Welcome and thank you for joining Heidelberg Pharma's conference call to discuss 2025 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 can ask written or audio questions. Please note that you can ask questions only online. I would now like to turn the call over to Dr. Dongzhou Jeffery Liu, CEO of Heidelberg Pharma. Please go ahead, Jeffrey.
Thank you. Hello, everyone. Good afternoon, and welcome to the Heidelberg Pharma conference call to discuss our 2025 fiscal year's result and to provide the 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 Walter Miller. We look forward to provide you with an update on the company and the progress we have been making. Please know 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. 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 uncertainties affecting our business, please refer to our 2025 management report. This was published this morning and is available on our website. That said, let me start. Next slide, please. First of all, let me just touch on some key points from today's talk and also they're shown 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 the Heidelberg German headquarters regularly and work very closely with the team and lead the transformation process. Despite the challenges we have all faced in the past year, the team is doing wonderful, intelligent work, and it is inspiring to work with them and to 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 30th 2025. This decrease is a result of the strategic refocusing measures that we implemented last fall. More on this shortly in the presentation. Our lead clinical program is HDP-101.
We will use the international non-proprietary name called pamlectabart tismanitin, in the future, and it is currently being evaluated in an ongoing phase I and a phase II-A clinical trial in patients with relapsed and refractory multiple myeloma. 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 in place the necessary GMP manufacturer supply chain, which is of critical importance given the complexity of producing this type of ADC compound. We also have a very strong IP portfolios with more than 20 patent families and over 50 family members cover our platform, payloads and the method we use.
During today's presentation, Walter will reveal our financial result and the recent steps we have taken to significantly extend our cash runway, which now extended into mid-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 diagnostic imaging agent TLX250-CDx, now called TLX250-Px, to Telix Pharmaceuticals. We subsequently monetized a part of the potential royalty stream from their agreement with HealthCare Royalty. As a part of the agreement with HealthCare Royalty, we were to receive $70 million milestone payment upon FDA approval of TLX250-Px. Then 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, manufacturing, and controls 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 two third-party manufacturers and the supply chain partners that will require remediation prior to resubmission. 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 reduce 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 a significant scale back or put on hold on other programs, clinical program, and the preclinical R&D work. This decision was difficult, and it impacted many of our colleagues, and resulting 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, to ensure the future of our company. I would like to honor... Acknowledge our former employees who dedicated their time and talent to the company now helping us go as of today. Let me now turn the call over to Walter, who will discuss the expenses 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 $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 $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 cap for 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 $70 million from HCRx linked to FDA approval in 2025 will now be significantly reduced because approval did not occur within the agreed timelines. Despite the decreased amount for this approval milestone, the structure of the agreement continues to provide attractive non-dilutive 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 30th 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 amanitin 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 cost 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 EUR -0.91 . Looking at the balance sheet. Non-current 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. Non-current 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 $20 million received from HealthCare Royalty in 2025, which also has to be deferred as a financial liability. Looking at current liabilities. Trade payables rose to EUR 7.2 million compared to EUR 5.5 million for the prior year.
Due to the strategic refocusing announced in September 2025, 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 EUR 30.9+ million at the end of 2024. 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 2025.
In March 2025, we amended the existing license agreement with HCRx, dated March 2024, providing Heidelberg Pharma with an immediate payment of $20 million, which translates in a cash inflow of EUR 18.4 million. As a reminder, we waived a sales-based milestone payment of $15 million and the FDA approval milestone for TLX250-Px was reduced from $75 million to $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 slide for the R&D update, particular focus on the HDP-101, our most important, you know, projects. As you can see from this slide, give you a very quick refresher on HDP-101. This, you know, we have an official INN. We call it pamlectabart tismanitin, which is being developed for the treatment of multiple myeloma, a 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 binds specifically to BCMA and delivers the amanitin payload directly into the cancer cell, where it inhibit RNA polymerase II and ultimately induce the cell death.
Our ongoing phase I-A, II-A clinical trial is evaluating HDP-101 in patients with relapsed or refractory multiple myeloma, whose disease has progressed on multiple lines of therapy and who have very limited treatment options. The study is designed to evaluate the safety, tolerability, pharmacokinetics, and the preliminary efficacy of HDP-101 in this patient population. The phase I, also called the dose escalation study, is ongoing. 10 cohorts so far, we have completed almost complete patient enrollment. We have seen encouraging safety as well as early efficacy signals. The latest available result from Cohort 8 were presented in November 2025 at the World ADC Conference and discussed during the webcast we held around that event. Please turn the next slide, please. Let me just briefly highlight the preliminary efficacy data result from the Cohort 8.
We were truly excited to report that of the eight patients treated in this cohort, which is 140 microgram per kilo dose, two experienced complete response. two other patients experienced partial response. One experienced stable disease and two progressed. One patient was not available. Consider, these patients' 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 Cohort 8 in the ongoing phase I trial. Look at this full cohort 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 three stringent complete remission.
In Cohort 8 alone, we are seeing a preliminary objective response rate of 57%, with four out of seven evaluable patients responding, including, as noted in the previous slide, two stringent complete response. While the result from the cohort eight are still preliminary, they provide encouraging evidence that HDP-101 has meaningful anti, antitumor activities even in heavily pre-treated patients, demonstrating promising dose-dependent anti-cancer activity with deep clinical response. Please turn on the safety. Next slide. 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 level tested so far, including the most recent Cohort 9. The Cohort 9 dose was found to be safe and tolerable, and the evaluation of efficacy is ongoing.
Up to Cohort 9, the MTD, maximum tolerable dose, are still not yet reached. Across all nine cohorts, we have observed no sign of ocular toxicity, no infusion reaction, no extensive marrow suppression, and no liver damage. A transient reduction in platelet counts, we also call the thrombocytopenia, was seen in some of the cohorts trials. This effect was manageable and has been mitigated through adjusted dosing regimen strategy. In addition, there's no evidence of irreversible toxicity in patients receiving treatment so far for more than 12 months. All patients had relapsed refractory multiple myeloma and were heavily pre-treated and have exhausted all available treatment options. That is the data we deliver based on this huge history treatment patient.
The safety data from Cohort 9 have re-supported moving to the next cohort at a dose of 218 micrograms 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 II- A 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 this overall pipeline. Next slide, please. 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 then we'll bring the recommended phase II dose in the second half of this year. Hopefully in Q3. I also wanted to note that our recently announced partner Huadong 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 a 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 populations and is an important requirement for advancing the development of this product globally, including testing in Asian populations.
Our other development programs are available for partnering. For HDP-101, 102 for non-Hodgkin lymphoma, we have put recruitment for ongoing phase I study on hold, but are continuing to treat the one patient still enrolled in the trial. With 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 now developing this program further on our own. HDP-104 for colorectal cancer will now be developed further internally. Turning to our partner programs, starting with our partner Takeda. As you remember, in 2017, we signed the exclusivity research agreement with Takeda related to several targets for joint development ADC using amanitin.
Under the terms of the agreement, Heidelberg Pharma produced several ATACs using antibodies from Takeda's proprietary portfolios. As a result of this work, Takeda acquired an exclusivity license in 2022 to commercially develop an ATAC with an undisclosed target. Takeda is responsible for further preclinical and clinical development, as well as the 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 tumors. We are excited to see the progress of our partner Takeda is making and looking forward to this program advancing to further clinical development. Look at the Telix. In 2017, we licensed our legacy asset, the diagnostic antibody girentuximab, or now called the TLX250-Px, to the Australian company, Telix Pharmaceuticals.
As discussed earlier, Telix received a complete response letter for this biologics license application or BLA for TLX250-Px this summer. In the press release reported in 2025, announced the results published in February, Telix indicates that based on the two Type A meetings with the 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 radioimmunoconjugate program, also called the TLX250-Px. Telix recently reported that they received regulatory approval to start the global phase II and III trials in the metastatic clear cell renal cell carcinoma.
In addition, a phase I-B and II investigator-initiated trial, IIT, is exploring TLX250-Px in combination with other therapies in the same indication. Let me bring up the 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 result with our leading program, HDP-101, and I expect to move this into phase II-A 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 $32 billion in 2033.
Most importantly, our work holds the promise of helping patients who today have limited treatment options. Next slide, please. With that, I would like to thank you for all your attention and your continued interest and support in Heidelberg Pharma. We will now open the call to your questions. Operator. Thank you.
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 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. You know, I know a lot of our investors, analysts or even the ADC world, you know, industry, also including academia, you know, 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. This is two dose that we're right now testing in the clinical phase I trials. As I can share with you that today the trial is ongoing, and there's all the signal regarding safety and efficacy is measurable and in a good way to moving forward.
We hope to get, you know, particularly the Cohort 10. This is higher, 218 microgram per kilo. We're going to bring this initial safety and efficacy data to the safety review committee early April. We need their assessment and see whether we can report this data in the coming, you know, months conference. We do plan to present this particularly Cohort 9 and 10 clinical result at the later years of this conference globally. Thank you for this one. We'll keep you updated as well as we release the data outside. Thank you.
Okay. Next question is, "When will you be able to say whether there is an 11th cohort?
I'm sorry, say that again. Another, higher cohort?
Yes. At what time will you be able to say if there is gonna be a Cohort 11 or if you already have the dose for phase II?
Okay. Yes, good question. You know, because this trial is ongoing, what I can share with you is, first of all, the safety is manageable. You know, the MTD, maximum tolerated dose, is not reached yet. We do the data evaluation because that gives us some time on the Cohort 10, particularly 218 dose. That'll take the time to measure the efficacy signal, you know, what is overall response because we enroll so far, you know, up to five-six patients in this cohort. We need a little more time to assess the efficacy data readout. I can share the principle with looking at this, so whether we do Cohort 11 or not.
Because that is not decided yet, we're going to bring this to the SRC committee early April, but we do have internal discussion as well. But for our consideration, you know, we want to see that, first of all, is this, you know, safe enough? Is the MTD dose almost there? Or the particular efficacy. You know, even though we have a very limited patient number in each cohort, but I want to see whether the efficacy data of Cohort 8, 9, 10. Is it continue to go up, improve the efficacy readout, or is it, you know, reach a plateau? But I can share with you, we are almost close to the end of phase I-A study. We are trying everything we can to move to phase II-A. The expansion study with relative what we call the recommended phase II dose moving forward. That is, you know, information I can share you, but we are not have a decision on Cohort 11 for the time being. Thank you.
Okay. 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 two companies?
Okay, good question. It's a hard question. You know, we are in the same pharma industry. We are in the same category. Huadong also have ADC, and Heidelberg is a ADC focused biotech. Huadong, you know, five years ago invested Heidelberg Pharma because the ATAC technology. We're really thinking an amanitin-based ADC can provide some very unique solution to the unmet medical needs. Particularly right now, you know, there's a lot of Top1 inhibitor, you know, and very limited choice to choose the payload. And amanitin gives us the opportunity to provide additional payload and mechanism to kill the cancers. I think that is, you know, we have the same missions on ADC conjugate drug.
We have a lot of synergy between these two companies and in particular the ADC teams. You know, I'm also working every day and working with both teams, and particularly they started some new initiatives collaborating together for some projects. In particular 101, 103 right now, Huadong already has the China rights. 101 in China already started. The first patient in March 17, they already started. We keep very close and, you know, working together both teams on this program in China because they can provide additional valuable clinical outcome results in addition to MRCT right now running, sponsored by Heidelberg Pharma.
You know, in terms of my timing, you know, I spend as much as I can, you know, probably every day, you know, working with the Heidelberg Pharma team, you know, online or virtually or even on site. You know, I'd be in the Heidelberg office almost every month, you know. I stay here at least, you know, I cannot give a precise number on how many days, but at least a really decent number of days to stay in the Heidelberg office. I'm flexible if I need to more frequently come here. There's no problem. Right now there's a lot of virtual working environment, you know, so I'm really confident in moving forward and we're going to be bringing this particular, the ADC collaboration, if we do have a collaboration program together, more close together. 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 at biotech conferences and actively negotiate out licensing agreements? Are you primarily responsible for clinical development internally?
Yeah. A good question, too. You know, as I'm growing the responsibilities, you know, my assumption is that, not assumption, I already did that, is a full profile as a senior management, as a CEO, you know, for the company. Take all the opportunity to broadcasting, promoting our program or project or asset or technology platform globally. Find a partner. You know, for me, I think in, you know, particularly in this CEO position, my major, you know, working not on R&D. I have a very strong, you know, background on R&D perspective. There's no question.
In the last, you know, almost 10 years, I served as president of another biotech, you know, early 90, let me see, 2019, you know, for one year. You know, took care of our entire business for that biotech. Come to Huadong, you know, we have right now almost 100 ongoing projects and inventions inside are almost 60. I also take some responsibility to bring this compound outside to find a partner to add the license and BD deals. I'm very active. I attend a JP Morgan for the last five years. Come to the Heidelberg Pharma business role as a CEO and a leader of this company.
You know, I'm thinking every day, you know, not only R&D perspective, clinical trials and new pipeline assets. I'm also thinking how we can earn the money, how we can save the money, how we can raise the money. You know, the three answers is a key, you know, for me to lead the company, working with the colleagues, working with you know, Heidelberg Pharma teams, turnaround and move back to a growing path for next couple of years. You know, I'm fully you know aware of this needs and also like to launch that. We already did that. You know, this year's JP Morgan, they bring several potential collaboration. Right now we are talking with them. You know, that's this one word to you is I'm fully responsible, all business expected. Of course, there's you know, CFO have their expertise on the financial part. I'm CEO as well, you know. I do want to work with the team to get a better financial support 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?
Maybe this is a question more for me as the CFO. As we presented the guidance in the last minutes, I think this is almost answered. Here what I can indicate for our cash runway until mid-2027, the EUR 20 million are included, what is probably obvious. We also have reflected in that cash runway already the milestones we 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 very solid and confident base to take that into our planning. 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? 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. 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%-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 ongoing collaboration for that. Also study scope and costs, 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. You know, right now, it's time to think about, you know, moving forward for the further clinical development for HDP-101. The clinical phase II-A, which we call the expansion study, is on the agenda. Also, we already prepared for last couple months how we design the study, how we finalize the protocol, how to get this clinical site PI selected and initiated. As I can share with you, the phase II-A is well-designed. Is very good. You know, we discussed this phase II-A study with FDA, you know, years ago.
Then we get, you know, aligned also very supportive from FDA, gave us the use of one dose. You know, if you can call that recommended phase II dose to conduct it at the expansion study that they're acceptable. That is the regulatory communication so far. We go that direction. We're going to use one recommended phase II dose so far collected and move to the phase II- A study. Right now, we are very close to finalize that. Then that's number one. Number two, for this trial, we're going to conduct in 30 multiple myeloma patients. We carefully design what kind of a patient recruitment requirement needed.
Of course, you know, naive patient or pre-treated with BCMA therapy is also under consideration. You know, we want to have both of them in the trial. This is the current consideration. Then the third you asked about, the cost. You know, we, because we already have this very good learning from phase I study and the performance of each clinical site, the PIs collaboration, and also including the CROs collaboration. So they're gonna be more efficient in terms of the team effort, expert effort, and the resources and budget used for these trials. From my perspective, I'm really confident we're going to run this phase II- A study very pretty soon.
Use the best knowledge, the best management, and the most important best cost-efficient method of moving forward. I cannot tell you when the readout, but this is 30 patient, pretty large number of patient enrollment. We do want to have a lot of biomarker, you know, collected as much as possible. You mentioned the 17p deletions. We're collecting that data, you know, as much as we can. But this is really a POC concept testing. We want to reproduce what had been observed so far at the Cohort 8, you know, that is more than 50% overall response. That's very promising result. The Cohort 9 right now is ongoing, and Cohort 10 ongoing.
I hope that the data generated from the phase I, we can reproduce at the phase II or even better, you know, statistically meaningful outcome. With that being said, I hope by middle of next year, we're gonna have some initial data on this one. Hopefully, if not top line, but we'll try our best to fast recruit the patient in and enroll them in, and then get them dosed and have the first couple of months of initial data. We're going to, you know, keep the outside world, you know, informed because we also are expecting this result to come out and then, you know, same as you. That's my, you know, answer to you. Now stay tuned. I think we're gonna announce the first patient in for the phase II-A study, you know, if that ready and everything go right direction. Thank you.
Now we have questions on the phase I combination therapy of HDP-101. 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. You know, right now, the cancer therapy is, you know, doesn't matter what the mortality come from, is chemotherapy, TCE, RT, ADC, or et cetera. I think, come to very recent trend is combination therapy together. That is how the cancer therapy go direction. Come back to one. You know, we think about this is automatically going to have some combination therapy, you know, in the later stage. For example, you know, phase II to be something initial testing. Right now, for Heidelberg Pharma, we want to focus, finish phase I- A first. We get the testing of the safety and the FSA signal and conclusive study as quick as possible.
Based on this, you know, assumption or result, we move to phase II-A monotherapy to testing the recommended phase II dose in a little bit large quantity of patients, number 30 and see whether we can reproduce the phase I particular Cohort 8, 9, 10s efficacy data, so meaningful and et cetera. This is our focus now. Talking about the partner with Huadong, they because they use, you know, they already have knowledge of our progress of the phase I data. They know what the roughly safety dose and what the recommended, you know, 140 is looks very good dose. They start in 110, but they're going to go to 175 eventually. They have a very quick bridging study in China.
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 designed. Thank you for that suggestion. Combo therapy definitely is ADC, not only for one. You know, entire world thinking what is a strategy use a combination therapy for cancer treatment. In particular, really right now, we go that direction. There's too many modality available. They have their individual strengths, but put them together, they definitely provide lot of solutions for unmet medical needs, in particular cancer tough cancer treatment. Yes, we are collecting more data, more efficacy signal, and also as the progress with China partner Huadong Medicine's program in China, we're going to have more thinking of the 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?
Sorry, which program are we talking about?
The current R&D programs, so one or two.
Regarding the remaining one, well. As you know, 102, due to you know, the financing situation last year, if we do have the Telix payment, we're going to move very fast on the 102 clinical trial. That one, you know, unfortunately, we have to you know, put the recruitment further on hold. We have three patients in the Cohort 1, a lower dose. That is the situation for 102. We're open for partnering, you know, for this one. This is CD37 ADC. Not only the amanitin payloads are novel, but the CD37 also relatively novel as well.
Because this, you know, when you look at all these ADC approvals, there are no CD37 as a TA, ADC target. So, you know, we are open to have more partners talk to us. We do have in these three patients, you know, the data we can share with them. You know, this is a phase I asset. So that one, I cannot discuss, you know, further because this is not ready to discuss yet. But, you know, we're open to discuss with all potential collaborators. As I actively looking for that outside out-licensing.
For the 103, we have China right, license to give to Huadong Medicine. They also conduct some internal study, particularly reproducing the efficacy data in the animal models. They're working on it. You know, if this data pretty good, they're going to start a phase I in China for 103. Meanwhile, you know, PSMA ADC, amanitin-based is a unique opportunity for us to demonstrate for this prostate cancer, very high demand in, lot of medical needs. Even though they have other TCE, you know, dual target TCE engagers in the development.
I still think ADC can provide unique opportunity for this very high needed, you know, also high mortality rate, particularly in the Western world, for this indication. For this one, we're definitely open to partner and, you know, the most important of all three to have some initial clinical data. I think that more convincing, the more value. As you know, we are preparing the IND documentation package, so means that this asset's ready to conduct clinical trials. We have CMC, we have toxicologists, we have preclinical animal DMPK pharmacology study ready. That is, you know, the stage we are. You know, we're open to all potential collaborators who come to us, and we're very actively looking for partners for these two assets. Thank you.
Thank you. With this, we come to the end of our Q&A session. Please send any further question you may have to the IR department of Heidelberg Pharma. With this, I would like to conclude the conference call.
Great. Thank you so much.
Thank you, everybody.
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