Heidelberg Pharma AG ($HPHA)

Earnings Call Transcript · March 26, 2026

XTRA DE Health Care Biotechnology Earnings Calls 63 min

Earnings Call Speaker Segments

Operator

Operator
#1

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

Dongzhou Liu

Executives
#2

Thank you, and hello, everyone. Good afternoon, and welcome to the Heidelberg Pharma conference call. to discuss our 2025 fiscal year results and provide a business update. My name is Jeffery Liu, and I'm the CEO of Heidelberg Pharma. Joining me today on the call is our Chief Financial Officer, Mr. Walter Miller. We look forward to provide you with an update on the company and the progress we have been making. Please note that the presentation today is available for you to download on the Heidelberg Pharma's website. This conference call is being recorded, and a replay will be available after the live event. Please turn to the next slide. Thank you. But before we begin, I just want to make a note on this. We will make 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. With that, let me start. Next slide, please. First of all, let me just touch on some key points from today's talk and also they are showing on this slide. Heidelberg Pharma is focused on the development of innovative antibody drug conjugate also called ADC. Based on our proprietary managing payload technology, to our knowledge, we are the only company using a managing 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 visited a Lender German headquarter regularly and working very closely to the team. and leading the transformation process. Despite the challenges we are all fit in the past year, the team is doing wonderful intelligent work and it is inspiring to work with them and witness their activity to drive the company moving forward. We currently have about 35 employees a significant reduction from the approximately 120 employees we had at the end of fiscal year 2025 on November 30, 2025. This decrease is a result of the strategic refocusing measures as we implemented last fall. More on this shortly in the presentation. Our lead clinical program is HDP-101. We will use the international nonprimary name called pamlectabart tismanitin in the future and is currently being evaluated in an ongoing Phase I and Phase IIa clinical trial in patients with relapsed and refractory multiple meal. We are seeing encouraging efficacy and safety data, which we will discuss in more detail later in this presentation. I would like to note a couple of other important points. Heidelberg Pharma already has placed the necessary GMP manufacturer supply chain. This is a critical importance given the complexity of producing this type of ADC compound. We also have a very strong IP portfolio with more than patent families and our 50 family members covered our platform, payloads and the method they use. During today's presentation, water will review of financial results and the recent steps we have taken to significantly extend our cash runway, which now is ended into middle of 2027. I will discuss the progress we are making with HDP-101 and provide you an outlook on what we expect in the coming months. Please turn to the next slide, please. You will recall that we had licensed our legacy diagnostics imaging agent, TLX250-CDx now we called TLX250-Px to Telix Pharmaceuticals. We subsequently monetize a part of the potential royalty stream from their agreement with health care royalty. As a part of the agreement with health care reality, we will to receive USD 70 million milestone payment upon FDA approval of TLX250-Px and we plan to use this money to fund our ADC pipeline, 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, the Telix reported that the company has received a complete response letter, CRL, identifying difference relating to the chemistry manufacturers control CMC package. FDA requested additional data to establish comparability between the drug products used in the XCN Phase III clinical trials and the scale of manufacturer process intended for commercial use. Additionally, the FDA documented notice of defenses issued to 23rd party of manufacturer and supply chain partners that will require meditation paired to resubmissions. So given this unexpected delay in the approval, we need to take a quick and major steps to use 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 P1 and a significantly reduced operating event. That side 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 pre-clinical R&D work. This decision was difficult and they impacted many of our colleagues and the result in the workforce reduction of approximately 75% by mid of this year. Such measures were necessary to continue the development of CPI and extend our cash runway. Therefore, ensure the people of our company. I would like to acknowledge our former employees who dedicate their time and talent to the company now having us go as today. Let me now turn the call over to Walter, who will discuss the expense and the savings resulting from these measures and the recent additional steps we have taken to put the company on a firm financial footing. He will also review the financials for fiscal year 2025 and provide financial guidance for 2026, Walter, please.

Walter Miller

Executives
#3

Thank you, Jeffery. Turning to the amended agreement, healthcare royalty and the participation of Soleros capital. Earlier this month, we announced a further amendment to the existing royalty purchase agreement with Healthcare Royalty including the participation of Folio's 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-Tx. Under the amended agreement, Heidelberg Pharma is eligible to receive USD 20 million from Solis Capital, subject to customary closing conditions. These conditions have been fulfilled already and the payment is expected to be received soon. Another payment of USD 25 million will become due upon FDA approval of TLX250-Px. As a quick reminder, in March 2024, Heidelberg Pharma entered into an agreement with Selco Royalty for the sale of royalties on TLX250 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 royalty stream alongside certain other contractual changes. The participation Soleus Capital has no impact on the payments from health care royalty. It is important to note that the original milestone payment of USD 70 million from HCRX linked to FDA approval in 2025 will now be significantly reduced because approval did not occur within the agreed time lines. The structure of the agreement continues to provide attractive nondilutive funding for the companies. The upfront payment from Soleus Capital. -- immediately strengthens our cash position by the potential future approval milestone payments and royalties on sales will allow us to participate in the long-term success of the product. Let's turn now to the financial statements for fiscal year 2025, which ended on November 30, 2025. Starting with the P&L, the company reported sales revenue and other income of EUR 6.9 million in fiscal year 2025, a significant decrease year-over-year as expected, given lower revenue from collaboration agreements for the ATEC 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 M&A linkers to licensing partners. Research and development costs rose year-over-year to EUR 38.7 million from EUR 21.8 million in 2024, mainly due to higher costs for the ongoing clinical trial with timetable the initiation of the second clinical trial with HDP-102 and restructuring-related costs, which amounted to EUR 9.6 million. At 79% of operating expenses, R&D remained the largest cost item. Administrative costs were EUR 7.6 million an increase over the prior year figure of EUR 6.7 million and accounted for 15% of operating expenses. Restructuring expenses in this line item were EUR 1 million. Other expenses for business development, marketing, commercial market supply activities and all other items, which mainly comprise staff and travel costs increased slightly year-over-year to EUR 2.4 million from EUR 2.3 million in the prior year and made up 5% of operating expenses. Net loss for 2025 was EUR 42.3 million, up significantly from 2024 due to lower sales revenue and significantly higher R&D expenses as well as the restructuring measures initiated. Earnings per share were minus EUR 0.91. Looking at the balance sheet. Noncurrent assets at EUR 9.8 million by end of November 2025 were down considerably compared to the prior year figure of EUR 13.2 million. Other current assets were EUR 13.3 million, down from EUR 18.1 million in the prior year. The 2025 figure included inventory of EUR 10.6 million. Cash totaled EUR 15 million in 2025. Total assets at the end of the fiscal year amounted to EUR 38.1 million compared to EUR 60.7 million in the previous year. The decrease was mainly due to cash outflows. Turning to liabilities. Noncurrent liabilities totaled EUR 37.8 million compared to EUR 21.8 million for 2024. Most of this amount was attributable to the additional upfront payment of USD 20 million received from Healthcare Royalty in 2025, which also has to be deferred as a financial liability. Looking at current liabilities. Trade payable rose to EUR 7.2 million compared to EUR 5.5 million for the prior year. Due to the strategic refocusing announced in September 25, the company recognized restructuring provisions of EUR 3 million for staff, building vacancies, litigation costs as it retirement obligations and onerous contracts. Turning to equity. At the end of the reporting period, Equity was negative at EUR 10.9 million compared to positive EUR 30.9 million at the end of '24. Extraordinary charges of EUR 10.6 million were incurred as a result of the restructuring measures and contributed significantly to the year-over-year change in equity. The equity ratio was minus 28.6% versus 50.8% for the prior year. Just a quick look at cash flow for the year. Starting with the financial activities in '25. In March 2025, we amended the existing license agreement with HRX dated March 24, providing Heidelberg Pharma with an immediate payment of USD 20 million, which translates in a cash inflow of EUR 18.4 million. As a reminder, we wave a sales-based milestone payment of USD 15 million. FDA approval stone for TLX250 was reduced from USD 75 million to USD 70 million, with further significant reductions if FDA approval occurs after 2025. You see our use of cash as well as cash proceeds from financing activities. Average monthly cash used was EUR 1.2 million. The most important point on this slide is at the bottom. The payment we expect to receive in April from Soleus Capital extends our cash reach into mid-2027. Let's now look forward to the guidance for 2026. We expect sales revenue and other income of between EUR 11 million and EUR 15 million in 2026, mainly related to milestone payments and supply delivery to partners. With the strategic focus we started last fall, we expect to significantly reduce operating expenses to between EUR 25 million and EUR 29 million. Cash outflow is expected to be between EUR 0 million and EUR 4 million in total resulting in a monthly cash outflow of between EUR 0 million and EUR 4.3 million. This careful management of our costs and the cash inflow from Soleus Capital. We expect to have sufficient funds for ongoing equations until mid-2027. Let me now turn the call back to Jeffery, who will provide an update on our R&D activities, focusing on HDP Bannon. Jeffery, please?

Dongzhou Liu

Executives
#4

Thank you, Walter. Yes, let me give you the next couple of slides for the R&D update, particularly focus on the HDP-101the most important projects. As you can see from this slide, give you a very quick refresher on HDP-101. This we have an official -- in name, we call the Paleo emanating is being developed for the treatment of multiple mesomatype of blood cancers. The global incidence of multiple enva is approximately 180,000 globally, and the disease remains associated with a high mortality rate. HDP-101 target BCMA surface antigen that's highly expressed on myeloma cells. The antibody components want specifically to PCI and delivers a managing payload directly into the cancer cells where it inhib polymers 2 and ultimately induce the cell death. Our ongoing Phase I/IIa clinical trial is evaluating HDP-101 in patients with relaxed or refractory multiple metal whose disease has progressed on multiple lines on therapy and who have very limited treatment options. The study is designed to evaluate the safety, tolerability for mocks and the preliminary efficacy of HDP-101 in this patient population. The Phase I called the dose escalation study is ongoing. Turing cohort so far, we complete almost patient enrollment. We have seen encouraging safety as well as early efficacy signals. The latest available results from cohort 8 were presented in November 2025 at the World ADC Conference and discussed during the website webcast we help around that event. Please turn to the next slide, please. So let me just briefly highlight the preliminary efficacy data result from the cohort -- we were truly excited to report that of the 8 patients treated in this cohort, which is 140-microgram per kilo dose, 2 is various complete response to other patients is very partial response, 1 is saves stable disease and 2 progress, 1 patient was not evaluable. Consider this patient disease had the progress of following multiple lines of therapy. This result of particular compelling and encouraging. Please turn to the next slide. Thank you. This slide summarize our objective response rate for the higher dose cohort 5 through 8 in the ongoing Phase I trial. Look at this 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 stent complete remission. In 48 alone, we are seeing a preliminary objective response rate of 57%, with 4 out of 7 invaluable patients responding including, as noted in the private slide, 2 stringent complete response. While the results from the cohort are still preliminary they provide encouraging evidence that HDP-101 has meaningful under-tumor activities, even in heavily pretreated patients, demonstrating promise in dose-dependent anticancer activity with deep clinical response. Please on the safe side. So this led focus on the safety measures in the clinical trials. From the safety perspective, CB1 has shown a favorable tolerability profile across all dose levels tested so far, including the most recent cohort 9. The Corona dose was found to be safe and tolerable and the evaluation of the efficacy is ongoing. Up to Cohort the MTD Maxim tolerable dose are still not yet reached. Across all cohorts, we have observed now in of our cooler toxicity, no infusion reaction, not insensitive mellosuppression and non-liver damage. Our transient reduction in plate cost, we also called the thermoset pane was seen in some of the cohort trials. But this effect was manageable and has been mitigated through adjusted dosing resuming strategy. In addition, there is no evidence of in reversible toxicity in patients receiving treatment so far for more than 12 months. All patients had relaxed refractory myeloma and were heavily pretreated and have exhausted all available treatment option, so that is the data we deliver based on this huge heat treatment patients. The safety data from Coho9havesupported moving to the next cohort at the dose of 118-gram per kilo. Enrollment in cohort is now underway. When the optimal dose has been identified in the Phase I clinical trial, the trial will be moved into the Phase IIa dose expansion stage to test this dose in a large patient population. We expect to move into the dose expansion study in Q2 and Q3 of this year. Let's now take a look at this overall pipeline. Next slide, please. So our focus will remain on HDP-101 for the treatment of multiple melanoma. We expect to complete this Phase I part of the ongoing trial still in the first half of this year and will bring the recommended Phase II dose in the second half of this year, hopefully in Q3 I also wanted to note that the recently announced or partner Badunmedicine has initiated a Phase I bridging study in China. The trial will evaluate the safety, tolerability for cocinetics and efficacy of HDP-101 in Chinese patients with plasma cell disorder, including multiple myeloma. The bridging study is being conducted to ensure that the safety and efficacy data of ATEC technology-based ADC is comparable across the worst population and it's an important requirement for advancing the development of this product globally, including the testing and Asian population. Our other development programs are available for partnering for HDP-101 or 2 for non-Hodgkin lipoma we have put a recruitment for ongoing Phase I study on hold but continue to treat 1 patient still enrolled in the trial. With clinical HDP-103right now, the status for the treatment of advanced hostile cancer, we are preparing the study application for the Phase I clinical trial However, we have not developed this program further on ourselves. LTB4 for collector cancer will not be developed further internally. Turning to our partner program, starting with our partner with Takeda. And as you remember, in 2017, we signed exclusivity research agreement with agita related to several targets for joint development ADC using Amenity. Under the terms of agreement, Tadano Pharma produced several -- at using antibodies for Takeda prefatory portfolios. As a result of this work, Takeda acquired an exclusive license in 2022, to commercially develop an APAC with an undisclosed target. Takeda is responsible for further preclinical and clinical development as well as a potential commercialization of the licensed product candidate. In January of this year, we announced receipt of the milestone payment with the dosing of the first patient in the Phase to 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 clinical further development. Looking at the Calix. In 2017, we outlicense or legacy asset, the diagnosis antibody green type or now called TL20 to the Australian company, Telix Pharmaceuticals. As discussed earlier, Telix received a complete response letter for the biological license application or BLA for TCS this summer. In the press release reporting 2025 be not result published in February, Telix indicated based on the 2 type A meeting with FDA. Tenet believe that it has aligned with the agency on key outstanding issues for the BLA resubmission. -- including the demonstration of drug productive 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 presubmission -- our license agreement with Telix also covered the development of a therapeutic radio immuno conjugation program, also called the TLX-250-Px. Telix recently reported that they received regulatory approval to start a global Phase II and III trials in the metastatic clear cell renal carcinoma in addition of Phase Ib and 2 investigator initiated trial IT, is exploring PLX-250Px in combination with other therapies in the same indication. So let me wrap up on the next slide, please. In 2025, we certainly had a major sale with Telix CRL that forced us to make difficult decisions about our business strategy. At the same time, we are seeing highly promising early results with our leading program, HDP-101and expect to move this into Phase IIa in the Q2, Q3 of this year. We have taken further steps to put the company on a firmer financial footing and are excited to report further clinical progress in the months ahead. We are in a truly dynamic space in biotech the ADC market is expected to grow to USD 32 billion in 2033. Most importantly, all work for the promise of helping patients with today's type limited treatment option. Next Slide, please. So with that, I would like to thank you for all your attention and your continued interest support in a Heidelberg Pharma. We will now open the call to your questions. Operator?

Operator

Operator
#5

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

Walter Miller

Executives
#6

Yes. Let me answer that question. Thank you for that question. Very good. I know a lot of investors, analysts or even the ADC world industry, also including academia, I'd like to know what's new, what's the update and particularly the higher dose cohorts 9 and Cohort 1, which is a 175-microgram per kilo and micron per kilo. So this is 2 doses we're right now testing in the clinical Phase I trials. So 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. And we hope to get particular the Cohort 1 that is higher to 18 micrograms per kilo. And we're going to bring this initial safety and FX data to the Safety Review Committee early April and need their assessment and see whether we can report this data in the coming months conference. But we do plan to present this particle cohort 9 and 10 clinical result the later years of this conference globally. So thank you for this one. We keep you updated as soon as we release the data outside. Thank you.

Operator

Operator
#7

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

Dongzhou Liu

Executives
#8

I'm sorry, say that again, another -- higher cohort?

Operator

Operator
#9

Yes. At what time will you be able to say if there is going to be a cohort 11 or if you already have the dose for Phase 2?

Dongzhou Liu

Executives
#10

Okay. Yes, good question. Because this trial is ongoing, -- what I can share with you is, first of all, the safety is manageable. And the MTT maximum tolerability dose is not reached yet. And we do the data evaluation because they give us some time on the cohort 10, particularly to 18 dose that take the time to measure the efficacy signal, what is overall response because we enrolled so far up to 5 to 6 patients in this cohort. So we need a little more time to assess the efficacy data readout. But I can share the principle we looking at is whether we do cool or not because it's not decided yet. We got to bring this to the SRC committee early April, but we do have internal discussion as well. While for all consideration, we want to see that, first of all, is that a safe enough as MTD dose is almost there or the particular efficacy. Even though we have a very limited patient number in each cohort, but I want to see the measure is that the efficacy data of Cohort 8, 9, 10, as we continue to go up, improve efficacy reading out or rebates. So -- but I can share with you we are almost close to the end of Phase III study. And we are trying everything we can to move to Phase IIa, those the expansion study with relative what we call the recommended Phase II dose moving forward. So that is information I can share with you, but we are not have a decision on cohort 1 for the time being. Thank you.

Operator

Operator
#11

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

Dongzhou Liu

Executives
#12

Okay. Good question. It's no question. But we are in the same pharma industry we're in the same category, hartals have ADC. And Heidelberg is an ADC focus about tech. And on 5 years ago, invested Heidelberg Pharma is because the ATAC technology. We're really thinking a managing base ADC can provide some very unique solution to the unmet medical needs, particularly right now, you know there's a lot of top line inhibitor and may limit the choice to choose the payload. And I'm managing the opportunity to provide additional payload the mechanism to kill the cancers. So I think that is -- we have the same missions on ADC conjugation drug. And we have a lot of synergy between these 2 companies and particularly the ADC teams. So I'm also working all the heydays and working with both teams -- and particularly, they started some new initiatives collaborating together for some projects. So particular 103 right now is I don't already have the China right. So while 1 in China already started, the first patient in March '17 already started. So we very close working together, both teams on this program in China because they can provide additional valuable technical outcome result in addition to MRCT right now running by -- sponsored by Heidelberg home. So in terms of my timing, I spend as much as can probably every day working with the Heidelberg Pharma team online or virtual man side. In the handlebar office, almost every remote say here, at least I cannot give precise how many days, but I leave a really decent number of days stay in Hamburg office. So I'm level, if I need more frequently come here, it's no problem. So right now, there's a lot of virtual working environment. So I'm really confident that moving forward, we're going to bring this particularly the ADC collaboration if we do have a collaboration program together, more close together. And so hopefully, answer your question.

Operator

Operator
#13

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

Dongzhou Liu

Executives
#14

Yes. Good question, too. As growing the responsibilities and my something that not as something I already did that. It's close profile as the senior management as the CEO for the company, take all the opportunity to broadcasting promoting or program or project or assets technology platform globally, find a partner. For me, I think particularly in this CEO position, my major working not on R&D, a very strong background in R&D percent. That's no question. But in the last almost 10 years, I see not about tech President early 2019 for 1 year, taken our entire business for the biotech -- and I come to had, we have right now have almost 100 ongoing projects and invented inside almost safety -- so I also take some responsibility to bring this compound outside to find a partner to have the licensing BD deals. So I'm very active attending Morgan for the last 5 years. And I come to the Heidelberg Pharma business role as the CEO and the leader of the company, I'm thinking every day, not only R&D perspective clinical trials and new pipeline settles. I'm also think how we can earn the money, how we can save the money, how we can raise them on the 3 answers is key for me to lead the company, working with the colleagues working with high number of pharmacies change around and move back to growing at for the next couple of years. So I'm fully aware of this leads and also like to be large back. We already did that. This year, CP Morgan they bring several potential collaboration. Right now, we are talking with them. So that 1 word to you is I'm fully respond to all business expected and of course, the CFO have their expertise on the financial part. But MBA as well. So I do want to work with the team to get a better financial supporting and outlook for the future.

Operator

Operator
#15

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 Fraudong HDP Phase 2 comments? And can you provide an indication of the size of this potential milestone?

Walter Miller

Executives
#16

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

Operator

Operator
#17

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

Walter Miller

Executives
#18

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

Operator

Operator
#19

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

Dongzhou Liu

Executives
#20

Okay. I think that's -- I'd like to answer that question. Very good question. Right now, is time to think about moving forward for the further clinical development for STP. So the clinical Phase IIa basically called expansion study. is on the gene. And also, we already prepared for the last couple of months, how we designed the study, how we finalize the protocol, how to get this clinical side, the PI selected and the initiative. So as I can share with you, the Phase IIa is we designed is very good, we discussed this Phase I study with FDA years ago. And then we get aligned also very supportive from day gave us a use of 1 dose. If you can call that recommended Phase II dose to conduct the expansion study that they are accessible. So that is the regulatory communication so far. We go that direction. We're going to use 1 recommended Phase II dose so far collective move to the Phase IIa study. So right now, we are very close to finalize that. And that's number one. Number two, for this trial, we're going to conduct in 30 multiple alone patients -- and we carefully design what kind of patient recruitment requirement needed. And of course, naive patients are pretreated with therapy is also under consideration. We want to have both of them in the trial. This -- the current consideration. And then the third, you asked about the cost -- because we already have this very good learning from Pasi study and the performance of each clinical side, I collaboration and also include the CLOs collaboration. So they're going to be more efficient in terms of the team effort, expertise effort and the resources and budget use for these trials. So from my perspective, I'm really confident we're going to run this Phase III study very pretty soon and then use the best knowledge the best management and the most important best are cost-efficient, mass of the move forward. I cannot tell you the readout, but this is a 30 patient the large number of patient enrollment. We do want to have a lot of biomarker collect data as much as possible. You mentioned the P-17 deletions. We're collecting that data at the most we can. But this is really a POC concept testing. -- they want to reproduce what has been observed so far in the cohort 8, that is more than 50% overall response. That's very promising results and call how the right now is ongoing core ongoing. So I hope that the data generated from the Phase I we can reproduce a Phase II or even better that is meaningful outcome. So with that being said, I have a middle of next year, -- we're going to have some initial data on this one. obits not top line, but we're trying our best to faster recruit the patient in and enroll them in and then get the dose. And have the first couple of months of initial data. And we're going to keep our fab work informed because they also are expecting these results to come out and then as same as you. So as my answer to you and I'll stay tuned. I think we're going to announced the first patient in for the Phase III study, if that's ready and everything go right the direction.

Operator

Operator
#21

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

Dongzhou Liu

Executives
#22

Very good question. Right now, the cancer therapy is it doesn't matter what the mortality come from. It's a chemotherapy, TCE, RT, ADC or sellers. So I think I come to a very recent trend is combination therapy together -- so that is how the cancer therapy go direction. So come back to Model 1, we think about -- this is automatically going to have some combination therapy in the late stage. For example, Phase IIb, something initial testing. But right now, for handoff, we want to focus finish is first. We get the testing of the safety and the FSC signal and conclusive study as quick as possible. And then based on this assumption of result, we moved to Phase IIa monotherapy to testing the recommended Phase II dose in late large quantity of patient and see whether we can reproduce the Phase 1 particular cohort 910 efficacy data, so meaningful and et cetera. So this is a focus now -- and talking about the partner with pardon, because they use -- they already have knowledge of our progress of the Phase I data, they know what roughly safety and whether recommended 140 those very good dose, they're starting 140, but they're going to go to 175 eventually. So they have a very quick bridging starting in China and then the -- I cannot give you too much on that information, but they do have very good comprehensive clinical development program moving forward in China territory design. So thank you for that suggestion combo therapy of ADC, not only for 1 entire award thinking what is the strategy use on combination therapy for cancer treatment, in particular, really right now, we go that direction too many mortality available. They have their individual streams, but put them together it definitely provide a lot of solutions for unmet medical needs in particular cancer tough cancer treatment. So yes, we -- lagging more data, more efficacy signal and also the progress with China partner automedicines program progress in China. We're going to have more thinking of combination therapy as well.

Operator

Operator
#23

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

Dongzhou Liu

Executives
#24

So sorry, which program are we talking about?

Operator

Operator
#25

The currently XXXXXXXXXXXXXXX is going to be --

Dongzhou Liu

Executives
#26

Our remaining well -- as you know, no 2 are due to the Benatsituation last year, if we do have the tale payment, they're going to move very fast on the 2 clinical trial. So that one, unfortunately, we have to put this recruitment further on hold. We have 3 patients in the Cohort 1, the lower dose, -- so that is the situation for Model 2. We open for pardoning for this one. This is CD37, DC, not only the managing payloads and novel but CD37 also relative novelty as well because this -- when you look at all this approval C, there are no CD37 as TA as an ADC target. So we are open to have more other talk to us. We do have the 3 patient data we can share with them. This is a Phase I asset. So that one, I can disclose further because there is not in the ready to disclose yet. But we're open to discuss out potential collaborator and they're actually looking for that outside or licensing. And for the 103, we have China right likes to give to auto medicine. So they also conduct some internal study, particularly in some reproducing the efficacy data in the animal models. They're working on it. And then if this data is pretty good, they're going to start the Phase I in China for 3. But meanwhile, PCA, ADC, minting base is a unique opportunity for us to demonstrate for the fast cancer, very high demanding a lot of medical needs. Even though they have other TCE, dual target TCE engagers in the development, but I still think BDC can provide unique opportunity for this very high needed also higher mortality rate, particularly in the Western world for this indication. So for this one, we debit open to partner and -- but the most important model to have some initial clinical data. I think that's more commencing more value. But as you know, we are preparing the R&D documentation package. So it means that this asset is ready to conduct clinical trials. So we have CMC, we have cosecologies. We have preclinical animal DMPK pharmacology study ready. So -- so that is the stage we are. But we opened to all potential collaborations come to us, and we're very actively looking for a partner for these 2 assets. Thank you.

Operator

Operator
#27

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

Dongzhou Liu

Executives
#28

Great. Thank you so much.

Walter Miller

Executives
#29

Thank you everybody for joining.

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