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© 2024. Zai Lab. All Rights Reserved.NASDAQ:ZLAB | HKEX:9688 Zocilurtatug pelitecan (ZL-1310) AACR-NCI-EORTC 2025 Highlights Oct 24, 2025
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Forward-Looking Statements This presentation contains forward-looking statements about future expectations, plans, and prospects for Zai Lab, including, without limitation, statements regarding product candidates in our pipeline including zocilurtatug pelitecan (zoci or ZL-1310) and related clinical trials and preclinical studies, the potential benefits and safety and efficacy of ZL-1310, and the potential treatment of small cell lung cancer (SCLC) and other DLL3- expressing tumors. These forward-looking statements may contain words such as “aim,” “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “forecast,” “goal,” “intend,” “may,” “plan,” “possible,” “potential,” “target,” “will,” “would,” and other similar expressions. Such statements constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are not statements of historical fact or guarantees or assurances of future performance. Forward-looking statements are based on our expectations and assumptions as of the date of this presentation and are subject to inherent uncertainties, risks, and changes in circumstances that may differ materially from those contemplated by the forward-looking statements. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including but not limited to (1) our ability to successfully commercialize and generate revenue from our approved products, (2) our ability to obtain funding for our operations and business initiatives, (3) the results of clinical and pre-clinical development of our product candidates, (4) the content and timing of decisions made by the relevant regulatory authorities regarding regulatory approvals of our product candidates, (5) risks related to doing business in China, and (6) other factors discussed in our most recent annual and quarterly reports and other reports we have filed with the U.S. Securities and Exchange Commission (SEC). We anticipate that subsequent events and developments will cause our expectations and assumptions to change, and we undertake no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as may be required by law. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this presentation. Our SEC filings can be found on our website at www.zailaboratory.com and on the SEC’s website at http://www.sec.gov. This presentation does not constitute an offer to sell or the solicitation of an offer to buy any securities of Zai Lab Limited.
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Zocilurtatug pelitecan (DLL3 ADC) Highlights from ENA 2025 Next Steps and Conclusions Q&A with Dr. Amado 3 Rafael Amado, MD President, Head of Global Research and Development, Zai Lab Agenda Zai Lab global portfolio overview
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Zai Lab Global Portfolio Overview Program Preclinical Phase I Phase II Phase III Zoci (ZL-1310) DLL3 ADC) ZL-6201 (LRRC15 ADC) ZL-1222 (PD-1/IL-12) ZL-6202 (undisclosed) ZL-1223 (undisclosed) ZL-1503 (IL13/IL31R) 2L+ SCLC (Zoci monotherapy) Other NECs Areas of Focus ✓ Oncology and immunology ✓ First- or best-in-class ✓ Addressing areas of unmet needs Note: *Sarcoma and potentially other LRRC15-positive solid tumors, such as breast cancer and other malignancies. Sarcoma and others* Mod-to-Sev AD Solid tumors Solid tumors Solid tumors Global-Rights Assets 1L SCLC Ph3 in 2026 Registrational study in 2026 1L SCLC Ph1 in 2026 (Zoci+PD-L1 ±chemo) (Novel combo) At least 1-2 INDs per year Proven Clinical Development Expertise ✓ Integrated R&D centers in the U.S. and China ✓ Extensive global drug development expertise ✓ End-to-end R&D team with no reliance on CROs Global R&D Capabilities Overview Ph3 initiated
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Zoci – Potentially First- and Best-in-Class DLL3 ADC in SCLC Clear Development Path Ahead Industry-leading Development Speed Compelling Global Data in A Difficult- to-treat Population <2 Years From Phase 1 start1 to global registrational stage >1.5 Years Global development lead time2 68% ORR in 2L (1.6 mg/kg) 80% ORR in untreated brain-met pts 6.1m DOR in 2L+ Deep and Durable Response Best-in-class Safety 13% Grade ≥3 TRAEs No Grade ≥2 ILD 2L+ SCLC 1L SCLC Other NECs Registrational study initiated Registrational and novel combo studies3 to start in ’26 Registrational cohort to start in ‘26 Abbreviations: Overall response rate (ORR), duration of response (DOR), treatment-related adverse events (TRAEs), interstitial lung disease (ILD), small cell lung cancer (SCLC), neuroendocrine carcinomas (NECs). Note: (1) Zai Lab enrolled the first patient in its global Phase 1 study in the U.S. in January 2024; (2) Comparison of the initiation timelines for global Phase 1 studies of other DLL3 ADCs within the same class; (3) Registrational study to start with zoci + PD-L1 +/- chemo in 2026 based on the maturing data from the ongoing Phase 1 study; Phase 1 study to explore novel combination to start in 2026 Overview
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Zocilurtatug pelitecan (DLL3 ADC) Highlights from ENA 2025 Next Steps and Conclusions Q&A with Dr. Amado 6 Rafael Amado, MD President, Head of Global Research and Development, Zai Lab Agenda Zai Lab global portfolio overview
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SCLC: A Common and Devastating Cancer with Few Effective Treatments 7 ✓ 2/3 diagnosed with extensive-stage disease3 ~15% SCLC1 ~372,000 newly diagnosed patients with SCLC each year worldwide1,2 ~34,0001,2 ~73,0001,2 ✓ Limited treatment options in both the U.S. and EU SCLC remains an area of high unmet medical need Abbreviations: Small cell lung cancer (SCLC), overall survival (OS). Notes: (1) J Thorac Oncol. 2023 Jan;18(1):31-46; Lung Cancer Foundation of America. (2) WHO Globocan 2022. (3) Sabari JK, et al. Nat Rev Clin Oncol. 2017;14:549-561. (4) Li N, Chu Y, Song Q. Brain Metastasis in Patients with Small Cell Lung Cancer. Int J Gen Med. 2021 Dec 21;14:10131-10139. doi: 10.2147/IJGM.S342009. PMID: 34992434; PMCID: PMC8710975. (5) Among patients with SCLC and synchronous brain metastases at initial diagnosis (n=5711) or no brain metastases at initial diagnosis (n=27,458). Zhou G, et al. Cancer Med. 2023;12:1195–1203. (6) IMpower133 study and CASPIAN study results. Patients with brain metastases at baseline are not excluded. Lung Cancer Up to 70% of SCLC pts eventually develop brain metastases4 ✓ Brain metastases associated with poor survival outcomes 5 mos 12~13 mos Median OS for ES-SCLC Pts w/ brain metastases at initial diagnosis5 Overall pts6 Disease Landscape
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ES-SCLC: Poor Efficacy and Safety Outcomes Persist Across Treatment Lines 8 Significant opportunity remains to improve upon efficacy, safety, or accessibility in SCLC Aabbreviations: Antibody-Drug Conjugate (ADC); Duration of Response (DoR); Grade 3 or higher (Gr3+); extensive-stage small cell lung cancer (ES-SCLC); Cytokine release syndrome (CRS). Sources: NCCN Guidelines: SCLC. Version 2.2025; UpToDate: Extensive-stage small-cell lung cancer: Initial management; Treatment of refractory and relapsed small cell lung cancer. Notes: (1) IMpower133 study and CASPIAN study results. (2) Anti-PD-L1 (atezolizumab or durvalumab) + platinum + etoposide. (3) atezolizumab or durvalumab. (4) Platinum + etoposide re-treatment if progression in more than 6 months, or single-agent chemotherapy (lurbinectedin, topotecan, irinotecan) if progression in less than 6 months. (5) Giannis Mountzios, M.D., Ph.D et al. 2025 NEJM, Tarlatamab in Small-Cell Lung Cancer after Platinum-Based Chemotherapy; In May 2024, IMDELLTRA received FDA accelerated approval for the treatment of adult patients with ES-SCLC with disease progression on or after platinum-based chemotherapy. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). ~60-70% Response Rate1 ~4-5 months DOR1 ~12-13 months OS1 35% Response Rate5 6.9 months DOR5 11.2 months OS5 Platinum-doublet chemo + anti-PD-L12 (with anti-PD-L1 maintenance3) Platinum-doublet re-treatment, or other chemotherapies4, or IMDELLTRA5 SOC Efficacy Safety ~60% Gr3+ Toxicities1 27% Gr3+ Toxicities5 56% CRS of any grade5 Treatment lines First Line ES-SCLC Second Line ES-SCLC Disease Landscape
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Zocilurtatug pelitecan (ZL-1310): Novel Delta-Like Ligand 3 (DLL3) Targeting ADC 9 • DLL3 is a neuroendocrine-specific antigen that is a validated target and is highly expressed in small cell lung cancer (SCLC), an indication with a high unmet medical need1-3 • Zocilurtatug pelitecan, also known as ZL-1310, is a novel DLL3-targeting ADC developed using the camptothecin derivative-based TMALIN® (Tumor Microenvironment-Activable LINker-payload) platform4 ‒ Efficient payload delivery to the targeted cells with DAR=8 ‒ Potent bystander killing mediated by the Topo-1 inhibitor payload C24 ‒ TME-specific payload release and accumulation, minimizing systemic toxicity Abbreviations: delta-like ligand 3 (DLL3); drug-to-antibody ratio (DAR); immunoglobulin (Ig); monoclonal antibody (mAb); tumor microenvironment (TME). Sources: Sabari JK, et al. Nat Rev Clin Oncol. 2017;14(9):549‒61; Saunders LR, et al. Sci Transl Med. 2015;7(302):302ra136; Petrelli F, et al. Mol Clin Oncol. 2021;15(4):218; Liu LN, et al. Poster presented at: ELCC; March 22, 2024; Prague, Czech Republic. A: Humanized anti-DLL3 IgG1 mAb B: Cleavable tripeptide-based linker C: Camptothecin derivative payload, C24 A B C ENA Presentation
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ZL-1310-001: Study Overview (NCT06179069) 10 • Phase I, open-label, dose-escalation and expansion study of ZL-1310 as monotherapy and in combination with atezolizumab or atezolizumab and carboplatin in SCLC • Preliminary data was previously reported1. Data reported here are an update from the ongoing monotherapy parts ‒ 115 patients dosed across dose escalation and expansion cohorts • 102 patients had the opportunity of at least 1 post baseline scan for response assessment per RECIST v1.1 (Efficacy Evaluable Population) with median follow-up time 7.1 months Patients with metastatic or extensive-stage SCLC with ≥ 1 prior platinum-based chemotherapy regimen • Asymptomatic brain metastasis (treated or untreated) allowed • Prior DLL3-targeted therapy allowed • Archival biopsy collected for retrospective DLL3 testing • ECOG PS 0-1 Part 1A: Dose escalation ZL-1310 IV q3W Part 2: Dose expansion ZL-1310 IV q3W 0.8 mg/kg 1.6 mg/kg 2.4 mg/kg 2.8 mg/kg 1.2 mg/kg 2.0 mg/kg 1.6 mg/kg 1.2 mg/kg 2.0 mg/kg R Data cut-off: September 15, 2025. Abbreviations: intravenous (IV); once every 3 weeks (Q3W); Performance Status (PS); randomization (R); Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1); small cell lung cancer (SCLC). Note: (1) Patel, M.R. et al. JCO 2025, 43, 3041, ASCO 2025. ENA Presentation
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Baseline & Disease Characteristics 11 As of September 15, 2025, 115 pts were enrolled across 6 dose cohorts: • 90.4% of patients received prior anti-PD(L)1 therapy • 43.5% of patients received at least 2 prior lines of therapy • 32.2% of patients has asymptomatic brain metastasis at baseline; 13 of these patients were untreated; had no prior brain radiotherapy Note: *Patients with brain metastases listed as target or non-target lesion, includes both previously treated and untreated lesions. ENA Presentation
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Safety - Doses Selected for Expansion Appear Well Tolerated 12 TEAE, n (%) 1.2 mg/kg N=27 1.6 mg/kg N=45 All Dose Levels N=115 Any TEAE 23 (85.2) 45 (100) 110 (95.7) Grade ≥3 6 (22.2) 13 (28.9) 40 (34.8) Leading to Dose Interruption 3 (11.1) 14 (31.1) 38 (33.0) Leading to Dose Reduction 1 (3.7) 3 (6.7) 8 (7.0) Leading to Drug Discontinuation 0 0 5 (4.3) Leading to Death 0 0 2 (1.7) Serious TEAE 5 (18.5) 14 (31.1) 31 (27.0) TEAEs Related to ZL-1310 18 (66.7) 39 (86.7) 96 (83.5) Grade ≥3 0 6 (13.3) 23 (20.0) Leading to Dose Interruption 1 (3.7) 5 (11.1) 22 (19.1) Leading to Dose Reduction 0 3 (6.7) 7 (6.1) Leading to Drug Discontinuation 0 0 5 (4.3) Leading to Death 0 0 1 (0.9) Serious TEAE Related to ZL-1310 0 4 (8.9) 9 (7.8) ✓ 2/72 (2.8%) Pneumonitis/ILD across the 1.2 – 1.6 mg/kg dose levels, both Grade 1 Data cut-off: September 15, 2025. Percent with a Treatment-related Adverse event (TRAE) from all dose levels overall and those with max Grade ≥3 displayed on the graph. Abbreviations: Alanine Aminotransferase (ALT); Aspartate aminotransferase (AST). Note: Neutropenia includes AEs coded as Neutropenia and Neutrophil count decreased; Lymphopenia includes Lymphocyte count decreased and Lymphopenia. Thrombocytopenia includes Platelet count decreased and Thrombocytopenia. Leukopenia includes White blood cell count decreased. Pneumonitis / ILD includes AEs coded as Interstitial lung disease and Pneumonitis. ENA Presentation 9.6 47.0 11.3 31.3 27.8 20.93.5 15.73.5 14.8 12.20.9 11.32.6 9.6 8.7 7.0 1.7 6.1 5.2 1.7
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Efficacy – Target Tumor Regression Observed Across Dose Levels and In Patients with Brain Metastasis At Baseline 13 Note: All the responses are confirmed for 28 patients in the dose escalation cohort. ✓ Pts received a median of 6 treatment cycles (range 1- 22) of ZL-1310 ✓ Of the 76 pts with tumor tissue samples available, four (4/76, 5.3%) were found to be DLL3-negative (IHC=0) by retrospective immunohistochemistry analysis via central laboratory ENA Presentation ✓ ✓ ✓ ✓
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Efficacy - Best Overall Response per RECIST v1.1 by Investigator: Efficacy Evaluable Population 14 Data cut-off: September 15, 2025. Abbreviations: Complete Response (CR); duration of response (DOR); partial response (PR); partial response observed, and follow-up is ongoing in this patient and response to be confirmed (uPR); confirmed overall response rate + uPR for patients ongoing (Best ORR); Stable Disease (SD). 3% 3% n=15 1.2 mg/kg n=19 1.6 mg/kg n=53 All 2L 44% 38% 44% 30% 51% 68.4% 60% 6% 2L Patients Patients with brain metastasis n=102 n=32 27% 7% 47% 53% 26% 10% 58% 60% 3% 3% 28% 66%Best ORR: All Patients 4% 50% • High response rate observed in patients with brain metastasis at baseline • 8/10 (80%) ORR for patients without prior brain radiotherapy • Response was higher in less heavily treated patients; retained activity after DLL3-targeted therapy • 40% ORR (1 CR, 3 PR) in 10 with prior DLL3-targeted therapy • 43% ORR (1 CR, 2 PR) in 7 pts with prior tarlatamab • Activity observed at both ongoing dose expansion dose levels • median DoR of 6.1 months in all patients across lines (48/102 responders) 68% 60% ENA Presentation
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Efficacy - Responses were rapid and sustained 15 Data cut-off: September 15, 2025. Abbreviations Progression-free Survival; (PFS) Note: median PFS obtained via Kaplan-Meier method. • Responses occurred fast; median time to confirmed objective response < 6 weeks • median PFS was 5.4 months in all patients • Continued enrollment and longer follow-up is ongoing for the 1.2 and 1.6 mg/kg dose levels ENA Presentation Percent Change from Baseline in Sum of Diameters of Target Lesions (%) RECIST v1.1 by Investigator Assessment Efficacy Evaluable Patients within 12 months (n=102) median PFS for All Treated to 12 month: 5.4 months (95%CI: 4.1, 6.8)
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A global, randomized phase 3 trial comparing ZL-1310 vs investigator’s choice therapy in ES-SCLC progressed on or after platinum-based chemotherapy has initiated Conclusions Zai Lab Confidential. All Rights Reserved. 16 • Zocilurtatug pelitecan is potentially a first-in-class and best-in-class DLL3 ADC for the treatment of ES-SCLC • Safety - Zoci at 1.2 or 1.6mg/kg is well tolerated (n=72) • No patients discontinued due to toxicity to date, enrollment is on-going • Low percentage of ≥G3 TRAE observed (13.3% for 1.6 mg/kg) • 2.8% (2/72) patients had ILD/pneumonitis and both cases are G1 (asymptomatic) • Efficacy - Zoci demonstrated a high response rate in ES-SCLC progressed on or after platinum-based chemotherapy • Observed efficacy consistent over time with additional patients and longer follow-up • Best ORR of 68% in 2L patients treated at 1.6 mg/kg • Clinically meaningful response among patients with brain met at baseline and those previously treated with DLL3-targeting T-cell engager therapy • 80% (8/10) ORR observed in patients with untreated brain metastases at baseline • 43% (3/7) ORR in those received prior tarlatamab therapy • Response is durable (est DoR of 6.1 months across all lines and doses) and clinically meaningful in this difficult-to-treat population ENA Presentation
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From Phase 1 to a global, randomized, pivotal trial in <2 years – demonstrating rapid execution Zocilurtatug pelitecan (ZL-1310) (Randomized study dose, Q3W) Investigator’s choice of therapy R Eligible Patients • ES-SCLC • Must have progressed following the platinum-based regimen • Received only 1 line of prior systemic therapy, or 1 line of chemotherapy followed by tarlatamab • At least one measurable lesion • ECOG 0-1 Primary endpoints: BICR-ORR, OS Secondary endpoints: PFS, DoR, safety, PROs 2L+ ES-SCLC Registrational Study Design 17 Abbreviations: Chemotherapy free-interval (CTFI), Patient-Reported Outcomes (PRO). *majority of patients enrolled in this study are estimated to be 2L. Stratification factors • Brain mets: Yes vs No • Prior systemic treatment*: 1L CTFI ≥90 days vs. 1L with CTFI <90 days vs. 2L • Investigator’s choice: tarla vs. others Pivotal trial design
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Zocilurtatug pelitecan (DLL3 ADC) Highlights from ENA 2025 Next Steps and Conclusions Q&A with Dr. Amado 18 Rafael Amado, MD President, Head of Global Research and Development, Zai Lab Agenda Zai Lab global portfolio overview
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Advancing Zoci into 1L SCLC to Broaden Impact Across Lines of Therapy Notes: (1) ) Zoci + PDL-1 +/- chemo. Zoci monotherapy versus investigator’s choice2L+ SCLC Phase 3 initiated Zoci + PD-L1 ± chemo1L SCLC Phase 1 dose escalation ongoing 1L & beyond SCLC Novel combination Phase 1 start in 2026 1L SCLC Doublet or Triplet combinations1 Phase 3 start in 2026 Expanding to 1L SCLC (Entering Phase 3 in 2026) Next Steps
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NECs Represent a Large, Underserved Opportunity – Expanding Zoci’s Reach Beyond SCLC 350~400K Est. global prevalence of NEC1 Selected Tumor Types2 Min 5-Yr OS rate % of DLL3 expression GEP NEC 15% 77% NEPC 5~8% 76% Merkel Cell Carcinoma 14% 70% Abbreviations: Gastroenteropancreatic neuroendocrine carcinomas (GEP NEC), neuroendocrine carcinomas (NECs), neuroendocrine prostate cancer (NEPC). Notes: (1) Zai Lab analysis; Incidence and survival of neuroendocrine neoplasia in England 1995−2018: A retrospective, population-based study; (2) Include but not limit to the three tumor types listed. Other major subtypes include SCLC, Large cell neuroendocrine carcinoma of the lung (LCNEC), Neuroendocrine Carcinoma of Bladder (NECB), Cervix (NECC), Endometrium and Medullary thyroid cancer (MTC). 20 No DLL3-targeted therapies approved ➢ Advance into registrational enabling cohort in NEC in 2026 ➢ Data update for Zoci monotherapy in 1H 2026 Unmet Medical Needs in NECs Key Next Steps Global Basket Trial Ongoing May 2025 Enrollment initiated As of Today Preliminary data support advancement into registrational enabling study next year Next Steps
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Zoci – Potential First- and Best-in-Class ADC in SCLC; Rapidly Advancing into 1L SCLC and NEC Potential Upcoming Data and Clinical Development Milestones: 2L+ SCLC ❑ Updated data on intracranial activity in H1 2026 1L SCLC ❑ Phase 1 data from ongoing doublet/triplet by H1 2026 ❑ Pivotal trial start with zoci + PD-L1 +/- chemo in 2026 ❑ Phase 1 start to explore novel combination in 2026 NEC ❑ Phase 1 data in H1 2026 ❑ Advance into registrational enabling cohort in 2026 ✓ High response rates and durable benefit in a difficult- to-treat population – 68.4% ORR at 1.6 mg/kg in 2L SCLC – mDoR of 6.1m across all doses and lines of therapy ✓ Compelling activity in patients with brain metastases – 80% ORR in patients without prior radiation ✓ Potential best-in-class safety profile – Grade ≥3 TRAEs of 13% – No Grade ≥2 ILD and no TRAEs leading to drug discontinuation or death with 1.6 mg/kg Strong and Differentiated Efficacy and Safety Profile: Next Steps
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Zocilurtatug pelitecan (DLL3 ADC) Highlights from ENA 2025 Next Steps and Conclusions Q&A with Dr. Amado 22 Rafael Amado, MD President, Head of Global Research and Development, Zai Lab Agenda Zai Lab global portfolio overview