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spk06: Good morning and thank you for standing by. Welcome to the IMV Inc. first quarter 2021 conference call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during the session, you will need to press star 1 on your telephone. If you require any further assistance, please press star 0. I would now like to hand the conference over to Pierre Labbé, Chief Financial Officer. Thank you. Please go ahead.
spk03: Thank you, Taka. Good morning, everyone. My name is Pierre Labbé, CFO at IMB, and I'm pleased to welcome you to our clinical and operational update and first quarter financial results conference call. I'm joined today by Fred Orr, our Chief Executive Officer, and Andrew Aul, our Chief Business Officer, who will be available for the question and answer period at the end of the call. Fred will begin with an overview of the company's operational highlights, and Andrew will follow with comments about the clinical program. I will conclude with the financial summary of the course. During this call, we will discuss our business outlook and make forward-looking statements. Any forward-looking statements made today are pursuant to and within the meaning of the safe harbor provisions of applicable securities laws. These comments are based on current expectations of management regarding future events and operating performance. There are no guarantees of future performance or results. All forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially. These risks are discussed in our continuous disclosure documents filed in compliance with applicable securities law. The press release, the MD&A, and the financial statements are all posted on our website at imv-inc.com. If you wish to receive a copy of these documents, please do not hesitate to contact us. Finally, take note that we will take questions only from cell-side panelists. I will now turn the call over to Fred. Fred?
spk05: Thank you, Pierre. Good morning, everyone, and welcome. I am very pleased today to have the opportunity to review our progress in the first quarter, including important milestones in our cancer T cell therapy program. Our clinical programs continue to progress according to plan, including the initiation of our phase-through relapse refractory DL-BCL study in combination with MERS-Kitruda. With respect to this important study, we completed regulatory filings, and we have started enrolling clinical sites in the U.S. and Canada and are expanding into other countries. At the same time, we continue to expand the footprint of mavropepimutase beyond the current ongoing trials in solid and hematological malignancies. Earlier this week, we announced a new investigator-initiated study in breast cancer, which we plan to initiate in the third quarter of this year. Andrew will provide further details about this study later in the call, but I want to share the enthusiasm that we have about this study. First of all, surviving has been identified by investigators at Providence Cancer Institute in Portland, Oregon, has a biomarker of resistance to treatment in this patient population. This discovery is giving us the opportunity for the first time to test our surviving targeted T cell therapy in an earlier line of treatment. It is also a neoadjuvant study. providing a unique opportunity to access complete tumor resection after surgery and thus demonstrate the in vivo response to our therapy. We believe that both the level of information and demonstration that can come out of this study has the potential to create significant value for our platform and our shareholders. We are also on track to initiate in the second half of the year a phase one study in non-muscle invasive bladder cancer through a collaboration with the research center of University Laval in Quebec City. This study is sponsored by IMV and will be partly funded by government grants. In this study, which is also in an earlier line of treatment, we will be targeting mage protein family member A9 and surviving. Both have been associated with the biology of bladder cancer and a poorer prognosis. This is an exciting milestone for the company as this is the first in human trial for our second immunotherapy, DPX-RMH. This trial has the potential to further demonstrate the versatility of our platform and its ability to generate targeted T cell therapies for various indications. Andrew will also give more detail about this dual targeted immunotherapy later in the presentation. Before I turn the conference to Andrew, I wish to welcome to IMV2 exceptional new board members, Mr. Kai Kovalenko and Dr. Michael Callas, following the recent departure of Wayne Pisano and the announced retirement of James Hall following this year's annual meeting. I would like to take this opportunity to thank both of them, Wayne and James, for their dedication and guidance throughout the years and wish them the very best going forward. Mr. Kyle Tuvalanka currently serves as Chief Financial Officer and Chief Operating Officer at Goldfinch Bio, a precision medicine company. Kyle brings over 20 years of experience as a senior leader in the biopharmaceutical industry with a successful track record in forming and negotiating strategy collaborations, leading financings, including the idea of blueprint medicine, as well as building and directing business and finance functions. I also want to welcome Dr. Michael Kalos, a pioneer and internationally recognized expert in T-cell therapy and immunotherapy, who brings over 25 years of experience across cell therapy and immuno-oncology in global organizations such as Jensen and Eli Lilly. The laboratory is founded and directed at the University of Pennsylvania, played a key role in the success of the cell therapy program at Penn, including the clinical development that led to the approval of Kim Rhea, the first-ever FDA-approved CAR T-cell therapy. Finally, a management update today. Dr. Joanne Schindler gave her resignation for personal reasons effective June 11, 2021. Over the next week, Joanne will transition responsibilities while remaining in her role as chief medical officer and we are actively working with our recruitment firm to hire a new chief medical officer who will drive MAVOPEPIMIT-S towards registration. In the meantime, our clinical and regulatory teams will continue to execute and keep on track of our development program. We thank Joanne for her contribution during her tenure and wish her the very best. This concludes my opening remarks, and I will now turn the conference over to Andrew for a more detailed review of our clinical program.
spk04: Thank you, Fred. Good morning, everyone. Before I get into the specifics, I'd like to emphasize, as illustrated on slide six, the steady progress IMV has made expanding the clinical footprint supporting the broad utility of Mavarapipramine S. I'm also excited to present for the first time our second clinical asset, DPX-SAMAGE, a dual targeted T-cell therapy that will be first investigated in bladder cancer. Looking ahead, We now have clear path to market for Maverick Pippermint S in DLBCO and compelling data in many indications with multiple pending catalysts set to occur over the next 12 months. I would like to remind you all that the clinical success demonstrated with Maverick Pippermint S is supported by the outstanding value proposition behind IMB's novel DPX platform. This technology has enabled the demonstration of efficacy through a unique and potentially synergistic mechanism with other immunotherapies that is well tolerated, easy to administer, and importantly, cost-effective to manufacture. It also supports DPX-MH, and we're exploring its application for other non-peptide therapeutic targets. With that said, I will now review the progress of our oncology programs starting on slide nine with relapsed refractory DLBCL. As Fred mentioned, we filed our investigational new drug application with the FDA and the clinical trial application to Health Canada in parallel to support the initiation of the Phase 2B study. Considering the typical procedures and potential questions regulators may ask prior to approval, we anticipate the trial to be initiated towards the end of quarter two this year. This trial will first involve US and Canadian sites, and then expand to Europe and Australia later this year. Our strategy here is to move as quickly as possible for this trial, and to activate as many sites as necessary to ensure rapid recruitment. We know the space is competitive, although from initial conversations with prospective clinical sites, we are confident that the differentiation of Mavripep, Monassim, Keytruda will drive timely enrollment. As a reminder, This trial is a three-arm, randomized, parallel group, Simon two-stage study that will assess the combination of maverick peppermint S and K-truda with and without cyclophosphamide, with a third arm to evaluate maverick peppermint S as a single agent. Across the three arms of this study, IMV's lead compound will be evaluated in up to 150 patients with relapsed or refractory DLBCL. who have received at least two prior lines of systemic therapy and who have failed autologous stem cell transplant or CAR-T therapy. The primary endpoint of the study is the objective response rate centrally evaluated Per Lugano 2014 criteria and measured by the number of subjects achieving a best response of partial or complete response during the two-year treatment period. All subjects will be evaluated for their baseline PD-L1 expression. So to validate the exceptional spiral data we reported this year, or last year, I should apologize, that highlighted PD-L1 as a predictive biomarker for clinical success. By the current timeline, we anticipate dosing our first patient shortly and look forward to presenting an interim clinical analysis for this trial early in 2022. I will now briefly discuss our plans in recurrent ovarian cancer on slide 10. As previously communicated, biomarker analyses are ongoing from the tissue collected in the DECIDE trial and are expected to be completed this quarter. The goal here is to better understand the treatment activity and potential predictive biomarkers in this population to help inform the next stage of development. With the balance and efficacy Sorry, with the balance of efficacy and tolerability demonstrated with Mavropipmin S in patients with ovarian cancer, use early in the treatment regimen is a natural fit. As a trial in this population will be larger and longer, the ability to predict response is really important. Once the analysis is completed, we will request a meeting with the FDA in the second half of this year to finalize the design of the next trial. We will also present the analysis of the translational data set in an upcoming scientific conference. Before discussing the new investigator initiated study in breast cancer, I'll quickly mention that there's no material update to provide with respect to the basket trial. As a demonstration of our expanded footprint in oncology and the potential of our lead immunotherapy, We announced earlier this week that Mavripepiment S will be investigated in patients with hormone receptor positive HER2 negative breast cancer. I would like to remind you this population includes nearly 70% of all patients with breast cancer and the unmet need remains high considering the well understood poor response to neoadjuvant endocrine treatment. This investigator initiated phase 1B study will be conducted at the Providence Cancer Institute in Portland in Oregon and is expected to begin later this summer. The trial is a three-arm investigation of Mavripepiment in combination with an aromatase inhibitor with and without radiotherapy or cyclophosphamide prior to surgery. Across the three arms of the study, Mavripepiment S will be evaluated in 18 subjects with resectable non-metastatic hormone receptor positive HER2 negative breast cancer. The primary objective is to evaluate the safety of the neoadjuvant combination. The study will also examine the tumor microenvironment in detail to validate the therapeutic hypothesis that survival-specific T cells are driving the efficacy of Mavropepmin S in solid tumors. As such, this study will also include an extensive translation analysis of collected tissue and serum to identify markers of activity in the tumor and within the tumor microenvironment. We're particularly enthusiastic about the therapeutic potential of Mabropipamine S in breast cancer. As Fred mentioned, we know that survival expression is positively correlated with negative outcomes in this tumor type. Not only will this trial deepen our understanding of both Mabropipamine S and the DPX platform in a new and different population of patients, but it will also identify markers that may de-risk future clinical studies in other solid tumors with high survival expression. Moving on to slide 12, I'd like to briefly introduce our second clinical product, DPX-MAGE, a dual-targeted T-cell therapy. This product combines the DPX platform and two types of cancer antigens, survival and MAGE A9. MAGE A9 is a member of the MAGE protein family, which is frequently expressed in human cancers, including bladder, lung, and kidneys. Selected peptides of MAGE-A9 will be formulated with selected peptides from the surviving protein and the DPX platform to form a new and dual targeted T-cell activating therapy, DPX-MH. Dr. Faday and his team have successfully completed preclinical evaluations and we are really excited to move this important therapy into clinic. Our first investigation of DPX-MH will be as monotherapy in patients with non-muscle invasive bladder cancer and in combination with a checkpoint inhibitor in muscle-invasive bladder cancer. This IMV-sponsored trial will be led by Dr. Yves Fadet and his team. Dr. Fadet is a professor of surgery and researcher in cancer immunotherapy at the Hospital Research Center at Laval University in Quebec City. The first study will evaluate DPXMH with and without cyclophosphamide prior to transurethral resection of recurrent low-grade or high-grade non-muscle-invasive bladder cancer, and is scheduled to be initiated in the second half of this year. The second study, which will be initiated sequentially, will evaluate DPXMH and an anti-PD-1 for the treatment of muscle-invasive bladder cancer prior to and following sussectomy. Before turning the conference back to Pierre for a review of the quarter's financials, I'll quickly mention that there is no material update to provide with respect to the COVID-19 program in this quarter. Pierre, I'll pass the conference back to you.
spk03: Thanks, Andrew. Before I get into the financial, I want to underline a change in our accounting policy. Effective January 1, 2021, we adopted the U.S. dollar as our functional and presentation currency. Prior to this date, the functional and presentation currency was the Canadian dollar. The change in the functional currency from the Canadian dollar to the US dollar was made to more closely reflect the primary economic environment in which we currently operate. The change in functional currency was applied prospectively. For the change in presentation currency, it was applied retrospectively. And therefore, the financial statements are presented in U.S. dollars together with the comparative information as of December 31, 2020, and for the three-month period ended March 31, 2020. You can find more information on this stage in Note 2 of the financial statements for the three-month period ended March 31, 2021. Now back to the financials. For the three-month period ended March 31, 2021, R&D expenses were $4.7 million compared to $5.1 million for the same period last year. The decrease of $400 was mainly due to a decrease in expense related to the ongoing basket draw and also the timing of manufacturing activities for DPX Survive Act and DPX Surmage. It was partly offset by an increase and personal costs due to an increase in net count, and expenses related to the preclinical development of DPX COVID-19. The government assistance totaled $1.2 million for the three-month period in March 2021, compared to $400,000 in Q1 2020. This increase is mainly explained by government grants from the Canadian government for the development of DPX COVID-19. The G&E expenses increased to $3.2 million from $2.3 million last year, and this is explained entirely by an increase of $900,000 in insurance premiums. The net loss and comprehensive loss was $7 million or $0.10 per share for the quarter, compared to $7.2 million, or $0.14 per share, for the same period last year. As of March 31, 2021, the company had cash and cash equivalents of $30.5 million, compared to $36.3 million at the end of 2020. For the purpose of assessing the corporation as a going concert, although it is difficult to predict funding requirements. Based on the current operation plan, it is anticipated that existing cash and cash equivalents and identified potential sources of cash will fund operations and capital expenditure requirements until the first quarter of 2022. These estimates are based on assumptions and plans which may change and which could impact the magnitude and or the timing of operating expenses CAPEX and the corporation's cash fund. It also does not take into account any use of the ATM that we have in place or any other potential non-dilutive funding. Cash and cash equivalent decreased by $5.8 million in the first quarter of 2021. We used $7.8 million of cash in operating activities and $0.4 million in investing activities. Financing activities generated $2 million, and effect of foreign exchange on cash generated $0.1 million. The cash generated by financing activities come from our at-the-market facility for gross proceeds of $2.3 million. As of May 11, 2021, the number of issued and outstanding common shares was 67.8 million, And a total of 5.1 million stock options, DSUs, and warrants were outstanding. Finally, take note that the corporation's financial statements for the three-month period ended March 31, 2021, and the related MD&A are available on CDAR, on EDGAR, and on the company's website. Thanks for your attention. And I will now turn the call back over to Fred for his closing comments before the Q&A session. Fred?
spk05: Thanks, Pierre. Our presentation today should give you a good indication of the significant recent progress we have made expanding the footprint of Mavropepimut S in new indications and broadening our pipeline towards new targeted T-cell therapies. At the same time, we are able to attract new and high-quality board members that will provide valuable guidance on advancing IMV to the next level on our path from a clinical stage company today to a successful pharma tomorrow. As we continue making progress in our quest to deliver improved outcomes for patients, we are also grateful for the continued support of all our dedicated employees, stakeholders, partners, and shareholders. Thank you for your attention. Operator, we are now ready to take questions.
spk06: As a reminder, to ask a question, you will need to press star 1 on your telephone. To withdraw your question, press the pound or hash key. Please stand by while we compile the Q&A roster. Your first question comes from the line of Tom Schrader of BTIG. Please go ahead. Your line is open.
spk07: Hi, this is Kaveri for Tom. Thanks for taking our question. I just have one. Can you talk about your rationale for selecting HR-positive HER2-negative breast cancer? There aren't a lot of immunotherapies approved in this setting, and patients seem to respond well to therapies like CDK inhibitors and SIRDS.
spk05: Thanks for your question. This is Freddy. I'll start answering and maybe Andrew can complete. So it's really the investigators that found us, found our surviving T cell therapy because they have, like Andrew was explaining, identified that in the neoadjuvant setting, so it's really in the neoadjuvant setting first, the rate of response of the drugs that are currently being used is quite low. It's below 10%. But when you are looking at those non-responders, which is the majority of women being treated at the neurodegenerative stage, and you look at what could be the potential reasons for that, they found out that sorbivine was one of the most up-regulated biomarkers for resistance to treatment. So they found us. Really, we didn't find them. But what we like very much about it, and you've heard us saying this many times, we believe that there are two things that are important for making T-cell therapy work. The first one is creating a meaningful dose of T-cells in the blood of patients, so controlling the pharmacokinetics, which we are doing with our platform, DPX. And the second thing is targeting something in cancer that is really associated with the biology of cancer, something that plays a role in the evolution of cancer or resistance to treatment. And this is really the perfect case here for us. Not only we have all of this, but it's also in a much earlier line of setting, in a neoadjuvant setting where it's probably the best place for immunotherapy to be, And at the same time, the bar is quite low, again, in the neoadjuvant setting. I don't know, Andrew, if you want to add more on this.
spk04: Yeah, I just had a little flavor. And I think it's important to recognize as a sort of a strategic driver for IMV now that the idea of following the biology with the high expression of survival in this population that appears to be more resistant to treatments is a really compelling reason to go into this population. I mean, commercially, it is the largest point in breast, the largest size population in breast cancer, and it's obviously very appealing for the reasons that Fred mentioned with respect to earlier lines of treatment, a more immune-able population, and potentially a more available population, as we understand that that late line in breast cancer is very competitive. But this idea of following the biology in a population where we will be able to collect tissue to do analysis and then maybe identify other solid that we can follow behind that is a really exciting step forward for this technology. And importantly, as we're now creating other therapeutics with other therapeutic targets, we may start to find a improved rationale for even further expansion of the IMV footprint beyond what we're showing with maverick pavement so it's a it's an excellent question and i think the observation that we're following the biology is important to reiterate great thank you and congrats on the progress thank you your next question comes from joe pump guinness of hc wainwright please go ahead your line is open
spk02: Hey, guys. Good morning, and thanks for taking the question, and sad to see Joanne go. Good luck in your next steps. So just continuing in the breast cancer vein here, I wanted to just continue on talking about benchmarking. So first, with regard to the upcoming study, I know you talked about broadly the inclusion criteria, but what stages of diseases are the patients going to be? And then what Let me know if this is a fair statement since you talked about, you know, response rates being, you know, essentially under 10%. Is it fair then that any responses that you see above that based on the translational analyses that you'll be conducting could certainly implicate a role for the immunotherapy? And what would you consider to be a meaningful improvement of responses at this point? Thank you.
spk05: Thank you, Joe. Like we said, it's a very early line of setting where women are typically treated with neoadjuvant aromatase inhibitors and sometimes neoadjuvant chemotherapy, depending on some specific analysis of the state of the tumor. And basically, you don't see a lot of tumor downstaging or reduction, but it can certainly provide some benefits before the surgery. So that's really where this is used and has limited benefits other than, like I was just saying, for surgery. And so to answer your question, yes, you know, the promise of immunotherapy, as you know, is the potential to early create an immune activation or an immune response in patients so that you could improve the long-term outcomes of patients. And that's why we like to be really at this line, because that's where immunotherapy can really make a difference, what we like. And thanks for asking the question, too, is that, yes, we will be able to see the activity of the T cell therapy on the tumors. We will be able to see the impact between the start of treatment and surgery and see if T cell therapy can really make a bigger difference than what is currently used for neoadjuvant.
spk02: That's helpful. Thank you. And if I could just shift gears for a second, I'll admit maybe I'm just watching the news too much and, you know, talking about manufacturing and everyone's just so concerned about different supply chains in the United States or what have you and across the world. So you obviously have made the case about, you know, very low-cost manufacturing for your assets, and that's very encouraging, you know, especially when you compare against other types of immunotherapies or cellular therapies. So with that said, what could you consider any sort of rate limiting steps with regard to the manufacturing process that anyone might be concerned about or shouldn't be concerned about even if it's like sourcing the peptides or anything external that might cause potential concern if there's ever any supply chain issues?
spk05: Well, first of all, I have to say that, luckily, we are not experiencing any supply chain issues related to manufacturing, and the reason is that the technology, the drug delivery technology we are developing, it's a lipid nanoparticle technology, but the composition and the way it's manufactured is quite different from what is the source of supply chain issues in the world, which are, you know, those LNP technologies for mRNA vaccines. So if you think about the lipid composition is different, all the elements that we are using are different. As you know, it was invented by the company, and we own a very strong IP portfolio on this platform. And to my knowledge, we are really the only one in the world at this time developing a platform like this. so it brought access from those supply chain issues. On the peptide side of things, again, peptide vaccines are the next generation of vaccines, I would say. There's not a lot of peptide vaccine currently in development, so we don't suffer any supply chain issues related to peptide manufacturing. There's more than 100 peptides approved by the FDA, a lot of capacity in the world, so we don't foresee that in the future there's going to be a limiting factor for manufacturing.
spk02: Got it. Fred, I really appreciate that color. Thanks a lot. Thanks.
spk06: Again, if you would like to ask a question, press star 1 on your telephone. Your next question comes from Ted Tenthoff of Piper Sandler. Please go ahead. Your line is open.
spk01: Great. Thanks, guys. And thanks for all the updates on all the progress. I wanted to ask about the 2B study of maverick peppermint and Keytruda in DLBCL. And again, sort of to get a better understanding of what you think the contribution of the low-dose cyclophosphamide is. And I know that in that study you have the single-arm maverick peppermint If that ends up showing that cyclophosphamide is not really adding anything, would it be removed from other studies? And kind of how do you see cyclophosphamide fitting into the future there? Will that all be data-driven? And are there differences between DLBCL maybe and the other indications? Thanks.
spk05: Thanks, Ted. So first part of the answer is yes. Yes, we are testing the contribution of CPA in the design of the study. If we see a contribution, we're going to keep a little CPA in the treatment. It's a drug that's available. The safety profile is good, so it won't be a problem. If it doesn't show any meaningful benefit, then we'll simply remove it and we'll just keep Mavropepimutase and Keytruda as the combination. There is a lot of preclinical science around the use of cyclophosphamide with other immunotherapeutic agents. However, we are the first to generate T cell therapy activity in with this technology in the LBCL. So I believe that confirmation in human is really what should be the base for the decision, and that's what we are doing. Either way, there's going to be a path to market for the combination. Will this translate into the same thing in other indications? It's certainly something we're going to be looking at, but at the same time, like you said, there are important factors differences in the tumor macroenvironment, for example, between, let's say, the LBCL and ovarian cancer. And that's where a metronomic dose of chemotherapy can really help the T cells access the tumor. And it might not be the case in the LBCL, but, for example, it could be the case in ovarian. So we really want to base the decision on clinical data as we move forward for CPA.
spk01: Okay, cool. Awesome. I appreciate it. I'm really excited to see more data coming this year. Thank you, Ted.
spk06: Your next question comes from Chelsea Stelic of IA Capital Markets. Please go ahead. Your line is open.
spk09: Hi, good morning. I just have one or two quick questions just on the finance side. So I guess although the $30 million is sort of enough to fund operations through to the first quarter of 2022, I just kind of want to gauge the further appetite in accessing the ATM again, and if so, what the use of the funds would be. I guess I'm just trying to get more clarity and specificity on funding for future operations.
spk05: Pierre, you want to take that one?
spk03: Yeah, sure. Thanks, Jessie. Yeah, for the use of the ATM, I think we don't have any specific plan to use it. It's a tool that is there. that we can have access to if we believe that makes sense for the company in terms of share price and things like that. And that's how we used it in the past. So there's no guarantee that we will use the ATM in the next 12 months. So just wanted to mention that... in the cash that we add and in the duration of the cash. We don't take into account any use of the ATM, but it doesn't mean that we will use it in the next few months.
spk05: Okay, that's helpful. Maybe Andrew? Yeah, sorry, I don't know if Andrew, you want to add on the BD activities too that we are doing with the platform?
spk04: Andrew? Sorry, it was on mute. Yeah, in the office. To make very clear, we have a healthy appetite for mechanisms that are non-dilutive in our funding as well, and I am encouraged by the progress we're making in those discussions. I think for a company that is our size, we need to remain open to sort of the possibility of creating business development momentum. And as we create more therapeutic opportunities in our pipeline by sort of leaning into our technology as perhaps a drug delivery mechanism to create opportunities for other mechanisms that are maybe not peptide targets, we do start to open a revenue stream for non-dilutive opportunities through business development that is complementary to anything we will do through either an ATM or through other fundraising mechanisms. And it's an important element to balance the value of IMV in the mid-term and the long-term by an ultimate funding mechanism.
spk09: Okay, perfect. Thank you. I guess just one more question from me. With the growing headcount, what can we sort of expect for GNA over the next year?
spk03: Yeah, for the GNA, we don't expect an increase in terms of headcount and cost related to the gna because as i mentioned the increase that we saw in the first quarter was directly related to an increase in insurance premium that we had in june of 2020 so nothing related to the addition of more people in june thank you that's uh it's all for me and i'm looking forward to sort of the second half of the year when there's quite a few catalyst events so
spk06: There are no further questions at this time. I will turn the call over to Frédéric Ors for closing remarks.
spk05: Well, thank you very much, everyone, for your time this morning and all the good questions, and have a good rest of the day.
spk06: Ladies and gentlemen, this concludes today's conference call. Thank you for participating. You may now disconnect.
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