Heidelberg Pharma AG (HPHA) Earnings Call Transcript & Summary

Welcome, everybody, to our M2M new format, new event at BioRN. M2M stands for Member to Member. So we are here to showcase our members to other members. My name is Annalisa Zuccotti. I'm in charge of communication and events at BioRN. And today, I came to Ladenburg, at Heidelberg Pharma. And then here with Artjom, please shortly introduce yourself.

Thank you very much, Annalisa. It's great to be here and to present -- and the opportunity to present our company to the audience. So my name is Artjom Wischnjow. I'm Associate Director Business Development here at Heidelberg Pharma. Actually, I'm scientist by training and still a scientist in my heart. I studied Biotechnology at Technical University, Darmstadt, done my Ph.D. at the University Hospital in Heidelberg. After that, I joined Novartis for a couple of years and 2018, so to say, back to the roots, joined Heidelberg Pharma as a group leader in a bioanalytical department, and since 2020, I'm part of the [indiscernible] team.

Great. Thank you. So we are also happy that you are back to Heidelberg and after your little tour through Europe. So while we were preparing this event, so we thought about the name M2M and Stephanie and I, my colleague, in communication, we continuously talk about M&M's. So we decided to start the interview with the icebreaker, so I brought here 2 jars, one with M&M's, one with gummy bear, you can keep one. So be careful with your decision.

I would definitely prefer M&M's.

M&M's, perfect. That's all...

With peanut butter.

Only peanuts? So peanut butter was impossible to find here, but we will keep for the next meeting. Great.

Thank you.

So Artjom, we will be able to keep that. But actually, when we arrived here this morning, we asked the same question to your colleagues. So we have now a very short video to give you an impression about Heidelberg Pharma. And also, we are curious to see if your colleagues have the same taste. Thank you, Stephanie, for starting it.

Hello. This is Stephanie from BioRN and today I'm right on site at Heidelberg Pharma for the M2M event. But before we start, I would like to show you around and give you some insights. And I'm really very curious who we're going to meet on our way now to the conference room. So are you curious as well? Are you going to follow me? Okay. So let's go. I think here's somebody waiting for me. Hello. Hello. Hi, I'm Stephanie from BioRN, nice to meet you.

Nice to meet you. My name is Aniko.

Nice to meet you, Aniko. I have some energy sweets with me. Do you like or do you prefer M&M's or better happy [indiscernible]?

So definitely M&M's. So my favorites are those with peanut butter. They're really delicious.

So the energy is with you. Okay, Aniko, what are we going to do now?

So I'll take you upstairs to the lab space and there, you can see what we are doing here at Heidelberg Pharma.

Great. So let's go. What do you do at Heidelberg Pharma?

I'm the head of Biochemistry & Cell Biology – department at Heidelberg Pharma and in my department, we are performing the conjugation of the antibodies to the payloads, and we make the characterization and also testing their ADCs for the efficacy on the cells.

Okay. Sounds very interesting.

It is. It is highly interesting. And now, yes, I bring you to the bioanalytical department in regard to the analytical characterization of ADCs are performed.

Okay. Very good. How many people work here at Heidelberg Pharma?

So I think so, approximately 120 people.

Wow.

Quite much people, yes.

Okay.

So we have here a Chemistry department, Biochemistry Cell Biology department, Bioanalytics and also the Clinical Team and CMC and many different other departments.

Great. So I'm really curious to see now the lab space. Here we go, okay.

Let's go.

So let's go. Door is going to open and we'll get inside.

[indiscernible].

Okay.

And here, I think [indiscernible].

It should be this room, I guess. Let suppose.

No.

No. Let's have a look, maybe the next door. [indiscernible] She is there, okay.

[indiscernible].

Hi, [ Marisa ]. Nice to meet you.

Hi.

Great. This is the lab space and [ Marisa ], what are you doing here?

Hi, I'm [ Marisa ]. I'm the Director of the Bioanalytical Department, and we are characterizing and analyzing our antibodies, our payloads and antibody drug conjugates in biological matrices. And therefore, we are developing our own bioanalytical methods, mainly immunoassay as well as HPLC, mass spectrometry-based assay. And now you will meet my colleague, [indiscernible].

Very good. Thank you very much. But before we close this with you, a question for you. What do you prefer? BioRN M&M's or BioRN [indiscernible]?

[indiscernible].

So the BioRN energy is with you. Thank very much, [ Marisa ]. Bye-bye.

Thanks a lot.

Thank you very much, Stephanie, and happy that the energy is with Heidelberg Pharma now. Great. Thank you very much. So now we have literally seen Heidelberg Pharma. We can start with some questions. So maybe you would like to tell us shortly the story of this company. When was it founded, by whom, what was the motivation of the founders and so on?

So actually, the history of Heidelberg Pharma goes back to 2 companies. The WILEX, it's a Munich-based -- has been a Munich-based company and Heidelberg Pharma Research, its subsidiary. And WILEX was founded in the late '90s by a group of scientists and medical doctors from the Technical University, Munich and became a publicly listed company around 2000. The Heidelberg or Ladenburg based subsidiary was a spin-off of Boehringer Mannheim. And the scientists here were focusing first on small molecules and later on developing ADCs. After WILEX was restructured around 2010, 2012, the main office has been moved to Heidelberg, to Ladenburg, and the company was renamed to Heidelberg Pharma. We have -- from this time, we have a legacy portfolio that is out-licensed to different partners around the world. For instance, Telix Pharmaceuticals, in Australia or RedHill in Israel.

Okay. Perfect. So as you can see, I'm starting asking some questions to Artjom and I have a long list. So it will be a good half an hour. But obviously, you can post also your questions in the chat and will be selected shortly of them for asking later. So we said we keep going. So maybe you can tell us about the major efforts and development of the company since the foundation?

I will start from the restructurings around 2012. So after this restructuring, the entire company started focusing on developing novel innovative antibody drug conjugates with a unique -- really unique mode of action. And maybe I can ask one question back. Maybe you're mushroom picker?

No. My in-laws are mushroom pickers and then I cook and eat them only.

Okay. But maybe someone in the audience are familiar with the so-called green death-cap mushroom. And our technology -- our platform technology is actually based on the toxin, Amanitin, that has been identified many, many years ago in this poisonous mushroom. There are 2 major milestones I would like to mention. First of all, we have established total synthesis of Amanitin derivatives that we are using for our ADC platform. So we are not collecting mushrooms from the forest. And the second, very important milestone was bringing the payload Amanitin into the clinic. So we are currently in Phase I clinical trial with our elite candidate, HDP-101, which is targeting BCMA for treatment of multiple myeloma.

Okay. Perfect. And what is the mission of the company today. So you gave us this nice overview on the journey, but what is today the mission?

Very good question. Of course, the mission of the company is to provide new options in cancer therapy to the patients. We call our technology, ATAC technology. And this platform technology enables us to produce potentially effective treatments for a wide range of tumors with the ability to overcome tumor resistance and to eradicate dormant tumor cells that are, how we believe, involved in the disease relapse. We also have -- we are developing a platform-wide specific biomarker that potentially would help us to identify patients whose tumors are more vulnerable to treatment with ATACs. This whole technology, ATAC technology is like an engine that allow us to build a rich proprietary pipeline of potentially best-in-class drug candidates for both hematological and solid tumor indications.

Okay. And has something changed along this journey that you just described?

Yes. Indeed, indeed, yes. Over the years, the company has developed a really extensive expertise and extensive patent portfolio around this compound, Amanitin. We all in the company are super proud that we are the first in the world, to our knowledge, that has brought an ADC with the payload, Amanitin, in the clinical development. And over the last couple of years, the company has experienced a constant growth. And our current goal is to become a global player in the ADC field. The current strategy is to validate the technology, platform and clinical trials to broaden its application based on its mode of action and use the technology to develop new therapeutic options for patients. We have a hybrid business model. So I've mentioned before, we have our own proprietary pipeline, which we constantly feel with new candidates, but we also out-licensed our technology to partners in pharma and biotech around the world.

Okay. Perfect. So I think we will come back later to this out-licensing eventually. So we've heard about the foundation, the history, this journey and a new consolidated mission at Heidelberg Pharma. So now if you would use a few words, how would you describe the unique selling point of this innovation made at Heidelberg Pharma. So what makes your company innovative?

I will try to do it in few words. See as -- so our therapeutic approach is the inhibition of RNA Polymerase II. This is a mode of action that has never been used in the clinic before. By targeting such a fundamental cell function like the mRNA synthesis allow us to potentially to target untreatable tumors. And I mentioned before, this dormant tumor cells, which are the cause for tumor relapse. We believe having the biomarker in our toolbox makes it to a very powerful tool to identify patients who would likely benefit from treatment with our ATACs.

Okay. Perfect. So thank you for keeping the promise and used a few words. But now I give you also the opportunity to dig into the science behind that. And I mean, the view that you are listening, most of you are scientists. And so I think they will enjoy this if you tell us about the scientific approach behind that?

Of course. So to -- as I said, to our knowledge, we are the first company bringing Amanitin and this mode of action, the inhibition of RNA Polymerase II into the clinic. And there's quite a simple reason for this. There's only one specific inhibitor of RNA Polymerase known to man and that's Amanitin. But its toxicity prevented its usage for treatment of patients. And what Heidelberg Pharma has done over the last couple of years, we, researchers here have engineered a therapeutic window to Amanitin and enabled its application for patient treatment. Speaking as a scientist, Amanitin is a beautiful molecule. It's a bicyclic octapeptide, which is super hydrophilic. And this hydrophilicity makes it -- differentiates it also from payloads that are currently in development or already approved in the clinic. And this hydrophilicity makes it to a perfect payload to target resistant tumor cells. One of the potential resistance mechanisms of tumor cells is upregulation of the cell called efflux pumps. And you can imagine these tumor cells like bucket with the hole. So you pump a payload or a toxin inside the cell to kill the cell. But the efflux pumps just pump the drug out. So this cell can survive the treatment. But being so hydrophilic, Amanitin is not a substrate to those efflux pumps and can overcome this resistance mechanism. I have mentioned several times already this ability to kill dormant tumor cells or so-called cancer stem cells. The reason is also quite simple. So even those nondividing tumor cells need some kind of housekeeping transcription. They cannot just shut down the RNA Polymerase or the mRNA synthesis. But by targeting such a fundamental cell function, we can even kill those cells. And another beautiful story I would like to tell, and it's very -- it's actually really a beauty of the science. It's the biomarker story. So we found this potential biomarker just by serendipity. During collaboration with MD Anderson Cancer Research, the researchers, they found that some tumor cells are more sensitive to treatment with Amanitin. Those cells were so-called 17p deleted cells. So tumor cells often delete a sequence of chromosome 17 where the TP53 tumor suppressor gene is located to become more aggressive. And really, just by serendipity, we found that another gene is in the close proximity of -- to TP53, and this is POLR2A. POLR2A is a gene that is encoding for a major subunit of RNA Polymerase II. So the intracellular target of Amanitin. And by deleting TP53, POLR2A is co-deleted in over 95% of cases. So what happens? This tumor cells have less RNA Polymerase in the nucleus. So at the end, we need less -- we need to bring less molecules of Amanitin inside those cells to drive the cell [indiscernible]. And from my point of view, it's a real beauty of science.

Yes. Thank you. Perfect. This is really what we wanted to hear about the beauty of science, and we see also your commitment and enthusiasm in telling the story. So today, we are here in a bigger context. So Heidelberg Pharma is one of many biotechs company here in this innovative ecosystem. Heidelberg Pharma has been since -- the very beginning since its foundation member of BioRN. And so I checked this [indiscernible] it was the early 2000. And yes, so you have the opportunity now. So members are listening to you. So how can you have other members? So what can you offer them?

I believe, as I said, we are members since more than 20 years, early 2000s and being more than 20 years in the biotech business, we definitely could share our extensive experience and knowledge with start-ups in our BioRN region.

Perfect. Thank you. And I mean, in a network -- so a network means belonging and exchange. So let's look on the other side. So how can other members support you? So which kind of members can support you? Are we talking about Global Pharma, other biotechs? So you talked before about out-licensing. So let's describe a bit there. So give more insights in that.

So I believe the -- how other members can actually help us is further establishing our region as a huge bioscience and pharma hub. I have an idea in my mind is that we, in our region, can become kind of a German Silicon Valley. And like at Silicon Valley...

Not a European Silicon Valley?

Maybe European -- let's plan for success. And like at Silicon Valley, each company in our region can benefit -- contribute and benefit from this established image. And I believe this is also a possibility to win the so-called war of talents.

Yes. One of the big topics.

Definitely.

Yes. So I've seen that we have some questions in the chat. So I was -- therefore, I was a bit distracted. So one question from Umar Khalid. So in the clinical trial, is Heidelberg Pharma also testing combinational therapy options?

Currently, we are not testing combinational options, but I'm pretty sure. So we believe that treatment of cancer, the key is in combination. And probably in future, we will consider also combination therapy in the clinical trial.

Yes. Perfect. And then another question is, so first of all, apologies, she missed first minutes, maybe you have replied, but I don't think so. So what are side effects on animal models of targeting such a fundamental process?

So ATACs, we have done a lot of modeling and trials with our ATACs. And I have to say, compared to other ADCs, ATACs have a very clear tox profile. So what we have seen in animal trials was especially liver tox which comes from unspecific uptake of ADCs, well-described and well-known toxicity. So unspecific uptake of ADCs by the liver and related kidney tox.

Okay. So I would say last question because we have still some questions as Stephanie is not convinced that will be the last, let me see. So what kind of application can support or accelerate the development of ADCs [ maybe in the R&D phase, preclinical phase, clinical trial, et cetera ]?

Very good question. Application, you mean software, what kind of application?

Maybe we can take the next question and [ Angra ], you can specify with application if you have time. Going back, what is the preferred route of administration for the therapies that you have tested in animals so far? So from [ Victor ].

Currently, we are testing intravenous application of the ADCs.

Okay. I don't see at the moment the specification of the previous question. Probably there will be more questions in the chat. We collect them. We'll send it to you, and we share the answer with the participant, okay?

Yes.

Thank you. So I think we had a very nice overview with some more deep insights at Heidelberg Pharma. Thank you very much. Now maybe some questions a bit more about you. So how does a typical day at Heidelberg Pharma looks like for you?

I believe it starts like for everyone with a cup of coffee and checking e-mails, and so here, at Heidelberg Pharma, I'm responsible for contracting, for in-licensing questions, out-licensing and of course, supporting our scientists, especially in communication with the outer world. So acting like kind of an ambassador, but also internally. So we have -- besides the R&D teams, we have also a finance department, the legal department. So I'm helping -- I'm building kind of a bridge between those departments and bringing all together helping them to bring our technology and our company forward.

Okay. So it's a lot of communication.

It's a lot of communication, a lot of e-mails, a lot of calls, yes.

Yes. Perfect. Thank you. And if you are not in Ladenburg, in the office, where can we find you? Don't say home office.

Probably, yes. But also Ladenburg, at home. So I live here in Ladenburg and I think in my garage or in my garden.

Okay. Okay. So take notes if you're [indiscernible].

I was asking Artjom that he could nominate the next member that could join our M2M series. So we can repeat, sorry for that, who you would like to see in an interview and why?

Yes. So I would like to see [indiscernible] next M&M because I [indiscernible] list of BioRN members. And I believe that -- so we have potential great synergy between our company and [indiscernible]. We are bringing the therapy. [indiscernible] bring the diagnostics. We're being able to diagnose the cancer at the early stage and being able to provide more tailored therapy to the patients. It's a great effort. And from my point of view, it's all about the patient...

Okay. Perfect. So we will definitely get in touch with [indiscernible] representatives, so we have with Heidelberg. And yes, let's see, we still review [indiscernible]. So we are coming to the end of the interview. I would like to thank you, Artjom, for piloting with us this new event. So you see there are still some programs to be sorted. But for sure the interview has been recorded and will be available on our -- in our media launch soon in the next days. You can watch that in on [indiscernible]. You can share it with your colleagues. You can come back to Artjom with some meetings. And yes, thank you to Heidelberg Pharma to listen to us. We are already a next page for M2M. So this would be a 3 in 1 with [indiscernible]. So you can tune in [indiscernible] and yes, join us for the next M2M. Thank you very much.

Thank you very much.

Yes. Bye-bye.