Q4 2019 Earnings Call
Ladies and down today, probably going to begin shortly you continue to say goodbye. Thank you for your patience.
[music].
Good afternoon weapons that after next fourth quarter, and your and 22 financial results Conference call.
I guess, some all participants will listen only mode.
Following the formal remarks, well open up the call for questions.
Please note today's call this quarter.
The copies request at this time, let's turn the call them to this Smith your director of corporate development at Investor Relations Absolutely. Nick. Please proceed.
Thank you very good afternoon, everyone and thanks for joining us on todays conference call to discuss after next this fourth quarter and year end 2019 financial and operating results.
Andrew results in company updates press releases now available on our website today, our coal Robert Riedl, Our President and Chief Executive Officer review, our business in clinical progress and she's gone up our Chief Financial Officer, and Chief Business Officer will review the financial results.
In addition, Andy Kid, our Chief operating Officer, Katherine King, our senior Vice President of clinical development, or where that's where the Q and 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 the meaning of the private Securities Litigation Reform Act of 1995, which involve risks and uncertainties that can cause actual results could differ materially.
Forward looking statements were made only as of today, 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 and the company's current and subsequent filings with the FCC.
It's now my pleasure to turn the call over to Norbert.
Thank you Nick and good afternoon, everyone. We appreciate you joining us on our call today.
Actually doing these extra ordinarily intelligent sorry.
Recent events related to the ongoing called is 19 endemic have traded it significantly up on certain t. onto world.
And within our industry.
Against that picked up we think it is really important cost to communicate to our children.
Oh, that's we have made across all pipeline program and.
Also to provide you with an update on the impact corporate 19 is having on not walk isn't it specifically.
Before getting into those impacts I'd like to leave you with a significant progress we've made in 2019.
Yeah. It was marked by normal its critical milestones and speed lensless execution by our team.
In support of all mission developing novel therapies for patients suffering from challenging CNS disorders.
At the outset luckier, we set ambitious clinical development goes.
I tend to the old advancing obviously off or can it get stage product candidate.
Two new phase two study.
Thanks to the Cherry pick up football team.
We accomplish those goals and initiated for phase two studies last year.
These studies will evaluate and characterize the ability of our novel compounds.
To address significant unmet needs in D. I think that's up chronic pain.
P.S.P. and called the different pm.
I am very quote everything that seems accomplish throughout the year to achieve that's development.
It's also important to note that we have continued all momentum into 2020.
Happy, making good progress across each of our studies.
Of course, we like many clawed our way into sleep.
Peeling thing some challenges introduced by the corporate 19 endemic and in light of these challenges we have made certain decisions regarding our clinical development activities.
Let's start with an update and why it's 70 suite.
Oh I saw the off that compound in Pts he is focused along.
In 2019.
We began evaluating and why except in Italy in an initial exploratory phase two study in patients with P.S. Steve.
This study in approximately 150 patients.
It's intended to evaluate for the first time the effects of the unique and novel mechanism up into like 73.
All the way of symptoms experienced by people with P.S.C.
To date.
We have achieved approximately 80% of our targeted woman and.
My old mentally enrollment in this study has people quite thing and thinking well.
Well, they're asking someone gets options at this high level all done by the Cobot 19 pandemic.
So far we have been able to manage intermediate.
We are working with our investigator sites to develop appropriate accommodations to support patient continuity.
Such as home to anybody else I did talk.
And that's what participant follow up.
Where these I'll be quiet and feasible.
Given trouble specific needs of patients with kids ski.
We feel it isn't the includes don't patient welfare to continue enrollment into study at this time.
And we appreciate the perseverance and dedication.
Oh investigator insights.
To keep moving to study for what.
We continue to bring on new patients into this study and we'll make every effort to do so as long as it remains what's possible and feasible.
We will remain vigilant in our continuous evaluation of the impact of corporate much into the study.
Including primarily focus on patient safety and well being.
Close dialogue with all its sites and Seattle.
Given the ongoing on talking to your own Covance nine chicken.
We anticipate providing updated guidance on the expected timing of completion entity, we thought of data.
From this study of the future date.
Now, let's discuss in why extra nine to five.
But you didn't phase two clinical development into chronic pain indication.
Painful diabetic peripheral neuropathy and probably mileage.
In 2019.
So first phase two studies in patients with these conditions.
Oh, hi, studying problem Alger evaluates the it picked up and why it's to not to five on validated nuclear imaging Biomark has sent clipping processing.
We saw that's 29 to five we thought it didn't statistically significant changes in these biomarkers.
That piece Biomark effects.
We are culminated with good it can be meaningful and statistically significant improvement in pain and other problem al just didnt.
Alongside.
No I thought you will find ways to not to fight in patients is painful DPN.
The comparing second is a pain reduction we saw in that study.
Okay, and formed dose selection patient inclusion and exclusion criteria and other design cut on the times for our Calvin studies in chronic pain.
Which are aimed at validating PC.
Together. These initial studies have provided tremendous the important information on anybody actually like to fight.
It gets into the Blaine and enhances and indeed accepted mediated pathways.
It's activity as fast as abnormalities in central Penn processing.
Can be observed objectively <unk> MACI.
Right that activity translates into compelling 16 goes up symptom improvement.
In patients who have experienced paying clinically.
Based on these first phase two studies.
In late 2019.
We initiated two follow up phase to be studies.
Well I mean painful TPN.
And one in trouble manager.
Leveraging both most learned in the initial studies and intended to value that the effects we observed in dose study.
Both studies are designed to evaluate the safety and efficacy.
He likes to nine to five all by itself week period.
We completed all off the startup work insights have been actively screening and enrolling patients in these studies.
However.
In light of challenges to screening and enrollment caused by the coldest 19 pandemic.
On March 27.
We temporarily suspended the enormity of new patients into both of these stuff.
Importantly.
Patients that have already in the whole it may continue in these studies.
The order cold and in accordance with the guidelines set forth by the F. D N C D C.
Ducting fitting it could study.
We will continue to Monty talked this situation very closely.
Maintain active dialogue with all at sites and you know.
To determine when it is it hopefully gets to be lumen waldman.
He's done.
And we anticipate updating our guidance that won't be expected timing off the topline results from these studies.
Future date, following their comments kind of involvement.
Finally, let's just telco developmental and why it felt like eight.
For the treatment of copies of impairment associated with pocketed Susie.
Yes, we recently published in the journal movement disorder.
We saw a remarkable besides withstand weiss for Fibrate.
Yeah, Hi, rehabilitated and funds tradable model in non human primate.
Showing striking and deliberately bonuses of corporate its deficit.
Based on those data, we've got very excited attendances yardstick.
To initiate our first study up and why it's four or five eight in patients with Parkinson's mild cognitive impairment.
At December.
This exploratory phase two study will evaluate the safety and potentially could its benefits.
Okay, and why it's four or five agent parkinsons patients for the first time.
However.
Through the particular risks posed by Corbett 19 through these more buying other patients.
We have decided to suspend the along the Gulf new patients in this study as well.
Despite the suspension of new enrollment.
Those patients who already are involved in this study may continue.
Systems with the protocol and based on medical Guy.
When appropriate.
Got you we initiated our investigational and why it's full flight AIDS in patients with cognitive deficits.
And we look forward to providing updates on our plan.
It's timelines for this call them at a future date.
Yes, we come to the the impact of the Cobiz 19 pandemic on our business.
I wanted to emphasize that why a multiple Texas informed our decision.
On the how best to put secrets each study.
The health and safety all patients.
Off the personnel involved in conducting these studies.
And so far away employees.
Has remained at the forefront Claude how about your valuation.
With regard to haptics employees and operations.
We instituted type of the suites and remote working protocols some weeks ago.
I had up to stay at home order issued as of March 21st.
Hi, all government in Illinois.
Which remains in effect, who at least a concept.
Fortunately.
Before he has collection of depend Debbie.
We have taken steps to accelerate shipping to the U.S.
Oh, I investigation to talk products to facilitate uninterrupted supply.
I'll, let studies.
We will continue to take any potentially affect over an extended disruption.
But we feel comfortable about where we always think got 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.
Oh, he's talking cash balance.
The financing includes it's the participation of multiple existing investors and importantly.
We were pleased to have to support of a number of Newell quality health care dedicated investors as well.
Including debt financing.
We expect our Calvin cash will provide us with financial runway into 2022.
We hope that one will be the neighborhood might have boots indigo did though he's out.
And we anticipate that it can.
On a number of sequencing alley.
Well I typically off course, we expect to provide updated guidance.
With regard to the timing of I'll call Clinica de though he's out.
Following because I'm snowfall this study.
I'll now turn the call over to watch fish to leave your fourth quarter and he and financial results.
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 noted.
We expect our current cash including $33 million in net proceeds from the common stock offering in January 2020.
Should enable after next to fund operations through this year through next year and into Twentytwenty too.
With respect to our income statement revenues were zero point $9 million and $3.7 million for the fourth quarter and full year 2019, respectively.
As compared to $1 million.
$6.6 million for the same periods 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 from the fourth quarter and full year 2019, respectively.
As compared to $10.9 million and $48.8 million for the same period than 2018.
The decrease in R&D expenses. During 2019 was primarily driven by reduction in product and clinical development spend related to N.Y. X two nine to five.
We reported DNA 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 than 2018.
This increase in spend from 2018 2019, it's primarily driven by cost related to employee compensation, including $4.1 million in noncash 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.
The same period in 2018.
For the full year 2019, net loss was $57.4 million.
Compared to a net loss of $53.3 million for 28 King.
I'll now turn the call back over to Norbert.
Thanks Ashish.
Before we begin taking questions I would like to convey our sincerely sympathy.
For those steeply and personally affected by corporate 19.
Hello.
I want you will either they do that we're doing everything we can communicate the pandemics effect on our business.
If I could temporarily pauses toy enrollment being implemented in me I'll follow up for undergoing phase two studies.
We continue to be very optimistic about the potential a product candidate itself.
Meaningfully help patients with chronic pain.
Posttraumatic stress disorder and copies of impairment.
This is certainly a challenging time for all of us.
I have great confidence into capabilities.
Zillions and commitment of our team.
And our ability to persist in our mission to putting these important potentially new therapeutic options to patients.
All right up we're now ready for questions.
Thank you.
In order to ask a question. Please press star one on your telephone to draw. Your question. Please press the pound.
Please standby will become polished you any losses.
One moment please.
Our first question comes from Mark then that I've asked <unk>. Your line is open.
Yes, Hey, guys couple of questions first.
Can you give us a sense of just past couple of weeks in the new normal how enrollment was going in the P.T.S.G.
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 well be finishing up.
And then second of all another company Exosome licensed in a Pfizer product for for Fibromyalgia Verbosity I was curious what you know about the product and what you think about it as a potential competitive to your problem. Thank you.
Hey, Mark as always thanks for your question I'm going to house Andy.
Oh, I see all way as well as Kathleen that's what's your question on how has it been going in the past couple of weeks with respect to P.T. a steep.
And a habit kicked off plan.
Yeah. Thanks Mark.
So obviously were keeping a very close eye on the progress of the study at the site level or not just enrollment that obviously norbert of it into patients and that and trying to make accommodations wherever we can.
No we still see in I think reasonably good progress recently in P.S.C.
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 say that there has been progress in the last two weeks and for what it's worth we have find that encouraging.
Good Teflon anything you want to add to that.
No I think that covers well thank you.
Okay, sorry, Mark that you have a follow up to that.
No no that's good and then the other question.
Yes, you have a crystal was an excellent in licensing in ethanol I I'm, calling alpha she deal with answer to that.
Yeah, Hi, Mark Thanks for the question, Yeah, I had robots. It seems you know as the parents are not serotonin nor up enough friend, we I think inhibitor.
Pretty much like the lots of seen in that regard, which has a anti depressant activity and also a is a therapy for patients with five in my Alger.
I think I think that or we look.
At the space, a fibromyalgia asurespace major unmet need and those patients need.
Additional therapeutic options to address the significant symptoms and a lot affecting effects of that just one or should we welcome a progress and moved from progress across Oh, all the various domains. It's a very different mechanism of action targets than what were we.
Working on a may have complimentary affects and and and so Oh, where are you going to see its progress forward and ER and how patients.
Thanks.
Thank you. Our next question from Charles Duncan of Cantor Fitzgerald. Your line is open.
Hi, guys. Thanks for taking our questions. Hopefully you can hear me well I'm not sure how working out Capex [laughter]. Good I wanted to ask his question on the P.T.S. de 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 he had to stop that enrollment now what do you think about the powering assumptions or the ability to demonstrate in effect size.
And it's a that's studies ability to inform next steps.
Terrific. Thanks, Charles So first of all the SBLF mentioned in the past. The P.T.S.P. study is our first inpatient study and the goal here really is to find it signals.
That's a guides us out too and Nick studies that often so it isn't really a study power for statistical significance, It's a 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 have communicated for this study to be approximately auditing 50 patients when it's all said and done.
That continues to be all goal if for some reason that becomes difficult or impossible to do.
And 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 they are and then that becomes necessary because at this point I'll call. It continues to achieve ideally complete enrollment in that stuff.
That's helpful Norbert, but I I guess I assume that you're thinking about different statistical analysis plans and things that you would do.
To replace or or deal with I'm missing data or occasions.
Oh, Yeah of course fights and.
It has to do was missing data patients that have to deal with great maybe increasing top outweighed depending on how things go and so of course in close dialogue with all our clinical chemo statisticians and ultimately isn't necessarily see agency, we won't see if and how is that stayed up needs to be treated differently.
We all costs money towing and will be calling that's meticulously so that any deviation pumping from the initial plan is kept up properly and becomes part of hope you look at the data.
Okay, but you you believe that towards the end of the year or consistent with your previous timing will be able to glean some take lease from their data and consider going forward.
But look I answer that buy things that is very much hope we have.
With the flu agencies that you're killing T X fuel begins with <unk> 19, I don't think I couldn't go it's five definitive about that but certainly it continues to be all goes.
Yeah. That's there everyone has a very similar challenges let me ask a follow up question, perhaps to Ashish.
When when you consider that changes with regard to nine to five and four or five to eight I believe that you had guided to having cash into 2022, and and I guess could you provide us a little bit more granularity on on that cash.
Guidance. It's it's those two programs were to be stopped say for a year well, but that's what would that due to the balances cash balances.
Yeah. So it's no surprise that the bulk of our span.
Is on R&D and an ongoing clinical studies in particular and those two pain studies chronic pain studies are our largest ongoing studies as enrollment of those studies. This 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 twentytwenty to.
As the deciding how far into twentytwenty, two or giving any updated guidance I think we will provide that as appropriate and when we know more about a what the impact is how how 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 have restarted.
Enrolling patients are really at this point, it's probably too difficult a two foggy to tell.
Got it Okay. That's helpful. I appreciate the color Ashish and Norbert good luck.
Thank you. Thank you Charles Thanks, you.
Thank you.
Next question comes from Larche go of Wedbush Securities Your line somewhere.
Hi, good afternoon, and thanks for taking the questions I guess, one on 783 and I I think you kinda talk to this already but if you could just kind of.
Maybe clarify one on what was your assumption around Discontinuations are dropouts for the study and then two I'm just given the patient demographic here. How are you thinking about the heterogeneity I guess of the unfolding situation here and I'm kind of the impact on the variability in the seven.
83 study.
Okay.
Thank you so much for the question.
I couldn't do you want to kick it off food was an answer.
Yeah. Thank you.
I think in terms of drop out a leading in the time, leading up to the issues with coated 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 makes sense.
With respect to respect I had 200 and variability I think what we're doing is making every effort to document both in our files that also in our electronic data set the ways that different measurements might be taken during this time be they variations in time or variations and nothing.
So that we can factor that into our analysis and me and I said it becomes important so again I think its 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.
Okay. Thank you and then I guess, one quick follow up if I may then.
What kinda 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.
Jeff and I think you can take a bit.
Sure Yeah, I think many of the factors you've described right the ability of site staff to go to work the ability of patients to attend visits a the willingness to leave the home and a feeling a security and in doing so I also think just getting things back to normal and the rest of everyday life is gonna be a big factor to our ability to reach.
Starts Oh, we do intend to use this time in pause to position ourselves well for restarts unless we monitor conditions boasting the clinical trial, we're all going in the broader world unless we consider geographic differences in terms at the time that different locales, maybe able to get back to work well take that all into account doesn't make those choices, but again.
Close communication and monitoring as we see the situation develops.
Thanks, very much guys. Good luck.
Thank you.
Thank you. Our next question from some Ritu Baral kaleo on both sides.
Oh, Hi, this is why laundry coupon taking my question my.
My question on to 95 Muslim women.
A little more granularity on how awful less aggressive buyers to suspending the trial have you seen any increases in dropouts, Samsung I read one both meaning what the colvin. Thanks.
Okay great.
Hey, too.
So do you know of cost at the study started.
Late last year.
And as I mentioned in my prepared remarks.
The sites up and running and we have screening I think it it's not easy to give you said himself has been significantly changed.
Really has just like the other studies impacted sites in house had to pay up for it was I think impact on.
Number of patients, but overall it.
Since the studies they literally on a going happen as good a mess on bad to ask before example have wanted to keep you see study.
And then my follow up so you.
You mentioned, while you don't see things like yeah neat need on do you currently you get another child ascended right now do you currently have not five Tonight decides to me.
What you would eventually need if you have something to trial.
Yeah. Good quite quick question I'd much rather leap in my prepared remarks, but I'm gonna have Andy.
I Love all they do a little more that's because we have we depend a lot of attention to making sure. We don't have any disruptions in.
Supplies, so a hint at all but you shouldn't be too it's going to yeah. Thanks, Norbert yeah. So we actually have.
Sufficient supply for all four of our studies investigational product and placebo already manufactured and in the U.S.. So you're not Norbert point as you. All know we we do use contract manufacturing organizations outside the U.S., we weren't quite proud.
Active I think and and manufacturing supply. The ahead of time and then when this situation started building in February we just made sure everything was shipped over to the U.S. I'm just in case.
Obviously the situation unfolds I was unfortunately it has.
So so yeah, we have we have all materials, we need for the most part there package and ready to go some are still to be package, but that's all done in the U.S. fairly short lead times. So we're very comfortable indicates 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.
Disgusting externally, we feel comfortable we have the supply we need.
Thank you that's very helpful.
Thank you.
Thank you. Our next question crossing Gary Nachman I'd be ammo capital markets. Your line is open.
Hi, guys, good afternoon, and hope, you're saying safe and healthy during this pandemic just back to two nine to five 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 anyway, even if there's a long delay and is DPN, even more challenging than fibrocell, it's diabetic patients could be compromise with cope with 19, just in terms of having that additional.
Risk factor.
Okay. So I think we're going to do that.
Any team effort, yeah, I kick it off by somewhat Gary Thanks for the questions.
Yes, we help actually shared with you.
Everyone Lucasian.
The current phase to be studies in can you pay the top of my Allergan.
Appeal to on the would be information would be obtained in the previous phase two studies we conducted.
And we have how often.
To achieve statistical significance on what is it clinically meaningful and colleagues in these studies and so.
I cannot see at this point that before.
<unk>.
Besides off the studies because the fundamental itself the goal of what people want to accomplish here have not changed if my guess become a little bit more complicated didn't commit and that was is off the data, but I do not foresee at this point that people would change the study per se.
Besides just the study as a at least does though corporate Tonight.
He wants to take over the next one.
Well just.
So it's hard to yeah, what's the DPN population, yeah, I mean, I think that's certainly a a concern is that a you know the diabetes is believed to be a risk factor I guess is more data comes in we'll learn more about about how much that's the case and.
And whether a diabetic patients need to take additional precautions and so clearly, yes as compared to fibromyalgia, which is not unknown risk factor I mean could be that there is and ability to restart the fiber study I had to be on study I think we'll just have to keep an eye on high things evolve in general and you know as as as life gets back to normal.
You know watch what what is what our additional steps that are still needed for people and vulnerable populations, which of course, we did we don't yet know.
Okay, and I guess, whether it's with 73 or two nine to five what's in allowable periods for starting Reenrollment and studies that you stop the study and data to remain viable.
Is there any sort of timeframe on that I know I mean everyone's going through it across the industry. I'm. Just curious you know six weeks versus months versus a year like is there a korea that that you think is.
Allowed as part of these studies.
I think a lot of this will depend on the you know the general experience across the industry I think the FDIC guidance and that you have any guidance as I've come out of generally.
Taking a 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 extensive which some of these unusual situations are kind of tolerated in a way than they might not normally be within a study hi, something.
We just don't yet know, but I think we were encouraged that the guidance seem to suggest there was going to be significant flexibility and we would read that as UBS as tolerating or allowing for causes that enrollment that might not normally occur within a study in an accommodating those you know these studies or not.
Designed just registration studies, so ultimately a lot of that will probably be within our our own control to determine in consultation with the right experts.
Okay.
Then just last question is are there any overlapping sites across the studies, whether it's the T.N. and hi, Brad or TST or you know I'm, assuming parkinsons is gonna be maybe different sites, but you know sotera certain sites that come onboard soon or are there certain studies that you might be able to restart.
Sooner than others.
Across the country Yep. Thank you Catherine could you take that.
Yeah. There is some overlap in terms of aside but I think they're driving factor is gonna be the ability of those sites to do work and an assessment of care for though well being and welfare of patients who may be on hold so I think we've had really good discussion here today about the differences in terms of patients for parkinsons patients with DPN.
Well factor that into the decisions in terms of when we get started to.
Okay. Thanks, guys.
Thank you need to get me [noise].
Thank you again, if you like asked the question. Please press Star then one when you touched on telephone.
Our next question Carl Jessica five JV long along so [laughter].
Hi, This is you're going to call for Jessica. Thank you for taking your questions. NPR you mentioned certain measures were taken a support continued ideal patients enrolled in a two nine to five clinical studies could you elaborate on what he's specific measure SAR and then following up on the question asked earlier in the.
Paul to help us think about the quarterly R&D spend falling temporary suspension of the new patient enrollment not to nine to five in four or five eight studies. Thank you.
Catherine I'm going to help you answered the question I I used to your because you can see late it's to do not your fivefold wasn't putting interest definitely.
Ah Tonight.
Okay, Kesten kindred picked up here.
Yeah, I think let me answer it kind of broadly in generally for all the patients who will continue in our studies during this time.
Well working carefully with individual sites or the investigators and their staff to address local concerns and local constraint 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 a delivery of study drug.
I could be changing in 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 Oh, we also may allow some remote business, where that is appropriate for the design of the study and that sort of data that's being measured but again were customizing nose to the individual challenges that both sites and patients are facing and trying to be sure that we were signed it does meet unique <unk> specifically.
No go back in the high.
How do you go this is ashish with regard to spend projections, you know again I think that.
We will we Oh, we have been guiding toward the durability of our cash when she which we think is it's quite strong.
The topped up the balance sheet, a with a financing in early January that serves us well and continues to serve us well as we look at our cash under a number of different scenarios that you can imagine that weve.
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, or we would expect reduced spend on R&D as that R&D spend is largely tied to enrollment up [laughter] studies, which of course paused temporarily at the moment, we would expect a reduction in that for the duration of the pause.
And and possibly even for a period as where are we starting up a that enrollment.
[laughter].
Thank you.
Thank you I'm showing no further questions at this time I know your turn the call back over to normal for any closing remarks.
Thank you operator, and two things Youre for your questions and for being on the call.
We don't hold what you're 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 you well and enjoy the rest of your day.
Thank you for joining US today, you may now disconnect.
[music].