Q3 2020 Axsome Therapeutics Inc Earnings Call

[music].

Good morning, and welcome to the X. I'm Therapeutics Conference call. Currently all participants are in a listen only mode.

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

Yes.

Operator: Later we will conduct a question and answer session, and instructions will follow at that. As a reminder, today's conference call is being recorded. I would now like to turn the conference over to our host, Mark Jacobson, Chief Operating Officer at Axsome Therapeutics. Please go ahead, sir.

Later, we will conduct a question and answer session and instructions will follow at that time.

As a reminder, today's conference call is being recorded.

I'd now like to turn the conference over to our host Mark Jacobson Chief operating officer at Acxiom Therapeutics. Please go ahead Sir.

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

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 third 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 and source of future clinical trials, regulatory plans, future research and development plans, and possible intended use of cash and investment. These forward-looking statements are based on current information, assumptions, and expectations that are subject to change and involve risks and uncertainties that may cause actual results to differ materially from those contained in the forward-looking statement.

Our earnings press release, providing a corporate update and details of the company's financial results for the third quarter of 2020 crossed the wire a short time ago. It is available on our website at <unk> 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 intended utilization of our investigational agents are critical and nonpolitical plans or plans to present or report additional data, yes. It's a good conduct and the source of future critical trials regulatory plans future research and development plan.

Cost borne intended uses 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 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 from these forward looking statements, which are made only as of today's date and the company disclaims any obligation to update such statements.

Mark L. Jacobson: 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 made only as of today's date, and the company disclaims any obligation to update such statements. Joining me on the call today are Dr. Herriot Tabuteau, Chief Executive Officer; Nick Pizzie, Chief Financial Officer; Lori Englebert, Senior Vice President, Commercial and Business Development; and Dr. Cedric O'Gorman, Senior Vice President of Clinical Development and Medical Affairs. Dario will first provide an overview of the company and then review recent developments and upcoming milestones. Following Dario, Lori will comment on our commercialization approach, and then Nick will review our financial results. We will then open the line for questions. I shall now turn over the call to Herriot. Thank you, Mark. Good morning, everyone.

Joining me on the call today are Dr. Aereo to Butoh, Chief Executive Officer Nick.

Easy Chief Financial Officer, Lori Inglebert, Senior Vice President commercial and business development and Dr., Cedric O'gorman Senior Vice President clinical development and medical Affairs.

Mario will first provide an overview of the company and then review recent developments and upcoming milestones.

The one area, where he will comment on our commercialization approach and then Nick will review our financial results. We will then open the line for questions.

I will now turn over the call to area.

Thank you Mark good morning, everyone and thank you all for joining Exosome Therapeutics third quarter 2020 financial results and business update conference call.

Herriot Tabuteau: And thank you all for joining Axsome Therapeutics' third quarter 2020 Financial Results and Business Update conference call. Over the past several months, we continued to advance our AXS 05 and AXS 07 product candidates towards NDE submissions in major depressive disorder and migraine, and we intensified our commercial launch readiness activity. Committed capital from our recently announced term loan facility combined with cash on hand approached $400 million.

Over the past several months, we continue to advance our access to fiber in excess of seven product candidates ports, indeed submissions in major depressive disorder and migraine.

We intensified our commercial launch readiness activities.

Committed capital from our recently announced crumbling facility combined with cash on hand approach $400 million strengthening our balance sheet through these anticipated commercial launches.

Herriot Tabuteau: Strengthening our balance sheet through these anticipated commercial launches. In the quarter, we also advanced the rest of our late-stage pipeline, including... Two positive FTA breakthrough therapy designation meetings for AXS 05 in Alzheimer's disease agitation and AXS 12 in narcolepsy, and we scheduled an FDA meeting for AXS14, our product candidate for the treatment of fibromyalgia.

In the quarter, we also advanced the rest of our late stage pipeline, including.

Two positive after the breakthrough therapy designation meetings for access to five in old timers disease agitation.

Texas 12 in narcolepsy.

We scheduled after eating 40 access 14 or product candidate for the treatment of fibromyalgia.

Our intellectual property portfolio continues to grow with recently if you didn't allowed patents for access to five in depression now extending the 24th.

Herriot Tabuteau: Our intellectual property portfolio continues to grow, with recently issued and allowed patents for XS05 in depression now extending to 2040. We anticipate an active next few months as we complete our NDA submissions for AXS 05 and AXS 07. Release top-line efficacy data from open-label trials with these product candidates. Initiate phase 3 trials for AXS05 and AXS12 in Alzheimer's disease agitation and narcolepsy, and meet with the FDA on Axis 14 for fibromyalgia. I will provide a brief pipeline update before handing it over to Lori, who will discuss our commercialization strategy for XSO5 in depression. Then, the NIC will discuss our financial results. Starting with AXSO5, our novel oral and MDA receptor antagonist.

We anticipate an active next few months as we complete our India submissions for access to five in excess of seven.

Released top line efficacy data from open label trials with these product candidates.

Phase three trials for access to fiber and excess 12 in old-timers disease agitation and narcolepsy.

And meet with the FDA, we exit 14 fibromyalgia.

I will provide a brief pipeline update before handing it over to Laurie will discuss our commercialization strategy wakes up to five in depression.

Nick will discuss our financial results.

Starting with excess <unk> five our novel oral NMT receptor antagonist.

Herriot Tabuteau: Pre-submission activities for the NDA for AXS 05 for the treatment of MDD are nearing completion. We expect to submit the NDA in January instead of by year-end, reflecting a COVID-19-related logistical delay from one vendor. We have completed a Phase 3 Open Label Long-Term Comet Safety Trial of XSO5 in Depression.

Pre submission activity for the India for access to five for the treatment of MTD or nearing completion.

We expect to submit the NDA in January.

Data by year end, reflecting COVID-19 related logistical delay from one vendor.

We have completed.

Phase three open label long term comet safety trial of the excess of five into pressure, but.

Herriot Tabuteau: The three Phase 2 open-label efficacy sub-studies of the COMET trial have also been completed, and we are on track to report top line results from these efficacy studies by year end. Additionally, our placebo-controlled merit trial in TRD, or treatment-resistant depression, is on track to report results in the first half of next year. Moving on to our program in Alzheimer's disease agitation with AXSO5, which received FDA breakthrough therapy designation in June, results of the subsequent breakthrough therapy meeting for the syndication confirmed the pivotal status of our positive completed advanced one trial. Consequently, only one additional Phase 3 trial is needed to support the filing of an NDA for AXS05 in this indication, and we remain on track to initiate that study before year end. Moving now to our Migraine Program with AXS 07. The major NDE-related items are on track for completion by year-end.

The three phase two open label Efficacies sub studies. The Comet trials have also been completed and we are on track to report topline results.

From these efficacy studies by year end.

How about the feeble controlled never trial in CRD four treatment resistant depression is on track to report results in the first half of next year.

Moving onto our program in all timers disease agitation with access to five.

Which received breakthrough therapy designation in field.

Results for the subsequent breakthrough therapy meeting for the syndication confirmed the pivotal status of our positive completed advanced one trial.

Consequently, only one additional phase three trial if needed to support the filing of an IND D.A. <unk> access to five in this indication and we remain on track 20 feet that study before year end.

Looking now to our migraine program with X. I supposed to happen.

The major India related items on track for completion by yearend.

Herriot Tabuteau: We now plan to submit the NDA in the first quarter of 2021 versus previous guidance of the fourth quarter of 2020 in order to allow for the inclusion of supplemental manufacturing information. We believe that this approach will enhance the robustness of our submission. We have completed the Movement Phase 3 Open Label Long-Term Safety Trial of XSO7 in migraines.

We now plan to submit <unk>, the first quarter of 2021 versus previous guidance of the fourth quarter of 2020 in order to allow for inclusion of supplemental manufacturing function.

We believe that this approach will enhance the robustness of our submission.

We have completed the movement phase three open label long term safety trial of access to seven in migraine when.

Herriot Tabuteau: We now expect to announce efficacy results from this trial in the fourth quarter of 2020. Moving next to our narcolepsy program with AXS 12, which received FDA breakthrough therapy designation in August. We recently announced the expedited development status and plan for AXS 12 following a breakthrough therapy meeting. One phase three efficacy trial, which along with the previously completed phase two concert trial, will be used to support the filing of an NDA for approval of AXS 12 for the treatment of cataplexy and narcolepsy.

We now expect to announce efficacy results from this trial in the fourth quarter of 2020.

Moving next to our narcolepsy program with excess well, which received ft. A breakthrough therapy designation in August.

We recently announced the expedited development status and plan for excess 12, following breakthrough therapy meeting.

Want to phase three efficacy trial, which along with the previously completed phase two concert trial will be used to support the filing of an IND D.A. for approval of the excess 12.

Treatment of Cataplexy and narcolepsy.

We remain on track to initiate this phase three trial in the first quarter of 2021.

Herriot Tabuteau: We remain on track to initiate this Phase 3 trial in the first quarter of 2021. Ahead of the potential launches of AXS 05 and AXS 07 starting next year, our commercial readiness activities have been accelerating. These activities include the build out of our proprietary digital-centric commercialization platform. Our partnership with Viva Systems, announced yesterday, will provide digital technology that will be incorporated into the DCC platform.

Head of the potential launches accessible five any excess of seven starting next year, our commercial readiness activities have been accelerating that.

Activities include build out of our proprietary digital centric commercialization HPCC platform.

Our partnership with Veeva systems announced yesterday will provide digital technology that will be incorporated into the DPC platform.

We are excited both why the clinical profile of our product candidates and our planned commercialization approach.

I will now turn it over to Lori will provide some observations as it relates to the growing EBITDA pressure.

Lori Englebert: We are excited both by the clinical profile of our product candidates and our planned commercialization approach. I will now turn it over to Lori, who will provide some observations as it relates to the growing need and oppression and some insights into our planned commercialization approach. Thank you, Aereo, and good morning, everyone.

And some insights into our planned commercialization approach.

Thank you area and good morning, everyone.

We are excited to talk to you. This morning for the first time about our commercialization plans.

As you May have noticed yesterday, we announced a partnership with Veeva to help build our proprietary digital centric commercialization platform.

I'll speak more about why we believe this commercialization of course makes sense for us later.

Lori Englebert: We are excited to talk to you this morning, for the first time, about our commercialization plans. As you may have noticed, yesterday we announced a partnership with Viva to help build our proprietary, digital-centric commercialization platform. I will speak more about why we believe this commercialization approach makes sense for us later, but first, I'd like to remind everyone why we believe AXSO5 has the potential to have such a significant impact on the MDD market. It should come as no surprise that the pandemic is having a profound effect on people. One of the most striking effects is the sharp rise in depression. Results of an epidemiological study recently published in JAMA demonstrated that the number of U.S. adults with depression symptoms has increased 300% compared with prior to the pandemic. This increase is even more notable given the prevalence of depression was already high pre-pandemic. Additionally, the increase is heavily skewed towards individuals who are already in the moderate to severe depression category.

But first I'd like to remind everyone. Why we believe axis. That's why has the potential to have such a significant impact on the entity market.

We are increasingly excited about the opportunity to meaningfully change the way physicians do you, what's achievable, but the pharmacological treatment depression.

I had a lasting impact on patients.

It should come as no surprise that depend on it is having a profound effect on people.

One of the most striking effects, it's a sharp rise in depression.

Results of an epidemiological study recently published in Jama demonstrated at the number of U.S. adults with depression symptoms has increased 300% versus prior to the pandemic.

This increase is even more notable given the prevalence of depression was already high pre pandemic.

The increase is heavily skewed towards individuals who were already in a moderate to severe depression category.

On top of a sharp increase in prevalence ended the market still has extremely high unmet needs.

Three primary market research with physicians and patients four areas continually identified as high unmet needs are one position.

Physicians want new yeah.

Different patient friendly approaches to treatment.

While there are many approved agents all current oral anti depressants work, primarily through the minor Ehman Arctic system.

To physicians and patients want faster onset of action.

Most commonly used therapies today take six to eight weeks two weeks therapeutic effect.

Right because this is what better opportunities for a mission.

Lori Englebert: On top of a sharp increase in prevalence, the MDD market still has extremely high unmet needs. Through primary market research with physicians and patients, four areas continually identified as high M.N.E.E.D.s are one; physicians want new, different patient-friendly approaches to treatment. While there are many approved agents, all current oral antidepressants work primarily through the monoaminergic system. Two, physicians and patients want a faster onset of action. Most commonly used therapies today take six to eight weeks to reach therapeutic effect. Physicians want better opportunities for remission. However, we know through published research that only about a quarter of patients on a standard antidepressant achieve remission within a 10 to 14 week time frame, and four. Patients and physicians want to stop trading off efficacy for safety and tolerability. Current standard antidepressants are typically associated with weight gain, increased sexual dysfunction, and cognitive impairment.

We know we published research that only about a quarter of patients on a standard anti depressant achieve remission were going to tend to 14 week timeframe.

And for.

Hey, since institutions want to stop trading off efficacy or safety and Tolerability.

Current standard antidepressants typically are associated with weight gain increased sexual dysfunction and cognitive impairment.

If successfully developed exercise has the potential to address these unmet needs and bring meaningful advancements to physicians and patients for the treatment of entity.

Since the approval of Triferic, we entered a preference and 1959, there had been no new oral mechanism of action for entity.

As an M.D.A. receptor antagonists exercise if approved would be the first new oral mechanism of action for the treatment of into D. and over 60 years.

In clinical trials to date treating them an exercise has been associated with rapid release, a depression symptoms, including achievement of our mission as compared to the placebo and active competitors.

Importantly.

Benefit was seen in both patient and physician reported outcomes.

<unk> five was well tolerated and was not associated with weight gain increased sexual dysfunction cognitive impairment in our trials.

As I mentioned earlier yesterday, we announced a partnership would be there to help build our proprietary digital centric commercialization or DCC platform.

Lori Englebert: If successfully developed, AXSR5 has the potential to address these unmet needs and bring meaningful advancements to physicians and patients for the treatment of MDD. Since the approval of tricyclic antidepressants in 1959, there has been no new oral mechanism of action for MDD. As an NMDA receptor antagonist, AXSR5, if approved, would be the first new oral mechanism of action for the treatment of MDD in over 60 years. In clinical trials to date, treatment with AXSO5 has been associated with rapid release of depression symptoms, including achievement of remission, as compared to both placebo and active comparators. Importantly, benefit was seen in both patient and physician-reported outcomes. AXSO5 was well tolerated and was not associated with weight gain, increased sexual dysfunction, or cognitive impairment in our trials.

Yeah somebody says he platform incorporates specialized digital tools proprietary data and analytics integrating systems and an intelligent operating model.

The goal of using evolving technology and digital execution is to optimize physician and patient engagement and.

And thereby increase the effectiveness and efficiency of our promotional efforts as compared to traditional approaches.

Using a digital centric commercialization approach well one allow us to make extensive use of remote detailing.

I've real time data said to seamlessly integrated platforms that use sophisticated technology.

Allow our reps to make informed dynamic decisions.

And to allow us to leverage the evolving digital ways in which patients and clinicians access information.

The decision to take its digital centric commercialization approach with data driven.

On this slide we highlight some key HCP trends give us confidence we are taking the right approach.

One remote detailing which was about 10% pre carbon has increased significantly.

Lori Englebert: As I mentioned earlier, yesterday, we announced a partnership with VIVA to help build our proprietary digital-centric commercialization, or DCC, platform. The Axsome GCC platform incorporates specialized digital tools, proprietary data and analytics, integrated systems, and an intelligent operating model. The goal of using evolving technology and digital execution is to optimize physician and patient engagement and thereby increase the effectiveness and efficiency of our promotional efforts as compared to traditional approaches. Using a digital-centric commercialization approach will, one, allow us to make extensive use of remote detailing, and have real-time data fed to seamlessly integrated platforms that use sophisticated technology to allow our reps to make informed, dynamic decisions. And two, allow us to leverage the evolving digital ways in which patients and clinicians access information.

And then leveling out around 50% of all engagements.

HM Okay.

By contrast, our primary physician targets right that's right.

I've been to have you as the doctors are committed detailing.

As of the end of September 63% of all there's it's like I addressed opposite more remote.

And three remote detailing appears to result in significantly longer engagements with physicians whatever more detail, averaging around 25 minutes versus less than five minutes for traditional and office call.

This is an indicator that physicians are becoming more comfortable with the approach and that remote calls can be highly a factor.

Key trends for consumers are very clearly trending towards digital.

As shown on the chart on this slide time spent with digital media has been rapidly increasing in the U.S. in recent years, surpassing traditional media for the first time in 2018.

And what in just two years isn't on media time is already 25% higher than traditional media.

Lori Englebert: The decision to take this digital-centric commercialization approach was data-driven. On this slide, we highlight some key HCP trends that give us confidence we are taking the right approach. One, remote detailing, which was about 10% pre-COVID, has increased significantly and is leveling out around 50% of all engagements. 2, Psychiatrists, our primary physician target for ACES 05, have been the heaviest adopters of remote detailing. As of the end of September, 63% of all visits to psychiatrists' offices were remote. And three, remote detailing appears to result in significantly longer engagements with physicians, with a remote detail averaging around 25 minutes versus less than five minutes for a traditional in-office call. This is an indicator that physicians are becoming more comfortable with the approach and that remote calls can be highly effective. Furthermore, key trends for consumers are very clearly trending towards digital.

This is a trend that we expect to continue to grow.

We believe that the macro trends around the Cardinal health crisis.

I told you telling adoption by physicians.

And the increased reliance on digital by consumers are unlikely to change after dependent.

Given what we know about the marketplace.

HCP and consumer trends combined with the potential for exercise.

Our initial launch engagement strategy willing.

Will include an extensive use ever met detailing.

Augmented by conventional detailing as needed.

And primarily focus on psychiatrists and mental health focused PC Pete.

We believe that this approach will not only increase quality and [laughter].

But also significantly reduce the cost per physician interaction, providing greater flexibility in rep number and rich.

For patients, we intend to focus our investment on using digital omni channel approach.

We are very excited about our first launch and believe our digital centric commercialization or DCC platform approach is not only scalable, but also relevant for all sort of on launches.

This approach should provide and she peas, and patience meaningful engagements that are optimized and differentiated.

I look forward to sharing with you more about our plans here.

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

Thank you Lori and good morning, everyone today, I will discuss our third quarter 2020 results and provide financial guidance.

Lori Englebert: As shown on the chart on this slide, time spent with digital media has been rapidly increasing in the U.S. in recent years, surpassing traditional media for the first time in 2018. And within just two years, digital media time is already 25% higher than traditional media. This is a trend that we expect to continue to grow. We believe that the macro trends around the current mental health crisis... Virtual Detailing Adoption by Physicians and the Increased Reliance on Digital by Consumers are unlikely to change after the pandemic.

We ended the third quarter with approximately $202 million in cash compared to roughly $191 million at the end of the second quarter, a net increase of approximately $11 million due to the net proceeds from our new term a loan facility with Hercules capital.

R&D expenses were $14.8 million for the quarter ended September 32020 versus $15.8 million for the comparable period in 2019.

The decrease of $1 million was driven by the completion of the majority of our clinical trials, which were ongoing in the comparable prior period.

Lori Englebert: Given what we know about the marketplace, HCP, and consumer trends, combined with the potential for AXS05, our initial launch engagement strategy will include an extensive use of remote detailing, augmented by conventional detailing as needed, and primarily focused on psychiatrists and mental health-focused PCPs. We believe that this approach will not only increase quality and effectiveness, but also significantly reduce the cost per physician interaction, providing greater flexibility in rep number and reach. For patients, we intend to focus our engagement on using a digital omni-channel approach. We are very excited about our first launch and believe our digital-centric commercialization, or DCC, platform approach is not only scalable but also relevant for all slot-alone launches.

<unk> expenses were $6.3 million for the quarter ended September Thirtyth 2000, $23.1 million for the comparable period in 2019.

The change was primarily due to an increase in non cash related stock compensation expense along with the continued build out of the commercial function.

In the quarter, we secured a 225 million dollar term loan facility with Hercules capital is committed non dilutive capital further strengthens the company's balance sheet and gives us additional financial flexibility through the anticipated potential commercial launches starting next year.

We believe our current cash position of over $200 million, along with the committed capital from our 225 million dollar term loan facility is sufficient to fund our anticipated operations based on our current operating plan into at least 2024.

Nick Pizzie: This approach should provide HCPs and patients meaningful engagements that are optimized and differentiated. I look forward to sharing with you more about our plans for the future. I would like to now turn over the call to Nick, who will provide a financial update. Thank you, Lori. And good morning, everyone. Today, I will discuss our third quarter 2020 results and provide some financial guidance. We ended the third quarter with approximately $202 million in cash, compared to roughly $191 million at the end of the second quarter, a net increase of approximately $11 million due to the net proceeds from our new term loan facility with Hercules Capital.

That concludes our third quarter 2020 financial review I will now turn the call back to Marc to lead acuity discussion.

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

One moment to Wyoming somehow the Cuban a roster.

Again, that's star one for any audio questions.

We have our first question from Charles Duncan with Cantor Fitzgerald.

Hi.

Good morning, Ariel and team. Thanks for taking our question congrats on good quarter of progress looking forward to more in the in the near term have a couple of questions for you and try to be brief.

First is relative to the long term safety studies for both Oh, five and seven common and movement.

I'm wondering if you can provide some color on the completion rates or persistence because it seems to me that I know those are safety study, but in both cases patients staying on drug is going to say something about the perception of a ethic C or lack of tolerability issues.

Nick Pizzie: R&D expenses were $14.8 million for the quarter ended September 30, 2020 versus $15.8 million for the comparable period in 2019. The decrease of $1 million was driven by the completion of the majority of our clinical trials, which were ongoing in the comparable prior period. G&A expenses were $6.3 million for the quarter ended September 30, 2020, and $3.1 million for the comparable period in 2019. The change was primarily due to an increase in non-cash-related stock compensation expense, along with the continued build-out of the commercial function. In the quarter, we secured a $225 million term loan facility with Hercules Capital.

And Andy you end up for the patient overtime. So wondering if you can give us some color on that and then I have follow up.

Oh, good morning, Charles and thank you for the question.

That is certainly something that we've looked at it as a reminder, both of these studies.

Just over a one year period, so that's a long time.

And then one of the things that you have to do when you run studies like Mad is you've got to make some baseline assumptions as to you know what the rates would be discontinuations.

And you know what we can tell you is that we've been lead with that with the persistence rates.

And in that region.

<unk> discontinuation of throughout the study I have been lower than we expected we do intend to announce results of these studies war of the sub studies in monkeys and called it out by yearend and at that point, we'll have more information for you.

Nick Pizzie: This committed, non-dilutive capital further strengthens the company's balance sheet and gives us additional financial flexibility through the anticipated potential commercial launches starting next year. We believe our current cash position of over $200 million, along with the committed capital from our $225 million term loan facility, is sufficient to fund our anticipated operations based on our current operating plan into at least 2024. That concludes our third quarter 2020 financial review. I will now turn the call back to Mark to lead the Q&A discussion. Thank you, Nick.

Okay. That's helpful. So you feel like a patients are remaining on the study, perhaps even even greater amount than you had anticipated.

So it will have a greater details we want to point out the results of the study but.

But certainly in terms of on the assumption that we made for when you would expect to be drop off right.

The one year period please.

Longer I'm, sorry was that we were pleased.

Is that a that wouldn't be actually observer was lower than we projected.

Okay. That's helpful. And then I wanted to move on to access so five in Alzheimers agitation I I've listened to Cedrik.

Hi station yesterday, I see pad and I noted that you plan to start a another ah well phase three the only the only one needed Ah.

Mark L. Jacobson: Operator, may we please have our first question? One moment while we compile the Q&A roster. Again, that's star number one for any audio questions.

To move forward again by the end of the year and so when when you look at that presentation at sea Ted It seemed like the responder rate with a notable.

Operator: We have our first question from Charles Duncan with Cantor Fitzgerald. Hi, good morning, Ariel and team. Thanks for taking our question. Congratulations on the good quarter progress.

And so I'm wondering if you can provide any color on what you thought they can't take away wise will take that so private sector its presentation on yesterdays.

Charles Cliff Duncan: Looking forward to more in the near term. I have a couple of questions for you. I'll try to be brief.

Sure. So we were excited to present results.

Charles Cliff Duncan: The first is relative to the long-term safety studies for both 05 and 07 comets and movements. I'm wondering if you can provide some color on the completion rates or persistence because it seems to me that I know those are safety studies. But in both cases, patients staying on the drug is going to say something about the perception of efficacy or lack of tolerability issues for the patient over time. So I'm wondering if you can give us some color on that. And then I have a follow up. Good morning, Charles.

Advanced trial at a scientific form I'm sure we presented a it before but certainly see dad is is one of the Oh from your forms for all times disease related illnesses.

The key takeaways or this is a this is a rare finding having never to see.

In this patient population in this indication.

Herriot Tabuteau: Thank you for the question. That is certainly something that we've looked at as a reminder. Both of these studies dosed patients over a one-year period, so that's a long time.

Herriot Tabuteau: And then one of the things that you have to do when you run studies like that is you've got to make some baseline assumptions as to what the rates would be of discontinuations. And, you know, what we can tell you is that we've been pleased with the persistence rates and that the rate of discontinuation throughout the study has been lower than what we expected. We do intend to announce the results of these studies or of the sub-studies Comet by year end, and at that point, we'll have more.

The improvement incentives on the primary outcome measures the CNI into clinically meaningful response rates and I think the fact that there is no drug approved for Abi's education had a lot of people excited with the data and then of course and with safety perspective, not associated with sedation or cognitive impairment so important.

Herriot Tabuteau: Okay, that's helpful. So you feel like patients are remaining on the study, perhaps even a greater amount than you had anticipated? So we'll have greater details for you when we report out the results of the study, but certainly, in terms of the assumptions that we made for what you would expect to be the drop-off rate over a one-year period, we were pleased that it was long-term. I'm sorry, it was, and we're pleased that what we actually observed was lower than. Okay, that's helpful. And then I wanted to move on to AXS 05 and Alzheimer's agitation.

This patient population.

Ah high rates of completion of the study and low.

Low rates of fall similar to placebo, which was also a good so I think taken a totality people are looking forward to the next trial and the continued development for the Sofa mystification.

Yes in that presentation, you mentioned that the trial was paying design I imagine, you're probably pretty far down the process of doing that can you provide some color what that next phase III looks like in terms of size or timing.

Herriot Tabuteau: I listened to Cedric's presentation yesterday at CTAD, and I noted that you plan to start another, well, phase three, the only one needed to move forward by the end of the year. And so when you look at that presentation at CTAD, it seemed like the responder rate was notable, and so I'm wondering if you could provide any color on what you thought the key takeaway was with AXS 05 and Cedric's presentation yesterday at CTAD. Sure, so we were excited to present the results of the ADVANCE trial at a scientific conference. So, you know, we presented it before, but certainly CTAG. Premier Forums for Alzheimer's Disease-Related Illnesses

10 am claims.

So Charles we're very close to providing all that information.

As we mentioned in all repaired remarks, we are on track to launch that.

That confirmatory phase three trial this year, we have.

Disclosed of course or general parameters around the designers will be randomized withdrawl design.

And so.

You'd like designing feature.

Will be placebo controlled.

And that relates to.

Your size question since this will be a two on trial would expect it to be.

Smaller than the last study just by the fact that it's two two arms versus three arms, but will provide you.

Herriot Tabuteau: The key takeaways are that this is a rare finding, having efficacy in this patient population. So, you know, we were very pleased with the results of the ADVANCE-1 trial. And not only was there a very significant reduction in symptoms, but the reduction was clinical. One of the takeaways when you look at the data, you know, we thought... [inaudible] The Average Reduction, a very strong set of results. And of course, not only do you want to control symptoms, but you want to make sure that. The safety profile is there, and the drug is well-tolerated, especially in this vulnerable population, and so we're pleased to have it. [inaudible] You know, I'll let Cedric maybe make some comments. He has many.

Additional.

Details.

Soon as we.

Get ready to start the study by you and.

Okay. Thanks area. Thank Cedric for the added color.

Just for taking my question.

Thank you we have a question for market Goodman with SBB Leerink.

Yes. Good morning. So can you just give us a little more color on two issues. One you mentioned that Oh five has been delayed into January because of one vendor.

How much are we on top of that situations such that you're very confident that it's only gonna be delayed into January.

Or is this one of those things where it.

It's a little open ended and then the second issue was the Uhm for Oh, seven you talked about the NDA in the first quarter, including extra manufacturing information can be give us kind of the same sense of confidence that uhm.

Cedric O'Gorman: With regard to the reaction from, from the forum, and thereafter, after our break. Yeah, hi Charles, and thanks Ariel. And, you know, the main takeaway from the CTAD was that there was a great level of interest. At one point, the attendees numbered close to 600.

My first question with respect to what's going on here, maybe you can give us a little more color and how much. We're we're on top of it and stuff.

It's definitely gonna be not any more delay than that.

So.

Mark for those questions with regards to access all five it is one vendor and the logistical issue is very straightforward because of covid related backup the or not able to deliver.

Cedric O'Gorman: So that was really great. We were encouraged by that. And then, as Ariel said, the translation of the improvement in symptoms on the primary outcome measures, the CMAI, into clinically meaningful response rates. And I think the fact that there is no drug approved for ADL, agitation, got a lot of people excited with the data. And then, of course, in the safety perspective, not associated with sedation or cognitive impairment, so important to this patient population, high rates of completion in the study, and low rates of falls, similar to placebo, which was also good. So I think, taken in totality, people are looking forward to the next trial and the continued development with AF505. Now, in that presentation, you mentioned that the trial was being designed. I imagine you're probably pretty far down the process of doing that.

A report to us until the very end of December. So that's later than we had expected.

So so we're on top of it.

And we will definitely get that by the end of December.

But we wanted to make sure that.

We let you know that it could slip in to January so we're pretty confident that we'll be able to violent in January. So it is one isolated.

Vendor and it is only a report so with regards to access some seven.

This is a.

A little bit of a different situation.

Here. This is a situation whereby by the end of the year. We will have completed all the major activities, which are needed to file our NDA and we're on track to do that.

And <unk>.

Cause of the unique manufacturing.

Behind the mosaic technology, we want to make sure that we have as robust as possible of a submission package. So we continue to generate data and the question is how much do you include.

Herriot Tabuteau: Can you provide some color on what that next phase three looks like in terms of size or time? [inaudible] So Charles, we're very close to providing all that information, because as we mentioned in our prepared remarks, we are on track to launch that confirmatory phase 3 trial this year. [inaudible] This will be a two-long trial. We would expect it. I'm not studying just the fact that it's two arms.

And.

And since we will be having some data.

In the early part of the year, we'd love to be able to include that in in the package.

But to provide some additional color on that I'm going to turn it over to.

To Mark Jacobson.

Good morning, Mark. So so just just want to be clear this is not.

The result of a manufacturing or stability issue or anything like that exactly a area said that we will have data available that.

Herriot Tabuteau: But we'll, we'll provide for you. So. We get ready to start. Okay, thanks, Ariel. Thanks, Cedric, for the added color.

That we think wood wood.

Add to the submission given it but novels delivery technology, and so that will allow us to make a package as robust as possible.

Thanks.

Thank you.

Once again for any questions you May press Star one now on your telephone keypad.

Charles Cliff Duncan: Thanks for taking my question. Thank you. We have a question for Mark Goodman with SVB. Good morning.

And we have a question for me I tunes in jail with Guggenheim partners.

Hey, guys. Thank you for taking my question I have two questions.

Marc Harold Goodman: So, Herriot, can you just give us a little more color on two issues? One, you mentioned that O5 has been delayed into January because of one vendor. How much are we on top of that situation such that you're very confident that it's only going to be delayed into January? Or is this one of those things where it's a little open-ended?

First with regard to the marriage.

<unk> can you maybe I think it didn't make some call them, but I misheard, but can you maybe just talk about what could I schedule of the drug do you need to fly that initial date.

Before you started H T E N T I D. And then do you actually need it <unk> maybe this one could.

Herriot Tabuteau: And then the second issue was for O7; you talked about the NDA in the first quarter, including extra manufacturing information. Can you give us kind of the same sense of confidence that, you know, my first question, with respect to what's going on here, maybe give us a little more color and how much we're on top of it, and it's definitely going to be not, you know, any more delayed than that? So thanks, Mark, for those questions. With regard to AXS05, it is one vendor. And the logistical issue is very straightforward.

Could be sufficient so that's one piece and then where do you go out to the comment disclosure that we're gonna have again. This is going to be non placebo controls are just trying to get a sense of what level of disclosure, you'll make and how should we ended up right. There, though state I'd given likeable receive a long in the study. Thank you.

Thank you Jan so with regards to the marrow trial. The this is a study in PRD it as a randomized withdrawal study.

And so that will give us.

So new information with regards to Oh five in that study design because all of our prior studies have been parallel group studies.

Herriot Tabuteau: Because of COVID-related backup, they are not able to deliver a report to us until the very end of the month. So that's later than we had expected, so we're on top of it, and we will definitely get that by the end of December, but we wanted to make sure that we let you know that it could flip into January, so we're pretty confident that we'll be. With regard to AXS 07. This is a little bit of a different situation. Here we are in a situation whereby, by the end of the year, we will have completed all the major activities which are needed to file our NDA, and we're on track to do that. And because of the unique manufacturing behind the Mosaic technology, we want to make sure that we have as robust a submission as possible. So we continue to generate data, and the question is, how much do you include? And since, you know, we will be having some data in the early part of the year. We'd love to be able to include that. But to provide some additional color on that, I'm going to turn it over to Mark Jacobson. Good morning, Mark.

This.

These data will supplement data that we will be releasing by year end.

From our comments <unk> trial, which is open label as you mentioned.

But with regard to to to <unk>.

Remember that the label that will be filing for his MTBE, which is the broadest vindication and that includes all subsets.

Of major depressive disorder, which includes patients who failed one anti depressant, where patients who failed to a more entitled presence.

Who would who may be classified as a treatment resistant and as long as in patients who have.

Suicidal ideation.

Et cetera. So.

So we have a broad label, which captures.

The entire spectrum of mbd patients and the point of the mirror trial as well as the comments sub studies is to provide data to clinicians in terms of how the product performs.

In these various populations.

So by the time.

That.

We launched the trial, we hope to have we will have we hope to have these data so.

Some of these neat accomplishment certainly will be sharing them with you before year end.

Now for the comments sub studies as you mentioned.

So these are openly.

Ultimately will trials, but we do measure efficacy and and we do expect to get meaningful data from those studies and the reason for that is they reflect.

Mark L. Jacobson: So I just want to be clear, this is not the result of a manufacturing or stability issue or anything like that. It's exactly as Ariel said that we will have data available that we think would, (inaudible). Once again, for any questions, you may press star 1 on your telephone keypad. We have a question from Yatin Suneja with Guggenheim Partners. Hey guys, thank you for taking my question. I have two questions.

Yatin Suneja: First, with regard to the MERIT study, can you maybe, I think you did make some comments that I mentioned, but can you maybe just talk about what characteristics of the drug you need to further elucidate before you start a phase 3 in TRD? And then, you know, do you actually need a phase 3, or maybe this one could be sufficient? So that's one piece.

Yatin Suneja: And then, with regard to the comment disclosure that we're going to have, again, this is going to be a non-placebo control, so just trying to get a sense of what level of disclosure you will make and how we should interpret those data given the lack of placebo in the study. Thank you. Thank you, Jan.

Herriot Tabuteau: So, with regard to the merit trial, this is a study in TRD. It is a randomized withdrawal study, and so that will give us some new information with regard to O5 in that study design, because all of our prior studies have been parallel groups. These data will supplement data that we will be releasing by year-end from our Comet PRD, which is Open Label. But with regard to TRD. Remember that the label that we'll be filing for is MDD, which is the broadest indication and that includes all subsets of major depressive disorder, which includes patients who failed one antidepressant or patients who failed two or more antidepressants, who may be classified as a treatment. As well as patients who have suicidal ideation, et cetera.

Thanks for the question this is Nick Peasy.

So related to your first question when can we see a pick up in SG&A costs. Obviously, there's a lot of work that's going on right now and the commercial function.

And we do expect to see.

Probably a bump in the SG&A cost starting in Q1 as we prepare for.

The data for prepared for launch readiness.

Thank you.

Our next question comes from Joseph Tom I've counted company.

Hi, there. Thank you for taking my questions. The first one on on Alzheimer's agitation. If if you could just give us I you know I know there are others that are looking at more episodic treatment for for acute agitation associated with all timers. If you can just give us based on your research you know could could a episodic product and.

Herriot Tabuteau: So we have a broad label that captures the entire spectrum of MDD patients, and the point of the merit trial, as well as the comment substitution, is to provide data to clinicians in terms of how the product performs. So by the time that we launch the trial, we hope to have, we will have, we hope to have these data, Sony Theta Published, and certainly we'll be sharing them with you.

A chronic treatment be using combination or would these be sort of two separate subset of patients and then second on on a X S. O. Seven you know looking ahead to that lodge, we touched on access O. Five would this remote in in virtual launch plan be amenable to access O seven in my.

Herriot Tabuteau: Now, for the comet sub-studies, as you mentioned, these are open-label trials, but we do measure efficacy, and we do expect to get meaningful data from those. The reason for that is that they reflect real-world use.

Great and with neurologist or would you have to kind of tailor the approach when it comes time. Thank you.

Okay.

Uhm.

Hi, Thank you for for the question.

Herriot Tabuteau: This is how patients are treated by clinicians. And every day, when patients are treated by clinicians for their depression, the clinicians have to assess whether or not the patients are responding and how well they are doing. And typically, what clinicians do is they look at improvement in symptoms. There are some objective measures too, which really do not.

So what's.

And I think an important characteristic to remember about excess will five and eat. The agitation is this is <unk>. This is the treatment, which would be chronic and the goal of that treatment would be to prevent patients from actually ending up in an institution whether that be a nursing her.

Home for a hospital your because of their symptoms or uncontrolled. So so from that perspective I guess.

Nick Pizzie: [inaudible] and Chronicle Response defined as at least a 50% reduction in... Onset of Action, Do Patients Get Better Fast? So while all those things are accessible by clinicians, and those are the types of measures which we'll be looking at, who will be providing data? I want to report out the Just one quick question on the P&L. I mean, I see the R&D line kicked up a little bit, but G&A still remains pretty reasonably low. At what point should we see an inflection on G&A, given that you would have to build infrastructure around the two launches? How should we model that?

There is no reason that a priori that various treatments uhm, let's see treatments for very acute disease, which results.

<unk> results in in patient needing additional care. There's no reason to think that that our product would not be used with with other treatments thing that that that's more.

Uhm and then with regard to your question around X S O seven and.

The apps to the applicability of our DCC platform to commercialization of that product candidate and I'm going to turn it over to Laurie.

High Desert.

So first let me just set the groundwork that part of the benefit of us being able to Utilise 50, 50 platform is that we get the benefit of building that from scratch.

Nick Pizzie: And then just if you can comment on the R&D, is it going to trend up given that there are more studies, but there are some finishing also? Just if you, Hey Yatin, thanks for the question. This is Nick Pizzie.

A lot of companies do to the pandemic have had to retrofit their system as well as their sales forces. It. So we're we're actually in a in a very very good play as we think through the launches that are coming up in our purposely scalenus, making.

Nick Pizzie: So related to your first question, when can we see a pickup in SG&A costs? Obviously, there's a lot of work that's going on right now in some of the commercial functions, and we do expect to see a bump in SG&A costs starting in Q1 as we prepare for launch readiness. Our next question comes from Joseph Thome with Cowan & Company. Hi there.

Making a platform scalable T.

To upcoming launches if you noticed on the receptivity of remote detailing are virtually virtual detailing narrows are also extremely high in fact.

Joseph John: Thank you for taking my questions. The first one on Alzheimer's agitation, if you could just give us, you know, I know there are others that are looking at more episodic treatment for acute agitation associated with Alzheimer's. If you can just give us, based on your research, could an episodic product and a chronic treatment be used in combination, or would these be sort of, you know, two separate subsets of patients? And then, secondly, on AXS07, you know, looking ahead to that launch, we touched on AXS05. Would this remote and virtual launch plan be amenable to AXS07 in migraine and with neurologists, or would you have to kind of tailor the approach when it comes time? Thank you. I give this a thank you for the question.

Psychiatrist and nurses typically are in the top three.

Once that are most receptive to remit detailing.

Great. Thank you that's very helpful.

Thank you we have a question from Vikram Poortith with Morgan Stanley.

Hi, Good morning. This is Thomas slave very for <unk>, you don't release mentioned set the I P portfolio for excess Oh five to depression, that's recently been expanded can.

Herriot Tabuteau: So what's an important characteristic to remember about XSO5 and EV agitation is that this is a goal, this is a treatment that would be chronic, and the goal of that treatment would be to prevent patients from actually ending up in an institution, whether that's because of their symptoms or not. From that perspective, I guess there is no reason a priori that various treatments, let's say treatments for Very Acute Disease, which results in And then, with regard to your question about the XSO7 and the applicability of our DCC platform to the commercialization of that product. First, let me just set the groundwork that... Part of the benefit of us being able to utilize http://www.youtube.com.au. We're actually in a very good place.

Lori Englebert: The launches that are coming up and are purposely scaling, making a platform that is scalable to our, If you notice the receptivity of remote detailing or virtual detailing, neuros are also extremely high. In fact, psychiatrists... Great.

Around depression, specifically.

Joseph John: Thank you. That's very helpful. Thank you. We have a question from Vikram Purohit with Morgan Stanley. Hi, good morning. This is Thomas Lavery on behalf of Vikram Purohit.

Are not home kinetic patents, so those patents or the new patents or based upon the positive.

The results that we have generated in our clinical trials, thus far in our efficacy trials.

Vikram Purohit: Your release mentions that the IP portfolio for AXS 05 in depression has recently been expanded. Can you provide us with some color on the nature of these patent claims? And, if possible, can you talk about how these patent claims expire in 2040 versus the prior patents in your portfolio that expire in 2035? Thank you.

So.

And by the way that this this is.

This is by design.

To.

Our strategy is to continue to expand our IP portfolio and.

And it's nice to see that not only is it.

Is it broadening and deepening but also the runaway is that Guinea extended.

Thank you.

We have a question from Ram <unk> with H C Wainwright.

Herriot Tabuteau: Thank you for the question. What we're referring to are new patents that have been issued, which are more standard or more typical method of use patents for treating depression, and so those patents go out to several of those patents go out to. You know, in fact, I think at least one has issued, we've gotten, a notice of allowance for more, and then we expect, and more than that. And so those could number a significant number of patents for that patent family.

Yeah.

Thanks, So much for taking my questions I think most of these are probably for Laurie I was wondering if you could comment on the current status of the commercial organization. How established it is at this juncture and at what stage you expect to be by the end of the year and whether the kinetics of the establishment of that.

Herriot Tabuteau: And the way that they differ from the prior patent families is that our prior patents go out to 2036. Those were primarily pharmacokinetics. And what's nice about Pharmacokinetic Patents is one of the... strong features of a Pharmacokinetic Patent is that it's agnostic to indication, so it covers all indications. So we wanted to make sure that we had those first, which we do have.

Herriot Tabuteau: And then so this new family of patents around depression specifically are not pharmacokinetic patents. The positive results that we have generated in our clinical trials thus far in our efforts, So, and by the way, you know that this is, by design. Our strategy is to continue to expand our IP portfolio, and it's nice to see that not only is it broadening and deepening, but also the runway is getting extended. We have a question from Ram Selvaraju with H.C. Wainwright.

Raghuram Selvaraju: Thanks very much for taking my questions. I think most of these are probably for Lori. I was wondering if you could comment on the current status of the commercial organization, how established it is at this juncture, and at what stage you expect it to be by the end of the year, and whether the kinetics of the establishment of the commercial organization are being impacted at all by the change in the timeline for the NDA filing of AXS 05, in particular. I wouldn't imagine that that's the case, but just wanted to And then I had a couple of additional follow-ups regarding the BIFA partnership, but maybe we can start there. Hi Ram.

That might be counter detailing and so on and then secondly, if you can comment on what specific product in acts one pipeline, particularly on a late stage level, the visa relationship might be especially useful for or if you expect it to be pretty much equivalent be useful for.

Lori Englebert: Thanks and good morning. So the status of the commercial organization is we are actively building, you know, as commercialization efforts ramp up. We have a very strong team, one that I am extremely proud of. Page PAGE of NUMPAGES www.verbalink.com, What I can tell you about the impact of the timeline is no, there's no, there are no. We are planning a very, Analysis is being done to ensure that we are, Okay, great. And then, with respect to the Viva partnership, maybe you can comment on two aspects that are particularly intriguing. Firstly, the way in which this relationship might potentially enable you to build a competitively privileged position from a commercialization standpoint relative to any potential competitor products, entities that might be counter-detailing, and so on. And then secondly, if you can comment on what specific products in Axsome's pipeline, particularly at the late stage level, the Viva relationship might be especially useful for, or if you expect it to be pretty much equivalently useful for all of Axsome's products. That's a great question. I'll answer your second question first.

All of the accident.

Candidates. Thank you.

Yeah, that's a great question and so I'm going to your second one first the you know as I mentioned in my my previous comment we are purposely building. This in a scalable fashion and I do think that with the approach that we're taking where we are are.

Leveraging trends in the market place to be as effective as possible and building. This infrastructure from scratch allows us to be highly efficient and flexible and so the flexible pieces I think very important for us we get to monitor.

And optimize.

Our approach to the market, meaning we get to monitor as adoption increases how we intend to scale.

And that would be applicable to both the except for seven months as well as the exit for five.

In terms of how we think this will be.

Beneficial to us in a competitive standpoint.

As as I mentioned before most companies are having to retrofit their systems and retrofitting systems is never easy because it.

It's clunky and increases.

Opportunities for.

Lori Englebert: As I mentioned in my previous post, we are purposely building this in a scalable fashion, and I do... with the approach that we are taking where we are. Leveraging trends in the marketplace to be as effective as possible. We get to monitor and optimize our approach. We get to monitor as a way to increase how we, And that would be applicable to both the AXSOS 7 law... In terms of how we think this will be beneficial to us, as I mentioned before, most companies are having to... Retrofitting systems is never easy, opportunities for it Getting to do this from scratch, from the very beginning, will allow us to have a very efficient, real-time, dynamic ability to optimize our engagements with both. Fantastic. Thank you very much for that.

Raghuram Selvaraju: Ari, just a couple of questions on sequencing, if I may. Do you expect the meeting with the FDA with respect to the fibromyalgia indication to occur before or after the meeting with the FDA to discuss AXSO5 and smoking cessation? Which one do you expect? Fibromyalgia.

<unk> effect on cataplexy into this.

The study that we will be conducting we'll have that as the primary endpoint. So.

Herriot Tabuteau: Okay, great. And then, with respect to the narcolepsy trial, can you give us a bit of color on how long you expect that trial to enroll for? What would you expect the timeframe to be between the start of enrollment and completion of enrollment? It's premature for us to comment on the exact timing there.

So thats study was the.

Crossover trial with roughly.

20 patients. So if it were a parallel group trial that would have been roughly a 40 patient trial.

Herriot Tabuteau: What we can do is give you some parameters to maybe help you think about it. I think one determinant will be the size of the study. Once we launch the trial, we'll provide details around that size.

Herriot Tabuteau: This is a reminder, though, what we saw in the Phase 2 trial was a very pronounced effect on Cataplex themes. The study that we'll be conducting, we'll have that as the primary endpoint. So that study was the crossover trial. So if it were a parallel group trial, it would have been roughly a 40-patient trial. If you look at the package inserts for at least one other drug, [inaudible] that has studied this level of impairment from cataplexy, the number of patients per I'm not saying that that will be the sizing of our trial because it will not be. That gives you kind of a sense, and with regard to our Concert Trial. We were able to enroll that study in approximately six months with around 12 clinical trials. Again, you know, this is not...

That is a fair assumption that that would naturally be overlap.

Herriot Tabuteau: This will translate directly into timing for our Phase 3 trial, but those are certainly metrics which are available, you know, really search for them, and which we certainly will be using to inform our timeline projection, which we'll provide to you. You know, we'll provide you with some more information around that. Okay, and just as a follow-up to that, do you expect to use any or all or some of the clinical sites that originally enrolled patients for concerts in this upcoming phase three? Would that be a fair assumption?

Thank you very much.

Thank you we have time for a few more questions on the next question comes from Matt Kaplan with Ladenburg.

Hi, just got it congrats guys on your progress during the quarter I just wanted to follow up a little bit on the narcolepsy I'd smell.

Sales and plan and specifically I guess and you know with respect to beyond the clinical data from the Comet studies and the planned phase three additional study what else do you need to complete to put yourself in a position to file the end yet.

Sure.

Sure so away from at I. I think you led off with Narcolepsy I think you meant to say MDD in terms of.

Herriot Tabuteau: That is a fair assumption that they wouldn't naturally be over. Thank you very much. Thank you. We have time for a few more questions, and the next question comes from Matt Kaplan, at last. I just wanted to follow up a little bit on the narcolepsy development plan, and specifically, I guess you know with respect to beyond the clinical data from the Comet study and the planned phase 3 additional study, what else do you need to complete to put yourself in position to file the NDA? Sure. So, Matt, I think you started off with narcolepsy.

And correct me, if I'm wrong, but I think that that's your question in terms of what remains.

For the energy violent right.

Well I want to follow up on them, but yes, Oh, both narcolepsy and and MDD.

Okay terms, so so starting with MDD, where a user.

The indiegogo pre in the submission activities or the major ones or largely complete so why in terms of the clinical trials for example, what could be rate limiting specifically the <unk>.

A comment and long term safety trial that we announced has been completed and we'll have the results for the common such studies by the end of the year and we'll we'll announce those so we're in great shape there in terms of on.

Matthew Lee Kaplan: I think you meant to say MDD in terms of, And correct me if I'm wrong, but I think that's your question in terms of what remains for that NDE filing. Well, I want to follow up on both of them, but yes, both narcolepsy and MDD.

Things that need to be done from a patient perspective from patient data perspective, and now really to putting it altogether.

Herriot Tabuteau: So starting with MDD, we're The NDA, the pre-NDA submission activities, the major ones, are largely complete. So in terms of the clinical trials, for example, which would be rate-limiting, specifically the Comet Law Firm safety trial that we announced has been completed, and we'll have results for the Common Stuff studies by the end of the year, and we'll announce those. So we're in great shape there in terms of... Goodman, David Amsellem, Vikram Purohit, Jason Gerberry, Charles Duncan, Myles Minter, putting it all together and making sure that we have a quality submission.

And making sure that we have a quality submission package.

And then with regards to to narcolepsy.

And what would be needed point in the filing there and.

Herriot Tabuteau: And then, you know, with regard to narcolepsy and what would be needed for an NDA filing there. So, as you know, we did have a breakthrough therapy meeting with the FDA, and based upon the results of that meeting, we intend to submit. The one phase 3 trial and the one phase 3 trial, along with the completed concert phase 2 trial, those will be used for NDE5. Thanks for the detail. And then maybe a question for Lori with respect to your plans that utilize the DCC approach. Can you speak to other examples of companies or products that have been launched in a similar fashion, or some of the components of what you're thinking about that have been successful in the past? Sure, so we don't believe that there are any other companies using a platform. The trends in the marketplace are what's driving, largely led by, Several companies that have launched in a primarily remote fashion over the past few years have instances where that approach worked very well.

Lori Englebert: But again, what benefit we get is that we don't have to click. Field Force, that was primarily prepared to be face-to-face and switch them to remote. Reintegrate Systems, Complex, we get to build it from scratch. Thanks Lori and congratulations again on the progress during the quarter. Thank you. We have a question from Joon Lee with Trust Security. Thank you for taking our questions. This is Miguel on the line for June.

Joon So Lee: Could you provide more specifics on what manufacturing data related to the MOSAIC platform will be added for AXS07? What are the key discussion points for the upcoming meeting with the FDA regarding AXS05 for smoking cessation, and what is the role of the new collaboration moving forward? So with regard to the additional manufacturing information, this is standard information when you manufacture additional batches. So we continue to manufacture additional batches of the drug. And while we already have very long-term stability data on other batches, we think that because of the unique nature of the delivery technology.

Herriot Tabuteau: This can only help to make the Submission robust and assure that there are no hiccups during review. With regard to the excess O5 in smoking cessation, what we're gonna be looking for from that FDA meeting is guidance on the, Ford, uh, process to get the product approved.

Herriot Tabuteau: So, um, and, you know, that is typically, you know, what we like to do early on in development with our product candidates, um, is to, uh, uh, get agreement, primarily with the agency, on various points of clinical development that would give us confidence to be able to move quickly once we have that information. We would have gotten that information already, but with XSO5 and smoking cessation. The development there was a little bit different because we did conduct that Phase II trial in collaboration with Duke University. So, but we're looking forward to this FDA meeting and Thank you so much.

Once we have that information.

Typically we would.

We would have gotten that information already but with excess of five in smoking cessation.

The development there was a little bit different because we did conduct that phase two trial under our collaboration.

With Duke University.

So.

But we're looking forward to this after the meeting and to getting clarity on the path forward.

Thank you so much.

Thank you.

Joon So Lee: We have time for one more question that comes from Myles Minter with William Blair. Hey everyone, thanks for taking the questions. Maybe just one for Lori.

We have time for one more question that comes from Myles mentor with William Blair.

Myles Robert Minter: I'm just wondering with the DCC commercial rollout, obviously, the initial focus will be to really touch those neuropsychs and neurologists out there, but given the nature of the platform, have you had any considerations for primary care physicians and how they might be integrated into this program that a traditional sales force that you might implement cannot? Myles, thanks for the question. I absolutely so part of our initial targeting. We're calling our mental health focus PCP, and there's a very large. A subset of those who are high prescribers.

Lori Englebert: So we will absolutely use this platform. Keep in mind that this is not just a remote DT. We're looking to optimize all channels and how we...

Lori Englebert: So we do believe that there are ways to be effective. Okay, thanks for that. And then maybe on the Comet study, are we only going to see relapse rates from the sub studies that you're running under that umbrella? Or did every participant get a Madras reading before and at the exit of that study?

Mhm address rating before an exit of that study and then maybe how you're thinking about relatively interpreting that diet or on either start a Charles I'll just lay out there, we say ready lap stripes within three to four month period.

Herriot Tabuteau: And then maybe how you're thinking about relatively interpreting that data? I know the START-A trials are obviously out there, and we see relapse rates within a three to four month period. Obviously, 300 patients at six months and 100 patients at a year is more than enough to see something there. Is that the most relevant data set for this particular population, or are you more willing to leverage this or compare this to real-world prescribing data and what we're seeing in the clinic with SSRIs?

<unk> three out of patients at six months in 100 patients of the year is more than enough to say something that is that the most relevant data set for this particular population or are you more willing to live for each day. So compare this to real world prescribing diner on what the state and the clinic with it so saros. Thanks [noise].

Herriot Tabuteau: Thanks. So with the comment trial, What we'll be looking at is the response of patients in the study, we'll be looking at the onset of action, so when do you start to see meaningful improvement from patients, and then we'll be following the patients out over time, so it'll give us a sense of and also persistence of The, you mentioned relapse. Typically, you would look at relapse by conducting a trial which specifically looks at relapse, and those This is not that type of study.

So with with a comment trial.

Wood will be looking at is is.

The response of patients in the study we'll be looking at alternative action. So when do you start to see meaningful improvement.

From patients and then we'll be following the patients out over time, so it'll give us a sense of and also persistence of effects.

The you mentioned relapse typically.

You would you would look at relapsed if you buy by conducting a trial, which specifically looks at relapse and.

And those or of the randomized rolls study types of design. This this is not that the that type of study so.

Herriot Tabuteau: But because patients are going to be treated, and will have been treated over a one-year period, we'll have plenty of information on persistence. Okay, thanks for the question.

Not because patients are going to be treated will have been treated over one year period will have plenty of information on persistence of effects.

Okay, that's actually the questions.

Thank you I'll now turn the call over to our speakers for any closing comments or remarks.

Mark L. Jacobson: I'll now turn the call over to our speakers for any closing comments or remarks. Well, you know, we're excited about the pipeline. This is an industry-leading CNS pipeline, and we're also excited about the potential to make meaningful changes in the lives of patients with our product candidates, should we develop them successfully. We expect the next few months to be very busy. So we look forward to keeping you updated on our progress. I'll speak to you during the next... This concludes the call. Everyone may now go.

Right.

We're excited.

About the potential of our pipeline. This is an industry leading CNS pie.

Pipeline and we're also excited about the potential to make meaningful changes in the lives of patients with our product candidates should we develop and successfully.

We expect the next few months to be very busy with our planet filings and our continued launch radios activities. So.

So we look forward to it keeping you updated on our progress and.

And will speak to you.

During the next conference call.

Thank you.

Thank you that concludes the call every one of them and I'll disconnect.