Q2 2020 Axsome Therapeutics Inc Earnings Call
Operator: All participants are in a listen-only mode. Later, there will be a question and answer session, and instructions will follow at that time. As a reminder, today's conference call is being recorded. Now, I'd like to turn the conference over to your host, Mark Jacobson, Chief Operating Officer of Axsome Therapeutics. Please go ahead.
Currently all participants are in listen only mode. Later, there will be a question and answer session and instructions will follow with that time.
Minder Today's conference call is being recorded no external conference over to your host Marc Jacobs Chief Operating Officer Oxen Therapeutics. Please go ahead.
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 second 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 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 statement.
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 second quarter 2020 crossed the wire a short time ago 'cause is available on our website excellent dot com.
During today's call, we will be making certain forward looking statements.
These statements may include statements regarding.
One other thing the efficacy safety and intended utilization of our investigational agent.
Cynical Nonclinical plan no. We're pleased to present a report additional data do you anticipate conduct in the source of future clinical trial regulatory plans future research and development plan impossible 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 that may cause actual results to.
The 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.
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 only made 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; Dave Merrick, Chief Commercial Officer; and Dr. Cedric O'Gorman, Senior Vice President of Clinical Development and Medical Affairs. Ari will first provide an overview of the company and then review recent developments and upcoming milestones. Following Ari, Nick will review our financial results. We will then open the line for questions. I shall now turn the call over to Ariel.
Including our quarterly and annual report.
You are cautioned not to place undue reliance on these forward looking statements, which are only made as of today's date can the company disclaims any obligation to update such statements.
Joining me on the call today are Dr. Aereo to do you go 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.
Area will first provide an overview of the company and then review recent developments and upcoming milestones following Myrio, Nick will review our financial results be we'll then open the line for questions.
I'll now turn the call over to area.
Thank you Mark good morning, everyone and thank you all for joining acts on Therapeutics second quarter, 2020, <unk> financial results and business update conference call.
Mark L. Jacobson: Thank you, Mark. Good morning, everyone, and thank you all for joining Axsome Therapeutics' second quarter 2020 financial results and business update conference call. Over the past several months, we continue to advance our AXS 05 and AXS 07 product candidates towards NDE submissions in major depressive disorder and migraine, respectively. Across our broad development pipeline, we achieved several important clinical and regulatory milestones, including two FDA breakthrough therapy designations. I will provide a pipeline update, highlight the achievements in the quarter, and we'll then review our upcoming milestones, starting with AXSO5 and depression. This morning, in addition to our regular quarterly financial results press release, we issued a separate press release focused solely on the progress in our depression program, including the generation of new clinical data.
Over the past several months, we continue to advance our exit so five in excess of seven product candidates ports in these submissions in major depressive disorder and migraine respectively.
Across our broad development pipeline.
He'd several important clinical and regulatory milestones, including two ft, a breakthrough therapy designations.
I will provide a pipeline up the highlight the achievements in the quarter. The will then review our upcoming milestones.
Starting with access to five and depression.
This morning. In addition to our regular quarterly financial results press release, we issued a separate press release focused solely on the progress you know depression program, including the generation of new clinical data.
Herriot Tabuteau: We remain on track to submit the NDA for AXS05 and the treatment of major depressive disorder, or MDD, in the fourth quarter. To that end, we have completed a successful pre-NDA meeting with the FDA for AXS05 in MDD. In addition, we have completed enrollment in the phase three open-label safety trial of AXS05 in MDD, which we call a comet study, to support the planned NDA filing. We are also conducting three Phase II open-label efficacy sub-studies of the COMET trial, which will evaluate the efficacy and safety of AXS05 in three clinically pertinent MDD patient populations. Comment TRD Trial and Treatment Resistant Major Depressive Disorder or TRD, The Common AU Trial in Antidepressant Unresponsive MBD, defined as patients who continue to have depressive symptoms despite treatment with one standard antidepressant, and the Common SI Trial in Patients with Suicidal Attitude.
We remain on track to submit the NDA for excess all five in the treatment of major depressive disorder <unk> M D in the fourth quarter.
To that end you have completed a successful pre IND meeting with the FDA for excess all five in MDD.
In addition, we've completed enrollment in the phase three open label safety trial of excess who five in MPD, which we call Connett study to support the planned and E filing.
We also conducting three phase two open label efficacy sub studies.
Comment trial, which will evaluate the efficacy and safety of excess of five three clinically coordinate MDD patient populations.
The comments you already trial, the treatment resistant major depressive disorder with C or D.
The content you Trialing anti depressant unresponsive to MPT.
Defined as patients who continue to have the persistent and despite treatment with one standard antidepressants.
And the common ESI trial in patients with suicidal ideation.
Herriot Tabuteau: Advocacy results from these studies are expected in the fourth quarter of this year and will further inform the antidepressant profile of AXS05. We have also initiated a Phase II, double-blind, placebo-controlled, randomized withdrawal study in patients with TRD, which we call the MERIT trial. Results from their trial are expected in the first half of 2021. The MERIT and COMET TRD trials are being conducted in lieu of the previously planned Phase III trial in TRD.
Efficacy results from these studies or expected in the fourth quarter of this year will further inform the anti depressant profile they accessible five.
We also initiated a phase two double blind placebo controlled randomized control study in patients with key already which we call the merit trial.
Results from her trial or expected in the first half of 2021.
The merits and comments you already trials or being conducted in lieu of the previously planned phase three trial to already.
Herriot Tabuteau: This approach will more quickly generate clinically useful information with AXS05 in this treatment-resistant MVD population starting as early as the fourth quarter of 2020. Overall, these new trials will generate additional data on XSO5 across a broad spectrum of MDD patient types by the time of commercialization. We believe that this information will be helpful to prescribers and patients, especially given the new mechanism of action of AXS05. Moving on to our program in Alzheimer's disease agitation with AXSO5. In June, we received breakthrough therapy designation from the FDA for AXS05 in the treatment of Alzheimer's disease agitation. This designation is supported by the positive results from our ADVANCE I pivotal trial, which demonstrated a substantial reduction in agitation in Alzheimer's disease patients as compared to placebo.
This approach will more quickly generate clinically useful information with access to five in this treatment resistant and be population starting as early as the fourth quarter 2020.
Overall, new trials will generate additional data or need access to five across a broad spectrum of MBT patient tags by the time of commercialization.
We believe that this information will be hopeful to prescribers and patients, especially given the new mechanism of action you access all five.
Moving on to walk around and old-timers disease agitation with excess.
In June we received breakthrough therapy designation from the FDA <unk> access to five in the treatment of old-timers disease education.
This designation is supported by the positive results from our advanced one pivotal trial, which demonstrated substantial reduction in agitation in all times to these patients as compared to placebo.
Herriot Tabuteau: We are on track to initiate the second phase three trial of the XSO5 in this important indication in the fourth quarter of this year. Switching now to our Migraine Program with AXS 07. We remain on track to submit the NDA for AXS 07 for the acute treatment of migraine in the fourth quarter. To that end, we have completed enrollment in the Phase 3 Open Label Safety Extension Trial of XSO7 in Michigan, which we call the movement study to support the planned NDA filing. 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.
We're on track to initiate second phase three trial of the access all five in this important indication for the fourth quarter of this year.
Switching now to our migraine program with Exco seven.
We remain on track to submit the NDA for excess or seven for the acute treatment of migraine in the fourth quarter.
To that end, we've completed enrollment in the phase three open label safety extension trial, the access to step in migraine, we called the limit study to support the planned indeed filing.
As we move towards the filing of our indeed in the fourth quarter.
That's all five endpoint access so seven our commercial team that's focused on launch readiness activities to ensure successful commercial execution.
Moving next to our North LFC program with excess 12.
Herriot Tabuteau: Moving next to our narcolepsy program with AXS 12. Last week, we received FDA breakthrough therapy designation for AXS12 for the treatment of cataplexy in patients with narcolepsy. The designation was supported by the positive results from a Phase 2 concert study that demonstrated substantial and rapid improvements in cataplexy and excessive daytime sleepiness with AXS12 as compared to placebo. We are on track to initiate phase three trials of AXS 12 in the treatment of narcolepsy in the fourth quarter of 2020. Our industry-leading, late-stage CNS pipeline has now been granted three FDA Breakthrough Therapy designations, for AXS05 in MDD, AXS05 in Alzheimer's disease agitation, and AXS12 in cataplexy in narcolepsy. These designations exemplify our commitment to developing potentially life-changing medicines for patients with difficult-to-treat CNS conditions and highlight our innovative approach to clinical development and the potential for our products to provide significant advances in patient care.
Last week, we received FDA breakthrough therapy designation for excess 12 for the treatment of cataplexy in patients with narcolepsy.
But designation was supported by the positive results from a phase two concert study, which demonstrated substantial and rapid improvements in cataplexy and excessive daytime sleepiness with excess 12 as compared to placebo.
We are on track to initiate phase three trials of excess 12 in the treatment of narcolepsy.
Fourth quarter of 2020.
Our industry, leading late stage CNS pipeline has now been granted three if he breakthrough therapy designations.
Wakes up to five an MTD you access so five animals language. The these agitation in excess 12 in cataplexy in north let's see.
These designations exemplify our commitment to developing potentially life changing medicines for patients with difficult to treat CNS conditions and highlight our innovative approach the clinical development and the potential for products to provide significant advances in patient care.
With regards to major upcoming milestones the rest of the year promises to be a busy time.
Herriot Tabuteau: With regard to major upcoming milestones, the rest of the year promises to be a busy time. We remain on track to submit our NDAs for AXS05 in Major Depressive Disorder and for AXS07 in the Acute Treatment of Migraine, both in the fourth quarter. We anticipate efficacy results with AXS05 from the COMET TRD trial in treatment-resistant depression, the COMET-AU trial in antidepressant-unresponsive MDD, and the COMET-SI trial in MDD with suicidal ideation, all in the fourth quarter. And we expect to launch our second phase three trial of AXS05 in Alzheimer's disease education and our phase three trials of AXS12 in n I would now like to turn the call over to Nick, who will provide a financial update.
We remain on track to submit our Andes access to five major depressive disorder.
Ample access so seven can be acute treatment of migraine both in the fourth quarter.
We anticipate efficacy results with the access all five of common tier or de trial in treatment resistant depression.
Comedy you trial in anti depressant, unresponsive, MPD and the common ESI trial, and M.D.D. with suicidal ideation.
All in the fourth quarter.
And we expect to launch our second phase three trial, they access to five at all times disease education.
And our phase three trials of excess 12 in local EPCI all in the fourth quarter.
I would now like to turn the call will become Nick.
We will provide a financial update.
Nick Pizzie: Thank you, Ariel, and good morning, everyone. We remain in a strong financial position as we continue to accelerate our clinical programs and commercial readiness while maintaining sound fiscal discipline. We ended the second quarter with approximately $191 million in cash compared to roughly $197 million in cash at the end of the first quarter, a net decrease of approximately $6.5 million. During the quarter, we issued 141,678 shares, yielding gross proceeds of approximately $12.5 million. R&D expenses were $10.5 million for the quarter ended June 30th, 2020, versus $11 million for the comparable period in 2019. The decrease of half a million dollars was driven by the completion of a majority of our clinical trials, which were ongoing in the comparable prior period.
Thank you area and good morning, everyone.
We remain in a strong financial position as we continue to accelerate our clinical programs and commercial preparedness, while maintaining sound fiscal discipline.
We ended the second quarter with approximately $191 million in cash compared to roughly $197 million in cash at the end of the first quarter, a net decrease approximately $6.5 million.
During the quarter, we issued 141678 shares yielding gross proceeds of approximately $12.5 million.
R&D expenses were $10.5 million for the quarter ended June Thirtyth 2020 versus 11 million for the comparable period in 2019.
The decrease about half a million dollars was driven by the completion of the majority of our clinical trials, which were on going into comparable prior period.
Nick Pizzie: G&A expenses were $7.2 million for the quarter ended June 30, 2020, and $2.4 million for the comparable period in 2019. The increase was primarily due to an increase in non-cash related stock compensation expense along with the build out of the commercial function. Looking forward, we believe 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 second quarter 2020 financial review. I will now turn the call back to Mark to lead the Q&A discussion.
Gene expenses were $7.2 million for the quarter ended June Thirtyth, 2020, and $2.4 million for the comparable period in 2019. The increase was primarily due to an increase in noncash related stock compensation expense along with the build out the commercial function.
Looking forward, we believe 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 second quarter 2020 financial review I will now turn the call back to Mark to lead the Kunaev discussion.
Thank you Nick operator May we please have our first question.
Mark L. Jacobson: Thank you, Nick. Operator, may we please have our first question? Certainly. And thank you. At this time, if you'd like to ask a question, please press star 1 on your telephone keypad. Our first question comes from Joon Lee with Truist Securities. Your line is open.
Certainly.
Thank you at this time, if you'd like to ask a question. Please press star one on your telephone keypad. Our first question comes from Julie with Truest Securities. Your line is open.
Hi.
Thanks for taking my questions and congrats on all the progress.
A question of a common such studies R&D shortly hypothesis generating or is it possible that results can be incorporated into the and the submission and I.
Joon So Lee: Hi, thanks for taking my questions and congrats on all the progress.
Thank you.
Thank you for the question the comic trial will be a incorporated into the submission is our long term safety study and then the sub studies of the common trial, well, which are measuring efficacy of these different patient populations.
Joon So Lee: A question on the comet sub-studies, are these purely hypothesis-generating, or is it possible that results can be incorporated into the NDA submission? And I have a follow-up. Thank you.
You know those data we also expect to be who did a immediate filing.
And I'd be going into mechanics of how you are going to enroll patients into the sub study well you'd be enrolling additional patients into the comment a phase three long term safety study.
Herriot Tabuteau: Thanks, Joon, for the question. The COMET trial will be incorporated into the NDA submission. It is our long-term safety study. And then the sub-studies of the COMET trial, which are measuring efficacy in these different patient populations, those data we would also expect to be included in the NDA.
Due to enroll in one of these three studies subsidies or will you be selecting for those already enrolled in the long term safety comment phase three study a into these phase two study and I have one more hope after that.
unknown: And regarding the mechanics of how you are going to enroll the patient into this sub-study.
unknown: Will you be...
unknown: [inaudible]
There will be enough subjects being enrolled.
Herriot Tabuteau: There will be enough subjects being enrolled in total because, as we disclosed, the number of subjects enrolled in the COMET study is above 800 patients. So there certainly are enough subjects in that sub-study. So the sub-studies are prospectively defined patient groups, and also efficacy data is being collected in those patients prospectively. And those will be separate fiscal analysis plans.
In total because is we disclosed the number subjects enrolled in the comment.
He is.
<unk>.
800 patients. So while there are certainly aren't enough subjects in that some studies. So the the such studies or prospectively defined patient groups and ER and also what efficacy data is being collected in those pictures respectively.
And those will be a separate this disciplines.
Joon So Lee: And then, regarding your Phase 2 merit study, which is a randomized withdrawal study, are you aware? It's very interesting that you're taking this approach, which tends to have a lower placebo effect. Are you aware of any antidepressants approved using a randomized withdrawal study design?
Right and then regarding your face to Merit study, which is a randomized control study Oh, you, where it's very interesting that you're you're taking this approach which tends to have lower seaborne effect Oh are you aware of any.
Petsense approved on a randomized control study design.
Herriot Tabuteau: Ah, yes. The, um...
Yes the.
Herriot Tabuteau: I mean, if you look at the FBS Ketamine data package, one of the studies that worked was a randomized withdrawal study design.
If you look at the via the as Ketamine data package. So one of the studies that were randomized control study design.
Joon So Lee: Thank you so much.
Great. Thank you so much and got them out to talk about.
unknown: Thank you very much and good luck with all the programs.
unknown: Webbs
Yes.
Mark Goodman: Thank you.
Thank you.
unknown: Our next question comes from Mark Goodman with SVB-Lyric. Your line is open.
Our next question comes from Marc Goodman with SVB easier.
Your line is open.
Hi, This is Ron on the line from Mark. Thanks for taking the question I was curious these subs studies that you have coming out of the comment trial did that come from some ft. A guidance from your pre Andean meeting or is that sort of your own plan of building out more.
unknown: Hi, this is Rowana on the line for Mark. Thanks for asking the question. I was curious, these sub-studies that you have coming out of the COMET trial, did that come from some FDA agency?
unknown: Ashwani Verma, Yatin Suneja, Joon Lee, Ari Maizel, and Axsome
unknown: out a more robust data package.
Robust data package.
Herriot Tabuteau: So I'll let Cedric speak to that, but yeah, just to, you know, just to answer the first part of your question: that did not come from FDA guidance, and this is really...
So I'll, let a cedric speak to that.
But but yeah, just do you know.
The answer the first one of your question that did not come from if you guidance and a this is really.
US wanting to make sure that.
There is as much information as possible available to clinicians given the new mechanism of action of of the drugs and we wanted to study.
Herriot Tabuteau: We wanted to make sure that there was as much information as possible available to clinicians given the new mechanism of action of the drug, and we wanted to study it in a wide spectrum of MDD patients.
In a wide spectrum of MDD patients.
Cedric O'Gorman: Thanks for the question. The only thing I would add is that given that we have such a rich patient population, a rich MDD patient population in Comet, it really was a terrific opportunity with the hundreds of patients that are enrolled to look specifically at the important clinical populations of treatment-resistant depression, major depressive disorder, and then suicidal ideation. And as you recall, the long-term safety study was fed by both our short-term treatment-resistant depression study and our short-term major depressive disorder study. So it really was a very sort of elegant way and an important way to look at these patients in order to look at their efficacy outcomes and, as Herriot said, sort of guide clinical utility and further characterize the antidepressant profile of AXS05.
Thanks for the question the only thing I would add is that given that we have such a rich patient population rich MDD patient population in comment I mean really was a terrific opportunity with the hundreds of patients that are in road to look specifically at the important clinical populations on treatment.
This and depression major depressive disorder, and then suicidal ideation and as you recall the long term safety study has been fielded by both our short term treatment resistant depression study and our short term major depressive disorder study. So really was a very sort of Ali.
Can weigh in an important way to look at these patients in order to look at their their efficacy outcomes and as everyone said you sort of guide clinical utility in further characterize the antidepressant profile of access so five.
Got it thanks, and then one quick question on could you maybe explain a little bit clinically what the differences between tier or D and unresponsive MDD is that something that physicians will easily recognize and how do we think about that in terms of tree.
Cedric O'Gorman: Could you maybe explain a little bit clinically what the difference is between TRD and unresponsive MDD? Is that something that physicians will easily recognize? And how do we think about that in terms of treatment paradigm?
And then paradigm.
Cedric O'Gorman: Yes, so they are well-recognized clinical populations. So for unresponsive MDD, you're talking about a patient population of patients who continue to have depressive symptoms despite treatment with one antidepressant. And then for the treatment-resistant depression population, that is also widely recognized as patients who have failed to respond or continue to have depressive symptoms despite two or more antidepressants. So very distinct groups, well-recognized by physicians and prescribers, and that's why we approach the definitions in that way.
Yes, so they are well recognized clinical population so for unresponsive van de de you're talking about a patient population, who like the patients who continue to have depressive symptomatology. Despite treatment with one antidepressant and then for.
The treatment resistant depression population.
That is also widely recognized as patients who have failed to respond or that's continued to have depressive symptoms. Despite two or more antidepressants. So very distinct groups well recognized two to physicians and prescribers and that's why we we approached the Uh huh.
Definitions in that way.
Great. Thanks.
unknown: Great, thanks. Our next question comes from Charles Duncan with Cantor Fitzgerald. Your line is open. Hi, this is Pete Stavropoulos on behalf of Charles. Congratulations on all the progress and for the initiation of the new studies. One quick question for me is, is there anything you can tell us about the movement trial regarding persistence of patients on AXS-07?
Our next question comes from line of Charles Duncan with Cantor Fitzgerald. Your line is open.
Hi, This is up piece the problem with on for Charles Congratulations on all the progress.
And TV a initiation of a new.
Studies one quick question for me is or is there anything you can tell us about the movement trial regarding persistence of patients on.
Herriot Tabuteau: So with regard to the movement study, we've had great patient retention, I think better than expected. And obviously, when we provide the results of that trial, we'll give you...
To access a zero seven.
So the.
So with regards to the movement study, we've had a great patient retention I think I better than expected and obviously when we provide the result of that trial will give you more details.
unknown: Okay, thank you. Congratulations again. Our next question comes from the line of Matt Kaplan with Leidenberg-Thalmann. Your line is open.
Okay. Thank you congratulations again.
Thank you.
Our next question comes from line of Matt Kaplan with Ladenburg Thalmann. Your line is open.
Matthew Lee Kaplan: Hi guys, good morning. I wanted to ask if you could provide a little more color in terms of what your current thoughts are in terms of the Phase III program in narcolepsy. You mentioned starting two trials. Do you expect to start, I guess, two studies simultaneously later this year?
Hi, guys good morning.
To ask a little if you could provide a little more color in terms of what your thoughts kinda talk Saar in terms of the phase three program and let's see you mentioned starting to trial do you expect to start I guess two studies simultaneously.
Herriot Tabuteau: Thank you, Matt, for the question. That is the plan. So right now, you know, we're planning to launch our phase three program, and we'd like to do that in parallel as much as possible. We do anticipate that two phase three studies would be needed. And by launching them in parallel or as close to in parallel as possible, that should accelerate the timing of commercialization.
Yeah.
I think you map for the question that that is the plan. So right now it will planes launch on phase three program and we'd like to do that in parallel as much as possible. We do anticipate that two phase three studies would be needed and by launching them in parallel were close to in parallel.
It's possible that should accelerate the timing commercialization.
Matthew Lee Kaplan: Okay, that's helpful. And then going back to the sub-studies, the comment sub-studies, and the merit study, do you expect the results of the efficacy studies from those four studies to be included in the label if AXS05 is approved for MDD?
Okay. That's helpful and then going back to the sub studies the comments I've studied and Americas study do you expect the results the efficacy results from those four studies to be included potentially in a label Ah Yes, Exosome five is approved.
Randy.
So.
Herriot Tabuteau: So, to be clear, these studies are not studies that are being conducted to support specific labeling. However, the data will be included in our FDA package. And what's important, too, about what we're doing is that the indication that we're filing the NDA for is MDD, which is very broad. Okay, that's very helpful. Thanks for taking the questions.
To be clear and there are these studies or not studies that are being conducted.
To support specific labeling however that the the data will be included in our Ah if the package and what's what's important to about what we're doing is is the the indication that we're finding the need for his mbd, which is very broad and the data that's been January.
Did indeed stuff studies encompass MTD.
Okay. That's very helpful. Thanks for taking my questions.
Our next question comes from the line a mild winter with William Blair. Your line is open.
Myles Robert Minter: Our next question comes from the line of Myles Minter with William Blair. Your line is open.
Myles Robert Minter: Hey guys, thanks for taking the questions. Just firstly on Merrick, again, just wondering what your definition of treatment response in that trial would be prior to randomization to the withdrawal portion of the study. I'm assuming it's, you know, a 50% improvement from baseline on the Madras, but correct me if I'm wrong there, and over what treatment time period would that be? Thanks.
Hi, guys. Thanks for taking the questions just a firstly on Merrick again, just wondering what your definition of a treatment response in not Shaw with Bay Prod randomization to the withdrawal portion of the study.
I'm, assuming it's 50% improvement from by someone on the mattress, but correct me if I'm wrong.
And I Hope watch a treatment time period would not be thanks.
So thanks milestone from for the question and I'll lead off and see if Cedric as anything else to that he'd like to add the is so in order to be randomized in a in the married study so patients have to have.
Herriot Tabuteau: So, thanks Myles for the question. I'll lead off and see if Cedric has anything else that he'd like to add.
Herriot Tabuteau: So in order to be randomized in the merit study, patients have to have not only a specific reduction, but they have to be in remission. So these are patients who remit, which is a very stringent definition, and that is sustained. And then with regard to what a relapse would be defined as, we have not yet disclosed that, but it would be a return of symptoms.
Oh, not not specific reduction, but they have to be remission. So ah. So these are patients who are who remit and so which is a very stringent definition and that that is sustained and then.
It's too.
What <unk> relapse would would be defined as we have not get disclose that but it would be a return of symptoms [noise].
[noise] [noise] and then maybe just a follow up on May the.
unknown: And then maybe just to follow up on me, you mentioned in parallel the S-Ketamine approval package, which is starting to look a lot like that Spravato one, so just curious as to whether
You mentioned in parallel the.
Yes, ketamine approval package.
This is starting to look a lot locked up for pottery barn, So just curious as to what a.
Herriot Tabuteau: Somewhere down the track, you're going to be running a study in the elderly. I ask it because of, you know, a pretty benign safety profile that you saw in the advanced one study of Alzheimer's disease patients, and I just wondered whether you've already sort of overcome that safety concern in an elderly population and why, you know, we haven't seen an elderly patient trial pop up in these additional trials that you've announced today. Cheers.
Some of my future down the track you've gotten should be running a studying the elderly.
I asked because of.
Pretty benign sexy part father, sorry on the advanced one study adults honest assays patients and just wondering whether you've already sort of I become not safety concern in an elderly population and why you know we have insane.
Totally patient trial pop up in they saw immense additional chaucer's announced today she is.
So certainly one of the benefits of the advanced trial. In addition to demonstrating efficacy at all times that he's agitation is that it did provide us very clear sense of the safety profile. It makes it to five in the elderly. So that's really helpful to us and thinking about additional.
Herriot Tabuteau: So, certainly, one of the benefits of the advanced trial, in addition to demonstrating efficacy and Alzheimer's disease agitation, is that it did provide us with a very clear sense of the safety profile of XSO5 in the elderly. So that's really helpful to us in thinking about additional potential future indications. And while the current sub-studies do not include the elderly, in the future, we may certainly look at that patient population in MD
Potential future and indications.
And while the current subsidies are not include the elderly.
In the future, we certainly look at that patient population in a meeting.
Myles Robert Minter: Okay, and then final one from me, just in terms of the patient population you're enrolling in Merit, none of those have come from Comet, yes, these are newly treated patients. With Merit, it's not like you're trying to define remission in Comet and then use those patients to be randomized into the withdrawal period of Merit. These are two completely separate trials.
Okay, and then follow on from May just essentially the patient population youre enrolling in merit, none of storage has come from comment yes, they saw nearly traded patients.
Its merits, it's not like you're trying to define Brian mission out of call, Matt and use those patients to be randomized into the withdrawal period of merit basic true completely separate Charles yes.
[noise]. So they are two completely separate trials, but but as you can imagine the in the consummate study we have a lot of patients awarded though some of whom have a T or d. and we would look to certainly leverage.
Herriot Tabuteau: So they are two completely separate trials, but as you can imagine, in the COMET study, we have a lot of patients who are de novo, some of whom have a TRD, and we would look to certainly leverage the recruitment effort as much as possible. So patients from COMET who may have a TRD would definitely be included, and that's one of the reasons why we launched the COMET TRD study. It's a very efficient way with our current clinical program to get those patients who have TRD, and so it reduces recruitment effort, it gives us a patient population that's already there, and allows us to generate randomized control data in a very efficient and rapid fashion.
The recruitment effort as much as possible so patients from common who may have to redeem would definitely be included and and and that's one of the reasons why we launched the commentary or de study its a very efficient way with our current clinical program to get those patients who have to your Dee Ann.
And so you can read it reduces recruitment effort to get gives us a patient population that's already there.
And it allows us to generate randomize control data in a very efficient and rapid fashion.
Myles Robert Minter: It's very helpful. I'll leave it there. Thanks guys.
That's very helpful. All life at that affects us.
Our final question comes from Atlanta from Silver Adrianne with H.C. Wainwright. Your line is open.
Raghuram Selvaraju: Our final question comes from Lorraine Abram Selvaraju, with HC Wainwright. Your line is open.
Hi, Thanks, very much for taking my questions I'm very quickly on extra box. The team I was wondering if you could comment on what some scenarios might be regarding the scope of clinical development. If the FDA might ask you to recapitulate, a study or studies that have already been done or if.
Herriot Tabuteau: Hi, thanks very much for taking my questions. Very quickly on S-riboxetine, I was wondering if you could comment on what some scenarios might be regarding the scope of clinical development, if the FDA might ask you to recapitulate a study or studies that have already been done, or if There might be the possibility of your having to look at a completely different kind of clinical development paradigm with a set of endpoints that haven't yet been evaluated within the context of fibromyalgia, if you could comment on that.
There might be the possibility of youre, having to look at a completely different kind of clinical development paradigm with a set of endpoints that haven't yet been evaluated within the context of fibromyalgia you could comment on that.
So.
Herriot Tabuteau: So thank you everyone for the question. So with regard to XS14, as you know, and as you pointed out, we do have positive results from two controlled trials. One of them is the Phase 3 trial, and one of them is the Phase 2 trial. And so the simple studies were conducted. But we don't believe that the endpoints have changed much, if at all, for fibromyalgia.
Thank you remember the question.
So with regards to excess 14 is a is you know when it's as you pointed out we do have a positive results from a two controlled trials one of them as a phase three trial. It was a phase two trial and so the simple studies were conducted we don't believe at the end points of change.
Much if at all for fibromyalgia.
Herriot Tabuteau: But what we'd like to do is meet with the FDA to actually sit down with them, go through the data, and come up with what the next steps are and what the clinical plan is. So before we make any pronouncements and before we speculate, we do want to meet with the FDA. We think we're in a great position, given the two positive studies, to do that. And as soon as we have met with the FDA and we've gotten written confirmation, we'll provide you with all the details.
But what we'd like to do is a is meet with the FDA to actually sit down with them through the data and come up with what the next steps or and what the clinical plan is so you know before we make any pronouncements and before we speculate we do want to meet with the FDA. We think we're in a great position given the two positive studies.
To do that and it you know and as soon as we have met with the FDA and gotten.
Written confirmation will provide you a little.
Herriot Tabuteau: Great. And then, on the COMET-SI trial, can you comment on whether this trial would, if positive, have any direct implications for the specific utilization of AXSO5 in suicidal depression? And if that's potentially a specific indication that we could see included on the label, and if that's the case, would the COMET-SI study be sufficient, or what additional development work might potentially be necessary to specifically firm up the evidence in support of the drug in suicidal depression specifically?
With all the details.
Okay, Great and then on the call, but as I trial can you comment on whether this trial would if positive have any direct implications for the specific utilization of access so five in suicidal depression.
And if that's potentially a specific indication that we could see included on the label and if that's the case, what the comment I study be sufficient or what additional development work what might potentially be necessary to specifically from up a the evidence in support of the drug in suicidal depression specific.
Herriot Tabuteau: So thanks, Ron, for the question. So the CometSI trial is hypothesis-generating, and the reason why it's important is that one of the features of AXS05 that we have seen is its rapid onset of action. So we've seen statistically significant separation from placebo as early as week one and also at week two. As a reminder, those were key secondary endpoints in our GemIIni trial. And so it makes sense that for patients with suicidal ideation, those features would be relevant. So we'll await the results of the CometSI trial and see. Whether or not future clinical studies in that specific patient population are merited, but we do think that the results will provide very important information for clinicians as we commercialize the product.
So two things around for the question. So this commodify trial or is it hypothesis generating and the reason why it's important is a one of the features of the exits will five that we've seen as its rapid onset of action. So we've seen a statistically signal.
I can separation from placebo Israelis week, one and and also lead to a as or as a reminder, those were key secondary endpoints.
In our Gemini trial, and so the it makes sense, but for patient somewhat suicidal ideation that those features would be relevant.
So we'll wait the result of the Communists, I trial and and to see.
Whether or not a future clinical studies in that specific patient population or merited, but we do think that that the result.
We do think that the results will provide very important information for clinicians isn't commercialize the product.
Herriot Tabuteau: Okay, and then just one very quick clarification. So it was my understanding from going through the press release that the Comet TRD and merit studies would be effectively the additional basis for supporting a filing in TRD and that Comet AU would not expressly be taken into consideration in terms of the supporting evidence for AXS05 in the TRD indication. Can you just elaborate on whether that is indeed correct or not correct?
Okay, and then just one very quick clarification.
So it with my understanding from going through the press release that the comment T. R D and Merit study would be.
Actively the additional basis for supporting a filing and PRT and that comment you would not expressly be taken into consideration in terms of the supporting evidence for excess supply than the TRD indication I can you just elaborate on whether that is the correct or not correct.
So the the studies these studies or to provide.
Herriot Tabuteau: So the studies, these studies are to provide information that we think will be clinically relevant and useful for patients as well as physicians as we launch the product. And the data from these trials will certainly be included in our NDE filing. Just to be clear, the indication that we are filing for is NDD more broadly, which encompasses obviously all of these subsets, and the indication is not specifically for a particular subset, but it's for the broad NDD patient population, which includes all of these subsets.
Information that we think we clinically relevant.
And useful for patients as well as physicians as we launch the product and these are the data from from these trials I'm certainly be included in our in E filing or just to be clear the indication that a that we are filing war is M.D.D. more broadly which encompasses abhi.
Mostly all of these subsets and the indication is not specifically for any particular subset, but its full abroad.
MDT patient population, which includes all of these subsets.
Okay. Thank you very much.
Raghuram Selvaraju: Okay, thank you very much.
Since there are no more questions I will turn the call back to Axsom CEO for any concluding remarks.
Herriot Tabuteau: Since there are no more questions, I will turn the call back to Axsome's CEO for any concluding remarks.
Well. Thank you all for attending our conference call. Today. This is an exciting time for axle them as we advance our pipeline of potentially life changing medicines, we look forward too busy rest of the year into updating you went out progress.
Herriot Tabuteau: Well, thank you all for attending our conference call today. This is an exciting time for Axsome as we advance our pipeline of potentially life-changing medicine. We look forward to a busy rest of the year and to updating you on our progress.
This concludes todays conference call. We thank you for your participation you may now disconnect.
Operator: This concludes today's conference call. We thank you for your participation. You may now disconnect.