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. During today's presentation, all participants will be in a listen-only mode. Please note that today's call is being recorded. The presentation will be followed by a Q&A session where you may ask written or audio questions. Please note that you can ask questions only online. I would now like to turn the call over to Professor Doctor 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 the 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 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 risk 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 ahead. 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. 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/II- A study in the indication multiple myeloma. 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. 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 Royalty, we are fully financed until 2027. What are the main parts 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 toolbox 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. It has another mechanism of action, the inhibition of RNA polymerase II, which results in programmed 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 I 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 as HDP-201 to a preclinical development stage.
HDP-201 targets GCC that is expressed on the surface of intestinal cells and cancer cells and various gastrointestinal tumors. The third pillar of our technology are Toll-like receptor 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 two 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 four projects using Amanitin as a payload in different indications. 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 HDP-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. We expect a progress update 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 were 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 should any of the programs make it to the market. Indeed, 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 surface 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 myeloma is currently more than 180,000 people, with a mortality of 120,000. The study with HDP-101 is a first-in-human phase I/II-A clinical trial. We treat patients with relapsed and/or refractory multiple myeloma in 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 recommended phase II dose and to determine the safety and tolerability. To evaluate this, we are treating two to six patients in each cohort with an increasing dose of HDP-101. First promising efficacy signals have been seen. In the phase II-A 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 different cohorts and the dosing. On the bottom, you see the treatment duration in days. Let me comment on three remarkable preliminary results.
One patient from cohort three was over 400 days on treatment with a stable disease. Over that long period, we couldn't see any accumulated toxicity or severe side effects. In cohort five, we see a 50% objective response rate. Three out of six patients profited from the treatment by having a partial remission, and one patient turned out to have a complete response. The complete responder is a U.S.-based female patient suffering from multiple myeloma since 2002. She received nine prior lines of therapy. She's still undergoing treatment and feels very well. She's active. Her quality of life has improved considerably as a result of the treatment.
The fact 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 option for patients with multiple myeloma. You will remember that in the fifth cohort after administration of the first dose of HDP-101, which was 100 mcg/kg , all patients experienced a drop in the thrombocyte count, which completely normalized without further intervention after a few days and was clinically unremarkable. In order to mitigate the effect of the initial administration, an adjustment and optimization of the medication regimen was developed based on the recommendations of the Safety Review Committee. Cohort six consisted out of three arms with different dosing regimens.
Patients in arm A were treated with a single dose of HDP-101 on day one of each 21-day cycle following a pre-medication. Patients in arm B received a weekly dose of HDP-101. The dose was split, with patients being administered the drug proportionally on days one, eight, and 15 of each cycle. Arm C received a partial dose of HDP-101 on days one and eight of the first cycle, and then a single dose on day one of each of the following 31-day cycles. The dose was lowered to 90 mcg/kg with the aim of minimizing the risk to the patients in these three arms. HDP-101 was well-tolerated across all 10 patients in cohort six, with no dose-limiting toxicities detected in any of the three parallel treatment arms.
The patient recruitment of cohort seven is complete, and patients are under treatment with an escalated dose of more than 100 mcg/kg. The highest dose trial period in two arms with different split dosing. One arm includes additional pre-medication. HDP-101 is well-tolerated in this cohort as well, and 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 outcomes. We don't think that we already have reached the MTD, the maximum tolerated dose, of HDP-101. Our expectations are that the cohort eight 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 mid-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 three treatment strategies had a positive effect on the transient thrombocytopenia. We saw responses at the dose of 90 mcg/kg, the treatments and assessments are still ongoing. The seventh cohort was opened in December. All patients have completed the DoT observation periods, 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, as already mentioned, one complete remission in one patient. This is a promising outcome so far, 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 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 a worldwide incidence of more than 550,000 and a 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 package for the clinical trial application, submitted in it in selected European countries. We already have received the regulatory approvals to conduct the clinical trial from the authorities in Moldova and Israel. The inclusion and dosing of the first patient is expected in the next few weeks.
The study design of the first human clinical trial with HDP-102 can be seen on this slide. We plan to conduct a multicenter, multinational open-label phase I-A/I-B trial. In the phase I-A part, up to 32 patients with relapsed or refractory B-cell malignancy will be treated to evaluate the safety tolerability, pharmacokinetics, and the pharmacodynamics of this ATACs. The goal of the phase I-A is to find the optimal and safe starting dose for the phase I-B part. The second part is a 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 bind to PSMA 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, tolerability, and pharmacokinetic studies have shown that HDP-103 has a promising therapeutic window. There is also a very high prevalence, 60% of a 17p deletion in metastatic castration-resistant prostate cancer. The increased sensitivity of prostate cancer cells with the 17p deletion has already been preclinical validated. As we have previously reported, tumor cells with the 17p deletion are particularly sensitive to Amanitin. PSMA ATACs might be particularly suitable for the treatment or treating metastatic castration-resistant prostate cancer. The necessary preclinical and toxicological studies 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. I would like hand over to my colleague, Walter Miller.
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 a 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 under the breakthrough classification, which allows for a phased 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 a deficiency in the area of manufacturing CMC had been identified. The new application was submitted at the end of December 2024. On February 26, 2025, good news were 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 August 27, 2025. This means that the authority will make a decision on 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 EAP, since December 2023 to provide patients with pre-approval 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 2024 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 the royalties from the global sales that we signed in March 2024. This year in March, we concluded an amendment to that agreement. On this slide, the amended terms are highlighted in petrol. A $25 million upfront payment was already received in March 2024. Therefore, there is no change on that. We originally agreed on a sales-related milestone payment in the amount of $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 $20 million upon signature of this amendment. This happened already earlier this month. The $75 million payment upon FDA approval of TLX250-CDx was reduced to $70 million with further reductions if FDA approval occurs after the end of 2025. Last, the second tier of the two-tier escalating cap on cumulative royalties sold to HCRx 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 tier 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 $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 that extends our cash reach. The approval payment of $70 million reduces the risk of market uptake. 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 2024.
This significantly higher figure is due to the HCRx transaction in March 2024, 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. Non-current assets were EUR 13.2 million as of end of November 2024, compared to EUR 13.7 million in 2023. 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 non-current financial liabilities of EUR 21.8 million is attributable to the upfront payment from HCRx, which is initially being recognized less transaction costs. Therefore, non-current 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, 2023. The equity ratio was 50.8% at year-end 2023 compared to end of 2024, compared to 27.1% at year-end 2023. This slide show our profit and loss statement for fiscal year 2024. 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 FY 2024 compared to EUR 16.8 million for 2023. Breaking that down, we generated sales revenue of EUR 6.9 million compared to EUR 9.9 million euro in the year before. This comprises revenue from collaboration agreements for the ATAC technology of EUR 6.8 million in 2024 and EUR 9.8 million in 2023. Sales revenue in 2024 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 EUR 6.9 million 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 2023 with EUR 38 million. The cost of sales concerns the group's costs directly related to sales revenue. These costs were mainly related to expenses for the supply of ATAC linkers to licensing partners. In 2024, 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 2023 decreased to EUR 21.8 million in 2024. Due to lower external production costs for ADC projects and reduced costs for the ongoing clinical trials with HDP-101. At 67% of operating expenses, R&D remained 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 cost of EUR 4.1 million, of which EUR 0.4 million concerned expenses from stock options. The compared figure for 2023 are EUR 3 million, thereof EUR 0.3 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 2023, and expenses related to the annual general meeting, supervisory board remuneration, and a stock market listing, which was EUR 0.8 million, respectively EUR 0.7 million in 2023. 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 2023, 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 a net loss of EUR 20.3 million in FY 2024. 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.
In the previous year, it was a EUR 5.8 million inflow and was significantly lower than the prior year figure, which reflected the unscheduled disposal of Emergence's 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 2024. This significantly higher figure is due to the HCRx transaction in March 2024, while the previous year's result was dominated by the EUR 10 million repayment of a loan. The total change in cash in fiscal year 2024 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. 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 2025. Sales revenue generated by Heidelberg Pharma Research GmbH, especially for ATAC technology, is expected to account for about one-third 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 out-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 2025 for Heidelberg Pharma AG business operations is expected to improve significantly compared to 2024. 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 million to EUR 4.6 million. In 2024, the monthly outflow was EUR 1.2 million. Based on the current budget and considering additional expected payments of $70 million, less transaction costs from HealthCare Royalty upon market approval of TLX250-CDx and entitlement to a further $20 million resulting from the amendment of 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 II-A 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 received the authority approvals for a phase I-A, phase I-B in Moldova and Israel. We are very excited that our second ADC will soon be evaluated in humans. The submission of the clinical trial application for HDP-103, the candidate against prostate cancer, is planned for the end of 2025.
For the last ATAC, HDP-104, toxicological studies shall start later this year. The progress that 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.
Ladies and gentlemen, at this time, we will begin the Q&A session. You may ask a question using the raise hand icon below the presentation window. We will call on each person and ask you to unmute yourself. You can also ask questions in writing via the Q&A button below the presentation window. I will then read the questions aloud. One moment for the first question, please. The first question comes from the line of [Marietta Miemietz] . Please accept the request to unmute yourself.
Yes, good afternoon, thank you. I have a couple financial questions, a couple 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. Is that correct? In the unlikely event of a severe delay to FDA approval of TLX250-CDx, how would you bridge from year-end 2025 to the date when you actually receive the milestone? On the pipeline front, with regards to HDP-101, I was just trying to clarify what exactly we're going to see at EHA. Are we already going to get any cohort seven data?
If not, I mean, when do you expect to share full safety and initial efficacy data for cohort seven and also the dose that you're using there, when would you expect to start cohort eight? For HDP-102, I was just wondering if you would be able to share already a little bit more detail on the inclusion/exclusion criteria for the phase I and whether the molecule will only be given in monotherapy or what combinations might be allowed and generally what you think the timelines are to recruit the 42 patients. Thank you very much.
Maybe I start with the two questions on the financials. Thank you, [Marietta], for the questions. Indeed, we already received the $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 are financed already well into 2026. If there would be another delay in the approval of the Telix asset, we know that early in the second half of 2025, and with that, we have at least a cash runway of six to nine months to manage that.
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.
Thank you.
For the pipeline questions, indeed, we plan for a major update for the EHA presentation. This will include cohort six safety and efficacy data for cohort seven. We since all patients already completed the DoT period, so the safety data will also given for cohort seven. Since the efficacy is always delayed and it takes some weeks and months, there will probably an early glimpse on the efficacy data at the EHA. Since this is not so much time until then, there will be not complete efficacy data. If you look on the complete response patients, it took more than half a year. In a nutshell, complete cohort six, safety cohort seven, and maybe early efficacy on cohort seven.
The question for cohort eight, as having said, DLT period is completed, so the Safety Review Committee will convene very soon in a few weeks. We expect thereafter, cohort eight will already be started to recruit patients. One or two. Sorry. It is a monotherapy. It will be an all-comer study. We are not focusing on one NHL indication, but an all-comer study. 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. This will also depend on the data we obtain during the dose escalation. Inclusion/ exclusion criteria, there is nothing special, typical phase I. 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. We believe that will be also a good recruitment rate for the 102 study as well.
Thank you very much.
Next up, we've received several written questions on whether you will be doing a cohort eight and which dosing scheme you will be using?
Yeah. Since we discussed this in length internally and externally, and everybody tells us we should go to the maximum tolerant dose in order to maximize the direct response, because in the long run, we want to have the maximum response rate and the maximum duration of response. Since we have not seen any dose-limiting toxicities in cohort six or cohort seven, it's highly likely that we will run a cohort eight. The learnings from the different cohorts is obviously from the treatment arms. We reduced from cohort six to cohort seven from three arms to two arms.
We will go with both arms, but we will prioritize the arm with the what we call the step-up dosing for the cohort eight, for the split dose in the first cycle, allowing for pre-medication, and from the second cycle on, no split dose. This was the priority arm used for cohort eight.
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 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. We don't have the picture of the 17p deletion that usually comes with the SSC meeting. It will take, let's say, a few weeks more to get all the information for all patients. We are not currently disclosing how many patients are still being treated. It's not all, but more than half of the patients are still being treated.
Next up, another written question. Which publications or posters have been submitted to the AACR?
Honestly, I don't know all the them from my memory. We should have a press release, and the press release comes on Wednesday for the AACR publications and posters.
Okay. Next question is, what potential milestone payments would be linked to Huadong starting at phase II with HDP-101? What would be the ballpark figure for this?
Walter?
Indeed, there is a milestone payment for CN, when Huadong is entering in a phase II with HDP-101. So far we did not communicate the amount or the. Let's assume we have reflected that in the guidance for 2025.
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 intense discussions around this one. My personal opinion, we believe the ATAC technology is very well placed for this one. We have seen a complete remission without dose-limiting toxicities. Our payload is non-genotoxic. We are killing non-dividing 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 this 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 Royalty was adjusted?
It's not off the table, but with the deal and the non-dilutive money, we are, let's say, cashing in on 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 the value for the shareholders. 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.
Another question that came in a written form, asking for an update on the Binghamton University collaboration
It's working very well. We are working with Nathan Tumey. We are, let's say, testing already the payload technology on different antibodies and generating preclinical data. We are very excited about having a non-cytotoxic but immunostimulatory payload. That's going on 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 three with the 400 days, it was also offered to switch to the next higher dose. This will be up to the discretion of the SRC, but this is typically being offered because it's an upside for them to switch to a higher dose.
Let's get to the last question. How is the monthly financial requirement expected to develop in the coming month and then in 2026?
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 spend EUR 2,500,000 to EUR 3 million per month as an average. As a general outlook for 2026, 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 one year later also in the clinic, in our perfect scenario. The cash need will further increase. Hopefully, this answers the question.
Can you give any guidance on when you will have a first ATAC candidate?
Yeah. There seems to be huge interest. Internally, we have already our favorite identified, it's foreseeable, but I'm a little bit reluctant to give timelines on this one. We are doing now efficacy studies, and we selected already the target and the antibody for that candidate.
Thank you. This concludes the Q&A session. I will now hand the call back to Andreas for closing remarks.
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, with the royalty fees, which give us non-dilutive money. We are not diluting the shareholders. We are not diluting the assets, but having, let's say, two more years runway, which is, in these challenging times, also a remarkable achievement. With the clinical data, for the first time, we see objective responses in patients. We see the complete response in one patient, heavily pre-treated. 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. 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.