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Healthcare - Biotechnology - NASDAQ - US
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EARNINGS CALL TRANSCRIPT
EARNINGS CALL TRANSCRIPT 2020 - Q4
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Operator

Ladies and gentlemen, thank you for standing by and welcome to HOOKIPA’s Full Year 2020 Financial and Corporate Update Call. At this time, all participants in listen-only mode. After the speakers presentation there will be a question and answer session.

[Operator Instructions] I must advise you that this conference is being recorded today Thursday, 18th of March 2021. I would like to hand the conference to our first speaker today, Matt Beck. Please go ahead, sir..

Matthew Beck Executive Director of Investor Relations

Good morning. This is Matthew Beck the Head of Investor Relations for HOOKIPA. A Slide deck accompanying today's call is available in the events section of the HOOKIPA website. Please manually advance the slides as we prompt you through them.

Turning to Slide 2, HOOKIPA executive team is here with me today including Chief Executive Officer, Joern Aldag; Chief Financial Officer, Reinhard Kandera; Chief Medical Officer and Head of Global Research and Development, Igor Matushansky, Chief Business Officer Christine [Baker] and Chief Technology Officer, Roman Necina.

Turning to Slide 3, our Safe Harbor slide, during today's call, we will be making certain Forward-Looking Statements. These statements may include statements regarding, among other things, the efficacy, safety and intended utilization of investigational agents, our clinical and non-clinical plans.

Our plan to present or report additional data, the anticipated conduct and the source of future clinical trials, regulatory plans, future research and development and possible intended use of cash and investments.

These forward-looking statements are based on current information, assumptions and expectations that are subject to change and involve risks and uncertainties that may cause the actual results to differ materially from those contained in the forward-looking statements.

These and other risks are described in our periodic filings made with the Securities and Exchange Commission, including our quarterly and annual reports. You are cautioned not to place undue reliance on these forward-looking statements, which are only made as of today's date. The Company disclaims any obligation to update such statements.

For today's call, Joern will provide opening remarks. Reinhard will offer high-level comments on our financials and then we will open up the call to Q&A. With that, I will pass the call to Joern..

Joern Aldag

Hey. Good morning everyone. Nice to talk to you. Very welcome to HOOKIPA's earnings call. Please turn to Slide 4. We had a strong year in 2020, culminating with promising clinical data in both our oncology and our infectious disease spaces and a follow-on offering that has secured our cash runway through to the end of 2022.

The data we presented make us proud, early clinical proof-of-concept in HPV positive cancers in checkpoint inhibitor refractory patients, in a monotherapy setting, and secondly immunogenicity and signs of efficacy in the CMB prophylactic setting. In addition, we raised $81 million and extended our runway to year-end 2022.

We are expecting a lot more data this year in both programs. Beginning at AACR next month, where we will disclose early clinical translational data supporting our mechanism of antigen specific T-cell generation.

We hope to show you at AACR for the first time that patients with cancer, who were injected systemically with HB-201 or HB-202 at dose level 2, will have had an increase in PE systemic pro-inflammatory cytokines and chemokine levels, which would suggest a virus induced immune activation and a strong and persistent induction of HPV16 E7/E6 specific T-cells.

At ASCO, we hope to show initial data from our alternating dual vector treatments in patients, hopefully boosting T-cell responses even more. Data from higher doses will be explored and demonstrated in the second half of 2021. Also antibody T-cell and efficacy data from more Cyndi patients will be shown publicly in the second half of 2021.

Please turn to Slide 5. Despite the COVID pandemic, our oncology accrual dynamics are very positive and faster than expected. As a reminder, our initial oncology therapies build from our replicating technology and expressing the E7/E6 fusion protein from HPV16, are being tested and in an ongoing Phase I2 trial.

Worth repeating HB-201 is currently tested as a monotherapy or a standalone treatment, no checkpoint inhibitors targeting advanced metastatic patients, who have progressed on checkpoint inhibitors or platinum based therapy or both. I'm sure, you will agree with me that showing an effect in such a setting is a great result.

In June 2020, we also filed our IND submission for our HB-212 program and in October, we dosed the first patient in our HB-201/HB-202 alternating to vector program. We know from preclinical testing, that by combining HB-202 and HB-201 in an alternating sequence, we generate stronger immune responses than using a single vector.

HB-202 carries the same E7/E6 antigen as HB-201, but it is based on a different vector backbone. Like HB-201 alone, our HB-201/HB-202 is being tested in a dose escalation Phase 1 trial of late stage HPV16-positive metastatic patients who have progressed on checkpoint inhibitors and/or platinum containing regimens. Please turn to Slide 6.

The initial clinical data from our HB-201 Phase one trial, which included patients on the first two dose levels showed us favorable tolerability profile. In terms of efficacy in the 15 invaluable patients, we saw one complete response, one partial response and numerous stable disease patients.

The efficacy for the first two doses and the Phase I escalation shows a remarkable trend the 73% disease control rate and 18% response rate from the head and neck squamous cell carcinoma HPV16-positive subgroup are comparable or better than response rates from studies of PD-1 inhibitors in earlier line head and neck cancer patients.

So specifically, we compared to nivolumab and pembrolizumab. The December interim analysis, data were generated with our initial two dose levels. We are continuing to explore additional dose regimens and levels as we optimize for the recommended Phase two dose.

In that data set, we highlighted one patient WHO after progressing twice on prior rounds of Timbral, clinically progressed on HB-201 monotherapy. The investigator asked to keep the patient on his HB-201 regimen, while adding pembrolizumab in combination.

As of the data cut off, the patient had begun to respond with visible and radiological signs of tumor shrinkage. With the off protocol edition of Timbral, the patient is no longer included in our recorded HB-201 data.

However, it is encouraging sign to see a synergistic response with the combination of HB-201 and a checkpoint inhibitor and see that this is safe. We plan to explore the simultaneous HB-201 or HB-201/HB-202 combination and checkpoint inhibitor combination in the Phase II portion of the trial.

Two weeks ago, we announced that the preclinical data on our HB-201/HB-202 alternating to vector program was published in cell reports medicine.

These preclinical data showed that alternating IV administration of two replicating arena viral vectors induce tumor specific responses exceeding 50% of the circulating CVAT-cells, which resulted in tumor cures and long-term immunity against tumor re-challenge. Please turn to Slide 7.

As I mentioned earlier, we are currently analyzing and will report early translational data on our HB-201 and HB-202 vectors, at the upcoming virtual AACR Conference in April.

The abstract title off preliminary analysis of immunogenicity of HB-201 and HB-202 and arena virus based cancer immunotherapy in patients with advanced HPV16-positive cancers was reduced last week. We will report on invivo CD8 T-cell proliferation and biomarker data from patients treated with single HB-201 or HB-202 vectors.

We also have time to update clinical data from the HB-201 program and report initial safety, tolerability, and efficacy data from the HB-201/HB-202 program at the ASCO Conference in June.

This might be the first time that, we show patients data, which demonstrates the superiority of the alternating two vector approach over the single vector approach with regards to T-cell induction and efficacy. We expect to identify the recommended Phase II dose in Q4 of 2021. Please turn to Slide 8. Switching gears now to CMV.

HB-101 is a preventative vaccine based on our non-replicating technology designed to stimulate the immune system against cytomegalovirus infection or reactivation and organ transplant situations.

From the ongoing Phase II trial in kidney transplantations, we reported late last year positive safety, immunogenicity, and preliminary efficacy data that exhibited reductions in CMV viremia, the use of anti-virus and CMV disease in post-transplant patients and in-line with our expectations.

Also, we have confirmed our mechanism of action of driving T-cell and antibody responses. Enrollment in this Phase II trial continues slower than expected. COVID is the primary driver of the difficult accrual.

Many transplant sites either shutdown or drastically slowed their transplant schedules for many months to avoid immunosuppressing patients during the intense outbreak periods. We plan to wind down accrual no later than the third quarter of this year, by which time we will have recruited approximately 100 patients against an original target of 150.

As you may recall, our trial protocol includes monitoring patients and their outcomes for 12-months post-transplant. The next data release planned for the second half of this year will provide further efficacy data to inform about the path forward for this program.

We are in the process of analyzing the opportunities in the CMV space beyond kidney transplant, looking at liver transplant, hematopoietic stem cell transplants and Prophylaxis of congenital CMV infections.

Our collaboration with Gilead in which we are seeking therapeutic cures for Chronic Hepatitis B and HIV continues to progress, and is further approaching the clinic. We anticipate reaching select milestones, including one request for development for the HIV program in 2021.

We believe we are progressing to the satisfaction of Gilead, however, are unable to provide development timelines as Gilead is controlling this. With that, I will turn over to Reinhardt for comments on all financials. Go to Slide 9 please..

Reinhard Kandera

Thank you, Joern. Good morning everyone. On the financial side of the business as well, we are looking back to a very successful year 2020. Despite the progress that we made in our clinical studies, our loss increased only marginally, and our operating cash flow even slightly decreased compared to 2019.

Most importantly, with our successful $81 million follow on financing in December, we are advancing to the next development phase with a solid cash balance. Slide 9, summarizes our fourth quarter and full-year 2020 financial results and that will focus on the full-year results.

If you can see there, we had an increase in revenues by more than 60% to almost $20 million, which is proof of the progress that we are making in our collaborations with Gilead, which is currently our only source of revenue.

These revenues include cost reimbursements of $13 million, and more than $6 million from recognition of upfront and milestone payments. Our R&D expenses increased by 18% to approximately $55 million and the main cost driver in 2020 was our HPV16-positive cancer program, followed by the courts and our Gilead collaboration and the CMB program.

We expect our R&D costs to continue to grow in 2021, as we continue to progress on these programs. Our G&A expenses grew, as we continue to expand our operations, the main driver of the increase were personal expenses, including non-cash stock compensation expense.

Our other income of more than $9 million includes approximately $6.5 million in grants, as well as exchange rates and currency translation gains. Bottom line, they showed the net loss of $44 million in 2020, slightly up from $43 million in 2019. Our 2020 operating cash outflow was $39.3 million, which compares to $41.7 million in 2019.

Our year-end cash balance was $143.2 million at the end of 2020, which gives us a solid financial footing to further grow our outstanding as we progressed our R&D progress. With that, I would like pass back to Joern..

Joern Aldag

Thank you. Before I end with the milestones, you can expect over the next 15-months or so I would like to comment on the CORONAVIRUS pandemic and how it is affecting HOOKIPA. Our top priority is the health and safety of our employees followed by business continuity. We continue to operate from home in the U.S. at 100% productivity level.

While the NS labs have opened full time and other staff are working part time from home. Here also I would say the productivity is very high. Travel has reduced to an absolute minimum.

Our employees quickly adapted to the new circumstances, we maintain close contact with our trial site CMOS and development partners and have adapted to the situation hoping that with vaccinations now, things will change relatively soon back to more normal.

I'm indeed very proud of our people and their drive to support the company’s and our shareholder’s objectives throughout this unusual period. And I'm very proud that in summary, we are maintaining our clinical milestones throughout 2021.

We will present translational oncology data at AACR in April, and this will contain a whole series of T-cell data and other transactional data I have mentioned earlier in the talk. We plan to present additional HB-201, and an initial HB-201/HB-202 to vector data at ASCO in June, and this will be clinical data and also translational data.

We will report additional CMV data from the Phase II trial in the second half of this year. I'm very pleased to keep us corporate and promising clinical progress in 2020 and early 2021.

We are laser-focused on execution to produce compelling proof-of-concept data without proprietary renal viral-based products and intend to do so with our clinical data readouts, later this year. With this, I would like to end the introduction and we will open up the line for Q&A. Operator..

Operator

Thank you sir. [Operator Instructions]. Sir your first question comes from the line of [Stephen Malong] (Ph) from RBC Capital Markets. Please go ahead, your line is open..

Unidentified Analyst

Good morning. This is Steve on for Brian, and thanks for taking our question. In light of the possible synergy between checkpoint inhibitors and HB-201, can you share any updates in your thinking as to how HB-201/HB-202 for the platform in general and they combine with additional systemic set of toxic therapies like IRN chemo? Thanks..

Joern Aldag

Yes, I will pass this on to Igor..

Igor Matushansky

Thanks for the question. Of course, as we think about moving up our therapies from monotherapy in the advanced settings to earlier settings, we are beginnings to strategize how that would combine with other therapies that are far more commonly used in the first line, including chemotherapy and radiation therapy.

We are doing pre-clinical work to see how these various chemotherapies interacts with our 200 therapies, and we are also speaking with various academic groups about doing some exploratory investigator initiated endorse biomarker studies to assess the preliminary nature of these interactions, as you know, probably checkpoint inhibitors and other meta therapies have for the most part interacted favorably with chemotherapy than in terms of pooling response rates and survival in those patients.

And we believe the same will hold true for our approach as well, we will of course stretch cautiously by doing some investigator initiated exploratory biomarker studies as we pre-alluded to advancing our therapies in combination with a more standard once you mentioned, the first line settings..

Unidentified Analyst

Thank you..

Operator

Your next question comes from the line of [Christopher Lu] (Ph) from SVB Leerink. Please go ahead, your line is now open..

Unidentified Analyst

Hey, guys. This is Chris on for Andy. So, just thinking about the AACR presentation, and I know the focus is on immunogenicity and safety for the alternating dose regimen.

But just wondering if there could be any potential preliminary efficacy data, like a case study or something small like that?.

Joern Aldag

Igor?.

Igor Matushansky

At AACR, we will be focusing exclusively on updating our translational datasets. At ASCO we will, of course be doing a more formal clinical update, in which case you would expect to see additional clinical data, including safety, efficacy, and of course, any additional anecdotal data we will share as of the cut-off date for that presentation.

But at AACR formally we will not be doing any clinical updates, just translational data. But the translation data for which we will be coming will be coming from more recent patients, but the efficacy data, we will have to wait for ASCO..

Unidentified Analyst

Sure.

And is there a way we should think about the potential read through from the immunogenicity data to potential efficacy?.

Igor Matushansky

Well, you know if you follow our preclinical story, we have continuously stated and published that our efficacy always correlates to our mechanism of action. And so we have shown pre-clinically multiple times that the better our induction of antigen specific CDAT-cells, the better our tumor control in the preclinical setting.

And clearly that is I would say the whole goal of trying to go to higher dose levels using two vectors in alternating manner, and everything else to try to do a dose escalation phase in order to improve our immunogenicity, because clearly based on our preclinical data set, we believe that translates to improved efficacy.

We are getting the data out as fast as we can. And so clearly the translational data, we could generate a little bit faster than our clinical efficacy data. And we will get that out for AACR. But again, it is just the timing I think the clinical efficacy data, we will have to wait until ASCO..

Unidentified Analyst

Got it. And just one final question, if I may. It sounded like we are having multiple potential clinical updates for the alternating dose regimen.

Is that correct?.

Igor Matushansky

No, well, no, I mean, again, we will update at AACR, we will focus again on translational data, that translational data will come forth from 201 and from 202, 201. At ASCO, we will update the clinical efficacy for both 201, and for 202, 201.

Clearly, later on in the year at other conferences, we will continue to update it in both the translational and the clinical efficacy. But for the next several months, translational data will come at AACR and clinical update data will come at ASCO and probably at ASCO we will clearly try to make some correlations between the two..

Unidentified Analyst

Got it. Thanks..

Operator

Your next question comes from the line of Alec Stranahan of Bank of America. Please go ahead, your line is open..

Alec Stranahan

Hey, guys, thanks for taking my questions. Two from me. First on the HB-101 program. We are certainly looking forward to the data updates and the kidney transplant study in the second half of this year.

But I guess at what point or what additional data would you guys need to see to feel comfortable to expand the program into congenital or other transplant settings, like you mentioned, and then I wanted to dig a little bit more into the translational data.

So, looking at your recent publications, or reports, I guess, as you are looking at the percent of anti cancer T-cells produced by either HB-201 alone or the HB-201/HB-202 combo. Is there a certain amount of T-cell education that needs to be surpassed, to achieve clinical responses, the FPR or CR. Does this really vary from patient-to-patient.

I guess slightly differently, how would you frame that 50% tumor-specific T-cells generated with the combo - anticipated clinical responses. Thank you..

Joern Aldag

So let me quickly answer on 101.

We have shown into 101 trial that, when we have the ability to administer three doses to patients, we are actually getting a full proof-of-concept if you want of our hypothesis, which is that we are driving antibody and T-cell responses and we are controlling CMV viremia to a significant extent, the use of antivirals and we are controlling, hundred percent CMV disease.

These are the key end points of the things that you would want to control, and the data we have shown publicly, earlier was on the basis of fewer patients, relatively few patients. But we think that this is a confirmation of our proof-of-concept.

Going forward, we are trying to get as many patients possible in which we are confirming the data that we have seen earlier and if we are confirming it, I think that would be a very strong signal for moving the program forward.

At this point in time, we have chosen solid organ transplant as a relativity fast and low patient way to get to proof-of-concept of our technology.

At this point in time, we are looking at, will we be taking it forward and solid organ transplant? Could we also take it forward and hematopoietic STEM cells, transplant, or potentially even find a way to get it announced for congenital trial in which we are trying to prevent CMV disease in a congenital setting.

So, these things are being analyzed and asked for as seeing more patients coming in. As I'm saying, if we are confirming the data that we have seen before we would feel comfortable to progress the trial. Igor, maybe you take the second question..

Igor Matushansky

So, this is a great question, and I wish, I or anyone else send the easy answer to what a number would correlate and guarantee a response.

I think that, in general, if you look at the work of others specifically, I would say most comparably in the TCR space, the more we can get antigen-specific T-cells into the blood of the patients, ''The better correlation to response''.

However, there has been, I would say, no magical number, no kind of a hard line percentage that could be identified that guarantees a response either. A lot of it has to do with not just the quantity, but the quality of the CD8 T-cells. How many of them are activated are non-exhausted. So there is a straightforward number.

I will say that, if you look at putting everything we know together, I would say, if you could generate a response that gives you a high single-digit percent CD8 T-cell from an active either therapy like ours, that would be very, very remarkable and probably has not been demonstrated via direct realize that in the past, and if we could demonstrate something like this, there, I would say would be a good chance that it will correlate to sponsors and it would lead to improve the efficacy.

So, I would say what number would we be very, very excited, the kind of number that no one in this kind of space has been able to demonstrate before as measured directly from a patient's blood without any kind of artificial expansion, I would say a minimum of high single-digit percentages..

Alec Stranahan

Great. Thanks again..

Operator

Another question comes from the line Ingrid Gafanhão form Kempen. Please go ahead, your line is open..

Ingrid Gafanhão

Hello good morning, good afternoon and thank you for taking the question. I’m glad to see some progress also in the in the Gilead partnership front.

Was just wondering, is there any significant milestones that we could expect for these years?.

Joern Aldag

Yes. There you should expect a milestone in the HIV program. And that milestone is linked to what is called request for development in Gilead language.

Request for development is the moment where they commit to bringing a program forward to clinical trial, where they are committed to bio-distribution Tox studies and also to manufacturing for the clinics. We have passed as milestones HPV. This is to come for HIV, and we are expecting it sometime in the middle of the year.

Apart from that, we are unable to talk about timelines, we would expect HPV program looking at standard timelines in the industry, or specifically, and HOOKIPA would expect that to be late this year or early next year to be moved in the clinic..

Ingrid Gafanhão

That is great. Thank you very much..

Operator

Another question comes from the line Roy Buchanan from JMP Security. Sir, please go ahead, your line is open..

Roy Buchanan

Great, thanks for taking the questions. I appreciate the clarity on the CMV program. So, for the update in the second half of the Phase II for HB-101, what post transplant durations you are going to report for viremia and antiviral efficacy.

I know you mentioned that the primary endpoints or this the efficacy endpoints are 12-months, but are you going to report any earlier data points and do you have any information on how the follow-up has been for the trial especially considering COVID and I have a follow-up..

Joern Aldag

Igor do you want to take that..

Igor Matushansky

Thanks for the question. So, I think you are right, the overall follow-up for the program is designed to be 12-months following transplant. Well efficacy points will of course be given not only as the viremia in terms of percentage in a number of viremic events in the 12-months period.

But also for us all the I would say subcategories of that duration of a viremia, insensitive viremia, et cetera, et cetera and of course, the concomitant use of antivirals again. Were they used, how long they were used, etcetera. So, all of that will be reported at the endpoint of the 12-month time point and all that information will be followed.

We are going to be updating the program, as I stated previously in the second half of this year but probably not any sooner. And in terms of how the follow-up has been, I think when the majority of impact that we have had on some COVID, as Joern indicated earlier has been on, I would say accrual.

In other words, because our sites are, I would say, not being able to perform as many elective procedures, and while it is a live donor kidney transplant, serious procedure, it is still an elective.

Many of them are of course, stopping elective procedures and, but even more so they are stopping clinical trials that are related with elective procedures, due to simply administrative efforts that require the most of the hospitals that focus on COVID-related issues.

Now, well this has affected, new accrual and continual accruals, it has not really affected follow-up. The patients are followed routinely as for standard of care, and our clinical trial does not have any additional, I would say hardships in order for a follow-up. So, follow-up for these patients has not been affected..

Roy Buchanan

Okay. That make sense. Thanks. And then, kind of more general question. I guess, you guys haven't seen any safety and tolerability issues with arenavirus vector data.

Have you thought about using the replicating technology for infectious disease, particularly for hard to treat viruses like hepatitis B and if Gilead thought this was a good idea, would that should be possible under the existing agreement, and would that require a new request for development from them? Thanks..

Igor Matushansky

The answer to both those questions is, yes. We have thought about it. And I would say, that conversation is on the table, for discussion with Gilead. No final decisions have been made, whether we will be using our replication defective programs still or not, and the contract is completely open from that point of view..

Roy Buchanan

Okay. Thank you..

Operator

Next question comes from the line of Asthika Goonewardene from Truist Securities. Please go ahead, your line is open..

Asthika Goonewardene

Hi, good afternoon, and good morning to you, and nice to speak to you guys. I would like to focus on AACR please. Igor to ask about how many patients - what translational data will you have.

And maybe can you give a little more color on the kind of analyses, specifically, where do you have some of that data that tell us what percentage of entrance to see T-cell bras to total CD8 compartment? And then I got to pull off on that..

Igor Matushansky

Sure. So, AACR data will present, I would say single-digit number of patients based coming from our first analysis. It will be, I would say, a combination of 201 patients as well as 202, 201 but most 201, because we have had more patients and analyzed and more with them in a first batch.

The data will be focused mainly on using direct [indiscernible] as a readout. So the first, readout and as a direct [indiscernible] it is not reported as a percentage, that percentage could be back calculate it, of course, but the data is primarily not reported as a percentage because it is coming out of a direct [indiscernible] analysis.

The analysis that translates into I would say percentages is based on different analysis called intracellular staining analysis of that data, we will probably - we have not performed as much and will probably not be releasing at AACR, we will probably be releasing it as closer to ASCO..

Asthika Goonewardene

Great. And then I know COVID hampers sample collections. But I'm just wondering would you also happen to have any real biopsy data or maybe new data on T-cell fitness and AACR..

Igor Matushansky

T-cell to say fitness? Is that the question?.

Asthika Goonewardene

Yes..

Igor Matushansky

So, we will not be showing any T-cell fitness data at AACR, we will be showing, basically, as Joern said earlier, interferon gamma cytokine signature data, the biopsy data that we will - our R&D is collecting, and that data will be available, most likely at the Sims Conference.

And part of that data we will of course be looking at tumor infiltrating lymphocytes, and actually looking at the at the exhaustion state are those CD8 T-cells as well, as the Sims Conference is about a month after the AACR and a month before ASCO..

Asthika Goonewardene

Great. Excellent. Thank you so much for taking my questions guys..

Operator

[Operator instructions] And another question comes from the line of [indiscernible] H.C. Wainwright. Please go ahead, your line is open..

Unidentified Analyst

Thanks for taking my question. I have two. One regarding the HB-101. So, I know we could expect the safety data at the second half of this year.

Could we also expect some - and any feedback from data for your interaction with the FDA in this year?.

Joern Aldag

Igor.

Igor Matushansky

For the 101 program. Right. So, I would say that currently, the way we are looking at the program is that summer over the second half of this year will be basically doing an analysis and putting together a package for the FDA.

If that package, I would say is - if we get a response from the FDA within a reasonable amount of time, the answer could be yes. But I think if you want me to give you a ballpark, a general ballpark figure for when FDA feedback might be expected, it could either late this year or early next year..

Unidentified Analyst

Okay, that is great. And also regarding the 301 program. I'm just curious. Could you give us more color on the general strategy for the clinical development, would that be more like 201, 202. My question is like is could we also expect some alternating dosing strategy for this program? Thanks..

Igor Matushansky

Sure. I think what we are currently thinking about this program is to basically go in directly with the alternating approach as a primary approach. So I think, we are going to go directly with kind of what we call the alternating [indiscernible] approach into patients, and we are going to use antigen to spoke about that PSA and PSMA.

And we are probably going to go into this similar to two to 200 program in the advanced setting in a monotherapy setting or the advanced monotherapy in patients who progressed on standard of care..

Unidentified Analyst

So, maybe I have a follow-up with that. Also, so you will be testing the [ITIV] (Ph) in both and also as well as the IV -..

Igor Matushansky

No. No, for prostate cancer it is a little bit different as I’m sure you know a lot of prostate cancer is bone, metastatic bone lesions. And because of the propensity for bone that fill into tumor injection is not the better strategy.

And so for the prostate cancer program just due to the pattern of metasticies, which majority of those patients present will probably only going to pursue the intravenous approach..

Unidentified Analyst

I see. Thank you. Thank you for update..

Operator

There are no more questions at this moment. Please continue..

Joern Aldag

Well, I think, in that case where we are done for today, I'm very pleased that you participated in this call.

And I would like to just say that, we are all very, very excited to keep about multitude of different readouts that we have in front of us, in both programs, very rich, first half as we have just discussed with concert and interesting data coming out for 101 in the second half.

So overall, we sync at this point in time, we are rich in new data and we are really curious to seeing it, and presenting it to you. Thanks for that for participating in this call and if there are any further questions from folks, please let us know directly as well. Thanks a lot. Bye, bye..

Operator

That concludes the conference for today. Thank you for participating. You may now all disconnect..

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