Vistagen Therapeutics Q1 2024 Earnings Call Transcript

Quartr
Provided by Quartr
August 10, 2023

There are 6 speakers on the call.

Operator

Greetings, and welcome to the Vistigen Therapeutics Fiscal Year 20 24 First Quarter Corporate Update Conference Call. During the presentation, all participants will be in a listen only mode. Afterwards, we will conduct a question and answer session. And as a reminder, this conference is being recorded Thursday, August 10, 2023. I would now like to turn the conference over to Mark Flather, Vice President of Capital Markets, please go ahead.

Speaker 1

Thank you, Jennifer. Good afternoon, everyone, and welcome to Visagen's Q1 fiscal year 2024 corporate update and Webcast. This afternoon, we issued a press release providing an overview of our progress this last quarter. We encourage you to review this, which can be found on the Investors section of the Visagen website. Before starting today, We want to remind you that we may make forward looking statements regarding our business based on our current expectations and information.

Speaker 1

The forward looking statements speak only as of today, Except as required by law, we do not assume any duty to update the future in the future any forward looking statement made today. Forward looking statements involve risks and uncertainties, and our actual results could differ materially from those anticipated by any forward looking statements we may make today. Additional information concerning risks and factors that could affect our business and financial results is included in our fiscal year 2024 1st Quarter Form 10 Q for the period ending June 30, 2023, and in future filings that we'll make with the SEC from time to time, all of which will be which are and will be available on our website and the SEC's website. With that taken care of, we'd like to Thank and welcome all the stockholders, analysts and everyone taking an interest in Vistgen. I'm joined on the call today by Sean Singh, our Chief Executive Officer and Josh Prince, our Senior Vice President of Business Operations.

Speaker 1

Sean will provide an overview of our progress, focusing specifically on the results from our positive Phase 3 PALISADE II trial evaluating the efficacy, safety and tolerability of Fathodenol PH94B nasal spray in adults with social anxiety disorder or SAD followed by a brief opportunity for questions from sell side analysts. We want to remind you that this call is being webcast and will be available for replay after the call is completed. The replay link can be found in the Investors Events section on our website. I'd now like to turn the call over to our Chief Executive Officer, Sean Singh, to update you on a recent inspiring news regarding the PALISADE II Phase 3 study results.

Speaker 2

Thank you, Mark, and good afternoon, everyone, and thanks for joining our call. As I've said before many times, our team has remained steadfast in our core mission, which is to radically improve The mental health and well-being of millions of individuals around the world who are suffering from a wide variety of anxiety, depression and other CNS disorders that Severely disrupt their daily lives. And as we've recently announced, we've solidified a major cornerstone in that mission focused on improving the lives of The over 25,000,000 individuals in America who are affected by social anxiety disorder or SAD, There's indeed an active and growing need for a new faster acting option for treatment of SAD without abuse potential or the side effects and safety concerns that often are associated with the currently approved medicines. We remain focused on addressing this significant unmet health Mental health need for individuals across a broad range of demographics and in a diverse range of communities across the globe. We're committed to innovation of multiple differentiated treatments in alignment with our mission to shift the treatment paradigm for anxiety, Depression and multiple other CNS disorders.

Speaker 2

So a lot has changed since our last conference call and let's get right to the biggest news in our company's It's been a long time since the positive Phase 3 studies brought new optimism for treatment of social anxiety disorder, and we are thrilled to be in a leadership position, the compelling top line results from our Phase 3 PALOCADE II trial that were announced on Monday. These Phase 3 results highlight the potential for fasadienol, which is innovative proposed mechanism of action to transform what's possible for millions of individuals living with SED in the U. S. And millions more who are affected worldwide. In the PALISADE II study, Fasadienol demonstrated a rapid and clinically meaningful reduction in the Subjective Units of Distress Score or HUD score indicating that a single administration of fasodionol has the potential to reduce rapidly Anxiety symptoms during an anxiety provoking situation, similar to perhaps how a rescue inhaler used on demand helps a person with asthma.

Speaker 2

To recap, this was a U. S. Multicenterrandomizedoubleblindplacebo controlled Phase 3 trial consisting of 4 visits by subjects to a clinic that were spaced out a week apart, a screening visit, A baseline setting public speaking challenge after administration of a placebo nasal spray, a second public speaking challenge where patients were randomized to either fasodionol or placebo, then a follow-up safety visit. HUD scores were captured at 1 minute intervals throughout each public speaking challenge and physician and patient assessment of improvement were captured after the 2nd speaking challenge was completed at visit 3. In order to progress the randomization of 2nd public speaking challenge or visit 3, subjects had to exhibit high levels of anxiety during the 1st public speaking challenge, the baseline challenge.

Speaker 2

Patients in the study were confirmed STD patients with a score of 70 or above on the Leavold Social Anxiety Scale, which commonly referred to as the LSAS, without other primary psychiatric disorders and not currently receiving active CNS medications. In total, 141 subjects were randomized in the trial, 70 on fastedionol and 71 on placebo. The total enrollment reflects the pause in enrollment after we received top line results from PALISADE 1 to allow for independent biostat to conduct an interim analysis of the 141 patients who were randomized and had completed the trial up to the date of the pause. Although the results of the independent interim analysis indicated the continuation of PALISADE II would not be futile, for business reasons we elected to extend our pause at PALISADE Pending our assessment of the then impending top line results of our PALISADE open label safety study, The results of 2 SAD public speaking challenge studies conducted by peer companies, further discussions with the FDA regarding continuing acceptability of the LSAS as the primary efficacy endpoint in Phase 3 studies for the treatment of SAD, as well as a comprehensive assessment, very important assessment of the expense, time, statistical and regulatory implications and logistical challenges associated with resuming PALISADE II.

Speaker 2

Following positive results from our PALISADE open label study, the results of the 2 SAD public speaking challenge studies conducted by peer companies, each of which did not meet their primary efficacy endpoint as measured by the SUDs. And our positive discussions with the FDA in early 2023 about the continuing validity and reliability of the LSAS as a primary efficacy endpoint, For strategic reasons, we chose to close PALISADE II with 141 completed subjects rather than resume the study and randomized an additional 67 subjects for a total of 208 subjects as originally planned. It's very important to note that through this process, PALFADE II was not altered in any way. It was simply stopped Early with an intention to treat population of 141 subjects instead of the originally planned 208. The statistical analysis plan was followed as originally planned.

Speaker 2

It was similar to PALISADE 1 and did not require a Type 1 error correction The primary endpoint in PALACEY II was a difference in mean SUD score during the public speaking challenge at visit 2 baseline and visit 3 treatment for patients To receive fastidienol compared to placebo. Fastidienol treated patients demonstrated a statistically significant greater change in Least Square's means For a difference between groups, the 5.8 with a p value of 0.015. We believe these results to be clinically significant, especially considering they're based on a single dose of fasodenol in a highly provocative public speaking challenge and is supported by high responder rates captured in the secondary and exploratory endpoints. The study had a secondary endpoint, the Clinical Global Impressions Improvement Scale or CGII. Rasadienol demonstrated a Responders were identified as those who were rated as very much less anxious or much less anxious after visit 3 With 37.7 percent of Fasadienol treated patients rated as responders as compared to 21.4% for those treated with placebo, with a P value of 0.033.

Speaker 2

To watch these results clearly demonstrate that physicians were able to recognize the improvement in patients Even with the full week between 2 public speaking challenges. The PALISADE II study also had an exploratory Patients' global impression of Change Scale or PGII, very excited by the patients' ability to recognize their improvement on fasidothienol because responders were identified on that scale as those who self rated very much less anxious We're much less anxious after visit 3. An impressive 40.6% of fastenial Methadienal treated patients rated themselves as responders as compared to only 18.6% of those treated with placebo with a p value of 0.003. This responder rate of more than double the rate of placebo clearly illustrates to us Potential for patients to engage with less fear and reduced avoidance of their anxiety provoking events and situations, Especially as they continue to use Fasadionol over time as we saw from LSAS data in our placebo controlled Phase crossover study in our open label PALISADE open label study. In addition, other than the other important Exploratory endpoint.

Speaker 2

The percentage of Fasadienol patients who improved by 20 or more suds points at visit 3 was almost double The rate of placebo with 35.7 percent of facetionol patients dropping by 20 or more points compared to 18.6% on placebo. The 20 point drop is very clinically relevant and likely makes a difference in improving patients' ability to engage in an anxiety provoking event. From a safety standpoint, similar to all of the prior studies of fasted iron ore completed to date, including our large PALISADE open label study That included 481 subjects and over 30,000 doses of fasidienol that were administered in that study. Fathodionol and PALISADE II was well tolerated with no serious or severe adverse events and there was no treatment emergent adverse event So now let's compare the primary endpoint in PALISADE 2 to the primary efficacy endpoint result in PALISADE-one. As many of you know, it's not uncommon in mental health studies to have both positive and negative studies And separate studies of similar design, particularly true of the subject scales that given the subject scales that have to be used in such And the potential for high and unexpected variability and placebo effects as we saw in PALSADE-one.

Speaker 2

This becomes even more likely when you add the task of consistently administering a complex public speaking challenge across numerous sites During an unprecedented pandemic, public health crisis and mental health epidemic, the key difference in the outcome of PALISADE 1 Compared to PALISADE II, it was a much higher placebo effect in PALISADE I. The drug effect in both studies was similar. This was generally true across the primary, the secondary and the exploratory endpoints. The end results of the primary endpoint in PALISADE 1 Was the Leased Square's mean change in SUDs from visit 2 to visit 3 of 15.6 points for fasodenol and 17.3 points Placebo with p value of 0.506. We firmly believe that the Systemic variability introduced by the pandemic contributed to these very unexpected and very different results between these two studies.

Speaker 2

A large portion of PALISADE 1 was fielded in 2021 through the height of the second wave of the pandemic, While the vast majority of PALISADE II was fielded in 2022, as the acute phase of the pandemic has subsided. This dynamic likely impacted PALISADE II disproportionately in terms of patient mindset, study protocol execution and study oversight. Subjects randomized in 2021 likely were different given the overall level of anxiety and uncertainty and general unrest, restrictions, mask wearing and the like during the acute phase of the pandemic. The high placebo rate in PALISADE-one also may have attributed to logistical issues Caused by COVID-nineteen in 2021, such as high site and CRO employee turnover, absenteeism, changes in raters, Time lapses between visit 2 and visit 3 due to unpredictable and intermittent clinical site closures and patients postponing travel, delayed monitoring visits and the like. As these dynamics became apparent as the acute phase of the pandemic subsided in early 2022, We also initiated retraining and renewed monitoring of sites as is customary with staggered start replicate studies.

Speaker 2

And that too may have had a much larger impact on PALISADE II since it was completed before the majority of patients went through that study. We view the results of PALISADE-one as an outlier, driven by the aforementioned reasons and we are highly confident in the On the exploratory endpoint in the PALISADE open label study and now the strong results in our placebo controlled Phase 3 PALISADE II trial. This is especially meaningful after the recent multiple failures in SED studies by peers that may have been subject to similar With the statistically significant and clinically meaningful results of PALISADE II, We're now positioned to move our Phase 3 development plan forward with the additional studies needed for a potential NDA submission, including a PALITADE III trial and a FEARLESS trial, allowing us to not only confirm the acute benefit of fasidien To confirm what we've also long believed that the acute use of Fasadienol for SAD events continued over time will lead to a reduction in disease severity. So coupled with the safety and tolerability profile we have already demonstrated, We believe fasodionol will be the ideal approach to SAD treatment in the future. Preparations are now underway to initiate these next studies.

Speaker 2

Protocol for PALISADE III will be substantially similar to PALISADE II. The SUDs again is the primary efficacy endpoint in clinic based public speaking challenges. In the study design of FEARLESS, we substantially similar to the multi week real world registration trials for the only three drugs approved for the treatment of SAD decades ago using the LSAS as the primary endpoint. As a new class of medicines, our 5 candidate faring nasal spray pipeline holds the potential to transform the treatment landscape across Numerous therapeutic areas. At the head of the class stands fastodionol's potential as demonstrated in the Phase 3 PALISADE II trial.

Speaker 2

That set the stage for the 1st fundamentally new class of medicine for individuals living with SAD in more than 20 years. Positive PALISADE II beta bolster our growing collection of evidence supporting future clinical studies of fastodionol across several disorders and gives us further confidence in the promise of our farrowing pipelines untapped potential overall. We've had some recent advancements in our other pharynx programs. Let's take a brief look at those. Results from our successful U.

Speaker 2

S. Phase 1 trial of Vitruvone, previously referred to as PH10, Build on successful Phase 1 studies and a positive randomized double blind placebo controlled Phase 2a study of Itruvone in major depressive disorder or MDD It was previously conducted in Mexico and stage iTruvo now for Phase 2b development in the United States as a standalone rapid onset faring product candidate for the treatment of MDD. U. S. Phase 1 trial was randomized, double blind, placebo controlled, We investigated the safety and the tolerability of a single dose and multiple doses of Vitruvosasal Spray in healthy adult subjects.

Speaker 2

There were no reported serious Adverse events or discontinuations that were due to adverse events in the study. Overall, iTruvo nasal spray was well tolerated and demonstrated a favorable safety profile consistent with all prior clinical studies of ITUVA. For Itruvone, we also reported important preclinical data of radiolabeled intranasal Itruvone in laboratory rats, which further validate its potential to treat MDD Without systemic absorption, these new data additionally support the proposed mechanism of action of Atruvo Nasal Spray As binding to receptors of peripheral chemosensory neurons in the nasal cavity, but not to neuronal receptors in the brain, thereby limiting transporter molecules to the circulatory system and minimizing potential systemic exposure. As was the case when we completed a similar study with prasadienol, these preclinical data further The substantial body of evidence supporting our TruVone's favorable safety profile. We're continuing our preparations for advancing into Phase 2b development of iTruVONE for MDD in 2024.

Speaker 2

We're also very excited about PH-eighty Fairy Nasal Spray, which has been highly studied in multiple indications. We recently reported a positive exploratory Phase 2a trial of PH-eighty Nasal Right, which provides new optimism for the acute treatment of moderate to severe vessel motor symptoms or hot flashes in women due to menopause. In a randomized double blind placebo controlled exploratory Phase 2a clinical study of PH80, it was designed to explore the efficacy, Safety and tolerability of PH80 for the acute treatment of menopausal hot flashes at women. PH80 induced a significant reduction And the daily number of hot flashes compared to placebo at the end of the 1st week of treatment and the improvement was maintained through each treatment week until the end of the treatment period. Baseline subjects reported a mean daily number of hot flashes of 7.7 in the PH80 group 18 subjects and 8.0 in the placebo group of 18 subjects as well.

Speaker 2

After 1 week of treatment, the number of hot flashes dropped to 2.8 in the PH80 group and 6.4 in the placebo group for a P value of less than 0.001. And after 4 weeks of treatment, the number of hot flashes dropped to 1.5 in the PH80 Group and 5.1 in the placebo group for a P value of less than 0.001. PH80 treatment also significantly reduced the severity and the disruption in function and sweating related to hot flashes during the treatment period as compared to placebo. PH80 as our other fairings was well tolerated, No serious adverse events and the adverse event profile comparable between PH80 and placebo. All 36 subjects completed 4 weeks of treatment and no subject discontinued participation in the study as a result of adverse events.

Speaker 2

One of the favorable aspects of running additional trials in this particular indication that there will be objective measures for these studies. That is to say it's easier to measure How many hot flashes are experienced and their frequency of those symptoms versus more subjective endpoints that we have seen in some of the other studies and different indications. Given the depth of our entire CNS pipeline and the robust body of successful safety and efficacy studies to date, We're also pursuing multiple potential strategic development and commercialization partnerships, both global and regional, to efficiently unlock the full value of our product candidate portfolio. We believe global and regional partnerships, especially for commercialization, to amplify our internal expertise and development activities and potentially accelerate key development timelines and enhance overall our efforts to deliver differentiated treatment options. So now for some brief comments about our financials.

Speaker 2

We've been able to reduce our cash burn rate, As you will see in our to be filed 10 Q shortly, and we've been implementing corporate initiatives streamline operations in order to conserve our resources. We do not anticipate any significant near term cash burn increases. As for our cash position, we've recently taken advantage of the unusually high trading volume in our stock Strengthen the cash position on our balance sheet by over an expected $30,000,000 in gross proceeds. To put this in high trading volume into perspective, more than $1,000,000,000 worth of our stock has traded Since the announcement of the PALISADE II results on Monday, 4 trading days ago. As is industry standard, we established an at the market agreement with Jefferies over 2 years Back in May of 2021.

Speaker 2

Until just recently, we'd only used this very sparingly back in calendar Q3 of 2021. We will continue to be very judicious in how we use this vehicle going forward And we have plenty of capacity remaining under ITM to further strengthen our balance sheet should we wish to do so as well as other strategic financing options and potential non dilutive grants partnering arrangements. So in closing, we remain steadfast in our core mission to improve mental health and well-being worldwide. As we continue advancing the next stages of our corporate development plan, we move forward with a solid team, a strong pipeline and an unwavering drive to innovate better solutions for CNS disorders in large primary care markets with significant unmet needs. So on behalf of the Visogen team, I'd like to thank you again for the privilege and for the opportunity to make a difference.

Speaker 1

Thank you, Sean. Jennifer, we'd now like to open up the call for questions from the sell side analysts participating in the call today.

Operator

Thank You can press the 1 followed by the 3. And our first question is from the line of Andrew Tsai from Jefferies. Please go ahead.

Speaker 3

Hey, everyone. Good afternoon. Thanks for taking my questions. And I wanted to offer Congratulations on the recent data. So now that you have PALISADE II on hand, How confident are you this study could be 1 of 2 traditionally supportive placebo controlled pivotal Phase 3 studies for a filing?

Speaker 3

And then second to that is, do you think you'll meet with the FDA? And if so, when could we get a resolution on the next steps in the NDA package? Thanks.

Speaker 2

Well, thanks, Andrew. I appreciate the question and thanks for the congratulations. It certainly enables, right, whether the FDA accepts Trial is pivotal. That's always to be determined downstream by the FDA. But there's no doubt in our mind, we didn't change anything.

Speaker 2

It's the only difference as I noted was the number of subjects. So there's no Type 1 error. There's No protocol amendment. There was no deviation at all from the original plan other than the number of subjects. So Having a highly statistic result with the profound safety profile that we've seen now in 100 and 100 of patients that have been exposed to fasodenol.

Speaker 2

You already remember, we had FDA feedback regarding Abuse liability and a favorable amount of feedback from the FDA. And that was even before our open label study delivered the results we reported. So I mean, I like where we stand. Having something in this disorder with a validated endpoint with highly static data And clean safety data, I really like our chances. So it's certainly going to be a key pillar And our NDA submission downstream, should we get to that point with additional studies, at least one of those studies.

Speaker 2

Got it.

Speaker 3

And then now that you're going to do a Palisade 3, as we think about The potential outcomes. Do you think PALISADE III would look similar to what you saw in PALISADE II or something even better? Because I don't know PALISADE II there's maybe some COVID going on, but the counterargument would be maybe there's some expectation bias due to the So how are you thinking about the outcome of PALISADE III and why?

Speaker 2

Well, I think there's a lot of reasons, of course, To be confident about our next couple of steps in the PALISADE III direction, first, certainly the world isn't really controlled Anywhere near to the degree it was in the pandemic. And that obviously impacts the entire ecosystem associated with executing successful clinical studies. There's a lot of lessons learned that we have been able to gather from the deconstruction of Palisade 1 for sure and I Suspect we will from PALISADE II. Things like subjects will have an olfactory smell test. They'll Restrictions on use of nasal swabs upfront of the event.

Speaker 2

So there's several things that are associated with just modest amendments to the protocol, but they're Positive lessons that you typically learn when you stagger start the studies. So that plus the Training that we've done, the proprietary training models that we have all up and down every aspects of conducting that type of study. I don't think there's anybody better to conduct And more expertise to conduct a public speaking challenge in a Phase 3 setting than we are. I have no reservations about that. So I really I like our I like the expertise we have internally.

Speaker 2

I like the force extenders that we've got in our network outside the Certainly Doctor. Leibowitz plays a key role in our ability to be successful with this clinical program with this drug. So Yes. We're excited.

Speaker 3

Got it. Okay. And speaking of PALISADE II, going back to the data, When can we expect you to share detailed results at a medical meeting or a publication? It would be great to see the curves of SUDs and so forth. And secondly, You've compared PALISADE II to PALISADE I and explained the differences.

Speaker 3

But can you also compare to the prior Phase II study And maybe compare contrast any efficacy differences that you saw, were there different baseline SUD scores for instance between these two Help us reconcile any differences. Thank you.

Speaker 2

Thanks. Well, first To your question about the data, this obviously falls into industry standard breaking news. So we're trying to Find a nice place to present the Phase 2 data in a breaking news context, hopefully sometime this fall, I think would probably be the earliest. So we'll have more information on that as we go forward. Certainly, abstracts and the like are already in circulation.

Speaker 2

And then as to your questions about estapalasate or to the Phase 2 studies, I mean, obviously, it's a different environment. That's a 3 study or 3 site study. But Josh, Prince, I want you to actually just address this just briefly, some of the things that we see.

Speaker 4

Yes. Hi. Thanks, Sean. Hi, everybody. Just to fill in the space there, I think the key is the Time difference.

Speaker 4

So when we think about how long it's been since those earlier Phase 2 studies were done, and you think about just the environment that we live Today versus then and through the pandemic, we think that has an effect. But overall, the efficacy seen for both PH94B and placebo in that Phase 2 study was everything was kind of shifted up compared to what we've seen with PALISADE II and PALISADE I. And we really do think it has to do with kind of the, again, the times and the types of patients and the

Speaker 2

Thanks, Andrew.

Operator

And our next question is from the line of Joanne Lee from Maxim Group. Please go ahead.

Speaker 5

Hi, good afternoon. Thanks for taking the questions and congratulations on the successful outcomes of the Recent Phase 3, the results were truly remarkable. Just given Fasadienol achieved positive results and now both PAL2 and the Open label study. Could you provide some insight on the rationale behind choosing to pursue both SUDs and LSAS as primary measures in the How 3 and fearless studies, was this decision influenced by any guidance from the FDA? Just curious on that.

Speaker 2

No, not well, thanks Joanna, first of all for the question. It's a great question. Look, we have long held the way That we think Fasadidal can help people. It's 2 distinct ways. It can certainly help people as we've shown in PALISADE II, in an acute setting.

Speaker 2

And as they take it out of their pocket or their purse or their backpack and they use it on demand in a patient tailored way, Has the ability to knock down very rapidly those symptoms. That's what PALISADE II showed. We also have placebo controlled Phase II data and Exploratory data from the open label, lots of subjects that also when it's used acutely, but used over time, It increases the confidence of a person and increases their resiliency. It reduces their Tendency to avoid situations that could benefit their lives. It reduces the opportunity cost in their lives.

Speaker 2

And that avoidance, the reduction in avoidance Engaging in social and performance situations is important. The Lebowitz scale captures both of those. So we're at a perfect spot right Because we've got one successful study in Phase 3 and you only need 2 adequate and well controlled studies to get an approval of a drug. And so it could either be from a PALISADE III or it could be from a fearless. Either way, what we're trying to do is look to the most efficient path To get this drug to patients as soon as possible, and it's one of those two tracks.

Speaker 2

It could be both. But you only need one Other besides the one we've got, at least that's our opinion at this point. So doing the LSAS based study, Again, it's consistent with the only 3 drugs ever approved for treatment of social anxiety disorder. That was the primary The endpoint we needed to make sure and we did find this out in the Q1 that the FDA still believe that to be a valid and reliable endpoint and they do. So that provides optionality there.

Speaker 2

The other side is, well, we already know what they think about the SUDs endpoint in the PALISADE program. Importantly, too, we have a keen interest given that social anxiety disorders normally the onset is typically in adolescence Between say ages 8 17. There's a huge number as we know of Minors who are affected with mental health disorders, especially social anxiety disorder. The Leibowitz scale, there's an LSAS CA, which is Our treatment opportunity to pediatrics to run a LIBORET scale based study using a modified version of that scale Similar to the way that the adult study was run, very difficult to envision a 10 year old giving a Public speech to a group of strangers, just a much easier to execute down the road in a pediatric setting as well. So It's really a nice combined set either one of the 2, ideally we see both.

Speaker 2

And then you have a very robust commercial opportunity that It extends into the pediatric arena.

Speaker 5

Got it. That was really helpful. And clearly lots of excitement around the SED program, but we're also really enthusiastic about the broader Ferent platform as well. Could you shed some color on the current statuses and progress of those programs, CHION 1580, particularly on the latter Page 80 with the positive preclinical data, we see the hot flash and other symptoms and menopause Receiving a lot of a lot more tension in the area of women's health. So curious if you could walk us through some of the timelines around those programs?

Speaker 5

Thank you.

Speaker 2

Sure. Well, first with respect to iTruvo and or PH10, that's now after a bit of a long run, it's staged To go into Phase 2b development in the U. S. The efficacy study was run outside the U. S.

Speaker 2

And so we really had to start Back to the point of the U. S. IND enabling program. So that one, because there had been no prior U. S.

Speaker 2

Activity or no prior U. S. IND, we did The whole standard battery of non clinical studies followed by small Phase 1 to then now be able to leap back Over, we believe the Phase 2a that was done and moving to Phase 2b. It's a tremendously exciting program given what we just also learned that Like 94B or fasidienol, there's no meaningful systemic exposure. And the kinds of Safety profile benefits that we see from Fasodionol are also in the iTruvo zone, meaning that We didn't we don't anticipate sexual side effects.

Speaker 2

We don't anticipate weight gain. We don't anticipate many of the types of Side effects and safety concerns that are associated with the currently approved systemic therapy. So I'm very excited about that as the standalone Treatment for major depressive disorder. As to PH80, again, you hit it. Hot flashes is hot right now with the new NK3 antagonist that was approved.

Speaker 2

There's been a lot more interest of late in that space. There's an enormous population course that's affected By hot flashes for many years with very limited options that don't cause some concern, whether it's hormonal therapy or the New class PH80 is majorly distinguished from both of those current treatment options and the antidepressants that are used for hot flashes. Because again, like, fasidienol and itruvone, we don't believe it's systemically absorbed. We think, Again, that it also has the ability with neurocircuitry that's associated with temperature to be able to reduce the daily number of hot flashes That just as we saw in the Phase 2a study, but also the severity of those hot flashes and the Types of things that disrupt lives, so sweating and function and the like. So it's exciting that the challenge with that one is Like PH10, we've got to go through what probably will be about a 12 to 15 months IND enabling program where we do the CMC work And the preclinical work that's needed to get back into Phase 2b setting.

Speaker 2

The difference with this one is that there is a there were There was a prior U. S. IND, so we don't think we need to do a Phase 1 study in order to get into Phase 2b For this indication. So it will be it's not a long it's not a lot of money, it's less than $2,000,000 for these IND enabling programs. We have to do similar work with PH15 and PH284, the other two varying assets in the pipeline.

Speaker 2

So That's the status of both.

Speaker 5

Got it. Thank you for all the additional details. Once again, congratulations and looking forward to more updates this year.

Speaker 4

Thanks, Joanna.

Operator

And our next question is a follow-up from the line of Andrew Tsai with Jefferies. Andrew, your line is live. Please proceed with your question.

Speaker 3

Thank you. Just a couple of more questions. Thank you so much for the time. I mean going back to PALISADE II, there does seem to be a consistent efficacy signal across very endpoints. So just wanted to make sure Were there other pre specified efficacy measures part of the study?

Speaker 3

And if so, how did those look? Just wanted to make sure all precession measures are separated from placebo in a static manner. Thanks.

Speaker 2

Sorry, Andrew. We're You're asking if there is a separation against placebo across all the endpoints. Yes, there was one secondary, the primary, one secondary and 2 exploratories and We reported on all those, so 4 total.

Speaker 3

Okay, great. And going to the label, the eventual label, If both PALISADE and FEARLESS succeeded, what would your eventual label look like for SAD? And would there be precedence around that label claim? Thank you.

Speaker 2

No, there is no precedent for an acute treatment for social anxiety disorder. We would be the first to blaze that trail with fasidienol. Drugs are used, Benzodiazepines, for example, try to achieve that, but with considerable risk of abuse and misuse and addiction. But they never they're not approved for the treatment of social anxiety disorder. So only the 3 antidepressants, 2 SSRIs and WILSON And they are approved for the chronic condition.

Speaker 2

There likely would be no limit in our opinion on how frequently somebody could use the drug acutely if it's PALISADE 2 +POSALISADE 3 that supports the label initially. If later, eventually, Fearless came along And the staggered starts, which is what we anticipate with PALISADE III first and fearless second sometime in 2024. It would be a case where the drug would be used acutely as needed, but over time. And what you try to achieve for someone ultimately at the end of the day is they won't have to take the drug. That's often and hopefully still also combined With Talk Therapy.

Speaker 2

So yes, the PALISADE II hits the acute side of that match What's achieved is only the acute label.

Speaker 3

Got it. And Really quickly, as we think about the NDA package in the future, any peripheral studies that you would need to do such as, I guess repeat just multiple dosing per day kind of studies For instance? Thank you.

Speaker 2

Sure. So we'll do open label extensions on each of the 2, The PALISADE III and the fearless study, so that there still has to be a safety database that gets established. And then the redose study that you mentioned, Joe, I think that's something We reported before, FDA wants to see what happens if someone uses the drug twice instead of just once in that Acute setting. So that's something we will before NDA, that's a small study that we'd likely be completing and most likely they'd be using a public speaking challenge well, so not too many subjects, not too expensive, but again trying to not so much for safety and we don't really worry about Multiple uses in a short period of time, but I think there is some interest at the agency in wondering whether more is better. We've certainly established the 3.2 micrograms used PRN is good in PALISADE II.

Speaker 2

So If better is available, great, but it won't be an essential component for going forward in calcite3 or the FLUELUS study.

Speaker 3

Got it. Actually very last one because I want you don't have much opportunity on conference calls. So in the study results, did PH94B work equally as well between males and females? And That's the last question. Thank you.

Speaker 2

I think that's something we'll be able to unpack. We don't have the full data set fully unpacked. We have the top line So that takes a little bit of time. But I don't think we see and we've long held since that was I think long, long time ago that that Was a question. But we think we don't think there's any reason to believe the drug doesn't work as well in women as in men or men as in women, whichever way you want to put it.

Speaker 2

But Fearless will give us okay.

Speaker 3

Thanks. Congrats.

Speaker 2

Thank you.

Operator

And there are no other sell side analysts in queue. You may proceed to closing comments.

Speaker 1

Excellent. Thank you, Jennifer, for your help today. And thank you, Andrew and Joanne. We appreciate your questions. If there are any additional questions, please do not hesitate to We also encourage you to sign up on our website to stay connected with the latest news from Vistigen.

Speaker 1

Thank you for participating in our call today. We appreciate everybody's attention and support. We look forward to keeping you current on our continuing progress. This concludes our call. Have a fantastic day.

Speaker 1

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Earnings Conference Call
Vistagen Therapeutics Q1 2024
00:00 / 00:00