ImmunityBio Reports Q2 Earnings Release Reflecting 60% Increase in Revenue in Q2 2025, With Year-to-Date Sales of $43 Million and 246% Unit Growth Since J-code
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Q2 2025 Revenue Growth with Continued Strong Sales Momentum:
$26.4 million 60% from Q1 2025, with year-to-date sales of approximately$43 million -
ANKTIVA® Unit Growth Since J-code:
246% unit sales volume growth in 1H 2025 compared to 2H 2024. -
Cash Position:
$153.7 million $80 million $96.0 million -
Non-Small Cell Lung Cancer (NSCLC): ImmunityBio has launched ResQ201A, a randomized controlled trial (RCT), in the
U.S. , evaluating its IL-15 superagonist N-803 in combination with tislelizumab, a PD-1 CPI from BeOne Medicines in patients with second-line lung cancer who were progressing on checkpoint inhibitors (CPIs). The Company has also submitted clinical trial applications for ResQ201A in the EU and theUK , withCanada expected to be submitted in early Q3 2025, and with plans underway to submit inAsia . -
Lymphopenia: The Company met with the Division of Non-Malignant Hematology at the
U.S. Food and Drug Administration (FDA) in June 2025 to present updated data from its lymphopenia program. The Division was supportive of the findings including the underlying science of stimulating lymphocytes with ANKTIVA and expressed a desire to support an efficient path to approval, noting that additional time will be required to finalize the appropriate development plan. Expanded Access Program (EAP) authorization has been activated for the indication for all solid tumors in patients who have failed first-line treatment on chemotherapy, radiotherapy or immunotherapy and exhibit low absolute lymphocyte counts (ALC < 1,000/μL). - Lynch Syndrome: Full enrollment reached in the randomized National Cancer Institute (NCI) cancer prevention clinical trial using ANKTIVA in combination with adenovirus vaccine in 186 patients with Lynch Syndrome.
- UK’s Medicines and Healthcare products Regulatory Agency (MHRA) approved marketing authorization application of ANKTIVA in combination with BCG for the treatment of adult patients with BCG-unresponsive non-muscle invasive bladder cancer with CIS with or without papillary tumors.
- Papillary NMIBC: ImmunityBio conducted a Type A meeting with the FDA in June 2025 to discuss its program targeting papillary-only non-muscle invasive bladder cancer (NMIBC) and the FDA’s response to the supplemental BLA (sBLA) filing. Contrary to the advice the FDA gave the Company in January 2025 to submit the sBLA, the FDA responded with a Refuse to File (RTF) notice in May 2025 on the basis of requiring a randomized control trial (RCT) against chemotherapy. At the June 2025 meeting, ImmunityBio provided new data regarding the updated results since the initial BLA filing of papillary-only data as well as real-world data of chemotherapy just published in this indication. In the papillary-only NMIBC new data based on 26 of the 100 subjects in Cohort A and 80 subjects in Cohort B (Papillary Alone) of our QUILT-3.032 trial, demonstrated long-term (36-month) progression free survival and bladder sparing with ANKTIVA in combination with BCG. ImmunityBio presented the newly published real-world data, which demonstrates that compared to chemotherapy, ANKTIVA in combination with BCG led to improved outcomes of progression-free survival and cystectomy avoidance at 36-months. To our knowledge, the results to date of ANKTIVA in combination with BCG represent the longest duration of follow-up with the longest duration of bladder sparing in these subjects. The Company indicated at the meeting that it would seek a new meeting request with this new data and withdraw the prior sBLA filing; however, the Company is re-evaluating this approach in consultation with its regulatory counsel and may seek to amend the initial filing with the new data rather than withdrawing it, with a commitment to initiate a RCT of chemotherapy-free ANKTIVA in combination with BCG versus chemotherapy in the Papillary Alone indication.
In addition, ImmunityBio has applied to the National Comprehensive Cancer Network (NCCN) to seek expansion of the BCG-unresponsive NMIBC guidelines to include papillary-only disease, in addition to the currently recognized CIS with or without papillary disease. The NCCN is expected to review the submission at its August 2025 meeting.
In the second quarter of 2025, ImmunityBio reported
“ANKTIVA continues to deliver clinical results and promising commercial potential for ImmunityBio,” said Richard Adcock, President and CEO of ImmunityBio. “We’re seeing robust demand across
“Our goal has always been to use our innovative science to attack a broad range of cancers, and we are deeply committed to this goal in order to meet the urgent needs of millions of patients,” said Dr. Patrick Soon-Shiong, Founder, Executive Chairman and Global Chief Scientific and Medical Officer of ImmunityBio. “To that end, we’ve begun global expansion of key clinical trials, including those for BCG-naïve NMIBC and second-line lung cancer. In addition, we’ve initiated enrollment across multiple trials to validate our novel lymphopenia rescue agent in prolonging duration of survival across multiple tumor types—a critical effort to address this life-threatening immune deficiency, and is often triggered by chemotherapy, radiation, or some immunotherapies.”
Second-Quarter Ended June 30, 2025 Financial Summary and Comparison to Prior Year Quarter
Product Revenue, Net
Product revenue, net increased
Research and Development Expense
Research and development (R&D) expense increased
Selling, General and Administrative Expense
Selling, general and administrative (SG&A) expense decreased
Net Loss Attributable to ImmunityBio Common Stockholders
Net loss attributable to ImmunityBio common stockholders was
Six Months Ended June 30, 2025 Financial Summary and Comparison to Prior Year Six Months Ended
Product Revenue, Net
Product revenue, net increased
Research and Development Expense
R&D expense decreased
Selling, General and Administrative Expense
SG&A expense decreased
Net Loss Attributable to ImmunityBio Common Stockholders
Net loss attributable to ImmunityBio common stockholders was
ImmunityBio, Inc. |
||||||||||||||||
Condensed Consolidated Statements of Operations |
||||||||||||||||
|
Three Months Ended June 30, |
Six Months Ended June 30, |
||||||||||||||
(Unaudited; in thousands, except per share amounts) |
2025 |
2024 |
2025 |
2024 |
||||||||||||
|
|
|
|
|
||||||||||||
Revenue |
|
|
|
|
||||||||||||
Product revenue, net |
$ |
26,421 |
|
$ |
990 |
|
$ |
42,930 |
|
$ |
990 |
|
||||
Other revenues |
|
4 |
|
|
57 |
|
|
12 |
|
|
97 |
|
||||
Total revenue |
|
26,425 |
|
|
1,047 |
|
|
42,942 |
|
|
1,087 |
|
||||
Operating costs and expenses |
|
|
|
|
||||||||||||
Cost of sales |
|
136 |
|
|
— |
|
|
194 |
|
|
— |
|
||||
Research and development |
|
52,430 |
|
|
48,832 |
|
|
98,406 |
|
|
100,154 |
|
||||
Research and development – related parties |
|
2,806 |
|
|
2,297 |
|
|
5,064 |
|
|
4,326 |
|
||||
Selling, general and administrative |
|
41,862 |
|
|
48,576 |
|
|
73,839 |
|
|
90,030 |
|
||||
Selling, general and administrative – related parties |
|
476 |
|
|
675 |
|
|
1,153 |
|
|
1,106 |
|
||||
Total operating costs and expenses |
|
97,710 |
|
|
100,380 |
|
|
178,656 |
|
|
195,616 |
|
||||
Loss from operations |
|
(71,285 |
) |
|
(99,333 |
) |
|
(135,714 |
) |
|
(194,529 |
) |
||||
Other income (expense), net: |
|
|
|
|
||||||||||||
Interest and investment income, net |
|
1,153 |
|
|
1,891 |
|
|
2,040 |
|
|
4,990 |
|
||||
Change in fair value of warrant and derivative liabilities,
|
|
6,989 |
|
|
1,894 |
|
|
(30,463 |
) |
|
(2,632 |
) |
||||
Interest expense – related party |
|
(15,474 |
) |
|
(29,787 |
) |
|
(30,787 |
) |
|
(59,245 |
) |
||||
Interest expense related to revenue interest liability |
|
(13,405 |
) |
|
(9,225 |
) |
|
(26,939 |
) |
|
(17,229 |
) |
||||
Interest expense |
|
(5 |
) |
|
(7 |
) |
|
(23 |
) |
|
(32 |
) |
||||
Other expense, net |
|
(278 |
) |
|
(17 |
) |
|
(319 |
) |
|
(37 |
) |
||||
Total other expense, net |
|
(21,020 |
) |
|
(35,251 |
) |
|
(86,491 |
) |
|
(74,185 |
) |
||||
Loss before income taxes and noncontrolling interests |
|
(92,305 |
) |
|
(134,584 |
) |
|
(222,205 |
) |
|
(268,714 |
) |
||||
Income tax expense |
|
(269 |
) |
|
— |
|
|
(35 |
) |
|
— |
|
||||
Net loss |
|
(92,574 |
) |
|
(134,584 |
) |
|
(222,240 |
) |
|
(268,714 |
) |
||||
Net loss attributable to noncontrolling interests, net of tax |
|
(19 |
) |
|
(20 |
) |
|
(39 |
) |
|
(41 |
) |
||||
Net loss attributable to ImmunityBio common stockholders |
$ |
(92,555 |
) |
$ |
(134,564 |
) |
$ |
(222,201 |
) |
$ |
(268,673 |
) |
||||
|
|
|
|
|
||||||||||||
Net loss per ImmunityBio common share – basic |
$ |
(0.10 |
) |
$ |
(0.20 |
) |
$ |
(0.26 |
) |
$ |
(0.40 |
) |
||||
Net loss per ImmunityBio common share – diluted |
$ |
(0.10 |
) |
$ |
(0.20 |
) |
$ |
(0.26 |
) |
$ |
(0.40 |
) |
||||
Weighted-average number of common shares used in computing net loss per share – basic |
|
888,216 |
|
|
686,938 |
|
|
870,786 |
|
|
679,885 |
|
||||
Weighted-average number of common shares used in computing net loss per share – diluted |
|
888,216 |
|
|
686,938 |
|
|
870,786 |
|
|
679,885 |
|
||||
ImmunityBio, Inc. |
||||||||
Selected Balance Sheet Data |
||||||||
(Unaudited; in thousands) |
June 30, 2025 |
December 31, 2024 |
||||||
|
|
|
||||||
Cash and cash equivalents, and marketable securities |
$ |
153,658 |
|
$ |
149,809 |
|
||
Total assets |
|
402,076 |
|
|
382,933 |
|
||
Total related-party debt |
|
492,084 |
|
|
461,877 |
|
||
Revenue interest liability |
|
307,049 |
|
|
284,404 |
|
||
Total liabilities |
|
971,895 |
|
|
871,062 |
|
||
Total ImmunityBio stockholders’ deficit |
|
(570,749 |
) |
|
(489,098 |
) |
||
Total liabilities and stockholders’ deficit |
|
402,076 |
|
|
382,933 |
|
||
ImmunityBio, Inc. |
||||||||||||||||
Summary Reconciliations of Cash Flows |
||||||||||||||||
|
Three Months Ended June 30, |
Six Months Ended June 30, |
||||||||||||||
(Unaudited; in thousands) |
2025 |
2024 |
2025 |
2024 |
||||||||||||
|
|
|
|
|
||||||||||||
Cash (used in) provided by: |
|
|
|
|
||||||||||||
Net cash used in operating activities |
$ |
(79,746 |
) |
$ |
(100,347 |
) |
$ |
(165,651 |
) |
$ |
(207,329 |
) |
||||
Net cash used in investing activities |
|
(16,142 |
) |
|
(51,490 |
) |
|
(12,013 |
) |
|
(87,112 |
) |
||||
Net cash provided by financing activities |
|
172,810 |
|
|
148,894 |
|
|
171,828 |
|
|
159,119 |
|
||||
Effect of exchange rate changes on cash and cash equivalents, and restricted cash |
|
76 |
|
|
12 |
|
|
66 |
|
|
(27 |
) |
||||
Net change in cash and cash equivalents, and restricted cash |
|
76,998 |
|
|
(2,931 |
) |
|
(5,770 |
) |
|
(135,349 |
) |
||||
Cash and cash equivalents, and restricted cash, beginning of period |
|
61,144 |
|
|
133,369 |
|
|
143,912 |
|
|
265,787 |
|
||||
Cash and cash equivalents, and restricted cash, end of period |
$ |
138,142 |
|
$ |
130,438 |
|
$ |
138,142 |
|
$ |
130,438 |
|
||||
About ANKTIVA
The cytokine interleukin-15 (IL-15) plays a crucial role in the immune system by affecting the development, maintenance, and function of key immune cells—NK and CD8+ killer T cells—that are involved in killing cancer cells. By activating natural killer (NK) cells, ANKTIVA overcomes the tumor escape phase of clones resistant to T cells and restores memory T cell activity with resultant prolonged duration of complete response.
ANKTIVA is a first-in-class IL-15 agonist IgG1 fusion complex, consisting of an IL-15 mutant (IL-15N72D) fused with an IL-15 receptor alpha, which binds with high affinity to IL-15 receptors on NK, CD4+, and CD8+ T cells. This fusion complex of ANKTIVA mimics the natural biological properties of the membrane-bound IL-15 receptor alpha, delivering IL-15 by dendritic cells and drives the activation and proliferation of NK cells with the generation of memory killer T cells that have retained immune memory against these tumor clones. The proliferation of the trifecta of these immune killing cells and the activation of trained immune memory results in immunogenic cell death, inducing a state of equilibrium with durable complete responses. ANKTIVA has improved pharmacokinetic properties, longer persistence in lymphoid tissues, and enhanced anti-tumor activity compared to native, non-complexed IL-15 in-vivo.
ANKTIVA was approved by the FDA in 2024 and by
About ImmunityBio
ImmunityBio is a vertically-integrated commercial stage biotechnology company developing next-generation therapies that bolster the natural immune system to defeat cancers and infectious diseases. The Company’s range of immunotherapy and cell therapy platforms, alone and together, act to drive and sustain an immune response with the goal of creating durable and safe protection against disease. Designated an FDA Breakthrough Therapy, ANKTIVA is the first FDA-approved immunotherapy for non-muscle invasive bladder cancer CIS that activates NK cells, T cells, and memory T cells for a long-duration response. The Company is applying its science and platforms to treating cancers, including the development of potential cancer vaccines, as well as developing immunotherapies and cell therapies that we believe sharply reduce or eliminate the need for standard high-dose chemotherapy. These platforms and their associated product candidates are designed to be more effective, accessible, and easily administered than current standards of care in oncology and infectious diseases. For more information, visit ImmunityBio.com (Founder’s Vision) and connect with us on X (Twitter), Facebook, LinkedIn, and Instagram.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, such as statements regarding future operating results and prospects, commercialization activities, momentum and market data, discussions and meetings with the
regulatory pathways and the regulatory review process and timing thereof, the application of the Company’s science and platforms to treat cancers or develop cancer vaccines, immunotherapies and cell therapies that have the potential to change the paradigm in cancer care, and ImmunityBio’s approved product and investigational agents as compared to existing treatment options, among others. Statements in this press release that are not statements of historical fact are considered forward-looking statements, which are usually identified by the use of words such as “anticipates,” “believes,” “continues,” “goal,” “could,” “estimates,” “scheduled,” “expects,” “intends,” “may,” “plans,” “potential,” “predicts,” “indicate,” “projects,” “is,” “seeks,” “should,” “will,” “strategy,” and variations of such words or similar expressions. 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. Forward-looking statements are neither forecasts, promises nor guarantees, and are based on the current beliefs of ImmunityBio’s management as well as assumptions made by and information currently available to ImmunityBio. Such information may be limited or incomplete, and ImmunityBio’s statements should not be read to indicate that it has conducted a thorough inquiry into, or review of, all potentially available relevant information. Such statements reflect the current views of ImmunityBio with respect to future events and are subject to known and unknown risks, including business, regulatory, economic and competitive risks, uncertainties, contingencies and assumptions about ImmunityBio, including, without limitation, (i) risks and uncertainties regarding the FDA regulatory submission, filing and review process and the timing thereof, as well as that associated with regulatory agencies outside of the
View source version on businesswire.com: https://www.businesswire.com/news/home/20250805482884/en/
Investors
Hemanth Ramaprakash, PhD, MBA
ImmunityBio, Inc.
+1 858-746-9289
Hemanth.Ramaprakash@ImmunityBio.com
Media
Sarah Singleton
ImmunityBio, Inc.
+1 415-290-8045
Sarah.Singleton@ImmunityBio.com
Source: ImmunityBio, Inc.
