Earnings Call: Q4 2018

Mar 6, 2019

Good day, ladies and gentlemen, and welcome to the 4th Quarter 2018 Xenon Pharmaceutical Incorporated Financial Results Conference Call. That time. As a reminder, this call is being recorded. Would now like to introduce your host for today's conference, Jodi Rates. Ma'am, you may begin. Thanks, Heather. Good afternoon. Thank you for joining us on our call and webcast to discuss our 2018 financial and operating results. Joining me on today's call are Doctor. Simon Pimstone, Xenon's Chief Executive Officer and Ian Mortimer, Xenon's President and Chief Financial Officer. Following this introduction, Simon will provide perspective on Xenon's progress, and then Iain will review our financial results. After that, we will open up the call to your questions. Please be advised that during this call, we will make a number of statements that forward looking, including statements about the sufficiency of our cash to fund operations into 2021, the timing of IND or IND equivalent submissions with regulatory agencies, the initiation of future clinical trials, the efficacy of our clinical trial designs and anticipated enrollment, the potential efficacy safety profile, future development plans, addressable market, regulatory potential of our product candidates, the timing of and results from ongoing clinical trials and preclinical development activities our ability to achieve certain milestones in our proprietary development programs, the results of our research and development efforts the status and timing of the potential addition of new programs to our pipeline and related development activities the timing of our public presentation and the potential to advance XEN496 into trial and XEN007 into a phase 2 or later stage clinical trial. Forward looking statements are subject to numerous risks and uncertainties many of which are beyond our control, including the risks and uncertainties described from time to time in our SEC filings. Our results may differ materially from those projected on today's call. We undertake no obligation to publicly update any forward looking statement. Today's press release summarizing our 2018 results and the accompanying annual report on Form 10 K will be available under the Investors section of our website at www.xenonpharma.com and filed with the SEC and CR. Now, I'd like to turn the call over to Simon. Thank you, Jody, and good afternoon, everyone. 2018 was a pivotal year for Xenon, as we built out our neurology pipeline and advanced multiple product candidates using a variety of development strategies including a precision medicine approach to address rare pediatric disorders this foundational work has resulted in 4 distinct therapeutic candidates, XEN496, XEN1101, EN901 and XEN007. These are expected to be in phase 2 or later stage development this year, as well as the potential for additional development candidates which we are very excited about and which we expect to report on in the second half of this year. On our call today, I'll provide an update on all of Xenon's clinical stage products before turning things over to Ian, who will then provide a financial and milestone overview. Let me start with XEN496, a Kv7 potassium channel modulator with the active ingredient ezogabine. We're developing XEN496 as a treatment for KCNQ2 epileptic encephalopathy or KCNQ2 epilepsy which is a rare severe neurodevelopmental pediatric disorder with a significant seizure burden and profound developmental impairment. Ezogabine was previously approved by the FDA as an anti epileptic drug or AED as an adjunctive treatment for adults with focal seizures with or without secondary generalization. In fact, ezogabine is the only AED previously approved by the FDA with a mechanism of action that potentiates Kv7 mediated potassium current. GlaxoSmithKline marketed ezogabine in various jurisdictions as potiga in the U. S. And as Trobalt in Europe, but withdrew the drug from the market worldwide in June 2017 citing commercial reasons. In the landscape of other approved AEDs in the adult population, ezogabine never gained a large market share due to a number of liabilities including pigmentation risk, especially the initial concerns about potential visual toxicity related to retinal pigmentation, which to date have not been proven as well as issues around the three times a day dosing regimen and Cmax related CNS adverse effects as well as urinary retention observed in approximately 1% of patients. While ezogabine was approved for adult focal epilepsy, published K series reported on the successful use of ezogabine in children with KCNQ2 epilepsy. Suggesting that XEN496 could be efficacious in this often hard to treat pediatric patient population with good reported tolerability. While non controlled, these clinical series reported improvements in seizure burden as well as in development and behavior. Treatment of KCNQ2 epilepsy. Importantly, we obtained a regulatory right of reference from GSK authorizing the FDA to reference GSK's non clinical and clinical data when considering our regulatory submissions. This is especially valuable considering that ezogabine has been used by thousands of patients. We established a strong a steering committee made up of key opinion leaders in pediatric epilepsy fields to help guide the clinical development of XEN496. In response to our pre IND briefing package submitted in 2018, the FDA indicated that it was acceptable to study XEN496 in infants and children up to four years old and that a single pivotal trial in approximately 20 patients may be considered adequate provided we show evidence of a clinically meaningful effect. Recognizing that ezogabine was initially developed as a hard coated tablet that is unsuitable for use in children We are finalizing a pediatric specific formulation and we expect to complete preclinical formulation testing with the final drug products in the second quarter of 2019. We're on track to file an investigational new drug or IND application in the third quarter of 2019 And based on this regulatory feedback, we anticipate initiating a Phase III clinical trial thereafter. This timeline is based on our assumption that the testing of our new XEN496 pediatric formulation in healthy adult volunteers will not be a regulatory requirement prior to initiating a Phase III clinical trial. We're excited that XEN496 provides us with the opportunity to move rapidly into late stage development and to apply a precision medicine approach to treating KCNQ2 epilepsy. We look forward to providing additional details regarding the clinical development of XEN496 including the final anticipated trial design and endpoints. Next in our development pipeline is XEN1101, a differentiated next generation Kv7 potassium channel modulator being developed for the treatment of focal adult epilepsy and potentially other neurological disorders. We announced final data from the XEN1101 Phase 1 clinical trial including the transcranial magnetic stimulation or TMS studies at the American epilepsy Society annual meeting this past December. Just to briefly review the objectives of the EN1101 Phase 1 clinical trial, which will evaluate the safety, tolerability, and PK of both single ascending doses and multiple ascending doses using a powder and capsule formulation of XEN1101 in healthy subjects. XEN1101 Phase 1 clinical trial also included a pharmacodynamic readout from TMS studies that were designed to assess XEN1101 ability and potency to modulate cortical excitability thereby demonstrating activity in the target CNS tissue. To summarize the results presented at AES, the phase 11101 data include a PK profile that supports once a day dosing, and exhibited an AE profile consistent with anti epileptic drugs of this class. The majority of AEs were mild or moderate resolved spontaneously and were consistent with anti epileptic drugs of this class sedation, including somnolence and drowsiness and dizziness, including light headedness and presyncope with the most common AEs, while mild cognitive effects including memory and speech impairment and blurred vision were also observed in a dose dependent manner. There were no serious AEs, no deaths, and no clinically significant ECG or laboratory findings and no urine refindings and no pigmentation was observed. Thus, these phase 1 data suggest that XEN1101 is generally safe well tolerated in the doses examined including single doses of up to 30 milligrams and multiple doses of up to 25 milligrams once daily. In the phase 1b TMS study, XEN1101 reduced corticospinal excitability as demonstrated by a concentration dependent elevation in resting motor threshold, the key TMS EMG measure. In addition, XEN1101 modulated TMS evoked EEG potentials otherwise known as TEPs in a patent consistent with reductions in cortical excitability. Overall, the phase 1b TMS study provides evidence of the CNS effects of a single 20 milligram dose of XEN1101 as indicated by suppression of cortical and corticospinal excitability and helped us with dose selection for our XEN1101 Phase 2b clinical trial where this 20 milligram dose was set as the mid dose of 3 active dose groups. We have recently initiated our phase 2b clinical trial in adult patients with focal epilepsy. The phase 2b clinical trial is designed as a randomized, double blind, placebo controlled, multicenter study, to evaluate the clinical efficacy, safety and tolerability of XEN1101 administered as adjunctive treatments in adult patients with focal epilepsy. Approximately 300 patients will be randomized in a blinded manner to 1 of 3 active treatment groups or placebo in a 2 to 1 to 1 to 2 fashion using doses of XEN1101 of 25 milligrams 20 milligrams 10 milligrams plus a placebo arm. The primary endpoint in this trial is the median percent change in monthly focal seizure frequency from baseline compared to treatment period of active versus placebo. An IND application for XEN1101 has been accepted by numerous regulatory authorities, including the FDA, and site selection and patient enrollment are now underway for the trial in the United States, Canada, and Europe. Depending upon the rates of enrollment, which we will have a better idea of around midyear, top line results from XEN1101 Phase 2b are anticipated in the second half of twenty twenty. Turning to the 3rd product a potent, highly selective NAV 1.6 sodium channel inhibitor being developed for the treatment of epilepsy. There is strong human genetic validation supporting the rationale for treating epilepsy by blocking the NAV 1.6 sodium channel. NAV1.6 is a highly expressed sodium channel in the excitatory pathways in the CNS. When mutations in the SCN8A gene, which encodes the NAB 1.6 sodium channel resulted a gain of function in the NaV1 6 sodium channel. Children can present with a very severe form of epileptic encephalopathy in infants known as SCN8A epilepsy or EIE13. Also at the December AES meeting, we disclosed interim results from a randomized double blind placebo controlled phase 1 clinical trial, to evaluate XEN901 safety, tolerability and PK in both single and multiple ascending dose cohorts of healthy adult subjects and included a pilot TMS arm as well. The XEN901 Phase 1 clinical trial is now complete. To summarize the results presented at AES briefly, XEN901 PK data demonstrated dose proportionality with a predicted half life of 8 to 11 hours which suggests that XEN901 could be compatible with a once or twice daily dosing regimen. The majority of AEs in the phase 1 trial were deemed unrelated to XEN901 were mild or moderate transient and resolved spontaneously. All AEs considered possibly related to XEN901 were mild, only muscle twitching, nausea, and dizziness were reported in more than one subject. The safety results suggest XEN901 is overall generally safe and well tolerated in the doses examined. The pilot TMS study for XEN901 was previously presented during AES, but to summarize, XEN901 showed increases in resting motor threshold and active motor thresholds of approximately 2% decreases in amplitude of TMS Evoque potential at 180 milliseconds or the P180 and an increase in delta power in the resting state EEG. The observed changes in TMS EMG and TMS EEG parameters suggest activity of XEN901 in the target CNS tissue. Given the PK and safety profile in phase 1 and the fact that we are reaching exposure in humans where we demonstrated efficacy in preclinical models. We are now planning for phase 2 development, either to evaluate XEN901 as a treatment for adult focal seizures or for rare pediatric forms of epilepsy including SCN8A epilepsy patients, depending on feedback from planned discussions with regulatory agencies. We expect to receive regulatory of 2019 and pediatric formulation development and juvenile toxicology studies are underway to support pediatric dosing. I also wish to update you today on our 4th development stage product XEN007, a CNS acting T type calcium channel modulator. Which contains the active ingredient flunarizine. Flunarizine is available in certain countries outside of the United States and has been approved for the prevention of chronic migraine and for vertigo. Given its activity on enhancing cerebral blood flow and reducing cortical spreading depression. Finarizine has been used in many indications and has been reported to have clinical benefits in treating multiple neurological disorders, including hemiplegic migraine or alternating hemiplegia of childhood or AHC, pediatric cyclical or periodic migraine and as adjunctive treatment in certain epilepsies. You may recall that we previously the FDA for XEN007 for the treatment of both AHC and HM. The FDA has recently granted Xenon a rare pediatric disease designation for the treatment of AHC with XEN007. Receipt of this RPD designation from the FDA is an important milestone for our XEN007 program. And it underscores the need to find treatments for AHC a rare severe and debilitating neurological movement disorder that presents within the 1st 18 months of life and causes lifetime mobility and increased mortality. Importantly, The RPD designation allows recipient companies upon approval of the subject indication to be eligible for a priority review voucher which may be used to obtain what is referred to as a priority review for Despite literature reports of efficacy with flunarizine in over 300 cases of AHC, there are no FDA approved drugs for AHC. And we have the support of key physicians and patient advocacy groups to pursue We will continue to obtain and evaluate regulatory feedback and anticipate supporting at least 1 phase or later stage clinical trial in an orphan neurological indication this year. Given the widespread use of flunarizine, In parallel with our regulatory interactions with the FDA, we are also considering other development strategies for XEN007. As we continue to explore our interest in pediatric epilepsy disorders, we have had a number of discussions with physicians who have expressed interest in supporting investigator sponsored studies and we are making very good progress working with an investigator on a specific protocol in order 7 across the variety of development pathways that I've outlined, we have entered into key exclusive licensing agreements in order to access regulatory files and drug product manufacturing. Also wanted to flag for you an important industry collaboration that was announced just last week, we along with Invitae and other corporate partners are sponsoring behind the seizure, a unique collaboration that aims to provide faster genetic testing for infants and young children with epilepsy previously available to two to four year old children, the behind the seizure program has now expanded eligibility to make no cost genetic testing available for healthcare providers to order testing for infants and children who have had an unprovoked seizure from birth up to age five. The aim is to encourage the rapid identification of the genetic causes of seizures in infants and children including those with KCNQ2 and SCN8A epileptic encephalopathies. By offering this no cuff genetic testing for very young patients. It is hoped that earlier diagnoses will lead to improved treatment outcomes through the introduction of personalized precision medicine approaches. Behind the seizures epilepsy panel comprehensively surveys more than 180 epilepsy genes, including KCNQ2 and SCN8A and to date hundreds of institutions in the United States have participated in the program. As a collaborating company, we received data reports containing all identified gene mutations and other variants and the physician's contact that ordered the test. In addition to the behind the seizures program data, we'll have access to retrospective mutation data for selected genes going back to 2017. This physician and genetic based information assists with identifying those physicians who have patients for example, with ultra orphan KCNQ2 and SCN8A epileptic encephalopathy. This data helps to build a registry of high priority physicians for the potential commercialization of our precision medicines and for selecting specific clinical sites and cases for our clinical trials of XEN496 and XEN901. Before turning this over to Ian, who will summarize our 2018 financial results and provide some concluding remarks, I want to reiterate how proud I am of the immense amount of progress the Xenon team has made over this past year. I believe that Xenon currently is one of the most innovative and exciting CNS pipelines in development in the biotech industry with numerous important catalysts over the next 12 months. We intend to pursue a to address rare pediatric disorders with a genetic basis such as KCNQ2 or SCN8A epilepsies or alternating hemiplegia of childhood as well as those targeting broader patient populations, including with 1101 adult patients with focal epilepsy, or children with more common forms of childhood epilepsy. With the support of a healthy balance sheet, we have 4 very promising drug candidates all poised to be in phase 2 or later stage development over the next 6 to 12 months. We are also working on numerous potentially new development candidates and we expect to have updates in this regard in the next 6 months as well With this positive backdrop, we intend to enthusiastically advance our drug development programs and I look forward to keeping you up to date on our progress. Now over to Ian. Thanks, Simon and good afternoon everyone. I'll start by providing an overview of our cash position and cash runway guidance and then I'll provide a few highlights of the financial statements. Cash and cash equivalents and marketable securities as of December 31, 2018, were $119,300,000. This compares to $43,700,000 as of December 31, 2017. As I noted on our last call, our balance sheet was strengthened this past year, through the successful completion of an underwritten public offering in September $59,200,000 net of underwriting discounts and commissions, but before operating expenses. Another positive benefit of this offering included the addition of high quality institutional and shareholders who continue to support our strategic goals. As of December 31, 2018, there was approximately 25,750,000 common shares outstanding and approximately 1,000,000 Series 1 per shares outstanding, which are convertible into common shares on a 1 for 1 basis at the option of the holder subject to certain limitations. Based on our current assumptions, which include fully supporting the planned clinical development of XEN496, XEN1101, XEN901 and XEN007, we anticipate having sufficient cash to fund operations into 2021. And this excludes any revenue generating generated from either existing partnerships or potential new partnering arrangements. I won't provide any specific comments on our financial statements as all of the details are covered in our press release and in the 10 K filing. However, I did want to bring to your attention a one time expense that occurred in September, where we incurred a one time $6,000,000 payment to Valleant or Bosch Health And this was for the buyout of all future milestone payments and royalties owed with respect to our XEN1101 product candidate. This was a very important transaction for Xenon as we now owe nominal future economics on all four assets within our proprietary clinical pipeline. Which gives us tremendous flexibility as we develop We anticipate initiating a phase 3 clinical trial for XEN496 for the treatment of KCNQ2 epilepsy. Advancing our ongoing XEN1101 Phase 2b clinical trial in adult focal epilepsy with the goal of approximately half the trial recruited by year end initiating a phase 2 clinical trial for XEN901 in either pediatric or adult epilepsy indication depending on And also we expect to initiate an investigator sponsored phase 2 clinical trial for XEN007 in the near term as well as working towards a phase 2 or later clinical trial in an orphan neurological indication, possibly alternating hemiplegia of childhood and this will obviously depend on regulatory input. We attend to achieve these development milestones with the support of a strong balance sheet that funds our portfolio into 20 21. To build on Simon's comments, in conclusion, we have built out an innovative CNS product portfolio that has both breadth and depth and with more to come. While I am proud of the great amount of progress that we have made over the past year, I'm even more excited looking to the future. With the prospect of having multiple neurology products in mid and late stage clinical development this year. We look forward to keeping you updated on our progress. Throughout the And your first question comes from Stephen Willey with Stifel. Your line is open. Yeah, thanks for taking the questions and congrats on progress. Just wanted to clarify regarding 496. So is it your intention then to secure definitive regulatory guidance on the proposed pediatric formulation and I guess the lack of a bridging study prior to submitting an IND filing? And if so, I guess kind of how does that logistically work? Will there be some formal FDA meeting that needs to go on the calendar, or is this just something that you can solicit from the agency, I guess anecdotally? Steve, it's Simon. Thank you. At the moment, we aren't looking to seek formal guidance before the IND submission anticipated for Q3. We do, as I've stated earlier in the call, anticipate getting in vitro and in vivo PK data on the new drug product formulation, probably quite early in Q2. Obviously, we'll look at that and make a determination. At current, our thinking is the likelihood lower rather than higher of needing a bio study, but a bioequivalent study and the current feeling is that we should be submitting without the need for bioequivalence IND in the third quarter. If we see anything in the data over the next few months, in terms of both in vitro and in vivo that may change that plan. Obviously, we will amend, but currently the plan is not to go to the FDA prior to their submission, which as I said is Q3. And then I think there's also kind of a bit of a discussion that's occurring with respect to endpoint selection for the phase 3 trial. I'm just kind of wondering if you can provide an update there as well. I think we've made very good progress in the last month or 2 with our KOLs. I'd say we're pretty close A lot of the protocol development, I'd say, focuses on 2 main issues, Steve. One is what exactly is the endpoint going to be? We've already had guidance and we've communicated this that the FDA would like see video EEG in that endpoint. What we don't know at this point is exactly what the duration of video EEG episodes will be 48 hours 72 hours 96 hours, 1 continuous video EEG or multiple. So that's under development with KOLs. The second is as we've guided again before, the feedback from the FDA was that a single pivotal trial of approximately 20 subjects should be sufficient assuming or provided, we show evidence of clinically meaningful effect. Now we need to define what the clinically meaningful effect is and if P value driven what does that look like? We're doing some of that power calculation work and of course what ties into that is what is protocol look like specifically? Is this placebo controlled or is it active baseline versus end of study controlled just with an active arm that's looking like where we're probably leaning. Again, this is all pre FDA interaction. I would say in the second quarter, Steve, we will have a final, protocol developed, statistical plan modeled, and we will be looking to submit to the FDA again in the third quarter. We don't think at this point, we need prior interaction with the FDA We think we'll submit the IND in Q3 with a protocol that's been inputted by, really the key opinion leaders in the space. Very helpful. And then, just on 901, I know the phase 1 dose escalation data really seems to suggest that you've got asset with a really wide therapeutic window here. Yes. And I know that you're guiding to Phase 2 development occurring in either Peds or adults as kind of being the next step. But how are you guys thinking about just pushing dose further presumably you'd like to reach a DLT at some point and just whether or not that's more easily accomplished just with the existing formulation in an adult patient population? Yes. I think that's an excellent point, Steve. And, you know, we don't know which way the FDA is going to go on this. You know, we think there is a very strong rational for getting this drug into refractory ATA gain of function children. Some kids do respond interestingly, the best drugs typically for the ATA gain of function where they do respond to typically sodium channel blockers. So this does again provide further support for a more selective on target drug that we can dose with higher receptor occupancy better tolerability. The morbidity and mortality of these children is high about 10% SUEH by the age of ten to twelve in these kids. So there's absolutely no question that a proportion of these children are still markedly refractory and we would like to motivate given safety both pre clinically and clinically to date that we could we could design and have really designed a very safe titration based protocol that we think could test the activity of this drug in these children in a very safe manner. The to your point, think if we're really going to sufficiently dose escalate above the phase 1 doses that would probably be more likely in an adult patient population. Again, we're doing some preclinical work to further expand our therapeutic index. But we'd obviously have to take into consideration whether it's an adult or pediatric study. And I think in an adult study, we may well be able to go to more DLTs. We did not reach MTD in the phase 1. And so we actually don't know whether we're at the how far off we are from the maximum tolerated dose. What I will say is at the concentrations we did achieve with good tolerability in the phase 1, we get well above the predicted efficacy range based on the animal data. So I think that's that's probably at least that's a good benchmark. We're getting above the predicted efficacy exposure. We don't know what the MTD is that's probably something we would test if we go into adults. So I think Steve long winded answer, but we are hoping to get into Peds as quickly as we can if supported by juvenile tox, which is obviously just initiating. We'll have that done in time obviously for, for when we'd like to submit, but we are going to the FDA shortly, at least submitting Quest around whether the next phase of development could be a pediatric study for 901. And if the answer is yes, These are the things we need to do, but we could get there. That would be the focus probably for this year. If the answer is no, they'd like to see more adult work Then I think in the second half of the year, we can expect a phase 2 trial proof of concept in focal adults with focal epilepsy. And there I think we would certainly look to push those. Very helpful. Thanks for taking the questions. Your next question comes from Maury Raycroft with Jefferies. Your line is open. Hi, everyone. Congrats on the updates and thanks for taking my questions. To start, for 1101 for the Phase 2b, I'm wondering how many sites and what potential number of patients you anticipate being enrolled by midyear? And you commented that you should have a better idea on how the trial is going by midyear. Will you provide an update at that point? Maury, it's Ian. So obviously, the total trial number is 300 subjects and what we said in our prepared remarks today is that we think we should be about halfway, in terms of patients enrolled by the end of year. We haven't provided any guidance on where we will be at midyear. I think, you know, kind of in Simon's comments and I'd echo them is you need to be a number of months into a study just to see what that enrollment curve looks like. So I think by mid year, we'll be able to confirm that we're on track for our top line data in the second half of twenty twenty. And then for 7, you've mentioned you have a licensing agreement to access regulatory files and drug manufacturing info Just clarifying on that, does that encompass, right of reference to historical efficacy and safety data? So there's no so this isn't in the U. S, right? So it's not a rightive. So it's very different than 496 where The writer reference we received from GSK is such that the FDA can refer to the GSK regulatory filings with FDA. Flunarizine was never developed in the U. S. So we have 2 relationships. We have a relationship, on primarily it's kind of it's broader than just preclinical, but it's primarily on talks. But you kind of think about the preclinical package, nonclinical package, as well as clinical day So it's not a right of reference, but we can use that information in our submission to FDA. And then the second relationship we have is with a manufacturer of the commercial product outside of the U. S. So essentially that would be our CMC section. So a huge amount of the heavy lifting that we would need to provide to FDA, we have we've gained through relationships with 2 other third parties. Got it. That's helpful. And then on the behind the seizure program, just wondering if you're planning on providing updates on that program along the way and if that program is going to be expanded outside the U. S. As well? Yeah, I'll start with the second one. We don't know that. I think that's a question for Invita and we're focusing the relationship for now in the U. S. Testing. I don't have an answer. In terms of the first question, you know, we haven't planned to provide updates. It's something we'll certainly consider You know, we're using this primarily for us to help to build the registry, both for commercial reasons, but also incident cases for the clinical trial So we hadn't certainly planned, updates and, but, you know, we will certainly consider this and and maybe do some annual updating of this as we look forward. Thank I am showing no further questions at this time. I'd like to turn the call back over to Jodi Race for closing. Oh, I am sorry. We do have another that's popped up from Maury Raycroft with Jefferies. Your line is open. Hi, I just had one more question. I was just wondering for the new development candidate you mentioned, are those from in house development or are they from outside partners and would you potentially even revisit some of the candidates from the Genentech collaboration? Yes. So the answer to the second part of your question is not at this point. Genentech is, fully focused on the 17 pain program. It's internalized as gen at Genentech as we buy and we'll provide guidance as Genentech gives us authority to do under our confidentiality disclosure requirements, or provisions. So, that the answer to that is no, not at this time. In terms of the first part of your question, where might new development candidates come from? Marie, I think you can expect much of the same, which means We've got some very exciting internal programs. Some which are actually quite advanced, others which are earlier stage. But we also have some very interesting concepts that can be maybe considered more along the lines of what you've seen with the 496007 for new development opportunities that think could be fast tracked and that fit beautifully within our strategic areas of focus neurology, often opportunities, ion channel modulation and some other mechanisms within that bag as well. But there's actually a considerable amount of activity underway, both on the discovery in house, but also we've got some really, I think, very creative ideas, not too dissimilar to what you've seen with with previous announcements. And I think again, depending on how work goes over the next few months, we certainly hope a name to have some announcements around new development opportunities in the second half of this year, which could add very considerably to the pipeline if those 2 are now in studies we have underway to be in our favor. Pleasure. Thank you. And I am showing no further questions at this time. I'd like to turn the call back over to Jody Rates for closing remarks. Thanks for joining This does conclude the program and you all may disconnect. Everyone have a wonderful day.