Q3 2021 Relmada Therapeutics Inc Earnings Call
Greetings and welcome to role model Therapeutics, Inc. Third quarter 2021 earnings call. At this time, all participants are in a listen only mode.
Operator: Greetings and welcome to Ramada Therapeutics Inc.'s Third Quarter 2021 earnings call. At this time, all participants are in a listen-only mode. A question and answer session will follow the formal presentation. If anyone requires operator assistance during the conference, please press star zero on your telephone keypad. As a reminder, this conference is being recorded. I would now like to turn the conference over to your host, Tim McCarthy.
And the answer session will follow the formal presentation.
Only once you require operator assistance during the conference. Please press star zero on yourself on P pad.
As a reminder, this conference is being recorded I would now like to turn the conference over to your host Tim Mccarthy.
Thank you operator, and thank you all for joining us this afternoon.
Timothy McCarthy: Thank you, operator, and thank you all for joining us this afternoon. With me on today's call are our Chief Executive Officer, Sergio Traversa, and Chief Accounting and Compliance Officer Chuck N. This afternoon, Ramada issued a news release, providing a business update and announcing financial results for the three and nine months ended September 30th, 2021, and filed its quarterly report on Form 10Q with the SEC. Please note that certain information discussed on the call today is covered under the State Harbor provision of the Private Securities Litigation Reform Act.
On today's call are Chief Executive Officer, Sergio took herself and chief accounting and compliance officer Chuck Yes.
This afternoon, My mother issued a news release, providing a business update and announcing financial results for the three and nine months ended September 30th 2021 and filed its quarterly report on Form 10-Q with the SEC.
Please note that certain information discussed on the call today is covered under the safe Harbor provision.
Private Securities Litigation Reform Act, we caution listeners that during this call for a modest management team will be making forward looking statements.
Timothy McCarthy: We caution listeners that during this call, a modest 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. These forward-looking statements are qualified by the questionnaire statements contained in Romato's press release issued today and the company's SEC filings, including in the annual report on Form 10K for the year ended December 30th, 2020, and subsequent filings.
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.
These forward looking statements are qualified by the cautionary statements.
And in the modest press release issued today and the company's SEC filings, including including in the annual report on Form 10-K for the year ended December 32020, and subsequent filings.
Timothy McCarthy: This conference call also contains time-sensitive information that is accurate only as of the date of this live broadcast, November 11, 2021. Romata 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 would like to turn the call over to Sergio.
This conference call also contains time sensitive information that is accurate only as of the date of this live broadcast November 11 2021.
Undertakes no obligation to revise or update any forward looking statements.
Select events or circumstances. After the date of this conference call.
Now I would like to turn the call over to Sergio Sergio.
Sergio Traversa: Thank you, Tim, and good afternoon to everyone. And we also have on the call today Maggie Shenuda, who is our CFO on top of justice.
Thank you Tim and good afternoon to everyone and we also have on the call today magazine, but without that piece that was CFO from top false hope gestures.
Sergio Traversa: And I'm pleased to welcome you to Ramada's third world of 2021 conference. On today's call, I will provide an update on the comprehensive development program for our lead product candidate for L-1017 for the adjunctive and monotherapy treatment of major depression disorder or MDD. Highlight the substantial market opportunity for this compelling product candidate and review upcoming questions. Following this, I will turn the call over to Magid Snedgneuda, Chief Financial Officer, for a review of the finances.
And I'm pleased to welcome you to remind that third quarter 2021 conference call.
On today's call I will provide an update on the comprehensive development program for our lead product candidate for El Pen 17 for the adjunctive and monotherapy treatment of major depressive disorder or <unk>.
Highlight the substantial market opportunity for this compelling product candidate and upcoming milestones. Following this I will turn the call over to Maggie Schnoodle Chief Financial Officer for a review of the financials.
Sergio Traversa: We then provide a brief overview of the data that we recently presented at the Neuroscience Education Institute Congress last year. With that, I will begin by highlighting the point that we will have a beta readout in each quarter of next. I will elaborate further on this shortly, but in summary, in the first quarter of next year, 2022, we expect top-line results from our second human abuse potential or haps study, this one assessed in World 1017 versus Incervenous Keta.
We then provide a brief overview of the data that we addressed and recently presented at the Neuroscience Education Institute called Congress Lawsky.
With that I will begin by highlighting the following.
We will have data readouts in each quarter of them actually.
I will elaborate further on this shortly but in summary in the first quarter of next year 'twenty 'twenty. Two we expect topline results from our second human abuse potential or Hap study each one obsessing 10 17 versus intravenous kit.
Following Easter in the second quarter, we anticipate top line data from relying on sleep.
Sergio Traversa: Following this, in the second quarter, we anticipate top-line data from Reliance Street, the ongoing monotherapy registration of phase to In the third and fourth quarters of 2022, we expect top-line results from Reliance 1 and Reliance 2, respectively, the two ongoing phase three sisters with two arm placebo control. Pio subsist.
The ongoing monotherapy Registrational phase three trial.
In the third and fourth quarters of 2022 we expect topline results from the last one.
And rely on us to respectively.
The two ongoing phase III assisted two on placebo control.
B, what sort of studies.
Sergio Traversa: With that, I would like now to reiterate the important development and regulatory update that we provided for REL 1017 last year. To begin with, Reliance 3, which aims to randomize 364 patients, is expected to be completed in the second quarter of 2022, prior to the anticipated conclusion of Reliance 1 and Reliance 1, the adjunctive NDD studies, which I will discuss momentarily.
That's it.
Now to reiterate the important development and regulatory update that we provided for real time 17 last months too.
To begin with they rely on street, which aims to randomized 364 patients is expected to be completed in the second quarter of 2020 prior to the anticipated conclusion over last one camera.
The adjunctive <unk> studies, which I will discuss momentarily.
Sergio Traversa: This MD Monotherapy study is for individuals who are diagnosed with depression and are not currently taking standard antidepressant therapy. Importantly, conducting Relance III as a phase three study meaningfully reduced the time for a potential approval of RELPence and Tenth as an MDM monot. In addition, in order to support potential regulatory submission seeking approval for well 1017 as a monotherapy, as well as adjunctive treatment, The FDA confirmed that based on what is known at this time, RELNADA will not be required to conduct a two-year carcinogenicity study of REL-107, with an understanding that sufficient preclinical safety data has been generated today.
These MTP monotherapy PD study is for individuals who are diagnosed with depression and that is not currently taking standard antidepressants.
Importantly, conducting run out of three is a phase III study may meaningfully reduce the time for a potential approval around pension and <unk> is an MPD mono PERC.
In addition in order to support potential regulatory submission seeking approval for both Pennsylvania team as a monotherapy as well as adjunctive treatment.
S. P. A confirmed that based on what he is long at this time well neither will not be required to conduct two years carcinogenicity study of real time for them.
With an understanding that sufficient preclinical safety data that's been generated to date.
Sergio Traversa: The FDA also confirmed that RALMATA does not need to conduct a TQT cardiac study in humans to support cardiac safety in a potential regulatory system for REL 1017. The data provided to date, as well as the data to be generated from the P-Program, will be adequate to evaluate and confirm the cardiostafety profile of REL-1017. Moving on, I will now provide an update on the ongoing Reliance 1.
The FDA also confirmed that bring them out or does not need to conduct the D. E. T. Cardiac study in humans to support safety and the potential regulatory submission for <unk>.
17.
The data provided to date as well as the data to be generated from the phase II program would be adequate to evaluate ankle felt the positive safety profile of <unk>.
Moving on.
I will now provide an update on the ongoing you're right that's one.
And related to studies.
Sergio Traversa: Android is to study, each of which would include 365 participants per study across 55 sites as well first. As a reminder, Reliance 1 and 2 are designed to evaluate VAL-17 as an adjunctive treatment for MDD. And both include two arms, placebo, and 25 milligrams of relative to 1010, both of which are in addition to a standard antidepressant treatment for participants who have had an inadequate response to a minimum of one and up to three standard antidepressant therapy.
Each of which will include the 364 participants per study across 55 sites as well as for study.
As a reminder, relapsed wanted to I was designed to evaluate <unk>.
17, as an adjunctive treatment for MTV and.
And both into two arms placebo and 25 milligrams of routers are going to keep.
Both of which are in addition to our standard antidepressant treatment for participants who have had an inadequate response to a minimum of one and up to three standard antidepressant.
The clinical trial protocol remains unchanged with the primary endpoint being changing Matt Drudge score at day 28, and key secondary endpoints include the change in micro score at day, seven and the changing clinical global impression of severity score at day 28.
Sergio Traversa: The clinical trial protocol remains unchanged, with the primary endpoints being the changing Madras score at day 28, and key secondary end points include the change in Madras score at day 7, and the change in global impression severity score at day 28, which is CGS versus CGIS.
The C. G S. S T G I F.
Sergio Traversa: Both Reliance 1 and Reliance 2 are progressing with top-line data expected in the second half of. The Reliance Development Program also includes Reliance OLS, a long-term open label study that is a role for both rollover participants from all three Piedon studies, as well as the Novo Reliance OLS is ongoing and enrolling participants as. Data from this long-term open-label study will be part of the N As we look ahead to the key reliance clinical development problem, Data, the catalyst I outlined earlier.
Reliance won and what else too are progressing with topline data expected in the second half of next year.
<unk> development program also includes the reliance O L. S. A long term open label safety study.
If he is enrolling both rollover participants from all three people those studies as well as de Novo petition.
Reliance OLS is ongoing and enrolling participants takes place.
Data from the long term open label safety study would be part of the NDA filing package.
Yeah.
As we look ahead to the T rely on its clinical development program.
The catalyst I outlined.
It is important to note that we are highly confident that we have more than sufficient powered those studies to demonstrate the desired effect and target. The decrease in my address court, who they'll improve.
Sergio Traversa: It is important to know that we are highly confident that we have more than sufficient power; our studies to demonstrate the desired effect and targeted degrees in Madras core improved significantly, while REL 1017 demonstrated eight points of improved score to placebo in the phase two trial. Moving on, our second PAP study, evaluating Belt as 10-17 versus intravenous ketamine, which has an established history as an effective positive control, is ongoing. Based on the current rate of recruitment, we will extract top-line results from this study in the first quarter of 2020.
Cool.
Oh significant wild well 10, 17 demonstrate an eight point.
Bruno scores to placebo in the phase two trial.
Moving on.
Second Pap study evaluating relative pen 17 versus intravenous ketamine, which has an established history isn't affected positive control is ongoing.
Based on the current rates of recruitment we expect top line results from this study in the first quarter of 'twenty.
Okay.
As a reminder, in the third quarter, we announced positive topline results from our first Hap study evaluating well pen 17 aversion Oxycodone 40 milligrams is an active control.
Sergio Traversa: As a reminder, in the third quarter, we announced positive top-line results from our first AP study, evaluating well 10-17 versus oxycodone 40 milligrams as an active process. As we discussed this data blank on our last two investor calls, I won't go into too much detail here. I will reiterate that this study was designed in a manner that followed the FPA 2017 guidelines on the assessment of the reduced potential of drugs. Topline results?
As we've discussed these data link on our last two investor calls I won't go into too much detail here.
However.
I will reiterate that this study was designed in a manner that.
All of the SBA 2017 guidance on the assessment they'll get huge potential.
Topline results.
Sergio Traversa: For primary importance, the results show that all three doses of REL-1017, evaluated in recreational opium users, demonstrated a highly statistically significant difference versus the active control drug oxycodone 4-minute. Notably, a highly statistically significant difference was confirmed between the active control and 150 milligrams of REL-107, which is the maximum tolerated dose and six times the proposed therapeutic. Other secondary end points, such as desire to take the drug again, were consistent with those of the primal end point and demonstrated no evidence of any meaningful abuse potential.
The primary endpoint showed that all three doses of wealth in southern teams evaluated and recreational opioid users demonstrated a highly statistically significant differences versus yes, the control drug Oxycodone 40 milligrams.
Notably the highly statistically significant difference was confirmed between the active control and 150 milligrams already 10, 17, which is the maximum tolerated dose and six times the proposed therapeutic dose.
The secondary endpoints such as design have taken the drug again were consistent with those of the primary one point demonstrated no evidence of any meaningful abuse, but importantly.
Sergio Traversa: Importantly, these results are consistent with HAP study results that have been seen in other drugs that affect the CNAs and which have been scheduled at classes 4, 5, or even unscheduled. I also wanted to take a moment to reaffirm the need for a new therapeutic option with the potential clinical profile that Rang 1017 presents. Over 17 million individuals in the US suffer from NPD, and the current options are limited in their ability to help. Current antidepressant standards have significant side effects and can take up to four, six weeks to show. 65% of patients do not respond to their first antidepressant treatment, and 30% do not respond to any of the current available coral.
Importantly, these results are consistent with Hap study results that have been seen in other drugs with the effect of the CNS and which have been schedule of classes four five or even unscheduled.
I also wanted to take a moment to reaffirm the need for a new therapy.
With the option with the potential clinical profile.
Then ramped down 17%.
Over 17 million individuals in the U S suffer from MPD and.
And the current options are limited in their ability to help these patients.
Current antidepressants standard.
Have significant side effects and can take up to four six weeks to show efficacy.
65% of patients do not respond to the first time through the person treatment.
And 30% do not respond to any of the currently available oral treatment. Furthermore.
Sergio Traversa: Furthermore, there are only three FDA-approved adjunct treatments for major depression disorder, all of which are antipsychotics, which can often cause long-term serious side effects. It is evident that new treatment options are needed, and we believe the REL 1017 has the potential to make a difference for these patients and their care giver as a monotherapy or junkie. I will now pass the call over to maggot for his view of finances, and we'll then touch on the recent poster presentation at the recently held Neuroscience Education Institute.
There are only three FDA approved adjunctive treatment for major depression disorder, all of weights of antipsychotic, which often can cause long term senior side of things.
It is evident that new treatment options are needed and we believe the route 10 17 has the potential to make a difference for these patients and their caregivers.
Monotherapy or junk.
I will now pass the call over to Magnus. Please review of financials I will then.
Touch on the recent poster presentation at the recently held Neuroscience Education Institute Congress.
Maged S. Shenouda: Sure. Thank you, Sergio, and good afternoon.
Go ahead Mike.
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 nine months ended September 32021, which I will now review.
Maged S. Shenouda: Everyone. Today we issued a press release announcing our business and financial results for the three months and nine months ended September 30, 2021, which I will now review. For the third quarter ended September 30, 2021, total research and development expense was approximately $34 million, as compared to $11.2 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 REL-1017.
For the third quarter ended September 32021, total research and development expense was approximately $34 million as compared to $11 $2 million for the comparable period of 2020.
Increase was primarily related to an increase in costs associated with the execution of our broader clinical program for <unk> 10 and 17.
Total general and administrative expense for the third quarter ended September 32021 was approximately $8 $7 million as compared to $5 $9 million for the comparable period of 2020 increase.
Maged S. Shenouda: Total general and administrative expense for the third quarter ended September 30, 2021, was approximately $8.7 million as compared to $5.9 million for the comparable period of 2020. The increase was primarily due to an increase in personnel
The increase was primarily due to an increase in personnel cost stock based compensation and consulting services for.
For the third quarter ended September 32021, we recorded a net loss of approximately $42 $6 million with $2.44 per basic and diluted shares.
And diluted share compared to a net loss of $16 $9 million or $1.05 per basic and diluted share in the comparable period of 2020.
Maged S. Shenouda: increase in personnel costs, stock-based compensation, and consulting services.
Maged S. Shenouda: For the third quarter ended September 30, 2021, we recorded a net loss of approximately $42.6 million, or $2.44 per basic and diluted share compared to a net loss of $16.9 million, or $1.5 per basic and diluted share in the comparable period of 2020. Turning to the results for the nine months ended September 30th, 2021.
Turning to the results for the nine months ended September 32021, total research and development expense was approximately $65 $3 million.
Compared to $21 $1 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 all 10 and 17 for the nine months ended September 32021 general and administrative expense was approximately $26 two.
Yeah.
As compared to $18 $8 million for the comparable period of 2020.
Maged S. Shenouda: Total research and development expense was approximately $65.3 million as compared to $21.1 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 REL-1017. For the nine months ended September 30, 2021, general and administrative expense was approximately $26.2 million as compared to $18.8 million for the comparable period of 2020. The increase was primarily due to an increase in personnel costs, stock-based compensation, and consulting services.
Increase was primarily due to increase in personnel cost stock based compensation and consulting services.
For the nine months ended September 32021, we recorded a net loss of approximately $91 $4 million or $5.36 per basic and diluted share compared to a net loss of $38 $7 million or $2.52 per basic and diluted share in the comparable period of time.
'twenty.
On September 30th 2021, the company had cash and cash equivalents and short term investments of $88 $1 million, which compares to 117 to $117 $1 million on December 31, 2020, I'll now hand, the call back over to Sergio for further remarks on our most recent progress.
Sergio.
Thank you Maggie.
Earlier this month I mean last week, we presented a total of eight poster at the <unk>.
Maged S. Shenouda: For the nine months ended September 30, 2021, we recorded a net loss of approximately $91.4 million, or $5.36 per basic and diluted chair, compared to a net loss of $38.7 million, or $2.52 per basic and diluted chair, in the comparable period of 2020. On September 30th, 2021, the company had cash and cash equivalents and short-term investments of $88.1 million, which compares to $117.1 million on December 31st, 2020.
N E I Congress.
Florida, and three posters with new data pets, resulting from post hoc analyses from our phase two trial.
First the post hoc analysis of the symptom of depression question that the S. The queue.
Cologuard and subscale scores from patients Keith could it be 10 70 showed improvement in sub scales of cognition.
Motivation and society, irritability and sleep function.
Signaling that benefit from 10 to seven.
They extend well beyond just mood improvement these data suggest that rather than 17, Manhattan potentially meaningful implication for patients working and social.
Sergio Traversa: I'll now hand the call back over to Sergio for further remarks on our most recent progress. Thank you, Magid. Earlier this month, meaning last week, we presented a total of eight posters at the NEI Congress, including three posters with new data sets resulting from post-off analysis from our phase to try. First, the post-talk analysis of the symptom of depression questionnaire, the SDQ, total and subscale scores from patients clicked with REL TENS-17 showed improvement in subscales of cognition, motivation, anxiety, irritability, and sleep function, signaling that benefits from REL1017 may extend well beyond just moving. Data suggests that REL1017 might have potentially meaningful implications for patients' working and social abilities.
Sure.
The second poster included a post talk analysis of a subset of mtc patients expediencies dysfunction symptoms prior to treatment right.
It showed a clinically meaningful improvement in the clinical administered the social piece, they scaled schools, which is used to measure the social people sleep after relative the 17th treatment.
It suggests that rose 10, 17 may not only be exempt from generating these social symptoms.
Other N M D E and the Tigers did.
May actually be beneficial in patients affected by such dumps.
Finally.
While some of the current standard of care anti depressant, that's shown an increase in lipid metabolism.
It's with patients.
Patients will then be the at risk at all.
Talking about even showed that 10 17 did not significantly as a leader.
Essentially are lacking in cardiovascular risk.
In summary, rather than 17 development program remains on track and we expect key data casualties in each quarter next year.
Sergio Traversa: A second poster included a post-talk analysis of a subset of MDD patients who experienced dissociative symptoms prior to treatment practice and showed the clinically meaningful improvement in the clinically administered dissociative state scale scores, which is used to measure dissociative state after relative 17-3. This suggests that REL-1017 may not only be exempt from generating dissociative symptoms such as other NMNDA antagonists, but it may actually be beneficial in patients affected by such patients. Finally, while some of the current standard of care antidepressants have shown an increasing lipid metabolism abnormalities in patients with MDD at risk, A post-talk analysis showed that REL-1017 did not significantly outperform the libid, potentially lacking in
To reiterate we expect topline results from the tack on half study. This one obsessed and welcomed 17 versus intravenous CASM in the first quarter, followed by topline data from the reliance three monotherapy trial in.
In the second quarter.
In the third and fourth quarters of training 22, we expect top line results from the reliance one ambulance to adjunctive trial perspective.
Importantly, as Mike noted our robust R&D initiative are supported by a strong balance sheet.
In closing.
I remain grateful to the Red mud team for their continued hard work and dedication to executing on our mission.
Also like to extend my sincere thanks to the participants and clinical partners involved in the resident in 17 clinical trials for their effort in advancing these imports on therapy through the clinic as expeditiously as possible.
Sergio Traversa: In summary, the RELTEN-17 development program remains on track, and we expect key data catalysts in each quorum next. To reiterate, we expect top-line results from the second half study, this one assessing Brept 17 versus intravenous catamine in the first quarter, followed by top-line data from the Reliance III monotherapy trial in the second quarter. In the third and fourth quarters of 2022, we expect top-line results from Importantly, as Maga noted, our robust R&B initiative is supported by a strong bond.
I believe we will now open up the call for questions and the.
Operator.
Can you please open up.
Yes.
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 queue. You May press star two if he would like to remove your question from the queue.
For participants using speaker equipment and may be necessary to pick up your handset before pressing the star keys.
One moment, please where we pull for questions.
Our first question is from Andrew Tsai with Jefferies. Please proceed.
Okay, great. Thanks, guys for taking my questions.
I noticed that there are any like Congress I noticed you also share some additional secondary.
Sergio Traversa: In closing, I remain grateful to the Remodal team for their continued hard work and dedication to executing on our mission. I would also like to extend my sincere thanks to the participants and clinical partners involved in the REL-1017 clinical trials for their effort in bringing this important therapy to the clinic as expeditiously as possible.
Endpoints for the Oxycodone abuse liability study I couldn't help but notice while the means increase the little for us not that don't own a secondary.
End points the scores like the median stayed at 50. So I thought that was interesting I was wondering if you can kind of talk about that but at the same time I. Just felt like you know there you know I guess, it's part of my second question is like did you ever find out who what the outliers where hum.
Sergio Traversa: I believe we will now open up the call for questions and the operator. I think we should please open up. Yes.
Operator: If you would like to ask a question, please press star 1 on your telephone keypad, and a confirmation tone will indicate your lines in the. You may press star 2 if you would like to remove your question from. For participants using speaker equipment, it may be necessary to pick up your headset before pressing the start button. One moment, please; will we pull for questions? Our first question is from Andrew Sy with Jeffries. Okay, great. Thanks guys for taking my questions. I noticed at the NEI Congress, you also shared some additional secondary endpoints for the oxycodone abuse liability study.
Scored high what exactly high on in terms of the Vas score and I guess what were they exactly feeling to make them score higher and then can you confirm that they were definitely not feeling euphoric mood or anything like that but maybe it's it's it's because of CNS effects. Thanks.
Well, thank you Andrea for the for the question.
Look on the data that you've presented that the.
Last week, the old data centers out for publication at some point it would be probably showed the all the details would be we'd be there oh.
Andrea R. Tan: I couldn't help but notice while the means increased a little for S methadone on the secondary endpoints, the scores, but the median stayed at 50. So I thought that was interesting. I was wondering if you kind of talked about that. But at the same time, I just felt like, you know, I guess it's part of my second question is like, did you ever find out who the outliers were, who scored high, what exactly high in terms of the vast?
I'll just summarize that the yeah. There is really marginal difference between primary and secondary endpoint that they are.
We can say database ecosystem and they confirmed that.
There is slight different from placebo that is totally expected from any CNS drugs that affect the mood, especially about the massive dose of six times within our beauty.
But not not none of these data are inconsistent with the with the primary importance. It is just a confirmation.
Andrea R. Tan: score, and I guess what were they exactly feeling to make them score higher, and then can you confirm that they were definitely not feeling an euphoric mood or anything like that, but maybe it's it's because of CNSFX. Thanks
On your second question on the.
The straight answer.
But no we did not reach out to us we cannot reach out to the subject after they.
They completed the study you don't really know who they are it's all sort of in the hands.
Sergio Traversa: Well, thank you, Andrea, for the question. Look, the data that we presented at the NEI last week; the old data set is out for publication at some point when we publish, so all the details would be there. I would just summarize that there is a very marginal difference between the primary and the secondary endpoint.
Hands of it of the site itself for it respect the privacy.
There are some question that's been asked in the body. This question our unlimited questions like that in the study.
And D. We did look at the outlier, though without knowing who they are or why they they were outliers, but what we have nowadays is that D.
Sergio Traversa: We can say they are very, very consistent, and they confirm that, you know, there is a slight difference from placebo that is totally expected from any CMS drug that affects the mood, especially at the massive dose of six times the therapeutic dose. But none of these data are inconsistent with primary importance. It's just a confirmation. On your second question, the straight answer is they, well, no, we did not reach out, and we cannot reach out to the subject after they, you know, they complete the study. We don't really know who they are, it's all, following the hands of the site, it's all, with respect to privacy.
The the vast majority of every other really single digit.
A number of outlier so it was not.
Oh can I say it was not.
An extensive right like Cavite scores across the.
Different set of subject there was all this.
I remember the exact number but it wasn't a single digit number of probation that for whatever reason they score a hot.
Do you see that as a positive.
No because although we cannot confirm we don't you know we don't that this study was not designed.
To detect up to show any antidepressant effect, but you know with over 90% of the subject.
So you're not feeling any likeability in only a single digit number of subjects.
Liking the drug significantly weakened weekend, we suspect that there was something in these patients that need them and do subject they've made them last week in particular.
Sergio Traversa: There is some question that has been asked in the various questionnaires, an unlimited questionnaire in the study, and we did look at the outliers without knowing who they are or why they were outliers, but what we have noticed is that the vast majority may there are really a single digit number of outliers. So I was not, How can I say, was not, and extensive, right, likability scores across, you know, different sets of subjects.
Because basically they could have been that they witnessed depressed basketball with Ed withdrawal symptoms from.
As I have seen me and 60.
Psychological we'd always kingdom and taking a massive those rapid acting antidepressant. They may have felt some benefit.
Sergio Traversa: There was only, I don't remember the exact number, but it was a single-digit number of patients that, for whatever reason, scored high, and we see that as a positive signal because, although we cannot confirm it, we don't, you know that the study was not designed to detect or to show any antidepressant effect. But, you know, with over 90% of the subjects totally not feeling any likability and only a single digit number of subjects liking the drug significantly, we can, you know, we suspect that there was something in this patient that made them like this drug in particular.
I hope I answered your question.
Yes.
One of those things.
Right Yeah. It is yeah.
Look the phase III honest at all all of these questions.
We look forward to the Katherine data.
Right and I'm speaking of the Phase III studies I did have one hypothetical question is that the first phase III monotherapy depression data in Q2, so hypothetically if it happened to show next data on efficacy, let's just say it doesn't hit day 28, or maybe it doesn't show rapid effect.
Next I guess the question would be then why should that not be a negative rate read through to your phase III agile studies.
Sergio Traversa: That, you can speculate that it could have been that they were depressed, or they had withdrawal symptoms from diet and diet and psychopsychiatric with our symptoms and took a massive dose of a rapid-acting antidepressant and may have felt some benefit. So I hope I answered your question. Yes, very much more than. Right, it is.
Well first we hope that the data will come from what we've seen in phase two.
The only way that that could happen.
The drug is pace through the data readout right.
So there's no doubt that there is a very very strong efficacy signal. So that's this is not a confirmed a repeat that in monotherapy, the only or potentially one reason could be.
Sergio Traversa: Right, thank you. Look, phase three will answer all these questions extensively, and we look forward to the catamine data.
Sergio Traversa: And speaking of the phase three studies, I did have one hypothetical question about the first phase three monotherapy depression data in Q2. So hypothetically, if it happened to show mixed data on efficacy, let's just say it doesn't hit day 28, or maybe it doesn't show rapid effects. I guess the question would be then, you know, why should that not be a negative read-through to your phase three adjunctrine? Well, at first, we hope that the data will confirm what we have seen in phase two. The only way that that could happen, look, we know the drug in phase two, the data are real, right? So there is no doubt that it has very, very strong efficacy.
There'll be some form of synergy between it.
Current and existing treatment, even if they fail.
To show efficacy and adding an MBA, so I would not read that by chance it doesn't work well in monotherapy, but we can say that the as adjunctive treatment.
It would not work as well and there may be some reason that you do.
You asked me directly I, we don't believe that that's the case, but that.
The messages that I would not.
Correlate the monotherapy.
Directly to the adjunctive treatment because there was a difference junkie.
Sergio Traversa: So if that signal is not confirmed or repeated in monotherapy, the only or potentially one reason could be that there is some form of synergy between a current and existing treatment, even if it fails to show efficacy and adds to an MNDA. So I would not read that if, by chance, it doesn't work well as monotherapy, we can say that, you know, the treatment as a junkie would not work as well.
It does seem to have taken two drugs.
That's just one as a monotherapy.
Yeah to be honest I do believe that the.
But it sounds like to be the case.
Right. Thank you very last question very quickly is just for the monotherapy study can you remind us the primary endpoint day 28, I guess, what kind of minimum separation versus placebo on mad dress.
Which would be the minimum that you would like to see and are these assumptions then similar to the phase III at an M. D. D. Studies. So can you just remind us one more time.
Sergio Traversa: There may be some reason. If you ask me directly, we don't believe that's the case, but the message is that I would not correlate the monotherapy directly to the junkie treatment because there is a difference in a junkie that's taking two drugs versus one monoteria. But, you know, to be honest, I do believe that that's not going to be the case.
Here's one I can't give you a more straight answer.
The the statistical plan is the same exactly the same for all the three phase III, the two giant staying with the monotherapy and the eight these designs.
Sergio Traversa: Very last question very quickly is just for the monotherapy study. Can you remind us the primary endpoint, day 28, I guess, what kind of minimum separation versus placebo on Madras would be the minimum that you would like to see? And are these assumptions then similar to the phase three adjunct MDD studies? So can you just remind us one more time. Thank you.
The attack.
That was.
Two points and the mazo score versus placebo. So if we hit two points.
It says that this study will be statistically significant that's the way. This statistic has been designed.
Oh, all the tree all between studies now.
That would be the reason those two points because the rule of thumb.
Not like the F. B a guidance of course bad times is that looking at all the approved products.
Sergio Traversa: Yes, this one I can give you a more straight answer. The statistical plan is the same, exactly the same, for all the three, phase three, the two genital monotherapies. And it is designed to detect a delta of two points in the Maza score versus placebo. So if we hit two points, Elsa, the study will be statistically significant. That's the way the statistical plan has been designed for all the three studies.
Two points.
Mono therapy or even a junkie.
Is that is clinically meaningful delta.
You know potentially could get to an approval there are a lot of other factors in the accrual but in term of like efficacy I believe buzz professionals problem or problems that two point desktop it's clinically meaningful therefore, it should be right you shouldn't deserve.
Everything staying the same you shouldn't show an approval for treatment resistant.
Sergio Traversa: Now, the reason for the two points, because the rule of thumb is not like the FDA guidance, of course, but the rule of thumb is that looking at all the approved products, two points as a monotherapy or even adjunctive is a clinically meaningful delta that, you know, potentially could get to an approval. There are a lot of other factors in approval, but in terms of like efficacy, I believe it was Professor Fava that published that two points delta. It's clinically meaningful, therefore it should be, right? You should deserve everything staying the same. It should deserve approval.
Depression that is not something that we are you know.
We are doing over there looking at a one and a half point becomes you know the corresponding number for potentially getting an approval.
It's a conservative 232, we had eight point there.
We left a lot of a lot of room and we wanted to be concerned about because we know that.
Safety, there was moldavia ability more patients more sites.
Uh huh.
So we left some room for some something doesn't go the way you like but if we show one fourth of the efficacy.
We have seen in phase II.
Sergio Traversa: For treatment-resistant therapy or depression, that is not something that we are doing or we are looking at. One and a half points becomes, you know, the correspondent number for potentially getting approval. Consider that in phase two, we had eight points delta. So we left a lot of room and we wanted to be conservative. We know that, you know, phase three, there is more viability, more patients, more sight, so we left some room for something that doesn't go the way we like it, but if we showed one-fourth of the efficacy that we have seen in phase two, it would still be statistically significant. Perfect. Thank you, Sergeant. Thank you, Andy.
It still would still be the PCP this thinking.
Okay perfect. Thank you Sergio.
Thank you Andrew.
Our next question is from Tim So so nature with Guggenheim Partners. Please proceed.
Hey, guys. Thank you for taking my question manga and good to hear your voice just a couple for me.
With regard to the Radiance C, which has now been upgraded to phase three can you just help us understand like what exactly was the conversation with the FDA and then in terms of that led to it being phase three.
When you were thinking about a phase two and then how is your filing strategy I'm going to be are you going to complete all three studies and then five just trying to get a sense of you know the type of label you are hoping to get.
Yatin Suneja: Our next question is from Jatin Suneha with Duggenheim Partners. Hey guys, thank you for taking my questions. Magad, good to hear you, hear your voice. Just a couple for me.
So that's you know a couple of questions on the reliance and then one question on the Academy study that you're doing can you just help us understand what you are doing differently. In this study to make sure you do get a separation between ketamine in the placebo arm, which did not happen in the first study.
Yatin Suneja: With regard to Radiance 3, which has now been upgraded to Phase 3, can you just help us understand what exactly the conversation with the FDA was about? And then in terms of that led to it being Phase 3, because earlier you were thinking about a phase, And then what is your filing strategy going to be? Are you going to complete all three studies and then file, just trying to get a sense of, you know, the type of label you are hoping to get? questions on the reliance.
Okay.
Okay.
Well, Thank you guys and first of all the questions and the oldest radio side. So the first question was what does change.
Yeah, Yeah. The monotherapy study has become.
Sergio Traversa: And then one question on the catamine study that you're doing; can you just help us understand what you are doing different in this study to make sure you do get a, Okay. Well, thank you, Yatim, first for the questions, and it was very insightful. So the first question was, what has changed? We are, you know, the monotherapy study has become a filing or a pivotal study. Well, we did not actually have a conversation with TXTI in the sense that, you know, we sent the proposal of, you know, making it phase three, and we waited the traditional 30 plus 30 or the 60 days, that usually signal that the FDA does not have anything in a post for moving ahead with the program, and that's what we did.
Finding people tell you what that study well the we did not actually have a conversation with the P. S. T E in the sense that yes.
Yes.
<unk>.
We send a proposal.
Makes it to phase III.
And we waited the traditional 30, plus 30 to 60 days that usually sticking them that the FDA does not have anything in.
Opposed.
Sure you know when we head to the program and that's what we'd be so we waited until.
And all of a sudden now and then we didn't hear anything again from the FCA. So we make it to phase III.
Not a lot of different the product was exactly the same so the thought that there was no change or.
Sergio Traversa: So we waited until, you know, the end of August and beginning of September. And then we didn't hear anything against us from the FBA, so we made it phase three. Because we are not a lot different. The protocol is exactly the same.
In the in the problem. The question is that what has changed that makes us think to do a phase three instead of a phase III two things one.
Was the feedback from the SBA on the two year Carcinogenicity studies and the PQ T that showed that the FDA is somewhat comfortable with.
Sergio Traversa: There was no change in the problem. The question is, what has changed that makes things to do a phase three instead of a phase two? Two things. One was the feedback from the FTA on the two-year carcinogenesis study and the TQT that showed that the FAA is somewhat comfortable with the safety and tolerability of the drug. And then the abuse, the HAP study in July, that we do believe could have been an issue with the FDA to expand a trial to like 350 patients, all outpatient. So we put together all these data and, you know, we took some risk that Stacey, we are now relatively comfortable or comfortable, but there is no single data that shows that the drug has any efficacy in monotherapy, although we do believe that it's not very different from a junkie.
No, we the safety and Tolerability.
Of the drug and then not be the abuse. The Hap study in July.
I do believe could have been an issue with the S. P. A to expand it trial to like Oh.
350 patients.
All outpacing shall we put together all of these things done.
We took some risk that the FDA could have said well you don't have a efficacy data as a monotherapy safety, who you know well excuse me comfortable or comfortable but there was no single data that shows that the drug has any efficacy in monotherapy, although we do believe that.
That is not very different from Johnson and so that was the reason that we initially we thought about when the phase two and then it basically then we saw the SBA relatively comfortable we had the abused they used to do is perceived as the us very positive feedback.
Sergio Traversa: And so that was the reason that we initially thought about in phase two and then in phase three. Then we saw the FDA relatively comfortable. We had the abuse data; they were perceived as very positive and took some little risk, but it worked. And so that's why we move to, you know, we make it become a fail three and file. The second question was, it was on ketamine, like the differences.
Took somebody who is at work.
And so that's why we moved to.
We make it to be coming in.
Hey, if phase III study.
The second question was.
It was on the Academy the differential between the press study in this study to make sure that this time the academy in the placebo arm separately.
Sergio Traversa: study and this study to make sure that this time the academy Hell yeah, no.
Sergio Traversa: Oh, yeah, no, that's easy. The first failed, unsuccessful ketamine study was the reason was that oral ketamine had a very poor bioavailability and did not work as a control. We had almost half of the patients. They were taking oral catamine, and they thought they were taking placebos in the qualification part of the study. So that didn't work. And now we are using intravenous catamine that we kind of look at what Johnson and Johnson has done with Eschatam in Provato. So I believe it's 50 milligrams, the infusion over 40 minutes, this kind of standard.
Oh, yeah, no that's easier than the first.
Oh, that's successful Ketamine study was the reason was that oral ketamine couldn't get them in the biotherapeutics is very important and did not work physical until like we had to almost half of the patients. They were taking all the cat M and you thought about taking placebo in the qualification parts of the southern so they would not do the work.
Now we are using an intravenous ketamine, we we kind of.
Look at what the Johnson <unk> Johnson has gone with the extra had somebody we just pro rata.
My name is 50 milligrams a day.
Fusion over 40 minutes, and it's kind of a standard.
Sergio Traversa: And that definitely works as a... is a control. There is no doubt that the control will work, and the study has been progressed in 19. Looking forward to this. Got it, got it. Yeah, on the regulatory front, correct? Look, we're fast-tracked, so we are planning to do a scrolling NDA, usually rolling in the area where you file the kind of standard, the CNC, probably we will file the old preclinical package. We haven't really decided on the final study for phase three, but I do believe that, you know, the if they are not too far apart one from the other, it's probably worth a five model for phase three and the ethic as we started together, and clearly there is like a month in one and the other, then maybe we will file whatever we have available, and not wait for me. Reliance 2 and 3.
And that's definitely works as it is.
As a control.
Okay.
If.
There's no doubt that the controlled with work.
And the study has been progressing nicely.
And maybe looking forward to this and Q1 got it got it yeah the regulatory correct.
Look we there fast track so we are planning to do.
All of them.
N D a.
Usually rolling NDA, you'll file.
The kind of standard at CMC.
Probably we will file.
The clinical package.
We haven't really decided yet.
The final study is of course, the phase III, but I do believe that that you know the.
If they're not too far away from DIY was probably worth two five module pardon me the face to India, because he started together.
Clearly the news last month, one and the other than maybe we will file.
We have available.
Yeah.
And not to wait for it.
Whereas two and three but it'll be two of them, but the plan is to do a rolling NDA somebody won't be FDA cleared enough time to review.
Sergio Traversa: But it's a bit too early. But, you know, the plan is to do a rolling A, so we want to be a P.A. to have enough time to review the more standard things like CMC and preclinical. So if there is anything that they would like us to do more, we will have time. We won't delay.
More of a standard with CMC and preclinical so.
I mean is there anything that they would like us to do more we will have time, we won't we won't be late.
And finally Scott.
Got it maybe one question for Maggie can you maybe help us a with the P&L until steep rising R&D just trying to get a sense how much was noncash debt and then how should we model sure second half of this year and then like this.
Yatin Suneja: Got it. Maybe one question for Magid. Can you maybe help us with the P&A? I mean, so steep rising, R.N.
Maged S. Shenouda: Non-cash did. Sure. Yep, yep. So thanks for the question, Yotsin. With regard to the non-cash components of R&D for the quarter, that was $11.8 million for the R&D line and 6.4 million for the SG&A line. And, you know, with regard to just the remainder of the year, I would say, you know, I'm pointing to our 10Q, which we expect to file tomorrow morning. And certainly, you know, we're not giving guidance, but, you know, the question relates to expenses going forward and sort of our ability to meet that. We believe we have sufficient funding to continue with ongoing operations for at least 12 months. Thank you.
You know just for Q1 of next year. Thank you.
Yep Yep. So thanks for the question you're asking.
With regard to noncash components of R&D for the quarter that was.
$11 $8 million for the R&D line and $6 4 million for the SG&A line and with regard to just the remainder of the year I would say.
Im pointing to do our 10-Q, which we expect to file tomorrow morning and <unk>.
Certainly you know, we're not giving guidance but.
The question relates to expenses going forward and sort of our ability to meet that you.
You know we believe we have sufficient funding to continue with ongoing operations for at least 12 months.
Alright, thank you so much.
Yatin Suneja: Got it. Thank you so much. Sure.
Sure.
Our next question comes from Joon Lee with true Securities. Please proceed.
Operator: Our next question comes from June Lee with true securities. Hi, thanks for the updates and for taking our questions. You know, I would not have thought to ask this question except the fact that it's come up for another company that just reported data from the TRD study. And, you know, given your phase two also included TRD patients, you know, that I asked, did you see any suicidal ideation in your trial as an SAE? And I have a follow-up. Thank you, June.
Hi, Thanks for the update and for taking our questions. Yeah, I wouldn't have thought to ask this question.
The fact that it's come back for another company that just reported data for Trs <unk> study.
And you know given your phase two also included T. R. D patients you know I thought I asked did.
Did you see any suicidal ideation in your trial.
Nancy and I have a follow on.
Yeah, Thank you Julie and deal with it.
June Lee: I knew that this question could have or would have come up. Of course, we look at the data, and that was released two days ago. We only know what was in the press room, nothing more than that. And so the three answers are that, no, we have not seen any suicidal action in any of our studies. We do believe that the MNDA antagonist actually is supposed to reduce this suicidality ideation. If you look at there is another competitor that is working on a nasal form of ketamine, and they are running the trial as a suicidality ideation reduction. So, the M&D antagonists, they are specifically...
They expressed a cook, who they are or would that would've come up a little bit.
Of course, we look at the data.
And that has been released two days ago, we only know what there wasn't depression is nothing more than that.
And I told the street is that no we have not seen Amy suicidal ideation.
In any of our study.
Oh, we do believe that denim NDA antagonist.
Actually yeah supposedly reduced as we decided on aviation is not if you looked at there is another four hour competitor that he's working on that on the when they need some form of ketamine and they're running the trial as it sweeps about let's see aviation reduction so adamant that they are specifically.
The idea is supposedly be specific syndicated so it reduces the risk for suicide.
Sergio Traversa: They are supposed to be specifically indicated for reducing the risk. Now, the program that showed a side effect, an increase in suicidality. Look, it's, you know, when you, It is a 5H2A irony, right?
Now the the program that showed is a side effect.
An increase in Suicidality okay.
Good.
It is a five H three items right.
Sergio Traversa: And if you remember, and I do, because I spent six years on the development and launch of the process by fluoxetine, that is a re-fake of serotonin. And the issue, one of the, it is a black box of serotonin, iron, it's treated out. So it's a totally different mechanism, and I do go with Yes, look, it's all speculative, right? I really don't know.
If you remember and they do because it was like sprint six here on the development and launch a process like the philosophy that we have taken so its own and be the issue one of the if there was a black box of serotonin in Ireland since she was it out of it.
It's a it's a totally different.
Mechanism of action.
Great.
Sure.
Yeah look it's still speculative.
I really don't know its five age to a versus b or pay so it's all it's all spectrum.
Sergio Traversa: It's 5H2A versus VAPA, so it's all speculative. But, you know, if there is an explanation, this could be one. With that said, we looked into it, spoke with a few, Special. When you take such a high dose of silo typing, And this is not drug abuse, right? These are patients with depression, so they don't want to have, you know, the, I don't know what I'll call it, like the psychotomyatic, the trip, right? It's not something that they enjoy.
If there was an explanation this could be it could be one way.
That said, we look at that we spoke with a few right specialist.
It would take such a high dose of Siloed tabby.
And these are not drug abuse right. These are patients with depression. So they don't want to have.
The to Cogs.
Besides that something that takes a trip, but it's not something that they enjoy if you are heavily depressed.
Sergio Traversa: If you are heavily depressed and you have treatment-resistant depression, you take a massive dose of psilocybin, you know, for more than a few minutes, and you are totally confused. That's why, you know, it's an in-clinic treatment. So if you are depressed and you're at the start of Confucian, you may, you know, mention solicitality, but, you know, I will not be too much.
Yep treatment resistant depression taken massive those upside the siding.
You know that.
Florida.
More than a few minutes you have totally confused.
Right now it's an in clinic treatment.
So.
You could have depressed and you've got to you all.
Even start the confusion.
You May you mentioned suicidality, but they're not.
I would not read too much into them.
Okay got it momentarily.
Sergio Traversa: It is momentarily, and I believe it was just on eShol, right after during the acute phase. It is way too early because, But your phase two was also inpatient monitored for two weeks, but you saw suicidality instead of being an inpatient. Yeah, no, we have seen nothing, no. Okay. No issues. We don't expect.
I believe it was just on Vishal write offs during the acute phase.
So it's way too early to speculate.
But your phase two was also in patients monitored for two weeks, but you saw those who sat down despite it being named patient study.
You know we have seen that oh, okay. Okay.
Incidentally.
We don't have the same job.
And then just a follow up question is you know I was really intrigued by the poster showing symptoms could be using the S. E. T. S. DQ scale, which was not stat Sig I believe at least seven which was the last day of dosing, but became stopped six seven days later.
June Lee: And then the follow-up question is, you know, I was really intrigued by the poster showing symptom improvement using the STQ scale, which was not STG, I believe, at day 7, which was the last day of dosing, but became stat 6, seven days later. You know, what is the significance of SDQ within physician circles versus academic circles? And how is it used?
What is the significance of the queue within consistent circles versus academic circles.
And how is it used.
Sergio Traversa: And why do you think it separated like seven days later? later, as opposed to the last day of dosing during the trial, during the dosing period. Yeah, I answered the first question first. Sorry, the second question first.
And why why do you think it separated like seven days later.
As opposed to the last day of dosing during the trial period during the dosing period.
Yeah as I answered the first question first.
The second question first.
Sergio Traversa: You know, the patient is slower to react in the cell phone minister, like questions, and then, you know, when he's asked questions from the clinician. And so the Madras and the CGI, they are a lot quicker to detect the signal. The patient needs a little bit more time, right? They had time to go home, and they realized when they went home without taking anything there that they were actually feeling better in terms of depression symptoms, and they reported that when they came in at day 14 at the control.
Patience is slower to react.
In the self administered questionnaire.
And then when you ask questions from the clinician.
So the my dress and the T G I.
A lot quicker to detect a signal the patient needs a little bit more time on that had time to go home and they realize when they went home and without taking anything that we're actually feeling better and I'm talking about the pressure seen sometimes they report that when they come in at the 14th at the control.
Sergio Traversa: So it's not, it's really useful that there is a slower response from BSTQ compared to Maldras and CGI just because it's patient reported spontaneously. So that's what we believe is the reason that day 14 was better than the day set. That the patient had to, needed some time to get used to not having depression symptoms before they were reporting that. And so it reminded me
It's not it's not that big.
The usual that there is a slower.
From B execute compare to my lesson and CGI, just because patients supported some furniture.
And.
That's a big plus.
What we believe is the reason that they 14 was better than the base because the patient had to.
Neither sometime to get used to not having the depression symptoms before they were reporting that.
And sorry remind me the first question.
Oh no you.
Sergio Traversa: How is it used by the physicians, the SDQ, or is it purely an academic metric? Well, what I believe was published and invented by an eminent academic. So, I don't know what, look, the FDA, most likely, they look at everything, right, based on all the previous anti-depression approved.
How is it used by dispositions the SDK or is it purely an academic metric to use.
Well it wasn't but he was published invented by an eminent academic so the I don't know what look the F D. A.
Most likely they look at everything right based on all the previews.
Antidepressant improve.
Uh huh.
Is it is it mean.
Sergio Traversa: It means something, but it's only a support for the madras. From our conversation with the FDA, I do believe Maga, correct me if I'm wrong, but I do believe that they consider the CGI and matters somewhat similar. Yes. So we try to split it into two different endpoints, and they get back to us. Well, you know, if you are okay with the Madras, of course, you would be okay with the CGI, right? So don't play. I mean, we're not playing, but the, the, the.
Something but.
It's only a support for demand drugs.
From a conversation we'd be the FCA I do believe magnet correct me, if I'm wrong, but I do believe that they.
They can see the CGI and Martha somewhat similar yes, so we tried to place it into different end points.
Things got back to Us and said well you know it you're done if.
If you are okay with it but of course, you would be okay with the CGI right. So don't don't don't play.
No place, but the.
Sergio Traversa: They are strictly correlated. SDQ is not strictly correlated, so it has some meaning, but you have to be, you have good results on the madras. All right, well, thank you so much. I hope I, thank you. Yeah, thank you.
He said you know the.
Strictly correlated epicure is not strictly correlated so it has some meeting about that.
You have to be good.
Good results from the my address.
Okay, well. Thank you so much I hope I yeah. Thank you yeah.
June Lee: Yeah, yeah, that's pretty good. And I'm looking forward to all the data every quarter next year.
Yeah, Yeah, it's pretty good and looking first at all the other data point.
Every quarter next year. Thank you.
Operator: Thank you. Thank you. Our next question is from Andrea Tan with Goldman Sachs. Please proceed.
Okay.
Our next question is from Andrew <unk> with Goldman Sachs. Please proceed.
Andrea R. Tan: Thanks for taking the questions. Sergio, the first one, just a follow up on your comments on the plans for the rolling NDA submission. Would positive results from Reliance 3 support approval for monotherapy use, or would you need to run a second trial to secure that indication? And I'll say,
Thanks for taking the question Serge Yeah. The first one.
Just a follow up on your comments on the plan to get a rolling NDA submission with positive results from alliance three support approval for monotherapy is or would you need to run a second child to secure that indication.
I'd say, it's a good question by the way to Cook with up to north of that.
Sergio Traversa: It's a good question, by the way, good afternoon. Then, And if, that's our opinion, so the FDA never commented on that. If all the three studies are positive, we do believe that one monotherapy study would be to get an indication on the left. If it would be the only positive study, then I don't think that it's going to work, right? So we will have to run at least another one again. That's our current thing.
<unk>.
Yeah.
Okay beef if that's.
Our opinion.
The FDA never comment commented the coffee.
He founded three studies are positive.
We do believe that that one monotherapy study would be.
Two to get an indication on the label.
If it would be the only positive study then I don't think that it's going to work.
So we will have to run at least another one at the moment.
So that's our current thinking.
Andrea R. Tan: And then just wondering if you could comment on what you're seeing with enrollment in the Reliance 1 and 2 trials that's delaying the timing of those readouts. And in particular, do you see this in any way reflecting commercial dynamics that could play out if all 1017 were approved? Yeah, you mean by the, it takes a little longer to
Okay, and then just wondering if you could comment on what you're seeing with enrollment and other lines, one and two trials that's delaying the timing of that would read out.
And in particular do you see this in any way, reflecting commercial dynamics that could play out if all 10 17 of our aircraft.
Yeah and domain.
It takes a little longer to complete the adjunctive a little Dizzy.
Sergio Traversa: Yeah, do you mean why it takes a little longer to complete the adjunctive? This most simple answer is the quality of the trial. We have a lot, a lot of, we pay a lot of attention to the quality of, you know, that we really want the patients to be depressed. And so, and that, you know, there is a pretty high selection of the patient, meaning, not selection that we don't know if the patient will respond or not, but definitely, we want to be sure that the patient is depressed, does not have a personality disorder, or does not have anything that, you know, would not be an appropriate patient for an antidepressant.
The simple answer is the quality of the of the trial.
Yeah, we have a lot a lot of.
We paid a lot of attention of the quality of deals.
We really want the patients to be surprised and so that's the there is a pretty high its selection of the of the patient selection that we.
We don't know at which patients respond or not but definitely we want to be sure that the patient sees the price that's not that personality disorder or does not have anything that.
Would not be an appropriate patient for an antidepressant.
And you know the failure rates from screening is about 50%. So why not put to patients is not enrolled because it does not qualify so we have very stringent inclusion.
Sergio Traversa: And the failure rate from screening is about 50%. So one out of two patients is not enrolled because they do not qualify. So we have very stringent inclusion and exclusion criteria, mostly focused on safety, of course, but also on being sure that we don't enroll everybody. Enrolling is very easy.
Inclusion and exclusion criteria, mostly focus on the safety of course, but focus also on being sure that you know we don't enroll everybody enrolling is very easy.
Sergio Traversa: If you want just to complete the study, you can do it very, very quickly, but that's not what you want to do. We want a study that would reflect the effect of the program or drug and that it takes a little bit more time. Monotherapy is supposed to be locked faster. We just talked in September, so we'll see what the ramp up is, but not the inclusion and exclusion criteria are the same as an adjective, but the patient selection is, there is more patients on it. Thanks, Sergio. Thank you, Brett. Our next question comes from Jay Olsen with Oppenheimer. Oh, hey, congrats on the progress and thanks for taking the questions. Maybe just to follow up on the
If you if you want just to conclude the study you can do it very very quickly, but that's not what he wants you to want to study that would reflect the effect of the of the program on drug.
And that it takes a little bit more more time.
Monotherapy is supposed to be a lot closer.
We just talked about in September itself, you can see.
See what the ramp up phase but are not.
They create inclusion and exclusion criteria.
Same as it is in a geography, but the patient collection, it's a there's more patients.
Got it thanks Danielle.
Thank you.
Our next question comes from Jay Olson with Oppenheimer. Please proceed.
Oh, Hey, congrats on the progress and thanks for taking the questions maybe just to follow up on the recent.
Jay Olsen: Recent competitors results in TRD.
Recent our competitors.
And T R D M D.
Do you see any read across from that Compass passwords study for psilocybin and TRT to your own.
Jay Olsen: Do you see any read across from that compass?
Jay Olsen: Compass Pathways Study for psilocybin and TRG to your own psilocybin
Jay Olsen: psilocybin program from Arbor Mentis, and can you maybe give us an update on the current status of that compound? Yeah, sure, sure. Thank you, Jay.
Suicide than program from Arbor, Memphis, and can you maybe.
Give us an update on the current status of that compound.
Yeah sure sure. Thank you Jason nice to hear from you.
Sergio Traversa: Nice to hear from you. No, the perspective, if there is any correlation, straight answer is not, the base of our program on the silozybing is totally different from pretty much every other competitor that works on psilocybin. We are not doing anything regarding psychiatry, and so no depression is neurodegenerative diseases, and we want to leverage our expertise on the neuroplastic effect at BDNF, and a 5H2A agonist at the end of the Cascades pretty much results in a similar neuroplastic effect, similar to an MNDA antagonist, so we want to leverage what we, Now I understand of that science in neurodegenerative diseases, and we use enormously lower dose compared to the.., competition and works in psychiatry.
They'll be prospectively, if there is any correlation straight answers now.
The did base all of our progress on the silos timing is totally different from our.
Pretty much every other competitor that works on psilocybin.
Not doing anything regarding psychiatry, and so now the pressrelease neuro degenerative diseases, and we want to leverage our expertise on the neuro plastic.
The BD and a half and five.
It's five Ht agonist as at the end of the Cascade pretty much results in a similar or even a plastic effect similar to an M. B a and so we want to leverage would be no I understand though the best science in neuro degenerative diseases, and we use it enormously lowered those compare.
To too.
The competition that works in psychiatry.
Sergio Traversa: And the basis of that is that we, our scientists, say we, but it's actually our science, do not believe that you need to get high or to get like a psychotomymatic, whatever effect to have a neuroplastic or neuroplastogenic effect. So we go for a much lower dose for a chronic treatment, and not in psychiatry, or neurodegenerative. There's no correlation between what the other companies are doing and what
And the base of that is that we our science is let's say, we but it is actually outside.
We do not believe that you need to.
Get higher to get like Psychotomimetic.
We're in effect to them.
Yeah.
In Europe last week, Oh, neuro plus the journey.
So we go for a much lower dose for chronic treatment.
And not in the psychiatry neuro degenerative disease.
There's no correlation between what the.
Companies are doing what we do the status we work in a matter of factory, maybe we could not do that.
Sergio Traversa: The status, we work in the manufacturing. Believe it or not, it is not the easiest compound to produce synthetically. And I don't know Maggie, shut me up if I can talk too much, but actually, we have designed and generated our own proprietary synthesis with the prison chemist, and so we are going through manufacturing right now, and you know dealing with the FDA, of course, the silo-siding about the problem we are working on is two sets of is in two parts, right? One is silo-shybing, the molecule.
It is not the easiest.
Compounded to produce synthetically and.
No no maggots shut me up if I talk too much but we actually we have.
We have a design and generated our own appropriate studies Institute.
With the freedom chemist.
So we are going through the amount of factoring a right now and dealing with the SBA of course.
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The pilots I think about the pro.
We are working on is to pencil.
He's in two parts one is siloed Heidi.
The the molecule that's one that we would like S. E T. A agrees, especially because we use very low dose compared to the other players and we would like to leverage all the safety data.
Sergio Traversa: That's one we would like if the FTA agrees, especially because we use a very low dose compared to the other players, and we would like to leverage all the safety data. There is a pretty sizable package of safety for silo-siping, especially at a low dose. And so definitely, if the FTA agrees, then theoretically, the manufacturing will be completed, then theoretically, we can go straight to phase two sometime probably in the second half of next year. You know, honestly, we are very big; we dismiss this phase three program of uh, of um, REL-1017. So, I mean, Salgo-Sagging is going on, but it's not a distraction fault.
Pretty sizable package of safety for cyclists swiping, especially at the.
No dose and and so definitely if the FDA agrees then theoretically it could be in the manufacturing.
We completed then theoretically we can go straight into phase II sometime probably in second half of next year.
Honestly, we have babies you get these massive phase three program all.
All of them.
Rather than 17, so silo side than it is going but it is not the construction for the real focus is growth in 17.
Sergio Traversa: The real focus is REL-1017. It would be the focus up to the phase-play data, then we both both. We will focus on... Tylosiding as well. But the plan is to start phase two sometime in the second half of next year when manufacturing would be done, and the FTA, if the FTA will agree, right, to skip the, you know, the preclinical stage in phase one, as we do believe. And the second part of the program is derivatives of psilocybin, which is a new chemical entity.
B the focus after that.
Phase II data then we vote.
Hope was on on.
I look siding as well.
Understood.
Be able to do the things to start the phase two sometimes in the second half of next year when manufacturing would be done and the S. T. A.
Yeah, we'll agrees to skip it.
But at what preclinical and phase one as we do believe.
And the second part of the program is derivatives of psilocybin is a new chemical entity. So that's a full fledged development. So we will start where we are sympathizing now, but they will start from in vitro and I believe we are doing some animal studies now, but it's very.
Sergio Traversa: So that's full-flesh development. So we will start, we're synthesizing now, but we will start from like in vitro. And I believe we are doing some animal studies. But, you know, it's really earlier than the silo-siding and the silo-siding model.
It's a lot earlier than the decided deciding of deciding what type of mark.
Sergio Traversa: I hope I've answered you. Yeah, that's great. That's super helpful. Thank you very much. And maybe just one follow-up. Can you comment on what particular forms of neurodegeneration you're thinking about studying when you initiate your phase two trials? Um, let me try. Let me try without.
I hope I don't think.
Yep.
Yeah, that's great. That's super helpful. Thank you very much and maybe just one follow up can you comment on what particular forms of neuro degeneration that you're thinking about studying when you initiate your your phase two trials.
Let me try.
They try without.
Yes, so we are focusing on.
Sergio Traversa: Yes, so we are focusing on diseases where there is damage to the nerves of some nerds. I would say acute damage. So, if we are right, and psilocybin is very safe, and especially at the doses that we're using, potentially, it could speed up the recovery or limit the damage of the nerves or speed up the recovery if there is a way to measure the recovery. I would not say more than, Also, because we have been discussing with, though we will discuss with the FTA, we want to be sure that they are in agreement with what we want to do. But that's pretty much what the plan would be.
Diseases, where they've used the damage.
Of the nuts Osama notes.
I would say acute damage.
So and it is.
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And Tyler I believe is a very safe and and especially that the doses that you're using potentially could speed up the.
It'd be the recovery of the or limit the damage of course speed up the recovery there.
There is no.
The way to measure that.
Colby.
So I would not say more than that.
Because you know we have been and we are discussing with though we will discuss with the C. H.
We want to be sure that they are in agreement on what we want to do but you know that that's pretty much the would be the plan so more acute nerve injury and our attempt.
Sergio Traversa: So more acute nerve injury and attempting to improve the reduce the damage and or improve the recovery. Great, that's super helpful. So there is more than one indication where acute nerve damage can be generated, can be, can happen for it, but I, Okay, so like final cord injury or stroke.
Attempting to <unk>.
Improve the reduce the damage and or improved our recoveries there.
Great that's super helpful.
More than one indication of course, it's not talking about.
Acute nerve damage that can be generated can be.
It can happen, but I hate to lose it.
So okay, it's not only with the final cord injury or stroke.
I don't know spinal cord injury.
Sergio Traversa: No, spinal cord injury. I was involved 25 years ago. I would never get close to that.
I have been involved 25 years ago, when they were getting close to that.
And the other.
Sergio Traversa: And not a spinal cord injury. Okay, all right. Great. Thank you so much. I appreciate the additional colors.
No spinal cord injury.
Okay. Okay, all right great. Thank you so much I appreciate the additional color.
Operator: Thank you, Day. Thank you. Ladies and gentlemen, there is enough time. I'd like to turn a call back to Sergio Travesa.
Thank you.
Thank you.
And gentlemen, there are no further questions at this time I would like to turn the call back to Sergio Chavez for any closing remarks.
Sergio Traversa: For any closing room, Thank you, Operator, and, well, thank all of you for joining us on the call. We are pleased to share our recent progress with you, and as Relatenth's clinical development program continues to attend. We are excited about the main important catalyst that lies ahead of us in 2022, and we'll keep you updated on clinical trials and activities in the coming months. Next year is really the year where we will know if we have a drug or not. And we do believe, I do believe that we do have a drug and it's potential to be a very good drug in helping a lot of people.
Yeah.
Thank you operator, and thank all of you for joining us on the call Tonight.
I'm pleased to share our recent progress with U N is a resident in 17 clinical development program continues to advance.
Excited about the many important catalysts that lie ahead of us in 2022, and it will keep you updated on clinical readouts in the activities in the coming months.
Next year is really neat.
What would be the year, where we.
We don't know if we have a drug or not.
And.
Do believe I do believe that we do have a drug in.
It's a potentially it can be a very very good product and helping a lot of people.
Operator: Thank you all again for joining the call and enjoy the rest of your day. Thank you. This concludes today's conference. You may disconnect your lines at this time. Thank you very much for your participation.
Thank you all again for joining on the call and enjoy the rest of them.
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This concludes today's conference you may disconnect. Your lines at this time. Thank you very much for your participation.