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Zai Lab Ltd

For the period ended Sep 30, 2025. Filed Nov 6, 2025.

View on SEC.gov

About this filing

A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.

Sep 30, 2025 · Filed Nov 6, 2025

ZLAB$25.48+12.7%Stored close · as of Nov 6, 2026

What changed in Management’s Discussion and Analysis?

Read the current filing

Previous report: 10-Q

Period ended 2025-06-30; filed 2025-08-07.

0001628280-25-038548

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

Current report: 10-Q

Period ended 2025-09-30; filed 2025-11-06.

0001704292-25-000024

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

The baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.

Compared 109 previous paragraphs and 111 current paragraphs.

68 unchanged; 27 reworded; 16 added; 14 removed; 0 previous and 0 current paragraphs rearranged.

Tables are not compared: 6 previous and 6 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.

A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.

Added paragraphs (16)

Current report

•Zocilurtatug Pelitecan (Zoci, DLL3 ADC) (formerly ZL-1310): In October 2025, we presented updated data from the global Phase I clinical trial evaluating zoci for the treatment of patients with ES-SCLC at the AACR-NCI-EORTC International Conference. The data demonstrated a best overall response rate of 68% in 2L patients treated at the 1.6 mg/kg dose in ES-SCLC. The median duration of response was 6.1 months across all patients and is clinically meaningful in this population with advanced disease. Meaningful activity in patients with brain metastases was also observed, including an 80% response rate in patients with untreated brain metastases. The data also demonstrated a well-tolerated safety profile at 1.6 mg/kg, with Grade ≥ 3 treatment-related adverse events of 13%, no Grade ≥2 interstitial lung disease, and no drug discontinuations. We have initiated a global registrational study of zoci monotherapy in 2L+ SCLC.

Current report

•Tisotumab Vedotin (TIVDAK, Tissue Factor ADC): In September 2025, the Hong Kong Department of Health approved TIVDAK in Hong Kong for the treatment of adult patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy. TIVDAK is currently under regulatory review for its Biologics License Application by the NMPA, which was accepted in March 2025.

Current report

•Bemarituzumab: In September 2025, our partner Amgen announced that the descriptive follow-up analysis of the Phase III FORTITUDE-101 clinical trial evaluating bemarituzumab in FGFR2b positive 1L gastric cancer has been completed. At the pre-specified interim analysis (the primary analysis), overall survival was significantly improved with bemarituzumab plus chemotherapy (mFOLFOX6) versus chemotherapy alone (median OS of 17.9 months versus 12.5 months). However, at the follow-up analysis, the magnitude of the previously observed survival benefit attenuated (median OS of 14.5 months versus 13.2 months). Data was presented in October 2025 at the ESMO conference in Berlin. In November 2025, Amgen announced that FORTITUDE-102, a Phase Ib/III study evaluating bemarituzumab in combination with nivolumab and chemotherapy in the same patient population, was stopped.

Current report

•ZL-1503 (IL-13 / IL-31): In November 2025, we initiated a global Phase I/Ib study to evaluate safety, tolerability, and pharmacokinetics of ZL-1503 in healthy volunteers and participants with moderate to severe atopic dermatitis.

Current report

•Efgartigimod (FcRn): In August 2025, our partner argenx announced topline results from the pivotal ADAPT SERON study of VYVGART in patients with AChR-Ab seronegative gMG. The study met its primary endpoint (p-value=0.0068), demonstrating that AChR-Ab seronegative gMG patients treated with VYVGART achieved a statistically significant and clinically meaningful improvement in MG-ADL (Myasthenia Gravis Activities of Daily Living) total score compared to placebo. Based on these results, argenx plans to submit an sBLA to the FDA seeking expansion of the VYVGART label to include adult AChR-Ab seronegative gMG patients. VYVGART was well tolerated and safe across AChR-Ab seronegative subtypes and consistent with the established safety profile in patients with AChR-Ab seropositive gMG and other indications. No new safety concerns were identified. We participated in the study in Greater China and are considering a potential China regulatory submission.

Current report

In September 2025, we joined the registrational UNITY study of the subcutaneous formulation of efgartigimod given by pre-filled syringe in Sjorgen’s disease in Greater China.

Current report

•Xanomeline-Trospium (or KarXT) (M1/M4-agonist): In September 2025, the “China Schizophrenia Prevention and Treatment Guidelines (2025 Edition)” were officially released, and KarXT was included for the first time, marking the first national-level guideline globally to include KarXT. The guidelines emphasize KarXT’s broad efficacy across all three symptom domains (positive, negative, and cognitive symptoms) and its unique safety profile, supporting long-term adherence and functional recovery. The NMPA accepted the NDA for KarXT for the treatment of schizophrenia in January 2025.

Current report

•Povetacicept (Pove, APRIL/BAFF): In September 2025, our partner Vertex announced that the FDA had granted Breakthrough Therapy Designation to pove for the treatment of IgA nephropathy. We participated in the global Phase III RAINIER study of pove in patients with IgAN in Greater China. Vertex has completed full enrollment of the Phase III study, including the interim analysis cohort for potential accelerated approval in the United States.

Current report

During the third quarter, we continued to strengthen our business through key new additions to our global leadership team. For example, we appointed Dr. Shan He as Senior Vice President, Chief Business Officer in September 2025. Dr. He is a respected leader with deep expertise in healthcare strategy, capital markets, and entrepreneurship. She will be responsible for leading and directing strategy for business development and strategic partnerships. We also announced the creation of our Oncology Scientific Advisory Board (“SAB”) in August 2025. This newly formed Oncology SAB is comprised of distinguished oncology leaders and will support the advancement of our robust oncology products and pipeline, including multiple internally developed investigational therapies.

Current report

Research and development expenses decreased by $18.1 million in the three months ended September 30, 2025, primarily due to:

Current report

•a decrease of $22.6 million in licensing fees in connection with decreased upfront and milestone payments for our license and collaboration agreements; and

Current report

•an increase of $5.7 million in CROs/CMOs/Investigators expenses related to ongoing clinical trials.

Current report

Research and development expenses decreased by $23.0 million in the nine months ended September 30, 2025 primarily due to a decrease of $14.6 million in personnel compensation and related costs and a decrease of $8.7 million in CROs/CMOs/Investigators expenses primarily driven by our resource prioritization and efficiency efforts.

Current report

Selling, general, and administrative expenses increased by $2.9 million in the three months ended September 30, 2025 primarily driven by higher general selling expenses to support the growth of NUZYRA and VYVGART, partially offset by decreases in selling expenses related to ZEJULA. Selling, general, and administrative expenses decreased by $11.6 million in the nine months ended September 30, 2025, primarily due to our resource prioritization and efficiency efforts.
Removed paragraphs (14)

Previous report

•ZL-1310 (DLL3 ADC): In May 2025, the FDA granted Fast Track designation to ZL-1310 for the treatment of ES-SCLC, and in June 2025, we presented positive data from the ongoing global Phase Ia/Ib clinical trial evaluating ZL-1310 for the treatment of patients with ES-SCLC at the 2025 American Society of Clinical Oncology (“ASCO”) Annual Meeting. The data demonstrated clinically meaningful anti-tumor activity in the heavily pretreated population of patients with SCLC across dose escalation and expansion cohorts. In 2L SCLC, the objective response rate was 67% across all dose levels (n=33) and 79% at 1.6 mg/kg dose (n=14).

Previous report

The data also demonstrated a well-tolerated safety profile at target doses of less than 2.0 mg/kg, with Grade ≥ 3 treatment-related adverse events of 6%, no Grade ≥2 interstitial lung disease, and no drug discontinuations. We plan to initiate a pivotal trial in 2L SCLC later this year. In addition, in April 2025, we initiated a global Phase I/II study in patients with selected solid neuroendocrine tumors, allowing us to evaluate its therapeutic potential beyond SCLC.

Previous report

•Bemarituzumab: In June 2025, we announced positive topline results for the Phase III FORTITUDE-101 clinical trial evaluating bemarituzumab in FGFR2b positive 1L gastric cancer. Bemarituzumab plus chemotherapy (mFOLFOX6) met its primary endpoint of overall survival at a pre-specified interim analysis, demonstrating a statistically significant and clinically meaningful improvement in OS as compared to placebo plus chemotherapy in people living with unresectable locally advanced or metastatic gastric or GEJ cancer with FGFR2b overexpression and who are non-HER2 positive. The most common treatment-emergent adverse events (>25%) in patients treated with bemarituzumab plus chemotherapy were reduced visual acuity, punctate keratitis, anemia, neutropenia, nausea, corneal epithelium defect and dry eye. While ocular events were consistent with the Phase 2 experience and observed in both arms, they occurred with greater frequency and severity in the Phase 3 bemarituzumab arm. We plan to file for regulatory approval in China in the second half of 2025.

Previous report

•Repotrectinib: In April 2025, China’s NMPA accepted the supplemental NDA for repotrectinib for the treatment of adult patients with NTRK+ solid tumors. The application is intended for patients whose disease is locally advanced or metastatic, or where surgical resection is likely to result in severe morbidity, and who have either progressed following prior therapies or have no satisfactory alternative treatment options.

Previous report

•ZL-6201 (LRRC15 ADC): In April 2025, we presented new data at the American Association for Cancer Research (“AACR”) Annual Meeting 2025 reflecting that ZL-6201 efficiently internalizes within and kills tumor cells, while also exhibiting a strong bystander killing effect in the tumor microenvironment. Based on these findings, we plan to initiate IND-enabling studies of ZL-6201 as a potential treatment for patients with sarcoma and other LRRC15-positive solid tumors, such as breast cancer and other malignancies, in 2025.

Previous report

•ZL-1222 (PD-1 / IL-12): In April 2025, we presented data at the AACR Annual Meeting 2025, marking the first public disclosure of this global asset. Findings from the pre-clinical studies demonstrate its potent antitumor activity in both anti-PD-1 sensitive and resistant tumor models, with improved systemic safety. These results indicate its potential to benefit patients who are unresponsive or resistant to the current immune-oncology therapies.

Previous report

•Efgartigimod (FcRn): In April 2025, our partner argenx announced that the FDA had approved VYVGART Hytrulo prefilled syringe (“PFS”) for self-injection in gMG and CIDP. PFS is the third approved administration option for efgartigimod, providing additional flexibility and convenience for patients. In July 2025, the China Guidelines for the Diagnosis and Treatment of Myasthenia Gravis (MG) (2025) was published, emphasizing the importance of Minimal Symptom Expression (“MSE”) as the primary treatment goal in MG. The guidelines have highlighted VYVGART’s ability to achieve MSE rapidly and provide durable benefit. VYVGART is now recommended for early use in mild-to-moderate and highly active patients and for sustained long-term treatment to maximize potential benefit.

Previous report

•ZL-1503 (IL-13 / IL-31R): In June 2025, we announced new preclinical data highlighting the potential of ZL-1503 as a promising treatment for moderate-to-severe atopic dermatitis and other IL-13 and IL-31-driven diseases. The favorable preclinical safety profile, prolonged half-life and durable suppression of both the inflammatory and pruritogenic (itch-causing) pathways in atopic dermatitis support the continued advancement of ZL-1503 toward clinical development.

Previous report

Research and development expenses decreased by $11.0 million and $4.9 million in the three and six months ended June 30, 2025, respectively, primarily due to:

Previous report

•a decrease of $4.4 million and $14.4 million, respectively, in CROs/CMOs/Investigators expenses related to ongoing clinical trials; partially offset by,

Previous report

•an increase of nil and $20.0 million, respectively, in licensing fees for our license and collaboration agreements.

Previous report

Selling, general, and administrative expenses decreased by $8.7 million and $14.4 million in the three and six months ended June 30, 2025, respectively, primarily due to decreases in personnel compensation and related costs related to our resource prioritization and efficiency efforts.
Reworded paragraphs (27)

Previous wording

You should read the following discussion and analysis of our financial condition and results of operations together with our 2024 Annual Report and our unaudited condensed consolidated financial statements and the accompanying notes for the three and six months ended June 30, 2025 included in Item 1. Financial Statements.

Current wording

You should read the following discussion and analysis of our financial condition and results of operations together with our 2024 Annual Report and our unaudited condensed consolidated financial statements and the accompanying notes for the three and nine months ended September 30, 2025 included in Item 1. Financial Statements.

Previous wording

We are a patient-focused, innovative, commercial-stage, global biopharmaceutical company with a substantial presence in both Greater China and the United States. We are focused on discovering, developing, and commercializing products that address medical conditions with significant unmet needs in the areas of oncology, immunology, neuroscience, and infectious disease. We intend to leverage our competencies and resources to positively impact human health in Greater China and worldwide. We currently have seven commercial programs – ZEJULA, VYVGART / VYVGART Hytrulo, NUZYRA, OPTUNE, QINLOCK, XACDURO, and AUGTYRO – with products that have received marketing approval and that we have commercially launched in one or more territories in Greater China. We also have multiple programs in late-stage product development and a number of ongoing pivotal trials across our portfolio.

Current wording

We are a patient-focused, innovative, commercial-stage, global biopharmaceutical company with a substantial presence in both Greater China and the United States. We are focused on discovering, developing, and commercializing products that address medical conditions with significant unmet needs in the areas of oncology, immunology, neuroscience, and infectious disease. We intend to leverage our competencies and resources to positively impact human health. We currently have seven commercial programs – ZEJULA, VYVGART / VYVGART Hytrulo, NUZYRA, OPTUNE, QINLOCK, XACDURO, and AUGTYRO – with products that have received marketing approval and that we have commercially launched in one or more territories in Greater China. We also have multiple programs in late-stage product development and a number of ongoing pivotal trials across our portfolio.

Previous wording

Net product revenue was $109.1 million for the second quarter of 2025, an increase of 9% compared to the prior year period, primarily due to higher sales of VYVGART, driven by an extension of duration of therapy and increasing market penetration, XACDURO, which was launched since the fourth quarter of 2024, and NUZYRA, supported by increasing market coverage and penetration. These higher sales were partially offset by softer sales of ZEJULA, due to evolving competitive dynamics within the PARPi class.

Current wording

Net product revenue was $115.4 million for the third quarter of 2025, an increase of 13% compared to the prior year period, primarily due to higher sales of NUZYRA, supported by increasing market coverage and penetration, and XACDURO, which was launched since the fourth quarter of 2024. These higher sales were partially offset by softer sales of ZEJULA, due to evolving competitive dynamics within the PARPi class.

Previous wording

•Tumor Treating Fields (TTFields): In May 2025, our partner NovoCure presented results from the Phase III PANOVA-3 trial of TTFields therapy for pancreatic cancer at the 2025 ASCO Annual Meeting and simultaneously published in the Journal of Clinical Oncology. The Phase III PANOVA-3 trial evaluated the use of TTFields therapy concomitantly with gemcitabine and nab-paclitaxel as a first-line treatment for unresectable, locally advanced pancreatic adenocarcinoma compared to gemcitabine and nab-paclitaxel alone. The trial met its primary endpoint, demonstrating a statistically significant improvement in median overall survival for patients treated with TTFields. TTFields therapy concomitant with gemcitabine and nab-paclitaxel demonstrated improvement in several secondary endpoints including the one-year survival rate, improved quality of life, and extended pain-free survival. We plan to file for regulatory approval in China in the second half of 2025.

Current wording

•Tumor Treating Fields (TTFields): In August 2025, the NMPA granted Innovative Medical Device Designation for TTFields therapy for patients with pancreatic cancer based on the positive results from the Phase III PANOVA-3 trial. This designation offers opportunities to expedite the regulatory review and approval process. The Phase III PANOVA-3 trial evaluated the use of TTFields therapy concomitantly with gemcitabine and nab-paclitaxel as a first-line treatment for unresectable, locally advanced pancreatic adenocarcinoma compared to gemcitabine and nab-paclitaxel alone. The trial met its primary endpoint, demonstrating a statistically significant improvement in median overall survival for patients treated with TTFields. We participated in the study in Greater China. We plan to file for regulatory approval in mainland China in the fourth quarter of 2025.

Previous wording

In this section, we discuss our results of operations for the three and six months ended June 30, 2025 compared to the same periods in 2024.

Current wording

In this section, we discuss our results of operations for the three and nine months ended September 30, 2025 compared to the same periods in 2024.

Previous wording

Our product revenue is primarily derived from the sales of our commercial products primarily in mainland China, net of sales returns and rebates to distributors with respect to the sales of these products.

Current wording

Our product revenue is primarily derived from the sales of our commercial products in mainland China, net of sales returns and rebates to distributors with respect to the sales of these products.

Previous wording

Our net product revenue increased by $9.0 million and $27.5 million in the three and six months ended June 30, 2025, respectively, primarily due to higher sales of VYVGART, driven by an extension of duration of therapy and increasing market penetration, XACDURO, which was launched since the fourth quarter of 2024, and NUZYRA, supported by increasing market coverage and penetration. These higher sales were partially offset by softer sales of ZEJULA, due to evolving competitive dynamics within the PARPi class.

Current wording

Our net product revenue increased by $13.5 million and $41.0 million in the three and nine months ended September 30, 2025, respectively, primarily due to NUZYRA, supported by increasing market coverage and penetration, XACDURO, which was launched since the fourth quarter of 2024, and higher sales of VYVGART, driven by an extension of duration of therapy and increasing market penetration. These higher sales were partially offset by softer sales of ZEJULA, due to evolving competitive dynamics within the PARPi class.

Previous wording

Cost of product revenue increased by $7.9 million and $12.7 million in the three and six months ended June 30, 2025, respectively, primarily due to increasing sales volumes.

Current wording

Cost of product revenue increased by $10.2 million and $22.9 million in the three and nine months ended September 30, 2025, respectively, primarily due to increasing sales volumes.

Previous wording

In the three and six months ended June 30, 2025, collaboration revenue increased by $0.5 million and $1.3 million, respectively, and cost of collaboration revenue increased by $0.1 million and $0.3 million, respectively, which are related to promotional activities in mainland China.

Current wording

In the three and nine months ended September 30, 2025, collaboration revenue increased by $0.3 million and $1.6 million, respectively, and cost of collaboration revenue increased by $0.2 million and $0.1 million, respectively, which are related to promotional activities in mainland China.

Previous wording

•a decrease of $8.8 million and $12.7 million, respectively, in personnel compensation and related costs primarily driven by our resource prioritization and efficiency efforts,

Current wording

•a decrease of $1.9 million in personnel compensation and related costs primarily driven by our resource prioritization and efficiency efforts; partially offset by

Previous wording

Research and development expenses attributable to clinical programs increased by $4.9 million in the six months ended June 30, 2025, primarily driven by an increase in licensing fees for our license and collaboration agreements, partially offset by a decrease in CROs/CMOs/Investigators expenses related to ongoing clinical trials.

Current wording

Research and development expenses attributable to clinical programs decreased by $4.9 million in the three months ended September 30, 2025, primarily driven by a decrease in licensing fees for our license and collaboration agreements, partially offset by an increase in trial costs related to ongoing clinical trials. Research and development expenses attributable to clinical programs remained flat in the nine months ended September 30, 2025, primarily driven by an increase in licensing fees for our license and collaboration agreements, partially offset by decreases in trial costs due to our resource prioritization and efficiency efforts.

Previous wording

Research and development expenses attributable to clinical programs decreased by $4.4 million in the three months ended June 30, 2025, primarily driven by a decrease in CROs/CMOs/Investigators expenses related to ongoing clinical trials.

Current wording

Research and development expenses attributed to preclinical programs decreased by $12.5 and $9.3 million in the three and nine months ended September 30, 2025, respectively, primarily driven by a decrease in licensing fees for our license and collaboration agreements.

Previous wording

Interest income decreased by $0.5 million and $1.5 million in the three and six months ended June 30, 2025, respectively, primarily due to decreased interest rates.

Current wording

Interest income decreased by $0.7 million and $2.2 million in the three and nine months ended September 30, 2025, respectively, primarily due to decreased interest rates.

Previous wording

Interest expense increased by $0.8 million and $1.8 million in the three and six months ended June 30, 2025, respectively, primarily due to higher levels of short-term debt.

Current wording

Interest expense increased by $0.7 million and $2.5 million in the three and nine months ended September 30, 2025, respectively, primarily due to higher levels of short-term debt.

Previous wording

Foreign currency gains were $2.8 million and $3.5 million in the three and six months ended June 30, 2025, respectively, primarily driven by remeasurement gain due to appreciation of the RMB against the U.S. dollar, compared to foreign currency losses of $4.1 million and $6.2 million in the three and six months ended June 30, 2024, respectively, primarily driven by remeasurement loss due to depreciation of the RMB against the U.S. dollar.

Current wording

Foreign currency gains were $6.4 million and $9.9 million in the three and nine months ended September 30, 2025, respectively, compared to $14.5 million and $8.3 million in the three and nine months ended September 30, 2024, respectively. The foreign currency gains were primarily driven by remeasurement gains due to appreciation of the RMB against the U.S. dollar.

Previous wording

Other income, net was $3.8 million in the three months ended June 30, 2025, compared to other expense, net of $8.9 million in the three months ended June 30, 2024, primarily due to higher government grants of $3.3 million and decreased loss on our equity investment in MacroGenics of $10.0 million.

Current wording

Other expense, net was $0.5 million in the three months ended September 30, 2025, compared to other income, net of $3.4 million in the three months ended September 30, 2024, primarily due to a decrease in government grants.

Previous wording

Other income, net increased by $3.1 million to $3.6 million in the six months ended June 30, 2025, primarily due to decreased loss on our equity investment in MacroGenics.

Current wording

Other income decreased by $0.8 million to $3.0 million in the nine months ended September 30, 2025, primarily due to decreased loss on our equity investment in MacroGenics offset by a decrease in government grants.

Previous wording

Income tax expense was nil in both the three and six months ended June 30, 2025 and 2024.

Current wording

Income tax expense was nil in both the three and nine months ended September 30, 2025 and 2024.

Previous wording

Net loss was $40.7 million in the three months ended June 30, 2025, or a loss per ordinary share attributable to common stockholders of $0.04 (or loss per ADS of $0.37), compared to a net loss of $80.3 million in the three months ended June 30, 2024, or a loss per ordinary share of $0.08 (or loss per ADS of $0.82).

Current wording

Net loss was $36.0 million in the three months ended September 30, 2025, or a loss per ordinary share attributable to stockholders of $0.03 (or loss per ADS of $0.33), compared to a net loss of $41.7 million in the three months ended September 30, 2024, or a loss per ordinary share of $0.04 (or loss per ADS of $0.42).

Previous wording

Net loss was $89.2 million in the six months ended June 30, 2025, or a loss per ordinary share attributable to common stockholders of $0.08 (or loss per ADS of $0.82), compared to a net loss of $133.7 million in the six months ended June 30, 2024, or a loss per ordinary share of $0.14 (or loss per ADS of $1.37).

Current wording

Net loss was $125.1 million in the nine months ended September 30, 2025, or a loss per ordinary share attributable to stockholders of $0.11 (or loss per ADS of $1.15), compared to a net loss of $175.4 million in the nine months ended September 30, 2024, or a loss per ordinary share of $0.18 (or loss per ADS of $1.80).

Previous wording

To date, we have financed our activities primarily through private placements and public offerings, including our September 2017 initial public offering and various follow-on offerings on Nasdaq and our September 2020 secondary listing and initial public offering on the Hong Kong Stock Exchange. We have raised approximately $164.6 million in private equity financing and approximately $2,677.8 million in net proceeds from public offerings after deducting underwriting commissions and the offering expenses payable by us. Our operations have consumed substantial amounts of cash since inception. The net cash used in our operating activities was $92.7 million and $132.3 million in the six months ended June 30, 2025 and 2024, respectively. For information on our research and development activities and related expenditures, see the Research and Development Expenses, Selling, General, and Administrative Expenses, License and Collaboration Arrangements, and Results of Operations sections above. In addition, as of June 30, 2025, we had commitments of $1.1 million related to commercial manufacturing development activities and capital expenditures.

Current wording

To date, we have financed our activities primarily through private placements and public offerings, including our September 2017 initial public offering and various follow-on offerings on Nasdaq and our September 2020 secondary listing and initial public offering on the Hong Kong Stock Exchange. We have raised approximately $164.6 million in private equity financing and approximately $2,677.8 million in net proceeds from public offerings after deducting underwriting commissions and the offering expenses payable by us. Our operations have consumed substantial amounts of cash since inception. The net cash used in our operating activities was $124.8 million and $159.1 million in the nine months ended September 30, 2025 and 2024, respectively. For information on our research and development activities and related expenditures, see the Research and Development Expenses, Selling, General, and Administrative Expenses, License and Collaboration Arrangements, and Results of Operations sections above. In addition, as of September 30, 2025, we had commitments of $0.7 million related to commercial manufacturing development activities and capital expenditures.

Previous wording

We have also identified opportunities to access capital through debt arrangements on favorable commercial terms. As of June 30, 2025, we had such debt arrangements with Chinese financial institutions that allow certain of our subsidiaries to borrow up to approximately $240.2 million (or RMB1,721.7 million) to support our working capital needs in mainland China. As of June 30, 2025, we had short-term debt outstanding of $174.5 million (or RMB1,244.7 million) pursuant to these debt arrangements. These debt arrangements provide us with additional capital capacity that will give us enhanced flexibility to execute on our corporate strategic goals. For more information, see Note 10.

Current wording

We have also identified opportunities to access capital through debt arrangements on favorable commercial terms. As of September 30, 2025, we had such debt arrangements with Chinese financial institutions that allow certain of our subsidiaries to borrow up to approximately $275.4 million (or RMB1,971.7 million) to support our working capital needs in mainland China. As of September 30, 2025, we had short-term debt outstanding of $203.0 million (or RMB1,442.6 million) pursuant to these debt arrangements. These debt arrangements provide us with additional capital capacity that will give us enhanced flexibility to execute on our corporate strategic goals. For more information, see Note 10. In addition, after the third quarter, we entered into a new facility with a Chinese financial institution that will allow certain of our subsidiaries to borrow up to an additional RMB300 million (approximately $42.1 million). For more information, see Note 19.

Previous wording

As of June 30, 2025, we had cash and cash equivalents, current restricted cash, and short-term investments of $832.3 million, which we expect will enable us to meet our cash requirements including the funding of operating expenses, capital expenditures, and debt obligations for at least the next 12 months.

Current wording

As of September 30, 2025, we had cash and cash equivalents, current restricted cash, and short-term investments of $817.2 million, which we expect will enable us to meet our cash requirements including the funding of operating expenses, capital expenditures, and debt obligations for at least the next 12 months.

Previous wording

Net cash used in operating activities decreased by $39.6 million in the six months ended June 30, 2025, primarily due to a decrease of $44.6 million in net loss and an increase of $11.5 million in net changes in operating assets and liabilities, partially offset by a decrease of $16.5 million in other adjustments to reconcile net loss to net cash used in operating activities.

Current wording

Net cash used in operating activities decreased by $34.3 million in the nine months ended September 30, 2025, primarily due to a decrease of $50.3 million in net loss, partially offset by a decrease of $8.2 million in other adjustments to reconcile net loss to net cash used in operating activities and $7.8 million in net changes in operating assets and liabilities.

Previous wording

Net cash provided by investing activities increased by $320.8 million in the six months ended June 30, 2025, primarily due to an increase of $313.7 million in proceeds from the maturity of short-term investments, a decrease of $8.5 million from acquisitions of intangible assets, and an increase of $1.2 million in proceeds from the sale of our equity investment in MacroGenics, partially offset by an increase of $2.7 million in purchases of property and equipment.

Current wording

Net cash provided by investing activities increased by $346.6 million in the nine months ended September 30, 2025, primarily due to an increase of $313.7 million in proceeds from the maturity of short-term investments, a decrease of $36.0 million from acquisitions of intangible assets, and an increase of $1.2 million in proceeds from the sale of our equity investment in MacroGenics, partially offset by an increase of $4.4 million in purchases of property and equipment.

Previous wording

Net cash provided by financing activities decreased by $17.9 million in the six months ended June 30, 2025, primarily due to $82.8 million in repayment of short-term bank borrowings and $0.9 million in payments of public offering costs, partially offset by an increase of $54.4 million in short-term debt proceeds and an increase of $11.4 million in proceeds from exercises of stock options.

Current wording

Net cash provided by financing activities decreased by $39.3 million in the nine months ended September 30, 2025, primarily due to an increase of $116.7 million in repayment of short-term bank borrowings and $8.2 million in employee taxes paid related to net share settlement of equity awards, partially offset by an increase of $74.3 million in short-term debt proceeds and $12.1 million in proceeds from exercises of stock options.

Previous wording

For more information regarding recently issued accounting standards, see Part II – Item 8. Financial Statements and Supplementary Data – Recent Accounting Pronouncements in our 2024 Annual Report. The Company has not adopted any new accounting standards in the three and six months ended June 30, 2025.

Current wording

For more information regarding recently issued accounting standards, see Part II – Item 8. Financial Statements and Supplementary Data – Recent Accounting Pronouncements in our 2024 Annual Report. The Company has not adopted any new accounting standards in the three and nine months ended September 30, 2025.