Heidelberg Pharma Aktie

Ladies and gentlemen, thank you for standing by. Welcome, and thank you for joining Heidelberg Pharma's conference call to discuss 2025 fiscal year results and provide a business update. [Operator Instructions] Please note that today's call is being recorded. I would now like to turn the call over to Dr. Dongzhou Jeffrey Liu, CEO of Heidelberg Pharma. Please go ahead, Jeffrey.

Thank you, and hello, everyone. Good afternoon, and welcome to the Heidelberg Pharma conference call to discuss our 2025 fiscal year's results and provide a business update. My name is Jeffrey Liu, and I'm the CEO of Heidelberg Pharma. Joining me today on the call is our Chief Financial Officer, Mr. Walter Miller. We look forward to providing you with an update on the company and the progress we have been making. Please note that the presentation today is available for you to download on the Heidelberg Pharma's website. This conference call is being recorded, and a replay will be available after the live event. Please turn to the next slide. Thank you.

But before we begin, I just want to make a note on this. We will be making forward-looking statements during the call and the question-and-answer section. For more detailed information on the risks and uncertainty affecting our business, please refer to our 2025 management report. This was published this morning and is available on our website. With that, let me start. Next slide, please. First of all, let me just touch on some key points from today's talk and also showing on this slide. Heidelberg Pharma is focused on the development of innovative antibody drug conjugate, also called ADC. Based on our proprietary Amanitin payload technology, to our knowledge, we are the only company using Amanitin for drug development for ADC category. We are in the highly promising areas of drug development. I'm excited about this work we are doing.

As you know, I joined the company as CEO in November 2025 last year after serving on the Supervisory Board for several years. It's an honor to lead this company. I visit Ladenburg, German headquarter regularly and working very closely to the team and leading the transformation process. Despite the challenges we all faced in the past year, the team is doing wonderful intelligent work, and it is inspiring to work with them and witness their activity to drive the company moving forward. We currently have about 35 employees, a significant reduction from the approximately 120 employees we had at the end of fiscal year 2025 on November 30, 2025. This decrease is a result of the strategic refocusing measures as we implemented last fall. More on this shortly in the presentation. Our lead clinical program is HDP-101. We will use the international nonproprietary name called parlectaranitin in the future and is currently being evaluated in an ongoing Phase I and Phase IIa clinical trial in patients with relapsed and refractory multiple myelomac.

We are seeing encouraging efficacy and safety data, which we will discuss in more detail later in this presentation. I would like to note a couple of other important points. Heidelberg Pharma already has placed the necessary GMP manufacturer supply chain, which is a critical importance given the complexity of producing this type of ADC compound. We also have a very strong IP portfolio with more than 20 patent families and over 50 family members covered our platform, payloads and the method we use. During today's presentation, Walter will review our financial results and the recent steps we have taken to significantly extend our cash runway, which now extended into mid of 2027. I will discuss the progress we are making with HDP-101 and provide you an outlook on what to expect in the coming months.

Please turn to the next slide, please. You will recall that we had licensed our legacy diagnosis imaging agent, TLX-250CDx, now we call TLS-250PX to Telix Pharmaceuticals. We subsequently monetized part of the potential royalty stream from the agreement with HealthCare Royalty. As part of the agreement with Healthcare Royalty, we were to receive USD 70 million milestone payment upon FDA approval of TLX-250Px and we plan to use this money to fund our ADC pipelines, including the new pipelines. We have expected Telix to receive U.S. FDA marketing approval for this product in August last year. Unfortunately, this didn't happen. Instead, Telix reported that the company had received complete response letter, CRL, identifying deficiency relating to the chemistry manufacturers control CMC package.

The FDA requested additional data to establish comparability between the drug products used in the ZIRCON Phase III clinical trials and the scale-up manufacturing process intended for commercial use. Additionally, the FDA documented notice of deficiency issued to 2/3 party manufacturer and supply chain partners that will require remediation prior to resubmission. So given this unexpected delay in the approval, we need to take quick and major steps to extend our cash runway. Thus, in September 2025 last year, we made a strategic decision to focus our R&D activity on our leading program, which is HDP-101 and significantly reduced operating expense. Next slide, please. In September 2025, we initiated a comprehensive program to focus the company on its most advanced development candidate, HDP-101 and significant scale back or put on hold on other programs, clinical programs and preclinical R&D work.

This decision was difficult, and they impacted many of our colleagues and result in the workforce reduction of approximately 75% by mid of this year. These measures were necessary to continue the development of HDP-101 and extend our cash runway, therefore, ensuring the future of our company. I would like to acknowledge our former employees who dedicate their time and talent to the company helping us go as today. Let me now turn the call over to Walter, who will discuss the expense and the savings resulting from these measures and the recent additional steps we have taken to put the company on a firmer financial footing. He will also review the financials for fiscal year 2025 and provide the financial guidance for 2026. Walter, please.

Thank you, Jeffrey. Turning to the amended agreement with Healthcare Royalty and the participation of Soleus Capital. Earlier this month, we announced a further amendment to the existing royalty purchase agreement with Healthcare Royalty, including the participation of Soleus Capital Management, a U.S.-based life sciences investment firm. The amended agreement covers the partial monetization of Heidelberg Pharma's future royalties on the worldwide sales of Telix imaging diagnostic agent, TLX250-Px. Under the amended agreement, Heidelberg Pharma is eligible to receive USD 20 million from Soleus Capital, subject to customary closing conditions. These conditions have been fulfilled already, and the payment is expected to be received soon. Another payment of USD 25 million will become due upon FDA approval of TLX250-Px.

As a quick reminder, in March 2024, Heidelberg Pharma entered into an agreement with Healthcare Royalty for the sale of royalties on TLX250-Px up to a defined cap, which agreement was amended in March 2025. As part of the recently announced amended agreement, Heidelberg Pharma has agreed to an increased capital royalty stream alongside certain other contractual changes. The participation of Soleus Capital has no impact on the payments from healthcare royalty. It is important to note that the original milestone payment of USD 70 million from HCRx linked to FDA approval in 2025 will now be significantly reduced because approval did not occur within the agreed time lines. Despite the decreased amount for this approval milestone, the structure of the agreement continues to provide attractive nondilutive funding for the company.

The upfront payment from Soleus Capital immediately strengthens our cash position, while the potential future approval milestone payments and royalties on sales will allow us to participate in the long-term success of the product.

Let's turn now to the financial statements for fiscal year 2025, which ended on November 30, 2025. Starting with the P&L. The company reported sales revenue and other income of EUR 6.9 million in fiscal year 2025, a significant decrease year-over-year as expected, given lower revenue from collaboration agreements for the ATAC technology. The figure also includes other income of EUR 5.5 million, mainly comprised of exchange rate gains of EUR 3.2 million, research allowances and government funding of EUR 0.5 million and a milestone payment of EUR 1.4 million recognized in 2025 in connection with the previous sale of a minority stake. Operating expenses, including depreciation and amortization increased considerably to EUR 49 million in 2025 compared to the previous year's amount of EUR 32.6 million.

2025 figure included expenses related to the restructuring measures in the amount of EUR 10.6 million for staff costs, major contracts and asset and inventory write-downs. Cost of sales was EUR 0.3 million and related mainly to expenses for the supply of M18 linkers to licensing partners. Research and development costs rose year-over-year to EUR 38.7 million from EUR 21.8 million in 2024 mainly due to higher costs for the ongoing clinical trial with pamlectabart tismanitin, the initiation of the second clinical trial with HDP-102 and restructuring-related costs, which amounted to EUR 9.6 million. At 79% of operating expenses, R&D remained the largest cost item. Administrative costs were EUR 7.6 million, an increase over the prior year figure of EUR 6.7 million and accounted for 15% of operating expenses. Restructuring expenses in this line item were EUR 1 million.

Other expenses for business development, marketing, commercial market supply activities and all other items, which mainly comprise staff and travel costs increased slightly year-over-year to EUR 2.4 million from EUR 2.3 million in the prior year and made up 5% of operating expenses. Net loss for 2025 was EUR 42.3 million, up significantly from 2024 due to lower sales revenue and significantly higher R&D expenses as well as the restructuring measures initiated. Earnings per share were minus EUR 0.91. Looking at the balance sheet. Noncurrent assets at EUR 9.8 million by end of November 2025 were down considerably compared to the prior year figure of EUR 13.2 million. Other current assets were EUR 13.3 million, down from EUR 18.1 million in the prior year. The 2025 figure included inventory of EUR 10.6 million. Cash totaled EUR 15 million in 2025.

Total assets at the end of the fiscal year amounted to EUR 38.1 million compared to EUR 60.7 million in the previous year. The decrease was mainly due to cash outflows. Turning to liabilities. Noncurrent liabilities totaled EUR 37.8 million compared to EUR 21.8 million for 2024. Most of this amount was attributable to the additional upfront payment of USD 20 million received from Healthcare Royalty in 2025, which also has to be deferred as a financial liability. Looking at current liabilities. Trade payable rose to EUR 7.2 million compared to EUR 5.5 million for the prior year. Due to the strategic refocusing announced in September '25, the company recognized restructuring provisions of EUR 3 million for staff, building vacancies, litigation costs, asset retirement obligations and onerous contracts.

Turning to equity. At the end of the reporting period, equity was negative at EUR 10.9 million compared to positive EUR 30.9 million at the end of '24. Extraordinary charges of EUR 10.6 million were incurred as a result of the restructuring measures and contributed significantly to the year-over-year change in equity. The equity ratio was minus 28.6% versus 50.8% for the prior year. Just a quick look at cash flow for the year. Starting with the financial activities in '25. In March 2025, we amended the existing license agreement with HCRx dated March '24, providing Heidelberg Pharma with an immediate payment of USD 20 million, which translates in a cash inflow of EUR 18.4 million. As a reminder, we waived a sales-based milestone payment of USD 15 million and the FDA approval milestone for TLX250-Px was reduced from USD 75 million to USD 70 million with further significant reductions if FDA approval occurs after 2025.

You see our use of cash as well as cash proceeds from financing activities. Average monthly cash used was EUR 1.2 million. The most important point on this slide is at the bottom. The payment we expect to receive in April from Soleus Capital extends our cash reach into mid-2027. Let's now look forward to the guidance for 2026. We expect sales revenue and other income of between EUR 11 million and EUR 15 million in 2026, mainly related to milestone payments and supply delivery to partners. With the strategic focus we started last fall, we expect to significantly reduce operating expenses to between EUR 25 million and EUR 29 million. Cash outflow is expected to be between EUR 0 million and EUR 4 million in total, resulting in a monthly cash outflow of between EUR 0 million and EUR 0.3 million.

With careful management of our costs and the cash inflow from Soleus Capital, we expect to have sufficient funds for ongoing operations until mid-2027. Let me now turn the call back to Jeffrey, who will provide an update on our R&D activities, focusing on HDP-101. Jeffrey, please.

Thank you, Walter. Yes, let me give you the next couple of slides for the R&D update, particularly focused on the HDP-101, our most important projects. As you can see from this slide, give you a very quick refresher on HDP-101. This -- we have an official name we call pamlectabart tismanitin, which is being developed for the treatment of multiple myeloma type of blood cancers. The global incidence of multiple myeloma is approximately 180,000 globally, and the disease remains associated with a high mortality rate. HDP-101 target BCMA, a surface antigen that's highly expressed on myeloma cells. The antibody components bind specifically to BCMA and delivers amanitin payload directly into the cancer cells, where it inhibits RNA polymers to and ultimately induced cell death.

Our ongoing Phase I/IIa clinical trial is evaluating HDP-101 in patients with relapsed or refractory multiple myeloma, whose disease has progressed on multiple lines on therapy and who have very limited treatment option. The study is designed to evaluate the safety, tolerability, pharmacokinetics and the preliminary efficacy of HDP-101 in this patient population. The Phase I called the dose escalation study is ongoing. 10 cohorts so far, we complete almost patient enrollment. We have seen encouraging safety as well as early efficacy signals. The latest available results from Cohort 8 were presented in November 2025 at the World ADC Conference and discussed during the website -- webcast we held around that event. Please turn to the next slide, please. So let me just briefly highlight the preliminary efficacy data result from the Cohort 8.

We were truly excited to report that of the 8 patients treated in this cohort, which is 140 microgram per kilo dose, 2 experienced complete response. 2 other patients experienced a partial response. 1 experienced stable disease and 2 progressed. One patient was not evaluable. Consider this patient disease had progressed following multiple lines of therapy, these results are particularly compelling and encouraging. Please turn to the next slide. Thank you. This slide summarizes objective response rate for the higher dose cohort 5 through 8 in the ongoing Phase I trial. Look at these 4 cohorts together from Cohort 5 to Cohort 8, we saw an objective response rate of 38 with 11 out of 29 patients responding to the treatment, including 3 stringent complete remission. In Cohort 8 alone, we are seeing a preliminary objective response rate of 57%, with 4 out of 7 evaluable patients responding, including, as noted in the previous slide, 2 stringent complete response.

While the results from the Cohort 8 are still preliminary, they provide encouraging evidence that HDP-101 has meaningful antitumor activities even in heavily pretreated patients, demonstrating promising dose-dependent anticancer activity with deep clinical response. Please turn on the safety next slide. So, this slide focus on the safety measures in the clinical trials. From the safety perspective, HDP-101 has shown a favorable tolerability profile across all dose levels tested so far, including the most recent Cohort 9. The Cohort 9 dose was found to be safe and tolerable, and the evaluation of the efficacy is ongoing. Up to Cohort 9, the MTD maximum tolerable dose has still not yet reached. Across all 9 cohorts, we have observed no sign of ocular toxicity, no infusion reaction, no extensive myelosuppression and no liver damage.

A transient reduction in platelet counts, which is also called thermbocytopenia was seen in some of the cohort's trials. But this effect was manageable and has been mitigated through adjusted dosing regimen strategy. In addition, there's no evidence of reversible toxicity in patients receiving treatment so far for more than 12 months. All patients had relapsed refractory myeloma and were heavily pretreated and have exhausted all available treatment options. So that is the data we delivered based on this huge history treatment patients. The safety data from Cohort 9 has supported moving to the next cohort at a dose of 218 microgram per kilo. Enrollment in cohort is now underway. Once the optimal dose has been identified in the Phase I clinical trial, the trial will be moved into the Phase IIa dose expansion stage to test this dose in a large patient population.

We expect to move into the dose expansion study in Q2 and Q3 of this year. Let's now take a look at the overall pipeline. Next slide, please. So, our focus will remain on HDP-101 for the treatment of multiple myeloma. We expect to complete this Phase I part of the ongoing trial still in the first half of this year and will bring the recommended Phase II dose in the second half of this year, hopefully in Q3. I also wanted to note that the recently announced our partner, [indiscernible] Medicine has initiated a Phase I bridging study in China. The trial will evaluate the safety, tolerability, pharmacokinetics and efficacy of HDP-101 in Chinese patients with plasma cell disorder, including multiple myeloma. The bridging study is being conducted to ensure that the safety and efficacy data of ATAC technology-based ADC is comparable across diverse population and is an important requirement for advancing the development of this product globally, including the testing in Asian population.

Our other development programs are available for partnering for HDP-101 or HDP-102, for non-Hodgkin's lymphoma, we have put recruitment for ongoing Phase I study on hold, but are continue to treat the 1 patient still enrolled in the trial. With clinical HDP-103 right now, the status for the treatment of advanced prostate cancer, we are preparing the study application for the Phase I clinical trial. However, we are not developed this program further on ourselves. HDP-104 for colorectal cancer will not be developed further internally. Turning to our partner program, starting with our partner with Takeda. As you remember, in 2017, we signed exclusivity research agreement with Takeda related to several targets for joint development ADC using Amanitin. Under the term of agreement, Heidelberg Pharma produced several ATACs using antibodies from Takeda proprietary portfolios.

As a result of this work, Takeda acquired an exclusive license in 2022 to commercially develop an ATAC with an undisclosed target. Takeda is responsible for further preclinical and clinical development as well as a potential commercialization of the licensed product candidate. In January of this year, we announced receipt of the milestone payment with the dosing of the first patient in the Phase I/II clinical trial in patients with solid tumor. We are excited to see the progress of our partner, Takeda, is making and looking forward to this program advancing to clinical further development. Look at Telix. In 2017, we out-licensed our legacy asset, the diagnosis antibody girentuximab or now called TL250-Px to the Australian company, Telix Pharmaceuticals. As discussed earlier, Telix received a complete response letter for the biological license application or BLA for TL-250Px this summer.

In the press release reporting 2025, we announced the results published in February, Telix indicated that based on the 2 Type A meeting, with FDA. Telix believes that it has aligned with the agency on key outstanding issues for the BLA resubmission, including the demonstration of drug product comparability between the clinical trial materials and the scale up commercial production. Telix said it was completing the agreed deliverables and the documentation required for the resubmission. Our license agreement with Telix also covered the development of therapeutic radioimmunoconjugation program, also called TLX250-Tx. Telix recently reported that they received regulatory approval to start the global Phase II and III trials in the metastatic clear cell renal carcinoma. In addition, a Phase Ib and II investigator-initiated trial, IIT, is exploring TLX250-Tx in combination with other therapies in the same indication.

So let me wrap up on next slide, please. In 2025, we certainly had a major setback with Telix CRL that forced us to make difficult decisions about our business strategy. At the same time, we are seeing highly promising early results with our leading program, HDP-101 and expect to move this into Phase IIa in the Q2, Q3 of this year. We have taken further steps to put the company on a firmer financial footing and are excited to report further clinical progress in the months ahead. We are in a truly dynamic space in biotech. The ADC market is expected to grow to USD 32 billion in 2033. Most importantly, our work holds the promise of helping patients with today have limited treatment option.

Next slide, please. So, with that I would like to thank you for all your attention and your continued interest support in Heidelberg Pharma. We will now open the call to your questions. Operator?

[Operator Instructions] So the first question is, when will there be an update on cohorts 9 and 10? And in what format? Will you present it at a conference in the future?

Yes. Let me answer that question. Thank you for that question. Very good. I know a lot of our investors, analysts or even the ADC world industry, also including academia, like to know what's new, what's update and particularly the higher dose Cohort 9 and cohort 10. This is 175 microgram per kilo and 218 microgram per kilo. So, this is the 2 dose we're right now testing in the in the clinical Phase I trials. So, as I can share with you that today, the trial is ongoing. And all the signal regarding safety and efficacy is measurable and in a good way to moving forward. And we hope to get particularly the cohort 10, this is higher 218 microgram per kilo. And we're going to bring this initial safety and efficacy data to the safety review committee early April and need their assessment and see whether we can report this data in the coming months conference.

But we do plan to present this a particle cohort 9 and 10 clinical results at the later years of this conference globally. So, thank you for this one. We'll keep you updated as soon as we release the data outside. Thank you.

Next question is, when will you be able to say whether there is an 11th cohort?

I'm sorry, higher cohort?

Yes. At what time will you be able to say if there is going to be a cohort 11 or if you already have the dose for Phase II?

Okay. Yes. Good question. Because this trial is ongoing, what I can share with you is, first of all, the safety is manageable. And the MTD maximum tolerability dose is not reached yet. And we do the data evaluation because they give us some time on the Cohort 10, particular to 18 dose. That takes time to measure the efficacy signal, what is the overall response because we enrolled so far up to 5 to 6 patients in this cohort. So, we need a little more time to assess the efficacy data readout. But I can share the principle we're looking at is whether we do cohort 11 or not because that's not decided yet. We're going to bring this to the SRC committee early April, but we do have internal discussion as well. Well for our consideration, we want to see, first of all, is this safe enough is the MTD dose, is it almost there or the particular efficacy.

Even though we have a very limited patient number in each cohort, what I want to see the measures is the efficacy data of Cohort 8, 9, 10. Is it going to continue to go up, improve the efficacy reading out or is it [indiscernible]? So, what I can share with you, we are almost close to the end of Phase Ia study. And we are trying everything we can to move to Phase IIa dose expansion study with relative what we call the recommended Phase II dose moving forward. So that is information I can share with you, but we are not have a decision on Cohort 11 for the time being. Thank you.

Next question is, is your dual role of CEO of Heidelberg Pharma and also as CSO of Huadong Medicine, a sustainable long-term solution? And how do you split your time between the 2 companies?

Okay. Good question. It's a hard question. But we are in the same pharma industry. We are in the same category. Huadong also have ADC and Heidelberg is an ADC-focused biotech. And Huadong 5 years ago, invested Heidelberg Pharma is because ATAC technology. We're really thinking amanitin based ADC can provide some very unique solution to the unmet medical needs. Particularly right now, there's a lot of top inhibitor and very limited choice to choose the payload. And amanitin gave us the opportunity to provide additional payload mechanism to kill the cancers. So, I think that is -- we have the same missions on ADC conjugation drug. And we have a lot of synergy between these 2 companies and particular the ADC teams.

So I'm also working all the early days and working with both teams and particularly, they started some new initiative collaborating together for some projects. So particular 101, 103 right now is Huadong already have the China right. So 101 in China already started. The first patient in March 17 already started. So, we keep very close working together both teams on this program in China because they can provide additional valuable clinical outcome result in addition to MRCT right now running by -- sponsored by Heidelberg Pharma. So, in terms of my timing, I spend as much as 10 probably every day working with the Heidelberg Pharma team online or virtual or on site. I'd be in the Heidelberg office almost every month, stay here, at least I cannot give a precise how many days, but at least a really decent number of days to stay in Heidelberg office.

So I'm [indiscernible] if I need more frequently come here, there's no problem. So right now, there's a lot of virtuous working environment. So I'm really confident moving forward, we're going to be bringing this particular the ADC collaboration, if we do have a collaboration program together more close together. And so hopefully answer your question.

There's a follow-up question on that. What are your main responsibilities at Heidelberg Pharma? Do you represent the company in the capital markets, biotech conferences and actively negotiate out-licensing agreements? Are you primarily responsible for clinical development internally?

Yes. Good question, too. As [indiscernible] growing the responsibilities, my something that not something I already did that is a full profile as a senior management and the CEO for the company, take all the opportunity to broadcasting, promoting our program or project or asset or technology platform globally, find a partner. For me, I'm thinking particularly in this CEO position, my major working, not on R&D, a very strong background on R&D perspective, there's no question. But in the last almost 10 years, I serve another biotech President early 2019 for 1 year, take care of entire business for the biotech. And come to Huadong, we have -- right now have almost 100 ongoing projects and invented inside almost 50.

So, I also take some responsibility to bring this compound outside to find a partner to the licensing BD deals. So I'm very active attending JPMorgan for the last 5 years. And come to the Heidelberg Pharma business role as the CEO and a leader of this company, I'm thinking every day, not only R&D perspective, clinical trials and new pipeline setters. I'm also thinking how we can earn the money, how we can save the money, how we can raise the money. The 3 answers is a key for me to lead the company, working with the colleagues, working with Heidelberg Pharma teams change around and move back to a growing path for the next couple of years. So I'm fully aware of these needs and also like to be launch that. We already did that. This year, JPMorgan, we bring several potential collaborations.

Right now, we are talking with them. So that's, if there's one word to use is I'm fully responsible for all business aspect. And of course, there's our CFO have their expertise on the financial part. But I'm [indiscernible] as well. So I do want to work with the team to get a better financial supporting and outlook for the future. Thank you.

Next question is, can you provide an update on the cash burn rate? Does the guidance for the fiscal year already include anticipated milestones? Should Huadong HDP Phase II commence? And can you provide an indication of the size of this potential milestone?

Yes. Maybe this is a question more for me as the CFO. As we presented now the guidance in the last minutes, I think this is almost answered. Here, what I can indicate for our cash reach until mid-'27, the EUR 20 million are included, what is probably obvious. We also have reflected in that cash reach already the milestones received from Takeda as well as from Huadong earlier this year. Further upcoming milestones from collaborations are not considered so far. So our planning is very conservative, either we have it contracted or we have a very solid and confident base to take that into our planning. So therefore, further upcoming milestones are really generating additional upside for the company also for our flexibility.

Next question is, can you update us with management ownership, including any options outstanding? And what plans are there for the executives to add to any existing equity ownership?

As you know from the annual report, we have several stock option plans in place going back into 2016. The philosophy of the company is always to have all the employees participating in the upside of the company. So therefore, these are very broad stock option plans. The last issue of stock option was back in 2023. Currently, we are in talks to issue another tranche to all the remaining employees, including the management and executive management. This will be something that we will execute already this year. Overall, the participation is between 3% and 5% of the total share capital.

Next question is, can you share your thoughts on the planned Phase II study design with HDP-101 monotherapy also regards to the 17p deletion post-BCMA setting and on collaboration for that, also study scope and cost and when you expect that there will be interim readouts available?

Okay. I think that's -- I'd like to answer that question. Very good question. Right now, it's time to think about moving forward for the further clinical development for HDP-101. So the clinical Phase IIa, which we call the expansion study is on the agenda. And also, we already prepared for the last couple of months, how we designed the study, how we finalize the protocol, how to get this clinical site PI selected and initiated. So as I can share with you, the Phase IIa is well designed. It's very good. We discussed this Phase IIa study with FDA years ago. And then we get aligned also very supportive from FDA gave us the use of 1 dose if you can call that recommended Phase II dose to conduct the expansion study that they are acceptable. So that is the regulatory communication so far.

We go that direction. We're going to use 1 recommended Phase II dose so far collected and moved to the Phase IIa study. So right now, we are very close to finalize that. And then that's number one. Number two, for this trial, we're going to conduct in 30 multiple myeloma patients. And we carefully designed what kind of patient recruitment -- requirement needed. And of course, naive patients or pretreated with BCMA therapy is also under consideration. We want to have both of them in the trial. This is the current consideration. And then the third, you asked about the cost because we already have this very good learning from Phase Ia study and the performance of each clinical site, the PI collaboration and also include the CROs collaboration.

So they're going to be more efficient in terms of the team effort, expertise effort and the resources and budget use for these trials. So from my perspective, I'm very confident that we're going to run this Phase IIa study pretty soon and then use the best knowledge, best management and the most important, best cost-efficient method moving forward. And I cannot tell you when the readout, but this is 30 patients with a large number of patient enrollment. We do want to have a lot of biomarkers collected as much as possible. You mentioned the P17 deletions. We're collecting that data as much as we can. But this is really a POC concept testing. We want to reproduce what has been observed so far at Cohort 8, that is more than 50% overall response. That's very promising result. And Cohort 9 right now is ongoing and cohort 10 ongoing.

So I hope that the data generated from the Phase I, we can reproduce at the Phase II or even better statistic meaningful outcome. So with that being said, I hope by mid of next year, we're going to have some initial data on this one, hopefully if not top line, but we're trying our best to first recruit the patient in and enroll them in and then get the dose and have the first couple of months initial data. And we're going to keep outside world informed because we also are expecting these results to come out and then as same as you. So that's my answer to you, and stay tuned. I think we're going to announce the first patient in for the Phase IIa study if that's ready and everything go right direction. Thank you.

Now we have questions on the Phase I combination therapy of HDP-101. So what would be prerequisites for that study? Is there already evidence of a synergistic effect? And would you be conducting this with a strategic partner? And do you expect it to be accelerated based on promising data?

Very good question. Right now, the cancer therapy is -- it doesn't matter what the mortality come from is chemotherapy, TCE, CAR-T, ADC or [indiscernible]. So I think come to very recent trend is combination therapy together. So that is how the cancer therapy go direction. So come back to 101, we think about this is automatic going to have some combination therapy in the late stage, for example, Phase IIb something initial testing. But right now, for Heidelberg Pharma, we want to focus -- finish Phase Ia first. We get the testing of the safety and efficacy signal and conclude the study as quick as possible. And then based on this assumption of result, we move to Phase IIa monotherapy to testing the recommended Phase II dose in a relatively large quantity of patients 30 and see whether we can reproduce the Phase I particular cohort 8, 9, 10 efficacy data, so meaningful and et cetera.

So this is our focus now. And talking about the partner with Huadong, because they use -- they already have knowledge of our progress of the Phase I data. They know what the roughly safety dose and what the recommended 140 looks a very good dose. They started with 140, but they're going to go to 175 eventually. So they have a very quick bridging study in China. And then they I cannot give you too much on that information, but they do have very good comprehensive clinical development program moving forward in China territory as a design. So thank you for that suggestion. Combo therapy definitely is ADC, not only for 101, entire world thinking what is the strategy use on combination therapy for cancer treatment, particular really right now, we go that direction. There's too many mortality available. They have their individual streams, but put them together, they definitely provide a lot of solutions for unmet medical needs, particular cancer -- tough cancer treatment.

So yes, we -- as we're collecting more data, more efficacy signal and also as the progress with China partner [indiscernible] Medicines program -- progress in China, we're going to have more thinking of combination therapy as well. Thank you.

Next question is on the currently resting programs. Would they only be continued after a partnering deal? Or would they also be financed by Heidelberg Pharma if enough funds would be available in the future?

So I'm sorry, which program are we talking about?

The current investing programs, so 102.

Our Remaining, well, as you know, 102 due to the [finance] situation last year, if we do have the Telix payment, we're going to move very fast on the 102 clinical trial. So that one, unfortunately, we have to put this recruitment further on hold. We have 3 patients in the Cohort 1, lower dose. So that is the situation for 102. We're open for partnering for this one. This is CD37 ADC, not only the managing payloads and novel, but CD37 also relative novelty as well because this -- when you look at all the approval ADC, there are no CD37 as TA as ADC target. So we are open to have more partnering talk to us. We do have in the 3 patients, the data we can share with them. This is a Phase I asset. So that one, I cannot disclose further because this is not in the ready to disclose yet, but we're open to discuss all potential collaborator and actively looking for that outside out-licensing.

And for the 103, we have China right [indiscernible] to give to Huadong Medicine. So they also conduct some internal study, particularly in some reproducing the efficacy data in the animal models. They're working on it. And then if this data is pretty good, they're going to start the Phase I in China for 103. But meanwhile, BCMA-ATAC [indiscernible] is a unique opportunity for us to demonstrate for this prostate cancer, very high demanding a lot of medical needs, even though they have other TCE dual target TCE engagers in the development. But I still think ATAC can provide unique opportunity for this very high needed also high mortality rate, particularly in the Western world for this indication.

So for this one, we're definitely open to partner and -- but the most important for 103 to have some initial clinical data. I think that's more convincing, more value. But as you know, we are preparing the IND documentation package. So it means that this asset is ready to conduct clinical trials. So we have [indiscernible], we have toxicologies. We have preclinical animal DMPK pharmacology study ready. So -- so that is the stage we are on. But we're open to all potential collaboration come to us, and we're very actively looking for partner for these 2 assets.

And with this, we come to the end of our Q&A session. Please send any further questions you may have to the IR department of Heidelberg Pharma. And with this, I would like to conclude the conference call.

Great. Thank you so much.

Thank you, everyone for joining.

Hi, and very welcome, everybody, who joined our webinar today. My name is Andras Strassz. I'm the Chief Medical Officer of Heidelberg Pharma. And today, we want to share with you some exciting new news about our clinical development. As you might know, we are developing [indiscernible] asset, which has recently achieved a point and I think you will learn today about this new data in our clinical program.

But first things first, on top of that, again, I'm thanking all of you who have joined this session. What is Heidelberg Pharma and what is our technology? Those who might not know that we are developing a new mode of action and novel ADCs and these ADCs has shown already really positive signs in the clinical, which means that it leads to definitely responses in a couple of myeloma -- in a few myeloma patients. But what is new about this ADC that this ADC has a new payload. And as of today, we are the single developer of this new type of ADCs and which is protected with our patent families.

And we know that the payload makes the difference in ADCs. So if you change the ADC payload, if you optimize the ADC payload, you can achieve a wonderful results as we did in our clinical studies. On top of the new mode of action, which I will tell you a little bit more today, this ADC has a premise that it's specifically active on [ 7 typically ] patient population. As you know, this is a general issue in oncology, not just in multiple myeloma, but also in other solid tumors and hematological malignancies.

But today, we will talk specifically about our lead compound, our flagship compound, which is the HDP-101. And what is HDP-101, is an ADC, which is designed by us. And the backbone antibody is targeted to BCMA. The B-cell maturation antigen, which is a well-known target in myeloma, which has superb results in other treatment mobilities, including ADCs, CAR-T cells and bispecific molecules.

But what we did, we attached a new molecule and molecule, which was never before used in the clinic, which is Amanitin. And Amanitin is coming from the nature. It's come from the [indiscernible] mushroom and it's a well-known toxin in the nature. But so far, nobody was able to exploit this drug -- as a drug in clinic.

What is completely new that the target of this payload. The target is the inhibition of RNA polymerase II. And RNA polymerase II is an essential cell cycle independent element, which is a eucretic function, it produces mRNA. And if we shut down RNA polymerase II, the cells cannot produce synthesized proteins and goes to apoptosis. Why I'm saying this is cell cycle independent. It has nothing to do with cell division. And therefore, this type of ADCs can kill dormant tumor cells, which is not true for other currently on the market or in development ADCs, which are using more like chemotherapy, classical chemotherapy, origin payloads.

And because if it's a new mode of action, its circumstances -- and the currently known resistance mechanism and we can produce this payload synthetically. And we attach it to the ADC, because it's so powerful, we keep the drug antibody ratio exactly by 2, because we know that the rate limiting is really for each and every cycling, the rate limiting is the amount of RNA polymers II in the cells.

so much about the introduction. And now I hand over this presentation to Professor Raab, who is one of our principal investigators and who was contributing a lot to this development and still contributing a lot to this development. But I think he's more capable to explain you and put into perspective our clinical results. After his talk, I will also give a short summary on our current achievements and development. But I think we should hear first Professor Raab's interpretation of our clinical data.

Good morning or good afternoon. I'm Marc Raab from the Heidelberg Myeloma Center and I'm happy to share the most updated data on the development of HDP-101 in multiple myeloma. Multiple myeloma is a bone marrow microenvironment disease originating from plasma cells that has around 180,000 patients currently worldwide and most of them still actually succumb to the disease at the end. The current tremendous progress in therapy and therapeutic options, namely with the T-cell redirecting therapies like bispecifics and CAR-T cells, are still considered not curative for almost all patients. So even the most advanced standard of care options largely lack curative potential.

Furthermore, those just mentioned treatment options, the most advanced ones like T-cell redirecting therapies, are largely bound to large experienced centers like academic hospitals or huge specialized centers. For example, however, in the U.S. almost 85% of all patients are treated in a community setting like office-based physicians or small community centers. So in this regard, HDP-101 and ADCs in general address a high unmet need for this patient population. So briefly, what is HDP-101? It's an anti-BCMA antibody directed, as I said, against BCMA, a surface antigen on myeloma cells. And it has a payload with Alpha-Amanitin, which constitutes a toxin that is single first-in-class and has no known other resistance mechanism so far and the mechanism action is unique.

ADCs in general are very suitable for administration in community hospitals, in outpatient settings and, for example, as well in patients who relapse after T-cell redirecting therapies. Other myeloma patient populations that are difficult to treat in general, even with T cell reducting therapies, are high-risk cytogenetic, high-risk myeloma in general, older age with comorbidities and frailty indexes, rapid progression, requiring off-the-shelf options, so not feasible for CAR-T cell therapy, for example, and as I mentioned, the broad availability and simple logistics in many parts of the world, even in advanced countries like U.S. or Europe.

So ADCs in general and very specifically HDP-101 offer very convenient dosing regimens and safety aspects compared to the bispecifics and CAR-T cells. As I said, outpatient administration is very feasible for this class of agents. The off-the-shelf availability is much better than especially for CAR-T cell therapy. Non T cell approach is also, again, needed after the last exploration of the T cell redirecting their periodic approaches. And of course, the great opportunity to combine with the standard of care drugs and combination regimens is absolutely paramount in multiple myeloma as has been shown for many decades now with several combination regimens very successfully advancing therapies.

And very specifically for HDP-101, there seems to be no ocular toxicity, which is very different from other ADCs, especially one ADC that is already approved, but with limited use, because of the side effects. So as we have published previously, HDP-101 is able to overcome quite some resistance mechanisms in multiple myeloma.

So you can see on the left graph here, it is well able to address and to kill efficiently resting nondividing myeloma cells which is actually, especially in the remission setting and after induction therapy, for example, probably the most important population of myeloma cells in the patient, finally leading later to relapse.

As well, it is very efficiently able to kill myeloma patient cells that are derived from myeloma patients who were resistant refractory to existing standard of care combinations. And it was also able to kill patient cells with very low expression of the target antigen on the surface, which is also important, because some T cell redirecting therapies might lead to some down-regulation on the surface of the antigen. So this is important to know.

So the HDP-101 Phase I/II trial that is currently ongoing has, of course, the objective to explore safety, tolerability and to find the MTD and the RP2D doses. Up to now, we have solid data up to a Cohort 7, as you can see. In Cohort 6, we introduced a dosing regimen optimization strategy, which I will allude to a little bit later. And the key eligibility criteria, as you can see here, were that those patients had to have exposure to standard of care drugs that are available for multiple myeloma and largely did not have any other promising and efficacious alternative available.

So far in the dose Cohorts 5 to 7 with the relevant doses between 90 and 112 mg per kg, you see with the green and red bars here in the swimmers plot, you see that we see already quite some remission, quite some durable remissions also in patients, again, in this very heavily pre-treated patient population with a patient here, for example, in the 100 mg per kilogram dose, reaching a complete remission, lasting more than 2 years. In other patients in this advanced patient population, achieving a partial response that is also durable for more than a year in some patients.

So let me quickly introduce you to this patient -- to Cohort 5, as I alluded already in the previous slide, too. It was a 70-year-old lady, that already had the diagnosis of multiple myeloma in 2002. So up to enrollment, she had 9 prior lines of therapy. So basically, everything that was available, including BCMA CAR-T cell therapy and the GPRC5D bispecific antibody and iberdomide new CELMoDs class in combination with Dex, which she had immediately prior to enrollment. So almost all available therapies and all promising efficacious therapies have been applied in this patient.

So in 2023, she was enrolled in HDP-101 -- in the HDP-101 trial, achieved a PR on partial remission already after 2 cycles. And by end of the first year, a stringent complete remission could be confirmed. Overall, the treatment was very well tolerated, mild adverse events. No keratopathies or no eye tox, no-liver damage or lung toxicities were found and no real toxicities were reported. There was only one transient thrombocytopenia in the first cycle, which recovered quickly.

So actually in the same cohorts of the Cohort 5, but we found a channel phenomenon, obviously, that most patients had a very transient but quickly onsetting dip, so to say, in the platelets, so thrombocytopenia, around day 5. So this is days, not weeks, which recovered quickly in a few days later. However, that reached grade 3 or 4 toxicity level. And we had one patient with some short-term transaminase elevation in the first week after exposure.

So that led to a strategy in Cohort 6, with adjusting the dosing regimen in 3 different ways: one with premedication; another so in RMB, so to say, with a weekly dosing instead of the Q3 weekly dosing; and RMC, a third regimen for dose optimization where we split the first dose only to once weekly, so day 1 and 2 and 8. And then after that, resume 3 weekly dosing thereafter. And that was set up to explore whether the thrombocytopenia, the early dip in platelets and maybe the liver enzyme elevation, which we saw in one patient only could be mitigated to using those regimens.

And as you can see here, on the right side, Cohort 7, Cohort 5, you have seen this graph as a comparison before. Cohort 7, as you can see here, we didn't see any of the platelet dips in the early days after a first administration anymore, both in the weekly dosing as well as in the split dose for the first dose only and then the Q3 weekly -- Q3 dosing -- Q3 weekly dosing after it. So this adjustment in dosing regimen, which is actually a minor adjustment, if you have a split on the first dose and give some premedication successfully mitigated this thrombocytopenia phenomenon, we saw in Cohort 5, even in a higher dose. And very importantly, of course, it did not affect efficacy.

You see that the Cohort 6 with the split dosing and dose adjusted regimens. 90 mg per kg, but also in the higher Cohort, the Cohort 7 that I just showed you, we continue to see responses despite having no split doses or Q weekly dosing in place. So that led us to focus in the Cohort 8 now in only 2 different scheduling regimens or dosing regimens. So one with a -- with a Q1 dosing and one with a split dose in the first dose only entry medication to be taken further in exploration.

And the cycle Cohort 8 with 140, so still in dose escalation, 140 mg per kg. Now, and this is very up-to-date data as of 2 weeks ago, basically, we saw that we see in 4 out of those 7 patients, early responses, as you can see here in green, the partial responses and even early on in the first 3 cycles, 2 patients already achieved a stringent complete remission. So very rapid responses in the majority of patients, again, in a very heavily pretreated patient population that was basically devoid of other options -- therapeutic options available.

And I would say, equally important to the great response rates that we seem to see in this cohort. There doesn't seem to be the platelet drop, the thrombocytopenia in the first few days to occur, as you can see here on the early data graphs here now on the platelets, some minor dips, but that recovered quickly and does not reach really like high-grade thrombocytopenia. Similar to the liver elevations -- liver enzyme elevations, we see in one patient a very minor slight elevation for a few days, but that is then mitigated later on and no higher grade liver enzyme elevations in terms of liver toxicity or something like this can be detected even in the 140 mg per kg dosing schedule.

Overall, in terms of side effects, you see that if you concentrate on grade 3, 4 side effects across all cohorts so far, you see overall relatively few high-grade 3-4 toxicities, and those were mainly hematological in nature, mainly, of course, with thrombocytopenia as expected, that's what I have shown you just in that previous slides. And some anemia, which of course, very common as well in heavily pretreated patients, like myeloma fourth, fifth, sixth line.

More importantly, although longer follow-up is here, certainly needed in Cohort 8 with 140 mg per kg dosing to the highest dosing so far, we didn't have any Grade 3, 4 side effects so far. So no early high-grade toxicity at all being found in this highest dose cohort with it, as I showed you, dosing regimen adjusted to split dosing. Importantly, again, no ocular or renal toxicity has been found so far and the dip in platelets has been mitigated by the adjusted dosing regimen.

Also, interestingly and importantly, for those patients who have exceeded 12 months of therapy, we do not see any cumulative or delayed toxicity. So it's not going to have a long-term cumulative effect in terms of thrombocytopenia or any other damage we can see. No toxicity seems to occur so far.

Again, summarizing across all cohorts response rates. So all cohorts taken together so far, we have a 38 overall response rate with a few patients reaching even complete remissions and very promising the highest Cohort now, the Cohort 8, with 140 mg per kg. We see 4 out of 7 patients with 57% of the patients responding and almost 30% or 2 out of 7 reaching a CR within the first 3 cycles. So clearly exceeding what we have ever seen with any ADC in myeloma in the single-agent advanced patient population setting.

So let me summarize the unique features of HDP-101 and what those features might have in terms of potential benefits for patients. So as I have shown you, HDP-101 is highly effective against non-proliferating dormant myeloma cells, is highly effective against myeloma cells that have very low BCMA expression on the surface. It carries a novel mechanism of action with the Alpha-Amanitin to which all patients will be naive -- treatment naive. It has so far a very favorable safety profile, especially now after split dosing in the first cycle. And therefore, it's very prone to be very active and easy to combine with other standard of care therapies, which, as I said, has been very important in myeloma in the history so far of drug development.

So all that might lead to really strong deep and long-lasting tumor responses, overcoming resistance acquired by previous lines of therapy. And therefore, especially in combination, leading to a best-in-class efficacy and tolerability profile in multiple myeloma, not only in the relapsed/refractory setting, but also in early relapses or potentially, of course, even in frontline later on in combination therapy. And this is all especially true if you compare it to already available ADCs in multiple myeloma that are now on the market and their specific features.

With this, I thank you for your attention, and I'm happy to take questions.

[Operator Instructions] So the first question is the presentation on the 8th Cohort shows that the responding patients are not from the post-BCMA population. Current plans target approval for use specifically in the post-BCMA patient population. However, the current data while admittedly very preliminary, do not appear particularly promising on this. Could you comment on that, please?

Yes. Thank you so much. First of all, I thank Professor Raab for this really excellent summary. And before I answer this specific question, I will also ask you to -- there is still time to ask your questions. So please do not hesitate to post your question into the webinar. We will try to address most of them.

So regarding the specific questions, yes, our study currently is not limited to post-BCMA or preceding naive patients. We accept for the dose escalation, we accept both patient population. And it is true that for the monotherapy development, we will pursue most likely the post-BCMA field, but we're still considering and not considering actually planning to develop this drug in BCMA naive patient population in earlier lines of treatment in the combination treatment.

So generating data in both population is important for us. And because we don't control, so we cannot control that how many patients we will have who has BCMA naive or post-BCMA in a particular cohort, it's just really as the patients are getting into the study. But still, in the BCMA naive patient population in the last cohort, I think 4 responders in such a small cohort is quite substantial, especially if you compare to the early results from other ADCs. This is really something that is outstanding and it gives us confidence to further develop this drug as a monotherapeutic agent in -- particularly in both BCMA naive and post-BCMA setting.

Next question, please.

Is it correct that fast track status is generally applicable and does not refer specifically to a post-BCMA patient population?

Yes, this is correct. So we got the fast track designation just recently. And this does not specify the BCMA status. It is written as a fourth line plus patients who received the majority of the currently available myeloma treatment, not including BCMA-directed drugs.

Next question is to what extent should or could the positioning of HDP-101 and study planning be considered? Is it an option to aim directly for the third line of treatment and position HDP-101 as the first choice BCMA therapy? Would this significantly change the scope or schedule of the study?

This doesn't -- has a change or any impact on the current scope of the ongoing Phase I dose escalation, first-in-human study. But however, we already have, and I will demonstrate you after our Q&A session, I have some slides on our current development plan. And this development plan includes development in a post-BCMA field and also development in BCMA naive earlier lines, which is particularly second line of treatment. So those who have not received any prior BCMA drug.

And we also -- because of the 17p deletion, sorry, I briefly mentioned in the beginning of our presentation, we also developing -- also plan to develop this drug in the high-risk patient population where we know that the number of 17p deleted patients are higher.

Next question is currently, as far as I can see, the 17p deletion population is no longer being mentioned to any great extent. Do you have any 17p deletion patients in the ongoing Phase I? And are you planning to integrate this patient cohort into clinical trial planning?

Yes. So currently, we do have 70 patients with 17p deletion. And as you know, that the definition that with 17p deletion has recently has been updated. So as our original plan, we still would like to enroll and further test all of our patients for 17p deletion with a [indiscernible] tumor biopsy.

And -- but to report anything meaningful for that, we need a larger cohort of patients. And that's why we plan only to report this data after the Phase IIa part of the study is completed, and we want to do a subgroup analysis on, if possible, a subgroup analysis on this particular patient population in the Phase III setup. And as I said, we also plan to have studies, specifically studies, maybe already pivotal studies in the high-risk myeloma population, which we all know is quite there, we all -- that we see quite often 17p patients.

Do we have any further questions?

Yes. So how many of the patients that were not reaching the stringent complete response status in the former cohorts have died shortly after stopping treatment?

As of today, we have not released this data, but as of today, it's a definition of what it's short. So as of today, we have no knowledge on any patients who passed away quickly after stopping the studies. Obviously, we're following up each and every patient for survival data. But again, this data will be reported at the end of the study, then we have more or more robust and more larger set of patients.

[Operator Instructions] So next question is Alpha-Amanitin payload on HDP-101 eventually will be released into the system after the affected cells go into apoptosis. As such, it is expected that it will be cleared in the liver and cause some hepatotoxicity. Is there a hypothesis why are there no liver associated side effects?

Yes. Excellent question. So yes, the assumption is right that Alpha-Amanitin after it does its job and kills the myeloma cell, it is released into the circulation. But as of today, if you saw our previous report and posters and presentations, we continuously reported that we have not measured free, we were not able to measure free payload. We measure actually 3 different kind of free payloads variants, but we're not able to measure any of them or then we were able to measure the amount of these payloads were really minimal. And which means that the free payload concentration even after the cycling is so minimal that it's not -- could not cause a significant liver damage to a human body.

As you all know that -- or you might know that liver is really the only target organ for the fee payload, because only the liver cells has the specific transporter to pick up Alpha-Amanitin. But as I just said, the Alpha-Amanitin half-life is so short that it's washed away from the circulation really fast and goes to the [indiscernible] to that.

Next question is how many patients are in Cohort 9? How many of them are post-BCMA and how many show a 17p deletion?

Yes. Thank you so much. Unfortunately, because cohort 9 is still ongoing. We are not able to release any data as of today on Cohort 9. Stay tuned. We will release as soon as possible. We will release data on Cohort 9, hopefully really soon.

Next question is by -- is the complete response patient in the fifth cohort no longer on treatment?

The patient experience after 2 years of treatment, the patient was in 2 years in the study. After 2 years of treatment the patient was -- has shown signs of disease progression and was taken off study.

Next question, P53 has also been implicated in Amanitin mechanism and efficacy. Is this a consideration you will have in your clinical trial design?

I think I already answered this question. This is the P53 is the 17p deletion story. So we rule specifically into the 17p deletion patient. And yes, we consider this in our current trial design and further trial designs as well.

Okay. Currently, there are no further questions. So with this, I would like to hand back to Andras.

Thank you. Okay. Thank you so much for the excellent question. But still, if you have -- if you want to ask questions, please do not hesitate, maybe end of my session. And my conclusion is we can still have some time if there are any further questions coming in. So on top of -- but Professor Raab said, I just want to really highlight the key take-home messages on our today's session and recent announcement in our clinical development. So I really want to -- to focus on the last cohort. So what is the take-home message. This is the highest cohort and the highest dose that we tested. It's 140 micrograms per kilogram.

And having said that, just a reminder that this drug is really potent. So we are in the microgram range and not in the milligram range in other ADC, it's just to keep in mind, because of the different mode of action. This is a highly potent drug. And this has also -- has been demonstrated as expected in our clinical trial. So we enrolled 8 patients in this cohort from which 7 is a evaluable patient. And from this 7, we already sold 4 patients who responded to the drug.

And -- and what was a really important change from the previous quarter. As you remember, as Professor Raab showed you that in the previous cohort, in the lower dose cohorts, those responses were not coming really quickly. So we see a partial response in a couple of cycles and then it deepened maybe into a more deeper response.

But now we already saw patients presenting VGPR after cycle one and which was deepened in stringent complex remission after a couple of cycles. And most of the -- and again, please remember, this is preliminary data. So the study is still ongoing. These patients are still ongoing. So don't draw the conclusion that the duration of response is short because these patients are still ongoing. And you know that we had a patient on a significantly lower dose who was treated for 2 years with a really good and massive duration of response for this patient.

But this is efficacy. So efficacy results in our perspective are really excellent, outstanding, and we are really happy to share this information with you. But how about the safety? Because I think this is, again, a focus on this last cohort. You see the lack of Grade 3 and 4 side effects of any of the patients, especially in the first couple of cycles. And again, as Professor Raab said, please focus on the lack of ocular toxicity. As you might know that other ADCs, especially monomethyl auristatin-based ADCs are known to have ocular toxicity or known to have caused really strong myelosuppression, not just thrombocytopenia. I'm talking about real myelosuppression, which is lymphopenias, neutropenia, this is a common side effect for these other toxin-based ADCs.

This is what you don't see with Amanitin. This is really because of the different mode of action, because the different mode of action ensures that the free payload does not harm the surrounding, does not harm any other cells, not capable to harm any other cells, just deliver cells, as we mentioned previously, be that who has the specific update. But as we demonstrated and as I answered in the question and answers, the free payload is washed away really quickly from the circulation.

So in summarizing, compared -- I do know BCMA is a crowded market. We know that BCMA -- a lots of drugs are available in the BCMA, CAR-Ts, bispecifics, other ADCs. All of them are excellent drugs. They are capable to induce really deep and durable responses for many of the patients, but some of them comes with costs. Obviously, CAR-Ts are not really suitable to apply in the outpatients. I think this is a highly complex treatment. Bispecifics are linked with cytokine release syndrome, also the patient has to undergo more surveillance.

And as mentioned here, the T cell exhaustion and the exhaustion of the CAR-Ts and the nature and our own T cells are a problem with this drugs. Other ADCs are more like off-the-shelf and the outpatient settings and the importance of the outpatient setting is that majority of the patients are still in outpatients, starting also in the U.S. and in Europe. So this is a broad applicability for ADC is clear in that -- for that particular reason.

And don't forget, the hallmark or the key to each and every patient treatment, especially earlier lines treatment is the combination. And if we are able to develop a drug which has this really light safety profile that we presented in the last cohort, this opens up tremendous opportunity to combine with other drugs, which means that we don't have and we don't expect to see any kind of synergistic side effect with other drugs.

And because as Professor Raab just demonstrated, we had this transient thrombocytopenia, but we managed to keep it in the way with this new treatment modalities with the premedication and the discrete dosing in the first cycle. So having said that, where are we going with this drug? And this is really important. And I think I already highlighted in the question and answer session. Obviously, one of the lowest hanging fruit for us is the post-BCMA. Currently, this patient has really limited treatment option. And this is one of our key strategies to establish this drug as a monotherapy in a late-line setting in a post-BCMA field.

Why do we think that this is feasible? First of all, we already had not one patients who showed the response despite they were treated with BCMA drugs prior especially that showcase patient that Professor Raab presented to you that patients particularly had received a CAR-T cell treatment and the BCMA and achieved only the VGPR on the CAR-T treatment. And after that, after a certain post, was put in our clinical trial and the patient was stringent complete remission for 2 years in our clinical trial, which I think it's a beautiful story and the patient was as the PI said to us was really happy with the drug. And currently, just recently was diagnosed with disease progression after 2 years of treatment.

So post-BCMA field is obviously one of our lowest hanging fruit but because of the broad capability with combination, we would like to develop this drug in combination treatment as well. And one of the approach is to go in a kind of second, third line treatment with combine this drug be it with immunomodulatory drug dexamethasone or other combinations are also possible. But this is similar to the DREAMM 8 study, for example, or similar to the DREAMM 7 study, which was recently approved in Europe and also partially in U.S. from the GSK really good data presented with this combination. So obviously, this is something that we can -- that we want to target as well.

But we also do not forget the third pillar, which is the high-risk patient population. We biologically expect to see, and this was demonstrated nonclinically in several papers. I know that you more likely knew this data, that this drug should be more effective on patients who harbor the 17p dilution. And this is something that you see quite often in the high-risk patient population. However, addressing this is a kind of rare mutation, which means that 10% of the newly diagnosed patient shows, I think, it's not at the top of my head, the most recent result. But is enriched in the later lines. So in later setups, you see more patients of this.

So addressing this, if we can demonstrate in our clinical trials that we have an increased efficacy or enhanced efficacy in this particular patient population, then we definitely will develop this drug also as a third pillar in the high-risk setup, either as a newly diagnosed [indiscernible] or as a relapse refractory drug, of course, is also required, especially the newly diagnosed that this is done in the combination setting.

So regarding time lines. So currently, we have the Phase I dose escalation and the Phase II expansion, early expansion ongoing. We plan to finalize the study in the next fiscal year. And after that, when we have the results ready, we would like to initiate the already announced single agent trial -- pivotal single agent trial and which is capable to -- or has the premise or the potential to apply for an accelerated approval.

So converting this accelerated approval you need in a Phase III trial and we already plan to do this Phase III trial in an earlier lines of treatment, be the combination treatment. Of course, this needs to have as a prerequisite, a combination safety study, which we can do in the next couple of years. And then we can convert the accelerated or conditional approval to full approval already with the combination treatment and addressing 2 huge markets on the myeloma field, as you can see. And we can also, as a life cycle management on the later development, we would like to also explore other combination, other lines of treatment.

And nevertheless, and at the end, we would like to address the high-risk patient population also in the newly diagnosed and in the relapse setting. So this Amanitin ADCs apex as we call them, they really show these responses. And don't forget, currently, the dose escalation is ongoing. So we have not reached MTD yet. We are seeking to reach this MTD as soon as possible. But that's why we highlighted this last cohort, because we think that this is clearly below the maximum tolerated dose. We haven't seen any Grade 3/4 acute toxicity for this patient population.

But we have really provided clinical evidence that Amanitin works as a platform, Amanitin works and has a therapeutic window because we have responders on a dose level where you don't see toxicities -- uncurable toxicities, but you see responses developing in this patient. It has a really good safety profile.

One of our investigators told me recently that the patients were really happy with this drug. This is one of the most mildest drug ever because they don't have -- they don't suffer -- most of the patient which we saw this thrombocytopenia, they don't feel anything. So they are not feeling sick. They are not losing hair. They are not feeling nausea, fatigue, or any kind of really typical or cytokine release syndrome or any itches, rashes, nothing. So there is no ocular toxicity, no real renal toxicity. Myelosuppression is really just limited to this thrombocytopenia, but there is no real myelosuppression in the terms of eliminating precursor cells or stem cells.

And we don't have -- and on the tested doses, we don't have definitive liver damage. We do see elevations of liver function tests, but those are not fulfilling the criteria of definitive liver damage and those left findings are just transient. And this is really demonstrating that it can overcome resistance, overcome resistance from prior BCMA targeted drugs or overcome resistance to other prior multiple myeloma drugs.

So all of our patients who are in the study are heavily pre-treated. This is a last resort type of trial. So whoever we enrolled in that study has really limited treatment option in the particular countries, which includes U.S. and Germany. There are quite a few really powerful drugs are available. And we are still able to achieve really good responses in this really heavily treated designation.

I know it's already spoiled in the questions, but I'm happy to announce that we just received the fast track designation from FDA recently. Why -- to put it into perspective, why it's important? This is important because it's an external validation. So the U.S. FDA validated our clinical results and granted us the faster designation, which opens up for us more opportunities when we talk about later lines of development of this drug.

And I just can echo myself that we have not reached the MTD yet. We hope that we can reach it soon. And this drug has a really good therapeutic potential and we expect to have the recommended Phase II dose early 2026. So in the -- so to say, in the upcoming month, so stay tuned for the next results.

But looking a little bit broader and behind that. But obviously, we were talking about only myeloma patients. But these clinical results are really have an outlook on other similar ADCs because HDP-101 is not our single molecule. We already have HDP-102 in the clinic. We tested the first dose cohort, and that those cohort was without [ DRT ] and in CD37 positive non-Hodgkin lymphoma.

We also have a prostate cancer program, which can be developed targeting PSMA, which is also a quite high unmet medical need for those patients to develop a mild drug as maybe similar in my drug as HDP-101 further really not so easy patient population as per [indiscernible] cancer, who are really elderly and frail for that. And we have a portfolio, including many other drugs like gastric and colorectal cancer drug. And also, we have a few collaboration with other persons like Takeda.

With that, I will conclude my summary, and I'm looking to the question and answer, and I ask our colleagues do we have any further questions?

Yes. We got a couple of more questions. So first one is, why did treatment get stopped for the successfully responding patients if there were no harmful side effects and they did not die? Wouldn't progression be a reason to increase the successful treatment instead of just stopping it?

We -- most of the patients who respond to the drug are treated until disease progression, or there are some cases there, and this is individual decisions that patients make the selection not to continue a clinical trial. But this is something that we cannot control, but majority of the patients are treated until disease progression.

And can you give an update on how you think about out-licensing or partnering HDP-101? What data or the derisking of HDP-101 would you need to show to qualify for an attractive deal? And when do you consider is a good timing for partnering?

Really excellent question. I will redirect discussion to our business development expert. I'm not really the expert. I am the clinical expert in the community, and we will get back to you with the answer.

Next question is, can you provide an estimate on the cost for the planned clinical trials? Do you have sufficient resources to conduct all planned clinical trials in parallel? Or would you need to prioritize?

As you might already know from the recent announcement that we had to prioritize some tasks. But what I can assure you that the HDP-101 clinical trial is our utmost priority to complete this study, which would enable us also to do the next steps and create the financial means for the next steps of development.

When do you expect your Chinese partner Huadong to start its registered HDP-101 Phase II in China? Which data is Huadong looking for before making that decision?

Thank you so much. I can't share the details, but really soon. So preparations are ongoing.

There are no further questions at this time.

Thank you so much. And having said that, thank you all for participating in this excellent webinar. Thank you, especially for your questions. Thank you, Professor Raab, for the excellent summary. And please stay tuned and look forward for our next release. I think we all agree that this data is really demonstrating that the HDP-101 development is progressing in the right direction. And hopefully, we can give you more updates on cohort -- on the ongoing Cohort 9 soon and with the development.

And with that, I conclude this webinar.

Ladies and gentlemen, thank you for standing by. Welcome, and thank you for joining Heidelberg Pharma's conference call to discuss today's news. [Operator Instructions] Please note that today's call is being recorded. [Operator Instructions]

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 the 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 will recall that Heidelberg Pharma monetized the potential royalty streams from TLX250-CDx, the imaging agent that we out-licensed to Telix Pharmaceuticals in 2017. Under this royalty agreement, we were to receive a USD 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 Telix 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 Telix first BLA submission in summer 2024 had been rejected by the FDA, this was due to questions on the Chemistry, Manufacturing, and Controls or CMC, and not related to the efficacy and safety data. These issues were subsequently addressed by Telix 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, Telix 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 build 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 USD 45 million. In addition, we are eligible to receive up to USD 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 Telix last month, the milestone required to receive the USD 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, Telix received a CRL from the FDA. In its related press release and conference call, Telix provided some 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.

Telix outlined 3 specific areas noted by the agency. Deficiencies related to CMC, particularly the complexity of commercial manufacturing. Insufficient demonstration of comparability between the product used in the successful Phase III ZIRCON trial and the intended commercial-scale product. Form 483s, which are deficiency notices issued to 2 third-party manufacturing partners, which must be remedied before resubmission.

Telix has indicated it believes the issues are readily addressable and it's beginning submission remediation immediately. Telix will request a Type A meeting with the FDA as soon as possible and we 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 the following measures today. The clinical development of HDP-101, our leading ATAC candidate that is currently in the Phase I/IIa trial in multiple myeloma will be continued as planned. After the recommended Phase II dose has been established, we plan to conduct a Phase IIa 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 prepare 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. Debt 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, over the brake 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 a 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, 8 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 microgram per kilogram.

As you can see on the slide, in Cohort 6, 90 microgram per kilogram, 2 out of 10 patients showed partial response. One patient is still ongoing with a partial response after 18 treatment cycles. In Cohort 5 at 100 microgram, 2 patients had partial responses, and 1 stringent complete response. And this stringent complete response is lasting 22 months up to date. And this was out of 6 patients.

In Cohort 7 at 112.5 microgram per kilogram, 2 patients out of 6 had a partial response.

In Cohort 8, dosed at 140 microgram per kilogram, preliminary data shows 2 patients with a partial response and 1 patient with a very good partial response out of 6 evaluable patients.

Altogether in Cohort 5 to 8, we have seen an overall response rate of 36%. And in Cohort 8, the preliminary overall response rate is even 50%. HDP-101 demonstrates a strong safety and tolerability profile, and this 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 the Phase Ia/Ib clinical trial in non-Hodgkin lymphoma. The first patient cohort with 3 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 microgram of Cohort 1. Two patients 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 microgram per kilogram in Cohort 2. 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 1, 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 on the status of our Amanitin-based pipeline. HDP-101 has completed Cohort 8 in the ongoing Phase I study in multiple myeloma. Cohort 9 has already started with a dose of 175 microgram per kilogram. We expect to establish the recommended Phase II dose in 2026 and to start the Phase IIa 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.

[Operator Instructions] Our first question is from Marcus Wieprecht.

Can you hear me?

Yes.

Excellent. Marcus 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 are quite interesting 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 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-'26. 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.

I suggest I answer the first question and then I hand over to Walter. Of course, these -- the data was really compelling. Toronto, we 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 discussions. 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 the 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 time lines could look like. All other speculation in the first indication anyhow, Telix mentioned it could take 1 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 planning because we do not depend on such a decision on our planning.

So -- and the question would be probably what are your financing ideas besides expecting in case of an approval, the $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-'26, at least until March '27 to secure the going concern and to have then enough time to rebuild the activities.

Our next question is a written question from Thomas Schießle with EQUI.TS GmbH. And he asks if Cohort 9 will be the final cohort.

Yes. Very good question. My Supervisory Board is asking me always the same. It's a little bit a glass ball question. And finally, it's a data-driven one. We have seen that -- in the Cohort 8, a very good tolerability. We have not seen any signs of toxicity. So we are very proud. We probably are aware, Cohort 5, we 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 3, Grade 4 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 2 DLTs in 2 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 2 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 Lieder with FL AlphaCap. He asked that in the slides, you did not flag HDP-101 as available for partnering. Why? And then the second question is, can you quantify the cost savings and onetime costs of your cost adjustment measures?

I think the first one. It's just that we've 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 pharmas and medium pharmas of the world. And it's -- these all know that we are very open for partnering of HDP-101. The second part, Walter?

Yes. So when it comes to the cost savings. So currently, in our guidance, we have indicated monthly expenses of EUR 3 million to EUR 3.5 million. When the restructuring and focusing is done, we expect that in a phase out over the next 6 to 9 months, so we have the final structure by mid of '26. We will then have a monthly burn between EUR 1 million and EUR 1.5 million. And when it comes to restructuring expenses, it's a little bit uncertain what -- 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.

Have a follow-on question from Thomas. 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 a question, can we secure a financing. And 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. But as I said, today, it's not the time to choose a structure. It's more to secure the financing.

And he has one other question. Is Cohort 10 within the planning as outlined?

Simple answer, yes.

At this time, we have no open questions. So I will hand it back over to you, Andreas.

There's a new one, Lori.

Yes. Konrad Lieder 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. 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 confidentially under the licensing agreement. And as Huadong is also a publicly listed company, we can't give advice or comment their business. But as Andreas Pahl mentioned, we are in preparation to provide the medication and all other things. So it's well underway.

At this time, I feel that -- I believe there are no other questions. So now I will end 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. And 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. But unfortunately, we have to take the decision. We face challenging times. But 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, and we are highly confident that we will make Heidelberg Pharma a success story even with a reduced team.

So we are looking very much forward in the future. Thanks everybody.