On February 23, 2026 Myriad Genetics, Inc. (NASDAQ: MYGN), a leader in molecular diagnostic testing and precision medicine, reported financial results for its fourth quarter ended December 31, 2025, and reaffirmed its financial guidance on business performance for the full-year 2026.

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"We ended 2025 with positive momentum in a number of key areas, including within the Cancer Care Continuum where we drove another quarter of high single-digit volume growth in Hereditary cancer testing year-over-year and recognized improving volume growth for our Prolaris prostate cancer test. I’m also pleased to report improving volume growth in our GeneSight mental health test. We attribute this momentum to strengthened execution across the commercial team and the enterprise overall. Prenatal testing has been uneven through 2025 but we continue to make progress and expect growth to reaccelerate in the coming quarters," said Sam Raha, President and CEO, of Myriad Genetics. "2026 is a milestone year for Myriad Genetics, with three significant new test launches, including Precise MRD, starting with a targeted alpha launch for breast cancer expected in March 2026, and full commercial launches of our AI-enabled Prolaris prostate cancer test in partnership with PATHOMIQ expected in the second quarter of 2026, and the multiple prenatal screen test, FirstGene, expected in the second half of 2026. We are looking forward to these tests supporting clinical decisions starting in 2026 and being important components of our growth in 2027 and beyond."
Financial and Operational Highlights
•Test volumes of 382,000 in the fourth quarter of 2025 increased 2% year-over-year.
•The following table summarizes year-over-year testing volume changes in the company’s core product categories:
Three months ended December 31, Twelve Months Ended December 31,
(in thousands) 2025 2024 % Change 2025 2024 % Change
Product volumes:
Hereditary cancer
82 75 9 % 315 294 7 %
Tumor profiling(1)
12 12 — % 48 53 (9) %
Prenatal 150 160 (6) % 637 666 (4) %
Mental Health 138 127 9 % 537 507 6 %
Total 382 374 2 % 1,537 1,520 1 %
(1) Tumor Profiling decreased for the twelve months ended December 31, 2025 compared to the same period in the prior year due primarily to a decrease in testing volume for EndoPredict due to the sale of the company’s international EndoPredict business in August 2024.

•The following table summarizes year-over-year revenue changes in the company’s core product categories:
Three months ended December 31, Twelve Months Ended December 31,
(in millions)
2025 2024 % Change 2025 2024 % Change
Product revenues:
Hereditary cancer
$ 96.8 $ 94.3 3 % $ 372.4 $ 364.5 2 %
Tumor profiling(1)
31.5 30.8 2 % 121.7 125.8 (3) %
Prenatal 44.9 44.9 — % 186.3 177.1 5 %
Mental Health 36.6 40.6 (10) % 144.1 170.2 (15) %
Total $ 209.8 $ 210.6 — % $ 824.5 $ 837.6 (2) %

•Operating expenses in the fourth quarter of 2025 were $152.5 million, decreasing $37.4 million year-over-year. Adjusted operating expenses in the fourth quarter of 2025 decreased $7.0 million year-over-year to $139.0 million, reflecting the company’s commitment to disciplined cost management while maintaining investments in key strategic areas.
•Operating loss in the fourth quarter of 2025 was $5.7 million.

Cash Flow and Liquidity
Fourth quarter 2025 cash flow provided by operations was $10.6 million; adjusted operating cash flow in the fourth quarter of 2025 was $17.9 million. Capital expenditures and capitalization of internal use software costs totaled $6.0 million in the fourth quarter 2025 resulting in adjusted free cash flow of $11.9 million in the fourth quarter of 2025.

As of the end of the fourth quarter of 2025, the company had cash and cash equivalents of $149.6 million.

Business Performance and Highlights
Oncology
The Oncology business delivered revenue of $84.7 million in the fourth quarter of 2025.
•Fourth quarter 2025 hereditary cancer testing revenue in Oncology increased 2% year-over-year driven by a 9% year-over-year increase in volume.
•Fourth quarter 2025 Prolaris testing revenue grew 16% year-over-year. The company continues to make progress and intends to commercially launch its first AI-enabled prostate cancer test, in partnership with PATHOMIQ, in the first half of 2026.
•The company advanced personalized breast cancer risk assessment through the launch of the first integrated AI and genetic risk platform, developed in partnership with Clairity and MagView. The company believes this solution enhances its leadership in precision breast health.
•The company showcased nine new oncology and Molecular Residual Disease (MRD) research abstracts at the 2025 San Antonio Breast Cancer Symposium, highlighting continued progress in its precision oncology pipeline. The company believes these data reinforce the scientific strength behind the company’s MRD and hereditary cancer programs and underscore Myriad Genetics’ commitment to advancing clinically meaningful innovations for patients and providers.
•In January 2026, at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Gastrointestinal Cancers Symposium, collaborators from the National Cancer Center Hospital East in Japan reported positive interim key outcomes from MONSTAR-SCREEN-3, a multi-center, prospective study of patients with resectable Stage I-IV colorectal cancer that incorporates Precise MRD. These outcomes include 100% baseline sensitivity and highly sensitive detection of residual disease post-surgery.

Women’s Health
The Women’s Health business delivered revenue of $88.5 million in the fourth quarter of 2025.
•Fourth quarter 2025 hereditary cancer testing revenue and volume for the unaffected population increased 3% and 11% year-over-year, respectively, demonstrating progress with implementing the company’s electronic medical records (EMR) solutions and breast cancer risk assessment programs.
•Prenatal testing revenue in the fourth quarter of 2025 was stable year-over-year, while volume decreased 6% year-over-year reflecting transition dynamics following the second quarter 2025 implementation of the company’s new order management system.
•The multi-site CONNECTOR study, using the company’s FirstGene Multiple Prenatal Screen, continues to see meaningful progress in enrollment and the Company expects this study to support future commercial launch activities and expand capabilities in prenatal testing.

Mental Health
GeneSight test revenue was $36.6 million in the fourth quarter of 2025.
•Fourth quarter 2025 revenue continues to reflect the impact of UnitedHealthcare’s discontinuation of coverage of multi-gene panel pharmacogenetic testing, including GeneSight, effective in the first quarter of 2025.
•GeneSight test volume in the fourth quarter of 2025 grew 9% year-over-year, reflecting ongoing improvement in the year-over-year volume growth through 2025.

Financial Guidance
Myriad Genetics does not provide forward-looking guidance in accordance with accounting principles generally accepted in the United States (GAAP) for the measures on which it provides forward-looking non-GAAP guidance as the company is unable to provide a quantitative reconciliation of forward-looking non-GAAP measures to the most directly comparable forward-looking GAAP measure, without unreasonable effort, because of the inherent difficulty in accurately forecasting the occurrence and financial impact of the various adjusting items necessary for such reconciliations that have not yet occurred, are dependent on various factors, are out of the company’s control, or cannot be reasonably predicted. Such adjustments include, but are not limited to, strategic realignment, certain litigation charges and loss contingencies, costs related to acquisitions/divestitures and the related amortization, impairment and related charges, depreciation, equity compensation, tax benefits, and other adjustments. For example, stock-based compensation may fluctuate based on the timing of employee stock transactions and unpredictable fluctuations in the company’s stock price. Any associated estimate of these items and their impact on GAAP performance could vary materially.

Below is a table summarizing Myriad Genetics’ full-year 2026 financial guidance*:
(in millions, except percentages)
2026 Guidance
FY 2026 Comments
Revenue $860 – $880
Reiterate the full year 2026 revenue range. Q1’26 revenue is expected to be between $200 and $203 million, or 2% to 4% growth over Q1’25. This reflects current business trends offset by an unfavorable YOY comparison for Prenatal testing.

Expect 2H’26 revenue to be greater than 1H’26
Adjusted Gross Margin %**
68% – 69% Gross margins expected to fluctuate quarter to quarter given product mix and pricing trends.
Adjusted EBITDA***
$37 – $49
Q1’26 adjusted EBITDA is expected to be near breakeven
*
Assumes currency rates as of February 23, 2026.
**
Adjusted Gross Margin is defined as Gross Margin plus non-cash cost of sales, such as amortization of intangible assets and share-based compensation expense, and non-recurring one-time expenses.
***
Adjusted EBITDA is defined as Net income (loss) plus income tax expense (benefit), total other income (expense), non-cash operating expenses, such as amortization of intangible assets, depreciation, impairment of long-lived assets, and share-based compensation expense, and one-time expenses such as expenses from strategic realignment, legal settlements, and divestitures and acquisitions.

These projections are forward-looking statements and are subject to the risks summarized in the safe harbor statement at the end of this press release.

Conference Call and Webcast

A conference call will be held today, Monday, February 23, 2026, at 4:30 p.m. ET to discuss Myriad Genetics’ financial results and business developments for the fourth quarter of 2025. A live webcast of the conference call can be accessed on Myriad Genetics’ Investor Relations website at investor.myriad.com. To participate in the live conference call via telephone, please register at View Source Upon registering, a dial-in number and unique PIN will be provided to join the conference call. Following the conference call, an archived webcast of the call will be available at investor.myriad.com.

(Press release, Myriad Genetics, FEB 23, 2026, View Source [SID1234662856])

On February 23, 2026 MacroGenics, Inc. (NASDAQ: MGNX), a clinical-stage biopharmaceutical company focused on developing innovative antibody-based therapeutics for the treatment of cancer, reported that the U. S. Food and Drug Administration (FDA) has placed a partial clinical hold on its Phase 2 LINNET study of lorigerlimab, an investigational, bispecific DART molecule that targets PD-1 and CTLA-4, in patients with gynecologic cancers. Under the partial clinical hold, no new patients will be enrolled in the LINNET study until the partial hold is lifted by the FDA. Current study participants may continue to receive study drug.

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The FDA’s partial clinical hold was initiated following the Company’s recent notification to the FDA of a temporary pause in enrollment of new participants in the LINNET trial due to the occurrence of recent safety events. The safety events that prompted the enrollment pause occurred across four patients and included Grade 4 thrombocytopenia (N=2), Grade 4 myocarditis (N=1), and Grade 4 neutropenia and concurrent septic shock (N=1) which led to a Grade 5 event. To date, 41 study participants have been dosed at 6 mg/kg every 3 weeks across the platinum-resistant ovarian cancer (PROC) and clear cell gynecologic cancer (CCGC) cohorts.

"At MacroGenics, our top priority is patient safety," said Eric Risser, President and CEO. "MacroGenics is fully committed to working closely with the FDA to resolve the partial clinical hold and we intend to resume study enrollment as soon as possible."

About the LINNET Study

The LINNET study is evaluating lorigerlimab, an investigational, bispecific DART molecule that targets PD-1 and CTLA-4, as monotherapy in a Simon two-stage trial in eligible patients with PROC who have received up to three prior lines of therapy. If a predefined activity threshold is met in the first stage — based on approximately 20 patients — the study may expand to enroll an additional 20 patients. The study was also designed to enroll up to 20 patients with CCGC who have received at least one prior line of therapy. The primary endpoint is objective response rate (ORR), with multiple secondary endpoints.

(Press release, MacroGenics, FEB 23, 2026, View Source [SID1234662855])

On February 23, 2026 Lyell Immunopharma, Inc. (Nasdaq: LYEL), a clinical-stage company advancing a pipeline of next-generation chimeric antigen receptor (CAR) T-cell therapies for patients with cancer, reported that members of its senior management team will present and participate in the following investor conferences:

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TD Cowen 46th Annual Health Care Conference on Monday, March 2, 2026, in Boston, Massachusetts; presentation at 9:10am Eastern Time
Leerink Annual Global Healthcare Conference on Monday, March 9, 2026, in Miami, Florida; fireside chat at 10:00am Eastern Time
Citizens Life Science Conference on Tuesday, March 10, 2026, in Miami, Florida; fireside chat at 11:55am Eastern Time
A live webcast of each presentation can be accessed through the Investors section of the Company’s website at www.lyell.com. Following each live presentation, a replay of the webcast will be available on the Company’s website following the presentation date.

(Press release, Lyell Immunopharma, FEB 23, 2026, View Source [SID1234662854])

On February 23, 2026 Labcorp (NYSE: LH), a global leader of innovative and comprehensive laboratory services, reported an expanded collaboration with PathAI to deploy AISight Dx1, an FDA-cleared digital pathology platform, across its national network of anatomic pathology labs and hospital collaborations. The cloud-based technology allows pathologists to view and manage slides digitally and use AI to support key steps in the diagnostic process.

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"Labcorp is committed to building a modern, AI-powered infrastructure that sets a new standard for efficiency, collaboration and innovation in pathology," said Dr. Marcia Eisenberg, chief scientific officer at Labcorp. "PathAI’s technology allows us to scale digital pathology nationwide and integrate AI insights into routine care—delivering faster, more consistent results for patients and providers."

Labcorp will deploy AISight Dx across its anatomic pathology labs and hospital collaborations, enabling fully digital workflows for case management, slide review, collaboration and annotation. The platform also integrates AI-powered image analysis, secure storage and system connectivity to deliver faster turnaround, greater efficiency, reliable quality and improved collaboration. Labcorp will also incorporate digital pathology workflows in support of its precision medicine products.

"Labcorp’s leadership in diagnostics makes them an ideal partner in our mission to modernize pathology through software and AI," said Dr. Andy Beck, co-founder and CEO of PathAI. "The deployment of AISight Dx across Labcorp’s network brings high-quality, efficient digital pathology to a national scale."

The expansion builds on Labcorp’s 2019 strategic investment in PathAI, a collaboration that has since advanced to include AI-driven clinical trial support and validation of novel AI-pathology solutions.

(Press release, LabCorp, FEB 23, 2026, View Source [SID1234662853])

On February 23, 2026 ImmunityBio, Inc. (NASDAQ: IBRX), a commercial-stage immunotherapy company, reported full-year 2025 financial and operational highlights, including approximately $113 million in net product revenue for ANKTIVA, representing an approximately 700% increase year-over-year. The Company also reported a 750% increase in unit sales volume and a 20% quarter-over-quarter increase in net product revenue, demonstrating sustained commercial momentum. In parallel, ImmunityBio expanded its global regulatory footprint to 33 countries across four jurisdictions and secured the first approval for ANKTIVA in combination with checkpoint inhibitors for lung cancer.

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Global Regulatory Approvals

ANKTIVA in combination with BCG for the treatment of BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) carcinoma in situ (CIS), with or without papillary tumors, is now authorized across four major regulatory jurisdictions encompassing 33 countries:

United States: FDA approval (April 2024)
United Kingdom: MHRA authorization (July 2025)
Kingdom of Saudi Arabia: SFDA accelerated approval for BCG-unresponsive NMIBC CIS (January 2026) and conditional accelerated approval for metastatic NSCLC in combination with checkpoint inhibitors (January 2026), the first jurisdiction globally to authorize ANKTIVA for lung cancer
European Union: European Commission conditional marketing authorization covering all 27 EU member states plus Iceland, Norway, and Liechtenstein (February 2026)
This global regulatory footprint of 33 countries was established in under two years from initial 2024 FDA approval, representing the most rapid international expansion for an immunotherapy in this indication.

First Approval for Lung Cancer and Label Expansion Plans

In January 2026, the SFDA granted conditional accelerated approval for ANKTIVA in combination with checkpoint inhibitors for the treatment of metastatic NSCLC, making Saudi Arabia the first jurisdiction globally to authorize ANKTIVA outside of bladder cancer. The commercial launch in Saudi Arabia is planned within 60 days of approval. Submissions to multiple additional regulatory authorities (Ex-USA) for accelerated approval are planned for 2026, with discussions with the U.S. FDA regarding an accelerated approval pathway also planned for 2026. The Company is pursuing further label expansion across multiple tumor types and for the treatment of chemotherapy-induced lymphopenia, supported by ongoing clinical trial programs.

Long-Term Patent Protection

Multiple issued patents, including U.S. Patent Nos, protect the combination of ANKTIVA plus checkpoint inhibitor therapy. 9,925,247 and 11,071,774, with patent terms extending beyond 2035. These patents cover the combination of IL-15 receptor agonist therapy with anti-PD-1 and anti-PD-L1 checkpoint inhibitors across multiple tumor types, providing long-term exclusivity protection for ANKTIVA’s expanding combination indications.

"In under two years from initial FDA approval, ImmunityBio has built a global commercial footprint spanning 33 countries across four regulatory jurisdictions, with $113 million in full-year net product revenue representing 700% year-over-year growth," said Dr. Patrick Soon-Shiong, Founder, Executive Chairman, and Global Chief Scientific and Medical Officer of ImmunityBio. "The SFDA’s accelerated approval of ANKTIVA in combination with checkpoint inhibitors for metastatic NSCLC marks a defining moment for the Company, the first authorization of ANKTIVA beyond bladder cancer and the first validation of its role as a lymphocyte-stimulating agent in solid tumors. We are now pursuing accelerated approvals in multiple additional jurisdictions and engaging with the U.S. FDA on a regulatory pathway for this indication. In parallel, our pipeline spans over 30 active and planned clinical trials across 10 tumor types, including randomized trials in BCG-naïve bladder cancer, first-line NSCLC, glioblastoma, and pancreatic cancer. ANKTIVA’s mechanism activating NK cells, CD8+ T cells, and memory T cells without expanding regulatory T cells positions it as a backbone immunotherapy across the oncology landscape, and our expanding patent portfolio protecting these combinations through 2035 and beyond ensures long-term commercial exclusivity."

Commercial Partnerships and Global Infrastructure

ImmunityBio has established strategic partnerships and infrastructure to support the global commercial launch of ANKTIVA:

European Union and United Kingdom: Partnered with Accord Healthcare to deploy over 100 sales, medical, and marketing professionals across 30 countries in the EU, UK, and European Free Trade Association (EFTA) member states. ImmunityBio also established an Irish subsidiary in Dublin to support European distribution and commercialization strategy.
Kingdom of Saudi Arabia: Partnering with BioPharma & Cigalah to expand access to ANKTIVA in Saudi Arabia and, over time, throughout the MENA region. ImmunityBio has formed a KSA subsidiary to support commercial launch operations in the Kingdom.
"Our 2025 financial results reflect the growing clinical adoption of ANKTIVA as a foundational backbone of immunotherapy for bladder cancer," said Richard Adcock, President and CEO of ImmunityBio. "Our partnership with Accord Healthcare deploys over 100 commercial professionals across 30 European countries, and our collaboration with BioPharma & Cigalah positions us for rapid commercial execution in Saudi Arabia and the broader MENA region. With subsidiaries now established in Dublin and the Kingdom of Saudi Arabia, we have the infrastructure to support sustained commercial growth across all 33 countries where ANKTIVA is authorized. As we advance toward initial international commercial activities, we remain focused on disciplined execution: completing enrollment in our BCG-naïve randomized trial with a BLA filing targeted by Q4 2026, expanding the ANKTIVA label into lung cancer and lymphopenia, and converting our 700% revenue growth trajectory into durable, long-term value for shareholders."

3 Year Global Strategy: ANKTIVA as a Backbone to the Cancer BioShield Platform

ImmunityBio is advancing enrollment in ongoing and planned key randomized clinical trials across multiple therapeutic areas, with anticipated submissions of completed single-arm trials as summarized below to implement the 3-year global strategy of ANKTIVA as the backbone in the following protocols:

A. ANKTIVA + Standard of Care

B. ANKTIVA + CAR-NK / M-ceNK

C. ANKTIVA in the Treatment of Lymphopenia

A. ANKTIVA + STANDARD OF CARE

1. Non-Muscle Invasive Bladder Cancer (NMIBC): ANKTIVA + BCG

QUILT-2.005 Randomized Trial (BCG-Naïve CIS): ANKTIVA + BCG; BLA filing targeted by Q4 2026
QUILT-3.032 Single Arm Trial (BCG-Unresponsive Papillary): Response submitted to U.S. FDA regarding additional data for BCG-unresponsive papillary-only NMIBC; awaiting Agency review
ResQ133A-NMIBC Single Arm Trial: Intravesical recombinant Mycobacterium (rBCG) in participants with NMIBC eligible to receive intravesical Tice BCG, addressing the global BCG shortage
ResQ132EX-NMIBC Expanded Access: Expanded access use of rBCG in NMIBC; over 570 patients dosed to date at 58 sites
ResQ132 Clinical Trial: Ablation therapy in participants with intermediate-risk non-muscle invasive papillary bladder cancer
Recombinant BCG Regulatory: Planned submission to SFDA and U.S. FDA meeting scheduled for March 2026
2. Non-Small Cell Lung Cancer (NSCLC): ANKTIVA + Chemotherapy + Checkpoint Inhibitor

QUILT-3.055 Single Arm Trial (2L+ NSCLC): ANKTIVA + checkpoint inhibitor. Accelerated approval by SFDA (January 2026). Planned submissions to multiple regulatory authorities (Ex-USA) for accelerated approval in 2026. Discussions planned with the U.S. FDA in 2026 for the accelerated approval pathway
QUILT-2.023 Randomized Trial (1L NSCLC): ANKTIVA + chemotherapy/checkpoint inhibitor versus chemotherapy/checkpoint inhibitor alone
ResQ201A Randomized Trial (2L NSCLC): ANKTIVA in combination with tislelizumab + 2 cycles of docetaxel versus docetaxel alone
3. Pancreatic Cancer: ANKTIVA + Chemo + CAR-NK

QUILT-88 Single Arm Trial (2L+ Metastatic): ANKTIVA + CAR-NK (PD-L1 t-haNK) + chemotherapy. Clinical trial completed. RMAT Designation granted
ResQ108B-PANC Single Arm Trial (Neoadjuvant Locally Advanced 1L): ANKTIVA + zabadinostat + sotevtamab
Planned Randomized Trial (1L Metastatic): ANKTIVA + CAR-NK (PD-L1 t-haNK) + Abraxane + gemcitabine versus Abraxane + gemcitabine, trial design pending finalization
4. Hepatocellular Carcinoma (HCC): ANKTIVA + Checkpoint Inhibitor

Planned 2L+ HCC Randomized Trial: ANKTIVA + zabadinostat + checkpoint inhibitor
5. Colorectal Cancer: ANKTIVA + Checkpoint

ResQ203D-CRC Randomized Phase 3: Colorectal patients undergoing resection/ablation of colorectal metastases: ANKTIVA + zabadinostat + tislelizumab versus standard of care
6. Multiple Tumor Types: ANKTIVA + Checkpoint Inhibitors

QUILT-3.055 Single Arm Trial (2L+ NSCLC and Multiple Tumor Types): Clinical trial completed. Accelerated approval for advanced NSCLC (SFDA, January 2026). Planned submissions for the expansion of the label in the Middle East, North Africa (MENA), for multiple tumor types
B. ANKTIVA + CAR-NK / M-ceNK-Designated Clinical Trials

1. Pancreatic Cancer: ANKTIVA + CAR-NK

QUILT-88 Pancreatic Cancer ANKTIVA + CAR-NK: 2L+ metastatic pancreatic cancer; ANKTIVA + CAR-NK (PD-L1 t-haNK) + chemotherapy. Clinical trial completed. RMAT Designation
2. Triple Negative Breast Cancer: ANKTIVA + CAR-NK

QUILT-3.067 Triple Negative Breast Cancer (TNBC) ANKTIVA + haNK: Single arm trial. Clinical trial completed
Planned Randomized Trial (2L+ TNBC): ANKTIVA + CAR-NK (PD-L1 t-haNK) + Trop2 Antibody: Trial design pending finalization
3. Glioblastoma: ANKTIVA + CAR-NK

QUILT-3.078 Glioblastoma Single Arm Trial (Recurrent) ANKTIVA + +CAR-NK: CAR-NK (PD-L1 t-haNK) + ANKTIVA + bevacizumab. Enrollment completed
Planned Randomized Trial (Neoadjuvant Glioblastoma) ANKTIVA + CAR-NK: ANKTIVA + CAR-NK (PD-L1 t-haNK) versus standard of care
Planned Randomized Trial (2L Recurrent Glioblastoma) ANKTIVA + CAR-NK: ANKTIVA + CAR-NK (PD-L1 t-haNK) + bevacizumab + TTF versus standard of care
4. Non-Hodgkin Lymphoma: ANKTIVA + CAR-NK

QUILT-106 Relapsed Refractory Non-Hodgkin’s Lymphoma (iNHL) Single Arm Trial CAR-NK (CD-19 t-haNK): No lymphodepletion. Relapsed/refractory NHL: CAR-NK (CD19 t-haNK) + rituximab. Enrolling
ResQ215A Relapsed Refractory NHL Single Arm Trial ANKTIVA + CAR-NK (CD19 t-haNK): Lymphodepletion. Flu/Cy + CAR-NK (CD19 t-haNK) + ANKTIVA + rituximab. Enrolling
ResQ215B Indolent Non-Hodgkin’s Lymphoma (Including Waldenstrom’s) Single Arm Trial: No lymphodepletion. CAR-NK (CD19 t-haNK) + ANKTIVA + rituximab
Planned Randomized Trial Relapsed/Refractory NHL: Lymphodepletion. Flu/Cy + CAR-NK (CD19 t-haNK) + ANKTIVA + rituximab versus Flu/Cy + CAR-NK (CD19 t-haNK) + rituximab
5. Multiple Tumor Types: M-ceNK (World Bank of Natural Killer Cells)

NK2022 & NK2023 (Cancer Patients & Healthy Donors): 64 subjects completed apheresis and M-ceNK manufacturing cell therapy process development for robotic training and future AI robot manufacturing. Cells cryopreserved and stored.
QUILT-3.076 Safety Phase 1 of Apheresis and M-ceNK + ANKTIVA Completed: Solid tumor: apheresis followed by M-ceNK + ANKTIVA. 10 patients treated with autologous M-ceNK infusion
ResQ209 Phase 2 Platinum Resistant Ovarian Cancer M-ceNK + ANKTIVA Single Arm Trial: Ovarian cancer: apheresis followed by M-ceNK + ANKTIVA + gemcitabine
LYMPHOPENIA STRATEGY

1. Sepsis: Community Acquired Pneumonia (CAP): ANKTIVA + iNKT

ResQ219-CAP Phase 2 Single Arm Trial (N=20): ANKTIVA + iNKT. Clinical trial protocol submitted to the FDA. USA trial sites
ResQ218-CAP Planned Phase 3 Randomized Trial: ANKTIVA + iNKT versus standard of care. To be initiated in Saudi Arabia, United States and planned UAE.
2. Radiation-Induced Lymphopenia: ANKTIVA

Real-World Evidence: Radiation-induced lymphopenia (Completed)
ResQ210 Randomized Trial Radiation-Induced Lymphopenia in Biochemical Recurrent and Localized Prostate Cancer: Radiation alone versus radiation + ANKTIVA. To be submitted.
3. Treatment Induced Infection: Multiple Myeloma: ANKTIVA

Planned Single Arm, Relapsed Multiple Myeloma: Bispecific antibody + ANKTIVA
2025 Financial Highlights

Metric

2025

YoY Change

Full-Year Net Product Revenue

$113M

~700%

Unit Sales Volume

3,745

~750%

Q4 2025 Net Product Revenue

$38.3M

431%

Cash and Marketable Securities Position

As of December 31, 2025, the Company had consolidated cash, cash equivalents, and marketable securities of $242.8 million.

Fourth-Quarter 2025 Financial Summary

Product Revenue, Net

Product revenue, net increased $31.1 million during the three months ended December 31, 2025, as compared to the three months ended December 31, 2024, due to an increase in sales of ANKTIVA, which was approved in April 2024.

Research and Development Expense

Research and development (R&D) expense increased $28.7 million to $63.9 million during the three months ended December 31, 2025, as compared to $35.2 million during the three months ended December 31, 2024. The increase was due to a $14.0 million one-time write-off of fixed assets, higher manufacturing and distribution costs driven by increased production and clinical trial activities, higher license fees, and higher salaries and benefits, partially offset by lower stock based compensation.

Selling, General and Administrative Expense

Selling, general and administrative (SG&A) expense decreased $3.0 million to $38.7 million during the three months ended December 31, 2025, as compared to $41.7 million during the three months ended December 31, 2024. The decrease was due to lower litigation settlement and commercial consulting costs, partially offset by higher headcount costs driven by growing sales and marketing activities.

Net Loss Attributable to ImmunityBio Common Stockholders

Net loss attributable to ImmunityBio common stockholders was $61.9 million during the three months ended December 31, 2025, as compared to $59.2 million during the three months ended December 31, 2024. The increase in loss was primarily driven by higher R&D expense described above, changes in the fair value of a related-party convertible note, and fixed asset write-offs, partially offset by higher product revenue, lower SG&A expense, lower related-party interest expense, and changes in the fair value of warrant liabilities.

Full-Year 2025 Financial Summary

Product Revenue, Net

Product revenue, net increased $98.8 million during the year ended December 31, 2025, as compared to the year ended December 31, 2024, due to an increase in sales of ANKTIVA, which was approved in April 2024.

Research and Development Expense

R&D expense increased $28.4 million to $218.6 million during the year ended December 31, 2025, as compared to $190.2 million during the year ended December 31, 2024. The increase was mainly due to a $14.0 million one-time write-off of fixed assets, higher clinical trial costs, salaries and benefits, and manufacturing costs driven by increased production activities.

Selling, General and Administrative Expense

SG&A expense decreased $18.8 million to $150.0 million during the year ended December 31, 2025, as compared to $168.8 million during the year ended December 31, 2024. The decrease was primarily driven by lower costs related to litigation settlements and commercial consulting activities, partially offset by higher stock-based compensation expense, recruiting and training expenses, salaries, benefits and commissions, and travel expenses due to growing sales and marketing activities.

Net Loss Attributable to ImmunityBio Common Stockholders

Net loss attributable to ImmunityBio common stockholders was $351.4 million during the year ended December 31, 2025, compared to $413.6 million during the year ended December 31, 2024. This reduction of loss was primarily driven by increased product revenue, lower SG&A expense described above, lower related-party interest expense, and changes in the fair value of warrant liabilities, partially offset by higher R&D expense described above, changes in the fair value of derivative liabilities and a related-party convertible note, an increase in interest expense related to the revenue interest liability, and lower interest and investment income.

(Press release, ImmunityBio, FEB 23, 2026, View Source [SID1234662852])