Q2 2020 BioXcel Therapeutics Inc Earnings Call

The conference call.

Operator: At this time, all participants are in a listen-only mode. If anyone should require operator assistance, please press star zero on your telephone keypad. A question and answer session will follow the formal presentation. As a reminder, this conference is being recorded. It's now my pleasure to turn the call over to Vimal Mehta, CEO. Please go ahead.

At this time, all participants are pretty listen only mode. If anyone should require operator assistance. Please press star zero under telephone keypad question answer session will follow the formal presentation.

As a reminder, this conference is being reported it's now my pleasure to travel coal over 10 millimeter CEO. Please go ahead.

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 second quarter of 2020. We appreciate everyone's time and attention. Joining me on the call today are Vince O'Neill, Chief Medical Officer, Will Kane, Chief Commercial Officer, Raina Benabu, Chief Development Officer, and Rob Risinger, Senior Vice President of Clinical Development. Our CFO, Richard Steinhart, is currently on medical leave and is unable to join us today.

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Good morning, everyone and thank you for joining our conference Gardner disguised by X. I'm Kinda Goodix financially sound business highlights for the second board.

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We appreciate everyone's time and attention joining me on the card 30 odd events are named Chief Medical Officer.

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But it seemed to see any other senior vice President clinical development.

Let's see airport. It started steinhart is currently on medical leave Andy the neighbor to join US today, and these apps and our controller.

Vimal D. Mehta: In his absence, our controller, Michael Stanton, will be reviewing the financial results on today's call. Months in, COVID-19 is still creating uncertainty in the world and continues to affect each and every one of us. Healthcare workers will forever be our heroes as they remain committed to protecting our lives and halting the spread of the virus. In accordance with the U.S. CDC and State of Connecticut earlier this year, we implemented a work-from-home policy for all employees.

Starting then we'll be reviewing the financial reserves on today's call.

Mines in go read 19, instead of creating uncertainty in the award and continues to affect each and every one of.

Okay, and what cards, we bought I want to be out what do you know they remain committed to protecting I would like them hard thing be it's part of the wise.

In accordance with the U.S., they didn't see and stared O'connor degree or Leah.

Earlier this year I'd be implemented at work from home policy bought all employees, we have been monitoring the impact of that Britain <unk> in order to do it doesn't mean, the best practices for continuing operations, while mitigating this.

Vimal D. Mehta: We have been monitoring the impact of the pandemic in order to determine the best practices for continuing operations while mitigating risk. At the end of the second quarter, we initiated our return to work plan, slowly bringing a limited number of staff back to the office and implementing strict rules to protect our employees. Except for challenges in accessing elderly care facilities, we are fortunate that we have not experienced any significant delays to our ongoing or planned clinical trials. However, we continue to closely monitor the situation and provide updates as needed. As many of you know, this is one of the most exciting times in BioXcel's history, from positive results in two pivotal Phase C trials of BXCL501 to a very successful follow-on offering.

No. That's taken Gordon remains your daughter Darned to walk plan slowly, bringing a limited number I would stop back to golf <unk> and implementing it strict rules to protect our employees.

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And provide update as needed.

As many of you know this is one of the most exciting times in buyer it sounds history from <unk> they'd be reserves in dope ever thought would face the price or be axiall quite well one we're very successful follow on offering.

Vimal D. Mehta: We cannot tell you how pleased we are with our progress. We remain committed to and on track with our commercial, clinical, and development plans as we advance the investigation of our two candidates, BXCL501 and BXCL7. I will start off with our lead Neuroscience Clinical Candidate, BXCL501. As a reminder, 501 is a proprietary thin film formulation of dexmedumedine, or DEX, for the treatment of acute agit

We cannot tell you how plays Riyadh <unk> dollar progress we remain committed.

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We bought ecstatic last month, we announced positive top line results from both Cidade de phase two times or be Axiall fiber one for the acute treatment of vegetation in patients really schizophrenia and bipolar disorder.

Vimal D. Mehta: We were ecstatic last month to announce positive top-line results from both Serenity Phase T Trials of BioXcel 501 for the acute treatment of agitation in patients with schizophrenia and bipolar disorder, achieving the primary, secondary, and exploratory endpoints. I would like to quickly recap those results, which we also reviewed in greater detail during a conference call last week. As you may recall, the two serenity studies were similarly designed as double-blind placebo-controlled parallel group trials with a total of 759 patients, 18 to 75 years of age. In each trial, patients were randomized to one of three arms receiving a film of either 120 microgram, 180 microgram, or a matching placebo. The primary objective of the trials was to determine the effect on agitation at 2 hours using the PANS Excitory Component Scale or PEC, a validated means to quantify the degree of agitation. The key secondary endpoint was the earliest time at which an effect on agitation was apparent as a change from the baseline impact total score.

Achieving the primary secondary and exploratory endpoint.

I would like to quickly recap those reserves, which we also revealed in greater detail during a conference call last month.

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Vimal D. Mehta: Both trials demonstrated statistically significant and clinically meaningful improvement in the PEC score and demonstrated statistically significant improvement in the PEC score as early as 20 minutes after treatment. BioXcel 501's rapid onset is an extremely important benefit for both the caregiver and the patient. To further confirm the primary endpoint, our exploratory endpoints also demonstrated highly statistically significant and clinically meaningful reductions in agitation measures, with durable reductions in agitation lasting at least four hours. As for the BioXcel 501 safety profile, it was well-tolerated with no serious adverse events. We could not be happier with the outcome of Serenity 1 and 2.

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We could not be happier with the outcome of Cidade de wanting to do.

Vimal D. Mehta: These encouraging data represent an important milestone for patients with schizophrenia and bipolar disorder, as well as their caregivers. We have a pre-NDA meeting scheduled with the FDA in October and look forward to submitting an NDA expected in the first quarter of 2012. In preparation for a potential approval by the FDA and the commercialization of BioXcel 501, we have built out our management team and hired Will Kane as Chief Commercial Officer, former head of the U.S. General Medicine Business Unit at Allergan, and Dr. Raina Benable as Chief Development Officer, former Chief Medical Officer at Cognivue. Both hires have extensive experience in bringing neuroscience products to market and will be integral in developing our pre- Will and Raina's focus over the next 12 months is to develop the infrastructure needed, including building and hiring the medical affairs team, the managed markets team, and the sales force.

These encouraging data had it presents an important milestone for patients with its schizophrenia and bipolar disorder as well as they have can't do it.

We have it be N D. A meeting scheduled would that be in October I look forward to somebody being in India expected in the first quarter of 2001 do well.

In preparation for a potential approval by the M.D.A., Andy commercialization not be Axiall fiber one we have been out our management team and have hired really came at chief commercial officer form I heard of the U.S. agenda in medicine business, you any dialogue and end up that they not.

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Well the tires to have extensive experience in bringing new refined products to market and we'll be in peak in developing all what be launch plan and go to market strategy, well and they know the forecast over the next strident months, its or don't love the infrastructure needed, including bending and hiding the medical.

Fair theme, the managed markets steam and assays for we wouldn't be valued prepared for a potential product launch by 2022.

Vimal D. Mehta: We will be well prepared for a potential product launch by 2020. Furthermore, these strong results from the Serenity Trials highlight BioXcel 501's beneficial mechanism of action in helping reduce agitation despite the underlying neuropsychiatric disease. This, in turn, opens the candidate's potential to be an effective treatment for a variety of conditions ranging from acute to chronic agitation. And as you know, we are already well underway investigating BXCL501 in patients suffering from dementia and opioid withdrawal symptoms and are preparing to initiate a phase 2 trial for the treatment of delirium later this year. Moving to Tranquility, our Phase 1b slash 2 trial for the acute treatment of agitation in dementia. This proof-of-concept trial is an adaptive design intended to identify the most effective and tolerable dose or doses in this elderly patient population using three exploratory efficacy endpoints. The Pittsburgh Agitation Scale and a modified version of the Cohen-Minesfield Agitation Inventory.

Furthermore, these strong results from that say they do does highlight be axiall fiber ones beneficial mechanism affection and helping to reduce agitation despite the underlying neuropsychiatric diseases.

They said and done opens a candidate or data showed adobe to being affected the men's whatever ideal conditions, if anything from acute to chronic agitation.

And as you know, we got already well underway investigating be axiall fiber one in patients suffering from dementia and acquired withdrawal symptoms and are preparing to initiate a phase two trial, what they might have the Lady M. Later this year.

Moving to dangling out of Phase one beat last June time for the acute treatment of vegetation and dementia.

This proof of concept barley, then adaptive design intended to identify the most effective and all everybody adult or does it and there's certainly patient population using three excellent I'd be happy get the I'd point back bed bug education at scale.

Okay, and MRT fired what is your and all the on Mindspeed education in rent already.

Vimal D. Mehta: We have currently finished dosing the first two arms of the trial, 30 micrograms and 60 micrograms in a total of 30 patients. After reviewing the safety and tolerability data, we are now initiating the next dose, 90 micrograms. Please note, we are evaluating lower doses than previously tested in schizophrenia and bipolar patients because these elderly individuals may be intrinsically more sensitive to DEX, the active ingredient in BioXcel 501.

We have currently finish the only thing they fought stool arms of their pod 30, microgram and 60 micrograms anecdotal or 30 patients after reviewing that safety and Tolerability data, we have no initiating the next door 90 microgram. Please note.

We are evaluating Lord knows is then baby athlete that started in schizophrenia and bipolar patients. Because these are dudley individuals may be intrinsically more things seem to decks that active ingredient in be axiall fiber one.

One we have identified the optimum dose for the patient population, we plan to advance the program into late stage that would love men in consultation with David do you recall that the M.D.A. granted fast track status do they have done lament they'll be actually in fiber one.

Vimal D. Mehta: Once we have identified the optimum dose for this patient population, we plan to advance the program into late-stage development in consultation with the FDA. Recall that the FDA granted fast-track status to the development of BioXcel 501 in dementia. Based on findings from the 90-mcg cohort, the company will report top-line results expected in the fourth quarter of 2020 or, if needed, proceed to an additional dose cohort. With no FDA-approved therapies to treat agitation in dementia and off-the-shelf drugs having a black box warning for the elderly, a treatment is desperately needed for this large patient population. Particularly given that they are at a significant risk of falling and injuring themselves when having an agitation episode.

And dementia.

Based on findings from the 90 microgram cohort the company will report top line. The that is expected in the fourth quarter 2020, odd if needed, but see do any additional score.

No M.D.A. approved therapies to would be that you did chen and dementia and awfully well bug, having a black box warning <unk> allegedly it beat meant is desperately needed for this large patient population.

Especially given that they are added significant this go falling and injecting then theres been having an education episode.

Vimal D. Mehta: After reviewing the serenity results, we are confident that BioXcel 501's significant calming response shown in schizophrenia and bipolar patients will be repeated in dementia since 501's mechanism of action seems to directly target agitation regardless of the underlying condition. With this patient population among the highest at risk for COVID-19, we are making sure we are taking all precautionary measures to guarantee that both the patients and caregivers remain healthy by reducing the risk of potential exposure. This past quarter, we announced that the first patient has been enrolled in the Phase 1b slash 2 release trial for the treatment of opioid withdrawal symptoms, and we are already and currently enrolling the third dose cohort of 90 micrograms. This is the fourth indication to enter the clinic for BioXcel 501, again highlighting the potential versatility of this candidate across vastly different conditions.

After reviewing that they didn't study design, we have gone for Dan that'd be actually added five or one significant commingled as far as shown in schizophrenia and bipolar Beijing will be the breeder didn't dementia centsfive all ones mechanism of action seems to directly tied to get education, regardless of the underlying condition.

With this patient population among the highest started this fall over 19, we haven't making sure. We are taking all the cautionary majors to got NB that both the patients and category remained healthy why did you think that it's got potential exposure.

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Currently enrolling that toward goes score of 90 microgram.

Do you see that Onefourteen delegation to enter the clinic for being in fiber one.

Again, highlighting the potential of what's the ability of the Skandi date at Krotz wasley different conditions.

In addition for the first time, they can needed will be used and it's up chronic <unk> men with ascending dose cohort, though fiber one being administered twice daily two out of all was a bargain for 10 days.

Vimal D. Mehta: In addition, for the first time, this candidate will be used as a subchronic treatment with ascending dose cohorts of 501 being administered twice daily, 12 hours apart for 10 days. We are looking forward to reporting top-line results from the release trial in the first quarter of 2021. Managing addiction has been a major challenge, and this crisis has only been exacerbated by the COVID-19 pandemic. The symptoms associated with opioid withdrawal are extremely debilitating and uncomfortable, often resulting in relapse and continued drug abuse.

Looking forward to reporting topline data from the release trial in the <unk> 2021.

Managing addiction has been a major challenges and these guys see there's only been accepted by the go in 19 bend to make the same time associated with opioid withdrawn Arctic family. They believe dating and I'm going for a day about that makes a.

Breaking dot they started to extend ready to figure out to all fun, there's anything in the lapse.

And continued drug abuse.

Vimal D. Mehta: With accidental drug overdose as the number one cause of death in the U.S. for individuals under the age of 50 years old, a new treatment option is needed that helps alleviate withdrawal symptoms in order to assist in breaking the cycle of addiction. We believe BioXcel 5.0.1 has the potential to provide relief from debilitating opioid withdrawal symptoms, diminishing the urge to relapse in hopes of helping the individual on their path to recovery. In addition, we plan to initiate a Phase II trial in patients with agitation associated with delirium, with and without COVID-19, this year. We believe our compassionate use program initiated last month at Massachusetts General Hospital, which provides BXCL 5.0 to critically ill COVID-19 patients in the ICU suffering from delirium and agitation, will be symbiotic with our plans to pursue delirium as an additional indication with B

Accidentally drug overdose as the number one cause of death in the U.S. what individual under the age of 50 years or in news feed burned off trend is needed that help alleviate withdrawal symptoms in order to assist in breaking that cycle of addiction.

We believe we actually had fiber one has the potential to provide relief from debilitating opioid withdrawal symptoms diminishing the artists to the lab in hopes of helping the individual on that path to recovery.

In addition.

We plan to initiate a phase two trial in patients with education associated with the Lady EM.

Good and without Colvin 19 to see Vicki.

We believe our compassionate use program initiated last month at in Massachusetts General Hospital, which Boulevard Bxc in five went on to critically ill go over 19 patients invites you suffering from the lithium in that division will be same biotic with our plan to put a futility and then additionally.

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To wrap up this quarter as neuroscience highlight we received a notice of allowance from the U.S. patent and trademark office brought it back end applications related to five will be.

Vimal D. Mehta: To wrap up this quarter's Neuroscience Highlight, we received a Notice of Allowance from the U.S. Patent and Trademark Office for a patent application related to FIBO. The patent is expected to cover film formulations containing DEX and methods of treating agitation using such film formulations, strengthening our intellectual property position and providing additional value for our stakeholders. The patent, which is to be issued in the third quarter of 2020, is expected to extend IP protection until 2013.

The paradigm is expected to cover fitting formulations containing decks and my third off teething education, using that spread and formulation is that defending our intellectual property position and providing addition value bought always stay accord.

The bad then we'd see.

We just to be sure in the third quarter of 2020 is expected to extend IP protection until 2013.

No that we have shown fiber ones effectiveness in doing delegation react excited to explore all of the potential opportunities ranging from acute on chronic use in hopes of expanding the market value.

Vimal D. Mehta: Now that we have shown 501's effectiveness in two indications, we are excited to explore all of the potential opportunities ranging from acute to chronic use in hopes of expanding the market value. We truly believe that BioXcel 501 will offer a safe, effective, and easy-to-administer therapy for the millions of individuals that suffer from agitation in the U.S. and around the world, regardless of the underlying diagnosis. We are focused on continuing to validate 501 success across conditions marked by agitation and look forward to exploring numerous potential indications such as alcohol withdrawal, PTSD, traumatic brain injury, and phobia. Now, I would like to turn the conversation to our Immuno-Oncology Clinical Candidate BioXcel 701, our orally available systemic innate immunity activator designed with a dual mechanism. Starting off, the Phase 2 efficacy portion of the Phase Approximately 30 eligible men with TNEPC will receive 0.3 mg of BioXcel 701 twice daily on days 1 to 14 of each 21 day cycle plus 200 mg of ketone administered intravenously on day one and then every 21 days.

It really believed that be xcl fiber, one villalta safe effective and easy to administer therapy for the millions of individuals that suffer from education in the U.S. and out on the war regardless of the underlying diagnosis.

We had focused on continuing to validate fiber one success across conditions market by agitation and look forward, where exploding numerous potential indications.

As alcohol withdrawal PTSD traumatic brain injury and phobia.

No.

I would like to done the conversation to our immuno oncology clinical candidate be axios that one on one hour orderly overlay about a systemic innate immunity activate a design with their dual mechanism affection.

Starting off the phase two every case the portion of the phase one be flash stewed dry love being Seattle, San Bruno one in combination with get through the 14 men emerging neuroendocrine prostrate cancer that or D. N. The BT is progressing on track approximately.

Eligible in men with Dan Nipisi will receive.

0.3 milligram, albeit Seattle, San Bruno one twice daily on days, one to 14 of each 21 day cycle, plus 200 milligram of Keytruda administration intravenously on day, one and then every 21 days.

Vimal D. Mehta: This split dose totaling 0.6 milligrams per day. The recommended dose when used in combination with Keytruda is based on results from the Phase 1b safety lead-in, which showed on-target side effects consistent with cytokine activation. In addition, based on preliminary evidence of activity in the Phase 1b safety portion of the trial, we recently initiated a separate cohort for castrate-resistant prostate cancer patients who have failed Texan-based chemotherapy and up to two lines of second-generation androgen pathway blockers. This cohort is expected to run concurrently with the TNEPC cohort. Initial efficacy data from this trial are expected later this year. BXCL-701 is designed to generate an adaptive immune response, causing tumors to be more reactive to immunotherapies, including Keytruda.

This split daus totaling <unk> 0.6 milligram per day.

The next Monday doors when used in combination with Keytruda. It based on reserves from the phase one be safety lead in we showed on thought of goods side effect consistent mid cycle kind activation.

In addition, based on preliminary evidence of activity in the phase one be safety portion of their tide V. Secondly initiated a separate go hard fought castrate resistant prostate cancer patients who have fared back seven based chemotherapy and up to.

Two lines of second generation androgen bought to be a block.

This call heart is expected to it I'm gone currently do the D. D N need BC cohort initial efficacy data from this tialata expected to be report there later this year.

Next year that when no one was designed to generate a and adaptive immune response, causing doing what it would be more the active doing may not that big a including get trued up our preliminary clinical biomarker data that showed doors and time the men dependent changes.

Vimal D. Mehta: Our preliminary clinical biomarker data showed dose- and time-dependent changes in circulating IL-18 concentrations from baseline. This is consistent with our understanding of the MOA of BXCL-501, as IL-18 is a multifunctional cytokine that serves as a bridge between innate and adaptive immune responses. We believe this candidate has the potential to be an effective treatment for patients in these subpopulations of prostate cancer.

In sector, leading ideally deemed concentration from baseline. This is consistent with our understanding of the I'm only or be axiall fiber one as I Eylea Dean is a multi functional cytokine that sounds as a bridge between innate and adaptive immunity. We believe this can eat it has.

<unk> potential to be an effective treatment for patients indeed, subpopulation southcross strict Ken.

We are also progressing the clinical evaluation will be a kids have all where no one via the open label Phase two boss care trial conducted at the MD Anderson Cancer Center.

Vimal D. Mehta: We are also progressing the clinical evaluation of BXCL-7101 via the open-level Phase 2 BASKET trial conducted at the MD Anderson Cancer Center. This study is evaluating the combination of BXCL501 and Keytruda in patients with advanced solid cancer and consists of two arms, checkpoint naive patients and patients who are refractory to checkpoint therapy. In June, the safety portion of the trial was complete, and recently, the trial met the efficacy bar in both arms, allowing the study to proceed to completion. We look forward to presenting initial data at a scientific conference later this year. Furthermore, the combination trial of BioXcel 701, BAMPAC from Nectar, and Avalumab from Pfizer and Merck AGA in second-line pancreatic cancer will start following the completion of Nectar and Pfizer's phase 1b safety study of BAMPAC and Avalumab and the outcome of, We are also further exploring compelling combinations with BioXcel 501 in additional indications with high-end methods. In July, we raised gross proceeds of approximately $200 million in a public offering, which helped to significantly strengthen our balance sheet.

These studies evaluating the combination of B and C. N fiber one in Canada in patients with advanced solid cancers and consists of two checkpoint naive patients and patients who are reflected two checkpoint therapy in June the safety abortion, another part of us complete and de thinly.

The trial met that if he gets you bought in both how long. They started to proceed to completion, we look forward to presenting initial data at the same big Scientific conference later this year.

Part of that mode. The combination dialogue bx yields that when no one bank back from that that and that value, Matt from Pfizer and might have kg in second line pancreatic cancer really started following the completion of Nektar then find that phase one be safety study of them back on a value ma'am.

And the outcome of that.

We are.

Also part of that exploding compelling commendation it'd be axiall fiber one in addition indication with high unmet needs.

In July we raised gross proceeds of approximately 200 million and net public offering which had significantly 10 10, our balance sheet.

Michael Stanton: This cash, together with our current reserves, provides BioXcel with a cash runway well into 2022 to fund key clinical, regulatory, operational, and commercial activities. With that, I would like to turn the call over to our controller, Michael Stanton.

This cash together with our current reserves worldwide by XL, a cash should underway value into 2000 joined due to foreign key clinical regulatory operational and commercial activity.

With that I would like to turn the call award to our controller, Michael Stanton Micah.

Michael Stanton: Thanks, Vimal. Once again, thank you all for joining us this morning, and a special welcome to our shareholders. VTI reported a net loss of $21.4 million for the second quarter of 2020, compared to a net loss of $8.5 million for the same period in 2019. The second quarter 2020 results include approximately $2 million in non-cash, stock-based compensation, compared to $1 million for the same period in 2019. Research and development expenses were $17.9 million for the second quarter of 2020, compared to $6.5 million for the same period in 2019. The increase was primarily due to increased clinical trial activity. General and administrative expenses were $3.5 million for the second quarter of 2020 as compared to $2.1 million for the same period in 2019. The increase was primarily due to salaries, non-cash compensation costs, and professional fees. Total operating expenses for the second quarter of 2020 were approximately $21.4 million, compared to total operating expenses of approximately $8.6 million for the same period in 2019.

Thanks.

Once again, thank you all for joining us this morning, and especial welcome to our shareholders.

T I reported a net loss of 21.4 million for the second quarter of 2020 compared to a net loss of 8.5 million for the same period in 2019. The second quarter 2020 results include approximately 2 million in noncash.

Cash stock based compensation compared to 1 million for the same period in 2019.

Research and development expenses were 17.9 million for the second quarter of 2020.

Compared to 6.5 million for the same period in 2019.

The increase was primarily due to increases in clinical trial activity.

General and administrative expenses were three and a half million for the second quarter 2020, as compared to 2.1 million for the same period and 2019th the increase was primarily due to salaries noncash compensation costs and professional fees.

Total operating expenses for the second quarter of 2020, or approximately 21.4 million compared to total operating expenses of approximately eight point sixmillion for the same period and 29 team.

As of June 30, 2020, cash and cash equivalents totaled approximately 65.5 million.

Michael Stanton: As of June 30, 2020, cash and cash equivalents totaled approximately $65.5 million. This does not include the $187.5 million in net proceeds generated from our equity offering that closed on July 31, 2020. That concludes the financial review of our second quarter. Now, I would like to turn the call back to Vimal for any further comments. Thanks, Michael. We would now like to open the call to questions. Operator.

This does not include 187.5 million net proceeds generated from on equity offering that closed on July 31st 2020.

That concludes the financial review of our second quarter now I would like to turn the call back to them all for any further comments.

Thanks, Michael.

We would now like to open the call two questions operator.

Operator: Thank you, and I'll be conducting a question and answer session. If you would like to be placed in the question queue, please press star 1 on your telephone. A confirmation tone will indicate your line is in the question queue. You may press star 2 if you'd like to remove your question.

Thank you will now be conducting a question answer session. If you like you placed in the question Q. Please press star one under telephone keypad, a confirmation Tony <unk>. Your line is in the question Q you May press star to if you'd like to move or question, probably Q for participants using the speaker equipment, maybe necessary to pick.

Operator: If you are using speaker equipment, it may be necessary to pick up your handset before pressing star 1, and that's star one to be placed. One moment, please, while we pull. Our first question today is coming from Jeff, from Bank of America. Your line is now, Okay, great. Thanks, guys, for the questions, and congrats on the progress. I just had a couple.

Perhaps it before pressing star one once again that star one to be placed in the question Q1 moment. Please poll for questions.

My first question today is coming from Geoff Meacham.

Bank of America.

Okay, great. Thanks, guys for the so the question congrats on the progress.

Just had a couple so when you just.

Jeff: So when you... As it relates to the serenity studies, I know you guys have time to dig through that. Is there any data on the elderly population in that study that could be helpful? Just as a read-through to the dementia study, and just more specifically asking about optimal dosing and moving up on that. And then I have one follow-up.

As it relates to the Serenity studies I know you guys have a time to dig through that is there any data in the elderly population that study that that could be helpful. Just as a read through to the dimension study and I'll just more specifically asking on your optimal dosing and moving up on that and then I had one follow up.

Thank Jeff or for that question, we as you said, we'd been digging through the data and what vad I wouldn't be I'd be that analyses, Rob will provide you some perspective on it yeah. So so we've looked at and both trials the overall a piece for.

Rob: Thanks, Jeff, for the question. As you said, we've been digging through the data, and wherever we are with the analysis, Rob will provide you with some perspective on it. Yeah, so we've looked at, in both trials, the overall AEs for patients age 65 through 75 that were dosed both with 120 or 180 micrograms, and there was no different AEs than the younger patients. There was really no difference in the profile, and I'll also say there were no SAEs in this population or any patient in these trials. Okay, that's helpful. And then, just as it relates to tranquility and the dosing, if you assume that maybe one of the lower doses is what's moved forward into Phase 3, I know you guys are planning on having several doses available, but if you had an even lower one available for dementia, just give us a sense for maybe how you think about that commercially, you know, from a pricing and sort of reimbursement access perspective Good morning, Jeff. This is Will.

Our patients age 65.

Through 70 fives that were dosed, both with 120 or 180 microgram and there was no different HM east and the younger patients I really no different than the profile and I'll also say there were no essay eat in this population or.

Or any patient and these trial.

Okay. That's helpful. And then just as it relates to the tranquility and and the dosing.

If you if you assume that maybe one of the lower doses is whats move forward on a phase three I know you guys were planning on having several doses available, but if you hadn't even lower one available for dementia, just give us a sense or maybe how you think about that commercially you know from a you know from a pricing on.

And sort of reimbursement access perspective.

Good morning, Josh. This is will so I think obviously, we'll wait to see the data.

Unknown Executive: So, I think, obviously, we'll wait to see the data and how that plays out relative to the, you know, optimal dose for that population. I think it will give us an opportunity, then, to think through pricing, potentially by indication or by dose strength. Again, we'll have to wait and see how that plays out.

And how that plays out relative to the.

Optimal dose for that population I think well give us an opportunity then to think through pricing potentially by indication or by do strength again, we'll have to wait and see how that plays out.

Unknown Executive: And then, as you can appreciate, for the geriatric dementia population, the Alzheimer's population, that is mostly a Medicare Part D population, so that would involve interactions with those PDPs and pay organizations, but I think it would give us a strong position, given the lack of approved treatments for acute agitation in dementia, Alzheimer's, et cetera. So, I think it would serve us well, or it wouldn't in any way hamper us in terms of launching the product if the dosage was okay. Thanks a lot, guys. I appreciate it.

And then I did you can appreciate for geriatric dementia population. The Alzheimer's population that is mostly in Medicare part D populations, so that would involve interactions with with those.

Those pdps and pay organizations, but I think it would give us a strong position given the lack of abuse approved treatments for acute agitation in a in dementia, Alzheimer's et cetera. So I think oh, so I think it would serve as well or wouldn't it wouldn't anyway hamper us in terms of launching the product at the dosing we are different.

Okay, great. Thanks, a lot guys I appreciate it.

Sure Thank Jeff.

Thank you. My next question today is coming from Robyn Karnauskas from Truest Securities. Your line is a lot.

Operator: Our next question today is coming from Robyn Karnauskas from Truist Securities. Your line is now live. Bye, guys. Thanks for taking my questions and congratulations. Okay, I have a few.

Hi, guys. Thanks for taking my question congratulations.

How do you.

Sorry.

Yeah.

So you said he goes up to 60 in the phase two trial for.

Thank you trial for schizophrenia.

You didn't see a stop that benefit there and if I recall.

Robyn Kay Shelton Karnauskas: Let me just start with..., https://www.youtube.com www.youtube.com.uk Double-blinded, but is there any sort of rule, given the adaptive trial design, that doesn't see efficacy or see efficacy at that time point or what that bar is just trying to get a sense, If you have any sense yet of how high you could go. And then the next question would be, so you mentioned that you're going after 90, and that's going to take you into the fourth quarter. What happens if you go even higher? And what is the bar for going even higher above 90? Because that could, could that push you into the first quarter?

For intervention.

Overlapping PK PD with the other indications you're going after like you have any sense of whether or not.

Double blinded, but is there any sort of rule given the adaptive trial design.

Not yet.

You can see Uh huh.

Just trying to get a sense of if you have any said how high you could go and then.

Next question would be I see you mentioned you're going after.

Fourth quarter.

You know what happens if you go even higher.

The bar for going even higher.

Could that puts you into first quarter, just trying to guess timeline.

Vimal D. Mehta: Just trying to get a sense of the timeline. Great question. Let me address your second question about the timeline. I think these cohorts generally won't take too long to complete if the COVID-19 situation does not impact our access to elderly care. That can become challenging if cohorts go without any COVID-19 delays, and we can complete it pretty quickly. So depending on, as you indicated, once 90 is completed, do we choose to go further to 120 or 105? Whatever dose we choose, data will guide us. So could it go to Q1?

Oh, Great question, let me address with your second question about the timeline I.

I think these school hard are generally one big too long to complete if go read in 19 situation does not impact ex our access to their Dudley good thing.

That can become challenging.

If coal hard to go without any like you know covering named in delays and we can complete it pretty quickly so depending on as you indicated ones Ninetys completed do we choose to go farther to $1.90 or one off by whatever doors, we will choose.

They're not really guy does so could it go do go one it's very hard to predict what our goal is that as soon as we can complete these recruitment and moved up program forward. So if it's hard to predict at this time as we have indicated in our pets legal.

Vimal D. Mehta: It's very hard to predict, but our goal is that as soon as we can complete these recruitments and move the program forward, so it's hard to predict at this time, as we have indicated in our press release. I will pass it on to Rob regarding the other aspect of the question, which is related to what activity we saw in Serenity with the lower doses. Sure.

I will pass it on to Rob regarding the other aspects of that portion, which is really due to award activity. We saw in seen anybody with a lower does it.

Well.

Rob: So, um... We designed the Serenity trials and the development around agitation, schizophrenia, and bipolar based on our Phase II trial. That Phase II trial was a dose-ranging trial, and as you're pointing out, we saw efficacy at a range of doses. It was really remarkably dose responsive.

Sure so.

We designed the serenity trials in the development around agitation in schizophrenia and bipolar based on our phase two trial that phase two trial was a dose ranging trial and as you're pointing out. We are we saw efficacy at a range of doses that was really remarkably dose response.

Now this was obviously patients with schizophrenia, and we found some efficacy actually at 60 micrograms in that phase two trial, we chose to take the higher doses into this around 80 trials because they proved to be a greater proportion of response.

Rob: Now, this was obviously patients with schizophrenia, and we found some efficacy at 60 micrograms in that phase two trial. We chose to take the higher doses into the Serenity trials because they proved to be a greater proportion of response, a greater magnitude of response, and maybe slightly faster in terms of their efficacy. So we have a lot of things to consider, but the point is that in patients who are much younger, realize, patients with schizophrenia, we showed efficacy at doses of 60 micrograms, and that's why we're testing lower doses in patients with dementia. We know that the IV formulation is labeled to use about half the dose in the elderly. So, we actually have a plethora of data to design these trials, and we're using the exact same approach that we used to generate the pivotal trials that were robustly positive.

That's a greater magnitude of response and maybe slightly faster in terms of their efficacy. So we have a lot of things to consider but the point is that in patients who are much younger realize patients was 'cause a friendly we showed efficacy at doses of 60 micrograms and that's why we're.

Testing lower doses in patients with men shop.

We know that the Ivy formulation.

Is labeled for use about half the dose and the elderly. So we actually have a plethora of data to Oh design. These trials and we're using the exact same approach that we've used to generate the pivotal trials that were robustly positive we're doing the same thing with them.

Vimal D. Mehta: We're doing the same thing with dementia. Robyn, I'd also like to add to Vimal, even if you remember in our phase 2 schizophrenia trial, AT was statistically significant. So we start seeing activity with the lower doses, and in schizophrenia and bipolar, considering the nature of the patient, then you optimize the dose where you start seeing the maximum number of results. So that's why we had those escalated to 120 and 180.

Uh huh.

Robin I like to air It also been model or even if you remember in our phase two schizophrenia trial 80 wise that is particularly significant so we start seeing a activity a with the Lord knows it and in schizophrenia and bipolar conceding the needs that up.

And then you optimize the doors, where you start seeing maximum number of its funny, but that's why we had those escalated the onetwenty in running today.

Right. That's a quick follow up just want to be clear, but I know that gets lower.

But from what I understood.

Robyn Kay Shelton Karnauskas: Right, so just a quick follow-up, just want to be clear, but I know they get to start lower for IV, but from what I understand from our conversations is that the IV PK looks somewhat similar, so we don't really know if that's actually needed for going forward. What is in the protocol, the bar for going even higher? The allowance for you to go higher. I guess so.

Is that.

Okay look somewhat similar so we don't really know actually needed.

For asking.

In the protocol the bar.

Hi.

You know higher.

You could argue that.

Could be a bladder cancer if its I'd look exactly the same its first PK PD with these older patients with younger patients sort of as you're sort of a leading to witness schizophrenia trial, you may need to go.

If you want to have better efficacy, so what does that work.

Vimal D. Mehta: And then... Yeah, Robyn, there's no bar for us to escalate. [inaudible] Or, for example, are you enrolling patients faster as COVID cases come down in certain parts of the country? Any more just not I know you can't get specific, but just, type of color that would help us feel more comfortable that there wouldn't be any more flowing again.

[music].

It's too.

The allowance.

Yeah.

Yeah Robin.

There was no bar for us to escalate.

Okay.

Yes.

Apart.

Hi safety as the bar if you of course, we're not going to do anything on safe. So.

Hi, This is the bar and then.

And then color any more clarity.

Have you seen any increase in enrollment.

Vimal D. Mehta: We do see higher enrollment when there are no impacts with COVID-19 or no shutdowns by the state or by the federal level to get access to these facilities. We do see trials go quite fast if there is no disruption. Okay, perfect. Thanks for taking my question. Thank you, Robyn.

Yes.

Yeah shift like from the beginning of this route.

As the Cobi impact change for example are you enroll.

Hasten faster.

It's come down certain parts of the country.

Anymore.

No I knew you can't get specific but just any.

Type of color.

Comfortable that there could be slowly potentially.

Oh, we do see a hot enrollment vendetta no impact to the colder 19, no shutdowns by the state or by the upside to level.

Operator: Thank you. Our next question today is coming from Yatin Suneja from Guggenheim Partners. Your line is now... Hey guys, thank you for taking my questions; just a couple from me also.

To get access to these facilities, we do see dies do go quite fast if there's not a disruption.

Okay perfect. Thanks for taking my question.

Thank you <unk>.

Your next question today is coming from your teams Tunisia from Guggenheim Partners. Your line is.

Yatin Suneja: With regard to the safety considerations, could you maybe talk about how these older patients are also more sensitive on the safety side? And then with regard to the change in blood pressure or drop in heart rate, what might be acceptable, like how much drop in heart rate would you anticipate given that you saw that in your earlier trials and scriptures? Yeah, so.

Hey, guys. Thank you for taking my questions asked a couple from me well also.

HM consideration.

About how this all the Chicago.

How to build so more sensitive to London.

And then Liberty got good the change in blood pressure on crop hot rolled <unk>.

What might be acceptable how much dropping hot so would you anticipate given that you saw that.

On the trials in switching from one then they have.

Yeah. So.

Rob: We're looking at overall safety as we continue to escalate the dose. And we know, particularly in the elderly, safety of anything with respect to cardiovascular changes can result in, for example, falls or syncope, where people, if you will, pass out. And so that's one of the key safety measurements that we're monitoring closely. And so that's what we do. Those are the kinds of events that were monitored. But we continue to escalate.

We're looking at overall safety as we continue to escalate the Doe.

And where you know, particularly we know that in the elderly safety of anything with respect to cardiovascular changes can result, and for example balls or syncope, where people if you will pass out.

And so that's one of a key safety measurements that we're monitoring closely.

And so that's what we are.

You know the those are the kinds of events that were monitoring.

But we continue to escalate.

Got it and then income so can you just comment also on the comedy Central is it just consider more difficult given give people are setting who is getting a consent.

Rob: And then in terms of, you know, can you just comment also on like how many centers, is this considered more of a caregiver setting, like who's giving consent, and then who is, are patients able to take the film themselves, or is the caregiver that is providing the film? Yeah, we haven't entirely disclosed that. So it's at a typical care center where many patients with dementia are residing. Okay. That's it.

And then who is our patients able to take the film themselves. What is the Kid give a that is providing the film to them.

Yeah, we we haven't entirely disclose that so.

It's at a typical care center for a where many patients with dementia our residing.

Okay, that's all I had things.

Operator: Thanks, Yatin. Thank you. Our next question today is coming from Sumant Kulkarni from... Kevin Corderline is now. Thanks for taking my questions. I have two.

Thanks Yep.

Thank you. My next question to me is coming from Sumant Kulkarni from.

Canaccord your line is.

Alright, Thanks for taking my questions I have two or the first one is very specific could you. Please with the data young btwenty 19th let's start from Sep two a quantitative context for investors from bridging from an intravenous dosing Alzheimer's patients, let's see if an effective dose for the sentiment for education in dementia. That's the first question. The second one is indeed.

Sumant Satchidanand Kulkarni: The first one is very specific. Could you please put the data in your May 2019 poster from ASCP into a quantitative context for investors bridging from an intravenous dose in Alzheimer's patients to a safe and effective dose for the film for agitation and dementia? That's the first question. The second one is, in the agitation and geriatric dementia setting, clearly, there is a risk-benefit profile that must be considered. What I mean is the risk of someone agitated versus not being treated, even if the treatment has some side effects; how might you be specifically able to address this aspect when you go to the FDA, for example, for approval? The range of plasma concentrations with the IV, Proof-of-Concept Trial that now produces a RAF score of minus one. Now realize that you can treat agitation with a RAF score of zero. But the range that produced a RAF score of minus one was between 100 and 300.

Additionally, geriatric dementia, setting clearly that the risk benefit profile that must be considered what I mean is that it's got someone I do deep list as not being treated even if the different tests and side effects, how might you be specifically everyday justice aspect. When you go to yet you.

But again.

Looks like Google.

Yeah, the range of plasma concentrations with the I'd.

Kind of proof of concept trials.

That produce now a raft score.

Of minus one.

I realize that you can treat agitation with the rest score of zero.

The range the produced a raft score of minus one was between 103 hundred.

<unk> grabbed profile.

Rob: And so we know we can achieve that with our sublingual proprietary formulation. With respect to safety, the risk benefit profile, we know that agitation, patients, especially with dementia and agitation, have a number of risks just from the condition, those risks include physical harm to themselves. They include Falls. They include, you know, accidents, and falls. So we are, obviously, these are also things that we're monitoring closely. And this is a placebo-controlled trial, as most of our trials will be. So we'll have comparator data is what I'm suggesting.

And so we know we can achieve that with our sublingual proprietary formulation.

With respect to the safety.

The risk benefit profile, we know that agitation patients.

Especially with dementia and agitation.

Have a number of risk just from the condition.

Those risks include physical harm to themselves.

Includes falls.

Include accidents.

And falls. So we are obviously these are also things that we're monitoring closely and this is a placebo controlled trial as most of our trials will be.

So we'll have compared or data is what I'm, suggesting.

Got it and just a follow up did that up what are some of the specific quantitative better than it does you said youre setting as whole goods on the safety when you move to the next cohort.

Rob: And just to follow up on that, what are some of the specific quantitative parameters you are setting as hurdles for safety when you move to the next cohort? Because this is a proof-of-concept trial, if you will, or dose ranging, we're looking for any safety signals that would prevent us from testing higher doses. And that means, Sumant, that if there is a syncope, or there is a syncope and a risk of fall, so those are the key parameters that we monitor for safety. Obviously, you monitor all blood pressure and heart rate, and those changes.

[noise] because these are this is a proof of concept trial, the fuel or dose ranging.

We're looking for any safety signals that would prevent us from testing higher doses.

Okay and that in so mine that if they think up be or that it didn't seem to be and livecycle fall. So those are the key Pat I mean does that real money to a part of the safety obviously.

Your monitored out all the blood pressure and hard to those changes, but I think effect, though from a door. That's condition perspective is that the that he's anything could be or whether there's anything could be an important.

Rob: But I think the key factor from a dose escalation perspective is whether there is any syncope or whether there is any syncope in a fall. Got it, thanks. Thank you. As a reminder, that's star number one to be placed in the question queue. Our next question today is coming from Dil Kim from BMO Capital Markets. Your line is now live.

Got it thanks.

Thank you as a reminder, that star one to be placed the question Q. Our next question today, it's coming from Doe Kim from BMO capital markets. Your line is now what.

Hi, This is James and on for Doug. Thanks for taking the questions and congrats on the progress a one on D. Delirium program given that you have all that additional data from serenity the MGH study.

Operator: Hi, this is James Sanon-Perdot. Thanks for taking the questions and congratulations on the progress. One on the delirium program, given that you have all that additional data from Serenity, the MGH study, plus the data from IV dexmed, do you think there's a potential for an accelerated path, or do you still anticipate running a path? So, you're right. If it is COVID-19 patients, there could be some accelerated path, including emergency use authorization. But I think that market is like, you know, that need is sporadic, and that market is unpredictable.

The data I'd be decks, Matt do you think there's a potential for an accelerated path or do you still anticipate burning assays.

Thanks.

So.

You are right or if it is a core we 19 patients there could be some accelerated bad including emergency use authorization.

But I think that market is like you know that need these four today and that market is unpredictable. They had we absolutely think focusing from a commercial opportunities I used to you because.

Vimal D. Mehta: Where we are focusing from a commercial opportunity is ICU-based delirium for our first trial because that's a very well-established situation, agitation for the delirium patient. So I'm going to pass this on to Reina. She can put a little more color on the hyperactive delirium patient and what they experience in terms of it. Yes, so agitation and delirium in several places in the hospital are the reasons for higher mortality, poor outcomes, etc. And there is a lofty track record of IV decks in the successful management of delirium. And given our data with the film, I have no doubt that we can certainly pursue and really increase the outcomes of those patients with delirium in several sets. Great, thanks, congrats on the progress, looking forward to the Tranquility. Thank you. Thank you. Thank you. Our next question today is coming from Raghuram Selvaraju from... and Wayne White, your line is now live.

Delirium fought our plus right because that's a very well establish situation [laughter] agitation for their delivery ambition, so I'm going to parts. They don't do they not as you can put little more Carla the high but at the delivery ambition and what the expedient in terms of education.

Yes, so agitation and delirium in several places in the hospital is the reason for higher mortality for outcomes et cetera, So and there is a lofty track record of Ivy decks in.

In successful management, delirium, so and keeping our data with the film I have no doubt that we can certainly pursue and really increase the outcomes.

Of those patients with the Larry I'm in several settings.

Great. Thanks, Congrats on the progress I'm looking forward to the tranquility.

Thank you.

Next question from.

So from C. Wainwright your line is a lot.

Thanks, very much for taking my questions. So firstly on the tranquility program I had to a classical 40 points. Firstly, if you have great efficacy with the 90 microgram dose.

Rob: Thanks very much for taking my questions. So firstly, on the Tranquility Program, I had two. Firstly, if you have great efficacy with the 90 microgram dose, just if you look at the efficacy profile and assume that the safety is all clear. What exactly would be your incentive to pursue higher doses? In other words, the 90 microgram doses look very potent and look like they would give you, you know, a high degree of statistical significance. What would be your specific incentive for looking at higher doses? And then, secondly, can you comment on the medications that are excluded in the Tranquility Study, in particular those that are known to be associated with a high risk of falls in this population? And in particular, you know, I'd be interested to know whether Nudextra and Nuplizid are excluded medications. Yeah, the only medications right now that are really excluded would be medications that would increase blood pressure, like pressors. For example,

If you look at the efficacy profile and assuming that the safety as all clear.

What exactly would be your incentive to pursue higher doses in other words, the 90 minute microgram doses looking very potent and looks like it would give you you know a high degree of statistical significance, what would be or specific incentive but looking at higher doses and then secondly can you comment on medications that are excluded.

And quality study in particular, those that are known to be associated with high risk of falls in this population in particular.

I'd be interested to know whether new Dexter nuclear that are excluded medication. Thank you.

Yeah I'm the only medications right now that are really excluded would be medications that would increase blood pressure like pressers <unk>.

For example.

We have intentionally tried to include patients who are on a range of.

Rob: We have intentionally tried to include patients who are on a range of other medications. We know that the population is treated with polypharmacy, unfortunately. So, we're trying to... Test this as safely as possible. But nonetheless, in as generalizable a population as possible, as is feasible. So the exclusions right now have to do with press, www.youtube.com.au. Okay, thank you.

Other medications, we know the population is treated with polypharmacy, Unfortunately, and so we're trying to.

Yes, this is safely as possible, but nonetheless than as generalizable, a population as Paul a as is feasible.

Oh, the exclusions right now have to do with Pressers.

Things that might alter blood pressure and a negative way.

Okay. Thank you. That's helpful. In addition, I wanted to ask about opioid withdrawal efficacy endpoints, which efficacy endpoints you anticipate are likely to be most applicable.

Operator: That's helpful. Now, in addition, I wanted to ask about opioid withdrawal efficacy, which efficacy endpoints you anticipate are likely to be most applicable in that context. And also, if you could enumerate what the potential advantages of a drug like 501 might be in that indication versus, for example, Lusamira or Lofexin. We are using the CALS, the Clinical Opiate Withdrawal Scale, and the SALS, the Subjective Opiate Withdrawal Scale of GOSUX.

Contacts and also if you get a numerate what the potential advantages of the drug like fiber one might be that syndication versus for example, a semi regardless accident.

We are using the cowles, the clinical opiate withdrawal scale and ER, south subjective opiate withdrawal scale of gossip.

This is the.

Rob: This is the... Registrational Endpoint that the FDA accepts. For example, to demonstrate efficacy to treat opiate withdrawal symptoms. We believe that BioXcel 501 has both robust, and we believe it is rapid.

Registrational endpoint that the FDA access.

For example to demonstrate efficacy it to treat opiate withdrawal symptoms.

We believe that be Axiall fiber one has both robust effect in terms of treating opiate withdrawal symptoms. We believe is rapid we believe it is also a should have a magnitude of effect likely greater than Samirah. Now. This is based upon our eyes.

Rob: We believe it also should have a magnitude of effect likely greater than Lusimira. Now, this is based upon our IV proof of concept trial in patients undergoing withdrawal, and that is also based on preclinical data showing selective and highly potent agonist relative to. Ram, I do want to address your initial question.

D proof of concept trial.

In patients undergoing withdrawal.

And that is also based on preclinical data showing the selective and highly potent agonism relative to some mirror.

And I do want to address your initial question if <unk> 90, microgram, we see great IP Casey do we have any incentive to go forward with I think what we are really trying to achieve that is a.

Vimal D. Mehta: If with 90 micrograms we see great efficacy, do we have any incentive to go for it? I think what we are really trying to achieve here is a sweet spot of effectiveness and tolerability and also coverage. We are here not just treating Alzheimer's dementia patients; we have all kinds of dementia patients, and we want to see what doses work in what kind of patients so that we can get a good handle on them, and then we can choose for our late stage development the right kind of a dementia population where we see optimal efficacy as well as safety. Okay, great. And then just a couple more.

So it's part of effectiveness and that dollar Liberty and also the coverage. We are here not just reading Alzheimers dementia patients, we gotta, having all crime third dementia patients and we wanted to see.

What those is working in what kind of patients. So that we can get a good handle and then we can choose what our leads to the problem and like I don't know for dementia population, where do we see all female efficacy as well as safety.

Okay, Great and then just a couple more I was wondering if you could provide us with an update on the Colgate 19 associated delirium compassionate use program and if you are seeing any additional interest any demand from hospitals beyond MGH in that context.

Vimal D. Mehta: I was wondering if you could provide us with an update on the COVID-19 associated delirium compassionate use program and if you are seeing any additional interest, or any demand from hospitals beyond MGH in that context. And then if you could provide us with your sort of updated perspective on potential lifestyles with regard to 501. We've talked previously on other calls about phobias. I was just wondering... You know, have you had any thoughts about conditions like PTSD, middle of the night awakening, things like that, where a calming agent like this might potentially be applicable? Of course, in the very, very long run, after you get through all of these initial... That's right. That's right. As you mentioned, there is quite a bit of potential with 5.0.1 to expand and capture the market.

And then if you could provide us with your sort of updated perspective on potential lifestyle indications as it were in the long run with regard to fiber one I mean, we've talked previously on other calls about phobias I was just wondering if you know you had any thoughts about conditions like TTS needs.

Middle of the night, a weakening things like that where calming agent like that might potentially be applicable of course into very very long run off do you get through all that these initial indications. Thank you.

That's right that started out as you mentioned these would be the quite a bit of potential with fiber one to expand and capture the market opportunity. The Larry I'm MGMT them, just sturdy and they will provide debate if they provided as I've been would then be will provide bard what that has done.

Vimal D. Mehta: Delirium MGH is an MGH study, and they will provide the update. If they provide us with an update, then we will provide it, but what that has done, coming to your question, is created interest among a lot of key opinion leaders who are the leaders in this field, and we are working with them to design our Phase II trial in delirium. So that trial or that visibility, like interest and FDA support to use it for compassionate use, has been helpful, and we have speeded up our development for delirium agitation. I will pass it on to Rob and Reina to talk about more broadly how they are thinking about PTSD, alcohol withdrawal, or phobias. There is quite a bit of opportunity, so Rob and Reina, and TBI, phobia, for example, people think of Phobias actually have..., go to www.youtube.com or the link in the description below, a huge and continuing problem.

Turning to your question because they didn't present a lot of key opinion leaders who are the leaders in this for you and we are working with them to design I want phase two trial into late and so that dialogue or that visibility or like a known to us and every two years support.

Do you there's quite a compassionate use has been helpful and be able to speed. It up I wouldn't have lemon for delirium education, I will pass it onto job and they know the dog aboard more broadly about like you know, how they're thinking about b D as de alcohol withdrawal or fulvia, there's quite a bit of opportunity.

I'd say at all and then.

And.

Man.

<unk> for example people think of focus is like a fear or flying.

Or a fear of high Tobey is actually have a certain amount of background anxiety as well. It does a sector lies and there is a thing called agoraphobia, which limits people's ability to even leave their home. So it's hard for them to the employed often they can't leave the house.

There is potential application across a number of these anxiety disorders as well as PTSD, a huge and and continuing problem.

Rob: For patients, not just military personnel, but many, many patients develop PTSD from accidents and trauma. There again, there's evidence that... Dexmedetomidine may have. Beneficial Effects in Traumatic Brain Injury Patients, not just in the acute trauma and treating with delirium, there's evidence of that, but there is also potential evidence of long-term recovery. They have, for example, sleep-wake disturbances. It's a classic symptom.

For patients not just military but many many patients develop PTSD from accidents and trauma never again, there's and evidence that.

[music].

Thanks, Matt it's how many in may have.

Beneficial effects and traumatic brain injury patients I'm not just in the acute trauma and treating with delirium. There's evidence of that but there was also potential evidence of long term recovery. They have for example, sleep wake disturbances. It's a classic symptom almost every patient has that an obvious.

Rob: Almost every patient has that. And obviously, dexmedetomidine can potentially improve sleep as a biomimetic sleep aid. So it augments sleep in a very specific way that is unique, very different than benzodiazepines or other sleep aids. So I'll let Dr. Benabou speak to that.

Mostly.

Excellent and told many can potentially.

Improves sleep as a bio mimetic sleep I'm sort of augment sleep in a very specific way that is unique.

Very different than benzodiazepines or other sleep agents, so I'll, let dr. been up to speed to other.

Yes.

Raina Benabu: Thank you very much, Rob. So, honestly, I think we add value to patients' lives if we can either prevent, predict, or optimize a disease state. So there's a lot that we can do in terms of lifestyle on a daily basis as well. And 501 has clearly demonstrated a Reliable, Consisting, Excellent Efficacy and Safety Profile that is due to its central mechanism of action.

Well. Thank you very much Rob so honestly I think we add value in patients lives. If we can either event predict.

Sure and optimize a disease state show so there's there's a lot the weekend.

On on a daily basis, as well, so and and fiber one has clearly demonstrated a.

A reliable consisting excellent efficacy and safety profile that is due to his central mechanism of action. So were confident that we can also make a difference in all those other indications as Rob mentioned and I would like to also.

Raina Benabu: So we're confident that we can also make a difference in all those other indications. And I would also like to add that at some point, we will engage FDA in a conversation where we can seek that there will be opportunity for a broader agitation level if we can prove our drug is working through a central mechanism after having efficacy in a couple of these indications. So there is quite a bit of strategy that is needed to do life cycle management and capture the full potential of this drug.

At some point, we will engage ever be in their conversation bad we can see or add that there will be approach under deepwater brought a agitation lay both.

If we can prove our drug is working through central mechanism, but having the efficacy in couple of these indications. So then pick whatever those strategy that is needed to do the lifecycle management and capture the full potential of this drug and I think good news is that we have both clinical demon commercial team and.

Vimal D. Mehta: And I think the good news is that we have both a clinical team and a commercial team and our medical team. They are working very closely to prioritize them and what strategy to use to expand the potential of 501. Thank you. Thanks, Ralph. Thank you. We've reached the end of our question and answer session. I'd like to turn the floor back over to management for any further or closing comments. Thank you again for joining our call today. I'm extremely proud of BioXcel's tremendous growth on both the clinical and corporate front, and we remain focused on continuing this momentum for the remainder of 2020 and beyond.

ER our medical team they are working very closely how to prioritize them and what the strategy to use to expand the potential of fiberlan.

Thank you.

Thanks So.

Thank you we reached about question answer session I'd like to turn the floor back over to management for any further or closing comments.

Thank you again for joining our call today I'm extremely proud about by excels tremendous growth on both the clinical and corporate friends and we remain focused on continuing this momentum for the remainder of 2020 and beyond have agreed.

Vimal D. Mehta: Have a great day, and please reach out to us if you have any additional questions. Thank you. Thank you. That does conclude today's teleconference and webcast. You may disconnect your line at this time, and have a wonderful day.

Okay and please reach out to us if you have anybody should cushions. Thank you.

Thank you that does conclude today's teleconference and webcast you may disconnect. Your lines at this time and have a wonderful day, we thank you for your participation today.