Q4 2022 Minerva Neurosciences Inc Earnings Call
Speaker 1: You.
Speaker 1: You
Speaker 2: Good day, and thank you for standing by. Welcome to Minerva Newer Sciences full year 2022 financial results and business update conference call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question and answer session.
Speaker 2: To ask a question during this session, you'll need to press star 1-1 on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star 1-1 again. Please be advised that today's conference is being recorded.
Speaker 2: I would now like to hand the conference over to your speaker today, Jeff race president of nerve. New responses please again.
Speaker 3: Good morning.
Speaker 4: A press release with the company's fourth quarter and year-end 2022 financial results and business highlights became available at 7.30 a.m. Eastern Time today and can be found on the investors section of our website. Our annual report on Form 10-K was also filed electronically.
Speaker 4: with the Securities and Exchange Commission this morning and can be found on the SEC's website at www.SEC.gov.
Speaker 4: Joining me on the call today from Minerva are Dr. Remy Lutringa, Executive Chairman and Chief Executive Officer and Mr. Fred Almholm, Chief Financial Officer.
Speaker 4: Following our prepared remarks, we will open the call for Q&A.
Speaker 4: Before we begin, I'd 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 the purposes of the Safe Harbor provisions under the Private Securities Litigation Reform Act of 1995.
Speaker 4: We caution that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those indicated.
Speaker 4: 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.
Speaker 4: including our annual report on Form 10-K for the year ended December 31, 2022, filed with the Securities and Exchange Commission earlier today.
Speaker 4: Any forward-looking statements made on this call speak only as of today's date, Wednesday, March, the 8th, 2023, 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.
Speaker 4: I'd now like to turn the call over to Remi Lutringer. Thank you, Jason. Good morning, everyone. Thank you for joining us today for a review of 2022 and our plans for 2023.
Speaker 4: During the year, we had multiple interactions with the Efj regarding the regulatory path forward for our lead compound, Voluperidone, for the treatment of negative symptoms of patients that lose schizophrenia.
Speaker 4: In March 2022, we attended a Type C meeting in which the FDA advised on its remaining concerns which we outlined in our press release in April 2022.
Speaker 5: Specifically, the FDA was concerned with
Speaker 5: The applicability of the phase to be data conducted in Europe to the US population and the phase 3 study had not met the primary endpoint.
Speaker 5: In addition, the FDA sought reassurance that Minerva could reliably identify those patients who do not need any psychotics and how to evaluate the stability of those patients.
Speaker 5: The FDA also noted that Roliparidin may be used by prescribers in a way that differs significantly from the intended monotherapy use and noted that the sponsor had not presented data to show that Roliparidin does not interfere with the safety or efficacy of anti-psychotic medications. For more information, visit www.fema.gov
Speaker 5: Following the 5C meeting, Minerva provided additional data, which we believe addressed the concerns raised by the FDA.
Speaker 5: In August 2022, we submitted an NG8 for role-operidum for the treatment of negative symptoms in patients with schizophrenia.
Speaker 5: This submission was supported by results from late-stage, well-controlled studies in patients with moderate to severe negative symptoms and stable positive symptoms of schizophrenia.
Speaker 5: Studies mean 101C03 phase 2B and mean 101C07 phase 3.
Speaker 5: Both studies had very similar overall study design.
Speaker 5: Those were built in center, multinational, randomized, double-blind, placebo-controlled, parallel group studies in which patients received either placebo, 32 mg or 64 mg doses of rhodoperidone.
Speaker 5: In both studies, if patients were taking anti-psychotic treatments, there were discontinued, and the short, washer period was implemented before being randomized to one of the three arms. Both studies captured comparative placebo control data through the 12-week double-blind period.
Speaker 5: Both studies also provided long-term exposure data regarding the safety and tolerability of Roliparidin and efficacy based on blinded doses of Roliparidin, specifically intended to demonstrate the maintenance or continuation of improvement in negative symptoms.
Speaker 5: The stability of positive symptoms and the low rate of relapses of positive symptoms following 24 weeks, study mean 101C03 and 40 week, study mean 101C07 open label periods.
Speaker 5: I've mentioned above, with the exception of the duration of the open labor period, these two studies were nearly identical with respect to patient population and made assessment tools.
Speaker 5: Positive and Negative Syndrome Scale, PANS. Personal Social Performance Scale, PSP. Clinical Global Impression, CGI.
Speaker 5: As such, the data from these studies were the basis for the decision to submit the NDA as we believed they provided sufficient evidence to support long-term safety and efficacy in adults in an area of high-end medical need and consequently merit an in-depth review by the psychiatric division.
Speaker 5: November 30th. During that meeting, the FDA confirmed that the RTF remained in effect.
Speaker 5: We remain committed to developing a body paradigm as a potential transformative treatment for those patients with negative symptoms of schizophrenia.
Speaker 5: and we anticipate further discussion with the FDA over the coming months regarding the status of the rhodopyridin MDA and the development program.
Speaker 5: I look forward to provide more information as it becomes available. I will now turn it over to Fred to discuss our financial performance.
Speaker 6: Thank you, Remy. Earlier this morning, we issued a press release summarizing our operating results for the fourth quarter and year ended December 31st, 2022. A more detailed discussion of our results may be found in our annual report on Form 10K filed with the SEC earlier today.
Speaker 6: Cash, cash equivalents, and restricted cash as of December 31, 2022 were approximately $36.2 million compared to $60.9 million as of December 31, 2021.
Speaker 6: In January 2023, we received a refund of our NDA filing fee of $3.1 million from the FDA.
Speaker 6: This refund was made in accordance with the federal Food, Drug, and Cosmetic Act.
Speaker 6: which allows a fee waiver for a small business submitting its first human drug application.
Speaker 6: We expect that the company's existing cash and cash equivalents will be sufficient to meet its anticipated capital requirements for at least the next 12 months from today based on our current operating plan.
Speaker 6: The assumptions upon which this estimate are based are routinely evaluated and may be subject to change.
Speaker 6: Research and development expense for the fourth quarter of 2022 and 2021 was $3.2 million in 2018.7 million dollars, respectively.
Speaker 6: a decrease of $15.5 million. The decrease in R&D expense was primarily due to an impairment charge of $15.2 million in the fourth quarter of 2021.
Speaker 6: to the carrying value of in-process research and development related to our MEN-301 development program.
Speaker 6: Our R&D expense for the years ended December 31, 2022 and 2021 was $14.6 million and $32 million, respectively.
Speaker 6: a decrease of $17.4 million.
Speaker 6: The decrease in R&D expense was primarily due to an impairment charge of $15.2 million in the fourth quarter of 2021.
Speaker 6: to the carrying value of in-process research and development related to MIN 301.
Speaker 6: as well as lower clinical trial costs during 2022. Non-cash stop compensation costs included within R&D expense for the years ended December 31, 2022 and 2021 was $2 million and $2.4 million respectively. General and administrative
Speaker 6: and 2021 with $10.6 million and $13.3 million, respectively, a decrease of $2.7 million.
Speaker 6: The decrease in G&A expense for both the fourth quarter and year end of December 31st, 2022, versus the prior year period.
Speaker 6: was primarily due to lower compensation expense and lower legal and insurance fees. Non-cash stock compensation costs included in G&A expense.
Speaker 6: for the years ended December 31, 2022 and 2021 was $2.1 million and $2.8 million, respectively.
Speaker 6: For the fourth quarter of 2022.
Speaker 6: Net loss was $6.7 million, or a loss per share of $1.26, basic and diluted, as compared to a net loss of $21.3 million for the fourth quarter of 2021, or a loss per share of $3.99, basic and diluted.
Speaker 6: For the year ended December 31, 2022.
Speaker 6: Net loss was $32.1 million, or a loss per share of $6.01, basic and diluted, versus a net loss of $49.9 million for the year ended December 31, 2021.
Speaker 6: or loss per share of $9.35, basic and diluted.
Speaker 6: Now I would like to turn the call over to the operator for any questions. Operator.
Speaker 2: As a reminder, to ask a question, you'll need to press star 1-1 on your telephone.
Speaker 2: To withdraw your question, please press the pound key. I'm sorry, please press star 1-1 again. Please wait for your name to be announced.
Speaker 2: Please stand by. We'll compile the Q&A roster. Thank you. Please stand by.
Speaker 2: Our first question comes from the line of Andrew Sall with Jeffries. Your line is open. Your line is open.
Speaker 7: Hi, good morning. Thanks for all the updates. So the first question is, can you possibly remind us the latest and greatest outstanding issues the FDA has following your recent Type A meeting with the NDEA? I think last time, um,
Speaker 7: You said the FDA did propose a few items in mind and you'd kind of share it with us, but I'm just curious, what are those things that cause the FDA to issue the RTF and then maintain their stance afterwards?
Speaker 1: Thanks.
Speaker 5: Hello. Really great question. So clearly, as we mentioned, we already outlined what are the concerns after the Type C meeting we had with the NDIS in April last year.
Speaker 5: But clearly, I mean, I think we've made a lot of progress, but I think the two main points, and as we mentioned as well, are the fact that, you know, they are still struggling with the applicability of the phase 2b study, the C-diversity study results. By the way, they...
Speaker 5: suggested or we have really confirmed that the this study is a positive study but I mean they are struggling with the fact that this study has no US patients so they won't agree to be sure that US and non-US patients are similar in terms of disease, in terms of negative symptoms
Speaker 5: most in terms of negative symptoms because as you know there is no drug approved for negative symptoms, so they want to be extremely sure about this. So this is the first point and the second point they are still having some concerns about the phase three study and this is due to the fact that we have used a type 1 correction which is the Housh-Bastian syndrome.
Speaker 5: and it is not at all telling you if the drug is working or not this but I mean so this is other two main concerns so if you allow me and let me comment on the two concerns so the first one we continue to have the dialogue with the NBA and we are providing them with data showing that
Speaker 5: Basically, I mean, the patients we have included in XUS or outside the US, compared to the patients we've included in the US, keep in mind that for the Phase 3 we had patients from the US are extremely similar in terms of baseline, in terms of...
Speaker 5: the effect of our drug on the negative symptoms and on the overall disease. We even have provided the information or data from other studies which have been performed by other sponsors in order to make our case even stronger. So I am really confident that this is something which we will overcome.
Speaker 5: No concerning the phase 3 study, yes indeed, I mean only the 64 milligram dose hit of the 0.05 p-value but keep in mind that I mean as we already discussed...
Speaker 5: Our NBA is asking for an approval of 64 milligrams only. We are not asking for an approval for 32 milligrams. So clearly I think if you're looking really to what we have seen in the phase three with 64 milligram it is very very similar to what we have seen in the phase two beam.
study and something which is extremely important is that we had only one key secondary endpoint if you remember which was the PSP which is looking to to everyday functioning of the patients and there we had a p-value which was highly significant of 0.016 so clearly when you are looking to
Do these patients improve? Clearly they're improving in a significant way with a good p-value in the phase 2 and in the phase 3. So clearly I mean this is you know what are the issues.
Yes, it's very clear and thanks. And so now it sounds like you're going to talk to them over the coming months about the NDA and so forth. And any thoughts on the timing of the resolution or an outcome of this? Is it also going to be another type A meeting?
from in a few months or weeks, like we put it like this, and basically that. But I think if you want me an additional comment, what you are trying to really bring over the message and I think it's a completely fair message is that we have a lot, a lot of information in our NDA.
of PSP, but I mean you have four sub-courses and we have analyzed the four sub-courses in detail, which again confirms that the drug is improving functioning in patients. So what we are trying to really bring over as a message to the FDA is that the reasons, I mean I gave you before, are not reasons of a refusal to file but are...
and having the death mask to get the frame. So this is the dialogue that's going and in terms of timing and force, they cannot give you more details. Makes sense, makes sense. And very last question. To the extent you can share who at the FDA has been overseeing the ND application, I'm just curious if it was Billy Don and if so, does this departure change?
your calculus on anything as it pertains to the NDA. Thanks.
That's a great question as well. So clearly, I mean, as you know, when you're submitting your NDA and those types of type-by-meetings are mostly with the psychiatry division, because I mean the decision for the results of the file is coming from the division, as I mean, the BGP for clearly amen.
The main dialogue has been with the trichotic division. This said, indeed Dr. Dem was also involved, obviously, because he was a person overlooking the trichotic division and the other divisions of the neuroscience divisions, neurology one, two, three, yes, but.
And also what is very important is that Dr. Ghan is...
very keen to not only have a p-value but to see a function improvement which we have with rhodoperidone. So clearly I don't think that it will be a problem for us, as Dr. Don left, but it's clear that he understood that function improvement is important.
I'm confident that the other people still at the FDA will understand and I think the person who has been nominated in the place of Dr. Dan is also a person who is very, how to say knowledgeable and open to innovation.
as not a problem but I think the people see it in place, we continue to work along the lines that Dr. Dunn has proposed in the past.
Thanks so much Remy for all the updates. Best of luck.
Thank you. One moment for our next question.
One moment for our next question.
Our next question comes from the line of Douglas Sal with HC Wainwright. Your line is now open.
Hi, Remy. Good morning. So just as a follow up, obviously, there's still some uncertainty, but when you envision.
The path forward for all the paradigm and your interactions with the agency.
Do you think that one study would potentially be sufficient to address their concerns, or would you need to potentially run both a monotherapy as well as an adjunctive therapy study, or could that potentially be carried out in one trial? Thank you. The question is, how is N innovative in severe.
Like always, great question.
So to be very clear, I mean, the FDA never asked us to run an additional study. Yes, I mean, so so but they asked us as I already. I think this cost review is that I mean, they wanted us to to continue to feed them with with additional information and as they speak. I mean, this is exactly what.
what we are doing. Your comment about the monotherapy and add-on is an interesting one. So clearly we developed a Rolleperidone in monotherapy for several reasons. The first reason is to...
demonstrate that I mean we have a specific improvement of negative signals because this monotherapy versus placebo is the only way to do it. I mean you cannot do it if you put for example an deep psychotic on board because because you don't know exactly what is going on here in order to claim that you have a specific effect and second I mean
you will unblind the study immediately because you have the side effects of antibiotics. So this was one of the reasons. The second reason is very important I think for patients at the end of the day, that the scientific community and the medical community is more and more.
saying that all the patients with a diagnostic schizophrenia should not be treated continuously with antipsychotic. And even more importantly, there is no data coming out really showing that...
there is a significant part of the patients with a diagnostic schizophrenia who do not need continuous treatment with anti-psychotics. So this is exactly the patient population we have targeted. Remember, we targeted patients where they needed to have a minimum TEXT
score of negative symptoms on the PANS. Just to show the impairment is there. This had to be stable over the last six months and they needed to have stable positive symptoms.
And I mean, when you're looking to our data, what you see that yes, we have this improvement of negative symptoms of PSP, but I mean, these patients stay extremely stable on positive symptoms and at an extremely low level, yes. I mean, they are.
at 14 points when they enter the study and they are 14 points when they go out of the study. And as you know, the minimum score, if you have no symptoms, if you have no positive symptoms, is 7 points. So these patients are completely stable in terms of positive symptoms.
I presented also the relapse rate. The relapse rate we have there is very low, around 12% over a period of one year, which is below what you see in the...
possible randomised withdrawal studies with anti-psychotic. So clearly, I think we have demonstrated that, I mean, at minimum the patient population we have included does not need continuous treatment with anti-psychotic.
So I cannot go into the details because we never disclosed it, but we have provided also evidence to the FDA that if a patient really needs antipsychotics, he is responding extremely well to antipsychotics. so
So long story short, to your question about the study, an additional study, monotherapy, or a study where we are combining monotherapy plus a combination with anti-psychotics. Obviously, we have worked on this, we have thought about it since the beginning of the development of Roliparidin, but I think...
These are really questions you are asking yourself or you are doing after a minute. You have a complete in-depth review by the MBA or MBA and this is usually what the companies have to do, you know, post approval. So here we are, as we know, we are completely open for.
post approval trials. Last but not least, just when you're looking to what we are proposing as labeling clearly, the labeling is monotherapy for the specific patient population we targeted in our trials. What we are proposing here, and again we have data and we have shown these data.
this kind of thing, as you can see, is post-approval work, because we have two well-controlled and well-apricate studies, and this is normally the basis of an MDF review.
So, Remy, I hear your point, but I guess I'm just wondering and I ask you, I mean, there's come a point I'm just wondering and I ask you, I mean, there's come a point
where pragmatism needs to rule just because, while yes, there may be a path forward with the existing data set, clearly the agency has expressed reservations.
And if you said, you know, so from an efficiency standpoint, just carrying out another study might just be the most efficient way to go. You know, even to some extent, maybe financially at this point. I mean, if we step back and think about when we had the first result from that phase three, if you had pivoted to run.
a follow-up study, that study would have probably read out by now. Then you would be able to go back to the agency or go to the agency with an inkontrovertible data set, nothing for them to really question. So, I mean, I guess, you know, I don't know if that's...
So I guess at what point do you feel you've exhausted those options?
So, so clearly I mean, well, you know, I hear you very well and I mean you're not the only one telling us just go on and run another study, yes, but which kind of study do you run? And then you you you started by saying okay, monotherapy, Adam, you know, so the question here and but there is why we try really to get complete clarity again.
I don't understand something wrong. I mean, I'm convinced that the package we have is enough. But if we think about an additional study, we need complete clarity about the study. We need a complete blessing from the FDA about the study because there are some precedents where companies have done a study.
that they are doing the right thing. And basically when they came back with a positive study, this was one of the studies they had to carry out. And so all the MDA did not completely agree to this. So we are looking to really get to complete clarity and.
I think it's this what is driving us. But again, I think we have as a package of the data for the idea jumping in and reviewing our engine.
But Remy just to clarify that final point just to make sure so everybody can understand because I think it is very important
from NAM on what potential additional studies may be needed? The answer is no. Yeah. What we are, what we are. So you're still simply pursuing trying to get the existing data set approved. Exactly. So, I mean, we are not discussing about an additional study. We have opened the door since long to do a post-approval study, but I mean, what we are trying to understand is, you know, what they need as additional analysis in our data set we have currently. And what we are also discussing is that the...
If you go according to the guidance of refuse to file, the reasons I mentioned at the beginning of this call are not part of the refuse to file. So what we are trying to understand is what the FDA needs with our beta package.
in order to start the review. I think more we are advancing, more it becomes clear that indeed we have the data needed. So give us a little bit of time and we will give you the update on what is the outcome of this constructive discussion going on currently.
Okay, thank you.
Again, ladies and gentlemen, that's star 1-1 to ask your question.
I'm showing no further questions at this time. I'd like to hand the conference back over to Dr. Lasslinger for closing remarks.
Thank you so much and really thank you Andrew and Luke for these important questions. I hope it really clarifies that.
You know, we we really have a very very important dialogue still going on that we will get clarity very soon about You know, what are the next steps, but I mean, I think I will try to explain that we have really a very important data package which needs to have an in-depth review
by the FDA and we are confident that this will happen. And if this video starts, I think everybody will understand that Rhodoperidone is really an important drug to address the huge and magnetic indeeduringoth
We are looking forward to really update you as soon as we have more clarity about the data going on currently with the FDA. Thank you so much for your being with us today.
Thank you for your participation. You may now disconnect. Everyone have a wonderful day.
To raise and lower your hand during Q&A, you can dial star 1-1.
I have.
Will.
The.
of the speaker's presentation, there will be a question and answer session. To ask a question doing a session, you'll need to press star 1-1 on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star 1-1 again. Please be advised that today's conference is being recorded. I would now like to hand the conference over to your speaker today, Jeff Rayce, president of the nerve.
New responses, please begin. Good morning. A press release with the company's fourth quarter and year-end 2022 financial results and business highlights became available at 7.30 a.m. Eastern time today.
www.SEC.gov.
and Mr. Fred Almholm, Chief Financial Officer. Following our prepared remarks, we will open the call for Q&A.
Before we begin, I'd 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 the 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 10K for the year ended December 31st, 2022, filed with the Securities and Exchange Commission earlier today. Any forward-looking statements made on this call speak only as of today's date, Wednesday, March 8th, 2023.
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'd now like to turn the call over to Remi Lutringer. Thank you, Jason. Good morning, everyone. Thank you for joining us today for a review of 2022 and our plans for 2023.
During the year, we had multiple interactions with the FDA regarding the regulatory past for our lead compound, lowly peridone for the treatment of negative symptoms of patients that most kids are free now.
In March 2022, we attended a type-c meeting in which we have very advised when it's remaining concerns which we outlined in our press release in April 2022.
Specifically, the FDA was concerned with the applicability of the phase to be data conducted in Europe to the US population and the phase 3 study had not met the primary end point. In addition, the FDA sought reassurance that Minerva could reliably and that if five those patients could do not need any psychotics.
sponsor had not presented data to show that Roliparidin does not interfere with the safety or efficacy of anti-psychotic medications. Following the Type C meeting, Minerva provided additional data, which we believed addressed the concerns raised by the FDA. In August 2022, we submitted an...
Studies mean 101 C03 face to B and mean 101 C07 face 3. Both studies had very similar overall study design.
or 64 mg doses of rhodoperidone.
In both studies, if patients were taking anti-psychotic treatments, they were discontinued, and the short washer period was implemented before being randomized to one of the three arms. Both studies captured comparative placebo control data through the 12-week double-blind period. Both studies also provided long-term exposure data regarding the safety and polarity of all the curit worthy.
of improvement in negative symptoms. The stability of positive symptoms and the low rate of relapses of positive symptoms following 24 weeks. Study mean 101 C03 and 40 week. Study mean 101 C03, open label periods.
I've mentioned above, with the exception of the duration of the open-led period, these two studies were nearly identical with respect to patient population and main assessment tools, positive and negative symptoms scale pan, personal social performance scale, PSP, clinical global impression, CGI. Such the data from these studies were the basis.
for the decision to submit the MDA as we believed they provided sufficient evidence to support the long-term safety and efficacy in adults in an area of high-end medical need and consequently merit an in-depth review by the psychiatric division of the FDA. In October 2022, we received a...
We remain committed to developing all the paradigm as a potential transformative treatment for those patients with negative symptoms of schizophrenia.
And we anticipate further discussion with the FDA over the coming months regarding the status of the Rolly Perlin and the development program.
I look forward to provide more information as it becomes available. I will now turn it over to Fred to discuss our financial performance.
Thank you, Remi. Earlier this morning we issued a press release summarizing our operating results for the fourth quarter and year ended December 31st, 2022.
A more detailed discussion of our results may be found in our annual report on Form 10J followed with the SEC earlier today.
Cash equivalents and restricted cash as of December 31, 2022 were approximately $36.2 million compared to $60.9 million as of December 31, 2021.
In January 2023, we received a refund of our NDA filing fee of $3.1 million from the FDA. This refund was made in accordance with the Federal Food Drug and Cosmetic Act.
which allows a fee waiver for a small business to many its first human drug application. We expected the company's existing cash and cash equivalents will be sufficient to need anticipated capital requirements for at least the next 12 months from today based on our current operating plan. The assumptions upon which this estimate are based.
are routinely evaluated and may be subject to change. Research and development expense for the fourth quarter of 2022 and 2021 was $3.2 million and $18.7 million, respectively.
a decrease of $15.5 million. The decrease in R&D expense was primarily due to an impairment charge of $15.2 million in the fourth quarter of 2021 to the carrying value of in-process research and development related to our MIN 301 development program. Our R&D expense for the years ended December 31, 2021.
of in-process research and development related to MEN-301, as well as lower clinical trial costs during 2022.
Non-cash stock compensation costs included within R&D expense for the years ended December 31st, 2022 and 2021 was $2 million and $2.4 million respectively. General and administrative expense for the fourth quarter of 2022 and 2021.
was $1.9 million and $2.6 million respectively, a decrease of $0.7 million.
GNA expense for the years ended December 31, 2022 and 2021 with $10.6 million and $13.3 million respectively, a decrease of $2.7 million. The decrease in GNA expense for both the fourth quarter and year ended December 31, 2022 versus the prior year periods.
was primarily due to lower compensation expense and lower legal and insurance fees. Non-tash stop compensation costs include in GNA expense.
For the years ended December 31, 2022 and 2021 was $2.1 million and $2.8 million respectively. For the fourth quarter of 2022, net loss was $6.7 million or a loss per share of $1.26 basic and diluted. As compared to a net loss of $21.3 million,
for the fourth quarter of 2021, or loss per share of $3.99 basic and diluted.
For the year end of December 31st, 2022, net loss was $32.1 million or a loss per share of $6.1 million, basic and diluted, versus a net loss of $49.9 million for the year end of December 31st, 2021, or a loss per share of $9.35 million, basic and diluted.
Now we would like to turn the call over to the operator for any questions. Operator.
I would like to turn the call over to the operator for any questions. Operator. Thank you.
As a reminder, to ask a question, you'll need to press star 11 on your telephone. To withdraw your question, please press the pound key. I'm sorry, please press star 11 again. Please wait for your name to be announced.
Please stand by. We will compile the Q&A roster. The first question comes from the line of Andrew Sal with Jeffrey, Scholeines. opticaliN
Hi, Morning. Thanks for all the updates. So the first question is, can you possibly remind us that latest and greatest outstanding issues the FDA has following your recent type A meeting with the NDA? I think last time...
You said the FDA did propose a few items in the mine and you'd kind of share it with us, but I'm just curious, what are those things that cause the FDA to issue the RTF and then maintain their stance afterwards? Thanks.
Yeah, hello, really great question. So, clearly, I mean, as we mentioned, just we already outlined what are the concerns after the type C meeting we had with the FDA yesterday in April last year. Alright, so about the...
But clearly, I think we've made a lot of progress that I think the two main points, as we mentioned as well, are the fact that they're still struggling with the applicability of the phase to be studied, the C03 study results. By the way, they suggested that we have really confirmed that the study, study is a positive strategy.
still having some concerns about the phase 3 study and this is due to the fact that we have used a type 1 correction, which is the HOSCHDAR correction. As you know for HOSCHDAR correction, you need to add the through-dose hitting a p value of 0.05. In our case, it is all the highest dose.
which has hit the p value of 0.05. So it's my opinion really technical and it is not at all telling you if the drug is working or not, but that means this is of the two main concerns. So if you allow me, let me comment on the two concerns. For the first one.
We continue to have the dialogue with the FDA and we are providing them with data showing that basically I mean the patient we have included in XUS or outside the US compared to the patients we've included in the US keeping mind that for the phase 3 We we had patients from the US are extremely similar in terms of baseline in terms of
the effect of our drought on the negative symptoms and the overall disease. We even provided the information or data from other studies which have been performed by other sponsors in order to make our case even stronger. So I'm really confident that this is something which will overcome. No concerning the...
The phase 3 study, yes indeed, I mean only the 64 milligram dose hit the 0.05 p-value, but keep in mind that as we already discussed, our NDA is asking for an approval of 64 milligrams only. Yes, we are not asking for an approval for
32 milligrams. So clearly I think if you're looking really to what we have seen in the phase 3 with 64 milligrams it is very very similar to what we have seen in the phase 2b study and something which is extremely important is that we had only one key secondary endpoint if you remember which was the PSP which...
in a significant way with a good p-value in the phase 2B and in the phase 3. So clearly this is one of the issues. I don't know if I answered your question. Yes, it's very clear. Thanks. So now it sounds like you're going to talk to them.
over the coming months about the NDA and so forth. Any thoughts on the timing of the resolution or an outcome of this? Is it also going to be another Type A meeting? I don't even know how you classify it. But any clarity around the potential timing of that outcome here.
So I think we cannot be clear about the timing. I mean the dialogue is ongoing and we hope obviously to have the shortest timeline but as we mentioned this will happen in the next few months or few weeks, let me put it like this. But I think if you allow me an additional comment, what we are trying to really bring over as a message and I think it's a completely complete date.
Fair message is that we have a lot of information in our NDA. For example, what I was mentioning just before about comparability between US and non-US patients. We have a lot of information about the functionally proven of the patients because if you remember.
PSP, the key primary we had in the phase three was the topics core of PSP, but I mean you have four sub courses and we have analyzed the four sub courses in details which again confirms and I mean the drug is improving functioning in patients. So what we are trying to really bring over the message to the FDA is that...
You know, the reasons, I mean, I just gave you before, I'm not the reason for the issues in file, but I have topics which, first of all, need an in-depth review. An in-depth analysis of our NDA, a dialogue with a sponsor to really go into the details of all the data we have to show that what we've already done is...
is an effective drug for patients suffering from negative symptoms and having a dead and I think I've skipped a frame. So this is the dialogue of going and in terms of timing and force, they cannot give you more details. Makes sense. Makes sense. And very last question. To the extent you can share a...
Who at the FDA has been overseeing the ND application? I'm just curious if it was Billy Don and if so, does this departure change your calculus on anything as it pertains to the NDA? Thanks. There's a great question as well. So clearly, I mean, I don't know when you're submitting your NDA. And there was a pie chain or pie-by-me, things are mostly with the PICOTO division, that's because I mean...
The decision for a refusal to file is coming from the division, I mean, basically for clearly I mean, the main dialogue has been with the Plycratic division. This said indeed the doctor then was also involved obviously because he is...
He was a person overlooking the other division of the neuroscience division. Neurology 1, 2, 3. But yes, I think what I can say is that Dr. Dan is known to be a person who is really open to...
to development or to to indications with no approved treatment. And also what is very important is that Dr. Van is very keen to not only have a p-value, but to see a function of the problem which we have with the body paradigm. So clearly, I mean.
I don't think that it will be a problem for us, Dr. Van Left, but it's clear that he understood that the function of improvement is important. So I'm confident that the other people still at VFDA will understand. And I think the person who has been nominated in the place of Dr. Van Left also heard.
along the lines, Dr. Duh has proposed in the past.
Thanks so much, Remy, for all the updates. Best of luck. You're welcome. Thank you. One moment for our next question.
Our next question comes from the line of Douglas Sal with HC Wainwright. Your line is now open.
Hi, Remy. Good morning. So just as a follow up, obviously there's still some uncertainty, but when you envision.
the path forward for all the paradigm and your interactions with the agency. Do you think that one study would potentially be sufficient to address their concerns, or would you need to potentially run both a monotherapy as well as an adjunctive therapy study?
Or could that potentially be carried out in one trial? Thank you. So, like always, a great question, and so to be very clear, I mean, the FDA never asked to run an additional study, I mean, so what they asked us, although I already, I think discussed with you is that I mean, as I wanted us to...
to continue to feed them with additional information and I would speak, I mean this is exactly what we are doing. And you're comment about monotherapy and Adon is an interesting one. So, so clearly, we developed
Rotterdam in monocerapy for a certain reason that you know the first reason is to demonstrate that I mean we have a specific improvement of negative symptoms because it monocerapy versus placebo is the only way to do it. I mean you cannot do it if you put for example an anti-psychotic on board because because you don't know
exactly what is going on here, in order to claim the divest-based key effect. And second, I mean, you will not blind the study immediately because I mean you have the side effects of anti-psychotics. So this was one of the reasons. The second reason is very important, I think, for patients in the end of the day, is that the scientific community and the medical community is no more and more.
not need continuous treatment with with with andipsacotics. So this is a good thing. I mean the patient population we have targeted remember with targeted patients whereas I needed to have a minimum
core of negative symptoms of the puns, just to show the impairment is there. This has to be stable over the last six months and they needed to have stable positive symptoms.
And I mean, when you're looking to our data, what you see that yes, we have this improvement of negative symptoms of PSP, but I mean, these patients stay extremely stable on positive symptoms and at an extremely low level, yes. I mean, they are.
At 14 points when they enter the study, and they are at 14 points when they go out of the study, as you know, the minimum score, if you have no symptoms, if you have no positive symptoms, is seldom a point. So, I mean, so these patients are completely stable in terms of positive symptoms. And...
Remember as well, I presented also the relapse rate. And the relapse rate we have there is very low, I mean around 12% over a period of one year, which is below what you see in the...
possible randomized withdrawal studies with anti-psychotic. So clearly, I think we have demonstrated that, I mean, at minimum the patient population we have included does not need continuous treatment with anti-psychotics. So I cannot go into the details because we never disclosed it, but we have provided also.
evidence to the to the to the FDA that You know if a patient really needs anti-psychotics He is responding extremely well to anti-psychotics So it's a long story short to your answer to your question about the study an additional study of Monocerapy or a study where we are combining Monocerapy
asking yourself or you're doing after I mean you have a complete in-depth review by the MBA or MBA and this is usually what the companies have to do you know post approval so here we obviously as we know are completely open for post approval trial and last but not least just I mean when you're looking to.
What we are proposing as labeling clearly, I mean, the labeling is monotherapy for the specific patient population we targeted in our trials and what we are proposing here, and again, we have data and we have shown this data to the FDA that if a patient has a redox and needs an undepsychotic, then the check is doing the job.
And this is normally the basis of an NBR review.
So, so let me, I heard your point, but I guess I'm just wondering and
So, let me, I heard your point, but I guess I'm just wondering and I ask you and he?, do expect that we have come into their heart I guess on the sign?
where pragmatism needs to rule just because, while yes, there may be a path forward with the existing data set, clearly the agency has expressed reservation.
And if you said, you know, so from an efficiency standpoint, just carrying out another study might just be the most efficient way to go. You know, even to some extent, maybe financially at this point, I mean, if we step back and think about when we had the first result from that phase three, if you had pivoted to run a follow-up study.
That study would have probably read out by now. And then you would be able to go back to the agency or go to the agency with an ink controversial data set, nothing for them to really question. So I mean, I guess, I don't know if that's, so I guess at what point do you feel you exhausted those options? So, so, so, so, can't tell you what, you know, I hear you, I hear you very well.
we have is enough. But if we think about the Navi-San study, we need complete clarity about the study. We need complete blushing from the FDA about the study because there are some precedents where companies have run a study thinking that they are doing the right thing. And basically, when they came back with a positive study, this one of the studies they had to carry out.
sure so everybody can understand that I think it is very important.
So as part of your current interactions with the agency, part of that discussion is to get clarity from them on what potential additional studies may be needed. The answer is no, what we have.
So you're still simply pursuing trying to get the existing data that approved? Exactly. So, I mean, we are not discussing about the additional study. We have opened the door since long to do a post-approval study. But I mean, what we are trying to understand is, you know, what they need as additional analysis.
understand is what they would they need with our data package in order to how to say start with review and I think more we are going to be more clear that indeed I mean we have the to data need it so give us a little bit time and we will
give you the update on what is the outcome of this constructive discussions going on currently.
update on what is the outcome of this constructive discussion going on currently. Okay. Thank you.
Again, ladies and gentlemen, that's star 1, 1 to ask your question. I'm showing no further questions at this time. I'd like to hand the conference back over to Dr. Lissinger for closing remarks.
Thank you so much and really thank you Andrew and Duc for these important questions. I hope it really clarifies that we really have a very, very important dialogue still going on that we will get clarity.
by the FDA and we are confident that this will happen. And if this video starts, I think everybody will understand that Brody Peridon is really an important drug to address. The U.C. and Medi-Can-Date is no approved treatment in the U.S. So we're looking forward to really update you as soon as we have more.
clarity about the value of going out currently with the FDA. Thank you so much for your being with us today. Thank you. This concludes today's conference call. Thank you for your participation. You may now disconnect. Everyone, have a wonderful day. Thank you.