Q1 2020 Earnings Call

Following the formal remarks, well open up the golf for your question. Please get a bicycle is being recorded as a company.

At this time I would like to turned to go over to NEXMET Senior director of corporate development Baxter relationship. After next please proceed.

Thank you operator, good afternoon, everyone and thanks for joining us on todays conference call to discuss after next is first quarter 2020 financial and operating results.

Our press release, describing financial results and recent highlights is now available on our website.

Before we begin I'd like to welcome to research analysts, who recently initiated coverage on the comparing Rob summarize you from H.C. Wainwright at a mild winter from William Blair. We're glad to have you both on the call.

Today, I don't recall Norbert read all our President and Chief Executive Officer will review our business in clinical progress followed by Ashish condo or Chief Financial Officer on Chief Business Officer.

Review the financial results.

Addition, Andy Kid, our Chief operating Officer, and Catherine King, Our senior Vice President of clinical development are with us for the Q and a portion of the cool.

I'd like to remind everyone that statements made during this conference call work with forward looking statements within the meaning of the private Securities Litigation Reform Act of 1995, which involve risks and uncertainties that could cause actual results could differ materially.

Any forward looking statements are made only as of today are we disclaim any obligation to update these forward looking statements.

We see the forward looking statements disclaimer in our financial results release issued this afternoon and the risk factors and the company's Curt and subsequent filings with the FCC.

Now my pleasure to turn the call over to Norbert.

Thank you Nick and good afternoon, everyone.

I appreciate you taking the time to join us on our call today.

We hope you enjoy loved ones all its safe and in good health.

That's what is called that links doing almost between call. It only 45 days ago.

Like so many of us quite the industry, our research and development efforts have been impacted by the cobot 19 condemning.

In addition to the temporary suspension of new patient enrollment in clean.

Oh for ongoing phase two study.

We have made up additional adjustments to ensure the health couldn't say feel for patients.

If the person that involved in conducting always studies.

And all employees.

Yes, I piece necessary interest Pensacola Justin.

I'm very pleased with the adaptability, okay our team.

And importantly, with the recent progress that we estimate.

Let's start with all first choice Kobe scope exploratory study.

And why it seven eight in posttraumatic stress disorder.

We are pleased to have been able to continue your new patient enrollment in this study.

Even doing de escalation of the Cobiz 19 pandemic.

That's true maybe call. It we are targeting an element of approximately 150 patients.

So we have LD with do you have picked up in a way of seven eight we across a wide range of symptoms experienced by people was PTSD.

We have been working closely with all the investigator sites since the old click off the content make two into appears to continue with any of this study and.

Well I didnt necessarily basis, we have to meet certain accommodations for sites and patients.

Touches virtually participant follow up.

Of course.

We are carefully monitoring and recording any deviations from the original ponder close.

To be in that position choice had any impact because endemic might have.

On the data from this study.

We're very encouraged by the continued involvement and we have no achieved over 90% of all the targets.

Accordingly, we intend to complete in the home in the coming week.

And anticipate reporting data in late 2023.

I really called up until that could help us out what's hitting that makes you, especially in light of peace, killing circumstance.

We also maybe think put at that site.

Investigator and patients in this study for that persisted and commitment.

Let's move on to it and why it's two nine to five.

It's in phase two clinical development into chronic pain indication.

Painful diabetic peripheral neuropathy.

And fibromyalgia.

We initiated a phase to be study each of these indications to.

Two validates the positive safety and efficacy signals.

Said, we observed in our pilot phase two studies.

That's you know we make the decision in late March to temporarily suspended p. and all that up new patients in both of these ongoing studies.

We continue to money towards the situation very closely.

And maintain active dialogue with all its height and COO.

To determine the raises a copy it so he's doing a moment.

That's you couldn't imagine we have you got to get these studies, we saw good efficiently as soon as we determined that it is possible.

Entering the best interest of patient safety.

State or quality to do so.

We do provide more guidance on the resumption of these studies into the anticipate its timing of state I think though.

And if you try to date.

Finally, let's talk wondering why its full fibrates for the treatment of cooperative impairment associated with Parkinson's disease.

Due to the particularly post by corporate nine team to this patient population.

We made the decision in late March to suspend the along with the new patients in this study as well.

We're very excited to evaluate the potential talked independents itself in likes for five days.

Jason.

Based on the very compelling because I think nonhuman primate.

However, we are keenly focused on patient safety into killed environment.

I recognize that the delayed imposed on this study.

Maybe more extensive.

We will provide updates on our plans it's timelines for this program.

I do future date.

The course, all studies, we are working poor the necessarily consideration to.

To determine when.

How best.

To efficiently at least thought involvement.

With our top cardio and she's being patient safety.

Instead of quality.

The specific onto the nation's fairly close to studies based on the this effect was post by corporate 19.

Who each patient population.

We're also evaluating study visit and potentially quite evident.

To determine what is most appropriate for each indication in study.

In addition to the expected that vary across all patient population.

We are taking into consideration to specific operating conditions at the site level.

Which varies depending on the type of site in the region.

And how these conditions may affect each sites conducting the study.

We expect that careful attention.

So all of these elements will enable us to resuming walnuts it's constantly.

Overall, I'm very proud of to work our team has gone to make the necessary adjustments.

We continue our forward momentum across all programs.

And importantly.

Our strong financial position enables us to make these decisions.

Without compromising our long term strategic goals.

With that I'll now turn the call all but two ashish till we view all coast Wanna financial results.

Thank you Norbert.

Despite the challenging environment, an impact to our business from corporate 19.

We're running the company officially and we are fortunate to have a strong balance sheet.

Third by our financing in January.

Brought in net proceeds of $33 million.

We anticipate our current cash will support us to fund our operations into Twentytwenty to.

And to deliver read out multiple programs.

For the Q1 numbers, starting with the balance sheet, we ended the first quarter with $121 million into cash and cash equivalents compared.

Compared to $98.8 million at the end of 29 team.

Revenues for the first quarter were zero point $8 million compared to zero point $9 million, the same period and 2018.

These revenues are related to our research collaboration agreement with Alexander.

We expect to come to its contractual conclusion this year.

Importantly, we are not reliant on these revenues to fund our operation.

Before programs in clinical development and a strong research pipeline majority of our stands is focused on research and development.

R&D expenses were $11.1 million for the first quarter.

The last time, the twin than the $12.5 million, an R&D expenses for the same period in 2019.

We do expect R&D expenses decreased during the enrollment suspension period.

For our clinical studies and of course to ramp up again, I had a recommencement of enrollment.

We reported DNA expenses of $4.9 million for the first quarter.

Paired to $5.7 million the same period in 2019.

The decrease in zero point $8 million was primarily driven by a decrease in legal and patent related costs.

Finally, our net loss for the first quarter was $14.7 million compared to a net loss of $16.7 million the same period and 29 here.

With that I'll turn the call back over to more.

[laughter] thing so she.

Before we open the call it up for questions.

I would like to its place so it since you're closer to two all voted in our community.

Who are working tirelessly to limit this put up the cone of either.

And just specialty two boats healthcare workers on the front line.

I would also like to express our appreciation to the patients enrolled in our studies.

It's relative to the clinicians and couldn't it could side cosmos.

Shifting Oscar is ensuring the safety of these patients.

Why do we are undoubtedly faces challenges related to the Cobiz 19 pandemic.

We are confident the steps we have taken to mitigate certain take a study with.

And believes the cash we have on hand can enable multiple important clinical data readouts across all pipeline.

We will be happy to begin taking your questions now.

[laughter].

Alright, ladies and gentlemen, if you know question at this time piece for US. This argument that number one key on your touched on telephone. If your question has been answered are you wish to remove yourself from the Q. Please press the cocky.

My first question comes from a wrong, so soundbars Rogers from H.C. Wainwright. Your line is open.

Thanks very much for taking my question can you hear me.

Yep Somebody's in New York, though.

Okay, Great I, just wanted to personal I'll start off by adopting a little bit. So we're a little bit of additional contextual information around the PTSD trial outlook I was wondering if you could walk us through some of the secondary efficacy outcome measures that are being used in this study and maybe give us a little bit more color on.

Which ones you consider to be most likely to be clinically meaningful assuming you see on effects on them. So for example, you know what I know you're using the PCL five but yes, you why in a couple of other studies you could maybe point us to the ones that you think are most likely to be import.

Okay, well I'm supposed to on a except as a true here you on that on the call.

I appreciate the question asked Nick mentioned at the beginning we have to benefit of having pets in king.

Well it depends on the called as well, so I'm going to engage didn't see India I take it off like Vice affiliate that they do what they said previously they need that the P.S.T. study as you talk the alluded to isn't expected until Weve taken is finding studies that guides further development and therefore your questions I believe I live in question asked to.

What kind of six cents are you looking for and expect to see so I hope that says people fight fight anything to give you a little bit offsetting salveen probably look at that.

Yeah, Thanks, Norbert and thanks, Rob.

It's an interesting question I do think though it's quite difficult to.

Give you a.

Straightforward prioritized less of the efficacy endpoints because you know any study like this we've got very limited in real estate to work when it's in terms of the you know the the patients that the sites and what it's practical to measure and so we don't include endpoints Todd. If we don't think are critically important and so all of the.

Efficacy and safety measures that we've included server.

Totally different purpose, so whatever as you mentioned the PCL five or the other cap five which is our primary endpoints.

The P.S. key why the had a there's a whole range of different endpoints in there.

I think perhaps the way we would look at it as a little different which has that.

As we look across the different things that we're measuring what we're looking for as a pattern of response to the drive a that makes logical sense and so that doesn't mean that anyone endpoints I side, obviously at the primary endpoint. The cap five we think is particularly important step that twice the primary endpoint.

But I think your question was specific to secondary endpoints its more of helping to reinforce a pattern of all the activity that we see I'm not I think that's why clearly a number of domains are covered by those and find some of them are passion reports and some other merkel action reported a and that's more of the way. We're looking at is that there will be a pattern or a pathway if you like through.

What's different measures that together kind of former coherent story about what the drug can do.

Okay. That's very helpful. I was wondering also if you could comment on the development, possibly for PTSD, assuming the phase two data is sufficiently positive to contemplate a moving the drug forward down back.

In particular, what the outlook is for a.

Non dilutive funding from sources that would potentially have an interest in seeing an effective drug for PTSD I'd be if there might potentially be an accelerated router regulatory submission in the syndication given the nature of the unmet medical need.

Okay, all right so to say there's several it's heavily that takes all civilized pops to your question I look I would say that's what we have done in the past.

Is that to engage with the agent.

As we move compounds into clinical development phase one face to face to be.

Indicates okay. If you see our goal is to house the data sets said and he described.

The one that will be a lot because the discussion point with F.D.A. out to a hobby tens and build on the observations in findings. We are making was supposed to take to informing Nick.

Then you could studies that almost be slowing towards topic that is probably its final stages. So that will be very much dialogue is agency and one in which we hope to actually have a degree of fix it didnt see because there has not been in the pool set a P.S.C. in more than 10 years.

He available capital piece, all exercise to treat.

Mentally did your question since himself P.T.I.C., so they said tremendous needs.

And hopefully this is that path forward.

Then mechanism of action that we believe is particularly relevant to Pts these helpful.

And with respect to funding.

She she has actually provided that has picked it multiple times in us, saying that we are typically well funded.

To actually conduct the studies that we plan to do.

In the space, we'll keep you see and parkins and.

We I think how all the capabilities or can easily.

Bill the capabilities to take those all the way who to commercialization.

Right and that would include P.T. as he and in an indication like chronic pain.

Well ultimately we are looking at it pretty men's is tremendous.

Efforts to commercialize it looks like that globally.

I think we understand all limitations and open minded at the right time.

With that I beg your position to consider.

How are we tend to be expedite that to the finish line, but it depends on the compound. It didnt piece you see I think we're very confident that we help you know skills and capabilities to put seapass clinical development on the long for quite some time.

Right. So your next question comes from to line up My assessment there from William Blair. Sir Your line is open.

Oh, hi, everyone, a good year for on choices and thanks for taking the questions just on 793.

I'm wondering whether it'd be the proportion of patients that you expect to sort of responsible shape on stage one of that trial.

Has actually been realized now that you've got 90% or Ivory enrolled and do you expect that lets say you Barbara sponsors to sort of changed during carpet non chain I've, just saying hearing specific clean psychiatry.

Patients might even have rights or access to telemedicine, and sorry patients might be actually having more physician contact and responding better throughout this period, just curious any thoughts there.

Great My very warm welcome to you as Phil it's great to hear your voice.

And well I can draw so call it.

I think I'm going to how Kathleen can call said I'm, sorry, and then followed with Andy for maybe a rounded out a little more Catherine if you could maybe take the first step at this.

Sure. Thanks.

So we are carefully watching the impact of cobot 19 across both operations and result in the PTSD study Oh, we remain blinded. So at this stage I won't comment on the placebo response, there, but I will say that I think we are making sure that we collect data that allows us at the time of the now.

Just to be able to both investigate perhaps descried differences that we might observed related to covert 19, perhaps patients were enrolled during this time versus others. So I think we're well positioned to be able to interpret this data I'm taking into account the impact to covert 19 might have.

Andy Uh Huh.

Yes definitely agree I think mild you can argue lots of different ways, what the impact of covert 19 might be and perhaps so all of Santa Barbara true to some extent for different people and different environments.

And so I think we're really focused on you know trying to complete the study as Norbert mentioned with the right focus on patient safety and doing what we can to ensure data quality and we will we will know eventually.

Many of these theories turn I'd have an impact or not but I think like Catherine side, We're just things already scrupulous about making sure that we collect all the relevant data so that we can interpret it correctly.

The Guy that that's certainly fair then just curious on the 10 in the 50 milligram initial does choices and I predicted to bring the effect you fringe from your preclinical studies.

Equally you'll see a condition ones and then or is it similar to something like the phase two trial its trading onto five in J.P. anyway, we actually saw the hydrogen might be full outside of that therapeutic index. Just wondering what to expect there. Thanks yep. So great. So so re.

[laughter] two pretty even mid 40 killed and fall in how we owe life. It's looking at the lights go it's in a lot at first being patient studies.

And so my this indicates a seven they see it is.

He stated by doing extensive preclinical work.

Thanks, Mezz Blayne exposure in these three I think its animal models.

Correlates with optimal.

Effect sizes or efficacy in the small.

And then be do of course single and multiple ascending dose studies in healthy volunteers in clinical phase one studies.

And as we've seen good pace with every component we have.

We mentioned I see us if you look for spinal fluid has is several good populating exposure.

And then carbonate the levels of pain.

Himself all components.

With the behavioral markets in which we saw the most optimal effect.

With respect to efficacy and he's animal markets and.

That's how we then that's it's if you will the doses we select so they tended to 50 here with collected that way.

They just completely uncorrelated.

It's always says that you had in the DPN study hasn't examples maybe measurements 10 50 into one but because these are independent compound and independent behaviour models, you intend to put indication.

So there is no wheeling guessing for been compared to another each component is solidly itself.

In its own context.

All the way from preclinical phase one two plaintiffs projects he is that.

And even then we actually look at a range to be was in a I think pretty accurately.

Assessment of where we should see human efficacy as well. So that's how it's being supportive for Tonight to fyfe and the pockets of 73 and cultivate as well.

Okay. Thanks to the color I'll hop back into queue.

Thank you Mike.

Next up we have Marc Goodman from actually be Leerink. Your line is open Sir.

Hey, guys. So first question is on the P.T.S.T. study, if you're gonna be finishing up and in the coming weeks enrollment.

Why are you pointing to late.

In the year for the data just given how long. The study was couple of months I just would have figured we we might be able to get it in the third quarter and then second of all can you remind us of the Allegan collaboration interest, where we are and and whats next what we should be expecting thank you.

So.

Let me just kicking off or maybe.

Maybe I didn't kick off the computer question on why does it takes a different or why go right I'll be providing the guidance, providing and then I can touch on the elegant.

Oh gosh, it could touch on the L. again, but yeah no. Thanks. Thanks markets. That's a good question. So just to kind of you know at a high level go through that the timing.

It's it's a it's a nine week process in the study, including a week a follow up you know and then of course, we have to go through the process of cleaning up and checking but they said before we can lock the database and ER we are.

You know were quite I'm focused on making sure that that happens in a robust way and some of that requires interaction with sites and may take a look a little while in this environment to do that we also then of course as you know with the study design and all the different endpoints want to allow enough time to fully analyzed that make sense of the data. So you know I think the ended the year.

There is a reasonable timeline given all of that when you sort of put all all three of those steps together.

And then pay markets Ashish with regard to the allergenic collaboration.

That's a collaboration that started when we first launched the company back in 2015 and a it's a collaboration of joint effort jointly funded effort that has gone very well for both parties I have been quite productive for both parties. It will come to its contractually predetermine.

In conclusion did here and continues to go well on the pathway toward what we expect to be a a straightforward.

Conclusion.

You know the up the close of the Abbvie acquisition of allergy and last week a has not resulted in any deviation from that perspective or expectation on our park I am we're happy to be partnered with or without the new Abbvie high in the same way that we've had been.

And with a dollar again on that collaboration front.

Thanks.

Next question comes from Charles Duncan from Cantor Fitzgerald. Your line is open.

Thank you Robert and team are probably too early for size, but congrats on the progress and the PTSD.

Trial.

Had a couple of questions on the pipeline and then one for Ashish first of all of regarding the 73 study and PTSD you you've done good job there.

Addressing questions regarding you know.

Oh, it the patient quality and what you're doing to.

Keep track of quality event data, but have you seen any geographic changes in terms of enrollment and maybe going back to miles question have you seen increased interest by investigative sites to enroll patients is a is it the case that P T.

Steve maybe on the rights or would you anticipate that to be may be a longer term impact of Kobe 19.

Quick question things trial, its I I'm going to handsets to kept put into what we fly.

Yeah, we did see some differences geographic is one factor, but I think we also see a difference in terms of the type of investigator that we're working with I'm certainly major academic medical centers large hospitals. They are not able to persist doing clinical research in this setting because they have to shift their patient.

Their focus to patient care.

On the other hand community centers that are more focused on research are able to continue operations. During this time and those are the sites that were seeing being able to effectively operate effectively take precautions against covered 19 exposure.

And again provide follow up for patient visits and procedures as they required by the protocol.

So those are the sites that we see that are able to continue operating with respect to interest I think our inclusion exclusion criteria are looking for folks who have a PTSD in their medical history as opposed to new instances.

And so I'm not sure that were necessarily seeing a drive based on call that but we are seeing again the ability of sites you are not encumbered by patient care to be able to continue to do that research at this time.

Maybe not try but Ah I guess increased expression of the symptoms is just what I was wondering maybe maybe go.

Two.

Yeah.

So there is a process in the screening criteria, where we are looking for sort of not flare or not and.

Temporary increase and no symptoms, it's meant to sort of make sure that we've got a good they find that we can measure from so that we can be successful in the trial and those procedures have been in place throughout the trial and continue to be relied on and that's where enrolling patients now.

Very helpful. Catherine and then with regard to next steps I know there might be a couple of of different alternatives, but you know.

[laughter] tried being on and assuming success in that trial.

What kind of timeline could it could it be to turn around a phase three protocol surely you've talked a lot about this could could should meet with the agency maybe in the first quarter could you see a next study be started by mid year next year could do you think that's reasonable.

So so Todd I I think it's.

Probably premature to answer that question.

Because what we typically typically do which we guided by the data would be 10 of AIDS.

As to our plan, which was picked to a next study.

And then how to engage the agency in discussing those plans.

We have found that most helpful to do that truly based on data.

As opposed to speculation, but they did you say.

Do you have Hayes fleet plan.

Just just as a reminder, this study is an extremely choices are finding study.

And so I do not want to misguides into leaving that you. All piece next step is that becomes played into phase three study.

Because it's quite possible that people to work more conventional pace tool for phase two piece gotten used to be determined.

I don't want to set expectations that might be extremely difficult to achieve.

Yeah, I get it I'm, just thinking about the unmet need.

And maybe the stresses we all feel can I ask [laughter].

So yeah.

Look I hear you I and the unmet need and all missing so I look I I hope, we can convey that but we are updating of the idea that could they didnt vitamins, so who knows.

Sure.

Your next question comes from each of our Awesome, calling your line is open.

Good afternoon, guys. Thanks for taking the question I actually I'd just follow up on Charles is question, a little bit I mean out outside of the screening process just looking at the caps fives.

Most of the items of course are related to well, it's pretty Pts T trial, obviously, there most of the items related to that end question. Obviously were for each has a triggering event for peak, yes people got fair number of items that.

Seems correspond to more anxiety driven questions, maybe depression, driven questions I'm thinking like 911 et cetera et cetera.

Is there anything that you can do to address potential sounding or changes in individual items to the caps five are you thinking about any sort of.

[laughter] is.

Subscale analysis or anything within their that might mitigate might mitigate any.

Exaggerated stress stress response.

As far as like prospectively.

Yeah, Hey return to Andy and Thanks for the question you know I think it does come back a little bit to the question, though that Ramassage start which is kind of how do we piece together all the data from the study.

No because you know what you just pointed I just maybe one possible in Korea. There there there's lots of I think way, it's a different patterns can manifest in the data. It's the nature of these scale and the caps five as the primary so yes. We are thinking through you know what are some analyses that would make sense to presuppose.

Testified to do.

That might help us understand if there was an impact from this period of time and if so what that was and we do have the ability specifically with respect to depression anxiety of some other secondary endpoints that could help corroborate if there's.

An issue as opposed to relying on one or two individual items in a in a scale that's really validated as more of an overall.

Set of subscales, an overall scale than you know particular line item. So I think it goes back to appoint of looking at that and totality and looking out under the sort of interesting pathways are patterns that exists derive the secondary endpoints to help us make sense of what's going on in addition to that you know Katherine said, we're we're collecting data.

And also feedback from the sites to understanding of what are what are they seeing ER with patients on ground level until that that'll help us interpret as well.

How frequently are you, making these assessments and also I wanted to follow up on Norbert.

Okay.

Absolutely equally virtual [laughter] follow up and assessments or you are you are you talking about specific primary and secondary endpoints assessment done over Tele medicine, where before they were not.

[noise] correctly and do I'll tell you I think you'll be too.

Yes, I'm virtual he says I need to sort of like them to get the quest itself definitely put your tissue.

That's what happened.

Happy to do it this is the revised operation. However, it was talking about before.

We are talking about virtual patient follow up that doesn't mean that were components of a study visit could be done virtually in a way that gives us good quality data. So we aren't doing these things without sort of discussion about the validity of the data that's being gathered we are suggesting that it be done a video not just with the phone as possible.

But ways to gather that data that allows us to do it with a telemedicine or a phone or a video has been made an option to decide to the patients.

We've also required in in clinic, a follow up her safety somebody other city procedures to acquire in person presence and so.

Those two things together have allowed us to make some accommodations for the way that patients might just at the site.

How are you accounting for how you accounting for compliance with.

More virtually.

Yeah, so not much different than we had been in the trial already a we had a very careful compliance support and assessment process within the trial a that remains in effect and fully operational during this time as well so there hasn't been much of a change in our ability to measure compliance in that trial.

Got it great. Thanks for taking my question.

Thank you will be too.

All right. Your next question comes from to line up Laura Chico from Wedbush. Your line is open.

Hi, good afternoon. Thanks for fitting me in here I just have to so I guess continuing on the that last line do you have any sense in terms of how retention in the southern 83 study might have been impacted by the pandemic and I guess that specifically I'm trying to understand how might just have changed relative to your original assumptions and then I have one follow up.

Yeah. Thanks, Laura it's Andy I think that first one straight forward you know, we've we've not seen an impact on retention on early termination in terms of you know the before and after.

I think of course, you know.

There's one or two patients that have.

Withdrawn from the Saudis, citing the current covered situation is the reason, which is entirely I think to be expected, but at the higher level. You know, there's always patients I withdraw from studies and at the higher level, we've not seen a difference pretty post and I think across the whole study that particular measure is tracking very much in.

Wine with what we were expecting to see.

Okay, Great and then maybe a more strategic question high level. I guess, you know was 73 did on track them to ride by year end 20.

And you talked a good deal about kind of the criteria for for restarting I guess is there a possibility that we might only see one or two of the earlier efforts restart and I guess the only reason I ask you know given that cobot has perhaps change recruitment feasibility in some therapeutic areas where did you reconsider.

Reprioritizing some of your clinical efforts at this stage.

Oh, so I can tell you looked at this point.

We are ambitious and as you go through saw.

The problem Alogent study as we are starting to see P. and study.

Because I assume that one.

Clinical studies sites are fully confident that they can provide the appropriate and taking vitamins.

It should actually in April both those patient populations.

To go back into it Didnt can twice.

The one that perhaps concerns I live in more ways to Parsons and study.

Because it is an elderly population that is particularly by the liberal too cold is 19.

And patient safety is so of course, the it's a major concern there. So we have to money took that carefully like which is which is why I said.

In my opening remarks, after they maybe a little more expensive.

Look I mean, I engage with my P. announcement, we engage with other physicians and Chief Medical officer and so on.

If they say setting that sometimes she is that that's patient population might not be suitable for all willing to.

Conducted a study and if they say vaccine that put techs and.

Ah, that's putting push us quite a way out Oh, I don't know that ultimately going to happen that way, but.

I I clearly out more concerns about.

The elderly patient population in a parkinsons environment. As an example, then I have about it probably has a patient population, which is generally a copy of your just when Paul.

That's very helpful. Thank you.

Your next question comes from Gary Nachman from BMO capital markets. Your line is open.

Hi, guys. Good afternoon I'm just following on the last question on two nine to five specifically described the ongoing communication, you're having with the sites and how quickly the DPN fiber studies could we initiate when things open up a bit.

So I think.

He thinks so the question.

I'm not going to comment on how quickly other than to see as quickly as possible would be my platform and but it's really not.

No based on which I can give you that's our guidance because.

It is still a little bit too uncertain at this stage, but to the first part of your question Kathleen can maybe comment on.

Yes.

He earlier part of your question.

[laughter] did you would cost actions can do follow up.

Yeah.

So I guess that the answer that I would give a similar to our experience with P.T.S.C.. We are seeing sites that are able to operate if they are more community base and research focus as opposed to part of it academic medical center part of the hospital.

Until I think we will use what we've learned from the ongoing PTSD trial to consider how site operations play a factor in one we're able to restart.

But we do have close communication with those sites and are able to see where they're able to operate.

Okay and I'm just curious like you know in terms that as communications how competitive you think the environment is gonna be when things open up from the pandemic because so many companies are going to want to we initiate clinical studies. So do you have a sense of where you're going to fall relative to two the competition with that.

[laughter]. So that's that's how to answer sites because.

We have not be doesn't do you have visibility to that but I will tell you that we have been really thoughtful in making sure that number one we remain and maintain regular dialogue, which the sites we see the various.

Groups, we are working with.

We have clearly six notes that we will be ready as soon as they have their d., we have to means to conduct these studies.

And so I think the relationships that we have no chuck over the years.

We will be a daily really helpful is making sure that we aren't as high up on the totem pole without the need to be.

Who actually find Oh itself well placed in what we will undoubtedly be a more competitive in vitamins and also an environment, where I think the throughput is going to be slow.

So all the new Melissa precautionary measure that sets the sites needs to take.

And so I think that passed on to I think you used the concern you're correct that.

It might be different fields to basically go back to the previous level.

For a a speech and throughput but I.

I I could be pretty confident that real though place adult position to be ready to go as soon as soon as we can.

Okay that perspective is helpful. And then lastly, Norbert while a number these clinical studies are on hold what else are you doing with your earlier stage pipeline can you spend more time trying to evaluate and accelerate earlier stage compounds are doing some preclinical work.

Yeah. So we actually don't often talk about that and I'm glad to clean up the question we are.

It doesn't really in an ongoing process in house in four years snow tool basically clean and whole fight a compelling.

I think Chris mentioned on occasion, we have synthesized and coal flies and characterized altogether more than a thousand compound since we shifted to.

Making small synthetic molecules that deficit is one that is very important to us because we I pipeline company not a one component companies.

He just unfortunately, however that at least for the last several weeks.

So that's what totally has been shut down.

The call itself be basically have to follow the same all does everybody else it.

And that has always had an impact on how much we can do.

But as a general does and so I just re up hole fighting compound.

It is actually also part of all these are sort of British agreement to sell again no EFI.

And if anything we have been slow selling by the mandatory Chuck I'll note that Lisa facilities to pick up here and maybe not.

Okay. That's helpful. I mean used in the past you talk a lot about the library. So it's good to hear that that's still progressing okay I got it.

Yep. Thank you Kelly.

And we also have a question, let's start from Jessica Fye.

JP Morgan your line is open.

Hi. This is you go on the call for Jessica. Thank you for taking our question I've a couple of questions regarding the P. S. T program first question is on the baseline demographics do you think the enroll population will be similar to the population enrolled in the SFR start SSR ice studies what characteristics to beat.

Front baseline exclusion inclusion criteria.

And second do you believe you need to run to central Phase three studies to support approval.

Oh, I'm gonna have and keep it though yeah, yeah. Thanks, a UCO so the baseline demographic graphics versus the at Sri Studies I mean, those studies were conducted quite a long time ago.

So for example, you know back in those days when those studies were conducted you know people talked out of military population. They talked about I'm veterans are desert storm veterans now of course, and Twentytwenty, we talk about veterans of Afghanistan and Iraq.

I think there's also an increasing awareness and diagnosis of PTSD for other sources of trauma, particularly sexual assault on things like that so I I think that that baseline demographics are difficult to compare with studies that took place.

Not long ago, I think what we've always said is we are trying to appropriately limit our patient population.

But not limited to large an accent. So we do want to have a diversity all.

Types of trauma age group time, since trauma et cetera, but would IPH introducing more complicated variables such as childhood trauma complex PTSD things like that and then coming to those conclusions. We look back not only SSR I studied but other studies conducted in PTSD more recently by other sponsors.

And try to learn as much as we can what lessons learned and those studies.

Great. Thank goodness.

Okay and then the second part of the question about the to control Phase three studies.

Right so again.

Norbert said earlier.

The rest of that development program is something that will be driven by the data that we see and discussions with the agency.

Whether it's you know two phase three studies, two pivotal studies or you know or or a more expedited path to market I think it's something that remains to be seen based on agency discussions I do think the point that came out of the Q and eight is important to remember that this is an area off very high unmet needs.

And a and one that is.

Certainly increasing in terms of incidence and prevalence.

And I think in terms of the surrounding social and medical morbidity.

Thank you so much.

We have another follow up question from Ram Selvaraju from.

Thank you see Wainwright your line is open.

Thanks, that's very quickly I was wondering you know we have to kind of prepare for all kinds of unexpected situation given the nature of the and done it assuming that there might potentially be future flare up that could.

After the pause research to be reimpose are you thinking about potential contingency plans, particularly with respect to possible. Additional studies that you have undertaken to future and essentially conducting those in countries that may have managed to control the corona virus pandemic significantly better than.

Unfortunately seems stuff in the case here in the U.S.

That does that lead equates west too so.

First of all I sincerely hope.

So we will not heavily surgeons or.

Hey, massive increase as some projects, yes flu season comes back to our student the October November timeframe.

But look I also believe said that wouldn't be talk about hi.

Becoming ready again to actually do studies.

That they will not do that in a cobiz 19 fleet environment like because.

It was 19 will be with us.

For quite some time and so whatever precautionary measure the types of taking which was picked two P.P.E.

It's cleaning testing whatever that is.

I probably going to be.

How fluid even if the is at least surgeons.

Unless it is a cup of coffee research institutes actually Liberty pushes us Olympic ER in another unprecedented ways. So let's hope that that's not going to happen, which was picked up in conducting studies elsewhere.

I I, usually login CLIA that other countries.

Seemed to have gotten to a more normal or more stable place much quicker than we are.

Talking with you in the states.

As an organization we have not.

Active clinical studies X U.S. up to this point.

I wouldn't be perfectly open minded to do so.

As long as I couldn't belief that stays as appropriate patient population that actually looking for that really available is not the geography is because that will be the driving force behind it I have no geographic pestilence Crusade.

And would certainly be open minded to looking at those alternatives like I'm sure other companies are doing as well.

Thank you.

And another follow up from Charles Duncan from Cantor Fitzgerald. Your line is open.

Yeah. Thanks for taking the follow up just one pipeline question and then one question for Ashish.

Regarding the pipeline question to nine to five in chronic pain.

You know.

Understanding that there's really two cohorts being rolled in those studies before and after cobot 19.

And I'm wondering if you could speculate on well first of all tell us whether or not those patients remain on track again, it's so if you could speculate and a potential impact that longer administration period.

We have in terms of dry being effect size with you know drug arm activity M. Perhaps reduce control arm voice or what what do you think could happen out of that first cohort if they remain on drug.

Okay. So so talk to you mentioned all know because that's why we have suspended the studies, we are actually allowing patients in this study to actually complete.

They're talking needs if they stay on subject to walk to study is a well do you find 12 week study.

And the patients complete the study and then that song.

And so we will see I'd just like this P.T. and see where the question is is there a disciplined.

I mean, those patients that completes its a subject before and after.

If we refer to cope with 90, and then we would apply the same clicks you're going to go there.

And and see what we did two ways to remember is to say look Smith.

Stopping stopping you from all these albeit in these studies for now.

Because they have a very disciplined I would say.

Goal that we are pursuing because they are meant to be studies that validates our previous dissolved in two studies, we do it wasn't problem Algovita DPN.

They typically ideally can serve passed legislation trials.

And therefore, we anticipate two days our quality I have a much much higher level of sensitivity.

They like house in the Pts These studies I have to sensitivity in most for patient safety, but certainly for did a quality.

We actually very much.

Looked at that couldn't be decided to suspend involvement in this stuff you could call.

We will see but 60 patients will not stay on block once the study.

Has completed its 12 week.

Oh, Okay. That's helpful. On can you give us a EUR estimate.

Even broad in terms as a percent patients enrolled in each of those two studies are in that first cohort four cobot 90.

No actually.

I won't close we have not done that as a metal principle. The first time, we actually have thought there was this piece. He has he you call. It said was so far along that we want it to make sure that.

Do you understand so that should now out to wipe me say this far in that's basically take it all the way, but generally speaking we do not actually be pause on Saturdays of enrollment and then you have arpine itself.

Okay. Okay, and then you might that credit report fish yeah, okay. Good.

Yeah quick question for Ashish, a understanding that cash spend on a quarterly basis is a function of enrollment in part and I know it's hard to.

Yes, when enrollment is going to start back up but when you look at that 11 million R&D stand in the first quarter was most of that you know <unk> most that before you stopped enrollment and and can you give us some.

And a guide posts in terms of what you'd anticipated to be in the second quarter.

Sure Yeah. Thanks for the question Charles Ah, Yes, the $11 million and R&D expenditure in the first quarter did reflect screen covert 19.

Ah escalation and and printing suspension activity I think that a it's fair to say that a as we have put three of the studies on pause.

We should expect a.

A decrease in R&D expenditure in the second quarter I don't know how dramatic it will be in that it wasn't.

Hey, you know full on off switch.

I'll, both with regard to certain activities and expenditures that still reflect a activities are associated with.

Q1, which still need to be accounted for.

But also we've discussed in other other parts of the call them Queuing Bank.

We have taken steps measures tend to remain very closely engaged with RCR rose with our sites so as to be in a.

Favorable position when we start as possible and that means these are ongoing projects. They have ongoing project management costs. So this isn't a entirely shut off we are very disciplined about our spending I think as you see Oh I am and so I think in the second quarter given the.

Suspensions of these activities, we should see some decrease from but hard to say how much that will be.

In terms of looking ahead.

No I hope is that in the third quarter in the fourth quarter were ramping back up to a begin enrollment again and while we can't give that guidance based on lack of clarity today, that's certainly our hope and so I won't be able to give you guidance on on those going forward.

Okay and good thanks for taking Oh.

All right I'm showing no further questions at this time I would like to turn the call over back to Norbert for any closing remarks.

Thank you operator, and I think joy for your questions. It was really great to have as much shelf and engagement as we've had terrific.

I appreciate your time enjoy tension please stay safe be rail and enjoy the rest of your they.

Good afternoon, and it wouldn't even.

Thank you for joining US today, you may now disconnect.

[music].