Q4 2021 Relmada Therapeutics Inc Earnings Call
Greetings and welcome to the real motto Therapeutics fourth quarter and full year 2021 earnings call. At this time all participants are in a listen only mode. A brief question and answer session will follow the formal presentation. If anyone should require operator assistance. During the conference. Please press star zero on your telephone Keypad. Other reminder, there.
Operator: Greetings and welcome to the Relmada Therapeutics fourth quarter and full year 2021 earnings call. At this time, all participants are in a listen only mode.
Operator: A brief question and answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press star zero on your telephone. As a reminder, this conference is being recorded. It is now my pleasure to introduce your host, Tim McCarthy of Lifesci Advisors. Thank you, Tim. Thank you, Paul.
This conference is being recorded it is now my pleasure to introduce your host Tim Mccarthy of lifestyle advisors. Thank you Tim you may begin.
Thank you Paul and thank you all for joining us this afternoon.
Tim McCarthy: And thank you all for joining us this afternoon. With me on today's call are Chief Executive Officer Sergio Traversa and Chief Financial Officer Maged Shenouda. This afternoon, Relmada issued a news release providing a business update and announcing financial results for the 3 and 12 months ended December 31, 2021. Please note that certain information discussed on the call today is covered under the safe harbor provisions of the Private Securities Litigation Reform Act. Be cautious, listeners; during this call, Relmada's management team will be making forward-looking statements. However, actual results could differ materially from those stated or implied by these forward-looking statements due to risks and uncertainties associated with the company's business.
With me on today's call are Chief Executive Officer, Sergio Teresa and Chief Financial Officer magazine do that.
This afternoon <unk> issued a news release, providing a business update announcing financial results for the three and 12 months ended December 31 2021.
Please note that certain information discussed on the call today is covered under the Safe Harbor provisions of the private Securities Litigation Reform Act.
We caution listeners that during this call them out as a management team will be making forward looking statements.
Actual results could differ materially from those stated or implied by these forward looking statements due to risks and uncertainties associated with the company's business.
Tim McCarthy: These forward-looking statements are qualified by the cautionary statements contained in Relmada's press release issued today and the company's SEC filings, including in the annual report on Form 10-K for the year ended December 30, 2020, and subsequent filings. This conference call also contains time-sensitive information that is accurate only as of the date of this live broadcast, March 23, 2022. Relmada undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date of this conference call. Now, I'd like to turn the call over to Sergio. Sergio?
Forward looking statements are qualified by the cautionary statements contained in <unk> press release issued today and the company's SEC filings, including in the annual report on Form 10-K for the year ended December 32020, and subsequent filings.
This conference call also contains time sensitive information that is accurate only as of the date of this live broadcast March 'twenty three 2022 .
Undertakes no obligation to revise or update any forward looking statements to reflect events or circumstances. After the date of this conference call.
Now I'd like to turn the call over to Sergio Sergio.
Yeah.
Sergio Traversa: Thank you, team, as always, and good afternoon to everyone. I'm pleased to welcome you to the Relmada fourth quarter and the Full Year 2021 conference. During today's call, I will review our recently achieved milestones and provide an update on an anticipated clinical trial readout timeline for REL 1017, our lead product candidate that we are currently studying as an adjunctive treatment and monotherapy for patients with major depressive disorder or MPD. Following my comments, Maged Shenouda, our Chief Financial Officer, will review the financial results and recent strengthened our..., and we will then take your, view. We expect 2022 to be a catalyst-rich year for Relmada.
Thank you team as always and good afternoon, everyone I'm pleased to welcome to the <unk> fourth quarter and full year 2021 conference call.
During today's call I will review, our recently achieved milestones and provide an update on our anticipated clinical trial readout timeline for route 10 17, our lead product candidate they've got currently studying as an adjunctive treatment and monotherapy for patients with major depressive disorder or <unk>.
M D.
Following my comments magnets you knew that was chief financial Officer will review.
The financial result, and recently strengthened balance sheet and we will then take your questions.
Looking ahead, we expect 2020 to be a catalyst rich year for red mud.
Sergio Traversa: We kicked off 2022 by reporting top-line results from the second Human Abuse Potential, or HAP, study, which I will recap shortly. We intend to generate relevant 17 clinical data readouts, beginning mid-year, for the ongoing Reliance Phase III trial. We anticipate completing the enrollment of Reliance 3, the ongoing monotherapy registrational phase 3 trial, followed by top-line data readout by mid-year 2020. In the third and fourth quarters of this year, we expect top-line results from Reliance 1 and Reliance 2.
We kicked off 2022 by reporting top line results from the sides on human abuse potential or cap.
Which it will recap shortly we intend to generate the resident in 17 clinical data readout, beginning media for the ongoing reliance phase II trial.
We anticipate completing enrollment over last three the ongoing monotherapy Registrational phase III trial.
Worried by topline data readout by midyear 2022.
In the third and fourth quarter Bcf, we expect top line results from reliance one and two respectively.
Sergio Traversa: These are two ongoing Phase III sister, two-arm, placebo-controlled pivotal studies evaluating VAL1017 as a potential adjunctive treatment for MDMA. The goal of this comprehensive development program is to address the significant need for a new therapeutic option for the 17 million individuals in the U.S. who suffer from MDD. Current antidepressant therapies have significant limitations in terms of efficacy, and they can take up to four to six weeks to show any
Are these like two ongoing phase III SR through arm placebo controlled pivotal studies evaluating <unk> as a potential adjunctive treatment for MVP.
The goal of these comprehensive development program.
To address the significant need for a new therapeutic option.
The 17 million individuals in the U S who suffer from MD.
Sergio Traversa: Up to 65% of patients do not respond to their frontline antidepressant treatment, and up to 40% of patients take combination therapy. Furthermore, there are only three FDA-approved adjunctive treatments for MDD, all of which are anti-psychotics, which offer limited efficacy and can cause long-term side effects. It is evident.
Current anti depression therapy have significant limitations.
<unk>.
Can take up to four to six weeks to show any effect up to 65% for patients do not respond to the frontline antidepressant treatment.
And up to 40% of patients take combination debt.
Furthermore, the only three FDA approved adjunctive treatment for MDT, all of which are antipsychotic.
Recall for limited efficacy and can cause long term side effects.
He is evident.
Sergio Traversa: New treatment options are needed, and we believe RELPEN17 has the potential to be a safe and effective option for these patients, and they are cared for at the moment of therapy and adjunct. We have made significant progress in advancing our development program to this end. In February, we reported positive coupling data from our second TAP study, which compared RELM 1017 versus intravenous CAT. As a reminder, our first HAP study comparing REL1017 versus Oxycodone was completed in July 2021 and presented in a poster presentation late last year at the 60th annual meeting of the American College of Neuropsychopharmacists.
The new treatment option on need it and we believe <unk> has the potential to be a safe and effective option for these patients and caregivers.
Yes, the monotherapy and adjunctive treatment.
We made significant progress in advancing our development program will this end.
In February we reported positive topline data from our second pack.
Which can play a role.
Dean versus intravenous Scott.
Yeah.
As a reminder, our first Hap study comparing route.
The University of Chicago.
It's completed in July 2021, and presented in a poster presentation late last year had the 60, if envelope meeting of the American College of Neuropsychopharmacology <unk>.
Sergio Traversa: Both studies were designed in accordance with the FDA 2017 Abuse Potential Guidance and the 2022 Clinical and Regulatory Standards by incorporating extensive input from FDA staff on the measures and the comparator on trial data. While we went into extensive detail during our February investor call on the Ketamine Hub Study results, I would like to recap just the main points. The primary endpoint, as is typical in these studies, was a drug-like score comparison of three doses of REL1017 to ketamine, the ketamine dose at 0.5 milligrams per kilograms in venous administration over 40.
Both studies were designed in accordance with the FDA two.
2017 abuse potential guidance.
Two 220 to 2022 clinical and regulatory standards by incorporating extensive input from FDA on the majors and the competitors on trial design.
While we went into extensive detail during our February investor call on the Cat <unk> study results I would like to recap just a main findings.
The primary endpoint.
Typically in these studies was a drug liking score comparison of about $3 is the route that 17 to Curt I mean, yes.
Yes, I mean, those that 0.5 milligrams per kilograms intravenous administered over 40 minutes.
Sergio Traversa: The three doses of REL1017 were the same as in the oxycodone study that we presented last, and they were the 25 milligram therapeutic dose, 75 milligrams, which is three times the therapeutic dose, and 150 milligrams, which is six times the therapeutic dose and is the maximum tolerated.
The three doses umbrella and 17 were the same as it can be Oxycodone study that we presented last year and they were at the 25 milligram. The therapeutic dose the 75 milligram, which is three times the therapeutic dose and 150 milligram, which is six times, the therapeutic dose and the maximum tolerated dose.
51 subject completed all arm of the study.
Sergio Traversa: 51 subjects completed all arms of... The FDA Guidance on Abuse Potential Trials details that the statistical analysis should be based on data from participants who complete the study, the all-completed population. Data based on the all-completed calculation for both of the HAP studies showed a statistically significant difference from ketamine and oxycodone on all tested doses of brown tenserin.
The FDA guidance on abuse potential trial details of the statistical analysis should be based on data from participants who complete the study all completely population.
Data based on the old Completer population for both.
Pep studies showed a statistically significant difference from Kathleen and Oxycodone, all tested doses of route and empty.
Sergio Traversa: And they were statistically equivalent to placebo at all tested doses of RALP-107. In summary, the findings of these two HAP studies. Arton Sistan with the 2019 DA State Department of Astronatodon states that the D. Isomer lacks.
Andy with statistical equivalent to placebo all tested doses of Ralph Thanks, Adam.
Okay.
In summary, the finding of these two studies.
Consistent with the 2019 with D. A statement estimates it states that the D isomer lax.
Sergio Traversa: Significant Respiratory Depression Reduction and Addiction Library. The results of the oxycodone and ketamine HAP study also confirm and support the previous data published regarding the potential for abuse of alkanesinamide. We believe that the oxycodone comparative data significantly increases the risk of schedule 2 potential for REL1017, and that the catamine comparison data significantly derives the drug's Schedule 3 protection. Collectively, the data generated today from our REL 1017 program indicates that REL 1017 could be proposed as a Schedule V drug and eventually unscheduled following one or two years or more.
And if we can rescue the authority of the presence of action and addiction liability.
Yeah.
The results will be Oxycodone Academy Hap study also confirmed and support.
Previous data regarding the potential for abuse overall uncertainty.
We believe that the oxycodone comparative data significantly de risk any scheduled to potential for welcome 17th.
And then the ketamine comparison base that significantly de risks the dragging schedule III.
Collectively the data generated to date from our rate in 17 program.
Indicate that 17 could be proposed at the scheduled five drugs.
And eventually Nonscheduled following one or two years of market.
Okay.
Sergio Traversa: In order to support the regulatory potential regulatory submission seeking approval for REN1017 as a monotherapy, as well as the junk depletion, the FDA confirmed that based on what is known at this time, Relmada will not be required to conduct a two-year Scarsimogenesis-Card-3-Nose Initiative study of REL1017 with an understanding that sufficient preclinical safety data have been generated today.
In order to support the regulatory potential regulatory submission seeking approval for win 10 17, as a monotherapy as well as adjunctive treatment. The FDA confirmed that based on what is known at this time.
Grandmother will not be required to conduct the two years customer.
Got it so he knows the initiatives.
Things are and team with an understanding that sufficient preclinical safety data that's being generated today.
Sergio Traversa: The FDA also confirmed that Relmada does not need to conduct a TQT cardiac study in humans to support cardiac safety in a potential regulatory submission for relative severity. The data provided to date, as well as the data to be generated from the ongoing Phase 3 program, would be adequate to evaluate and confirm the cardiac safety of Ralph-107. Moving on to the Phase 3 program, we anticipate the completion of enrollment in Reliance 3, the ongoing monotherapy registration trial for the Phase 3 trial, followed by top-line data readout by Reliance 3 aims to randomize up to 364 patients and is targeted at individuals who are diagnosed with depression and are probably taking standard antidepressants.
Yeah. They also confirmed the remodel does not need to conduct the EQT cardiac study.
To support cardiac safety and a potential regulatory submission or relative to 17.
The data provided to date as well as the data to be generated from the ongoing phase II program would be adequate to evaluate then confirm the cardiac safety a welcome Kevin.
Yeah.
Okay.
Moving on to the Phase III program.
We anticipate the completion of enrollment they'll rely on street and the ongoing monotherapy Registrational phase II trial, followed by a top line data readout by the media.
But I have great aims to randomize up to two young guns for patient and.
And these targets for individuals who are diagnosed with depression, and I'm, probably taking standard antidepressants.
Importantly.
Sergio Traversa: Importantly, this is prior to the anticipated conclusion of Reliance 1 and Reliance 2, the adjunctive MDD studies, which I will discuss momentarily. As a reminder, conducting Reliance 3 as a Phase 3 study could mean it will reduce the time for a potential approval of REL 1017 as an MDD monothem. I mean, I'll give you an update on the ongoing Reliance I and Reliance II studies, each of which is designed to include up to 364 participants per study across 55 sites per study.
[noise] disease prior to the anticipated conclusion of reliance one and brother has a true.
The adjunctive <unk> studies, which I will discuss my thoughts.
As a reminder, conducting rely on study is a phase III study could meaningfully reduce the time for a potential approval to well 10 17 is the MDT manav.
Let me now provide an update.
I'm going to rely on one and really in two studies each of which is the seismic include up to 364 participants first studies.
Rose 55 study sites first steps.
Sergio Traversa: As a reminder, Reliance 1 and Reliance 2 are designed to evaluate REL1017 as an adjunctive treatment for MDD, and both include two ARCs, placebo, and 25 milligrams of REL1017. Both arms are studying the use of Valentin Seventeen in addition to a standard anti-depressant for participants who have had an inadequate response to at least one and up to three standard anti-depressant treatments.
As a reminder, Williams won and reliance too are designed to evaluate route density.
And as an adjunctive treatment MDT and both into two arms placebo and 25 milligrams of route than 70.
Both arms are studying the use of <unk>. In addition to our standard antidepressant for participants who have had inadequate response to at least one and up to three standard antidepressant therapies.
Sergio Traversa: The primary endpoint is the change in Madras score at day 28. Key secondary endpoints include the change in MAGRA score at week 7, and the Changed Clinical Global Impression Severity Scale, the CGIS score at day 20. Day 28 was chosen as the primary endpoint in agreement with the FDA with an understanding that depression is a chronic disease and that day 28 would support REL 1017 as a chronic. Both Reliance One and Reliance Two are progressing, with top-line data expected in the second half of. The Reliance Development Program also includes the Reliance OLS, a long-term open-label safety study that is enrolling both rollover participants for Reliance Oilers is an ongoing and evolving participant as well.
The primary endpoint is the change in my address score at day 28, Keith.
Key secondary endpoints include the change in my last call a big seven.
And changing clinical global impression of severity.
Scale. They are C. G I H score at day 28.
They 28 was chosen as the primary endpoint in agreement with the FDA, we didnt understanding that depression is a chronic disease.
And the day 28 would support <unk> 17 is a chronic pain.
Reliance one and the reliance to progressing with topline data expected in the second half of D. C.
Good Alliance development programs also includes the reliance or L. S. Theyre long term open label safety study that.
And that is a rolling book rollover participants for all three pivotal studies as well as the normal participants reliance OLS is ongoing and enrolling participants as planned.
Sergio Traversa: Data from this long-term open-label safety study will be part of the planned NDA filing. I would also like to add that the recent pre-planned interim safety analysis conducted on a periodic basis by an independent, Independent Data Monitoring Committee, the IDMC, confirmed the lack of safety signals and concluded with the recommendation for the studies to proceed as planned. This analysis reviewed data from all of the ongoing Reliance trials, including open-label safety. I would like to highlight that the phase two data were published in the peer-reviewed American Journal of Psychiatry, a widely read psychiatric journal in the world, late in 2021. The manuscript for the details, for the details, finding that from the phase two study assessing REL 1017 as adjunctive treatment for NDD.
Data from these long term open label safety study, we'd we'd be part of the plan.
NDA filing package.
I would also like to add that the recent pre planned interim safety analysis conducted on a periodic basis by an independent.
Independent data monitoring Committee D. I B M C confirm the lack of safety signals and concluded with the recommendation for the studies to proceed as planned.
These analyses you data from all of the ongoing and reliance trial, including the open label safety study.
I would like to highlight that the phase II data were published in the peer reviewed American journal of Psychiatry.
The most.
Widely read psychiatry, Jonathan the work late in 2021.
The amount of slip further details.
For the details.
<unk> debt from the phase two study assessing routing 17 as adjunctive treatment for <unk> the primary endpoint demonstrated be.
Sergio Traversa: The primary endpoint demonstrated be rapid, significant and sustained efficacy versus placebo relevance. As our robust REL17 development program continues to advance expeditiously, we continue to be supported by a strong balance sheet, which was further enhanced by the successful oversubscribed follow-on offering that closed in the fourth quarter of last year and generated gross proceeds of $172.5 million. With that, I will turn now the call to Maged for review of the financial, including further details on the completed public offering. Maged, the stage is yours.
Rapid significant and sustained efficacy versus placebo route density.
Is that a robust rather than 17 development program continues to advance expeditiously. We continue to be supported by a strong balance sheet, which was further enhanced by the successful oversubscribed follow on offering that closed in the fourth quarter of last year.
<unk> generated gross proceeds of $172 $5 million.
With that I will turn.
Turning now to call to magnet for review of the financial and Couldnt afford to details on the completed topics.
Stages, you on Earth sure. Thank you Sergio and good afternoon, everyone. Today, we issued a press release announcing our business and financial results for the three months and 12 months ended December 31, 2021, which I will now review.
Maged Shenouda: Thank you, Sergio, and good afternoon, everyone. Today we issued a press release announcing our business and financial results for the three months and 12 months ended December 31, 2021, which I will now discuss. For the fourth quarter ended December 31, 2021, total research and development. Approximately $25.3 million, compared to $14.9 million for the comparable period. The increase was primarily related to the associated with the Ex- Broughter Clinical Program for Reltons. Research and development expense for the most recently completed fourth quarter included a non-cash charge of $1.5 million, related to stock-based compensation.
Maged Shenouda: We also ended the 4th quarter of 2020 with a prepaid R&D expense balance of $26 million related to advance payments to our CRO. Total General and Administrative Expense for the fourth quarter ended December 31, 2021 was $9 million, compared to $6 million for the comparable period. The increase was primarily due to an increase in personnel costs, stock-based compensation, and consulting.
Maged Shenouda: The Non-Cash Charge Related to Stock-Based Compensation, Included in General and Administrative Expense totaled approximately $600,000. Million dollars in the most recent fourth quarter ended December 31, 2021. We recorded a net loss of approximately $34.4 million, or $1.82 million, per basic and diluted share, compared to a net loss of $20.8 million, or $1.30, and Deluded Chair for the comparable period of. For the year ended December 31, 2021, total research and development, approximately 90.6 million dollars, compared to $36 million for the comparable period of 2020. The increase was primarily related to an increase in costs associated with the execution of a broader clinical program for relatively young people.
For the fourth quarter ended December 31, 2021, total research and development expense was approximately $25 $3 million as compared to $14 $9 million for the comparable period of 2020 the.
The increase was primarily related to an increase in costs associated with the execution of a broader clinical program for rail 10 17 Reese.
Research and development expense for the most recently completed fourth quarter included a noncash charge of $1 $5 million related to stock based compensation expense. We also ended the fourth quarter of 2021 with a prepaid R&D expense balance of $8 $6 million related to advance payments to our CRO.
Maged Shenouda: Research and development expense for the year included a non-cash charge of $15.9 million related to stock-based compensation. Included the Novel Psilocybin One-Time Acquisition. $10 million dollars to our- third quarter. There was also a one-time cash, 5 Million Dollars Related Total General and administrative expense for the year ended December 31, 2021 was approximately 35.1 million, 24.9 million Unknown Speaker 07.01.2011, The increase was primarily due to an increase in personnel costs, stock-based compensation, The Non-Cash Charge Related to Stock-Based Compensation, Ltd., General and Administrator totaled approximately $24.7 million. The year ended December 31, 2021. We recorded a net loss of approximately $125.8 million.
Total general and administrative expense for the fourth quarter ended December 31, 2021 was approximately $8 $9 million as compared to $6 million for the comparable period of 2020.
The increase was primarily due to increase in personnel cost stock based compensation and consulting services.
The noncash charge related to stock based compensation expense included in general and administrative expense totaled approximately $6 $6 million in the most recently completed fourth quarter.
Maged Shenouda: $7.16 per base, compared to a net loss of $59.5 million, or $3.81 per basic and diluted chair. December 31, 2021, had cash and cash equivalents in short-term investments of $211.9 million, which compares to 117.1 million. December 30th. This includes $161 million in net proceeds from the public offering closed in December 2021, through which we sold 10.1 million shares of our common stock at $17. I will now ask the operator to please open the call for questions.
For the fourth quarter ended December 31, 2021, we recorded a net loss of approximately $34 $4 million or $1.80 per basic and diluted share compared to a net loss of $28 million or $1.30 per basic and diluted share for the comparable period of 2020.
Maged Shenouda: Thank you. We will now be conducting a question and answer session. If you would like to ask a question, please press star 1 on your telephone keypad. A confirmation tone will indicate that your line is in the question queue.
Operator: You may press star 2 if you'd like to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys. One moment, please, while we poll for questions. Thank you. Our first question comes from Andrew's Thai with Jeffries. Please proceed with your question. Okay, thanks, everyone. And good afternoon.
For the year ended December 31, 2021, total research and development expense was approximately $96 million as compared to $36 million for the comparable period of 2020.
The increase was primarily related to an increase in costs associated with the execution of a broader clinical program for rail 10, 17 research and development expense for the year included a noncash charge of $15 $9 million related to stock based compensation expense, which included the novel Psilocybin onetime acquisition.
Payment of $10 $2 million to Arbor, Mantas and the third quarter of 2021. There was also a onetime cash payment of $2 $5 million related to this acquisition.
Total general and administrative expense for the year ended December 31, 2021 was approximately $35 $1 million as compared to $24 $9 million for the comparable period in 2020.
The increase was primarily due to an increase in personnel cost stock based compensation and consulting services.
Noncash charge related to stock based compensation expense included in general and administrative expense totaled approximately $24 $7 million for 2021.
For the year ended December 20th at December 31, 2021, we recorded a net loss of approximately $125 $8 million or $7 16 per cents per basic and diluted share compared to a net loss of $59 $5 million or $3 81 per basic and diluted share.
In the comparable period of 2020.
On December 31, 2021, the company had cash and cash equivalents and short term investments of $211 $9 million, which compares with $117 1 million on December 31, 2020. This includes $161.2 million in net proceeds.
From the public offering closed in December 2021 through which we sold $10 1 million shares of our common stock at $17 per share.
I will now ask the operator to please open the call for questions operator.
Yeah.
Thank you we will now be conducting a question and answer session. If you would like to ask a question. Please press star one on your telephone keypad.
Formation tone will indicate that your line is in the question queue. You May press star two if you'd like to remove your question from the queue.
For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys, one moment, please while we poll for questions.
Thank you. Our first question comes from Andrew Tsai with Jefferies. Please proceed with your question.
Andrew's Thai: I'm just curious about the DMC Safety Committee disclosure, which is routine. I'm curious if there were any kind of adverse events of special interest that they were looking for. I mean, can you confirm if they were looking for withdrawals of dependents, addiction, euphoria, and so forth, what they looked at in this blinded review? Thanks. But thank you, Andrew. I was sure you wouldn't pick it up.
Okay, Thanks, everyone and good afternoon.
Just curious on the DMC Safety Committee disclosure, which is retained I'm curious if there were any kind of ease of special interests that they were looking for it I mean can you confirm if they were looking for withdrawal. It dependents addiction, you for and so forth where they looked at in this.
Blinded reveal thanks.
Alright. Thank you Andrea I was sure you would pick it up.
Be it.
Sergio Traversa: The committee is totally independent, so they only communicate to us if there is anything that would be of any concern in terms of safety, that includes anything, and I believe it includes withdrawal symptoms, or anything that would be out of the normal course or out of the ordinary. We haven't heard anything. We got just a very simple and brief communication that the trial could continue as planned. That was it.
The committee is delta independent so they only communicate to us if there is anything there would be any warranted in terms of safety that includes anything and I. Do believe includes we traveled in terms of anything that would be out of the of the normal course of after the all day about it we haven't heard anything we've got just a very simple.
And in brief.
Mitigation try again continuous black it was so there was nothing that would be okay.
Sergio Traversa: So there was nothing that would be of any worry. To be honest, Andrew, we have seen, and you have seen, a lot of data over the last few years, and there's been no signal that safety would be of any real big worry. We're always worried about everything, but safety is probably not what we are worried about the most.
New world to be honest and do you.
We have seen and you have seen a lot of data over the last few years and there's been no signal that safety.
It would be of any real big water, maybe you're always worried about everything but safety is probably not what we are already the most.
I hope I answered your question.
Andrew's Thai: Right. Okay. Of course, that's great, Cutler.
Of course, that's great color and then I'll try to ask this one is just I'm wondering if you can give us a flavor of what we can expect to see in the top line release in mid 2022 for reliance three presumably we'll see day seven day 28 efficacy AE rates, what we see.
Curves are what do we see response rates readmission rates and so forth have you thought about what you plan to disclose.
Well, yes, we looked at we will disclose everything that we will receive from the.
From the static.
Statistical Group.
Group that run this statistical analysis with a caveat that clearly we wanted to leave.
<unk> four for the presentation publications, but in term of topline, we usually usually we do see it.
Primary and secondary endpoints.
Ah I I don't know if we would yeah. We would receive the car was I'm not we tend to be very quick. So you don't want to hold the data for too long.
The company. So whenever we have something that is material we tend to do it but yeah very very.
Quickly in a day or two.
Yes.
As a way to tell you that.
It depends on what we received from the Statistical group definitely primary and secondary endpoints.
Great Alright, thank you.
Thank you Andrew.
Thank you. Our next question comes from Andrea <unk> with Goldman Sachs. Please proceed with your question.
Sergio Traversa: And then I'll try to ask this one is just, I'm wondering if you can give us a flavor of what we can expect to see in the top line release in mid 2022 for Reliance 3. Presumably, we'll see day 7, day 28 efficacy, and AE rates. Will we see curves?
Sergio Traversa: Will we see response rates, remission rates, and so forth? Have you thought about what you plan to disclose? Thanks. Well, yes, we will disclose everything that we receive from the statistical group that runs the statistical analysis, with the caveat that we clearly want to leave details for the presentation publications. But in terms of the top line, we usually receive the primary and secondary points. I don't know if we will receive the curves or not. We tend to be very quick.
Everyone. Thanks for taking my question, maybe just sticking on with the monotherapy studies start here just curious if you could help frame expectations ahead of the study and what you've seen specifically from your prior studies that give you confidence and El pen 17, demonstrating.
Sergio Traversa: We don't want to hold data for too long inside the company. So whenever we have something that is material, we tend to do it very, very quickly in a day or two. So that's a way to tell you that it depends on what we receive from the statistical group. Definitely primary and secondary.
You know as a monotherapy.
And then I have a follow up thanks.
Yeah, well, good afternoon, and Andrea and thanks for your question.
Sergio Traversa: Great. All right. Thank you. Thank you, Andrea.
Operator: Thank you. The next question comes from Andrea Tan with Goldman Sachs. Please proceed with your question. Hey everyone, thanks for taking my question. Maybe sticking on with the monotherapy study, Sergio, just curious if you could help frame expectations ahead of this study and what you've seen specifically from your prior studies that gives you confidence in REL 1017 demonstrating a benefit here as a monotherapy. And then I have a follow-up. Thanks. Yeah, well, good afternoon, Andrea.
But we kind of can.
Ken.
Andrea Tan: And thanks for your question. So, what we kind of, you know, can, can, can be applied to monotherapy is clearly the, you know, the lack of any, you know, is the, You know, it's the, There is not much else that we can apply or infer from phase two into the monotherapy data. We can kind of, I don't know.
Can be applied to the monotherapy is clearly the you know the.
The lack of any.
But then support abuse they'd get seen and the safety that's pretty common to all the studies what do we don't have is any based on efficacy as a monotherapy. We do have very strong efficacy data for the adjunctive.
Therapy, but not as a monotherapy. So that's what really it would be the most interesting data points in that.
Yeah.
There's not much else that you can apply for in the from phase two into the.
The monotherapy data.
We can kind of speculate that patients.
Sergio Traversa: Speculate that patients that have failed one or two or three previous antidepressants are not completely different from patients that have not failed any previous antidepressants. So we don't see any major differences between the two patient populations, but we'd be very anxious to see this efficacy result and as monotherapy. Got it. And then, is there anything that can be inferred, or will there be any read through from the monotherapy results to the adjunctive pivotal studies here?
That failed.
Failed, one or two or three previous anti depressant theyre not completely different trauma from patients.
Not failed, Indiana than any previous antidepressant.
So we don't see a major differences between the two patient populations, but we.
But we would be very anxious to see these efficacy.
<unk> as a monotherapy as well.
Got it and then is there anything that can be in further.
Will there be any read through from the monotherapy results to that that junket pivotal studies here.
[laughter] well.
Sergio Traversa: Well, that's a very difficult question to answer, but... If the study is successful as monotherapy, then we could infer just because we already have data as an adjunctive treatment positive, so we can infer that probably there is some indication of efficacy across all the patient population for all the adjunctive and monotherapies.
So that's a very difficult question to answer but but.
Okay.
The study is successful.
And as a monotherapy and then Oh, we call deferred just because we already have data.
As an adjunctive treatment positive so we can further.
Robbie there is some indications of efficacy in all across all the patient population across all the hedge RMT with monotherapy.
Sergio Traversa: If it doesn't or doesn't work the way that we hope and we believe, then it's, you know, it's more, it gets more speculative, right? If it, let's say it fails as monotherapy, but we have positive phase two as an adjunctive cell, I would say, I'm pleased to say that if this study in monotherapy is not positive, I would not read too much into the adjunctive cell and want to go a little bit more in detail.
Population.
If it doesn't go the way that we hope and we believe.
Then as you know it's more if he gets more speculative right, but let's say trails as monotherapy, but we have positive phase two as an adjunctive. So I would say I would tend to say that if this study in monotherapy is not positive I would not read through much into the adjunctive.
Sergio Traversa: What we don't know is if there is any role for the inadequate response to the underlying antidepressant therapy as an adjunct. For example, we don't know if there is any synergistic effect between, Right, a non-effective SSRI or SNRI and an MMDA channel blocker.
And if you want to go a little bit more in detail. What we don't know if there is any role of the <unk>.
I think with response to the underlying antidepressant therapy is Doug we don't know if there is any synergistic effect between.
Alright.
A non effective it's a virus in awry.
The minimum D a channel blocker.
Sergio Traversa: That's what we learned from the monotherapy and the adjunctive therapy trial. Thank you very much; more Maged Shenouda, Andrea Tan, Uy Ear, Basma Ibrahim, Unknown Executive, Lin Tsai, Guofang Li, Sergio Traversa, Timothy McCarthy, Andrew Cutler, Relmada, Well, we have a rolling NDA, so we will start to file the modules like the preclinical and the TMC well in advance than when we have the clinical data. The goal is to, it takes about six months, realistically, it's a big deal, right, potentially for two indications, and there's a new chemical entity.
That's what we can learn from the monotherapy and adjunctive therapy trial.
Okay got it.
There's all the speculation so it's a we really.
We want to see the data and then it can be more accurate.
And.
Realistic.
Got it and then maybe just one last question just given that you are looking to include data from relying loss in your filing package can you just remind us on the timeframe there for that amount of follow up and when you think you might have a completion for that question.
Well, we have a rolling NDA. So we will start to file the models like the preclinical and CMC well in advance than when we have the clinical data. The goal of these two it takes about six months realistically is the big Reits, there potentially for two indications and theirs.
Sergio Traversa: So it's a big NDA. And so we calculate six months as a fair time to do it correctly. And, you know, you know what happens when you don't do it correctly. That's not the situation that we want to find ourselves in.
New chemical entity, so it's a big N D E and so we calculate six months is a fair time to do it correctly.
You know what's happened when you don't do it correctly, that's not the situation that we wanted to find out what itself. So.
You know if everything goes about.
Sergio Traversa: So, you know, if everything goes according to the plan, we should be able to complete the NDA by mid-2023. Perfect. Thanks, Sergio.
According to the plan, we should be able to complete the NBA by mid 2023.
Perfect. Thanks Nokia.
Thank you Andrea.
[noise].
Andrea Tan: Thank you, Andrea. Thank you. Our next question comes from June Li with Truist Securities. Please proceed with your question. Hi, thanks for taking our questions and congratulations on all the progress. So now that you have completed two successful human abuse potential studies, has your outlook changed on possibly looking towards ex-US opportunities and regions where they have maybe stricter substance abuse laws? I believe China may have been one of them. And do you have any plans to enter the US and enter the EU at this point? I have a follow.
Thank you. Our next question comes from Joon Lee with Truth Securities. Please proceed with your question.
Hi, Thanks for taking our questions and congrats on all the progress.
So now that you have completed two successful human abuse potential study has your outlook changed on possibly looking towards ex U S opportunities in regions, where they have maybe stricter substance abuse laws I believe China may have been one of them and do you have any plans to enter the U S enter the U S on point.
Operator: So now that you have any plans to enter the US and enter the US and enter the US and enter the US. Thank you, Joan. Um, the... No, the... It's a bit too early, and look, we are extremely busy and committed to the U.S. phase 3 program. In terms of areas where there is more sensitivity to substance abuse, Japan is the one that is the most sensitive.
Yeah.
Alright, Thank you Jud.
No.
Got it.
It's a bit too early.
And look we are extremely busy and committed to the U S phase III program.
In term of.
The areas, where there is more sensitivity to like a substance abuse or Uh huh.
Japan is the one that is the most is the most sensitive.
June Li: Europe, we had few interactions with the EMA, with the European FDA, and there was no specific; I just mentioned our specific interest in the abuse potential of the drug. With that said... There were preliminary conversations, so I don't know if it was the right time for the regulators to go deeper into that, on these aspects. So we will do something, we will look into that, but a little bit later on, we really would like to fix the program correctly and do it right. That's the real focus.
Europe , we had few interaction with the mirror with the European FDA and.
There was no specific.
You just mentioned I was just interesting in the in the abuse potential of the drug with that said they were preliminary conversations. So I don't know if it was the right time for the regulators to go deeper in debt.
These aspects.
Right.
We'll do something we will look into that but little bit later on we really would like the phase II program.
Correctly and to do it right.
Yes sure.
Sergio Traversa: Sure, great. And then, in addition to the phase 2a data that you published in the American Journal of Psychiatry, you also published data showing a rapid rise in BDNS after in human subjects, those with S methadone. So can you elaborate on the significance of that? And what do you plan to do with that information?
Great and then in addition to the Phase Iia data that you published in American Journal of Psychiatry, Jaco published data showing rapid rise in bdnf's. After in human subjects dosed with S. Method. So can you elaborate on the significance of that and what do you plan to do with that information are you following that up with any other studies. Thank you.
June Li: Are you following that up with any other studies? Thank you. Yeah, it's a great question.
Yeah, and that's a great question well, what we have done already.
Sergio Traversa: Well, what we have done already, we use these data, they were new data, and to strengthen the IP. So we put the BDNF data and, you know, the neuroplastic effect into a patent filed in 2018, that is under review. And the clear indication is that, mechanistically, an M&A channel broker, they are very different from anything that is like SSRIs and the traditional mechanism of action. And it would indicate clearly that, scientifically and mechanistically, there is a neuroplastic effect with an increase in functionality and an increase in the proliferation of dendrites, and connection between nerve cells, and that happened very quickly. And this, you know, BDNF, brain-derived neurophobic factor, is a growth factor.
We have used these data they work they do.
New data and to strengthen the IP so it could be the bdnf data in that.
The neuro plastic affecting threat patent filed in 2018 that is under review.
And what was the clear indications that.
Mechanistically NMDA channel broker, they're very different from anything that is I guess, just sort of EIS and rite aid.
Traditional mechanism of action.
It would indicate clearly debt.
Antifreeze and Mechanistically the reason Europe plastic effect, we did increase in functionality and increase in.
The proliferation of dendrites.
Connection between <unk> and ourselves and that's happened very quickly in this.
Bdnf brain derived neurotrophic factor is a growth factor. So there should be some correlation between that being a nice increase in the in Europe plastic effect just to be clear edge on the SBA does not consider bdnf as a surrogate for.
Sergio Traversa: So there should be some correlation between the BDNF increase and the neuroplastic effect. But just to be clear, John, the FDA does not consider BDNF as a surrogate for clinical efficacy in depression. So we won't use it with the FDA and say, oh, increase the BDNF, and there is efficacy. That's not going to fly.
The clinical efficacy in depression, so we won't use it with the FDA as they increase the bdnf and there is efficacy.
Fly and but clearly for IP is very very interesting that's been confirmed.
Sergio Traversa: But clearly, for IV, it's very interesting, and it's confirmed by the extended and sustained effect of the drug after, you know, the therapy is stopped. So at least for one week after the interruption of the treatment, you still see a very nice and prolonged and sustained antidepressant effect. So the clinical results, they match very, very clearly the scientific and mechanistic expectation. So we will continue, eventually, for other indications to try to understand better and to leverage this potential for a neuroplastic effect of the drug.
<unk> extended and sustained effect of the drug.
After the therapy is stopped so at least for one week after interruption of the treatment you still see a very nice and prolonged and sustained anti depressant effect. So the clinical resolved they match very very clearly.
<unk> scientific and mechanistic expectation so.
We we we we will continue eventually for other indications too.
Try to understand better and to and to leverage this potential for neuro plastic effect of the drug.
Sergio Traversa: So very important data, very important data. Yes, and then if I could follow up with one quick question, when you do complete enrollment in the monotherapy study, would you disclose completion of enrollment? Yeah, you probably will.
Good day, ladies important data very important data.
Yeah, and then if I could follow up with one quick question. When you do complete enrollment in the monotherapy study would you disclose completion of enrollment.
Sergio Traversa: We usually, companies usually do, and we don't want to be different from anybody else in these aspects. All right. Looking forward to the data. A few weeks. Yeah, a few weeks. You know, the statin station that they usually take. Andrea Tan, Uy Ear, Basma Ibrahim, Andrew Cutler, Relmada. Sounds good.
It's already well usually companies, usually do and we don't want to be different from anybody else in these aspects.
Right.
Looking forward to data weeks, yeah, a few weeks.
This station they usually they take it.
It really wide range of timing when you know when they lock the database and when they provide the top line. They usually tell us like two to four weeks.
But southeast Asia is a narrow range for us a little bit less narrow, but so you assume that when we complete the enrollment.
Probably around the months, so we will adopt the topline data.
June Li: Thank you. Thank you, John. Thank you. Our next question comes from Yatin Samidja with Guggenheim. Please proceed with your question. Hey guys.
Sounds good thank you.
Thank you John .
Thank you. Our next question comes from your teens, Tunisia with Guggenheim. Please proceed with your question.
Operator: Thank you for taking my question. A couple of questions for me. Can you talk about, Sorry, Yati, you broke up. Can you just talk about the discontinuation rate, what you might have assumed in the study and how it might be trending? How is the conversion from randomized to open?
Hey, guys. Thank you for taking my question. A couple of question for me can you talk about what you might be seeing on the commission.
You shouldn't read what assumptions you might.
How many are moving.
Sorry, I think you broke up can you.
Just talk about the discontinuation rate are what you might have assumed in the study and how it might be trending how is the conversion from a randomized to the open label.
Yes, we can.
Yatin Samidja: Yes, we can. I know how specific I should be before Maged shuts me down. But the dropout rate is significantly, not statistically, right, but it's very much lower than what we assume. We look at the history, and we discussed it with the CRO who has a lot of experience in running depression studies. And we assume mid double digits, around 15% in the statistical plan, to be sure that we reach a number of patients that can be evaluated that is high enough for the power of the study. And what we have seen so far across the board is much lower than that, I would say. I would love to meet Singaporeans.
I don't know how specific I should be.
Before Margaret shut me down but.
The dropout rate is significantly no statistically right, but it's very much lower than what we assumed we look at historical and we discussed them. This year or that has a lot of experience in running the pricing studies and we assume mid double digits around 15% in the statistical plan.
To be sure that we reach a number of patients that these and it can be evaluated it is high enough to for the power of this study and what we have seen so far across the board, it's much lower than that I would say is low.
Low to mid single digits.
Sergio Traversa: So according to the CRO, that's not something that's not been seen before in the present study. Now, I'd like to be always direct and open. What we can read through that is like safety, compliance, and tolerability, it shouldn't. Doesn't look to be an issue. I would not, you know, make the big step on reading anything into efficacy because half of the patients are not taking what? Got it.
So according to the shallow theres not theres not been seen before in that.
In Depression study now.
I'd like to be always directed and open.
What we can read through that.
Is it safety compliance taller ability it should not that doesn't look to be an issue I would not make the big step one reading anything into efficacy because half of the patients taking placebo.
Got it.
Yatin Samidja: Right. In terms of the rollover, that's also a number that the it's a very good number. So about three out of four patients, they accept and are happy to continue from the 28 days to rollover into long-term safety. That's much higher than the average for this kind of stuff. Yeah.
In term of the rollover.
That's also a number that are due.
It's it's really good number so about three of the four patients.
Hey.
Except I'm happy to continue from the 28 days to rollover into the long term safety that it's much higher than the average for these kind of things.
Got it okay. That's helpful.
Sergio Traversa: Got it. Again, that's helpful. Faith and Tolerability and Acceptance and Compliance, David Grady. Got it, got it.
Safety, and Tolerability and acceptance and compliance they look very good.
Yatin Samidja: Very helpful. Then, one more question. So I think one of the pushbacks or the things that we generally discuss with investors is the performance of the placebo arm in phase two. So can you just talk about how much cushion we might have in the phase three studies, how you might be controlling it, any reason to believe that the monotherapy placebo rate might be different than the adjunctive one? Just give us some comfort and color around it.
Got it got it very helpful. And then one more question. So I think one of the pushback or the things that we generally discuss with investors is the performance of the placebo arm in phase two so.
So can you just talk about how much cushion we might have in the phase III studies, how you might be controlling at.
Any reason to believe that the monotherapy placebo rate might be different than the adjunctive. One is it gives us some comfort in the color around it.
Sergio Traversa: No, I can give you, I can share what we discuss on a daily basis. We are fully aware that, you know, the placebo effect is, you know, and that is strictly related to the quality of the patient population, meaning, you know, the patient should be a depressed patient to enter the study. And for phase two, I do remember the delta from baseline to day 7, all the placebos were around 8 or 9 points. That's a little bit lower than what has been seen historically, slightly lower, but there is one point.
No I can't give you can share what is you know what we discussed on a daily basis.
We are fully aware that placebo effect as you know.
And that is strictly related with the quality of the of the patient population, meaning the patient should be a depressed patients that to enter the study.
And the.
D.
For the phase two.
Remember the delta from baseline to day.
74 of the placebo was around eight to nine points.
That's a little bit.
Lower than what has been seen historically.
Lower but there was one point the study was seven days on placebo placebo effect tend to increase overtime. So seven days to have a placebo delta from a baseline of eight nine points of day seven he's not unusual it's actually even on the high side, we have seen placebo effect of 456 points.
Sergio Traversa: The study was seven days; the placebo effect tends to increase over time. So seven days to have a placebo delta from baseline of eight, nine points at day seven is not unusual. It's actually even on the high side; we have seen placebo effects of four, five, six points in other studies at day seven. So there is really nothing unusual there.
I mean, either the studies.
At day seven so there is really nothing unusual there is something unusual or is a slightly higher that was also expected because in in cleaning studies. They tend to have a higher placebo effect than allocation studies.
Sergio Traversa: It is something unusual is slightly higher, but that was also expected because in clinic studies, they tend to have a higher placebo effect than outpatient studies. So the second part of your question, what we are doing to try to minimize as much as possible the placebo effect. Well, there is no magic, no secret that can be used that nobody else has used, but we try to put all the experience together.
So on the second part of your question, what we are doing to try to minimize as much as possible the placebo effect, but there.
There is no magic no secret.
That can be that the reuse that nobody else has used but we tried to put together all the experience and the Doctor pharma is the principal investigator has published a lot about.
Sergio Traversa: And Dr. Fava is the principal investigator; he publishes a lot about the potential for the placebo effect. And so he's kind of an expert on trying to control as much as possible the unusual placebo response. With that said, there are tidbits here and there, like there is a statement that the patient is reading before he's administered the Madras scale every time that states that he has 50,000 chances to take the placebo. The nurses are trained not to make comments about the patient looking good or better, because that could alter the response of the patient.
The potential for a placebo effect and so it's kind of an expert on Oh.
I would tell you on trying to.
Control as much as possible our newest placebo response with that said look there is no debate.
Bits here and there like there was a statement that the patient is reading before he is administered the mazo scale every time.
<unk> that the you know is 50% chances to placebo.
First is our train not to make comments about the patients who can go the better that could operate the response of the patient. So all these together they can make some difference we do believe that what really makes a difference.
Sergio Traversa: So all these, together, they can make some difference. But we do believe that what really matters at the end of the day is the quality and, you know, to be sure that the patient's enrollment is a patient affected by, you know, MVD by major depression. And to do that, we use as a strategy, a development strategy, what we have used in phase two, that is, the safer questionnaire. So the patient is re-diagnosed using a different diagnostic tool, that is, the safer questionnaire before it gets randomized. So it can meet all the inclusion criteria based on the size and the Madras scale before it gets randomized. But before it gets randomized, it goes to another phone call.
At the end of the day is the quality and to be sure that the patients enrolled is a patient that has affected my MVD by major depression and to do that we do we do we use as a strategy.
Element studies would be abusing.
Phase two that is the safer question. There. So the patient is re diagnosed using a different diagnostic tool that is a sacred questioner before he get trying to buy some of it is it can meet all the inclusion criteria based on the size and the the Madras scale.
Before he gets randomized, but before it gets ready to buy it.
Sergio Traversa: So it's not a very, it's another long process. And it goes to another doctor, you know, diagnosed but using the safer questionnaire. According to everybody that we have consulted, that is the best way possible to control placebo because it reduces the percent of patients that should not belong or should not be involved in this kind of study because they are not patients affected by depression. It was a long answer, but I wanted to be specific. Thank you so much.
It goes through another it's a phone call so its not their baby.
Is another long process are.
And then it goes to another diagnosed but using the same question. According to everybody that we have consulted.
It's is the best way possible to control placebo because it's.
Reduce the percent of patients that shouldnt that belongs I should not be involved in these guys know studied because theyre not patient affected by major depression, there was a long answer, but I want it to be.
Got it thank you so much.
Thank you.
As a reminder, if you would like to ask a question. Please press star one on your telephone keypad, a confirmation tone will indicate your line is in the question queue.
Sergio Traversa: Thank you. As a reminder, if you would like to ask a question, please press star 1 on your telephone keypad. A confirmation tone will indicate your line is in the question area.
Our next question comes from Jay Olson with Oppenheimer. Please proceed with your question.
Operator: Our next question comes from Jay Olson with Oppenheimer. Please proceed with your question. Oh, hey, thanks for taking the question. Can you remind us how the human abuse study results compare to Spravato? And would the human abuse data appear on the FDA-approved label so they could be used for promotional purposes? Thank you, Jay. Good afternoon.
Oh, Hey, thanks for taking the question could you remind us how the human abuse study results compare to <unk> provider and what the human abuse data appear in the FDA approved label. So they could be used for promotional purposes.
Jay Olson: Well, the first question, how the Comparison with ketamine of REL1017 compared with Spirato, they are totally different. S-ketamine is a low-dose ketamine. The isomer of racemic ketamine, but works exactly the same as racemic ketamine, according to all the literature.
Thank you Jay and good afternoon.
Well the first question of how the.
Comparison with Cat I mean, a real thin 17 per bandwidth spell out that they are totally different.
I mean, it is a low dose get them in the eyes of many.
Semi cap I mean, but worked exactly the same as it is we're seeing a cat I mean, according to work with each other so the J&J run. This study because probably was asked by the FDA, but clearly the expectation was not.
Sergio Traversa: So J&J ran the study because probably it was asked by the FDA, but clearly, the expectation was not that S-ketamine is less potentially abusable than racemic ketamine. That is exactly what happened. You have seen the data for REL1017, right? There are, I don't know how many zeros after the period in chemo's p-value compared to ketamine. So the data are completely different.
Not that a S ketamine is less.
Actually it would be reasonable then receive me catch exactly what that you have seen the data real time 75, there I don't know how many zeroes after the period in terms of P value.
There too to Catherine so are they the debates are completely different.
And if the abuse data they don't abuse data or the lack of abuse meaningful abuse potential data for relatives and team will be on the label can be used promotional.
Sergio Traversa: And if they abuse data, or non-abuse data or the lack of abuse, meaningful abuse potential, data for relatives and teens, who will be on the label, can be used for promotion. Well, the straight answer is that the FDA will decide. We won't emphasize it.
Well the straight answer is that the FDA will decide.
We want to emphasize.
Sergio Traversa: Martino, Andrea Tan, Uy Ear, Basma Ibrahim, Andrew Cutler, Relmada, probably people I assume won't won't be the focus of of the attention of the clinician. So personally, if you ask me directly, maybe some centers that mimic what the DEA has already published in 2019, that the isomer lack abuse potential and a risk of respiratory depression. That's, Well, they could speculate that could be in the label by mimicking the DAs.
What's about the lack of abuse potential over rather than 17 as a as a promotional tool.
It's efficacy rapid acting sustained efficacy that they have a lot.
More powerful with these data and I don't think anybody would think that there is any risk of abuse. So a time of potential approval is probably you know people I assume won't.
Won't be the focus of the attention of the clinician. So personally I'd be asked me directly.
Maybe some centers that mimic what they'd be a is already published in 2017 and 19 that Oh, the ice on the lake abuse potential and a risk of respiratory depression.
I could speculate that could be in the label, but Mimi Mimi King D D a statement.
Okay, great. Thank you and maybe as a follow up can you talk about any findings from your market research as you test the rail 10 17 profile with.
Jay Olson: Okay, great. Thank you. And maybe as a follow-up, could you talk about any findings from your market research as you test the rail 1017 profile with prescribers, as you plan for your commercial launch and, especially, if you have any feedback from employers in the U.S., and then if you are considering a partner, XUS? Thank you. Yes, so we did, you know, it's never too early to discuss with the payers, so we keep everybody that is in the chain as updated as possible.
Prescribers as you plan for your commercial launch and especially if you have any feedback from payers in the U S.
And then if you're considering a partner ex U S. Thank you.
Yeah, so we'd be yeah.
It's never too early to discuss with the payer so we keep.
Everybody that is in the chain as updated as possible from my experience the payers really consider.
Jay Olson: From my experience, the payers really consider seriously, right, to get into a conversation when they have phase 3 data, you know, before data, from their perspective, they need to show me the data, and then we can discuss. Like really top-down, and it's MonoTherapy, a bit more challenging in terms of reimbursement and depending on the price because the frontline therapy that is currently proposed and supported by the payers is generic SSRI. They work a little bit, and they're relatively safe, and they're extremely inexpensive.
Seriously like to get into a conversation when they have phase III data.
Before before data from their perspective, they didn't get stuck in a show me that they can run rate weekend, we can discuss.
Like really top down.
And.
Is the O D.
Our monotherapy, it's a bit more challenging in term of reimbursement and depending on the price because the frontline therapy.
As currently proposed.
Supported by the Payors is generic they works little bit and our debt relatively safe and they are extremely famous spaces. So that's a that's a little bit of a hard though.
Sergio Traversa: So that's a little bit of a hurdle to our comments on monotheranity. Adjunctive; there is no antidepressant approved for this use. So that would be a great presentation, but it's going to be very difficult for the presentation by a mass market patient population. So that one, we don't believe is going to be a major challenge to get reimbursement and is a, I don't know how to call it, but it's on the front line, a junkie. With that said, going back for a second to Mono Tele, the data in phase three will be any close to the phase two data that we have seen in monotherapy, meaning monotherapy will mimic somewhat the adjunctive phase two data. It's going to be difficult for payers, you know, not to reverse a drug that works much faster than If you can, you know, get out or improve your depression status quicker, you are more productive. That's more European, but I do believe the U.S. also focuses on that, and so the pharmacognomic, if you can, improve and go to work a lot faster than if you take an SSRI.
Due to our communism monotherapy adjunctive there was no antidepressant approved so that's that would be great, but it's going to be very difficult.
Good treatment, where there is no competition in term of antidepressants and works fast and.
Hopefully, we don't believe it will be priced at D. S. Ketamine, Oh scared them in range. So it would be.
Potentially affordable by yeah.
Bye.
Mass market the patient population.
So that's why we don't believe it's going to be a major challenge to get reimbursement and that and is it is it hasn't really I have to call. It but is it frontline adjunctive treatment.
That said going back for a second with the monotherapy.
If you did data in phase III would be any close to the phase two data that we have seen in monotherapy, meaning.
Meaning the monotherapy, we will mimic somewhat the injunctive phase II data, it's going to be.
Going forward the pay as you know not to reimburse the drug the drug works much faster there is pharmacodynamic data too right.
If you can you know get out well improve your depression studies quicker.
More productive that's more European but I do believe the U S. Also focus on these aspects too right.
And so the farm like economic if you can.
Jay Olson: That probably is of a lot more value than saving some reimbursement or some payers money by using, you know, starting with an SSRI. So if you have a rapid acting and sustained efficacy drug, it's going to be difficult not to reimburse it, even as a monotherapy. The key will be clinical. Okay, great, and any plans to find the XUS commercial partner? Andrea Tan, Uy Ear, Basma Ibrahim, Andrew Cutler, Relmada Andres Tan, Uy Ear, Basma Ibrahim, Sergio Traversa, Timothy McCarthy, Andrew Cutler, Relmada Andres Tan, Uy Ear, Basma Ibrahim, Not before, not before phase three data. We don't expect anything to happen outside the US before phase three. We also would like to retain, you know, the global right. That is, right, there is a volume in the Global Right.
Improve and go to work a lot faster than if you take an SSRI, that's probably has a lot more value than a than to save.
Reimbursement, though some payers money.
Using you know starting with them if that's all right. So if you have a rapid acting and sustained efficacy drug it's going to be difficult to reverse its even as it isn't all about therapy.
He will be clinical data.
Okay, great and any plans to find an ex U S commercial partner.
Sergio Traversa: Okay, got it. Thank you, Jay. Thank you. There are no further questions at this time. I'd like to turn the call back over to Sergio Traversa for any final...
Ah well.
Yeah.
As always in this kind of like situations pre phase III data. He was always some conversationally in there about.
We don't believe that nothing will happen, but we have to close to phase three data and nobody will sign an agreement or paying right.
And the other with price.
A few months before phase three data straight answer is not.
Not before not before phase three there, but we don't expect anything happened outside the U S. B.
Before phase three data, we also would like to retain.
The global rights.
These are but maybe it's the volume kind of in the global rights.
Okay got it basically asking the question.
Thank you David.
Thank you there are no further questions at this time I'd like to turn the call back over to Sergio <unk> for any final remarks.
Sergio Traversa: Thank you. Thank you, operator. Well, thank you very much, everyone, on the call for the interest, the time, and the interest in our program. And I would also like to thank, you know, the Relmada team for the effort and the energy they're putting into this program, and the clinician and the patient who are really helping to complete this ambitious but realistic program to, you know, offer patients hope. Thank you. This concludes today's conference. You may disconnect your lines at this time. Thank you for your participation.
Thank you and thank you operator, and well. Thank you very much everyone on the call or the interest the time and the interest in our program and I would like to thank culturally you know their mother team for the effort and the energy that we're putting in this program and the clinician and the patient that are really helping to complete these ambitious but.
Realistic.
Program.
To offer patients.
Who are the better solution to treat depression, Ted wish everyone at once.
Wonderful retropubic. Thank you.
This concludes today's conference you may disconnect your lines at this time. Thank you for your participation.