Earnings call transcript: Heidelberg Pharma Q4 2024 sees revenue drop

Heidelberg Pharma AG reported its Q4 2024 earnings, revealing a decline in total sales revenue to €12 million, down from €16.8 million in the previous year. Despite this, the company’s net loss improved slightly to €19.4 million from €20.3 million. The company’s stock price saw a modest increase of 1.14%, closing at €2.64, following the earnings report. According to InvestingPro analysis, the company currently appears fairly valued, with a Financial Health Score of 2.5, indicating moderate overall stability. The stock has shown resilience with a nearly 9% return over the past six months.

Want deeper insights? InvestingPro subscribers get access to over 10 additional key metrics and expert analysis for Heidelberg Pharma.

Key Takeaways

• Heidelberg Pharma’s total sales revenue decreased by 28.6% year-over-year.
• Net loss improved by €0.9 million, reflecting better cost management.
• Stock price increased by 1.14%, indicating a positive investor response.
• The company extended its cash runway into 2027 through a strategic transaction.

Company Performance

Heidelberg Pharma’s performance in Q4 2024 was marked by a decline in revenue but an improvement in net loss. The reduction in operating expenses and R&D costs contributed to this improvement. The company remains focused on developing targeted cancer therapies, leveraging its unique ATEC technology platform.

Financial Highlights

• Revenue: €12 million, down from €16.8 million in 2023.
• Net loss: €19.4 million, improved from €20.3 million.
• Cash position: €29.4 million, down from €43.4 million.
• Operating expenses: €32.6 million, reduced from €38 million.
• R&D costs: €21.8 million, down from €28.1 million.

Outlook & Guidance

Heidelberg Pharma projects sales revenue of €9-11 million for 2025 and expects operating expenses to range between €40-45 million. The company anticipates a cash inflow of €50-55 million in 2025, supported by milestone payments, ensuring funding into 2027. Analyst consensus from InvestingPro shows strong optimism, with price targets ranging from €9.54 to €12.25, suggesting significant upside potential. However, EPS is forecast to decline to -€1.07 in 2025.

Access the complete Pro Research Report and 30+ additional metrics with an InvestingPro subscription.

Executive Commentary

CEO Andreas emphasized the company’s commitment to developing effective cancer therapies with fewer side effects, stating, "We are dedicated to developing highly effective cancer therapies for the benefit of patients." He also highlighted the strategic importance of the company’s cash position, saying, "With the money in the bank, we have more time to increase the value of the assets."

Risks and Challenges

• Revenue Decline: The significant drop in revenue could impact future financial stability.
• Market Competition: Intense competition in the oncology sector may challenge market share.
• Regulatory Approvals: Delays in obtaining necessary approvals could hinder product launches.
• R&D Costs: Continued investment in R&D is critical, but cost management remains a challenge.

Q&A

During the earnings call, analysts inquired about potential licensing partnerships and the application of ATEC technology in autoimmune diseases. The company confirmed ongoing discussions with partners and expressed optimism about clinical trial recruitment and future product developments.

Overall, Heidelberg Pharma’s Q4 2024 earnings report reflects a mixed performance with a focus on strategic cash management and product development initiatives.

Full transcript - Heidelberg Pharma AG (HPHA) Q4 2024:

Andreas, Chief Executive Officer or Chief Scientific Officer, Heidelberg Pharma: The new project HDP two zero one uses exotecan as an active compound. For all ATEC projects, the global rights, excluding China, are with us. Wodong, our Chinese partner, has a license for HDP one hundred and one and one hundred and three and an option for HDP 104 or for China. Wodong used to have an option on the HDP 102 project for the same territory as well, but has not executed it due to internal strategic reasons. The rights for the Exotecan project belong to us, but we are open for partnering.

This slide shows our partnered programs. The partnership with Takeda Oncology is still ongoing. In 2017, we signed an exclusive research agreement with Takeda related to several targets for joint development of ADCs using Amenhotin. Under the terms of the agreement, Heidelberg Pharma produced several ATECs using antibodies from Takeda’s proprietary portfolio. As a result of this work, Takeda acquired an exclusive license in September 2022 to commercially develop an ATEC with a selected target.

Takeda is responsible for further preclinical and clinical development as well as potential commercialization of the licensed product candidate. The project is on track and we expect a progress update in the second half of twenty twenty five. Looking at our legacy assets. As a reminder, few years ago, we out licensed several clinical product candidates that were no longer part of our core business of ADCs. These are being developed solely by licensing partners and Heidelberg Pharma is eligible to receive development milestone payments as well as royalties on sales, should any of the programs make it to the market.

Indeed, following positive Phase three results, our licensing partner Telix submitted a Biologics license application for TLX250 CDX for the identification of clear cell renal cell carcinoma, which is essentially the basis for the royalty purchase agreement with HERCAR Royalty. We will go into more detail about this project later. Now we come to the R and D update starting with our ATEC technology and proprietary projects. Let me start with our lead program, HDP101 in multiple myeloma, a type of blood cancer. As a brief reminder, HDP 101 consists of an anti BCMA antibody, a specific linker, and the toxin, Amenetin.

BCMA is a surface protein highly expressed in multiple myeloma cells and to which BCMA antibodies specifically bind. Just a few words on the indication multiple myeloma. Multiple myeloma is a type of blood cancer that develops from plasma cells in the bone marrow and can affect more than one part of the body. Plasma cells are a type of blood cell that makes antibodies to fight infection created by bone marrow. In myeloma, the bone marrow makes a lot of abnormal plasma cells.

Worldwide incidence of multiple myeloma is currently more than one hundred and eighty thousand people with a mortality of one hundred and twenty thousand. The study with HDP101 is a first in human Phase one2a clinical trial. We treat patients with relapsed and or refractory multiple myeloma in study centers in The U. S. And Europe.

The study is designed to assess the safety, tolerability, pharmacokinetics and the efficacy of HDP101. The Phase one part of this trial is a dose escalating study and the goal is the identification of the recommend Phase two dose and to determine the safety and tolerability. To evaluate this, we are treating two to six patients in each cohort with an increasing dose of HDP101. First promising efficacy signals have been seen. In the Phase IIa part, a larger number of patients will be treated with the optimal dose RP2D.

I’m very pleased to show you first efficacy data from our Phase one clinical trial. The swimmer plot graph shows on the left different cohorts and the dosing. On the bottom, you see the treatment duration in days. Let me comment on three remarkable preliminary results. One patient from cohort three was over four hundred days on treatment with a stable disease.

Over that long period, we couldn’t see any accumulated toxicity or severe side effects. In cohort five, we see a 50% objective response rate. Three out of six patients profited from the treatment by having a partial remission and one patient turned out to have a complete response. The complete responder is a U. S.

Based female patient suffering from multiple myeloma since 02/2002. She received nine prior lines of therapy. She’s still undergoing treatment and feels very well. She’s active. Her quality of life has improved considerably as a result of the treatment.

And the fact that we can no longer detect any tumor cells in this patient at that dosage level in the Phase one trial is extremely encouraging for us. We believe this confirms our view that this therapeutic approach is effective and that HDP101 has promising potential as a treatment option for patients with multiple myeloma. You will remember that in the fifth cohort after administration of the first dose of HDP101, which was 100, all patients experienced a drop in the thrombocyte count, which completely normalize without further invention after a few days and was clinical unremarkable. In order to mitigate the effect of the initial administration an adjustment on optimization of the medication regimen was developed based on the recommendations of the Safety Review Committee. Therefore, Court six consisted out of three arms with different dosing regiments.

Patients in arm A were treated with a single dose of HDP101 on day one of each twenty one day cycle following a premedication. Patients in arm B received a weekly dose of HDP101. The dose was split with patients being administered drug proportionally on days one, eight and 15 of each cycle. C received a partial dose of HDP101 on days one and eight of the first cycle and then a single dose on day one of each of the following twenty one day cycles. The dose was lowered to ninety micrograms per kilogram with the aim of minimizing the risk to the patients in these three arms.

HDP101 was well tolerated across all 10 patients in CORT6 with no dose limiting toxicities detected in any of the three parallel treatment arms. The patient recruitment of CORT7 is complete and patients are under treatment with an escalated dose of more than one hundred micrograms per kilogram. The highest dose trial period in two arms with different split dosing. One arm includes additional pre medication. HDP101 is well tolerated in this cohort as well and this is there are still no evidence of any dose limiting toxicity.

We expect to have the seventh cohort completed soon. Subsequently, the safety review committee will meet and discuss the outcomes. We don’t think that we already have reached the MTD, the maximum tolerated dose of HDP101. Our expectations are that the cohort eight with a further escalated dose will be conducted. We plan to present the new clinical data at the EHA Congress an important meeting of the European Hematology Association that will take place in Milan in the June.

Let me summarize on this slide the interim data from our ongoing study. In the sixth cohort, 10 patients have been treated. There were no signs of dose limiting toxicities. All three dose treatment strategies had a positive effect on the transient thrombocytopenia. We saw responses at the dose of ninety microgram per kilogram, but the treatments and assessments are still ongoing.

The seventh cohort was opened in December. All patients have completed TUT observation periods and some are still under treatment. We now have currently treated thirty four patients. The treatment with HDP101 was very well tolerated The drug showed favorable safety and demonstrated efficacy with, as already mentioned, one complete remission in one patient. This is a promising outcome so far and we are looking forward to gaining more data.

Let’s take a look at the next ATEC candidate. HTP one hundred and two is an ATEC targeting CD37 that is overexpressed on B cell lymphoma cells. Heidelberg Pharma is planning to develop HDP 102 for non Hodgkin lymphoma. Non Hodgkin lymphoma, NHL in short, is one of the more common types of cancer with the worldwide incidence of more than five hundred and fifty thousand and the mortality of more than two hundred and fifty thousand cases per year. In preclinical trials, this development was shown to have a very large therapeutic window.

Our clinical team has prepared the data package for the clinical trial application submitted in it in selected European countries. We already have received the regulatory approvals to contact the clinical trial from the authorities in Moldavia and Israel. The inclusion and dosing of the first patient is expected in the next few weeks. The study design of the first human person human clinical trial with HDP 102 can be seen on this slide. We plan to conduct a multicenter multinational open label Phase 1a1b trial.

In the Phase 1a part, up to 32 patients with relapsed or refractory B cell malignancy will be treated to elevate the safety tolerability pharmacokinetics and the pharmacodynamics of this ATEX. The goal of the Phase 1a is to find the optimal and safe starting dose for the Phase 1b part. The second part is a dose expansion study including up to 15 patients. Our other ATEC product candidate coming along is HDP one hundred and three, which we plan to develop for the treatment of metastatic castration resistant prostate cancer. The antibody used bind to PSMA surface antigen that is over expressed on prostate cancer cells.

This is a promising target for the ATEC technology because PSMA shows only a very limited expression in normal tissue. In vitro and evivo efficacy, tolerability and pharmacokinetic studies have shown that HDP103 has a promising therapeutic window. There’s also a very high prevalence sixty percent of a 17PD lesion in metastatic and castration resistant prostate cancer. The increased sensitivity of prostate cancer cells with the 17PD lesion has already been preclinical validated. As we have previously reported, tumor cells with a 17PD lesion are particularly sensitive to Amenhotep.

So PSMA ATAX might be particularly suitable for the treatment or treating metastatic castration resistant prostate cancer. The necessary preclinical and toxicological studies with HDP103 have been completed. A clinical trial to investigate tolerability and efficacy is currently being planned. The clinical team has begun preparations for the study protocol. We plan to submit a clinical trial application for HTP103 to the regular authorities in the second half of twenty twenty five.

Now I would like to hand over to my colleague, Walter.

Walter, Chief Financial Officer, Heidelberg Pharma: Thank you, Andreas. Thank you, Amprayas. Turning to our out license clinical legacy assets. In ’27 just a second in 2017 we out licensed diagnostic antibody givintuximab or TLX250CDX to the Australian company TLX Pharmaceuticals. The license agreement also converted the development of a therapeutic radio immune conjugate program.

Positive top line data from the Phase III CIRCON study on PET imaging for diagnosing kidney cancer were published in November 2022. The TLX250 CDX was granted a rolling review under the breakthrough classification, which allows for a phase submission and review of the required modules according to a pre agreed schedule with the FDA. The BLA submission in The US was completed in June 2024. FDA had not accepted the PLA at that time because a deficiency in the area of manufacturing, CMC, had been identified. The new application was submitted at the December 2024.

On 02/26/2025, good news were shared by Chelix. The FDA had accepted the BLA for Telix two fifty CDX, granted a priority review and provided a prescription drug user fee act date, the so called PDUFA date of 08/27/2025. This means that the authority will make a decision on approval by August. According to Telix, they expect the potential market launch in the second half of this year. In parallel to progressing the approval process, Telix has been carrying out a global early access program, so called EIP, since December 2023 to provide patients with pre approval continuous access to TLX250 CDX for the detection of CCRCC.

Patients are routinely dosed in The EU, The US and Australia. We are excited by the progress and the commitment of Telix in advancing this program and bringing it to the market to help patients. As mentioned earlier, we have sold a portion of our future royalties from the worldwide sales of TLX250CTX to HealthCare Royalty in March 24 and amended the agreement recently. In the lower part of the slide, you see some basic information about kidney cancer. Let us now come to the financial results.

You might remember the transaction with Healthcare Royalty on royalties from the Global Sales that we signed in March 24. This year in March, we concluded an amendment to that agreement. On this slide, the amended terms are highlighted in Petrol. A USD 25,000,000 upfront payment was already received in March 24, therefore, is no change on that. We originally agreed on a sales related milestone payment in the amount of $15,000,000 USD.

This milestone would have been difficult to achieve due to the delay of the potential market launch of DLX250 CDX. Therefore, it was eliminated and converted into a payment of 20,000,000 USD upon signature of this amendment. This happened already earlier this month. Furthermore, the 75,000,000 USD payment upon FDA approval of DLX250 CTX was reduced to 70,000,000 USD with further reductions if FDA approval occurs after the end of twenty twenty five. And last, the second tier of the two tier escalating cap on cumulative royalties, O2HZRx, has increased.

When the escalating cap has been reached, royalty payments will return to Heidelberg Pharma and HZRX will receive a low single digit royalty tail percentage thereof. If the fixed amount of the first tier is reached in the defined time period, this condition will not materialize. Based on the agreement with HCRX and expected incremental payments of in total 90,000,000 USD this year to Heidelberg Pharma, the company anticipates an extended cash runway into 2027. The advantages of the agreement with HCRX are obvious. It’s an attractive non dilutive financing opportunity that extends our cash reach.

The approval payment of 70,000,000 USD reduces the risk of market uptake. And finally, the defined cap for the royalty stream secures participation in mid- and long term upside. Turning now to financial cash flow and balance sheet. Looking at financing cash flow. The financing cash flow improved from an outflow of 10,100,000.0 Euro in the previous year to an inflow of 22,800,000.0 Euro in ’24.

This significantly higher figure is due to the HCRX transaction in March 24, while the previous year’s result was dominated by 10,000,000 Euro in loan repayments to our main shareholder. Let’s take a deeper look at the balance sheet. Non current assets were €13,200,000 as of November 2024 compared to €13,700,000 in 2023. Current assets decreased from 56,600,000.0 in the previous year to EUR 47,600,000.0 this year. Cash included in this item amounted to EUR 29,400,000.0 and was down on the prior year figure of EUR 43,400,000.0 due to outflows for the business and loan repayments.

Other current assets increased to EUR 18,100,000.0 compared to the previous year figure of EUR 13,300,000.0. Inventories included in this figure rose from €10,500,000 to €11,800,000, while other receivables grew from €1,300,000 to €5,700,000. Total assets at the end of the fiscal year amounted to 60,700,000.0 Euro, in the previous year 70,400,000.0 Euro. This decrease was mainly due to outflow of cash. Turning to liabilities.

The new balance sheet item of non current financial liabilities of 21,800,000.0 Euro is attributable to the upfront payment from HCRX, which is initially being recognized less transaction costs. Therefore, non current financial liabilities increased significantly from 1,200,000.0 Euro in the previous year to 21,900,000.0 Euro. Current liabilities fell to €8,000,000 at the close of the reporting period compared to €19,800,000 at the close of the prior year. €5,000,000 thereof were for the loan repayment and €3,700,000 were accrued revenues from the license with Huardang. Equity at the end of the reporting period was €30,900,000 compared to €49,300,000 as of 11/30/2023.

The equity ratio was 50.8% at year end ’20 ’20 ’3 compared to end of twenty four compared to 27.1% at year end twenty three. This slide show our profit and loss statement for fiscal year twenty twenty four. As a reminder, our fiscal year ends on November 30. Starting with sales revenue and other income. The Heidelberg Pharma Group generated sales revenue and other income totaling EUR 12,000,000 in ’24 compared to EUR 16,800,000.0 for 2023.

Breaking that down, we generated sales revenue of EUR 6,900,000.0 compared to EUR 9,900,000.0 in the year before. This comprises revenue from collaboration agreements for the ATAC technology of €6,800,000 in 2024 and €9,800,000 in 2023. Sales revenue in 2024 dropped year over year as planned, given the lower level of monetization from partnerships, especially in terms of material deliverables. Other income amounted to €5,100,000 compared to €6,900,000 previous year and was dominated by the recognition of research allowances and governmental funding totaling €2,800,000 that was significantly more than in the previous year with €100,000. The total amount of income also includes income from the reversal of unused accrued liabilities and other items.

Let’s turn to operating expenses. They include depreciation and amortization and decreased considerably to €32,600,000 in this year compared to EUR 23,000,000 with EUR 38,000,000. The cost of sales concerns the group’s costs directly related to sales revenue. These costs were mainly related to expenses for the supply of M and A T Linkers to licensing partners. In 2024, these costs amounted to 1,800,000.0 Euro, well below the previous year’s figure of 3,300,000.0 Euro and represented 5% of the operating expenses.

Research and development costs of 28,100,000.0 Euro in 2023 decreased to 21,800,000.0 Euro in 2024, due to lower external production costs for ADC projects and reduced costs for the ongoing clinical trials with HDP101. At 67% of operating expenses, R and D remained the largest cost item. Administrative costs were 6,700,000.0 Euro, an increase on the prior year figure of 5,200,000.0 Euro and accounted for 21% of operating expenses. These include staff costs of 4,100,000.0 Euro, of which 400,000.0 Euro concerned expenses from stock options, a compared figure for 23, are 3,000,000 Euro, thereof 300,000.0 Euro for stock options. Administrative costs also include legal and operating consulting costs in the amount of 1,200,000.0 Euro compared to 800,000.0 for ’23 and expenses related to the Annual General Meeting, Supervisory Board remuneration and a stock market listing, which was 800,000.0 Euro, respectively 700,000.0 Euro in 2023.

Other items amounted to EUR 600,000.0 compared to EUR 700,000.0 for the prior year. Other expenses for business development, marketing, commercial market supply activities and all other items, which mainly comprise staff and travel costs, increased to 2,300,000.0 Euro year over year compared to 1,400,000.0 Euro in 2023 and made up 7% of operating expenses. The Heidelberg Pharma Group recognized a net loss for the year of 19,400,000.0 Euro compared to a net loss of 20,300,000.0 Euro in fiscal year twenty twenty four. Basic loss per share improved from minus 0.44 Euro in the previous year to minus 0.42 Euro this year. Let’s have now a more detailed look on the cash flow.

Net cash outflow from operating activities during the reporting period was EUR 29,600,000.0 in the previous year, EUR 33,700,000.0. The decrease is mainly due to a lower level of expenses. Total cash outflow from investing activities came to EUR 400,000.0. In the previous year, it was a EUR 5,800,000.0 inflow and was significantly lower than the prior year figure, which reflected the unscheduled disposal of a merchant’s shares. The net change in cash flows from financing activities improved from an outflow of EUR 10,100,000.0 in the previous year to an inflow of 16,100,000.0 Euro in 2024.

This significantly higher figure is due to the HZRX transaction in March 2024, while the previous year’s result was dominated by the 10,000,000 repayment of a loan. The total change in cash in fiscal year twenty four came to minus 14,000,000 Euro, previous year was minus 37,900,000.0 Euro. This corresponded to an average outflow of cash of €1,200,000 per month and in the previous year 3,200,000.0. We have now almost reached the end of our presentation and I would like to give you a brief outlook for the coming year. We expect the Heidelberg Pharma Group to generate between EUR 9,000,000 and EUR 11,000,000 in sales revenue and other income in the fiscal year 2025.

Sales revenue generated by Heidelberg Pharma Research GmbH, especially for ATAC technology, is expected to account for about one third of this figure, with deferred revenue and potential milestone payments to Heidelberg Pharma AG contributing a slightly higher amount. Other income will mainly comprise government grants and the passing on of patent costs in the context of out licensing. Based on current planning, operating expenses are expected to be in the range between EUR 40,000,000 and EUR 45,000,000. Earnings before interest and tax in the 2025 fiscal year are expected to be between EUR 30,000,000 and EUR 35,000,000. This figure is excluding FX effects.

We assume that over the next few years, total expenses will exceed the income. If income and expenses develop as anticipated, the change in cash funds in 2025 for Heidelberg Pharma AG business operations is expected to improve significantly compared to 2024. The expected cash inflow will be between 50 and 55,000,000 Euro due to further payments. This corresponds to an average monthly inflow of cash of 4.2 to €4,600,000. In 2024, the monthly outflow was €1,200,000.

Based on the current budget and considering additional expected payments of USD 70,000,000, less transaction costs from Healthcare Royalty upon market approval of TLX250CDX and entitlement to a further US dollar $20,000,000 residing from the amendment of the agreement for the sales of royalties, our company is funded into 2027. I will now turn the call back to Andreas for the operational outlook for the year ahead.

Andreas, Chief Executive Officer or Chief Scientific Officer, Heidelberg Pharma: Thank you, Walter. We are very pleased with the strong progress we made last year. What do we expect for the year ahead? For HTP-one hundred and one, we expect to reach the recommend Phase II dose soon and our goal is to start the Phase IIa later this year. Our Chinese partner, Huadong reviewed, received an approval from conducting a clinical study with HTP-one hundred and one in China and plans to start the Phase two in 2025.

The exact conditions for the planned trial are still being worked out. HTP-one hundred and two received the authority approvals for a Phase 1a, Phase 1b in Moldova and Israel. We are very excited that our second ATAG will soon be evaluated in humans. The submission of the clinical trial application for HTP 103, the candidate against prostate cancer is planned for the end of twenty twenty five. And for the last ATEC, HTP 104, toxicological studies shall start later this year.

The progress we have made over the past year reinforces our belief that our technology has a compelling mode of action, giving us a unique position in the development of cancer therapies. Our mission remains unchanged. We are dedicated to develop highly effective cancer therapies with fewer side effects for the benefit of patients. Thank you very much for joining our presentation today. We would like now to open the call to questions.

Moderator: Ladies and gentlemen, at this time, we will begin the q and 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 and a button below the presentation window. I will then read the questions aloud.

One moment for the first question, please. The first question is from the line of Christophe Pabst. Please accept the request to unmute.

Christophe Pabst, Analyst: Sorry. I my impression was that the slide got stuck, and so it’s no question at this moment. Thank you.

Moderator: Okay. Thank you. The next question comes from the line of Marietta Mimetz. Please accept the request to unmute yourself. Please go ahead.

Marietta Mimetz, Analyst: Yes. Good afternoon and thank you. I have a couple of financial questions, a couple of pipeline questions, please. On the financial front, I infer from your guidance that the $20,000,000 upfront that you received from health care royalty alone would be sufficient to allow you to end the year with a positive cash position. So is that correct?

And in the unlikely event of a severe delay to FDA approval of TLX250 CDX, how would you bridge from year end ’25 to the date when you actually receive the milestone? And then on the pipeline front, with regards to HDP one zero one, I was trying to clarify what exactly we’re going to see at Are we already going to get any cohort seven data? And if not, I mean, when do you expect to share full safety and initial efficacy data for cohort seven? And also the dose that you’re using there? And when would you expect to start cohort eight?

And then for HACEK 102, I was just wondering if you would be able to share already a little bit more detail on the inclusionexclusion criteria for the exclusion criteria for the Phase one and whether the asset will only be the molecule will only be given in monotherapy or what combinations might be allowed and generally what you think the timelines are to recruit the 42 patients. Thank you very much.

Walter, Chief Financial Officer, Heidelberg Pharma: So maybe I start with the two questions on the financials. Thank you, Marietta for the questions. Indeed, we already received the 20,000,000 us dollar from the amendment with HCRX and with that amount, we are well financed, beyond the end of this fiscal year in 2025. Knowing that the going concern always foresees a minimum twelve months horizon from the test date of the auditors with that amount, we are financed already, well into ’26. And, if there would be another delay in the, the, in the approval of, of the tailings asset, we know that early in the second half of twenty five and with that we have at least a cash runway of six to nine months to manage that And, we don’t expect that there will be another delay, but even if there would be a delay, it will be managed.

And we also have a good plan in place in that case to, to manage our cash manage, our cash reach and to have a proper cash management in place.

Marietta Mimetz, Analyst: Thank you.

Andreas, Chief Executive Officer or Chief Scientific Officer, Heidelberg Pharma: For the pipeline questions, indeed, we plan for a major update for the EHA presentation. So this will include cohort six safety and efficacy data for cohort seven, we since all patients already completed the DLT period. So the safety data were also given for cohort seven. And since the efficacy is always delayed and it takes some weeks and months, so there were probably an early glimpse on the efficacy data, at the EHA. But since this is not so much time until then, there will be not complete efficacy data.

And if you look in the complete response patients, it took more than half a year. So in a nutshell, complete cohort six, safety cohort seven and maybe early efficacy on cohort seven. And the question for cohort eight, as having said, the OT period is completed. So the safety review committee will convene very soon in a few weeks, and we expect then thereafter the cohort eight will already be started to recruit patients. One or two, sorry.

It’s a monotherapy. It will be an all comer study, so we are not focusing on one NHL indication, but an all comer study. And the idea is to look for safety primarily, and then in an extension expansion phase to maybe focus, for example, for the big indication like DLBCL or CLL, but this will also depend on the data we obtain during the dose escalation, inclusionexclusion criteria, there’s nothing special, typical phase phase one. So we do not have any specific inclusion or exclusion criteria. For this one, recruitment, we believe that with the success of the HDP 101 study, this is what we also observed in the 101 study, having the clinical data really stimulates the interest of patients and PIs to recruit patients in our studies.

So we believe that will be also, a good recruitment rate for the one on one one or two study as well.

Marietta Mimetz, Analyst: Thank you very much.

Moderator: We received several written question on whether you will be doing a cohort eight and which dosing scheme you will be using.

Andreas, Chief Executive Officer or Chief Scientific Officer, Heidelberg Pharma: Yeah. Since, we discussed this in length internally and externally, and everybody tells us we should go to the maximum tolerated dose in order to maximize the drug response because in the long run, you want to have the maximum response rate and the maximum duration of response. And since we have not seen any dose limiting toxicities in cohort six or cohort seven, it’s highly likely that we will run a cohort eight. And the learnings from the different cohorts is, obviously, from the treatment arms. So, we reduced from code six to code seven, from three arms to two arms.

We will leave we will go with both arms, but we will prioritize the arm with what we call the step up dosing for the COD eight, for the split dose in the first cycle, allowing for pre medication. And from the second cycle on no split dose. This was the priority arm used for cohort eight.

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

Andreas, Chief Executive Officer or Chief Scientific Officer, Heidelberg Pharma: That’s a little that question is a little bit early because we do not have the full picture. It’s just that the completion of the of the DOT period and not all centers are immediately putting the data into the database. So we don’t have the picture of the seven PT lesion. This usually comes with the SSC meeting. Some of us take, let’s say, a few weeks more to get all the information for all patients.

And we are not currently disclosing how many patients are still being treated. So it’s not all, but more than half of the patients are still being treated.

Moderator: Yep. Next up, another written question. Which publications or posters have been submitted to the AACR?

Andreas, Chief Executive Officer or Chief Scientific Officer, Heidelberg Pharma: Honestly, I I don’t know all the them from my memory. I’ve been we should have a a press release, and the p press release comes on Wednesday for the AACR publications and posters.

Moderator: Okay. Next question is, what potential milestone payments would be linked to Guangdong starting at phase two with HDP one zero one? What would be the ballpark figure for this?

Walter, Chief Financial Officer, Heidelberg Pharma: Well, indeed, indeed, there is a milestone payment for CN, when Hua dong, is enduring, interface two with HDP one zero one zero one. So far we did not, communicate, the amount or the, but you can, let’s assume we have reflected that in the, in the guidance for ’25.

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

Andreas, Chief Executive Officer or Chief Scientific Officer, Heidelberg Pharma: Very good question. Of course, we have intense discussions around this one. And my personal opinion, we believe the ATEC technology is is very well placed for this one. We have seen a complete remission without those limiting toxicities or a payload is non geno toxic, they’re killing non dividing cells. What I can say today, we are exploring this option.

We are doing preclinical studies in this regard and we are looking also for possibilities to evaluate this in patients.

Moderator: We have one more written questions. And that is, are there negotiations with potential licensing partners still ongoing, or is this currently off the table after the contract with healthcare royalties was adjusted?

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

Moderator: Then another question that came in a written written form, asking for an update on the Bingham University collaboration.

Andreas, Chief Executive Officer or Chief Scientific Officer, Heidelberg Pharma: It’s it’s working very well. We are working with Nathan Toomey. We are, let’s say, testing already the payload technology on different antibodies and generating preclinical data. So we are very excited about having a non cytotoxic but immunostimulatory payload. So that’s going on very, very well.

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

Andreas, Chief Executive Officer or Chief Scientific Officer, Heidelberg Pharma: This is what we typically do. For example, for the patient from call three with the four hundred days, it was also offered to switch to the next higher dose. So this will be up to the discretion of the SSC, but this is typically being offered because it’s an it’s an upside for them to to switch to a higher dose.

Moderator: And then let’s get to the last question. How is the monthly financial requirement expected to develop in the coming month and then in 2026?

Walter, Chief Financial Officer, Heidelberg Pharma: So when we have a look on the guidance, we see, we plan operating expenses between 30 and 35,000,000, depending on a cash in, the calculation is that we spend 2 and a half to 3 million, per month as an average. As a general outlook for ’26, when we have another project in the clinic, HDP 102, we expect that this will further increase and, having in mind that HDP 103 will follow one year later also in the clinic, in our perfect scenario. So, the cash need will further increase. Hopefully, this answers the question.

Moderator: And can you give any guidance on when you will have a first iTech candidate?

Andreas, Chief Executive Officer or Chief Scientific Officer, Heidelberg Pharma: Yeah. So, that seems to be a huge interest. Internally, we have already our favorite identified. So it’s foreseeable, but I’m a little bit reluctant to give timelines on this one. So we are doing now efficacy studies and we selected already the target and the antibody for that candidate.

Moderator: Thank you. This concludes the Q and A session. I will now hand the call back to Andreas for closing remarks.

Andreas, Chief Executive Officer or Chief Scientific Officer, Heidelberg Pharma: Yes. I would like to thank everybody for attending today’s conference. We have the feeling that we had an outstanding year. We have, let’s say, made very good progress in financing the company with the royalty deals, which give us non dilutive money. We are not diluting the shareholders.

We are not diluting the assets, but having, let’s say, two more years runway, which is these challenging times also a remarkable achievement. And with the clinical data for the first time, we see objective responses in patients. We see the complete response in one patient heavily pretreated. So we believe it’s a clinical validation of the platform of the HTP-one hundred and one. People are already, let’s say, applauding us that we have a drug.

So exciting times. We continue. We would like to see more patients treated with HDP one hundred and one and also for HDP one hundred and two to enter the next stage for the company and our pipeline.

This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.