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Cara Therapeutics Inc (CARA -2.24%)
Q3Â 2019 Earnings Call
Nov 12, 2019, 9:00 a.m. ET
Contents:
- Prepared Remarks
- Questions and Answers
- Call Participants
Prepared Remarks:
Operator
Good afternoon and welcome to Cara Therapeutics Third Quarter and 2019 Financial Results Conference Call. [Operator Instructions] 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.
Jane Urheim -- Investor Relations
Good afternoon. This is Jane Urheim with Stern Investor Relations, and welcome to Cara Therapeutics third quarter 2019 financial results and update conference call. The news release become available just after 4 O'clock 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 Investors section of the 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 statement include statements concerning the expected timing of the completion and announcement of the results from our ongoing clinical trials, the expected timing and design of our planned clinical trials, future regulatory and development milestones for our product candidate, the company's projected timeline for the submission of its first NDA, the potential for CR845 to be a therapeutic option in multiple pruritus indications.
The size of markets that are potentially addressable by our product candidates and our 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, 2018, and its other documents subsequently filed with or furnished to the Securities and Exchange Commission.
Participating on this call are Dr. Derek Chalmers, Cara's President and CEO; and Dr. Mani Mohindru, Chief Financial Officer and Chief Strategy Officer.
I'll now turn the call over to Dr. Chalmers.
Derek Chalmers -- Chief Executive Officer, President and Director
Thanks, Jane, and good afternoon, everybody, and thanks for joining us on today's call. So, we've certainly realized significant progress across our clinical development pipeline this quarter and in recent months, including an expansion of our Oral KORSUVA clinical program into two new pruritic patient populations with high unmet need, atopic dermatitis, and chronic liver disease associated pruritus or CLD-aP.
We've also advanced our Phase II trial of Oral KORSUVA in non-hemodialysis patients with chronic kidney disease associated pruritus or CKD-aP, where we're on track to report topline data before the end of this year.
And lastly following a recommendation from the Independent Data Monitoring Committee or IDMC, we increased the target enrollment of our second pivotal Phase III trial of KORSUVA Injection in hemodialysis patients with CKD-aP the KALM-2 trial by approximately 20% from 350 patients to 430 patients to maintain our prespecified conservative statistical power for KALM-2's primary endpoint.
We do expect KALM-2 to fully enroll by the end of this quarter and remain on track to file our first new drug application for KORSUVA Injection in the second half of next year. In addition, on the corporate side, we entered into a nonexclusive commercial license agreement with Enteris BioPharma for oral formulation rights to Enteris' Peptelligence Technology to develop and commercialize Oral KORSUVA in any indication worldwide, excluding South Korea and Japan.
Now that aligns with our strategic goals to allow advancement of Oral KORSUVA into Phase III trials next year, pending the results from our ongoing Phase II trials. And finally with the strengthened balance sheet from our $136 million follow-on offering in July of this year, we are well positioned for, and we are looking forward to multiple major clinical milestones in the fourth quarter of this year and into 2020.
So, let's start with our lead program which is KORSUVA Injection and hemodialysis patients with CKD-aP. That pivotal program includes four Phase III studies, the KALM-1, a US efficacy trial, which read a positive top line data in May of this year. KALM-2, a global efficacy trial, we also have a US open label 52-week safety study and a global open-label safety study.
Both KALM-1 and KALM-2 were designed to investigate the efficacy of KORSUVA Injection at a dose of 0.5 micrograms per kilo versus placebo and that's administered three times per week after scheduled dialysis sessions over a 12-week treatment period and we also have a 52-week open label extension phase for safety.
And the top line results we announced in May of this year for KALM-1 analysis of the primary endpoint demonstrated that KORSUVA Injection significantly reduced itch intensity with 51% of subjects achieving at least a three point improvement in worst itching intensity as measured on a numeric rating scale or NRS compared to 29% of subjects in the placebo group.
The trial also meant, all secondary endpoints, 39% of subjects treated with KORSUVA achieved at least a four-point improvement in the worst itching intensity NRS compared to 18% in the placebo group, and patients on KORSUVA also experienced statistically significant and clinically meaningful improvements in itch-related quality of life measures as assessed with two complimentary multi-dimensional itch-related QL questioners the 5-D itch and the Skindex-10.
KORSUVA was also generally well tolerated with a safety profile consistent with prior clinical trials at their stores, and overall, these data indicate a robust sustained anti-pruritic effect of KORSUVA over a three-month treatment period. More data from the KALM-1 trial will be presented as a late breaking presentation at the American Society of Nephrology's Annual Meeting this Friday in Washington DC.
Moving on to our ongoing pivotal Phase III trial KALM-2, which is a global study similar in design to KALM-1. In October of this year, we announced that we increased target enrollment for this trial to 430 patients and approximately 20% increase from the 350 original target. And this was based on the recommendation of the IDMC to maintain our prespecified conservative statistical power for the primary endpoint. This additional enrollment is progressing well and we expect to complete full enrollment before the end of the fourth quarter.
I'd also like to give a quick update on our ongoing long-term safety studies. Our open label 52-week extension safety trial, which was initiated in Q2 of 2017, currently has approximately 185 patients through six months of treatment with over 100 of these patients having completed one year of exposure.
To-date, the safety and tolerability appears to be consistent with data reported from our first Phase III and prior Phase II trials of KORSUVA Injection in hemodialysis patients and based on the most recently completed Independent Data Safety Monitoring Board evaluation, the last of which was in October of this year. No new or inconsistent safety signals have been observed.
Our second open label 12-week global safety study launched in the second quarter of 2019 is expected to enroll up to 250 patients. As a reminder, this trial was not required by any of the regulatory agencies, but rather it was part of our strategy to use additional clinical sites to accelerate the safety exposures required for a potential NDA filing.
So overall we're pleased with the progress we've made this quarter across our KALM pivotal Phase III program in hemodialysis patients. And with no therapies currently approved in the US or Europe, we are working expeditiously to advance KORSUVA Injection pending positive data from KALM-2 to an NDA filing in the second half of 2020.
Aligned with this timeline for regulatory filing, we've also initiated key pre-commercial activities across functional groups, including med affairs, commercial, and CMC, where we've already established an appropriate CMO agreement to enable commercial scale manufacturing.
So we look forward to updating you on these activities as we move closer to NDA submission next year. Now, I'd like to shift to the second major part of our pipeline, our ongoing programs with Oral KORSUVA, which we believe could be a potential novel treatment option for patients with pruritus across multiple clinical populations.
So turning to our lead Oral KORSUVA program, our ongoing US Phase II trial for predialysis stage 3 to 5 CKD patients with moderate to severe pruritus. So this trial is a multi-center, randomized, double-blind, placebo-controlled 12-week trial, designed to evaluate the safety and efficacy of three doses of Oral KORSUVA of 0.25 mg, 0.5 mg and 1.0 mg tablet strength given once daily to these patients.
The primary endpoint in this trial is the change from baseline and the weekly mean of the daily 24 hour worst itch NRS score at week 12 of the treatment period and secondary endpoints include change from baseline and itch-related quality of life scores at the end of week 12 as assessed by the total Skindex-10 and 5DH skills as well as the proportion of patients achieving an improvement from baseline of greater than three points or greater than four points with respect to the weekly mean of the daily 24-hour worst itch NRS score at week 12.
In July, we announced completion of enrollment in this trial following the recommendation of the IDMC that the trial did not require any modifications to the original enrollment target of 240 patients based on an interim statistical power analysis. So we're currently completing data cleaning for this trial and we remain on track to report top line data a little later this quarter.
We believe there's significant opportunity for Oral KORSUVA and pre-dialysis CKD patients were based on pruritus-related drug prescription data, it's estimated there are approximately 2.5 million patients in the US currently receiving some sort of treatment for pruritus and that's typically generic antihistamines or corticosteroids, neither of which effectively serves to alleviate the pruritus-related quality of life burden for these patients in the long-term.
We also recently initiated Phase II trials for the treatment of pruritus in two additional populations, atopic dermatitis or AD and primary biliary cholangitis or PBC respectively. AD is of course one of the most common chronic inflammatory diseases with prevalence rates of up to 5% in adults and approximately 25% in children. Pruritus is the defining symptom of AD with a point preference estimated at approximately 87% to 100%. And in a similar fashion to CKD associated pruritus, current treatments across the AD patient spectrum fall short, consisting of topical corticosteroids, high dose antihistamines or antidepressants.
In July, we initiated randomized double-blind placebo-controlled Phase II study designed to evaluate the efficacy and safety of oral KORSUVA in moderate to severe pruritus and approximately 240 patients with atopic dermatitis. Subjects were randomized to three tablet strengths of Oral KORSUVA of 0.25 mgs, 0.5 milligrams and 1 milligram taken twice daily versus placebo for 12 weeks followed by a four week active extension phase.
The primary efficacy endpoint is the change from baseline in the weekly mean of the daily 24 H-NRS or I-NRS score at week 12 of the treatment period and secondary endpoints include change from baseline and itch-related quality of life scores as assessed by the total Skindex-10 and 5-D itch scales as well as a proportion of patients achieving an improvement from baseline of at least four points, with respect to the weekly mean of the daily 24-hour I-NRS score at week 12.
We do expect this trial to be fully enrolled next quarter and we expect top line data readout later in 2020. We also recently initiated a Phase II trial in patients with pruritus with hepatic impairment due to PBC. Pruritus is a common symptom of cholestatic liver diseases with 20% to 30% of patients experiencing pruritus, but with the prevalence of up to 70% in patients with PBC. The Phase II multi-center, randomized, double-blind, placebo-controlled 16-week trial is designed to evaluate the safety and efficacy of 1 milligram tablet of Oral KORSUVA taken twice daily versus placebo in approximately 60 patients with PBC and moderate to severe pruritus.
The primary efficacy endpoint in this trial is the change from baseline in the weekly mean of the daily 24-hour worst itch NRS score at week 16 and secondary endpoints include change from baseline in itch-related quality of life scores as assessed by the total Skindex-10 and 5D-itch scales as well as the assessment of proportion of patients achieving an improvement from baseline of at least three points with respect to the weekly mean of the daily 24-hour worst itch NRS score at week 16 and we aim to report top line data from this trial in 2020.
So overall we are encouraged by our progress this past quarter. Our clinical team is working hard to execute on several key milestones in the coming weeks and months, which will position us for a significant events this quarter and into 2020. And in addition our successful follow-on financing has significantly strengthened our balance sheet and positioned the company well to achieve our late-stage development and regulatory goals through 2020.
And with that, I will now turn the call over to Mani, who will discuss our financial results for this quarter in more detail. Mani?
Mani Mohindru -- Chief Financial Officer and Chief Strategy Officer
Thank you, Derek, and good afternoon, everyone. As a reminder, the full financial results for the third quarter of 2019 can be found in our press release issued today after the market closed. For the third quarter of 2019, we reported a net loss of $32.8 million or $0.74 per basic and diluted share compared to a net loss of $19.4 million or $0.51 per basic and diluted share for the same quarter of 2018.
For the third quarter of 2019, we recognized revenue of $5.8 million compared to $5.1 million for the same quarter of 2018. For the third quarter of this year, we reported R&D expenses of $36 million versus $22.3 million in the same period of 2018. The increase in the third quarter of 2019 was primarily due to the upfront payment of $8 million related to the license agreement with Enteris, a net increase in clinical trial costs as well as increases in stock-based compensation expense and payroll-related costs.
G&A expenses were $4.2 million during the third quarter of 2019 compared to $3.2 million in the same period of 2018. The increase in 2019 was due to higher consulting and accounting fees as well as increases in stock-based compensation expense. Other income was $1.3 million for the third quarter of 2019 versus $1 million for the same period of prior year resulting from an increase in interest and accretion income due to higher average balance of our investment portfolio for the 2019 period.
As of September 30th, 2019, our cash, cash equivalents and marketable securities totaled $249.1 million compared to $182.8 million at December 31st, 2018. This increase in the balance of cash and marketable securities primarily resulted from net proceeds of $136.5 million from the follow-on offering of common stock in July of 2019 and proceeds of approximately $6.1 million from the exercise of stock options that was partially offset by cash used in operations of $78.1 million.
Now turning to our financial expectations. Based on the projected cost of our clinical development plans and timing expectations, we expect that our current cash, cash equivalents and marketable securities as of September 30th, 2019 will be sufficient to fund our operations into the second half of 2021 not accounting for any potential milestone payments under our existing collaborations.
I'll now turn the call back over to Michelle for Q&A session.
Questions and Answers:
Operator
[Operator Instructions] Our first question comes from Chris Howerton of Jefferies. Your line is open.
Christopher Howerton -- Jefferies -- Analyst
All right. Well, I guess, I stayed on the phone line. Thank you, Mani and Jane for the background. Anyway, thanks for taking the questions as well. I think for me, just a couple. So, for Derek, I think, last time we spoke, there was some potential for a discussion with the FDA regarding accelerated approval and also potentially some discussion about an abbreviated safety database. So, just checking and to see maybe if you had that discussion with the FDA and if any of those thinking has evolved over time?
Derek Chalmers -- Chief Executive Officer, President and Director
Right. Hey Chris, thanks for the question. I think what you're referring to is the idea with the Oral KORSUVA program for pre-dialysis patients. There our thought is from a regulatory perspective that the exposures we've already achieved with IV would be credited toward an NDA for Oral KORSUVA for the pre-dialysis population.
So the thought was for that particular application with Oral KORSUVA that would be the possibility and again this is obviously up to the FDA per consultation, but the possibility that we could file an SNDA in relation to that particular patient population whereby we could reference the safety exposures we've already achieved with IV, that's where we think we have a possibility of an abbreviated or shortened NDA not with our KORSUVA Injection program, where our plan has been all along and still is despite the fact we have a breakthrough designation.
We take the conservative view here. We're going to have two large Phase III trials in relation to the efficacy component and we're going to achieve ICH guidelines in terms of both overall exposures and long-term both overall exposures and long-term safety exposures. So that's our approach for both of those programs.
Christopher Howerton -- Jefferies -- Analyst
Got it. Okay. Well, thanks so much for the clarification, I guess. For the other question I would have maybe just related to the chronic liver disease just because I don't think that that's been discussed too much just maybe if you could give us some thoughts in terms of what a clinical and meaningful outcome would be in that patient population in particularly since we already seeing with the NRS reduction would be in chronic kidney disease. So, do you think that same type of magnitude is the type of effect one would expect and clinicians would hope to see or is it a different frame of reference?
Derek Chalmers -- Chief Executive Officer, President and Director
Yeah, and that's a great question, Chris. First of all, let me say right up front, of course, there is no available effect with therapies for that patient class as of yet.
So any therapy here is going to be an advancement. And when it comes to clinical meaningfulness, as you know, we are quite confident in relation to CKD-aP whereby we essentially empirically looked at clinical meaningfulness based on our Phase II data-set really at the request of the FDA when we were in discussions related to breakthrough designation.
And there by virtue of that anchorage statistical analysis, we know the threshold for clinical meaningfulness in the CKD hemodialysis patient population as approximately three points. That's something we haven't looked at in lever, and so we're going to have endpoints that do accommodate both three point and four point reductions. And as you know, four point has been the dogma in relation to dermatological indications. There hasn't been a great deal of data related pruritus in liver patients, but we're going to look at both thresholds within that patient population.
Christopher Howerton -- Jefferies -- Analyst
Got it. Okay. All right. Well, thanks for taking my questions, and I'll hop back in the queue. I appreciate it.
Derek Chalmers -- Chief Executive Officer, President and Director
Thanks, Chris.
Operator
Our next question comes from Jason Gerberry of Bank of America. Your line is open.
Chi Fong -- Bank of America -- Analyst
Hey thanks for taking the question. This is Chi on for Jason. Two from me. I guess on the DSMB recommendation to increase the enrollment size by roughly 23% for KALM-2. Maybe if you can help us -- help walk us through how that is derived and whether that enrollment expansion does or does not have a different expectation for treatment effect size compared to what we have seen from KALM-1. And the second question is on atopic derm. I was just curious where do you see Oral KORSUVA fit into the pipeline where there are about perhaps a dozen of biologic and oral targeted immunomodulators in the mid to late-stage development for atopic derm? Thank you.
Derek Chalmers -- Chief Executive Officer, President and Director
Okay. Thanks, Chi. So on the first question. So the IDMC recommendation that we increased the sample size and that was based on a conditional power analysis. So there what we're trying to maintain is a very conservative level of power to see a statistical difference between the two groups.
From that analysis, there really is no influence as to what the odds ratio is at that point or the p-value is at that point is really analysis based on beta and not-alpha. So we're trying to make sure we, if you like, reduce the odds of missing a statistical difference.
So there is no read through if you like from having to increase the sample size to achieve that power as to the size of the effect size between the two groups there. So that's really just a beta analysis, it's not an alpha analysis in that format.
And to the second question in terms of AD, you're correct. There seems to be a new biologic for AD every other week popping up, but all of those biologics are essentially focused on the moderate to severe disease atopic population. And as you know that's the minority of that population with the vast majority been mild to moderate pathology.
And what we know and is well known in the literature and we certainly know from enrolling in our trial is that the degree of pruritus in the mild to moderate population can be very severe. And so there we think if you like our advantage is going to be as a novel option for the vast majority of atopic dermatitis patients, where biologics are simply not appropriate for that population.
And even within the moderate to severe AD population there may be an opportunity to use Oral KORSUVA in combination with the biologic for the most severe patients where they're not perhaps getting a more rapid response to the pruritus.
There we see no obstacle to use in our molecule or drug candidate with any of these biologics. As you remember, we don't have any metabolic issues with KORSUVA. It's not metabolized through the lever, there's very minimal opportunity for drug-drug interactions here.
So there's really two aspects to the strategy here. It would be a first-line therapy on and so on and treating pruritus moderate to severe pruritus really across the AD population. And for the more severe patient, it could be used in combination with any of the biologics.
Chi Fong -- Bank of America -- Analyst
If I may ask a follow-up question on that. Thanks for the color that you provided on the AD. Just curious, I know that you've said previously the Phase II main criteria is going to be focusing on the moderate or severe patients, but just curious how you're going to be able to leverage the enrollment criteria to make sure you have a healthy mix of them out to moderate and the moderate to severe end of Phase II? Thank you.
Derek Chalmers -- Chief Executive Officer, President and Director
Yeah, Chi, that's the magic of clinical trials. We can stratify within our groups to make sure we have the desired proportion of mild to moderate patients and moderate to severe patients within those groups and that's what we're doing.
Chi Fong -- Bank of America -- Analyst
Thank you.
Derek Chalmers -- Chief Executive Officer, President and Director
Thanks, Chi.
Operator
Our next question comes from David Amsellem of Piper Jaffray. Your line is open.
David Amsellem -- Piper Jaffray -- Analyst
Thanks. So, wanted to delve a little further into the upsizing of the KALM-2 study and forgive me if you addressed this in some way or even tangentially, but I wanted to get your thoughts, Derek, on what could explain the fact that KALM-1 was not upsized, but this was upsized and I guess some kind of theorizing that because you have the European site in KALM-2 and as these are patient-reported outcomes, measures that there might be some variability between the two studies. And I'm just wondering, if you think that, that is something that holds any weight or there might be something else going on?
Derek Chalmers -- Chief Executive Officer, President and Director
Yeah. Thanks, David. You've come up with what we regard as one of the most likely explanations although I have to say we don't have any empirical data.
As you know, we don't see any data as part of this interim conditional power assessment as all with the IDMC. But as you well know there's a historical data out there particularly with patient reported outcomes that they can be differences in response rates in certain regions of Europe versus the US.
Our assumption is because really the only main difference between the KALM-2 and KALM-1 they're pretty much analogous in design and size is that we've included some ex-US sites in the KALM-2 trial. Our assumption is that we've introduced some additional variability by virtue of having those sites in the trial.
David Amsellem -- Piper Jaffray -- Analyst
Okay. All right. That's helpful. And then another question switching gears to the oral and I wanted to get your thoughts on atopic derm, in particular. I mean one thing that especially in these populations and with patient for reported outcomes that we're mindful over placebo responses. Is it your view that in the atopic derm setting, we're more likely to see a more healthy placebo response, if you will compare to the more severely ill CKD and PBC patients. How do you think about that?
Derek Chalmers -- Chief Executive Officer, President and Director
Yeah, that's a good question, David. I don't know if I have any rationality to sway me one way or the other. We just don't have enough data yet in AD to come up with any of that in terms of placebo rates. What I can say is, based on our study so far, which as you know have focused on CKD, we do tend to see similar placebo rates across trials for this particular outcome for pruritus.
So, that is one piece of data. We do have as of yet I can't give you data empirically across patient populations, but that's something we're going to get to next year and we'll have that data available. But we just don't have enough data to know whether the degree of response and placebo is going to be related to the degree of pathology or the duration of that pathology and the patient and that's all data we were interested in and have thought about, but it's just the data we don't have yet.
But as I said a couple of times on these calls, we think by virtue of where we act in the pruritus pathway, we really should have the ability to, if you like, benefit the pruritic response by virtue of the kappa activity, not only in those sensory afference but also on immune cells.
So there should be a dual benefit to the patient regardless of what the initiating pathology is there. So that's the theory. And in a couple of quarters time, I guess, we're going to have the data, we can discuss that in real empirical detail.
David Amsellem -- Piper Jaffray -- Analyst
Okay. And then one last question is another hypothetical to the extent that you do get a good signal in atopic derm. How does that inform your thinking regarding pruritus? We're exploring for treatment of pruritus in other dermatologic indication such as say psoriasis or in smaller populations like prurigo nodularis. How do you think about that?
Derek Chalmers -- Chief Executive Officer, President and Director
Yeah. Again, I think, we have a mechanism that should be broadly applicable by virtue of how we work and are ultimately and I know you and I have discussed this a couple of times.
I think our ultimate aim for KORSUVA and treating pruritus for Oral KORSUVA is the -- if our theory is true and we are broadly applicable then at some point we should have a broad label for the molecule, which would be somewhat analogous to the old approach for chronic pain medications. So, our belief, if we ensure efficacy across these major pruritic parts of systemic disease related-pruritus, dermatological related-pruritus, neuropathic related-pruritus then we could make a strong case that this is a molecule.
They should have a broader label on them, we can see application really across the spectrum of pruritic conditions. So that's the approach we're taking broadly at this point, but obviously we are focused on patient populations where we think we have the most promise and seen a response and CKD was an obvious place to start. There was a great deal of, if you like, validating information related to the mechanism and then there's also some interest in data related to atopic dermatitis and kappa that makes us think that could be an interesting patient population also, but ultimately I think if the mechanism is broadly applicable, we'd like to see this with a broad label.
David Amsellem -- Piper Jaffray -- Analyst
Great. Thanks, Derek.
Derek Chalmers -- Chief Executive Officer, President and Director
Thanks, David.
Operator
Our next question comes from Annabel Samimy of Stifel. Your line is open.
Annabel Samimy -- Stifel -- Analyst
Hi, thanks for taking my question. I don't know if you answered this earlier, but have you had that FDA meeting in the fall and I know you have a breakthrough destination. Did you mention that you were able to gain fast track some kind of fast track status from them or are we still waiting to hear about that?
Derek Chalmers -- Chief Executive Officer, President and Director
Yeah, now we are not lined up for fast track status in relation to the KORSUVA Injection program that's not something we're counting on.
And I would say in earlier Annabel, we've really taken the conservative view that we need to follow ICH guidelines here and we've designed the program that way to make sure that when we file, this is a very robust package that goes to the agency with all the appropriate requirements in terms of overall exposures and long-term exposures within it.
So, we're not counting on fast track exposure, where we would see a benefit with breakthrough and something we're certainly going to apply for would be priority review once we filed the NDA and that's certainly something we're going to be looking for, but at this point, we're not counting on fast track status.
Annabel Samimy -- Stifel -- Analyst
Okay. Actually, I meant priority review first. Thanks for clarifying that. But OK secondly I know that you would mention that with the new powering of KALM-2, you're not, it's really not alpha, it's the beta that you're really aiming for. But I mean maybe I can ask it a little bit differently to what level do you think delta can drop and still reach statistical significance for KALM-2? Maybe you can help us think about it that way.
Derek Chalmers -- Chief Executive Officer, President and Director
Well, I don't know, if I can have an answer to that. I'm not qualified statistically to give you that answer, Annabel. Let me just say that we powered both trials similarly based on our Phase II effect sizes or odds ratio. So, they're both powered if you like with the same assumptions within it. And obviously our assumptions in relation to standard deviation were based on our US Phase II and we did apply that both to our US KALM-1 and our global KALM-2. So there might be some differences there that weren't accommodated in those assumptions. But the actual effect size or odds ratio, we've modeled on, we didn't change between the two trials.
And again we said the power threshold at a conservative level is not really related to again a statistical difference here. We're increasing the likelihood that we can see a difference. And from that, I really can't derive an alpha value. I'm sure there's some smart statisticians who could based on some of the data, but they all reside in our IDMC. So, we don't see any of that data, and so this is really a means to reduce the odds of a mess, if you like.
Annabel Samimy -- Stifel -- Analyst
Okay. All right. And then just on the last question I have is related to the commercial partnership we have with Vifor Fresenius. Are there any other activities that are going on in the background their side or there any future milestones you might be expecting on some of the clinical data readout that we should be looking forward to? And just correct me, please. I can't remember if they had any opt-in rights for the oral for the CKD population. If you could just clarify that for us, please?
Derek Chalmers -- Chief Executive Officer, President and Director
Yeah, right. So, Annabel, the last point just to be clear, they have no opt-in rights for the oral, for anything that with hemodialysis patients. So, that license is solely based on KORSUVA Injection. So that formulation specifically for hemodialysis patients with CKD-aP.
So there is no opt-in rights there. And in terms of activities between the two companies we do have ongoing discussion in relation to that, particularly as to how we're going to deal logistically with the co-promotion here in the US where, as you know, we got -- we have a 50-50 split in terms of Fresenius clinics in the US.
So that's an ongoing discussion milestones related to development of regulatory. And as we said before, so regulatory milestones, yes, when we get to that point, and then of course commercial sales milestones in the licensed territory, which is ex-US, Europe predominantly, some other territories and then sales tiered by, sorry, sales royalties tiered by sales amounts, if you like in the licensed territory. So that's how that relationship was drafted.
Mani Mohindru -- Chief Financial Officer and Chief Strategy Officer
Let me just add. The next set of milestones is around $30 million tied to the regulatory outcomes, yeah.
Annabel Samimy -- Stifel -- Analyst
Is it just outcome or a filing?
Derek Chalmers -- Chief Executive Officer, President and Director
It's an outcome. It's an outcome.
Mani Mohindru -- Chief Financial Officer and Chief Strategy Officer
Outcome, yeah.
Annabel Samimy -- Stifel -- Analyst
Okay. All right. Great. Thank you.
Operator
Our next question comes from Charles Duncan of Cantor Fitzgerald. Your line is open.
Pete Stavropoulos -- Cantor Fitzgerald -- Analyst
Hi. This is Pete Stavropoulos on for Charles. One question I have for Oral KORSUVA in the CKD-aP pre-dialysis study. You have varying degrees of kidney function which can affect elimination of the drug. Do you anticipate the varying degrees of kidney function make somehow confound the results both from the safety and efficacy point?
Derek Chalmers -- Chief Executive Officer, President and Director
No. Hey, Pete, that's a great question. It was actually one of the reasons that before we started the Phase II, we actually ran a PK study, a Phase I study specifically within these pre-dialysis stage 3 to 5 patients. And there, you are correct, there is some degree of variability in kidney function there, but not enough to change our dosing regimen for all of those patients from once a day.
It's really a question of the length of the beta phase on the elimination of 845, and you're correct, that's almost totally via the kidney. But we did, per PK analysis, we really can cover all of those patient types with once a day dosing with Oral KORSUVA.
Pete Stavropoulos -- Cantor Fitzgerald -- Analyst
Okay. Thank you.
Derek Chalmers -- Chief Executive Officer, President and Director
Thanks, Pete.
Pete Stavropoulos -- Cantor Fitzgerald -- Analyst
And one second. You announced an oral presentation at Kidney Week 2019. What kind of [Indecipherable] should we anticipate seeing there?
Derek Chalmers -- Chief Executive Officer, President and Director
You're going to see a little more detailed KALM-1 data and that will be presented by one of the KALM-1 PIs, Dr. Stephen Fishbein on Friday afternoon at ASN.
Pete Stavropoulos -- Cantor Fitzgerald -- Analyst
All right. Thank you. Congrats on the quarter.
Derek Chalmers -- Chief Executive Officer, President and Director
Thanks, Pete.
Operator
Our next question comes from Alan Carr of Needham & Company. Your line is open.
Joseph Stringer -- Joseph Stringer -- Analyst
Hi. This is Joey on for Alan. Thanks for taking our questions. So, for the Oral KORSUVA Phase II, what effect size on H-NRS are you -- do you expect to see based on some of the PK -- earlier PK work that you've done just in terms of number of patients with greater than three point improvement in worst itch NRS. Would you sort of expect it to be similar to what was observed in KALM-1 around 50%?
Derek Chalmers -- Chief Executive Officer, President and Director
Yeah. Thanks, Joey. I mean I won't have the -- I don't have the answer for that today, but we will have the answer to that very, very soon in terms of the absolute number there. But again our assumptions on design and the oral Phase II trial were really based on data we had from our IV experience within CKD patients. So, if you like the effect size, we've modeled that on is related to the IV effects as you're correct in that assumption. And the other comforting aspect of the Phase II data set, of course, as you know we completed our interim conditional power assessment in July of this year specifically within the Phase II trial and there we didn't increase the sample size to maintain our conservative power to see a difference between the groups.
So that makes us feel good that we -- our assumptions based on IV to oral were actually viable and appropriate and we were in the ballpark of high-power, high-beta to see a statistical difference.
Joseph Stringer -- Joseph Stringer -- Analyst
Great. Thanks. And just as a follow-up. Would you be disclosing Skindex-10 and 5-D itch data in the top line as well?
Derek Chalmers -- Chief Executive Officer, President and Director
Yes, we will. We will certainly have the main primary obviously and the main secondary endpoints.
Joseph Stringer -- Joseph Stringer -- Analyst
Great. Thank you.
Derek Chalmers -- Chief Executive Officer, President and Director
Thanks, Joey.
Operator
Our next question comes from Esther Hong of Janney. Your line is open.
Esther Hong -- Janney -- Analyst
Hi. First question, so as we get closer to data from the Phase II trial about Oral KORSUVA and non-dialysis patients and assuming that it's positive and initiation is set to kick off next year of Phase III, if it is positive, what would a Phase III trial design look like?
Derek Chalmers -- Chief Executive Officer, President and Director
Thanks, Esther, I mean, that's really going to be based on what we see in our Phase II data. And as you know, the Phase II is really a dose ranging trial. We have our ideas based on exposure as to which tablet strength should be appropriate, but we really need that empirical data to see what's the most appropriate tablet strength to carry forward into Phase III.
So that's the first question we need to answer from our Phase II. We're obviously looking for sustainability of effect and that's why we run this Phase II as if you kind of like a Phase III like 12-week treatment period. So we are going to get valuable data there, that's going to establish sustained effect, which is important for us.
And based on these types of data outputs and also as far the effect size we see within that trial that will dictate the powering requirements we need, and therefore the sample size to run the Phase III. So we really need the Phase II data, which is not too far now and before we think about what the design of the Phase III looks like.
But in terms of treatment period, it is going to be analogous to what we've just run in our Phase II by design.
Esther Hong -- Janney -- Analyst
All right. And then what can we expect at the World Congress of Itch meeting this month? Maybe just kind of?
Derek Chalmers -- Chief Executive Officer, President and Director
You can expect to see some really nice data from us. You are going to see.
Mani Mohindru -- Chief Financial Officer and Chief Strategy Officer
More analysis of the Phase II IV study.
Derek Chalmers -- Chief Executive Officer, President and Director
Yeah. You're going to see some analysis on sleep responses from our eight-week Phase II study in hemodialysis patients. You're going to see some more quality of life data presented there also in poster format. And as I just discussed with Joey and Pete, the KALM-1 data-set is going to be an oral late-breaker and you're going to see a little more detail from our KALM-1 Phase III trial.
Esther Hong -- Janney -- Analyst
Okay, great. Thank you.
Derek Chalmers -- Chief Executive Officer, President and Director
Thanks, Esther.
Operator
Our next question is a follow-up from Chris Howerton of Jefferies. Your line is open.
Christopher Howerton -- Jefferies -- Analyst
Hey, thanks for taking the follow up. Just really quick I just wanted to follow-up on Annabel's question with respect to the meeting in the fall with the FDA. Was there -- and do we have that wrong that there was going to be a meeting and if not or if there was meeting have you had that -- what were you're hoping to get alignment there. Just maybe a clarification for that or set it straight, I suppose?
Derek Chalmers -- Chief Executive Officer, President and Director
Yeah, Chris, I'm not sure what meeting in the fall you're referring to, but with the respect to change in the status of the application and trying to go for accelerated or some sort of advanced filing mechanism. That's not something we have in mind.
We do have communications with the FDA on the logistics of how we're going to file our data and the various modules and those are going along fine and we have all the answers we need in terms of moving forward. But there wasn't a specific meeting related to accelerated approval.
Christopher Howerton -- Jefferies -- Analyst
Okay. Great. Totally makes sense, I guess, made it up then. I appreciate the clarification. Thanks for the color.
Derek Chalmers -- Chief Executive Officer, President and Director
All right, Chris. Thank you.
Operator
There are no further questions. I'd like to turn the call back over for any closing remarks.
Derek Chalmers -- Chief Executive Officer, President and Director
Okay. So thank you, everybody for joining us today. I'd like to thank the Cara team, our study investigators, and most importantly the patients who participate in our trials for their continued commitment and support and we look forward to updating everybody again very soon. Thank you everybody. Have a good day.
Mani Mohindru -- Chief Financial Officer and Chief Strategy Officer
Thank you.
Operator
[Operator Closing Remarks]
Duration: 47 minutes
Call participants:
Jane Urheim -- Investor Relations
Derek Chalmers -- Chief Executive Officer, President and Director
Mani Mohindru -- Chief Financial Officer and Chief Strategy Officer
Christopher Howerton -- Jefferies -- Analyst
Chi Fong -- Bank of America -- Analyst
David Amsellem -- Piper Jaffray -- Analyst
Annabel Samimy -- Stifel -- Analyst
Pete Stavropoulos -- Cantor Fitzgerald -- Analyst
Joseph Stringer -- Joseph Stringer -- Analyst
Esther Hong -- Janney -- Analyst
