Q2 2022 VistaGen Therapeutics Inc Earnings Call
Speaker 2: Greetings and welcome to VistaGen Therapeutics, second quarter of fiscal year 2022 results conference call. At this time, all participants are in a listen only mode. A question and answer session will follow the formal presentation.
Greetings and welcome to Vista Gen Therapeutics second quarter of fiscal year 20, twenty-two results conference call at.
But this time all participants are in a listen only mode.
The question and answer session hope all the formal please presentation.
Speaker 2: If anyone should require operator assistance during a conference, please press star zero on your telephone keypad. As a reminder, this conference is being recorded.
If anyone should require operator assistance during the conference. Please press star zero on your telephone keypad.
As a reminder, this conference is being recorded.
Speaker 2: It is now my pleasure to introduce your host, Mark Flather, Vice President of Investor Relations. Thank you.
It is now my pleasure computers your host Mark ladder, Vice President of Investor Relations. Thank you you may begin.
Speaker 3: Thank you, Doug. Hello and welcome to Visigen's conference call covering its fiscal year 2022 second quarter financial results and recent accomplishments.
Hello, and welcome to this conference call covering its fiscal year of 2022 second quarter financial results and recent accomplishments at Marshall out a vice President Investor Relations or decision. Thank you for joining us today and walk into our shareholders analysts and anyone taken an interest in decision joining me today or something or Chief Executive Officer.
Speaker 3: I am Mark Flatter, Vice President of the Vest Relations at Vistigen. Thank you for joining us today and welcome to our shareholders' analysts and anyone taking an interest in Vistigen. Joining me today are Sean Singh, our Chief Executive Officer, Jerry Dodson, our Chief Financial Officer, Dr. Mark Smith, our Chief Medical Officer.
Jerry Dodson, our Chief Financial Officer, Dr. Mark Smith, our Chief Medical Officer.
Speaker 3: Format for this call will consist of prepared remarks from management followed by an opportunity for questions. To ask a question during the Q&A portion of this call, be sure to hit star followed by the one key at any time to be placed into the queue.
After this call will consist of prepared remarks from management, followed by an opportunity for questions to ask a question during the Q&A portion of this call be sure to hit Star followed by the one key at any time to be placed into the queue.
Speaker 3: Please call us being webcast and we'll be available for replay. The link can be found in the investors IR calendar section of our website, vistagen.com.
This call is being webcast and will be available for replay the link can be found in the investors IR calendar section of our website Vista Gen Dot com on today's call. We will make forward looking statements regarding our business based on our current expectations and current information forward looking statements speak only as of today and accept as required by law do not assume any duty.
Speaker 3: 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. Do not assume any duty to update in the future any forward-looking statement made.
To update in the future any forward looking statements made today of course forward looking statements involve risks and uncertainties in our actual results could differ materially from those anticipated by any forward looking statement that we may make today additional information concerning risks and factors.
Speaker 3: course for looking statements involved risks and uncertainties, and our actual results could differ materially from those anticipated by any forward looking statement that we may make today. Additional information concerning risks and factors.
Speaker 3: that could affect our business and financial results is included in our most recent quarterly report on Form 10Q filed earlier today with the Securities and Exchange Commission.
That could affect our business and financial results is included in our most recent quarterly report on Form 10-Q filed earlier today with the Securities and Exchange Commission SEC and a future filings that we make with the SEC from time to time, all of which are or will be available on our website and the SEC website now with the formalities out of the way I'd like to turn the call.
Speaker 3: and in future filings that we make with the SEC from time to time, all of which are or will be available on our website and the...
Speaker 3: Now with the formalities out of the way, I'd like to turn the call over to our Chief Executive Officer Sean
Over to our Chief Executive Officer, Sean thing.
Speaker 4: Thank you, Mark. Good afternoon, everyone. On behalf of our entire team at VistaGen, thank you for joining this call today. We sincerely hope you are all safe, healthy, and doing well.
Thank you Mark good afternoon, everyone on behalf of our entire human visage and thank you for joining this call today, we sincerely hope, you're all safe healthy and doing well.
Speaker 4: The current mental health treatment paradigm requires new, faster acting medicine.
The current mental health treatment paradigm requires new faster acting medicines medicines without the negative side effects and safety concerns that are often associated with currently approved options.
Speaker 4: Medicines without the negative side effects and safety concerns that are often associated with currently approved op.
Speaker 4: As the prevalence of anxiety and depression disorders has grown considerably over the last 20 months, both in the US and across the globe, the unmet need has become more acute than ever.
As the prevalence of anxiety and depression disorders has grown considerably over the last 20 months, both in the U S and across the globe.
[noise] unmet needed to become more acute than ever.
Speaker 4: During the second quarter of our fiscal 22, we continued our strong performance and continued to build momentum across all aspects of our business.
During the second quarter of our physical twenty-two we continued our strong performance and continues to build momentum across all aspects of our business cause.
Speaker 4: As we head toward the end of 21 and into 2022, we are increasingly confident and excited about the potential of RC and SPIPeline to mitigate many mental health challenges and make meaningful improvements in the lives of millions of individuals around the world for suffering from the debilitating effects of anxiety and depression.
As we head towards the end of 21 and into 20 twenty-two we are increasingly confident and excited about the potential of R. C. N S pipeline to mitigate many mental health challenges and make meaningful improvements in the lives of millions of individuals around the world.
Sports suffering from the debilitating effects of anxiety and depression.
Speaker 4: Among the milestones we achieved during the second quarter of fiscal 22 was the initiation of Palisade II.
Among the milestones we treat achieved during the second quarter of physical twenty-two cause the initiation of palisade to.
Speaker 4: Second, major phase three trial in our Palisade Phase Three program for PH-94B in Social Anxiety Disorder or STD.
The second major phase three trial, and our palisade phase three program for ph, 94, B and social anxiety disorder or S. A D.
Speaker 4: Like Palisade 1, Palisade 2 is a US multi-center, randomized, double-blind, placebo-controlled Phase III clinical study designed to evaluate the efficacy, safety, and tolerability of our pH-94 DNA, full spray, or the acute treatment of anxiety in adults with SED.
Like past palisade, one palisade too is the U S multicenter randomized double blind placebo controlled phase three clinical study.
Designed to evaluate the efficacy safety and Tolerability of our ph 94, the nasal spray where.
What are the acute treatment of anxiety and adults with S. A D.
Speaker 4: As a reminder, according to the U.S. National Institute of Health, FAD is the third most common psychiatric condition in the U.S. after depression and substance abuse. And it now affects over 20...
As a reminder, according to the U S National Institute of Health S. A D is the third most common like you had your condition in the U S. After depression and substance abuse.
And then now sex over 23 million Americans.
Speaker 4: The initiation of PALS-A2 is another important step forward in our efforts to confirm the positive efficacy and safety data we observed in phase 2 development of pH 94B in SAD.
The initiation of policy too is another important step forward and our efforts to confirm the positive efficacy and safety data we observed in phase two development of ph 94, B N S. A D.
Speaker 4: successfully developed in our Palisade Phase 3 program. Phase 24B has the potential.
If successfully developed and are palisade phase three program.
Each 94, B has the potential to be the first F.
Speaker 4: FDA approved fast-acting, non-sedating, acute treatment of anxiety for millions in the US who suffer from the debilitating effects of SAD.
F D. A approved fast acting non to dating acute treatment of anxiety for millions in the U S to stop them from the debilitating effects of S. A D.
Speaker 4: Big 34B is designed to be used as needed on demand. It's an acute treatment of anxiety for adults with FAD, treating their anxiety and fear of embarrassment, judgment, or humiliation in the context of an anxiety provoking interaction.
He finally poor being designed to be used as needed on demand as an acute treatment of anxiety for adults with S. A D treating their anxiety and fear of embarrassment judgements or humiliation in the context of an anxiety provoking interaction.
Speaker 4: situation or event in a manner similar to how a rescue inhaler is used to prevent the onset of an asthma.
Situation or event.
In a manner similar to how a rescue inhaler is used to prevent the onset of an asthma attack or is it a cute migraine treatment is used to prevent the onset of a migraine episodes.
Speaker 4: or as an acute migraine treatment is used to prevent the onset of a migraine.
Speaker 4: A market approval of P-H-94B in the US would also pave the way for potential regulatory approvals in numerous additional high-value markets around the world.
A market approval of Th 94, B and the U S would also paved the way potential regulatory approvals and numerous additional high value markets around the world.
Speaker 4: All ongoing studies in our Palisade Phase 3 program for PH-94B and SAD are progressing well. And we remain on track for top-line data from Palisade 1 in mid-22 and from Palisade 2 in the second half of 2022.
All ongoing studies and Ah palisade phase three program for us for ph 94 be an S. T. D are progressing well and we remain on track for top line data from palisade, one in mid 22 and from palisade two in the second half of 2022.
Speaker 4: With this unique mechanism of action and safety profile, we've observed in all clinical studies today.
With its unique mechanism of action safety profile, we've observed in all clinical studies to date.
Speaker 4: We believe Pete's 904B also has therapeutic potential across a broad range of anxiety disorders beyond it.
We believe Pete's 94, B also has therapeutic potential across a broad range of anxiety disorders beyond S. A D.
Speaker 4: During the quarter, we launched our laboratory phase 2A clinical development program for pH 94B with the initiation of a phase 2A clinical trial and adjusted the disorder with anxiety.
During the quarter, we launched starts floor towards faith to a clinical development program for ph 94, B with the initiation of the face to a clinical trial and adjustment disorder with anxiety.
Speaker 4: With emotional stress and impaired functioning brought on by sudden changes in health, safety, economic and social circumstances that many have experienced at heightened level since the beginning of the pandemic, the increasing prevalence of adjustment disorder with anxieties become very apparent to our team and the clinicians within our ecosystem.
It was emotional stress an impaired functioning brought on by sudden changes in health they.
They see he can Mexican social circumstances that many have experienced at heightened level since the beginning of the pandemic.
The increasing prevalence of adjustment disorder with anxiety has become very apparent to our team and the clinicians within our ecosystem we.
Speaker 4: We believe P-940-PS potential to offer hope to the growing number of individuals whose ability to function in their daily lives has been impaired by the onset of a just
We believe Peach 94, B S potential to offer hope to the growing number of individuals whose ability to function in their daily lives. It's been impaired by the onset of adjustment disorder.
Speaker 4: We expect top line results for this phase 2a study in the second half of 2022.
We expect topline results for this space to a study in the second half of 2022.
Speaker 4: and the coming quarters, we plan to initiate additional small exploratory phase 2A studies to assess pH 34B's potential in populations suffering from anxiety disorders beyond SAD and adjustment disorder. We believe the current treatment alternatives are inadequate.
In the coming quarters, we plan to initiate additional small exploratory phase two eight studies to assess page 74 beef potential populations suffering from anxiety disorders beyond their C. D. An adjustment disorder, well, we believe the current treatment alternatives are inadequate.
Speaker 4: During the quarter, we also reported important new pre-clinical data on P-H-94B's potential mechanism of action.
During the quarter. We also reported important new preclinical data on ph 94, b as potential mechanism of action.
Speaker 4: Data from a tissue distribution study and laboratory rats demonstrate that a single intranasal administration of radio labelled P-94B was largely confined to the nasal passages, with minimal or undetectable levels in most other tissues, including the CNF.
Ada from a tissue distribution study in laboratory rats demonstrate that a single Internasal administration of Radiolabeled Peach 94, B was largely confined to the nasal passages with minimal or undetected will levels and most other tissues, including the C. N S.
Speaker 4: and importantly, no appreciable activity was observed in the brain. We believe these results further highlight how the mechanism of action of pH-9-4B was fundamentally differentiated from that of all current anxiety therapy.
And importantly, no appreciable activity was observed in the brain we.
We believe these results further highlighted how the mechanism of action of Pizza 94, B is fundamentally differentiated from that of all current anxiety therapies.
Speaker 4: Because PH-94B administered internationally involves binding to peripheral neurons in the nasal passages, we believe there's limited transport of PH-94B molecules to the circulatory system, thereby minimizing systemic exposure.
Because th 94 be administered intranasal involves binding to peripheral neurons in the nasal passages. We believe there's limited transport a peach 94, b molecules to the circulatory system, thereby minimizing systemic exposure.
Speaker 4: When this radio labeled pH-94B data is combined with previously announced pre-clinical electrophysiology data, demonstrating that the mechanism of action of pH-94B does not involve direct activation of GABA A receptors, which is in distinct contrast to the mechanism of action that bends it as-
When this radiolabeled ph knife would be data combined with previously announced preclinical electrophysiology data demonstrating that the mechanism of action of Pizza 94, B does not involve direct activation of Gaba a receptors, which is in distinct contrast to the mechanism of action benzodiazepines, we'll see a growing body of evidence.
Speaker 4: We see a growing body of evidence suggesting that pH 94B has potential to achieve anti-anxiety effects without requiring systemic uptake and distribution and without causing benzodiazepine-like side effects and safety concerns.
Testing the ph 94, b as potential to achieve anti anxiety effects without requiring systemic uptake and distribution and without causing benzodiazepine like side effects and safety concerns.
Speaker 4: Regarding our other clinical stage drug candidates, pH 10 nasal spray and our oral pro drug AB 101, we are on plan to initiate our phase to be study for pH 10 as a potential standalone rapid onset treatment of major defensive disorder in mid-22, and to initiate our drug drug interaction study of the combination of AB 101 with Probenicid in the end of this calendar year.
Regarding our other clinical stage drug candidates th 10 nasal spray in our oral prodrug gave you Wanna one we're on plan to initiate a face to be studied for ph 10, as a potential stand alone rapid onset treatment of major depressive disorder in mid twenty-two and to initiate our drug drug interaction study of the combination.
Asian, a baby one O one with probenecid near the end of this calendar year.
Speaker 4: We believe our current cast position is sufficient to advance our CNS pipeline well beyond the steady stream of potential data and regulatory catalysts from our policy to phase three program for pH 94B in SAD, not only in calendar 22, but into calendar 2023. As well as other important clinical opportunities.
We believe our current cash position is sufficient to advance R. C. N S pipeline well beyond the steady stream of potential data and regulatory catalysts for more palisade phase three program for ph 94, B and S. A D.
Not only in calendar twenty-two but into calendar 20 twenty-three.
As well as other important clinical opportunities across our pipeline.
Speaker 4: Believe we have the flexibility and options to further strengthen our balance.
Believe we have the flexibility and options to further strengthen our balance sheet.
Speaker 4: beyond the multiple key data readouts with potential to be significant value creating catalyst for the company.
And the multiple key data readouts with potential to be significant value, creating catalysts for the company.
Speaker 4: As we advance development of mental health treatments with groundbreaking potential, we've added to our strong team of great people with extensive experience in CNS drug development, clinical operations, CMC, commercial operations, and medical and regulatory affairs.
Cause we advanced development of mental health treatments with groundbreaking potential we've added to a strong team of great people with extensive experience in CNS drug development clinical operations, CMC commercial operations and medical and regulatory affairs.
Speaker 4: During our last quarter, we also expanded leadership expertise on our board of directors with the additions of Mary Routano and Maggie Fitzpatrick to our board, which now has a female led majority.
During our last quarter. We also expanded leadership expertise on a board of directors with the editions of married with tunnel and Maggie Fitzpatrick to our board, which now has a female lead majority.
Speaker 4: Navigate distinction and board representation within the biopharmaceutical space.
[noise] distinction and board representation within the biopharmaceutical space.
Speaker 4: Our experience team is well positioned to advance our programs through important late-stage clinical and regulatory milestones and navigated responsible path forward to potential commercialization of PH9-4B in social anxiety.
Our experienced team as well positioned to advance our programs through important late stage clinical and regulatory milestones and navigate a responsible path forward to potential commercialization of ph 94, b and social anxiety disorder.
Speaker 4: Our team is comprised of amazing individuals who not only possess vast knowledge and experience within our industry.
Our team is comprised of amazing individuals, who not only possessed vast knowledge and experience within our industry, but it also share a passion for social change in a line with our corporate values.
Speaker 4: But we also share our passion for social change and align with our corporate value.
Cause we forged forward is change makers of the mental health Arena, we are confident and very excited about the potential bar C. N S pipeline to make meaningful transformations in the daily lives with those impacted by mental illness.
Speaker 4: As we forge forward, it's change makers of the mental health arena. We are confident and very excited about the potential of our CNS pipeline to make meaningful transformations in the daily lives of those impacted by mental illness.
Speaker 4: Now I'd like to turn it over to Jerry Dotson, our CFO , to summarize some highlights from our fiscal year 22-second quarter financial results. Eric?
Now like to.
Turn it over to Jerry Dobson, our CFO to summarize some highlights from a fiscal year 22 second quarter financial results Gary.
Sean [noise].
Speaker 5: Sean. As Sean mentioned, I'll highlight a few items from the second quarter of our fiscal year 2022 financial results. 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.
Sean mentioned I'll highlight a few items from the second quarter of our fiscal year 20 twenty-two financial results I would also encourage everyone to review on a quarterly reports on Form 10-Q that we filed with the F. C. C. Earlier this afternoon for additional details and disclosures.
Speaker 5: For the second quarter of our fiscal year 2022, ending on September 30th, 2021, this did not recognize approximately $0.4 million in non-cash sub-licens revenue from the $5 million upfront payment that we received in the second quarter of fiscal 2021 related to our pH 94D development and commercialization agreement with Affamad Sarafutec.
For the second quarter of our fiscal year 2022.
On September 30th 2021, [noise] resurgent recognized approximately zero point $4 million in non-cash sublicense revenue from the 5 million dollar upfront payment that we received in the second quarter of fiscal 2021 related to our ph 94 the development.
And commercialization agreement with half of them in therapeutics.
Speaker 5: We recognize the approximately 0.3 million related to this agreement in the second quarter of fiscal year 2021 that ended on September 30, 2020.
We recognized approximately 0.3 million related to this agreement in the second quarter inch fiscal year 2021 that ended on September 30th 2020.
Our research and development expenses increased by about $7.7 million from 2.4 million to 10.1 million for the second quarter ended September 30th 20, <unk> and 2021, respectively.
Speaker 5: Our research and development expenses increased by about $7.7 million from 2.4 million to 10.1 million for the second quarter ended September 30th, 2020 in 2021. Respective.
This would increase results primarily from conducting or a palisade phase three program for ph 94, B N S. A D.
Speaker 5: This increase results primarily from conducting our Palisade Phase III program for pH 94B in SAD, with a continuation of Palisade I, and the initiation of Palisade II, and Palisade Long-Term Safety Study, as well as the initiation of our Phase II A study.
With the continuation of palisade, one and the initiation of palisade too.
In palisade Longterm safety study.
As well as the initiation of our phase two a study.
Speaker 5: of pH 94B for the treatment of adjustment disorder with anxiety.
Ph 94, b for the treatment of adjustment disorder with anxiety.
While we continued nonclinical development and outsource manufacturing activities for both ph 94, B N th 10.
Speaker 5: While we continued nonclonical development and outsourced manufacturing activities for both PH-94B and PH-10.
Speaker 5: All of that, accounting for increased expenses of approximately $5.9 million during the quarter ended September 30th, 2021, compared to the same quarter of the previous fiscal year.
All of that accounting for increased expenses of approximately $5.9 million. During the quarter ended September 30th 2021 compared to the same quarter of the previous fiscal year.
Speaker 5: Fowries and benefits expense for the quarter ended that Timber 30 is 2021, increased by approximately $1.6 million versus the expense for the comparable prior year quarter, primarily due to the hiring of additional senior management and other personnel focused on clinical operations, outsourced manufacturing activities, and regulatory affairs.
Salaries and benefits expense for the quarter ended September 30th 2021 increased by approximately $1.6 million versus G expense for the comparable prior year quarter, primarily due to the hiring of additional senior management and other personnel focused on clinical operations outsourcing.
Manufacturing activities and regulatory affairs.
Speaker 5: General and administrative expenses increased to approximately $3.1 million from approximately $1.3 million for the quarters ended September 30th 2021 and 2020 respective
General and administrative expenses increased to approximately $3.1 million from approximately $1.3 million for the quarters and did September 30th 2021, and 2020, respectively.
The increase was primarily due to the hiring of additional senior management personnel and expenses incurred.
Speaker 5: The increase was primarily due to the hiring of additional senior management personnel and expenses incurred in connection with various customary pre-commercialization activities for pH 94B.
Connection with various customary pre commercialization activities for ph 94 B.
Speaker 5: Our net launch for the second quarter of fiscal 2022.
Our net loss for the second order of some school 2022.
Speaker 5: quarter ending September 30th, 2021 was approximately $12.8 million versus a loss of $3.3 million for the Comprehensive Order of Fiscal Year 2021.
A quarter ending September 30th 2021 was approximately $12.8 million versus a loss of $3.3 million for the comparable quarter of fiscal year 2021.
Speaker 5: At September 30th, 2021, the company had cash and cash equivalent of approximately $93.6 million.
At September 30th 2021, the company had cash and cash equivalents of approximately $93.6 million.
Speaker 5: I'd also note that between October 1st, 2021 and today, the company has received approximately $1.1 million in the additional cash proceeds from the exercise as outstanding one.
I'd also note that between October 1st 2021 and today.
The company has received approximately $1.1 million in additional cash proceeds from the exercise is outstanding ones.
Again, please refer to our quarterly report on Form 10-Q filed earlier today with the SEC for additional details and disclosures.
Speaker 5: 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.
I'll now turn the call back to Sean.
Speaker 4: Thanks, Jerry. So we continue to march forward, determine the resilience and unwavering towards...
Thanks, Gerry so.
So we continue to March forward determined and resilience and unwavering towards several significant and potentially transformative milestones across our pipeline.
Speaker 4: several significant and potentially transformative milestones across our pipe.
Speaker 4: with patients and investor focused priorities, guiding our mission to improve the lives of millions of people who battle mental health challenges every day. Our team at Visage Inn is thankful for the privilege and for the opportunity to make a difference for those needing changes in their treatment office.
With patience and Investor focused priorities guiding our mission to improve the lives of millions of people, who battle mental health challenges every day.
Our team adversity, just thankful for the privilege and for the opportunity to make a difference for those needing changes in their treatment options are accomplishes this year and as we advanced towards our goal of becoming a top tier biopharmaceutical company would not at all be possible without the commitment and hard work in durance of our entire decision team our collaborators in our.
Speaker 4: Our accomplishments this year and as we advance towards our goal of becoming a top-tier biopharmaceutical company would not at all be possible without the commitment and hard work and endurance of our entire Visogen team, our collaborators and our stock.
Stockholders.
Speaker 4: We thank you for your continued support and we look forward to creating life-changing value for patients.
Thank you for your continued support and we look forward to creating life changing value for patients and for all of our stakeholders.
Speaker 3: Thank you, Sean. This concludes our prepared remarks. Operator, we'd like now like to open up the call for a question.
Thank you Sean This concludes our prepared remarks, operator, when Latin I'd like to open up the call for questions.
Thank you.
Speaker 2: Thank you. Ladies and gentlemen, at this time, we will be conducting an answer session. If you'd like to ask a question, you may press star one on your telephone keypad. A confirmation tunnel indicate your line is in the question queue. You may press star two if you would like to remove your question from the queue. For a participant, she's in speaker equipment, it may be necessary to pick up your handset before pressing the star key. Once again, that is star one to ask a question.
Ladies and gentlemen at this time, we well, we can talk to and and answer session. If you'd like to ask a question you May press star one on your telephone keypad, a confirmation total and you can't your line is in a question too.
You May press Star two if you would like to remove your question from the queue.
Four participants shouldn't speaker equipment, it may be necessary to pick up your handset before pressing the starkey once again that is star one to ask a question.
Speaker 2: Our first question comes from the line of Brian Scorney with Robert W. Baird. Please proceed with your question.
Our first question comes from the line of Brian Scorning with Robert W. Barracks. Please proceed with your question.
Speaker 6: Good afternoon everyone. Thank you for taking my question. I guess I'm on the initiation.
Hey, good afternoon, everyone. Thank you for taking my question I guess on the on the initiation of long, but I was just hoping you could kind of walk us through how to think about how randomize patients and screened out patients are handled in the follow up and and how how're you kind of look at monitoring me.
Speaker 6: as long as you study. I was just hoping you could kind of walk us through how to think about sort of how we're randomized patients and screened out patients are handled in the follow-up and how you kind of look at
Speaker 6: monitoring the the grudge level, drug exposure levels that they have. And then I think the gating factor on the study was animal talk studies. I guess was there anything of note in those studies to speak up and to assume that being clear to enroll patients on the study means there was nothing of note.
The drug level drug exposure levels that they have and then I think the gating background. The study was with animal talk studies I guess, what <unk> was there anything of note in those studies to speak up and can we assume that being cleared to enroll patients on the study means there there was nothing of note.
[noise] Hey, Brian Thanks for the question. So no there was nothing we note in the six months talk studies that support us getting into the long term safety study Mark Smith's are cmo's on I'll, let market dress some of your questions regarding the study.
Speaker 4: Hey, Ryan, thanks for the question. So, no, there was nothing to note in the six months talk studies that support us getting into the long-term safety study. Mark Smith, our CMO's on, I'll let Mark address some of your questions regarding the study.
Speaker 4: It's not going on. It's not going on. It's not going on. Yeah, so the placebo control studies, we are looking for patients who get very stressed out by public speaking. So we're kind of self-selecting some of those patients. But for the long term safety, we're really looking for all comers.
And if I could go on.
Yeah. So the [noise] the placebo controlled studies, we are looking for patients who.
Get very stressed out by public speaking so we're kind of you know self selecting some of those patients but for the long term safety, we're really looking for all comers.
Speaker 7: Pretty much everybody was social anxiety disorder. We want to give them a try on this medication. So those that maybe didn't quite make the inclusion exclusion for the placebo control, maybe because they were...
Pretty much everybody with social anxiety disorder, we wanted to give them a try on this medications. So so that maybe didn't quite make the inclusion exclusion for the placebo controlled maybe because they were not.
Speaker 7: not quite thick enough or maybe they were on already taking like an SSRI. They're on to background medications.
Not quite sick enough or maybe they were on already taken like an SSRI. There on some background medications that were not allowed in the placebo controlled sake. We're we're allowing all those people know to come in to the long term safety. So a lot of those people who screen failed for the two randomized trials.
Speaker 7: that we're not allowed in the placebo controlled site. We're allowing all those people now to come in to the long-term safety. So a lot of those people who screen-failed for the two randomized trials, we will allow them to go in now to the long-term safety. Now the FDA has given us the green light on that. So I think it'll be very interesting to see how some of these other patients.
We will allow them to go in now to the long term safety. The has the F. D. A has given us the green light on that so I think it'll it'll be very interesting to see how some of these other patients.
Speaker 7: you know respond to the medication and also those with we want to make sure that it's safe to use on top of background any depress
Respond to the medication and also those with we want to make sure that it's safe to use on top of background antidepressants.
Speaker 7: which we believe it will be, but this will provide some evidence for the
In which we believe it will be but this will provide some evidence for that.
Speaker 7: And you also asked about how do we monitor how much they're taking. So it's two ways. The old fashioned way, we essentially weighs a mile before and after each visit.
And maybe it also asked about how do we monitor how much they're taking so it's two ways Ah the old fashioned way we.
Essentially way the bio vial before and after each visit that'll give us an indication of how many.
Speaker 7: That'll give us an indication of how many administrations they delivered. And the second way is we're asking them to actually record on a cell phone app. So they'll each have an app on their smartphone. And we ask them at the end of each day to record how many times they took it.
Administrations they delivered.
The second way is we're asking them to actually record on a cellphone app so they'll.
They'll eat each have an app on their smartphone and we asked them at the end of each day to record how many times they took it and the previous outpatient study on average even though they can take it up to four times a day on average they took it about one and a half times a day. So we'll see if that continues.
Speaker 7: In the previous outpatient study on average, even though they can take it up to four times a day, on average they took it about one and a half times a day. So we'll see if that continues in this long-term safety. That'll be important information, I think, for us.
News in this long term safety that'll be important information I think for us as two guiding the folks how to take this medication.
Speaker 7: as to guiding folks how to take this medication.
Great and then maybe if I could just ask a follow up on I'm, just trying to get some granularity on sort of how to think about the timeline for palisade read out I think the in the protocol. It allows for up to seven weeks from screening to last visit a patient. So should we all sorts of <unk>, maybe another six weeks on top of that for data.
Speaker 6: Great. And then maybe if I get just a follow up on just trying to get some granularity on sort of how to think about the timeline for Palisade read out. I think in the protocol, it allows for up to seven weeks from screening to last visit of a patient. So should we also expect maybe another six weeks on top of that for data lock and scrubbing. I'm just trying to figure out like once you announce the completion of enrollment, would you think it's about a quarter from that completion to top line data? Yeah, I'd say for it.
<unk> scrubbing I'm, just trying to figure out like once you announced the completion of enrollment would would you think it's about a quarter from from that completions the top line data.
Yeah, I'd say four to six weeks you know after we enroll our last patient.
Speaker 7: after we enroll our last patient. So, you know, the protocol itself could go fairly quickly, but yes, you're right. I mean, there could be a little prolonged screening period. So, yeah, four to six weeks, I would expect.
So you know the the protocol itself could go fairly quickly, but yes, you're right I mean, there could be a little prolong screening period. So yeah four to six weeks I would expect.
Okay. Thank you mhm.
Uh-huh.
Speaker 2: Our next question comes from the line of Andrew Psywood Jeffrey. Please receive a new question.
Our next question comes from the line of Andrew Sorry, what Jeffrey. Please proceed with your question.
Speaker 8: Hey, good afternoon. This is part of the emergency for Andrew. So I just have a few questions and I appreciate your time today. If I could begin, you know, you just briefly talk about the caravan 14 regular level study to see where the drug goes. To confirm, it does stay in the peripheral neurons and do not get into the brain. Do you know how it gets eliminated by the body?
Hey, good afternoon.
Associates for Andrew size send a few questions and I appreciate your time today.
If I could begin you know you can't really.
They talk about the cardio the carbon 14 regulate this study to see what a drug does too.
To confirm it does say in the peripheral neurons in does not get into the brain do you know how it gets eliminated by the body.
[laughter]. Good question [laughter]. Good question the shorter answer a short answer is we really don't know in this particular study most was gotten eliminated through the feces and some in the here and now I'm not sure that's true and man to be honest because.
Speaker 7: Good question. Good question. The shorter answer is we really don't know. In this particular study, most was gotten eliminated through the feces and some in the urine.
Speaker 7: Now, I'm not sure that's true in man, to be honest, because I think in this particular study, we were giving a lot of volume to these rats, and I think some of it went back down their nasoferinx and into the...
I think in this particular study we were given a lot of volume two these rats and I think some of it went back down there nasopharynx and into their got that.
Speaker 7: That could happen in humans as well if they sniff too hard or something. But the shorter answer is we don't believe...
That could happen in humans as well, if they sniff too hard or something.
But the shorter answer is we don't believe.
Speaker 7: It's taken up into the brain. That was very clear in this study. That most of it was contained in the nasaferin, and then some of it went back down the throat. But a lot of people try to give drugs through the nose like oxytose and hoping that some will get across.
It's.
Taken up into the brain.
That was very clear in this study that most of it was contained in the nasopharynx and then some of it went back down the throat, but.
No, but a lot of people try to give drugs.
Through the nose.
[noise] nose, and like oxytocin, hoping that some will get across.
Speaker 7: and then into the brain. That is not why we're giving this in the nose. We're giving it in the nose because that's where the receptors are. But back to your question, how to eliminate it. Honestly, we don't know completely. We actually, we were just researching this and much to my surprise.
And then into the brain that is not why we're giving this in the nose were given in the nose, because that's where the receptors are but back to your question how to eliminate honestly, we don't know completely we actually I was just we were just researching this and much to my surprise, we learned to that.
Speaker 7: We learned that the nose actually has a lot of cytochrome P450 enzymes in it, not as much as the liver, but quite a substantial amount. And so obviously this is a mechanism by which drugs can be metabolized, so it may be metabolized locally right in the nose.
The nose actually has a lot of cytochrome P 450 enzymes in it.
Yeah not.
Not as much as in the liver, but quite a substantial amount you know and so obviously this is you know a mechanism by which drugs can be metabolized. So it may be metabolized locally right on the nose much to my surprise to be honest and we may investigate that so that that actually.
Speaker 7: much to my surprise to be honest and we may investigate that. So that actually may be how it's eliminated. And one other caveat for that C14 experiment.
Maybe how it's eliminated and one other caveat for that C. 14 experiment, we were measuring C. 14. So we don't know if the the ph 94, B was modified it could've been metabolized and so whatever what small amount we were seen in the.
Speaker 7: We were measuring C14, so we don't know if the PH94B was modified, you know, could have been metabolized. And so whatever, what small amount we were seeing in the body, we're not even sure that was parent drug. So still a lot to be learned.
And the body, we're not even sure that was parent drug so I'm still a lot to be learned here.
Thank you for the excellent.
Speaker 8: Thank you for the explanation to follow up just briefly on that. Do you know if there's any changes in heart, ray or blood pressure after administration into the nasoferin?
Explanations you follow up just briefly on that you know if there's any changes in heart rate or blood pressure after administration instead of nasopharynx.
So early experiments that Dr. Monte did discover these ferrets early experiments when he was back in academia. He did see some transient changes in blood pressure and heart rate and mainly to Ah Ah.
Speaker 7: So early experiments that Dr. Monty did, the discover of these experiments, early experiments when he was back in academia, he did see some transient changes in blood pressure and heart rate. Mainly to a slight decrease in blood pressure, slight decrease in heart rate and heart rate variability.
Slight decrease in blood pressure slight decrease in heart rate and heart rate variability. So yes, there were some transitory effects. So we do believe this does affect the sympathetic parasympathetic nervous system and we're actually looking forward now to some small studies.
Speaker 7: So yes, there were some transitory effects, so we do believe this does affect the sympathetic, parasympathetic nervous system. And we're actually looking forward now to some small studies.
Speaker 7: not part of the placebo control because we didn't want to complicate that. But some smaller studies where we will be examining this and heart rate blood pressure, skin conductance was a consistent change. We'll be also looking at this in an upcoming PTSD study where we enroll PTSD patients.
[noise] not part of the placebo control because we didn't want to complicate that but some smaller studies, where we will be examining this and.
Heart rate blood pressure skin conductance was a consistent change will be also looking at this in an upcoming Ptsd's study, where we enrolled PTSD patience and look at some biomarkers like this because we believe this drug part of this mechanism of action is to tone down.
Speaker 7: and look at some biomarkers like this, because we believe this drug, part of its mechanism of action is to tone down the fight or flight response. And so we'll be measuring these biomarkers in upcoming studies. Oh.
Fight or flight response, and so we'll be measuring these biomarkers an upcoming studies.
That will provide more guidance on that as we go forward.
Speaker 8: Thank you. Just a few more questions. So we know that the palestate one and two studies are ongoing. Do both US palestate studies need to be successful for you to file an NDA? Because we asked only because the phase two had a very high P value. So could that be a supporting study? And what do you do in one of the two studies failed? Do you have some sort of head or backup that you can leverage?
Oh. Thank you just a few more questions. So we know that the palisade one and she studies are ongoing.
Both U S palisade studies need to be successful for you to file an MBA because we asked them only because the face you had a very high P value so could that be a supporting static.
What do you do it one of the two studies failed. So you have some sort of a head your backup that you can leverage yeah.
Yeah.
Speaker 4: Good question. Well, that's the standard required. Mark, let me address this. The standard requirement is what applies here. So obviously, as is the case normally, you need two adequate well-controlled studies to anchor your NDA.
Good cloud is the theater require Mark let me dress is the standard requirement is what applies here. So obviously as is the case normally you need to adequate well controlled studies to anchor your NDA.
Pelted one policy to our intended.
Speaker 4: to suit that purpose if one of them doesn't read out as supportive then we also have a Palestinian global
To suit that purpose, if if one of them doesn't read out as supportive then we also have palisade global.
Speaker 4: that will start sometime in the middle of next year. That will be to support regulatory submissions outside the United States.
That will start sometime in the middle of next year that will be to support regulatory submissions outside the United States, but it could also be further supportive of what we might need to do in the U S. I don't think it's safe at the moment, we certainly haven't had guidance from the agency that the phase two study could be used to support just adding one.
Speaker 4: but it could also be further supportive of what we might you to do in the US. I don't think it's safe at the moment. We certainly haven't had...
Speaker 4: guidance from the agency that the Phase II study could be used to support just adding one more phase study, a Phase III study on top of that. So I think we have to just assume that the track we're on is intended through this whole program is intended to ultimately successfully support the NDA and the United States in mid-23.
More face study Ah phase three study on top of that so I think we have to just assume that the track. We're on is is intended through this whole program is intended to ultimately a successful support the the NDA in the United States mid twenty-three.
I'll say global would launch we expect some time in the middle of next year.
Speaker 4: How the global would launch, we expect some time in the middle of next year.
Gosh, that's the global phase three trial.
Speaker 4: Yeah, it'll be a replicate of what we see in Pals, they'd one Pals, they'd two, or just involve whether jurisdictions besides the United States. So let's take a break, thank you.
Yeah, it'll be a replica of what we see in palisade ones healthy too or just involve other jurisdictions.
Besides the United States.
Wonderful okay. Thank you.
Speaker 8: And again, just a few more questions. The next question is, you know, think a little bit about the competitive landscape in SAD, other than the SSRIs, Fenzos, beta blockers. We see that companies are starting up anxiety studies. So what's your messaging around that competitive environment?
And again, just a few more questions. The next question is.
About the competitive landscape and S. A D. Other than the U S. S. R. I's Benzos beta blockers, let me see.
That companies are starting up.
Anxiety studies, so what's your messaging around that competitive environment.
Speaker 4: Well, look, there's never one size fits all for any of these neuropsychiatric indications. We are considerably downstream, as you know. We're certainly not aware of anybody in the Phase III arena, who's got...
Well look there's never one size fits all for any of these neuropsychiatric indications, where we are considerably downstream. There's you know we're certainly not aware of anybody in the phase III Arena, whose Scott.
Speaker 4: type of product profile that we're advancing with pH 94B. So we certainly hope the world continues to get as many anxiety and depression.
Type of product profile that we're advancing with ph 94 b. So.
We certainly hope the world continues to get as many anxiety and depression treatment options as possible because we do know that no one size fits all but on the other side were extremely confident about where we're positioned with with.
Speaker 4: treatment options as possible because we do know that no one sites fits all. But on the other side, we're extremely confident about where we're positioned with Peace 94 being a social anxiety disorder.
With pizza 94, being social anxiety disorder.
Speaker 8: Gotcha, thank you. And so for PE34B for adjustment disorder, you started the phase 2 study. How did you end up choosing kind of the four times a day, dosing regimen rather than, you know, 2 or 6? And what makes you kind of feel that four times a day dosing will be a safe ineffication.
Gotcha. Thank you and so for a P. H I think will be for adjustment disorder. You started the phase two study how did you end up choosing kind of the four times a day dosing regimen, rather than you know two or six and what makes you kind of feel that four times a day dosing.
Will be safe and efficacious.
Speaker 4: Remember, our objective with the program, the Phase 2A program is to be able to explore not PSI for these potential in a fairly broad range of anxiety disorders beyond SAD. So these are exploratory Phase 2A studies, which means first time in these populations.
Well remember our objective with the program the face to aid programs to be able to explore not pizza for these potential in a fairly broad range of anxiety disorders beyond S. A D. So these are exploratory phase two a studies, which means first time in these populations.
Speaker 4: And so it may not be that 94b is used the same way in all different anxiety disorders
So it may not be that 94 bees use the same way in all different anxiety disorders.
Speaker 4: And is this one designed from a different perspective as you've just noted? I'll let Mark add a little more color to that, but our purpose here, remember, these are small exploratory phase 2A studies to try to get some information, to be able to assess potential to move in the phase 2B, as we want to see additional indications for pH 94B, as we build on top of what we hope to be, the initial first and foremost focus in social anxiety.
And is this one is designed from a different perspective as you just noted I'll, let Marc out a little more color to that but our our purpose here I remember these are small exploratory phase two a study tried to get some information to be able to assess potential to move into phase two b.
As we want to see additional indications for page 94, B as we build on top of what we hope be the initial first and foremost focus.
In social anxiety disorder.
Mark.
Speaker 7: Yeah, so the way we chose the dose was really based on our preclinical talk studies. So we gave that four times a day, intranasally, in our talk studies. So we knew that we had coverage for that preclinically.
Yeah. So the the way we chose the dose was really based on our preclinical talk studies. So we in the [noise].
<unk> gave that four times a day enter nasally and our talk studies. So we knew that we had coverage for that Preclinically. So this is the highest recommended dose 3.2 micrograms intranasal a four times a day. So we decided you know because this is.
Speaker 7: So this is the highest recommended dose, 3.2 micrograms, intranasally, four times a day. So we decided, you know, because this was the first time, actually one of the very first placebo-controlled trials I'm aware of in the U.S. in adjustment disorder, we decided to just push our dose, you know, because it's been so well tolerated and give it the best chance in this disorder beyond SAD.
The first time actually one of the very first placebo controlled trials I'm aware of in the U S and adjustment disorder, we decided to just push our dose because it's been so well tolerated and give it the best chance in this disorder beyond.
D.
Gotcha and you know what.
Speaker 8: Data have you seen to kind of show that this drug will have an effect kind of throughout the day given kind of, you know, our long work days anywhere from like 8 a.m. wake up, six a.m. wake up, you know, 10 o'clock in the morning, 10 o'clock in the morning,
Data have you seen to kind of show that this drug will have.
Kind of throughout the day, given kind of you know our long workdays anywhere from like eight am wake up successfully.
10, 11 PM sleep time.
Mhm, yeah. So.
Speaker 7: Yeah, so again, most of our studies have been single dose, but we did have one outpatient study where they, in social anxiety disorder, where they were allowed to take it up to four times a day.
Again, you know.
Most of our studies have been single dose, but we did have one outpatient study, where they and and social anxiety disorder, where they were allowed to take it up to four times a day.
Speaker 7: um... and like i said they on average they took it one and a half there were few people that took it you know two or three uh... times a day uh... there were uh... can't recall anybody that needed to take it you know boom boom boom you know uh... it seemed and this is anecdotal but it seemed from that study that people were taking it you know one two times a day and that seemed to be sufficient
And like I said, they on average they took it one and a half there were a few people that took it two or three.
Times, a day there was I can't recall anybody that needed to take it you know boom boom boom you know so it seems this is anecdotal but it seemed from that study that people were taking it one two times a day and that seemed to be sufficient but again, we do.
Speaker 7: But again, we do plan to do another study next year where we address the question you've just posed to see what happens with people do redose. How long does the dose last?
You plan to do a another study next year, we address the question of just post to see what.
What happens with people do Redose, how long does the dose last and so it will be addressing those some of those questions next year and some ancillary studies.
Speaker 7: and so we'll be addressing some of those questions next year in to mancillaries.
One of the key benefits of the product profile that we envision for Pete's 94, B is the fact that it does have a.
Speaker 4: But one of the key benefits of the product profile that we envision for P-94B is the fact that it does have a shorter duration of effect than say, a benzodiazepine, and that allows us...
A shorter duration of effect and say a benzodiazepine and that allows us.
Speaker 4: hope and some confidence that it's going to be a very flexible treatment alternative for people. There are not only multiple different events within a particular day where people might have anxiety-provoking triggers.
Some hope and some confidence that it's going to be a very flexible treatment alternative for people that are not only multiple different events within a particular day, where people might have anxiety provoking triggers.
Speaker 4: but it could be the very same event throughout a longer period in the day. So the ability to use the drug up the four times a day is very important and that it should not, as we've seen so far in our clinical development, impair, talkative functioning and sports sedation. It's really distinct from what a benzodiazepine delivers.
But it could be the very same events throughout a longer period and a day. So the ability to use the drug up to four times a day is very important and that it should not as we've seen so far in all clinical development impair talking to a functioning and or sedation, it's really distinct from a benzodiazepine delivers.
Speaker 4: and even as to the rapidity of the onset. So, faster onset, but without the side effects and safety concerns of benzodiazepines is a critical component of why we are advancing a pH 94 B forward in the city.
And and even as to the rapidity of the onset so fast or onset, but without the decided effects and safety concerns of benzodiazepines as a critical component of why we are advancing a ph 94 b forward in the city.
Yep, Thank you and I mean, they're definitely seems to be in on that need it in that category I. Just wanted to ask do you have time for a few more questions.
Speaker 8: Yes, thank you and I mean there definitely seems to be an undetected category. I just want to ask you have time for a few more questions.
Clark.
Oh sure [laughter].
Speaker 9: I want to come back. Yeah, we would happen to take additional questions, but yeah, we've got a few more in the queue and we'll come back if the questions aren't answered. Is that good?
I wonder.
Let's go back to you I would happy to take additional questions, but yeah. We've got a few more in the queue and we'll come back if if the questions aren't answered that good yeah.
Wonderful thank you.
Excellent.
Speaker 2: Our next question comes from the line of Tim Lugo with William Blair. Please proceed with your question.
Our next question comes from the line of Tim Lugo with William Blair. Please proceed with your question.
Oh, Thanks for taking my question congratulations on the progress in the corner.
Speaker 10: No, thanks for taking the question and congratulations on the progress in the quarter. Mark, I think you mentioned giving the prior experience, you were expecting a 1.4 or maybe 1.5 times a day use. Is that roughly what's occurring in the open label study as of now? And I guess as a follow up, I know there's an maximum of four times a day. Is there also a minimum in that study for how much patients use per day?
Mark I think you mentioned given the prior experience you were expecting a 1.4 or five times a day cause that's roughly what's occurring in the open label study as of now.
And.
I guess as a follow up I know, there's a match my little four times a day. So they're also a minimum not study or how much patience meals per day.
It's too early to tell what the average dose is gonna be we'll be monitoring that though throughout the study.
Speaker 7: It's too early to tell you know what the average dose is going to be. We'll be monitoring that though throughout the study.
Speaker 7: But no, there's no minimum. And we instruct patients they don't have to take it every day. And that's the beauty of this drug is that they only take it when they need it. I mean, they may go several days and not.
But no there's no minimum and you know we instruct patients they don't have to take it every day and you know and that's that's the beauty of this drug is that you know they only take it when they need it I mean, they may go several days and not.
Speaker 7: you know encounter a social stressor. So in those days there's no need to take it.
Counter Ah social stressors, so in those days, there's no need to take it but then another day. They may have a very stressful day and they may need to take it two or three times that day. So there's no minimum there is a maximum of four based on our.
Speaker 7: But then another day they may have a very stressful day.
Speaker 7: and they may need to take it two or three times that day. So there's no minimum, there is a maximum of four based on our talks work.
Talks talks work, but no minimum and we will be will.
Speaker 7: but no minimum and we will be monitoring this through the app regularly. But I don't have any data to share with you right now.
We will be monitoring this through the app regularly, but I don't have any data to share with you right now.
Okay, well, that's that's that's understandable.
Speaker 10: Okay, let's understandable. And for the long term study, since you don't have a public speaking requirements in that trigger, are you collecting through the app? What is kind of triggering you?
In the long term study since it since you don't have the public speaking requirements and that trigger are you collecting through the what is kind of triggering you.
No not per se.
Speaker 7: No, not per se. We are actually looking into that. We are discussing that. That was measured in the phase two study.
They were actually I'm looking into that we are discussing that that that was [noise] measured in the phase two study at.
Speaker 7: And, you know, there was various things that that study was all done in New York. So, there were, you know, things like being on, you know, subways and stuff that were individual, maybe, to that environment.
And you know there was various things that that study was all done in New York. So there were you know things like being on you know subways and stuff that were individuals maybe to that environment, but.
Speaker 7: We're discussing that, whether that would be feasible, but currently we're not collecting that information.
We're we're discussing that whether that would be feasible, but currently we're not collecting that information.
Speaker 10: Okay, and can you just roughly describe how enrollment is going in Palisade 1 and your happiness with site conduct today?
Okay and can you just roughly describe how enrollment a growing in palisade one and.
Happiness at the sight conduct today.
Speaker 7: Yeah, I mean, it's going according to plan and we were pretty confident we will deliver as planned. Now, you know, next summer.
Yeah, I mean, it failed and according to our plan and yeah, we were pretty confident we will deliver.
As planned the next summer.
Speaker 10: Okay, it's great to hear. And maybe one last question. Can you just talk about, I know you have the adjustment disorder study up and running. And I also know that you're planning on a number of other phase 2A, so can you kind of get us a map of the additional phase 2 when you expect to start on and when we can start seeing some data coming out of us?
Okay, that's good to hear and and maybe one last question and can you just talk about I know you have the adjustment disorder setting up and running.
And I'll also though that you were planning a number of other faiths to it. So she can kind of give us a map of the additional faith too when you're supposed to start.
Where he can start system data coming out of it.
Speaker 4: There are some of those studies we've mapped out for you before. 2022 will be initiating what is the remaining?
Yeah, that's the thing most of those studies.
We've mapped out for you before 2022 will be initiating the remaining.
Speaker 4: components from the Phase IIA, Exploratory Phase IIA program for 94B. So, some will start in the first half of the year and others in the second half of the year in 22. But they all should be up and running during the course of 22. The adjustments to SOAR study should read out near the end of 22. The others won't read out in 22 most likely, but adjustments to SOAR study will.
Components from the phase two eight exploratory phase two a program for 94 B. So some will start in the first half of the year and others in the second half of the year in 22, but they all should be up and running during the course of 22. The adjustment disorder study should read out near the end of 22 and the other's won't read out in <unk>.
The two most likely but just in sort of study will.
Okay, great to hear congrats on the cargo.
Makes sense.
Our next question comes from the line, Okay. So Mccarthy with Maxim Group. Please proceed with your question.
Speaker 2: Our next question comes from one of Jason McCarty with Matt from Group. Please receive a good question.
Speaker 4: Hey guys, thanks for thinking the question. A lot of questions asked and answered. Sounds like a lot of progress has been made. Maybe a very broad general question. Sean, maybe or Mark, maybe you guys can talk a little bit about your thoughts on...
Hey, guys. Thanks for taking the question a lot of questions asked and answered it sounds like a lot of progress has been made maybe a very broad general question sure maybe or Mark maybe you guys can talk a little bit about your thoughts on.
Speaker 4: The mental health space, particularly what happens after the compass read out the other day. And, you know, the views of the space around the need for safety with some of these drugs. It was a big deal on the psychedelic side, but there's a lot of positive safety aspects around 94V and the drugs that you're developing. Can you talk a little bit about that impact?
The mental health space, particularly what happened after the confidence read out the other day and the views of the space around the need for safety with some of these drugs. It was a big deal on the psychedelic side, but there's a lot of positive safety aspects around 94, b and the drug.
That you're developing can you talk a little bit about that impact.
Speaker 4: Yeah, absolutely. It's a critical component of every screen that we put into each candidate across the pipeline. And the safety is a critical component of the success we think of any drug and either neuropsych or neurology. So the tradeoff you typically have to make.
Yeah, absolutely. It's a critical component of every screen that we put in to each candidate across the pipeline and the safety is a critical component of the success, we think of any drugs in either neuropsych or neurology. So the trade off you typically have to me.
Speaker 4: between the benefits for the underlying condition and the cost associated with the satisfaction of safety concerns. It's a...
Between the the benefits or the underlying condition and the costs associated with the side effects and safety concerns. It's it's.
Speaker 4: It's a tough challenge sometimes, especially as it affects compliance. So each of our three candidates, as in all clinical work today, no preclinical work supportive of that, it just had an exceptional...
It's a tough challenge, sometimes especially as it affects complain so each of our three candidates as in all clinical work today no preclinical work supportive of that it's just had an exceptional.
Speaker 4: side effects and safety profile. And a lot of that has to be really driven towards the mechanism of action. And whether it's the fairings or whether it's AV-101, there's a differentiation from what's out there today that has very...
Side effects and safety profile and a lot of it has to be really driven towards the mechanism of action and whether it's the fairings or whether it's easy one O. One.
There's a differentiation from what's out there today that has very well established concerns associated with their use we just don't see those and.
Speaker 4: well-established concerns associated with their use. We just don't see those. And...
Speaker 4: To be able, especially what we've seen recently with 94B in the GAVA A study and in the C14 study, it just continues to fortify what we had thought about these candidates going into them early on. It's just there, they're completely different. It's not have to require...
To be able, especially what we've seen recently with 94, B and the Gaba a study and and the.
C 14 study it just continues to fortify what we had thought about these candidates going into them early on it's just there are completely different to not have to require systemic uptake and distribution of 94, b intend to achieve anti anxiety and anti depressant effects.
Speaker 4: and distribution of 94B and 10 to achieve anti-anxiety and antidepressant effects.
Speaker 4: That's radical. And it's something that we think if we're successful in the space 3 program with 94B, it will carry us quite well into the commercial arena. So it's a big deal. We've seen, again, as Mark laid out to you some of the rational, we think it supports why we're seeing.
Yeah, that's radical and it's something that we think if we're successful in the space program with 94, B It will carriers white well into the commercial arena. So it's a big deal. We've seen again is mark laid out to you. Some of the rationale we think that supports why we're seeing such.
Speaker 4: such an excellent safety profile. And I think is...
Such an excellent safety profile and I think is.
Speaker 4: As things continue in the program, I don't think we anticipate seeing anything different than what we've seen so far through clinical development, but of course we're going to be watching it carefully.
You know if things continue in the program I don't think we anticipate seeing anything different than what we've seen so far from clinical development, but of course, we're going to be watching it carefully.
Great. Thank you Sean.
Speaker 2: Our next question is follow up from Andrew Pry with Jeffries. Please proceed with your question.
Our next question is a follow up from Andrew Sorry was that please. Please proceed with your question.
Thank you I just wanted to know I appreciate the time that you've taken today to answer them. All of these questions very thoroughly I'm sure that the street.
Speaker 8: Thank you. I just want to note, I appreciate the time that you've taken today to answer all of these questions very thoroughly. I'm sure that the Street Appreciation as well as investors do. Just one last question for you. You know, presumably in the face to study for pH 94B, there were patients that did not respond to the drug. So you're a figure out why that may be the case. And if so, you'll do it too. So, youFCC this?
Street appreciates as well as investors do just one last question for you you know presumably in the face to study for a ph 94, B there were patients that is.
Not respond to the drug.
Figure out why that may be the case and if so how did you address it in the phase three study just trying to I'm wondering how you can maximise essentially the probability of success for those phase three trials.
Speaker 8: How did you address it in the Phase 3 study? Just trying to, I wonder how you can maximize, essentially, the probability of success for those Phase 3 trials.
Mark go ahead and just that.
Yeah.
Speaker 7: Well, I'll take the second part of your, how do we maximize probability of success? I mean, it's really through a two-step inclusion, exclusion criteria.
Well I'll I'll take the second part of your Ah how do we maximize probability of success I mean, we it's really through a two step inclusion exclusion criteria. So were including patients you know who have pretty severe social anxiety disorder.
Speaker 7: We're including patients who have pretty severe social anxiety disorder. That's based on the Leibowitz scale. So we're looking for patients like that. But on top of that, we're also making sure that they have a sufficient response.
We you know that's based on the Leibowitz scale and so we're looking for patients like that but on top of that.
We're also making sure that they have a sufficient [noise] you know response stress response to the public speaking itself. So we're looking for people, who you know [laughter] get pretty stressed out by the five minute talk we ask them to do and does that mean, so where you know where we're asked.
Speaker 7: to the public speaking itself. So we're looking for people who, you know, get pretty stressed out by the five minute talk, we ask them to do. And does that mean, so we're, you know, we're asking a lot of these subjects that we appreciate them, you know, participating in this study. So I think that the fact that they have high scores,
And a lot of the subjects that we appreciate them participating in the study. So I think that the fact that they have high scores.
Speaker 7: coming in makes them more sensitive to see a drug effect. So that's sort of how we're maximizing our success. I'm really following on the phase two protocol very closely. Now back to your question, yes, there were some patients who didn't respond. I think it was trying to remember. I think it was about 25-
Coming in makes them more sensitive to see a drug effect. So that's that's sort of how we are maximizing bar success I'm really following on the phase two protocol very closely [laughter] now back to your question. Yes. There were some patients who didn't respond I think it was trying to remember I think it was about two.
530%, who did not respond.
Speaker 7: who did not respond completely to the drug in the phase two. And it's a good question. We don't know exactly what will predict response and not response genetically or physiologically. I think that's an interesting question, but it is the minority of people who did not respond luckily.
Completely.
To the drug in the face too and it's a good question. We don't know exactly what will predict response and not response, you know genetically are physiologically.
I think that's an interesting question, but it is a minority of people who did not respond luckily.
Speaker 7: and didn't seem to be related to gender that we can tell because in the open label study, both males and females responded to the drug.
And it didn't seem to be related to gender that we can tell because in the open label study both males and females responded to the drug doesn't seem to be related to age or gender, but you know, we'll continue to look into that and because I I agree. It is an important question.
Speaker 7: Doesn't seem to be related to age or gender, but you know, we'll continue to look into that and because I agree it is an important question
Speaker 7: But it is a minority, thankfully, at least from that phase two.
But it is a minority thankfully at least from that phase two data.
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Speaker 3: All right, that's all the time we have for questions today. If you have any additional questions, please contact us at IR at fifthagend.com or call any of the phone numbers listed on our press release today. Thank you for tuning in and we appreciate everyone's attention and support. We look forward to keeping you current on our continuing progress. This concludes our call. Have a great day and you may all disconnect now.
Continuing progress.
Conclude your call and have a great day and you may all disconnect now.
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Speaker 1: The pro.