Aptinyx Inc.
Q4 2019 Earnings Call Transcript

Published: 31 Mar 2020

[Operator:]

Good afternoon and welcome to the Aptinyx Fourth Quarter and Year End 2019 Financial Results Conference Call. At this time, all participants are on a listen-only mode. Following the formal remarks, we will open up the call for questions. Please be advised today’s is recorded at the company’s request.At this time, I’d like to turn the call over to Nick Smith, Senior Director of Corporate Development and Investor Relations at Aptinyx. Nick, please proceed.

[Nick Smith:]

Thank you, Valerie. Good morning, everyone and thank you for joining us on today’s conference call to discuss Aptinyx’s fourth quarter and year end 2019 financial and operating results. Our financial results and company updates press release is now available on our website.Today on our call, Norbert Riedel, our President and Chief Executive Officer will review our business and clinical progress, and then Ashish Khanna, our Chief Financial Officer and Chief Business Officer will review the financial results. In addition, Andy Kidd, our Chief Operating Officer and Catherine King, our Senior Vice President of Clinical Development are with us for the Q&A portion of the call.Before we begin, I’d like to remind everyone that statements made during this conference call will include forward-looking statements within meaning of the Private Securities Litigation Reform Act of 1995, which involve risks and uncertainties that can cause actual results to differ materially. Any forward-looking statements are made only as of today and we disclaim any obligation to update these forward-looking statements. Please see the forward-looking statements disclaimer in our financial results release issued this afternoon and the risk factors in the company’s current and subsequent filings with the SEC.It’s now my pleasure to turn the call over to Norbert.

[Norbert Riedel:]

Thank you, Nick and good afternoon everyone. We appreciate you joining us on our call today, especially during these extraordinary and challenging times. Recent events related to the ongoing COVID-19 pandemic have created a significant degree of uncertainty around the world and within our industry.Against that backdrop, we think it is very important for us to communicate to our shareholders the progress we have made across our pipeline programs and also to provide you with an update on the impact COVID-19 is having on our business specifically.Before getting into those impacts, I'd like to review with the significant progress we made in 2019. The year was marked by numerous clinical milestones and to the relentless execution by our team in support of our mission of developing novel therapies for patients suffering from challenging CNS disorders.At the outset of last year, we set ambitious clinical development goals that centered around advancing all three of our clinical stage product candidates into new Phase 2 study. Thanks to the terrific efforts of our team, we accomplished those goals and initiated for four Phase 2 studies last year.These studies will evaluate and characterize the ability of our novel compound to address significant unmet needs in the areas of chronic pain, PTSD and cognitive impairment. I am very proud of everything the teams accomplished throughout the year to achieve that development progress.It is also important to note that we have continued our momentum into 2020 and have been making good progress across each of our studies. Of course, we like many throughout our industry are experiencing some challenges introduced by the COVID-19 pandemic, and in light of these challenges we have made certain decisions regarding our clinical development activities.Let’s start with an update on NYX-783, as our study of that compound in PTSD is furthest along. In 2019 we began evaluating NYX-783 in an initial, exploratory Phase 2 study in patients with PTSD. The study in approximately 150 patients is intended to evaluate for the first time the effects of the unique and novel mechanism of NYX-783 on a broad array of symptoms experienced by people with PTSD.To date, we have achieved approximately 80% of our target enrollment and by all metrics enrollment in the study has been progressing and tracking well. While there have been some disruptions at the site level brought on by the COVID-19 pandemic, so far we have been able to manage and mitigate them.We are working with our investigator sites to develop appropriate accommodations to support patient continuity, such as home delivery of study drug and virtual participant follow-up where these are required and feasible.Given some of the specific needs of patients with PTSD, we feel it is in the interest of patient welfare to continue enrollment in this study at this time, and we appreciate the perseverance and dedication of our investigators and sites [ph] to keep moving this study forward.We continue to enroll new patients into this study and will make every effort to do so as long as this remains responsible and feasible. We will remain vigilant in our continuous evaluation of the impacts of COVID-19 to this study, including primary focus on patient safety and well-being and close dialogue with our sites and CROs [ph]Given the ongoing uncertainty around COVID-19, we anticipate providing updated guidance on the expected timing of completion and readout of data from this study at a future date.Now let's discuss NYX-2925, which is in Phase 2 clinical development in two chronic pain indications, painful diabetic peripheral neuropathy, and fibromyalgia. In 2019 we read out our first Phase 2 studies in patients with these conditions. Our first study in fibromyalgia evaluated the effects of NYX-2925 on validated neuro-imaging biomarker of central pain processing.We saw that 2925 resulted in statistically significant changes in these biomarkers and that these biomarker effects were correlated with clinically meaningful and statistically significant improvement in pain and other fibromyalgia symptoms.Along side, we run our first study of NYX-2925 in patients with painful DPN. The compelling thickness of pain reduction we saw in that study helped inform dose selection, patient inclusion and exclusion criteria and other design parameters for our current studies in chronic pain, which are aimed at validating these segments.Together, these initial studies have provided tremendously important information on NYX-2925. It gets into the brain and enhances NMDA receptor-mediated pathways. Its activity addresses abnormalities in central pain processing that can be observed objectively through imaging and that activity translates into compelling signals of symptom improvement in patients who have experienced pain chronically.Based on these first Phase 2 studies, in late 2019 we initiated two follow-up Phase 2b studies, one in painful DPN and one in fibromyalgia leveraging what was learned in the initial studies and intended to validate the effect we observed in those studies. Both studies are designed to evaluate the safety and efficacy of NYX-2925 over a 12 week period. We've completed all of the start-up work and sites have been actively screening and involving patients in these studies.However, in light of challenges to screening and enrollments caused by the COVID-19 pandemic, on March 27tj we temporarily suspended the enrollment of new patients into both of these studies. Importantly, patients that have already enrolled may continue in these studies, further protocols and in accordance with the guidelines set forth by the FDA and CDC in conducting clinical studies.We will continue to monitor this situation very closely and maintain active dialogue with our site and CROs [ph] to determine when it is appropriate to resume enrollment in these studies. And we anticipate updating our guidance around the expected timing of the top line readouts from these studies at a future date following the commencement of enrollment.Finally, let's discuss our development of NYX-458 for the treatment of cognitive impairment associated with Parkinson's disease. As we recently published in The Journal Movement Disorders, we saw remarkable results with NYX-458 in a highly validated and translatable model in non-human primates, showing striking and durable reversal of cognitive deficits.Based on those data, we were very excited and enthusiastic to initiate our first study of NYX-458 in patients with Parkinson's mild cognitive impairment last December. This exploratory Phase 2 study will evaluate the safety and potential cognitive benefits of NYX-458 in Parkinson's patients for the first time.However, due to the particular risks posed by COVID-19 to these more vulnerable patients, we have decided to suspend the enrollment of new patients in this study as well. Despite the suspension of new enrollment those patients who are already on hold in the study may continue, consistent with the protocol and based on medical guidance.When appropriate, we are eager t reinitiate our investigation of NYX-458 in patients with cognitive deficits and we look forward to providing updates on our plans and timelines for this program at a future date.As we consider the impact of the COVID-19 pandemic on our business, I want to emphasize that while multiple factors informed our decisions on how best to proceed with each study. The health and safety of patients of the personnel involved in conducting these studies and of our way employees has remained at the forefront throughout our evaluation.With regards to Aptinyx' employees and operations, we instituted travel restrictions and remote working protocols some weeks ago, ahead of the stay at home order issued as of March 21st by our governor, Illinois which remains in effect for at least April 7th.Fortunately, before the escalation of the pandemic, we have taken steps to accelerate shipping to the US of our investigational TAD [ph] products to facilitate uninterrupted supply for our studies. We will continue to track any potential effects of an extended disruption, but we feel comfortable about where we are with regard to supply at the present time.We are also fortunate to have a very healthy balance sheet and strong cash position. In January, we completed a common stock offering, adding net proceeds of approximately $33 million to our already strong cash balance. The financing included the participation of multiple existing investors. And importantly we were pleased to have the support of a number of new, quality health care dedicated investors as well.Including that financing, we expect our current cash will provide us with financial runway into 2022. We hope that runway will enable multiple clinical data readouts and we anticipate that it can under a number of different scenarios. But ultimately of course we expect to provide updated guidance with regards to the timing of our clinical data results, following the resumption of our studies.I will now turn the call over to Ashish to review our fourth quarter and year end financial results.

[Ashish Khanna:]

Thank you, Norbert. Beginning with the balance sheet, we ended the fourth quarter with $98.8 million in cash and cash equivalents, compared to $150.6 million at the end of 2018. As Norbert noted, we expect our current cash, including the $33 million in net proceeds from the common stock offering in January 2020 should enable Aptinyx to fund operations through this year, through next year and into 2022.With respect to our income statement, revenues were $0.9 million and $3.7 million for the fourth quarter and full year 2019 respectively, as compared to $1 million and $6.6 million for the same period in 2018.Our revenues are related to our research collaboration with Allergan which we expect to come to its contractual conclusion this year. Importantly, we are not reliant on these revenues to fund our operations.The majority of our spend remains heavily concentrated in research and development. R&D expenses totaled $10.6 million and $44.3 million for the fourth quarter and full year 2019 respectively, as compared to $10.9 million and $48.8 million for the same period in 2018. The decrease in R&D expenses during 2019 was primarily driven by a reduction in product and clinical development spend related to NYX-295.We reported G&A expenses of $4.5 million and $19 million for the fourth quarter and full year 2019 respectively, as compared to $4.8 million and 12.7 million for the same period in 2018. This increase in spend from 2018 to 2019 is primarily driven by costs related to employee compensation, including $4.1 million in non-cash stock compensation expense, as well as professional fees to support ongoing business operations.Finally, we reported a net loss of $13.8 million for the fourth quarter 2019 compared to a net loss of $14.1 million for the same period in 2018. For the full year 2019, net loss was $57.4 million, compared to a net loss $53.3 million for 2018.I'll now turn the call back over to Norbert.

[Norbert Riedel:]

Thanks, Ashish. Before we begin taking questions, I would like to convey our sincere sympathy to those deeply and personally affected by COVID-19. Further, I want to reiterate that we are doing everything we can to mitigate the pandemic effects on our business.Despite the temporary pauses to enrollment being implemented in three of our four ongoing Phase 2 studies, we continue to be very optimistic about the potential our product candidates have to meaningfully help patients with chronic pain, posttraumatic stress disorder and cognitive impairment.This is certainly a challenging time for all of us. But I have great confidence in the capabilities, resilience and commitment of our team and our ability to persist in our mission to bring these important potential new therapeutic options to patients. Operator, we are now ready for questions.

[Operator:]

Thank you. [Operator Instructions] Our first question comes from Marc Goodman of SVB Leerink. Your line is open.

[Marc Goodman:]

Yes. Hey, guys. Couple of questions. First, can you give us a sense of just the past couple of weeks in the new normal how enrollment was going in the PTSD trial? Obviously, it sounds like you still need another 30 odd patients or whatever, so we're just trying to figure out when you think - you know your best guess is that that study will be finishing up?And then second of all, another company Axsome licensed in a Pfizer product for fibromyalgia, reboxetine, I was curious what you know about the product and what you think about it as a potential competitor to your product? Thank you.

[Norbert Riedel:]

Okay. Mark, as always, thanks for your question. I'm going to have Andy, our COO as well as Catherine address your question on how has it been going in the past couple of weeks with respect to PTSD and have it kicked off by Andy.

[Andy Kidd:]

Yeah. Thanks, Mark. So obviously we're keeping a very close eye on the progress of the study at the site level, not just enrollment, but obviously Norbert alluded to patient visits and trying to make accommodations where we can.You know, we've still seen I think reasonably good progress recently in PTSD. But it's sort of a day by day, week by week situation as you can appreciate. So it's just really hard to make predictions about how long the rest of enrollment is going to take at this point. But I can't say that there has been progress in the last two weeks and for what it's worth we have found that encouraging.

[Norbert Riedel:]

Catherine, anything you want to add to that.

[Catherine King:]

No, I think that covers it well. Thank you.

[Norbert Riedel:]

Okay. Sorry Mark, did you have a follow up to that.

[Marc Goodman:]

No, no. That's good. And then the other question.

[Norbert Riedel:]

Yes, the other question was on Axsome in licensing in [indiscernible] I'm going to have Ashish go give you an answer to that.

[Ashish Khanna:]

Yeah. Hi, Mark. Thanks for the question. Yeah, as reboxetine [ph] as you know is a serotonin-norepinephrine reuptake inhibitor. It's pretty much like duloxetine in that regard, which antidepressant [ph] activity and also a therapy for patients with fibromyalgia.You know, I think - I think that we look at the space of fibromyalgia as a space of major unmet need and those patients need additional therapeutic options to address the significant symptoms and life affecting effects of that disorder, so we welcome progress and root for progress across all the various domains. It's a very different mechanism of action target than what we're working on. They have complementary effects. And so we're eager to see its progress forward and help patients.

[Marc Goodman:]

Excellent.

[Operator:]

Thank you. Our next question is from Charles Duncan of Cantor Fitzgerald. Your line is open.

[Charles Duncan:]

Hi, guys. Thanks for taking our questions. Hopefully you can hear me well, I'm not sure how we're connected. Good. I wanted to ask you a question on the PTSD program and what you talked about on the prepared remarks. I think that you said it was about 80% or so enrolled and I guess I'm wondering if you had to stop that enrollment now, what do you think about the powering assumptions or the ability to demonstrate an effect size and it's - that studies ability that inform next steps?

[Norbert Riedel:]

Terrific. Thanks, Charles. So first of all as we have mentioned in the past, the PTSD study is our first inpatient study and the goal here really is to find a signal that guides us out to a next study thereafter. So it isn't really a study powered for statistical significance, its signal finding exploratory study.Having said that, I think our goal is to do as much as we can to get as close as possible to the enrollment numbers that we had communicated for the study to be approximately 150 patients when it's all said and done. That continues to be our goal. If for some reason that becomes difficult or impossible to do, then I think we will look at what can be and what can be not potentially conclude from this study at that stage of completion. But let us get there when that becomes necessary because at this point our goal continues to achieve ideally complete enrollment in that study.

[Charles Duncan:]

That's helpful, Norbert. But I guess, I assume that you're thinking about different statistical analysis plans and things that you would do to replace or deal with missing data or patients?

[Norbert Riedel:]

Yeah, of course, right. And it has to do with missing data patients. It has to do with maybe increasing dropout rates, depending on how things go. And so of course in close dialogue with our clinical team, our statisticians and ultimately, if necessary, with the agency we will see if and how that data needs to be treated differently.We are of course monitoring and recording that meticulously so that any deviation from the initial plan is kept up properly and becomes part of how we look at the data.

[Charles Duncan:]

Okay. But you believe that towards the end of the year or consistent with your previous timing we'll be able to glean some takeaways from that data and consider going forward?

[Norbert Riedel:]

Look, I answered that by saying that is really much the hope we have, with the fluidity that we are currently experience with COVID-19, I don't think I can go as far as to be definitive about that, but certainly it continues to be our goal.

[Charles Duncan:]

Yeah, that's fair. Everyone has very similar challenges. Let me ask a follow up question perhaps to Ashish. When you consider the changes with regard to 2925 and 458, I believe that you had guided to having cash into 2022 and I guess could you provide us a little bit more granularity on that cash guidance if those two programs were to be stop say for a year, what would that do to the balances, cash balances?

[Ashish Khanna:]

Yeah. So it's no surprise that the bulk of our spend is on R&D and then on ongoing clinical studies in particular and those two pain studies, chronic pain studies are our largest ongoing studies. As enrollment of those studies is paused, it's reasonable to expect that our spend will be reduced for a period of time.We'll continue to guide that our cash should get us into 2022. As to deciding how far into 2022 or giving any updated guidance, I think we will provide that as appropriate and when we know more about what the impact – and during that impact is on these studies and then seek to give guidance on the anticipated timing of read out for those studies once we have a sense, once they've restarted enrolling patients. Really at this point it's probably too difficult to far me to tell.

[Charles Duncan:]

Got it. Okay, that's helpful. I appreciate the color Ashish and Norbert, good luck. Thank you.

[Norbert Riedel:]

Thank you, Charles.

[Ashish Khanna:]

Thank you.

[Operator:]

Thank you. Our next question comes from Laura Chico of Wedbush Securities. Your line is open.

[Laura Chico:]

Hi, good afternoon. And thanks for taking the questions. I guess one on 783 and I think you've kind of talked to this already, but if you could just kind of maybe clarify one on, what was your assumption around discontinuation or dropouts for the study?And then two, just given the patient demographic here, how are you thinking about the heterogeneity, I guess of the unfolding situation here and kind of the impact on the variability in the 783 study?

[Norbert Riedel:]

Okay. Laura, thank you so much for the question. Catherine, do you want to kick off with an answer?

[Catherine King:]

Yes. Thank you. So I think in terms of dropout leading - in the time leading up to the issues with COVID-19, we were tracking pretty well toward plan in terms of dropout. I think we're watching that very carefully as the situation unfolds and we are working with individual sites to address individual situations where we can to support continued participation in the trial in ways that make sense.With respect to heterogeneity and variability, I think what we're doing is making every effort to document both in our files, but also in our electronic dataset the ways that different measurements might be taken during this time, be there variations in time or variations in method, so that we can factor that into our analysis in the event that it becomes important. So again, I think it's careful attention to the details, careful documentation and then making sure that we've got the ability to factor those into the analysis going forward.

[Laura Chico:]

Okay. Thank you. And then I guess one quick follow up if I may. Then what kind of signal are you looking for before you would restart enrollment? Is this just purely related to the site availability, maybe shelter in place orders, a confluence of multiple things? But I guess when - what would you need to see in order to restart enrollment?

[Norbert Riedel:]

Catherine, I think you can tackle that too.

[Catherine King:]

Sure. Yeah. I think many of the factors you have described right, the ability of site staff to go to work, the ability of patients to attend visit, the willingness to leave the home and a feeling of security and doing so. I also think just getting things back to normal in the rest of everyday life is going to be a big factor to our ability to restart.We do intend to use this time and pause to position ourselves well for a restart. So as we monitor conditions both in the clinical trial world and in the broader world, as we consider geographic differences in terms of the times that different locales may be able to get back to work, we'll take that all into account and to make those choices. But again close communication and monitoring as we see the situation develop.

[Laura Chico:]

Thanks very much, guys. Good luck.

[Norbert Riedel:]

Thank you, Laura.

[Catherine King:]

Thank you.

[Operator:]

Thank you. Our next question comes from Ritu Baral of Cowen. Your line is open.

[Unidentified Analyst:]

Hi, guys. This is Lyla. Thanks for taking the question. My question is on 295 and I was wondering if you could provide a little more granularity on how enrollment was progressing prior to suspending the trial. Have you seen any increases in dropouts for the patients that were already enrolled, meaning what [ph] to COVID? Thank you.

[Norbert Riedel:]

Okay, great. So you know of course that these studies started late last year and as I mentioned in my prepared remarks the sites are up and running and we are screening. I think it is not easy to give you a sense of has it significantly changed. It clearly has just like the other studies impacted sites and has had [ph] therefore, a resulting impact on the number of patients. But overall I think the study is a little early on, I don't have as good a measure on that as we - for example we have on the PTSD study.

[Unidentified Analyst:]

Got you. And then if you don't mind if I just follow up. You briefly mentioned the supply, that you're increasing your supply…

[Norbert Riedel:]

Yes…

[Unidentified Analyst:]

To meet the needs, do you currently – given that the trial is suspended right now, do you currently have enough supplies for 925 to meet what you would eventually need if you were to complete the trial?

[Norbert Riedel:]

Yeah, great question. I was rather brief in my prepared remarks, but I'm going to have Andy elaborate a little more on that because we have really paid a lot of attention to making sure we don't have any disruptions in supplies. And so I hand it over to Andy to add further on to.

[Andy Kidd:]

Yeah. Thanks, Norbert. Yeah, so we actually have sufficient supply for all four of our studies investigational product and placebo are already manufactured and in the US. So you know it's Norbert point as you all know, we do use contract manufacturing organizations outside the U.S. We were quite proactive I think in manufacturing supply ahead of time and then when this situation started building in February we just made sure everything was shipped over to the U.S. just in case. Obviously the situation unfolded as unfortunately it has.So yeah we have we have all the materials we need, for the most part they're packaged and ready to go, some are still to be packaged, but that's all done in the U.S. a fairly short lead time. So we're very comfortable.In the case of a very long delay, which at this point I don't think we envisage of course we would have issues with shelf life and things like that. But I think with reasonable scenarios that are being discussed externally we feel comfortable that we have the supply we need.

[Unidentified Analyst:]

Okay, great. Thank you. That's very helpful.

[Andy Kidd:]

Thank you.

[Operator:]

Thank you. Our next question comes from Gary Nachman of BMO Capital Markets. Your line is open.

[Gary Nachman:]

Hi, guys. Good afternoon and hope you're staying safe and healthy during this pandemic. Just back to 2925, can you potentially reduce the overall size of the studies from what you previously targeted if you need to do that? And when you resume enrollment, does it not change the statistical analysis in any way, even if there's a long delay? And is DPN even more challenging than fibro, if diabetic patients could be compromised with COVID-19 just in terms of having that additional risk factor?

[Norbert Riedel:]

Okay. So I think we're going to do that in a team effort. Yeah, I kick it off by - first of all Gary thanks for the questions. As we have actually shared with you on several occasions the current Phase 2b studies in DPN and fibromyalgia are built on the information we obtained in the previous Phase 2 studies we conducted and we have powered them to achieve statistical significance on what is a clinically meaningful endpoint in these studies.And so I cannot see at this point that we would reduce the size of this study because the fundamentals of the goal of what we want to accomplish here have not changed. It might have become a little bit more complicated in the ultimate analysis of the data, but I do not foresee at this point that we will change the study per see in the size of the study as a result of COVID-19. Who wants to tackle the next one? Is it harder?

[Andy Kidd:]

Yeah, with the DPN population, yeah, I mean, I think that's certainly a concern is that you know, the diabetes is believed to be a risk factor I guess as more data comes in we'll learn more about how much that's the case and whether diabetic patients need to take additional precautions and so clearly yes, as compared with fibromyalgia which is not a known risk factor it could be that there is an ability to restart the fiber study ahead of the DPN study, I think we'll just have to keep an eye on how things evolve in general and you know as life gets back to normal you know what are additional steps that are still needed for people in vulnerable populations which of course we don't yet know.

[Gary Nachman:]

Okay. And I guess whether it's with 783 or 2925, what's an allowable period for starting re-enrollment in studies that you stop, for the study and data to remain viable? Is there any sort of time frame on that? I know, I mean everyone's going through it across the industry. I'm just curious you know if it's weeks versus months versus a year like is there a period that that you think is allowed as part of these studies?

[Andy Kidd:]

I think a lot of this will depend on the - you know the general experience across the industry. I think the FDA guidance and the EMEA guidance have come out of generally, taken the view that you know these are very unprecedented times. And you know there isn't a clear playbook and it's a lot of things are case by case.You know, and so I think that the extent to which some of these unusual situations are kind of tolerated in a way that they might not normally be within a study is something that we just don't yet know. But I think we were encouraged that the guidance seemed to suggest there was going to be significant flexibility and we would read that as tolerating or allowing for partisan enrollment that may not normally occur within a study and accommodating those.You know these studies are not designed as registration studies. So ultimately a lot of that will probably be within our own control to determine in consultation with the right experts.

[Gary Nachman:]

Okay. And then last question are there any overlapping sites across the studies whether it's DPN and fibro or PTSD or you know I'm assuming Parkinson's is going to be maybe different sites. But you know, so there are certain sites that come on board sooner or are there certain studies that you might be able to restart sooner than others across the board?

[Norbert Riedel:]

Thank you. Catherine, could you take that.

[Catherine King:]

Yeah. There is some overlap in terms of the sites, but I think the driving factor is going to be the ability of those sites to do work and an assessment of care for the well-being and welfare of patients who may be enrolled.So I think we've had a really good discussion here today about the differences in terms of patients with Parkinson's patients with DPN and we'll factor that into the decisions in terms of when we'll get started to.

[Gary Nachman:]

Okay. Thanks, guys.

[Catherine King:]

Thank you.

[Operator:]

Thank you. [Operator Instructions] Our next question comes from Jessica Farr of JPMorgan. Your line is open.

[Unidentified Analyst:]

Hi. This is Yuko on the call for Jessica. Thank you for taking our questions. In the PR, you mentioned certain measures we're taking to support continuity of patients enrolled in the 2925 clinical studies could you elaborate on what the specific measures are?And then following up on the question asked earlier in the call, could you help us think about the quarterly R&D spend following temporary suspension of the new patient enrollment in the 2925 and 458 studies? Thank you.

[Norbert Riedel:]

Catherine, I am going to have you answer the question. Yuko, you asked related to 2925 or was it to 783?

[Unidentified Analyst:]

Its 2925.

[Norbert Riedel:]

Okay. Catherine, can you take that please?

[Catherine King:]

Yeah, I think let me answer it kind of broadly and generally for all the patients who will continue in our studies during this time, we're working carefully with individual sites, the investigators and their staff to address local concerns and local constraints and also to comply with operating procedures required by their institutions and their clinics.And so some types of things that we might employ could be delivery of study drugs, could be changing and the timing of visits to ensure that there aren't contact with a large number of people in a waiting room or something like that.We also may allow some remote visits where that is appropriate for the design of the study and the sort of data that's being measured. But again we're customizing those to the individual challenges that both sites and patients are facing and trying to be sure that we respond to those needs unique clearly and specifically. Norbert, back to you.

[Ashish Khanna:]

Hi, Yuko. This is =Ashish. With regard to spend projections you know, again I think that we have been guiding toward the durability of our cash which we think is quite strong. We talked up the balance sheet with the financing in early January that serves us well and continues to serve as well as we look at cash under a number of different scenarios that you can imagine that we've modeled out with regard to how long this pandemic impacts our enrollment efforts across these studies in and we're quite confident across those scenarios that the cash that we have gets us into 2022 whether that's well into 2022 or even all the way through it really has to be determined as we understand the path out of the pauses.In the meantime we would expect reduced spend on R&D as that R&D spend is largely tied to enrollment of patient studies which of course paused temporarily at the moment, so we would expect a reduction in that for the duration of the pause and possibly even for a period as we're restarting up that enrollment.

[Unidentified Analyst:]

Thank you.

[Operator:]

Thank you. I'm showing no further questions at this time. I turn the call back over to Norbert for any closing remarks.

[Norbert Riedel:]

Thank you, operator. And to thank all for your questions and for being on the call. We look forward to communicating further updates to you as they become available. We appreciate your time and your attention and in particular under these circumstances please stay safe, be well and enjoy the rest of your day.

[Operator:]

Thank you for joining us today. You may now disconnect.+