Q3 2020 BioXcel Therapeutics Inc Earnings Call
All participants are in a listen only mode.
Operator: At this time, all participants are in a listen-only mode. Just to remind everyone, certain matters discussed in today's conference call and or answers that may be given to questions asked are forward-looking statements that are subject to risks and uncertainties relating to future events and or the future financial performance of the company. Actual results could differ materially from those anticipated in these forward-looking statements. The risk factors that may affect results are detailed in the company's most recent public filings with the U.S. Securities and Exchange Commission, including its quarterly report on Form 10-Q for the quarterly period ended September 30th, 2020, which can be found on its website, www.bioxceltherapeutics.com, or on www.sec.gov. A question and answer session will follow the formal presentation. As a reminder, this call is being recorded. It's now my pleasure to turn the call over to Vimal Mehta, CEO. Please go ahead.
Just to remind everyone certain matters discussed during today's conference call or answers that maybe given to questions asked are forward looking statements that are subject to risks and uncertainties relating to future events or the future.
The company.
Actual results could differ materially from those.
Anticipated in these forward looking statements. There was factors that may affect results are detailed in the company's most recent public filings with the U.S. Securities and Exchange Commission, including its quarterly report on form 10-Q for the quarter excuse me for the quarterly period ended September Thirtyth 2020, which can be found on its website www dot by ILEC cell therapeutics.
Dot com or on Www Dot FCC Dot Gov, a question and answer session will follow the formal presentation. As a reminder, this call is being recorded its now my pleasure to turn the call over to halt the moment that CEO. Please go ahead.
Thank you operator, good morning, everyone and thank you for joining our conference call.
Vimal D. Mehta: Thank you, operator. Good morning, everyone, and thank you for joining our conference call to discuss BioXcel Therapeutics' Financial Results and Business Highlights for the third quarter. We appreciate everyone's time and attention. Joining me on the call today are Richard Steinhart, Chief Financial Officer, Will Kane, Chief Commercial Officer, Vince O'Neill, Chief Medical Officer, Reina Benabu, Chief Development Officer, Frank Yocca, Chief Scientific Officer, and Rob Risinger, Senior Vice President of Clinical Development. As the COVID-19 pandemic continues to create uncertainty in the world,
Okay. That's caused by the time to be a big financial results and business highlights for the third quarter of 2000 and Wendy.
We appreciate everyone's time and attention joining me on the call today are they started steinhart, our chief financial officer that really came to form a start off with the rents on the Chief Medical Officer.
They're not Venables Chief Development Officer, Sangakkara, Chief Scientific Officer, and Rob the singer Senior Vice President of clinical development.
As that already 19 pandemic continues to create uncertainty in the award I.
I am very proud of our team for their commitment collaborate.
Vimal D. Mehta: I am very proud of our team for their commitment, collaboration, and drive as we make significant progress on the clinical, commercial, and corporate levels. During this challenging time, most importantly, we remain dedicated to serving and protecting the health of our community. I will begin today's call by discussing our lead clinical candidate, BioXcel 501. As a reminder, 501 is a proprietary, orally dissolving, sublingual Thin Film of Dactamidine for the treatment of agitation across numerous neuropsychiatric disorders and opioid withdrawals.
Creation and drive as we made significant progress on the clinical commercial and corporate fronts.
During this challenging time, most importantly, we remain dedicated to serving and protecting the health of our community.
I will begin today's call by discussing our lead clinical candidate.
DXP held by one.
As a reminder, fiber one is a proprietary orally dissolving sublingual Tim.
Infill of document imaging for the treatment of agitation across numerous neuropsychiatric disorders and opioid withdrawal symptoms.
Earlier this year, we announced positive.
Vimal D. Mehta: Earlier this year, we announced positive top-line data from our pivotal serenity trials for the acute treatment of agitation in patients with schizophrenia and bipolar 1 and 2 disorders, which demonstrated 501's ability to quickly and safely calm patients without excessive, Last month, we had our pre-NDA meeting with the FDA. Based on the outcome of our discussion, we have initiated rolling submissions and are on track to submit a complete application to the FDA in the first quarter of 2021. We continue to expand our leadership team and our core medical and commercial teams in order to build the corporate framework needed for the potential commercial launch of BioXcel 501 upon approval by the FDA. Turning to our clinical development program, we recently completed a crossover bioequivalence study in healthy volunteers that assessed the bioequivalence of BXEL501 administered sublingually or buckily, meaning between the lower lip and gum.
Topline data from our pivotal data in new designs for the acute tiedemann of agitation in patients with schizophrenia, and bipolar one into disorders, which demonstrated by fiber ones ability to quickly and safely calm patients without excessive sedation.
Last.
Monday, we had our pre NDA meeting with the FDA based on the outcome our of our discussion we have initiated a rolling submission and are on track to submit a complete application to the FDA in the first quarter of 2021.
We continue to expand our leadership.
Good evening, and our core medical and commercial teams in order to build the quad play extreme was needed for the potential commercial launch of the Axiall fiber one upon approval by the FDA.
Turning to our clinical development programs.
We recently completed a crossover bioequivalence study in healthy volunteers that assess the bioequivalence, albeit axiall fiber, one administer sublingual lease or partially meaning between the lower lip and income.
This data from these trials supported the bye.
Vimal D. Mehta: Data from this trial supported the bioequivalence of 501 following sublingual or buccal delivery of the thin film and will be included in our NDA submission. The ability to administer 501 either sublingually or bucally further shows the ease of our new product. An FDA approval of 5.0.1 for the acute treatment of agitation in patients with schizophrenia and bipolar disorders would represent a giant step forward in our long-term vision of establishing a leading neuroscience foundation. To this end, we are well on our way to exploring this candidate in multiple follow-on indications. Moving to the Tranquility Study, our Phase 1b2 trial for the acute treatment of agitation in patients suffering from dementia, the purpose of which is to identify the most effective and tolerable doses in this elderly patient population. We will review the findings from this trial and either report top-line results later this quarter or, if needed, proceed to an additional dose cohort. As you know, there are no FDA-approved treatments for agitation associated with dementia, and current off-label treatments have black box warnings.
Equipments or fiber one following sublingual or bulk local delivery of the painful and will be included in our NDS our mission.
The ability to administer fiber one either sublingual Lee or Buckley further shows that ease of our new products.
And FDIC approval of fiber one for the acute treatment of agitation in patients with schizophrenia and bipolar disorders would represent a giant step forward in our long term vision of establishing a leading neuroscience franchise.
To this end, we are well on our way.
Excluding these candidates in multiple follow on indications.
Moving to the time quality study our phase one b two trial for the acute treatment of agitation in patients suffering from dementia.
With the portfolio of the study is to identify the most effective and.
Led by those new in this elderly patient population, we really view the findings from this trial and he does report topline results later this quarter or if needed proceeds to enter additional dose cohort.
As you know there are no FDA approved treatment.
Audio station associated with dementia, and Scott earnings off label treatment have black box warning.
As a reminder, we have received fast track designation for this indication, which will help facilitate the development of the Axiall fiber one in dementia.
Vimal D. Mehta: As a reminder, we have received FastTrack designation for this indication, which will help facilitate the development of BioXcel 501 in dementia with the FDA. Now, turning to the release study, our Phase 1b2 trial of BioXcel 501 for the treatment of opiate withdrawal symptoms. The study is progressing well, and we remain on track to report top-line results in the first quarter of 2021. With opioid abuse cases on the rise, we believe BioXcel 501 has the potential ability to mitigate the debilitating withdrawal symptoms by reducing the individual's hyperarousal, resulting in an easier recovery period and decreasing the rate of relapse. In addition, we recently received FDA clearance for our IND application for the acute treatment of agitation associated with delirium, a potential fifth indication for this candidate. Delirium can be caused by multiple underlying diseases, including COVID-19, and presents itself across multiple medical settings, including ICUs, medical and surgical wards, and emergency rooms.
If EBITDA FDA.
Turning to the release study our phase one b two trial of be Axiall fiber one for the treatment of opioid withdrawal symptoms. This study is progressing well and we remain on track to report topline results in the first quarter of 2021.
With opioid abuse cases on that I mean, we believe the axiall fiber one has the potential ability to mitigate that debilitating withdrawal symptoms by reducing the individuals hyper arousal, resulting in an easier recovery period and decreasing deviate overlaps.
In addition, we recently received FDA clearance for our I envy application for the acute treatment of agitation associated with delirium, a potential first indication for this candidate Bill.
Delirium can be caused by myself multiple underlying diseases.
Including COVID-19 and design itself across multiple medical settings, including IC use medical and surgical wards and emergency rooms.
We are preparing to initiate a phase two trial in patients with agitation associated with.
Vimal D. Mehta: We are preparing to initiate a phase 2 trial in ICU patients with agitation associated with delirium, including COVID-19 patients, in the coming months. As you can see, we remain committed to exploring the full potential of BioXcel 501 as a treatment for acute episodes of agitation in schizophrenia and bipolar disorders and dementia. We are advancing our programs in subchronic treatment for opiate withdrawal symptoms and agitation associated with delay, and we plan to evaluate 501 as a chronic treatment for managing agitation in dementia patients. We truly believe 501 can be an effective therapy for the millions of individuals suffering from agitation, many of whom do not have any viable treatment options. Now, I would like to turn the conversation to our Immuno-Oncology Clinical Candidate, BioXcel 701, an Orally Available Systemic Innate Immunity Activator.
Lithium including COVID-19 patients in the coming months.
As you can see we remain committed to exploring the full potential of fight Bxc fiber one at the pigment for acute happy sales of agitation in schizophrenia, and bipolar disorder and dementia.
Well, we are advancing our programs in sub chronic treatment for opioid redraws mten and agitation associated with delivering.
And we plan to evaluate fiber one as a chronic treatment for managing agitation and dementia patients.
We.
Truly believe fiber one can be effective therapy for the millions of individuals suffering from agitation many of whom do not have any viable treatment options.
Now I would like to turn the conversation to our immuno oncology clinical candidates Bx Seattle.
Seven or one an orderly ever level systemic innate immunity activator.
This week, we along with our collaborator MD Anderson presented two posters on safety and efficacy initial efficacy from both ongoing combination trials of.
Vimal D. Mehta: This week, we, along with our collaborator MD Anderson, presented two posters on safety and initial efficacy from both ongoing combination trials of BioXcel 701 and Keytruda at the Society of Immunotherapy of Cancer's annual meeting, or SIDS. In the ongoing Phase 1B2 trial in advanced prostate cancer and the MD Anderson-led Phase 2 basket trial, we observed encouraging antitumor activity in both cold and hot tumors, supporting BXCL701's mechanism of action and ability to stimulate both the innate and acquired immune system and augment responses in combination with checkpoint inhibitors.
The Axiall 701, and Keytruda at the society of immunotherapy of cancer, and while meeting our safety in the ongoing phase one b two trial in advanced prostate cancer and the MD Anderson Lad phase two basket trial, we observed and.
Encouraging anti tumor activity in both core and hot tumors supporting Bfcs, our no one's mechanism of action and ability to stimulate both demand and acquired immune system and augment responses in combination with checkpoint inhibitors.
All in all we believe the Axiall terminal one is one of the most advanced cancer treatments in development designed to enhance innate immunity.
Vimal D. Mehta: All in all, we believe BXCL 701 is one of the most advanced cancer treatments in development designed to enhance innate immunity. We look forward to continuing to ADVANCE 701 with plans to provide additional efficacy data from both trials. As you can see, we have continued to execute on all fronts.
We look forward to continuing to advance our one on one with.
I plan to provide additional efficacy data from both trials.
As you can see we have continued to execute on all fronts.
To support these increased activity.
Vimal D. Mehta: To support these increased activities, we raised gross proceeds of approximately $200 million in a public offering in July, providing BioXcel a cash runway well into 2022 to achieve our upcoming clinical, regulatory, operational, and commercial models. With that, I would like to turn the call over to our CFO, Richard Steinhart.
We raised gross proceeds of approximately 200 million in a public offering in July providing buyer accella cash run rate.
Well into 2022 to achieve our upcoming clinical regulatory operational and commercial milestones.
With that I will like to turn the call over to our CFO Richard Steinhart better.
Thanks once.
Richard I. Steinhart: Thanks, Vimal. Once again, thank you all for joining us this morning. BTI reported a net loss of $24.8 million.
Once again, thank you all for joining us this morning.
BTI reported a net loss of $24.8 million.
Richard I. Steinhart: 3rd quarter of 2020 compared to a net loss of nine million dollars for the same period in 2019. The third quarter of 2020 results include approximately $5.3 million in non-cash stock-based compensation compared to approximately $800,000 for the same period in 2019. Research and development expenses were $16.3 million for the third quarter of 2020 compared to $7.1 million for the same period in 2019. The increase was generally attributable to increased clinical trial costs. Professional Research Costs Related to the Acceleration of the Company's Research and Development Activities, primarily related to its Serenity 1 and 2 trials, as well as increased costs associated with its Tranquility and Release trials. However, these amounts were partially offset by reduced costs related to the BXCL-701 pancreatic cancer trial.
Third quarter Twentytwenty compared to a net loss of $9 million for the same period in 2019.
Third quarter 2020 results include approximately five.
$23 million in noncash stock based compensation compared to approximately $800000 for the same period in 2019.
Research and development expenses were $16.3 million for the third quarter of 2020 compared to $7.1 million for the same period in 2019.
The increase was generally attributable to increased clinical trial costs and professional research costs related to the acceleration of the company's research and development activities.
Primarily related to its serenity, one and two trials as well as increased costs associated with its tranquility and release trials.
These amounts were partially offset by reduced costs related to the DXL 71 pancreatic cancer trial.
Personnel costs also increased primarily related to the growth of BTI. Its clinical team as the company continues to expand its clinical programs and in preparation of the potential commercial launch of DXL five.
Richard I. Steinhart: Personnel costs also increased, primarily related to the growth of BTI's clinical team as the company continues to expand its clinical programs and in preparation of the potential commercial launch of BXL 501 in the U.S. Non-cash stock-based compensation also increased as a result of the additional personnel combined with increased grant date fair values arising from higher market prices of the company's common stock. General and administrative expenses were $8.5 million for the third quarter of 2020, compared to $2 million for the same period in 2019. The increase is primarily due to increased non-cash stock-based compensation. Personnel Costs Related to the Growth of BTI's Operations, combined with increased grant date fair values arising from higher market prices of the company's common stock. Professional fees also increased, which is primarily attributable to increased corporate, legal, and investor relations fees combined with increased insurance premiums. Total operating expenses for the third quarter of 2020 were approximately $24.8 million compared to total operating expenses of approximately $9.1 million for the same period in 2019. As of September 30, 2020, cash and cash equivalents totaled approximately $233.4 million.
No one in the U.S.
Noncash stock based compensation also increased as a result of the additional personnel combined with increased grant date fair value arising from higher market prices of the company's common stock.
General and administrative expenses were $8.5 million for the.
The third quarter of Twentytwenty compared to $2 million for the same period in 2019.
The increase was primarily due to increased non cash stock based compensation and personnel costs related to the growth of BTI the operations combined.
Combined with increased grant date fair values arising from higher more.
Market prices of the company's common stock.
Professional fees also increased which is primarily attributable to increased corporate legal and investor relations fees combined with increased insurance premiums.
Total operating expenses for the third quarter of 2020 for approximately $24.8 million.
Compared to total operating expenses of approximately $9.1 million for the same period in 2019.
As of September Thirtyth, Twentytwenty cash and cash equivalents totaled approximately $233.4 million.
That concludes the financial review of our third quarter.
Richard I. Steinhart: That concludes the financial review of our third... Now I'd like to turn the call back to Vimal for any further comments. Thanks, Richard. We would now like to open the call to questions. Operator.
Now I'd like to turn the call back to Bill for any further comments.
Mm.
Thanks, Richard we would now like to open the call to questions operator.
Operator: Thank you. Ladies and gentlemen, if you would like to ask a question at this time, please press star 1 on your telephone keypad. The confirmation tool will indicate that your line is in the question queue. You may press star 2 if you would like to remove your question from the queue.
Thank you, ladies and gentlemen, if you would like to ask a question at this time. Please press star one on your telephone keypad a confirmation.
They should do indicate that your line is in the question queue.
You May press Star two if you would like to remove your question from the queue for participants using speaker equipment. It may be necessary to pick up your handset before pressing the star keys.
Jess Meacham: For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star key. Our first question comes from the line of Jess Meacham with Bank of America. Please proceed with your question. Hey guys, thanks a lot for the question. Appreciate it. Just had a couple on 501.
Our first question comes from the line of Geoff Meacham with Bank of America. Please proceed with your question.
Hey, guys. Thanks.
A lot for the question a appreciate it I'm just had a couple actually on fiber one.
Maybe for a bit more for well just wanted to maybe get an update about how the commercial preparations are going just for the for the launch and what efforts you guys need to make.
Vimal D. Mehta: Maybe for Vimal or for Will, I just wanted to maybe get an update about how the commercial preparations are going, you know, just for the launch and what efforts do you guys need to make at this point to educate positions on the profile and maybe talk through the generic, you know, the availability of generic options and maybe the kind of backdrop that, you know, that provides. And then, just as it relates to the regulatory aspects, just wanted to get, I mean, high-level, whatever color you can give us on the, you know, the pre-NDA meeting and maybe any points or any updates that you think you'd have to make with respect to the overall, you know, the process. Thank you. Thanks, Jeff.
At this point to educate physicians on.
The on the profile and and maybe talk through the generic.
You know the availability of generic options and maybe the what kind of backdrop that you know that provide and then just as it relates to the regulatory just wanted to get a high level or whatever color you can give us on the you know the pre NDA.
Meeting and maybe any any any points or any updates that you think you'd have to make with respect to the overall.
The totality of the development program. Thank you.
Thanks, Joe.
Unknown Executive: I will pass it on to Will to cover the commercial portion, and then we'll take on the pre-end here. Thanks, Vimal. Good morning, Jeff, and thanks for the question. I'm very pleased with the progress that we are making relative to preparation for commercial launch. As we've talked about in previous calls, we have started adding core leadership to the commercial organization, including a head of marketing. We recently brought on a head of commercial operations, and I'm narrowing in on a head of market access. And we're building out the teams. And so, we're well on our way, not only to staffing, but we've embarked on a bolus of market research to help inform our launch strategy, et cetera, so that we'll be ready when the time comes. In addition, collaborating with Raina and the medical affairs team, we've moved to add field medical leadership to the company, including the head of our MSL team and our payer MSL team. And they will be building out their teams.
I will pass it on to Vale to cover the commercial push in and then we'll take on the PND. Thanks.
Thanks.
Hey, good morning, Jeff and thanks for the question. So I'm I'm very pleased with the progress that we're making a relative to preparation for commercial launch.
As we've talked about in previous calls we have started adding core leadership to the commercial organization, including a head of marketing. We recently brought on head of commercial operations and.
Narrowing in on a ahead of market access and we're building out the teams and so you know we're well on our way I'm not only just staffing, but you know we've embarked on a a bolus of market research to help inform our launch strategy et cetera, So that will be ready when the time comes in addition, collaborating with a with rain that.
No Medical Affairs team, we've moved to add medical field medical leadership to the company, including ahead of our MSL team and our parents all team.
And they will be building out their teams and as we've talked about previously we intend to deploy them in the first quarter of 2021, so that they can begin interacting with with key.
Unknown Executive: And as we've talked about previously, we intend to deploy them in the first quarter of 2021 so that they can begin interacting with key opinion leaders and other key clinicians and healthcare providers to begin the process of educating them on agitation and being able to answer questions, et cetera, relative to the 501 clinical data to date. So we are well on our way, and things are progressing very nicely. Specific to your question about the marketplace and generic options, so as I mentioned, we've done a good bit of market research to date. We have more to go, but the feedback is not inconsistent with what we thought. The clinical profile of the drug is actually very well received by both clinicians and pharmacists.
And opinion leaders and other key clinicians and health care providers to to begin the process of educating on agitation and and being able to to answer questions et cetera relative to the fiber one clinical data to date.
So we are we are well on our way and things are progressing very nicely.
Specific to your question on the marketplace engineered.
Options. So as I mentioned, we've done a good bit of market research to date, we have more to go but.
But the feedback is not inconsistent with what we thought the clinical profile of the drug actually is very well received by both clinicians and pharmacists.
Vimal D. Mehta: Yes, they acknowledge that their current standard of care is generics, but they also point out the limitations, which we've highlighted many times with those treatments, such as their tolerability and safety concerns, et cetera, and, of course, the nature of injections, which is really not counter to the relationship and the treatment paradigm that they would like to use should they have another treatment option. So the oral thin film, as you know, should facilitate the opportunity to engage these clinicians to consider 501 as a viable treatment option for patients with mild to moderate agitation, and there are a significant number of those, as we've talked about, as, Now I'll turn it over to Vimal for the regulatory question. So regarding our pre-NDA meeting, FDA agreed to a rolling submission, and we have already submitted some of the first package, and we are on track to submit a complete application in 2021.
Yes, they acknowledged that their current treatment of standard of care is.
Generics, but they also point out the limitations, which we've highlighted many times with those with those treatments such as their tolerability and safety concerns et cetera and of course the.
The nature of injections, which is really not counter to the relationship and the treatment paradigm that they would like to use so they have another treatment option. So.
The the orphan thin film as you know should facilitate the opportunity to engage these clinicians to consider fiber one as a viable treatment option for patients with mild to moderate to agitation and there are significant number of those as we've talked about as well.
So I'll turn it over to.
Some of the regulatory question.
So regarding our peer India meeting.
Like every agreed to a rolling submission and we have already submitted some of those plus package and we are on track to submit.
Complete application in 2021.
The primarily some.
Vimal D. Mehta: The primarily, some of the things that need to be put together is the CMC package, which is related to the 12-month stability of the film, as well as some of the clinical analysis and subgroup analysis that will be presented. So, all in all, overall, we feel that we are in a good position to submit our NDA and are on track for Q1 2021. Okay, great. Thanks, guys. Thanks, Jeff.
Some of the thing that need to be put together is CMC package, which is related to the 12 month durability.
Of the of of the volume as well as some of the clinical analyses and subgroup analyses that we'll be presenting so all in all overall.
We feel that we are in a good position to so.
Cemented our NDS and is on track for Q1 2021.
Okay, great. Thanks, guys.
Thanks, Jeff.
Thank you. Our next question is coming from the line of Graig Suvannavejh with Goldman Sachs. Please proceed with your question.
Graig C. Suvannavejh: Thank you. Our next question is coming from the line of Graig Suvannavejh with Goldman Sachs. Please proceed with your question. Hi, good morning.
Hi, good morning, Thanks for taking the time.
Vimal D. Mehta: Thanks for taking the time. Could you maybe walk us through, for the dementia study, what you might be looking for from the 90 dose, and then, you know, what you might expect to see in higher doses you're testing if you end up going there? Thank you for the question. So the primary outcome of the tranquility study is really looking at the safety and tolerability profile. This is what we have been looking at throughout the clinical trial. So at the end, we're going to review the study findings and either report top-line results this quarter, or, if necessary, we will proceed to another dose cohort, giving the results on safety and tolerability. And, Greg, I will just add to what Raina said, that we will also look at the PK data, exposure data, and any data we can glean about the efficacy from the blinded data and triangulate all that information to make our decision about the 90-microgram dose or, if needed, go to another dose cohort. Okay, thanks very much. Thank you.
Could you maybe walk us through for the dementia study, what you might be looking for from the 90 day.
Yes, and then what you might expect to see in higher doses. You are testing if you end up going there.
Okay.
Yes. Thank you for the question.
So the primary outcome of the Tranquility study is really looking at the safety and Tolerability profile. This is what we have been looking throughout the clinical trial. So.
At the end, we going to review the study findings in either report topline results.
It's this quarter or if necessary. We will proceed to another dose cohort.
Given the results on the safety and Tolerability.
And Greg I would just add to our name out there that we will look at also the PK data exposure data.
And any data we can glean about.
The efficacy from the blinded data.
And triangulate all that information to make our decision on the 90.
Microgram dose or if needed go to another another dose cohort.
Okay. Thanks very much.
Okay.
Thank you. Our next question comes from the line of Robyn Karnauskas with Trust Securities. Please proceed with your question.
Robyn Kay Shelton Karnauskas: Our next question comes from the line of Robyn Karnauskas with Truist Securities. Please proceed with your question. Hi, good morning, and congratulations on the progress. So I have two questions.
Hi, good morning, Congrats on the progress so I have two questions.
First congrats on a more IP I'd like you to maybe outline for us.
Vimal D. Mehta: First, congrats on more IP. I'd like you to maybe outline for us, if you can, I don't know if you can, what additional IP we should expect in the next 12 to 18 months that might really solidify. Patients might how Transcribed by https://otter.ai, www.youtube.com.uk, Thanks Robyn. We will handle this question in two parts. I will take the IP question, and we will take the second question.
If you can I don't know if you can.
Additional.
What additional IP, we should expect over the next 12 to 18 months it might really solidify your position.
To protect against any generic and second for delivering this is it's a newer market for all of US can you walk us through you know how many films do you think a patients might take how diverse is.
This market in other words like how how variable are patients and how many how much filmmaker each patient take help us understand how to model that market. Thank you.
Thanks Robin.
Davis will handle this question in two parts I will take the IP question and when we take that second question.
Vimal D. Mehta: Regarding intellectual property, we are very excited that we got our patent issued in October. That's our first patent on BioXcel 501 related to the composition of the film and its use in agitation. So, that's our first strategy, and that patent will give us market exclusivity until 2039. In addition, the overarching strategy of the company has been to look at the exposure levels that we are experiencing in each trial, whether it's schizophrenia bipolar patients or dementia patients or OPR, and come up with the different dose ranges at which these patients will be treated. As you can understand, in an acute agitation scenario versus subchronic, the dose requirements are different, and also in a chronic situation, those requirements will be different. So we are patenting those exposure levels also.
Uh huh.
And I believe you are very we're very excited that we got our patent issued in October that's our first patent on B Axiall fiber one related to the composition of the failed and its use in agitation.
So that's our first strategy and that pattern will provide us market exclusive.
Regarding until.
Due to 2039.
In addition, the overarching strategy of the company has been to look at that exposure levels that we are experiencing in each trial is rather schizophrenia bipolar patients or dementia patients on opioids and coming up with the different.
With the ranges at which these.
These patients will be treated as you can understand that.
In acute agitation scenario versus sub chronic that those requirements are different and also in a chronic situation. Those requirements are different so we are presenting those.
Exposure.
Levels also so thats, our second part of the strategy. Besides our full burden. In addition, we continue.
Vimal D. Mehta: So that's our second part of the strategy, besides our film patent. In addition, we continue, we have already filed patents related to the method of use for dexmedimedine, particularly for the treatment of agitation. So there is a broad IP strategy around to maintain market exclusivity for our different indications as well as for the whole franchise. And we have almost a dozen patents, a family of patents that are in progress and being prosecuted for BXL files.
We are we have already filed patents related to our method of use for document imaging, particularly for treatment of agitation today.
There is a broad IP strategy.
Around to maintain the market exclusivity for for our different indication as well as for the whole franchise and.
We have almost doesn't burden that family of patents that are in progress and being prosecuted.
For the.
The excel file.
With that.
Unknown Executive: With that, I will pass it on to Will and Raina to provide color on the delirium, both in the medical setting as well as in the commercial setting. Sure. Thanks, Ramon. Good morning, Robyn.
I will pass it on to villain way now to provide color on the delivery and both on the medical setting as well as the commercial debt.
Sure. Thanks for him on the morning, Robin and thanks for the question. So as as we discussed in our view the commercial potential provider one as a treatment for agitation diarrhea.
Unknown Executive: Thanks for the question. So, as we've discussed, in our view, the commercial potential for 501 as a treatment for agitation and delirium is significant, especially when you consider that there are no approved treatment options for agitation associated with this condition. According to the American Delirium Society, I know there are more than 7 million hospitalized patients every year that suffer from delirium, and the majority of them actually do experience agitation as part of their episode.
Jim is significant especially when you consider that there are no approved treatment options for agitation associated with this condition.
According to the American dealer in society, and other more than 7 million hospitalized patients every year that suffer from delirium and the majority of them actually do experiencing at experience agitation as part of their episode.
Earlier.
We're focused on multiple settings in hospitals, we talked about the IC, which is where arenas.
Unknown Executive: We're focused on multiple settings in hospitals. We talked about the ICU, which is where Reyna's Phase II study will be conducted, but also medical and surgical wards where we believe the opportunity is equally, if not a little more significant for the product, and of course, the emergency department. Relative to the number of films, the way I think about it and the way I think we'll learn more about it through the trial is that, you know, an average episode of dulirum can last three to five days. And in any given day, there could be multiple films used.
Two study will be conducted but also medical and surgical awards, where we believe the opportunity is is equally if not a little more significant for the product and of course in emergency departments relative to the number of films the way I think.
Got it and the way I think we'll we'll learn more about it through the trial is that new an average episode of Julianne can last three to five days.
And in any given day, there could be multiple films used the trial is designed to test that so.
Unknown Executive: The trial is designed to test that. So I can't give you an exact number, but it could be, you know, certainly greater than one or two, which we would expect to be the case in the emergency department, to maybe three to four in the medical and surgical wards and ICU settings. But that will be determined by the trial. Rayna?
So I can't give you an exact number but it could be certainly.
Certainly greater than than one or two which we would expect to.
To be the case in emergency department to to maybe for three to four in the in the medical surgical more tonight's you settings, but that will be important by by the trial screen.
Screener.
Reina Benabu: Yeah, thank you, Will. So, you are absolutely right. We are putting together this Phase II trial, which is a multicenter, randomized, adaptive, sequentially ascending dose-finding design. And we selected our doses based on the robust data from Serenity but also from a wealth of literature data on dexamethamidine in agitated delirium, culminating with a Carrasco paper that really showed tremendous efficacy even in Haldol-resistant patients. So that, we're gonna evaluate those doses, the 120, 180, 240, and 300 milligrams, and we'll also evaluate them with the PK data and with some preliminary efficacy data associated with a RAS scale. Well, then our goal is really to find the best efficacious and tolerable dose to move to phase two trials and discuss in very close alignment with the FDA how we're gonna do that, and And just to follow up and be clear.
Thank you will so absolutely right. We are putting together this phase two trial, which is multi center randomized.
Yes.
Adaptive sequentially ascending dose finding design and.
Selected our Ddos our doses.
Based on the robust data from serenity, but also from a wealth of literature data on deck for Tommy Dine in agitated delivery accommodating whether classical paper.
That really show the tremendous efficacy even in haldol resistant patients. So that we're going to evaluate those those is the 121 82 for 300 milligrams and we're going to evaluate also with the PK data and with also some preliminary efficacy.
Data associated with a rack scale well then our goal is really to find the best efficacious and tolerable dose to move to then another phase two trials and discuss in very close alignment with the FDA, how we're going to do that and this is where we are going to decide where ours, which our doses.
Going to be.
And just to follow and be clear so.
Reina Benabu: At what point, you know, in other trials, you've not been able to redose, right, except for maybe opioid withdrawal, where you're dosing more frequently. In this study, would you be able to give more than one film over a certain period of time? Or in phase two, would you be able to give more than one film over a certain period of time? Because that'd be different, right, than other agitation trials outside of, Exactly, Robyn. So, as Will said, the average duration of delirium is between three to five days.
What point you in other trials, you've not been able to read out with rate except for maybe opioid withdraw where your dosing more frequently in this study would you be able to give more than one film over a certain period of time or in the phase two as you built give more than one so over a certain period.
Time, because I'd be different rate than other agitation trials outside of opioid withdrawal.
Exactly Robin so as well said the average duration of delirium is between three to five days. So that is why in our phase two trial, where were trying to evaluate the optimal starting jo.
Reina Benabu: So, that is why, in our phase two trial, we're trying to evaluate the optimal starting dose. So, the patient would likely have a good reduction in the rise scale with the first dose, and then he would take other doses over a period of two to four hours. And then that will lead the patient into a calming zone for 24 hours, three days, or even five days. This is what we're shooting for.
Yes, so the patient would likely have a good reduction in the rise scale with the first dose and then he will take other doses in a period of two to four hours.
And then that will lead to patient into a calming zone during that period of 24 hours three days or even five days. This is what we're.
Turning for certain Robyn I can add in terms of the frequency of dosing that will be determined through the trial.
Vimal D. Mehta: So, Robyn, I can add, in terms of the frequency of dosing, that will be determined during the trial. But coming back to your question, can we dose more than one film in a day? Yes, we can dose multiple films in a day. That's how the trial is designed.
Coming back to your question can we do more than one fail in a day, yes, we can do multiple funds and today, that's how the trial design.
Great last question sorry.
Vimal D. Mehta: Great, and then last question, sorry. So, when you're thinking about dementia for the next... After your phase one, is that something you would also explore? Because, you know, with dementia, obviously, people can have episodic experiences that last more than one day. Would you incorporate that?
So many so when you're thinking about demand for the next study Dr. your fees wine.
Is that something you would also explore debenture, obviously people can have episodic experiences that are blocking more than one day, Mike would you incorporate.
The ability for more than one dose because that would be just.
Vimal D. Mehta: The ability to take more than one dose because that would, again, be different. Transcribed by https://otter.ai. For the next step for dementia, So, the tranquility study is a foundational study, and once we have the unblinding and we have the data in front of us, that will inform us what doses can be used, can we, what you are referring to is whether we can use more than one dose, repeat dosing, and we'll find out through this study. In addition, we'll get a very good understanding, and we will get informed how we can use it in an episodic setting when somebody has agitation, and they need treatment immediately; how it can be used in a chronic setting, and we have stated that we plan to move 501 into the chronic setting, so can it be used daily or can it be used alternatively, all of that will be informed by the results we get from the tranquility study.
And then what you've done in the past for pivotal.
Just for the next step for dementia is the question.
So Ben communities sturdy their foundation study.
And once we have the Unblinding and we have the data in front of was that will inform us.
What dozing can be use can be.
What you are referring to is can we use more than one those repeat dosing.
And we'll find out through this study in addition, really good a very good understanding and we go to inform.
How we can use it in episodic setting when somebody has agitation and they need treatment immediately how.
Can be used in a chronic setting and we have stated that we plan to move fiber one into the chronic setting. So can it be used daily how can it be used ordinary days all of that will be informed by that is that is when you get from the.
From that Bankability study in addition.
Vimal D. Mehta: In addition, we are developing Apple Watch to catch the agitation in very early stages and what doses will be required for that. So, I think we are getting very close to tranquility, and once the tranquility data card has been rolled out, that will inform us about all of those decisions, and then we will be able to discuss that with the street more broadly. Great, thank you. Thank you. Our next question comes from the line of Yatin Suneja with Guggenheim Partners. Please proceed with your question. Hey guys, thank you for taking my question. I have a quick one on tranquility and then on...
We.
Developing Apple was two guys agitation in very early stages and what those it will be required for that so I think we are getting very close on bankability and rather than Banco Liberty data card has been rolled out that will inform on all of those what decisions. We can and then we will be able to discuss.
That does too.
More broadly.
Great. Thank you.
Thank you. Our next question comes from the line of Yatin Suneja with Guggenheim Partners. Please proceed with your question.
Hey, guys. Thank you for taking my question I have a quick one on tranquility.
It's having a one so when you said you could go for additional dose could you actually go down on the dose and then if you go down on the dose will you be able to expand the 90 microgram arm or not.
Vimal D. Mehta: So when you said you could go for an additional dose, could you actually go down on the dose? And then if you go down on the dose, will you be able to expand the 90-microgram arm? I think the data from 90 micrograms will inform what the next dose cohort needs to be, whether we go up in terms of the titration or we go down. The PK data, exposure data, will inform us about what exposure levels we are getting. So it's really going to be a triangulation of exposure data, tolerability data, and what dose and what scale we need to take to the FDA to convince them to go to the next stage of their development. That's our goal.
It's not it's not clear to us whether the expansion.
Happiness downtime traded Washington, Uptight duration, which you did when you know when the 60 microgram dose was extended and then.
I'll ask you about the second half of this.
So.
Thanks for the question the fee.
I think that.
We dropped from 90 megawatt ground will inform ward nexpose dose cohort value.
Needs to be that we go up in terms of the dietician or we go down the PK data exposure data will inform us that what exposure levels, we are getting through.
Dave really going to be at Bangor relation of exposure data that our liberty data and what daus and what the scale, we need to take to then be to convince them to go to the next stage of their development Thats. Our goal. So at this point in time, both scenarios are very much policy well rather too.
Vimal D. Mehta: So at this point in time, both scenarios are very much possible, whether to go up or down on the dose cohort. Okay, and then on 7-01... Data at CITSI. Can you maybe talk about, you know, how the expansion phase... We are in different tumor types. So, as you expand, are you going to be enriching for those... Vince, do you want to take that question? Sure, thanks Vimal. Yeah, good morning. So I'll take the prostate study first because that's the easiest one to answer.
To go up or down on their dose cohort.
Okay, and then on seminal one.
We saw the Big City can you maybe talk about.
How the expansion phase of those trials are going to want to call. It seems like there were.
In different type different too.
Especially in the MD Anderson study. So as you expand are you going to be enriching for those two tumor type where you saw PR and then who makes that decision given that this is I think an MD Anderson conducted study and then on the on the safety side like what sort of modification you want to implement.
Thing two as it relates to the hype attention. Thank you.
Vince you want to take that question.
Sure. Thanks, Adam all yeah. Good morning, So I'll I'll take on the prostate study course, that's the easiest one to answer. It's obviously there are two cohorts there on cohort one is I'd know carcinoma.
Vimal D. Mehta: So obviously, there are two cohorts there, and cohort one is adenocarcinoma castrate-resistant disease, and cohort two is NEPC. So those are pure of or pure, if you will, patient subsegments or subgroups. In the MD Anderson study, you're absolutely right. This is a basket trial.
Mike.
Castrate resistant disease cohort two is any PC. So those are those are pure over pure if you will.
Patient.
Patient sub segments or sub groups and the MD Anderson study you're absolutely right. This is a basket trial.
I think going forward, having seen activity as you just said.
Vimal D. Mehta: I think going forward, having seen activity, as you've just said, and if you look at the waterfall plot, that does quite nicely illustrate that point. What would typically happen in a study like this is that, yes, where activity has been seen, the investigator would tend to enrich, it's not a hard and fast rule, but would tend to enrich for those types of patients going forward, and we anticipate that's what will happen here. You're absolutely right, this is an IST, it's the MD Anderson Study, they hold the IED, they're the decision makers on the trial, but I would anticipate that happening going forward. You're absolutely right. And yeah, on your second point, sorry, about safety and risk mitigation and so on. So again, I would make the point that, based on the data we presented, we are seeing on target toxicity. That was expected.
And and if you look at the waterfall plot that does quite nicely illustrate that point.
What would typically happen in a study like this is that yes. We are aware that activity has been seen the investigator would tend to enrich it's not a hard and fast rule, but would tend to enrich for those types of patients going forward and we anticipate that.
What will happen here, you're absolutely right. This is a nice tea, it's MD Anderson study, who would be on D.M. There the decision makers on the trial EM, but I would anticipate that happening going forward, you're absolutely right I agree.
Yes.
Yeah on your second point, sorry on the safety and risk mitigation and so on so again.
I would make the point that you know based on the data. We presented we are seeing on target toxicity that was expected that's been seen with other agents that also activate the innate immune system and so some of the site the kinds of seeing similar safety profiles, the bi specifics or things that say similar safety profiles and again they have introduced.
Vimal D. Mehta: That's been seen with other agents that also activate the innate immune system. So some of the cytokines have seen similar safety profiles. The bispecifics are seeing very similar safety profiles.
Vimal D. Mehta: And again, they have introduced safety mitigation plans that essentially increase or improve the tolerability. And we are doing something very, very similar currently. The actual detail, and it really shouldn't be any mystery, you know, it comes down to a closer follow-up, closer monitoring of patients within the first week, because really these events are all occurring within the first week. The detail, the granularity, we will present that at us in a few months' time. So hopefully that answers your question. So it's very useful.
Safety mitigation plans and that essentially increase of better the tolerability and we're doing something very very similar.
But the actual detail and it really shouldn't be any mystery comes into closer follow up closer monitoring of patients within the first week because really these events are all our current.
Within the first week the detail of the granularity you will we will present that to that could you and a few months time, so hopefully that answers your question.
Taylor Thank you.
Sure, let me just add little bit more color to award.
Vimal D. Mehta: Let me just add a little bit more color to what Vinh said at the overarching, we would say this is one of the most advanced innate immunity activators, which is systemic, and we are trying to find the efficacy signal in both cold and hot tumors. So both the studies that are ongoing give us what the agent's activity is, and it will allow us to develop our more advanced development plans and a probability path that all of that work will be done once we have these two trials completed. Thank you. Our next question comes from the line of Sumant Kulkarni with Canaccord.
Instead at the overarching we were this is that one of the most advanced.
Innate immunity activator, which is systemic and we are trying to find the efficacy signal in both cold and hot tumors. So both those studies that are ongoing gives us.
What what the agent's activities and it will allow us to double up our more advanced development plans.
And our profitability pad all of that work will be done once we have these two trials completed.
Thank you.
Thank you. Our next question comes from the line of Xenon Kulkarni with Canaccord. Please proceed with your question.
Sumant Satchidanand Kulkarni: Please proceed with your question. Morning, I have three questions, actually. The first one is about tranquility. If you do decide to go to another cohort, how can you help frame what that means for investors?
Good morning, I have three questions actually.
Actually the first one is on quality. If you do decide to go to another cohort how can you help frame what that means for investors because the only real conclusion that might be able to be John is that the prior highest those the steep enough for you to be comparable to proceed so any thoughts on how the company might be able to take an interim look at efficacy in the fourth quarter as you move onto the next dose that's the first question.
Vimal D. Mehta: Because the only real conclusion that might be able to be drawn is that the prior highest dose is safe enough for you to be comfortable proceeding. So any thoughts on how the company might be able to take an interim look at efficacy in the fourth quarter as you move on to the next dose? That's the first question. Rob, do you want to take that one? Sure, thanks Sumant. You're pretty much right.
Rob do you want to take that question sure. Thanks in March.
Sure you're pretty much right I mean, as we need.
Vimal D. Mehta: I mean, as we... As we escalate the dose, we are dose escalating essentially based on safety. And so when a dose is safe and well-tolerated, we escalate to the next higher planned dose level. And on the reverse, if we see peak exposure levels and we think that we need to go down on the dose, we'll consider that as well. So, but I think after a 90 microgram dose, the conclusion is done, that's the best way to put it. And then these decisions will be made, and then we can either announce the top line data or inform that we are moving to another dose score. And then I'll ask the next two questions up front. So if you move to chronic treatment of agitation and dementia, could you comment on the potential for any cognitive upsides or downsides of DEX in the geriatric patient population?
As we escalate the dose.
We are dose escalating essentially based on safety and so when a dose is safe and well tolerated.
Did we escalate to the next higher planned dose level.
And on the reverse if we see that likely now.
Peak exposure like rather than view thing that we need to go down on that goes we'll consider that as well so but I think after 90 megawatts.
Randy.
Confusion is done that's the best way to put it and then these decisions will be made and then we can eat that announced the topline data or inform that we are moving to another dose score.
Got it and then I'll, let the next two questions upfront. So if you move to chronic treatment of education and dementia could.
Comment on the potential for any cognitive upsides or downside the decks in the geriatric patient population and on seven one there were some but even taking that 60 decently now that the triple combo is not proceeding what are your priorities for your next indication other than prostate cancer.
Vimal D. Mehta: And on 701, there was some very intriguing data at CITSI recently. Now that the triple combo is not proceeding, what are your priorities for your next indication other than prostate cancer? I can try that. So we will divide the question into two, and Frank and Rob will answer the first question, and then Vince will take on the seven or one questions. So Sumant, with regard to your question on chronic usage and cognition, I would hazard a guess to say that I'm not sure that the drug would enhance cognition, but I don't think it would deter it either.
I can try that so we will we will take divide the question.
Turning to do I'm, Frank and Rob will answer the first question. So and then Vince will take on the seven to one question. So smart with regard to your question on chronic usage and cognition.
I would hazard, a guess to say that.
I'm not sure that the drug would enhance cognition, but I don't think it would deter turret either.
Frank D. Yocca: So I think it would have a neutral effect as opposed to some of the other drugs that are being used. And, of course, the use of benzodiazepines in this population is something where you do get a negative cognitive effect. So that's what I would be thinking up front. Vince, do you want to take the second question? Sure. Good morning, Sumant. So I think the question was, where do we go after this? Boiling it down.
So I think it would have a neutral effect as opposed to some of the other drugs that are that are being used and of course the use of benzodiazepine. In this population. This is something where you do get a negative cognitive effect. So I, that's what I would be thinking upfront.
Yes.
Right.
Vince do you want to take the second question.
Sure Morningstar line. So I think I think the question was and where do we go after this.
Bundling it done so.
Vimal D. Mehta: So we certainly had some discussions with our advisors and our collaborators. We have some initial thoughts on that, but we haven't made any public statements yet.
We certainly had some discussions with them our advisors on our collaborators and we have some initial thoughts about we havent made any.
Public statements yet.
I think you're probably you will be on the right track if you if you view it.
Vimal D. Mehta: I think you're probably – you will be on the right track if you view it in the following way. We clearly would be thinking of pursuing indications in the tumor types where we're seeing activity. I think we would need a bit more information on that, a bit more data. But it is worth noting that uveal melanoma is an extremely difficult cancer to treat. Pleomorphic sarcoma, similarly, but both orphans or ultra-orphans are high in medical needs.
In the following way, we clearly and this would be a standard approach of course, we would be thinking of pursuing indications in the tumor types, where we're seeing activity I think you would need a bit more information on that bit more data.
But it is worth noting that you'll melanoma is extremely difficult cancer to treat polymorphic sarcoma. Similarly, both orphans or ultra orphan both high end medical needs and from a development point of view.
Vimal D. Mehta: And from a development point of view, there's probably quite a straightforward approach there. So again, this is under discussion. Got it. Thank you. Thank you. Our next question comes from the line of Ram Selvaraju with H.C. Wainwright.
That's probably a quite a stick for what approach there. So again. This is under discussion just now I think we'll make that definitive statement test.
Subsequent to that would be the initial financial.
Got it thank you.
Thank you. Our next question comes from the REIT excuse me from the line of Ram Selvaraju with H.C. Wainwright. Please proceed with your question.
Raghuram Selvaraju: Please proceed with your question. Your line is live; you may proceed with your question. We will move on to our next question, which is coming from the line of Samir Devani with RxSecurities. Please proceed with your question.
Correct.
From your line is live you May proceed with your questions.
Well move onto our next question, which is coming from the line of <unk> Mir Giovanni with Rx Securities. Please proceed with your question.
Yeah, Hi, everyone. Thanks for taking my questions I've, just got a couple with wells.
So just following.
Samir Devani: The first one, just following your pre-NDA meeting and getting Priority Review. The second question is just on 701. Very encouraging data there.
During your pre NDA meeting I was wondering if you just could comment on your confidence potentially and getting priority review.
The second question is just on seven I won some very encouraging data that I just wondered if you could elaborate on the responses in the prostate cancer study and the responses youve seen and can you comment.
Vimal D. Mehta: I just wondered if you could elaborate on the responses in the prostate cancer study. Thank you. Thank you. Thank you. Can you comment on whether they are in the NEPC group or the ADEM group? I will take the first question.
On whether they are in the NEPC group or the other night carcinoma agree. Thanks.
So I will take that was bush and Samir. Thank you for asking the question.
Vimal D. Mehta: Samir, thank you for asking the question. In the pre-NDA, like you know, once we submit the full application, after 74 days, we will learn from the FDA whether priority review has been accepted. If that is the case, then we could get approval for the drug in four months, approximately four months earlier than the standard review. And our medical and commercial teams are preparing for both scenarios. If it turns out to be that we will get the approval early, we will be ready to do the commercial launch. For your question related to the 701, I will pass it on to Vince.
In the PND like you know once we submit full application.
74 days, we will learn from them.
That priority review has been accepted if that is the case then we could get approval of the drug for months approximately four months earlier than those channels review.
And our medical and commercial teams both are preparing for both scenarios if it turns out to be.
That will get the approval early we'll be ready to do the commercial launch for your question related to the 71 I will pass it on to Vince Vince.
Vimal D. Mehta: Sure, thanks. Thanks, Vimal. Good morning.
Sure. Thanks maximal.
Good morning, and so.
So on the prostate side just to just to be clear, what we're presenting what we have.
Vimal D. Mehta: So on the prostate side, just to be clear, what we're presenting, or what we have presented, I should say, is really a complete and final Phase 1b safety experience with associated efficacy. So the efficacy portion is well under way, and we will give an update as we start to talk. To answer your question directly, of the 12 patients, actually 13, but 12 were valuable, detailed in the poster, but half of those were adenocarcinoma, CRPC, the other half were neuroendocrine diseases, and the very deep, i.e., 85% reduction in PSA with some minor shrinkage in the CT scan, that was in an adenopatient, so that's the direct answer to your question.
I should say it certainly is really a complete and final phase one b safety experience with associated efficacy of activity. So the efficacy portion is well underway and we will give an update that as we said to what some of the year.
John to your question directly all the 12 patients actually 13, but.
The 12 were valuable and detailed in the poster, but half of those were adenocarcinoma CR P.C. and the other half were and you ran different disease EM and the very deep I, 85% reduction in PSC with some minor shrinkage and seating scan that was in an AD no patient. So thats the direct answer to your question.
Vimal D. Mehta: Great, thanks very much. Thank you. It appears we have no additional questions at this time, so I'd like to pass the floor back to management for closing comments. Before we conclude, I want to thank everybody for joining us today. As you have heard throughout the call, BioXcel has made significant progress advancing both BXCL501 and BXCL701 this quarter, and we look forward to providing results from the ongoing trials as well as updates on our other upcoming key milestones over the next several months.
Great. Thanks very much.
Thank you. It appears we have no additional questions at this time, so I'd like to pass the floor back to management for closing comments.
Before we conclude I want to thank everybody for joining us today as you have heard throughout the call buyer.
Excel has made significant progress advancing both be axiall fiber, one and be axiall seven or one this quarter.
And we look forward to providing results from the ongoing trials as well as an update on our other upcoming key milestones over the next several months.
Good day and please.
Vimal D. Mehta: Have a great day and please reach out to us if you have any additional questions. Thank you. Ladies and gentlemen, this does conclude today's teleconference and webcast. Once again, we thank you for your participation, and you may disconnect your lines at this time.
[laughter] reach out to us if you have any additional questions. Thank you.
Ladies and gentlemen, this does conclude today's teleconference and webcast. Once again, we thank you for your participation and you may disconnect your lines at this time.
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