May 5, 2016
Executives
Jesse Baumgartner - Stern Investor Relations Dr. Derek Chalmers - President and CEO Joe Stauffer - Chief Medical Officer Joe Schoell - Chief Financial Officer
Analysts
Sarah Weber - Piper Jaffray Esther Hong - Stifel Alan Carr - Needham & Company Frank Breeze - Laidlaw Chiara Russo - Cantor Fitzgerald
Operator
Good afternoon and welcome to the Cara Therapeutics First Quarter 2016 Earnings Conference Call. At this time, all participants are in a listen-only mode.
There will be a question-and-answer session at the end. Please be advised that this call is being recorded at Cara's request.
I would now like to turn the call over to the Cara team. Please proceed.
Jesse Baumgartner
Good afternoon. This is Jesse Baumgartner with Stern Investor Relations and welcome to Cara Therapeutics first quarter 2016 earnings conference call.
The news release with our first-quarter financial results and corporate update became available at 4:01 PM today and can be found on our website at www.caratherapeutics.com. You may also listen to a live webcast and replay of today's call on the investor section of our website.
Before we begin, let me remind you that statements made on today's call regarding matters that are not historical facts are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Examples of these forward-looking statements include statements concerning the expected timing for the Company's clinical trials and the reporting of clinical trial results, the potential results of ongoing and planned clinical trials and future regulatory and development milestones for the company's product candidates and the Company's expected cash reach.
Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Risks are described more fully in Cara Therapeutics filings with the Securities and Exchange Commission including the risk factors section of the Company's annual report on Form 10-K for the year ended December 31, 2015 and its other documents subsequently filed with or furnished to the Securities and Exchange Commission.
All forward-looking statements made on today's call speak only as of the date on which they are made. Cara Therapeutics undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.
Now, let me turn the call over to Cara's President and CEO, Dr. Derek Chalmers.
Dr. Derek Chalmers
Thanks, Jesse. Good afternoon, everybody and thanks for being with us on the call.
Today, I am joined today by our Chief Medical Officer, Joe Stauffer, and our Chief Financial Officer, Joe Schoell. So, 2016 is shaping up to be a very important year for us here at Cara.
Today, we are going to provide updates on our rapidly progressing clinical pipeline as we move into two additional late-stage indications, continuing to execute on our overall development while maintaining a strong financial position. Joe will provide some more color on our upcoming trials but first, I will walk through the higher level overview and the expected news forward during the next two quarters.
First, as many of you saw last month, we were very pleased to announce the rapid removal of the clinical hold for CLIN3001, our adaptive Phase 3 trial of I.V. CR845 for post-op pain.
Finding, a mutually agreeable path forward so quickly speaks to the efficiency and execution of our clinical team, our productive collaboration with the FDA and the broader safety profiles seen today with I.V. CR845.
We are able to use this analysis as an opportunity to take advantage of the trials adaptive design and identify two doses of CR845 moving forward. 1 microgram per kilo and 0.5 microgram per kilo, which we believe will define the optimum therapeutic dose range in less patient population.
This is supported by interim efficacy signals for pain, for supplemental opioid use and for opioid related side effects observed through these first 90 patients dosed. With these decisions now behind us, we continue to work through the logistics of implementing this more efficient three-arm pivotal protocol with their clinical size and we expect patient recruitment to resume later this month.
Once we have enrolment back up and running, we will be able to provide more accurate guidance on interim assessment and complete data readouts from this particular trial. Now, moving onto what the rest of the year holds for broader pipeline.
With the planned initiation of our adaptive Phase 2, 3 trials for uremic pruritus for later this quarter and our Phase 2b study for Oral CR845 in osteoarthritis patients during the second half of the year, we are now pursuing three important indications with significant market opportunities. Joe is going to review the protocol details for this programs but I just want to quickly touch on our strategic thoughts for each.
For the UP indication, the trial will be a two-part adaptive trial. Part A will be examining three doses of I.V.
CR845, anchored around the 1 microgram per kilo dose used in our successful Phase 2 trial in the same patient population. This time dozed over an eight-week treatment period to identify the optimum doze to carry forward into the Part B 12-week trial In addition to this IV trial in dialysis patients, we will also be initiating a multiple ascending dose study for Oral CR845 in end-stage renal stage patients, with the aim of identifying tablet strength which are bioequivalent to establish efficacious IV doses and could inform an ultimate transition to Oral CR845 for this particular indication.
This approach may ultimately allow us simpler reimbursement pass for the drug in end-stage renal patients and could provide a suitable formulation to walk back into the pruritus population in the broader chronic kidney disease clinical population. Finally, for Oral CR845 in chronic pain, building off our Phase 2a data in osteoarthritis patients where we saw both pain and rescue medication reduction over two-week treatment period, we are now planning to move into a much larger 330 patients study, testing three tablets strengths of CR845 over an eight-week treatment period to inform potential registration trial designed for this particular indication.
With the recent increased regulatory focus from CDC, the FDA itself and NIH to kappa prescription opioid abuse and associated deaths and the increasing physician and media focused to the novel approach is to chronic pain, we believe CR845 has a significant potential to provide an alternative approach to traditional new opioids and deliver effective pain relief in the absence of abuse, misuse and addiction, as already indicated by our established human abuse liability data. It’s important to remember that for each of these two later-stage programs we are moving forward based on positive signals identified from our initial proof-of-concept studies, which provided important insights into appropriate dosing.
We believe this approach help de-risk these larger trials and provides us with the best chance for ultimate success. So, we look forward to keeping you informed as we began both of these studies during the coming months.
Before I turn the call over to Joe Stauffer, I just wanted to highlight that we’ve moved into diversified late-stage programs while efficiently using our capital base and maintaining a strong financial position. We ended Q1 with $96 million on hand in the bank.
With that, let me turn the call over to Joe Stauffer for more detail on our upcoming trial initiations and then, Joe Schoell will take us through the details on the financials.
Joe Stauffer
Very good. Thanks, Derek.
So, as Derek indicated, we are very pleased to be back on track with our CLIN3001 trial after a timely and productive dialogue with our colleagues at the FDA. And while we continued to expect patient recruitment to resume this month, we are also hard at work preparing for our two additional trial initiations in UP and chronic pain.
So, starting with uremic pruritus, we continue to anticipate initiation of our registration program for I.V. CR845 in hemodialysis patients, suffering from moderate to severe uremic pruritus during second quarter.
And we're making significant progress on site selection and qualification to this end. The trial will be a two-part Phase 2/3 adaptive design as we discussed last quarter.
Part A will be a randomized, double-blind, placebo-controlled study of three doses of I.V. CR845, administered three times a week after dialysis over an eight-week period in 160 patients.
Part B will be a randomized, double-blind, placebo-controlled study of one optimized dose of I.V. CR845, administered three times per week over a 12-week treatment period in up to 240 patients.
The primary endpoint will be reduction in worst itching scores from baseline values measured on a standard Numeric Rating Scale alongside secondary quantitative quality of life endpoints measured on the validated Skindex-10 scale and complementary QoL measurements. The dose selected for Part A will be anchored around the 1 microgram per kilogram dose, used in our successful two-week Phase 2 trial in end-stage renal disease patients.
Then as Derek touched on, we will also initiate a pharmacokinetic safety trial of multiple doses of Oral CR845 in hemodialysis patients to define bioequivalent tablet strengths to confirm our ability to develop an oral tablet formulation for this indication. Data from this trial will inform Oral CR845 doses that can be employed in future trials for moderate to severe uremic pruritus.
We also remain on track to initiate our Phase 2b trial of Oral CR845 in osteoarthritis patients during the second half of the year. As I walk through last quarter, the trial will be a double-blind, multiple dose Phase 2b with twice-daily doses of CR845, administered over an eight-week treatment period in OA patients with moderate to severe pain.
The study will include 330 patients randomized across three CR845 tablet strengths and a placebo arm at 15 sites across United States. Tablet strengths employed in this Phase 2b trial will be based on observed reductions in pain scores and rescue medication in our completed MAD Phase 2a trial.
The primary endpoint will be different from baseline in pain scores in CR845 treated patients versus placebo at the end of the eight-week treatment period. I will finish up by saying that we continued to be pleased with our progress across multiple clinical programs and we of course plan to provide updates around the initiation and expected timelines of each of our trials as they accrue during the coming quarters.
And with that, I will turn it over to Joe Schoell for the financials.
Joe Schoell
Thanks, Joe. As a reminder, the full financial results for the first quarter can also be found in our press release issued today after the market close.
We reported a net loss of $10.7 million, or $0.39 per basic and diluted share for the first quarter 2016, compared to a net loss of $4.7 million or $0.21 per share basic and diluted share for the same period in 2015. We recognized $7,000 of revenue during the first quarter for the sale of clinical compound to Maruishi.
For the first quarter of 2015, collaborative revenue was $489,000, comprising revenue that had been deferred upon entry into the license agreement with Maruishi. R&D expenses were $8.5 million in the first compared to $3.4 million in same period of 2015.
The higher R&D expenses in the first quarter of 2016 were principally due to a net increase in direct pre-clinical and clinical trial costs, consultant services in support of pre-clinical and clinical trials, an increase in payroll and related costs for R&D personnel. The acceleration of amortization of leasehold improvements at our Shelton, Connecticut facility prior to the relocation of our corporate headquarters to Stamford, Connecticut and some increased rent.
General and administrative expenses were $2.4 million in the first quarter of 2016 compared to $1.8 million in the same period 2015. The increase in the first quarter of 2016 was primarily due to increases in payroll and related costs, in investor relation costs and in professional and consulting fees, franchise taxes and in rent and the acceleration of amortization of leasehold improvements as noted previously.
Other income was $149,000 of interest income and dividends earned on cash, cash equivalents and marketable securities during the first quarter of 2016 compared to $14,000 of interest income during the same period in 2015. The increase in the first quarter ended March 31, 2016 was primarily due to an increase in interest income and dividends earned on a more diverse portfolio of investments in 2016, including marketable securities, as well as higher interest rates on a higher average balance of cash and cash equivalents and marketable securities in 2016 as a result of our follow-on offering of common stock, which closed in August 2015.
As of March 31, 2016, cash and cash equivalents and marketable securities totaled $96.2 million compared to $106.7 million at December 31, 2015. The decrease in the balance of cash and cash equivalents and marketable securities primarily resulted from $9.8 million of cash used in operations and $0.8 million of cash that was restricted to serve as collateral for a letter of credit issued to the landlord of our Stamford, Connecticut lease.
Turning to financial guidance. Based on timing expectations, projected costs for current clinical development plans, Cara expects that its existing cash, cash equivalents and available-for-sale marketable securities as of March 31, 2016 will be sufficient for the company to fund its operating expenses and capital expenditure requirements through the end of the first quarter of 2018, without giving effect to any potential milestone payments under existing collaborations.
Now, we will open it up to Q&A. Operator?
Operator
Thank you. [Operator Instructions] Our first question comes from the line of Charles Duncan with Piper Jaffray.
Your line is open.
Sarah Weber
Hi. This is Sarah on for Charles.
Thanks for taking the question. I have two.
So on the uremic pruritus trial, will patients in Part A be able to roll over into Part B and is it reasonable to say we could expect that data by year end ’17?
Dr. Derek Chalmers
Hi, Sarah. Thanks for that.
I’m going to let Joe talk about that.
Joe Stauffer
So it will roll over from A to B.
Dr. Derek Chalmers
Yes.
Joe Stauffer
Yes. So it would be the expectation now.
In terms of finishing out to ‘17, we can give you a much better update once we get the trial started in rolling with our sites. This is a big trial, more sites and before.
So, give us time to get back to you with how it really looks and then we can give you some more solid data on timeline.
Sarah Weber
Okay. Thanks.
So then on the post-op pain program are you planning to conduct any additional pre-clinical or Phase 1 work to support the two go-forward doses?
Dr. Derek Chalmers
No. We are fine there.
Sarah Weber
Okay. Thanks for taking my question.
Dr. Derek Chalmers
Thanks, Sarah.
Joe Stauffer
Welcome.
Operator
Our next question comes from the line of Annabel Samimy with Stifel. Your line is open.
Esther Hong
Hi. This is Esther Hong in for Annabel Samimy.
My questions are in regards to the Phase 3 post-op pain trial. First, what signals or indications do you have that provide confidence the 1 microgram per dose is the optimal dose?
And second if mild hypernatremia is easily manageable, why was the 2 microgram per kg dose dropped and then third is jus timing? When should we expect the second Phase 3 trial to initiate and is the NDA filing still on track for end of 2016, early 2017?
Thanks.
Dr. Derek Chalmers
Okay. Hi, Esther.
Let me start and then I will let Joe talk about time a little bit. So in terms of the dose selection sought and I think we said this last time.
Essentially, this is based on the interim trends and efficacy we've seen in these first 90 patients dosed, where we see changes in both pain scores and supplemental opioid use. We also see changes in the usual new opioid related side effects, principally nausea and vomiting that we’ve talked about before.
So that was a little like adding bonus, if you like of having this interim assessment for safety that we can look at the numbers and reassure ourselves of those signals. Also, again, I think as we should last time, looking at the basic pharmacology of CR845 that is the potency of the drug, which as you know is in the picomolar range, which essentially means that plasma exposures and the picogram per mill level will be saturating for this drug.
And looking at our PK data for the 1 microgram per kilo level, we are certainly well above what would be a saturating concentration for this drug. So, we are comfortable on the pharmacology.
We’ve seen interim signals from these first 90 patients. And then the last item that support of -- as we discussed again previously, the very robust efficacy we saw in our uremic pruritus study was at the 1 microgram per kilo level.
Again confirming what the same mechanism of action that is reduces hyperactivity, anti-inflammatory activity. We can see robust efficacy for that dependent variable.
So, all of that makes us comfortable that we've chosen a dose that's going to show a great pharmacology at the target. As to why we were focused on that dose and not the other those, we saw, as we mentioned in the 10-Q, transient increases to the mild level in serum sodium, And as you know and as we agreed with the agency, we have stopped the rules related to that particular dependent variable, not related to any side effects we have observed.
We never have in relation to that but it is one item we’d agreed to monitor. And so at about an interest in not getting anywhere close to stopping rules and stopping criteria and really defined as we said the optimal dosing range both for efficacy and for any perceived, if you like you side effects of the drug as far as the agency is concerned, we chose the 1 microgram dose as a top dose going forward.
Joe, do you want to add?
Joe Stauffer
Sure. And you had two other -- well, you had two others parts of your question.
Derek answered the 2 microgram part, why did we drop that. We want to continue also to identify a mild factor or low factor as well and that’s why we are adding in the 0.5 micro kilo.
It also balances up a trial quite well. And as far as timeline, you said 2016, we are in 2016 now so we plan on submitting the NDA end of 2017 and that depends on enrollment.
Esther Hong
Okay. And then when did the second Phase 3 trial?
Joe Stauffer
Sorry about that. Yes.
So, we will take an interim assessment to look at this data for this Phase 3 portion. We should do that in first quarter next year and then based on what we see we will start that next trial and then continue on with this trial as well.
Esther Hong
Okay. Great.
Thank you.
Operator
Our next question comes from the line of Alan Carr with Needham & Company. Your line is open.
Alan Carr
Hi. Thanks for taking my questions.
A couple here. Wonder if you could talk a bit more about FDA's thinking towards hypernatremia in your discussions and their sensitivity to it?
And then also for this interim assessment in -- looks like an early 2017. I guess can you tell us more about how that will be carried out on and what changes you might make at that point and then you said that you will start a second Phase 3 trial then reach a level of confidence that you would just run?
At some point you talked about three trials. You might run three Phase 3 trials.
So can you tell us a little bit about decision process at that point?
Dr. Derek Chalmers
Sure. I got.
So it’s really three questions here. The first was I believe serum sodium and this is really the last remaining piece for the FDA to look at.
We believe it was a pretty quick turnaround with us and them through this clinical hold. So it is something that they haven't seen before in terms of pharmacology.
This is a new pharmacology to them. And so unlike other new opioids that have older other inherent side effects that they are kind of attune to respiratory depression and all these other issues.
Because this is a kappa, this is something that they wanted us to pay attention to them and we need too and so because if serum sodium goes too high or too low, you can get patients into trouble. We never had that there with any of our doses but it's an optical thing in terms of a blood level.
And so we are very comfortable now that we know where we need to be and I think the FDA is as well. In terms of the interim assessment, remember that’s a plan that we have through a charter with an independent data monitoring committee, which is made up of the statistician and an M.D.
PhD., neurologists and statisticians as well as anesthesiologists. The charter that’s blessed between us and the FDA, there are rules within that charter for how we take a look at the data and I’m going to obviously share our secrets with everybody how we do.
It is something that I'm -- we are pretty proud of that we were able to negotiate with the agency. And in terms of the decision, so once the IDMC looks at the data, they give us guidance as to what they recommend and those choices can be anything from the worst-case scenario, let's start there which is nothing appears to be working.
None of the doses, the two remaining doses appear to be working. Well, we wouldn’t be good stewards of our investors’ money if we were to continue at that point so we would obviously stop.
Without anticipating that, so let’s go to the more positive end. Perhaps both doses seem to be working quite well.
In other words, we have enough conditional power based on the look that the IDMC has that we can continue on with our target sample size, which is approximately 120 to 125 per arm. And if that’s the case, we will likely continue doing that.
If one of those doses, let’s say the lower dose, 0.5 microgram per kilogram doesn't appear to have what I call horsepower, the efficacy horsepower to take us forward we would drop that dose and then continue 1 with placebo and the 1 microgram per kilo. I guess the fourth option is that we are comfortable with what we see.
But we know we could be a lot more comfortable if we needed to increase the sample size, so sample size re-estimation. And that's all pre-specified and pre-planned and that allows us to go up to about 150 patients per arm if we needed to.
We don’t think at this point, based on what we've seen before that we will need to go that high, but we put it in there as a buffer and a hedge to make that decision. So it gives us a lot of optionality and that’s why the trial is designed this way.
And that’s the whole spirit of Phase 2, 3, adaptive design
Alan Carr
And can you remind me, the interim is triggered by enrollment of how many patients?
Joe Stauffer
That’s a good question. It is.
It’s trigged by approximately 180 patients, or about 60 per arm.
Alan Carr
Okay. Great.
Thanks very much.
Dr. Derek Chalmers
Thanks, Alan.
Operator
Our next question comes from the line of Jim Molloy with Laidlaw. Your line is open.
Frank Breeze
Hi. This is actually Frank on for Jim.
Thanks for taking the questions. My first question, first part of the is question is are there any automatic stopping rules in any of the other trials that we should know about beforehand and did the FDA mandate any additional safety laws in the IV pain trial that weren’t already there, like any in the hip, knee, or even in the pruritus trials?
Dr. Derek Chalmers
No. There is no other extra stopping rules that we are putting here.
So, we just have to continue on doing what we are doing and work with them. The next formal look is the IDMC for interim assessment.
Frank Breeze
Okay. Great.
And then in terms of the partner, Maruishi, are we still on track for second half ’16 pruritus data? Any idea when second half, would it be late or early?
Dr. Derek Chalmers
Yes. We haven’t guided on when we are getting data out of the Maruishi Phase 2 but they are on track and they are moving forward with the PMDA discussions and they are on track to move into efficacy trials this year.
Frank Breeze
Okay. Great.
And then another one. Has there been an any interest from larger pharma partners either in license CR845 or exploring outright acquisition of Care overall?
Dr. Derek Chalmers
Frank, that’s something we haven't talked about publicly. But we are looking at molecules for very large market spaces.
We’ve already proven these are non-usable molecules so. There have been -- and frequent and frequent request for information along the way but that’s something we don't, we haven't talked about.
Frank Breeze
Okay. Thanks.
And then in terms of the -- is it impossible if the first of the Phase 2, 3 trials for the I.V. CR845 for UP hits and it's big enough?
Can you possibly use it as a registration trial?
Joe Stauffer
Well, we would. It’s set up to go out to 12 weeks.
And so, we can off itself, we can. Even if it hits and if it’s clean.
When I say clean, I mean safe and we certainly anticipate it will be safe then we would position it as a pivotal trial. Again, that’s a discussion that we would have to have with the agency though upon review of the deal.
Frank Breeze
Okay. And then I'm a little confused in terms of the -- can you restate the timing for the Oral CR845 for UP?
Joe Stauffer
Oral for UP, so we are starting that this year. It's just a -- it's a pharmacokinetic trial.
So, we want to get a handle on what this drug looks like orally in these patients, right. These patients are quite sick.
They have lots of different medications on board. And even though the drug isn’t metabolized, these are not like say osteoarthritis patients or even healthy subjects.
And so we just want to make sure that the way they handled the drug orally would be safe and well-tolerated. We certainly expect that.
But we won't know that until we get to the trial started and finished but we are going to start soon/
Frank Breeze
And then one final one. Why is it so easy to -- in terms of efficacy why is it easy to translate the 1 microgram per cake per kg from the UP to post-op pain?
Dr. Derek Chalmers
Mechanisms are same, Frank. The mechanism of action here for OA 45 is essentially inhibit sensory nerves and C-fibers and some other fiber types roughly and also inhabit inflammatory responses from a range of inflammatory cells and essentially the TNF-alpha cascade.
That’s the mechanism for the drug and that applies to pruritus as well as in -- so that's our argument there is if the exposure is given a reduction in one dependent variable, then it's most likely going to work in the other clinical situation.
Frank Breeze
Okay. Great.
Thanks a lot for taking my questions
Joe Stauffer
Thanks, Frank.
Operator
Our next question comes from the line of Ken Trbovich with Janney. Your line is open.
Unidentified Analyst
Hi guys. This is actually [indiscernible] on for Ken.
Thanks for taking my question. First question, can you just help us think about how to model the upcoming milestones both from a reissuing CKD and I guess, specifically, which trials are those milestones tied to?
Joe Schoell
This is Joe Schoell. As far as the milestone, CKD’s milestones are predicated on us, completing our trials to completion of the Phase 3.
As far as Maruishi’s combination and it’s dealing with them going forward with the uremic pruritus trial, as well as us finishing the pain trials. I think we said in the last quarter we don’t expect milestones in 2016.
Unidentified Analyst
So the Maruishi payment is tied to two different clinical progress in multiple trials?
Dr. Derek Chalmers
Yes. It’s tied to us, completing our program here in our U.S.
trials. We received milestones payments from Maruishi.
With the idea of Cara license agreement, they have the ability to use our U.S. trial late and their submissions to the PMDA and we also received milestone payments when they complete their clinical trials, larger payments in uremic pruritus and smaller later payments in Phase 3 for post-op pain.
Unidentified Analyst
But there is a $1 million milestone payment that’s tied to a Specific Phase 3 trial, correct?
Joe Schoell
That’s correct.
Unidentified Analyst
And that is we have an ongoing trial.
Dr. Derek Chalmers
No, we haven’t disclosed the detail on that. But you are correct, there is $1 million milestone associated with Phase 3 completion.
Unidentified Analyst
Okay. And then just -- sorry not to -- I know this has been talked about a lot but just going back to the resumption of recruitment.
Because of the un-blinding, have all those patients can no longer be reenrolled into the trial under a different dosage?
Joe Stauffer
That’s correct. Because it's unblinded, all those patients will be used as part of the overall safety database of 1500.
But we obviously can’t use them for efficacy. So, we like to use the terms sequester, right.
So it’s almost like its own little separate Phase 2 trial. Going forward, the trial is smaller but we can’t use those same patients.
Unidentified Analyst
Okay. Great.
Thank you so much.
Joe Stauffer
Thank you.
Operator
Thank you. And our next question comes from the line of Chiara Russo with Cantor Fitzgerald.
Your line is open.
Chiara Russo
Yes. Hey guys.
Thanks for taking the questions. Just kind of a quick question here.
I know that you guys came out with sort of an updated dosing schedule for the pain trial. It seems to me -- and please correct me if I’m wrong, it seems like the dosing is converging on both sort of the IV, UP and the unique pruritus trial.
Do I have that somewhat correct?
Joe Stauffer
I think you do, yes.
Chiara Russo
Okay.
Joe Stauffer
Just happing to work out a bit.
Chiara Russo
Well, obviously, through the full adapter phases but is that due to sort of the pricing and marketing philosophy?
Dr. Derek Chalmers
Yes. So the other thing to bear in mind here, Chiara is that the UP dosing is three times a week.
They received a three times a week after dialysis. The IV dosing is cue six.
So with the pre-surgical dosing that’s five times a day in relation to the post-op trial. So, ultimately, those are very different types of dosing regimens and there will be different concentrations prevail for those.
So those are easily translatable into different prices.
Chiara Russo
Okay. Just wanted to make sure with that.
And then my last question is obviously, I think we have a good understanding. We have our hands around the UP itch opportunity but looking out part of that, what does an oral Anti-H look like for instance say in like a dermatology space?
Joe Stauffer
That’s a great question. We actually have looked look at some dermatologic conditions here.
Just thinking about where else might have placed atopic dermatitis or itching due to say a psoriasis. Even cholestatic, it's a people that are having livers and/or gallbladder that are not working well.
So, what we call cholestatic itch. And we believe that those are nice places to look at as well.
Obviously in that case, they would you have to be oral because they are chronic outpatients. But those are kind of the big three or four that we are looking at right now.
Chiara Russo
Okay. Great.
Thanks guys.
Dr. Derek Chalmers
Thanks, Chiara.
Operator
Thank you. And I’m showing no further questions at this time.
I’d like to turn the call back to management for closing remarks.
Dr. Derek Chalmers
Okay. Thank you all, everybody for participating in today’s call and we look forward to updating you again very, very soon.
Have a good Cinco de Mayo. Thank you, everybody.
Operator
Ladies and gentlemen, thank you for participating in today's conference. This does conclude the program and you may all disconnect.
Everyone have a wonderful day.