Q1 2020 Earnings Call

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Accent Therapeutics conference call. Currently all participants are any listen only mode. Later, there will be a question and answer session and instructions will follow at that time.

I mean flights or thing with his presentation on the company website at <unk> Dot com.

A reminder, today's conference call is being recorded I.

I would now like to turn the conference over to your host Marc Jacobs and Chief operating officer at Exome Therapeutics. Please go ahead.

Thank you operator, good morning, and thank you all for joining us on today's conference call.

Earnings press release, providing a corporate update and details of the Companys financial results for the first quarter of 2020 crossed the wire short time ago, and it's available on our website at some dot com.

During today's call, we will be making certain forward looking statements. These statements may include statements regarding.

Among other things the efficacy safety and intend to do utilization of our investigational agents.

Our critical noncritical player our plans to present or report additional data, we anticipate to conduct in that source of future clinical trials regulatory plans future research and development plan.

Possible intended use of cash and investments.

These forward looking statements are based on current information assumptions and expectations that are subject to change in the Gulf risks and uncertainties that may cause actual results to differ materially from those contained in the forward looking statements.

These and other risks are described in our periodic filings made with the Securities and Exchange Commission, including our quarterly and annual reports.

You are cautioned not to place undue reliance on these forward looking statements, which are only made as of today's date in the company disclaims any obligation to update such statements.

Joining me on the call today are Dr. area to Butoh, Chief Executive Officer, Nick PZ, Chief Financial Officer, Dave Merrick, Chief Commercial Officer, Dr., Cedric O'gorman Senior Vice President of clinical development and medical Affairs.

Mario will first provide an overview of the company, including reviewing recent developments and upcoming milestones.

In the area, Nick will review our financial results.

We'll then open the line for question.

Sure I'll now turn it over the call to area.

Thank you Mark good morning, everyone. Thank you all for joining axon Therapeutics first quarter 2020 financial result business update conference call.

Over the past several months, we accelerated our evolution into a leading CNS company.

During this time, we continued to advance our broad and deep late stage portfolio novel differentiated medicines targeting difficult to treat CNS indications that had limited or no treatment options that affect significant patient populations.

We now believe we have one you most robust CNS pipelines in the industry.

Our late stage pipeline, it's not only broad but also proven.

As we have now generated or announced positive efficacy results from well controlled clinical trials in five different indications, including the crushing.

Old-timers disease agitation migraine narcolepsy fibromyalgia.

Overall these conditions effect more than 60 million patients in the U.S. alone.

The prevalence seriousness of high unmet need represented by these conditions underscored the importance of our investigational medicines in the clinical data generated with them thus far.

The resulting opportunities or significant.

On the slide usually snapshot of select indications and our late stage pipeline for which we now have positive efficacy data from controlled clinical trials.

For our access to five product candidate, we announced positive 88, enabling result in major depressive disorder in December showing a rapid and substantial improvement in depressive symptoms.

And last week, we announced positive result from our pivotal dance one trial on the access to five old-timers disease education, which similarly demonstrated rapid and substantial symptom improvement in this condition.

You have also announced positive India legally result in migraine without access so seven product candidate demonstrating superior efficacy.

Last month, we announced positive result from our intercept trial of excess so seven in the early treatment of migraine.

Our excess 12 product candidates for narcolepsy has demonstrated in our concert trial significant improvement in cataplexy excessive daytime sleepiness the key symptoms narcolepsy.

And our excess 14 product candidates fibromyalgia has demonstrated a differentiated profile positive result.

Both of these two in a phase three trial.

Overall, our product candidates have the potential to generate total peak sales of up to $9 billion. In just these indications based on clinical data generated thus far.

This robust portfolio highlights the potential to improve the lies millions of patients it significantly increase shareholder value.

With regards to our upcoming milestones.

We remain on track to file I went into yet.

Access so five major depressive disorder in the fourth quarter.

The India supported by positive efficacy results from our pivotal ascend in Gemini trials.

A phase three open label long term safety extension study or the accessible fiber to further support in the filing is ongoing.

And to date more than 800 patients have been dose in this trial.

We also remain on track to file I will indeed for excess so seven in migraine in the fourth quarter.

The Andy is supported by positive efficacy results from our momentum and intercept trials.

A phase three open label long term safety extension study of excess so seven to further support the filing is ongoing.

And to date more than 700 patients have been dosed in this trial.

As we move towards the filing of our indie games in the fourth quarter full access so five and for access so seven our commercial team is focused on launch readiness activities to ensure successful commercial execution.

In parallel look to continue the momentum in our other late stage development programs, including the exit so five and old timers disease education.

Highly distressing disabling condition.

For which there is no proof medicine.

Following the recent announcement of positive topline results from our pivotal advanced one trial in this indication we intend to meet with the FDA as soon as possible to discuss these data.

We expect these discussions to inform the design of our next study, which we anticipate initiating the second half of this year.

We also anticipate initiating phase three trials with the excess 12, narcolepsy and the second half of this year.

Building on the strong result from our positive fees to cancer trial.

By focusing on commercial readiness to make health products available to patients starting as early as next year.

By advancing rest of our development pipeline through innovation.

We will continue to build an industry, leading CNS company with an energetic culture that challenge is the status quo to speed innovative therapies to patients.

I would now like to turn the call over to Nick will provide a financial update.

Thank you area and good morning, everyone I will focus on key highlights in the quarter provide some financial guidance.

We ended the quarter in a strong financial position that is consistent with our ability to rapidly advance our clinical programs and commercial preparations, while maintaining highly efficient fiscal management.

R&D expenses were $27.5 million for the quarter ended March 31st 2020 versus $7.6 million for the comparable period in 2019.

The quarter included a one time charge of $10.2 million related to the upfront cost associated with the Pfizer and licensing agreement of which $7.2 million with non cash related.

Net of the costs related to the Pfizer licensing agreement R&D expenses were $17.3 million.

The increase versus the first quarter 2019 was due to significantly more clinical trial activity. During this most recent period, including the stride one intercept and advance one trials. The access so five in excess of seven open label safety studies and to close out cost for our concert Gemini ads.

Trials.

All of these trials aside from the excess of five an access those seven open label safety studies have now been concluded and are in the process of being close out.

DNA expenses were $5 million for the quarter ended March 31st 20, Twond and $2.8 million for the comparable period in 2019.

The change was primarily due to increased personnel costs, mainly from higher stock compensation expense, along with the build out of the commercial function.

We ended the first quarter with $197.3 billion in cash compared with $220 million at the end of the fourth quarter.

We believe that our current cash position is sufficient to fund our anticipated operations based on our current operating plant for at least two years.

That concludes our first quarter 2020 financial review.

I'll now hand, the call back tomorrow to lead the queuing it discussion.

Thank you Nick operator can we please have our first question.

[noise] and in order to ask a question. So please press Star then the number one on your telephone keypad.

Your first question comes from Charles Duncan with Cantor Fitzgerald.

Hey, good morning, Aereo and team.

[laughter] congrats on the clinical successes in the last 12 weeks in 12 months.

And thanks for taking the questions I had a couple of questions with regard to be MD eightys.

For all five in MVP and no seven in migraine I wondered what are the rate limiting stats for the March to Andy a filing is there any new clinical data, including safety exposure or CMC activities and our these steps would you characterize them as experiment.

Phil or box checking milestones.

Thank you Charles for the question.

The rate limiting steps.

Really.

From a time perspective.

I would be our open label safety extension trials, we do need 300 patients treated for six months and 100 patients treated for one year.

Each product candidates is for successful five as well as excess of seven.

And we do expect to have.

Those studies completed in the third quarter put us on track to file our.

And you guys in the fourth quarter.

With regards to CMC activities or a registration batches.

Which oh or being manufactured.

Now.

Good thing for US is is that we have been manufacturing.

Clinical trial supplies at commercial scale.

And also a at the same a CMO that.

He wore a commercial production so lots of there's no scale up and done no.

With regards to a manufacturing and any kind of size.

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Uh huh tweaks and experimentation, but I would say that there is no rate limiting step in and out there was no extensive experimentation Oh. This is simply manufacturing a registration batches.

For regulatory purposes.

And area would you would you schedule a pre Andy a meeting before.

Hi, there if those to the safety or CMC activities are completed.

Previous meetings or standard.

And and also a you know there recommended so yes.

So those two.

Pre India meetings for bill excess of five in excess of 7.4 process.

Okay and then just one last question you you very nicely outlined a call it the market opportunity for.

For these two candidates in the United States and it's it's substantial but when I think about challenges.

With the indications that you're seeing and I'm kind of wondering if first of all that market opportunity may grow certainly with the impact of co bid.

In psychiatry, but also on particularly curious about what your your thoughts are with regard to actually U.S. commercial strategies would you consider out licensing or or what are your current thoughts there.

So with regards to watch the effective.

With that 19 pandemic.

On our market opportunities.

Fortunately.

The measures that have been put in place.

This concludes social distancing as well as sheltering in place for key risk factors a war for depression and I'm in fact and increased incidence of depression has been documented pets and recorded.

Various sources.

So while it was a one unfortunately that is.

The reflection of the current environment that that.

No with regards to market opportunities outside of West would you think that they are significant.

Correct that.

They'll potentials that we outlined.

Did this just to get folks a sense of a number of patients whose lives we could impact or those numbers or just left and axle doesn't mean team worldwide rights.

Product candidates.

As part of our strategy.

No. We stated that corporate strategy is to license product candidates outside the U.S. So when I say that is part of our strategy and that is part of our ongoing activities.

Okay, well look forward to increase visibility on that probably over the course the yourself I. Appreciate you taking my questions. Congrats on the progress can be an eventful year for you.

Thank you.

Your next question comes from Marc Goodman with TBB Leerink.

Hey, Good morning, I was just curious as you're thinking about commercializing the migraine truck, what's your thoughts on how the or see GRP have played out so far and what you're considering doing or advertising TTC on the on the television to be able to compete with them.

Unknown Attendee: ??

Thanks, Mark the question I'll turn that over to Dave.

Yeah, Hey, good morning, Mark.

Thanks for joining us this morning.

Well I think the you know the uptake of the oral CDR piece has been a strong and I think that helps to speak to a de unmet need out there that there is a marketplace that is still searching for.

Unknown Attendee: Good morning, ladies and gentlemen, and welcome to the Axsome Therapeutics Conference Call. Currently, all participants are in a listen-only mode.

Unknown Attendee: Later, there will be a question-and-answer session, and instructions will follow at that time. Accompanying slides for this presentation are available on the company website at axsome.com. As a reminder, today's conference call is being recorded. I would now like to turn the conference over to your host, Mark Jacobson, Chief Operating Officer of Axsome Therapeutics. Please go ahead.

Therapies that go beyond traditional triptans to meet additional needs.

That that patients have and I think when you look at access so seven.

We fared very well in terms of our differentiated profile with the data that we have a direct head to head would rise a trip cancer. We feel good about how the market is is reacting to new acute therapies I'm not a completely surprised.

Mark L. Jacobson: Thank you, operator. Good morning, and thank you all for joining us on today's conference call. Our earnings press release providing a corporate update and details of the company's financial results for the first quarter of 2020 crossed the wire a short time ago and is available on our website at Axsome.com. During today's call, we will be making certain forward-looking statements. These statements may include statements regarding, among other things, the efficacy, safety, and intended utilization of our investigational agents, our clinical and non-clinical plans, our plans to present or report additional data, the anticipated conduct in the source of future clinical trials, regulatory plans, future research and development plans, and possible intended use of cash and investments. These forward-looking statements are based on current information, assumptions, and expectations that are subject to change and involve risks and uncertainties These and other risks are described in our periodic filings made with the Securities and Exchange Commission, including our quarterly and annual reports. You are cautioned not to place undue reliance on these forward-looking statements, which are only made as of today's date, and the company disclaims any obligation to update such statements.

Mentioned, given the unmet need regarding consumer and direct to consumer.

Advertising I think there are a number of ways to engage with consumers TV is one of the ways that we can engage with consumers I don't think we're at a point, where we'll take any options off the table, but when I think of engaging with a consumer is one of the benefits of electronic engagement is we have more specific data.

Around those customers you can engage electronically.

We can make sure that those that we engage with our kind of qualified in terms of where they are in their treatment journey. So we won't take any options off the table. This early but certainly we would look to engage consumers to the extent that we would use to TV, we'll we'll see where that goes but we would lead more towards.

It means that's the most efficient means to reach them.

Thanks.

Your next question comes from the line of Mr. Li with Suntrust.

Hi, guys. Thank for taking my questions and congrats on the progress I've a question on a Alzheimer's disease agitation do you plan to seek accelerated path to market similar to what a TV. It did for deposit based on a single stage three and if so what do you need to prepare for that meeting.

Mark L. Jacobson: Joining me on the call today are Dr. Herriot Tabuteau, Chief Executive Officer; Nick Pizzie, Chief Financial Officer; Dave Merrick, Chief Commercial Officer; and Dr. Cedric O'Gorman, Senior Vice President of Clinical Development and Medical Affairs. Ariel will first provide an overview of the company, including reviewing recent developments and upcoming milestones. Following Ariel, Nick will review our financial results, and we will then open the line for questions. I shall now turn over the call to Ariel.

And the along with that do you feel the FDA off today is more or less common data is that the FDA five years ago. Thank you.

Thanks for the question Jim we're very excited about the results in all sometimes the these agitation and Ah I think.

Ariel: Thank you, Mark. Good morning, everyone, and thank you all for joining Axsome Therapeutics' first quarter 2020 financial results and business update conference call. Over the past several months, we have accelerated our evolution into a leading CNS company. During this time, we continue to advance our broad and deep late-stage portfolio of novel, differentiated medicines targeting difficult-to-treat CNS indications that have limited or no treatment options and that affect significant patient populations. We now believe we have one of the most robust CNS pipelines in the industry. Our late-stage CNS pipeline is not only broad but also proven, as we have now generated or announced positive efficacy results from well-controlled clinical trials in five different indications, including depression, Alzheimer's disease agitation, migraine, narcolepsy, and fibromyalgia. Overall, these conditions affect more than 60 million patients in the U.S. alone. The prevalence, seriousness, and high unmet needs represented by these conditions underscore the importance of our investigational medicines and the clinical data generated with them thus far. The resulting opportunities are great.

Oh, what underlies your question is a clinical need there and.

Ariel: This slide is a snapshot of select indications in our late stage pipeline for which we now have positive efficacy data from controlled clinical trials. For our AXSO5 product candidate, we announced positive NDA enabling results in major depressive disorder in December, showing rapid and substantial improvement in depressive symptoms. And last week, we announced positive results from our pivotal ADVANCE1 trial of AXS05 in Alzheimer's disease agitation, which similarly demonstrated rapid and substantial symptom improvement in this condition. We have also announced positive NDA-enabling results in Migraine, with our AXS07 product candidate demonstrating superior efficacy. And last month, we announced positive results from our Intercept Trial of XSO7 in the early treatment of migraines. Our AXS12 product candidate for narcolepsy has demonstrated in our concert trial significant improvement in cataplexy and excessive daytime sleepiness, the key symptoms of narcolepsy.

It is true that this is an indication for which nothing is approved the a young but need as well as a public health need there is high because these patients do you need to be treated and you alternatives that are out there currently or contraindicated certainly.

Ariel: And our AXS14 product candidate for fibromyalgia has demonstrated a differentiated profile and positive results in both a phase 2 and a phase 3 trial. Overall, our product candidates have the potential to generate total peak sales of up to $9 billion in just these indications based on the clinical data generated thus far. This robust portfolio highlights the potential to improve the lives of millions of patients and significantly increase shareholder value. With regard to our upcoming milestone,

Ariel: We remain on track to file our NDA for AXS05 in major depressive disorder in the fourth quarter. The NDA is supported by positive efficacy results from our Pivotal Ascend in Gemini trial. These three open-label, long-term safety extension studies of XS05 to further support the NDE filing are ongoing, and to date, more than 800 patients have been dosed in this trial. We also remain on track to file our NDA for AXS 07 in migraine in the fourth quarter. The NDA is supported by positive efficacy results from our Momentum and Intercept trials. A Phase 3 Open Label Long-Term Safety Extension Study of XSO7 to further support the NDE filing is ongoing, and to date, more than 700 patients have been dosed in this trial.

Nick Pizzie: As we move towards the filing of our NDAs in the fourth quarter for AXS05 and for AXS07, our commercial team is focused on launch readiness activities to ensure successful commercial execution. In parallel, we look to continue the momentum in our other late-stage development programs, including AXSO5 and Alzheimer's disease agitation, a highly distressing and disabling condition for which there is no approved medicine. Following the recent announcement of positive top-line results from our pivotal Advance 1 trial in this indication, we intend to meet with the FDA as soon as possible to discuss these data. We expect these discussions to inform the design of our next study, which we anticipate initiating in the second half of this year. We also anticipate initiating Phase 3 trials with AXS12 in narcolepsy in the second half of this year, building on the strong results from our positive phase two concert trial.

The against with a black box warnings against their use in this population. So no. We're you'll note that our.

Pivotal phase through three advanced trial results or a strong.

And what we're looking to do as quickly as possible to meet with yet.

And we need to have those discussions with.

Our base case or and area, though is that we wouldn't be conducting one additional trial that has always been our assumption and that's the usual path are now.

As youre pointing out there has been instances in the past with yet he hasn't from products.

Such as Ah Ah Pimavanserin with a one a positive pivotal trial in indications, which nothing is.

Uh huh.

However, I just want to faith that that it's not the way too to to run a business is that it's not to to hope work for the best but is the plan for most likely scenario, that's what we've done and and we think that there certainly is oh wait to accelerate.

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The exit some five in the syndication.

Given what we currently no. So we'll know more you know once we said, yes, yes, we're looking to do that as its interesting as possible.

Thank you have a whether or not yet in terms of whether or not yet. He is more more comedy on now than it was a five years ago I will comment on that.

Huh.

We we are young company. So we don't have the same history at some other companies and problem.

Or more appropriate to ask them to answer that question.

Thank you for that that clarification I just have one more follow up you know you have a very high class problem up having to meet with the FDA for for many programs. You had listed seven meetings with the FDA Jets. The second half of 20 or you actually going to have seven separate meetings or would you have maybe two to three meetings to discuss multiple.

I programs simultaneously just curious from a disclosure standpoint on when we can hear back.

On on the FDA feedback if that is your plant surety updates as you get the feedbacks. Thank you.

So what do I don't know, where we lifted seven at the meetings or or maybe just a permanent or actually with the FDA.

We do have a number for Iran's.

Going which is true and yeah. We also do you have breakthrough therapy designation wakes up to five major depressive disorder and.

And fast track designation war.

One reason fraction an all time.

Station. So those designations are more important because they allow more frequent.

Communications with the FDA ER and so certainly there are a lot of interactions and what we've done in the past.

He is a.

When our interactions due to development, which is which is material.

Such as changing.

From a timing.

Then we have talked about that.

Sure that with investors.

We plan to Wow.

Follow that same out at the same playbook and certainly you know anything that Oh, we think is material.

Nick Pizzie: By focusing on commercial readiness to make our products available to patients starting as early as next year and by advancing the rest of our development pipeline through innovation, we will continue to build an industry-leading CNS company with an energetic culture that challenges the status quo to speed innovative therapies to patients. I would now like to turn the call over to Nick, who will provide a financial update.

War that that is a significant one together.

Communicate expeditiously.

Street.

Thank you very much.

Your next question comes from.

Yeah, So new Gee with Guggenheim partners.

Hey, guys. Good morning. Thank you for taking my question just a couple on the filing a deal Pac pride to view four or five and seven and then can you comment that if there's any impact on the ongoing safety studies over the long term extension study because of coal.

Good.

Then I have a follow up.

For accessible five.

In major depressive disorder, because we have breakthrough therapy designation is eligible for six month review.

We will certainly be seeking that that's a decision that that he's me, though typically after the Andy's file.

But certainly that is one of the features.

Further the designation for access and seven we currently anticipate standard review.

And in terms of the impact of little bit 19 on the ongoing.

Open label safety extension trial.

Oh currently we're not anticipating significant impact largely because a significant number of pieces have already been wrong in them. So in those that.

But each of the open label studies, all five and it was seven the goal is to have 600 patients treated for three months and 100 patients treated for one year and.

Nick Pizzie: Thank you, Ariel, and good morning, everyone. I will focus on key highlights from the quarter and provide some financial guidance. We ended the quarter in a strong financial position that is consistent with our ability to rapidly advance our clinical programs and commercial preparations while maintaining highly efficient fiscal management. R&D expenses were $27.5 million for the quarter ended March 31, 2020, versus $7.6 million for the comparable period in 2019. The quarter included a one-time charge of $10.2 million related to the upfront cost associated with the Pfizer licensing agreement, of which $7.2 million was non-cash. Net of the costs related to the Pfizer licensing agreement, R&D expenses were $17.3 million. The increase versus the first quarter of 2019 was due to significantly more clinical trial activity during this most recent period, including the STRIDE-1, Intercept, and ADVANCE-1 trials, the AXS05 and AXS07 open-label safety studies, and close out costs for our CONCERT, GEMINI, and Mementum trials. All of these trials, aside from the AXS05 and AXS07 Open Label Safety trials, have now been concluded and are in the process of being closed out.

Currently have a north of 700 800, he shares each of those studies.

One of the Oh aspects of clinical trials, which is most impacted by cold It has to do.

Oh patients are not being able to were not wanting to go to watch.

I think one trial sites for their visits those visits or less frequent in long term see extension trial, so why that benefits us and Ah.

The other reason why outpatient said typically need to go to control side, just to get a drug supply and would you have a.

We do have alternatives in place to make sure that a drug supply gets to patients in their homes should they choose not to.

Their homes.

Got it and then did you got to the T. R. D study that you plan to initiate could you talk about the timeframe well for completion. We understand this is not going to be age. They study similar to the stride one that took a lot longer but just help us understand you leave more time can that be should thinking about.

The progression that you might already be doing in anticipation of talking that study that I Commission.

Mark L. Jacobson: G&A expenses were $5 million for the quarter ended March 31, 2020, and $2.8 million for the comparable period in 2019. The change was primarily due to increased personnel costs, mainly from higher stock compensation, along with the build-out of the commercial function. We ended the first quarter with $197.3 million in cash, compared with $220 million at the end of the fourth quarter. We believe that our current cash position is sufficient to fund our anticipated operations based on our current operating plan for at least two years. That concludes our first quarter 2020 financial review. I will now hand the call back to Mark to lead the Q&A discussion.

We anticipate that the timeframe from completing a that second tier de study will be shorter than the timeframe.

But oh that we experienced and complete the first you study and we'll know more than once nail down the exact design of that trial.

And once we do some more internal projections and we'll certainly share our thoughts or once there what's been crystallize the.

With the street.

Hi, Thank you very much.

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Your next question comes from the line of Rob Summer Roger.

Unknown Attendee: Thank you, Nick. Operator, can we please have our first question? And in order to ask a question, simply press star, then the number one on your telephone keypad. And your first question comes from Charles Duncan on Cancer Fish Gerald.

[noise] H.C. Wainwright.

Hi, Thanks, very much for taking my questions. Firstly I just wanted to see if you could reconfirm that the phase three a confirmatory treatment resistant depression study with access so five is going to be placebo controlled.

Charles Cliff Duncan: Hey, good morning, Ariel and team. Congratulations on the clinical successes in the last 12 weeks and 12 months, and thanks for taking the questions. I had a couple of questions with regard to the NDAs for 05 in MDD and 07 in migraine. For example, I wondered what the rate-limiting steps were for the March 2 NDA filing. Is there any new clinical data, including safety exposure or CMC activities? And are these steps, would you characterize them as experimental or box-checking milestones?

So from a we're still finalizing the design of that study, but that is certainly one possibility and one from finalizes that design and confirmed that.

Discussions with <unk>.

Yeah.

But you know.

Okay, Great and can you comment on or give us an update on the status of access so five smoking cessation or with all the shots on goal that you currently have a it seems like maybe.

You might be thinking about prioritizing other things, but just wanted to get a sense of how you're thinking about that at this time.

Ariel: Thank you, Charles, for the questions. The rate-limiting steps, really, from a time perspective, would be our open-label safety extension trials. We do need 300 patients treated for six months and 100 patients treated for one year for each product candidate. This is for AXS05 as well as for AXS07.

We're excited about the smoking cessation opportunity I'm very large patient population and I probably.

The largest uh huh teaching.

That Oh, we're targeting and with all the areas product candidates in the various indications and our goal is to meet with Yep.

Discuss the next steps are in smoking cessation programs. So that is one of our milestones for this year.

Ariel: And we do expect to have those studies completed in the third quarter, which would put us on track to file our NDAs in the fourth quarter. With regard to CMC activities, there are registration batches which are being manufactured. Now, a good thing for us is that we have been manufacturing our clinical trial supplies at commercial scale and also at the same CMO that we're using for commercial production. So there's no scale-up that needs to be done. With regard to manufacturing and any kind of science, there are always tweaks and experimentation, but I would say that there is no rate-limiting step, and there is no extensive experimentation. This is simply manufacturing our registration batches for regulatory purposes.

Okay, Great and then on extra box a team was just wondering whether you had gotten the chance to talk to the agency about what else.

We expect to see what else they will be.

Hi, guys to potentially countenance, the approval or that sort of oxiclean fibromyalgia, and if you have gotten a sense from them as to what additional clinical data.

It's Eric.

Oh, we have not yet met with your P.H. discuss except for team.

That is also one of our stated corporate goals for this year. So while we do I expect that that will happen and yeah. We're looking forward to discuss the data package, which is already been generated.

And that did a package as a reminder.

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Okay and then just lastly on the Narcolepsy program I was wondering if you could give us your thoughts on the nature of the competitive landscape for access 12, particularly in light of the recent phase three data on it's key to 18, and how you see ASCII to 18 as a competitive X and obviously it looks like that's going to be schedule dates as well.

Ariel: And, Ariel, would you schedule a pre-NDA meeting before either of those two, the safety or CMC activities, are completed?

Ariel: The pre-MDM meetings are standard and also, you know, they're recommended. So, yes, you know, we do those pre-MDM meetings for both AXS 05 and AXS 07 as part of our process.

It's not going to be schedule, but if you had any thoughts there that would be helpful.

So this is an area.

Hi, unmet medical need a where patients need new treatment options.

If he to 18 or understanding it's still still has the same active ingredient.

Ariel: Okay, and then just one last question. You very nicely outlined, call it, the market opportunity for these two candidates in the United States, and it's substantial. But when I think about the challenges with the indications that you're seeing, I'm kind of wondering if, first of all, that market opportunity may grow, certainly with the impact of COVID in psychiatry, but also, I'm particularly curious about what your thoughts are with regard to Axios' commercial strategies. Would you consider outlicensing, or what are your current thoughts there?

As as island so wide.

So.

We do think that that would be beneficial to have much other molecules that differently and their dose that not dramatically different lease such as excess 12.

Now.

With regards to Chase is 12 <unk>.

Like about that product candidate is that it had a positive effect across a range of.

Okay.

I'm not just kind of flex.

Tons weakness.

It also positively affected cognitive function and.

Ariel: So with regard to the effect of the COVID-19 pandemic on our market opportunities, unfortunately, the measures that have been put in place, which include social distancing as well as sheltering in place, are key risk factors for depression. And, in fact, an increased incidence of depression has been documented and has been reported from various sources. So, unfortunately, that is a reflection of the current environment that we're in.

As a reminder, the product is very well tolerated is the time dosing.

We do not expected schedule, which Uh huh.

Another point of differentiation.

From the current a product which is currently.

Cataplexy and and certainly thing, but that feature in addition to a.

The broad range of constant improvement welcome.

Patient and commissions.

Great. Thank you very much in congrats on all the progress once again.

Yeah.

Your next question comes from the line of Bert Hazlett with BP I T.

Ariel: Now, with regard to market opportunities outside of the U.S., we do think that they are significant. You are correct that the sales potentials that we outlined, and we did this just to give folks a sense of the number of patients whose lives we could impact, those numbers are just for the U.S., and Axsome does maintain worldwide rights due to our product candidates. It's part of our strategy. We stated that our corporate strategy is to license our product candidates outside of the U.S. So that is part of our strategy, and that is part of our ongoing activities.

Yeah. Thank you just one or two clarifying points one is.

With regard to access so far in Alzheimer's disease education.

That's a seems to be very important data.

Not that a MDD at TRG is not important without molecule, but but but that given the unmet need is is important.

Is there a chance for breakthrough designation and then specifically when do you intend to meet with the FDA.

And then could you with regard to that indication could you do a little bit more to frame. The opportunity you unmet need is material here what is the state of treatment or they treated with off label Benzos or atypical antipsychotic still a even with a black box, it's just a little bit more about the opportunity in addition to.

Ariel: Okay, we'll look forward to increased visibility on that probably over the course of the year or so. Appreciate you taking my questions. Congratulations on the progress. It is going to be an eventful year for you. Thank you.

To kind of the timetable with regard to your interactions with FDA would would be helpful. Thank you.

Ariel: Thank you.

Thank you thanks work with the question.

Oh, what Cedrik us.

Mark Goodman: And your next question comes from Mark Goodman with CBB Lyric.

Talk about the a treatment landscape among oh, well answer questions around a hefty interactions.

Mark Goodman: Hey, good morning. I was just curious, as you're thinking about commercializing the migraine drug, what are your thoughts on how the oral CGRPs have played out so far? And whether you're considering doing advertising DTC on television to be able to compete with them?

Bird at the moment, there's absolutely no approved treatment for a agitation associated with Alzheimer's disease, it's highly prevalent in high disabling and associated with increased mortality accelerated causing the tiny of your institutionalization.

And that and there's a real need so currently.

Dave Merrick: Thanks Mark for the question, and I'll turn that over to Dave.

Positions and prescribers and health care South of nursing home, our resorting to have to use off label <unk> prescriptions of anti psychotic drugs, which as you point out of the black box warning rank do some of the elderly, but it really a it emphasizes the tremendous needs that people are still resorting to these assets Psychotics that's.

Dave Merrick: Yeah. Hey, good morning, Mark. Thanks for joining us this morning. Well, I think the, you know, uptake of oral CGRPs has been strong. And I think that helps to speak to the unmet need out there that there is a marketplace that is still searching for therapies that go beyond traditional tryptans to meet additional needs that patients have. And I think when you look at AXS 07, I think we fare very well in terms of our differentiated profile with the data that we have in direct head-to-head with bryzotriptan.

Like their own association with increased mortality morbidity cardiovascular problems and stroke. So there's definitely a need for any treatment first of all and the need for an approved treatment, which has not yet been achieved.

Dave Merrick: So we feel good about how the market is reacting to new acute therapies. But I'm not completely surprised, as I mentioned, given the unmet need regarding consumer and directed consumer advertising. I think there are a number of ways to engage with consumers. TV is one of the ways that we can engage with consumers. I don't think we're at a point where we'll take any options off the table, but when I think of engaging with consumers, one of the benefits of electronic engagement is that we have more specific data around those customers you can engage electronically with, and we can make sure that those that we engage with are kind of qualified in terms of where they are in their treatment journey. So we won't take any options off the table this early, but certainly, we would look to engage consumers to the extent that we would use TV. We'll see where that goes, but we would lead more towards electronic means as the most efficient means to reach them. Thanks.

The lag from requesting a meeting to getting a meeting but this is a priority do agree that these are important data.

And.

We'll have more to say a ones we interact agency.

Okay. Thank you.

Your next question comes from the line of Matt Kaplan with Ladenburg Thalmann.

Hi, Good morning, guys and thanks for taking the questions I'm just wanted to dig in a little more to excess 12 or narcolepsy. What's your what's your current sense in terms of the phase three design.

He plans to launch later this year and do you expect that you would have to do I guess, two phase three studies or could one be sufficient.

Thanks for the question Matt.

Versus the northwest seem a phase three design, we might get finalized the design. However, it will incorporate a lot of the elements from our successful phase two trials on Turkey, the endpoint I'm, certainly and one difference will be that.

Mark Goodman: Thanks.

Joon So Lee: And your next question comes from the line of Mr. Lee with SunTrust.

Joon So Lee: Hi guys, thanks for taking my questions and congrats on the progress. I have a question on Alzheimer's disease agitation. Do you plan to seek an accelerated path to market similar to what Acadia did for Neuplazid based on a single phase 3? And if so, what do you need to prepare for that meeting? And along with that, do you feel the FDA of today is more or less accommodating than the FDA of five years ago?

As to what the crossover study and would anticipate this would be apparel study.

And then we are planning on conducting two phase three trials and conducting them simultaneously.

Okay. That's very helpful. Thanks, So you have the detail.

Yeah.

Your next question comes from miles Mintel answer would you. Please state your company.

Ariel: Thank you.

Sorry must have caught up [laughter], it's up miles from interest from William Blair. Thanks for taking the questions.

Ariel: Thanks for the question, June. We're very excited about the results in Alzheimer's disease agitation, and I think what underlies your question is the clinical need there.

He 800 patients that Youve currently got involved with digesting lifecycle extension safety has access your thoughts.

Ariel: Thank you. I think it's true that this is an indication for which nothing is approved. The unmet need, as well as the public health need, there is high because these patients do need to be treated, and the alternatives that are out there currently are contraindicated or certainly advised against with the FDA black box warnings against their use in this population. Pivotal Phase II-III advanced trial results are strong.

I'm, just wondering whether you've got any more clarity or intend on talking with the F. T. I about the proportion of patients that would have to pay out eight such as MTGE. They fit that single safety trial to serve as part of the long term safety.

Database football is if those indications so theoretically you wouldn't have to run another one on the end of the next Saturday trial.

So thanks my question miles or so as you know that open label safety extension study does in patients with both your D and MTD.

Ariel: And what we're looking to do as quickly as possible is to meet with the FDA, and we need to have those discussions with the FDA. In the base case scenario, though, is that we would conduct one additional trial. That has always been our assumption, and that is the usual FDA path. As you were pointing out, there have been instances in the past where the FDA has approved products such as Pimivansirin with one positive pivotal trial and indications for which nothing is approved. However, I just want to state that that is not the way to run a business. It's not to hope for the best, but it's to plan for the most likely scenario.

And firms with the exact proportion thats never been or stated clearly when we're together.

Yes, now what we Bob.

Talked about is the way that we're thinking about it and with it that we're thinking about it used to have a number of patients over to your D.

In the long term working the trial those would be.

Sure.

One year.

That reflects the general.

Fortunate purity patient that's compared to MTD a in general population so while.

That was our thinking and and with regards to watch the M.T.D. trial.

Ariel: And that's what we did, and we think that there certainly is a way to accelerate the approval of XSO5 in the syndication, given what we currently know. So we'll know more once we meet with the FDA, and we're looking to do that as expeditiously as possible. In terms of whether or not the FDA is more accommodating now than it was five years ago, I won't comment on that. We are a young company, so we don't have the same history as some other companies, and it would probably be more appropriate to ask them to answer that question.

Certainly it probably becomes oh less relevant for that indication and up by the time that do file 40 or D.

As a reminder will have than a significantly more patients with TD in our overall Cds.

[noise]. That's that's helpful and then actually on the tape out a proposed trial I know the designs yet to be a definitive flea clarified.

But if it is placebo controlled and patients would theoretically have to file to a more prior antidepressants are you looking to control try pre on yours.

In those patients.

So.

Ariel: Thank you for that clarification. I just have one more follow-up question. You know, you have a very high-class problem of having to meet with the FDA. For many programs, you have listed seven meetings with the FDA in just the second half of 20. Are you actually going to have seven separate meetings, or will you have maybe two to three meetings to discuss multiple programs simultaneously? I'm just curious, from a disclosure standpoint, when we can hear back on the FDA's feedback, if that is your plan to share it? I would love to hear the updates as you get feedback. Thank you.

Just.

As a reminder, ER.

Indeed in stride one trial all patients were treated with Brown and are now certainly it would make sense that that a if we do have a study whereby we are dosing excess five that so we would restrict before around use of that.

Make sense, but it's typical practice in any clinical trial, whereby you would restrict additional use of the product that that Oh, yes, I guess that you're testing so.

Ariel: So, Joon, I don't know where we've listed seven FDA meetings, or just in terms of interactions with the FDA, we do have a number of programs that are ongoing, which is true, and we also do have breakthrough therapy designation for XSO5 and major depressive disorder, and fast track designation for treatment-resistant depression and Alzheimer's disease agitation. So those designations are important because they allow more frequent communications with the FDA, and so certainly there are a lot of interactions, and what we've done in the past When our interactions do lead to a development, which is which is material, such as, you know, a change in, [inaudible] Follow the same playbook, and certainly anything that we think is material or that is significant one way or the other, we would communicate expeditiously with the street.

Well, that's the right now our preliminary.

Our preliminary thoughts however, you know, we or you know finalizing the design that trial and finalizing the design of studies.

Takes into account a lot of important details and want to make sure that thinking about them very carefully and once we got the final design, though of the study.

Like more detail.

[laughter].

Yes, sorry, I guess the the question was more about in the prior history. If these patients would you look at restricting departure on use trial enrollment I I know the trial will be monotherapy per se, but if you were looking at the patient each street and might be looking at controlling private property on use coming into the trial.

<unk>.

Right now we would not anticipate a controlling pricing for me on use.

Just as we didn't do as fried one trial, where that is considered to be <unk> that was allowed to be not just allowed to be but was mandated by the trial design for that to be one of the prior antidepressants failures.

Okay Cool and then follow one for me, it's just on access trial.

Just curious how the slides a licensing deal when you got in access footing for fiber.

Ariel: Thank you very much.

Yatin Suneja: And your next question comes from Yatia Sanuji with Guggenheim Partners.

What that sort of extended clinical and non clinical database would do in terms of might be reducing the safety database that you would have to build for the snow Phillips you treatment. After a pivotal a pivotal trial is there any additional color there.

Yatin Suneja: Hey guys, good morning. Thank you for taking my question. Just a couple.

It certainly helps us the patient safety database with ER, Remoxy, and that's robots and team.

Ariel: On the filing, do you expect prior to review for 05 and 07? And then can you comment if there is any impact on the ongoing safety study or the long-term extension study because of COVID? Then I have a follow-up.

Which we licensed from Pfizer.

And teen thousands of patients I would've been exposed a war there's my sometime.

So those those picking numbers certainly would mean I teach guidelines.

And and we would look to in fact, we are looking to leverage that safety database that bridge safety database to accelerate will streamline our filings waste this woman exists.

Ariel: For AXS 05 in major depressive disorder, because we have the grapefruit therapy designation, it is eligible for six-month review, so we will certainly be seeking that.

Ariel: That's a decision that is made, though, typically after the NDA is filed. But certainly, that is one of the features of a breakthrough therapy designation. For AXS07, we do currently anticipate standard review.

Ariel: And in terms of the impact of COVID-19 on the ongoing open-label safety extension trials, currently, we're not anticipating a significant impact, largely because a significant number of patients have already been enrolled in those studies. For each of the open-label studies, 405 and 07, the goal is to have 600 patients treated for three months and 100 patients treated for one year. And we currently have north of 700 or 800 patients in each of those studies. One of the aspects of clinical trials which is most impacted by COVID has to do with patients not being able to or not wanting to go to the clinical trial sites for their visits. Those visits are less frequent in long-term safety extension trials. So that benefits us. The other reason why patients typically need to go to clinical trial sites is to get their drug supply, and we do have alternatives in place to make sure that drug supply gets to patients in their homes should they choose not to leave their homes.

Great. Thanks for the question congrats.

And your final question will come from the line of Joseph Stone, but colony company.

[noise] there. Thank you for taking my questions Joe from Cowen.

First on the all farmers data as you go through what you presented not too long ago is there anything looking forward to a phase three that you would change in terms of.

The enrollment criteria or how long you want to be following these patients in this study.

And then maybe to.

My second question on access 12, when looking at the primary endpoints for this study are getting looking at both cataplexy and daytime sleepiness and maybe is there one that the agency would be looking closer at in terms of.

No regulatory decision, making.

<unk> for the questions with regards to weather.

The next phase three war Alzheimer's disease education.

Program, we just have to be the last week, so and we want to make sure that we continue to mine it took to understand it to inform the potential design of the next thing.

With regards to Y axis 12, we will be looking at both Catholics necessity times weakness in our phase three program.

Yatin Suneja: With regard to the TRD study that you plan to initiate, could you talk about the time frame for completion? We understand this is not going to be a study similar to STRIDE-1 that took a lot longer, but just help us understand the time frame that we should be thinking about and the preparation that you might already be doing in anticipation of starting that study relatively soon.

Cataplexy is a we believe.

All the symptoms in narcolepsy, all are important but believe that kind of like sees is one of the ones with the highest fund that medical need. There currently has one product that is.

What cataplexy.

And and they're all our other products that are available for 70 times. So we'll be looking at both and the focus will be on complex.

Ariel: We anticipate that the time frame for completing that second TRD study will be shorter than the time frame for completing the first one that we experienced in completing the first TRD study. And we'll know more once we nail down the exact design of that trial and once we do some more internal projections. And we'll certainly share our thoughts once they're crystallized with the street.

Great. Thank you.

And at this time there are no further audio question are there any closing remarks.

Well. Thank you all for joining us on the call today, we are intensely focused on advancing what we believed to be the most robust late stage pipeline in the industry.

We look forward to up the on our ongoing progress.

Yatin Suneja: All right, thank you very much.

And ladies and gentlemen. This concludes today's conference call. Thank you for your participation you may now disconnect presenters. Please hold one moment.

Unknown Attendee: And your next question comes from the line of Ram Samarajah with HC Wainwright.

Unknown Attendee: Hi, thanks very much for taking my questions. Firstly, I just wanted to see if you could reconfirm that the phase three confirmatory treatment resistant depression study with AXSO5 is going to be placebo controlled.

Ariel: So Rahm, we're still finalizing the design of that study, but that is certainly one possibility, and once we have finalized that design and confirmed it through discussions with the FDA, we'll let you know.

Unknown Attendee: Okay, great. And can you comment on or give us an update on the status of AXSO5 smoking cessation? With all the shots on goal that you currently have, it seems like maybe you might be thinking about prioritizing other things, but just wanted to get a sense of how you're thinking about that at this time.

Ariel: We're excited about the smoking cessation opportunity, a very large patient population, and probably the largest patient group that we're targeting with our various product candidates and the various indications. And our goal is to meet with the FDA to discuss the next steps in the smoking cessation program. So that is one of our milestones for this year.

[music].

Unknown Attendee: Okay, great. And then on Estroboxetine, I was just wondering whether you had gotten the chance to talk to the agency about what else they expect to see, what else they will need from you guys to potentially count in an approval for S-riboxetine and fibromyalgia, and if you've gotten a sense from them as to what additional clinical data would be needed for you to generate.

Unknown Attendee: Ram, we have not yet met with the FDA to discuss AFS-14. That is also one of our stated corporate goals for this year, so we do expect that that will happen, and we're looking forward to discussing the data package which has already been generated, and that data package, as a reminder, includes a positive phase 3 and a positive phase 2 trial.

Ariel: Okay, and then just lastly, on the narcolepsy program, I was wondering if you could give us your thoughts on the nature of the competitive landscape for AXS 12, particularly in light of the recent phase three data on SP 218, and how you see SP 218 as a competitive entrant. Obviously, it looks like that's going to be scheduled; AXS 12 is not going to be scheduled. But if you had any thoughts there, that would be great.

Ariel: So this is an area of high unmet medical need where patients need new treatment options. Your FT218, you know, our understanding is still, still has the same active ingredient as Xyrem. So... We do think that it would be beneficial to have other molecules that work differently and that are dosed dramatically differently, such as AXS-12. With regard to JXS12, what we like about that product candidate is that it had a positive effect across a range of narcolepsy symptoms, not just cataplexy but excessive daytime sleepiness. It also positively affected cognitive function. And, as a reminder, the product is very well tolerated. It is daytime dosing, and we do not expect it to be scheduled, which would be another point of differentiation from the current product, which is currently approved for cataplexy. And certainly, that feature, in addition to the broad range of symptom improvement, would be welcomed by patients and clinicians.

Unknown Attendee: Great, thank you.

Bert Hazlitt: And your next question comes from the line by Bert Hazlitt with DT.

Bert Hazlitt: Yeah, thank you. I have just one or two clarifying points. One is, with regard to AXS05 in Alzheimer's disease agitation, that seems to us to be very important data. Not that MDD and TRD are not important with that molecule, but that, given the unmet need, is important. Is there a chance for breakthrough designation? And then specifically, when do you intend to meet with the FDA? And then, could you, with regard to that indication, do a little bit more to frame the opportunity? The unmet need is material here. What is the state of treatment? Are they still being treated with off-label benzos or atypical antipsychotics, even with the black box? Just a little bit more about the opportunity in addition to the kind of timetable with regard to your interactions with FDA would be helpful. Thank you.

Cedric O'Gorman: Thanks for the question. I'll let Cedric talk about the treatment landscape, and then I'll answer the questions around FDA interactions.

Cedric O'Gorman: Bert, at the moment, there is absolutely no approved treatment for agitation associated with Alzheimer's disease. It's highly prevalent and highly disabling and associated with increased mortality, accelerated cognitive decline, earlier institutionalization, and death. And there's a real need, so currently, physicians and prescribers and healthcare staff at nursing homes are resorting to using off-label prescriptions of antipsychotic drugs, which, as you point out, have the box warning around their use in the elderly. But it really emphasizes the tremendous need that people are still resorting to these antipsychotics despite their own association with increased mortality, morbidity, cardiovascular problems, and stroke. So there's definitely a need for treatment, first of all, and a need for an approved treatment, which has not yet been achieved.

Ariel: And with regard to the timing of FDA interactions, we are seeking to meet with the FDA as quickly as possible on this. There is, of course, always a lag from requesting a meeting to getting a meeting, but this is a priority. We do agree that these are important data, and we'll have more to say once we interact.

Ariel: Okay, thank you.

Matthew Lee Kaplan: Your next question comes from the line of Matt Kaplan with Lindenburg-Fallman.

Matthew Lee Kaplan: Hey, good morning guys, and thanks for taking the questions. I just wanted to dig in a little bit more on AXS 12 for narcolepsy. What's your current sense in terms of the phase 3 design that you plan to launch later this year, and do you expect that you would have to do I guess two phase 3 studies or could one be sufficient?

Ariel: Thanks for the questions, Matt. With regard to narcolepsy and the Phase 3 design, we have not yet finalized the design. However, it will incorporate a lot of the elements from our successful Phase 2 trial. So in terms of the endpoints, certainly. And, you know, one difference will be that the Phase 2 study was a crossover study, and we would anticipate that this would be a parallel group study. And then we are planning on conducting two phase 3 trials, and we will be conducting them simultaneously.

Myles Robert Minter: Sorry, I must have got a lag there. It's Myles Minter from William Blair.

Myles Robert Minter: Thanks for taking the question. The 800 patients that you've currently got enrolled or dosed in your Open Label Acute Safety of AXS 05. I'm just wondering whether you've got any more clarity or intend to talk with the FDA about the proportion of patients that would have to be TRD versus MDD for that single safety trial to serve as both the long-term safety... Database for both of those indications, so theoretically, you wouldn't have to run another one at the end of the next TRD trial.

Ariel: So thanks for the question, Myles. As you know, that Open Label Safety Extension study does include patients with both TRD and MDD. And in terms of the exact proportion, that's never been stated clearly, one way or the other, by the FDA. Now, what we've talked about is the way that we're thinking about it. And the way that we're thinking about it is to have a number of patients with TRD in the long-term portion of the trial, those who have been treated for one year, that reflects

Ariel: The General Proportion of TRD patients compared to MDD in the general treatment population. That was our thinking, and with regard to the EMDD trial, certainly, it probably becomes less relevant for that indication, and by the time that we do file for Tier D, once that study is completed, as a reminder, we will then have significantly more patients with Tier D in our overall safety database.

Ariel: That's helpful. And then actually on the TRD proposed trial, I know the designs are yet to be definitively clarified. But if it is placebo controlled, and patients would theoretically have to fail to take one or more prior antidepressants, are you looking to control bupropion use in those patients?

Ariel: So, just as a reminder, in the STRIVE-1 trial, all the patients were treated with bufoprion. And now, certainly, it would make sense that if we do have a study whereby we are dosing XSO5, that we would restrict bufoprion use. That is typical practice in any clinical trial, whereby you would restrict additional use of the product or the active ingredients that you're testing. So that's right now our preliminary design. As you know, we are finalizing the design of that trial and finalizing the design of the studies. It takes into account a lot of important details, and we want to make sure that we think about those very carefully, and once we have the final design of the study, we'll be able to provide you with more details.

Myles Robert Minter: Yeah, sorry, I guess the question was more about in the prior history of these patients, would you look at restricting bupropion use prior to enrollment? I know the trial will be monotherapy per se, but yeah, if you were looking at the patient history and maybe looking at controlling prior bupropion use coming into the trial.

Ariel: Right now, we would not anticipate controlling prior bupropion use just as we did in the STRIDE1 trial where that was considered to be, or that was allowed to be, not just allowed to be, but it was mandated by the trial design for that to be one of the prior antidepressant failures.

Myles Robert Minter: Okay, cool. And then the final one for me is just on AXS 12. Just curious how the Pfizer licensing deal when you got in AXS 14 for Fibro would do in terms of maybe reducing the safety database that you would have to build for this narcolepsy treatment after a pivotal trial. Is there any additional color there?

Ariel: It certainly helps us. The patient safety database for Robocin and S-Robocantine, which we licensed from Pfizer, contains thousands of patients who have been exposed for various lengths of time. So those patient numbers certainly would meet ICH guidelines. And we would look to, in fact, we are looking to leverage that safety database, that rich safety database, to accelerate or streamline our filings for excess 12 minutes.

Myles Robert Minter: Great, thanks for the questions. Congrats.

Joseph John: And their final question will come from the line of Joseph Stone with the Colony Company.

Joseph John: Hi there. Thank you for taking my questions, Joe and Colin. First, on the Alzheimer's data, as you go through what you presented not too long ago, is there anything looking forward to a Phase 3 that you would change in terms of the enrollment criteria or how long you want to be following these patients in this study? And then, maybe two, on my second question on AXS-12, when looking at the primary endpoints for this study, are you going to be looking at both cataplexy and daytime sleepiness And maybe there is one that the agency will be looking closer at in terms of regulatory decisions? Thank you.

Ariel: Thank you for the questions. With regard to phase three of our Alzheimer's disease agitation program, you know, we just got the data last week. So we want to make sure that we continue to mine it, to understand it, to inform the potential design of the next study. With regard to AXS 12, we will be looking at both cataplexy and inexpensive daytime sleepiness in our Phase 3 program. Cataplexy is, we believe, All the symptoms in narcolepsy are important, but we believe that cataplexy is one of the ones with the highest fundamental medical need. There is currently only one product that is approved specifically for cataplexy. And there are a lot of other products that are available for excessive daytime sleepiness. So we'll be looking at both, and the focus will be on cataplexy. Great, thank you.

Ariel: And at this time, there are no further audio questions. Are there any closing remarks?

Unknown Attendee: Well, thank you all for joining us on the call today. We are intensely focused on advancing what we believe to be the most robust late-stage CNS pipeline in the industry. We look forward to updating you on our ongoing progress. And, ladies and gentlemen, this concludes today's conference call. Thank you for your participation. You may now disconnect. Presenters, please hold one moment.

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