- With a permanent J-code (J9028) awarded in January 2025,
ImmunityBio’s February 2025 ANKTIVA® unit sales volume grew 97%
over unit sales volume in December 2024
- ANKTIVA sales momentum continues to trend upward quarter to
date 2025, with sales volume in February representing a 67%
increase month-over-month from January
- Sales volume in the 2 months in 2025 to date shows a 69%
increase over the sales volume in the 2 months prior (November and
December 2024) and already exceeds the total units for all of Q4
2024
- For the three-month period ending December 31, 2024 prior to
permanent J-code approval, ImmunityBio achieved net product revenue
of approximately $7.2 million, surpassing net product revenue of
$6.0 million in the prior quarter, a 21% quarter over quarter
increase
- FDA authorization of expanded access of an alternative source
of BCG in February 2025 is expected to address the issue of BCG
shortage with over 45,000 doses available
- Over 60 sites are now being activated to receive recombinant
BCG (rBCG) under the Expanded Access Program
- Global submission of marketing authorization applications
(MAAs) for the treatment of patients with BCG-unresponsive NMIBC
with CIS with or without papillary tumors for ANKTIVA in
combination with BCG to the Medicines and Healthcare products
Regulatory Agency (MHRA) and to the European Medicines Agency (EMA)
in the European Union (EU) have been accepted for review in
February 2025
- Regenerative Medicine Advanced Therapy (RMAT) designation
granted by the FDA in February 2025 for ANKTIVA and CAR-NK (PD-L1
t-haNK) in combination with standard-of-care
chemotherapy/radiotherapy indicated for:
- the reversal of lymphopenia and
- treatment of multiply relapsed locally advanced or metastatic
pancreatic cancer
- Over 100 participants have now received ANKTIVA in cancer
prevention trial with goal to prevent colon cancer in subjects with
Lynch Syndrome
- Analyst Investor Day Conference planned for April 2025
(invitations to follow)
ImmunityBio, Inc. (NASDAQ: IBRX), a leading immunotherapy
company, today announced certain operational results following
approval of the permanent J-code (J9028) in January 2025, as well
as its financial results for the fourth-quarter and full year ended
December 31, 2024.
With the issuance of the permanent J-code in January 2025,
ImmunityBio has seen increased sales momentum supporting a trend of
increases month-over-month as well as quarter-over-quarter, with
February unit sales volume increasing 67% over January, and
February and January unit sales combined exceeding unit sales
achieved for all of Q4 2024. ImmunityBio earned net product revenue
of approximately $7.2 million during the three-month period ending
December 31, 2024, which represented an increase of 21% over the
$6.0 million of net revenue earned during the third quarter of
2024.
The TICE BCG shortage was addressed with the FDA authorization
to ImmunityBio of Expanded Access of the recombinant BCG (rBCG)
supplied by the Serum Institute of India (SII). With the
authorization in February 2025, over 60 sites in the United States
are being activated to receive rBCG. The first patient dosed with
rBCG in the United States is anticipated in March 2025. ImmunityBio
anticipates that over 45,000 vials of rBCG will be available for
the United States in 2025 to address the overall BCG shortage.
Global submission of marketing authorization applications (MAAs)
for the treatment of patients with BCG-unresponsive NMIBC with CIS
with or without papillary tumors for ANKTIVA in combination with
BCG to the Medicines and Healthcare products Regulatory Agency
(MHRA) and to the European Medicines Agency (EMA) in the European
Union (EU) have been accepted for review in February 2025.
In January 2025, the Company announced a collaboration and
supply agreement with BeiGene, Ltd. (to be renamed to BeOne
Medicines, Ltd.), a global oncology company, to conduct a
confirmatory randomized Phase 3 clinical trial (ResQ201A-NSCLC),
combining BeOne’s tislelizumab, a PD-1 checkpoint inhibitor (CPI),
and our ANKTIVA (nogapendekin alfa inbakicept-pmln) product. The
Phase 3 ResQ201A-NSCLC study aims to confirm the efficacy and
safety of combination ANKTIVA plus CPI therapy previously
demonstrated in the QUILT 3.055 trial and provide evidence of the
potential for these two immunotherapeutic agents to improve overall
survival in patients with advanced or metastatic non-small cell
lung cancer who have acquired resistance to immune CPI therapy.
In February 2025, ImmunityBio received an important
authorization from the FDA designating ANKTIVA plus PD-L1 t-haNK as
Regenerative Medicine Advanced Therapies (RMAT). The significance
of a RMAT designation, which was established under the 21st Century
Cures Act, is to expedite the development and review of promising
therapeutic candidates, including cell therapies, that are intended
to treat, modify, reverse or cure a serious or life-threatening
disease. RMAT designation includes benefits, such as early
interactions with the FDA, including discussions on surrogate or
intermediate endpoints that could potentially support accelerated
approval and satisfy post-approval requirements, and potential
priority review of a product’s biologics license application (BLA).
The RMAT designation was granted for ANKTIVA and CAR-NK (PD-L1
t-haNK) in combination with standard-of-care
chemotherapy/radiotherapy indicated for:
- the reversal of lymphopenia and
- the treatment of multiply relapsed locally advanced or
metastatic pancreatic cancer
“The first quarter of 2025 has been an inflection point for the
Company with multiple milestones achieved. The approval of ANKTIVA
and the permanent J-code, the trajectory of adoption of ANKTIVA by
urologists for BCG unresponsive non-muscle invasive bladder cancer
CIS, the authorization of expanded access of recombinant BCG to
address the TICE BCG shortage, the acceptance of our global
marketing submission to EMA and MHRA, the collaboration with BeOne
for checkpoint inhibitor supply, and most importantly the
potentially transformative RMAT designation by the FDA of ANKTIVA +
PD-L1 t-haNK for the reversal of lymphopenia, all occurring at a
rapid pace and demonstrating excellent execution are a testament to
the strength of the organization and its ability to continue to
execute on its ambitious growth plans for this year,” said Dr.
Patrick Soon-Shiong, Founder, Executive Chairman, Global Chief
Scientific & Medical Officer of ImmunityBio. Dr. Soon-Shiong
continued, “The RMAT designation positions ANKTIVA to be the
backbone of our strategy for Immunotherapy 2.0 beyond checkpoints
and the potential foundation of this first-in-class IL-15 receptor
superagonist as a therapeutic cancer vaccine with over 100
participants enrolled in the Lynch Syndrome trial to evaluate
cancer prevention in this high-risk population.”
Fourth-Quarter Ended December 31, 2024 Financial Summary and
Comparison to Prior Year Quarter
Product Revenue, Net
Product revenue, net increased $7.2 million during the three
months ended December 31, 2024, as compared to the three months
ended December 31, 2023. The increase was driven by sales of
ANKTIVA after FDA approval in April 2024.
Research and Development Expenses
Research and development (R&D) expenses decreased $16.3
million to $35.2 million during the three months ended December 31,
2024, as compared to $51.5 million during the three months ended
December 31, 2023. The decrease was primarily driven by lower
research agreement expenses, inventory capitalization, less
contract manufacturing organization activities, and lower
consulting costs.
Selling, General and Administrative Expenses
Selling, general and administrative expense increased $8.6
million to $41.7 million during the three months ended December 31,
2024, as compared to $33.1 million during the three months ended
December 31, 2023. The increase was due to higher costs related to
post-commercialization activities and a litigation settlement.
Net Loss Attributable to ImmunityBio Common
Stockholders
Net loss attributable to ImmunityBio common stockholders was
$59.2 million during the three months ended December 31, 2024,
compared to $233.4 million during the three months ended December
31, 2023. The reduction of loss was primarily driven by product
revenue and changes in the fair value of related-party convertible
notes and warrant liabilities.
Fiscal Year Ended December 31, 2024 Financial Summary and
Comparison to Prior Year
Cash and Marketable Securities Position
As of December 31, 2024, the Company had consolidated cash and
cash equivalents, and marketable securities of $149.8 million.
Product Revenue, Net
Product revenue, net increased $14.1 million during the year
ended December 31, 2024, as compared to the year ended December 31,
2023. The increase was driven by sales of ANKTIVA after FDA
approval in April 2024.
Research and Development Expenses
R&D expenses decreased $42.2 million to $190.1 million
during the year ended December 31, 2024, as compared to $232.3
million during the year ended December 31, 2023. The decrease was
mainly due to less contract manufacturing organization activities,
inventory capitalization, lower research agreement expenses, and
lower consulting costs.
Selling, General and Administrative Expenses
Selling, general and administrative expenses increased $39.2
million to $168.8 million during the year ended December 31, 2024,
as compared to $129.6 million during the year ended December 31,
2023. The increase was primarily driven by higher legal expenses,
higher consulting fees and other operating costs related to
post-commercialization marketing activities and higher salary and
benefits expenses, partially offset by lower stock-based
compensation expenses.
Net Loss Attributable to ImmunityBio Common
Stockholders
Net loss attributable to ImmunityBio common stockholders was
$413.6 million during the year ended December 31, 2024, compared to
$583.2 million during the year ended December 31, 2023. This
reduction of loss was primarily driven by product revenue and
changes in the fair value of related-party convertible notes and
warrant liabilities.
ImmunityBio, Inc.
Condensed Consolidated Statements of
Operations
Three Months Ended
December 31,
Year Ended December
31,
(in thousands, except per share
amounts)
2024
2023
2024
2023
Revenue
Product revenue, net
$
7,206
$
—
$
14,150
$
—
Other revenues
346
139
595
622
Total revenue
7,552
139
14,745
622
Operating costs and expenses
Cost of product revenue
—
—
—
—
Research and development (including
amounts with related parties)
35,221
51,532
190,144
232,366
Selling, general and administrative
(including amounts with related parties)
41,731
33,110
168,783
129,620
Impairment of intangible assets
—
886
—
886
Total operating costs and expenses
76,952
85,528
358,927
362,872
Loss from operations
(69,400
)
(85,389
)
(344,182
)
(362,250
)
Other income (expense), net:
Interest and investment income, net
1,187
484
7,975
1,131
Change in fair value of warrant and
derivative liabilities, and related-party convertible notes
46,598
(116,352
)
76,904
(83,803
)
Interest expense (including amounts with
related parties)
(26,071
)
(31,862
)
(114,670
)
(128,934
)
Interest expense related to revenue
interest liability
(11,503
)
(264
)
(39,657
)
(264
)
Other income (expense), net (including
amounts with related parties) and loss on equity method
investment
10
(71
)
(15
)
(9,772
)
Total other income (expense), net
10,221
(148,065
)
(69,463
)
(221,642
)
Loss before income taxes and
noncontrolling interests
(59,179
)
(233,454
)
(413,645
)
(583,892
)
Income tax expense
—
40
—
40
Net loss
(59,179
)
(233,414
)
(413,645
)
(583,852
)
Net loss attributable to noncontrolling
interests, net of tax
(17
)
(22
)
(81
)
(656
)
Net loss attributable to ImmunityBio
common stockholders
$
(59,162
)
$
(233,392
)
$
(413,564
)
$
(583,196
)
Net loss per ImmunityBio common share –
basic
$
(0.08
)
$
(0.35
)
$
(0.59
)
$
(1.15
)
Net loss per ImmunityBio common share –
diluted
$
(0.09
)
$
(0.35
)
$
(0.62
)
$
(1.15
)
Weighted-average number of common shares
used in computing net loss per share – basic
733,204
667,811
697,312
508,636
Weighted-average number of common shares
used in computing net loss per share – diluted
734,542
667,811
700,443
508,636
ImmunityBio, Inc.
Selected Balance Sheet Data
As of December 31,
(in thousands)
2024
2023
Cash and cash equivalents, and marketable
securities
$
149,809
$
267,353
Total assets
382,933
504,452
Total related-party debt
461,877
681,537
Revenue interest liability
284,404
155,415
Total liabilities
871,062
1,090,389
Total ImmunityBio stockholders’
deficit
(489,098
)
(586,987
)
Total liabilities and stockholders’
deficit
382,933
504,452
ImmunityBio, Inc.
Summary Reconciliations of Cash
Flows
Three Months Ended
December 31,
Year Ended December
31,
(in thousands)
2024
2023
2024
2023
Cash (used in) provided by:
Net cash used in operating activities
$
(85,144
)
$
(115,271
)
$
(391,236
)
$
(366,757
)
Net cash provided by (used in) investing
activities
9,834
2,249
(12,246
)
(30,470
)
Net cash provided by financing
activities
106,929
200,539
281,630
558,341
Effect of exchange rate changes on cash
and cash equivalents, and restricted cash
(7
)
(27
)
(23
)
(292
)
Net change in cash and cash equivalents,
and restricted cash
31,612
87,490
(121,875
)
160,822
Cash and cash equivalents, and restricted
cash, beginning of period
112,300
178,297
265,787
104,965
Cash and cash equivalents, and restricted
cash, end of period
$
143,912
$
265,787
$
143,912
$
265,787
About ANKTIVA
Cytokine fusion proteins, such as ANKTIVA, represent a novel
class of biologics that improve immune responses by enhancing the
therapeutic potential of cytokines and promoting lymphocyte
infiltration at a site of disease. 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.
ANKTIVA is a first-in-class IL-15 receptor superagonist IgG1
fusion complex, consisting of an IL-15 mutant (IL-15N72D) fused
with an IL-15Rα, which binds with high affinity to IL-15 receptors
on NK, CD4+, and CD8+ T cells. This fusion complex of ANKTIVA,
which confers stability and longer half-life than recombinant or
native IL-15, mimics the natural biological properties of the
membrane-bound IL-15Rα, 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. By activating NK cells, ANKTIVA
overcomes the tumor escape phase of clones resistant to T cells
without stimulating immunosuppressive T-reg cells and restores
memory T cell activity with resultant prolonged duration of
complete response. Further, by stimulating the release of
interferon-γ, ANKTIVA restores MHC-I expression, making more tumor
cells targets for T-cell killing. As evidenced by its ability to
increase lymphocyte counts in healthy adults in Phase 1 testing,
ANKTIVA also has the potential to rescue lymphopenia, which is
associated with poor prognosis in cancer before treatment or as a
consequence of chemo- or radiation therapy.
ANKTIVA was approved by the FDA in 2024 for use in the
United States with BCG for the treatment of adult patients with
BCG-unresponsive non-muscle invasive bladder cancer with CIS with
or without papillary tumors. For more information, visit
ImmunityBio.com (Founder’s Vision) and
Anktiva.com.
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 platforms, alone and
together, act to drive an immune response with the goal of creating
durable immune memory generating safe protection against disease.
We are applying our 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,
market access initiatives and coverage under medical reimbursement
policies, the timing of shipments under the rBCG EAP, expected
available doses of rBCG supply, anticipated patient enrollment and
timing of dosing, the expectation that the rBCG EAP will enable
ImmunityBio to reliably bring an alternative source of BCG to
patients in the U.S., the utility of rBCG to improve immunogenicity
and safety in comparison to earlier strains and formulations of
BCG, the RMAT designation referenced herein and potential results
therefrom, the related anticipated EAP submission and timing
thereof, the related anticipated BLA submission and timing thereof,
global expansion efforts and anticipated timeline of regulatory
review of our pending MAAs by the MHRA and EMA, clinical trial
enrollment, data and potential results to be drawn therefrom, the
development of therapeutics for cancer and infectious diseases,
potential benefits to patients, potential treatment outcomes for
patients, the described mechanism of action and results and
contributions therefrom, potential future uses and applications of
ANKTIVA for the reversal of lymphopenia and use in combination with
checkpoint inhibitors or in cancer vaccines and across multiple
tumor types, 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 commercial launch execution, success and timing, (ii)
risks and uncertainties related to the regulatory submission,
filing and review process and the timing thereof with respect to
the FDA, EMA, MHRA and other regulatory agencies, (iii) risks and
uncertainties regarding the timing of shipments under the rBCG EAP
and ImmunityBio’s ability to establish and maintain a reliable
source of BCG under the EAP, (iv) whether the RMAT designation will
lead to an accelerated review or approval, of which there can be no
assurance, (v) ImmunityBio’s ability to submit the regulatory
submissions referenced herein on the anticipated timeline or at
all, (vi) the ability of ImmunityBio to fund its ongoing and
anticipated clinical trials, (vii) whether clinical trials will
result in registrational pathways, (viii) whether clinical trial
data will be accepted by regulatory agencies, (ix) the ability of
ImmunityBio to continue its planned preclinical and clinical
development of its development programs through itself and/or its
investigators, and the timing and success of any such continued
preclinical and clinical development, patient enrollment and
planned regulatory submissions, (x) potential delays in product
availability and regulatory approvals, (xi) the risks and
uncertainties associated with third-party collaborations and
agreements, including that with Serum Institute of India, (xii)
ImmunityBio’s ability to retain and hire key personnel, (xiii)
ImmunityBio’s ability to obtain additional financing to fund its
operations and complete the development and commercialization of
its various product candidates, (xiv) potential product shortages
or manufacturing disruptions that may impact the availability and
timing of product, (xv) ImmunityBio’s ability to successfully
commercialize its approved product and product candidates, (xvi)
ImmunityBio’s ability to scale its manufacturing and commercial
supply operations for its approved product and future approved
products, and (xvii) ImmunityBio’s ability to obtain, maintain,
protect, and enforce patent protection and other proprietary rights
for its product candidates and technologies. More details about
these and other risks that may impact ImmunityBio’s business are
described under the heading “Risk Factors” in the Company’s Form
10-K filed with the U.S. Securities and Exchange Commission (SEC)
on March 19, 2024 and the Company’s Form 10-Q filed with the SEC on
November 12, 2024, and in subsequent filings made by ImmunityBio
with the SEC, which are available on the SEC’s website at
www.sec.gov. ImmunityBio cautions you not to place undue
reliance on any forward looking statements, which speak only as of
the date hereof. ImmunityBio does not undertake any duty to update
any forward-looking statement or other information in this press
release, except to the extent required by law.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20250303380017/en/
Investors Hemanth Ramaprakash, PhD, MBA
ImmunityBio, Inc. +1 858-746-9289
Hemanth.Ramaprakash@ImmunityBio.com
Media ImmunityBio, Inc. Sarah Singleton +1
415-290-8045 Sarah.Singleton@ImmunityBio.com
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