ImmunityBio Reports Third-Quarter 2024 Financial Results
IBRX 11.12.2024
Drug:ANKTIVA-IL15 ANKTIVA
Diseases:NON-MUSCLE INVASIVE BLADDER CANCER (NMIBC)
Diseases:HIGH-RISK PROSTATE CANCER
- ANKTIVA®received a J-code (HCPCS Level II Code) in
October 2024 , effectiveJanuary 1, 2025 . - ANKTIVA (FDA-approved and commercially available in the
U.S. sinceMay 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 endedSeptember 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 theUnited Kingdom onNovember 1, 2024 .ImmunityBio intends to submit to theEuropean Medicines Agency (EMA) an MAA for ANKTIVA in theEuropean Union (EU) in Q4 2024, covering 30 countries, including 27 in the EU and 3 in the European Economic Area (Iceland ,Norway ,Liechtenstein ).
“The
“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
Third-Quarter Ended
Cash and Marketable Securities Position
As of
Research and Development Expenses
Research and development (R&D) expenses increased
Selling, General and Administrative Expenses
Selling, general and administrative expenses increased
Net Loss Attributable to ImmunityBio Common Stockholders
Net loss attributable to
Condensed Consolidated Statements of Operations | ||||||||||||||||
Three Months Ended | Nine Months Ended | |||||||||||||||
(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 noncontrollinginterests | (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 | $ | (85,729 | ) | $ | (95,582 | ) | $ | (354,402 | ) | $ | (349,804 | ) | ||||
Net loss per | $ | (0.12 | ) | $ | (0.19 | ) | $ | (0.52 | ) | $ | (0.77 | ) | ||||
Net loss per | $ | (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 | ||||||||||||
Selected Balance Sheet Data | ||||||||
(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 | ||||||
Summary Reconciliation of Cash Flows | ||||||||||||||||
Three Months Ended | Nine Months Ended | |||||||||||||||
(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
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
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