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5/28/2026
Welcome to today's event where we have the pleasure to present Expression Biotech. As you can see here on the front page the Q1 report is of course the reason for today and the main topic for today and of course the pipeline news. So it was through today's presentation I answer questions in the end. We are joined by CEO Ben Fransen and CFO Keith Alexander. As always, there's a box down below where you can ask questions. If you do it in Danish, I will try and translate to the best of my ability. We have a firm stop at 10.30, so I will catch as many questions as possible. But we have a firm stop at 10.30. So I will not take any more time and leave the word over to you, Bent.
Thank you, Michael. And good morning, everyone. And welcome to Expressions Q126 webcast. I'm Ben Fransen, CEO of Expression Biotech, and with me today is our CFO, Keith Alexander. I'll first walk through the key development across our pipeline and platform activities during the first quarter, and particularly progress in our HER2 breast cancer immunotherapy project, as well as our grant-funded infectious diseases programs before Keith takes over and goes through the financial results. And of course, we'll take questions in the end. We'll try to go through this quickly to allow for that. During Q1 2026, we continue to advance both our clinical program and broader platform activities. Across the quarter, we reported progress in financing activities, ESOB C001 clinical development, platform validation through partner programs, manufacturing advancement in the Nipah virus project, and continued strengthening of our IP position. Most notably, we reported encouraging preliminary immunogenicity observations from the ongoing phase one trial of ES2B-C001. Subsequently, we reported drug-specific antibody responses across all evaluable patients and continued progression of the program following an independent data safety monitoring board review. We selected Northway Biotech as a manufacturing partner for the Nipah virus vaccine program. We highlighted additional Oxford University-led malaria clinical data supporting the platform validation and scalability, and we announced a rights issue supporting continued clinical execution toward the planned phase one readout. Overall, Q1 reflected continued execution across both our clinical pipeline and platform ecosystem. This slide summarizes the core elements of Expressions investment case, which is shown across three pillars. First is ES2B-C001, our proprietary HER2-targeted immunotherapy program currently advancing through phase one clinical development. Supporting this is the Express protein expression platform, which has now demonstrated scalability and clinical applicability across multiple partner vaccine programs. This has been validated in clinical phase three and is, in fact, the foundation for all our pipeline and partnering activities. Thirdly, our ownership stake in ADAPMA provides continued strategic exposure to VLP-based immunotherapy technologies. Together, these elements position expression as a clinical stage biotech company supported by a validated and scalable vaccine technology platform. Now, turning to ES2B-C001, this remains our lead proprietary development program. The ongoing study is an open-label phase 1 dose escalation trial being conducted in Austria in patients with advanced HER2-positive and HER2-low breast cancer. The study evaluates three escalating dose cohorts using a five-dose intramuscular treatment regimen with objectives focused on safety, tolerability, and immunogenicity. We have now completed the first two dose cohorts at 50 on 150 micrograms and initiated dosing in the 450 microgram cohort. And importantly, based on observations to date, we continue to see no safety signals of concern. On the immunogenicity side, we continue to observe drug-specific antibody responses across all evaluable patients. Titlers are increasing across successive dosing visits and remaining elevated at later follow-up. Based on the data so far, we have also updated the planned clinical pathway. Rather than introducing a separate dose expansion stage before phase two, we now intend to continue the phase one program into a maintenance phase, evaluating booster dosing and longer-term immune responses, potentially in parallel with future phase two development subject to regulatory alignment. We believe this updated approach strengthens the overall clinical data package while preserving the planned end-2026 phase one readout timeline. Overall, the program continues to progress according to plan. This slide outlines our strategic development pathway for ES2B-C001. Our immediate focus remains on completion of the phase one and continued maturation of the immunogenicity and safety data package through 2026. In parallel, we are evaluating the design of a focused and capital efficient phase two proof of concept study in breast cancer. The objective of such a study would be to further characterize clinical activity and support the program's next stage of development. As clinical data mature, programs in the HER2 field may create opportunities for strategic dialogue and potential partnering. Importantly, our approach remains disciplined, generates robust clinical evidence, progresses the program systematically, and preserves strategic optionality as the data set evolves. Turning to malaria, one of the world's most significant infectious diseases, our express platform continues to support a broad portfolio of Oxford-led malaria vaccine programs. As shown on this slide, there are now 11 trials ongoing or completed across phase one and phase two development, including phase two B studies expected to read out during 2026. Importantly, several programs continue progressing through later stage clinical evaluation across multiple geographies. A key milestone for us remains the licensing agreement for R5.1 and R78C entered into with the Serum Institute of India, one of the world's largest vaccine manufacturers. This partnership provides further validation of the scalability of the express platform, the manufacturability of these vaccine candidates and the continued commercial interest surrounding these programs. And importantly, these activities remains largely grant-funded and partnership-driven, allowing platform expansion without significant capital burden to expression. Beyond breast cancer and malaria, we continue advancing several externally supported programs. Within the Avicii Disease Consortium, the Nipah virus vaccine program continues progressing and is now in the GMP manufacturing stage and remains fully externally funded through completion of clinical phase one. During the quarter, Northway Biotech was selected as a contract manufacturing partner, while analytical method development and manufacturing optimization activities continue. Within Mucovax, work continues supporting next generation mucosal influenza vaccine concepts and associated GMP compatible manufacturing tools. And finally, the Indigo Influencer Consortium concluded during Q1, following which we are evaluating low capital pathways to preserve future optionality from the program. Collectively, these programs continue validating the Express platform while contributing non-diluted funding and external collaboration opportunities. This provides an overview of the broader expression pipeline. At the top is ESOB C001, our fully owned and internally sponsored oncology program. Alongside this, we continue supporting multiple partner infectious disease programs, including malaria, nipah virus, and influenza-related initiatives. Across the pipeline, the programs are powered by the Express expression platform, and in several cases, combined with VLP, technologies through AdaptBank. Overall, the pipeline reflects a balanced structure consisting of one proprietary oncology program, multiple externally funded infectious disease collaborations, and continued platform validation across several indications. This slide highlights the experience supporting execution of our clinical and strategic objectives across management and board, The company combines deep experience in oncology, vaccine development, clinical execution, manufacturing, and partnering. We're also pleased to have strengthened the board recently with the addition of Michelle Baishio, who brings extensive international vaccine and biotech leadership experience. Collectively, the organization is well positioned to support continued clinical progression toward proof of concept. Looking ahead, we see a steady flow of operational and clinical milestones across both oncology and infectious disease programs over the next 12 to 18 months. For ES2B-C001, the primary focus remains continued maturation of the Phase 1 dataset, including maintenance dosing, durability assessments, and progression toward the planned end-2026 weed-out. In parallel, We expect continued business development and phase two preparation activities. Within the Nipah virus program, upcoming milestones include continued CMC manufacturing activities, toxicology and IND enabling studies and preparation for the future phase one initiation. And within malaria, we expect additional clinical readouts from the Oxford Lab and the Serum Institute of India supported programs across the coming quarters. Overall, we believe the company is positioned for multiple staggered development catalysts across both oncology and infectious disease programs. With that overview of our pipeline and strategic progress, I will hand over to Keith to walk you through our Q1 financial results.
Keith, I think you are unmuted. Maybe.
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