Q3 2023 VistaGen Therapeutics Inc Earnings Call
Speaker 2: The.
Speaker 3: Greetings. Welcome to Visigen Therapeutics 3rd Quetter, fiscal year 2023 Results Conference Claw. At this time, all participants are in a listen only mode. A question and answer session will follow the formal presentation. If anyone should require operator assistance during the conference.
Speaker 4: Please press star zero on your telephone keypad. Please note this conference is being recorded. I will now turn the conference over to Mark Lather, Vice President of Investor Relations. Thank you, you may begin.
Speaker 5: Thank you, Sherry. Hello, and welcome to Visogen's conference call, covering our third quarter of fiscal year 2023 financial results and a business update. Thank you for joining us today, and welcome to our stockholders, analysts, and anyone taking an interest in Visogen. Joining me today are Sean Singh, our Chief Executive Officer, and Jerry Dotson, our Chief Financial Officer.
Speaker 6: The format for this call will consist of prepared remarks from management followed by a brief opportunity for questions from sell-side analysts. This call is being webcasted and will be available for replay. The link to access the replay can be found in the investors events section of our website vistagen.com
Speaker 7: On today's call, we will make forward-looking statements regarding our business based on our current expectations and current information. The forward-looking statements speak only as of today and accept as required by law. We do not assume any duty to update in the future any forward-looking statement made today. Of course, forward-looking statements involve risks and uncertainties and our actual results could differ materially from those anticipated.
Speaker 8: make with the SEC from time to time, all of which are or will be available on our website and the SEC's website. Now I'd like to turn the call over to our Chief Executive Officer, Sean Singh.
Speaker 9: Thank you, Mark, and good afternoon, everyone. Thank you for joining the call.
Speaker 10: There is an active and growing need for new, faster-acting treatment options for anxiety and depression disorders, treatment options without negative side effects, and safety concerns that are often associated with the currently approved medicines.
Speaker 11: We remain focused on addressing the significant mental health care need for individuals across a broad range of demographics and in communities across the globe.
Speaker 12: Our team is committed to developing and commercializing multiple differentiated treatments that align with our mission.
Speaker 13: to shift the treatment paradigm for anxiety and depression disorders and improve the trajectory of mental health care one mind at a time.
Speaker 14: We'll start this call with a brief update on PH94B and our Phase 3 program in social anxiety disorder, or SAD.
Speaker 15: During the quarter, we further analyze Palisade 1 to obtain a better understanding of the unexpected results from that study.
Speaker 16: As a reminder, the study involved only a single dose of pH 94B to subjects who were randomized to the treatment arm in the study.
Speaker 17: All subjects were given a highly provocative public speaking challenge conducted only in a clinical setting.
Speaker 18: before a group of strangers and their change in the subjective units of distress or suds score was determined and measured as the primary endpoint.
Speaker 19: We move forward with this study methodology following our discussions with the FDA back in mid-2020 during the early phase of the COVID-19 pandemic when the world was sheltered in place and social interactions and even exposure to the outside world were not encouraged.
Speaker 20: Following are among the hypotheses we believe are potential explanations for the unexpected outcome in palisade 1.
Speaker 21: The study was conducted through surges of the COVID-19 pandemic.
Speaker 22: introducing significant additional variability in terms of changing social dynamics, subject stress, study site and CRO personnel turnover, mask wearing and scheduling and monitoring complexities.
Speaker 23: Also, the Public Speaking Challenge study design may not have been scalable to a large Phase III study, especially during the pandemic.
Speaker 24: given the various complexities of consistently administering the highly provocative challenge and requirements for rigorous adherence to the study protocol across numerous sites.
Speaker 25: and over an extended period.
Speaker 26: And also some subjects in the study may have had a reduced response to pH 94B due to impaired olfactory cell function potentially caused by the COVID-19 virus or even nasal swab testing for COVID-19 or influenza.
Speaker 27: After receiving the top line results from Palsyde 1, we paused Palsyde 2.
Speaker 28: which involves the same single dose post-randomization public speaking challenge methodology as Palsyde-1.
Speaker 29: We then engaged independent biostatisticians to conduct an interim analysis of available data from the 140 subjects randomized in the study at that time.
Speaker 30: Based on their independent review of the unblinded data from those 140 subjects, data we've not yet seen, independent statisticians recommended that we continue Policy 2's plan.
Speaker 31: Accordingly, during the quarter, we submitted protocol amendments to the PALSID II study protocol to the FDA.
Speaker 32: amendments that are aimed at minimizing the potential issues that may have played a part in the unexpected results that we saw in Palisade 1.
If we decide to resume Palisade II, we believe these protocol changes could considerably increase the probability of favorable results in the remaining third of the trial subjects.
However, a new and another important factor to note regarding our considerations for potentially resuming PALS-A2.
is that in December 2022, only a couple of months ago, two of our peers announced top-line results of their recently completed SAD studies using a single administration public speaking challenge study design, with SADs as the primary endpoint.
need to study achieved its primary efficacy in point. So after reviewing the information and data available to us at this time,
We believe it is not yet advisable.
to resume PALS-A2 before discussing our broader Phase III development plan for pH 94B in SAD with the FDA and assessing the results of the other two recently completed SAD public speaking challenges conducted during the pandemic that also did not achieve their primary efficacy endpoints. For more information, visit www.sasktel.com
We remain confident in PH94B's potential to be a game changer.
for individuals affected by social anxiety disorder.
We have been and we continue to explore all of our options for what we believe will be the best path forward.
with the highest probability of success.
for our Phase III program and SAD.
We are currently preparing to meet with the FDA to discuss our broader phase 3 development plan.
which includes the possibility of conducting a multiple administration, randomized double-blind, placebo-controlled phase 3 study of pH 94-B in adults, using the Lebuitt Social Anxiety Scale or LSAS as the primary measure to evaluate the efficacy of pH 94-B over time in patients with SAD.
to support a potential PH-94B NDA for treatment of SAD.
Unlike the PALISADE-1 and 2 Phase 3 studies, which involved assessment of the
after only a single administration of PH-94B in a clinic-based public speaking challenge with SUDS as the primary outcome measure.
The Phase III study contemplated as part of our broader plan would involve multiple administrations of pH 94B on an ad-needed basis up to four times a day in a real-world setting.
over multiple weeks, with the LSAS as the primary FGC endpoint.
Using the LSATs would be consistent with the design of all registration trials supporting the FDA's three precedent-setting approvals of treatments for SAD.
Given that the L-SAS measures overall improvement in disease severity by measuring both the reduction in fear and anxiety over time about social and performance situations, as well as the reduction in avoidance of those anxiety-provoking situations, we believe the L-SAS is appropriate to measure and reflect the true impact.
for PH94D on patients' daily lives.
We expect to announce our plan for policy 2 concurrently with other updates to our broader page 94b phase 3 development plan for SAD.
Another important component of our Phase 3 program in SAD is the Palisade Open Label Study, which we initiated back in October 2021, to evaluate the safety and tolerability of PH94B in adult subjects with SAD taken as needed prior to anxiety-provoking social and performance situations in daily life.
over a period of up to 12 months. In addition to assessing safety and tolerability of PH94B in that study, we also included several exploratory objectives.
including pH 94B's potential to achieve overall symptom reduction.
and improvement in severity of SAD as measured by the LSAS.
Again, it's the primary endpoint that's required by the FDA for all prior SAD approvals.
In August 2022, we closed recruitment and enrollment in Palisade's Open Label Study. A preliminary analysis of the final dataset observing nearly 400 subjects in that study is encouraging.
and although from an open label study and considered with our prior placebo-controlled multiple assessment phase 2 study of PH94B in a real-world setting, we have a very good
That study has helped inform many important aspects of our broader Phase III development plan for pH 94B and SAD.
The Open Label Study results, reinforced our beliefs in the potential of pH-94B use over time as needed of the four times per day in daily life.
to provide rapid onset, clinically meaningful, and sustained response with a favorable safety and tolerability profile.
We expect to have the final data readout of observations from this study in the first quarter of calendar 2023.
Moving next to our exploratory target indication for PH94B, adjustment disorder with anxiety.
We've completed our small Phase-2A double blind placebo controlled clinical trial to evaluate the efficacy safety and tolerability of PH-94B as a potential treatment of adults with adjustment disorder with anxiety.
Subjects self-administered PH94B at prescribed intervals four times per day for 28 days.
We anticipate announcing top-line data from this exploratory Phase 2a trial by the end of the first quarter of calendar 2023.
During the recent months, we achieved several milestones in our PH10 program in Major Depressive Disorder, or MDD. We submitted our US IND and subsequently received the FDA's green light to conduct sectors there.
The phase one randomized double blind placebo controlled safety study and healthy volunteers. That study is now underway and is intended to both confirm the favorable safety profile of pH 10, establish in three previous clinical studies conducted in Mexico, including positive published phase 2A study of pH 10 for the treatment of MDD.
as well as to facilitate our plans for Phase 2B development of PH10 in the U.S. as an all-stand alone treatment for MDD.
facilitate our plans for phase 2B development of pH 10 in the U.S. as a novel standalone treatment for MDD. We anticipate completing that study.
Phase one study by the end of the first quarter of 2023.
In all clinical studies today, pH 10, like pH 94B, has been well tolerated, has not caused psychological side effects such as disassociation, hallucinations and the like, or other safety concerns that may be associated with other rapid onset depression therapies such as ketamine.
Also of note, we recently received the FDA's Fast-Track designation for development of PH10-4 MDD. We have received the FDA's Fast-Track designation for development of PH10-4 MDD.
Similar to the large and growing anxiety market, there is significant unmet need for patients with MDD where the current treatments are either undesirable or inadequate.
with a differentiated mechanism of action that is designed to be fast acting, non-systemic, and non-sedating. We believe that PH-10 has the potential to shift the treatment paradigm for MDD considerably. Having PH-10 in the clinic in the U.S. and under the FDA's FAST-Check designation are important recent milestones and are planned to bring PH-10 to the many, many, many, many
individuals battling MBD and potentially other depression disorders. At the AV-101, our Phase 1B drug-drug interaction clinical study with oral preventative is ongoing. We anticipate completing that study during the second quarter of calendar 2023. After its conclusion, assuming no unexpected safety issues, we will crystallize the final components of our plan.
or exploratory Phase IIa development of AV101 alone or in combination with Probenecid, and on our own or with a collaborator.
as potential oral treatment for one or more CNS disorders involving the NMDA receptor.
Finally, I'd like to make a few comments about our recent acquisition of Farron Pharmaceuticals.
Now that this transaction has been completed, we have full ownership of worldwide intellectual property rights to PH94V and PH10, which previously were under exclusive licenses to us from Farrin that included customary milestone and royalty payment obligations over time.
As a result of the acquisition, we've eliminated all future royalty and milestone payment obligations for pH-9 or BN-PH-10, which significantly improves the potential commercial profile of these late-day assets. Should they be approved downstream?
In addition, we will retain all licensing revenues, including pre-commercial licensing revenues, should we enter into such transactions as we have in the past.
Further as a result of the fair and acquisition, we've added three early clinical stage varying product candidates to our five ones.
H15 for cognition improvement, H80 for migraine and hot flashes.
and pH 284 for appetite-related disorders.
Also of note, Visigen did not assume any debt as part of this transaction, any other liabilities from Farron nor did we bring on any Farron employees or take on any Farron facilities.
I would now like our CFO , Jerry Dotson, to summarize some highlights from our financial results for the third quarter of our fiscal year 2023.
our CFO , Jerry Dotson, to summarize some highlights from our financial results for the third quarter of our fiscal year 2023. Jerry?
Thank you, Sean. As Sean mentioned, I would like to highlight a few of the financial results from the third quarter of our fiscal year 2023. I would also encourage everyone to review our quarterly report on Form 10Q that we filed with the SEC earlier this afternoon for additional details and disclosures.
During the three months ended December 31, 2022, we recognized $179,600 of revenue related to the AFIMED agreement compared to recognizing $357,900 of revenue related to the agreement.
for the three months ended December 31, 2021. As a reminder, the revenue recognized in both of those periods is non-cash in accordance with the applicable accounting standards. We received the related cash from AFMA back in August of 2020.
Research and development expense decreased by $0.9 million from $7.9 million to $6.9 million for the quarters ended December 31, 2021 and 2022 respectively.
This decrease is primarily due to reduced expenses related to the Palisade Phase III program for PH94B, which as Sean has described includes Palisade I, Palisade II, and the Palisade Open Label study, as well as the PH94B Phase IIA study in adjustment disorder with anxiety.
and other non-clinical development regulatory and outsourced manufacturing activities for both PH94B and PH10.
We expect R&D expense in the final quarter of our fiscal 2023 to decrease.
Our general and administrative expense was flat at approximately $3.1 million for each of the quarters ended December 31, 2022, and 2021. Our net loss attributable to common stockholders for the quarter ended December 31, 2022, was approximately $9.8 million versus a net loss of approximately $10.7 million for the quarter ended December 31, 2021.
At December 31, 2022, the company had cash and cash equivalents of approximately $25.0 million. The community connected
Again, please refer to our quarterly report on Form 10Q filed earlier today with the SEC for additional details and disclosures.
I'll now turn the call back to Sean.
Thanks, Jerry.
We remain unwavering in our core mission to improve mental health and well-being worldwide. As we continue to advance the next stage.
of our corporate development, we move forward with a strong team, a strong pipeline, and a strong mission that drives us to innovate better solutions for mental health disorders.
of our corporate development. We move forward with the strong team, the strong pipeline and the strong mission that drives us to innovate better solutions from mental health disorders, all with significant unmet need.
This is an exciting endeavor for our company and we believe that we are very well positioned for 2023.
On behalf of the Visiting Team, I want to thank you for the privilege and the opportunity to make a difference, one mind at a time.
Thank you, Sean. This concludes our prepared remarks. Sherry, we would like to now open the call up for questions from
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 queue. You may press star 2 if you would like to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up the handset before pressing the star keys.
Our first question is from Andrew Sy with Jeffries. Please proceed.
Thanks. Hi, everyone. Good afternoon. Appreciate you taking the questions. First one is your upcoming FDA meeting in terms of discussing a possible pivot in the phase 3 design using LSAS and then multidosing over a long period of time. Can you talk about the scenarios here if the FDA says, okay, do a pivot.
what would you do with PALIS-A2? And if the FDA says no, what would you do with PALIS-A2? So, basically, what I'm trying to get at is, in what scenario could we see the PALIS-A2 results at the end of the day? Even though it hasn't finished, you did see a signal in the interim analysis. So, that's why I ask. Thanks.
Thanks, Andrew. Good question.
Look, we still have to assess really what would be the best path forward after not only we take a look further at what happened in the peer studies.
So there are questions associated with scaling up that methodology and executing on what is a very highly provocative challenge that requires exquisite adherence to protocol recipe. We submitted some protocol amendments to the FDA, so we'll see what their feedback is on that. Thank you.
can overcome some of those methodological challenges. We'll see what their opinion is on that, as well as which direction things go in the meeting where we're discussing a potential next step forward with LSAS as the basis, just like with the three approvals. So it's possible that we would simply unblind Palsy 2 as it is.
And then study there and see what we find from those unblinded data on 140 subjects.
Could be sensing, could be soft trend, could be positive signal, decent effect size, could be a lot of things.
We know what the interim analysis said, but we haven't seen the data. It's also possible of resuming Palisade II, depending on which direction things go with the FDA.
know what the interim analysis said, but we haven't seen the data. It's also possible of resuming Palisade 2 depending on which direction things go with the FDA. You know look...
The good thing going into the discussions with the FDA is that there is a lot of evidence already. There's faith to placebo controlled studies in 94B and STD that have substantial evidence showing it's rapid onset of effect.
following the acute administration. We talked about that study quite a bit.
than the placebo-controlled crossover study that was two weeks of real-world use.
Then, that amplified by what we've seen so far, we haven't yet recorded, but we'll soon.
observations from the long-term safety study and the LSAS component of that study in particular.
So there's a lot of things to ask the FDA. There's a lot of things to get feedback from the FDA on, and we'll make some decisions on the basis of that interaction as well as what we might learn more about. We need to do some work again with sites. We need to figure out some.
Some more information about what sites are around and willing to be involved. And if we work going to resume, would we want changes to be made that they may or may not be able to execute, depending on staffing and expertise, so we'll set the seat.
Right. Okay. Very helpful. Speaking of the open label data coming up, what exactly do you plan to share with us? Basically how much data can we expect to see in the top line release? Then secondly, how much data can we expect to see in the bottom line release?
pardon this long question, but one of the underlying issues in general of an open label study is there's no placebo. We don't necessarily know where the placebo is with trend. That said, I can think of the epilepsy space where there is an efficacy...
measure called seizure freedom, you know, because placebo can barely achieve seizure freedom and epilepsy. So that is perhaps why looking at seizure freedom rates in an OLE could make sense. So as we get back to the social anxiety space, I guess the question is what percentage of placebo patients across OLE can get all kinds of signs of seizure? What percentage of people amongst pickle is pressure?
can achieve remission in theory over, let's just say, 6 to 12 months because... And I guess, would you agree, looking at remission rates could be valuable of a data point, basically? Yeah. That's something we can discuss with FDA. All of the approval studies were, registration of studies for...
the three, anthida presence of proof for STD. Those are all 12 week studies. Again, you know, look, we obviously acknowledge the absence of a control group in any open-label study by definition. But the data from, again, I've noticed this before, nearly 400 subjects.
observed in that study, they provide very important additional information regarding PRN dosing of 94B.
And we take that together with the data from the placebo-controlled phase 2 study, where the real-world study, those studies provide a lot of evidence on how SAD patients would use 94B, for example, the frequency of use in the real-world setting.
and the appropriateness also of assessing improvement in SAD over time, utilizing the LSAS obviously as the key measurement for that, given that that's the historical precedent, that's the historical comparison, three of them now.
So, you know, we know each SAD patient is different. You know, SAD treatment is individualized and tailored to the situations that patients encounter in their daily lives. We think PRN use is the most appropriate dosing strategy for the treatment of SAD. Unlike the single highly provocative administration assessment that was in the PAL-1 and PAL-2 studies. We know you know, SAD treatment is the most appropriate dosing strategy for the treatment of SAD.
And that these, you know, these feared situations that people encounter, they're very predictable and are awaited with fearful and anxious anticipation. So they'll ask which, you know, get a long established by Dr. Lee-Boot, who's the PI, or the Phase II studies, and also...
currently working with us. That remains the most appropriate outcome measure for the type of study we might next do, right? That a double blind placebo controlled study that evaluates the efficacy of as needed use of 94 B, but over time.
for the treatment because we're trying to essentially do is reset the mind similar to how cognitive behavioral therapy works.
and rather than taking, say, a snapshot with SUDs and with the public speaking challenge, the office is more like a movie, assessing the improvement of the patient over time. And again, having those...
having the LSAS as the primary endpoint is consistent with the registrational trials for the existing approved treatment. So it may be prudent, as you said, to follow beyond 12 weeks. We know this is a chronic disorder. So repeat dosing is exactly the way we've long envisioned.
using pH 94-V to help people. And again, a lot of the reason we moved into the PAL-1 was where the world was at the time. In the middle of 2020, when we last met with the agency about phase three study design, you couldn't even go outside as you all remember. So exposing people to stressors over a long period of time, six weeks.
was probably what we would see in a phase three study, given the way that 94B's onset is rapid.
what we would be saying in a six-week study would be really what the what the antidepressants achieved in the 12-week period since they have a long onset of action. So, what we would show to your first part is we would certainly want to show
improvement on the LSAS at at least one month.
in probably two months given that we're aiming for a study design somewhere in the four to six week range.
So what we're looking for there is are we seeing a significant drop? Again, this is observed data. We understand it's a control group, but it definitely informs when you have nearly 400 subjects it gives us a lot of information to tack on top of really the other crossroads we were at back in 2020. We could have gone to the real world study then, but for the fact that we're in COVID.
And now I think we have that opportunity given that the world settled down a bit, vaccines are okay, and we have a lot more understanding of the safety associated with having people record their stressful events and having LSAS assessments for a long period of time.
Right. Thanks. Last one, and then I'll hop in the queue, is on the adjustment disorder data and coming up, it is also dose chronically placebo controlled 40 subject I believe. So I think the primary endpoint is day 28 AMA scores.
So can you kind of give us a reminder what existing drugs show at four weeks, just so we can have a comparator when that data comes.
Yeah, not a lot of comparators. That's a challenge with this disorder. It's in DSM-5, but there really aren't a lot of controlled studies. That's why this really lands in an exploratory study zone. HMA, you had to have somewhere around 20 to be enrolled, and people had to be on, if they were on anything, there was stable background antidepressants.
You know, the standard meds are used, but unfortunately, they're just, it's the same sort of.
collection of meds that we see in social anxiety sort of that
folks that had never really had experience with anxiety, but for in most cases, something here associated with the chaos, the domino effect from COVID, job loss, relationship loss, isolation, those things started to impair their functioning. That's adjustment disorder.
and anxiety that disrupted routines and so forth. So, Benzo's, beta blockers, ampid oppressions, alcohol, all kinds of things that really aren't optimal.
For FAD are also not optimal for adjustment disorder.
and thanks, Ron. Appreciate the progress.
Appreciate the progress. All right, Andrew. Thank you.
Our next question is from Tim Lugo with William Blair. Please proceed.
Thanks for taking the question. So the upcoming adjustment disorder study...
Can you remind me how many doses these patients are taking per day? And I guess following up with the prior question, do you have a sense of what the placebo rate is in this setting? I guess, yeah, is there any sort of historical strategy?
me how many doses these patients are taking per day and I guess following up with the prior question do you have a sense of what the placebo rate is in this setting? I guess you know there's any sort of historical studies you can compare to.
Yeah, I'll take that part first, Tim. There just isn't a lot of traffic historically in this disorder. And so I can't really give you a well-grounded number. In terms of the dosing regimen, we had, again, the tox support early on showed a lot of safety from 94B taken up to four times a day.
So we sort of forced that into this exploratory study. There wasn't a lot grounded that necessarily said four times is what was needed, but part of it was to also establish safety associated with taking the drug four times a day because that crosses over. Happy
into thoughts about safety related to taking 94B four times a day in multiple different SAD related anxiety provoking episodes. So there was a little bit of crossover.
intention by that study regimen. So in this one it's four times a day it's recommended to be spaced out an hour or so between doses.
in morning, late morning, early afternoon, and evening. So four times kind of spread out for hours or so in between. We know 94B has a rapid onset. We also know it has a fairly short duration of effect. So that's part of the benefit of it being...
sort of a better benzo without the baggage, right? Rapid onset, but without the lingering cognitive impairment.
So it was four times a day, split by a few hours, over 28 days.
Okay, thank you, it's helpful. And so outside of me.
You know, upcoming 94 B meeting.
It sounds like you got a couple assets through the Saren acquisition, you know, PHAD specifically. Can you just, you know, out of 1994, BIC, you rank kind of where the rest of the pipeline is in terms of priorities for the company?
Yeah, sure. Well, 94B, of course, way top of the list and across multiple indications in the two that we've acted on in the clinic, SAD and adjustment disorder, PH10, following right after that. We have a 2A that was done outside the U.S. That's the POC study for that.
asset in major depressive disorder, we had to bring it back to the US, do a full IND enabling program, optimize the formulation a bit. The small phase one that we're doing should be done here within a few months, and we'll announce on that probably early second quarter. That then lets us hopefully move right back into late stage phase 2B development with
There's early clinical data for 15, 80, and 284 done, again, outside the US in most cases, in some cases here. But we're going to need to do some ID enabling work for those three assets, similar to what we had to do for pH 10. We expect to be able to achieve some grant support. scallion organic, harder ago, Crews Couldn't ? ???????ab?????,
for that work. That was nonclinical work that gets us back into the clinic. AV101, we see probably more advanced than 8015 and 284 at this point because if we see the safety that we're hoping with this combination, we have a lot of preclinical data, really solid preclinical data across a few indications involving the NMD.
direction we want to go, but I think 2a would be the next priority after pH 10 for 2b with habe-101, and then we'll see how things go. We haven't had our hands on the new faran acids for too long, so we want to do a little more digging into the data sets that exist, but there are data, clinical data, across all those.
that are fairly encouraging and we just need to get more direct touch on all three of those as we see what we might want to do there's a lot of grant opportunities for those assets. The core focus hour predominantly is on 94 B followed then by 10. Thank you. Thank you.
As a reminder to star 1 on your telephone keypad if you would like to ask a question. We will pause for a brief moment to pull for questions.
And we do have a follow-up question from Andrew Tsai with Jeffries. Please proceed..
Thanks operator. So speaking of the PH94B, you did mention earlier some competitors reports of FAD top one data. My understanding is one of the competitors did in fact see a signal when they, depending on how they analyze the data they'll talk to the FDA.
is how I understand it. So I guess the question is if the FDA buys into their sides, and
long story short, whereas the FDA buys into your LSAS. Let's just say that scenario happens. How do you guys decide to proceed? Because I presume that you would have two options to go with here.
But we already know where the FDA is on on suds. There's no question about that. It's a valid endpoint. The public speaking challenge is a solid methodology. I have no issues about either of those. The question is, can you scale it effectively?
And into the size of a study that's necessary to be a regular fueron for algorithon.
So that's what we're trying to assess at the moment, right? We know the challenges that are associated with the protocol, with the methodology that was, for example, do you, is it the surveillance to whether or not you have the right raters that are changed as you move from the different visits, making sure that people...
and don't inhale the drug, making sure that people haven't destroyed the cells associated with where we need to drug the land. There's a lot of things that land on that one single administration assessment. And it's a very provocative trigger. I mean, those let's face two studies that appears dead.
their phase two study. So it's a holder from ball game when you move into ailing that methodology up to
And that's the worst session. It may be possible with the changes we've proposed to the FDA, or maybe something that we say just isn't. Isn't worth that risk and isn't necessary. If Palate 2 at the end of the day goes all the way, and what we end up having is a positive signal with a good effect size, but it's not that big, well, then that isn't going to support an NDA. If we think that there is going to be a rigorous adherence to the protocol, the sites would be involved, that the macro environment would be right, those all go into the thinking. But the fact is,
It's very unusual for three studies with the same methodology but distinct drugs within a six month period of time would not hit their primary endpoint, stat-sig on their primary endpoint. That's part of our thinking.
The other side of it is, as to the LSAS, A, we know there's historical comparators there. Although we don't think there's a regulatory risk with SUDs based on our prior interactions with the agency, there are three historical comparators that support LSAS as the primary endpoint for all six registration studies.
we'll just have to make a decision about what's the best way to put time, talent, and cash towards ultimately what we want. We want an NDA that is approved. We want study designs that fit the way we think the drug best.
that how we think people can be helped by it in the world. So, right. There's a lot of confidence behind the, if you look at those same drugs and depression.
Paxil's Olaf Defects are, they're words, a steady string of successes. There were multiple failures and multiple successes. But interestingly in SAD,
for the registrational studies, all were positive, and all used only the LSAS as the primary efficacy endpoint. But with a bit of a changed world now, with COVID's under control, and a lot of other factors that we would improve on, that some lessons learned from PALSID, one to transport into what we would do if the direction forward is that we make The U.S. is just the running out of testing in my mean way.
a Phase III study with LSS as the primary. The odd deck pretty nicely.
Right. Last question then is, if you ultimately, if you do proceed with L-SAS, how fast can you get two phase three studies up and running and having generated the data, you know, kind of walk us through the timelines?
Well, of course, a lot of that depends on funding. Right now we're not sitting on funding that supports all the way through those data readouts, but in an optimal scenario, we would be in a mode in about six months it takes to get going for the types of studies that we'd want to launch.
with the sites we would want to be involved in. Now we've been involved with now around almost 40 sites.
across the two studies. We know the landscape very well. SAD is back in motion as something that's being studied. It hadn't really been before we brought it back with Palisade 1.
So those studies if we would start them sometime before the end of the year we could see readouts in the fourth quarter of 24
And it'd be a staggered start again, two studies running in parallel, both a little bit of a staggered start, as we did with PAL-1 and PAL-2. The LSAS-based studies would run next to each other, and we think we could see readouts by the end of the fourth quarter of 24 if we get going here within the next several months. Great, all right, thanks again for taking these questions. They're very helpful.
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