Ladies and gentlemen, thank you for standing by. Welcome, and thank you for joining Heidelberg Pharma's conference call to discuss today's news. During today's presentation, all participants will be in a listen-only mode. Please note that today's call is being recorded. The presentation will be followed by a Q&A session where you may ask written or audio questions. Please note that you can ask questions only online. I would now like to turn the call over to Professor Dr. Andreas Pahl, CEO of Heidelberg Pharma. Please go ahead, Andreas. Good afternoon, ladies and gentlemen, and thank you for joining the Heidelberg Pharma conference call regarding our decision to tighten our strategic and operational focus and implement an extensive cost-saving program at Heidelberg Pharma. My name is Andreas Pahl, and I'm CEO of the company. Joining me on the call today is our CFO, Walter Miller. We will conduct this presentation in English. Should you wish to ask questions in German or English, please feel free to do so after the presentation. Please note that this presentation is available for download on the Heidelberg Pharma website. The conference call is being recorded, and the replay will be available on our website after the live event. Please be aware that we will be making forward-looking statements on this call as well as during the question-and-answer session. Please see our Safe Harbor Statement here. This morning, we published an ad hoc news release announcing our plans to implement extensive cost-saving measures at Heidelberg Pharma and to focus on the development of our lead ADC candidate, HDP-101. Let me briefly summarize the current situation. You would recall that Heidelberg Pharma monetized the potential royalty streams from TLX250-CDx, the imaging agent that we outlicensed to Telix Pharmaceuticals in 2017. Under this royalty agreement, we were to receive a $70 million milestone payment upon FDA approval of TLX250-CDx, and we plan to use this money to finance our ADC pipeline. We, as well as TLX, expected a positive FDA decision on the market approval of TLX250-CDx in late August, with the PDUFA date of August 27. The rationale for our optimism was the phase III data were clear and positive, with TLX250-CDx showing strong potential for detecting renal cancer. While TLX's first BLA submission in summer 2024 had been rejected by the FDA, this was due to questions on the Chemistry, M anufacturing, and Controls (CMC) and not related to the efficacy and safety data. These issues were subsequently addressed by TLX, and they submitted a second BLA, which was accepted by the FDA in February 2025. Priority review was granted, and the PDUFA date was set for August 27, 2025. Unfortunately and unexpectedly, instead of the expected approval, TLX received a Complete Response Letter from the FDA on the PDUFA date. Given that we had sold a portion of the future royalty streams to HealthCare Royalty and built our financing strategy on the anticipated milestone payment, we had to adapt our strategy, and we made the very difficult strategic decision to focus our R&D efforts and to significantly reduce operating expenses to extend our cash reach. Let me give a quick overview of the mentioned royalty agreement. In 2024, Heidelberg Pharma sold a portion of the future royalties for TLX250-CDx to HealthCare Royalty. We have already received upfront non-refundable payments totaling $45 million. In addition, we are eligible to receive up to $70 million from HealthCare Royalty upon FDA approval of TLX250-CDx. Under the agreement, the amount of $70 million will be reduced if the approval occurs after the end of this year. Given the Complete Response Letter by the FDA received by TLX last month, the milestone required to receive the $70 million payment has not yet been met. In our view, TLX250-CDx has still great potential for detecting renal cancer. As I have said, on August 27, its PDUFA date, TLX received a CRL from the FDA. In its related press release and conference call, TLX provided color on the Complete Response Letter. Importantly, the Complete Response Letter does not relate to the clinical study results on the safety or efficacy of the product. Rather, it is focused on technical and regulatory aspects of manufacturing and the supply chain. TLX outlined three specific areas noted by the agency: deficits related to CMC, particularly the complexity of commercial manufacturing, insufficient demonstration of comparability between the product used in the successful phase III clinical trial and the intended commercial scale product, Form 483s, which are deficiency notices issued to two third-party manufacturing partners, which must be remedied before resubmission. TLX has indicated it believes the issues are readily addressable and is beginning submission remediation immediately. TLX will request a Type A meeting with the FDA as soon as possible and will provide an update on the potential timing after that. The Breakthrough Therapy Designation remains in place. With the approval of the company's supervisory board, the executive management board of Heidelberg Pharma decided on the following measures today. The clinical development of HDP-101, our leading ATAC candidate that is currently in a phase I/II-A trial in multiple myeloma, will be continued as planned. After the recommended phase II dose has been established, we plan to conduct the phase II-A trial evaluating HDP-101 as a monotherapy. The second clinical program, HDP-102, that recently entered clinical development, will temporarily be paused. For our third ATAC, HDP-103, we've prepared the documentation for a clinical trial application as planned. Early research activities will be significantly scaled back. The company's situation, unfortunately, also has necessitated a company-wide workforce reduction. Staff will be reduced by approximately 75% by mid-2026. We have achieved important milestones in the last month, but given that we will not receive the significant milestone payment in the time expected, we must be extremely prudent and, unfortunately, hold a break and implement these cost-saving measures. After completion, a core team will remain to focus on the development of our lead candidate, HDP-101, and to fulfill all the obligations we have. With our current cash position of EUR 22.9 million at the end of August and the stringent cost-saving measures we are implementing, we expect to have sufficient cash to fund operations until mid-2026. We will update our current guidance issued in March, in due course. We deeply regret that we must take these steps, and we would like to warmly thank all our colleagues affected by these cuts for the many years of dedication, service, and contributions to Heidelberg Pharma. These are very painful times for all of us, but we must focus and significantly extend our cash reach, including to ensure that we remain a going concern. Let me briefly give you an update on our lead candidate, HDP-101. Last Saturday, Professor Jonathan Kaufman, a clinical investigator of the study at the Department of Hematology and Medical Oncology at the Emory University in Atlanta, presented new clinical data of HDP-101 at the International Myeloma Society Annual Meeting in Toronto. Today, eight cohorts have been conducted. The candidate was very well tolerated, and the study has shown very encouraging results. Patients showed biological activity of HDP-101 since the dosing with 90 micrograms per kilogram. As you can see on the slide, in cohort six, 90 micrograms per kilogram, two out of 10 patients showed partial response. One patient is still ongoing with a partial response after 18 treatment cycles. In cohort five, at 100 micrograms, two patients had partial responses, and one is stringent complete response, and this stringent complete response is lasting 22 months to date, and this was out of six patients. In cohort seven, at 112.5 micrograms per kilogram, two patients out of six had a partial response. In cohort eight, dosed at 140 micrograms per kilogram, preliminary data shows two patients with a partial response and one patient with a very good partial response out of six available patients. Altogether, in cohort five to eight, we have seen an overall response rate of 36%, and in cohort eight, the preliminary overall response rate is even 50%. HDP-101 demonstrates a strong safety and tolerability profile, and these data further support the therapeutic potential of HDP-101 in heavily pretreated patients with relapsed and/or refractory multiple myeloma. Our second clinical candidate, HDP-102, has recently started a phase I- A/I- B clinical trial in non-Hodgkin lymphoma. The first patient cohort with three patients is completed. The study sites are in the Republic of Moldova, Romania, and Poland. The study is designed to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of HDP-102 in patients with relapsed or refractory B-cell malignancies and to determine the recommended dose for future studies. Already, the data from the first cohort showed promising results. The treatment is well tolerated, and preliminary signs of biological activity have been already observed at the very low dose of 40 micrograms of cohort one. Two patients, though, showed a stable disease with a regression and decrease of lymph nodes. The effect was observed in different indications. The Safety Review committee recommended escalating the dose of HDP-102 to 65 micrograms per kilogram in cohort two. This preliminary data confirms the potential to successfully treat patients across multiple non-Hodgkin lymphoma indications. Knowing the medical need of our patients, it is with sincere regret that we must pause the trial. The patients from cohort one, which are still on treatment, will be treated with HDP-102 as long as there is no progression of the disease. This slide gives you a quick overview of the status of our Amanitin-based pipeline. HDP-101 has completed cohort eight and the ongoing phase I study in multiple myeloma. Cohort nine has already started with a dose of 175 micrograms per kilogram. We expect to establish the recommended phase II dose in 2026 and to start the phase II-A immediately afterwards. As mentioned earlier, the recently initiated clinical trial with the CD37 ATAC, HDP-102, is temporarily on hold. For HDP-103, our ATAC for prostate cancer, we are preparing the documentation for a clinical trial application. HDP-104 is ready for partnering, and we do not plan to do further internal development work on this program. With this update, I would like to thank you for your attention, and I'll now hand you back to the moderator for any questions you may have. Thank you, Andreas. Ladies and gentlemen, at this time, we will begin the Q&A session. You may ask a question using the raise hand icon below the presentation window. We will call on each person and ask you to unmute yourself. You can also ask questions in writing via the Q&A button below the presentation window. I will then read the questions aloud. One moment for the first question, please. Our first question is from Markus Wieprecht. Please unmute your line and go ahead and ask your question. Okay, can you hear me? Yes, I can. Yes, excellent. So yeah, thanks for taking my question, Markus Wieprecht, since recently with Pareto Securities. So I have actually two questions. And first of all, thanks for sharing the good clinical results presented over the weekend in Toronto at the IMS. I think they're quite interesting, you know, early signs of efficacy. And my question here would be, to what extent do these additional clinical data you have now on hand impact your ongoing partnering discussions? Is that anything you consider, you know, beneficial for these discussions, or what's the typical pushback you get in those negotiations? That would be question one. Second question relates, and I'm afraid I have to ask on the timing, on the expected milestone payment now from HealthCare Royalty. I mean, your current cash reach is now guided for mid-2026. How does that align with your best guess of receiving the milestone from HealthCare Royalty? And what's your plan B, maybe, if that does not align properly? That would be the second question. Thank you. I suggest I answer the first question and then hand over to Walter. Of course, Liz, the data was really compelling. Toronto, you received tremendous feedback. We see that the interest is rising in our HDP-101 program. You're probably aware of the pushback for the Blenrep and the outstanding safety data. So seeing no ocular tox is a real differentiating factor for the HDP-101. So we are active in partnering discussions. We continue with the partnering discussion. In simple words, every patient helps. So the people are asking for more patients. There's not a magic number, but they would like to see more patients and deep responses. And we believe it's a gradient. So as the clinical data comes in, the interest will rise, and we are confident for these partnering discussions ongoing. Walter? Yes, when it comes to the second question, when do we expect the payment from the approval of the Telix diagnostic? This is something we can't predict. So it's really something with Telix. And based on our assessment and our specialists, everybody advises to wait until the Type A meeting has happened. And then there is a clear guidance, what are the requirements from the FDA and how the timelines could look like. All other speculation, in a first indication anyhow, Telix mentioned it could take one year. This would be mid of next year. Whether this is true or not, it's not something we will base our financing and our plannings on because we will not depend on such a decision on our planning. And the question would be probably, what are your financing ideas besides expecting, in case of an approval, the EUR 70 million? Besides that, we are in talks. We are in discussions with other third parties evaluating several types of financing, but it's too early to comment on that in more detail. But it's our goal to extend our cash runway from mid-2026 at least until March 2027 to secure the going concern and to have then enough time to rebuild the activities. Our next question is a written question from Thomas Schießler with Aequitas GmbH. And he asks if cohort nine will be the final cohort. Yeah, very good question. My supervisory board is asking me always the same. It's a little bit a crystal ball question. Finally, it's a data-driven one. We have seen that in the cohort eight, very good tolerability. We have not seen any signs of toxicity. So we are very proud. You probably are aware at cohort five, you have seen the thrombocytopenia. That really, with the optimization of the dosing regimen, we can dose now to quite high doses as compared to the early ones. So since we have not seen any signs of grade three, grade four events in this cohort, we believe that that can become even a cohort 10. But again, it's data-driven. As soon as we see two DLTs in two patients, the dose escalation is finished. But the base case is that we believe there will be another cohort. We now have a question from Matthias Kros with Rhein-Neckar-Zeitung. How many employees do you have right now is the first question. And the second question is, are you in talks with Dievini concerning the financing? Walter? Currently, we have around about 115 employees. And as mentioned, we are talking to several third parties. We are also talking to our larger shareholders, what is obvious. I think we are not talking about anything that is not public. If you have two larger shareholders that represent 80% of the shareholding, it would be unexpected not to talk to them and to discuss further financing. So again, besides third parties, we are also talking to our shareholders, for sure. Our next question is from Konrad Leder with F.L. AlphaCap. He asks that in the slides, you did not flag HDP-101 as available for partnering. Why? Then the second question is, can you quantify the cost savings and one-time costs of your cost adjustment measures? I take the first one. It's just that we did not explicitly flag this out because it's not on sale on the street because we are directly talking to interested parties on partnering conferences, on these medical meetings to the big pharma and medium pharma of the world. And these all know that we are very open for partnering of HDP-101. The second part, Walter? Yeah, so when it comes to the cost savings, so currently in our guidance, we have indicated monthly expenses of EUR 3 million-EUR 3.5 million. When the restructuring and focusing is done, we expect that in a phase out over the next six to nine months, so we have the final structure by mid-2026, we will then have a monthly burn between EUR 1 million and EUR 1.5 million. When it comes to restructuring expenses, here it's a little bit uncertain how to, whether you count it as a phase out or whether you count it as a one-off payment, but it will be in a very low single-digit amount, so EUR 1 million probably, or in that region. We have a follow-on question from Thomas Schießler. Do you prefer equity-linked or debt financing? I think in our current situation, it's not a question how the structure looks like. It's more of a question, can we secure a financing? As a CFO, I would always like to see an equity financing because then it's in the bank and you don't have interest and other discussions. As I said, today it's not the time to choose a structure. It's more to secure the financing. He has one other question. Is cohort 10 within the planning as outlined? Simple answer, yes. At this time, we have no open questions. I will hand it back over to you. There's a new one, Laurie. Oh, yep, thank you. Konrad Leder has asked an additional question. Can you give an update on your Huadong partnership? When do you expect them to start phase II for HDP-101 in China? And are they fully committed? I can say they are fully committed. I'm not sure whether we can disclose about the start of phase II. Walter, I'm not sure whether we can disclose this. So what I can say, they are fully committed. We're preparing everything for them starting in China. But Walter, can you disclose more? No, it's really confidential under the licensing agreement. And as Huadong is also a publicly listed company, we can't give advice or comment on their business. But as Andreas Pahl mentioned, we're in preparation to provide the medication and all other things. So it's well underway. Okay. At this time, I feel that I believe there are no other questions. So now I will end it and hand it over to you, Andreas. Yes. I would like to thank everybody for participation and listening to our update. I truly would like to thank all the employees of Heidelberg Pharma for their contribution and passion. It's truly heartbreaking for me to see people have to leave Heidelberg Pharma because it has quite been a journey. We have the clinical data looks really compelling. Unfortunately, we have to take that decision. We face challenging times. As you've seen from the data, we are very excited about the technology. The clinical data looks very promising. We have quite some patients with objective responses. We are highly confident that we will make Heidelberg Pharma a success story even with a reduced team. We are looking very much forward in the future. Thanks, everybody.