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spk09: Thank you. Thank you. Thank you. Good afternoon ladies and gentlemen. and welcome to the Loomis Farmer third quarter earnings call. At this time, all participant lines are on a listen-only mode. Later, we'll conduct a question and answer session, and instructions will follow at that time. As a reminder, this call is being recorded. I will now turn the call over to Lisa Miller, Director of Investor Relations. Please go ahead.
spk08: Thank you. Before we proceed with the call, I would like to remind everyone that certain statements made during this call are forward-looking statements under U.S. federal securities laws. These statements are subject to risks and uncertainties that could cause actual results to differ materially from historical experience or present expectations. Additional information concerning factors that could cause actual results to differ is contained in our periodic reports filed with the SEC. The forward-looking statements made during this call speak only as of the date hereof, and the company undertakes no obligation to update or revise the forward-looking statements. Information presented on this call is contained in the earnings release we issued this afternoon and in our Form 8-K, which may be accessed from the Investors page at the company's website. Joining me on today's call are Rick Hawkins, CEO, President, and Chairman, John McHugh, Chief Operating Officer and Chief Scientific Officer, Gene Kennedy, Chief Medical Officer, and Carl Langren, Chief Financial Officer. Rick Hawkins will provide a corporate update. John McHugh will review the company's lead therapeutic candidate and target indications. Gene Kennedy will discuss our Phase 2B trial initiation and our concurrent pharmacokinetic, pharmacodynamic trial. And Carl Langren will wrap up the call with a review of the Q3 2020 financials and an update of cash guidance. I will now turn the call over to Rick.
spk04: Thank you, Lisa. Good afternoon, and thank you for joining us on today's call. After the market closed, we issued a press release announcing the initiation of our Phase 2b Oral Growth 210 trial. This trial will evaluate our oral therapeutic candidate for children with pediatric hormone deficiency, or PGHD. The press release also includes corporate updates related to our planned pharmacokinetic, pharmacodynamic, oral growth 212 trial and our third quarter financial results. The third quarter was an exciting time for Lumos Pharma, marked by significant achievements and corporate updates as we continue to execute on our mission of developing new therapies for patients with rare diseases. Specifically, as I mentioned, we are excited to announce the initiation of our Phase IIb Oral Growth 210 trial evaluating oral LUM201 for PGHD patients. The first focus of our Oral Growth Trials program involving LUM201 as a potential therapy for multiple indications currently treated with injectable growth hormone. The Wargrove 210 trial will evaluate three doses of LUM201 for PGHC patients with the goal of prospectively confirming our predictive enrichment marker, or PEM, strategy and identifying the optimal dose of LUM201 to be used in a registration trial. We eagerly anticipate our Phase 2b data readout, which is expected mid-year 2022. In conjunction with our Phase IIb trial in PGAC, Loomis Pharma also plans to conduct a separate single-site trial in PGAC focused on the pharmacokinetic and pharmacodynamic aspects of Loom 201 to further explore the pulsatile nature of Loom 201's mechanism of action. The initiation of our second concurrent study evaluating Loon 2.1 for PGHD patients remains on track to begin during the first quarter of 2021. While Jean Kennedy, our Chief Medical Officer, will speak about both of these trials in greater depth later on in this call, I want to take the time now to express the excitement that we feel at Lumos Pharma around this potential opportunity for our oral therapeutic to disrupt the injectable PGHD market by bringing long-lasting benefits to patients who are subjected to years of treatment with daily injections, for which there currently exists no available oral alternative. Additionally, the company is pleased to announce that in the third quarter, we received the first tranche $34 million of the $60 million proceeds owed Loomis Pharma from the sale of our Priority Review Voucher, or PRV. These non-diluted funds will be available to support the expansion of the company's pipeline through the acquisition or licensure of another novel therapeutic candidate for rare diseases. Specifically, we're looking to target therapies where the medical unmet need is high and the pathophysiology is clear. We anticipate the receipt of the second tranche of the PRV in the first quarter of 2021, which will serve to further strengthen our balance sheet and support our product candidate acquisition strategy beyond Loom 201. We feel fortunate to have both a solid balance sheet as well as an integrated and experienced management team in place, putting us in a strong position to continue to execute on our mission of developing treatments for patients suffering from rare diseases. With that, I'll turn the call over to John to provide an update on the company's lead therapeutic candidate and target indications. John?
spk05: Thank you, Rick. As Rick stated, we are excited to announce that our Phase 2B Oral Growth 210 trial evaluating oral LUM201 in PGHD patients is open for enrollment. We believe that LUM201 may offer a preferred treatment option for a significant subset of children suffering from growth hormone deficiency in terms of the convenience that it provides to patients, as well as potentially increased efficacy due to higher rates of compliance. As a reminder, growth hormone deficiency can be attributed to low or absent secretion of growth hormone from the pituitary glands. Children with untreated growth hormone deficiency will experience significant growth failure, and in many cases, attain an adult height of significantly less than five feet, with other potential consequences, including decreased bone mineralization, decreased lean body mass, and increased fat mass. PGHD is a well-recognized condition affecting approximately one in 3,500 children in the U.S., Japan, and five major countries in Europe. with an equally well-established market over $1 billion in size across these same regions. This market consists of the current standard of care of daily injections that were commenting the growth hormone administered to a child for seven years on average. Lumos Pharma's therapeutic candidate represents a significant opportunity for these patients as Bloom 201 provides a meaningfully different treatment option for PGHD, both in terms of its route of administration and its mechanism of actions. The first point of differentiation involves LUM201's route of administration as an orally administered tablet rather than an injectable therapeutic. While the current standard of care for PGHD consists of around 2,500 injections administered to a child over the average seven-year treatment timeframe, LUM201 is available in the form of a small tablet taken daily. This can potentially provide a therapeutic alternative to these 2,500 injections, which provide challenges for the children and the parents or caretakers. As a consequence, studies reveal significant compliance issues with the standard injectable treatment regimen, resulting in an impact on growth. With our unique LUM201 oral agent, the challenges associated with these injections can be alleviated, potentially leading to significant improvements in compliance and therefore efficacy in this patient population. Second, LUM201's unique mechanism of action has the potential to safely restore the periodicity and secretion of growth hormone to normal levels. Currently, the standard of care for PGHC therapeutics and others in development act outside of the body's natural feedback mechanisms. LUM201, however, is unique in that the molecule is not growth hormone, but is instead a growth hormone secretogod. LUM201 selectively acts on receptors in the pituitary and the hypothalamus to stimulate the body's ability to release growth hormone at the same intervals and within the same endocrine feedback loops as occur naturally. The natural secretion of the growth hormone into the body is pulsatile, with secretions occurring from 23 to 25 times over a given 24-hour period. LUM2-1 stimulates the secretion of growth hormone in a way that mirrors this natural pulsatile mechanism while amplifying the peaks of these pulses in order to restore growth hormone and IGF-1 to more normal levels. Preclinical data demonstrate that amplifying the pulsatile release of growth hormone produces greater efficacy than continuous exposure to growth hormone. Utilizing this endogenous release mechanism should enable a naturally occurring IGF-1 feedback loop to be activated if needed to ensure a proper balance of growth hormone and IGF-1 levels in the body. Given the endogenous nature of LUM201 activity as just described, the individuals who are able to benefit from this molecule must have an active but diminished functioning of the pituitary axis. For this reason, Lumos Pharm is targeting the moderate PGHD population of patients who are able to naturally produce growth hormone but in insufficient amounts to attain normal adult height. Based on our analysis of prior clinical data, predicate original markers, or PEMs, identify the moderate PGHD patient group likely to respond to LUM201 therapy, which represents approximately 50 to 60% of the total PGHD population. For our phase 2b oral growth 210 trial, we plan to use the same predictive enrichment markers, or PEMs, to identify potential LUM201 responders. PEM-positive patients reflect a baseline IGF-1 level above 30 nanograms per mil and a peak growth hormone level of greater than or equal to 5 nanograms per mil in response to a single dose of LUM201 and would be randomized into our trial. We believe that by using these predictive enrichment markers, our upcoming clinical trials will confirm data from earlier trials showing the potential for LUM201 to treat a significant subset of the PTHD population with an oral therapeutic. As such, we believe that Loom 201 offers a novel and differentiated treatment option for this subset of PM-positive children suffering from growth hormone deficiency. I would now like to turn the conversation over to Gene Kennedy, our chief medical officer, to discuss our PGHD trials. Gene?
spk06: Thanks, John. I will now take some time to provide more specifics on our Phase IIb ORA Growth 210 trial, evaluating Loom 201 that was just initiated. With regard to trial design, our study evaluates three dose levels of LUM201 in PGHD patients against a comparator arm of standard of care injectable growth hormone therapy. Dosing will be administered over six months with annualized growth height velocity as the primary clinical outcome measure. As previously stated, the two main objectives for this Phase IIb study are to prospectively confirm the utility of our predictive enrichment marker strategy in selecting likely LUM201 responders and to determine the optimal dose for a Phase III registration trial. We have chosen the dose levels of LUM201 for our Phase IIb trial for patients with PGHD based on supporting data from a prior PK-PD study of LUM201 in healthy adults. First, the pharmacokinetic, or PK, data in this adult study confirmed that higher doses of LUM201 administered do result in higher plasma concentrations of LUM201. The pharmacodynamic, or PD, data from this study demonstrate that as you increase the dose of LUM201 given, the body secretes more growth hormone until the natural feedback loop is stimulated, causing the release of further growth hormone to plateau. The three doses of LUM201 we are evaluating in our trial cover the full pharmacodynamic dose-response range seen in the adult volunteer study. As the PD data indicate, there is the potential for a significant increase in growth hormone secretion and, therefore, increased efficacy between the lowest and highest planned dose for our Phase IIb trial. As to the specifics of trial design, our study is designed to enroll and randomize 80 children to one of the four treatment arms. The primary endpoint of the trial is the success of our predictive enrichment marker strategy intended to select subjects likely to respond to therapy with LUM201. This will be assessed by the percentage of subjects defined as PEM test positive who have a positive growth response as measured by annualized height velocity from baseline to month six. The key secondary endpoints, in addition to safety, are first, the selection of a pediatric dose of LUM201 for use in future studies, including phase three, based on comparison of six months annualized height velocity achieved by daily injectable human growth hormone or different doses of LUM201. Additionally, we will evaluate the repeatability of the LUM201 strategy and the classification of patients as either PEM positive or PEM negative. We estimate, based on the expected PEM positive rate of 50% to 60%, as seen in prior studies with LUM201, we will need to screen approximately 140 children to identify the 80 children to be randomized. During the screening process, we will have the two tests that form our PEM strategy, baseline IGF-1 and LUM201 stimulation test, done as a paired set twice, approximately a week apart. We will then assess if the clinical determination of PEM positivity or negativity remains the same between the paired assessments. This will provide further clinical evidence as to the utility of our approach. While this trial is ongoing, Lumos remains on track to initiate a second concurrent trial of LUM201 for patients with PGHD during Q1 2021. This ORA Growth 212 trial is intended to further explore the effects of the mechanism of action of LUM201 in amplifying the natural pulsatile secretion of growth hormone by focusing on pharmacodynamic endpoints at two different doses in a limited number of children with PGHD in order to corroborate the amplified pulsatile secretion demonstrated in prior Loom 201 studies in adults. The trial is being conducted at a single specialized pediatric center with the ability to conduct the more frequent sample collection and monitoring required for these types of clinical trials. Once initiated, the study will run in parallel with our ongoing Phase 2b or a growth 210 trial with the goal of providing supportive data in future regulatory filings and ultimately in our commercial marketing efforts. Finally, we are excited by the potential that Loom 201 has to serve as a platform therapy for other indications for which recombinant growth hormone is approved. Pedding results from our concurrent trials of Loom 201, we plan to expand our clinical development program to evaluate Loom 201 and other indications, such as Turner syndrome and children born small for gestational age. Beyond Loom 201, we continue to actively pursue business development opportunities to license or acquire other rare disease assets in order to expand our pipeline and our ability to provide innovative therapies to those suffering from rare diseases. I will now turn the call over to Carl Langren, our CFO, to discuss financial results for the third quarter and review our cash forecast.
spk03: Carl? Thank you, Gene. We ended the third quarter of 2020 with cash and equivalents of $105.6 million and anticipate cash use of approximately $6.5 to $7.5 million in Q4 2020. This quarter end cash balance includes the first tranche of $34 million in proceeds from our PRV sale, and we anticipate receipt of the second $26 million tranche in Q1 2021. These non-diluted funds from the PRV sale will contribute to supporting the expansion of the company's rare disease pipeline. Lumos Pharma reported net income of $1.8 million for the third quarter of 2020, compared to a net loss of $2.7 million for the same period in 2019. As we have discussed, we sold the priority review voucher for $60 million in the third quarter. Given our previously reported $52.2 million net value for the PRV, we recorded other income of $6.3 million in Q3, which is net of $1.5 million in costs incurred related to the sale during the period. The second installment of $26 million is recorded within other receivables on our Q3 2020 consolidated balance sheets. Please refer to the press release we put out this afternoon for more detail on financial results. Looking ahead, we hope to speak with many of you participating in the Stiefel Healthcare Conference and the Jeffries London Healthcare Conference, both of which are scheduled for mid-November, as well as the Piper Sandler and Evercore ISI Healthcare Conferences in December. Now I'd like to turn the call back over to Rick before we open up for questions. Rick?
spk04: Thank you, Carl. We're excited about the initiation of our Phase IIb Oral Growth 210 trial in PGHD and energized by the opportunities that we see for lumospharma now and in the future. We believe that with our oral therapeutic candidate, LUM201, we have the potential to disrupt the PGHD market served by a treatment regimen of frequent injections. We're also actively looking to expand our rare disease portfolio to address other patients in need. With a solid balance sheet and experienced management team, we're operating from a position of strength to execute on our clinical development plan and look forward to continuing to provide updates as we progress. With that, we'll open the call to questions. Operator?
spk09: Thank you. To ask a question, you would need to press 1 on your telephone. To withdraw your question, please press the pound key. Our first question comes from the line of Yasmeen Rahimi with Piper Sandler. Your line is now open.
spk07: Hi, team. Thank you for taking our questions, and congrats on the tremendous progress. A couple questions. Maybe the first one is on the port on the Phase IIb study that got kicked off. Can you maybe help us understand if there are any specific protocol amendments that were put in place for doing the stimulation test? Just wanted to make sure that the IGF levels and any protocols are consistent with what is normally done in other sites. And then the second question is, what is the purpose of the PK-PD study that's going to start next year, next quarter, is the purpose just for labeling? I guess I just want to have a better understanding of the study and what that will, what are you hoping to gain from that study? And thank you again for taking my question.
spk04: Thank you, Yaz. And Gene, will you answer those questions?
spk06: Yeah, certainly. Appreciate the question. It's nice to talk to you. For our Phase IIb study, patients are first diagnosed with the standard stimulation test to diagnose them as to whether or not they have growth hormone deficiency. That's part of becoming eligible for our study. And then, once they get through that hurdle, they undergo the baseline IGF-1 and the LUM201 stimulation test under very prescribed conditions which are laid out in the protocol itself. All right, so it's all in the same document. So that way we can make sure that they're done in a consistent manner so we can have data that we can stand behind. Does that answer the question, or would you like some more color?
spk07: Well, I guess I just wanted to understand that. How is this protocol going to vary in the real world one day? Like is the protocol to qualify into the study different than what would be in practice?
spk06: Well, I think the short answer, or go ahead, Rick, if you want to answer.
spk04: No, you go ahead, Dean.
spk06: Okay. No, I think the short answer is that the normal pathway for diagnosing patients will remain unchanged. To date, there's been no need to segregate pediatric growth hormone deficient patients into those who have more severe non-growth hormone-secreting physiology, and a more moderate, some growth hormone-secreting physiology. So we believe to appropriately use this drug and have the option of selecting the correct patients, that yes, the additional LUM201 stim test, the IGF-1 baseline is just done commonly as is, but the additional LUM201 stim test would be another step to appropriately subset patients into two different groups of physiology so that the clinicians can then pick the right tool, injectable versus oral, for the patients who have, you know, based upon their physiology.
spk07: Thank you. That's helpful. And then thoughts on the PKPD. As far as our PKPD study?
spk06: Yes. So I know you've been through all our materials, and I'm sure you came across data that's been published for a while now. that shows when you frequently draw blood from an adult after a dose of LUM201, all of the, you know, 23 to 25 peaks of growth hormone secretion that John does a great job talking about in our normal presentations are amplified in those adults. We believe it would be very helpful to the field. You know endocrinologists. You know they are very scientifically driven. So we think it would be very helpful to support our mechanism of action to be able to generate similar data in a pediatric population. So that's the purpose of this study.
spk07: Thank you. And then maybe last question, sorry. What is the age group for the studies that are going to be enrolled? What's the cutoff?
spk06: Kids who are between the ages of 3 and 4, 10 to 11, boys and girls, but basically we want kids who are naive to treatment who haven't started puberty yet.
spk07: Thank you. And I'll jump back. Thank you. Thank you, team.
spk09: Thank you. Our next question comes from the line of Ed White with HC Wainwright. Your line is now open.
spk05: Good evening. Thanks for taking my questions. So just on the trial, you know, we're hearing that, you know, there could be a second wave to the pandemic, and I'm just wondering what precautions you're making now to make sure that you are able to stay on track to get your data in the middle of 2022? And then if you can just tell us the number of sites that you're planning to open and where they're going to be located. Is this going to be U.S. only, or are you going to have some of the sites outside of the U.S.?
spk04: Gene, why don't you answer that?
spk06: Yeah, certainly. So, you know, there's not much good to be said about COVID, but the fact that we hadn't actually opened our trial when it started I think gave us a distinct advantage because we were able to give our sites time to adapt how they see patients and adapt their patient flow to the realities they're facing now. So we've been working with the sites and communicating with them, and healthcare is, even though there's great concerns about another wave, given the fact that the personal protective equipment and the other adaptations have had months to mature, we're optimistic that kids are going to continue to be treated and trials can go on, hopefully in much better stead than when this came initially and caught everyone by surprise. So we're confident we've made modifications. Some things that you would typically do in person, like an investigator's meeting, we're going to do virtually. That's the world we all live in right now. But we think that we can get this trial done, as we said. Now, as far as how many sites and where we're doing them, that goes right into our strategy. We're going to have what we've said is roughly 40 sites. There's going to be a lot of sites in the U.S., but we have a geographic distribution from coast to coast. We also have a division between private practice clinics and larger academic centers. And as all of us are aware, those types of facilities would have different obligations and different challenges. if COVID should get to, let's say, New York City levels again in a different city at some point. So we think that gives us an advantage to, if there are problems, focus our efforts in areas that are doing better than some areas, and then if that shifts, shift our efforts back, if that makes sense. And we also do have an international strategy. We have sites that we're working to open in Poland, sites we're working to open in Australia and New Zealand. We're also looking at other opportunities, And we think having a diversity of sites outside the U.S. as well as within the U.S. gives us an ability to be flexible and respond to conditions as they happen.
spk05: Great. Thank you. And perhaps the last question that I want to ask is just on your business development BD opportunities. You know, now that you have the first crunch of the cash, I'm sure you were already looking at opportunities, but has any progress been made and, you know, your thoughts about what's out there in the space that you're looking for? Thank you.
spk04: Ed, it's a good question, and the way I can answer that is just to say that we're going to be patient. Our business development efforts are headed by a senior executive, Aaron Schuert. He's got about 27 years of experience in the space. We have looked at probably 75 opportunities to date, and a number of those opportunities are a handful. We've done a very deep dive. I'm convinced that our process is going to yield a positive return for us. and especially in light of the kinds of opportunities that we've seen. I think that the other point is that this is a very experienced management team in the rare disease space, and those opportunities are coming to us, and I think based on that experience and contacts in the industry. So I think we're going to have a positive outcome here.
spk05: Great. Thanks, Rick.
spk09: Thank you. Our next question comes from the line of Ian Yang with Jefferies. Your line is now open.
spk01: Hi, this is Suji Dowling for you, and thanks for taking our question. I have a question on the Phase 2B design. On the clinicaltrials.gov, it says the primary endpoint is the percentage of subjects by PEM who meet target growth. Could you elaborate on what target growth that you mean there? And also to clarify, Phase IIb only enrolls those kids who are PEM positive, right? Thank you.
spk04: Gene, will you take that?
spk06: Yeah, certainly. No, it's a great question, and we thought it was very important to, you know, test this PEM selection strategy in a statistically rigorous way before we launched our registration trial. The data we have shown And how we derived our PEM factors show that in a non-selected population with PEM negative and PEM positive kids, 50 to 60 percent of the kids had a positive growth response, albeit dose-dependent and then PEM positive kids, right? So when we have a PEM-selected population, we would expect the percentage of children to grow to exceed that 50% to 60% bar. So that's how we've set up our statistics there. I really don't want to go into the weeds without being able to actually, you know, show anything here verbally. But the idea is that the percentage of kids who grow in an enriched population obviously should be higher than the percentage of kids who grow in a non-enriched population or else you're not effectively enriching. Is that helpful?
spk01: Yeah, so the child will be in the kid who are P and positive, right?
spk06: Correct. The only PEM-positive kids will be among the 80 kids randomized to one of the four treatment doses.
spk01: I see. And then the target growth that you mentioned there, do you expect the growth to be higher than non-enriched population?
spk06: And, well, the percentage, the number of kids, because we're enriching for likely responders, right? So that's the thing. The overall, you know, instead of 50 to 60% of the kids growing, we expect a higher number to grow because we're enriching for kids we think are likely to respond. So that's really where the math comes down.
spk01: Oh, I see. Okay, great. Thank you. And follow-up question for the PCPD study. I think you guys previously mentioned that you're going to test two different doses. I just want to know how you're going to select those two doses to be tested.
spk06: In the Gene, go ahead. Yeah, in the PKPD study, quite simply, they're going to be two of the same doses we're using in the Oral Growth 210 trial. I don't believe we specifically stated which of the three doses we've moved forward into the Oral Growth 212 study, but it's going to be two of the same doses.
spk01: I agree. Thank you.
spk09: Thank you. Our next question comes from the line of Eleanor Pierce with Wealth Capital Partners. Your line is now open.
spk02: Yes, good afternoon. So about the doses that you just described that haven't been disclosed yet, how should we think about these doses in vis-a-vis what was used previously in previous trials? Higher in the same range? I know you discussed that they covered the entire range, but if you could provide a little bit more specificity, please.
spk04: Thank you for the question, Elmar. And John, will you answer that question, please?
spk05: Sure. So I think what we've told people in the past is in our Phase 2b trial, we're going to look at three doses, 0.8 mgs per kg, 1.6 and 3.2 mgs per kg. And for the the PK-PD study that we're doing, we're going to take two of those doses and go forward with them.
spk02: Okay, thank you. And so just to make sure that I understand the purpose of the PK study, and I think it's much clearer now. So your measure or there is an observation of 23, 24, 23 to 25 pulsatile secretions of growth hormones without treatment. Now, the treatment would amplify those peaks or increase the frequency. That's what you are trying to determine, or there is some other purpose for the study?
spk04: John, go ahead.
spk05: As Gene mentioned, what's been seen in adults so far with frequent sampling after six or 12 months of treatment with LUM201 is that you don't actually change the number of peaks, you just change the amplitude of those peaks, right? And by changing the amplitude of the peaks, you increase the amount of growth hormone that's released over 24 hours. And we'd like to show something similar to that in this PEM positive pediatric growth hormone deficient kits, right? So we'd like to make sure that we can replicate that and we understand exactly how we're affecting the pulse tau release with LUM201.
spk02: And just to confirm that it's a once daily administration of pills, and how many pills are in the 3.2 mcg per kilogram group regarding an average-sized child?
spk04: Go ahead, John. Not John, but Gene, go ahead.
spk06: Yeah, so the actual number of pills... You know, we have a couple different doses because we have a couple different size tablets because we have a couple different size doses in our phase 2B study. Our plan is to obviously only take one dose into phase 3. And I think we can give you more clarity at that point when we have our dose. But our expectation is that there will not be a significant pill burden here. That's why we're doing the thorough exploration of dose so we can actually get efficacy without any kind of significant pill burden for these kids.
spk02: Okay.
spk06: Thank you so much.
spk09: Thank you. I'm showing no further questions in the queue at this time. I'll hand the call back to Mr. Hawkins for closing remarks.
spk04: Well, we thank you for your interest and look forward to speaking with investors at the November and December investment conferences and other venues in the coming year. Thank you.
spk09: Ladies and gentlemen, this concludes today's conference call. you for your participation. You may now disconnect. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. you Thank you. Thank you.
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