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Edited Transcript of AXSM earnings conference call or presentation 9-May-19 12:00pm GMT

Q1 2019 Axsome Therapeutics Inc Earnings Call

New York City May 10, 2019 (Thomson StreetEvents) -- Edited Transcript of Axsome Therapeutics Inc earnings conference call or presentation Thursday, May 9, 2019 at 12:00:00pm GMT

TEXT version of Transcript

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Corporate Participants

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* Mark Jacobson

Axsome Therapeutics, Inc. - SVP, Operations

* Herriot Tabuteau

Axsome Therapeutics, Inc. - CEO

* Cedric O'Gorman

Axsome Therapeutics, Inc. - SVP, Clinicial Development and Medical Affairs

* Nick Pizzie

Axsome Therapeutics, Inc. - CFO

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Conference Call Participants

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* Marc Goodman

SVB Leerink - Analyst

* Ram Selvaraju

H.C. Wainwright - Analyst

* Matt Kaplan

Ladenburg Thalmann & Company Inc. - Analyst

* Bert Hazlett

BTIG - Analyst

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Presentation

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Operator [1]

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Good morning, ladies and gentlemen, and welcome to Axsome Therapeutics' conference call. (Operator Instructions) As a reminder, today's conference call is being recorded.

I would now like to turn the conference over to your host, Mark Jacobson, Senior Vice President of Operations at Axsome Therapeutics. Please go ahead.

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Mark Jacobson, Axsome Therapeutics, Inc. - SVP, Operations [2]

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Thank you, operator. Good morning and thank you all for joining us on today's conference call. This morning, our press release providing details of the Company's financial results for the first quarter 2019, recent clinical and regulatory achievements, and upcoming milestones crossed the wire a short time ago and is available on our website at axsome.com.

We will begin this call with prepared remarks by Dr. Herriot Tabuteau, Chief Executive Officer; Dr. Cedric O'Gorman, Senior Vice President of Clinical Development and Medical Affairs; and Nick Pizzie, Chief Financial Officer. We will then open the line for questions from analysts. Questions will be taken in the order that they are received.

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 these investigational agents, our clinical and nonclinical plans, our plans to present or report additional data, the anticipated conduct and the source of future clinical trials, regulatory plans, future research and development, 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 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 weight on these forward-looking statements and the Company disclaims any obligation to update such statements.

I would now like to turn the call over to Herriot.

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Herriot Tabuteau, Axsome Therapeutics, Inc. - CEO [3]

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Thank you, Mark. Good morning, everyone, and thank you all for joining us on the call today. The first five months of 2019 have been very productive for Axsome. So far this year, we have reported positive efficacy results from the Phase 2 trial of AXS-05 in major depressive disorder or MDD. As well as the Phase 2 trial of AXS-05 in smoking cessation.

We received FDA breakthrough therapy designation for AXS-05 in MDD. And earlier this week, we announced the expedited development and pivotal status of AXS-05 in MDD following our recent breakthrough therapy meeting with the FDA. During the quarter, we also launched the Phase 3 MOMENTUM trial of AXS-07 in the acute treatment of migraine as well as the Phase 2 CONCERT trial of AXS-12 in narcolepsy.

I would like to take a moment to review the current status of AXS-05 in light of the recent breakthrough therapy meeting before turning it over to Cedric, who will detail the status of our ongoing clinical trials. And then to Nick, who will follow up with a review of our first-quarter financial results.

As a reminder, AXS-05 is Axsome's novel, oral, investigational, NMDA receptor antagonist with multimodal activity. AXS-05 was internally developed at Axsome and is covered by more than 30 issued US patents with coverage extending to 2034.

Based on the breakthrough therapy meeting, the previously completed active controlled ASCEND trial in MDD is now considered pivotal. Meaning it is sufficient, along with the ongoing STRIDE-1 Phase 3 in treatment-resistant depression or TRD if positive to support the filing of a new drug application or NDA for approval of AXS-05 in the treatment of MDD.

Alternatively, Axsome may also file an NDA for AXS-05 for the treatment of MDD with the completed ASCEND trial and a placebo-controlled Phase 3 trial of AXS-05 in MDD if positive. We intend to initiate this new placebo-controlled Phase 3 trial in MDD in the second quarter of 2019 with top-line results expected in the second half of 2019.

Enrollment into the STRIDE-1 trial will continue in order to contribute treatment-resistant depression patients to our planned open label safety extension trial, which we will initiate shortly to build a safety database required for an NDA filing. Top-line efficacy results from the Phase 3 STRIDE-1 trial in TRD are anticipated in the second half of 2019.

The expedited development plan in depression significantly accelerates the potential filing of an NDA for AXS-05 in MDD, which we are targeting in 2020. If successfully developed, AXS-05 would represent a novel antidepressant with one of the first new mechanisms of action approved in several decades for the treatment of patients with this debilitating condition.

Reflecting our maturing pipeline, we have a number of important clinical trial readouts expected over the balance of the year, including efficacy results from the Phase 3 STRIDE-1 trial of AXS-05 in TRD and the planned placebo-controlled Phase 3 trial of AXS-05 in MDD, both in the second half of this year; results of the Phase 2 CONCERT trial of AXS-12 in narcolepsy, anticipated in the second quarter; and results of the Phase 3 MOMENTUM trial of AXS-07 in the acute treatment of migraine, now expected in the second half of this year.

I will now turn the call over to Cedric.

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Cedric O'Gorman, Axsome Therapeutics, Inc. - SVP, Clinicial Development and Medical Affairs [4]

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Thank you, Herriot. I am pleased to provide an update on our ongoing clinical programs. I would first like to spend a moment on AXS-05 in smoking cessation. Last month, we announced that Duke University had completed its top-line analysis of the Phase 2 trial of AXS-05 for smoking cessation treatment.

The analysis showed that AXS-05 met the prespecified primary endpoint and significantly reduced daily smoking as compared to the active comparator bupropion. The trial was a Phase 2 randomized double-blind active-controlled study to evaluate the efficacy and safety of AXS-05 for smoking cessation treatment.

These preliminary clinical findings of AXS-05 for smoking cessation are important because they provide additional data of the biologic activity of AXS-05. We are evaluating the next steps in the clinical development of AXS-05 as an aid for smoking cessation and look forward to providing an update in the near future.

Turning now to our depression program with AXS-05. The ongoing STRIDE-1 trial is a Phase 3 multicenter randomized double-blind active-controlled trial to assess the efficacy and safety of AXS-05 in the treatment of treatment-resistant depression.

As previously mentioned, screening and enrollment in the STRIDE-1 trial continue in order to build a safety database required for an NDA filing. We expect top-line efficacy results for STRIDE-1 in the second half of 2019.

In the second quarter, we plan to launch a randomized double-blind placebo-controlled Phase 3 trial of AXS-05 in patients with MDD and anticipate top-line data from this trial in the second half of this year. As previously mentioned, this placebo-controlled trial, if positive, may be used in conjunction with our completed ASCEND trial to support an NDA for the treatment of MDD.

In the second quarter, we also plan to initiate an open label safety extension trial to build the required safety database to support an NDA filing. Patients completing the ongoing STRIDE-1 and the planned placebo-controlled Phase 3 MDD trials will enter an open label safety extension trial to build the required safety database.

Now turning to agitation associated with Alzheimer's disease with AXS-05. Axsome is enrolling the ADVANCE-1 study, a Phase 2/3 multicenter randomized double-blind controlled trial to evaluate the efficacy and safety of AXS-05 in patients with agitation associated with Alzheimer's disease. To date, just under 50% of the target number of subjects have been randomized in this trial. Top-line results are anticipated in the first half of 2020.

Now I will discuss the Phase 3 MOMENTUM trial of AXS-07 in the acute treatment of migraine. MOMENTUM is a Phase 3 randomized double-blind multicenter controlled trial to assess the efficacy and safety of AXS-07 in the acute treatment of migraine and is being conducted pursuant to an FDA special protocol assessment or SPA. Earlier this week, we announced that the MOMENTUM trial is enrolling faster than anticipated and top-line results are now expected in the second half of 2019 versus previous guidance of the first quarter of 2020.

An important aspect of the MOMENTUM trial is that it is enrolling only patients with a history of inadequate response to prior acute migraine treatments. And to date, the majority of patients enrolled in the trial report allodynia, which is pain from a normally non-painful stimulus. Allodynia has been associated with worse treatment outcomes.

With a difficult-to-treat patient population and the use of rizatriptan as a potent active comparator, the MOMENTUM study sets a high bar for the demonstration of efficacy of AXS-07. We are however encouraged by the novel distinct dual mechanism of action and the unique pharmacokinetics of AXS-07 which provide a scientific basis for the potential of AXS-07 to demonstrate benefit in this difficult-to-treat population.

Lastly, I would like to remind you of our Phase 2 trial of AXS-12 in narcolepsy, the CONCERT study. AXS-12, reboxetine, is a novel oral highly selective and potent norepinephrine reuptake inhibitor. The CONCERT study is a Phase 2 double-blind randomized placebo-controlled crossover multicenter trial. Efficacy assessments will include the frequency of cataplexy attacks and measures of other symptoms of narcolepsy. This trial is ongoing and top-line results are anticipated later this quarter.

I would now like to turn the call over to Nick to provide the financial update for the first quarter of 2019.

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Nick Pizzie, Axsome Therapeutics, Inc. - CFO [5]

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Thank you, Cedric, and good morning, everyone. I will now cover the first quarter of 2019 financial results. Starting with our balance sheet, we had $42.6 million in cash as of March 31, 2019, an increase of $28.6 million from our December 31, 2018, balance of $14 million. This increase is primarily due to proceeds received from the at-the-market equity financing completed in January and our new growth capital term loan with SVB entered into in March.

Turning to the statement of operations, the Company incurred a net loss of $10.6 million or $0.32 per share for the quarter ended March 31, 2019, as compared to a net loss of $4.8 million or $0.19 per share for the quarter ending March 31, 2018. Operating expenses in the first quarter of 2019 increased by $3.2 million to $10.4 million as compared to $7.2 million in the first quarter of 2018.

Research and development expenses were $7.6 million for the period ending March 31, 2019, as compared to $4.8 million for the period ending March 31, 2018, an increase of $2.8 million. The increase was primarily due to the initiation and rapid progress of our MOMENTUM study, continued progress of our STRIDE-1, ADVANCE-1, and smoking cessation studies, along with the manufacturing costs related to our AXS-07 product candidate, which was partially offset by a reduction in the costs of our previously completed clinical trials and nonclinical work.

General and administrative expenses for the quarter ending March 31, 2019, were $2.8 million as compared to $2.4 million for the period ending March 31, 2018, an increase of $0.4 million. The increase was due to higher legal costs, external fees associated with operating as a public company, and personnel costs. Interest expense in the first quarter 2019 was $0.2 million as compared to $0.3 million for the first quarter of 2018.

We anticipate that our current cash position will be sufficient to fund our anticipated operating cash requirements into at least the first quarter of 2021. This guidance includes the new planned Phase 3 trial in MDD with AXS-05 as well as the planned AXS-05 open label safety extension study. Importantly, this runway extends beyond the data readouts for all of our ongoing and planned clinical trials with our CNS product candidates.

That concludes our first-quarter 2019 financial review. I will now turn the call back to Mark to lead the Q&A discussion.

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Mark Jacobson, Axsome Therapeutics, Inc. - SVP, Operations [6]

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Thank you, Nick. Operator, can we please have our first question?

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Questions and Answers

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Operator [1]

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(Operator Instructions) Marc Goodman, SVB Leerink.

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Marc Goodman, SVB Leerink - Analyst [2]

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Morning, guys. One of the questions I have gotten several times from investors is just related to the ASCEND trial and the dose that you chose to use for bupropion. The fact that it was 105 milligrams rather than the higher dose that is normally used. Can you just comment on the strategy there and how you think about it? And how physicians are going to view this with respect to how efficacious this product is?

And then the second question is can you just give us an update on your latest thoughts on commercialization for all of these opportunities? Thank you.

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Herriot Tabuteau, Axsome Therapeutics, Inc. - CEO [3]

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Thanks, Marc, for the question. So for the first question, I will turn it over to Cedric, and then I will take the commercialization question.

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Cedric O'Gorman, Axsome Therapeutics, Inc. - SVP, Clinicial Development and Medical Affairs [4]

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Hey, Marc, thanks for the question. That question, it does come up. So the full daily dose that was used in ASCEND was 210 milligrams of bupropion SR, sustained-release. And this is in fact a dose that is within the approved range for the treatment of major depressive disorder.

And further, GlaxoSmithKline, who originally developed the drug, also has part of their submission for the NDA filing including doses that were shown to be effective at that dose and lower. So if you look back over the literature, there is also evidence showing that 150 milligrams, 200 milligrams, and upward have been effective in treating depression.

So then you look at the actual results from ASCEND and you ask yourself whether the magnitude of improvement seen with bupropion reflects a clinically meaningful expected antidepressant effect. And as you can see, it does. So out to 6 weeks, you see a 12.7-point improvement and essentially that does reflect an antidepressant effect that you would expect to see.

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Herriot Tabuteau, Axsome Therapeutics, Inc. - CEO [5]

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And if I just may add to -- just to further stress one other point that Cedric alluded to. The fact of the matter is that the study was against an active comparator. Most trials are against placebo. And so it is definitely interesting to think about what the placebo-corrected reduction in the [madras] might have been, assuming that we had conducted a placebo-controlled trial.

With regards to commercialization, it is definitely our intent, as we've stated in the past, to partner outside of the US. In the US, we do intend to launch these product candidates ourselves. Having said that, we are open to partnerships if they would increase the value of the franchises that we plan to file NDAs for and eventually launch.

Given the fact that the paths to NDA for potentially both of our two lead product candidates appears to have been expedited, as you can imagine, this is a key area of focus for us. And we are actively building -- acting to build the organization on the commercial side.

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Operator [6]

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Ram Selvaraju, H.C. Wainwright.

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Ram Selvaraju, H.C. Wainwright - Analyst [7]

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Hi, thanks very much for taking my questions. Firstly, just a point of clarification. Your cash burn guidance, does that include additional clinical development for reboxetine, AXS-12, or not?

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Herriot Tabuteau, Axsome Therapeutics, Inc. - CEO [8]

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Hi, Ram. This is Herriot. Our cash guidance includes the current trials which are ongoing and also it includes the planned trials with AXS-05. So the new Phase 3 MDD trial, which is placebo-controlled, as well as the open label extension. It does not assume new studies for AXS-12.

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Ram Selvaraju, H.C. Wainwright - Analyst [9]

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Okay. (multiple speakers)

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Herriot Tabuteau, Axsome Therapeutics, Inc. - CEO [10]

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Nick, did I miss anything there?

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Nick Pizzie, Axsome Therapeutics, Inc. - CFO [11]

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Ram, just to be clear, so it does -- for AXS-12, it does include the Phase 2 study for reboxetine. So just to make sure that that clarification is made. And as Herriot stated, it also does include the Phase 3 study that is planned for MDD as well as the open label safety study for AXS-05. So they have been included in our new cash guidance.

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Ram Selvaraju, H.C. Wainwright - Analyst [12]

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Okay. And then just as a point of clarification, let us assume that the Phase 2 AXS-12 study is positive. What would be the logical theoretical next step there for development of that compound?

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Herriot Tabuteau, Axsome Therapeutics, Inc. - CEO [13]

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So for AXS-12, we fully intend to initiate and launch a Phase 3 trial with AXS-12 should the Phase 2 study be positive. And so that is part of our plans; we've stated that intention in the past. So we are looking forward to the readout of that study.

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Ram Selvaraju, H.C. Wainwright - Analyst [14]

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Okay. And then pursuant to your comments, Herriot, regarding commercialization within the United States and Axsome's stated intent to pursue commercialization of these candidates independently, how do you see the framing and development of the commercialization efforts and the establishment of sales and marketing infrastructure across these multiple therapeutic areas?

What kinds of synergies might you be able to exploit, assuming that two or maybe even three of the candidates in your current pipeline arrive on the market in roughly the same timeframe? But obviously, you are targeting different therapeutic areas within the broader scope of mass-market neurology.

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Herriot Tabuteau, Axsome Therapeutics, Inc. - CEO [15]

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So if you think about -- if you look at our pipeline and you look at the indications which we are targeting, they do fall into two broad buckets: one is neurology and the other one is psychiatry.

And so if you look at the indications, for example for AXS-05, if you look at the mood disorder indications, those would fall under psychiatry. And then if you were to look at Alzheimer's disease agitation, there is overlap there. Alzheimer's disease is treated primarily by neurologists, but the behavioral symptoms are treated by psychiatrists. So there is overlap there.

And then you have our neurology indications. So if you look at AXS-12, that is neurology; and the acute treatment of migraine, that is neurology. Having said that, there is also a lot of comorbidity, a lot of psychiatric comorbidities with both of those indications.

So we do look at those two pieces, if you will, with regards to building a sales force, psychiatry and neurology. Keeping in mind that there is an overlap there in the Venn diagram.

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Ram Selvaraju, H.C. Wainwright - Analyst [16]

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Okay, very helpful. And then just a point of clarification regarding the prior inadequate responses to migraine therapy for patients being rolled into the MOMENTUM study. Can you elaborate on that a little bit further? And maybe give us a sense of whether these patients have been cycled through multiple prior triptans already or they only failed one prior triptan or if they failed other migraine therapeutics beyond the triptan class? Thank you.

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Herriot Tabuteau, Axsome Therapeutics, Inc. - CEO [17]

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So I will turn it over to Cedric to answer that question.

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Cedric O'Gorman, Axsome Therapeutics, Inc. - SVP, Clinicial Development and Medical Affairs [18]

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Yes, thanks, Ram. So patients who are enrolled in the MOMENTUM trial, we use a validated questionnaire called the mTOQ-4 and this assesses efficacy response to prior acute treatments. And to your point, it is not specific to any particular one class, but generally the acute migraine treatment.

And there are four different aspects in the mTOQ-4 which evaluate prior response. And that is whether patients have had two-hour pain freedom, whether they have had efficacy that lasted a full 24 hours with one dose of the medication, whether they have been able to plan daily activities, and whether their daily activities have actually been disrupted as a result of not getting adequate response from their treatment.

And then it is scored, basically. And for those patients who have inadequate response, it is a score of 7 or higher. And they are essentially deemed then to be inadequate responders and are eligible to be enrolled into the MOMENTUM trial.

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Ram Selvaraju, H.C. Wainwright - Analyst [19]

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Great. Thanks very much for that clarification and congrats once again on all the progress.

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Operator [20]

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Maria Skobeleva, Cantor Fitzgerald.

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Unidentified Analyst [21]

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Hi, it's actually Charles with Cantor. First of all, morning, Axsome team. Congrats on the progress. Thanks for taking our questions. I may have missed this because I'm on a train with spotty cell service, but with regard to 05, there is other clinical studies such as tox studies or preclinical studies. And then in terms of manufacturing, will you be prepared to support the filing of an NDA by, say, this time next year or even earlier? Thanks.

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Herriot Tabuteau, Axsome Therapeutics, Inc. - CEO [22]

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Good morning, Charles, and thank you for the questions. With regards to the additional requirements for an NDA filing, in terms of preclinical studies, this is a 505(b)(2) NDA. So we can reference some of the more onerous clinical studies that normally would need to be done, such as carcinogenicity studies, which take a long time. So that is definitely a positive.

There are, though, bridging toxicity studies which are required, some of which we've conducted and which are underway. So we are in good shape there and we do not anticipate that being a gating factor.

And in terms of manufacturing, we also are in really good shape with regards to manufacturing. It is not a straightforward process, but it is one that we have been working on for a while. And so therefore we do not anticipate that there would be any sort of delay whatsoever. The manufacturing process is finalized and optimized and we should be in good shape to be able to fulfill that part of it, an NDA package, by next year.

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Unidentified Analyst [23]

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And then as a follow-up question with regard to 05, I'm wondering if -- I mean, it's hard to pick your favorite child, but I am wondering if you had it all to do it over again, would you perhaps had emphasized MDD over TRD? Or as you think about that right now, what would you see as the bigger opportunity? It seems like MDD is a larger prevalence or incidence challenge, but what do you think is the better indication to lead with?

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Herriot Tabuteau, Axsome Therapeutics, Inc. - CEO [24]

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So I think one thing to remember is that MDD encompasses what normally people talk about as MDD as well as TRD. So treatment-resistant depression is simply major depressive disorder, but in patients who have failed at least two prior treatments. So they are definitely more difficult to treat. So with a broad MDD indication, it does allow us to target the general MDD population.

Now, with regards to your question about if we had it to do all over again, would we have maybe emphasized MDD before TRD. I would say no; I think we are very happy with the sequence of clinical trials.

So the Phase 2 trial, the Phase 2 ASCEND trial in MDD did show the potential of the product, which is great and which is tremendous. We ran that study in a front-line population in order to be able to more clearly delineate the potential benefit for AXS-05.

But also with TRD, because we are running that study in a very difficult to treat patient population, where there is a high clinical need and where the bar for showing efficacy is much greater, we think that that is a great position to be in with AXS-05, given that it is an oral NMDA receptor antagonist with multimodal activity. So it allows us to essentially demonstrate the efficacy of the product candidate in the hardest-to-treat population. And we think that that can only be positive for the broader MDD indication.

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Unidentified Analyst [25]

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Okay, thanks for that color, Herriot. Just hop in one last question over to 07. Just coming back from AAN 19 and it just seems like a rapidly evolving space, migraine or acute therapy for migraine.

And I'm kind of wondering if you could share with us some further thoughts on differentiation of the molecule in what you are assuming to be the treatment paradigm in a couple of years. And then finally, do you anticipate running a long-term safety study with the compound?

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Herriot Tabuteau, Axsome Therapeutics, Inc. - CEO [26]

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So thank you, Charles, on the question on 07. We are very excited about the progress that we have made in the MOMENTUM Phase 3 trial with AXS-07. And as we stated, we now expect to have data this year.

With regards to what we view as some of the key differentiating features of AXS-07, now the clinical trial, the MOMENTUM clinical trial, will delineate that profile further. But the product is designed potentially to provide fast onset of action. We have a unique PK profile with MoSEIC meloxicam that results in rapid absorption of the product candidate. And because of the distinctive dual mechanism of action of AXS-07, we do expect that the efficacy should also be strong and more consistent than current migraine therapies.

Lastly, the meloxicam in our formulation does have a long half-life. And the point of that is to reduce symptom recurrence; in fact, that is one of the secondary endpoints that we are looking at is sustained pain freedom.

Now, all that is nice to say. We look forward to the results of the clinical trial to see if our thesis bears out. And we like to make things a little bit more difficult for ourselves up front. And in order to do that with this study, we designed a very stringent trial which is enrolling patients that are known to be difficult to treat. So patients who have a prior inadequate response and who also have certain symptomatology that is predictive also of worst outcomes with current migraine drugs. And we have also used a known potent active comparator, rizatriptan.

And so what you have with the MOMENTUM trial is if we do have success, it should be able to clearly delineate the differentiating factors of AXS-07. Especially since, with the rizatriptan active comparator, we are essentially conducting also (technical difficulty) that compares AXS-07 to currently available therapy.

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Unidentified Analyst [27]

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That's helpful. And regarding long-term safety, if this trial reads out, what do you anticipate having to do in terms of exposure to patients over time?

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Herriot Tabuteau, Axsome Therapeutics, Inc. - CEO [28]

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With regards to long-term safety, we definitely would anticipate and we expect that we will need to look at repeat dosing over an extended period of time, so six months and certainly for one year. And we are in -- we will be in discussions with the Agency to find out exactly what that safety database requirement will be.

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Unidentified Analyst [29]

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Okay, thanks for the added information. And congrats on the recent BTD and interaction with the Agency.

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Herriot Tabuteau, Axsome Therapeutics, Inc. - CEO [30]

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Thank you.

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Operator [31]

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Matt Kaplan, Ladenburg Thalmann.

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Matt Kaplan, Ladenburg Thalmann & Company Inc. - Analyst [32]

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Thank you and good morning, guys. Wanted to dig into kind of some of the new moving parts that you announced recently with respect to AXS-05 and the planned now Phase 3 in MDD and the open label extension studies. Can you give us a sense in terms of the designs that you are thinking of there and how you are going to achieve the timelines that you have laid out?

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Herriot Tabuteau, Axsome Therapeutics, Inc. - CEO [33]

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Thank you, Matt, for the question. I will turn it over to Cedric to talk about the design of the planned Phase 3 trial, the new Phase 3 trial, and the open label extension study.

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Cedric O'Gorman, Axsome Therapeutics, Inc. - SVP, Clinicial Development and Medical Affairs [34]

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Thanks, Matt. So we have had a lot of experience now with having run the successful ASCEND study and the ongoing STRIDE study, which is fully enrolled but we are going to keep screening and enrolling STRIDE to build the requisite safety database.

So we have built a very strong infrastructure and have established relationships now with numerous sites. We have run our feasibility analysis on running placebo-controlled trial and how many sites would take, what the screening expectation and enrollment would be, and how long it would be to generate top-line data.

So with regard specifically to the design of the placebo-controlled MDD study, well, the key point really is that we are excited that this can be placebo-controlled, given that ASCEND has demonstrated additional antidepressant effect for AXS-05 over bupropion. So that is the good piece of news.

And then everything else based around the design of the placebo-controlled trial will be very similar to how we approach ASCEND. So keeping a lot of things the same and hoping to build on what was a successful strategy, successful recipe previously.

And then in terms of the open label extension, which will comprise both patients who have MDD coming from our planned placebo-controlled trial as well as patients with TRD coming from our STRIDE-1 study, we anticipate to have a rich database of patients with depression treated long term up to 12 months with AXS-05 at the requisite numbers for six months and one year.

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Matt Kaplan, Ladenburg Thalmann & Company Inc. - Analyst [35]

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Thanks. That is very helpful. And then kind of a follow-up question for -- on Ram's, when he was asking about kind of cash and runway. Given the planned clinical trials that you have, how do you plan to or think about funding the Company going forward?

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Herriot Tabuteau, Axsome Therapeutics, Inc. - CEO [36]

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So thanks for the question, Matt. So let me turn it over to Nick, who will talk about how we think about financing plans.

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Nick Pizzie, Axsome Therapeutics, Inc. - CFO [37]

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Thanks, Matt, for the question. Yes, as I said in my opening remarks, our current cash takes us into at least the first quarter of 2021, which is well beyond the anticipated readouts of all of our current and planned clinical trials. So aside from potential opportunistic use of our ATM, we do not anticipate an equity offering prior to readouts of these pivotal trials in AXS-05 in depression.

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Matt Kaplan, Ladenburg Thalmann & Company Inc. - Analyst [38]

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Okay, thanks. That's very helpful and congrats again on the progress.

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Operator [39]

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Bert Hazlett, BTIG.

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Bert Hazlett, BTIG - Analyst [40]

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Thanks. Just a quick question regarding timing. Again, in terms of the AXS-05 placebo-controlled study in MDD, the Phase 3 that is upcoming, just thinking about how long it took to run the active control study and having this and thinking about IRB approval and other things.

Is it -- I don't want to say, is it realistic to really think you're going to have data in 2019 for this study? It seems like a tall order. I just want to make sure that we have our timelines correct. Thank you.

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Herriot Tabuteau, Axsome Therapeutics, Inc. - CEO [41]

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Bert, thank you for the question. So maybe it would help for us to kind of tell you how we think about it in terms of the numbers and that would help you to also come to your own assessment.

So if you look at the ASCEND trial which we conducted last year -- and as a reminder, as Cedric stated, the new Phase 3 trial that will be placebo-controlled in major depressive disorder, should have a similar design to the ASCEND study. We launched that study last year roughly at about the same time and were able to complete it at the end of last year. And we announced data, as you know, at the beginning of this year.

That study comprised 80 patients and it was conducted in approximately 4 centers. So that gives you a sense now in terms of Phase 3 trials, clearly there will be an increase in the number of centers. And to give you a sense, with the ongoing STRIDE-1 trial, we are currently conducting that study in more than 60 centers.

So applying really any kind of a reasonable number of centers to the rate for the ASCEND trial last year, that will give you a sense of how we think about the enrollment rate potentially and the ability to generate and report data by year end.

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Cedric O'Gorman, Axsome Therapeutics, Inc. - SVP, Clinicial Development and Medical Affairs [42]

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And Bert, if I could just add one thing as well. You had made the comparison to the STRIDE-1 study. And of course, another important distinction for the placebo-controlled MDD study is that these subjects do not need to have demonstrated a failure to one or two antidepressant treatments in their current depressive episode. So you are getting very straightforward depressed patients into the study, which would enroll more quickly than a TRD population.

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Bert Hazlett, BTIG - Analyst [43]

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Okay, thank you for the clarity.

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Operator [44]

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This concludes our question-and-answer session. I will turn the call back over to Axsome's CEO for any concluding remarks.

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Herriot Tabuteau, Axsome Therapeutics, Inc. - CEO [45]

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Well, thank you all for joining our call this morning. We have had a highly productive start to the year and we expect to continue this momentum through the balance of the year. We look forward to keeping you updated on our progress, including multiple top-line data readouts and clinical trial initiations. Thank you again for joining our call.

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Operator [46]

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This concludes today's conference. Thank you for your participation. You may now disconnect.