8/6/2026

speaker
Operator
Conference Operator

Hello and welcome to the GENMAP first half 2026 financial results conference call. As a reminder, this conference call is being recorded. During this telephone conference, you may be presented with forward-looking statements that include words such as beliefs, anticipates, plans or expects. Actual results may differ materially, for example, as a result of delayed or unsuccessful development projects. GENMAP is not under any obligation to update statements regarding the future, and many more. We encourage you to review our full financial statements and publicly filed reports and not to rely on any single financial measure. Please also note that GENMAP may hold your personal data as indicated by you as a part of our investor relations outreach activities in order to update you on GENMAP going forward. Please refer to our website for more information on GENMAP and our privacy policy. I would like to hand the conference over to our first speaker today, Jan van de Winkel. Please go ahead.

speaker
Jan van de Winkel
Chief Executive Officer

Hello, everyone, and welcome to our financial results call for the first half of 2026. With me today is our Chief Financial Officer, Anthony Pagano, our Chief Commercial Officer, Brad Bailey, and our Chief Medical Officer, Tahy Ahmadi. For the Q&A, we will be joined by our Chief Development Officer, Judith Klimovsky. As the operator said, we will be making forward-looking statements, so please keep that in mind during the call. As we pass the midpoint of the year, I can tell you we are in a really good place. We have been clear about what we set out to do, accelerate our late-stage pipeline, maximize our commercialized medicines, and stay disciplined with our capital. And that is exactly what we have been doing. We grew total revenue by 25%, driven by continued momentum across our portfolio. even as we have made focused and strategic investments in our late-stage programs, in launch readiness, and in the integration of mirrors. And we did all this while growing operating profits. To me, that says a lot about the quality of our business. And beyond financial performance, I'm enthusiastic about our recent pipeline progress, so let me walk you through the highlights. In June, we announced positive top-line results from the Phase III APCOR DL-BCL4 trial, which shows statistically significant, clinically meaningful improvement in progression-free survival. What is important about these results is what they demonstrate about the apcaritumab more broadly. It is growing evidence of the versatility of apcaritumab-based combinations across multiple lines of therapy. This data was followed by the European approval of tepkinli plus lenalidomide and rituximab for the treatment of follicular lymphoma in the second-line setting. This makes tepkinli the first and only bispecific-based therapy approved in Europe for this indication. Our presentations at medical conferences throughout the quarter have highlighted the strength of our portfolio. and we are looking forward to sharing with you p2-centimab data with updated results in colorectal cancer presented at ASMO in October. Based on this promising data, we are continuing to build momentum for p2-centimab. We are initiating two new phase three studies in colorectal cancer and Thij will share more detail on them in just a moment. Now let's turn to the catalysts we continue to look forward to this year on the next slides. As we move into the second half of the year, we are now in a position to provide some clarity on the timing for our highly anticipated data readouts. For RINA-S, we anticipate both Phase II and Phase III platinum-resistant ovarian cancer datasets will be available in the fourth quarter. For Pitocentumab, we are eagerly awaiting the readouts for both studies. and with better visibility, we can now say that the front line study is expected to read out in the fourth quarter, while the second and third line study is anticipated to read out in the first quarter of 2027. Finally, for APKinley, we anticipate that top line data from the front line APCOR DLBCL2 study, which will be based on an interim analysis, will also be available in the fourth quarter. What this means is that for each of our late stage programs, we remain on track for phase three readouts in the second half and then potential approvals and launches in 2027. This is what we have been building towards and it reflects our focused execution. So, exciting times ahead. Now I would like to hand you over to Tai to walk you through the details of the phase three colorectal studies. Tai, the floor is yours.

speaker
Tahy Ahmadi
Chief Medical Officer

Thank you, Jan. We are pleased to share our plans for pitoacetamab in colorectal cancer, which build on our ongoing phase three trials in head and neck cancer. As you can see on the slide, there are a significant number of patients impacted by these diseases. And as you know, PETO is a EGFR-LGR5 bispecific antibody. The rationale for its development in metastatic colorectal cancer is compelling. EGFR antibodies are approved as standard of care. And LGR5 is a marker of cancer stem cells in this disease. Combination of EGFR and LGR5 targeting has shown to be more effective than cetuximab in various preclinical models in RAS, RAF, wild-type colorectal cancer. And the early clinical data have been very encouraging, and we will be able to show more on this at ESMO in October. Based on this promising data, we are initiating two phase three studies, one in frontline and one in second line colorectal cancer. For frontline, we have already initiated a phase three, randomized trial, open label, a global trial that is designed to assess the efficacy and safety of pitoxetamab plus investigator choice chemotherapy of either mFolfox6 or Folfuri. A first-line therapy in patients with unresectable or metastatic left-sided colorectal cancer, that is RAS, RAF, wild-type. It will thus be versus the standard of care, namely Cytuximab plus chemotherapy. For the second-line colorectal cancer patients, the Phase III trial will be similarly a randomized open-label and global trial. This trial is designed to assess the efficacy and safety of pitocinamide plus investigator choice therapy of either modified Folfax 6 or Forfiri. The second line therapy in patients with unresectable metastatic colorectal cancer that are RAS, RAF, wild type. And here, the trial will be versus the standard of care, which is cetuximab or bevacizumab plus chemotherapy. So taken together with our two ongoing phase three trials in head and neck cancer, our plans to expand into locally advanced head and neck cancer, and the encouraging data we continue to generate Pituzentamab is a rapidly emerging as a generally multi-indication asset with the potential to reach a significant number of patients. And with that, I'm pleased to hand over to Brad for a review of the recent commercial performance for AppKinley and Tifda.

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