ImmunityBio, Inc. (NASDAQ: IBRX) today announced its financial
results for the third-quarter ended September 30, 2024.
- ANKTIVA® received a J-code (HCPCS Level II Code) in October
2024, effective January 1, 2025.
- ANKTIVA (FDA-approved and commercially available in the U.S.
since May 2024) is now widely accessible to patients through
commercial and government insurance programs (VA, DoD, Medicare).
ImmunityBio has secured coverage for over 200 million medical lives
through medical reimbursement policies.
- ImmunityBio achieved a net product revenue of approximately
$6.0 million during the three months ended September 30, 2024,
surpassing net product revenue of $1.0 million in the prior quarter
and analyst estimates.
- ImmunityBio has extended the shelf life of ANKTIVA from two
years to three years, with over 125,000 doses, providing ample
product for the market and for clinical trials.
- ImmunityBio submitted to the Medicines and Healthcare products
Regulatory Agency (MHRA) a Marketing Authorization Application
(MAA) for ANKTIVA in the United Kingdom on November 1, 2024.
- ImmunityBio intends to submit to the European Medicines Agency
(EMA) an MAA for ANKTIVA in the European Union (EU) in Q4 2024,
covering 30 countries, including 27 in the EU and 3 in the European
Economic Area (Iceland, Norway, Liechtenstein).
“The U.S. launch of ANKTIVA for NMIBC CIS continues to gain
momentum, and we are pleased to see the clinical impact for
patients,” said Richard Adcock, President and CEO of ImmunityBio.
“Our permanent J-code has been issued by Centers for Medicare and
Medicaid Services and will be effective January 1, 2025. Our
submission of ANKTIVA for NMIBC CIS to the MHRA in the UK for
potential approval demonstrates our plans for global expansion.
Further, we anticipate an EU submission this quarter.”
“The response from the urologists and clinical practices with
regard to the utility of ANKTIVA in NMIBC CIS has been gratifying.
ImmunityBio’s clinical trial in BCG naïve NMIBC is enrolling well,
and clinical sites have been expanded from the U.S. to multiple
global locations. In the urology space, initial clinical trials of
ANKTIVA are being designed for high-risk prostate cancer,” said Dr.
Patrick Soon-Shiong, Executive Chairman, Global Chief Scientific
& Medical Officer of ImmunityBio. “With the approval of ANKTIVA
and the label of activating NK cells, CD4+ CD8+ T cells with memory
T cells, ImmunityBio is focusing the regulatory development of
ANKTIVA in BCG naïve bladder cancer and non-small cell lung cancer
(NSCLC) patients who have failed checkpoint inhibitors.”
Third-Quarter Ended September 30, 2024 Financial
Summary
Cash and Marketable Securities Position
As of September 30, 2024, the Company had consolidated cash and
cash equivalents, and marketable securities of $130.4 million.
Research and Development Expenses
Research and development (R&D) expenses increased $2.0
million to $50.4 million during the three months ended September
30, 2024, as compared to $48.4 million during the three months
ended September 30, 2023. The increase was primarily driven by
personnel-related and other R&D costs, partially offset by a
decrease in external R&D expense driven by lower CMO fees and
material purchases.
Selling, General and Administrative Expenses
Selling, general and administrative expenses increased $4.1
million to $35.9 million during the three months ended September
30, 2024, as compared to $31.8 million during the three months
ended September 30, 2023. The increase was primarily driven by
higher salaries and benefits expense as a result of a reversal of
discretionary compensation not paid in the prior period and an
increase in consulting costs associated with commercial
activities.
Net Loss Attributable to ImmunityBio Common
Stockholders
Net loss attributable to ImmunityBio common stockholders was
$85.7 million during the three months ended September 30, 2024,
compared to $95.6 million during the three months ended September
30, 2023.
ImmunityBio, Inc.
Condensed Consolidated Statements of
Operations
Three Months Ended
September 30,
Nine Months Ended
September 30,
(in thousands, except per share amounts;
unaudited)
2024
2023
2024
2023
Revenue
Product revenue, net
$
5,954
$
—
$
6,944
$
—
Other revenues
152
82
249
483
Total revenue
6,106
82
7,193
483
Operating costs and expenses
Cost of product revenue
—
—
—
—
Research and development (including
amounts with related parties)
50,443
48,402
154,923
180,834
Selling, general and administrative
(including amounts with related parties)
35,916
31,816
127,052
96,510
Total operating costs and expenses
86,359
80,218
281,975
277,344
Loss from operations
(80,253
)
(80,136
)
(274,782
)
(276,861
)
Other income (expense), net:
Interest and investment income, net
1,798
35
6,788
647
Change in fair value of warrant and
derivative liabilities, and convertible note
32,938
21,782
30,306
32,549
Interest expense (including amounts with
related parties)
(29,322
)
(35,021
)
(88,599
)
(97,072
)
Interest expense related to revenue
interest liability
(10,925
)
—
(28,154
)
—
Other income (expense), net (including
amounts with related parties) and equity method investments
12
(2,302
)
(25
)
(9,701
)
Total other expense, net
(5,499
)
(15,506
)
(79,684
)
(73,577
)
Loss before income taxes and
noncontrolling interests
(85,752
)
(95,642
)
(354,466
)
(350,438
)
Income tax expense
—
—
—
—
Net loss
(85,752
)
(95,642
)
(354,466
)
(350,438
)
Net loss attributable to noncontrolling
interests, net of tax
(23
)
(60
)
(64
)
(634
)
Net loss attributable to ImmunityBio
common stockholders
$
(85,729
)
$
(95,582
)
$
(354,402
)
$
(349,804
)
Net loss per ImmunityBio common share –
basic
$
(0.12
)
$
(0.19
)
$
(0.52
)
$
(0.77
)
Net loss per ImmunityBio common share –
diluted
$
(0.14
)
$
(0.19
)
$
(0.53
)
$
(0.77
)
Weighted-average number of common shares
used in computing net loss per share – basic
695,895
498,375
685,261
454,994
Weighted-average number of common shares
used in computing net loss per share – diluted
697,961
498,375
688,939
454,994
ImmunityBio, Inc.
Selected Balance Sheet Data
Sept. 30, 2024
December 31,
2023
(in thousands)
(Unaudited)
Cash and cash equivalents, and marketable
securities
$
130,367
$
267,353
Total assets
364,570
504,452
Total related-party debt
699,118
681,537
Revenue interest liability
273,657
155,415
Total liabilities
1,108,732
1,090,389
Total stockholders’ deficit (including
noncontrolling interests)
(744,162
)
(585,937
)
Total liabilities and stockholders’
deficit
364,570
504,452
ImmunityBio, Inc.
Summary Reconciliation of Cash
Flows
Three Months Ended
September 30,
Nine Months Ended
September 30,
(in thousands; unaudited)
2024
2023
2024
2023
Cash (used in) provided by:
Net cash used in operating activities
$
(98,763
)
$
(87,403
)
$
(306,092
)
$
(251,486
)
Net cash provided by (used in) investing
activities
65,032
(15,631
)
(22,080
)
(32,719
)
Net cash provided by financing
activities
15,582
237,502
174,701
357,802
Effect of exchange rate changes on cash
and cash equivalents, and restricted cash
11
(1
)
(16
)
(265
)
Net change in cash and cash equivalents,
and restricted cash
(18,138
)
134,467
(153,487
)
73,332
Cash and cash equivalents, and restricted
cash, beginning of period
130,438
43,830
265,787
104,965
Cash and cash equivalents, and restricted
cash, end of period
$
112,300
$
178,297
$
112,300
$
178,297
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 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.
About ImmunityBio
ImmunityBio is a vertically-integrated biotechnology company
developing next-generation therapies and vaccines 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 natural killer 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 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 anticipated regulatory
submissions and timing thereof, market access initiatives and
coverage under medical reimbursement policies, shelf life of
ANKTIVA and product supply, global expansion efforts, effectiveness
of the permanent J-code for ANKTIVA, clinical trial plans and
timing, market and prevalence data, the regulatory filing and
review process and timing thereof, 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 and use 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 presentation 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, (iii) the ability
of ImmunityBio to fund its ongoing and anticipated clinical trials,
(iv) whether clinical trials will result in registrational pathways
and the risks and uncertainties regarding the regulatory
submission, review and approval process, (v) risks and
uncertainties associated with third-party collaborations and
agreements, (vi) 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, (vii) potential
delays in product availability and regulatory approvals, (viii)
ImmunityBio’s ability to retain and hire key personnel, (ix)
ImmunityBio’s ability to obtain additional financing to fund its
operations and complete the development and commercialization of
its various product candidates, (x) potential product shortages or
manufacturing disruptions that may impact the availability and
timing of product, (xi) ImmunityBio’s ability to successfully
commercialize its approved product and product candidates, (xii)
ImmunityBio’s ability to scale its manufacturing and commercial
supply operations for its approved product and future approved
products, and (xiii) 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
August 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/20241112689334/en/
ImmunityBio, Inc.
Investors Hemanth Ramaprakash, PhD, MBA +1-858-746-9289
Hemanth.Ramaprakash@ImmunityBio.com
Media Sarah Singleton +1-415-290-8045
Sarah.Singleton@ImmunityBio.com
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