Hello, and welcome to Virtual Investor Conferences. On behalf of the Life Sciences Investor Forum and our co-host, Zacks Small Cap Research, we're very pleased you joined us for our quarterly conference. Our next presentation is from Heidelberg Pharma. Please note you may submit questions for the presenter in the box to the left of the slides. You can also view a company's availability for one-on-one meetings by clicking "Book Meeting" in the top toolbar. At this point, I'm very pleased to welcome Andreas Pahl. He's the Chief Executive Officer of Heidelberg Pharma, which trades on the Frankfurt Stock Exchange under the symbol HPHA. Welcome, Andreas.
Thanks, John, for the introduction and the opportunity to present our company, our story over here. Since we are listed, please mind our safe harbor statement. I'm the CEO of an experienced management team within Heidelberg Pharma. We are, let's say, a group of five chief officers comprising the Chief Financial Officer, Chief Medical Officer, Chief Business Officer, and Chief Operating Officer. We all have a long history in the space, and we are driving the company to develop new cancer therapeutics for high unmet medical needs. What are the challenges in cancer and oncology in general? Almost one out of two people in the whole world will be diagnosed with cancer in their lifetime. It is still a huge burden for everybody, either themselves or close relatives. More than 90% of people dying from cancer death are caused by drug resistance.
What is existing in the world is that you have a standard of care therapy which works in the first weeks and months. For a longer-term survival, the cancer becomes resistant to current medications, and it does not work anymore. The cancer relapses. Finally, you die from that relapse of the tumor. This is just an example of how it can look like. You see here a melanoma patient. You see here the tumors growing under the skin of that patient before the treatment. Like mentioned, against the standard of care, a few weeks later, it looks like he is cured because of the virtual absence of all tumors under the skin of the patients. Unfortunately, again, a few weeks later, tumor cells are regrowing. They become resistant. There are so-called dormant tumor cells which just survive the standard of care.
They get resistant to the standard of care. They are relapsing. Because the standard of care is not working anymore, finally, that patient died a few weeks later because of the cancer. What is needed? We need new drugs with a new mode of action because a new mode of action is able to overcome the resistance to current cancer therapies. This is the precipitating idea of Heidelberg Pharma. Finally, we isolated a new compound, a new cell-killing compound from a class of mushrooms. People who are collecting mushrooms probably know that there is a certain group which is called the Amanita species of the green death cap mushroom you should avoid because there is a poison in this mushroom. This poison, for the experts in the field, has a new mode of action which has never been used in tumor therapy.
For the specialists, it's the inhibition of eukaryotic transcription, the inhibition of RNA polymerase II. What is important here? We have never found any tumor cell which was resistant to that amanitin. We can kill all tumor cells, whether they are surviving the standard of care or whether they are non-dividing. We have the unique weapon that we can kill every tumor cell. The challenge then, of course, was how can we make such a toxic compound usable for cancer therapy? What I call it, we call it the so-called ADC technology, which is a new technology that combines the power of antibodies with toxic compounds. I just want to show with that slide that's an approved technology. There are certain blockbusters already on the market. The technology is not new. What is new for us? The payload, what we put on this technology.
I created a picture to make this understandable, what we are doing. It looks like a cruise missile. The antibody we are using is the missile which delivers the payload. We can program the antibody here with the recognition site to detect a cancer cell in the human body. Call it the GPS system of the cruise missile. As soon as the cruise missile has found its target, the cancer cell, it drops the payload. Our drug, it's the Amanitin, the cytotoxic compound, which will be then dropped inside of the tumor cell and specifically kills the tumor cell. This is in contrast to conventional chemotherapy, which is completely unselective. It can kill all cells. That's the reason why you lose your hair, why you're vomiting, why you have a very hard time getting traditional chemotherapy.
We have here a targeted therapy, a missile which detects the tumor cell. How it looks like in the real world, we're here with a chemical linker. We conjugate, we link the cytotoxic compound, the Amanitin, to the antibody. Antibodies are a proven technology. They have a high specificity for certain targets. We can program this antibody to detect the tumor cell. What is then happening? The missile, the antibody detects the tumor cell. It binds to the tumor cell. It's getting uptaken by the tumor cell. In red, it releases our payload. It binds to a target. Finally, it kills the tumor cell. We fine-tuned for years this and to make this into a platform. This is how it looks like now, our ATAC platform, which we call it. You see here in blue the antibody.
In gray, that's the GPS system, the recognition for the tumor cell. You see here the payload is connected in red to the antibody. You see a small linker. As soon as this drug recognizes the tumor cell, it's getting internalized in the tumor cell and kills the tumor cell. We put quite some years in optimization of the platform. We are now in a plug-and-play mode. The beauty of that platform is that if we change the recognition system, so if you reprogram the antibody, we can target a different tumor type because each tumor type has specific recognition signals, targets on the surface, which are known, which need to be invented by us. We can use that target to reprogram our ATACs to address different tumor targets.
With one platform, we can generate a different ATAC individually for each tumor type. I have a, let's say, a drug-generating platform based on our technology. The other beauty of this is that we have a huge IP portfolio around this one. This just gives the idea for our lead program that we have a family of different IP patents around this one, which are comprising our payload, our platform, our antibody. We are a single player in the field. Nobody else in the world is using that payload, that platform. We can guarantee our partners, our investors, exclusivity on the drugs we are developing. Just one example of how this can work. Of course, we started by curing mice. What you typically look for is a mouse where they develop a tumor, so a tumor.
What you're doing, you inject human tumor cells under the skin of a mouse. The tumor is growing under the skin of the mouse here. You treat them either with the standard of care. In that case, it's an inheritable, well-known breast cancer medication. You compare this to our drug. What you observe here is that the tumor is growing. If it's untreated, it grows very much, and the mice are dying. You see here with the standard of care, the tumor is fairly resistant. You see only a small delay in the tumor growth. In contrast, if we now inject our drug into these tumors in these mice, you see that we completely drive this tumor into remission, which means the tumor completely disappears.
Even after a single injection, it stays in a complete remission, a complete absence when the tumor is treated with our drug. We were very confident that our drug is working in preclinical setting. We started programs to treat patients based on our technology and our platform. The first indication we looked for is multiple myeloma. Multiple myeloma is a type of blood cancer which derives from the bone marrow. The bone marrow cells become abnormal. It targets different organs. For example, it targets the bone of the patient. You see here the holes. It puts these punches at the bones. They become fragile, and the bones are breaking. Other organs are affected as well. You see a very high mortality here in the multiple myeloma. A huge unmet medical need.
What you are doing typically in clinical trials, you do a dose escalation where you start with low doses, increase the dose in order to look for the safety, tolerability, and the efficacy for your drug. Later on, you go to a larger number of patients in order to confirm and validate your drug effect and look for a larger response to your experimental drug. We developed this drug, what you see here in these bottles. We started the CMC process. We have a complete manufacturing process available. We produced the drug. We went to the FDA. We got the approval to test this drug in multiple myeloma patients. Here you see the first results of our drug in patients. This is so-called a Swimmer's plot. What you see here, that each patient treated with our drug on day zero.
To the right is the time in days which he is on treatment with our drug. As mentioned, the dose escalation starts at very low doses, which are ineffective, but just to demonstrate the safety. You see here on the left column that over the different cohorts, we increased the dose levels to look for the tolerability and the efficacy of our drug. As expected, termination here. People without an effective drug drop off the study very early. Here, cohort three, you see already one patient who stayed on treatment with our drug for more than a year. These patients are end-stage patients. They have seen every available drug in multiple myeloma they can get on. They became resistant to every available myeloma drug. They are desperately looking for any new alternative because they are out-treated patients.
They get the monotherapy. They get only our experimental drug. This patient here was the first success, the first demonstration that our drug is indeed working, giving the patients more than a year of lifetime under the treatment of our drug. We escalated further in cohort four. You see 80 microgram per kilogram. We saw a tremendous jump in cohort five with regards to efficacy. Now you see different coloring. A color of green means a partial response. These are objective response criteria determined by medical associations. The partial response means a more than 50% reduction in tumor volume. Here you see that already three out of six patients responded to our drug treatment. In particular, we were very keen on that patient here. You see here the color changes in the turquoise. Turquoise means a very good partial remission.
This means more than 90% reduction. Finally, it turned red here. It means a complete response. Complete response means complete absence of any tumor cell. That patient has now, after around a year, become completely free of any detectable tumor cell. Since this is such a remarkable success already in the very early stages of such a clinical study, I give you more color on that patient. That patient has been with multiple myeloma more than 23 years. She has seen nine different lines of therapy. Again, everything what you can imagine in the multiple myeloma setting. You see here, this is just a clinical marker, that you can look here in the tumor cells, and they are getting lower and lower over time. They are completely disappearing. She started treatment in October 2023.
She went on, let's say, to the first complete remission, which was later on to be confirmed a stringent complete remission in August 2024. She is now in almost 20 months in monotherapy with our drug. She is now close to 10 months in the complete remission. She has a very happy life. Because what we also not only see, we see a complete remission, the complete disappearance of the tumor cells. We also see a very mild safety profile. We do not see ocular toxicities, liver damage, lung, renal toxicities. We only have seen a very mild drop in the platelets in the very first cycle. Even that side effect disappeared. Now she is living without any severe adverse effects for close to two years and the complete absence of the tumor. She is traveling. She is gardening.
She has now a very good life based on our drug treatment. With that success, we are now continuing that clinical trial because we want to maximize the effect of the drug. We want to see more responders. We want to see a long duration of response. These are just the details. We do not go on the details for the sake of time that we have now called six and seven already completed. We are further increasing the dose. Again, without the observation of any side effects. Altogether, we have now eight patients with an objective response, which means more than 50% reduction of the tumor volume. Again, this is already quite a remarkable success during that early course of the clinical development.
For us, that's the clinical validation, what I promised you in the beginning, that we can overcome resistance, that we can give cancer patients new treatment options, and we can give them a very long survival time based on our drug treatment. We also looked then in the future, where are we going to end up with our drug? We looked into the monotherapy, what we are doing already in the dose escalation. Cancer therapy, it's also a matter of combination therapy. We looked at what drugs can be combined with our drug and put a development plan in perspective and also did a market analysis. Here, to be short, here in general, what we are doing now, that in 2025, we will finish up our dose escalation.
We start a so-called dose expansion, that the final dose will be selected and a larger number of patients will be treated with that drug, just to confirm that what we have seen in this rather low number of patients will be true in the bigger number of patients. We go for a registration trial, how the people in the space call it, so that we, let's say, have by the end of 2029 the data to aim for a drug approval first in the U.S. and other countries as well. Just to demonstrate to you here with the accelerated approval path, the market size, the addressable market size, that is just only for the U.S. population, we believe with 13,000-16,000 patients. We only take a market share of around 25%.
If we calculate this with the price of the competitors, we already have just for that market segment a multibillion-dollar drug for multiple myeloma because it's a high-priced market. In parallel, we also do a combination study. This will be bigger studies. The approval will be later. We shoot for a full approval again for big multibillion-dollar markets for our drug. I believe this makes it a very commercially attractive drug we are developing. That's the plan for Heidelberg Pharma for the future. Let me switch a little bit to say a few words about the company, the stock exchange, and some deals we made. Like mentioned, we are on the Frankfurt Stock Exchange. We are now trading around EUR 5. We have seen quite an increase this year with a market cap around 200 million. We have two major shareholders.
One is the Dievini Family Office, which owns around 45%. Dievini is the family office of Dietmar Hopp. This is one of the SAP founders here in Germany, Europe's biggest software company. He has a portfolio of biotech companies. In addition, three years ago, a China company, Huadong Medicine, which is number four of Chinese pharma companies, put also EUR 80 million into Heidelberg Pharma. It is now the second major shareholder of Heidelberg Pharma. The remaining 20% are in free float. We have some liquidity every day on the drug. That is just the share price. What you see here, since the beginning of the year, we do see quite a trend because the world is recognizing the progress. We see the progress in the phase one, in the clinical validation of our data. We have certain news around the clinical study updates.
We see quite a tremendous jump in the share price, becoming now closer to what we believe is a fair valuation of Heidelberg Pharma, which should be much higher as we are today. What you also see here is that we have deals financing so-called royalty deals. This is now currently the main driver for the financing of the company. To give you a brief background on this one, we have a legacy of Heidelberg Pharma from an old mother company, which stopped all the clinical development because of failures. They licensed one asset out to an Australian radiopharmaceutical company. They took the so-called TLX250-CDx for renal cancer into a development for a diagnostic. They had a successful phase three. They submitted a BLA. The PDUFA date, so the market approval, is expected for end of August.
What we did, we sold the royalty to specialist companies. We have a deal with Healthcare Royalty with up to EUR 115 million transaction volume. We already received EUR 45 million payments, non-refundable payments. The remaining EUR 70 million upon approval in August 2025. That is non-dilutive money for the company. We are not diluting the asset, not diluting the shareholders, but it finances our development programs. The royalty deal is kept. The factor is not disclosed. As soon as the cap is reached, all royalty payments revert to Heidelberg Pharma. Since we have double-digit royalties on TLX, we have a very attractive financing opportunity for our company. The other deal to mention is Huadong Medicine. As mentioned, they put an equity investment and also some license deals already.
They obtained the rights for China, mainland, and surrounding countries to our first two lead programs and option for other candidates, really to commercialize our drugs in China. They're already planning based on our phase I data to start trials in China for the HDP-101, which gives us the opportunity to profit from that deal as well. That's very shortly where we are with the company, with the financing, with the cash position, with the royalty deal, assuming that we get the EUR 70 million milestone upon drug approval in August. We have the runway into 2027 for the company. This means not only for the lead program, because we are planning for success. You see here that the lead program is going to the end of phase I. We start the phase II.
We just dosed the first patient for the second program, which is for non-Hodgkin lymphoma. The first patient is dosed. This will be ongoing. Later on this year, we start the first solid tumor program in prostate cancer. The first patient will be dosed by the beginning of 2026. We have a partner program with Techida, who are using our technology. There are quite a number of molecules, drugs coming out of our platform. As mentioned in the beginning, the attractiveness of the plug-and-play form, just by switching the target, we can generate a drug against a different tumor type. By this, I would like to conclude my presentation and just with a hallmark. We demonstrated already in patients that we can overcome the resistance.
We have at least one patient living close to two years with a monotherapy of our drug after more than 20 years in cancer history. We are a single player. We do not have competitors. We have a monopoly. We also have a biomarker for patient stratification. I believe we are in a very good position. We believe we are planning for success to generate a new disruptive class for LDCs. By this, I would like to conclude my presentation. Thank everybody for listening and watching. I am switching to the Q&A mode, looking into the questions. I can just ask them. The one is, any plans for a U.S. listing? This is, of course, we are considering this because we see limitations to German listings, but we have no current plans for this one.
Another question is, what attractive we need to invest in Heidelberg Pharma? That's very old because it's more than 20 years old. And Dietmar Hopp, so the SAP founder, built up a portfolio, for example, he's in Qwave, Emmetics, and other companies. The technology, and we have been a local company. SAP is very close to us. He was interested in the technology of Heidelberg Pharma. That was the reason why he invested in Heidelberg Pharma. He was a constant investor over years and, let's say, giving additional money in addition to the first investment in Heidelberg Pharma. Another question is about the relationship with Dievini and Huadong Medicine. Formally, we have seven seats in the supervisory board. Two seats are occupied with representatives from Dievini, and two seats are from Huadong Medicine.
We have a very good working relationship from the management and also between the investors. For example, I've been five times to China visiting Huadong Medicine. They're located in Hangzhou in order to manage the relationship with them. They are very active in developing new drugs, and they are highly interested in ADCs. The reason for Huadong Medicine to invest into Heidelberg Pharma has been our expertise in the space and our new payload technology. The other new question coming in, what are your milestones over the next 12 months? For the different programs, the next milestone will be by the end of the year for the HDP-101 program that we haven't then received the recombinant phase II dose.
What I was mentioning, that the final dose will be selected, and the first phase of that study will be closed, and we, let's say, transition to the next phase, the dose expansion. We also believe that for the HDP-102, that we do see first efficacy signals for a second drug based on our platform in a different indication, which gives another layer of validation. We also will, let's say, foresee the study start in China of the HDP-101 in Chinese patients based on our, let's say, non-Chinese data. This will also happen in the next 12 months. Finally, for the HDP-103, we will submit a clinical trial application by the end of the year. The first patient for prostate cancer will be treated in Q1 2026. Since no new questions have popped up, I would also like to thank people asking the questions.
Again, thanking everybody for listening. The partnering system is open. I'm happy to, let's say, go into one-on-one meeting with you. Otherwise, you can also, let's say, directly send messages either via live site or directly to Heidelberg Pharma. Happy to take any follow-up or questions. Thanks a lot. Have a nice day. Take care. Bye-bye.