Heidelberg Pharma AG (HPHA) Earnings Call Transcript & Summary

Ladies and gentlemen, thank you for standing by. Welcome, and thank you for joining Heidelberg Pharma's conference call to discuss 2024 fiscal year results and provide a business update. [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 welcome to the Heidelberg Pharma conference call to discuss our 2024 fiscal year results and provide a business update. My name is Andreas Pahl, and I'm the CEO of the company. Joining me on the call today is CFO, Walter Miller. 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. Before we start, 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. For a more detailed information on the risks and uncertainties affecting our business, please refer to our 2024 management report. It was published last Friday and is available on our website. On the call today, we will give you a brief corporate overview and outline key achievements. We will also provide an update on our programs. This will be followed by a review of our financials and an outlook for the year. Following our prepared remarks, we will have a question-and-answer session. Slide 3 gives you a snapshot of our company and highlights in general and in particular, over the last months. Heidelberg Pharma is a biopharmaceutical company focused on oncology. We have more than 110 employees and the company is listed in the prime standard on the Frankfurt Stock Exchange. Our lead program, HDP-101, is currently being tested in a clinical Phase I/IIa study in the indication multiple myeloma. And we are developing ADC technologies with different payloads, but the focus is on the toxin Amanitin. Our scientists established a complete GMP manufacturing supply chain. This is an essential achievement for our business as the product and antibody drug conjugate is highly complex and in our case, the synthesis consists of more than 14 chemical process steps. To our knowledge, we are the only company that develops Amanitin as a toxin. Therefore, we have been able to build a very strong IP portfolio at all levels. According to our current planning and taking into account payments from healthcare royalties, we are fully financed until 2027. What are the main part of our R&D work? We have focused on the toxin Amanitin over the last decade and expanded our technologies, our ADC technologies in 2023. Our goal is the development of an ADC tool box and the clinical product pipeline to overcome tumor resistance across cancer types. Let's begin with our proprietary Amanitin-based technology called ATAC technology. Heidelberg Pharma has extensive experience with the compound Amanitin and to the best of our knowledge, we are the first company to use it to develop new cancer treatments. There is another mechanism of action, the inhibition of RNA polymerase 2, which results in program cell death or apoptosis. It also offers the potential of breaking through drug resistance and destroying tumor cells, which could result in significant clinical advances. Beyond Amanitin, we started to work on Exatecan-based ADCs. The payload Exatecan is a topoisomerase or TOPO 1 inhibitor. It is a proven compound for cancer therapy, which is closely related to the payload used in already approved ADCs. The scientific team selected a lead candidate from this platform, which has been developed at HDP-201 to a preclinical development stage. HDP-201 targets GCC that is expressed on the surface of intestinal cells and cancer cells in various gastrointestinal tumors. The third pillar of our technology are toll-like receptors, 7 agonists. This immunostimulatory technology platform was developed in collaboration with Binghamton University in the U.S. The resulting immunostimulating ADCs have the potential to harness the patient's own immune system by making the tumor visible to the immune system to thus attack and eliminate malignancies. These immune stimulatory agents could be synergistic with cytotoxic agents, including ADCs generated by Heidelberg Pharma's ATAC technology. These ADC platforms, including different payloads and antibodies will lead to multiple development candidates with different modes of action. The next 2 slides will provide you with an overview of our pipeline, including our proprietary portfolio of candidates, our partner programs and our legacy assets. Our proprietary pipeline consists of 4 projects using Amanitin as a payload and different indication. The lead program is HDP-101 that is currently being tested in multiple myeloma. I will give you more details later. The new project HDP-201 uses Exatecan as an active compound. For all ATAC projects, the global rights, excluding China, are with us. Huadong, our Chinese partner has a license for HDP-101 and 103 and an option for HDP-104 all for China. Huadong used to have an option on the HDP-102 project for the same territory as well, but has not executed it due to internal strategic reasons. The rights for the Exatecan project belong to us, but we are open for partnering. This slide shows our partnered programs. The partnership with Takeda Oncology is still ongoing. In 2017, we signed an exclusive research agreement with Takeda related to several targets for joint development of ADCs using Amanitin. Under the terms of the agreement, Heidelberg Pharma produced several ATACs using antibodies from Takeda's proprietary portfolio. As a result of this work, Takeda acquired an exclusive license in September 2022 to commercially develop an ATAC with a selected target. Takeda is responsible for further preclinical and clinical development as well as potential commercialization of the licensed product candidate. The project is on track, and we expect a progress update in the second half of 2025. Looking at our legacy assets. As a reminder, a few years ago, we out-licensed several clinical product candidates that are no longer part of our core business of ADCs. These are being developed solely by licensing partners and Heidelberg Pharma is eligible to receive development milestone payments as well as royalties on sales for any of the programs that make it to the market. Indeed, the following positive Phase III results, our licensing partner, Telix submitted a biologics license application for TLX250-CDx for the identification of clear cell renal cell carcinoma, which is essentially the basis for the royalty purchase agreement with [Healthcare] Royalty. We will go into more detail about this project later. Now we come to the R&D update, starting with our ATAC technology and proprietary projects. Let me start with our lead program, HDP-101, in multiple myeloma, a type of blood cancer. As a brief reminder, HDP-101 consists of an anti-BCMA antibody, a specific linker and the toxin Amanitin. BCMA is a service protein highly expressed in multiple myeloma cells and to which BCMA antibodies specifically bind. Just a few words on the indication multiple myeloma. Multiple myeloma is a type of blood cancer that develops from plasma cells in the bone marrow and can affect more than one part of the body. Plasma cells are a type of blood cell that makes antibodies to fight infection created by bone marrow. In myeloma, the bone marrow makes a lot of abnormal plasma cells. Worldwide incidence of multiple myelomas currently, more than 180,000 people with a mortality of 120,000. The study with HDP-101 is the first in human Phase I/IIa clinical trial. We treat patients with relapse and/or refractory multiple myeloma and study centers in the U.S. and Europe. The study is designed to assess the safety, tolerability, pharmacokinetics and the efficacy of HDP-101. The Phase I part of this trial is a dose-escalating study, and the goal is the identification of the recombinant Phase II dose and to determine the safety and tolerability. To evaluate this, we are treating 2 to 6 patients in each cohort with an increasing dose of HDP-101. First, promising efficacy signals have been seen. In the Phase IIa part, a larger number of patients will be treated with the optimal dose RP2D. I'm very pleased to show you first efficacy data from our Phase I clinical trial. The swimmer plot graph shows on the left in different cohorts and the dosing. On the bottom, you see the treatment duration in days. Let me comment on 3 remarkable preliminary results. One patient from cohort 3 was over 400 days on treatment with a stable disease. Over a long period, we couldn't see any accumulated toxicity or severe side effects. In Cohort 5, we see a 50% objective response rate, 3 out of 6 patients profited from the treatment by having a partial remission and 1 patient turned out to have a complete response. The complete responder is a U.S.-based female patient suffering from multiple myeloma since 2002. We received 9 prior lines of therapy. She's still undergoing treatment and feels very well. She is active and her quality of life has improved considerably as a result of the treatment. And the fact is that we can no longer detect any tumor cells in this patient at that dosage level in the Phase I trial is extremely encouraging for us. We believe this confirms our view that this therapeutic approach is effective and that HDP-101 has promising potential as a treatment of -- for patients with multiple myeloma. You will remember that in the fifth cohort of the administration of the first dose of HDP-101, which was 100-microgram per kilogram. All patients experienced a drop in the thrombocyte count, which completely normalized without further intervention after a few days and was clinically and remarkable. In order to mitigate the effect of the initial administration of an adjustment on optimization of the medication regimen was developed based on the recommendations of the Safety Review Committee. Therefore, cohort 6 consisted out of 3 arms but different dosing regimens. Patients in Arm A were treated with a single dose of HDP-101 on day 1 of each 21-day cycle following a premedication. Patients in Arm B received a weekly dose of HDP-101. The dose was split with patients being administered drug proportionately on days 1, 8 and 15 of each cycle. Arm C received a partial dose of HDP-101 on days 1 and 8 of the first cycle and then a single dose on day 1 of each of the following 21-day cycles. The dose was lowered to 90-microgram per kilogram with the aim of minimizing the risk to the patients in these 3 arms. HDP-101 was well tolerated across all 10 patients in Cohort 6 with no dose-limiting toxicities detected in any of the 3 parallel treatment arms. The patient recruitment of Cohort 7 is complete, and patients are under treatment with an escalated dose of more than 100-microgram per kilogram. The highest dose trial period in 2 arms, it's different with the dosing. One arm includes additional premedication. HDP-101 is well tolerated in this cohort as well. And this is -- there is still no evidence of any dose-limiting toxicity. We expect to have the seventh cohort completed soon. Subsequently, the Safety Review Committee will meet and discuss the outcomings. We don't think that we already have reached the MTD, the maximum tolerated dose of HDP-101. Our expectations are that the Cohort 8 with a further escalated dose will be conducted. We plan to present the new clinical data at the EHA Congress, an important meeting of the European Hematology Association that will take place in Milan in the mid of June. Let me summarize on this slide, the interim data from our ongoing study. In the sixth cohort, 10 patients have been treated. There were no signs of dose-limiting toxicities. All 3 dose treatment strategies had a positive effect on the transient thrombocytopenia. We saw responses at the dose of 90-microgram per kilogram, but the treatment and assessments are still ongoing. The seventh cohort was opened in December. All patients have completed the DLT observation periods and some are still under treatment. We now have currently treated 34 patients. The treatment with HDP-101 was very well tolerated the drug showed favorable safety and demonstrated efficacy with this already mentioned 1 complete remission in 1 patient. This is a promising outcome so far, and we are looking forward to gaining more data. Let's take a look at the next ATAC candidate. HDP-102 is an ATAC targeting CD37 that is overexpressed on B-cell and lymphoma cells. Heidelberg Pharma is planning to develop HDP-102 for non-Hodgkin lymphoma. Non-Hodgkin lymphoma, NHL in short, is one of the more common types of cancer with the worldwide incidence of more than 550,000 and the mortality of more than 250,000 cases per year. In preclinical trials, this development was shown to have a very large therapeutic window. Our clinical team has prepared the data picture for the clinical trial application submitted in selected European countries. We already have received the regulatory approval to conduct the clinical trial from the authorities in Moldavia and Israel inclusion and doing of the first patient is expected in the next few weeks. The study design of the first in human clinical trial with HDP-102 can be seen on this slide. We plan to conduct a multicenter, multinational open-label Phase Ia/Ib trial. In the Phase Ia part, up to 32 patients with relapsed or refractory B-cell malignancy will be treated to elevate the safety, tolerability, pharmacokinetics and the pharmacodynamics of this ATAC. The goal of the Phase Ia is to find the optimal and safe starting dose for the phase Ib part. The second part is the dose expansion study, including up to 15 patients. Our other ATAC product candidate coming along is HDP-103, which we plan to develop for the treatment of metastatic castration-resistant prostate cancer. The antibody used to bind to PSMA. PSMA, a surface antigen that is overexpressed on prostate cancer cells. This is a promising target for the ATAC technology because PSMA shows only a very limited expression in normal tissue. In vitro and in vivo efficacy, colorability and pharmacokinetic studies have shown that HDP-103 has a promising therapeutic window. There's also a very high prevalence, 60% of the 17 PD lesion in metastatic castration-resistant prostate cancer. The increased sensitivity of prostate cancer cells with the 17 PD lesion has already been preclinically validated. As we have previously reported, tumor cells with the 17 PD lesion are particularly sensitive to Amanitin. So PSMA ATACs might be particularly suitable for the treatment or treatment metastatic castration-resistant prostate cancer. The necessary preclinical and toxicological strategies with HDP-103 have been completed. A clinical trial to investigate tolerability and efficacy is currently being planned. The clinical team has begun preparations for the study protocol. We plan to submit a clinical trial application for HDP-103 to the regular authorities in the second half of 2025. Now I would like to hand over to my colleague, Walter.

Thank you, Andreas. Turning to our out-licensed clinical legacy assets. In 2017, we out-licensed diagnostic antibody girentuximab or TLX250-CDx to the Australian company, Telix Pharmaceuticals. The license agreement also converted the development of therapeutic radioimmune conjugate program. Positive top line data from the Phase III ZIRCON study on PET imaging for diagnosing kidney cancer were published in November 2022. The TLX250-CDx was granted a rolling review and breakthrough classification which allows for a phase submission and review of the required modules according to a pre-agreed schedule with the FDA. The BLA submission in the U.S. was completed in June 2024. FDA had not accepted the BLA at that time because of deficiency in the area of manufacturing, CMC has been identified. The new application was submitted at the end of December 2024. On 26th of February '25, good news was shared by Telix. The FDA had accepted the BLA for TLX250-CDx, granted a priority review and provided a Prescription Drug User Fee Act date, the so-called PDUFA date of 27th of August 2025. This means that the authority will make a decision or an approval by end of August this year. According to Telix, they expect the potential market launch in the second half of this year. In parallel to progressing the approval process, Telix has been carrying out a global early access program, so-called [ELP], since December '23 to provide patients with preapproval continuous access to TLX250-CDx for the detection of CCRCC. Patients are routinely dosed in the EU, the U.S. and Australia. We are excited by the progress and the commitment of Telix in advancing this program and bringing it to the market to help patients. As mentioned earlier, we have sold a portion of our future royalties from the worldwide sales of TLX250-CDx to Healthcare Royalty in March '24 and amended the agreement recently. In the lower part of the slide, you see some basic information about kidney cancer. Let us now come to the financial results. You might remember the transaction with Healthcare Royalty on royalties from the global sales that we signed in March '24. This year in March, we concluded an amendment to that agreement. On this slide, the amended terms are highlighted in [bold]. A USD 25 million upfront payment was already received in March '24, therefore, with no change on that. We originally agreed on a sales-related milestone payment in the amount of USD 15 million. This milestone would have been difficult to achieve due to the delay of the potential market launch of TLX250-CDx. Therefore, it was eliminated and converted into a payment of USD 20 million upon signature of this amendment. This happened already earlier this month. Furthermore, the USD 75 million payment upon FDA approval of TLX250-CDx was reduced to USD 70 million with further reductions if FDA approval occurs after the end of 2025. And last, the second year of the 2-tier escalating cap on cumulative royalties, so to HR has increased. When the escalating cap has been reached, royalty payments will return to Heidelberg Pharma and HCRx will receive a low single-digit royalty tail percentage thereof. If the fixed amount of the first year is reached in the defined time period, this condition will not materialize. Based on the agreement with HCRx and expected incremental payments of, in total, USD 90 million this year to Heidelberg Pharma, the company anticipates an extended cash runway into 2027. The advantages of the agreement with HCRx are obvious. It's an attractive non-dilutive financing opportunity already extends our cash reach. The approval payment of USD 70 million reduces the risk of market uptake. And finally, the defined cap for the royalty stream secures participation in mid- and long-term upside. Turning now to financial cash flow and balance sheet. Looking at financing cash flow. The financing cash flow improved from an outflow of EUR 10.1 million in the previous year. to an inflow of EUR 22.8 million in '24. This significantly higher figure is due to the HCRx transaction in March '24, while the previous year's result was dominated by EUR 10 million in loan repayments to our main shareholder. Let's take a deeper look at the balance sheet. Noncurrent assets were EUR 13.2 million as of end of November '24 compared to EUR 13.7 million in '23. Current assets decreased from EUR 56.6 million in the previous year to EUR 47.6 million this year. Cash included in this item amounted to EUR 29.4 million and was down on the prior year figure of EUR 43.4 million due to outflows for the business and loan repayments. Other current assets increased to EUR 18.1 million compared to the previous year figure of EUR 13.3 million. Inventories included in this figure rose from EUR 10.5 million to EUR 11.8 million, while other receivables grew from EUR 1.3 million to EUR 5.7 million. Total assets at the end of the fiscal year amounted to EUR 60.7 million in the previous year, EUR 70.4 million. This decrease was mainly due to outflow of cash. Turning to liabilities. The new balance sheet item of noncurrent financial liabilities of EUR 21.8 million is attributable to the upfront payment from HCRx which is initially being recognized less transaction costs. Therefore, our noncurrent financial liabilities increased significantly from EUR 1.2 million in the previous year to EUR 21.9 million. Current liabilities fell to EUR 8 million at the close of the reporting period compared to EUR 19.8 million at the close of the prior year. EUR 5 million thereof were for the loan repayment and EUR 3.7 million were accrued revenues from the license with Huadong. Equity at the end of the reporting period was EUR 30.9 million compared to EUR 49.3 million as of November 30, '23. The equity ratio was 50.8% at year-end '23 compared to end of '24 compared to EUR 27.1 million at year end '23. This slide shows our profit and loss statement for fiscal year '24. As a reminder, our fiscal year ends on November 30. Starting with sales revenue and other income. The Heidelberg Pharma Group generated sales revenue and other income totaling EUR 12 million in fiscal year '24 compared to EUR 16.8 million for '23. Breaking that down, we generated sales revenue of EUR 6.9 million compared to EUR 9.9 million in the year before. This comprises revenue from collaboration agreements for the ATAC technology of EUR 6.8 million in '24 and EUR 9.8 million in '23. Sales revenue in '24 dropped year-over-year as planned, given the lower level of monetization from partnerships, especially in terms of material deliverables. Other income amounted to EUR 5.1 million compared to in previous year and was dominated by the recognition of research allowances and governmental funding totaling EUR 2.8 million that was significantly more than in the previous year with EUR 0.1 million. The total amount of income also includes income from the reversal of unused accrued liabilities and other items. Let's turn to operating expenses. They include depreciation and amortization and decreased considerably to EUR 32.6 million in this year compared to '23 with EUR 38 million. The cost of sales concerns the group's cost directly related to sales revenue. These costs were mainly related to expenses for the supply of Amanitin linkers to licensing partners. These costs amounted to EUR 1.8 million, well below the previous year's figure of EUR 3.3 million and represented 5% of the operating expenses. Research and development costs of EUR 28.1 million in '23 decreased to EUR 21.8 million in '24 due to lower external production costs for IDC projects and reduced costs for the ongoing clinical trials with HDP-101. At 67% of operating expenses R&D remains the largest cost item. Administrative costs were EUR 6.7 million, an increase on the prior year figure of EUR 5.2 million and accounted for 21% of operating expenses. These include staff costs of EUR 4.1 million of which EUR 0.4 million concerned expenses from stock options, a compared figure for EUR 23 are EUR 3 million thereof EUR 1.3 million for stock options. Administrative costs also include legal and operating consulting costs in the amount of EUR 1.2 million. compared to EUR 0.8 million for '23 and expenses related to the Annual General Meeting, Supervisory Board and the innovation and stock market listing, which was EUR 0.8 million respectively EUR 0.7 million in '23. Other items amounted to EUR 0.6 million compared to EUR 0.7 million for the prior year. Other expenses for business development, marketing, commercial market supply activities and all other items, which mainly comprise staff and travel costs increased to EUR 2.3 million year-over-year compared to EUR 1.4 million in '23 and made up 7% of operating expenses. The Heidelberg Pharma Group recognized a net loss for the year of EUR 19.4 million compared to the net loss of EUR 20.3 million in fiscal year '24. Basic loss per share improved from minus EUR 0.44 in the previous year to minus EUR 0.42 this year. Let's have now a more detailed look on the cash flow. Net cash outflow from operating activities during the reporting period was EUR 29.6 million in the previous year, EUR 33.7 million. The decrease is mainly due to a lower level of expenses. Total cash outflow from investing activities came to EUR 0.4 million. The previous year, it was EUR 5.8 million inflow and was significantly lower than the prior year figure, which reflected the unscheduled disposal of [emergence] shares. The net change in cash flows from financing activities improved from an outflow of EUR 10.1 million in the previous year to an inflow of EUR 16.1 million in '24. This significantly higher figure is due to the HCRx transaction in March 24, while the previous year's result was dominated by the EUR 10 million repayment of loan. The total change in cash in fiscal year '24 came to minus EUR 14 million. Previous year was minus EUR 37.9 million. This corresponded to an average outflow of cash of EUR 1.2 million per month and in the previous year, EUR 3.2 million. We have now almost reached the end of our presentation, and I would like to give you a brief outlook for the coming year. We expect the Heidelberg Pharma Group to generate between EUR 9 million and EUR 11 million in sales revenue and other income in the fiscal year '25. Sales revenue generated by Heidelberg Pharma Research GMBH, especially for ATAC technology is expected to account for about 1/3 of this figure, as deferred revenue and potential milestone payments to Heidelberg Pharma AG contributing a slightly higher amount. Other income will mainly comprise government grants and the passing on of patent costs in the context of our licensing. Based on current planning, operating expenses are expected to be in the range between EUR 40 million and EUR 45 million. Earnings before interest and tax in the 2025 fiscal year are expected to be between minus EUR 30 million and minus EUR 35 million. This figure is excluding FX effects. We assume that over the next few years, total expenses will exceed the income. If income and expenses develop as anticipated, the change in cash funds in '25 for Heidelberg Pharma's AG business operations is expected to improve significantly compared to '24. The expected cash inflow will be between EUR 50 million and EUR 55 million due to further payments. This corresponds to an average monthly inflow of cash of EUR 4.2 billion to EUR 4.6 million. In '24, the monthly outflow was EUR 1.2 million. Based on the current budget and considering additional expected payments of USD 70 million, less transaction costs from healthcare royalty upon market approval of TLX250-CDx and entitlement to a further USD 20 million resulting from the amendment the agreement for the sales of royalties, our company is funded into 2027. I will now turn the call back to Andreas for the operational outlook for the year ahead.

Thank you, Walter. We are very pleased with the strong progress we made last year. What do we expect for the year ahead? For HDP-101, we expect to reach the recommend Phase II dose soon and our goal is to start the Phase IIa later this year. Our Chinese partner, Huadong, reviewed -- received an approval for conducting a clinical study with HDP-101 in China and plans to start the Phase II in 2025. The exact conditions for the planned trial are still being worked out. HDP-102 receives authority approvals for a Phase Ia/Phase Ib in Moldovia and Israel. I'm very excited that our second ATAC will soon be evaluated in humans. The submission of the clinical trial application for HDP-103, the candidate against prostate cancer as planned for the end of 2025. And for the last ATAC, HDP-104, toxicological studies shall start later this year. The progress we have made over the past year reinforces our belief that our technology has a compelling mode of action, giving us a unique position in the development of cancer therapies. Our mission remains unchanged. We are dedicated to develop highly effective cancer therapies with fewer side effects for the benefit of patients. Thank you very much for joining our presentation today. We would like now to open the call to questions.

[Operator Instructions] The first question comes from the line of Marietta Miemietz.

I have a couple of pipeline questions, please. On the financial front, I infer from your guidance that the $20 million upfront that you received from Healthcare Royalty alone would be sufficient to allow you to end the year with a positive cash position. So, Is that correct? And in the unlikely event of a severe delay to FDA approval of TLX250-CDx, how would you bridge from year-end 25 to the date when you actually receive the milestone? And then on the pipeline front, with regards to HDP-101, I was just trying to clarify exactly we're going to see at EHA? Are we already going to get any Cohort 7 data? And if not, I mean, when do you expect to share full safety and initial efficacy data for Cohort 7 and also the dose that you're using there? And when would you expect to start Cohort 8? And for HDP-102, I was just wondering if you be able to share already a little bit more detail on the inclusion/exclusion criteria for the Phase 1 and whether the asset will only be -- the molecule will given monotherapy or what combinations might be allowed and generally what you think the time lines are to recruit the 42 patients?

Maybe I'll start with the 2 questions on the financials. Thank you, Marietta, for the questions. Indeed, we already received a USD 20 million from the amendment with HCRx. And with that amount, we are well financed beyond the end of this fiscal year in 2025 knowing that the going concern always foresees a minimum 12-month horizon from the test date of the auditors. With that amount, we have financed already well into '26. And if there would be another delay in the approval of the Telix asset, we know that early in the second half of '25. And with that, we have at least a cash runway of 6 to 9 months to manage that. And we don't expect that there will be another delay. But even if there would be a delay it will be managed and we also have a good plan in place in that case to manage our cash reach and to have a proper cash management in place.

Well, for the pipeline questions, indeed, we plan for a major update for the EHA presentation. So this will include Cohort 6 safety and efficacy data for Cohort 7, we since all patients already completed the DLT period. So the safety data was also given for Cohort 7. And since the efficacy is always delayed, and it takes some weeks and months. So there was probably an early glimpse on the efficacy data at the EHA. But since this is not so much time until then, there will be not complete efficacy data. And if you look on the complete response patients, it took more than half a year. So in a nutshell, complete Cohort 6, safety Cohort 7 and maybe early efficacy on Cohort 7. And the question for Cohort 8, as having said, DLT period is completed. So the Safety Review Committee will convene very soon in a few weeks and we expect thereafter the cohort 8 will already be started to recruit patients. 102, sorry. It's a monotherapy. It will be an all-comer study. So we are not focusing on one NHL indication, but an all-comer study and the idea is to look for safety primarily. And then in an extension/expansion phase to maybe focus, for example, for the big indication like DLBCL or CLL, but this will also depend on the data we obtain during the dose escalation. Inclusion/exclusion criteria that nothing special typical Phase I. So we do not have any specific inclusion or exclusion criteria for this one. Recruitment, we believe that with the success of the HDP-101 study, this is what we also observed in the 101 study. Having the clinical data really stimulates the interest of patients and PIs to recruit patients in our studies. So we believe that will be also good recruitment rates for the 102 study as well.

Next, we received several written questions on whether you will be doing a cohort 8 and which dosing scheme you will be using?

Yes, since we discussed it in the length internal and externally and everybody tells us we should go into the maximum tolerated dose in order to maximize the direct response because in the long run, you want to have the maximum response rate and the maximum duration of response. And since we have not seen any dose-limiting toxicities in cohort 6 or cohort 7, it's highly likely that we will run a Cohort 8. And the learnings from the different cohorts is obviously from the treatment arms. So we reduced from Cohort 6 to Cohort 7, from 3 arms to 2 arms. We will leave -- we will go with both arms, but we will prioritize the arm with what we call the step-up dosing for the cohort 8. For the split dose in the first cycle allowing for premedication and from the second cycle on no split dose. This was the priority arm used for cohort 8.

Next question is, all patients of the seventh cohort have been enrolled. How many patients are still being treated? Do any of these patients have the 17p deletion mutation?

That's a little -- this question is a little bit early because we do not have the full picture. It's Just, let's say, completion of the DLT period and not all centers are immediately putting the data into the database. So we don't have the picture of the 17p deletion. This unit comes with the SSC meeting. So it will take, let's say, a few weeks more to get all the information for all patients. and we are not currently disclosing how many patients are still being treated. So if not all, but more than half of the patients are still being treated.

Next another written question, which publications or posters have been submitted to the AACR?

Honestly, I don't know all the -- from my memory, I -- we should have a press release and the press release comes on Wednesday for the AACR publications and posters.

Next question is what potential milestone payments would be linked to Huadong starting a Phase II with HDP-101? What would be the ballpark figure for this?

Indeed, there is a milestone payment for [ CN ] in Huadong, which is entering in a Phase II with HDP-101. So far, we did not communicate the amount but you can -- let's assume we have reflected that in the guidance for '25.

Next up, another written question. There have been discussions about the potential of ADCs in the field of autoimmune diseases. Are there any considerations or preclinical data suggesting that your ATAC technology could be applied in this field?

Very good question. Of course, we have had intense discussions around this one. And my personal opinion, we believe the technology is very placed for this one. We have seen a complete remission without those limiting toxicities of our payload is non-genotoxic we're killing nondividing cells. What I can say today, we are exploring this option. We are doing preclinical studies in this regard and we are looking also for possibilities to evaluate these in patients.

We have one more written questions. And that is, are there negotiations with potential licensing partners still ongoing? Or is this currently off the table after the contract with Healthcare Royalties was adjusted?

It's not off the table, but with the deal and the non-dilutive money, we are, let's say, cashing in the company, we are not desperate. We are talking to potential licensing partners also developing a relationship. But with the money in the bank, we have more time to increase the value of the assets, increase the value of the company and increase for the shareholders. So it's not a black and white. We are entertaining these discussions. But since we are not desperate getting money from the license deals we will entertain the discussions. And depending on term sheets, we will, let's say, wait or act.

Then another question that came in a written form asking for an update on the Bingham University collaboration?

It's working very well. We are working with [Natumi] -- we are, let's say, testing already the payload technology on different antibodies and generating preclinical data. So we are very excited about having a noncytotoxic but immuno stimulatory payload. So that's going on very, very well.

The next question, will patients from the sixth cohort be offered the option to switch to the higher dose of the seventh cohort?

This is what we typically do, for example, for the patient from Cohort 3 with the 400 days, it was also offered to switch to the next higher dose. So this will be up to the discretion of the SSC, but this is typically been offered because it's an upside for them to switch to a higher dose.

And then let's get to the last question. How is the monthly financial requirement expected to develop in the coming months and then in 2026?

So when we have a look on the guidance, we see -- we plan operating expenses between EUR 30 million and EUR 35 million. depending on the cash in the calculation is that we spent EUR 2.5 million to EUR 3 million per month as an average. As a general outlook for '26, when we have another project in the clinic HDP-102, we expect that this will further increase. And having in mind that HDP-103 will follow 1 year later also in the clinic in our perfect scenario. So the cash need will further increase. Hopefully, this answers the question.

And can you give any guidance on when you will have a first ATAC candidate?

So there seems to be a huge interest. Internally, we have already our favorite identified, so it's foreseeable, but I'm a little bit reluctant to give time lines on this one. So we are doing now efficacy studies and we selected already the target and the antibody for that candidate.

This concludes the Q&A session. I will now hand the call back to Andreas for closing remarks.

Yes. I would like to thank everybody for attending today's conference. We have the feeling that we had an outstanding year. We have, let's say, made very good progress in financing the company with the royalty deals, which gives us nondilutive money. We are not diluting the shareholders, we are not diluting the assets but having, let's say, 2 more years run rate, which is in these challenging times of a remarkable achievement. And with the clinical data for the first time, we see objective responses in patients. We see the complete response in 1 patient heavily pretreated. So we believe it's a clinical validation of the platform of the HDP-101. People are already, let's say, applauding us that we have a drug. So exciting times. We continue. We would like to see more patients treated with HDP-101 and also for HDP-102 to enter the next stage for the company and our pipeline. Thanks, everybody, and looking forward.