Heidelberg Pharma AG

Heidelberg Pharma AG

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Q4 FY2025 · Earnings Call TranscriptMarch 26, 2026

Operator

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.

Dongzhou Jeffery Liu

Thank you, and hello everyone. Good afternoon, and welcome to the Heidelberg Pharma conference call to discuss our 2025 fiscal year's result and provide a business update.

My name is Jeffrey Liu, and I am the CEO of Heidelberg Pharma. Joined me today on the call is our Chief Financial Officer Walter, Mr.

Walter Miller. We look forward to provide you with the 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 the 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 making forward-looking statement during the call and the question-and-answer section.

For more detail information on the risk and uncertainty affecting our business, please refer to our 2025 management report. This was published this morning and is available on our website.

With that, let me start. Next slide, please.

Let me just touch on some key points from today's talk and also the showing on this slide. Heidelberg Pharma is focused on the development of innovative antibody-drug conjugate, also called ADC, based on our proprietary amanitin payload technology.

To our knowledge, we are the only company using amanitin for drug development for ADC category. We are in the highly promising areas of drug development.

I'm excited about this work we are doing. As I joined the company as the 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 Ladenburg German headquarter regularly and working very closely to the team, and leading the transformation process.

Despite the challenges we are all faced in the past year, the team is doing wonderful, intelligent work, and it is inspiring to work with them and witness their activity to drive the company moving forward. We currently have about 35 employees, a significant reduction from the approximately 120 employees we had at the end of fiscal year 2025 on November 30th of 2025.

This decrease is a result of the strategic refocusing measures as we implemented last fall. More on this shortly in the presentation.

Our lead clinical program is HDP-101. We will use the international nonproprietary name called pamlectatug tesamanitin in the future, and it's currently being evaluated in an ongoing Phase 1 and Phase 2a 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 a place, the necessary GMP manufacturer supply chain. This is the 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 our 50 family members covered our platform, payloads, and the method we use. During today's presentation, Walter will review our financial result and the recent steps we have taken to significantly extend our cash runway, which now extended into mid of 2027.

I will discuss the progress we're making with HDP-101 and provide you then outlook on what we to expect in the coming months. Please turn the next slide, please.

You will recall that we had licensed our legacy diagnosis imaging agent, TLX250-CDx, now we called TLX250-Px, to Telix Pharmaceuticals. We subsequently monetized the part of the potential royalty stream from their agreement with HealthCare Royalty.

As part of the agreement with HealthCare Royalty, we were to receive US$70 million milestone payment upon FDA approval of TLX250-Px, and we plan to use this money to fund our ADC pipelines, including the new pipelines. We have expected Telix to receive US FDA marketing approval for this product in August last year.

Unfortunately, this didn't happened. Instead, Telix reported that the company had received Complete Response Letter, CRL, identifying deficiency relating to the chemistry, manufacturing, controls, CMC package.

The FDA requested additional data to establish comparability between the drug products used in the Zircon Phase 3 clinical trials and the scale-up manufacturing process intended for commercial use. Additionally, the FDA documented notice of deficiency issued to two third party manufacturing and supply chain partners that will require remediation prior to resubmission.

Given this unexpected delay in the approval, we need to take a 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 the 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 colleagues and the result in the workforce reduction of approximately 75% by mid of this year. These measures were necessary to continue the development of HDP-101 and extend our cash runway.

Therefore, ensured the future of our company. I would like to acknowledge our former employees who dedicate their time and talent to the company and helping us go as today.

Let me now turn the call over to Walter, who will discuss the expense and the saving 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.

Walter Miller

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 US-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 €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 €5.5 million, mainly comprised of exchange rate gains of €3.2 million, research allowances and government funding of €0.5 million, and a milestone payment of €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 €49 million in 2025 compared to the previous year's amount of €32.6 million. 2025 figure included expenses related to the restructuring measures in the amount of €10.6 million for staff costs, major contracts, and asset and inventory writedowns.

Cost of sales was €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 €38.7 million from €21.8 million in 2024, mainly due to higher costs for the ongoing clinical trial with pamlectatug tesamanitin, the initiation of the second clinical trial with HDP-102, and restructuring-related costs, which amounted to €9.6 million.

At 79% of operating expenses, R&D remained the largest cost item. Administrative costs were €7.6 million, an increase over the prior-year figure of €6.7 million, and accounted for 15% of operating expenses.

Restructuring expenses in this line item were €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 €2.4 million from €2.3 million in the prior year and made up 5% of operating expenses.

Net loss for 2025 was €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 -€0.91.

Looking at the balance sheet, non-current assets at €9.8 million by end of November 2025 were down considerably compared to the prior-year figure of €13.2 million. Other current assets were €13.3 million, down from €18.1 million in the prior year.

The 2025 figure included inventory of €10.6 million. Cash totaled €15 million in 2025.

Total assets at the end of the fiscal year amounted to €38.1 million compared to €60.7 million in the previous year. The decrease was mainly due to cash outflows.

Turning to liabilities, non-current liabilities totaled €37.8 million compared to €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 €7.2 million compared to €5.5 million for the prior year. Due to the strategic refocusing announced in September '25, the company recognized restructuring provisions of €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 €10.9 million compared to positive €30.9 million at the end of '24. Extraordinary charges of €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 -28.6% versus 50.8% for the prior year. Just a quick look at cash flow for the year.

Starting with the financial activities in '25, in March 2025, we amended the existing license agreement with HCRx dated March '24, providing Heidelberg Pharma with an immediate payment of $20 million, which translates in a cash inflow of 18.4 €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 €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 €11 and €15 million in 2026, mainly related to milestone payments and supply delivery to partners.

With the strategic focus we started last fall, we expect significantly reduced operating expenses to between €25 and €29 million. Cash outflow is expected to be between €0 and €4 million in total, resulting in a monthly cash outflow of between €0 and €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.

Dongzhou Jeffery Liu

Thank you, Walter. Yes, let me give you the next couple of slides for the R&D update, particularly focus on the HDP-101, our most important project.

As you can see from this slide, give you a very quick refresher on HDP-101. We have an official INN name called pamlectatug tesamanitin, 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 inhibits RNA polymerase II and ultimately induces cell death. Our ongoing Phase 1/2a clinical trial is evaluating HDP-101 in patients with relapsed or refractory multiple myeloma whose disease has progressed on multiple lines on therapy and who have very limited treatment option.

The study is designed to evaluate the safety, tolerability, pharmacokinetics, and the preliminary efficacy of HDP-101 in this patient population. The Phase 1, or called dose escalation study, is ongoing.

10 cohorts so far, we complete almost the patient enrollment. We have seen encouraging safety as well as the early efficacy signals.

The latest available results from cohort 8 were presented in November 2025 at the World ADC Conference and discussed during a 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 evaluable. Considered these patients' disease had progressed following multiple lines of therapy, this result are particularly compelling and encouraging.

Please turn to the next slide. Thank you.

This slide summarizes objective response rate for the higher-dose cohort 5 through 8 in the ongoing Phase 1 trial. Look at this four cohorts together, from cohort 5 to cohort 8, we saw an objective response rate of 38% with 11 out of 29 patients responding to the treatment, including 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 8 are still preliminary, they provide encouraging evidence that HDP-101 has meaningful anti-tumor activities even in heavily pretreated patients, demonstrating promising dose-dependent anti-cancer activity with deep clinical response.

Please turn on the safety next slide. This slide focuses on the safety measures in the clinical trials.

From the safety perspective, HDP-101 has shown a favorable tolerability profile across all dose levels tested so far, including the most recent cohort 9. The cohort 9 dose was found to be safe and tolerable, and the evaluation of efficacy is ongoing.

Up to cohort 9, the MTD, maximum tolerable dose, is still not yet reached. Across all nine cohorts, we have observed no signs of ocular toxicity, no infusion reaction, no extensive myelosuppression, and no liver damage.

A transient reduction in platelet counts, which also called thrombocytopenia, was seen in some of the cohorts' trials, but this effect was manageable and has been mitigated through adjusted dosing regimen strategy. In addition, there is no evidence of irreversible toxicity in patients receiving treatment so far for more than 12 months.

All patients had relapsed, refractory myeloma and were heavily pretreated and have exhausted all available treatment options. That is the data we deliver based on this huge history treatment of patients.

The safety data from cohort 9 have supported moving to the next cohort at a dose of 218 microgram per kilo. Enrollment in cohort 10 is now underway.

Once the optimal dose has been identified in the Phase 1 clinical trial, the trial will be moved into the Phase 2a dose expansion stage to test this dose in a larger 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 our overall pipeline. Next slide, please.

Our focus will remain on HDP-101 for the treatment of multiple myeloma. We expect to complete this Phase 1 part of the ongoing trial still in the first half of this year and will bring the recommended Phase 2 dose in the second half of this year, hopefully in the Q2 or Q3.

I also wanted to note that the recently announced our partner Huadong Medicine has initiated a Phase 1 bridging study in China. The trial will evaluate the safety, tolerability, pharmacokinetics, and efficacy of HDP-101 in Chinese patients with plasma cell disorders, including multiple myeloma.

The bridging study is being conducted to ensure that the safety and efficacy data of ATAC technology-based ADC is comparable across diverse population and is an important requirement for advancing the development of these products globally, including the testing in Asian population. Our other development programs are available for partnering.

For HDP-101, how about you? For non-Hodgkin's lymphoma, we have put recruitment for ongoing Phase 1 study on hold, but are continue to treat the one patient still enrolled in the trial.

With clinical HDP-103 right now, the status for the treatment of advanced prostate cancer, we are preparing the study application for the Phase 1 clinical trial. However, we're not to develop this program further on ourselves.

HDP-104 for colorectal cancer will not be developed further internally. Turning to our partner programs, starting with our partner with Takeda.

As a remember, in 2017, we signed an exclusivity research program agreement with Takeda related to several targets for joint development ADC using amanitin. Under the terms of our agreement, Heidelberg Pharma produced several ATACs using antibodies from Takeda's proprietary portfolios.

As a result of this work, Takeda acquired an exclusive license in 2022 to commercially develop an ATAC with an undisclosed target. Takeda is responsible for further preclinical and clinical development, as well as the potential commercialization of the licensed products candidate.

In January of this year, we announced receipt of a milestone payment with the dosing of the first patient in the Phase 1/2 clinical trial in patients with solid tumor. We are excited to see the progress of our partner Takeda is making and looking forward to this program advancing to clinical further development.

Look at Telix. In 2017, we out-licensed our legacy asset, the diagnosis antibody girentuximab, or now called 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 reporting 2025 financial result published in February, Telix indicated that based on the two Type A meeting 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 this resubmission. Our license agreement with Telix also covered the development of therapeutic radioimmunoconjugation program, also called the TLX250-Tx.

Telix recently reported that they received regulatory approval to start a global Phase 2 and 3 trials in metastatic clear cell renal carcinoma. In addition, a Phase 1b and 2 investigator-initiated trial, IIT, is exploring TLX250-Tx in combination with other therapies in the same indication.

Let me wrap up. Next slide, please.

In 2025, we certainly had a major setback with Telix CRL that forced us to make a difficult decisions about our business strategy. At the same time, we're seeing highly promising early results with our leading program, HDP-101, and expect to move this into Phase 2a 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 US$32 billion in 2033. Most importantly, our work holds the promise of helping patients with today's have limited treatment options.

Next slide, please. With that, I would like to thank you for all your attention and your continued interest, support in Heidelberg Pharma.

We'll now open the call to your questions. Operator?

Thank you.

Operator

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 it be presented at a conference in the future?

Dongzhou Jeffery Liu

Yes, let me answer that question. Thank you for that question.

Very good. I know a lot of our investors, analysts, or even the ADC world, industry, also including academia, like to know what's new, what's update, and particularly the higher dose, cohort 9 and cohort 10, which is 175 microgram per kilo and 218 microgram per kilo.

This is two dose we right now testing in the clinical Phase 1 trials. As I can share with you that today the trial is ongoing, and there's all the signal regarding safety and the efficacy is manageable and in the good way to moving forward.

We hope to get, particular the cohort 10, that is highest, 218 microgram per kilo, and we're going to bring this initial safety and efficacy data to the Safety Review Committee early April and need their assessment and see whether we can report this data in the coming month conference. We do plan to present this particular cohort 9 and 10 clinical result at the later years of this conference globally.

Thank you for this one. We keep you updated as soon as we release the data outside.

Thank you.

Operator

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

Dongzhou Jeffery Liu

I'm sorry, say that again. Another higher cohort?

Operator

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 Jeffery Liu

Okay. Yes, good question.

Because this trial is ongoing, what I can share with you is, first of all, the safety is manageable, and the MTD, maximum tolerability dose, is not reached yet. We do the data evaluation, because that give us some time on the cohort 10, particularly 218 dose, that take time to measure the efficacy signal, what is the overall response, because we enrolled so far, up to five to six patients in this cohort.

We need a little more time to assess the efficacy data readout. I can share the principle we looking at this, whether we do cohort 11 or not, because it's not decided yet.

We're going to bring this to the SRC committee early April, but we do have internal discussion as well. For all consideration, we want to see the first of all is this safe enough?

Is the MTD dose is almost there? Or the particularly the efficacy, even though we have a very limited patient numbers in each cohort, but I want to see the measures is that the efficacy data from cohort 8, 9, 10, does it continue to go up, improve the efficacy reading out, or does it reach plateaus?

I can share with you, we are almost close to the end of Phase 1a study, and we are trying everything we can to move to Phase 2a dose expansion study with relative we called recommended Phase 2 dose moving forward. That is information I can share you, but we are not have a decision on cohort 11 for the time being.

Thank you.

Operator

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?

Dongzhou Jeffery Liu

Good question, it's a tough question. 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, 5 years ago invested Heidelberg Pharma is because the ATAC technology. We really thinking amanitin-based ADC can provide some very unique solution to the unmet medical needs, particularly right now, there's a lot of Topo I inhibitor, and very limited choice to choose the payload, and amanitin give us the opportunity to provide additional payload mechanism to kill the cancers.

I think that is, we have the same missions on ADC conjugation drug, and we have a lot of synergy between these two company, and particularly the ADC teams. I'm almost working all the holidays, and working with both team, and particularly they started some new initiative collaborating together for some projects.

Particularly 101, 103 right now is Huadong already have the China right. So 101 in China already started.

The first patient in March 17th already started. We keep a very close working together both team on this program in China because they can provide additional valuable clinical outcome result in addition to MRCT right now sponsored by Heidelberg Pharma.

In terms of my timing, I spend as much as can, probably every day, working with the Heidelberg Pharma team, online or virtual or even on-site. I be in the Ladenburg office almost every month, stay here, at least, I cannot give a precise how many days, but at least a really decent number of days stay in Ladenburg office.

I'm flexible. If I need a more frequently come here, it's no problem.

Right now there's a lot of virtual working environment. I'm really confidence moving forward we going to be bring this particular the ADC collaboration, if we do have a collaboration program together, more close together, and so hopefully answer your question.

Operator

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, at biotech conferences, and actively negotiate out-licensing agreements, or are you primarily responsible for clinical development internally?

Dongzhou Jeffery Liu

A good question, too. As I growing the responsibilities, I already did that, is a full profile as the senior management, as the CEO, for the company, take all the opportunity to broadcasting, promoting our program, our project, our asset, our technology platform globally, find a partner.

For me, I'm thinking, particularly in this CEO position, my major working not on R&D, I have a very strong background R&D perspective, there's no question. In the last, almost 10 years, I serve another biotech president, early 19 let me 2019, for one year, take care of entire business for that biotech.

Come to Huadong, we right now have almost a 100 ongoing projects, and invented inside almost 60. I also take some responsibility to bring this compound outside to find a partner as a license and BD deals.

I'm really active. I attending JP Morgan for the last 5 years.

Come to the Heidelberg Pharma business role as a CEO and a leader of this company, I'm thinking every day, not only R&D perspective, clinical trials, and new pipeline, etc. I'm also thinking how we can earn the money, how we can save the money, how we can raise the money.

The three answers is the key, for me to lead the company, working with the colleagues, works with, Heidelberg Pharma teams, change around and move back to a growing pass for next couple of years. I'm fully aware of this needs, and also like to be latch that.

We already did that. This year's JP Morgan, we bring several potential collaboration.

Right now we are talking with them. I be one word to you is I'm fully responsible for all business aspects.

Of course, there's CFO have their expertise on the financial part, but I'm MBA as well, I do want to working with the team to get better financial supporting and outlook for the future. Thank you.

Operator

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 2 commence?

Can you provide an indication of the size of this potential milestone?

Walter Miller

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-2027, the 20 million are included, what is probably obvious. We also have reflected in that cash reach already the milestones received from Takeda as well as from Huadong earlier this year.

Further upcoming milestones from collaborations are not considered so far. 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.

Operator

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

Walter Miller

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're in talks to issue another tranche to all the remaining employees, including the management and executive management. This will be something that we will execute already this year.

Overall, the participation is between 3% and 5% of the total share capital.

Operator

Next question is, can you share your thoughts on the planned Phase 2 study design with HDP-101 monotherapy, also regards to the 17p deletion, post-BCMA setting, and Huadong collaboration for that, also study scope and costs, and when you expect that there will be interim readouts available?

Dongzhou Jeffery Liu

I think I like to answer that question. Very good question.

Right now it's time to think about moving forward for the further clinical development for HDP-101. The clinical Phase 2a, which we call the expansion study, is on the agenda, and also we already prepared for last couple months, how we design the study, how we finalize the protocol, how to get this clinical site, the PI selected and the initiated.

As I can share with you, the Phase 2a is well-designed. We discussed this Phase 2a study with FDA, years ago, and then we get aligned also.

Very supportive from FDA gave us the use of one dose. If you can call that recommended Phase 2 dose to conduct 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 2 dose so far collected move to the Phase 2a study. Right now we're very close to finalize that.

Then this number one. Number two, for this trial, we're going to conduct in 30 multiple myeloma patients.

We carefully design what kind of patient recruitment requirement needed. Of course, naive patient or pretreated with BCMA therapy is also under consideration.

We want to have both of them in the trial. This the current consideration.

Then the third, you asked about the cost. Because we already have this very good learning from Phase 1 study, and the performance of each clinical site, the PIs' collaboration, and also include the CROs' collaboration.

They're going to be more efficient in term of the team effort, expert effort, and the resources, budget used for this trial. From my perspective, I'm really confidence we're going to run this Phase 2a study well pretty soon, and then use the best knowledge, best management, and the most important, best cost-efficient method moving forward.

I cannot tell you when the readout, but this is 30 patients. It's a large number of patient enrollment.

We do want to have a lot of biomarker collected as much as possible. You mentioned the 17p deletions.

We collecting that data as the most we can, but this is really a POC concept testing. We want to reproduce what had been observed so far at the cohort 8, that is more than 50% overall response.

That's very promising result. Cohort 9 right now is ongoing, and cohort 10 ongoing.

I hope that the data generated from the Phase 1 we can reproduce at the Phase 2, or even better, set as a meaningful outcome. With that being said, I hope by mid of next year, we're going to have some initial data on this one, hopefully if not top-line, but we try all best to fast-recruit the patient in, enroll them in, and then get the dosed, and have the first couple months initial data.

We're going to keep outside world informed because we also expecting this result come out, and then as same as you. As my answer to you, and stay tuned.

I think we're going to announce the first patient in for the Phase 2a study, if that ready and everything go right direction. Thank you.

Operator

Now we have questions on the Phase 1 combination therapy of HDP-101. What would be prerequisites for that study?

Is there already evidence of a synergistic effect? Would you be conducting this with a strategic partner, and do you expect it to be accelerated based on promising data?

Dongzhou Jeffery Liu

Very good question. Right now the cancer therapy is, doesn't matter what the modality come from, is chemotherapy, TCE, CAR-T, ADC, or etc.

I think come to very recent trend is combination therapy together. That is how the cancer therapy go direction.

Come back to 101, we think about this is ultimately going to have some combination therapy in the late stage. For example, Phase 2 2b or something initial testing.

Right now for Heidelberg Pharma, we want to focus finish Phase 1a first. We get the testing of the safety and the efficacy signal, and conclude this study as quick as possible.

Then based on this assumption or result, we move to Phase 2a monotherapy to testing the recommended Phase 2 dose in a relatively large quantity of a patient, number 30, and see whether we can reproduce the Phase 1 particular cohort 8, 9, 10's efficacy data, a meaningful and etc. This is overall focus now.

Talking about the partner with Huadong, they already have knowledge of our progress of the Phase 1 data, they know what roughly safety dose and what the recommended, 140 is looks very good dose. They starting at 140, but they're going to go to 175 eventually.

They have a very quick bridging study in China, and then 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 their design. Thank you for that suggestion.

Combo therapy definitely is ADC, not only for 101, entire world thinking what is the strategy use combination therapy for cancer treatment, particularly really right now we go that direction. Too many modality available.

They have their individual strengths, but put them together, they definitely provide a lot of solutions for unmet medical needs, particularly tough cancer treatment. Yes, as we collecting more data, more efficacy signal, and also as the progress with China partner Huadong Medicine's program progress in China, we're going to have more thinking of combination therapy as well.

Thank you.

Operator

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?

I'm

Dongzhou Jeffery Liu

sorry, which program are we talking about?

Operator

The currently resting programs, 102 and 103. 102

Dongzhou Jeffery Liu

and 103. Yes.

Oh, remaining. As 102, due to the finance situation last year, if we do have the Telix payment, we're going to move very fast on the 102 clinical trial.

That one, unfortunately, we have to put this recruitment further on hold. We have a three patient in the cohort 1, lower dose.

That is the situation for 102. We're open for partnering for this one.

This is CD37 ADC, not only the amanitin payload is novel, but CD37 also relatively novelty as well, because, when you look at all this approved ADC, there no CD37 as a ADC target. We open to have more partner talk to us.

We do have initial three-patient data, we can share with them. This is a Phase 1 asset.

That one, I cannot disclose further because it's not ready to disclose yet. We open to discuss for all potential collaborator, and it's actively looking for that outside our licensing.

For the 103, we have China right license to give to Huadong Medicine. They are also conduct some internal study, particularly in some reproducing the efficacy data in the animal models.

They're working on it. Then, if this data pretty good, they're going to start Phase 1 in China for 103.

Meanwhile, PSMA ADC, amanitin-based, is a unique opportunity for us to demonstrate for this prostate cancer, very high demanding, a lot of unmet medical needs, even though they have other TCE, dual-target TCE engagers in the development. I still think ADC can provide unique opportunity for this very high needed, also high mortality rate, particularly in the Western world, for this indication.

For this one, we definitely open to partner, but the most important for 103 to have some initial clinical data. I think that's more convincing, more value.

As we're preparing the IND documentation package. Means that this asset is ready to conduct clinical trials.

We have CMC, we have toxicologies, we have preclinical animal DMPK, pharmacology study ready. That is the stage we're on.

We open to all potential collaborator come to us, and we're very actively looking for partner for these two assets. Thank you.

Operator

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.

Dongzhou Jeffery Liu

Great. Thank you so much.

Bye-bye.

Walter Miller

Thank you, everybody, for joining.