On February 26, 2026 Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA and genetic testing, reported its financial results for the fourth quarter and full year ended December 31, 2025.

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Recent Financial Highlights

Generated total revenues of $665.5 million in the fourth quarter of 2025, compared to $476.1 million in the fourth quarter of 2024, an increase of 39.8%. Product revenues grew 39.8% over the same period.
Generated a gross margin1 of 66.9% in the fourth quarter of 2025, compared to a gross margin1 of 62.9% in the fourth quarter of 2024.
Generated total revenues of $2,306.1 million in the full year 2025, compared to $1,696.9 million in the full year 2024, an increase of 35.9%. Product revenues grew 36.2% over the same period.
Generated a gross margin1 of 64.7% in the full year of 2025, compared to a gross margin1 of 60.3% in the full year of 2024.
Processed approximately 923,600 tests in the fourth quarter of 2025, compared to approximately 792,800 tests in the fourth quarter of 2024, an increase of 16.5%.
Processed approximately 3,525,500 tests in the full year 2025, compared to approximately 3,064,600 tests in the full year 2024, an increase of 15.0%.
Processed approximately 233,300 oncology tests in the fourth quarter of 2025, compared to approximately 150,800 in the fourth quarter of 2024, an increase of 54.7%.
Processed approximately 800,800 oncology tests in the full year 2025, compared to approximately 528,200 in the full year 2024, an increase of 51.6%.
Achieved positive cash inflow of approximately $107.6 million2 in the full year 2025.
"We delivered an outstanding finish to 2025 with record test volumes, strong revenue that exceeded our January pre-announcement, and gross margins well ahead of our expectations even as we continued to invest significantly throughout the year," said Steve Chapman, chief executive officer of Natera. "With solid momentum already in 2026, we remain focused on our mission to transform the management of disease worldwide by expanding access to our testing and advancing the data that supports better patient care."

Fourth Quarter and Year Ended December 31, 2025 Financial Results

Total revenues were $665.5 million in the fourth quarter of 2025 compared to $476.1 million in the fourth quarter of 2024, an increase of 39.8%. The increase in total revenues was driven primarily by a 39.8% increase in product revenues, which were $661.2 million in the fourth quarter of 2025 compared to $472.9 million in the fourth quarter of 2024. The increase in product revenues was driven by an increase in volume and average selling price improvements.

Natera processed approximately 923,600 tests in the fourth quarter of 2025, including approximately 909,000 tests accessioned in its laboratory, compared to approximately 792,800 tests processed, including approximately 778,400 tests accessioned in its laboratory, in the fourth quarter of 2024.

In the fourth quarter of 2025, Natera recognized revenue on approximately 892,400 tests for which results were reported to customers in the period (tests reported), including approximately 878,000 tests reported from its laboratory, compared to approximately 771,700 tests reported, including approximately 758,200 tests reported from its laboratory, in the fourth quarter of 2024, an increase of 15.6% from the prior period.

Total revenues were $2,306.1 million in the full year 2025 compared to $1,696.9 million in the full year 2024, an increase of 35.9%. The increase in total revenues was driven primarily by a 36.2% increase in product revenues, which were $2,295.8 million in the full year 2025 compared to $1,685.1 million in the full year 2024. The increase in product revenues was driven by an increase in volume and average selling price improvements.

Natera processed approximately 3,525,500 tests in the full year 2025, including approximately 3,468,700 tests accessioned in its laboratory, compared to approximately 3,064,600 tests processed, including approximately 3,001,900 tests accessioned in its laboratory, in the full year 2024.

In the full year 2025, Natera recognized revenue on approximately 3,342,500 tests for which results were reported to customers in the period (tests reported), including approximately 3,288,600 tests reported from its laboratory, compared to approximately 2,926,400 tests reported, including approximately 2,867,400 tests reported from its laboratory, in the full year 2024, an increase of 14.2% from the prior period.

Gross profit2 for the three months ended December 31, 2025 and 2024 was $445.2 million and $299.6 million, respectively, representing a gross margin1 of 66.9% and 62.9%, respectively. Gross profit1 for the year ended December 31, 2025 and 2024 was $1,493.2 million and $1,023.2 million, respectively, representing a gross margin1 of 64.7% and 60.3%, respectively. Natera had higher gross margin1 in the fourth quarter of 2025 and for the full year 2025 primarily as a result of higher revenues and continued progress in reducing cost of revenues associated with tests processed. Total operating expenses, representing research and development expenses and selling, general and administrative expenses, for the fourth quarter of 2025 was $466.5 million, compared to $364.4 million in the same period of the prior year, an increase of 28.0%. Total operating expense for the full year 2025 were $1,801.4 million, compared to $1,245.5 million in the same period of the prior year, an increase of 44.6%. The increases in both periods were primarily driven by headcount growth to support new product offerings as well as increases in consulting and legal expenses. Amortization of acquired intangible assets for the fourth quarter and full year of 2025 was $1.7 million. No such amortization occurred in the fourth quarter or full year of 2024.

Loss from operations for the fourth quarter of 2025 was $22.8 million compared to $64.7 million for the same period of the prior year. Loss from operations for full year 2025 was $309.9 million compared to $222.3 million for the same period of the prior year.

Natera’s net loss for the full year 2025 was $208.2 million, or ($1.52) per diluted share, compared to a net loss of $190.4 million, or ($1.53) per diluted share, in 2024. Weighted average shares outstanding were 136.7 million in the full year 2025 compared to 124.7 million for the same period in the prior year.

At December 31, 2025, Natera held approximately $1,076.1 million in cash, cash equivalents, short-term investments and restricted cash, compared to $968.3 million as of December 31, 2024. As of December 31, 2025, Natera had a total outstanding debt balance of $80.3 million including accrued interest under its line of credit with UBS at a variable interest rate of 30-day SOFR plus 50 bps.

Financial Outlook

Natera anticipates 2026 total revenue of $2.62 billion to $2.70 billion; 2026 gross margin1 to be approximately 63% to 65%; selling, general and administrative costs to be approximately $1.125 billion to $1.225 billion; research and development costs to be $750 million to $850 million; and net cash inflow to be positive.

(Press release, Natera, FEB 26, 2026, View Source [SID1234663095])

On February 26, 2026 ImmVira Group reported preliminary positive results from its clinical trial evaluating MVR-T3011, an oncolytic virus, in BCG-naïve high-risk papillary Ta/T1 NMIBC patients for its leading oncolytic virus product, MVR-T3011, via intravesical administration. The data were presented in a poster at the ASCO (Free ASCO Whitepaper) GU 2026 Conference in San Francisco, California.

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In the study involving 18 BCG-naïve high-risk papillary Ta/T1 NMIBC patients treated with intravesical MVR-T3011 at two dose levels: 2×109 PFU (3 patients) and 1×1010 PFU (15 patients), preliminary data as of December 31, 2025, demonstrated encouraging efficacy and durability. Among the 14 evaluable patients, the 12-month recurrence-free-survival (RFS) rate was 100% (3/3) at the 2×109 PFU dose level. At the 1×1010 PFU dose level, the 3-month RFS rate was 100% (11/11). The 6-month and 9-month RFS rates were 75% (3/4) and 66.7% (2/3), respectively, but these data are preliminary, given the small patient numbers reaching those timepoints.

Consistent with BCG-unresponsive clinical data, MVR-T3011 maintained a favorable safety profile in this study with most treatment-emergent adverse events (TEAEs) being at Grades 1 or 2. No treatment-related adverse events (TRAEs) were observed.

Bladder cancer ranks as the ninth most prevalent cancer worldwide[1], with approximately 75% of cases classified as NMIBC. While Bacillus Calmette-Guerin (BCG) remains the current SOC for high-risk NMIBC, global shortages have limited its availability. As a result, oncolytic immunotherapy, which offers enhanced immune activation and potential durability, is emerging as a promising alternative.

"We are highly encouraged by the preliminary efficacy and safety data from the study," said Dr. Grace Zhou, Chairwoman and CEO of ImmVira. "MVR-T3011 shows its potential to serve as a reliable and widely accessible alternative to BCG, ultimately benefiting patients worldwide."

(Press release, Immvira, FEB 26, 2026, View Source [SID1234663094])

On February 26, 2026 Whitehawk Therapeutics, Inc. (Nasdaq: WHWK), a clinical-stage oncology therapeutics company applying advanced technologies to established tumor biology to efficiently deliver improved antibody drug conjugate (ADC) cancer treatments, reported participation at the following investor conferences:

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TD Cowen 46th Annual Health Care Conference – Dave Lennon, PhD, President and CEO, will participate in a hybrid presentation and fireside chat on Tuesday, March 3 at 10:30 AM ET

Leerink 2026 Global Healthcare Conference – executives will participate in investor meetings on Monday, March 9

Citizens Life Sciences Conference – Dave Lennon, PhD, President and CEO, will give a corporate presentation on Tuesday, March 10 at 12:30 PM ET
A live webcast of the TD Cowen and Citizens presentations can be accessed by visiting the Whitehawk Therapeutics IR website and will be available for replay for approximately 30 days following the event.

(Press release, Whitehawk Therapeutics, FEB 26, 2026, View Source [SID1234663093])

On February 26, 2026 Johnson & Johnson (NYSE:JNJ) reported preliminary results from a Phase 1b study evaluating pasritamig (JNJ-78278343), a first-in-class bispecific T-cell engaging antibody, in combination with docetaxel in patients with metastatic castration-resistant prostate cancer. The combination demonstrated a safety profile consistent with docetaxel alone, with no new or unexpected safety signals observed. The regimen also showed clinically meaningful efficacy, including high rates of prostate-specific antigen (PSA) responses and sustained PSA reductions, supporting continued development and advancement into Phase 3 studies. The results were presented for the first time at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Genitourinary Cancers Symposium (Abstract #171).1

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Pasritamig is designed to engage the immune system through a novel mechanism of action, binding CD3 on T cells and human kallikrein 2 (KLK2). KLK2 is a novel, highly specific prostate cancer target with minimal expression outside prostate tissue. By both activating and directing T cells to KLK2-expressing tumor cells, pasritamig enables targeted immune engagement. This differentiated, prostate-specific approach was intentionally built to focus immune activity on prostate cancer cells, which may help limit effects on healthy tissue, and supports administration in a doctor’s office rather than hospital setting.

"These data represent an important step forward for patients with advanced prostate cancer," said Professor Shahneen Sandhu,* M.D., Ph.D., MBBS, FRACP, Associate Professor, Consultant Medical Oncologist and researcher at Peter MacCallum Cancer Centre, and study investigator. "In a disease where outcomes remain poor for many patients, seeing encouraging clinical activity alongside a favorable safety profile in combination with docetaxel reinforces the potential of this approach and supports further clinical development."

"Based on these findings, we are increasingly confident in the potential of pasritamig to meaningfully improve outcomes for people with prostate cancer," said Charles Drake, M.D., Ph.D., Vice President, Prostate Cancer and Cross Cancer Immuno-Oncology, Johnson & Johnson. "The ability to combine pasritamig with docetaxel, where prior approaches in the field have fallen short, gives us a strong foundation for Phase 3 development. What we’re seeing with this combination, including deep and durable PSA responses, underscores the promise of this combination immunotherapy approach and our commitment to advancing innovation that can make a difference for patients."

Detailed Study Results

In the study, pasritamig was evaluated in combination with docetaxel in an outpatient setting in patients with metastatic castration-resistant prostate cancer whose disease had progressed following androgen receptor pathway inhibitor therapy. Approximately half of the patients (45 percent) had received at least one prior taxane-based regimen. The primary endpoint was safety and identification of the recommended regimen for further development in Phase 2/3 studies, with secondary and exploratory endpoints assessing clinical activity, including PSA response rates.1

As of December 9, 2025, 51 patients had received pasritamig plus docetaxel, including patients who were pretreated with a median of three prior therapies (range, 1-9). Reductions of 50 percent or greater in PSA levels were achieved in 64.7 percent of patients overall and in 75.0 percent of taxane-naïve patients. Reductions of 90 percent or greater in PSA levels were achieved in 39.2 percent of patients overall and 53.6 percent of taxane-naïve patients. Among taxane-naïve patients with bone-only disease, confirmed PSA reductions of 50 percent or greater and 90 percent or greater were observed in 88.2 percent and 76.5 percent of patients, respectively. Patients were able to continue pasritamig beyond docetaxel discontinuation. Those patients received a median of six docetaxel doses every three weeks and eight pasritamig doses every six weeks, supporting the potential for sustained disease control over time.1

The safety profile of pasritamig plus docetaxel was consistent with the known safety profile of docetaxel in metastatic castration-resistant prostate cancer. The most common treatment-related adverse events (TRAEs) occurring in at least 20 percent of patients included fatigue (60.8 percent), alopecia (41.2 percent), diarrhea and nausea (31.4 percent each), peripheral edema (27.5 percent), peripheral sensory neuropathy (25.5 percent) and dysgeusia (23.5 percent). Pasritamig-related adverse events occurring in at least 10 percent of patients were fatigue (33.3 percent) and non-chronic diarrhea (11.8 percent). Grade 3 or higher TRAEs attributed to docetaxel were observed in 29.4 percent of patients, compared with only two percent attributed to pasritamig. No patients experienced cytokine release syndrome of any grade or treatment-related deaths.1

Two ongoing Phase 3 studies are evaluating pasritamig in the metastatic castration-resistant prostate cancer setting. KLK2-comPAS (NCT07164443) is evaluating pasritamig as monotherapy, and KLK2-PASenger (NCT07225946) is evaluating pasritamig in combination with docetaxel.2,3 Beyond these Phase 3 studies, pasritamig is also being evaluated in earlier-phase combination studies. Pasritamig monotherapy has received Breakthrough Therapy Designation in China and Fast Track designation from the U.S. Food and Drug Administration, supporting its continued clinical development.

About the Study

The Phase 1b study (NCT05818683) is an open-label trial evaluating the safety and clinical activity of pasritamig in combination with docetaxel in patients with metastatic castration-resistant prostate cancer (mCRPC) whose disease has progressed following treatment with an androgen receptor pathway inhibitor. The primary objective is to determine the recommended regimen for further development based on safety, with secondary and exploratory endpoints assessing clinical activity. Pasritamig was administered intravenously every six weeks, with initial step-up doses given during the first treatment cycle, in combination with docetaxel administered intravenously every three weeks. Treatment was delivered in an outpatient setting. Corticosteroids were used only as standard premedication for docetaxel, and hematopoietic growth factor support was permitted as needed.4

About Pasritamig (JNJ-78278343)

Pasritamig (JNJ-78278343) is an investigational T-cell-redirecting bispecific antibody (bsAb) targeting human kallikrein 2 (KLK2) on prostate cancer cells and CD3 receptor complexes on T cells, leveraging the body’s immune system to selectively target and eliminate cancer cells. This innovative approach is being evaluated in pretreated patients with metastatic castration-resistant prostate cancer (mCRPC), a patient population with limited treatment options.

About Metastatic Castration-Resistant Prostate Cancer (mCRPC)

Metastatic castration-resistant prostate cancer (mCRPC) is a challenging and aggressive stage of prostate cancer where the disease progresses despite androgen deprivation therapy.5 Patients often experience metastasis to bones and lymph nodes, leading to poor outcomes and limited treatment options, including chemotherapy and second-line hormone therapies.6 The median overall survival ranges from 13.5 to 31.6 months depending on the site of metastasis, with a typical range of 15 to 36 months across the broader population.7,8 Survival rates can vary significantly depending on factors such as prior treatment history, disease burden, and response to therapy. The need for more effective treatments is critical, as the disease continues to impact a large number of men globally, with metastatic castration-resistant prostate cancer (mCRPC) being responsible for a substantial number of prostate cancer-related deaths.

(Press release, Johnson & Johnson, FEB 26, 2026, View Source;johnson-show-promising-antitumor-activity-with-combination-of-pasritamig-and-docetaxel-in-advanced-prostate-cancer-302698631.html [SID1234663092])

On February 26, 2026 Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) reported financial results for the fourth quarter and full-year 2025, along with recent product highlights and corporate updates.

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"2025 was a year of disciplined execution across both engines of our business with significant advancement across our global innovation pipeline and steady progress in our commercial business," said Dr. Samantha Du, Founder, Chairperson and Chief Executive Officer of Zai Lab. "We accelerated multiple global programs, including the rapid progression of zoci into pivotal development, enabled by our integrated U.S./China infrastructure which allows us to operate with speed and capital efficiency. In 2026, our focus is on executing against important catalysts – advancing late-stage immunology and oncology programs while preparing for the next wave of commercial growth. Together, these efforts mark an important step in Zai Lab’s continued evolution into a global biopharma leader."

"KarXT represents a significant new growth driver for Zai Lab, and its recent inclusion in a national expert consensus underscores the growing recognition of its novel mechanism and potential to meaningfully impact patients living with schizophrenia," said Josh Smiley, President and Chief Operating Officer of Zai Lab. "We are strengthening the VYVGART franchise by expanding hospital coverage and supporting longer treatment persistence. Concurrently, we are preparing for the potential approvals of TIVDAK, which would further strengthen our women’s health franchise, and TTFields in pancreatic cancer. Looking beyond 2026, the combination of new launches, potential label expansions and advancing global programs, positions us for multi-year growth and continued financial improvement."

Fourth Quarter and Full-Year 2025 Financial Results
•Total revenue was $127.6 million in the fourth quarter of 2025 and $460.2 million for the full-year 2025. Product revenue, net was $127.1 million in the fourth quarter of 2025, compared to $108.5 million for the same period in 2024, representing 17% y-o-y growth and 16% at constant exchange rate (CER); and was $457.2 million in full-year 2025, compared to $397.6 million for the same period in 2024, representing 15% y-o-y growth and 16% y-o-y growth at CER. This increase was primarily due to higher revenue for XACDURO and NUZYRA.
–ZEJULA was $56.0 million in the fourth quarter of 2025, an increase of 16% y-o-y from $48.4 million; and was $189.0 million in full-year 2025, compared to $187.1 million for the same period in 2024. ZEJULA continued to be the leading PARP inhibitor in hospital sales for ovarian cancer despite evolving competitive dynamics within the PARPi class in mainland China.
–VYVGART and VYVGART Hytrulo were $21.9 million in the fourth quarter of 2025 which includes a $5.6 million rebate for VYVGART related to the National Reimbursement Drug List (NRDL) renewal, compared to $30.0 million for the same period in 2024; and was $94.2 million in full-year 2025, compared to $93.6 million for the same period in 2024.
–XACDURO, which was launched in the fourth quarter of 2024, was $10.7 million in the fourth quarter of 2025, an increase of 225% y-o-y from $3.3 million; and was $22.9 million in full-year 2025, an increase of 593% y-o-y from $3.3 million. Growth was driven by strong patient demand and expanding hospital adoption but was partially constrained by supply limitations during the year.
–NUZYRA was $16.0 million in the fourth quarter of 2025, an increase of 45% y-o-y from $11.0 million; and was $60.8 million in full-year 2025, an increase of 41% y-o-y from $43.2 million. This growth was supported by increased market coverage and penetration.
•Research and Development (R&D) expenses were $61.6 million in the fourth quarter of 2025, compared to $52.3 million for the same period in 2024, and $220.9 million for full-year 2025, compared to $234.5 million for the same period in 2024. The fourth-quarter increase resulted from progress in clinical trials. The full year decline was primarily driven by lower personnel compensation due to strategic resource optimization.
•Selling, General and Administrative (SG&A) expenses were $73.0 million in the fourth quarter of 2025, compared to $82.6 million for the same period in 2024, and $277.6 million for full-year 2025, compared to $298.7 million for the same period in 2024. The decrease was primarily due to a reduction in general and administrative expenses due to strategic resource optimization.
•Loss from operations was $69.4 million and $229.4 million in the fourth quarter of 2025 and full-year 2025, respectively, and $49.6 million and $148.8 million, respectively, when adjusted to exclude non-cash expenses, including depreciation, amortization, and share-based compensation. Loss from operations was $67.9 million and $282.1 million in the fourth quarter of 2024 and full-year 2024, respectively. A reconciliation of loss from operations (GAAP) to adjusted loss from operations (non-GAAP) is included at the end of this release.
•Net loss was $50.4 million in the fourth quarter of 2025, or a loss per ordinary share attributable to common stockholders of $0.05 (or loss per American Deposit Share (ADS) of $0.46), compared to a net loss of $81.7 million for the same period in 2024 or a loss per ordinary share of $0.08 (or loss per ADS of $0.80). The net loss was $175.5 million for full-year 2025, or a loss per ordinary share attributable to common stockholders of $0.16 (or loss per ADS of $1.60), compared to a net loss of $257.1 million for full-year 2024, or a loss per ordinary share of $0.26 (or loss per ADS of $2.60). These decreases in net loss were primarily due to product revenue growing faster than net operating expenses and shift from foreign currency losses to foreign currency gains, offset by decreased interest income.
•Cash and cash equivalents, short-term investments and current restricted cash totaled $789.6 million as of December 31, 2025, compared to $879.7 million as of December 31, 2024.

2026 Strategic Priorities
Zai Lab will focus on the following strategic priorities in 2026 to drive near-term performance and long-term global value creation:
Advancing Differentiated Global Programs Across Oncology and Immunology
•Zocilurtatug pelitecan (zoci) (DLL3-targeting ADC): Advance three registration-enabling studies across 2L+ SCLC, 1L SCLC, and other neuroendocrine carcinomas (NECs) by the end of 2026. Three data readouts expected in 2026, including:
–2L+ SCLC: Updated global Phase 1 data highlighting intracranial response in patients with brain metastases.
–1L SCLC: Data from an ongoing Phase 1 combination study evaluating doublet and triplet regimens with a PD-L1 inhibitor, with or without chemotherapy; initiation of global Phase 1 study with novel combination.
–Extrapulmonary NECs: Data from the Phase 1b portion of the ongoing global Phase 1b/2 study.
•ZL-1503 (IL-13/IL-31Rα bispecific antibody): First-in-Human (FIH) data from the ongoing global Phase 1/1b study expected in the second half of 2026, paving the way for Phase 2 development in atopic dermatitis (AD).
•ZL-6201 (LRRC15-targeting ADC): Global Phase 1 ongoing.
•ZL-1222 (PD-1/IL-12 immunocytokine): Investigational New Drug (IND)-enabling studies expected to be completed in 2026.
•ZL-1311 (T-cell engager (TCE) targeting MUC17): IND submission expected by year end.
•Zai Lab is building capabilities in TCEs and exploring additional immunocytokines beyond IL-12, with further details to be provided throughout the year.
Commercial Execution and Key Near-Term Regional Launches to Drive Steady Growth
•VYVGART and VYVGART Hytrulo: Continue to increase patient utilization and duration of treatment in generalized myasthenia gravis (gMG) and chronic inflammatory demyelinating polyneuropathy (CIDP).
•KarXT: Planned commercial launch in the first half of 2026, supported by a targeted commercial strategy, physician education, real-world evidence generation, and preparation for potential NRDL inclusion in 2027.
•Povetacicept and elegrobart: Both have pivotal readouts in 2026 and are expected to further strengthen regional revenue growth in the near term.

Key Corporate Updates
Below are key corporate updates since our last earnings release:
•Business Development:
–We obtained the exclusive worldwide rights to develop and commercialize ZL‑1311, a next‑generation TCE targeting MUC17, which is a promising and druggable antigen overexpressed in up to ~50% of gastric and gastroesophageal junction cancers. This program represents Zai Lab’s first globally owned TCE and strategically expands our immuno‑oncology portfolio while leveraging our established expertise in GI cancers. ZL‑1311 is expected to enter global clinical development this year.
–We formed a strategic collaboration with SciClone Pharmaceuticals (SciClone) for AUGTYRO (repotrectinib), which was approved in mainland China for ROS1‑positive non‑small‑cell lung cancer in May 2024 and for NTRK‑positive solid tumors in January 2026. Through this collaboration, Zai Lab will leverage SciClone’s commercialization infrastructure to broaden access and accelerate the commercial rollout of this innovative therapy for patients in need across mainland China.
•NRDL Updates: In December 2025, Zai Lab announced the successful renewals of VYVGART (efgartigimod alfa injection) for gMG patients who are anti-acetylcholine receptor (AChR) antibody positive, NUZYRA (omadacycline) for community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSI) and ZEJULA (niraparib) for platinum-sensitive, first-line and recurrent ovarian cancer patients in China’s NRDL.

Recent Pipeline Highlights
Below are key product candidate updates since our last earnings release:
Oncology Pipeline
•Zocilurtatug Pelitecan (zoci, DLL3 ADC):
–Second-Line+ ES-SCLC: The global Phase 3 study evaluating the efficacy and safety of zoci versus investigator’s choice therapy (topotecan, lurbinectedin, or amrubicin) in patients with relapsed SCLC is ongoing. This pivotal study plans to enroll approximately 480 patients in 2L SCLC or 3L post‑tarlatamab SCLC, with the majority of enrollment anticipated to be completed this year.
–Extrapulmonary NECs: In January 2026, Zai Lab dosed the first patient in the global Phase 2 portion of its ongoing Phase 1b/2 study in NECs. Zai Lab plans to present an initial data readout from the Phase 1b portion in the first half of 2026, complete enrollment for the Phase 2 portion, and advance the program into the registrational stage within the year.
•ZL-6201 (LRRC15 ADC): In January 2026, the FDA cleared the IND application for a global Phase 1 study in patients with sarcoma and potentially other LRRC15-positive solid tumors. The global Phase 1 study has been initiated.
•Tumor Treating Fields (TTFields): In February 2026, the FDA approved Optune Pax for the treatment of adult patients with locally advanced pancreatic cancer concomitant with gemcitabine and nab-paclitaxel. It is the first treatment approved by the FDA for locally advanced pancreatic cancer in nearly 30 years. China’s NMPA granted Innovative Medical Device Designation for the treatment of pancreatic cancer in August 2025.
•AUGTYRO (repotrectinib, ROS1/TRK): In December 2025, China’s NMPA approved the supplemental New Drug Application (sNDA) for AUGTYRO (repotrectinib) for the treatment of adult patients with solid tumors harboring a neurotrophic tyrosine receptor kinase (NTRK) gene fusion.
Immunology, Neuroscience, and Infectious Disease Pipeline
•ZL-1503 (IL-13/IL-31Rα): In December 2025, Zai Lab dosed the first participant in a global Phase 1/1b study evaluating the safety, tolerability, pharmacokinetics, and efficacy of ZL-1503 for the treatment of AD. Zai Lab expects to report the first-in-human data from the global Phase 1 portion in the second half of 2026.
•VYVGART (FcRn):
–Ocular myasthenia gravis (oMG): Zai Lab partner argenx announced in February 2026 that the Phase 3 ADAPT OCULUS met its primary endpoint (p-value=0.012), demonstrating that patients living with oMG and treated with VYVGART demonstrated statistically significant improvement from baseline in Myasthenia Impairment Index (MGII) Patient Reported Outcome (PRO) ocular scores at Week 4 compared to placebo. In the overall population, mean change from baseline in patients treated with VYVGART was a 4.04 point improvement in MGII PRO versus a mean change of 1.99 MGII PRO score in patients treated with placebo. VYVGART was well tolerated and had a favorable safety profile in patients with oMG, consistent with prior studies. Zai Lab participated in the study in Greater China (mainland China, Hong Kong, Macau, and Taiwan, collectively).
–Seronegative generalized myasthenia gravis (sn-gMG): In January 2026, the FDA accepted for Priority Review a supplemental Biologics License Application (sBLA) for the treatment of adults with acetylcholine receptor antibody (AChR-Ab) sn-gMG, with a Prescription Drug User Fee Act (PDUFA) target action date of May 10, 2026. Zai Lab participated in the Phase 3 ADAPT SERON study in Greater China.
•KarXT (xanomeline and trospium chloride) (M1/M4-agonist): In December 2025, China’s NMPA approved the NDA for KarXT for the treatment of schizophrenia in adults. KarXT is the first schizophrenia therapy with a novel mechanism of action approved in more than 70 years, offering a fundamentally new approach to treating schizophrenia. The commercial launch in China is planned for the second quarter of 2026.
•Povetacicept (APRIL/BAFF): In December 2025, Zai Lab joined the global pivotal Phase 2/3 OLYMPUS study in primary membranous nephropathy (pMN) and dosed the first patient in mainland China. The FDA granted Fast Track and Orphan Drug designations for povetacicept in pMN, and the EMA has granted Priority Medicines (PRIME) designation.

•Elegrobart (anti-IGF-1R, subcutaneous): In December 2025, Zai Lab dosed the first patient in a registrational study in thyroid eye disease (TED) in mainland China. Partner Viridian plans to report topline results from two global registrational studies in patients with active TED and chronic TED in the first half of 2026.
Anticipated Major Milestones in 2026

Expected Clinical Developments and Data Readouts

Global Pipeline
Zocilurtatug Pelitecan (zoci, DLL3 ADC) (formerly ZL-1310)
•Second-Line+ ES-SCLC: Zai Lab to present updated data on intracranial activity from the ongoing Phase 1 study in the first half of 2026.
•First-Line ES-SCLC: Zai Lab to provide data readout from the Phase 1 study evaluating zoci combination therapy (with atezolizumab and/or chemotherapy) in the second half of 2026 and advance zoci into a registrational study in 2026 based on emerging data. Zai Lab also plans to initiate a Phase 1 study to explore zoci in a novel combination in the first half of 2026.
•Extrapulmonary NECs: Zai Lab to provide data readout from the global Phase 1b portion of the ongoing Phase 1b/2 study evaluating zoci in patients with selected solid tumors in the first half of 2026 and advance into registrational development in 2026.
ZL-1503 (IL-13/IL-31Rα)
•Zai Lab to provide the first-in-human data readout from the global Phase 1/1b study in 2026.

Regional Pipeline

Upcoming Potential NMPA Approvals
•Tisotumab Vedotin (Tissue Factor ADC) in recurrent or metastatic cervical cancer following progression on or after chemotherapy
•Tumor Treating Fields (TTFields) in locally advanced pancreatic cancer

Efgartigimod (FcRn)
•Myositis: Zai Lab partner argenx to provide topline results from the global Phase 2/3 ALKIVIA study evaluating autoimmune inflammatory myopathies (AIM or myositis) in the third quarter of 2026. Zai Lab participated in the study in Greater China.
Povetacicept (APRIL/BAFF)
•IgA Nephropathy (IgAN): Zai Lab partner Vertex remains on track to release interim analysis data of the global Phase 3 RAINIER study in the first half of 2026 and also complete the submission in the first half of 2026, if data from the interim analysis are supportive. The FDA has granted Breakthrough Therapy Designation for this indication.
•pMN: Zai Lab and partner Vertex plan to complete the Phase 2 portion of the global pivotal Phase 2/3 OLYMPUS study and initiate the Phase 3 portion in mid-2026.
Elegrobart (anti-IGF-1R, subcutaneous)
•Viridian to provide topline results from the global registrational REVEAL-1 study in active TED patients in the first quarter of 2026 and global registrational REVEAL-2 study in chronic TED in the second quarter of 2026. Zai Lab, through its license agreement with Zenas, obtained a sublicense to the Viridian anti-IGF-1R antibody and is proceeding with clinical development.

Conference Call and Webcast Information
Zai Lab will host a live conference call and webcast today, February 26, 2026, at 8:00 a.m. ET (9:00 p.m. HKT). Listeners may access the live webcast by visiting the Company’s website at View Source Participants must register in advance of the conference call.

Details are as follows:

•Registration link for webcast (preferred): View Source
•Registration link for dial-in: View Source

All participants must use the link provided above to complete the online registration process in advance of the conference call. Dial-in details will be in the confirmation email which the participant will receive upon registering.
A replay will be available shortly after the call and can be accessed by visiting the Company’s website.

(Press release, Zai Laboratory, FEB 26, 2026, View Source [SID1234663090])