ZLAB Q3 2026 earnings call transcript, November 5, 2026

Hello and welcome, everyone. Today's earnings call will be led by Dr. Samantha Du, ZLAB's founder, CEO, and chairperson. She will be joined by Dr. Rafael Amato, President and Head of Global Research and Development. And Dr. Yajin Chen, Chief Financial Officer. Dr. Shan He, our Chief Business Officer, and Dr. Yijia Wang, our operating partner, will also be available to answer questions during the Q&A portion of the call. As a reminder, during today's call, we will be making certain forward-looking statements based on our current expectations. These statements are subject to numerous risks and uncertainties that may cause actual results to differ materially from what we expect due to a variety of factors. including those discussed in our SEC filings. We will also refer to adjusted loss from operations which is a non-GAAP financial measure. Please refer to our earnings release furnished with the SEC on November 5th, 2026 for additional information on this non-GAAP financial measure. At this time, it is my pleasure to turn the call over to Dr. Samantha Du.

I'll focus on our two lead programs, Josie and... DL1503. Let me start with Josie, our potential first and best in class DL03 targeting ADC. At ESMO, we presented first-line small cell lung cancer data from our global phase one study of Josie plus atezolizumab. Across 33 efficacy available previously untreated patients at the selected 1.6 milligrams per kilogram dose, the doublet achieves a confirmed objective response... rate of 81.8%. Responses were rapid with nearly all observed in the first tumor assessment. We're also seeing encouraging signs of durability. In all 33 patients, the estimated six-month progression-free survival was 81.9%. Among the first 15 patients who had a median follow-up of 10 months, median progression-free survival and median duration of response had not been reached. At the data... ...cut off, 10 of these 15 patients had not progressed. For context, chemo IEO has historically delivered a median PFS of roughly five months. What further differentiates ZOZI is its potential to deliver this level of efficacy with substantially improved tolerability. With a 1.6 milligrams per kilogram doublet, grade 3 or higher ZOZI-related adverse events occurred in 9.1% of patients. There was a single... case of grade 1 interstitial lung disease, which is consistent with our monotherapy experience. By comparison, grade 3 or higher treatment-related adverse events occur in roughly 60% or more of patients with chemo I.O. We believe these results are unprecedented in first-line small cell lung cancer in an unselected patient population for platinum responsiveness. Together, this data challenged the conventional view of what an ADC-based regimen...

...and could achieve in first-line small cell lung cancer, both in terms of efficacy, durability, and tolerability. On the strength of this data, we're advancing ZOLSI 1.6 milligrams per kilogram plus immunotherapy doublet into a global randomized SACE-3 study. We're also building on this backbone with T-cell engager. The scientific rationale is complementary. ZOLSI rapidly reduces tumor burden, while the T-cell engager provides... ...durable immune-mediate screening. Importantly, ZOLSI's favorite profile may be particularly advantageous in these combinations, as T-cell engagers carry their own toxicity risk. Our global phase 1B study in small cell lung cancer with Amgen is moving rapidly, and our collaboration with BI is also advancing. Beyond first-line disease, our registration of phase 3 DELABATE study is evaluating ZOLSI in second-line. and later disease, including patients previously treated with TALATAMAP. Contingent on enrolling sufficient post-TALATAMAP, in addition to second-line patients, an interim analysis in 2027 could support a USBLA submission for accelerated approval. Turning to extra-pulmonary neuroendocrine carcinomas, or EPNECs. This is an aggressive disease where there is no established standard of care beyond first-line chemotherapy. Medical response rates are between 10 to 20%, and median overall survival is about six months. We have completed enrollment in our Phase 1b-2 second-line EPNEC study. Tomorrow, at the North American Neuroendocrine Tumor Society Conference, we will present preliminary results showing activity observed across a diversity of EPNEC subtypes. Based on the totality of the clinical data thus far, and

feedback from FDA, we plan to pursue a potential accelerated approval supported by this single-arm study. We expect final results in 2027 and a potential submission that same year. Now turning to immunology and ZL1503, I internally discovered long-acting IL-13, IL-31 receptor alpha bispecific antibody for atopic dermatitis. ZL1503 is designed to address and the first-line EPNEC. ZL1503 is designed to address the two major drivers of disease, IL-13 driven inflammation and IL-31 mediated itch. By simultaneously blocking both pathways, ZL1503 has the potential to break the itch-scratch inflammation cycle, providing more comprehensive disease control with a single biologic. ZL1503 also incorporates YTE modifications that extend its half-life with the goal of enabling substantially less frequent dosing. and currently available biologics. Next week, at the American College of Allergy, Asthma, and Immunology meeting in Phoenix, we will present first-in-human data from the single ascending dose portion of our global Phase I study in Healthy Volunteers. The SAG study has met its pre-specified endpoints, and we will share results demonstrating its safety profile, pharmacokinetics, immunogenicity, and sustained inhibition of the IL-13 inflammatory pathway. Two more data sets follow next year. First, clinical efficacy, including each control in patients with moderate to severe atopic dermatitis, and second, initial data from our fully enrolled IV to subcutaneous bridging study.

We are planning Phase IIb development in atopic dermatitis while also evaluating the potential for ZL1503 across additional IL-13 and IL-13. IL-31-mediated diseases. Our next wave of global assets continue to advance. This includes ZL6201, our LRR-C15-targeted ADC, ZL1311, our MAC17-targeting T-cell engager, and ZL1222, our PD-1 IL-12 immunocytocon. Lastly, with our China Regional Pipeline, we continue to progress multiple regulatory and development opportunities including potential additional filings for escartigimab and the ongoing registrational development of AllegroBard and thyroid eye disease. And with that, I'll hand it over to Yayin.

Our financial priorities are clear. Return our China commercial business to growth, maintain a disciplined cost structure, and fund our highest-value global program. Our third quarter results showed progress on all three. Total revenue was $108.2 million. Net product revenue increased 2% sequentially, reflecting continued stabilization of our China commercial business. Across our priority brands, ZLAB held its competitive position despite ongoing volume-based pricing-related dynamics and a competitive help. Inhibitor landscape, Vivgard volumes continued to grow sequentially on new patient starts. And Cox-T continued to gain traction ahead of potential NRDO inclusion next year. We expect a return to year-over-year product revenue growth in 2027, driven by continued demand across our priority brands and a new NRDO listing. At the same time, we have maintained strong discipline in managing our operating expenses. Both R&D and SG&A expenses remained relatively stable compared with the prior year period, reflecting the operational efficiencies and resource optimization initiatives we have implemented across the organization. Our China commercial business remained profitable, providing a strong operating function. As we continue investing in our global development program, we ended the quarter with a cash position of $659.7 million as of September 30th, 2026. And in October, we raised approximately $250 million in equity at no discount to market, which further provides the financial flexibility to continue

investing in the highest value opportunities. In summary, we have a profitable commercial business, a disciplined cost structure, and a balance sheet that supports our global innovative pipeline through its most important milestones. With that, I will open it up for questions. Thank you. We will now begin the question and answer session. To withdraw your question, please press star 11 on your telephone and wait for your name to be announced. To withdraw your question, please press star 11 again. Please stand by while we compile the Q&A roster.

Thank you for your participation in today's conference. This does conclude the program. You may now disconnect your lines.