Minerva Neurosciences (NERV) Q4 2020 Earnings Call Transcript

Minerva Neurosciences (NERV -0.78%)
Q4 2020 Earnings Call
Mar 08, 2021, 8:30 a.m. ET

Contents:

• Prepared Remarks
• Questions and Answers
• Call Participants

Prepared Remarks:

Operator

Welcome to Minerva Neurosciences year-end 2020 conference call. [Operator instructions] There will be a question-and-answer session following today's prepared remarks. This call is being webcast live on the investor section of Minerva's website at ir.minervaneurosciences.com. As a reminder, today's call is being recorded.

I would now like to turn the call over to William Boni, vice president of investor relations and corporate communications at Minerva. Please proceed.

William Boni -- Vice President of Investor Relations and Corporate Communications

Good morning. A press release for the company's fourth-quarter and year-end 2020 financial results and business highlights became available at 7:30 Eastern time today and can be found on the investor section of our website. Our annual report on Form 10-K was also filed electronically with the Securities and Exchange Commission this morning and can be found on the SEC's website at www.sec.gov. Joining me on the call today from Minerva are Dr.

Remy Luthringer, executive chairman and chief executive officer; and Mr. Geoff Race, executive vice president, chief financial officer, and chief business officer. Following our prepared remarks, we will open the call for Q&A. Before we begin, I would like to remind you that today's discussion will include statements about the company's future expectations, plans, and prospects that constitute forward-looking statements for purposes of the Safe Harbor provisions under the Private Securities Litigation Reform Act of 1995.

We caution that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those indicated. These forward-looking statements are based on our current expectations and may differ materially from actual results due to a variety of factors that are more fully detailed under the caption, Risk Factors, in our filings with the Securities and Exchange Commission, including our annual report on Form 10-K for the year ended December 31, 2020 filed with the SEC earlier today. Any forward-looking statements made on this call speak only as of today's date, Monday, March 8, 2021, and the company disclaims any obligation to update any of these forward-looking statements to reflect events or circumstances that occur after today's call, except as required by law. I would now like to turn the call over to Remy Luthringer.

Remy Luthringer -- Executive Chairman and Chief Executive Officer

Thank you, Bill, and good morning, everyone. Thanks for joining us today. I'm very pleased to present an update on progress and our earnings report for the full-year 2020. In May last year, we announced top-line results from the double-blind portion for the phase 3 trial with roluperidone and negative symptoms of schizophrenia.

Although the study did not meet statistical significance, we remained highly encouraged by the promising signals that emerged. We look forward to sharing data from the phase 3 nine-months open-label extension, which will be available in the first half of this year. Following our Type C meeting with the FDA in November 2020, during which the FDA cautioned us that an NDA submission based on the then-current data from the phase 2b and phase 3 studies would be highly unlikely to be filed, we continue our dialogue with the agency. We are providing information to the FDA on several topics highlighted in the meeting minutes.

Furthermore, we will also initiate a pivotal bioequivalence study with approximately 48 healthy volunteers, comparing the formulation employed in the phase 2b and phase 3 trials, as well as at least one new formulation designed in conjunction with our commercial supply partner, Catalent, Inc., to facilitate large scale manufacturing. We are working to address the FDA's requests and comments and we are motivated by the agency's encouragement to continue the development of roluperidone for the treatment of negative symptoms of schizophrenia. Among emerging therapies in development for negative symptoms, roluperidone is the most clinically advanced. We remained committed to bringing roluperidone as quickly as possible to patients in need of such a treatment.

We're looking forward to 2021 with a significantly improved cash position following the recent sale of our rights to the seltorexant's royalty to Royalty Pharma, from which we received $60 million upfront and will receive a further $95 million subject to the achievement of certain milestones. First, I would like to provide a more detailed update on our lead program, roluperidone, a drug which has the potential to treat negative symptoms. Our primary objective in 2021 is to continue the development path forward to meet the regulatory requirements to submit an NDA for roluperidone. First, the nine-months open-label extension of the phase 3 trial has been completed on schedule a few weeks ago, and I am happy to report that no patient was discontinued due to COVID-19 illness.

The total of 333 patients, around 65% of those enrolled, ended the nine-month open-label extension, in which those patients already being treated with roluperidone remained on treatment on the same dose received in the 12-week double-blind phase, 32 milligram and 64 milligram. Those patients who received placebo in the 12-week double-blind phase were randomized to either 32 milligram or 64 milligram. We are very pleased that a total of 202 patients, around 61%, completed the open-label extension of the study. Data are expected to be available in the first half of 2021.

These data are important because as we observe interface to this six-months extension, they may demonstrate if improvement of negative symptoms is sustained or increased over the one-year duration, if improvement of negative symptoms leads to improved functioning, whether roluperidone maintains or improves positive symptoms and or agitation, and whether the safety and tolerability profile of roluperidone is maintained over the one-year administration period. I look forward to sharing a detailed presentation of the findings when data become available. In parallel, we continue to move forward with activities necessary to support the submission of a new drug application for roluperidone. First, we intend to initiate the bioequivalence study I described earlier.

Importantly, we believe that by showing bioequivalence across formulations, we will address the specific comment made by the FDA about the phase 2b formulation. Second, we are in the process of submitting the requested scientific literature in support of the psychometric properties of the primary and key secondary endpoints used in our clinical development as requested by the FDA. Following the completion of the pivotal bioequivalence study, we plan to request the pre-NDA meeting with the FDA to discuss certain matters, including data from the phase 3 open-label extension, data from the bioequivalence study, and potential NDA submission of roluperidone for the treatment of negative symptoms of schizophrenia. I will now move on the recent developments in the seltorexant program.

You will remember that in mid-2020, Minerva exercised its right to opt-out of a joint development agreement with Janssen for the future development of seltorexant. As a result, we are entitled to collect mid single-digit royalties on potential future worldwide sales in certain indications with no further financial obligations to contribute development costs to Janssen. On January 19 of this year, we announced that Royalty Pharma had acquired Minerva's royalty interest in seltorexant and that we received an upfront payment of $60 million, with the potential to receive up to further $95 million in additional payments contingent on achieving certain clinical, regulatory, and commercialization milestones. Seltorexant is currently in phase 3 clinical development by Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson, for the adjunctive treatment of major depressive disorder with insomnia symptoms.

We are delighted to have partnered with Royalty Pharma, the leader in acquiring pharmaceutical royalties across the life science industry. It has enabled us to secure significant nondilutive funding, both immediate and potentially over the long term, that would support our top priority, the continued development of roluperidone, our lead asset. In summary, we remained committed to developing roluperidone as a potentially transformative treatment in the treatment of the negative symptoms of schizophrenia. I look forward to sharing data from the phase 3 open-label extension with you soon and the pivotal bioequivalence study in this coming months, as well as continuing to update our investors on the ongoing dialogue with the FDA.

I will now turn it over to Geoff to discuss our financial performance.

Geoff Race -- Executive Vice President, Chief Financial Officer, and Chief Business Officer

Thank you, Remy. Earlier this morning, we issued a press release summarizing our operating results for the fourth-quarter and year ended December 31, 2020. A more detailed discussion of our results may be found in our annual report on Form 10-K filed with the SEC earlier today. Cash, cash equivalents, and restricted cash as of December 31, 2020 were approximately $25.5 million, compared to $46 million as of December 31, 2019.

In January 2021, the company received the $60 million cash payment from Royalty Pharma in connection with their acquisition of the company's royalty interest in seltorexant. We presently expect that the company's existing cash and cash equivalents, which include its financial resources at year-end 2020, combined with the $60 million payment received in January from Royalty Pharma will be sufficient to meet its anticipated capital requirements for at least the next 12 months from today based on our current operating plan. The assumptions upon which this estimate is based are routinely evaluated and may be subject to change. Research and development expenses were $3.6 million and $28.5 million for the fourth quarters of 2020 and 2019 respectively.

R&D expenses were $22 million and $58.1 million for the years ended December 31, 2020 and 2019 respectively. The decrease in R&D expense for the fourth quarter ended December 31, 2020 was primarily due to a $19 million charge taken in December 2019 for the impairment of the in-process research and development related to MIN-117 following the results of the phase 2b tried in MDD which failed to meet its primary and key secondary endpoints. The decrease in R&D expense for the year ended December 31, 2020 was due also to the approximately $11 million from the completion of the phase 2b clinical trial of MIN-117 in December 2019 and the completion of the double-blind portion of the phase 3 clinical trial of roluperidone in May 2020. Noncash-stock compensation expense included in R&D expenses was $3 million and $2.6 million for the years ended December 31, 2020, and 2019, respectively.

G&A expenses were $3.7 million and $3.8 million for the fourth quarters of 2020 and 2019, respectively. G&A expenses were $17.36 million and $17.7 million for the years ended December 31, 2020, and 2019, respectively. The decreases in G&A expenses for the fourth quarter and year ended December 31, 2020, were primarily due to lower pre-commercial expenses in 2020, offset by higher insurance costs. Noncash-stock compensation expense included in G&A expenses was $6.7 million and $6.5 million for the years ended December 31, 2020, and 2019, respectively.

Net loss was $7.3 million for the fourth quarter of 2020 or loss per share of $0.17 basic and diluted, compared to net loss of $29.9 million for the fourth quarter of 2019 or loss per share of $0.77 basic and diluted. Net income was $1.9 million for the year ended December 31, 2020, or income per share of $0.05 basic and diluted, compared to a net loss $72.2 million or loss per share of $1.85 basic and diluted for the year ended December 31, 2019. Collaborative revenue was $41.2 million and $0 for the years ended December 31, 2020, and 2019, respectively. The increase in collaborative revenue was the result of the company's exercising its right to opt out of the co-development agreement with Janssen during 2020.

As a result of the opt-out, the company has no further performance obligations and recognized revenue of $41.2 million which had previously been included on its balance sheet under deferred revenue. Now, I'd like to turn the call over to the operator for any questions. Operator?

Questions & Answers:

Operator

[Operator instructions] Our first question comes from the line of Tom Schrader with BTIG. Your line is now open.

Julian Harrison -- BTIG -- Analyst

Hi, this is Julian on for Tom. Thank you for taking my questions. I'm wondering if there are any data points from the upcoming open-label extension analysis that could maybe specifically address some of the pushback you got from the FDA in your recent Type C meeting. And then on the bioequivalent study, is it fair to assume this is the gating step to filing an NDA, or would the CMC package here likely be the last detail?

Remy Luthringer -- Executive Chairman and Chief Executive Officer

Hi, Remy speaking. So, obviously great questions. I -- I really think there's there's a -- indeed, you're -- you're right. I mean, the extension data will be really very encouraging to us because as, you know, negative symptoms is a chronic part of the disease and you need to really demonstrate that immediate effect is sustained over time, yeah? So, as I -- I mentioned in my -- in my presentation, I mean, we are really looking forward to check again because we have already the latest data from the phase 2b.

Remember we had six months extension on top of that three months or 12 weeks double-blind phase. So, we could see in this study a -- a continuous improvement that the negative symptoms. And also, obviously an improvement in terms of functioning. So -- so, first of all, I mean, we will be able to confirm that the negative symptoms continue to improve.

Second, does this transform into a functional improvement and as you know, what is really important is that these patients are able to function again that they can go back to have a job as of to have a decent family life. The functioning is extremely important. So, we will be able to check this because we are measuring PANSS and PSP all along as the -- the extension of the -- of the 9-month extension, so we will have data for one year. We will also be able to -- to check what is going on in terms of positive symptoms and what we can call relapses to see if I mean, we -- we have a limited number of relapses as we head in the phase 2b.

So, this will be obviously very important. And last but not least, as you know, I mean, we -- we really put this extension in place to -- to confirm the -- the efficacy data but also to check the box about 12-month exposure of other drugs. So, we would also be able to -- to check in terms of safety, yes, and long-term safety, yeah? So -- so, in my opinion, extremely important data. And if you remember, yes indeed, it's no longer placebo-controlled but it is still blinded for the doses.

So, we will review to have the possibility to -- to check between 64 mg and -- and 32 milligram. And for your second question about the bioequivalence study, yes indeed, I think this is really is a -- is important study. If we can -- as in this preliminary study we did some time ago, demonstrate again bioequivalence between the different formulations. I think this is really the -- the driver of moving toward the pre-NDA meeting.

Julian Harrison -- BTIG -- Analyst

Great. Thank you.

Operator

Thank you. Our next question comes from the line of Jason Butler with JMP Securities. Your line is now open.

Jason Butler -- JMP Securities -- Analyst

Hi, thanks for taking the -- the questions. A couple on the open-label extension. Can -- can you just give us a sense of how many patients from the placebo arm or the double-blind trial rolled over into the open-label extension? And then secondly, the -- how are you thinking about releasing the data? Will you released the data in conjunction with a medical meeting, or could we get it as soon as you've finished the analysis that you've outlined in -- in the press release? Thanks.

Remy Luthringer -- Executive Chairman and Chief Executive Officer

Good question, Jason. So -- so, clearly, I mean -- I mean, in terms of off-placebo patients who -- who went to -- to the extension phase, I think it was quite equivalent between the three treatment arms. So -- so, we had more or less the same number of placebo patients who switched to -- to either -- sorted to our 64 milligrams because this is what happens when they are going into the -- into the extension. And I think this data as -- as I think I -- hopefully, I -- I -- I was able to convince everybody.

I think these data are extremely important because this will be an -- an additional piece of information about the efficacy of -- of the molecule. I think we -- we will have a -- a specific announcement at the specific event but for this -- this release of this data because they are so important. So, as soon as we have the data available, we'll think about the best format to communicate the data.

Jason Butler -- JMP Securities -- Analyst

Great. And -- and -- and then just one more, Remy, on the mITT analysis. Any updated thoughts on, you know, or interactions with FDA or your advisors on the -- the -- the agency's willingness to accept the -- the analysis without the -- with -- excluding that single outlier site?

Remy Luthringer -- Executive Chairman and Chief Executive Officer

So, you know, as always, it's a matter of review, yes? Because yeah -- yeah, we go into the data more deeply. I mean, they will -- they will really check all the data we have to really confirm that I mean, this 17 patients is from this side that really means the assessment of efficacy as well as assessment of some vital signs if it was not done according to how it should have been done. So -- so, when you're looking to, you know, to what has been done in the past, particularly by -- by the psychiatric division. I mean, a lot of files -- a lot of NDAs have moved forward with modified ITT population, yes?.

I mean -- so -- so, clearly I mean, we are confident that I mean, these 17 patients should not be in the -- in the analysis and there are precedents were made by the FDA. Again, after -- after having reviewed very carefully the data, we're happy with our modified ITT population to be considered. So -- and -- and this is what came out basically from -- from the Type C meeting. It really confirmed that based on a matter of review, they are willing to consider ITT and mITT data.

Jason Butler -- JMP Securities -- Analyst

OK. Great. Thanks for taking the questions.

Remy Luthringer -- Executive Chairman and Chief Executive Officer

Thank you, Jason.

Operator

Thank you. Our next question comes from the line of Biren Amin with Jefferies. Your line is now open.

Jeet Mukherjee -- Jefferies -- Analyst

Yeah. Hey. Good morning, guys. This is Jeet on for Biren.

Just a couple of questions from me. Again, on that modified ITT point, were -- are there any specific examples of agents being approved in the neuroscience space that actually went ahead with their modified ITT analysis that perhaps included or excluded a group of patients? And just in terms of the open-label extension data, are we going to see endpoint data such as PSP or CGIS to kind of make the point on improvements in patient performance and -- and status? Thanks.

Remy Luthringer -- Executive Chairman and Chief Executive Officer

Yeah. So -- so, definitely there are precedents. I mean -- and as I just mentioned before, as I mean, in -- in the space of -- of -- of psychiatry and -- and specifically with psychotic division, yes? I mean, without going into the details -- but I mean, you have a -- approvals like Spravato, you have approvals like brexpiprazole. But I mean, definitely, the modified ITT population has been -- has been accepted by -- by the FDA, yes? So, again, I think we are not doing something special here.

I mean, what is important is that the FDA gets to confer this site, that this site did not provide plausible data. So -- so, this -- this is what -- what I can say about this. So, can you repeat the second question, sorry? I -- what is the second point you -- you --

Jeet Mukherjee -- Jefferies -- Analyst

Yeah. The second question was just on the -- the open-label extension data. Will we -- will we get a -- are we getting PSP and perhaps CGIS data just to talk about patient performance?

Remy Luthringer -- Executive Chairman and Chief Executive Officer

Sure. Sure. Yeah. So, I mean, as I mentioned before I mean, we -- we continued during the open-label to measure the all efficacy parameters including PANSS, PSP, CGI, and so on.

As -- I mean, so, technically, yes indeed. We will have this and I think we will be able to really to redemonstrate as we demonstrated already that the PSP improvement is very linked to the improvement of negative symptoms. So, if you remember, PSP total score was already significant into double-blind. But indeed, we will have all these data, we will have again the analysis of -- from whereas a functional improvement is coming.

Is it related to negative symptoms? And more specifically, you know, we will also have abolition there. So, all this will happen and will be presented definitely, yes.

Jeet Mukherjee -- Jefferies -- Analyst

Great. Thank you so much.

Remy Luthringer -- Executive Chairman and Chief Executive Officer

You're welcome.

Operator

Thank you. Our next question comes from the line of Joel Beatty with Citi. Your line is now open.

Joel Beatty -- Citi -- Analyst

Hi. Thanks for taking the questions. The first one is on bioequivalence. Could you compare the differences in the three different formulations for us from phase 2, phase 3, and then also if you plan to be in the commercial supply.

And then, you know, go along with that comparison, could you tell us about what you plan to show on the bioequivalence study to help confer FDA?

Remy Luthringer -- Executive Chairman and Chief Executive Officer

Yeah. So -- sorry, again, I mean, as you know, I mean, what we are trying to demonstrate is -- here that the exposure of the drug. So, the AUC of the drugs was a different formulation or the same because as I've mentioned in the past, I mean the efficacy when you're doing the PK/PD analysis. The efficacy of roluperidone is coming mostly from the parent compound that it is related to exposure to AUC and not at all to Cmax.

So, this is extremely clear from our PK/PD analysis which had been done by some key external people who are really specialists in the -- in the phase. So, that would -- what we -- what we tried to achieve between phase 2b and phase 3, if you remember, Joel, was to keep this AUC, which our preliminary, you know, PK. The study showed that we wanted to reduce the Cmax of the parent compound and one of the metabolites BFB-520 is because we wanted to even further improve the safety margin in terms of the effect on -- on QTc promulgation. So -- so, this is the difference between phase 2b and phase 3 formulation and we were able to do it.

Remember we presented this in one of our webcasts, where we could show that, I mean, we kept the AUC and we reduced Cmax of, again, parent -- and the -- and the -- and the BFB-526 metabolite. No -- no phase is a -- it could face three ends and the -- and the final formulation. Nothing -- nothing major has changed. It is just the same percentage of some ingredients and this should not change at all -- the bioequivalence.

So, it is really to confirm once more -- so I mean -- and we already have the information that I mean this is completely comparable between phase 3 and to find a formulation which is currently produced by Kopin. Hello?

Joel Beatty -- Citi -- Analyst

Got it. Thanks. And then -- and then one other question in the mITT for the 17 patients. Is -- is there any way to get a kind of like a real actual data from those patients or is that something that doesn't exist?

Remy Luthringer -- Executive Chairman and Chief Executive Officer

Sure. You have to explain to me what do you mean by real actual data. So -- so, can you be more precise?

Joel Beatty -- Citi -- Analyst

Well, I guess that's, you know, yeah. I -- I guess, you know, were -- were they -- I mean, it sounds -- it sounds like the data was so implausible that it doesn't reflect actual readings. So -- so, have you been able to confirm, for example, that those patients were -- were dosed in actual readings were -- and assessments were taken?

Remy Luthringer -- Executive Chairman and Chief Executive Officer

Sure, sure, sure, and that's OK. Now -- now I understand. So, basically, I think there is no doubt about it that those patients exist, where it is also clear that -- that it means a lot of the data for efficacy and for -- against vital signs have just been carried forward, that forms a baseline. So -- so, there is no modification of these data over time in which is completely implausible, yes? I mean, it's a -- clearly -- I mean -- and I gave some examples in the past.

So, clearly, I mean, the patients exist but the assessments have not been done in the right way.

Joel Beatty -- Citi -- Analyst

Thank you.

Remy Luthringer -- Executive Chairman and Chief Executive Officer

You're welcome, Joel.

Operator

Thank you. Our next question comes from the line of Myles Minter with William Blair. Your line is now open.

Myles Minter -- William Blair -- Analyst

Thanks for taking my questions and apologies for the background noise. This is a clarification question. I believe for the mITT analysis to be sort of accepted by the FDA that -- that would be a process for review but out of the exact same meaning, they're actually stating that the NDA in its current format would be unlikely to be filed. So, that would mean that it wouldn't get a review.

So, my -- my question is, is that the correct interpretation? And then, was the unwillingness to recommend the filing or acceptance of that filing -- was that just due to the fact you didn't have this open-label safety dataset on hand and -- and now you're taking the boxes and you have everything in place? Or -- or am I completely misinterpreting that? Thanks.

Remy Luthringer -- Executive Chairman and Chief Executive Officer

So -- so, I mean, you know, as you know, Minerva is a -- is an extremely transparent organization and we gave exactly the terms of what we received in the -- in the minutes. So -- so, this is a -- to answer one of -- one of -- one of your points. It is clear -- what I mean, the open-label data was not available at the time and we are really hoping that I mean, with this open-label data will be an additional piece of information confirming that I mean roluperidone is a -- is a -- is an efficacious drug. So -- so, afterward, I mean, we will go to the level of review.

I think, I mean, if you go according to these guidelines, some of this is guidance from the end of 2019. If we are able to convince the FDA about our phase to be data, this is obviously related to the -- to the bioequivalence study, which will make the phase to be a being one of the two studies you -- you have in your efficacy data package. If this shows bioequivalence, I mean, if we can demonstrate bioequivalence, I don't see really a reason why we could not move to that review process. So -- and this is what our advisors are telling us and, you know, what the FDA also says.

These are -- the -- I mean -- if, I mean, this goes to review, I mean, this will go to -- to an outcome. So, it's -- it's -- it's, I think, a dynamic process. As I mentioned in my -- in my presentation, we really are having a dialogue open busy every day. You know, we -- we gave them information about the type of metric aspects of the different scales, we gave them a whole.

I mean, we managed a calculation of the total score of PSP. So, it's a constant dialogue and I'm extremely confident that, I mean, if we are doing a great job in explaining even better our data and the way we have analyzed them and what is in the data, I think, we would have a positive year from the FDA and we would be able to move forward with the FDA.

Myles Minter -- William Blair -- Analyst

Yeah, understood. That's -- that's very helpful. And my second question is just on the bioequivalence study. I understand the last time you were talking about that to us it was around about 36 patients and now it's gone up to 48.

Is that just an additional cohort for their commercialization formulation or are there added patients for some other age in that trial? Thanks very much.

Remy Luthringer -- Executive Chairman and Chief Executive Officer

Yeah. So, some of those running -- when we spoke together, I mean, you know, I was speaking about the guideline. No, we have done a -- a repower calculation -- powering calculation, sorry, and it ends up with 48 subjects. So, we are -- we are going to the safe side, basically.

I mean, having more and more subjects or healthy subjects because you're not leading these patients here, it's -- it's healthy subjects. So, it's -- the powering, it is indicated that 48 is the number to go on this year. Obviously, as you know, because this is of a controlled trial whereas a subject is his own control. And basically, here you -- you might go to have some drug policies.

I mean, you never know it becomes how to go to find a job and he does not want to do period three. So -- so, clearly we -- we are also anticipating or including in our modeling and you know of our calculations that maybe one or two subjects might draw upon. So, it's -- it's great to be on the safe side, basically. By the way, something very --

Myles Minter -- William Blair -- Analyst

That's a helpful one.

Remy Luthringer -- Executive Chairman and Chief Executive Officer

So -- sorry to interrupt. Just something very important is that we also have submitted other protocols to the FDA. And that we -- we are definitely waiting to have any feedback. But, I mean, so we stand again in a -- in a very open and constructive mindset with the FDA.

Myles Minter -- William Blair -- Analyst

Right. Lots of , uh,  interactions with the FDA and looking for the isolated label data. So, thanks very much.

Remy Luthringer -- Executive Chairman and Chief Executive Officer

Thank you.

Operator

Thank you. Our last question comes from the line of Douglas Tsao with H.C. Wainwright. Your line is now open.

Douglas Tsao -- H.C. Wainwright -- Analyst

Hi, good morning, and thanks for taking the questions. Just -- I mean, in terms of the open-label extension we're going get the data for the 64 and 32-milligram doses. You've sort of homed in on the 64 milligrams or more sort of consistent effect across the studies now. Is there anything that you could see from the 32 milligrams that would perhaps make you sort of revisit that in terms of the, you know, your sort of thoughts for the molecule going forward? Thank you.

Remy Luthringer -- Executive Chairman and Chief Executive Officer

Yeah. So, I mean, sort of, technically, I mean, I have not given up on 32 milligrams because -- because I remember, I mean, it's a phase to be. It was very clear that 32 milligrams were really different from -- from -- from placebo. When you're looking at the effect size of the data we have in phase 3, 32 milligrams is again showing a nice improvement.

Obviously, I mean, the placebo had also a larger improvement and that's the reason why I think we -- we could not show a p-value at the end of the day. When you're looking to integrate it, when I speak integrate it, I mean, it's a combined phase 2b and phase 3 double-blind data. I mean, the two doses are highly significant with a very decent side effect. So -- so, indeed, I mean, if -- I mean, the expansion data are again pointing toward the fact that 32 milligrams continuously prove negative symptoms over a period of one year, I think, 32 milligrams is a -- is an important those.

I'm not saying that this would be part of the -- of the find -- of the finding of the NDA but I mean 32 has clearly shown that we have the pharmacological effect with this dose. So, let us have the data, let us analyze the data and we will see what we are doing with 32 milligrams. But all are pointing toward the fact that 32 is clearly showing a --a pharmacological effect of an improvement of the patients.

Douglas Tsao -- H.C. Wainwright -- Analyst

OK. Great. Thank you. And just as a follow-up in terms of your analysis that made you confident that the effect is really AUC, not Cmax which makes sense.

I'm just curious you reference some PD markers. I'm just curious what PD markers you focused on? Thank you.

Remy Luthringer -- Executive Chairman and Chief Executive Officer

For the -- for the PK/PD analysis.

Douglas Tsao -- H.C. Wainwright -- Analyst

Yeah.

Remy Luthringer -- Executive Chairman and Chief Executive Officer

I mean, it was definitely based on the -- on the PANSS negative scores. I mean, so -- so here we are really referring to PANSS negative. So, we did exposure versus plasma exposures versus negative symptoms coming out from the PANSS. And clearly, when you're looking at -- to what is explaining is the improvement of the PANSS negatives scores, it is AUC and not at all Cmax.

So, it's -- this is from where I'm making this comment, it's a very, very careful analysis compare -- I mean, between the -- between -- between PANSS parameters and the -- from the pharmacokinetic parameters.

Douglas Tsao -- H.C. Wainwright -- Analyst

OK, great. Thank you.

Remy Luthringer -- Executive Chairman and Chief Executive Officer

You're welcome.

Operator

Thank you. There are no further questions. I will now turn the call back to Remy Luthringer for closing remarks.

Remy Luthringer -- Executive Chairman and Chief Executive Officer

Yes, thank you so much. Thank you really, everybody, for all these great questions. I wanted also to take this opportunity to thank patients and -- and families and caregivers who have participated in this phase 3 study. As you had heard, I mean, some of these patients went to the end of the 12 weeks and more than 200 patients.

So, thank you again for this help. Hopefully, to develop that extremely innovative drug which would be one of the first treatments for negative symptoms. I'm looking forward to updating you on the next upcoming milestones. Open-label data and bioequivalence later.

Thank you again. I'm looking forward to speaking with you soon. Bye.

Operator

[Operator signoff]

Duration: 42 minutes

Call participants:

William Boni -- Vice President of Investor Relations and Corporate Communications

Remy Luthringer -- Executive Chairman and Chief Executive Officer

Geoff Race -- Executive Vice President, Chief Financial Officer, and Chief Business Officer

Julian Harrison -- BTIG -- Analyst

Jason Butler -- JMP Securities -- Analyst

Jeet Mukherjee -- Jefferies -- Analyst

Joel Beatty -- Citi -- Analyst

Myles Minter -- William Blair -- Analyst

Douglas Tsao -- H.C. Wainwright -- Analyst

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