STOCK TITAN

ImmunityBio Reports Sales Momentum & Unit Growth Since Permanent J-code Issuance (J9028) in January 2025 and Financial Results for Year End 2024

Rhea-AI Impact
(Neutral)
Rhea-AI Sentiment
(Neutral)
Tags

ImmunityBio (NASDAQ: IBRX) reported strong growth following its ANKTIVA product's permanent J-code issuance in January 2025. February 2025 unit sales volume increased 97% compared to December 2024, with a 67% month-over-month growth from January 2025.

Key financial highlights include Q4 2024 net product revenue of $7.2 million, a 21% increase from Q3's $6.0 million. The company's cash position stood at $149.8 million as of December 31, 2024. Annual net loss decreased to $413.6 million in 2024 from $583.2 million in 2023.

Notable developments include:

  • FDA authorization for expanded access to alternative BCG source with 45,000 doses available
  • MHRA and EMA acceptance of marketing authorization applications for ANKTIVA
  • RMAT designation for ANKTIVA and CAR-NK combination therapy
  • BeOne Medicines collaboration for Phase 3 NSCLC trial

ImmunityBio (NASDAQ: IBRX) ha riportato una forte crescita dopo l'emissione permanente del codice J per il suo prodotto ANKTIVA a gennaio 2025. Il volume delle vendite unitario di febbraio 2025 è aumentato del 97% rispetto a dicembre 2024, con una crescita mensile del 67% rispetto a gennaio 2025.

I principali risultati finanziari includono un fatturato netto da prodotto nel Q4 2024 di 7,2 milioni di dollari, un aumento del 21% rispetto ai 6,0 milioni di dollari del Q3. La posizione di cassa dell'azienda era di 149,8 milioni di dollari al 31 dicembre 2024. La perdita netta annuale è diminuita a 413,6 milioni di dollari nel 2024, rispetto ai 583,2 milioni di dollari nel 2023.

Sviluppi notevoli includono:

  • Autorizzazione della FDA per l'accesso ampliato a una fonte alternativa di BCG con 45.000 dosi disponibili
  • Accettazione da parte di MHRA ed EMA delle domande di autorizzazione all'immissione in commercio per ANKTIVA
  • Designazione RMAT per ANKTIVA e terapia combinata CAR-NK
  • Collaborazione con BeOne Medicines per la sperimentazione di fase 3 sul NSCLC

ImmunityBio (NASDAQ: IBRX) reportó un fuerte crecimiento tras la emisión permanente del código J para su producto ANKTIVA en enero de 2025. El volumen de ventas unitarias de febrero de 2025 aumentó un 97% en comparación con diciembre de 2024, con un crecimiento mensual del 67% desde enero de 2025.

Los principales aspectos financieros incluyen ingresos netos por productos en el Q4 2024 de 7.2 millones de dólares, un aumento del 21% respecto a los 6.0 millones de dólares del Q3. La posición de efectivo de la compañía era de 149.8 millones de dólares al 31 de diciembre de 2024. La pérdida neta anual se redujo a 413.6 millones de dólares en 2024, desde 583.2 millones de dólares en 2023.

Desarrollos notables incluyen:

  • Autorización de la FDA para el acceso ampliado a una fuente alternativa de BCG con 45,000 dosis disponibles
  • Aceptación por parte de MHRA y EMA de las solicitudes de autorización de comercialización para ANKTIVA
  • Designación RMAT para ANKTIVA y terapia combinada CAR-NK
  • Colaboración con BeOne Medicines para el ensayo de fase 3 de NSCLC

ImmunityBio (NASDAQ: IBRX)는 2025년 1월 ANKTIVA 제품에 대한 영구 J 코드 발급 이후 강력한 성장을 보고했습니다. 2025년 2월의 판매량은 2024년 12월에 비해 97% 증가했으며, 2025년 1월에 비해 월간 성장률은 67%에 달했습니다.

주요 재무 하이라이트로는 2024년 4분기 제품 순수익이 720만 달러로, 3분기의 600만 달러에서 21% 증가했습니다. 회사의 현금 보유액은 2024년 12월 31일 기준으로 1억 4,980만 달러에 달했습니다. 연간 순손실은 2023년 5억 8,320만 달러에서 2024년 4억 1,360만 달러로 감소했습니다.

주목할 만한 발전 사항은 다음과 같습니다:

  • BCG 대체 출처에 대한 확대 접근을 위한 FDA 승인, 45,000회 분량 가능
  • ANKTIVA에 대한 마케팅 승인 신청서의 MHRA 및 EMA 수용
  • ANKTIVA 및 CAR-NK 복합 요법에 대한 RMAT 지정
  • 3상 NSCLC 시험을 위한 BeOne Medicines와의 협력

ImmunityBio (NASDAQ: IBRX) a rapporté une forte croissance suite à l'émission permanente du code J pour son produit ANKTIVA en janvier 2025. Le volume des ventes unitaires de février 2025 a augmenté de 97 % par rapport à décembre 2024, avec une croissance mensuelle de 67 % par rapport à janvier 2025.

Les principaux points financiers incluent un chiffre d'affaires net de produit de 7,2 millions de dollars au T4 2024, une augmentation de 21 % par rapport aux 6,0 millions de dollars du T3. La position de trésorerie de l'entreprise s'élevait à 149,8 millions de dollars au 31 décembre 2024. La perte nette annuelle a diminué à 413,6 millions de dollars en 2024, contre 583,2 millions de dollars en 2023.

Les développements notables incluent :

  • Autorisation de la FDA pour un accès élargi à une source alternative de BCG avec 45 000 doses disponibles
  • Acceptation par la MHRA et l'EMA des demandes d'autorisation de mise sur le marché pour ANKTIVA
  • Désignation RMAT pour ANKTIVA et thérapie combinée CAR-NK
  • Collaboration avec BeOne Medicines pour l'essai de phase 3 sur le NSCLC

ImmunityBio (NASDAQ: IBRX) berichtete von starkem Wachstum nach der permanenten Vergabe des J-Codes für sein Produkt ANKTIVA im Januar 2025. Das Verkaufsvolumen im Februar 2025 stieg um 97 % im Vergleich zu Dezember 2024, mit einem monatlichen Wachstum von 67 % im Vergleich zu Januar 2025.

Wichtige finanzielle Highlights umfassen einen Nettoumsatz von 7,2 Millionen US-Dollar im Q4 2024, ein Anstieg von 21 % gegenüber den 6,0 Millionen US-Dollar im Q3. Die Liquiditätsposition des Unternehmens betrug zum 31. Dezember 2024 149,8 Millionen US-Dollar. Der jährliche Nettoverlust sank 2024 auf 413,6 Millionen US-Dollar, verglichen mit 583,2 Millionen US-Dollar im Jahr 2023.

Bemerkenswerte Entwicklungen umfassen:

  • FDA-Zulassung für erweiterten Zugang zu alternativen BCG-Quellen mit 45.000 verfügbaren Dosen
  • Akzeptanz der Anträge auf Marktzulassung für ANKTIVA durch MHRA und EMA
  • RMAT-Status für ANKTIVA und CAR-NK-Kombinationstherapie
  • Zusammenarbeit mit BeOne Medicines für die Phase-3-Studie zu NSCLC

Positive
  • 97% growth in ANKTIVA unit sales (Feb 2025 vs Dec 2024)
  • 21% QoQ revenue growth to $7.2M in Q4 2024
  • FDA expanded access authorization for 45,000 BCG doses
  • RMAT designation received for ANKTIVA combination therapy
  • Net loss reduced by $169.6M year-over-year
Negative
  • Annual net loss of $413.6M in 2024
  • SG&A expenses increased by $39.2M to $168.8M in 2024
  • Q4 2024 net loss of $59.2M

Insights

ImmunityBio's Q4 2024 results showcase strong commercial traction for ANKTIVA following its permanent J-code issuance. The 21% sequential revenue growth to $7.2 million in Q4 is encouraging, but the post-quarter acceleration is more compelling—February unit sales jumped 97% from December and 67% from January, with 2025's first two months already exceeding Q4 2024's total units.

The company's financial trajectory shows improving fundamentals. The quarterly net loss decreased substantially to $59.2 million from $233.4 million year-over-year, driven by both revenue introduction and $16.3 million in R&D cost reductions. While SG&A expenses increased by $8.6 million to support commercialization, this investment appears justified given the sales momentum.

The $149.8 million cash position remains a key consideration against the current burn rate. However, several catalysts could enhance the company's commercial outlook: the FDA's expanded access authorization for recombinant BCG addresses a critical market shortage with 45,000 doses becoming available; the EMA/MHRA regulatory reviews could open international markets; and the RMAT designation potentially accelerates additional indications.

The BeiGene collaboration for a Phase 3 trial combining ANKTIVA with tislelizumab represents an important strategic expansion beyond bladder cancer into NSCLC, significantly broadening the addressable market opportunity while sharing development costs.

ImmunityBio's ANKTIVA is demonstrating promising market adoption in BCG-unresponsive non-muscle invasive bladder cancer with CIS, addressing a significant unmet need. The FDA's authorization of expanded access to recombinant BCG is particularly significant amid the ongoing TICE BCG shortage that has hampered treatment protocols nationwide. The availability of 45,000 rBCG vials in 2025 and activation of over 60 clinical sites represents a substantial improvement in the treatment landscape.

The RMAT designation for ANKTIVA plus PD-L1 t-haNK is scientifically meaningful as it targets the critical issue of lymphopenia in pancreatic cancer patients. Lymphopenia (abnormally low lymphocyte counts) significantly compromises immune response against tumors, and addressing this could enhance both chemotherapy and immunotherapy efficacy in this notoriously treatment-resistant malignancy.

The BeiGene collaboration exploring ANKTIVA with tislelizumab in patients who've developed resistance to PD-1 inhibitors represents an important scientific approach. Checkpoint inhibitor resistance remains one of oncology's most challenging problems, and IL-15 receptor engagement through ANKTIVA theoretically offers a complementary mechanism to potentially re-sensitize tumors by enhancing NK cell and CD8+ T cell activity.

The cancer prevention trial in Lynch Syndrome patients (now with 100+ participants) represents a novel application of immunotherapy concepts to high-risk populations. This preventative approach could significantly impact clinical practice if successful, as effective cancer prevention strategies for these genetically predisposed individuals remain

  • 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)

CULVER CITY, Calif.--(BUSINESS WIRE)-- 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.

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

Source: ImmunityBio, Inc.

FAQ

What was ImmunityBio's (IBRX) revenue growth for ANKTIVA in Q4 2024?

IBRX reported Q4 2024 net product revenue of $7.2 million, representing a 21% increase from Q3 2024's $6.0 million.

How did IBRX's ANKTIVA sales perform after receiving the J-code in January 2025?

February 2025 ANKTIVA unit sales grew 97% compared to December 2024, with a 67% increase from January 2025.

What is the significance of IBRX's RMAT designation received in February 2025?

The RMAT designation expedites development and review of ANKTIVA plus PD-L1 t-haNK therapy, enabling early FDA interactions and potential accelerated approval.

How many BCG doses will be available through ImmunityBio's expanded access program in 2025?

Over 45,000 vials of recombinant BCG will be available in the US through the expanded access program in 2025.

What was ImmunityBio's cash position at the end of 2024?

IBRX reported consolidated cash, cash equivalents, and marketable securities of $149.8 million as of December 31, 2024.

Immunitybio Inc

NASDAQ:IBRX

IBRX Rankings

IBRX Latest News

IBRX Stock Data

2.28B
191.85M
73.51%
9.62%
7.47%
Biotechnology
Biological Products, (no Disgnostic Substances)
Link
United States
SAN DIEGO