863,187 ) $ ( 222,240 )
Adjustments to reconcile net loss to net cash used in operating activities:
Change in fair value of warrant liabilities 339,603 ( 3,441 )
Change in fair value of related-party convertible note 332,589 41,413
Non-cash interest expense related to revenue interest liability 19,598 23,285
Stock-based compensation expense 16,687 19,185
Depreciation and amortization 8,787 7,709
Write-off of convertible note receivable 7,442 —
Accretion of discounts on marketable debt securities, available-for-sale ( 3,798 ) ( 63 )
Non-cash lease expense related to operating lease right-of-use assets 1,954 1,830
Non-cash lease expense related to operating lease right-of-use assets – related parties 1,506 1,336
Realized gain on instrument-specific credit risk ( 1,425 ) —
Change in fair value of derivative liabilities ( 416 ) ( 7,509 )
Non-cash interest items, net ( 62 ) ( 124 )
Transaction costs allocated to warrant liabilities — 104
Other ( 218 ) 453
Changes in operating assets and liabilities:
Accounts receivable ( 10,901 ) ( 19,766 )
Inventories ( 3,971 ) 1,632
Prepaid expenses and other current assets 2,727 ( 3,825 )
Prepaid expenses – related parties ( 579 ) 746
Other assets ( 716 ) 1,143
Accounts payable 3,654 223
Accrued expenses and other liabilities 11,700 ( 4,210 )
Due to and due from related parties, net 1,165 44
Operating lease liabilities ( 2,076 ) ( 1,908 )
Operating lease liabilities – related parties ( 1,916 ) ( 1,668 )
Net cash used in operating activities ( 141,853 ) ( 165,651 )
Investing activities:
Purchases of marketable debt securities, available-for-sale ( 303,309 ) ( 15,161 )
Proceeds from maturities of marketable debt securities, available-for-sale 119,682 5,350
Proceeds from sales of marketable debt securities, available-for-sale 59,834 —
Cash paid for other equity securities ( 10,000 ) —
Purchases of property, plant and equipment ( 5,292 ) ( 2,202 )
Software development costs ( 34 ) —
Net cash used in investing activities ( 139,119 ) ( 12,013 )
The accompanying notes are an integral part of these condensed consolidated financial statements.
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ImmunityBio, Inc. and Subsidiaries
Condensed Consolidated Statements of Cash Flows (Continued)
(Unaudited; in thousands)
Six Months Ended
June 30,
2026 2025
Financing activities:
Proceeds from equity offerings, net of issuance costs $ 147,275 $ 173,136
Proceeds from the RIPA, net of issuance costs 74,946 —
Proceeds from exercises of warrants 53,542 —
Net share settlement for RSUs vesting ( 7,313 ) ( 1,524 )
Principal payments on premium financing ( 1,754 ) —
Proceeds from exercises of stock options 1,637 220
Proceeds from borrowings 61 —
Principal payments of finance leases ( 25 ) ( 4 )
Net cash provided by financing activities 268,369 171,828
Effect of exchange rate changes on cash and cash equivalents, and restricted cash 119 66
Net change in cash and cash equivalents, and restricted cash ( 12,484 ) ( 5,770 )
Cash and cash equivalents, and restricted cash, beginning of period 89,431 143,912
Cash and cash equivalents, and restricted cash, end of period $ 76,947 $ 138,142
The accompanying notes are an integral part of these condensed consolidated financial statements.
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ImmunityBio, Inc. and Subsidiaries
Condensed Consolidated Statements of Cash Flows (Continued)
(Unaudited; in thousands)
Six Months Ended
June 30,
2026 2025
Reconciliation of cash and cash equivalents, and restricted cash, end of period:
Cash and cash equivalents $ 75,670 $ 137,658
Restricted cash (included in Other Assets) 1,277 484
Cash and cash equivalents, and restricted cash, end of period $ 76,947 $ 138,142
Supplemental disclosure of cash flow information:
Cash paid during the period for:
Interest $ 40,078 $ 34,458
Income taxes 5 —
Non-cash investing and financing activities:
Conversion of related-party convertible note into equity $ 35,332 $ —
Issuance of common stock upon vesting of RSUs 17,265 3,884
Right-of-use assets obtained in exchange for operating lease liabilities 1,721 4,526
Property and equipment purchases included in accounts payable,
accrued expenses and due to related parties 2,382 1,304
Unrealized losses on marketable debt securities, net ( 336 ) ( 15 )
Unpaid offering costs included in accounts payable and accrued expenses 125 118
Initial measurement of warrants issued in connection with
equity offerings accounted for as liabilities — 61,823
Right-of-use assets obtained in exchange for finance lease liabilities — 307
The accompanying notes are an integral part of these condensed consolidated financial statements.
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ImmunityBio, Inc. and Subsidiaries
Notes to Unaudited Condensed Consolidated Financial Statements
1. Description of Business
In these notes to unaudited condensed consolidated financial statements, the terms “ImmunityBio,” “the company,” “we,” “us,” and “our” refer to ImmunityBio, Inc. and its subsidiaries.
Our Business
ImmunityBio, Inc. is a biotechnology company focused on innovating, developing, and commercializing next-generation immunotherapies designed to activate the patient’s immune system and deliver durable protection against cancer and infectious diseases. Our approach harnesses both the adaptive and innate immune systems with the goal of restoring immune function and generating lasting immunological memory in patients. At the core of our strategy is the Cancer BioShield platform, which is designed to stimulate critical lymphocytes, including natural killer (NK) cells, cytotoxic T cells, and memory T cells via our proprietary IL-15 superagonist, ANKTIVA. Our Cancer BioShield platform is anchored by this antibody-cytokine fusion protein and is complemented by a portfolio that includes adenovirus-vectored vaccines, allogeneic (off-the-shelf) and autologous NK-cell therapies, and additional immunomodulators intended to promote immunogenic cell death and support durable immune responses while potentially reducing reliance on high-dose chemo-radiation therapy.
2. Summary of Significant Accounting Policies
Significant Accounting Policies
Our significant accounting policies are described in Note 2 “ Summary of Significant Accounting Policies” of the “Notes to Consolidated Financial Statements” that appears in Part II, Item 8. “Financial Statements and Supplementary Data” of our Annual Report filed with the SEC on February 23, 2026, except as updated herein and the adoption of new accounting standards during the six months ended June 30, 2026. Management is currently evaluating the recently issued, but not yet effective accounting pronouncements.
Basis of Presentation
The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with U.S. GAAP and pursuant to the rules and regulations of the SEC. The unaudited condensed consolidated financial statements reflect all adjustments which are, in the opinion of management, necessary for a fair presentation of our financial position and results of operations. Certain items in the prior year’s consolidated financial statements have been reclassified to conform to the current presentation. These reclassifications had no effect on the reported results of operations . The unaudited condensed consolidated financial statements do not include all information and notes required by U.S. GAAP for annual reports and therefore should be read in conjunction with our consolidated financial statements and the notes thereto contained in our Annual Report filed with the SEC on February 23, 2026. These interim financials are not necessarily indicative of results expected for the full fiscal year.
Principles of Consolidation
The accompanying unaudited condensed consolidated financial statements include the accounts of the company and its wholly-owned subsidiaries, and one non-wholly owned subsidiary. All intercompany transactions and balances have been eliminated upon consolidation. For consolidated entities in which we have less than 100% ownership, we record net loss attributable to noncontrolling interests, net of tax, on the condensed consolidated statement of operations equal to the percentage of the ownership interest retained in such entities by the respective noncontrolling parties.
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Notes to Unaudited Condensed Consolidated Financial Statements (Continued)
Use of Estimates
The preparation of condensed consolidated financial statements in conformity with U.S. GAAP requires management to make certain estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the condensed consolidated financial statements and the reported amounts of revenues and expenses during the reporting period. On an ongoing basis, we evaluate our estimates and the assessment of our ability to fund our operations for at least the next 12 months from the date of issuance of these condensed consolidated financial statements. We base our estimates on historical experience and on various other market-specific and relevant assumptions that we believe to be reasonable under the circumstances. Estimates are assessed each period and updated to reflect current information and anticipated future events, and accordingly, actual results may ultimately differ materially from those estimates.
Convertible Note Receivable
As of March 31, 2026, a convertible promissory note’s maturity condition was deemed unlikely to be satisfied. Accordingly, we wrote off the convertible note receivable and all accrued and unpaid interest, and recorded a $ 7.4 million charge in other expense, net , on the condensed consolidated statement of operations during the six months ended June 30, 2026.
Liquidity
As of June 30, 2026, the company had an accumulated deficit of $ 4.6 billion. We also had negative cash flows from operations of $ 141.9 million during the six months ended June 30, 2026. The company will need to obtain additional financing to fund our future operations, including the commercialization of our approved product and the development and commercialization of our other product candidates.
The condensed consolidated financial statements have been prepared assuming the company will continue as a going concern, which contemplates the realization of assets and the satisfaction of liabilities in the normal course of business.
We expect to take some time to generate sufficient revenue from our approved product to offset expenses. We may also seek to sell additional equity through one or more follow-on offerings, or in separate financings, or obtain incremental subordinated debt in compliance with our existing revenue interest liability. However, we may not be able to secure such external financing in a timely manner or on favorable terms. Without significant sales of our approved product or additional funds, we may choose to delay or reduce our operating or investment expenditures. Further, because of the risk and uncertainties associated with the global commercialization of our approved product and our other product candidates, we may need additional funds to meet our needs sooner than planned.
As a result of continuing anticipated operating cash outflows as we commercialize our approved product and accelerate our development efforts, we believe that substantial doubt exists regarding our ability to continue as a going concern without additional funding or financial support. However, we believe our existing cash and cash equivalents, and investments in marketable securities; sales of our approved product; capital to be raised through equity offerings; and our potential ability to borrow from affiliated entities will be sufficient to fund our operations through at least the next 12 months following the issuance date of the condensed consolidated financial statements, including our Founder, Executive Chairman and Global Chief Scientific and Medical Officer’s intent and ability to support our operations with additional funds, including loans from affiliated entities, as required, which we believe alleviates such doubt.
Recent Accounting Pronouncements
Application of New or Revised Accounting Standards – Adopted
In November 2024, the FASB issued ASU 2024-04, Debt – Debt with Conversion and Other Options (Subtopic 470-20): Induced Conversions of Convertible Debt Instruments , which clarifies the requirements for determining whether certain settlements of convertible debt instruments should be accounted for as an induced conversion. This ASU is effective for fiscal years beginning after December 15, 2025 and interim reporting periods within those annual reporting periods, with early adoption permitted. We adopted this ASU on January 1, 2026 with no impact on our condensed consolidated financial statements.
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In July 2025, the FASB issued ASU 2025-05, Financial Instruments - Credit Losses (Topic 326), Measurement of Credit Losses for Accounts Receivable and Contract Assets , which provides a practical expedient related to the estimation of expected credit losses for current accounts receivable and current contract assets arising from transactions accounted for under Topic 606. The practical expedient permits an entity to assume that current conditions as of the balance sheet date do not change for the remaining life of the current accounts receivable and current contract assets. The ASU is effective for fiscal years beginning after December 15, 2025 and interim reporting periods within those annual reporting periods, with early adoption permitted. We adopted this ASU on January 1, 2026 with no impact on our condensed consolidated financial statements. We will apply the practical expedient in our future credit loss analyses.
Application of New or Revised Accounting Standards – Not Yet Adopted
In November 2024, the FASB issued ASU 2024-03, Expense Disaggregation Disclosures (Subtopic 220-40): Disaggregation of Income Statement Expenses , which requires that public business entities disclose additional information about specific expense categories in the notes to financial statements at interim and annual reporting periods. This ASU is effective for fiscal years beginning after December 15, 2026, and interim periods within fiscal years beginning after December 15, 2027. This ASU may be applied either on a prospective or retrospective basis. We are currently evaluating the impact of this standard on our disclosures.
In September 2025, the FASB issued ASU 2025-06, Intangibles - Goodwill and Other - Internal-Use Software (Subtopic 350-40): Targeted Improvements to the Accounting for Internal-Use Software , which clarifies and modernizes the accounting for costs related to internal-use software. The amendments in ASU 2025-06 remove all references to project stages and clarify the threshold entities apply to begin capitalizing costs. The ASU is effective for fiscal years beginning after December 15, 2027 and interim reporting periods within those annual reporting periods, with early adoption permitted. We are currently evaluating the impact of this standard on our condensed consolidated financial statements.
In December 2025, the FASB issued ASU 2025-11, Interim Reporting (Topic 270): Narrow-Scope Improvements , which is intended to improve the navigability of the guidance in ASC270 and clarifies that the topic applies when an entity provides interim financial statements and notes in accordance with GAAP. The ASU is effective for interim reporting periods within annual reporting periods beginning after December 15, 2027, with early adoption permitted. We are currently evaluating the impact of this standard on our condensed consolidated financial statements.
Other recent authoritative guidance issued by the FASB (including technical corrections to the ASC), and the SEC during the six months ended June 30, 2026 did not, or are not expected to, have a material effect on our condensed consolidated financial statements.
3. Revenues
The following table presents our disaggregated revenue for the periods presented (in thousands):
Three Months Ended
June 30, Six Months Ended
June 30,
2026 2025 2026 2025
Product revenue, net $ 50,672 $ 26,421 $ 94,839 $ 42,930
Other revenues 568 4 607 12
Total revenue $ 51,240 $ 26,425 $ 95,446 $ 42,942
Product Revenue, Net
During the three and six months ended June 30, 2026 and 2025, our product revenue was generated from U.S. sales of ANKTIVA.
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Notes to Unaudited Condensed Consolidated Financial Statements (Continued)
During the three and six months ended June 30, 2026, approximately $ 10.7 million and $ 19.2 million, respectively, of gross-to-net adjustments have been recorded as a reduction of revenue on the condensed consolidated statements of operations . As of June 30, 2026 and December 31, 2025, approximately $ 4.0 million and $ 2.0 million, respectively, of allowances for prompt payment discounts, product returns and chargebacks were included in accounts receivable, net, and approximately $ 9.8 million and $ 6.3 million, respectively, related to accrued rebates, co-payment assistance and other fees were included in accrued expenses and other liabilities, on the condensed consolidated balance sheets.
During the three and six months ended June 30, 2025, approximately $ 4.9 million and $ 8.1 million, respectively, of gross-to-net adjustments have been recorded as a reduction of revenue on the condensed consolidated statements of operations.
4. Inventories
Inventories consist of the following (in thousands):
June 30,
2026 December 31,
2025
Work-in-progress $ 16,679 $ 12,524
Finished goods 1,682 1,894
Inventories $ 18,361 $ 14,418
As of June 30, 2026 and December 31, 2025, the company had $ 0.6 million and $ 1.1 million, respectively, of inventory on hand that was produced prior to regulatory approvals. This inventory was expensed in research and development expense on the condensed consolidated statements of operations, as the future economic benefit was not probable. We began capitalizing inventory costs associated with ANKTIVA after receiving FDA approval in April 2024 when it was determined that the inventory had a probable future economic benefit. Inventory that is used for clinical development purposes is expensed in research and development expense , on the condensed consolidated statement of operations when consumed. The company’s long-term inventories, net consist of work-in-process and finished goods that are expected to be sold or consumed beyond 12 months.
As of June 30, 2026 and December 31, 2025, the allowance for inventory reserve was $ 0.2 million.
5. Financial Instruments
Investments in Marketable Debt Securities
As of June 30, 2026 and December 31, 2025, the remaining contractual maturities, amortized cost, gross unrealized gains, gross unrealized losses, and fair value of marketable debt securities, which were considered as available-for-sale, by type of security were as follows (in thousands):
June 30, 2026
Remaining
Contractual
Maturities Amortized
Cost Gross
Unrealized
Gains Gross
Unrealized
Losses Fair
Value
U.S. Treasury securities 0.4 $ 281,936 $ — $ ( 235 ) $ 281,701
December 31, 2025
Remaining
Contractual
Maturities Amortized
Cost Gross
Unrealized
Gains Gross
Unrealized
Losses Fair
Value
U.S. Treasury securities 0.4 $ 154,383 $ 101 $ — $ 154,484
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Notes to Unaudited Condensed Consolidated Financial Statements (Continued)
As of June 30, 2026 and December 31, 2025, all contractual maturities of marketable debt securities were 12 months or less.
During the six months ended June 30, 2026 and 2025, we evaluated our marketable debt securities and determined that unrealized losses resulted from changes in interest rates and market spreads after purchase. U.S. Treasury securities are issued, guaranteed, or otherwise supported by the U.S. government. Accordingly, the company does not consider these unrealized losses to be credit-related, and an allowance for credit losses is not necessary.
Accumulated unrealized losses on marketable debt securities that have been in a continuous loss position for less than 12 months and more than 12 months were as follows (in thousands):
June 30, 2026
Less than 12 months More than 12 months
Estimated
Fair
Value Gross
Unrealized
Losses Estimated
Fair
Value Gross
Unrealized
Losses
U.S. Treasury securities $ 281,701 $ ( 235 ) $ — $ —
Investment in Other Equity Securities
In March 2026, the company entered into a stock purchase agreement with an unrelated party to purchase preferred stock of the investee for cash consideration of $ 10.0 million. The preferred stock can be converted into common stock upon certain optional and mandatory conversion features. In addition, we have the priority in liquidation in the event of dissolution or winding up, and contingent redemption rights upon merger, consolidation, sale of substantially all assets or change of control. We elected to apply the measurement alternative under ASC 321 pursuant to which we measure our investment at cost, less impairment. As of June 30, 2026, we held an investment of $ 10.0 million in other assets , on the condensed consolidated balance sheet. We evaluate this investment for any indications of impairment in value on a quarterly basis. No factors indicative of impairment were identified during the three and six months ended June 30, 2026.
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6. Fair Value Measurements
Recurring Valuations
Financial assets and liabilities measured at fair value on a recurring basis are summarized below (in thousands):
Fair Value Measurements at June 30, 2026
Total Level 1 Level 2 Level 3
Assets at Fair Value:
Current:
Cash and cash equivalents $ 75,670 $ 75,670 $ — $ —
U.S. Treasury securities 281,701 281,701 — —
Noncurrent:
Restricted cash 1,277 1,277 — —
Total assets measured at fair value $ 358,648 $ 358,648 $ — $ —
Liabilities at Fair Value:
Current:
Contingent consideration $ ( 21 ) (1) $ — $ — $ ( 21 )
Noncurrent:
Related-party convertible note payable at
fair value ( Note 11 )
( 774,350 ) — — ( 774,350 )
Warrant liabilities ( Note 13 )
( 352,383 ) — — ( 352,383 )
RIPA derivative liability ( Note 10 )
( 23,700 ) — — ( 23,700 )
Stock option purchase liability ( Note 10 )
( 306 ) — — ( 306 )
Total liabilities measured at fair value $ ( 1,150,760 ) $ — $ — $ ( 1,150,760 )
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Fair Value Measurements at December 31, 2025
Total Level 1 Level 2 Level 3
Assets at Fair Value:
Current:
Cash and cash equivalents $ 88,334 $ 88,334 $ — $ —
U.S. Treasury securities 154,484 154,484 — —
Noncurrent:
Restricted cash 1,097 1,097 — —
Total assets measured at fair value $ 243,915 $ 243,915 $ — $ —
Liabilities at Fair Value:
Current:
Contingent consideration $ ( 22 ) (1) $ — $ — $ ( 22 )
Noncurrent:
Related-party convertible note payable at
fair value ( Note 11 )
( 477,093 ) — — ( 477,093 )
Warrant liabilities ( Note 13 )
( 84,417 ) — — ( 84,417 )
RIPA derivative liability ( Note 10 )
( 19,400 ) — — ( 19,400 )
Stock option purchase liability ( Note 10 )
( 322 ) — — ( 322 )
Total liabilities measured at fair value $ ( 581,254 ) $ — $ — $ ( 581,254 )
_______________
(1) Contingent consideration is recorded at estimated fair value and revalued each reporting period until the related contingency is resolved. The fair value measurement is based on inputs that are unobservable and significant to the overall fair value measurement (i.e., a Level 3 measurement within the fair value hierarchy) and are reviewed periodically by management. See Note 8 “Commitments and Contingencies—Contingent Consideration Related to Business Combinations” for more information.
Changes in fair value of contingent consideration were immaterial during the three and six months ended June 30, 2026 and 2025, and were primarily due to changes in foreign currency exchange rates.
Non-Recurring Valuations
Non-financial assets and liabilities are recognized at fair value subsequent to initial recognition when they are deemed to be other-than-temporarily impaired. There were no material non-financial assets or liabilities deemed to be other-than-temporarily impaired and measured at fair value on a non-recurring basis during the three and six months ended June 30, 2026 and 2025.
7. License Agreement
3M IPC and AAHI License Agreement
We have licensed rights to 3M-052, a synthetic TLR7/8 agonist, 3M-052 formulations and related technology from 3M IPC and its affiliates and AAHI. In 2021 we obtained nonexclusive rights in the field of SARS-CoV-2, and in June 2022 we modified those rights and expanded the scope of the license to include (1) SARS-CoV-2 and other infectious diseases including malaria, HIV, tuberculosis, hookworm and varicella zoster on an exclusive basis in countries other than low- and middle-income countries, and (2) oncology applications, when used in combination with our proprietary technology and/or IL-15 receptor superagonist. In consideration for the license, we agreed to make certain periodic license payments, including $ 2.25 million each year through June 2025. We have also agreed to make payments upon the achievement of certain regulatory milestone events and
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tiered royalties ranging from the low to high single-digits as a percentage of net sales. As of June 30, 2026, no such sales have been made and no such regulatory milestone events have been achieved. Beginning in April 2026, the annual minimum licensing payment is $ 1.0 million, which can be credited against any royalty payments due under this agreement.
During the three months ended June 30, 2026 and 2025, we recorded $ 0.4 million and $ 0.6 million, respectively, in research and development expense , on the condensed consolidated statements of operations. During the six months ended June 30, 2026 and 2025, we recorded $ 1.0 million and $ 1.1 million, respectively, in research and development expense , on the condensed consolidated statements of operations.
8. Commitments and Contingencies
Contingent Consideration Related to Business Combinations
VivaBioCell, S.p.A.
In April 2015, NantWorks, a related party, acquired a 100 % interest in VivaBioCell through its wholly-owned subsidiary, VBC Holdings for $ 0.7 million, less working capital adjustments. In June 2015, NantWorks contributed its equity interest in VBC Holdings to the company, in exchange for cash consideration equal to its cost basis in the investment. VivaBioCell develops bioreactors and products based on cell culture and tissue engineering in Italy.
In connection with our acquisition of VBC, we are obligated to pay the former owners contingent consideration upon the achievement of certain milestones related to the GMP-in-a-Box technology. If a government agency unconditionally approves the GMP-in-a-Box technology for commercial sale (the regulatory milestone) in the future, we will be obligated to pay an additional approximately $ 2.3 million to the former owners.
Altor BioScience, LLC
In connection with our 2017 acquisition of Altor, we issued CVRs under which we agreed to pay the prior stockholders of Altor approximately $ 304.0 million of contingent consideration upon calendar-year worldwide net sales of ANKTIVA exceeding $ 1.0 billion prior to December 31, 2026, with amounts payable in cash or shares of our common stock or a combination thereof. As the transaction was recorded as an asset acquisition, future CVR payments will be recorded when the corresponding events are probable of achievement or the consideration becomes payable. As of June 30, 2026, Dr. Soon-Shiong, our Founder, Executive Chairman and Global Chief Scientific and Medical Officer, and his related party hold approximately $ 139.8 million of net sales CVRs, and they have both irrevocably agreed to receive shares of the company’s common stock in satisfaction of their CVRs. We may be required to pay the other prior Altor stockholders up to $ 164.2 million for their net sales CVRs should they choose to have their CVRs paid in cash instead of common stock.
Litigation
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
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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 terminated the standstill agreement, and on April 11, 2023, Beike served an amended Request for Arbitration. We served an Answer and Counterclaims on May 19, 2023. Beike served a Reply to our counterclaims on June 21, 2023. Beike served its Statement of Claim on March 22, 2024, the company served its Statement of Defense and Counterclaim on June 21, 2024, and Beike served its Statement of Defense to the Counterclaim on August 2, 2024. After the parties completed discovery, Beike served its Reply and Defense to Counterclaim on January 17, 2025, we served our Rejoinder and Response to Defense to Counterclaim on March 14, 2025, and Beike served its Rejoinder on Counterclaim on March 28, 2025. The hearing in the arbitration was held from June 9, 2025 through June 13, 2025. Post-hearing submissions concluded in February 2026. The arbitration tribunal issued its award (the “Award”) on July 1, 2026. The Award denied all claims and counterclaims, declined to award damages or specific performance, and ordered that the parties should bear their own fees and costs. We intend to seek confirmation of the Award in the appropriate judicial forum.
SRS/Altor Shareholder CVR Arbitration
In connection with our 2017 acquisition of Altor, we issued CVRs under which we agreed to pay the prior stockholders of Altor approximately $ 304.0 million of contingent consideration upon the successful regulatory approval of a BLA by the FDA, or foreign equivalent, for ANKTIVA by December 31, 2022, and $ 304.0 million of contingent consideration upon calendar-year worldwide net sales of ANKTIVA exceeding $ 1.0 billion prior to December 31, 2026. As of June 30, 2026, Dr. Soon-Shiong, our Founder, Executive Chairman and Global Chief Scientific and Medical Officer, and his related party hold approximately $ 139.8 million of FDA approval CVRs and $ 139.8 million of net sales CVRs, and they have both irrevocably agreed to receive shares of the company’s common stock in satisfaction of their CVRs. Because the FDA did not approve our BLA on or before December 31, 2022, the first CVR milestone was not met.
On December 27, 2022, Shareholder Representative Services, LLC (SRS), in its capacity as shareholder representative on behalf of former Altor BioScience Corp. shareholders, sent the company’s subsidiary NantCell a notice of claims relating to the regulatory milestone CVR. The notice of claims asserted that SRS was exploring, and might pursue, claims on behalf of Altor shareholders for additional merger consideration in the amount of the $ 2.00 per share milestone payment under the regulatory CVR milestone. The notice stated that any such claim would be based on NantCell’s alleged failure to use commercially reasonable efforts to secure FDA approval of ANKTIVA on or before December 31, 2022. In a separate October 2022 letter, SRS requested that NantCell preserve all documents and information relating to its efforts to achieve milestones set forth in the regulatory milestone CVR, and requested that the company provide certain categories of documents under the information-sharing provisions of the CVR agreement.
After the company provided many of the requested documents, on September 29, 2023, SRS filed a demand for arbitration with JAMS, seeking to compel the company to produce additional documents identified in its October 2022 letter relating to its efforts to obtain FDA approval for ANKTIVA. The arbitration demand did not include any claims beyond SRS’s claim that it had a right to obtain additional documents, and sought a ruling that the company was obligated to provide additional documents. After the arbitrator issued a preliminary ruling regarding the scope of the company’s obligation to provide information under the CVR Agreements, the company produced additional documents responsive to SRS’s requests.
On August 27, 2025, several months after SRS’s document-access claim had been resolved, SRS requested leave to amend its JAMS arbitration demand to state a claim for breach of contract. SRS’s proposed amended demand alleged that the company and NantCell had failed to exercise commercially reasonable efforts to obtain FDA approval ANKTIVA on or before December 31, 2022. The JAMS arbitrator presiding over the document-access arbitration denied SRS’s motion for leave to amend its claims, and on September 26, 2025, the parties filed a joint stipulation asking that the JAMS document-access arbitration be closed.
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After SRS’s motion for leave to amend was denied, on September 26, 2025, SRS sent the company a further notice of claims and essentially the same arbitration demand, asserting that the company had breached its obligations to exercise commercially reasonable efforts to achieve FDA approval of ANKTIVA on or before December 31, 2022. SRS’s arbitration demand seeks relief in the form of payment, in the amount of approximately $ 164.2 million plus interest exceeding $ 50.0 million, to former Altor shareholders not affiliated with Dr. Soon-Shiong. SRS filed its most recent arbitration demand with JAMS on November 5, 2025. The company filed its response on November 19, 2025, and an arbitrator was appointed on January 16, 2026. The arbitration hearing has been scheduled to begin on January 25, 2027, and the parties are currently engaged in discovery. It remains too early to evaluate the likely outcome of the case or to estimate any range of potential loss. We believe the company exercised commercially reasonable efforts in its pursuit of FDA approval of ANKTIVA, and that the claims asserted against the company lack merit.
Securities Class Action
On March 26, 2026, a putative securities class action complaint, captioned Douglas v. ImmunityBio, Inc. et al ., No. 2:26-cv-03261, was filed in the U.S. District Court for the Central District of California against the company and our Executive Chairman, asserting violations of Sections 10(b) and 20(a) of the Exchange Act stemming from the company’s receipt of a warning letter from the FDA’s OPDP regarding a television advertisement (which never aired) and a podcast interview. The complaint alleges that the statements made in the television advertisement and podcast were knowingly and materially false and misleading. The complaint seeks unspecified damages and attorneys’ fees and costs. On July 15, 2026, the court appointed a lead plaintiff. The company intends to defend the case vigorously. The company is unable to estimate a range of loss, if any, that could result were there to be an adverse final decision in this action. If an unfavorable outcome were to occur, it is possible that the impact could be material to the company’s results of operations in the period(s) in which any such outcome becomes probable and estimable.
Shareholder Derivative Actions
On April 17, 2026, a shareholder derivative complaint, captioned Davies v. ImmunityBio, Inc. et al. , No. 2:26-cv-04130, was filed in the U.S. District Court for the Central District of California. On April 21, 2026, a second derivative complaint, captioned Mody v. ImmunityBio, Inc. et al. , No. 2:26-cv-04245, was filed in the same court. Both lawsuits name the company, our Executive Chairman, and every member our Board of Directors as defendants. The plaintiffs, suing derivatively on behalf of ImmunityBio, allege that the company’s directors and officers breached their fiduciary duties by making, permitting, or failing to prevent the same alleged misstatements identified in the securities complaint, and that, as a result, the company has suffered financial losses, potential financial exposure in the related securities lawsuit, reputational damage, and legal and regulatory costs. The complaints seek unspecified damages from the individual defendants to the company for damages sustained by the company, enhancements to the company’s corporate governance and internal procedures, and attorneys’ fees and costs. On June 29, 2026, the court entered a stipulated order that consolidated the Davies and Mody actions and stayed the consolidated derivative action through the motion to dismiss phase of the related securities lawsuit.
Dunkirk Facility Leasehold Interest
In 2022, we completed the acquisition of the Dunkirk Facility (approximately 409,000 rentable square feet) from Athenex. We believe this facility has the potential to provide us with a state-of-the-art biotech production center that will expand and diversify our existing manufacturing capacity in the U.S. and the ability to scale production associated with certain of our product candidates. The company accounted for the transaction as an asset acquisition because the Dunkirk Facility’s integrated set of assets and activities does not meet the definition of a business.
Upon the closing of the Dunkirk transaction, the company became the tenant of the Dunkirk Facility under the Fort Schuyler Management Corporation Lease, dated October 1, 2021 and as amended as of the February 14, 2022 closing date (as amended, the Dunkirk Lease), with the FSMC as landlord. The Dunkirk Facility, as well as certain equipment, is owned by the FSMC and is leased to us under the Dunkirk Lease. We believe that the Dunkirk Facility has construction needs that may require approximately 12 to 18 months to complete in order for it to be used as intended as a result of an ongoing dispute with the Dunkirk Facility’s general contractor and a stay in resolving the dispute related to Athenex’s ongoing bankruptcy proceedings.
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Notes to Unaudited Condensed Consolidated Financial Statements (Continued)
In December 2025, we entered into a second amendment to the Dunkirk Lease (the “second amendment”). Under the second amendment, the annual lease payment was increased to $ 0.5 million for a revised lease term through December 31, 2028. The company has the option to purchase the Dunkirk Facility at $ 1.00 on either January 1, 2028, or January 1, 2029. The second amendment was accounted for as a modification of a single lease contract. The lease is classified as an operating lease. As of December 31, 2025, we recognized an operating right-of-use lease asset and lease liability of $ 1.4 million, respectively, on the consolidated balance sheet. See Note 9 “ Lease Arrangements ” for more information. The second amendment also removed the original spending obligations assumed from Athenex totaling $ 1.52 billion and replaced them with a series of spending targets totaling $ 55.0 million, including minimum of $ 40.0 million cumulative capital spending to be complied through December 31, 2028, and minimum of $ 5.0 million of annual operating spending to be complied from 2026 to 2028. As of June 30, 2026, we are in compliance with the requirements of such targets.
We also agreed to meet certain headcount targets by hiring at least 100 full-time employees by the end of the three-year term of the amended lease. If the option to purchase is exercised, we are required to hire at least 450 full-time employees by December 31, 2032 through December 31, 2033; and we are prohibited from conveying the premises for a five-year period without obtaining the prior written consent of FSMC and Empire State Development.
Commitments
During the six months ended June 30, 2026, we did not enter into any significant contracts, other than those disclosed in these condensed consolidated financial statements.
In addition to those commitments already disclosed, we have conditional contractual commitments that are expected to be paid in fiscal year 2027 and beyond based on royalties on potential future net sales or the achievement of various development, regulatory, and commercial milestones for agreements with third parties. These payments may not be realized or may be modified and are contingent upon the occurrence of various future events, substantially all of which have a high degree of uncertainty of occurring. As of June 30, 2026, the maximum amount that may be payable related to the various development, regulatory, and commercial milestones commitments is $ 40.8 million.
In addition, we are also a party to various contracts with CROs and CMOs that generally provide for termination on notice, with the exact amounts in the event of termination to be based on the timing of the termination and the terms of the agreement.
9. Lease Arrangements
We lease property in multiple facilities across the U.S., Italy, and Ireland, including facilities located in El Segundo, CA and the Dunkirk Facility in upstate New York. Substantially all of our operating lease right-of-use assets and operating lease liabilities are related to facilities leases. Our finance leases are related to equipment rentals. See Note 12 “ Related-Party Agreements” for more information about our related-party leases.
Our leases generally have initial terms ranging from two to ten years and often include one or more options to renew. These renewal terms can extend the lease term from one to ten years and are included in the lease term when it is reasonably certain that we will exercise the option.
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ImmunityBio, Inc. and Subsidiaries
Notes to Unaudited Condensed Consolidated Financial Statements (Continued)
Supplemental balance sheet information related to our leases is as follows (in thousands):
Classification June 30,
2026 December 31,
2025
Assets
Operating lease assets (including
amounts with related parties) Operating lease right-of-use assets $ 31,271 $ 33,010
Finance lease assets Other assets 240 271
Total lease assets (including
amounts with related parties) $ 31,511 $ 33,281
Liabilities
Current:
Operating lease liabilities (including
amounts with related parties)
Operating lease liabilities $ 7,508 $ 7,535
Finance lease liabilities Accrued expenses and other liabilities 55 52
Noncurrent:
Operating lease liabilities (including
amounts with related parties)
Operating lease liabilities, less current portion 31,203 33,447
Finance lease liabilities Other liabilities 199 227
Total lease liabilities (including
amounts with related parties) $ 38,965 $ 41,261
Information regarding our lease terms is as follows:
June 30,
2026 December 31,
2025
Weighted-average remaining lease term:
Operating leases 4.3 years 4.6 years
Finance leases 3.9 years 4.4 years
Weighted-average discount rate:
Operating leases 11.1 % 11.1 %
Finance leases 11.6 % 11.6 %
Cash paid for amounts included in the measurement of lease liabilities is as follows (in thousands):
Six Months Ended
June 30,
2026 2025
Cash paid for operating leases (excluding variable lease costs) $ 6,312 $ 5,855
Financing cash flow from finance leases 25 4
Operating cash flow from finance leases 14 3
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ImmunityBio, Inc. and Subsidiaries
Notes to Unaudited Condensed Consolidated Financial Statements (Continued)
Future minimum lease payments as of June 30, 2026, including $ 13.0 million related to options to extend lease terms that are reasonably certain of being exercised, are presented in the following table (in thousands). Common area maintenance costs and taxes are not included in these payments.
Years Ending December 31: Operating
Leases
Finance
Leases Total
2026 (excluding the six months ended June 30, 2026)
$ 5,607 $ 40 $ 5,647
2027 11,175 79 11,254
2028 11,349 79 11,428
2029 10,221 79 10,300
2030 7,837 34 7,871
2031 1,523 — 1,523
Thereafter 458 — 458
Total future minimum lease payments 48,170 311 48,481
Less: Interest 9,459 57 9,516
Present value of lease liabilities $ 38,711 $ 254 $ 38,965
There have been no material changes related to our existing lease agreements from those disclosed in Note 10 “ Lease Arrangements” of the “Notes to Consolidated Financial Statements” that appears in Part II, Item 8. “Financial Statements and Supplementary Data” of our Annual Report filed with the SEC on February 23, 2026.
10. Revenue Interest Purchase Agreement
Revenue Interest Liability
On December 29, 2023, we entered into the RIPA with Infinity and Oberland. Pursuant to the RIPA, Oberland acquired certain initial Revenue Interests from us for a gross purchase price of $ 200.0 million paid on closing, less $ 7.5 million of issuance costs. Oberland had the option to purchase additional Revenue Interests from us in exchange for a $ 100.0 million Second Payment upon satisfaction of certain conditions in the RIPA, including receipt of approval from the FDA of our BLA for ANKTIVA on or before June 30, 2024.
In April 2024, the FDA approved our product ANKTIVA and as a result, on May 13, 2024 Oberland purchased additional Revenue Interests from us for a gross purchase price of $ 100.0 million, less $ 3.1 million of issuance costs. The issuance costs incurred are being amortized to interest expense over the estimated term of the debt.
On December 10, 2024, we entered into a First Amendment to the RIPA to add additional conditions to the payment of certain existing indebtedness. Such amendment did not have an impact on the valuation of the revenue interest liability or the embedded derivative liabilities related to the RIPA.
On March 30, 2026, we entered into a Second Amendment to the RIPA. Pursuant to the amendment, Infinity and Oberland acquired additional revenue interests for a gross purchase price of $ 75.0 million (the Third Payment). The amendment was accounted for as a debt modification. Issuance costs paid to the debt issuer totaling $ 0.1 million were capitalized as a debt discount against the RIPA and will be recognized in interest expense , on the condensed consolidated statement of operations over the expected term of the debt using the effective interest method. Third-party issuance costs totaling $ 0.1 million were recorded in operations in selling, general and administrative expense , on the condensed consolidated statement of operations.
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Notes to Unaudited Condensed Consolidated Financial Statements (Continued)
As consideration for the aforementioned payments, Oberland has the right to receive quarterly Revenue Interest Payments from us based on, among other things, a certain percentage of our net sales during such quarter, which are tiered payments ranging from 5.625 % to 12.50 % (before funding of the Third Payment, 4.5 % to 10.0 %; before funding of the Second Payment, 3.0 % to 7.0 %) of the company’s worldwide net sales, excluding those in China.
If the aggregate Revenue Interest Payments made to Oberland as of December 31, 2029 (Test Date) equal or exceed the Cumulative Purchaser Payments ($ 375.0 million) as of that date, the initially tiered revenue interest rate will be decreased to a single rate of 2.8125 % (before the funding of the Third Payment, 2.25 %; before the funding of the Second Payment, 1.50 %) of the company’s worldwide net sales, excluding those in China. If the aggregate Revenue Interest Payments made to Oberland as of the Test Date are less than the aggregate amount of Cumulative Purchaser Payments as of the Test Date, then following the Test Date the initially tiered revenue interest rate will increase to a rate that, had such increased rate applied during the period from December 29, 2023 through December 31, 2029, it would have resulted in Oberland receiving aggregate Revenue Interest Payments (excluding certain payments detailed in the RIPA) equal to the Cumulative Purchaser Payments as of the Test Date. In addition, if aggregate Revenue Interest Payments made to Oberland as of the Test Date are less than the aggregate amount of Cumulative Purchaser Payments as of the Test Date, then the company must make the True-Up Payment.
Oberland’s rights to receive Revenue Interest Payments under the RIPA shall terminate when Oberland has received payments (including any True-Up Payment) equal to 195.0 % of the then Cumulative Purchaser Payments unless the RIPA is terminated prior to such date (subject to certain Call/Put Option scenarios as described below). If Oberland has not received total payments (including any True-Up Payment) equal to 195.0 % of the then Cumulative Purchaser Payments on or before the twelfth anniversary of the RIPA, then the company shall be obligated to pay to Oberland an amount equal to 195.0 % of the then Cumulative Purchaser Payments less the aggregate payments (including any True-Up Payments) made as of such date.
The company’s obligations under the RIPA are guaranteed by certain of its subsidiaries meeting materiality thresholds set forth in the RIPA. To secure the company’s obligations under the RIPA and the subsidiary guarantors’ obligations under the guarantees, each of the company and the subsidiary guarantors has granted a security interest in substantially all its assets, subject to certain exceptions and limitations.
The RIPA contains affirmative and negative covenants and events of default, including covenants and restrictions that, among other things, restrict our ability to incur additional liens, incur additional indebtedness, make loans and investments, enter into transactions with affiliates, engage in mergers and acquisitions, engage in asset sales and exclusive licensing arrangements, and declare dividends to our stockholders, in each case, subject to certain exceptions set forth in the RIPA. As of June 30, 2026, the company was in compliance with all covenants.
The RIPA is considered a sale of future revenues and is accounted for as long-term debt recorded at amortized cost using the effective interest rate method. The company imputes interest expense associated with this liability using the effective interest rate method. The effective interest rate is calculated based on the rate that would enable the debt to be repaid in full over the anticipated life of the arrangement. The interest rate on this liability may vary during the term of the agreement depending on a number of factors, including the level of forecasted net sales. The company evaluates the interest rate quarterly based on its current net sales forecasts utilizing the prospective method.
During the three and six months ended June 30, 2026, we recorded $ 17.2 million and $ 31.1 million, respectively, of interest expense related to this arrangement. During the three and six months ended June 30, 2025, we recorded $ 13.4 million and $ 26.9 million, respectively, of interest expense related to this arrangement.
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Notes to Unaudited Condensed Consolidated Financial Statements (Continued)
The following table summarizes the revenue interest liability activity during the six months ended June 30, 2026 (in thousands):
Revenue interest liability, at December 31, 2025 $ 324,615
Proceeds from Third Payment, net of issuance costs 74,946
Interest expense recognized 31,063
Revenue interest payment ( 10,838 )
Embedded contingent derivative liability related to Third Payment ( 4,700 )
Revenue interest liability, at June 30, 2026 $ 415,086
Embedded Derivative Liabilities
Under the RIPA, the company has a Call Option to terminate the RIPA and repurchase the Revenue Interests at any time upon advance written notice, subject to certain limitations set forth in the RIPA. Additionally, Oberland has a Put Option enabling them to terminate the RIPA and to require the company to repurchase the Revenue Interests upon enumerated events, such as a bankruptcy event, failure to make a payment, an uncured material breach, default in certain third-party agreements, a breach or default under any subordination agreements with respect to indebtedness to existing stockholders, or subordinated notes during certain time periods, judgments in excess of certain amounts against the company, a material adverse effect, the loss of regulatory approval of our product candidates or a change of control.
The required purchase price with respect to the Call Option and/or Put Option, as applicable, shall be (a) 120.0 % of the Cumulative Purchaser Payments as of such date, if Oberland exercises the Put Option (other than in connection with a change of control) on or prior to the first anniversary the Closing Date, (b) 135.0 % of the Cumulative Purchaser Payments as of such date, if the Put Option or the Call Option is exercised in connection with a change of control on or prior to the date that is eighteen (18) months after the Closing Date, and (c) in all other cases, (i) 175.0 % of the Cumulative Purchaser Payments as of such date, if the Put Option or the Call Option is exercised no later than the date that is thirty six (36) months after the Closing Date, and (ii) 195.0 % of the Cumulative Purchaser Payments as of such date, if the Put Option or the Call Option is exercised later than the date that is thirty six (36) months after the Closing Date, minus, in each case, the total payments made to Oberland on or prior to such date.
Certain Call and Put Options are considered embedded derivatives requiring bifurcation as a single compound derivative instrument. The company estimated the fair value of the derivative liability using a “with-and-without” method. The “with-and-without” methodology involves valuing the whole instrument on an as-is basis and then valuing the instrument without the individual embedded derivative. The difference between the entire instrument with the embedded derivative compared to the instrument without the embedded derivative is the fair value of the derivative liability.
The company recorded $ 34.5 million for the initial fair value of the derivative liability upon the closing of the initial $ 200.0 million Revenue Interests acquired by Oberland. The company recorded an incremental $ 6.2 million for the fair value of the derivative liability upon the closing of the additional $ 100.0 million Revenue Interests acquired by Oberland in May 2024, and recorded an incremental $ 4.7 million for the fair value upon the closing of the additional $ 75.0 million funding in March 2026. The initial and incremental fair value allocated to the derivative liability is recorded against the RIPA as a debt discount, which is being amortized in interest expense, on the condensed consolidated statement of operations over the expected term of the debt using the effective interest method. Such embedded derivative is classified in derivative liabilities, on the condensed consolidated balance sheet. The embedded derivative is subsequently remeasured at fair value each reporting period using a Monte Carlo Simulation valuation technique, with the change in fair value being recorded in change in fair value of derivative liabilities , on the condensed consolidated statement of operations.
The estimated probability and timing of underlying events triggering the exercisability of the Put Option contained in the RIPA, forecasted cash flows and the discount rate are significant unobservable inputs used to determine the estimated fair value of the entire instrument with the embedded derivative. As of June 30, 2026 and December 31, 2025, the discount rate used for valuation of the derivative liability was 13.3 % and 11.7 %, respectively.
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Notes to Unaudited Condensed Consolidated Financial Statements (Continued)
The change in fair value of the derivative liability is as follows (in thousands):
Fair value, at December 31, 2025 $ 19,400
Embedded contingent derivative liability related to Third Payment 4,700
Change in fair value ( 1,100 )
Fair value, at March 31, 2026 23,000
Change in fair value 700
Fair value, at June 30, 2026 $ 23,700
Stock Purchase and Option Agreement
In connection with the RIPA, we entered into a SPOA with Oberland pursuant to which we sold an aggregate of approximately $ 10.0 million of our common stock at $ 4.1103 per share in a private placement. Oberland also had an option to purchase up to an additional $ 10.0 million of our common stock, at a price per share to be determined by reference to the 30-day trailing volume weighted-average price of our common stock calculated from the date of exercise.
This stock purchase option was classified as a derivative liability estimated at fair value at issuance. The initial $ 200.0 million received pursuant to the RIPA and $ 10.0 million received pursuant to the SPOA were allocated among the resulting financial instruments on a relative fair value basis, with $ 197.1 million allocated to the debt under the RIPA, $ 12.0 million allocated to the common stock issued under the SPOA, and $ 0.8 million allocated to the stock purchase option as of December 31, 2023.
In April 2024, Oberland exercised part of their option and purchased 858,990 shares of our common stock at an exercise price of $ 5.8208 per share generating net proceeds of approximately $ 4.9 million. In relation to this transaction, we recorded $ 7.6 million in additional paid-in capital, on the consolidated statement of stockholders’ deficit during the year ended December 31, 2024. Following such exercise, approximately $ 5.0 million remains available for future exercise under the SPOA as of June 30, 2026. This option expires on December 29, 2028.
This stock purchase option is classified in derivative liabilities , on the condensed consolidated balance sheet at its fair value and is subsequently remeasured at fair value each reporting period, with the change in fair value being recorded in change in fair value of derivative liabilities , on the condensed consolidated statement of operations.
The estimated fair value of the stock option purchase liability was computed using a Monte Carlo Simulation valuation technique that used the calculated exercise price and discounted it back to a present value at the risk-free rate with the following unobservable input at the following dates:
June 30,
2026 December 31,
2025
Expected volatility 105.9 % 119.7 %
The change in fair value of the stock option purchase liability is as follows (in thousands):
Fair value, at December 31, 2025 $ 322
Change in fair value ( 8 )
Fair value, at March 31, 2026 314
Change in fair value ( 8 )
Fair value, at June 30, 2026 $ 306
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ImmunityBio, Inc. and Subsidiaries
Notes to Unaudited Condensed Consolidated Financial Statements (Continued)
11. Related-Party Debt
Our related-party debt is summarized below (in thousands):
Balance as of June 30, 2026
Fair Value
Maturity
Year Interest
Rate Principal
Amount Amount Leveling
December 2024 Convertible Promissory Note 2027 Term
SOFR
+ 8.0 %
$ 480,000 $ 774,350 Level 3
Balance as of December 31, 2025
Fair Value
Maturity
Year Interest
Rate Principal
Amount Amount Leveling
December 2024 Convertible Promissory Note 2027 Term
SOFR
+ 8.0 %
$ 505,000 $ 477,093 Level 3
December 2024 Convertible Promissory Note
On December 10, 2024, in connection with an equity offering, the company and Nant Capital entered into a second amended and restated promissory note. Pursuant to the terms of the second amended and restated promissory note, Tranche 1 of the December 2023 Promissory Note with a principal amount of $ 125.0 million and Tranche 2 of the December 2023 Promissory Note with a principal amount of $ 380.0 million were combined into one convertible promissory note with a principal amount of $ 505.0 million with a maturity date of December 31, 2027. The December 2024 Convertible Promissory Note bears an interest rate of Term SOFR plus 8.0 % per annum, payable on a quarterly basis. Pursuant to the terms of the second amended and restated promissory note, the noteholder, in its sole discretion, may convert all of the outstanding principal amount into shares of common stock at a conversion price of $ 5.4270 per share. The company may prepay the outstanding promissory note, at any time, in whole or in part, without penalty. Upon receipt of a written notice of prepayment from the company, the noteholder has the option to convert the outstanding principal amount to be prepaid and the accrued and unpaid interest thereon into shares of the company’s common stock at the same conversion price of $ 5.4270 per share. In addition, the noteholder can request up to $ 50.0 million of the outstanding principal amount and accrued interest to be repaid upon consummation of a specified transaction.
On January 23, 2026, the company entered into an amendment to the December 2024 Convertible Promissory Note to provide the holder with the optional right to convert any portion of the outstanding principal amount into shares of the company’s common stock at any time prior to the maturity date. In accordance with ASC 470-50, the company concluded that the amendment did not represent a substantial modification of the December 2024 Convertible Promissory Note, and the note was not accounted for as an extinguishment and continues to be measured at fair value.
On March 31, 2026, Nant Capital converted $ 25.0 million of the principal of the December 2024 Convertible Promissory Note into 4,606,596 shares of common stock at a conversion price of $ 5.4270 per share. Upon conversion, the company derecognized the converted principal at its fair value of $ 35.3 million and recognized the par value of shares issued in common stock and the remaining excess in additional paid-in capital , on both the condensed consolidated balance sheet and the condensed consolidated statement of stockholders’ deficit. The company did not recognize any gain or loss upon conversion since the December 2024 Convertible Promissory Note is accounted for under the fair value option in accordance with ASC 825.
In connection with the conversion, during the three months ended March 31, 2026, the company reclassified $ 1.4 million of change in fair value related to instrument-specific credit risk that was previously recorded in accumulated other comprehensive income, on the condensed consolidated statement of stockholders’ deficit, to other expense, net , on the condensed consolidated statement of operations. This reclassification represents the portion of the cumulative change in fair value attributable to instrument-specific credit risk related to the converted principal amount.
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Notes to Unaudited Condensed Consolidated Financial Statements (Continued)
As of June 30, 2026, the remaining principal balance of the December 2024 Convertible Promissory Note was $ 480.0 million.
The company elected the fair value option for recognizing the December 2024 Convertible Promissory Note under ASC 825. Under the FVO election, the note was initially measured at estimated fair value upon issuance and is remeasured at estimated fair value on a recurring basis at each reporting period date. The estimated fair value of the convertible note was computed using the following unobservable inputs at the following dates:
June 30,
2026 December 31,
2025
Binomial lattice model:
Expected market yield 17.4 % 14.8 %
Expected volatility 77.5 % 87.5 %
The change in the fair value of this note was as follows (in thousands):
Fair value, at December 31, 2025 $ 477,093
Change in fair value of related-party convertible note 236,625
Conversion to common stock ( 35,332 )
Fair value, at March 31, 2026 678,386
Change in fair value of related-party convertible note 95,964
Fair value, at June 30, 2026 $ 774,350
Mandatory Prepayment Feature
The embedded derivative related to a contingently exercisable prepayment feature, which allows the noteholder to request up to a $ 50.0 million prepayment and accrued interest upon occurrence of a specified transaction (defined in the promissory note) was recorded as a derivative liability on the condensed consolidated balance sheet and measured at fair value prior to the second amended and restated promissory note.
Since the company elected the fair value option to account for the December 2024 Convertible Promissory Note, the embedded derivative is no longer required to be recorded separately but is considered when estimating the fair value of the December 2024 Convertible Promissory Note.
The following table summarizes the estimated future contractual obligations of our related-party debt as of June 30, 2026 (in thousands):
Principal
Payments Interest
Payments (1) Total
2026 (excluding the six months ended June 30, 2026)
$ — $ 28,372 $ 28,372
2027
480,000 56,282 536,282
Total $ 480,000 $ 84,654 $ 564,654
_______________
(1) Interest payments on our convertible promissory note are calculated based on Term SOFR plus the contractual spread per the loan agreement. The interest rate on our convertible promissory note as of June 30, 2026 was 11.73 %.
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ImmunityBio, Inc. and Subsidiaries
Notes to Unaudited Condensed Consolidated Financial Statements (Continued)
Interest expense consists of the following (in thousands):
Three Months Ended
June 30, Six Months Ended
June 30,
2026 2025 2026 2025
Interest expense on related-party convertible note $ 14,032 $ 15,474 $ 28,591 $ 30,787
In connection with the RIPA transaction, the outstanding related-party convertible note was subordinated to the RIPA payment obligations.
12. Related-Party Agreements
Our Founder, Executive Chairman and Global Chief Scientific and Medical Officer also founded and has a controlling interest in NantWorks, which is a collection of companies in the healthcare and technology space. As described below, we have entered into arrangements with NantWorks, and certain affiliates of NantWorks, to facilitate the development of new immunotherapies for our product pipeline. Affiliates of NantWorks are also affiliates of the company due to the common control by and/or common ownership interest of our Founder, Executive Chairman, Global Chief Scientific and Medical Officer, and principal stockholder.
NantWorks, LLC
Shared Services Agreement
Under the amended and restated shared services agreement with NantWorks dated as of June 2016, but effective as of August 2015, NantWorks, a related party, provides corporate, general and administrative, certain research and development, and other support services to us, and we provide certain of such services to them. The receiving party is charged for the services at cost plus reasonable allocations of employee benefits, facilities, and other direct or fairly allocated indirect costs that relate to the employees providing the services. During the three months ended June 30, 2026 and 2025, we recorded $ 1.0 million and $ 0.3 million, respectively, in selling, general and administrative – related parties , and $ 0.1 million of expense reimbursements under this arrangement in research and development – related parties , on the condensed consolidated statements of operations. During the six months ended June 30, 2026 and 2025, we recorded $ 2.1 million and $ 0.8 million, respectively, in selling, general and administrative – related parties expense , and $ 0.3 million and $ 0.5 million of expense reimbursements, respectively, under this arrangement in research and development – related parties expense , on the condensed consolidated statements of operations. These amounts exclude certain immaterial general and administrative expenses provided by third-party vendors directly for our benefit, which were reimbursed to NantWorks based on those vendors’ invoiced amounts without markup by NantWorks.
As of June 30, 2026 and December 31, 2025, we had a payable of $ 0.9 million and $ 0.2 million, respectively, for all agreements with NantWorks, which are included in due to/due from related parties, on the condensed consolidated balance sheets. We also recorded $ 0.9 million and $ 0.7 million of prepaid expenses for various services that we expect will be passed through to the company from NantWorks as of June 30, 2026 and December 31, 2025, respectively, which are included in prepaid expenses – related parties , on the condensed consolidated balance sheets.
Facility License Agreement
In 2015, we entered into a facility license agreement with NantWorks for office space in Culver City, California, which was converted to a research and development laboratory and a cGMP manufacturing facility. We recorded license fee expense for this facility totaling $ 0.9 million during the three months ended June 30, 2026 and 2025, and $ 1.8 million during the six months ended June 30, 2026 and 2025, respectively, in research and development – related parties expense , on the condensed consolidated statements of operations.
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Notes to Unaudited Condensed Consolidated Financial Statements (Continued)
Related-Party Leases
The company leases certain assets under operating leases with certain entities controlled by NantWorks and its affiliates or subsidiaries. Right-of-use assets for related-party operating leases totaled $ 11.7 million and $ 13.2 million, and the associated operating lease liabilities totaled $ 15.0 million and $ 17.0 million, as of June 30, 2026 and December 31, 2025, respectively. The company recorded operating lease expense totaling $ 1.1 million during the three months ended June 30, 2026 and 2025, and $ 2.3 million during the six months ended June 30, 2026 and 2025, respectively. Related-party leases were classified as either selling, general and administrative – related parties or research and development – related parties , on the condensed consolidated statements of operations, depending on the use of the facility.
Immuno-Oncology Clinic, Inc.
We have entered into multiple agreements with t he Clinic to conduct clinical trials related to certain of our product candidates. The Clinic is a related party as it is owned by an officer of the company and NantWorks manages the administrative operations of the Clinic.
Related to clinical trial and transition services provided by the Clinic, we recorded $ 1.0 million and $ 0.7 million during the three months ended June 30, 2026 and 2025, respectively, and $ 2.2 million and $ 1.2 million, respectively, during the six months ended June 30, 2026 and 2025 in research and development – related parties expense , on the condensed consolidated statements of operations.
As of June 30, 2026 and December 31, 2025 , we owed the Clinic $ 0.4 million and $ 0.1 million, respectively, which is included in due to related parties, on the condensed consolidated balance sheets .
13. Warrant Liabilities
The company issued warrants through RDOs. In the event of certain fundamental transactions involving the company, the holders of the warrants may require the company to make a payment based on a Black-Scholes valuation, using specified inputs that are not considered indexed to the company’s stock in accordance with ASC 815. Therefore, we classified the warrants as a liability at their fair value determined using the Black-Scholes option pricing model. The proceeds from issuance of common stock and warrants are allocated to warrants based on its fair value. The warrants issued by the company are summarized below:
Warrant Liabilities
The following table summarizes the change in carrying amount of warrant liabilities measured at fair value during the six months ended June 30, 2026 (in thousands):
Total February 2023
Warrants July 2023
Warrants April 2025
Warrants July 2025
Warrants
Fair value, at December 31, 2025
$ 84,417 $ 230 $ 293 $ 41,476 $ 42,418
Change in fair value 295,413 13,115 16,704 109,408 156,186
Warrant exercises ( 71,637 ) — — ( 60,737 ) ( 10,900 )
Fair value, at March 31, 2026
308,193 13,345 16,997 90,147 187,704
Change in fair value 44,190 2,061 2,625 12,836 26,668
Fair value, at June 30, 2026
$ 352,383 $ 15,406 $ 19,622 $ 102,983 $ 214,372
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ImmunityBio, Inc. and Subsidiaries
Notes to Unaudited Condensed Consolidated Financial Statements (Continued)
Warrant Exercises
The following table summarizes warrant exercise activity during the six months ended June 30, 2026:
Total February 2023
Warrants July 2023
Warrants April 2025
Warrants July 2025
Warrants
Warrants outstanding, at
December 31, 2025
65,053,571 2,814,523 3,584,648 29,024,768 29,629,632
Warrant exercises ( 17,191,435 ) — — ( 15,524,768 ) ( 1,666,667 )
Warrants outstanding, at
March 31, 2026
47,862,136 2,814,523 3,584,648 13,500,000 27,962,965
Warrant exercises — — — — —
Warrants outstanding, at
June 30, 2026
47,862,136 2,814,523 3,584,648 13,500,000 27,962,965
Subsequent to June 30, 2026, institutional holders exercised a total of 6,399,171 warrants pursuant to the February and July 2023 warrant agreements at an exercise price of $ 3.2946 . See Note 19 “Subsequent Event” for more information.
Warrant Valuation Assumptions
The estimated fair value of the warrants was computed using the Black-Scholes option pricing model with the following key assumptions at the following dates:
February and July 2023 Warrants April 2025 Warrants July 2025 Warrants
June 30,
2026 December 31,
2025 June 30,
2026 December 31,
2025 June 30,
2026 December 31,
2025
Exercise price per share $ 3.2946 $ 3.2946 $ 3.1010 $ 3.1010 $ 3.2400 $ 3.2400
Expected term 0.1 years
0.6 years
3.8 years
4.3 years
4.1 years
4.6 years
Expected average volatility 67.0 % 60.9 % 117.6 % 113.5 % 116.6 % 110.7 %
Expected dividend yield — — — — — —
Risk-free interest rate 3.7 % 3.5 % 4.1 % 3.6 % 4.1 % 3.7 %
The expected term is the time remaining until the expiration of the warrants. The expected average volatility was estimated based on the historical and implied volatility of our common stock. The expected dividend yield was based on our expectation of not paying dividends for the foreseeable future. The risk-free interest rate was based on the U.S. Treasury’s rates for U.S. Treasury zero-coupon bonds with maturities similar to those of the expected term of the award being valued. The significant unobservable inputs used in the warrant valuation are the expected term and the expected average volatility.
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Notes to Unaudited Condensed Consolidated Financial Statements (Continued)
14. Stockholders’ Deficit
Stock Repurchases
During the six months ended June 30, 2026 and 2025, no shares of our common stock were repurchased under the company’s 2015 Share Repurchase Program. As of June 30, 2026, $ 18.3 million remained authorized to use for share repurchases under the program.
Shelf Registration Statement
In 2024, we filed a shelf registration statement with the SEC on Form S-3ASR pursuant to which we may, from time to time, sell an indeterminate amount of our common stock, preferred stock, debt securities, depositary shares, warrants, subscription rights, purchase contracts, or units, and an associated prospectus related to the ATM.
Open Market Sale Agreement
In 2021, we entered into the ATM under which we may offer and sell, from time to time at our sole discretion, shares of our common stock through our sales agent. We pay our sales agent a commission of up to 3.0 % of the gross sales proceeds of any shares of our common stock sold through them under the ATM and also have provided them with customary indemnification and contribution rights.
In December 2025, we filed a prospectus supplement to our shelf registration statement in connection with entering into an amendment to the ATM to increase the amount available for future stock issuances under the ATM to $ 500.0 million. During the three and six months ended June 30, 2026, we received net proceeds totaling $ 45.1 million and $ 147.2 million, respectively, from the issuance of shares under the ATM. During the three and six months ended June 30, 2025, we received net proceeds totaling $ 98.2 million from the issuance of shares under the ATM. As of June 30, 2026, we had $ 349.2 million available for future stock issuances under the ATM.
We are not obligated to sell any shares and may at any time suspend solicitation and offers under the ATM. The ATM may be terminated by us at any time given written notice to the sales agent for any reason or by the sales agent at any time by giving written notice to us for any reason or immediately under certain circumstances and shall automatically terminate upon the issuance and sale of all of the shares.
Conversion of Promissory Note into Common Stock
On March 31, 2026, Nant Capital converted $ 25.0 million of the principal of the December 2024 Convertible Promissory Note into 4,606,596 shares of common stock. See Note 11 “Related-Party Debt” for more information.
Warrant Exercises
During the six months ended June 30, 2026, certain institutional holders of the April 2025 and July 2025 warrants exercised their rights to purchase our common stock. See Note 13 “Warrant Liabilities” for more information. During the three months ended June 30, 2026, there were no exercises pursuant to the 2023 and 2025 warrant agreements.
During the three and six months ended June 30, 2025, there were no exercises pursuant to the 2023 and 2025 warrant agreements.
Stock Purchase and Option Agreement
On December 29, 2023 and in connection with the RIPA, we entered into a SPOA with Oberland. Under this agreement, Oberland had an option to purchase our common stock. See Note 10 “Revenue Interest Purchase Agreement” for more information.
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Notes to Unaudited Condensed Consolidated Financial Statements (Continued)
15. Stock-Based Compensation
2025 Equity Incentive Plan
As of June 30, 2026, approximately 48.2 million shares were available for future grants under the 2025 Plan.
Stock-Based Compensation
The following table presents stock-based compensation included on the condensed consolidated statements of operations (in thousands):
Three Months Ended
June 30, Six Months Ended
June 30,
2026 2025 2026 2025
Stock-based compensation expense:
Stock options $ 4,974 $ 4,992 $ 9,764 $ 10,815
RSUs 3,544 4,656 6,923 8,370
$ 8,518 $ 9,648 $ 16,687 $ 19,185
Stock-based compensation expense in operating expenses:
Research and development $ 2,355 $ 2,761 $ 4,660 $ 5,073
Selling, general and administrative 6,163 6,887 12,027 14,112
$ 8,518 $ 9,648 $ 16,687 $ 19,185
Stock-based compensation expense capitalized into inventory totaled $ — during the three months ended June 30, 2026 and $ 0.3 million during the six months ended June 30, 2026. There was no stock-based compensation expense capitalized into inventory during the three and six months ended June 30, 2025. Capitalized stock-based compensation is recognized as an expense in cost of sales when the related product is sold.
Stock Options
The following table summarizes stock option activity and related information during the six months ended June 30, 2026:
Number of
Options Weighted-
Average
Exercise
Price Aggregate
Intrinsic
Value
(in thousands) Weighted-
Average
Remaining
Contractual
Life
(in years)
Outstanding at December 31, 2025 23,932,504 $ 4.97 $ 17 7.9
Granted 393,600 $ 7.25
Exercised ( 409,276 ) $ 4.00
Forfeited/expired ( 358,043 ) $ 5.13
Outstanding at June 30, 2026 23,558,785 $ 5.03 $ 100,928 7.5
Vested and exercisable at June 30, 2026 14,788,581 $ 5.68 $ 58,501 6.9
As of June 30, 2026, the unrecognized compensation cost related to outstanding stock options was $ 23.2 million, which is expected to be recognized over a remaining weighted-average period of 1.4 years.
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ImmunityBio, Inc. and Subsidiaries
Notes to Unaudited Condensed Consolidated Financial Statements (Continued)
During the six months ended June 30, 2026 and 2025, the total intrinsic value of stock options exercised was $ 1.8 million and $ 0.1 million, respectively. During the six months ended June 30, 2026 and 2025, cash proceeds received from stock option exercises were $ 1.6 million and $ 0.2 million, respectively.
As of December 31, 2025, a total of 9,657,097 vested and exercisable shares were outstanding.
Restricted Stock Units
The following table summarizes RSU activity during the six months ended June 30, 2026:
Number of
Units
Weighted-
Average
Grant Date
Fair Value
Nonvested balance at December 31, 2025 8,127,668 $ 6.56
Granted 320,048 $ 7.42
Vested ( 2,271,063 ) $ 3.98
Forfeited/canceled ( 245,573 ) $ 4.48
Nonvested balance at June 30, 2026 5,931,080 $ 7.68
As of June 30, 2026, there was $ 16.9 million of unrecognized stock-based compensation expense related to RSUs that is expected to be recognized over a weighted-average period of 1.4 years. During the six months ended June 30, 2026 and 2025, the total fair value of RSUs vested was $ 17.3 million and $ 3.9 million, respectively.
Related-Party Warrants
A total of 1,638,000 warrants issued to an affiliate of Dr. Soon-Shiong with an exercise price of $ 3.24 per share were outstanding as of June 30, 2026 and December 31, 2025. The fair value of $ 18.0 million assigned to the warrants will be recognized in equity upon achievement of a performance-based vesting condition pertaining to building manufacturing capacity to support supply requirements for ANKTIVA (which has not yet been satisfied). The warrants become exercisable 30 days following the achievement of the performance-based vesting condition (the initial exercise date) and expire on the 10th anniversary of the initial exercise date.
16. Income Taxes
We are subject to U.S. federal income tax, as well as income tax in California, other states and certain foreign jurisdictions. Except for state franchise taxes, the company has not been required to pay significant U.S. federal and state income taxes because of current and accumulated NOLs. The company computes its quarterly income tax provision using a forecasted annual effective tax rate and adjusts for any discrete items arising during the quarter. No tax benefit was provided for losses incurred in the U.S. and certain foreign jurisdictions because those losses are offset by a full valuation allowance.
During the three and six months ended June 30, 2026, we recorded an immaterial amount, respectively, and during the three and six months ended June 30, 2025, we recorded $ 0.3 million and an immaterial amount, respectively, in income tax expense , on the condensed consolidated statement of operations. The effective tax rates for the three and six months ended June 30, 2026 and 2025 differed from the U.S. federal statutory rate of 21%, primarily due to a valuation allowance on the company’s deferred tax assets.
Our federal returns for tax years 2022 through 2024 remain open to examination, and our state returns remain subject to examination for tax years 2021 through 2024. NOL carryforwards and tax credits are still subject to examination in the year they are used. No income tax returns are currently under examination by taxing authorities.
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ImmunityBio, Inc. and Subsidiaries
Notes to Unaudited Condensed Consolidated Financial Statements (Continued)
17. Earnings Per Share
Basic and Diluted Net Loss per Share of Common Stock
Basic net loss per share is calculated by dividing the net loss attributable to ImmunityBio common stockholders by the weighted-average number of common shares outstanding for the period. Diluted loss per share is computed by dividing net loss attributable to ImmunityBio common stockholders by the weighted-average number of common shares, including the number of additional shares that would have been outstanding if the potential common shares had been issued and if the additional common shares were dilutive.
The following table reflects the calculation of basic and diluted loss per common share (in thousands, except per share amounts):
Three Months Ended
June 30, Six Months Ended
June 30,
2026 2025 2026 2025
Net loss per ImmunityBio common share – basic and diluted
Numerator:
Net loss attributable to ImmunityBio common stockholders $ ( 230,378 ) $ ( 92,555 ) $ ( 863,160 ) $ ( 222,201 )
Denominator:
Weighted-average number of common shares outstanding –
basic and diluted
1,050,070 888,216 1,038,536 870,786
Net loss per ImmunityBio common share – basic and diluted $ ( 0.22 ) $ ( 0.10 ) $ ( 0.83 ) $ ( 0.26 )
Potentially dilutive securities, whose effect would have been antidilutive, were excluded from the computation of diluted net loss per share. The following table details the number of shares of common stock underlying those securities that were excluded from the computation of weighted-average number of common shares outstanding – diluted (shares in thousands):
Three Months Ended
June 30, Six Months Ended
June 30,
2026 2025 2026 2025
Related-party convertible note 88,447 93,053 88,447 93,053
Outstanding third-party warrants 47,862 35,424 47,862 35,424
Outstanding stock options 23,559 25,931 23,559 25,931
Outstanding RSUs 5,931 9,055 5,931 9,055
Outstanding related-party warrants 1,638 1,638 1,638 1,638
Total 167,437 165,101 167,437 165,101
The potentially dilutive securities shown in the table above exclude an option to purchase up to approximately $ 5.0 million of the company’s common stock pursuant to the SPOA entered in connection with the RIPA, as the exercise price cannot be determined until the date of exercise. See Note 10 “Revenue Interest Purchase Agreement” for more information.
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ImmunityBio, Inc. and Subsidiaries
Notes to Unaudited Condensed Consolidated Financial Statements (Continued)
18. Segment Information
We operate in one operating segment, and therefore have one reportable segment, focused on innovating, developing, and commercializing next-generation immunotherapies designed to activate the patient’s immune system and deliver durable protection against cancer and infectious diseases. Our CEO is the chief operating decision-maker of the company and manages and allocates resources to our operations on a company-wide basis. Consistent with this decision-making process, our CEO uses consolidated, single-segment financial information for purposes of evaluating performance, forecasting future-period financial results, allocating resources, and setting incentive targets. The measure of segment performance is net income (loss) as reflected in the condensed consolidated statement of operations. The CODM uses net income (loss) and loss from operations to allocate resources on a consolidated basis, which enables the CODM to assess both the overall level of resources available and optimize distribution of resources across functions, therapeutic areas, regions and research and development programs in line with our long-term corporate-wide strategic goals. As the company manages its assets on a consolidated basis, the measure of segment assets is total assets, as reflected in the condensed consolidated balance sheet.
Concentration of Major Customers
During the three months ended June 30, 2026, approximately 90 % of our total gross revenue was from our top four customers, which accounted for 42 %, 22 %, 16 %, and 10 % of our total revenue, respectively. During the six months ended June 30, 2026, approximately 92 % of our total gross revenue was from our top four customers, which accounted for 42 %, 21 %, 15 %, and 14 % of our total revenue, respectively.
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Notes to Unaudited Condensed Consolidated Financial Statements (Continued)
Net loss for our reportable segment is as follows (in thousands):
Three Months Ended
June 30, Six Months Ended
June 30,
2026 2025 2026 2025
Total revenue $ 51,240 $ 26,425 $ 95,446 $ 42,942
Cost of sales 298 136 536 194
Gross profit 50,942 26,289 94,910 42,748
Operating expenses
External research and development expense (including
amounts with related parties) (1)
10,424 8,552 30,506 14,063
Internal research and development expense (including
amounts with related parties): (2)
Personnel-related costs 26,602 23,632 52,452 46,697
Equipment, depreciation, and facility costs 13,410 13,111 26,998 26,303
Other research and development costs 10,380 9,941 18,849 16,407
Total internal research and development expense 50,392 46,684 98,299 89,407
Total research and development expense (including
amounts with related parties) 60,816 55,236 128,805 103,470
Selling, general and administrative (including
amounts with related parties) 51,823 42,338 97,593 74,992
Total operating expenses 112,639 97,574 226,398 178,462
Loss from operations ( 61,697 ) ( 71,285 ) ( 131,488 ) ( 135,714 )
Other income (expense), net
Interest and investment income, net 3,155 1,153 5,469 2,040
Change in fair value of related-party convertible note ( 95,964 ) 1,169 ( 332,589 ) ( 41,413 )
Change in fair value of warrant liabilities ( 44,190 ) 3,889 ( 339,603 ) 3,441
Interest expense related to revenue interest liability ( 17,192 ) ( 13,405 ) ( 31,063 ) ( 26,939 )
Interest expense (including amounts with related parties) ( 14,052 ) ( 15,479 ) ( 28,645 ) ( 30,810 )
Change in fair value of derivative liabilities ( 692 ) 1,931 416 7,509
Other income (expense), net 242 ( 278 ) ( 5,675 ) ( 319 )
Total other expense, net ( 168,693 ) ( 21,020 ) ( 731,690 ) ( 86,491 )
Loss before income taxes and noncontrolling interests ( 230,390 ) ( 92,305 ) ( 863,178 ) ( 222,205 )
Income tax expense — ( 269 ) ( 9 ) ( 35 )
Net loss ( 230,390 ) ( 92,574 ) ( 863,187 ) ( 222,240 )
Net loss attributable to noncontrolling interests, net of tax ( 12 ) ( 19 ) ( 27 ) ( 39 )
Net loss attributable to ImmunityBio common stockholders $ ( 230,378 ) $ ( 92,555 ) $ ( 863,160 ) $ ( 222,201 )
_______________
(1) Our external research and development expense supports our various preclinical and clinical programs.
(2) Our internal research and development expense includes payroll and benefits expenses, facilities and equipment expense, and other indirect research and development expenses incurred in support of our research and development activities.
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Notes to Unaudited Condensed Consolidated Financial Statements (Continued)
We generate a portion of our revenues from outside of the U.S. Information about our revenue by geographic region is as follows (in thousands):
Three Months Ended
June 30, Six Months Ended
June 30,
2026 2025 2026 2025
U.S. $ 50,722 $ 26,425 $ 94,904 $ 42,942
Europe 518 — 542 —
Total segment revenue $ 51,240 $ 26,425 $ 95,446 $ 42,942
19. Subsequent Event
Warrant Exercises
Subsequent to June 30, 2026, institutional holders exercised a total of 6,399,171 warrants pursuant to the February and July 2023 warrant agreements at an exercise price of $ 3.2946 per share resulting in the issuance of 6,399,171 shares of the company’s common stock for proceeds totaling $ 21.1 million. As of August 4, 2026, no warrants remain outstanding under the February and July 2023 warrant agreements.
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ITEM 2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS.
Forward-Looking Statements
The following discussion and analysis of our financial condition and results of operations should be read together with the description of our business and the condensed consolidated financial statements and related notes thereto Part I, Item 1. “Financial Statements” in this Quarterly Report. This Quarterly Report contains forward-looking statements within the meaning of Section 27A of the Securities Act and Section 21E of the Exchange Act that are based on our management’s beliefs and assumptions and on information currently available to our management. Actual results could differ materially from those discussed in or implied by such forward-looking statements. Factors that could cause or contribute to these differences include those discussed below and elsewhere in this Quarterly Report, particularly in Part II, Item 1A. “ Risk Factors .” Except as required by law, we do not undertake any responsibility to update any of these factors or to announce publicly any revisions to any of the forward-looking statements contained in this or any document, whether as a result of new information, future events, or otherwise. Forward-looking statements include, but are not limited to:
• our ability to successfully commercialize ANKTIVA globally in current and future approved indications (including NMIBC and NSCLC), and to obtain incremental regulatory approvals for new indications (including BCG-unresponsive NMIBC with CIS, with or without papillary tumors, BCG-unresponsive NMIBC papillary only, and NSCLC) from the FDA and applicable international regulatory agencies;
• our expectations regarding the operation and effectiveness of our approved product and product candidates and related benefits, potential future uses and applications of our approved product and product candidates, including potential use in cancer vaccines and across multiple tumor types, and the benefits and uses or our strategy and technology generally;
• our ability to obtain additional financing to fund our operations and advance the commercialization of our approved product and the development and commercialization of our other product candidates;
• our ability to comply with the terms, conditions, covenants, restrictions, and obligations set forth in the RIPA and related transaction documents;
• our ability to forecast operating results, including estimates regarding our future revenue and operating expenses, and make period-to-period comparisons predictive of future performance, including due to the impact of fluctuations in warrant, derivative, and fair value accounting measurement values;
• our beliefs regarding the benefits and perceived limitations of competing approaches, and the future of competing technologies and our industry;
• our beliefs regarding the success, cost and timing of our approved product and product candidate development activities and current and future clinical trials and studies, including study design, the enrollment of patients, and the timing of data readouts related thereto;
• our expectations regarding our ability to utilize the Phase 1/2 aNK, haNK ® , taNK, and NK-CAR (t-haNK ™ ) clinical trials data to support the development of our product candidates, including our NK-CAR (t-haNK), MSC, and M-ceNK ™ product candidates; the timing or likelihood of regulatory filings or other actions and related regulatory authority responses in the U.S. and jurisdictions outside of the U.S., including any planned meetings, investigational new drug, BLA, NDA or marketing authorization application or similar filings or pursuit of accelerated regulatory approval pathways or orphan drug status and Breakthrough Therapy , Fast Track or RMAT designations and any designation’s impact on BLA submission filing or approval timing and or approval probability;
• the ability and willingness of various third parties to engage in research and development activities involving our product or product candidates, and our ability to leverage those activities;
• our ability to enter into and successfully execute on clinical, regulatory and commercial arrangements internationally to accelerate the development and commercialization of ANKTIVA and our other product candidates;
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Management’s Discussion and Analysis of Financial Condition and Results of Operations (Continued)
• our expectations regarding the ease of administration and patient compatibility associated with our approved product and product candidates;
• our beliefs regarding the potential markets for our approved product and product candidates and our ability to serve those markets, including the rate and degree of market acceptance of any approved products;
• our beliefs regarding the potential manufacturing and distribution benefits associated with our approved product and product candidates, and our third-party CMOs’ abilities to follow cGMP standards to scale up the production of our approved product and product candidates;
• our plans regarding manufacturing and distribution of our approved product and potential future products, including the enhancement of our in-house manufacturing capabilities;
• our ability to attract and retain key personnel;
• our ability to obtain, maintain, protect, and enforce patent protection and other proprietary rights for our approved product and our other product candidates, and other technologies in development;
• the terms and conditions of licenses granted to us and our ability to license additional intellectual property relating to our product, product candidates and technology;
• our expectations regarding the results of market access initiatives and coverage under medical reimbursement policies;
• our expectations regarding the abilities of our international partners to drive commercialization of ANKTIVA in the EU and Middle East and North Africa regions;
• the expected shelf life of ANKTIVA drug substance and drug product and availability of product supply;
• our global expansion efforts and the accuracy of our assumptions related to tariffs and government policy changes, including Most-Favored Nation Prescription Drug Pricing;
• any government shutdown or budget disruption, which could adversely affect the U.S. and global economies, and materially and adversely affect our business and/or our future BLA submissions;
• the impact on us, if any, if the CVRs held by former Altor stockholders become due and payable; and
• regulatory developments in the U.S. and foreign countries.
Forward-looking statements include statements that are not historical facts and can be identified by terms such as “anticipates,” “believes,” “continues,” “goal,” “could,” “estimates,” “scheduled,” “expects,” “intends,” “may,” “plans,” “potential,” “predicts,” “indicate,” “projects,” “seeks,” “should,” “will,” “would,” “strategy,” and variations of such words or similar expressions. and the negatives of those terms. In addition, statements that “we believe” and similar statements reflect our beliefs and opinions on the relevant subject. Statements of past performance, efforts, or results of our preclinical and clinical trials, about which inferences or assumptions may be made, can also be forward-looking statements and are not indicative of future performance or results. These statements are based upon information available to us as of the date of this Quarterly Report, and although we believe such information forms a reasonable basis for such statements, such information may be limited or incomplete, and our statements should not be read to indicate that we have conducted a thorough inquiry into, or review of, all potentially available relevant information. These statements are inherently uncertain, and investors are cautioned not to unduly rely upon these statements.
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Management’s Discussion and Analysis of Financial Condition and Results of Operations (Continued)
Forward-looking statements involve known and unknown risks, uncertainties, and other factors that may cause our actual results, performance, or achievements to be materially different from any future results, performance, or achievements expressed or implied by the forward-looking statements. We discuss these risks in greater detail in Part II, Item 1A. “ Risk Factors ” of this Quarterly Report. Given these uncertainties, you should not place undue reliance on these forward-looking statements as a representation or warranty by us or any other person that we will achieve our objectives and plans in any specified time frame. Also, forward-looking statements represent our management’s beliefs and assumptions only as of the date of this Quarterly Report.
Except as required by law, we assume no obligation to update these forward-looking statements, or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, even if new information becomes available in the future. You should read this Quarterly Report completely and with the understanding that our actual future results may be materially different from what we expect.
ImmunityBio, ImmunityBio Care, ANKTIVA, ThAnktiva, haNK, taNK, ceNK, NK-92, Nant Cancer Vaccine, BioShield (and other BioShield-related trademarks), NANT 001, NANT XL, NANT 001 and Design, QUILT, Outsmart Your Disease, Smart Therapies for Difficult Diseases, NantKwest, VivaBioCell, and Infacell are trademarks or registered trademarks of ImmunityBio, Inc., its subsidiaries and affiliates.
ANKTIVA is approved or authorized in five regulatory jurisdictions, expanding its global footprint to 34 countries, for use in combination with BCG for the treatment of adult patients with BCG-unresponsive NMIBC with CIS, with or without papillary tumors. ANKTIVA has also received marketing authorization from the EDE and accelerated conditional approval from the SFDA in combination with checkpoint therapy for adult patients with metastatic NSCLC whose disease has progressed following standard-of-care therapy. Other than as set forth in such specific approved label, our product candidates, including N-803, are investigational agents that are restricted by federal law to investigational use only, and safety and efficacy have not been established by any agency, including, without limitation, the FDA.
This Quarterly Report contains references to our products and trademarks and products and trademarks belonging to other entities. Solely for convenience, trademarks and trade names referred to in this Quarterly Report, including logos, artwork, and other visual displays, may appear without the ® or TM symbols, but such references are not intended to indicate, in any way, that we will not assert, to the fullest extent under applicable law, our rights or the rights of the applicable licensor to these trademarks and trade names. We do not intend our use or display of other companies’ products or trade names or trademarks to imply a relationship with, or endorsement or sponsorship of us, by any other companies.
In this Quarterly Report, the terms “ImmunityBio,” “the company,” “we,” “us,” and “our” refer to ImmunityBio, Inc. and its subsidiaries.
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Management’s Discussion and Analysis of Financial Condition and Results of Operations (Continued)
Our Business
ImmunityBio, Inc. is a biotechnology company focused on innovating, developing, and commercializing next-generation immunotherapies designed to activate the patient’s immune system and deliver durable protection against cancer and infectious diseases. Our approach harnesses both the adaptive and innate immune systems with the goal of restoring immune function and generating lasting immunological memory in patients. At the core of our strategy is the Cancer BioShield platform, which is designed to stimulate critical lymphocytes, including natural killer (NK) cells, cytotoxic T cells, and memory T cells via our proprietary IL-15 superagonist, ANKTIVA. Our Cancer BioShield platform is anchored by this antibody-cytokine fusion protein and is complemented by a portfolio that includes adenovirus-vectored vaccines, allogeneic (off-the-shelf) and autologous NK-cell therapies, and additional immunomodulators intended to promote immunogenic cell death and support durable immune responses while potentially reducing reliance on high-dose chemo-radiation therapy.
ANKTIVA is our lead biological product and a first-in-class IL-15 receptor superagonist antibody-cytokine fusion protein. We are commercializing ANKTIVA for the treatment of BCG-unresponsive NMIBC with CIS, with or without papillary tumors.
ANKTIVA is approved or authorized in five regulatory jurisdictions, expanding its global footprint to 34 countries, for use in combination with BCG for the treatment of adult patients with BCG-unresponsive NMIBC with CIS, with or without papillary tumors. ANKTIVA has also received accelerated conditional approval from the SFDA in combination with checkpoint therapy for adult patients with metastatic NSCLC whose disease has progressed following standard-of-care therapy. The approved and conditionally approved labels highlight ANKTIVA’s ability to simultaneously activate NK cells, cytotoxic T cells, and memory T cells.
In May 2026, we announced the FDA accepted for review our sBLA for ANKTIVA indicated with BCG for the treatment of adult patients with BCG-unresponsive NMIBC with papillary tumors without CIS and assigned a PDUFA target action date of January 6, 2027. There can be no assurance that the FDA will ultimately approve our sBLA.
In July 2026, we announced the EDE of the UAE granted marketing authorization for ANKTIVA indicated with BCG for the treatment of adult patients with BCG-unresponsive NMIBC with CIS, with or without papillary tumours, and BCG-unresponsive NMIBC with papillary tumours without CIS, as well as for ANKTIVA in combination with CPIs for the treatment of adult patients with metastatic NSCLC whose disease has progressed following standard-of-care therapy.
ANKTIVA in combination with our CAR-NK therapy (PD-L1 t-haNK) has received RMAT designation from the FDA for use in combination with standard-of-care chemotherapy/radiotherapy for the reversal of lymphopenia and treatment of multiply relapsed locally advanced or metastatic pancreatic cancer. Separately, the FDA has authorized an EAP for ANKTIVA to treat lymphopenia in adult patients with refractory or relapsed solid tumors, regardless of tumor type, who have progressed following first-line standard-of-care treatment, including chemotherapy, radiation, or immunotherapy. The EAP includes patients with solid tumors who have failed first-line therapy and have a low ALC (ALC <1,000/μL).
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Management’s Discussion and Analysis of Financial Condition and Results of Operations (Continued)
We are seeking to expand development of ANKTIVA in combination with current standard-of-care therapies across multiple solid and liquid tumor indications including:
• BCG-unresponsive NMIBC with papillary tumors;
• BCG-naïve NMIBC;
• Second-line NSCLC;
• First-line NSCLC;
• Glioblastoma;
• Indolent non-Hodgkin lymphoma, including Waldenström macroglobulinemia;
• Pancreatic cancer;
• Prostate cancer; and
• Ovarian cancer.
In addition, ANKTIVA has been selected by the NCI for evaluation in a cancer prevention study in patients with Lynch syndrome, and we are evaluating the combination of ANKTIVA with other agents in colorectal cancer. The company is also supporting an ongoing EAP for rBCG to help address U.S. supply constraints. We are also establishing or conducting trials in multiple myeloma, HCC, and triple-negative breast cancer.
Significant Developments
The following is a summary of selected significant developments affecting our business that occurred since the filing of our Quarterly Report dated March 31, 2026 with the SEC on May 7, 2026:
• Q2 2026 net product revenue of $50.7 million, up 92% year-over-year and 15% sequentially from Q1 2026, marking the eighth consecutive quarter of sequential revenue growth since the commercial launch of ANKTIVA, driven by continued adoption among U.S. urologists and strong market access
• First-half 2026 net product revenue of $94.8 million, up 121% compared with the first half of 2025
• In July 2026, we announced the EDE of the UAE granted the broadest marketing authorization for ANKTIVA across BCG-unresponsive NMIBC for CIS and papillary disease and metastatic NSCLC
• The FDA accepted for review the company’s sBLA for ANKTIVA indicated with BCG in patients with BCG-unresponsive NMIBC with papillary tumors without CIS and assigned a PDUFA target action date of January 6, 2027
• Continued advancement across the clinical pipeline, with multiple anticipated regulatory, clinical, and data milestones expected over the next 12 months, including a planned 2026 sBLA submission for the Phase 2B QUILT-2.005 trial in BCG-naïve NMIBC CIS (with or without papillary tumors)
• Entered into an exclusive development and supply agreement with JBL, securing exclusive U.S. rights to develop, import, and commercialize intravesical Tokyo-172 BCG to support long-term supply for patients with NMIBC
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Management’s Discussion and Analysis of Financial Condition and Results of Operations (Continued)
Pipeline Summary
Product Candidate Indication Phase Status
ANKTIVA + BCG BCG-unresponsive NMIBC CIS Approved FDA, MHRA, SFDA, and EDE approval; EMA conditional marketing authorization
ANKTIVA + BCG BCG-unresponsive papillary sBLA EDE approval; FDA PDUFA target action date (January 6, 2027)
ANKTIVA + CPI Progressing, metastatic NSCLC Approved/Phase 3 EDE approval; SFDA accelerated conditional approval
ANKTIVA + BCG BCG-naïve NMIBC Phase 2B Fully enrolled
ANKTIVA + PD-L1 CAR-NK Recurrent GBM Phase 2/3 Phase 2 complete. Registrational trial planned.
ANKTIVA + PD-L1 CAR-NK Pancreatic cancer Phase 2 RMAT designation
CD19 CAR-NK + rituximab NHL Phase 1 QUILT-106
ANKTIVA Lymphopenia (solid tumors) Expanded Access FDA EAP authorized
rBCG (Serum Institute) NMIBC Expanded Access FDA EAP authorized
M-ceNK Solid tumors Phase 1 Completed
Ad-HPV HPV Phase 2 Initiated and enrolling
Cancer BioShield Platform Components Addressing the Immune System
As of June 30, 2026, our pipeline includes clinical-stage programs in the following indications:
• Bladder Cancer: BCG-unresponsive NMIBC with CIS, with or without papillary tumors (approved), BCG-unresponsive papillary (PDUFA target action date (January 6, 2027)), BCG-naïve NMIBC
• Lung Cancer: Progressing, metastatic NSCLC in combination with CPIs (marketing authorization from the EDE and accelerated conditional approval from the SFDA)
• Lymphopenia: Tumor-agnostic treatment of chemotherapy/radiation-induced lymphopenia (EAP authorized)
• Pancreatic Cancer: Advanced/metastatic disease (RMAT designation)
• Glioblastoma: Recurrent GBM (registrational trial planned)
• Non-Hodgkin Lymphoma: Waldenström macroglobulinemia and other CD19+/CD20+ lymphomas
• Colorectal Cancer/Lynch Syndrome: Cancer prevention in high-risk patients (NCI-sponsored)
• Prostate Cancer: High-risk prostate cancer
• Ovarian Cancer: Platinum-resistant ovarian cancer
• Infectious Diseases: HIV, Long COVID, universal nucleocapsid vaccine
• Apheresis Platform: M-ceNK with cryopreservation and storage
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ImmunityBio, Inc. and Subsidiaries
Management’s Discussion and Analysis of Financial Condition and Results of Operations (Continued)
Collaboration Agreements
We anticipate that strategic collaborations will continue to be an integral part of our operations, providing opportunities to leverage our partners’ expertise and capabilities to gain access to new markets for our approved product and acquire new technologies or further expand the potential of our technologies, approved product and product candidates across relevant platforms. We have initiated strategic commercial partnerships in Europe and the Middle East to expand access to our approved product and expect to continue to form additional commercial partnerships in other regions as our business grows. We also have a global arrangement with Serum Institute, one of the world’s largest vaccine manufacturers, to supply us with rBCG for use in our clinical development programs, and a development and supply agreement for the U.S. with JBL for Tokyo-172 BCG to address TICE BCG shortages.
We believe that our innovative approach to orchestrate and combine therapies for optimal immune system response will become a therapeutic foundation across multiple indications. Additionally, we believe that data from multiple clinical trials indicates ANKTIVA has broad potential to enhance the activity of therapeutic monoclonal antibodies, including CPIs, across a wide range of tumor types and potentially rescue lymphopenia by proliferation and activation of NK and T cells. We may also enter into supply arrangements for various investigational agents to be used in our clinical trials. See Part I, Item 1. “ Business—Collaboration and License Agreements ” of our Annual Report filed with the SEC on February 23, 2026 for a more detailed discussion regarding our collaboration and license agreements.
Agreements with Related Parties
Our Executive Chairman and Global Chief Scientific and Medical Officer also founded and has a controlling interest in NantWorks, which is a collection of companies in the healthcare and technology space. We have entered into arrangements with NantWorks, and certain affiliates of NantWorks. Affiliates of NantWorks are also affiliates of the company due to the common control by and/or common ownership interest of our Founder, Executive Chairman and Global Chief Scientific and Medical Officer.
Related-Party Debt
See Note 11 “ Related-Party Debt” of the “Notes to Unaudited Condensed Consolidated Financial Statements” that appears in Part I, Item 1. “Financial Statements” of this Quarterly Report for information regarding our related-party debt.
NantWorks, LLC
Our Founder, Executive Chairman and Global Chief Scientific and Medical Officer also founded and has a controlling interest in NantWorks, which is a collection of companies in the healthcare and technology space. We have entered into arrangements with NantWorks, and certain affiliates of NantWorks. Affiliates of NantWorks are also affiliates of the company due to the common control by and/or common ownership interest of our Founder, Executive Chairman and Global Chief Scientific and Medical Officer. See Note 12 “Related-Party Agreements” of the “Notes to Unaudited Condensed Consolidated Financial Statements” that appears in Part I, Item 1. “Financial Statements” of this Quarterly Report for more information regarding our agreements with NantWorks.
Immuno-Oncology Clinic, Inc.
We have entered into multiple agreements with the Clinic to conduct clinical trials related to certain of our product candidates. The Clinic is a related party as it is owned by an officer of the company, and NantWorks manages the administrative operations of the Clinic. See Note 12 “ Related-Party Agreements” of the “Notes to Unaudited Condensed Consolidated Financial Statements” that appears in Part I, Item 1. “Financial Statements” of this Quarterly Report for more information regarding our agreements with the Clinic.
Related-Party Leases
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 12 “Related-Party Agreements” of the “Notes to Unaudited Condensed Consolidated Financial Statements” that appears in Part I, Item 1. “Financial Statements” of this Quarterly Report for more information about our related-party leases.
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Management’s Discussion and Analysis of Financial Condition and Results of Operations (Continued)
Related-Party Warrants
A total of 1,638,000 warrants issued to an affiliate of Dr. Soon-Shiong with an exercise price of $3.24 per share were outstanding as of June 30, 2026. See Note 15 “Stock-Based Compensation” of the “Notes to Unaudited Condensed Consolidated Financial Statements” that appears in Part I, Item 1. “Financial Statements” of this Quarterly Report for more information regarding the related-party warrants.
Contingent Value Rights
In connection with our 2017 acquisition of Altor, we issued CVRs under which we agreed to pay the prior stockholders of Altor approximately $304.0 million of contingent consideration upon calendar-year worldwide net sales of ANKTIVA exceeding $1.0 billion prior to December 31, 2026, with amounts payable in cash or shares of our common stock or a combination thereof. As of June 30, 2026, Dr. Soon-Shiong, our Founder, Executive Chairman and Global Chief Scientific and Medical Officer, and his related party hold approximately $139.8 million of net sales CVRs. See Note 8 “Commitments and Contingencies” of the “Notes to Unaudited Condensed Consolidated Financial Statements” that appears in Part I, Item 1. “Financial Statements” of this Quarterly Report for more information regarding the CVRs.
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Management’s Discussion and Analysis of Financial Condition and Results of Operations (Continued)
Discussion of Condensed Consolidated Results of Operations
Comparison of the Three Months Ended June 30, 2026 and 2025
Three Months Ended
June 30,
2026 2025 $ Change % Change
($ in thousands)
Revenue
Product revenue, net $ 50,672 $ 26,421 $ 24,251 92 %
Other revenues 568 4 564 *
Total revenue 51,240 26,425 24,815 94 %
Operating cost and expenses
Cost of sales 298 136 162 119 %
Research and development (including amounts
with related parties)
60,816 55,236 5,580 10 %
Selling, general and administrative (including
amounts with related parties)
51,823 42,338 9,485 22 %
Total operating costs and expenses 112,937 97,710 15,227 16 %
Loss from operations (61,697) (71,285) 9,588 (13) %
Other income (expense), net:
Interest and investment income, net 3,155 1,153 2,002 174 %
Change in fair value of related-party convertible note (95,964) 1,169 (97,133) *
Change in fair value of warrant liabilities (44,190) 3,889 (48,079) *
Interest expense related to the revenue interest liability (17,192) (13,405) (3,787) 28 %
Interest expense (including amounts with related parties) (14,052) (15,479) 1,427 (9) %
Change in fair value of derivative liabilities (692) 1,931 (2,623) (136) %
Other income (expense), net 242 (278) 520 (187) %
Total other expense, net (168,693) (21,020) (147,673) 703 %
Loss before income taxes and noncontrolling interests (230,390) (92,305) (138,085) 150 %
Income tax expense — (269) 269 (100) %
Net loss $ (230,390) $ (92,574) $ (137,816) 149 %
_______________
* Not meaningful.
Product Revenue, Net
Product revenue, net increased $24.3 million during the three months ended June 30, 2026, as compared to the three months ended June 30, 2025, due to an increase in sales of ANKTIVA.
Other Revenues
Other revenues increased $0.6 million during the three months ended June 30, 2026, as compared to the three months ended June 30, 2025, primarily due to increased bioreactor and related consumable product sales.
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Management’s Discussion and Analysis of Financial Condition and Results of Operations (Continued)
Cost of Sales
Cost of sales increased $0.2 million during the three months ended June 30, 2026, as compared to the three months ended June 30, 2025. Cost of sales consists primarily of third-party manufacturing, distribution, and overhead costs. All costs associated with the production of ANKTIVA prior to receiving regulatory approval were expensed in research and development expense , on the condensed consolidated statement of operations in the period incurred and therefore are not reflected in cost of sales. As a result, our initial product gross margin is higher as our pre-launch inventory costs are not included in the cost of sales. We expect the cost of sales for ANKTIVA to increase and product gross margin to normalize in relation to product revenues as we deplete these inventories.
Research and Development Expense
Research and development expense consists of expenses incurred while performing research and development activities to expand the approved markets, label, and indications of our approved product ANKTIVA and to discover and develop our technology and product candidates. This includes conducting preclinical studies and clinical trials, manufacturing development efforts, and activities related to regulatory submissions for our approved product and product candidates. We expense research and development costs as they are incurred.
Our research and development expenses primarily consist of:
• clinical trial and regulatory-related costs;
• expenses incurred under agreements with investigative sites, CROs, and consultants that conduct our clinical trials;
• expenses incurred under collaborative agreements;
• manufacturing and testing costs and related supplies and materials;
• employee-related expenses, including salaries, benefits, travel and stock-based compensation; and
• facility and equipment expenses dedicated to research and development.
The company classifies its research and development expenses as either external or internal. The company’s external research and development expenses support its various preclinical and clinical programs. The company’s internal research and development expenses include payroll and benefits expenses, facilities and equipment expense, and other indirect research and development expenses incurred in support of its research and development activities. The company’s external and internal resources are not directly tied to any one research or drug discovery program and are typically deployed across multiple programs and are not allocated to specific product candidates or development programs.
We expect our research and development expenses to increase significantly for the foreseeable future as we continue to invest in research and development activities related to expanding our product into new indications and markets, developing our other product candidates, and conducting our ongoing and planned clinical trials .
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Management’s Discussion and Analysis of Financial Condition and Results of Operations (Continued)
The process of conducting clinical trials necessary to obtain regulatory approval is costly and time consuming. The successful development of product candidates is highly uncertain. At this time, we cannot reasonably estimate the nature, timing or costs required to complete the remaining development of our other product candidates or to expand potential approved markets and indications for ANKTIVA. This is due to the numerous risks and uncertainties associated with the development of product candidates.
The costs of clinical trials may vary significantly over the life of a project owing to, but not limited to, the following:
• per patient trial costs;
• the number of sites included in the clinical trials;
• the countries in which the clinical trials are conducted;
• the length of time required to enroll eligible patients;
• the number of patients that participate in the clinical trials;
• the number of doses that patients receive;
• the cost of comparative or combination agents used in clinical trials;
• the drop-out or discontinuation rates of patients;
• potential additional safety monitoring or other studies or incremental cohorts requested by regulatory agencies;
• potential CRO costs and overhead;
• the duration of patient follow-up; and
• the safety profile and efficacy of the product candidate.
Research and development expense increased $5.6 million during the three months ended June 30, 2026, as compared to the three months ended June 30, 2025. The following table summarizes our research and development expense during the three months ended June 30, 2026 and 2025, together with the changes in those items (in thousands):
Three Months Ended
June 30,
2026 2025 $ Change
External research and development expenses $ 10,424 $ 8,552 $ 1,872
Internal research and development expenses:
Personnel-related costs 26,602 23,632 2,970
Equipment, depreciation, and facility costs 13,410 13,111 299
Other research and development costs 10,380 9,941 439
Total internal research and development expenses 50,392 46,684 3,708
Total research and development expense $ 60,816 $ 55,236 $ 5,580
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Management’s Discussion and Analysis of Financial Condition and Results of Operations (Continued)
Research and development expense increased $5.6 million primarily attributable to the following:
• a $1.9 million increase in external research and development expenses, driven by higher clinical trial expenses, and external manufacturing costs, partially offset by lower regulatory expenses and lower external testing expenses;
• a $3.0 million increase in personnel-related costs, primarily due to higher salaries and benefits driven by increased headcount;
• a $0.3 million increase in equipment, depreciation, and facility costs, primarily due to higher depreciation expenses and lease expenses driven by the Dunkirk Lease amendment, and higher facility security costs, partially offset by lower building repair expenses; and
• a $0.4 million increase in other research and development costs, primarily due to higher distribution costs, and higher software license fees, partially offset by fewer supplies and materials purchases, and lower research agreement expenses.
We expect our research and development expense to increase significantly as we pursue label expansions for ANKTIVA in the U.S. and globally, advance our product pipeline, and execute planned clinical trials.
Selling, General and Administrative Expense
Selling, general and administrative expense consists primarily of salaries and personnel-related costs, including employee benefits and any stock-based compensation, for employees performing functions other than research and development. This includes personnel in executive, finance, human resources, information technology, legal, sales and administrative support functions. Other selling, general and administrative expenses include sales and marketing costs, facility-related costs not otherwise allocated to research and development expense, professional fees for auditing, tax and legal services, advertising costs, expenses associated with strategic business transactions and business development efforts, obtaining and maintaining patents, consulting costs, royalties and licensing costs, and costs of our information systems.
We expect that our selling, general and administrative expense will increase for the foreseeable future as we continue commercializing our approved product and expand operations in the U.S. and globally, build out information systems and increase our headcount to support continued research activities and the development of our clinical programs. We have incurred and expect that we will continue to incur in the future, additional costs associated with operating as a public company, including costs to comply with stock exchange listing and SEC requirements, future funding efforts, corporate governance, internal controls, investor relations, disclosure and similar requirements applicable to public companies. Additionally, as we pursue international product sales of our approved product we expect to incur the associated increases in our selling, general and administrative expense. If and when we believe that a regulatory approval of one of our other product candidates appears likely, we expect to incur significant increases in our selling, general and administrative expense related to the sales and marketing of any additional approved product candidates.
Selling, general and administrative expense increased $9.5 million during the three months ended June 30, 2026, as compared to the three months ended June 30, 2025, primarily attributable to the following:
• a $3.5 million increase in professional service expenses that was primarily attributable to an increase in consulting fees driven by commercialization and marketing related services, and an increase in audit and tax fees, partially offset by a decrease in legal expenses;
• a $2.7 million increase in personnel-related costs including salaries and benefits, commissions, recruiting and training expenses, and travel expenses due to growing sales and marketing activities, partially offset by a decrease in stock-based compensation;
• a $2.1 million increase in commercial-related expenses that was primarily driven by higher marketing expenses and higher distribution costs as a result of continued commercialization development and sales growth;
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Management’s Discussion and Analysis of Financial Condition and Results of Operations (Continued)
• a $0.6 million increase in equipment expenses that was primarily due to increased software license fees, and higher IT equipment purchase costs; and
• a $0.6 million increase in other expenses that was primarily attributable to a reduction in net shared service benefits, and an increase in depreciation and amortization expenses.
Other Income (Expense), Net
Other income (expense), net consists primarily of interest and investment income, interest expense, unrealized gains and losses from investments in equity securities, changes in fair value of warrant liabilities, derivative liabilities, and convertible notes, realized gains and losses on debt and equity securities, warrant issuance costs, write-off of a convertible note receivable, and gains and losses on foreign currency transactions.
Total other expense, net, increased $147.7 million during the three months ended June 30, 2026, as compared to the three months ended June 30, 2025, primarily attributable to the following:
• an increase of $97.1 million from the change in fair value of a related-party convertible note driven by the revaluation loss of $96.0 million associated with the increase in our common stock price during the three months ended June 30, 2026, as compared to the revaluation gain of $1.1 million during the three months ended June 30, 2025;
• an increase of $48.1 million from the change in fair value of warrant liabilities mainly driven by the increase in our common stock price and a corresponding increase in the fair value of the warrant liabilities;
• an increase of $3.8 million in interest expense related to the revenue interest liability as a result of the increased RIPA debt principal balance;
• an increase of $2.6 million from the change in fair value of derivative liabilities driven by recurring fair value adjustments at the end of each reporting period; partially offset by
• an increase of $2.0 million in interest and investment income, net, driven by a higher outstanding balance of treasury security holdings;
• a decrease of $1.4 million in interest expense due to the lower December 2024 Convertible Promissory Note balance, coupled with a decreased interest rate driven by a lower Term SOFR; and
• a decrease of $0.5 million in other income (expense), net, primarily due to income recognized from promotional equipment received during the three months ended June 30, 2026, compared to a loss on asset disposals during the three months ended June 30, 2025.
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Management’s Discussion and Analysis of Financial Condition and Results of Operations (Continued)
Comparison of the Six Months Ended June 30, 2026 and 2025
Six Months Ended June 30,
2026 2025 $ Change % Change
($ in thousands)
Revenue
Product revenue, net $ 94,839 $ 42,930 $ 51,909 121 %
Other revenues 607 12 595 *
Total revenue 95,446 42,942 52,504 122 %
Operating costs and expenses
Cost of sales 536 194 342 176 %
Research and development (including amounts
with related parties)
128,805 103,470 25,335 24 %
Selling, general and administrative (including amounts
with related parties)
97,593 74,992 22,601 30 %
Total operating costs and expenses 226,934 178,656 48,278 27 %
Loss from operations (131,488) (135,714) 4,226 (3) %
Other income (expense), net
Interest and investment income, net 5,469 2,040 3,429 168 %
Change in fair value of warrant liabilities (339,603) 3,441 (343,044) *
Change in fair value of related-party convertible notes (332,589) (41,413) (291,176) 703 %
Interest expense related to revenue interest liability (31,063) (26,939) (4,124) 15 %
Interest expense (including amounts with related parties) (28,645) (30,810) 2,165 (7) %
Change in fair value of derivative liabilities 416 7,509 (7,093) (94) %
Other expense, net (5,675) (319) (5,356) *
Total other expense, net (731,690) (86,491) (645,199) 746 %
Loss before income taxes and noncontrolling interests (863,178) (222,205) (640,973) 288 %
Income tax expense (9) (35) 26 (74) %
Net loss $ (863,187) $ (222,240) $ (640,947) 288 %
_______________
* Not meaningful.
Product Revenue, Net
Product revenue, net increased $51.9 million during the six months ended June 30, 2026, as compared to the six months ended June 30, 2025, due to an increase in sales of ANKTIVA.
Other Revenues
Other revenues increased $0.6 million during the six months ended June 30, 2026, as compared to the six months ended June 30, 2025, primarily due to increased bioreactor and related consumable product sales.
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Management’s Discussion and Analysis of Financial Condition and Results of Operations (Continued)
Cost of Sales
Cost of sales increased $0.3 million during the six months ended June 30, 2026, as compared to the six months ended June 30, 2025. Cost of sales consists primarily of third-party manufacturing, distribution, and overhead costs. All costs associated with the production of ANKTIVA prior to receiving regulatory approval were expensed in research and development expense, on the condensed consolidated statement of operations in the period incurred and therefore are not reflected in cost of sales. As a result, our initial product gross margin is higher as our pre-launch inventory costs are not included in the cost of sales. We expect the cost of sales for ANKTIVA to increase and product gross margin to normalize in relation to product revenues as we deplete these inventories.
Research and Development Expense
Research and development expense increased $25.3 million during the six months ended June 30, 2026, as compared to the six months ended June 30, 2025. The following table summarizes our research and development expense during the six months ended June 30, 2026 and 2025, together with the changes in those items (in thousands):
Six Months Ended June 30,
2026 2025 $ Change
External research and development expenses $ 30,506 $ 14,063 $ 16,443
Internal research and development expenses:
Personnel-related costs 52,452 46,697 5,755
Equipment, depreciation, and facility costs 26,998 26,303 695
Other research and development costs 18,849 16,407 2,442
Total internal research and development expense 98,299 89,407 8,892
Total research and development expense $ 128,805 $ 103,470 $ 25,335
Research and development expense increased $25.3 million primarily attributable to the following:
• a $16.4 million increase in external research and development expenses, primarily due to higher clinical trial expenses, contract manufacturing expenses, and consulting costs, partially offset by lower regulatory expenses;
• a $5.8 million increase in personnel-related costs, primarily due to increased salaries, recruiting costs, travel expenses, and decreased net shared service benefits, partially offset by decreased stock-based compensation expenses;
• a $0.7 million increase in equipment, depreciation, and facility costs, primarily due to higher depreciation expenses and lease expenses driven by the Dunkirk Lease amendment; and
• a $2.4 million increase in other research and development costs, primarily attributable to higher distribution costs driven by higher clinical trial activities, and higher software license fees due to new subscriptions, partially offset by decreased research agreement expenses.
We expect our research and development expense to increase significantly as we pursue label expansions for ANKTIVA in the U.S. and globally, advance our product pipeline, and execute planned clinical trials.
Selling, General and Administrative Expense
Selling, general and administrative expense increased $22.6 million during the six months ended June 30, 2026, as compared to the six months ended June 30, 2025, primarily attributable to the following:
• an $11.6 million increase in professional service expenses that was primarily attributable to increased legal expenses, increased consulting fees driven by commercialization and marketing related services, and higher audit and tax fees;
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Management’s Discussion and Analysis of Financial Condition and Results of Operations (Continued)
• a $4.8 million increase in personnel-related costs including salaries and benefits, commissions, recruiting and training expenses, and travel expenses due to growing sales and marketing activities, partially offset by a decrease in stock-based compensation;
• a $3.4 million increase in commercial-related expenses that was primarily driven by higher marketing related expenses and higher distribution costs as a result of continued commercialization development and sales growth;
• a $1.6 million increase in other expenses that was primarily attributable to a reduction in net shared service benefits, and an increase in depreciation and amortization expenses; and
• a $1.2 million increase in equipment expenses that was primarily due to increased software license fees, software purchases, and IT equipment purchases.
Other Income (Expense), Net
Total other expense, net, increased $645.2 million during the six months ended June 30, 2026, as compared to the six months ended June 30, 2025, primarily attributable to the following:
• an increase of $343.0 million from the change in fair value of warrant liabilities mainly driven by the increase in our common stock price that resulted in an increase in the fair value of the warrant liabilities and the issuance of July 2025 warrants, for which there was no comparable activity during 2026, partially offset by warrant exercises during 2026;
• an increase of $291.2 million from the change in fair value of a related-party convertible note driven by the revaluation loss of $332.6 million mainly associated with the increase in our common stock price during the six months ended June 30, 2026, as compared to the revaluation loss of $41.4 million during the six months ended June 30, 2025;
• an increase of $7.1 million from the change in fair value of derivative liabilities driven by recurring fair value adjustments at the end of each reporting period;
• an increase of $5.4 million in other expense, net, primarily driven by the write-off of our convertible note receivable and all accrued interest, partially offset by a reclassification of the cumulative impact from change in fair value of related-party convertible note related to instrument-specific credit risk associated with the partial conversion of the December 2024 Convertible Promissory Note during the three months ended March 31, 2026;
• an increase of $4.1 million in interest expense related to the revenue interest liability as a result of the increased RIPA debt principal balance; partially offset by
• an increase of $3.4 million in interest and investment income, net, driven by a higher outstanding balance of treasury security holdings; and
• a decrease of $2.2 million in interest expense due to the lower December 2024 Convertible Promissory Note balance, coupled with a decreased interest rate driven by a lower Term SOFR.
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Management’s Discussion and Analysis of Financial Condition and Results of Operations (Continued)
Financial Condition, Liquidity and Capital Resources
Sources of Liquidity
From inception through June 30, 2026, we have funded our operations primarily through proceeds from the issuance of related-party promissory notes, sales of common stock under our shelf registration statements, through RDO offerings (including the exercise of associated warrants) and the ATM, RIPA financings, and recently from net product sales associated with ANKTIVA.
Cash and Marketable Securities on Hand
As of June 30, 2026, we had cash and cash equivalents, and marketable securities of $357.4 million compared to $242.8 million as of December 31, 2025. We have typically invested our cash in a variety of financial instruments and classified these investments as available-for-sale. However, after our entry into the RIPA we can no longer invest our excess funds in corporate or European bonds. Certain of our investments are subject to credit, liquidity, market, and interest-rate risks. The general condition of the financial markets and the economy may increase those risks and may affect the value and liquidity of investments and restrict our ability to access the capital markets.
Shelf Registration Statement
In 2024, we filed a shelf registration statement with the SEC on Form S-3ASR pursuant to which we may, from time to time, sell an indeterminate amount of our common stock, preferred stock, debt securities, depositary shares, warrants, subscription rights, purchase contracts, or units, and an associated prospectus related to the ATM.
At-the-Market Offering
In 2021, we entered into the ATM under which we may offer and sell, from time to time at our sole discretion, shares of our common stock through our sales agent. In December 2025, we filed a prospectus supplement to our shelf registration statement in connection with entering into an amendment to the ATM to increase the amount available for future stock issuances under the ATM to $500.0 million. During the three and six months ended June 30, 2026, we received net proceeds totaling $45.1 million and $147.2 million, respectively, from the issuance of shares under the ATM. As of June 30, 2026, we had $349.2 million available for future stock issuances under the ATM.
Revenue Interest Purchase Agreement
On March 30, 2026, we entered into a Second Amendment to the RIPA. Pursuant to the amendment, Infinity and Oberland acquired additional revenue interests for a gross purchase price of $75.0 million (the Third Payment), less $0.2 million of issuance costs. Of the issuance costs incurred, $0.1 million was capitalized as debt discount and will be amortized to interest expense over the estimated term of the debt. See Note 10 “ Revenue Interest Purchase Agreement” of the “Notes to Unaudited Condensed Consolidated Financial Statements” that appears in Part I, Item 1. “Financial Statements” of this Quarterly Report for more information.
Exercise of Warrants
During the six months ended June 30, 2026, institutional holders exercised a total of 17,191,435 warrants pursuant to the April and July 2025 warrant agreements with exercise prices ranging from $3.101 per share to $3.240 per share resulting in the issuance of 17,191,435 shares of the company’s common stock for proceeds totaling $53.5 million. As of June 30, 2026, a total of 47,862,136 warrants remained outstanding under the warrant agreements. See Note 13 “ Warrant Liabilities ” of the “Notes to Unaudited Condensed Consolidated Financial Statements” that appears in Part I, Item 1. “Financial Statements” of this Quarterly Report for more information.
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Management’s Discussion and Analysis of Financial Condition and Results of Operations (Continued)
Partial Conversion of Related-Party Promissory Note
On March 31, 2026, Nant Capital converted $25.0 million of the principal of the December 2024 Convertible Promissory Note into 4,606,596 shares of common stock at a conversion price of $5.4270 per share. See Note 11 , “ Related-Party Debt ” of the “Notes to Unaudited Condensed Consolidated Financial Statements” that appears in Part I, Item 1. “Financial Statements” of this Quarterly Report for more information.
Stock Purchase and Option Agreement
On December 29, 2023 and in connection with the RIPA, we entered into a SPOA with Oberland. Under this agreement, Oberland acquired an option to purchase our common stock, at a price per share to be determined by reference to the 30-day trailing volume weighted-average price of our common stock, calculated from the date of exercise. The option is exercisable by Oberland at any time until the earliest of (i) December 29, 2028, (ii) a change of control of the company, or (iii) a sale of substantially all of the company’s assets. Among other limitations, the option may only be exercised to the extent that the common stock issuable pursuant to such exercise would not exceed 19.9% of the common stock outstanding immediately after giving effect to such exercise. As of June 30, 2026, approximately $5.0 million remains available for future exercise under the SPOA.
Uses of Liquidity
In addition to the cash used to fund our operating activities discussed in “ —Future Funding Requirements ” below, we will require cash to settle the following obligations:
• As of June 30, 2026, our indebtedness payable at maturity is $480.0 million. This convertible promissory note is held by Nant Capital, an entity affiliated with Dr. Soon-Shiong. In connection with the RIPA, our related-party promissory note is a general unsecured obligation of the company that is subordinated in right of payment to indebtedness, obligations, and other liabilities under the RIPA, the Revenue Interests issued pursuant to such agreement, and refinancing of the foregoing.
Although this promissory note is convertible into shares of common stock at $5.4270, there can be no assurance that it will be converted or that the company can refinance this promissory note or what terms will be available in the market at the time of any required refinancing. Furthermore, if prevailing interest rates or other factors at the time of refinancing result in higher interest rates upon refinancing, then the interest expense relating to the refinanced indebtedness would increase. These risks could materially adversely affect the company’s financial condition, cash flows and results of operations.
• On December 29, 2023 , we entered into the RIPA with Infinity and Oberland. Oberland has the right to receive quarterly Revenue Interest Payments from us based on, among other things, our worldwide net sales, excluding those in China, which will be tiered payments initially ranging from 5.625% to 12.50% (before funding of the Third Payment, 4.5% to 10.0%; before funding of the Second Payment, 3.0% to 7.0%) , subject to increase or decrease, following December 31, 2029 (the Test Date) depending on whether our aggregate payments made to Oberland as of the Test Date have met or exceeded the Cumulative Purchaser Payments. In addition, if our aggregate payments made as of the Test Date to Oberland do not equal or exceed the amount of the Cumulative Purchaser Payments as of such date, then we are obligated to make a one-time True-Up Payment to Oberland in an amount equal to 100% of the Cumulative Purchaser Payments as of the Test Date, less the aggregate amount of our previous payments to Oberland as of the Test Date. See Note 10 “Revenue Interest Purchase Agreement” of the “Notes to Unaudited Condensed Consolidated Financial Statements” that appears in Part I, Item 1. “Financial Statements” of this Quarterly Report for more information regarding the RIPA.
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Management’s Discussion and Analysis of Financial Condition and Results of Operations (Continued)
• In connection with our 2017 acquisition of Altor, we issued CVRs under which we agreed to pay the prior stockholders of Altor approximately $304.0 million of contingent consideration upon calendar-year worldwide net sales of ANKTIVA exceeding $1.0 billion prior to December 31, 2026, with amounts payable in cash or shares of our common stock or a combination thereof. As of June 30, 2026, Dr. Soon-Shiong and his related party hold approximately $139.8 million of net sales CVRs and they have both irrevocably agreed to receive shares of the company’s common stock in satisfaction of their CVRs. We may be required to pay the other prior Altor stockholders up to $164.2 million for their net sales CVRs should they choose to have their CVRs paid in cash instead of common stock. We may need to seek additional sources of capital to satisfy the CVR obligations if they are achieved.
• In connection with our acquisition of VivaBioCell, we are obligated to pay the former owners approximately $2.3 million of contingent consideration upon the achievement of a regulatory milestone relating to the GMP-in-a-Box technology.
Discussion of Condensed Consolidated Cash Flows
The following discussion of ImmunityBio’s cash flows is based on the condensed consolidated statements of cash flows in Part I, Item 1. “Financial Statements” and is not meant to be an all‑inclusive discussion of the changes in its cash flows for the periods presented below.
The following table sets forth our primary sources and uses of cash for periods indicated (in thousands):
Six Months Ended
June 30,
2026 2025
Cash (used in) provided by:
Operating activities $ (141,853) $ (165,651)
Investing activities (139,119) (12,013)
Financing activities 268,369 171,828
Effect of exchange rate changes on cash and cash equivalents, and restricted cash 119 66
Net change in cash and cash equivalents, and restricted cash $ (12,484) $ (5,770)
Operating Activities
During the six months ended June 30, 2026, net cash used in operating activities of $141.9 million consisted of a net loss of $863.2 million and $1.0 million of cash used in net working capital, partially offset by $722.3 million in adjustments for non-cash items. The changes in net working capital consisted primarily of an increase of $10.9 million in accounts receivable, net, a decrease of $4.0 million in operating lease liabilities, an increase of $4.0 million in inventories, and an increase of $0.7 million in other assets, partially offset by an increase of $11.7 million in accrued expenses and other liabilities, an increase of $3.7 million in accounts payable, a decrease of $2.1 million in prepaid expenses and other current assets, and an increase of $1.1 million with related parties. Adjustments for non-cash items primarily consisted of a $339.6 million change in fair value of warrant liabilities, a $332.6 million change in the fair value of a related-party convertible note, $19.6 million of non-cash interest expense related to the revenue interest liability, $16.7 million in stock-based compensation expense, $8.8 million in depreciation and amortization expense, a $7.4 million write-off of a convertible note receivable, and $3.5 million in non-cash lease expense related to operating lease right‑of‑use assets, reduced by $3.8 million of accretion of discounts on marketable debt securities, $1.4 million due to a realized gain on instrument-specific credit risk, a $0.4 million change in the fair value of derivative liabilities, $0.2 million in other items, and $0.1 million in non-cash interest.
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Management’s Discussion and Analysis of Financial Condition and Results of Operations (Continued)
During the six months ended June 30, 2025, net cash used in operating activities of $165.7 million consisted of a net loss of $222.2 million and $27.7 million of cash used in net working capital, partially offset by $84.2 million in adjustments for non-cash items. The changes in net working capital consisted primarily of an increase of $19.8 million in accounts receivable, net, a decrease of $4.2 million in accrued expenses and other liabilities, a decrease of $3.6 million in operating lease liabilities, and an increase of $3.1 million in prepaid expenses and other current assets, partially offset by a decrease of $1.6 million in inventories, a decrease of $1.1 million in other assets, and an increase of $0.3 million in accounts payable and related parties. Adjustments for non-cash items primarily consisted of a $41.4 million change in the fair value of a related-party convertible note, $23.3 million of non-cash interest expense related to the revenue interest liability, $19.2 million in stock-based compensation expense, $7.7 million in depreciation and amortization expense, $3.2 million in non-cash lease expense related to operating lease right‑of‑use assets, $0.4 million in other items, and $0.1 million of transaction costs allocable to warrant liabilities, reduced by a $7.5 million change in the fair value of derivative liabilities, a $3.4 million change in fair value of warrant liabilities, $0.1 million in non-cash interest, and $0.1 million of accretion of discounts on marketable debt securities.
We have historically experienced negative cash flows from operating activities. Although our net product sales have increased after the FDA approval of ANKTIVA, there can be no assurance these negative cash flows will not continue for the foreseeable future as we accelerate our initiatives which will require significant additional spending.
Investing Activities
During the six months ended June 30, 2026, net cash used in investing activities was $139.1 million, which included cash outflows of $303.3 million for purchases of marketable debt securities, $10.0 million cash paid for other equity securities, and $5.3 million for purchases of property, plant and equipment, partially offset by proceeds of $179.5 million from maturities and sales of marketable debt securities.
During the six months ended June 30, 2025, net cash used in investing activities was $12.0 million, which included cash outflows of $15.2 million for purchases of marketable debt securities and $2.2 million for purchases of property, plant and equipment, partially offset by proceeds of $5.4 million from maturities of marketable debt securities.
Our investments in property, plant and equipment are primarily related to acquisitions of equipment that will be used for the manufacturing of our approved product and product candidates and expenditures related to the build out of our manufacturing facilities. We expect to accelerate our capital spending as we scale our GMP manufacturing capabilities, which will require significant capital for the foreseeable future.
Financing Activities
During the six months ended June 30, 2026, net cash provided by financing activities was $268.4 million, which consisted of $147.3 million in net proceeds from equity offerings, $74.9 million in net proceeds from payments received pursuant to the RIPA, $53.5 million of proceeds from the exercise of warrants, $1.6 million in proceeds from the exercise of stock options, and $0.1 million in proceeds from borrowings, partially offset by $7.3 million related to net share settlement of vested RSUs for payment of payroll tax withholding and $1.7 million in principal payments on a premium financing.
During the six months ended June 30, 2025, net cash provided by financing activities was $171.8 million, which consisted of $173.1 million in net proceeds from equity offerings and $0.2 million in proceeds from the exercise of stock options, partially offset by $1.5 million related to net share settlement of vested RSUs for payment of payroll tax withholding.
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ImmunityBio, Inc. and Subsidiaries
Management’s Discussion and Analysis of Financial Condition and Results of Operations (Continued)
Future Funding Requirements
ANKTIVA is approved or authorized in five regulatory jurisdictions, expanding its footprint to 34 countries, for use in combination with BCG for the treatment of adult patients with BCG-unresponsive NMIBC with CIS, with or without papillary tumors. ANKTIVA has also received marketing authorization from the EDE and accelerated conditional approval from the SFDA in combination with checkpoint therapy for adult patients with metastatic NSCLC whose disease has progressed following standard-of-care therapy. As a result, we have begun to generate revenue, although we expect it to take some time to generate sufficient revenue from our approved product to offset our expenses, and we can provide no assurance when, or if, this will occur.
We began commercial distribution of ANKTIVA in May 2024 and our permanent J-code became effective in January 2025; however, we can provide no assurance with respect to our future U.S. and global revenues, market acceptance, reimbursement from third-party payors, or the profitability of our approved product or any other product candidate for which we may obtain approval. It may also take significant time to generate revenue from our approved product in international markets given uncertainties associated with government policy proposals such as Most Favored Nation drug pricing. We do not expect additional revenue from our other product candidates unless and until we obtain regulatory approval of and commercialize any of our other product candidates, and we do not know when, or if, this will occur. In addition, we expect our operating expenses to significantly increase in connection with our ongoing development activities, particularly as we continue the research, development and clinical trials of, and seek regulatory approval for, our other product candidates. We have also incurred and expect that we will continue to incur in the future additional costs associated with operating as a public company as well as costs related to future fundraising efforts. In addition, subject to obtaining regulatory approval of our other product candidates, we expect to incur significant incremental commercialization expenses for product sales, marketing, manufacturing and distribution. We anticipate that we will need substantial additional funding in connection with our continuing operations.
We expect that our operating expenses will increase substantially if and as we:
• commercialize our approved product in the U.S. and globally;
• continue research and development, including preclinical and clinical development of our other existing product candidates;
• seek regulatory approval of our approved product in incremental markets and indications and potentially seek regulatory approval for our other product candidates;
• seek to discover and develop additional product candidates;
• establish a commercialization infrastructure and scale up our manufacturing and distribution capabilities to commercialize any of our other product candidates for which we may obtain regulatory approval;
• seek to comply with regulatory standards and laws;
• maintain, leverage and expand our intellectual property portfolio;
• hire clinical, manufacturing, scientific and other personnel to support our product candidates’ development and future commercialization efforts;
• add operational, financial and management information systems and personnel; and
• incur additional legal, accounting and other expenses in operating as a public company.
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Management’s Discussion and Analysis of Financial Condition and Results of Operations (Continued)
As a result of continuing anticipated operating cash outflows as we commercialize our approved product in the U.S. and globally and accelerate our development efforts, we believe that substantial doubt exists regarding our ability to continue as a going concern without additional funding or financial support. However, we believe our existing cash and cash equivalents, and investments in marketable securities; sales of our approved product; capital to be raised through equity offerings, including but not limited to, the offering, issuance and sale by us of our common stock under our Form S-3ASR shelf registration statement; and our potential ability to borrow from affiliated entities will be sufficient to fund our operations through at least the next 12 months following the issuance date of the condensed consolidated financial statements based primarily upon our Founder, Executive Chairman and Global Chief Scientific and Medical Officer’s intent and ability to support our operations with additional funds, including loans from affiliated entities, as required, which we believe alleviates such doubt. In addition to funds from the future sales of our approved product, which we expect to take time to establish, we may also seek to sell additional equity, through one or more follow-on public offerings, or in separate financings, or obtain a credit facility, issue other debt in compliance with the terms of the RIPA, or engage in strategic partnership transactions. However, we may not be able to secure such external financing in a timely manner or on favorable terms, if at all. Without additional funds, we may choose to delay or reduce our operating or investment expenditures. Further, because of the numerous risks and uncertainties associated with the development and commercialization of our product candidates, we may need additional funds to meet our needs sooner than planned.
We will need to obtain additional financing to fund our future operations, including completing the commercialization of our approved product and the development and commercialization of our other product candidates. Changing circumstances may cause us to increase our spending significantly faster than we currently anticipate and we may need to raise additional funds sooner than we presently anticipate. Moreover, research and development and our operating costs and fixed expenses such as rent and other contractual commitments, including those for our research collaborations, are substantial and are expected to increase in the future.
Our future funding requirements will depend on many factors, including, but not limited to:
• our ability to successfully commercialize ANKTIVA or any future approved products in the U.S. or internationally;
• progress, timing, number, scope and costs of researching and developing our product candidates and our ongoing, planned and potential clinical trials;
• time and cost of regulatory approvals;
• our ability to successfully commercialize any of our other product candidates, if approved and the costs of such commercialization activities;
• revenue from product candidates that we may commercialize, if any, including the selling prices for such potential products and the availability of adequate third-party coverage and reimbursement for patients;
• interest and principal payments on our related-party promissory note, and repayment of Revenue Interests and Test Date payments due under the RIPA;
• cost of building, staffing and validating our own manufacturing facilities in the U.S., including having a product candidate successfully manufactured consistent with FDA and EMA regulations;
• terms, timing and costs of our current and any potential future collaborations, business or product acquisitions, CVRs, milestones, royalties, licensing or other arrangements that we have established or may establish;
• time and cost necessary to respond to technological, regulatory, political and market developments; and
• costs of filing, prosecuting, maintaining, defending and enforcing any patent claims and other intellectual property rights.
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Management’s Discussion and Analysis of Financial Condition and Results of Operations (Continued)
Unless and until we can generate a sufficient amount of revenues, we may finance future cash needs through public or private equity offerings, license agreements, debt financings, collaborations, strategic alliances and marketing or distribution arrangements. However, we may be unable to raise additional funds or enter into such other arrangements when needed on favorable terms, or at all.
To the extent that we raise additional capital through the sale of equity or equity-linked securities (including warrants), convertible debt or through our shelf registration statements, or other offerings, or if any of our current debt is converted into equity or if our existing warrants are exercised, your ownership interest will be diluted, and the terms may include liquidation or other preferences that adversely affect your rights as a stockholder. The incurrence of additional indebtedness would result in increased fixed payment obligations and could involve certain restrictive covenants, such as limitations on our ability to incur additional debt, limitations on our ability to acquire or license intellectual property rights and other operating restrictions that could adversely impact our ability to conduct our business. If we raise additional funds through strategic partnerships and alliances and licensing arrangements with third parties, we may have to relinquish valuable rights to our technologies or product candidates, or grant licenses on terms unfavorable to us and our revenue interest liability may come due. We have no committed source of additional capital and if we are unable to raise additional capital in sufficient amounts or on terms acceptable to us, we may be required to delay or reduce the scope of or eliminate one or more of our research or development programs or our commercialization efforts. Our current license and collaboration agreements may also be terminated if we are unable to meet the payment obligations under those agreements. As a result, we may seek to access the public or private capital markets whenever conditions are favorable, even if we do not have an immediate need for additional capital at that time.
Contractual Obligations
We have material cash requirements to pay related-party affiliates and third parties under various contractual obligations discussed below:
• We are obligated to make payments to several related-party affiliates under written agreements and other informal arrangements. We are also obligated to pay interest and to repay principal under our related-party promissory note. See Note 11 “Related-Party Debt” of the “Notes to Unaudited Condensed Consolidated Financial Statements” that appears in Part I, Item 1. “Financial Statements” of this Quarterly Report for information regarding our financing obligations.
• We are obligated to make payments to Oberland associated with our revenue interest liability, which do not have a fixed repayment schedule. Oberland’s right to receive payments under the RIPA shall terminate when Oberland has received maximum payments (including any True-Up Payment) equal to 195.0% of the then Cumulative Purchaser Payments unless the RIPA is terminated prior to such date.
Under the terms of the agreement, prior to the Test Date, every $100.0 million of worldwide net sales, excluding those in China, of less than or equal to $600.0 million in a calendar year will result in a tiered Revenue Interest Payment of approximately $12.5 million or 12.50% (after funding of the Third Payment). Worldwide net sales, excluding those in China, for a calendar year exceeding $600.0 million will result in a tiered Revenue Interest Payment of approximately $5.625 million or 5.625% (after funding of the Third Payment) for every $100.0 million of worldwide net sales, excluding those in China, above the threshold.
In the future, cumulative worldwide net sales, excluding those in China, levels up to the Test Date will determine whether or not we are required to make a True-Up Payment and implement modified payment rates. The amount of the obligation and timing of payment is likely to change . See Note 10 “Revenue Interest Purchase Agreement” of the “Notes to Unaudited Condensed Consolidated Financial Statements” that appears in Item 1. “Financial Statements” of this Quarterly Report for more information regarding the RIPA.
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Management’s Discussion and Analysis of Financial Condition and Results of Operations (Continued)
• We are obligated to make payments under our operating leases, which primarily consist of facility leases. See Note 9 “Lease Arrangements” and Note 12 “Related-Party Agreements” of the “Notes to Unaudited Condensed Consolidated Financial Statements” that appear in Part I, Item 1. “Financial Statements” of this Quarterly Report for information regarding our lease obligations.
• In connection with the acquisitions of Altor and VivaBioCell, we are obligated to pay contingent consideration upon the achievement of certain milestones. See Note 8 “Commitments and Contingencies—Contingent Consideration Related to Business Combinations” of the “Notes to Unaudited Condensed Consolidated Financial Statements” that appears in Part I, Item 1. “Financial Statements” of this Quarterly Report for information regarding our contingent consideration obligations.
• We have contractual obligations to make payments to related-party affiliates and third parties under unconditional purchase arrangements. See Note 11 “ Commitments and Contingencies—Unconditional Purchase Obligations” of the “Notes to Consolidated Financial Statements” that appears in Part II, Item 8. “Financial Statements and Supplementary Data” of our Annual Report filed with the SEC on February 23, 2026 for information on these unconditional purchase obligations.
• We have certain unconditional contractual commitments that are expected to be paid depending on the actual progress of build outs, completion of services, or in accordance with the terms of the respective third-party agreements as the payments become due. These are primarily related to capital expenditures and open purchase orders as of June 30, 2026 for the acquisition of goods and services in the ordinary course of business. As of June 30, 2026, the amounts of the contractual commitments that are expected to be paid are $58.9 million within one year and $32.2 million for fiscal year 2027 and beyond.
• In addition, we have conditional contractual commitments that are expected to be paid in fiscal year 2027 and beyond based on the achievement of various development, regulatory and commercial milestones for agreements with third parties. These payments may not be realized or may be modified and are contingent upon the occurrence of various future events, substantially all of which have a high degree of uncertainty of occurring. As of June 30, 2026, the maximum amount that may be payable related to these commitments is $40.8 million.
• In connection with our leasehold interest in the Dunkirk Facility, we are committed to spend $0.5 million a year in rent as well as an aggregate of $55.0 million for capital and operational expenses during the three-year term of the amended lease. We also agreed to meet certain headcount targets by hiring at least 100 full-time employees by the end of the three-year term of the amended lease. If the option to purchase is exercised, we are required to hire at least 450 full-time employees by December 31, 2032 through December 31, 2033; and we are prohibited from conveying the premises for a five-year period without the prior written consent of the counterparties. These amounts are not included in the discussion above. See Note 8 “Commitments and Contingencies—Dunkirk Facility Leasehold Interest” of the “Notes to Unaudited Condensed Consolidated Financial Statements” that appears in Part I, Item 1. “Financial Statements” of this Quarterly Report for more information on these obligations.
Critical Accounting Estimates
Our discussion and analysis of our financial condition and results of operations is based on our condensed consolidated financial statements, which have been prepared in accordance with U.S. GAAP. The preparation of condensed consolidated financial statements requires management to make certain estimates and assumptions that affect the reported amounts of assets, liabilities and expenses and the disclosure of contingent assets and liabilities at the date of the condensed consolidated financial statements and the reported amounts of revenues and expenses during the reporting period. Those estimates can be complex and actual results could differ materially from those estimates. Estimates are assessed each period and updated to reflect current information.
There have been no material changes to our critical accounting policies during the three months ended June 30, 2026 as compared to what was described in our annual consolidated financial statements and notes thereto included in our Annual Report filed with the SEC on February 23, 2026. See “ Critical Accounting Estimates ” that appears in Part II, Item 7. “Management’s Discussion and Analysis of Financial Condition and Results of Operations” of our Annual Report filed with the SEC on February 23, 2026 for the accounting policies we believe to be the most critical in understanding the judgments and estimates we use in preparing our condensed consolidated financial statements.
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Management’s Discussion and Analysis of Financial Condition and Results of Operations (Continued)
Recent Accounting Pronouncements
See Note 2 “ Summary of Significant Accounting Policies” of the “Notes to Consolidated Financial Statements” that appears in Part II, Item 8. “Financial Statements and Supplementary Data” of our Annual Report filed with the SEC on February 23, 2026 for a discussion of recent accounting pronouncements or changes in accounting pronouncements that are of significance, or potential significance, to us.
Subsequent Event
Warrant Exercises
Subsequent to June 30, 2026, institutional holders exercised a total of 6,399,171 warrants pursuant to the February and July 2023 warrant agreements at an exercise price of $3.2946 per share resulting in the issuance of 6,399,171 shares of the company’s common stock for proceeds totaling $21.1 million. As of August 4, 2026, no warrants remain outstanding under the February and July 2023 warrant agreements.
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ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK.
Financial market risks related to interest rates, foreign currency exchange rates, market risk on the price and volatility of our common stock, and inflation are described in Part II, Item 7A. “Quantitative and Qualitative Disclosures About Market Risk” of our Annual Report filed with the SEC on February 23, 2026. There have been no material changes to such financial market risks as of the date of this Quarterly Report. We do not currently anticipate any other near-term changes in the nature of our financial market risk exposures or in management’s objectives and strategies with respect to managing such exposures.
ITEM 4. CONTROLS AND PROCEDURES.
Evaluation of Disclosure Controls and Procedures
Our disclosure controls and procedures are designed to provide reasonable assurance of achieving their objectives of ensuring that information we are required to disclose in the reports we file or submit under the Exchange Act is accumulated and communicated to our management, including our CEO and CFO, as appropriate, to allow timely decisions regarding required disclosures, and is recorded, processed, summarized and reported, within the time periods specified in the SEC’s rules and forms. There is no assurance that our disclosure controls and procedures will operate effectively under all circumstances.
Management, with the participation of our CEO and CFO, evaluated the effectiveness of our disclosure controls and procedures as of June 30, 2026. The term “disclosure controls and procedures” (as defined in Rule 13a-15(e) of the Exchange Act) means controls and other procedures of a company that are designed to provide reasonable assurance that information required to be disclosed by a company in the reports that it files or submits under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms. Disclosure controls and procedures include, without limitation, controls and procedures designed to provide reasonable assurance that information required to be disclosed is accumulated and communicated to our management, including our CEO and CFO, as appropriate, to allow timely decisions regarding required disclosure. Management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving their desired control objectives, and management necessarily is required to apply its judgment in evaluating the cost-benefit relationship of possible controls and procedures. Based on the evaluation of our disclosure controls and procedures as of June 30, 2026, our CEO and CFO have concluded that, as of June 30, 2026, our disclosure controls and procedures were effective at the reasonable assurance level.
Changes in Internal Control over Financial Reporting
There have been no changes in our internal control over financial reporting (as defined in Rules 13a-15(f) and 15d-15(f) of the Exchange Act) during the fiscal quarter ended June 30, 2026, that our certifying officers concluded materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
Inherent Limitations on Effectiveness of Controls
Management recognizes that a control system, no matter how well conceived and operated, can provide only reasonable, not absolute, assurance that the objectives of the control system are met. Further, the design of a control system must reflect the fact that there are resource constraints, and the benefits of controls must be considered relative to their costs. Because of the inherent limitations in all control systems, no evaluation of controls can provide absolute assurance that all control issues and instances of fraud or error, if any, have been detected. These inherent limitations include the realities that judgments in decision making can be faulty, and that breakdowns can occur because of a simple error or mistake. Additionally, controls can be circumvented by the individual acts of some persons, by collusion of two or more people or by management override of the controls. The design of any system of controls also is based in part upon certain assumptions about the likelihood of future events, and there can be no assurance that any design will succeed in achieving its stated goals under all potential future conditions; over time, controls may become inadequate because of changes in conditions, or the degree of compliance with policies or procedures may deteriorate. Because of the inherent limitations in a cost-effective control system, misstatements due to error or fraud may occur and not be detected.
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PART II—OTHER INFORMATION
ITEM 1. 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 terminated the standstill agreement, and on April 11, 2023, Beike served an amended Request for Arbitration. We served an Answer and Counterclaims on May 19, 2023. Beike served a Reply to our counterclaims on June 21, 2023. Beike served its Statement of Claim on March 22, 2024, the company served its Statement of Defense and Counterclaim on June 21, 2024, and Beike served its Statement of Defense to the Counterclaim on August 2, 2024. After the parties completed discovery, Beike served its Reply and Defense to Counterclaim on January 17, 2025, we served our Rejoinder and Response to Defense to Counterclaim on March 14, 2025, and Beike served its Rejoinder on Counterclaim on March 28, 2025. The hearing in the arbitration was held from June 9, 2025 through June 13, 2025. Post-hearing submissions concluded in February 2026. The arbitration tribunal issued its Award on July 1, 2026. The Award denied all claims and counterclaims, declined to award damages or specific performance, and ordered that the parties should bear their own fees and costs. We intend to seek confirmation of the Award in the appropriate judicial forum.
Washington State Attorney General Investigation
In June 2025, the company received a request from the Attorney General of the State of Washington (the Request) seeking information and documents from the company relating to its relationship with the Access to Advanced Health Institute, a nonprofit biotech research institute located in Seattle (AAHI). ImmunityBio licensed and explored the development of AAHI’s RNA COVID vaccine and upon further investigation of the technology terminated the license. Dr. Soon-Shiong served on the board of directors of AAHI in his capacity as representative of a non-profit foundation. The company is cooperating with the Washington Attorney General’s Office with respect to the Request.
SRS/Altor Shareholder CVR Arbitration
In connection with our 2017 acquisition of Altor, we issued CVRs under which we agreed to pay the prior stockholders of Altor approximately $304.0 million of contingent consideration upon the successful regulatory approval of a BLA by the FDA, or foreign equivalent, for ANKTIVA by December 31, 2022, and $304.0 million of contingent consideration upon calendar-year worldwide net sales of ANKTIVA exceeding $1.0 billion prior to December 31, 2026. As of June 30, 2026, Dr. Soon-Shiong, our Founder, Executive Chairman and Global Chief Scientific and Medical Officer, and his related party hold approximately $139.8 million of FDA approval CVRs and $139.8 million of net sales CVRs, and they have both irrevocably agreed to receive shares of the company’s common stock in satisfaction of their CVRs. Because the FDA did not approve our BLA on or before December 31, 2022, the first CVR milestone was not met.
On December 27, 2022, Shareholder Representative Services, LLC (SRS), in its capacity as shareholder representative on behalf of former Altor BioScience Corp. shareholders, sent the company’s subsidiary NantCell a notice of claims relating to the regulatory milestone CVR. The notice of claims asserted that SRS was exploring, and might pursue, claims on behalf of
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Altor shareholders for additional merger consideration in the amount of the $2.00 per share milestone payment under the regulatory CVR milestone. The notice stated that any such claim would be based on NantCell’s alleged failure to use commercially reasonable efforts to secure FDA approval of ANKTIVA on or before December 31, 2022. In a separate October 2022 letter, SRS requested that NantCell preserve all documents and information relating to its efforts to achieve milestones set forth in the regulatory milestone CVR, and requested that the company provide certain categories of documents under the information-sharing provisions of the CVR agreement.
After the company provided many of the requested documents, on September 29, 2023, SRS filed a demand for arbitration with JAMS, seeking to compel the company to produce additional documents identified in its October 2022 letter relating to its efforts to obtain FDA approval for ANKTIVA. The arbitration demand did not include any claims beyond SRS’s claim that it had a right to obtain additional documents, and sought a ruling that the company was obligated to provide additional documents. After the arbitrator issued a preliminary ruling regarding the scope of the company’s obligation to provide information under the CVR Agreements, the company produced additional documents responsive to SRS’s requests.
On August 27, 2025, several months after SRS’s document-access claim had been resolved, SRS requested leave to amend its JAMS arbitration demand to state a claim for breach of contract. SRS’s proposed amended demand alleged that the company and NantCell had failed to exercise commercially reasonable efforts to obtain FDA approval of ANKTIVA on or before December 31, 2022. The JAMS arbitrator presiding over the document-access arbitration denied SRS’s motion for leave to amend its claims, and on September 26, 2025, the parties filed a joint stipulation asking that the JAMS document-access arbitration be closed.
After SRS’s motion for leave to amend was denied, on September 26, 2025, SRS sent the company a further notice of claims and essentially the same arbitration demand, asserting that the company had breached its obligations to exercise commercially reasonable efforts to achieve FDA approval of ANKTIVA on or before December 31, 2022. SRS’s arbitration demand seeks relief in the form of payment, in the amount of approximately $164.2 million plus interest exceeding $50.0 million, to former Altor shareholders not affiliated with Dr. Soon-Shiong. SRS filed its most recent arbitration demand with JAMS on November 5, 2025. The company filed its response on November 19, 2025, and an arbitrator was appointed on January 16, 2026. The arbitration hearing has been scheduled to begin on January 25, 2027, and the parties are currently engaged in discovery. It remains too early to evaluate the likely outcome of the case or to estimate any range of potential loss. We believe the company exercised commercially reasonable efforts in its pursuit of FDA approval of ANKTIVA, and that the claims asserted against the company lack merit.
Securities Class Action
On March 26, 2026, a putative securities class action complaint, captioned Douglas v. ImmunityBio, Inc. et al ., No. 2:26-cv-03261, was filed in the U.S. District Court for the Central District of California against the company and our Executive Chairman, asserting violations of Sections 10(b) and 20(a) of the Exchange Act stemming from the company’s receipt of a warning letter from the FDA’s OPDP regarding a television advertisement (which never aired) and a podcast interview. The complaint alleges that the statements made in the television advertisement and podcast were knowingly and materially false and misleading. The complaint seeks unspecified damages and attorneys’ fees and costs. On July 15, 2026, the court appointed a lead plaintiff. The company intends to defend the case vigorously. The company is unable to estimate a range of loss, if any, that could result were there to be an adverse final decision in this action. If an unfavorable outcome were to occur, it is possible that the impact could be material to the company’s results of operations in the period(s) in which any such outcome becomes probable and estimable.
Shareholder Derivative Actions
On April 17, 2026, a shareholder derivative complaint, captioned Davies v. ImmunityBio, Inc. et al. , No. 2:26-cv-04130, was filed in the U.S. District Court for the Central District of California. On April 21, 2026, a second derivative complaint, captioned Mody v. ImmunityBio, Inc. et al. , No. 2:26-cv-04245, was filed in the same court. Both lawsuits name the company, our Executive Chairman, and every member our Board of Directors as defendants. The plaintiffs, suing derivatively on behalf of ImmunityBio, allege that the company’s directors and officers breached their fiduciary duties by making, permitting, or failing to prevent the same alleged misstatements identified in the securities complaint, and that, as a result, the company has suffered financial losses, potential financial exposure in the related securities lawsuit, reputational damage, and legal and regulatory costs. The complaints seek unspecified damages from the individual defendants to the company for damages sustained by the company, enhancements to the company’s corporate governance and internal procedures, and attorneys’ fees and costs. On June 29, 2026, the court entered a stipulated order that consolidated the Davies and Mody actions and stayed the consolidated derivative action through the motion to dismiss phase of the related securities lawsuit.
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ITEM 1A. RISK FACTORS.
Investing in our securities involves a high degree of risk. You should carefully consider the risks described below, any of which may be relevant to decisions regarding an investment in or ownership of our stock. The occurrence of any of these risks could have a significant adverse effect on our reputation, business, financial condition, results of operations, growth, and ability to accomplish our strategic objectives. We have organized the description of these risks into groupings in an effort to enhance readability, but many of the risks interrelate or could be grouped or ordered in other ways, so no special significance should be attributed to the groupings or order below.
Risk Factor Summary
Risks Related to Our Financial Condition and Capital Requirements
• 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.
• We anticipate needing additional financing to fund our operations, complete the commercialization of our approved product, including for efforts to obtain approval for additional indications, conduct clinical trials, and develop and commercialize our other product candidates.
• The RIPA imposes Revenue Interest Payment obligations, which may adversely affect our financial position and results of operations, as well as affirmative and negative covenants, which restrict our 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.
Risks Related to the Discovery, Development and Commercialization of our Approved Product and our Other Product Candidates
• 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, obtain approval for additional indications, 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.
Risks Related to Reliance on Third Parties
• We have relied and will continue to rely on third parties and related parties to conduct some of our preclinical studies and clinical trials, manufacture products, and perform many essential services for any products that we commercialize. Any failure by a third party, related party, or us to perform as expected, comply with legal and regulatory requirements, manufacture products in compliance with cGMP, or conduct clinical trials according to GCP guidelines, and in a timely manner, may delay or prevent our ability to commercialize ANKTIVA internationally, to seek or obtain incremental regulatory approvals for ANKTIVA or our other product candidates, or may subject us to regulatory sanctions.
• 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 successfully commercialize our approved product or any other product candidates if approved.
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• 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.
Risks Related to Healthcare and Other Government Regulations
• While we currently have one product approved, we may be unable to obtain additional U.S. or foreign regulatory approvals and, as a result, may be unable to commercialize our other product candidates.
• 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 regulatory approval in other jurisdictions.
• Even though we have a regulatory 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, promoting 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 product candidates.
• If we are unable to establish adequate sales, marketing and distribution capabilities, we may not be successful commercializing our approved product or 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.
Risks Related to Intellectual Property
• 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.
• We or our licensors, collaborators, or any future strategic partners may become subject to third-party claims or litigation alleging infringement of patents or other proprietary rights or seeking to invalidate patents or other proprietary rights, and we may need to resort to litigation to protect or enforce our patents or other intellectual property or the patents or other intellectual property of our licensors, all of which could be expensive, time-consuming and unsuccessful, may delay or prevent the development and commercialization of our approved product and other product candidates, or may put our patents and other proprietary rights at risk.
Risks Related to Our Common Stock
• Dr. Soon-Shiong, our Founder, Executive Chairman, Global Chief Scientific and Medical Officer and principal stockholder, has significant interests in other companies which may conflict with our interests.
• Dr. Soon-Shiong, through his voting control of the company, has the ability to control actions that require stockholder approval.
• Conversion of related-party promissory notes, exercise of outstanding warrants and options to purchase our common stock, the achievement of the milestone under our outstanding CVRs, and potential additional equity issuances may dilute the ownership interest of existing stockholders or may otherwise depress the price of our common stock.
• The market price of our common stock has been and may continue to be volatile, and investors may have difficulty selling their shares.
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Risks Related to Our Financial Condition and Capital Requirements
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.
We are a biotechnology company with a limited operating history as a commercial company upon which you can evaluate our business and prospects regarding the commercialization of our approved product and we have a broad portfolio of product candidates at various stages of development. Prior to the approval of ANKTIVA for commercial sale, we primarily generated revenues from non-exclusive license agreements related to our cell lines, the sale of our bioreactors and related consumables, and grant programs. The company expects to continue to generate revenue from these programs.
In April 2024, the FDA approved ANKTIVA indicated with BCG for the treatment of adult patients with BCG-unresponsive NMIBC with CIS, with or without papillary tumors for commercial sale, and we have begun to generate revenue, although we expect it to take some time to generate sufficient revenue from our approved product to offset expenses. We can provide no assurance when, or if, this will occur. We do not expect additional revenue from our other product candidates unless and until we obtain regulatory approval of and commercialize any of such other product candidates, and we do not know when, or if, this will occur. In addition, we have limited experience and have only recently demonstrated an ability to successfully overcome many of the risks and uncertainties frequently encountered by companies in new and rapidly evolving fields, particularly in the biotechnology industry, including in connection with obtaining marketing approvals, manufacturing a commercial-scale product or arranging for a third party to do so on our behalf, and conducting sales and marketing activities necessary for successful product commercialization. Because of the numerous risks and uncertainties associated with the commercialization of our approved product and other development efforts, we are unable to predict when we may become profitable, if at all.
Since the commencement of our operations, we have incurred significant losses each year, and, as of June 30, 2026, we had an accumulated deficit of $4.6 billion. We expect to continue to incur significant expenses as we seek to expand our business, including in connection with commercializing our approved product globally, conducting research and development across multiple therapeutic areas, participating in clinical trial activities, continuing to acquire or in-license technologies, maintaining, protecting and expanding our intellectual property, seeking regulatory approvals, increasing our manufacturing capabilities and, upon successful receipt of FDA approval, commercializing our other product candidates. Our net losses may fluctuate significantly from quarter-to-quarter and year-to-year based on these variables. Furthermore, the timing and magnitude of sales of our approved product and other revenues remain uncertain and may take a significant amount of time to materialize. Since ANKTIVA is approved for use in combination with BCG (and currently TICE BCG is the only FDA-approved strain of BCG available in the U.S., except for rBCG available in limited quantities through our agreement with Serum Institute pursuant to an EAP), any shortage or supply chain issues associated with TICE BCG could impact the demand for ANKTIVA and our ability to commercialize our approved product.
We also face risks associated with the shift from development to commercialization of new products based on innovative technologies. Our ability to achieve profitability, if ever, is dependent upon, among other things, obtaining regulatory approvals for additional product candidates and successfully commercializing our approved product, and other product candidates alone or with third parties. However, our operations may not become profitable even with commercial sales of our approved product or other product candidates, even if they are successfully developed, approved and thereafter commercialized. Even if we do become profitable, we may not be able to sustain or increase our profitability on a quarterly or annual basis. As a result, it may be more difficult for you to assess our future viability than it could have been if we had a longer operating history.
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We anticipate needing additional financing to fund our operations, complete the commercialization of our approved product, including for efforts to obtain approval for additional indications, conduct clinical trials, and develop and commercialize our other product candidates. If we are unable to obtain such financing when needed or on acceptable terms, we may be unable to successfully commercialize our approved product or develop and commercialize our other product candidates. If we are unable to obtain such financing when needed or on acceptable terms, we could be forced to delay, limit, reduce, or terminate our development programs, commercialization efforts, and/or other operations.
The development of biopharmaceutical products, including conducting preclinical studies and clinical trials, is a very time-consuming, expensive and uncertain process that takes years to complete. Our operations have consumed substantial amounts of cash since inception. A significant portion of our funding has been in the form of related-party promissory notes. As of June 30, 2026, such indebtedness was comprised of a $480.0 million convertible promissory note held by an entity affiliated with Dr. Soon-Shiong.
As of June 30, 2026, we held cash and cash equivalents, and marketable securities totaling $357.4 million. We will need to obtain additional financing to fund our future operations, including the commercialization of our approved product and the development and commercialization of our other product candidates. Changing circumstances may cause us to increase our spending significantly faster than we currently anticipate and we may need to raise additional funds sooner than we presently anticipate. Moreover, research and development and our operating costs and fixed expenses such as rent and other contractual commitments, including those for our research collaborations, are substantial and are expected to increase in the future.
Unless and until we can generate a sufficient amount of revenue, we may finance future cash needs through public or private equity offerings, license agreements, debt financings, collaborations, strategic alliances or marketing and/or distribution arrangements. However, we may be unable to raise additional funds or enter into such other arrangements when needed on favorable terms, or at all.
To the extent that we raise additional capital through the sale of equity or equity-linked securities (including warrants), convertible debt, our shelf registration statements, or other offerings, or if any of our current debt is converted into equity or if our existing warrants are exercised, your ownership interest will be diluted, and the liquidation or other preferences may adversely affect your rights as a stockholder. If we incur additional indebtedness, our fixed payment obligations will increase, and we may have to comply with certain restrictive covenants that are similar to those associated with the RIPA, such as limitations on our ability to incur additional debt, limitations on our ability to acquire or license intellectual property rights and other operating restrictions that could adversely impact our ability to conduct our business. If we raise additional funds through strategic partnerships and alliances and licensing arrangements with third parties, we may have to relinquish valuable rights to our technologies or product candidates, or grant licenses on terms unfavorable to us, or exercise our Call Option (as defined in the RIPA) to purchase the outstanding revenue interest liability, which will require us to generate a significant amount of cash flow to offset these outflows. We have no committed source of additional capital, and if we are unable to raise additional capital in sufficient amounts or on terms acceptable to us, we may be required to delay or reduce the scope of or eliminate one or more of our research or development programs or our commercialization efforts. See “ —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 ” and Note 10 “Revenue Interest Purchase Agreement” of the “Notes to Unaudited Condensed Consolidated Financial Statements” that appears in Part I, Item 1. “Financial Information” of this Quarterly Report for more information. Our current license and collaboration agreements may also be terminated if we are unable to meet the payment obligations under those agreements. As a result, we may seek to access the public or private capital markets whenever conditions are favorable, even if we do not have an immediate need for additional capital at that time.
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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.
On December 29, 2023, we entered into the RIPA with Infinity and Oberland. Pursuant to the RIPA, Oberland acquired certain Revenue Interests from us for a gross purchase price of $200.0 million paid on closing, less certain transaction expenses. In addition, on May 13, 2024, Oberland purchased additional Revenue Interests from us in exchange for a $100.0 million Second Payment, which we requested upon satisfaction of certain conditions specified in the RIPA, including the receipt of approval from the FDA of our BLA for ANKTIVA indicated with BCG for the treatment of adult patients with BCG-unresponsive NMIBC with CIS, with or without papillary tumors on or before June 30, 2024. On March 30, 2026, we entered into an amendment to the RIPA providing for the sale of additional Revenue Interests to Oberland for a gross purchase price of $75.0 million (the “Third Payment”). In consideration for the aforementioned payments, Oberland has the right to receive quarterly Revenue Interest Payments from us based on, among other things, our worldwide net sales, excluding those in China, which are tiered payments ranging from 5.625% to 12.50% (before funding of the Third Payment, 4.50% to 10.00%), subject to increase or decrease, following December 31, 2029 depending on whether the aggregate payments made to Oberland as of that date met or exceeded the Cumulative Purchaser Payments (as defined in the RIPA). In addition, if the aggregate payments to Oberland as of December 31, 2029 do not equal or exceed the amount of the Cumulative Purchaser Payments, then we are obligated to make a one-time payment to Oberland in an amount equal to 100% of the Cumulative Purchaser Payments, less the aggregate amount of our previous payments to Oberland as of December 31, 2029 (the True-Up Payment, as defined in the RIPA). See Note 10 “Revenue Interest Purchase Agreement” of the “Notes to Unaudited Condensed Consolidated Financial Statements” that appears in Part I, Item 1. “Financial Information” of this Quarterly Report for more information.
The RIPA and our payment obligations to Oberland could have important negative consequences to holders of our securities. For example, a portion of our cash flow from operations will be needed to make required payments to Oberland and will not be available to fund future operations.
Payment requirements under the RIPA will increase our cash outflows. Our future operating performance is subject to market conditions and business factors that are beyond our control. If our cash inflows and capital resources are insufficient to allow us to make required payments, we may have to reduce or delay capital expenditures, sell assets or seek additional capital. If we raise funds by selling additional equity, such sales will result in dilution to our stockholders. There is no assurance that if we are required to secure funding we can do so on terms acceptable to us, or at all. Failure to pay amounts owed to Oberland when due would result in a default under the RIPA and could result in foreclosure on all or substantially all of our assets, which would have a material adverse effect on our financial condition and business operations.
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.
The RIPA contains affirmative and negative covenants and events of default, including covenants and restrictions that, among other things, restrict our ability to incur liens, incur additional indebtedness, make loans and investments, enter into transactions with affiliates, engage in mergers and acquisitions, engage in asset sales and exclusive licensing arrangements, and declare dividends to our stockholders, in each case, subject to certain exceptions set forth in the RIPA. Additionally, Oberland has a Put Option enabling them to terminate the RIPA and to require the company to repurchase the Revenue Interests upon enumerated events such as a bankruptcy event, failure to make a payment under the RIPA, an uncured material breach, default on certain third-party agreements, a breach or default under any subordination agreements with respect to indebtedness to existing stockholders, any right to repurchase or accelerate debt instruments like permitted convertible notes, existing stockholder indebtedness, or subordinated notes during certain time periods, judgments in excess of certain amounts against us, a material adverse effect, the loss of regulatory approval of our approved product, or a change of control. The triggering of the Put Option, including by our failure to comply with these covenants, would permit Oberland to declare certain amounts to be immediately due and payable. If we were to default under the terms of the RIPA, including by failure to make such accelerated payments, Oberland could exercise remedies, including initiating foreclosure proceedings against all or substantially all of our assets. Oberland’s right to repayment is senior to the rights of the holders of our common stock. Any triggering of the Put Option or other declaration by Oberland of an event of default under the RIPA could significantly harm our financial condition, business and prospects and could cause the price of our common stock to decline.
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Our debt and revenue interest liability could adversely affect our cash flows and limit our flexibility to raise additional capital.
We have a significant amount of debt and a revenue interest liability and may need to incur additional debt to support our growth. As of June 30, 2026, our indebtedness was comprised of a $480.0 million convertible promissory note held by an entity affiliated with Dr. Soon-Shiong and a revenue interest liability with Oberland under the RIPA in excess of $415.1 million. The total amount paid to Oberland depends on when we repay this debt, and is up to an overall cap of 195.0% of the Cumulative Purchase Payments as defined under the RIPA. See Note 10 “ Revenue Interest Purchase Agreement” of the “Notes to Unaudited Condensed Consolidated Financial Statements” that appears in Part I, Item 1. “Financial Information” of this Quarterly Report for more information.
Our substantial amount of debt could have important consequences and could:
• require us to dedicate a substantial portion of our cash and cash equivalents to make interest and principal payments on our debt and revenue interest liability payments, reducing the availability of our cash and cash equivalents, and cash flow from operations to fund future capital expenditures, working capital, execution of our strategy and other general corporate requirements;
• increase our cost of borrowing and even limit our ability to access additional debt to fund future growth;
• increase our vulnerability to general adverse economic and industry conditions and adverse changes in governmental regulations;
• limit our flexibility in planning for, or reacting to, changes in our business and industry, which may place us at a disadvantage compared with our competitors; and
• limit our ability to borrow additional funds, even when necessary to maintain adequate liquidity, which would also limit our ability to further expand our business.
The occurrence of any of the foregoing factors could have a material adverse effect on our business, results of operations and financial condition.
There can be no assurance that we can refinance the related-party promissory note or revenue interest liability or what terms will be available in the market at the time of refinancing. Furthermore, if prevailing interest rates or other factors at the time of refinancing result in higher interest rates upon refinancing, then the interest expense relating to the refinancing would increase. These risks could materially adversely affect our financial condition, cash flows and results of operations.
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.
In connection with our RDO transactions in the years ended December 31, 2023 and December 31, 2025, we entered into warrant agreements with certain institutional investors that allow such investors to purchase up to an aggregate total of 87,296,311 shares of our common stock, with exercise prices ranging from $3.1010 to $3.2946 per share. As of June 30, 2026, 47,862,136 warrants were exercisable with expiration dates ranging from July 24, 2026 to July 28, 2030. Subsequent to June 30, 2026, a total of 6,399,171 warrants were exercised pursuant to the February and July 2023 warrant agreements at an exercise price of $3.2946 per share. See Part I, Item 2. “Management’s Discussion and Analysis of Financial Condition and Results of Operations— Subsequent Event ” of this Quarterly Report for more information. As of August 4, 2026, 41,462,965 warrants were exercisable under the remaining warrant agreements, with exercise prices ranging from $3.1010 to $3.240 and expiration dates ranging from April 9, 2030 to July 28, 2030.
We account for the warrants as derivative instruments, and changes in the fair value of the warrants are included in other income (expense), net , on the consolidated statement of operations for each reporting period. As of June 30, 2026, the fair value of warrant liabilities included in the consolidated balance sheet was $352.4 million. We use the Black-Scholes option pricing model to determine the fair value of the warrants. As a result, the valuation of these derivative instruments is subjective, and the Black-Scholes option pricing model requires the input of subjective assumptions, including the expected stock price volatility and probability of a fundamental transaction (a strategic merger or sale). Changes in these assumptions can materially affect the fair value estimate. We could, at any point in time, ultimately incur amounts different than the carrying value, which could have a significant impact on our results of operations and financial position.
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We account for the revenue interest liability as a liability, net of a debt discount comprised of deferred issuance costs, the fair value of a freestanding option agreement related to the SPOA, and the fair value of embedded derivatives requiring bifurcation on the consolidated balance sheet. The company imputes interest expense associated with this liability using the effective interest rate method. The effective interest rate is calculated based on the rate that would enable the debt to be repaid in full over the anticipated life of the arrangement. Interest expense is recognized over the estimated term on the consolidated statement of operations. The interest rate on the liability and the underlying value of the bifurcated embedded derivative may vary during the term of the agreement depending on a number of factors, including the level of actual and forecasted net sales, and in the case of the derivative, specific probabilities associated with RIPA Put/Call events or Test Date payments underlying our Monte Carlo Simulation valuation technique. The company evaluates the interest rate quarterly based on actual and forecasted net sales utilizing the prospective method. A significant increase or decrease in actual or forecasted net sales will materially impact the revenue interest liability and/or the bifurcated embedded derivative, interest expense, and the time period for repayment.
Fluctuations in warrant, revenue interest liability, and derivative values, and changes in the assumptions and factors used in the model may impact our operating results, making it difficult to forecast our operating results and making period-to-period comparisons less predictive of future performance. In one or more future quarters, our results of operations may fall below the expectations of securities analysts and investors. In that event, the market price of our common stock could decline. In addition, the market price of our common stock may fluctuate or decline regardless of our operating performance .
Changes in the fair value of our convertible promissory note could have a material effect on our reported financial results.
We entered into a second amended and restated promissory note with Nant Capital on December 10, 2024 in connection with an equity offering. Pursuant to the terms of the second amended and restated promissory note, Tranche 1 of the prior promissory note (the December 2023 Promissory Note) with a principal amount of $125.0 million and Tranche 2 of the December 2023 Promissory Note with a principal amount of $380.0 million were combined into one convertible promissory note with an original principal amount of $505.0 million.
The December 2024 Convertible Promissory Note was accounted for as part of a debt extinguishment in accordance with ASC 470-50 as the terms of the December 2024 Convertible Promissory Note were substantially different than the terms of the December 2023 Promissory Note. The company elected the fair value option of accounting under ASC 825 for the December 2024 Convertible Promissory Note. As a result of the fair value option election, the December 2024 Convertible Promissory Note and the embedded derivative were accounted for as a single instrument in accordance with ASC 815. Changes in fair value of the December 2024 Convertible Promissory Note are recorded as a component of other income (expense), net, on the consolidated statement of operations. There is no current observable market for the December 2024 Convertible Promissory Note and, as such, we determined the fair value by using the binomial lattice model with key assumptions including an expected market yield, an expected volatility, and a risk-free rate. The changes in fair value of the December 2024 Convertible Promissory Note may have a substantial effect and may have a negative impact on our statement of financial position and statement of operations. It is difficult to predict the effect on our future financial results as the significant inputs are outside of our control.
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.
We have typically invested our cash in a variety of financial instruments, including investment-grade short- to intermediate-term corporate debt securities, government-sponsored securities and European bonds; however, under the terms of the RIPA, we can no longer invest our excess funds in corporate or European bonds. Certain of our investments are subject to credit, liquidity, market, and interest rate risk. Such risks, including the failure or severe financial distress of the financial institutions that hold our cash and cash equivalents, and investments, may result in a loss of liquidity, impairment to our investments, realization of substantial future losses, or a complete loss of the investments in the long-term, which may have a material adverse effect on our business, results of operations, liquidity and financial condition. To manage the risk to our investments, we maintain an investment policy that, among other things, limits the amount that we may invest in any one issue or any single issuer and requires us to only invest in high credit quality securities to preserve liquidity.
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Our ability to use NOLs and research and development credits to offset future taxable income may be subject to certain limitations.
In general, under Sections 382 and 383 of the Code, a corporation that undergoes an ownership change is subject to limitations on its ability to utilize its pre-change NOLs or credits to offset future taxable income or taxes. For these purposes, an ownership change generally occurs when the aggregate stock ownership of one or more stockholders or groups of stockholders who own at least 5% of a corporation’s stock increases its ownership by more than 50 percentage points over its lowest ownership percentage within a specified testing period (“ownership change”). We have not conducted a complete study to assess whether an ownership change has occurred or whether there have been multiple ownership changes since inception due to the significant complexity and cost associated with such a study. If we have experienced an ownership change, as defined by Section 382, at any time since inception (including as a result of the March 2021 merger which pursuant to which NantKwest and NantCell combined their businesses ), utilization of the NOL carryforwards or research and development tax credit carryforwards would be subject to an annual limitation under Section 382. Any limitation may result in expiration of a portion of the NOL carryforwards or research and development tax credit carryforwards before utilization. In addition, our NOLs or credits may also be impaired under state law. Accordingly, we may not be able to utilize a material portion of our NOLs or credits.
Since we will need to raise substantial additional funding to finance our operations, we may experience further ownership changes in the future, some of which may be outside of our control. Limits on our ability to use our pre-change NOLs or credits to offset U.S. federal taxable income could potentially result in increased future tax liability to us if we earn net taxable income in the future. In addition, under the legislation commonly referred to as the TCJA, as modified by the Coronavirus Aid, Relief, and Economic Security Act, the amount of NOLs generated in taxable periods beginning after December 31, 2017, that we are permitted to deduct in any taxable year beginning after December 31, 2020 is limited to 80% of our taxable income in such year, where taxable income is determined without regard to the NOL deduction itself. The TCJA allows post-2017 unused NOLs to be carried forward indefinitely. Similar rules apply under state tax laws. In addition, some states may suspend the use of NOL carryovers (e.g., as California has done for taxable years 2024 through 2026) that may result in state taxable income and liabilities.
Our transfer pricing policies may be subject to challenge by the Internal Revenue Service or other taxing authorities.
Our intercompany relationships are subject to complex transfer pricing regulations administered by taxing authorities in various jurisdictions. The relevant tax authorities may disagree with our determinations as to the value of assets sold or acquired or income and expenses attributable to specific jurisdictions. If such a disagreement were to occur, and our position were not sustained, we could be required to pay additional taxes, interest and penalties, which could result in one-time tax charges, higher effective tax rates, reduced cash flows, and lower overall profitability of our operations. We believe that our consolidated financial statements reflect adequate reserves to cover such a contingency, but there can be no assurances in that regard.
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.
The tax laws applicable to our business, including the laws of the U.S. and other jurisdictions, are subject to change, interpretation and certain jurisdictions may aggressively interpret their laws to raise additional tax revenue. It is possible that tax authorities may disagree with certain positions we have taken, are currently taking or will take, and any adverse outcome of such a review or audit could have a negative effect on our financial position and results of operations. Further, the determination of our provision for income taxes and other tax liabilities requires significant judgment by management, and there are transactions where the ultimate tax determination is uncertain. Although we believe that our estimates are reasonable, the ultimate tax outcome may differ from the amounts recorded on the consolidated financial statements and may materially affect our financial results in the period or periods for which such determination is made.
In addition, tax laws are dynamic and subject to change as new laws are passed and new interpretations of the law are issued or applied. For example, in August 2022, the U.S. enacted the IRA, which imposes a 15% minimum tax on the adjusted financial statement income of certain large corporations, as well as a 1% excise tax on corporate stock repurchases by publicly traded companies. Additionally, for taxable years beginning on or after January 1, 2022, the Code eliminated the right to deduct research and development expenditures currently and requires taxpayers to capitalize and amortize U.S. and foreign research and
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development expenditures over 5 and 15 tax years, respectively. However, on July 4, 2025, the U.S. enacted federal tax legislation commonly referred to as the OBBB Act, that revised these rules and permitted the deduction of certain U.S. research and development expenditures incurred in tax years beginning on or after January 1, 2025, while expenditures attributable to research and development conducted outside the U.S. must continue to be capitalized and amortized over a 15-year period. The OBBB Act additionally made changes to the calculation and deductibility of global intangible low-taxed income (renamed Net CFC Tested Income) and foreign-derived intangible income (renamed Foreign-Derived Deduction Eligible Income), in each case, a portion of which is generally deductible for U.S. federal income tax purposes for corporate taxpayers. We have evaluated the impact of the OBBB Act and estimated that the impact to our tax liabilities will not be adverse. Further updates, as well as any other changes to tax laws that are enacted, could adversely affect our tax liability.
The OECD also has proposals regarding the implementation of global minimum tax of at least 15% for multinationals with global revenue exceeding certain thresholds, known as “Pillar Two.” Although these rules are not currently applicable to us, we operate in participating countries that have implemented or are expected to implement these rules. On January 5, 2026, however, the OECD announced a “side-by-side” elective safe harbor that would exempt electing U.S.-parented multinational entities from the 15% global minimum tax for taxable years beginning on or after January 1, 2026. Currently, our expectation is that the Pillar Two structure will not have an adverse effect on the company’s operations outside the U.S. unless the safe harbor is eliminated.
Risks Related to the Discovery, Development and Commercialization of our Approved Product and our Other Product Candidates
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, obtain approval for additional indications, 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.
Now that we have received FDA approval for ANKTIVA indicated with BCG for the treatment of adult patients with BCG-unresponsive NMIBC with CIS, with or without papillary tumors, we have begun to generate revenue, although we expect it to take some time to generate sufficient revenue from our approved product to offset our expenses, and we can provide no assurance when, or if, this will occur. We began commercial distribution of our approved product in May 2024; however, we can provide no assurance with respect to our future revenues, both in terms of amounts and pace, market acceptance, reimbursement from third-party payors, or the profitability of our approved product or any other product candidate for which we may obtain approval. We are required to comply with certain post-marketing commitments, including completion of our QUILT-3.032 clinical trial and annual reporting for up to four years, with a final report submission to FDA by the end of 2029. Our business currently depends heavily on our ability to successfully commercialize ANKTIVA or any future approved products in the U.S. or internationally where we may obtain marketing approval. We may never be able to successfully commercialize our approved product or meet our, or analysts or other third parties’ expectations with respect to revenues. There is no guarantee that the infrastructure, systems, processes, policies, relationships, and materials we have built for the launch and commercialization of our approved product in the U.S. or elsewhere will be sufficient for us to achieve success at the levels we expect.
We may encounter issues and challenges in commercializing our approved product and generating substantial revenues. We may also encounter challenges related to reimbursement of our approved product, including potential limitations in the scope, breadth, availability, or amount of reimbursement covering our approved product. Similarly, healthcare settings or patients may determine that the financial burdens of treatment are not acceptable and as a result physicians may be reluctant to recommend our approved product to their patients. We may face other limitations or issues related to the price of our approved product. Our results may also be negatively impacted if we have not adequately sized our field teams or our physician segmentation and our targeting strategy is inadequate or if we encounter deficiencies or inefficiencies in our infrastructure or processes. Other factors that may hinder our ability to successfully commercialize approved product, or any of our other product candidates if or when approved and generate substantial revenues, include:
• the acceptance of our approved product by patients and the medical community, including industry groups and third-party payors;
• the ability of our third-party manufacturer(s) to manufacture commercial supplies of our approved product at acceptable costs, to remain in good standing with regulatory agencies, and to maintain commercially viable manufacturing processes that are, to the extent required, compliant with cGMP regulations;
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• our ability to remain compliant with laws and regulations that apply to us and our commercial activities;
• FDA-mandated package-insert requirements and successful completion of FDA post-marketing requirements;
• the actual market size for our approved product, which may be different than expected;
• the length of time that patients who are prescribed our drug remain on treatment;
• our ability to obtain and maintain marketing approval for our approved product outside of the U.S.;
• the sufficiency of our drug supply to meet commercial and clinical demands, which could be negatively impacted if our projections regarding the potential number of patients are inaccurate, we are subject to unanticipated regulatory requirements, or our current drug supply is destroyed, or negatively impacted at our manufacturing sites, storage sites, or in transit;
• the availability of reimbursement for our approved product and physicians’ understanding regarding the same;
• our ability to effectively compete with other therapies that may emerge for the treatment of bladder cancer; and
• our ability to maintain, enforce, and defend third party challenges to our intellectual property rights in and to our approved product or any of our other product candidates.
Any of these issues could impair our ability to successfully commercialize our approved product or to generate substantial revenues or profits or to meet our expectations with respect to the amount or timing of revenues or profits. Any issues or hurdles related to our commercialization efforts may materially adversely affect our business, results of operations, financial condition, and prospects. There is no guarantee that we will be successful in our launch or commercialization efforts with respect to our approved product. We may also experience significant fluctuations in sales of our approved product from period to period and, ultimately, we may never generate sufficient revenues from our approved product to reach or maintain profitability or sustain our anticipated levels of operations. Any inability on our part to successfully commercialize our approved product in the U.S., and any other international markets where it may subsequently be approved, or any significant delay, could have a material adverse impact on our ability to execute upon our business strategy.
In addition, while we have pursued additional regulatory submissions in the first quarter of 2026, such as a refiling of our sBLA after a submission in 2025 for BCG-unresponsive NMIBC patients in the papillary indication for which we received a PDUFA target action date of January 6, 2027, and are pursuing and anticipating certain additional regulatory submissions in 2026 and beyond following ongoing discussions with the FDA and other international regulatory agencies, the regulatory review process is dynamic and highly uncertain. Even if we are able to prepare and submit these regulatory submissions on the anticipated timeline, there can be no assurance that the FDA will accept the BLAs and other regulatory submissions for filing and review, and there can be no assurance that the FDA will ultimately approve such BLAs and submissions if accepted for filing and review.
For example, on May 2, 2025, we received an RTF letter from the FDA for the sBLA we submitted for use of ANKTIVA indicated with BCG in BCG-unresponsive NMIBC patients in the papillary indication stating that an RCT and an initial Pediatric Study Plan were required. We believed the RTF letter to be inconsistent with guidance received from members of FDA leadership during a January 2025 meeting to submit the sBLA based on the single-arm QUILT-3.032 trial, and notwithstanding this guidance, the FDA maintained that an RCT against chemotherapy was required at a June 2025 meeting held to discuss the RTF letter. We provided certain new data at the meeting.
After a series of productive meetings, a December 2025 Type B meeting with senior FDA officials was held. Topics included current standards of care, challenges associated with chemotherapy, patient management considerations, and perspectives on the interpretation of the company’s data. BCG-unresponsive disease remains a serious condition, with risks of progression to muscle-invasiveness disease, higher mortality, and limited bladder-sparing treatment options for patients. After the meeting, the Agency recommended submitting certain additional information to support a filing and review of the sBLA.
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In May 2026, we announced that the FDA had accepted for review the sBLA for ANKTIVA indicated with BCG for the treatment of adult patients with BCG-unresponsive NMIBC with papillary disease without CIS and assigned a PDUFA target action date of January 6, 2027. There can be no assurance that the FDA will ultimately approve our sBLA. Further, the FDA’s “real-time” release of newly issued CRLs, if applicable to any of our product candidates, could materially impact our competitive advantage and intellectual property.
Further, we have invested a significant portion of our efforts and financial resources in the development of ANKTIVA, our novel antibody-cytokine fusion protein , and our other product candidates, s econd-generation hAd5 vaccine candidates, and our NK cell therapy candidates. Our other product candidates will require additional clinical and non-clinical development, regulatory approval, commercial manufacturing arrangements, enhancement of our commercial organization and service providers, significant marketing efforts, and further investment before we can generate any revenue from the sale of these other potential products. We expect to invest heavily in our other current product candidates and in any future product candidates that we may develop. Our product candidates are susceptible to the risks of failure inherent at any stage of product development, including the appearance of unexpected adverse events or failure to achieve primary endpoints in clinical trials. Furthermore, we cannot assure you that we will meet our timelines for current or future clinical trials, including post-market study requirements for our approved product, which may be delayed or not completed for a number of reasons. Additionally, our ability to generate revenues from our approved product and any other combination therapy products will depend on the availability of the other therapies used in combination therewith, including BCG, with which our approved product and other product candidates are intended to be used. In particular, there has been a shortage of TICE BCG in the U.S. According to the American Urological Association, Merck & Co., Inc. is the sole manufacturer and supplier of TICE BCG in the U.S. and many other countries around the world. Increasing demand for BCG has led to U.S. supply constraints for TICE BCG, which has provided a market headwind in our ongoing commercial launch activities and which could materially impact the demand for our approved product and our ability to commercialize our approved product, and our efforts to introduce alternative sources of BCG in connection with our collaboration with Serum Institute and a development and supply agreement for the U.S. with JBL for Tokyo-172 BCG may not ultimately be successful in addressing this supply shortage.
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 recently began commercializing our approved product in the U.S. As a company, we have no prior experience commercializing a product. The success of our commercialization efforts for our approved product and any future approved products is difficult to predict and subject to the effective execution of our business plan, including, among other things, the continued development of our internal and external sales, marketing, and distribution capabilities and our ability to navigate the significant expenses and risks involved with the development and management of such capabilities.
For example, we have hired and contracted for service providers in areas to support commercialization, including in sales management, sales representatives, marketing, access and reimbursement, sales support, and distribution. There are significant expenses and risks involved with establishing and maintaining our sales, marketing, and distribution capabilities, including our ability to hire or contract, retain, and appropriately incentivize qualified individuals, provide adequate training to sales and marketing personnel, and effectively manage geographically dispersed sales and marketing teams to generate sufficient demand. Any failure or delay in the development and maintenance of these capabilities could delay or negatively affect the success of our commercialization efforts and our business. For example, the commercialization of our approved product may not develop as planned or anticipated, which may require us to, among others, adjust or amend our business plan and incur significant expenses.
Further, given our lack of experience commercializing products, we do not have a track record of successfully executing on the commercialization of an approved product. If we are unsuccessful in accomplishing our objectives and executing on our business plan, or if the commercialization of our approved product does not develop as quickly as planned, or any future approved products does not develop as planned, we may require significant additional capital and financial resources, we may not become profitable, and we may not be able to compete against more established companies in our industry.
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We have developed an approved product and are developing other product candidates in combination with other therapies, which expose us to additional risks.
We have developed an approved product and are developing other product candidates in combination with one or more other therapies. We are studying ANKTIVA therapy along with other products and product candidates, such as BCG, CPIs, hAd5 tumor-associated antigens, PD-L1 t-haNK, and M-ceNK. Since we have developed a product, or if we choose to develop other products for use in combination with an approved therapy, we are subject to the risk that the FDA, EMA or comparable foreign regulatory authorities in other jurisdictions could revoke approval of, or that safety, efficacy, manufacturing or supply issues could arise with the therapy used in combination with our approved product or our other product candidates. In particular, supply chain issues or shortages of other products used in combination with our approved product or any other product candidates could impact our ability to obtain FDA regulatory approval, meet clinical trial timelines, and commercialize our approved product or other product candidates. The FDA may require us to use more complex clinical trial designs in order to evaluate the contribution of each product and product candidate to any observed effects. To the extent that we do not have rights to already approved products, this may require us to work with another company to satisfy such a requirement or increase our cost of development. It is possible that the results of these trials could show that any positive results are attributable to the already approved product. Following product approval, the FDA may require that products used in conjunction with each other be cross labeled for combined use. If the therapies we use in combination with our approved product or our other product candidates are replaced as the standard of care for the indications we choose for our approved product or any of our other product candidates, the FDA or comparable foreign regulatory authorities may require us to conduct additional clinical trials. The occurrence of any of these risks could result in our own products, if approved, being removed from the market or being less successful commercially.
In addition, unapproved therapies face the same risks described with respect to our product candidates currently in development and clinical trials, including the potential for serious adverse effects, delays in clinical trials and lack of FDA approval. If the FDA or comparable foreign regulatory authorities do not approve or revoke their approval of these other therapies, or if safety, efficacy, quality, manufacturing or supply issues arise with, the therapies we choose to evaluate in combination with any of our product candidates, we may be unable to obtain approval of or market such other combination therapies.
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.
Our research and development programs of our other non-FDA-approved product candidates and ANKTIVA in new, non-FDA-approved indications, are at various stages of development. The clinical trials of our product candidates as well as the manufacturing and marketing of our product candidates will be subject to extensive and rigorous review and regulation by numerous government authorities in the U.S. and in other countries where we intend to test and market our product candidates. Before obtaining regulatory approvals for the commercial sale of any of our other product candidates, we must demonstrate through lengthy, complex, and expensive preclinical testing and clinical trials that our product candidates are safe, pure, and potent for use in their target indications. Each product candidate must demonstrate an adequate risk versus benefit profile in its intended patient population and for its intended use. The risk/benefit profile required for product licensure will vary depending on these factors and may include not only the ability to show tumor shrinkage, but also adequate duration of response, a delay in the progression of the disease, and/or an improvement in survival. For example, response rates from the use of our product candidates or their contribution of effect may not be sufficient to obtain regulatory approval unless we can also show an adequate duration of response. The clinical trials for our product candidates under development and ANKTIVA in new, non-FDA-approved indications, may not be completed on schedule, and regulatory authorities may ultimately disagree with our chosen endpoints or may find that our studies or study results do not support product approval. The FDA or foreign regulatory authorities may not interpret the results as we do or accept the therapeutic effects as valid endpoints in clinical trials necessary for market approval, or they may find that our clinical trial design or conduct does not meet the applicable approval requirement, and more trials could be required before we submit our product candidates for approval. Success in early clinical trials does not ensure that large-scale clinical trials will be successful, nor does it predict final results. Product candidates in later stages of clinical trials may fail to show the desired safety, tolerability, and efficacy traits despite having progressed through preclinical studies and initial clinical trials and after reviewing test results, we or our collaborators may abandon projects that we might previously have believed to be promising.
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In addition, we do not have data on possible harmful long-term effects of our product candidates and do not expect to have this data in the near future. As a result, our ability to generate clinical safety and effectiveness data sufficient to support submission of a marketing application or commercialization of our product candidates is uncertain and is subject to significant risk.
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.
There is an ongoing shortage of TICE BCG in the U.S., which has provided a market headwind in our ongoing commercial launch activities and may further adversely impact market uptake and the total addressable market of our approved product. The TICE BCG shortage may impact the number of patients who are treated with BCG for NMIBC with CIS, with or without papillary tumors, therefore limiting the pool of BCG-unresponsive patients who may be candidates for our approved product through both the use of chemotherapy in the first-line setting and also reducing the number of patients who may have been treated with an adequate amount of BCG to be considered BCG unresponsive. In addition, the TICE BCG shortage may also constrain the number of patients we can treat with our approved product since our product is administered in combination with BCG. In addition, ANKTIVA was awarded Fast Track designation by the FDA for the treatment of BCG-naïve NMIBC. We are currently running a Phase 2B randomized, two-cohort, open-label, multi-center trial of intravesical BCG with ANKTIVA versus BCG alone, in BCG-naïve patients with high-risk NMIBC with CIS (Cohort A) and NMIBC with papillary tumors (Cohort B), which is impacted by the availability of TICE BCG. If we do not complete new trials in a timely manner, our ability to generate clinical safety and effectiveness data sufficient to support submission of a marketing application or commercialization of our product candidates in new indications could harm our business, operating results, prospects or financial condition. In addition, our efforts to introduce alternative sources of BCG in connection with our collaboration with Serum Institute (including an EAP approved by the FDA) and a development and supply agreement for the U.S. with JBL for Tokyo-172 BCG and ultimately obtain regulatory approval for such alternative BCG supply may not be successful in mitigating the TICE BCG shortage, or at all.
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.
We do not have sufficient resources to pursue development of all or even a substantial portion of the potential opportunities that we believe will be afforded to us by our product candidates. Because we have limited resources and access to capital to fund our operations, our management must make strategic decisions as to which product candidates and indications to pursue and how much of our resources to allocate to each. Our management must also evaluate the benefits of developing in‑licensed or jointly owned technologies, which in some circumstances we may be contractually obligated to pursue, relative to developing other product candidates, indications or programs. Our management has broad discretion to suspend, scale down, or discontinue any or all of these development efforts, or to initiate new programs to treat other diseases. If we select and commit resources to opportunities that we are unable to successfully develop, or we forego more promising opportunities, our business, financial condition, and results of operations will be adversely affected.
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.
Since our approved product, current product candidates, and any future product candidates represent novel approaches to treating various conditions, it may be difficult to accurately estimate the potential revenues from our approved product and these other product candidates. Accordingly, we may spend significant capital trying to successfully commercialize our approved product or obtain approval for our other product candidates that have an uncertain commercial market. Our projections of addressable patient populations that may benefit from treatment with our approved product or other product candidates are based on our beliefs and estimates of the therapeutic benefit and adverse event profile of our approved product and other product candidates. These estimates, which have been derived from a variety of sources, including scientific literature, preclinical and clinical studies, surveys of clinics, patient foundations, or market research by third parties, may prove to be incorrect. Further, new studies or approvals of new therapeutics may change the estimated incidence or prevalence of these diseases. The number of patients may turn out to be lower than expected. Additionally, the potentially addressable patient population for our approved product or other product candidates may be limited or may not be amenable to treatment with our approved product or other product candidates and may also be limited by the cost of our treatments and the reimbursement of those treatment costs by third-party payors. Even if we obtain significant market share for our approved product or other product candidates, because the potential target populations may be small, we may never achieve profitability without obtaining regulatory approval for additional indications.
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There can be no assurance that we will complete strategic partnerships on acceptable terms, or at all.
We continue to execute and explore international strategic partnerships for the commercialization of ANKTIVA for certain indications, including new commercial partnerships with Accord Healthcare in the EU, and Cigalah Healthcare and Biopharma in the Middle East. Factors that may impact our ability, or decision, to enter into such strategic partnerships, include, without limitation, the put/call features of the RIPA that may be triggered by entry into strategic partnerships depending on their scope and terms, and ultimately there can be no assurance that we will complete transactions on acceptable terms, or at all. If we do not execute strategic partnerships in the near-term, it could eliminate or delay a potential source of near-term revenue or funding, and may impact our ability to raise additional funds to meet our business needs. In addition, there are significant risks involved with building and managing a commercial infrastructure on a stand-alone basis, which could materialize in the event we do not execute strategic partnerships, or depending on the geographic scope of any partnership.
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.
From time to time, we may publicly disclose preliminary, interim, or top-line data from our preclinical studies and clinical trials, which are based on preliminary analyses of then-available data, and the results and related findings and conclusions are subject to change following a more comprehensive review of the data related to the particular study or trial. Interim data from clinical trials that we may complete are subject to the risk that one or more of the clinical outcomes may materially change as patient enrollment continues and more patient data become available or as patients from our clinical trials continue other treatments for their disease, or as inclusion and exclusion criteria is discussed with regulators. We also may make assumptions, estimations, calculations, and conclusions as part of our analyses of data, and we may not have received or had the opportunity to evaluate all data fully and carefully. As a result, the interim, top-line, or preliminary results that we report may differ from future results of the same studies, or different conclusions or considerations may qualify such results once additional data has been received and fully evaluated. Top-line data also remains subject to audit and verification procedures that may result in the final data being materially different from the preliminary data we previously published. As a result, top-line data should be viewed with caution until the final data are available. Adverse differences between preliminary or interim data and final data could significantly harm our business prospects. Further, disclosure of interim data by us or by our competitors could result in volatility in the price of our common stock.
In addition, the information we choose to publicly disclose regarding a particular study or clinical trial is typically selected from a more extensive amount of available information, and you or others may not agree with what we determine is material or otherwise appropriate information to include in our disclosure. If the interim, top-line, or preliminary data that we report differ from actual results, or if others, including regulatory authorities, disagree with the conclusions reached, our ability to obtain approval for, and commercialize, our product candidates may be harmed, which could harm our business, operating results, prospects or financial condition.
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.
We cannot guarantee that any current or future clinical trials will be conducted as planned or completed on schedule, if at all, or that any of our other product candidates will receive regulatory approval. A failure of one or more clinical trials can occur at any stage of the clinical trial process, other events may cause us to stop a clinical trial temporarily or permanently, and our future clinical trials may not be successful.
Because our current product candidates include, and we expect our future product candidates to include, candidates based on advanced therapy technologies, we expect that they will require extensive research and development and have substantial manufacturing costs. In addition, costs to treat patients and to treat potential side effects that may result from our product candidates can be significant. Some clinical trial sites may not bill, or obtain coverage from Medicare, Medicaid, or other third-party payors for some or all of these costs for patients enrolled in our clinical trials, and clinical trial sites outside of the U.S. may not reimburse for costs typically covered by third-party payors in the U.S. As a result, we may be required by those trial sites to pay such costs. Accordingly, our clinical trial costs are likely to be significantly higher per patient than those of more conventional therapeutic technologies or drug products.
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Collaborations with other entities may be subject to additional delays because of the management of the trials, contract negotiations, the need to obtain agreement from multiple parties, and the necessity of obtaining additional approvals for therapeutics used in the combination trials. These combination therapies will require additional testing and clinical trials will require additional FDA approval and will increase our future costs.
Any inability to successfully complete preclinical and clinical development could result in additional costs to us, slow down our product development and approval process, or impair our ability to commence product sales and generate revenues. In addition, if we make manufacturing changes to our approved product or other product candidates, we may be required to, or we may elect to, conduct additional trials to bridge our modified approved product or other product candidates to earlier versions. These changes may require FDA approval or notification and may not have their desired effect. The FDA may also not accept data from prior versions of the product to support an application, delaying our clinical trials or programs or necessitating additional clinical trials or preclinical studies. We may find that this change has unintended consequences that necessitates additional development and manufacturing work, additional clinical and preclinical studies, or that results in an RTF letter or non-approval of a BLA and/or NDA.
Clinical trial delays could shorten any period during which our product candidates have patent protection and may allow our competitors to bring products to market before we do, which could impair our ability to successfully commercialize our product candidates and may harm our business and results of operations. In addition, we have in the past experienced clinical holds imposed upon certain of our or investigator-led clinical trials for various reasons, and we may experience further clinical trial holds in the future. If we fail to commence or complete, or experience delays in, any of our planned clinical trials, our stock price and our ability to conduct our business as currently planned could be harmed.
If we are required by the FDA or any equivalent foreign regulatory authority to perform clinical trials or studies in addition to those we currently expect to conduct, or if there are any delays in completing the clinical trials of our other product candidates, our expenses could increase substantially.
As result of the FDA approval of ANKTIVA indicated with BCG for the treatment of adult patients with BCG-unresponsive NMIBC with CIS, with or without papillary tumors, we are required to comply with certain post-marketing commitments, including completion of our QUILT-3.032 clinical trial and annual reporting for up to four years, with a final report submission to the FDA by the end of 2029.
Even if more of our product candidates are approved and commercialized, we may not become profitable.
If approved for marketing by applicable regulatory authorities, our ability to generate revenues from our other product candidates will depend on our ability to:
• price our other product candidates competitively such that third-party and government reimbursement leads to broad product adoption;
• prepare a broad network of clinical sites for administration of our other product candidates;
• create market demand for our other product candidates through our own or our partner’s marketing and sales activities, and any other arrangements to promote these product candidates that we may otherwise establish;
• receive regulatory approval for the targeted patient population(s) and claims that are necessary or desirable for successful marketing;
• manufacture our other product candidates through third-party CMOs or in our own manufacturing facilities or facilities owned by entities affiliated with Dr. Soon-Shiong in sufficient quantities and at acceptable quality and manufacturing cost to meet regulatory requirements and commercial demand at launch and thereafter;
• establish and maintain agreements with wholesalers, distributors, pharmacies, and group purchasing organizations on commercially reasonable terms;
• obtain, maintain, protect, and enforce patent and other intellectual property protection and regulatory exclusivity for our other product candidates;
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• successfully commercialize any of our other product candidates that receive regulatory approval;
• maintain compliance with applicable laws, regulations, and guidance specific to commercialization including interactions with health care professionals, patient advocacy groups, and communication of health care economic information to payors and formularies;
• achieve market acceptance of our other product candidates by patients, the medical community, and third-party payors;
• achieve appropriate reimbursement for our product candidates;
• maintain a distribution and logistics network capable of product storage within our specifications and regulatory guidelines, and further capable of timely product delivery to commercial clinical sites;
• effectively compete with other therapies or competitors; and
• following launch, ensure that our approved product will be used as directed and that additional unexpected safety risks will not arise.
We can provide no assurance with respect to the profitability or the market share that we might achieve for our product candidates, if approved. The target patient population for which we obtain approval may be narrower than we expect. Additionally, we may not be able to obtain the labeling claims necessary or desirable for the promotion of our approved product. Further, supply chain issues or shortages associated with combination products that may be used with our approved product, such as ANKTIVA in combination with BCG, may limit the demand for our approved product.
We are also party to agreements that may require substantial payments upon the occurrence of certain milestones. As an example, in connection with our 2017 acquisition of Altor, we issued CVRs under which we agreed to pay the prior stockholders of Altor approximately $304.0 million of contingent consideration upon calendar-year worldwide net sales of ANKTIVA exceed ing $1.0 billion prior to December 31, 2026 with amounts payable in cash or shares of our common stock or a combination thereof. As of June 30, 2026, Dr. Soon-Shiong and his related party hold approximately $139.8 million of net sales CVRs, and they have both irrevocably agreed to receive shares of the company’s common stock in satisfaction of their CVRs. We may be required to pay the other prior Altor stockholders up to $164.2 million for their net sales CVRs should they choose to have their CVRs paid in cash instead of common stock. If this were to occur, we may need to seek additional sources of capital and any such financing activities may be restricted by the covenants included in the terms of the RIPA. As such, we may face difficulties raising additional capital and may have to accept unfavorable terms and as a result, we may not be able to achieve profitability or positive cash flow.
In connection with our financing in December 2023, we entered into the RIPA with Infinity and Oberland. Oberland has the right to receive quarterly Revenue Interest Payments from us based on, among other things, our worldwide net sales, excluding those in China, which are tiered payments ranging from 5.625% to 12.50% (before funding of the Third Payment, 4.5% to 10.0%), subject to increase or decrease, following the Test Date depending on whether our aggregate payments made to Oberland as of the Test Date have met or exceeded the Cumulative Purchaser Payments. In addition, if our aggregate payments made as of the Test Date to Oberland do not equal or exceed the amount of the Cumulative Purchaser Payments as of such date, then we are obligated to make a one-time payment True-Up Payment as described above. In addition to other considerations of the RIPA and the associated impact to our profitability and cash flow, if we were required to make a True-Up Payment, we may need to seek additional sources of capital, and we may not be able to achieve profitability or positive cash flow.
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.
The timely completion of clinical trials in accordance with their protocols depends, among other things, on our ability to enroll a sufficient number of patients who remain in the trial until its conclusion. At times we work with CROs, and our internal teams or CROs may experience difficulties or delays in patient enrollment and retention in our clinical trials for a variety of reasons.
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Because the number of qualified clinical investigators is limited, we may need to conduct some of our clinical trials at the same clinical trial sites that some of our competitors use, which will reduce the number of patients who are available for our clinical trials at such clinical trial sites. In addition, in the past we have engaged, and we intend to continue to engage, in clinical trial efforts outside of the U.S., which gives rise to additional potential complexity and challenges, and further reliance upon third parties in foreign jurisdictions. Moreover, because our product candidates represent a departure from more commonly used methods for cancer and/or viral disease treatment, potential patients and their doctors may be inclined to use conventional therapies, such as chemotherapy and approved immunotherapies that have established safety and efficacy profiles, rather than enroll patients in any future clinical trial.
Delays or failures in planned patient enrollment or retention may result in increased costs or may affect the timing or outcome of the planned clinical trials, which could prevent completion of these trials and adversely affect our ability to advance the development of our product candidates or could render further development impossible.
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.
Results of our trials could reveal a high and unacceptable severity and prevalence of side effects, adverse events or unexpected characteristics. Combination immunotherapy that includes our current product candidates may be associated with more frequent adverse events or additional adverse events. Undesirable side effects or unacceptable toxicities caused by our other product candidates could cause us or regulatory authorities to interrupt, delay or halt clinical trials or order our clinical trials to be placed on clinical hold, and could result in a more restrictive label or the delay or denial of regulatory approval by the FDA or other regulatory authorities for any or all targeted indications. The FDA or comparable foreign regulatory authorities may also require additional data, clinical trials, or preclinical studies should unacceptable toxicities arise. We may need to abandon development or limit development of that product candidate to certain uses or subpopulations in which the undesirable side effects or other characteristics are less prevalent, less severe, or more acceptable from a risk/benefit perspective. Even if we were to receive product approval, such approval could be contingent on inclusion of unfavorable information in our product labeling, such as limitations on the indicated uses for which the products may be marketed or distributed, a label with significant safety warnings, including boxed warnings, contraindications, and precautions, a label without statements necessary or desirable for successful commercialization, or requirements for costly post marketing testing and surveillance, or other requirements, including a REMS to monitor the safety or efficacy of the products, and in turn prevent us from commercializing and generating revenues from the sale of our current or future product candidates. In addition, these serious adverse effects may not be appropriately recognized or managed by the treating medical staff, as toxicities resulting from our other product candidates are not normally encountered in the general patient population and by medical personnel. They may have difficulty observing patients and treating toxicities, which may be more challenging due to personnel changes, shift changes, house staff coverage or related issues. This could lead to more severe or prolonged toxicities or even patient deaths, which could result in us or the FDA delaying, suspending or terminating one or more of our clinical trials and which could jeopardize regulatory approval. Any of these occurrences may materially harm our business, financial condition and prospects.
The manufacture of our approved product and other product candidates is complex, and we may encounter difficulties in production, particularly with respect to process development, quality control, cGMP compliance, or scaling-up of our manufacturing capabilities. If we or our related parties, or any of our third-party manufacturers, encounter such difficulties, our ability to gain approval, or to provide adequate supply of our product candidates for clinical trials or our products for patients, if approved, could be delayed or stopped, or we may be unable to maintain a commercially viable cost structure.
The manufacture of our approved product and other product candidates involves complex processes, especially for our biologics, vectors and cell therapy product candidates, which are complex, highly regulated and subject to multiple risks. As a result of the complexities, the cost to manufacture biologics, vectors, and cell therapies is generally higher than traditional small molecule chemical compounds, and the manufacturing process is less reliable and is more difficult to reproduce. The manufacture of fusion proteins, DNA and vaccine vectors, and cell therapy products require significant expertise and capital investment, including the development of advanced manufacturing techniques and process controls. Manufacturers of cell therapy products
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often encounter difficulties in production, particularly in scaling up initial production. These problems include difficulties with production costs and yields, quality control, including stability of the product or other product candidates and quality assurance testing, shortages of qualified personnel, and compliance with strictly enforced federal, state, local, and foreign regulations. We may also find that the manufacture of our approved product or other product candidates is more difficult than anticipated, resulting in an inability to produce a sufficient amount of our other product candidates for our clinical trials or, if approved, commercial supply. Even minor deviations from normal manufacturing processes could result in reduced production yields, product defects, and other supply disruptions. Our approved product and other product candidates are manufactured using processes developed or modified by us, our affiliates, or by our third-party collaborators that we may not utilize for more advanced clinical trials or commercialization.
Currently we manufacture our approved product and other product candidates in our own manufacturing facilities, facilities owned by entities affiliated with Dr. Soon-Shiong and/or through third-party CMOs. Our clinical trials will need to be conducted with product candidates and materials that were produced under cGMP and/or GTP regulations, which are enforced by regulatory authorities. Our approved product and other product candidates may compete with other products and product candidates for access to manufacturing facilities. Moreover, because of the complexity and novelty of our manufacturing process, there are only a limited number of manufacturers that operate under cGMP regulations and that are both capable of manufacturing our approved product and other product candidates for us and willing to do so. If our third-party CMOs cease manufacturing for us, we would experience delays in obtaining sufficient quantities of our approved product for commercial supply and other product candidates for clinical trials and, if approved, commercial supply of such future products. Further, our third-party CMOs may breach, terminate, or not renew our agreements with them. If we were to need to find alternative manufacturing facilities or transfer between existing facilities it may take us significant time to find a replacement, if we are able to find a replacement at all and it would significantly impact our ability to develop, obtain regulatory approval for or market our approved product and/or other product candidates, if approved. The commercial terms of any new arrangement could be less favorable than our existing arrangements and the expenses relating to the transfer of necessary technology and processes could be significant.
We and our suppliers and third-party CMOs must maintain compliance with cGMP requirements and other applicable regulatory requirements. Any failure to comply with these regulations may require us to cease sales of our approved product or repeat clinical trials, which would delay the regulatory review process of our other product candidates. We may not be able to demonstrate sufficient comparability between products manufactured in different runs at the same or at different facilities to allow for inclusion of the clinical results from patients treated with products from these different runs, in our product registrations or to ensure a cGMP process to qualify our other product candidates.
We are also required to register certain clinical trials and post the results of certain completed clinical trials on a government-sponsored database, ClinicalTrials.gov, within specified timeframes. Failure to do so could result in enforcement actions and adverse publicity.
Reliance on third-party manufacturers entails exposure to risks to which we would not be subject if we manufactured the product candidate ourselves, including:
• ability to negotiate manufacturing and quality agreements with third parties under commercially reasonable terms;
• reduced day-to-day control over the manufacturing process for our other product candidates as a result of using third-party manufacturers for all aspects of manufacturing activities;
• reduced control over the protection of our trade secrets, know-how, and other proprietary information from misappropriation or inadvertent disclosure or from being used in such a way as to expose us to potential litigation;
• termination or non-renewal of manufacturing agreements with third parties in a manner or at a time that may be costly or damaging to us or result in delays in the development or commercialization of our approved product or other product candidates; and
• disruptions to the operations of our third-party manufacturers or suppliers caused by conditions unrelated to our business or operations, including the bankruptcy or personnel turnover at the manufacturer or supplier.
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Moreover, any problems or delays we or our third-party CMOs experience in preparing for commercial scale manufacturing of a product candidate may result in a delay in the FDA approval of the product candidate or may impair our ability to manufacture commercial quantities or such quantities at an acceptable cost, which could result in the delay, prevention, or impairment of clinical development and commercialization of our product candidates and could adversely affect our business. Furthermore, if we or our third-party CMOs fail to deliver the required commercial quantities of our product candidates on a timely basis and at reasonable costs, we would likely be unable to meet demand for our products and we would lose potential revenues. We may ultimately be unable to reduce the cost of goods for our other product candidates to levels that will allow for an attractive return on investment if and when those product candidates are commercialized.
In addition, the manufacturing process and facilities for our approved product and any other products that we may develop are subject to FDA and foreign regulatory authority approval processes, and we or our third-party CMOs will need to meet all applicable FDA and foreign regulatory authority requirements, including cGMP, on an ongoing basis. cGMP requirements include quality control, quality assurance and the maintenance of records and documentation. The FDA and other regulatory authorities enforce these requirements through facility inspections. Manufacturing facilities must submit to pre-approval inspections by the FDA that will be conducted after we submit our marketing applications, including BLAs and NDAs, to the FDA. Manufacturers are also subject to continuing FDA and other regulatory authority inspections following marketing approval. Further, we and our third-party CMOs must supply all necessary Chemistry, Manufacturing and Controls documentation in support of a BLA or NDA on a timely basis. Our or our third-party CMOs’ manufacturing facilities may be unable to comply with our specifications, cGMP, and with other FDA, state, and foreign regulatory requirements, and there is no guarantee that we or our third-party CMOs will be able to successfully pass all aspects of a pre-approval or continued inspection by the FDA or other foreign regulatory authorities. For example, on May 9, 2023 the FDA delivered a CRL to us regarding the BLA filed in May 2022, indicating that the FDA had determined that it could not approve the original BLA submission in its initial form, and the FDA made recommendations to address the issues raised. The deficiencies in the CRL related to the FDA’s pre-license inspection of the company’s third-party CMOs, among other items. The CRL we received in response to our initial BLA submission required us to resubmit the BLA to the FDA addressing the issues in the CRL, resulting in additional expense and delay. In April 2024, the FDA approved ANKTIVA indicated with BCG for the treatment of adult patients with BCG-unresponsive NMIBC with CIS, with or without papillary tumors.
Poor control of production processes can lead to the introduction of adventitious agents or other contaminants, or to inadvertent changes in the properties or stability of our product or other product candidates that may not be detectable in final product testing. If microbial, viral, environmental, or other contaminants are discovered in our product or other product candidates or in the manufacturing facilities in which our product or other product candidates are made, such manufacturing facilities may need to be closed for an extended period of time to investigate and remedy the contamination which could delay commercial sales and clinical trials and adversely harm our business. If we or our third-party CMOs are unable to reliably produce products to specifications acceptable to the FDA or other regulatory authorities, or in accordance with the strict regulatory requirements, we may not obtain or maintain the initial or continued approvals we need to commercialize such products. There is no assurance that either we or our third-party CMOs will be able to manufacture our approved product or any subsequently approved product candidate to specifications acceptable to the FDA or other regulatory authorities, to produce our product or other product candidates in sufficient quantities to meet the requirements for the launch of such products, or to meet potential future demand.
Deviations from manufacturing requirements may further require remedial measures that may be costly and/or time-consuming for us or a third party to implement and may include the temporary or permanent suspension of a clinical trial or commercial sales or the temporary or permanent closure of a facility. Any such remedial measures imposed upon us or third parties with whom we contract could materially harm our business.
As product candidates progress through preclinical and clinical trials to marketing approval and commercialization, it is common that various aspects of the development program, such as manufacturing methods and formulation, are altered along the way in an effort to optimize yield and manufacturing batch size, minimize costs and achieve consistent quality and results. Such changes carry the risk that they will not achieve these intended objectives. Any of these changes could cause our product or other product candidates to perform differently and affect our commercial sales or the results of planned clinical trials or other future clinical trials conducted with the altered materials. This could cause commercial sales to cease, delay completion of clinical trials, require the conduct of bridging clinical trials or the repetition of one or more clinical trials, increase clinical trial costs, delay approval of our product candidates, and jeopardize our ability to commercialize our other product candidates, if approved, and generate revenues.
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To the extent we use third-party CMOs, we are ultimately responsible for the manufacture of our products, once approved, and our other product candidates. A failure to comply with these requirements may result in regulatory enforcement actions against our manufacturers or us, including fines and civil and criminal penalties, which could result in imprisonment, suspension or restrictions of production, injunctions, delay or denial of product approval or supplements to approved products, clinical holds or termination of clinical trials, FDA Form 483s, warning or untitled letters, regulatory authority communications warning the public about safety issues with the biologic, refusal to permit the import or export of the products, product seizure, detention, or recall, operating restrictions, suits under the federal civil FCA, corporate integrity agreements, consent decrees, or withdrawal of product approval, certain of which we have received before, including but not limited to the previously disclosed untitled letters and the March 2026 FDA OPDP warning letter described elsewhere in this Quarterly Report.
Any of these challenges could cause us to cease commercial sales, delay completion of clinical trials, require bridging clinical trials or the repetition of one or more clinical trials, increase clinical trial costs, delay approval of our product candidate, impair commercialization efforts, increase our cost of goods, and have a material adverse effect on our business, financial condition, results of operations and growth prospects.
We may not be successful in managing the build-out of our manufacturing facilities and associated costs or satisfying manufacturing-related regulatory requirements.
We have entered into facility leases for our planned manufacturing operations and related activities under which we are responsible for the build-out of the facility space and associated costs. The build-out of these facilities and related equipment purchases are complex and specialized and will involve substantial capital expenditures, and it could take longer, and cost more, than currently expected. Significant delays and/or cost overruns would result in higher expenditures and could be disruptive to operations, any of which could have an impact on our operations and financial condition. For example, we have a leasehold interest in the Dunkirk Facility as described below. We will need to plan and fund the additional build-out of, and purchase additional equipment for, the Dunkirk Facility in connection with our plan for full manufacturing operations. In addition, it is possible that, once built, the leased facilities may prove to be less conducive to our operations than is currently anticipated, resulting in operational inefficiencies or similar difficulties that could prove difficult or impossible to remediate and result in an adverse impact on our financial condition or results of operations.
We also may not successfully realize the anticipated benefits from the capital expenditures at such facilities based on factors such as delays and uncertainties regarding development, regulatory approval, and commercialization of our product candidates, as well as the potential to lose access to the leased facilities.
Further, in the future if we transition from our current third-party CMOs to our own manufacturing facilities, or to alternative third-party CMOs, for one or more of our products or other product candidates, including our approved product, we will need to conduct additional preclinical, analytical and/or clinical testing and obtain FDA approval before such manufacturing changes are implemented. If we are unsuccessful in demonstrating the comparability of supplies before and after a manufacturing change, such manufacturing change can result in a delay or disruption in our clinical development plan or our ability to commercialize any approved product. Any production shortfall that impairs the supply of our product or other product candidates could negatively impact our ability to sell our approved product, complete clinical trials, obtain regulatory approval, and commercialize our other product candidates. A product shortfall could have a material adverse effect on our business, financial condition and results of operations and adversely affect our ability to satisfy demand for our product or other product candidates, which could materially and adversely affect our revenue and results of operations.
In addition, our planned operations, including our development, testing, and future manufacturing activities, are subject to numerous environmental, health, and safety laws and regulations. These laws and regulations govern, among other things, the controlled use, handling, release, and disposal of and the maintenance of a registry for, hazardous materials and biological materials, such as chemical solvents, human cells, carcinogenic compounds, mutagenic compounds, and compounds that may have a toxic effect on reproduction, laboratory procedures and exposure to blood-borne pathogens. If we fail to comply with such laws and regulations, we could be subject to fines or other sanctions. Failure to successfully complete our build-outs and successfully operate our planned manufacturing facilities and satisfy manufacturing-related regulatory requirements could adversely affect the commercial viability of our product candidates and our business.
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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.
We currently depend on a small number of suppliers for some of the materials used in, and processes required to develop, our approved product and other product candidates. For some of these reagents, equipment, and materials used in the manufacture of our approved product and other product candidates, we rely and we may in the future rely on sole source vendors or a limited number of vendors. Some of these suppliers may not have the capacity to support commercial scale or clinical trials and commercial products manufactured under cGMP by biopharmaceutical firms or may otherwise be ill-equipped to support our needs. We also do not have supply contracts with many of these suppliers and may not be able to obtain supply contracts with them on acceptable terms or at all. Accordingly, we may experience delays in receiving key materials and equipment to support clinical or commercial manufacturing. An inability to continue to source product from any of these suppliers could adversely affect our ability to satisfy demand for our approved product and other product candidates, which could adversely and materially affect our product sales and operating results or our ability to conduct clinical trials, either of which could significantly harm our business.
If any supplier with whom we contract fails to perform its obligations, we may be forced to enter into an agreement with a different supplier, which we may not be able to do on reasonable terms, if at all. In such scenario, our product could be delayed significantly as we establish alternative supply sources. In some cases, the technical skills required to manufacture our product or product candidates may be unique or proprietary to the original supplier and we may have difficulty, or there may be contractual restrictions prohibiting us from, transferring such skills to a back-up or alternate supplier, or we may be unable to transfer such skills at all. In addition, if we are required to change suppliers for any reason, we will be required to verify that the new supplier maintains facilities and procedures that comply with quality standards and with all applicable regulations. We will also need to verify that any new manufacturing process will produce our product according to the specifications previously submitted to the FDA or another regulatory authority. This process or re-qualification could take considerable time or resources, and any delay in the availability of product could significantly harm our business.
As we seek to develop and scale our manufacturing process, we expect that we will need to obtain rights to and supplies of certain materials and equipment to be used as part of that process. We may not be able to obtain rights to such materials on commercially reasonable terms, or at all, and if we are unable to alter our process in a commercially viable manner to avoid the use of such materials or find a suitable substitute, it would have a material adverse effect on our business. Even if we are able to alter our process so as to use other materials or equipment, such a change may lead to a delay in our clinical development and/or commercialization plans. If such a change occurs for a product candidate that is already in clinical testing, the change may require us to perform both ex vivo comparability studies and to collect additional data from patients prior to undertaking more advanced clinical trials.
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.
Human immunotherapy products are a new category of therapeutics. We use relatively novel technologies involving ANKTIVA, hAd5 constructs, and cell-based therapies, and our NK cell platform utilizes a relatively novel technology involving the genetic modification of human cells and utilization of those modified cells in other individuals. Because this is a relatively new and expanding area of novel therapeutic interventions, there are many uncertainties related to development, marketing, reimbursement, and the commercial potential for our approved product and other product candidates. There can be no assurance as to the length of the trial period, the number of patients the FDA will require to be enrolled in the trials in order to establish the safety, efficacy, purity and potency of immunotherapy products, or that the data generated in these trials will be acceptable to the FDA to support marketing approval. Adverse public attitudes may adversely impact our ability to enroll patients in clinical trials. The FDA may take longer than usual to come to a decision on any BLA and/or NDA that we submit and may ultimately
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determine that there is not enough data, information, or experience with our product candidates to support an approval decision. The FDA may also require that we conduct additional post-marketing studies or implement risk management programs, such as REMS, until more experience with our other product candidates is obtained. Finally, after increased usage, we may find that our product or other product candidates do not have the intended effect, do not work with other combination therapies or have unanticipated side effects, potentially jeopardizing initial or continuing regulatory approval and commercial prospects. More restrictive government regulations or negative public opinion could have an adverse effect on our business or financial condition and may delay or impair the commercialization of our approved product and development and commercialization of our product candidates or demand for our product or any products we may develop. Adverse events in our clinical trials, even if not ultimately attributable to our product candidates, and the resulting publicity could result in increased governmental regulation, unfavorable public perception, potential regulatory delays in the testing or approval of our potential product candidates, stricter labeling requirements for those product candidates that are approved and a decrease in demand for any such product candidates.
There is no assurance that the approaches offered by our approved product or other product candidates will gain broad acceptance among doctors or patients or that governmental agencies or third-party medical insurers will be willing to provide reimbursement coverage for our proposed product candidates. Public perception may be influenced by claims, such as claims that our technologies are unsafe, unethical or immoral and, consequently, our approach may not gain the acceptance of the public or the medical community. Negative public reaction to cell-based immunotherapy in general could result in greater government regulation and stricter labeling requirements of immunotherapy products, including our other product candidates, and could cause a decrease in the demand for our approved product and any other products we may develop. Moreover, our success will depend upon physicians specializing in the treatment of those diseases that our product or other product candidates target prescribing, and their patients being willing to receive treatments that involve the use of our product or other product candidates in lieu of, or in addition to, existing treatments they are already familiar with and for which greater clinical data may be available. The market for any products that we successfully develop will also depend on the cost of the products. Our goal is to reduce the cost of manufacturing and providing our therapies. However, unless we can reduce those costs to an acceptable amount, we may never be able to develop a commercially viable product. If we do not successfully develop and commercialize products based upon our approach or find suitable and economical sources for materials used in the production of our product or potential products, we will not become profitable, which would materially and adversely affect the value of our common stock. ANKTIVA and our other therapies may be provided to patients in combination with other agents provided by third parties or our affiliates. The cost of such combination therapy may increase the overall cost of therapy and may result in issues regarding the allocation of reimbursements between our therapy and the other agents, all of which may affect our ability to obtain reimbursement coverage for the combination therapy from governmental or private third-party medical insurers.
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 face an inherent risk of product liability as a result of the commercialization of our approved product and clinical development, testing and manufacturing of our other product candidates. For example, we may be sued if our approved product or other product candidates cause or are perceived to cause injury or are found to be otherwise unsuitable during clinical testing, manufacturing, marketing or sale. Any such product liability claim may include allegations of defects in manufacturing, defects in design, a failure to warn of dangers inherent in the product, negligence, strict liability, or a breach of warranties. Claims could also be asserted under state consumer protection acts. Large judgments have been awarded in class action lawsuits based on therapeutics that had unanticipated side effects. If we cannot successfully defend ourselves against product liability claims, we may incur substantial liabilities or be required to limit commercialization of our approved product or other product candidates. Even successful defense would require significant financial and management resources. Regardless of the merits or eventual outcome, liability claims may result in a regulatory investigation of the safety and effectiveness of our products, our third-party manufacturer’s manufacturing processes and facilities or our marketing programs and potentially a recall of our products or more serious enforcement action, including limitations on the approved indications for which our product candidates may be used or suspension or withdrawal of approvals, decreased demand for our products, injury to our reputation, costs to defend the related litigation, a diversion of management’s time and our resources, substantial monetary awards to trial participants or patients and a decline in our stock price.
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Our inability to obtain sufficient product liability insurance at an acceptable cost to protect against potential product liability claims could prevent or inhibit the commercialization of our approved product or other products we may develop, alone or with corporate collaborators. Our insurance policies may also have various exclusions, and we may be subject to product liability claims for which we have no coverage. While we have obtained clinical trial insurance for our clinical trials, we may have to pay amounts awarded by a court or negotiated in a settlement that exceed our coverage limitations or that are not covered by our insurance, and we may not have, or be able to obtain, sufficient capital to pay such amounts. Even if our agreements with any future corporate collaborators entitle us to indemnification against losses, such indemnification may not be available or adequate should any claim arise.
We will face significant competition from other biotechnology and pharmaceutical companies and from non-profit institutions.
Competition in the field of cancer and infectious disease therapy is intense and is accentuated by the rapid pace of technological development. We compete with a variety of multi-national biopharmaceutical companies and specialized biotechnology companies, as well as technology being developed at universities and other research institutions. These competitors have developed, may develop, and are developing product candidates and processes competitive with our approved product or other product candidates. Research and discoveries by others may result in breakthroughs which may render our approved product or other product candidates obsolete even before they generate any revenues. We believe that a significant number of products are currently under development, and may become commercially available in the future, for the treatment of conditions for which our product treats or for which we are developing product candidates. Many of our competitors have several therapeutic products that have already been developed, approved and successfully commercialized, or are in the process of obtaining regulatory approval for their therapeutic products in the U.S. and internationally. Many of our competitors, either alone or with their strategic partners, have substantially greater financial, technical, and human resources than we do, as well as significantly greater experience in the discovery and development of product candidates, obtaining FDA and other regulatory approvals of treatments and commercializing those treatments. Accordingly, our competitors may be more successful in obtaining approval of treatments and achieving widespread market acceptance, rendering our treatments obsolete or non-competitive, possibly even before we are able to enter the market. Accelerated merger and acquisition activity in the biotechnology and biopharmaceutical industries may result in even more resources being concentrated among a smaller number of our competitors. Smaller or early-stage companies may also prove to be significant competitors, particularly through collaborative arrangements with large and established companies. These third parties compete with us in recruiting and retaining qualified scientific and management personnel and establishing clinical trial sites and patient registration for clinical trials, as well as in acquiring technologies complementary to, or necessary for, our programs.
The availability and price of our competitors’ products could limit the demand and the price we are able to charge for our approved product or any of our other product candidates, if approved. The level of generic competition and the availability of reimbursement from government and other third-party payors will also significantly affect the pricing and competitiveness of our products.
We may not be able to implement our business plan if the acceptance of our approved product or other product candidates is inhibited by price competition or the reluctance of physicians to switch from other methods of treatment to our approved product, or if physicians switch to other new therapies, drugs or biological products or choose to reserve our products for use in limited circumstances. We may be adversely impacted if any of these competitors gain market share as a result of new technologies, commercialization strategies or otherwise.
We may seek orphan drug status or Breakthrough Therapy, Fast Track or RMAT designations or other designation from the FDA or comparable non-U.S. regulatory authorities for one or more of our product candidates, but even if any such designation or status is granted, it may not lead to a faster development process or regulatory review and may not increase the likelihood that our product candidates will receive marketing approval, and we may be subject to significant costs including those associated with EAPs, and be unable to maintain any benefits associated with such designations or status, including market exclusivity.
We have been awarded Breakthrough Therapy and RMAT designations, and may seek in the future such designations for current or future product candidates. Receipt of a designation to facilitate product candidate development is within the discretion of the FDA. Accordingly, even if we believe one of our product candidates meets the criteria for a designation, the FDA may disagree. If we are unable to obtain such approval, we may be required to conduct additional preclinical studies or clinical trials beyond those that we contemplate, which could increase the expense of obtaining, and delay the receipt of, necessary marketing
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approvals. In any event, the receipt of such a designation for our product candidates may not result in a faster development process, review, or approval compared to product candidates considered for approval under conventional FDA procedures and does not ensure ultimate marketing approval by the FDA. In addition, the FDA may later decide that the product candidates no longer meet the designation conditions. See Part I, Item 1. “ Business—Government Regulation—BLA/NDA Submission and Review by the FDA” of our Annual Report filed with the SEC on February 23, 2026 for additional information regarding these designations.
Accelerated approval, if granted, is usually contingent on the sponsor’s agreement to conduct, in a diligent manner, additional post-approval confirmatory studies to verify and describe the drug’s clinical benefit, and the FDA is permitted to require, as appropriate, that such studies be underway prior to approval or within a specified period after the date of approval. Sponsors must also update the FDA on the status of these studies, and the FDA has increased authority to withdraw approval of a drug granted accelerated approval on an expedited basis if the sponsor fails to conduct such studies in a timely manner, or send the necessary updates to the FDA, or if such post-approval studies fail to verify the drug’s predicted clinical benefit. Prior to seeking accelerated approval, we will seek feedback from the FDA or comparable non-U.S. regulatory authorities and will otherwise evaluate our ability to seek and receive such accelerated approval. There can be no assurance that after our evaluation of the feedback and other factors we will decide to pursue or submit a BLA for accelerated approval or any other form of expedited development, review or approval. Similarly, there can be no assurance that after subsequent feedback from the FDA or comparable non-U.S. regulatory authorities, we will continue to pursue or apply for accelerated approval or any other form of expedited development, review or approval, even if we initially decide to do so. Furthermore, if we decide to submit an application for accelerated approval, there can be no assurance that such application will be accepted or that any approval will be granted on a timely basis, or at all. The FDA or other comparable non-U.S. regulatory authorities could also require us to provide expensive investigational drug at non-commercial pricing or at no cost as part of a designation-associated required EAP. The FDA or other comparable non-U.S. regulatory authorities could also require us to conduct further studies prior to considering our application or granting approval of any type, including, for example, if other products are approved via the accelerated pathway and subsequently converted by FDA to full approval. A failure to obtain accelerated approval or any other form of expedited development, review or approval for our product candidate would result in a longer time period to commercialization of such product candidate, could increase the cost of development of such product candidate, and could harm our competitive position in the marketplace. Moreover, even if we are able to obtain accelerated approval for any of our product candidates, there is no guarantee that post-approval studies will be able to confirm the clinical benefit, which could cause the FDA to withdraw our approval.
Under the Orphan Drug Act, the FDA may grant orphan designation to a drug or biologic intended to treat a rare disease or condition or for which there is no reasonable expectation that the cost of developing and making available the drug or biologic will be recovered from sales in the U.S. If a product that has orphan drug designation subsequently receives the first FDA approval for the disease for which it has such designation, the product is entitled to orphan product exclusivity, which means that the FDA may not approve any other applications, including a full BLA to market the same drug or biologic for the same approved use or indication for seven years, except in limited circumstances. We may seek orphan drug status for one or more of our product candidates, but exclusive marketing rights in the U.S. may be lost if we seek approval for an indication broader than the orphan designated indication and may be lost if the FDA later determines that the request for designation was materially defective or if we are unable to assure sufficient quantities of the product to meet the needs of patients with the rare disease or condition. In response to Catalyst Pharms., Inc. v. Becerra , 14 F.4th 1299 (11th Cir. 2021), the FDA clarified in a January 2023 notice that it intends to continue to apply its longstanding interpretation of the regulations to matters outside of the scope of the Catalyst order. The Consolidated Appropriations Act of 2026, signed into law in February 2026, codified this longstanding FDA interpretation of the Orphan Drug Act, allowing the FDA to approve multiple versions of the same orphan drug for different sub-indications and subpopulations.
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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.
As a condition of biologic licensing, the FDA is authorized to require that sponsors of approved BLAs implement various post-market requirements, including REMS and Phase 4 trials. In connection with the regulatory approval of ANKTIVA indicated with BCG for the treatment of adult patients with BCG-unresponsive NMIBC with CIS, with or without papillary tumors, we are required to comply with certain post-marketing commitments, including completion of our QUILT-3.032 clinical trial and annual reporting for up to four years, with a final report submission to the FDA by the end of 2029. If we receive approval of our other product candidates, the FDA may determine that similar or additional or more burdensome post-approval requirements are necessary to ensure that our product candidates are safe, pure and potent. For example, in connection with FDA approval of another company’s drug, the FDA required significant post-marketing commitments, including a Phase 4 trial, revalidation of a test method, and a substantial REMS program that included, among other requirements, the certification of hospitals and their associated clinics that dispensed the drug, including the implementation of a training program and limited distribution only to certified hospitals and their associated clinics. To the extent that we are required to establish and implement any post-approval requirements, we will likely need to invest a significant amount of time, effort and money. Such post-approval requirements may also limit the commercial prospects of our product candidates.
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.
We have little to no prior experience in the marketing, sale and distribution of biopharmaceutical products. To achieve commercial success for our approved product and other product candidates, which we may license to others, we may rely on the assistance and guidance of those collaborators. In order to commercialize our approved product and our other product candidates for which we retain commercialization rights and marketing approval, if approved, we must continue to build out our marketing, sales and distribution capabilities, including a comprehensive healthcare compliance program, and/or arrange with third parties to perform these services, which will continue to take time and require significant financial expenditures, and could delay any product launch and we may not be successful in doing so. There are significant risks involved with building and managing a commercial infrastructure. We, our collaborators and third-party contractors, have to compete with other pharmaceutical and biotechnology companies to recruit, hire, train, manage and retain medical affairs, marketing, sales and commercial support personnel. Recruiting, training, and retaining a sales force is expensive and time-consuming and could delay any product launch. If the commercial launch of our approved product or any other product candidate for which we or our third-party contractors recruit a sales force and establish marketing capabilities is delayed or does not occur for any reason, we would have incurred these commercialization expenses prematurely or unnecessarily. These efforts may be costly, and our investment would be lost if we cannot retain or reposition our sales and marketing personnel. In the event we are unable to develop a commercial infrastructure, we may not be able to commercialize our current or future product candidates, which would limit our ability to generate product revenues. Even if we and/or our potential partners and/or third-party contractors are able to effectively establish a sales force and develop a marketing and sales infrastructure, such sales force and marketing teams may not be successful in commercializing our approved product or any other current or future product candidates. To the extent we rely on third parties to commercialize any products for which we obtain regulatory approval, which we are doing to a certain extent in connection with our approved product launch, we may have less control over their sales efforts and could be held liable if they failed to comply with applicable legal or regulatory requirements.
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.
We are in the process of commercializing our approved product. Our approved product and other product candidates, if approved by the appropriate regulatory authorities for marketing and sale, may not gain acceptance among physicians, patients, third-party payors, and others in the medical community. If our approved product or any other product candidate for which we obtain regulatory approval does not gain an adequate level of market acceptance, we may not generate significant product revenues or become profitable. Market acceptance of our approved product or any other product candidates by the medical community, patients and third-party payors will depend on a number of factors, some of which are beyond our control. For example, physicians are often reluctant to switch their patients, and patients may be reluctant to switch from existing therapies even when new and potentially more effective or safer treatments enter the market. Efforts to educate the medical community and
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third-party payors on the benefits of our approved product and other product candidates may require significant resources and may not be successful. Even if the medical community accepts that our approved product and other product candidates are safe and effective for their approved indications, physicians and patients may not immediately be receptive to such approved product or other product candidates and may be slow to adopt them as an accepted treatment of the approved indications, including, for example, if third-party payors require high co-payments or if physicians perceive that reimbursement will not be available on a timely basis or at all. If our product or any of our other product candidates is approved but does not achieve an adequate level of market acceptance, we may not generate significant revenues and we may not become profitable. The degree of market acceptance of our approved product or any of our other product candidates will depend on a number of factors, including:
• the continued safety and efficacy of our approved product or other product candidates;
• the prevalence and severity of adverse events associated with such approved product or other product candidates;
• the clinical indications for which the products are approved and the approved claims that we may make for the products;
• limitations or warnings contained in the product’s FDA-approved labeling, including potential limitations or warnings for such products that may be more restrictive than other competitive products or distribution and use restrictions imposed by the FDA with respect to such approved product or other product candidates or to which we agree as part of a mandatory REMS or voluntary risk management plan;
• changes in the standard of care for the targeted indications for such approved product or other product candidates;
• the relative difficulty of administration of our approved product or other product candidates;
• our ability to offer our approved product or other product candidates for sale at competitive prices, including the cost of treatment versus economic and clinical benefit in relation to alternative treatments or therapies;
• the availability of adequate coverage or reimbursement by third parties, such as insurance companies and other healthcare payors, and by government healthcare programs, including Medicare and Medicaid;
• the extent and strength of our marketing and distribution of such approved product or other product candidates;
• the safety, efficacy and other potential advantages over, and availability of, alternative treatments already used or that may later be approved for any of our intended indications;
• the timing of market introduction of our approved product or other product candidates and the availability of combination products like BCG, as well as competitive products;
• the willingness of the target patient population to try new therapies and of physicians to prescribe these therapies;
• the extent and strength of our third-party manufacturer and supplier support;
• adverse publicity about the product or favorable publicity about competitive products; and
• potential product liability claims.
If our approved product or any other product candidate that we commercialize fails to achieve market acceptance, it could have a material and adverse effect on our business, financial condition, results of operations, and prospects.
Our approved product and our product candidates may face competition sooner than anticipated.
The enactment of the BPCIA created an abbreviated approval pathway for biological products that are biosimilar to or interchangeable with an FDA-licensed reference biological product. Under the BPCIA, the FDA cannot make an approval of an application for a biosimilar product effective until 12 years after the original branded product was approved under a BLA. Certain changes, however, and supplements to an approved BLA, and subsequent applications filed by the same sponsor, manufacturer, licensor, predecessor in interest or other related entity do not qualify for the 12-year exclusivity period.
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Our approved product and/or product candidates may qualify for the BPCIA’s 12-year period of exclusivity. There is a risk that any product candidates we may develop that are approved as a biological product under a BLA would not qualify for the 12-year period of exclusivity or that this exclusivity could be shortened due to congressional action or otherwise, or that the FDA will not consider our approved product or any other product candidates we may develop to be reference products for competing products, potentially creating the opportunity for generic competition sooner than anticipated. Additionally, this period of regulatory exclusivity does not block companies pursuing regulatory approval via their own traditional BLA, rather than via the abbreviated pathway. Even if we receive a period of BPCIA exclusivity for our approved product, if subsequent products do not include a modification to the structure of the product that impacts safety, purity, or potency, we may not receive additional periods of exclusivity for those products. Moreover, the extent to which a biosimilar, once approved, will be substituted for any one of our reference product candidates in a way that is similar to traditional generic substitution for non-biological products is subject to state pharmacy law. Medicare Part B encourages use of biosimilars by paying the provider the same percentage of the reference product average sale price as a mark-up, regardless of which product is reimbursed. It is also possible that payors will give reimbursement preference to biosimilars even over reference biologics absent a determination of interchangeability.
For our small molecular product candidates, if qualified, the regulatory exclusivity period is less than for our biological product candidates. The FD&C Act provides a five-year period of non-patent marketing exclusivity within the U.S. to the first applicant to gain approval of an NDA for a drug where the FDA has not previously approved any other new drug containing the same active molecule or ion responsible for the action of the drug substance. During the exclusivity period, the FDA may not accept for review an abbreviated NDA or a 505(b)(2) NDA submitted by another company for a generic version of such drug where the applicant does not own or have a legal right of reference to all the data required for approval. However, an application may be submitted after four years if it contains a certification of patent invalidity or non-infringement. The FD&C Act also provides three years of marketing exclusivity for an NDA, 505(b)(2) NDA or supplement to an existing NDA if new clinical investigations, other than bioavailability studies, which were conducted or sponsored by the applicant are deemed by the FDA to be essential to the approval of the application, for example, new indications, dosages or strengths of an existing drug. As such, we may face competition from generic versions of our small molecule product candidates, which will negatively impact our long-term business prospects and marketing opportunities.
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.
Any name we intend to use for our product candidates in the U.S. will require approval from the FDA regardless of whether we have secured a formal trademark registration from the USPTO. The FDA typically conducts a review of proposed product names, including an evaluation of the potential for confusion with other product names. The FDA may also object to a product name if it believes the name inappropriately implies medical claims or contributes to an overstatement of efficacy. If the FDA objects to any of our proposed product names, we may be required to adopt alternative names for our product candidates. If we adopt alternative names, we will lose the benefit of any existing trademark applications for such product candidate and may be required to expend significant additional resources in an effort to identify a suitable product name that would qualify under applicable trademark laws, not infringe or otherwise violate the existing rights of third parties, and be acceptable to the FDA. We may be unable to build a successful brand identity for a new product name in a timely manner or at all, which would limit our ability to commercialize our product candidates.
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.
We are and will be dependent upon information technology systems, infrastructure, and data. In the ordinary course of our business, we will directly or indirectly collect, store, transmit, and otherwise process sensitive and confidential information, including intellectual property, preclinical, and clinical trial data, proprietary business information, and personal information of our clinical trial patients and employees, including in our data centers and on our systems and networks or on those of third parties. The secure maintenance, transmission, and processing of data is critical to our operations. The multitude and complexity of our systems and those of our CROs, CMOs, clinical sites, or other contractors or consultants may subject them to various threats, including interruption, destruction, malicious intrusion, and random attack. Privacy or security breaches or other incidents, including by third parties, employees, contractors or others, may pose a risk that sensitive or confidential information, including our intellectual property, trade secrets or personal information of our employees, patients, or other business partners may be exposed to unauthorized persons or to the public. Further, as many of our employees work remotely, our reliance on our and third-party systems has increased substantially and is expected to continue to increase.
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Despite the implementation of security measures, our systems, infrastructure and data, and those of our CROs, CMOs, clinical sites and other contractors and consultants, are subject to risks relating to cyberattacks, security breaches, or other incidents, including through viruses and other malware, employee error, unauthorized access, natural disasters, terrorism, war, fire, telecommunication and electrical failures, denial of service attacks, social engineering (including phishing attacks) and other means. As the cyberthreat landscape evolves, these cyberattacks are increasing in their frequency, sophistication and intensity and are becoming increasingly difficult to detect. The techniques used by cybercriminals change frequently, may not be recognized until launched and can originate from a wide variety of sources, including outside groups such as external service providers, organized crime affiliates, terrorist organizations or hostile foreign governments or agencies. Cyberattacks affect service reliability and threaten data confidentiality, integrity and availability. While we and our shared services partner, NantWorks, have invested, and continue to invest, in the protection of our data, systems, and infrastructure, there can be no assurance that our efforts, or the efforts of our partners, vendors, CROs, CMOs, clinical sites and other contractors and consultants, will be successful. Any failure or perceived failure in our systems, infrastructure or data, or to identify or prevent cyberattacks, security breaches or other incidents, including service interruptions could adversely affect our business and operations, result in the loss, unavailability, misuse, unauthorized use or acquisition, or other unauthorized processing of critical or sensitive information, and result in financial, legal, business or reputational harm. In addition, while we maintain cyber-liability insurance, our insurance may not be sufficient in type or amount to cover us against claims related to any such failures, security breaches, cyberattacks or other incidents, and there may be other losses that could potentially result from a service interruption, breach of our systems or loss of our critical or sensitive data not covered by such insurance.
If any such event were to occur, it could also cause interruptions in our operations, including a disruption of our product development programs. For example, the loss, corruption, or unavailability of clinical trial data from completed or ongoing clinical trials for a product candidate could result in delays in our regulatory approval efforts and significantly increase our costs to recover or reproduce the data or may limit our ability to effectively execute a product recall, if required. Any such event could result in liability, delays in the development and commercialization of product candidates, claims, demands or proceedings initiated by regulatory authorities or private parties, violations of laws, including laws that protect the privacy or security of personal information, significant liabilities, including regulatory penalties, and damage to our reputation and a loss of confidence in us and our ability to conduct clinical trials. In addition, we are adopting and exploring the use of AI in our business, and as an emerging and rapidly evolving technology, our use of AI introduces potential opportunities but also presents risks that could adversely affect our operations, information security and reputation. AI systems may produce inaccurate or flawed outputs due to flawed algorithms, or insufficient and/or erroneous training data. Reliance on flawed outputs could result in lower quality decision-making or prevent us from effectively utilizing AI in our business. We may also become vulnerable to operational disruptions if the AI technologies we use experience downtimes or are compromised by cyberattacks. If we do not effectively implement guardrails and train our staff on the safe and proper use of AI, or if our staff fail to effectively adhere to our established guardrails and training on the use of AI, we may experience adverse effects on our business, including data breaches, the loss of confidential information (including our intellectual property), unintentional disclosure of personal data, or other misuse of our proprietary information.
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.
Public health outbreaks, such as epidemics or pandemics may significantly disrupt our business. Such outbreaks pose the risk that we or our employees, contractors, suppliers, and other partners may be prevented from conducting business activities for an indefinite period of time due to the spread of the disease, due to shutdowns that may be requested or mandated by federal, state, and local governmental authorities or certain employers, or due to the economic consequences associated with the pandemic. Business disruptions could include disruptions or restrictions on our ability to travel, as well as temporary closures of our facilities and the facilities of our partners, clinical trial sites, service providers, suppliers, or contract manufacturers. For example, the COVID-19 pandemic caused a temporary disruption in our ability to recruit participants for our clinical trials in the calendar year 2020 and the first quarter of 2021. While it is not possible to predict whether another pandemic, epidemic, or infectious disease outbreak similar to COVID-19 will materialize, any measures taken by governments and local authorities in response to such future health crises have the potential to disrupt and delay the initiation of new clinical trials, the progress of our ongoing clinical trials and our preclinical activities, and potentially the manufacture or shipment of both drug substance and finished drug product of our approved product and our other product candidates for preclinical testing and clinical trials, may adversely impact our business, financial condition, or operating results.
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Risks Related to Reliance on Third Parties
We have relied and will continue to rely on third parties and related parties to conduct some of our preclinical studies and clinical trials, manufacture our approved product and other product candidates, and perform many essential services for any products that we commercialize, including services related to sales and marketing, distribution, government price reporting, customer service, accounts receivable management, cash collection and adverse event reporting. Any failure by a third party, related party, or us to perform as expected, comply with legal and regulatory requirements, manufacture products in compliance with cGMP, or conduct clinical trials according to GCP guidelines, and in a timely manner, may delay or prevent our ability to commercialize ANKTIVA internationally, to seek or obtain incremental regulatory approvals for ANKTIVA or our other product candidates, or may subject us to regulatory sanctions.
We have relied and will continue to rely on third parties and related parties to conduct some of our preclinical studies and clinical trials, manufacture our approved product and other product candidates, and perform many essential services for any products that we commercialize, including services related to sales and marketing, distribution, government price reporting, customer service, accounts receivable management, cash collection and adverse event reporting. Any failure by a third party, related party, or us to perform as expected, comply with legal and regulatory requirements, manufacture products in compliance with cGMP, or conduct clinical trials according to GCP guidelines, and in a timely manner, may delay or prevent our ability to commercialize ANKTIVA internationally, to seek or obtain incremental regulatory approvals for ANKTIVA or our other product candidates, or may subject us to regulatory sanctions.
Large-scale clinical trials require significant financial and management resources. We expect to be heavily reliant on third and related parties, including medical institutions, academic institutions, clinical investigators or CROs to conduct, supervise or monitor some or all aspects of our clinical trials, and in some cases, third-party CMOs to manufacture our approved product or other product candidates, which may force us to encounter delays and challenges that are outside of our control. Nevertheless, we are responsible for ensuring that each of our trials is conducted in accordance with the applicable trial protocol and legal, regulatory and scientific standards, and our reliance on CROs, clinical trial sites, and other third parties does not relieve us of these responsibilities. Our CROs and other third parties must communicate and coordinate with one another in order for our trials to be successful. We have a limited history of conducting clinical trials and have limited experience as a company in submitting and supporting the applications necessary to gain marketing approvals. Our relative lack of experience conducting clinical trials may contribute to our planned clinical trials not beginning or completing on time, if at all. Securing marketing approval also requires the submission of information about the product manufacturing process to, and inspection of manufacturing facilities and clinical trial sites by, applicable regulatory authorities.
For example, we will remain responsible for ensuring that each of our clinical trials is conducted in accordance with the general investigational plan and protocols for the trial and for ensuring that our preclinical studies are conducted in accordance with Good Laboratory Practice guidelines, as appropriate. Moreover, the FDA and comparable foreign regulatory authorities require us and the third parties upon which we intend to rely for conducting our clinical trials to comply with GCP guidelines for conducting, recording, and reporting the results of clinical trials to assure that data and reported results are credible and accurate and that the rights, integrity, and confidentiality of trial participants are protected. Regulatory authorities enforce these requirements through periodic inspections (including pre-approval inspections once a BLA or NDA is filed with the FDA) of trial sponsors, clinical investigators, trial sites, and certain third parties including CMOs. If we, our CROs, clinical trial sites, or other third parties fail to comply with applicable GCP guidelines or other regulatory requirements, we or they may be subject to enforcement or other legal actions, the clinical data generated in our clinical trials may be deemed unreliable and have to be repeated, and our submission of marketing applications may be delayed or the FDA or comparable foreign regulatory authorities may require us to perform additional clinical trials before approving our marketing applications. We cannot assure you that upon inspection by a given regulatory authority, such regulatory authority will determine that any of our clinical trials comply with GCP guidelines.
We rely on third parties to manufacture, package, label, and ship our approved product and some of our other product candidates for the clinical trials that we conduct. Any performance failure on the part of these third parties could delay commercialization of our approved product or other product candidates or the clinical development or marketing approval of our product candidates producing additional losses and depriving us of potential product revenues.
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Our CROs, clinical trial sites, and other third parties may also have relationships with other entities, some of which may be our competitors, for whom they may also be conducting clinical trials or other therapeutic development activities that could harm our competitive position. In addition, these third parties are not our employees, and except for remedies available to us under our agreements with them, we cannot control whether or not they devote sufficient time and resources to our ongoing clinical and preclinical programs. If these third parties conducting our clinical trials (i) do not successfully carry out their contractual duties, (ii) do not meet expected deadlines, (iii) experience work stoppages, (iv) do not conduct our clinical trials in accordance with regulatory requirements or our stated protocols, (v) need to be replaced, (vi) experience financial hardships, or (vii) terminate their agreements with us or if the quality or accuracy of the data they obtain is compromised due to the failure to adhere to our clinical trial protocols, GCP guidelines, or other regulatory requirements or for other reasons, our trials may need to be repeated, extended, delayed, or terminated, we may not be able to obtain, or may be delayed in obtaining, marketing approvals for our product candidates, we will not be able to, or may be delayed in our efforts to, successfully commercialize our product candidates, or we or they may be subject to regulatory enforcement actions. Additionally, we may need to conduct additional clinical trials or enter into new arrangements with alternative CROs, clinical investigators or other third parties, which we may not be able to do on commercially reasonable terms, or at all and which may involve additional cost and time and require management time and focus. As a result, delays could occur, which could compromise our ability to meet our desired development timelines. Furthermore, if any of the third parties conducting our clinical trials experience any financial hardships due to difficulties relating to the operation of their business, it could damage our business, financial condition, results of operations, and prospects. In addition, if an agreement with any of our collaborators terminates, our access to technology and intellectual property licensed to us by that collaborator may be restricted or terminate entirely, which may delay the continued development of our product candidates using the collaborator’s technology or intellectual property or require us to stop development of those product candidates completely. As a result, our results of operations and the commercial prospects for our product candidates would be harmed, our costs could increase and our ability to generate revenues could be delayed. To the extent we are unable to successfully identify and manage the performance of third-party service providers in the future, our business may be materially and adversely affected.
We have and we expect to continue to retain third-party service providers to perform a variety of functions related to the sale of our approved product and current or future product candidates, key aspects of which will be out of our direct control. These service providers may provide key services related to sales, market access, distribution, customer service, accounts receivable management, state reporting, compliance support, and cash collection. If we retain a service provider, we will substantially rely on it as well as other third-party providers that perform services for us, including entrusting our inventories of products to their care and handling. If these third-party service providers fail to comply with applicable laws and regulations, fail to meet expected deadlines or otherwise do not carry out their contractual duties to us, or encounter physical or natural damage at their facilities, our ability to deliver product to meet commercial demand would be significantly impaired and we may be subject to regulatory enforcement action.
In addition, we may engage in the future with third parties to perform various other services for us relating to adverse event reporting, safety database management, fulfillment of requests for medical information regarding our product candidates, and related services. If the quality or accuracy of the data maintained by these service providers is insufficient, or these third parties otherwise fail to comply with regulatory requirements related to adverse event reporting, we could be subject to regulatory sanctions.
Additionally, we have contracted with one or more third parties to calculate and report pricing information mandated by various government programs and may enter into further contracts in the future. If a third party fails to timely report or adjust prices as required or makes a mistake in calculating government pricing information from transactional data in our financial records, it could impact our discount and rebate liabilities, and potentially subject us to regulatory sanctions or FCA lawsuits.
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Our reliance on third and related parties can also present intellectual property-related risks. For example, collaborators may not properly obtain, maintain, enforce or defend intellectual property or proprietary rights relating to our product candidates or technology or may use our proprietary information in such a way as to expose us to potential litigation or other intellectual property-related proceedings, including proceedings challenging the scope, ownership, validity and enforceability of our intellectual property. Collaborators may also own or co-own intellectual property covering our product candidates or technology that results from our collaboration with them, and in such cases, we may not have the exclusive right to commercialize such intellectual property or such product candidates or technology. Collaborators may also gain access to our trade secrets or formulations and impact our ability to commercialize our proprietary technology. We may also need the cooperation of our collaborators to enforce or defend any intellectual property we contribute to or that arises out of our collaborations, which may not be provided to us.
We also anticipate that part of our strategy for pursuing the wide range of indications potentially addressed by ANKTIVA will involve further investigator-led clinical trials. While these trials generally provide us with valuable clinical data that can help form our future development strategy, we generally have less control over not only the conduct but also the design of these clinical trials. Third-party investigators may design clinical trials involving our product candidates with clinical endpoints that are more difficult to achieve or in other ways that increase the risk of negative clinical trial results compared to clinical trials we may design on our own. Negative results from investigator-led clinical trials, regardless of how the clinical trial was designed or conducted, could have a material adverse effect on our business and the perception of our product candidates.
Moreover, principal investigators for our clinical trials may serve as scientific advisors or consultants to us from time to time and receive compensation in connection with such services.
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.
Our reliance on third-party manufacturers, wholesalers, and distributors exposes us to the following risks, any of which could delay FDA approval of our product candidates and commercialization of our approved product or any other product candidates, if approved, result in higher costs, or deprive us of potential product revenues:
• our CMOs, or other third parties we rely on, may encounter difficulties in achieving the volume of production needed to satisfy commercial demand, may experience technical issues that impact quality or compliance with applicable and strictly enforced regulations governing the manufacture of pharmaceutical products, and may experience shortages of qualified personnel to adequately staff production operations;
• our wholesalers and distributors could become unable to sell and deliver our approved product or other product candidates for regulatory, compliance, and other reasons;
• our CMOs, wholesalers, and distributors could breach or default on their agreements with us to meet our requirements for commercialization of our approved product or other product candidates;
• our CMOs, wholesalers, and distributors may not perform as agreed or may not remain in business for the time required to successfully produce, store, sell, and distribute our approved product or other product candidates and we may incur additional costs;
• our CMOs, wholesalers, and distributors may misappropriate our proprietary information; and
• if our CMOs, wholesalers, and distributors were to terminate our arrangements or fail to meet their contractual obligations, we may be forced to delay our commercial programs.
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Our reliance on third parties reduces our control over our approved product and other product candidate development activities but does not relieve us of our responsibility to ensure compliance with all required legal, regulatory, and industry standards. For example, the FDA and other regulatory authorities require that our approved product, other product candidates and any other products that we may eventually commercialize be manufactured according to cGMP requirements. Any failure by our third-party manufacturers to comply with cGMP or maintain a compliance status acceptable to the FDA or other regulatory authorities or failure to scale up manufacturing processes, including any failure to deliver sufficient quantities of product candidates in a timely manner, could lead to a delay in, or failure to obtain, regulatory approval of any of our product candidates. On May 9, 2023, the FDA delivered a CRL to us regarding the BLA filed in May 2022, indicating that the FDA had determined that it could not approve the original BLA submission in its initial form, and the FDA made recommendations to address the issues raised. The deficiencies in the CRL related to the FDA’s pre-license inspection of our third-party CMOs, among other items.
The CRL that we received in response to our initial BLA submission required us to resubmit the BLA to the FDA addressing the issues in the CRL. In April 2024, the FDA approved ANKTIVA indicated with BCG for the treatment of adult patients with BCG-unresponsive NMIBC with CIS, with or without papillary tumors. Our third-party manufacturers are subject to periodic inspections by the FDA and other regulatory authorities, and failure to comply with cGMP could be the basis for the FDA to issue a warning or untitled letter, withdraw approvals for our approved product or our other product candidates previously granted to us, or take other regulatory or legal action, including a request to recall or seize our approved product or our other product candidates, total or partial suspension of production, suspension of clinical trials, refusal to approve pending applications or supplemental applications, detention of product, refusal to permit the import or export of other product candidates, injunction, imposing civil penalties or pursuing criminal prosecution.
Additionally, as we scale up manufacturing of our approved product or other product candidates and conduct required stability testing, we may encounter additional challenges or cGMP issues. These issues may require refinement or resolution in order to proceed with commercial marketing of our approved product or any of our other product candidates, if approved. In addition, quality issues may arise during scale-up and validation of commercial manufacturing processes. Any issues in our manufacturing process could result in increased scrutiny by regulatory authorities, delays in our regulatory review process, increases in our operating expenses, or failure to obtain or maintain approval for our approved product or other product candidates. If such issues relate to an approved product, we may not be able to commercialize the approved product as we planned or fail to meet commercial demand, any of which can materially and adversely affect our position in the market.
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.
The Clinic has conducted, is currently conducting, and in the future may conduct clinical trials involving our product candidates. The Clinic is a related party as it is owned by an officer of the company and additionally, NantWorks manages the administrative operations of the Clinic. Prior to June 30, 2019, one of the company’s officers was an investigator or sub‑investigator for certain of the company’s trials conducted at the Clinic. NantWorks, which is wholly owned by Dr. Soon‑Shiong, our Founder, Executive Chairman and Global Chief Scientific and Medical Officer, provides certain administrative services (and has loaned money) to the Clinic. Under certain circumstances, we may be required to report some of these relationships to the FDA.
Relying on a related-party clinical site to develop data that is used as the basis to support regulatory approval can expose us to significant regulatory risks. The FDA may conclude that a financial relationship between us, the Clinic and/or a principal investigator has created a conflict of interest or otherwise affected interpretation of the study. The FDA or comparable regulatory authorities may therefore question the integrity of the data generated at the applicable clinical trial site and the utility of the clinical trial itself may be jeopardized. If any data integrity, or regulatory non-compliance issues occur during the study, we may not be able to use the data for our regulatory approval. This could result in a delay in approval, or rejection, of our marketing applications by the FDA and may ultimately lead to the denial of regulatory approval of one or more of our product candidates.
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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.
We have formed, and may in the future form or seek, strategic alliances, or enter into collaborations with third parties or additional licensing arrangements that we believe will complement or augment our development and commercialization efforts with respect to our approved product, other product candidates and any future product candidates that we may develop. We plan to collaborate with governmental, academic, and corporate partners, including affiliates, to improve and develop ANKTIVA and hAd5 constructs, and other cell therapies for new indications for use in combination with other therapies and to improve and develop other product candidates, which may expose us to additional risks, or we may not realize the benefits of such collaborations.
Because some of our collaborations are conducted at outside laboratories, and we do not have complete control over how the studies are conducted or reported, the results of such studies, which we may use as the basis for our conclusions, projections, or decisions with respect to our current or future product candidates, may be incorrect or unreliable, or may have a negative impact on us if the results of such studies are imputed to our product candidates or proposed indications, even if such imputation is improper. Additionally, we may use third‑party data to analyze, reach conclusions or make predictions or decisions with respect to our product candidates that may be incomplete, inaccurate or otherwise unreliable.
We also plan to collaborate with governmental, academic and corporate partners, including affiliates, to improve and develop ANKTIVA and hAd5 constructs, cell therapies and other therapies for new indications for use in combination with other therapies and to improve and develop other product candidates, which may expose us to additional risks, or we may not realize the benefits of such collaborations.
Furthermore, conflicts may arise between us and our collaborators or strategic partners, and such strategic alliances, collaborations, or licensing arrangements may result in litigation, which is expensive and time consuming. For example, in 2019, Sorrento Therapeutics, Inc., with which we jointly established a new entity called NANTibody as a stand-alone biotechnology company, commenced litigation against us and certain of our officers and directors, alleging that we improperly caused NANTibody to acquire IgDraSol, Inc., a subsidiary of the company. Additionally, in 2020 we received a Request for Arbitration before the International Chamber of Commerce, International Court of Arbitration, served by Beike asserting a claim for breach of contract under our subsidiary Altor’s license agreement with them. See Part II, Item 1. “ Legal Proceedings ” for more information regarding these disputes. Any such developments could harm our product development efforts, and additional disputes with our licensors or strategic collaborators may be expensive and time consuming.
In addition, collaborations involving our product candidates will be subject to numerous risks, which may include the following:
• collaborators, including their related or affiliated companies, may be entitled to receive exclusive rights for or involving our products;
• collaborators have significant discretion in determining the efforts and resources that they will apply to a collaboration;
• collaborators may not pursue development and commercialization of our product candidates or may elect not to continue or renew development or commercialization of our product candidates based on clinical trial results, changes in their strategic focus due to the acquisition of competitive products, availability of funding or other external factors, such as a business combination that diverts resources or creates competing priorities;
• collaborators may delay clinical trials, provide insufficient funding for a clinical trial, stop a clinical trial, abandon a product candidate, repeat or conduct new clinical trials or require a new formulation of a product candidate for clinical testing;
• collaborators could independently develop, or develop with third parties, products that compete directly or indirectly with our product candidates;
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• a collaborator with marketing and distribution rights to one or more products may not commit sufficient resources to their marketing and distribution;
• collaborators may not properly maintain, defend, or enforce our intellectual property rights or may use our intellectual property or proprietary information in a way that gives rise to actual or threatened litigation that could jeopardize or invalidate our intellectual property or proprietary information or expose us to potential liability;
• disputes may arise between us and a collaborator that cause the delay or termination of the research, development, or commercialization of our product candidates, or that result in costly litigation or arbitration that diverts management attention and resources;
• collaborations may be terminated and, if terminated, may result in a need for additional capital to pursue further development or commercialization of the applicable product candidates;
• if an agreement with any collaborator terminates, our access to technology and intellectual property licensed to us by that collaborator may be restricted or terminate entirely, which may delay our continued development of our product candidates using the collaborator’s technology or intellectual property or require us to stop development of those product candidates completely; and
• collaborators may own or co-own intellectual property covering our product candidates or technology that results from our collaborating with them, and in such cases, we may not have the exclusive right to commercialize such intellectual property.
As a result, if we enter into collaboration agreements and strategic partnerships or license our product candidates, we may not be able to realize the benefit of such transactions if we are unable to successfully integrate them with our existing operations and company culture, which could delay our timelines or otherwise adversely affect our business. Additionally, exclusive rights that we may grant in connection with collaboration agreements may limit our ability to enter into new or additional collaboration agreements or strategic partnerships if we experience issues with existing collaborations. We also cannot be certain that, following a strategic transaction or license, we will achieve the revenues or specific net income that justifies such transaction. Any delays in entering into new collaborations or strategic partnership agreements related to our product candidates could delay the development and commercialization of our product candidates in certain geographies for certain indications, which would harm our business prospects, financial condition, and results of operations.
Any of these relationships may require us to incur non-recurring and other charges, increase our near and long-term expenditures, issue securities that dilute our existing stockholders, or disrupt our management and business. In addition, we face significant competition in seeking appropriate strategic partners and the negotiation process is time-consuming and complex. Moreover, we may not be successful in our efforts to establish a strategic partnership or other alternative arrangements for our product candidates because they may be deemed to be at too early of a stage of development for collaborative effort and third parties may not view our product candidates as having the requisite potential to demonstrate safety and efficacy.
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.
If conflicts arise between our corporate or academic collaborators or strategic partners and us, the other party may act in a manner adverse to us and could limit our ability to implement our strategies. Some of our existing academic collaborators and strategic partners are conducting multiple product development efforts. Such current or future collaborators or strategic partners could become our competitors in the future and could develop competing products, preclude us from entering into collaborations with their competitors, fail to obtain timely regulatory approvals, terminate their agreements with us prematurely or fail to devote sufficient resources to the commercialization of our approved product and the development and commercialization of our other product candidates. Competing product candidates, either developed by the collaborators or strategic partners or to which the collaborators or strategic partners have rights, may result in the withdrawal of our collaborator’s or partner’s support for our product or product candidates.
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Our use of joint ventures, strategic partnerships, and alliances may expose us to risks associated with jointly owned investments.
We may operate parts of our business through joint ventures, strategic partnerships, supply agreements, collaborations, and/or alliances with other companies. While such arrangements may, in some cases, give us access to technologies that we may not otherwise have or may give us access to capital, they involve risks not otherwise present in our own investments, including: (i) we may not control the venture, and it may divert management time and resources ; (ii) the partner(s) may not agree to distributions that we believe are appropriate; (iii) we may experience impasses or disputes with such partner(s) on certain decisions, which could require us to expend additional resources to resolve such impasses or disputes, including litigation or arbitration; (iv) our partner(s) may become insolvent or bankrupt, fail to fund their share of required capital contributions or fail to fulfil their obligations as a venture partner; (v) the arrangements governing these relationships may contain certain conditions or milestone events that may never be satisfied or achieved; (vi) our partner(s) may have business or economic interests that are inconsistent with our interests and may take actions contrary to our interests; (vii) we may suffer losses as a result of actions taken by the partner(s); (viii) conflicts may arise leading to disputes and efforts to terminate these arrangements and seek other remedies; and (ix) it may be difficult for us to exit if an impasse arises or if we desire to sell our interest for any reason. There can be no guarantee that the strategic partnerships that we currently have or may enter into will be successful. Furthermore, we may, in certain circumstances, be liable for the actions of our partners. Any of the foregoing risks could have a material adverse effect on our business, financial condition and results of operations.
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.
Our operations will be dependent upon the services of our executives and our employees who are engaged in research and development. If we lose the services of members of our senior management, particularly Dr. Soon-Shiong, our Founder, Executive Chairman and Global Chief Scientific and Medical Officer, for a short or an extended time, for any reason, we may not be able to find appropriate replacements on a timely basis, and our business, financial condition and results of operations could be materially adversely affected. Our existing operations and our future development depend to a significant extent upo
Text extracted from the filing as submitted to EDGAR. Formatting, tables and exhibits are simplified for reading; the original document is authoritative for anything you rely on.