Earnings Call Transcript - HOOK Q4 2020

Operator, 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 are in listen-only mode. After the speakers' presentation, there will be a question and answer session. 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, Head 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, the 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 comments 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, CEO

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 makes 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 express the E7/E6 fusion protein from HPV16, and are being tested in an ongoing Phase I trial. Worth repeating, HB-201 is currently tested as a monotherapy or a standalone treatment with 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 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 I trial, which included patients from the first two dose levels, showed us a 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 in the Phase I escalation shows a remarkable trend with a 73% disease control rate and an 18% response rate from the head and neck squamous cell carcinoma HPV16-positive subgroup, which are comparable or better than response rates from studies of PD-1 inhibitors in earlier line head and neck cancer patients. 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 II dose. In that data set, we highlighted one patient who, after progressing twice on prior rounds of Pembrolizumab, 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 addition of Pembrolizumab, the patient is no longer included in our recorded HB-201 data. However, it is an encouraging sign to see a synergistic response with the combination of HB-201 and a checkpoint inhibitor and to 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 vector program was published in Cell Reports Medicine. These preclinical data showed that alternating IV administration of two replicating arena viral vectors induced tumor-specific responses exceeding 50% of the circulating T-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 of preliminary analysis of immunogenicity of HB-201 and HB-202 and arena virus-based cancer immunotherapy in patients with advanced HPV16-positive cancers was released last week. We will report on in vivo 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 patient data demonstrating the superiority of the alternating two vector approach over the single vector approach concerning 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 in organ transplant situations. From the ongoing Phase II trial in kidney transplants, we reported late last year positive safety, immunogenicity, and preliminary efficacy data that exhibited reductions in CMV viremia, the use of antiviral agents, and CMV disease in post-transplant patients 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 shut down 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, we are unable to provide development timelines as Gilead is controlling this. With that, I would like to turn over to Reinhard for comments on all financials. Please go to Slide 9.

Reinhard Kandera, CFO

Thank you, Joern. Good morning, everyone. On the financial side of the business, we are looking back to a very successful year in 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 I 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 Gilead collaboration and the CMV 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 was personnel expenses, including non-cash stock compensation expenses. 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: we showed a 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 as we progress our R&D projects. With that, I would like to pass back to Joern.

Joern Aldag, CEO

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 a 100% productivity level while the 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, and we maintain close contact with our trial site CMOs and development partners while adapting to the situation, hoping that with vaccinations now, things will soon change back to normal. I'm indeed very proud of our people and their drive to support the company’s and our shareholders’ 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 translational data I have mentioned earlier in the talk. We plan to present additional HB-201 and an initial HB-201/HB-202 two-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 with our 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. Your first question comes from Stephen Malong from RBC Capital Markets. Please go ahead; your line is open.

Unidentified Analyst, 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 fit into the platform in general and how they combine with additional systemic therapies like chemotherapy? Thanks.

Joern Aldag, CEO

Yes, I will pass this on to Igor.

Igor Matushansky, Chief Medical Officer

Thanks for the question. Of course, as we think about moving our therapies from monotherapy in the advanced settings to earlier settings, we are beginning 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 preclinical work to see how these various chemotherapies interact with our therapies, and we are also speaking with various academic groups about doing some exploratory investigator-initiated biomarker studies to assess the preliminary nature of these interactions. As you know, checkpoint inhibitors and other therapies have, for the most part, interacted favorably with chemotherapy in terms of pooled response rates and survival in those patients. We believe the same will hold true for our approach as well. We will of course tread cautiously by doing some investigator-initiated exploratory biomarker studies as we prelude to advancing our therapies in combination with the more standard therapies you mentioned in the first line settings.

Unidentified Analyst, Analyst

Thank you.

Operator, Operator

Your next question comes from the line of Christopher Lu from SVB Leerink. Please go ahead; your line is now open.

Unidentified Analyst, Analyst

Hey, guys. This is Chris on for Andy. So just thinking about the AACR presentation, 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, CEO

Igor?

Igor Matushansky, Chief Medical Officer

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 any additional anecdotal data we will share as of the cut-off date for that presentation. But at AACR, we will not be doing any clinical updates, just translational data. But the translational data we will be coming from more recent patients. The efficacy data, we will have to wait for ASCO.

Unidentified Analyst, Analyst

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

Igor Matushansky, Chief Medical Officer

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. We have shown preclinically multiple times that the better our induction of antigen-specific T-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 sets, we believe that translates to improved efficacy. We are getting the data out as fast as we can. 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; the clinical efficacy data, we will have to wait until ASCO.

Unidentified Analyst, 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, Chief Medical Officer

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, Analyst

Got it. Thanks.

Operator, Operator

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

Alec Stranahan, Analyst

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 expanding 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, 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 in terms of anticipated clinical responses? Thank you.

Joern Aldag, CEO

So let me quickly answer on 101. We have shown in the 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 will, of our hypothesis, which is that we are driving antibody and T-cell responses, and we are controlling CMV viremia to a significant extent, thereby reducing the use of antivirals and controlling CMV disease. These are the key endpoints that you would want to control, and the data we have shown publicly earlier was based on 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 confirm 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 transplants as a relatively fast and low patient way to get proof-of-concept of our technology. At this point in time, we are assessing whether we will be taking it forward in solid organ transplants, or could we also take it forward in hematopoietic stem cell transplants, or potentially even find a way to get it announced for congenital trials, in which we are trying to prevent CMV disease in a congenital setting. So these things are being analyzed, and we are looking for 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, Chief Medical Officer

So this is a great question, and I wish anyone could provide an easy answer to what a number would correlate and guarantee a response. 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 no magical number or hard line percentage that could be identified that guarantees a response. 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 and non-exhausted is crucial. 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 of CD8 T-cell from an active therapy like ours, that would be very remarkable and probably has not been demonstrated via direct analysis in the past. If we could demonstrate something like this, there would be a good chance it would correlate to sponsors and lead to improved efficacy. I would say, what number would we be very, very excited about? The kind of number that no one in this 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, Analyst

Great. Thanks again.

Operator, Operator

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

Ingrid Gafanhão, Analyst

Hello, good morning, good afternoon, and thank you for taking the question. I’m glad to see some progress in the Gilead partnership front. Was just wondering, are there any significant milestones that we could expect for this year?

Joern Aldag, CEO

Yes. You should expect a milestone in the HIV program, and that milestone is linked to what is called a request for development in Gilead language. The request for development is the moment where they commit to bringing a program forward to clinical trial, where they are committed to bio-distribution toxicology studies and also to manufacturing for the clinics. We have passed our milestones for HPV, and 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 the HPV program to follow standard timelines in the industry, and specifically, HOOKIPA would expect that to move into the clinic late this year or early next year.

Ingrid Gafanhão, Analyst

That is great. Thank you very much.

Operator, Operator

Another question comes from the line Roy Buchanan from JMP Securities. Please go ahead; your line is open.

Roy Buchanan, Analyst

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 are you going to report for viremia and antiviral efficacy? I know you mentioned that the primary endpoints are the efficacy endpoints at 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, CEO

Igor, do you want to take that?

Igor Matushansky, Chief Medical Officer

Thanks for the question. I think you're right: the overall follow-up for the program is designed to be 12 months following transplantation. Efficacy points will be reported not just as viremia in terms of percentage and number of viremic events in the 12-month period, but also for us all the subcategories of that duration of viremia, insensitive viremia, et cetera. Of course, the concomitant use of antivirals will also be reported; were they used, how long they were used, et cetera. So, all of that will be reported at the endpoint of the 12-month time point, and that information will be followed. We are going to update the program, as I stated previously, in the second half of this year, but probably not any sooner. In terms of how the follow-up has been, I think the majority of the impact that we have had from COVID, as Joern indicated earlier, has been on accrual. In other words, our sites are not able to perform as many elective procedures, and while a live donor kidney transplant is a serious procedure, it is still elective. Many of them, of course, are pausing elective procedures. Our clinical trial does not have any additional hardships for follow-up; thus, the follow-up for these patients has not been affected.

Roy Buchanan, Analyst

Okay. That makes 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? If Gilead thought this was a good idea, would that be possible under the existing agreement, or would that require a new request for development from them? Thanks.

Igor Matushansky, Chief Medical Officer

The answer to both those questions is yes. We have thought about it. 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, but the contract is completely open from that point of view.

Operator, Operator

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

Asthika Goonewardene, Analyst

Hi, good afternoon, and good morning to you, and nice to speak to you guys. I would like to focus on AACR, please. Igor, can you ask how many patients will be included in the translational data? 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 T-cells respond to total CD8 compartment? And then I got a follow-up on that.

Igor Matushansky, Chief Medical Officer

Sure. So, AACR data will present, I would say, a single-digit number of patients based on our first analysis. It will be, I would say, a combination of 201 patients as well as 202, but mostly 201, because we have had more patients analyzed from the first batch. The data will focus mainly on using direct analysis as a readout. So the first readout is not reported as a percentage; that percentage could be back-calculated, of course, but the data is primarily not reported as a percentage because it's coming from a direct analysis. The analysis that translates into percentages is based on a different analysis called intracellular staining analysis of that data. We probably have not performed as much and will probably not be releasing it at AACR; we will probably be releasing it closer to ASCO.

Asthika Goonewardene, Analyst

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 at AACR?

Igor Matushansky, Chief Medical Officer

T-cell fitness? Is that the question?

Asthika Goonewardene, Analyst

Yes.

Igor Matushansky, Chief Medical Officer

So, we will not be showing any T-cell fitness data at AACR; we will be focusing on interferon-gamma cytokine signature data, and the biopsy data that we are collecting will most likely be available at the SITS Conference. Part of that data will naturally include examining tumor-infiltrating lymphocytes, looking at their exhaustion state as well. The SITS Conference is about a month after the AACR and a month before ASCO.

Asthika Goonewardene, Analyst

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

Operator, Operator

Another question comes from H.C. Wainwright. Please go ahead; your line is open.

Unidentified Analyst, 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 any feedback from data for your interaction with the FDA this year?

Joern Aldag, CEO

Igor?

Igor Matushansky, Chief Medical Officer

For the 101 program. Right. So, I would say that currently, the way we are looking at the program is that sometime over the second half of this year, we will be basically doing an analysis and putting together a package for the FDA. If that package receives response from the FDA within a reasonable amount of time, the answer could be yes. But if you want me to give you a ballpark figure for when FDA feedback might be expected, it could be late this year or early next year.

Unidentified Analyst, 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 HB-201, 202? My question is, could we also expect some alternating dosing strategy for this program?

Igor Matushansky, Chief Medical Officer

Sure. I think what we are currently thinking about this program is to basically go in directly with the alternating approach as a primary strategy. So I think we are going to go directly with what we call the alternating approach into patients, and we are going to use antigens that we have spoken about, like PSA and PSMA. We are probably going to follow a similar route to the 201 program in the advanced setting in a monotherapy setting for patients who have progressed on standard of care.

Unidentified Analyst, Analyst

So, maybe I have a follow-up with that. Also, will you be testing the other method in both as well as the intravenous?

Igor Matushansky, Chief Medical Officer

No. No, for prostate cancer, it is a little bit different. As I’m sure you know, a lot of prostate cancer is metastatic to bone, and because of the propensity for bone, that fills into tumor injection is not the better strategy. So for the prostate cancer program, just due to the pattern of metastasis that the majority of those patients present with, we will probably only pursue the intravenous approach.

Unidentified Analyst, Analyst

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

Operator, Operator

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

Joern Aldag, CEO

Well, I think, in that case, we are done for today. I’m very pleased that you participated in this call. I would like to just say that we are all very, very excited about the multitude of different readouts that we have in front of us in both programs; a very rich first half as we have just discussed, with interesting data coming out for 101 in the second half. Overall, we think at this point in time, we are rich in new data, and we are really curious to see it and present it to you. Thanks for participating in this call, and if there are any further questions from anyone, please let us know directly as well. Thanks a lot. Bye-bye.

Operator, Operator

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