Genmab A/S

Hello and welcome to the GENMAP first half 2024 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 nor to confirm such statements in relation to actual results, unless this is required by law. 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.

Hello and welcome to GenMob's conference call to discuss the company's financial results for the period ending June 30, 2024. With me today to present these results is our CFO Anthony Pagano, our Chief Operating Officer Anthony Mancini, and our Chief Medical Officer Tai Yamadi. For the Q&A, we will be joined by our Chief Development Officer, Judith Klimovski. As already said, we will be making forward-looking statements, so please keep that in mind as we go through this call. During today's presentation, we will reference products being developed under some of our strategic collaborations. This slide acknowledges those relationships. We have had a very exciting second quarter. The acquisition of ProfoundBio, which was completed in May, was an historic event for GenMob and one that will enhance our long-term growth profile. In just a moment, you will hear from Tahi on some of the exciting next steps that we have planned for Reina S. And later, Anthony Pagano will walk you through the financial impact of the acquisition. June was an exceptionally eventful month for Epkinley, which is now the first and only bispecific antibody approved in the U.S. to treat both relapsed or refractory follicular lymphoma and relapsed or refractory diffuse large B-cell lymphoma. In addition to the U.S. approval in relapsed or refractory follicular lymphoma, the CHMP adopted a positive opinion recommending TEP-Kinley, as abcaritumab is called in Europe, for the same indication. Both regulatory actions were supported by data from the APCOR NHL-1 trial, which was also recently published in the Lancet Hematology. I would also like to note the potentially imminent start of another Phase III trial for abcaritumab. This one in combination with lenalidomide for transplant ineligible patients with relapsed or refractory diffuse large B-cell lymphoma. Together with our partner, AbbVie, we continue to evaluate abcaritumab in multiple patient populations and treatment settings with the goal of establishing abcaritumab as a core therapy in B-cell malignancies. During our Q1 earnings call, we discussed the FDA approval and Japan NDA submission for TIFTAC, both of which occurred early in the quarter. As a reminder, with its approval in the U.S., TIFDAC became the first ADC with demonstrated overall survival data to be granted full FDA approval for the treatment of patients with recurrence or metastatic cervical cancer with disease progression on or after chemotherapy. I'm also excited to note that data from the Innovative 301 study, on which the approval was based, was recently published in the prestigious New England Journal of Medicine. By now, we hope that you have all had the chance to listen to our June 3rd call to review some of the exciting data that we presented at ESCO, including for TIFDAC, APKINDI, and of course, AKASUNLIMOP. Ty will provide you with a brief reminder of the very promising AKASUNLIMOP data and our next steps for the program on today's call. Before this, I would like to highlight the key change to the Akkasunlimab program that we announced on Monday. GenMob has now taken full control of the development of Akkasunlimab. This is a fantastic opportunity for us to own and advance this promising asset. Our partner BioNTech has opted to not participate in the further development of Akkasunlimab. And we understand that this decision was based on their strategic portfolio prioritization and does not reflect the strength or potential of Akasunlimab. This now becomes our second wholly owned candidate, medicine, entering phase three by the end of this year, underscoring our strong confidence in the clinical promise and commercial potential. We are exceptionally well-positioned to maximize the potential of Akasunlimab, and we are very excited about the future of this program. I would also like to add that even though our partnership is changing on this program, it remains extremely strong and collaborative, and we are committed to continuing to work together to advance innovative antibody treatments for patients. Finally, turning to medicines powered by our innovation. Johnson announced that tripovans has now been approved by the European Commission for the first-line treatment of adult patients with advanced non-small cell lung cancer with activating EGFR exon 20 insertion mutations. In addition, they have submitted a BLA for a subcutaneous version of amivantamab for all currently approved or submitted indication of IV tripovans in certain patients with non-small cell lung cancer. More recently, in July, Janssen announced approval in the U.S. for Darfalex Fospro in combination with Botizumab, Linalidomide, and Dexamethasone for the treatment of patients who are newly diagnosed with multiple myeloma and are eligible for autologous stem cell transplants. This combination, based on data from the Phase III Perseus study, has the potential to improve long-term outcomes for patients newly diagnosed with multiple myeloma, and further supports Darzalex as a backbone therapy for this disease. Anthony Mancini will provide you with a review of the recent performance for Darzalex, plus other select royalty medicines, as well as, of course, for Apkinley and TifTac. First, I'm pleased to hand over now to Tahi, who will provide you with a reminder of the significant progress we are making with our wholly-owned late-stage clinical programs, Akasunimab and Rhino-S. Tahi, the floor is yours.

Thank you, Jan. I'm sure by now you have all seen the Phase II Akasunimab data in combination with Pembrolizumab in second-line non-small cell lung cancer that we presented at ASCO. This data is very encouraging, demonstrating significant disease control and over-survival alongside a manageable safety profile. As a reminder, in this CPI pre-treated patient population, we presented an impressive median over-survival of 17.5 months and a 12-month OS rate of 69%. Additional data will be presented at medical conferences, including the World Conference on Lung Cancer in September next month. This will include translational data that should help you better understand our confidence in the Q6 week dosing schedule. And to ensure that there is no confusion, this will not include updated clinical data. We are simply too close to ASCO and therefore limited by a very short follow-up, which really prevents a meaningful impact on time to events analysis. That said, the encouraging data both from ASCO and the translation data that will be presented at WCLC reinforces our commitment to swiftly progressing the phase three trial in PDR1 positive patients with non-small lung cancer who progressed on a CPI either alone or in combination chemotherapy. And we expect to start this study before the end of the year. Given both our proven and extensive clinical development experience and our track record of acceleration, as you've seen with Epkinley, we are confident in our ability to advance acasunium up through phase 3 and beyond. Moving now to RINA-S. As a reminder, this slide summarizes why RINA-S aligns with our vision to transform the lives of patients. We believe it has the potential to broaden, deepen, and consequently expand activity beyond what has been seen with first-generation photoreceptor alpha approaches. becoming a potential best-in-class treatment for ovarian cancer and other folate receptor alpha-expressing solid tumors. In addition to efficacy, it also has a differentiated safety profile, avoiding interstitial lung disease and corneal toxicities seen with other ADC therapies. This differentiation, both in efficacy and safety, is a direct result of the novel proprietary hydrophilic linker technology developed by ProfoundBio. We're exceptionally well positioned to maximize the potential of Vena S, given both our full clinical development capabilities, the track record of acceleration, and our experience in the Gainox space already with TIFTAC. And as we said before, we anticipate the first potential approval for Vena S could be in 27, and importantly, we anticipate blockbuster peak sales potential. Now, this is what we shared with you when we announced the acquisition of ProfoundBio. Now that we are officially responsible for the development of reNA-S, let's take a look at our near-term plans. Previously, we told you that we would be providing an update to the initial encouraging Phase I ovarian cancer data that was presented at CITC last year. We can now confirm that you will see both updated data and additional follow-up at ESMO in September. I'm also pleased to note that we are on track to deliver on our accelerated development plan. We have aligned on the dose with health authorities and expect to start a phase three trial in second line plus platinum resistant ovarian cancer before the end of the year. So in summary, significant progress for both Akasunimab and Rina S. And we look forward to sharing more information with you when it becomes available. I will now hand it over to my colleague, Anthony Mancini. Thanks, Todd.