11/6/2025

speaker
Conference Operator

Thank you for standing by. This is the conference operator. Welcome to the ZineWorks third quarter 2025 results conference call and webcast. As a reminder, all participants are in a listen-only mode, and the conference is being recorded. After the presentation, there will be an opportunity to ask questions. To ask a question, press star 11 on your telephone keypad. Should you need assistance during the conference call, you may signal an operator by pressing star and then zero. I would now like to turn the conference over to Sarah Nell Inamander, Senior Director of Investor Relations. Please go ahead.

speaker
Sarah Nell Inamander
Senior Director of Investor Relations

Thank you, operator, and good afternoon, everyone. Thank you for joining our third quarter 2025 results conference call. As usual, before we begin, I'd like to remind you that we'll be making a number of forward-looking statements during this call, including without limitation, those forward-looking statements identified in our slides and the accompanying oral commentary. Forward-looking statements are based upon our current expectations and various assumptions and are subject to the usual risks and uncertainties associated with companies in our industry and at our stage of development. For discussion of these risks and uncertainties, we refer you to our latest STC filings as found on our website and as filed with the STC. In a moment, I will hand over to Leonie Patterson, our Executive Vice President and Chief Business and Financial Officer, who will provide an overview of our recent business and partnership updates, along with financial results for our third quarter 2025. Following this, Dr. Sabina Mikan, our Senior Vice President of Clinical Development, will provide progress updates on our phase one programs, CW191 and CW251. We will then pass the call over to Dr. Paul Moore, our Chief Scientific Officer, who will provide a brief overview of recent R&D developments. At the end of the call, Leonie Sabine, Paul and Ken Galbraith, our Chair and CEO, will be available for Q&A. As a reminder, the audio and slides from this call will also be available on the Zion Watch website later today. I will now turn the call over to Leonie.

speaker
Leonie Patterson
Executive Vice President and Chief Business and Financial Officer

Thank you, Chanel, and good afternoon, everyone. I'd like to start the call by walking you through recent progress on both clinical and preclinical programs within our wholly owned product pipeline. As you know, our team was pleased to present initial clinical data from the phase one trial of ZW191, an antibody drug conjugate targeting folio receptor alpha at the ENA conference in October. Sabine will provide a recap of the data we presented during our poster presentation later on today's call. We are encouraged by the preliminary Phase I data for GW191, which provides early clinical validation of our ADC approach, and we are pleased to announce that we have dosed the first patient in the Phase I clinical trial of GW251, a DAR4 ADC targeting GPC3 in hepatocellular carcinoma. Again, Sabine will talk more about the trial design later on today's call. We also continue to present preclinical data of ZW1528, a bispecific inhibitor of IL-4 and IL-31 to address respiratory inflammation at the European Respiratory Society Annual Congress. Additional information can be found on the ERS Congress website and a copy of the poster is available on the publications page of ZynWorks website. Meanwhile, our partner programs also continue to provide encouraging data at ESMO. Our partner, Jazz, presented a trial and progress poster on the DISCOVERHER PAN206 Phase 2 study of Xanadatamab in HER2 overexpressing solid tumors, as well as a two-year follow-up in first-line metastatic colorectal cancer showing durable responses and a favorable safety profile. In addition, yesterday, JAS announced that the ITT population for the primary PFS and interim OS analysis of the Horizon GEA-01 trial will include the full patient population enrolled in the study of 920 patients. Also at ESMO, J&J presented translational findings from the first in-human study of prasaritimig in metastatic prostate cancer. linking T-cell phenotypes with clinical activity. These updates highlight the strong momentum in our partnered portfolio and the long-term value these collaborations continue to build. With this in mind, I'm pleased to announce that this quarter, we recognized a $25 million development milestone as revenue from our collaboration partner, J&J, in association with Clinical Progress of Class Miramig, a first-in-class bispecific T-cell engager targeting KLK2 in phase three studies in metastatic castration-resistant prostate cancer, which was engineered using Zynwerks as a metric platform. As a reminder, we remain eligible to receive up to a further $434 million in development and commercial milestones from the J&J Collaboration, in addition to potential mid-single-digit royalties on global product sales. In addition, this quarter, we earned royalties of $1 million based on Zahira net product sales by Jazz and B1 Medicines. And we look forward to pivotal data from the Horizon GE01 study expected in the fourth quarter. I'd also like to highlight that as of November 4, 2025, we have completed share repurchases of $22.7 million of the remaining $30 million under our previously authorized share repurchase program, which reflects the leadership team's confidence in the company's outlook, the strength of our pipeline, and our long-term commitment to shareholder value. This program was primarily funded from Zahira development milestones and cumulative royalties received from Jazz and B1 related to initial regulatory approvals in biliary tract cancer in both the US and China, allowing us to efficiently deploy excess capital while maintaining full flexibility to fund operations and growth initiatives. This action reinforces our view that the stock remains undervalued, and it aligns with our disciplined, balanced approach to capital allocation designed to drive sustainable long-term returns. Turning now to our financial results, total revenue was $27.6 million in the third quarter of 2025 compared to $16 million for the third quarter of 2024. The increase was primarily due to a $25 million non-refundable milestone recognized from J&J in relation to clinical progress on prasaritamig in phase three studies in metastatic castration-resistant prostate cancer. and $1 million of royalty revenues from Jazz and B1 medicines. These increases were partially offset by a reduction in development support and drug supply revenue from Jazz, and due to a non-recurring milestone from GSK that was achieved in the third quarter of 2024. Overall operating expenses were $49.7 million for the three months ended September 30, 2025, compared to $50.2 million for the same period in 2024, representing a decrease of 1%. The decrease was primarily due to a reduction in expenses from ZW220 and ZW251, Zanidatamab and Zanidatamab-zobidotin, and a decrease in personal expenses. This was partially offset by an increase in preclinical and research expenses for our ZW209 and ZW1528 programs, progression of clinical studies for ZW171 and 191, and an increase in non-cast stock-based compensation expense. Net loss was $19.6 million for the three months ended September 30, 2025, compared to a net loss of $29.9 million for the same period in 2024. This was primarily due to an increase in revenue, partially offset by a decrease in interest income and an increase in income tax expense. As of September 30, 2025, we had $299.4 million of cash, cash equivalents and marketable securities, which is a decrease in cash resources compared to $324.2 million as of December 31, Our cash resources as of September 30, 2025 did not include the $25 million milestone from J&J recognized in the third quarter and expected to be received in the fourth quarter. We remain well capitalized and based on our current operating plans, we expect our existing cash resources as of September 30, 2025 when combined with the assumed receipt of certain anticipated regulatory milestones, will enable us to fund planned operations as the second half of 2027, which is anticipated to take us through multiple catalyst events on our pipeline. These achievements underscore the strength of our foundational partnerships and the relevance of our platform across multiple products moving into clinical development by our partners. For additional details on our quarterly results, I encourage you to review our earnings release and other SEC filings as available on our website at www.signworks.com. With that, I'd like to hand over to our Senior Vice President of Clinical Development, Dr. Sabine McCann, to run through progress on our clinical development programs.

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