This conference call transcript was computer generated and almost certianly contains errors. This transcript is provided for information purposes only.EarningsCall, LLC makes no representation about the accuracy of the aforementioned transcript, and you are cautioned not to place undue reliance on the information provided by the transcript.
spk05: that time, please press star 1 on your telephone keypad. If at any point your question has been answered, you may remove yourself from the queue by pressing the pound key. We ask that you please pick up your handset to allow optimal sound quality. If you should require operator assistance, please press star 0. Before we begin, we want to advise you that over the course of the call and question and answer session, forward-looking statements will be made regarding events, trends, business prospects, and financial performance, which may affect Plus Therapeutics' future operating results and financial position. All such statements are subject to risks and uncertainties, including the risks and uncertainties described under the risk factor section included in PLUS Therapeutics' annual reports on Form 10-K and quarterly reports on Form 10-Q filed with the Securities and Exchange Commission from time to time. PLUS Therapeutics advises you to review these risk factors in considering such statements. Plus Therapeutics assumes no responsibility to update or revise any forward-looking statements to reflect events, trends, or circumstances after the date they are made. It is now my pleasure to turn the floor over to Dr. Mark Hedrick, Plus Therapeutics' President and Chief Executive Officer. Sir, you may begin.
spk04: Great. Thank you very much, Kathryn. Good afternoon, everyone, and thank you once again for taking the time to join us today as we provide an overview of recent business highlights and discuss our 2021 second quarter financial results. Joining me on the call today is Mr. Andrew Sims, our Chief Financial Officer. Before Andrew provides a summary of our financial performance, I would like to provide an update on the company's business activities since our last call. Last quarter, I provided a detailed overview of the company, and I'll refer you back to that description. But in summary, for those new to the company, Pus Therapeutics is a clinical-age pharmaceutical company developing innovative, targeted radiotherapeutics for rare and difficult-to-treat cancers. Our lead drug is RNL, or rhenium nanoliposomes. It is a proprietary liposomal encapsulated radionuclide that is delivered local regionally via targeted three-dimensional convection-enhanced delivery directly to the tumor. The active agent is uranium-186 isotope, which is a dual-energy emitter releasing both cancer-killing beta particles, which are high-energy electrons, and gamma particles, which are useful for imaging and dosimetry. Uranium is a unique isotope, in part because of its energy profile. Its beta energy has a short path length, which gives one precision, a low dose rate, which provides a margin of safety, and a high energy density, which is particularly toxic for highly mitotic cells, which can overwhelm the innate DNA repair mechanism that can also contribute to radio resistance. Thus far, we've shown that we can successfully deliver 20 times the radiation dose one can deliver with traditional external beam irradiation. Our initial indication for RNL is recurrent glioblastoma, which affects approximately 12,000 to 13,000 patients annually in the U.S., and about the same number of patients in the EU. It is the most common and lethal form of brain cancer, and the treatment of this devastating disease remains a significant medical challenge. Published studies indicate that external beam radiation provides the best incremental improvement and survival of all therapies currently used for glioblastoma and it remains an essential component of multimodal therapy for both glioblastoma and in fact many other cancers. In theory, glioblastoma and frankly any tumor can be fundamentally controlled if a sufficient dose of radiation can be delivered to a particular tumor. RNL is currently under evaluation in the U.S. RESPECT GBM trial, which is a dual phase 1 and 2 multi-center sequential cohort open-label volume and dose escalation study on the safety, tolerability, and distribution of 186 RNL. The trial is currently funded to a significant degree by the U.S. National Cancer Institute. In short, the trial is progressing nicely, and we have now moved into an eighth dosing cohort. As a reminder, in November 2020, at the Society for Neuro-Oncology Annual Meeting, we provided an interim analysis of the first five dosing cohorts and 15 patients. And in March of 2021, in our BioEurope corporate presentation, we updated those interim results to include Cohort 6, and that data can be found on our website. Subsequently, following the successful completion of Cohort 6 and without any dose-limiting toxicities, the Data Safety and Monitoring Board recommended enrolling an additional cohort of three patients, or a cohort seven, at the same volume and radiation dose, but with a higher maximum convection flow rate, specifically at 20 microliters per minute. Then in June of this year, we announced that through cohort seven, no dose-limiting toxicities had been observed, And the DSMB recommended proceeding to the next dosing cohort, representing a 40% increase in both volume and radiation dose. So specifically where we are now at, we're introducing a volume of 12.3 milliliters, a radiation dose of 31.2 millicuries, and we're staying at the same maximum flow rate of 20 microliters per minute. As announced this AM, the first patient in the additional cohort has been successfully treated. And I think it might be helpful at this point in the product development cycle to provide a summary of what we have learned thus far in the RESPECT GBM trial and then consider next steps. So specifically, what we've learned is that hemispheric or one-sided Supratentorial, which is into the upper part of the brain, highly targeted and continuously infused or convected volumes of up to 12.3 milliliters and 31.2 millicuries of radiation have been well tolerated thus far. Up to four catheters can be successfully placed for delivery to best accommodate a variety of tumor sizes and geometries. Tumors up to approximately 25 CCs and with various morphologies can be treated. RNL seems thus far to be safe despite delivering up to 740 gray of absorbed radiation to the tumor, which by the way is 20 times the radiation typically delivered by external beam radiation therapy in the recurrent setting. Patients receiving prior bevucizumab did not convect as well as bev-naive patients, and in the past, we elected to focus the current trial only on bev-naive patients. Furthermore, because of the very substantial doses of radiation administered, when a tumor dies, we found that it induces local swelling or edema, which we can observe on MRI scans, which is so-called pseudoprogression. which is very obvious to see on imaging. So traditional imaging analyses looking at response criteria is suboptimal and of lesser value in this particular clinical situation. Although the Phase I is not designed or powered for efficacy, today 8 of 22 treated patients are still alive, which is obviously a good thing, But because many of those patients have been treated relatively recently and at the higher dosing cohorts and volume cohorts, it understandably makes efficacy determinations today a challenging enterprise. As to the issue of overall survival, what I can say is that we have observed that increases in both convective volumes and radiation dosage seemed to correlate with better tumor coverage and higher tumor-absorbed doses. And this, in turn, seems to correlate with overall survival. As I mentioned, 8 of 22 patients remain alive, and 3 of 22 patients have survived to 30 months or more, where average survival for a current GBM with standard of care is only about 8 to 10 months. This present cohort should complete enrollment this year, and later this year, we intend to provide a comprehensive update with safety and efficacy data as of that time point, including our updated proposed next steps for the clinical investigation of R&L and recurrent GBM. As mentioned last quarter, the go-forward clinical development plan depends in part on the observed safety outcomes in the present dosing cohort and the involving efficacy data readout of the dataset as a whole. There is the potential to further dose escalate following the current dose cohort dosing cohort as a protocol provides for another 33% increase in volume and radiation dose following the current cohort eight. Besides dose escalation, or perhaps in conjunction with dose escalation, we could potentially implement further changes to delivery parameters as we have done previously. It's also possible that the company may deem the present dose and delivery parameters to be acceptable to move forward and we could expand the enrollment at this present dose to generate further efficacy data to better inform and power a follow-on Phase II registrational trial. As mentioned previously, CMC activities and the availability of cGMP investigational drug product is the primary hard-gating item for a Phase II registrational trial. Therefore, CMC activities are a top priority for us. Our team continues to make excellent progress towards submission and is simultaneously laying the groundwork for commercial readiness. The team has been focused on CGMP drug product development, test method validation, material characterization, and supply chain planning. To that end, we have formally engaged with key suppliers for both critical materials and contract development work. Longer term, manufacturing relationships will be key to commercial success, and our team continues to make nice progress in developing those strategic partnerships. For example, Pyramal and Vicro and Eurofins are, to just name a few, and others are forthcoming. So we remain on track, without delay, to have the key CMC activities completed by year-end and stability testing complete thereafter such that we should be ready with CGMP product by mid-2022. Switching gears a bit, last quarter we noted that two pre-IND meetings had been requested from the FDA to discuss expanding the clinical indications for R and L. Both are complete, and based on the positive FDA feedback, we intend to move forward in filing INDs for both indications. The first is leptomeningeal metastases, an increasingly common secondary cancer complication occurring as a result of increasing overall survival rates that we are seeing for a variety of primary solid and hematologic tumors. LM affects over about 100,000 patients per year in the US, and patients can present with a broad range of signs and symptoms due to simultaneous involvement of multiple areas of the craniospinal axis. Most common tumors giving rise to LM are breast cancer, lung cancer, melanoma, gastrointestinal malignancies, and in cancers of unknown primary. There are no great current treatment options available And the goals of treatment in patients have been limited primarily to stabilizing or improving neurologic function, palliating symptoms, and improving quality of life. Median survival in this patient population is approximately and generously about four to six months if treated. In the planned forthcoming trial, we intend to treat... With RNL, the indwelling subcutaneous reservoir, called an amai reservoir, that sits under the skin and communicates directly with the ventricle and the leptomeningeal or cerebral spinal fluid space. And this is commonly placed in these patients. And it makes delivery a much more straightforward issue than we have in our current GBM trial. The trial will be an open-label, multi-site dose escalation trial evaluating feasibility, safety, dose, and potential efficacy. We plan to submit the IND for RESPECT-LM trial by Q3, perhaps as late as Q4 2021, and commence enrollment as soon as possible thereafter. The principal investigator will be Dr. Andrew Brinner, who's a professor of research at the Division of Hematology and Medical Oncology and clinical investigator at the Institute for Drug Development at the Mays Cancer Center at University of Texas San Antonio and MD Cancer Center. He's also the co-leader of the Experimental and Developmental Therapeutics Program there. Additionally, we believe there's an opportunity to help patients with pediatric brain cancer with R and L, and based on our pre-IND meeting feedback, we intend to submit an IND later this year or in early 2022 to investigate the use of R and L on kids with brain cancer. The details of that trial will be finalized later in 2021. The PI for that trial will be Dr. Ashley Plant, the Kochar Research Scholar, an attending physician in neuro-oncology and assistant professor of pediatrics at the LEAD trial site, which is the Lurie Children's Hospital of Chicago at the Northwestern University School of Medicine. Finally, I'd like to point out that we have been working diligently for some months to take our corporate communications to a new level. That includes in all areas, including public relations, investor relations, and scientific and clinical communications. You'll see the fruits of that work over the remainder of the year, but today you can find the first part of that, which is our clinical trial microsite for the Respect Trials. That can be found at respecttrials.com. The front end is intended to educate and illuminate potential patients and family members with GBM. On the back end that you won't see is a sophisticated compliance patient referral network to help match our clinical trials with patients that may be good candidates and facilitate that process of connecting them with the clinical trial site. And much more is to come in that regard. So at this point, I'll stop and turn the call over to my colleague, Andrew, for a brief review of the first quarter financial results. Andrew?
spk00: Thank you, Mark, and good afternoon, everyone. Please refer to our press release issued earlier today for a summary of our financial results for the second quarter ended June 30, 2021. As of June 30, 2021, cash and cash equivalents were $17.2 million compared to $8.3 million as of December 31, 2020. Cash used in operations for the six months of 2021 was approximately $5.4 million compared to $2.9 million in 2020. This difference is mainly due to timing differences on when certain accounts payable and accrued expenses were paid in 2020, in particular relating to the legacy government contract, together with increased R&D spend. There were no revenues in the six months of 2021 as compared to approximately $303,000 in the same period last year. This decrease was due to the closeout of the legacy government contract as previously disclosed. Research and development expenses were 2.2 million for the first six months of 2021 as compared to 1.3 million for 2020. The increase was anticipated and reflects additional RNL CMC development costs to obtain cGMP drug product. G&A expense was 2.8 million for the first six months of 2021 as compared to 3 million for 2020. The decrease was primarily driven by reduction due to tight management of professional and other fees. Interest expense decreased for the six months of 2021 to approximately $476,000 and approximately $601,000 for the same period in 2020, reflecting the pay down of debt principal to $4.3 million in 2020. Net loss for the six months to June 2021 was $5.5 million as compared to a net loss of $2.9 million for the equivalent period in 2020. The net loss was consistent year on year when excluding the book gains on the warrants reported in the first quarter of 2020. As noted in our quarterly filing, this required book transaction was eliminated in the second quarter of 2020 when the Series E warrants were amended. And now I'll turn it back to you, Mark.
spk04: Great, Andrew. Thanks a lot. So before we go into Q&A, let me just summarize the milestones we anticipate over the next few quarters. First of all, with respect to the respect to GBM trial, we intend to complete the current cohort and present a comprehensive trial update in Q4 this year. And it's our intention to alert folks of the timing of that as soon as we are able. Also at that time, we intend to provide an update on next steps in the clinical development of R and L for GBM based on the evolving data set. Upon completion of the current trial and data analysis, And then the Phase 1-2 meeting with the FDA is likely to help finalize the pivotal trial plan. Regarding the CMC activities for R&L, we plan to complete key cGMP manufacturing activities, and we remain on track to begin stability testing later this year with GMP investigational drug product anticipated to be available around mid-2022. At the end of the year, 2021, we anticipate possibly requesting a Type C FDA meeting to clarify and resolve any open CMC issues that may exist at that time. Regarding the RESPECT-LM trial, IND submission is planned for Q3-Q4 2021 in enrollment to begin following approval. We will provide a formal update on that trial once we hear back from the FDA, perhaps at our next quarterly earnings call. Regarding pediatric brain tumor therapy, an IND submission is planned for later in 2021 to follow the LM IND submission, which could be as late as early 2022. And as mentioned, we will provide a formal update on that trial once we hear back from the FDA. In terms of business development activities, we continue to be quite active. both in CMC and in assessing in-licensing and out-licensing opportunities, and we'll provide updates in an ongoing matter if and when we have news to report on that front. So, Catherine, with that, I think let's move to Q&A.
spk05: The floor is now open for questions. At this time, if you have a question or comment, please press star 1 on your touchtone phone. If at any point your question is answered, you may remove yourself from the queue by pressing the pound key. Again, we do ask that while you pose your question, you please pick up your handset to provide optimal sound quality. Thank you. Our first question is coming from Jason McCarthy with Maxim Group. Please go ahead.
spk01: Hey, everyone. It's Dave on the line for Jason. Thanks for taking my questions. Just out of curiosity here, are you currently or do you intend on holding any meetings with ex-U.S. regulators to discuss a path to potential approval outside the U.S.? Or do you plan on initiating any clinical trials in any ex-U.S. territories?
spk04: No, I appreciate the question. Right now, we don't. It doesn't mean that won't change. I think we want to really stick to U.S. approval and our CMC activities over the course of the remainder of the year. I think after we get to 2021 and the the pivotal plan starts coming together, then we will begin exploring in earnest potentially broadening that trial to include international sites or separate clinical trials.
spk01: Okay. That makes sense. And then earlier in the call, you mentioned that – With respect to the patient population that was being evaluated in the RESPECT trial, you mentioned that patients who had previously received bevacizumab didn't conduct as well as bevanaive patients. So am I correct in saying that you guys are now currently focusing on GBM patients who are bevacizumab-naive? that's the target patient population, basically.
spk04: Yeah, that's true. We excluded them maybe about nine months ago. It doesn't mean we can't treat them, but what it means to me is that we likely have to change the delivery parameters, perhaps the volume and the rate, to improve the coverage of the tumor. And that's something we can address downstream. But in terms of
spk01: in this to market as quickly as we can we're going to exclude those patients okay that makes sense and then you uh you mentioned something about a potential uh phase one two or rather a meeting with the fda regarding potential phase one two trial could that would that be potentially happening in 2021 uh my guess is that's going to be a 2022 event um i think we're going to have to wait and see
spk04: what cohort eight looks like and look at the evolving efficacy and safety data and then make a determination about whether we we continue to dose escalate i think that's probably unlikely but possible and right right now we're delivering uh pretty significant volumes and radiation doses such that theoretically we think we can create a radiation cloud covering the tumor and the microscopic disease of a sphere of about seven centimeters in diameter. So I think we're getting pretty close to the max. But once we have a look at the data, we see what efficacy looks like, what safety looks like, we'll make a determination about whether to escalate or not or whether to go into the next phase. And as I mentioned, that could include an expansion cohort or moving on to the next trial.
spk01: Okay. Thanks for the additional comment. I appreciate it.
spk04: You bet. Appreciate the question.
spk05: Our next question comes from Sean Lee with HC Wainwright. Your line is open.
spk02: Good afternoon, Mark and Andrew, and thanks for taking my questions. So my first question is on the current cohort, cohort eight. Like you mentioned, with the up volume and dosing, you can be able to create spheres about seven centimeters. So what percentage of GBM patients do you think that's sufficient to cover? And do you feel that you have to go to a higher dose cohort later on?
spk04: Yeah. That's a great question and really it gets into the therapeutic strategy of these patients. As you know, Sean, with GBM, it doesn't typically metastasize. It kills patients by local growth. If it's left untreated, it grows like a weed. You can surgically extirpate these tumors. But the problem is about 90% of the recurrences occur within a 2 centimeter rim around the tumor. So you have microscopic disease that you can't image, but you know instinctively is there. And it's likely going to be the catalyst for recurrence. So our concept is that if we could treat tumors that are roughly around 3 centimeters and cover call it a two-centimeter rim around that, which kind of accounts for a sphere, and that's an idealized geometry. These tumors don't often occur as spheres, but you can cover about a two-centimeter rim around a three-centimeter tumor, and you can, you know, theoretically not only ablate the tumor, which is I feel pretty confident we can do that reliably, but capture that microscopic disease. And in our view, that's where you're really going to see some potential improvements in efficacy. And then that might help downstream if patients do recur. For example, we've had patients that have lived beyond 30 months. Were they to recur, we could potentially entertain the concept of early retreatment and essentially play whack-a-mole. One can think about the art of what's possible here. In theory, you might be able to turn this into a chronic disease, certainly more chronic than it is today. It's an acute killer. That's how we look at it. So, yes, you could cover a tumor that's seven centimeters, but practically that just doesn't make any sense. I think the sweet spot is going to be kind of a three-centimeter tumor with a rim of one to two centimeters of a brain that's diseased but has microscopic disease. It's going to be the basis of a recurrence.
spk02: I see. Thanks for that. In terms of the next study, you mentioned you're likely looking to pursue a Phase II pivotal study. So would you be looking to go something towards a special protocol assessment with the FDA? Would you be pursuing, say, a breakthrough therapy designation? What are your plans on that, on the regulatory side?
spk04: Yeah, I think all those are possible, and those are in our planning, and it's just going to be kind of based on the data. And I think we'll kind of know more around Q3 or more likely Q4 of this year. And that's assuming that we stay on the same enrollment cadence we've been on and get cohort eight fully enrolled. And then the other thing is, and as I mentioned, we have a lot of patients that we've treated relatively recently that are still alive. And so we'll get more data as it relates to the evolving efficacy signal.
spk02: I see. My final question is on the upcoming ILM and pediatric brain cancer studies. So what's still left to do before you can initiate these studies? And also, would you wait until you have the new GMP manufactured drug before you initiate these studies, or would you go with your current stock?
spk04: Yeah, on the latter question, we can go ahead and begin those studies today with our current manufacturing protocol, which is sufficient for a phase one trial. As to timing on those, I would think about those sequentially. LM is the priority. And what's left there really is to finalize the IND, which, as mentioned, is going to be a Q3, maybe a Q4 event. and then submitting that, and then it really depends on, timing depends on the feedback we receive. We've already got a couple of sites identified, a number of others that we are investigating. We've identified the PI, and the PI is at a site that we're already working with and should be a relatively straightforward path to kick that trial off, assuming we come to agreement with the FDA. Regarding pediatric brain cancer, Similarly, we've identified the PI, the lead trial site. We're working with them to develop the protocol. But we're just bandwidth constrained, so that won't go in until after LM, which is likely going to be a filing date of maybe towards the end of the year. So we probably won't be able to be too definitive about the start of timing until early next year.
spk02: I see. Thanks for the additional color. That's all I have.
spk04: Thank you, Sean.
spk05: We'll go now to Ed Wu with Ascendant Capital. Your line is open.
spk03: Yeah, thank you for providing us the very thorough update. My question is on funding. Mainly, you've been able to fund most of your studies so far with various grants. Do you know what the funding plan will be if you do move to a Pavilion study?
spk04: Yeah. Ed, so I appreciate the question. You know, we're in a good cash position today. You know, we're really blessed and fortunate to have the majority of our clinical trial covered by the NCI. It really takes the pressure off in our need to raise capital. The management's philosophy is we like to stay at no less than 24 months of forward-looking cash, and we're pretty close to that right now. We tend to stay there. You know, I think it's just good biotech hygiene to have appropriate tools in place to allow us to be opportunistic and raise capital, you know, when the stars align, and we've done that sparingly and but strategically. Our plan is to kind of stay at about 18 to 24 months of cash, build to 24 a little bit more if we can, and then go out and raise additional capital once we get to a position where we're ready to embark upon a pivotal trial and raise sufficient capital such that we can go all the way to an approvable endpoint with that cash without going back to a partner or capital markets. So that's our plan. 24 months of cash is the baseline and raise additional cash when we need to get to an approvable endpoint and be opportunistic in the meantime.
spk03: Great. I was actually wondering, will the NCI fund the pivotal study? And also, you know, one of the reasons you guys moved to Texas was to get the state of Texas cancer funding. Is that an option for the pivotal study as well?
spk04: No, I don't think the latter is not. They'll fund up through Phase 2, and we've got Phase 2 covered. The NCI grant covers through – it's a Phase 1-2 design, and it covers that. That's up to 55 patients, and we're at 22 now, so there's still some runway there. I think it's possible to get grant funding, but, frankly – There's some trade-offs with having grant funding, as you're probably aware. There is to some degree a loss of control. So my guess is time is money, and we'll very likely want to fund that trial ourselves for practical reasons.
spk03: Great. Well, thank you for answering my questions, and good luck. Appreciate it, Ed. Thanks.
spk05: Once again, if you do have a question, you may press star 1 on your telephone keypad at this time. We'll go now to Imad Samad with Octavian. Your line is open.
spk01: Thank you. Thank you. Thank you, gentlemen, for the update, and thank you for taking the call. You know, Mark, you mentioned toward the end of the update about the BDM licensing activities. I was just wondering, could you give us some guidance on the types of opportunities the company is in search of and what the strategic goals and approach are vis-a-vis the current pipeline? For instance, what should we be expecting from the company? And how are you guys thinking or focused on that aspect of corporate strategy?
spk04: Hey, Amad. Appreciate the question. Obviously, the caveat is, you know, with BD is nothing's done until it's done. But I can get into the strategy a bit and tell you where our focus is right now. So our deal team is really active on three fronts. And what you've seen if you've been following the news over the last maybe quarter or so is that we're very active on the CMC front. We're partnering with leading suppliers and providers and And the most important of those we report publicly, so it's a good measure of progress. It's also not too early to think about things like barriers to entry, exclusivity in terms of these supply chain interactions, and further protections on that supply chain, and even reimbursement and ultimate margin. So those are all things that are central to us, and we're making progress along those fronts. So that's kind of point one. Point two is in licensing. And we are very active in evaluating additional new technology, both in the effort to expand the platform. We really like the radiotherapeutic space and also the pipeline. we are really focused on becoming increasingly more targeted. Now, as you know, with the RNL for GBM, that's delivered in a very targeted way, but it leverages convection-enhanced delivery and imaging, and you need a brain surgery in a way to do that. But we're also really looking beyond into other technologies and leveraging vascular access, either arterial or venous access, and potential molecular targeting techniques. So we've got a core expertise in delivery and drug formulation and radiotherapeutics, and I'm very interested in expanding in the targeted delivery space, and that's something that's spent a lot of time evaluating potential opportunities. Not to say that we're going to find something that comes pre-funded like R&L did with an NIH grant, but one can dream. And then finally, and probably a much, much, much lesser amount of time spent, we're still evaluating opportunities to out-license our two legacy drugs, which I didn't mention, but there is ongoing interest. But frankly, we're just going to need to see the right economics for that to make sense for us right now. So very active on those three levels, and we're going to You know, keep communicating, and when something happens, we'll let you know.
spk01: Great. Thank you. Thank you so much for the response and the opportunity. Appreciate it.
spk05: We have no further questions at this time. I would like to turn the floor back over to Dr. Hedrick for any additional or closing remarks.
spk04: Awesome. Thank you, Catherine. So I just want to say thanks to everybody that joined us on the call. And on behalf of the board, I'd like to just take a moment, as I do every quarter, to say thank you to our employees and our extended team members and now our multitude of academic collaborators with whom we work. And they work so hard and they're so dedicated to finding solutions for GBM and other really tough, gnarly cancers. I'd also like to thank the patients and the doctors and the hospital staff, who we spend a lot of time with, frankly, that significantly contribute to making these clinical trials possible. So thanks again, and please have a good evening.
spk05: Thank you. This does conclude today's conference call. Please disconnect your line at this time, and have a wonderful day.
Disclaimer