Q2 2022 BioXcel Therapeutics Inc Earnings Call

Good morning, and welcome to the bio <unk> cell Therapeutics second quarter 2022 financial results Conference call. At this time all participants are in a listen only mode. If during the conference you require operator assistance. Please press star zero on your telephone keypad.

Operator: Good morning and welcome to the BioXcel Therapeutics 2nd Quarter 2022 Financial Results Conference Call.

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Operator: 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 related to future events and or the future financial or business performance of the company. Actual results could differ materially from those anticipated in these forward-looking statements.

Our business performance of the company.

Actual results could differ materially from those anticipated any forward looking statements risk factors that may affect future results are detailed in the Companys quarterly report on Form 10-Q for the quarter ended March 31st 2021, which can be found at www dot biologics cell therapeutics dot com or on Www Dot S E C Dot Gov.

Operator: Risk factors that may affect future results are detailed in the company's quarterly report, on Form 10-Q for the quarter ended March 31, 2021, which can be found at www.bioxceltherapeutics.com or on www.sec.gov, which will be updated in its quarterly report on Form 10-Q for the quarter ended June 30, 2022.

Which will be updated in its quarterly report on Form 10-Q for the quarter ended June 30th 2022. As a reminder, today's conference is being recorded joining us on today's call are Dr. Emel Mehta, Chief Executive Officer, Richard Steinhart, Chief Financial Officer, Matt Wiley Chief Commercial officer, Dr. Rob Risinger.

Operator: As a reminder, today's conference is being recorded.

Keith Medical officer of Neuroscience, Dr. Frank JAKO, Chief Scientific Officer, and Dr. Vince O'neill, Chief Medical officer of oncology.

Operator: Joining us on today's call are Dr. Vimal Mehta, Chief Executive Officer, Richard Steinhardt, Chief Financial Officer, Matt Wiley, Chief Commercial Officer, Dr.

It is now my pleasure to turn the call over to Dr. <unk>. The CEO of <unk> Therapeutics. Please go ahead.

Operator: Rob Reisinger, Chief Medical Officer of, Neuroscience, Dr. Frank Yaka, Chief Scientific Officer, and Dr. Vince O'Neill, Chief Medical

Thank you operator, welcome everyone and thank you for joining our call today Goodbye compatibility financial performance and business highlights for the second quarter.

Operator: Officer of Oncology.

Operator: It is now my pleasure to turn the call over to Dr. Mehta, the CEO of BioXcel Therapeutics.

Kevin.

It has been a busy <unk>.

Bard in few months and we have been we have.

Vimal Mehta: Please go ahead.

Many exciting updates to review this morning.

No we are in a biopharmaceutical company utilizing artificial intelligence approaches to download.

So maybe Matt in neuroscience and immuno oncology.

You have heard me discuss our five year vision to become the premier.

I do on Neuroscience company and our progress from this past quarter.

All parts of our business continues to bring us closer to these ambitious goals.

Vimal Mehta: Thank you, operator.

Let me begin by highlighting our notable achievement.

Vimal Mehta: Welcome, everyone, and thank you for joining our call today to discuss BioXcel Therapeutics financial performance and business highlights for the second quarter of 2022. It has been a busy but rewarding few months, and we have many exciting updates to review this morning. As you know, we are a biopharmaceutical company utilizing artificial intelligence approaches to develop transformative medicines in neuroscience and human oncology.

The organization.

We have laid the foundation for a successful entry into the market economy.

Through Q.

For my moderate or severe agitation.

We've stated with bipolar one disorder audit schizophrenia.

Our sales team has been in the creative for over two months and key commercial activity.

Voluntary.

And eventual adoption.

We'll take launch in early July our priority remains delivering this new treatment option to hospital system health care professionals and patients.

Our chief commercial officer, Matt Wiley will discuss the progress and positive feedback from the field in more detail shortly.

Y J launch marked an important milestone for <unk>.

One program.

Continue our heavy focus on our people.

For your expansion strategy.

Let me summarize our progress since last quarter.

Vimal Mehta: You have heard me discuss our five-year vision to become the premier AI-driven neuroscience company, and our progress from this past quarter across all parts of our business continues to bring us closer to this ambitious goal.

Following a successful type b meeting with the FDA, we have part of the exit strategy, what our first strategic pillar, which is broadening the medical staffing we had 501 can be offered.

Vimal Mehta: Let me begin by highlighting our notable achievements across the organization. We have laid the foundation for a successful entry into the market for EGALMI.

On this Brian I'm excited to announce our lead trial for at home use this.

Vimal Mehta: Our FDA-approved acute treatment for mild, moderate, or severe agitation associated with bipolar I or II disorder or schizophrenia in adults.

Double blinded placebo controlled single and study design.

Elvira 160, microgram dose for agitation associated with bipolar one or two disorder and schizophrenia.

Vimal Mehta: Our sales team has been in the field for over two months, and key commercial activities are in full swing to create awareness and drive eventual adoption. With trade launch in early July, our priority remains delivering this new treatment option to hospital systems, healthcare professionals, and patients.

And will consist of two parts.

Vimal Mehta: Our chief commercial officer, Matt Wiley, will discuss commercial progress and early feedback from the field in more detail shortly.

Vimal Mehta: While EGALMI's trade launch marked an important milestone for the 501 program, we continue, our heavy focus on our three-pillar portfolio expansion strategy for the franchise.

So first part is similar to our tier one and two trials, which are the basis for our economy.

Earlier this year and is designed to assess efficacy and safety.

Vimal Mehta: Let me summarize our progress since last quarter. Following a successful Type B meeting with the FDA, we have further executed our strategy, for our first strategic pillar, which is broadening the medical setting where 501 can be offered.

Bipolar schizophrenia.

On Saturday night.

Vimal Mehta: On this front, I'm excited to announce our Serenity 3 trial for at-home use.

Maybe one thing to say.

These three Brian Murray and forgive me I'm, Brian the change from baseline in total score at two hours compared to placebo.

The second part of it to me is designed to assess safety compared to placebo when salesman is administered at home.

We believe <unk>, maybe David for the <unk> visa.

It really utilize many of the same investigator.

Clinical site as Steve maybe one in June .

Second we have already observed dose dependent response in our phase one <unk>.

Last to be sturdy 460, 81, Jordan one.

Microgram doses.

<unk>.

Market data shows a significant number of newly identified unclaimed and until you do that.

All our patients in the <unk> setting.

This is <expletive>.

So the claims data.

Joining that one third of the $25 million bipolar and schizophrenia.

Good afternoon.

Okay outside intrusion and setting.

Together this is a clearly defined medical need.

Large market opportunity in which we have already demonstrated the efficacy and safety of economy.

Additionally, the expedia as mid cycle.

Please will gain in the <unk> with the current commercial effort will have been very strong bridge to Venezuela.

Community use if approved.

We expect to initiate 73 in the second half of 2022.

Vimal Mehta: This pivotal double-blinded placebo-controlled single study is designed to evaluate BXCL501, 60-mcg dose for agitation associated with Bipolar I or II disorders and schizophrenia and will consist of two parts.

Next as part of our.

We started the expansion strategy, we have made strides in our clinical development program for 501, our pilot program for the acute treatment of agitation in patients with Alzheimer's disease that one thing that.

Vimal Mehta: The first part is similar to our Serenity 1 and 2 trials, which were the basis for our EGALMI approval earlier this year, and is designed to assess efficacy and safety in acutely agitated Bipolar and Schizophrenia patients in an institutional setting.

Vimal Mehta: Like Serenity 1 and 2, Serenity 3's primary efficacy endpoint is a change from baseline in PEP total score at two hours compared to placebo.

Vimal Mehta: The second part of Serenity 3 is designed to assess safety compared to placebo when self-administered at home.

Vimal Mehta: We believe Serenity 3 may be de-risked for the following reasons. First, it will utilize many of the same investigators and clinical sites as Serenity 1 and 2.

Vimal Mehta: Second, we have already observed dose-dependent responses in our Phase I-IIB study for 60, 80, 120, and 180-mcg doses.

Vimal Mehta: Decent market research shows a significant number of newly identified, unclaimed, and untreated episodes in Bipolar patients in the at-home setting.

Our tranquility to pivotal trial is enrolling with topline data are now expected in the first half of 2000 and joining me today.

Vimal Mehta: This is additive to the claimed data research showing that one-third of the 25 million Bipolar and Schizophrenia agitation-related episodes occur outside the institutional setting.

And we still anticipate initiating enrollment in the second half of this year or tranquility, our second pivotal trial in the program.

Vimal Mehta: Coupled together, this is a clearly defined medical need and large market opportunity in which we have already demonstrated the efficacy and safety of EGALMI.

With the recent approval of economy and a strong initial label, we believe the tranquility program.

Vimal Mehta: Additionally, the experience which psychiatrists will gain in the institutions with the current commercial effort will help build a strong bridge to eventual community use if approved.

Vimal Mehta: We expect to initiate Serenity 3 in the second half of 2022.

Has been significantly beavis. Additionally, the positive.

Is the safety and.

So all we built a data generated to date, along with breakthrough therapy designation from the FDA.

<unk> provides us continued confidence in the pivotal program.

Vimal Mehta: Next, as part of our indication strategy, expansion strategy, we have made strides in our clinical development programs for 501.

We look forward to progressing 501 towards a supplemental NDA of what agitation in patients with Alzheimer's.

Vimal Mehta: Our Tranquility Program for the acute treatment of agitation in patients with Alzheimer's disease is advancing well.

Vimal Mehta: Our Tranquility II Pivotal Trial is enrolling with top-line data now expected in the first, half of 2023, and we still anticipate initiating enrollment in the second half of this year for Tranquility III, our second pivotal trial in the program.

As I read the disease related agitation remains a clinically.

Significant and growing unmet need with an estimated $100 million episodes per year in the U S and no FDA approved therapies.

Vimal Mehta: With the recent approval of EGALMI and its strong initial label, we believe the Tranquility, Program has been significantly de-risked. Additionally, the positive efficacy, safety, and tolerability data generated to date, along, with breakthrough therapy designation from the FDA, provides us continued confidence in the Pivotal Tranquility Program.

Vimal Mehta: We look forward to progressing 501 towards a supplemental NDA for agitation in patients, with Alzheimer's.

We are excited by the potential of <unk> to play a key role in providing a much sought after solution for Alzheimer's agitation.

Vimal Mehta: Alzheimer's disease-related agitation remains a clinical area of significant and growing, unmet need, with an estimated 100 million episodes per year in the U.S. and no FDA-approved therapies.

<unk>.

Vimal Mehta: We are excited by the potential of 501 to play a key role in providing a much-sought-after, solution for Alzheimer's-associated agitation.

Partners to our indication expansion as Jeremy we are investigating the potential utility of <unk> one.

Vimal Mehta: Further to our indication expansion strategy, we are investigating the potential utility, of 501 as an adjunctive treatment in major depressive disorders.

Adjunctive treatment in major depressive disorder.

Vimal Mehta: Our Phase I Multiple Ascending Dose trial in healthy volunteers is progressing well, with our 30 and 60-microgram dose cohorts complete. This double-blinded placebo-controlled study includes multiple cohorts, each consisting, of 18 volunteers. The 80-microgram dose escalation portion of the trial is currently underway.

Our phase one multiple ascending dose trial in healthy volunteers is progressing well with our 30 and 60 microgram dose cohort is complete.

It is a double blinded placebo controlled study includes multiple cohort each consisting of 18 volume.

The 80 microgram dose escalation portion of the trial is currently underway.

Vimal Mehta: Data readout for this daily dosing study is expected in the first half of 2023, and, will inform our dose selection for a future proof-of-concept depression study.

Data readout for this daily dosing study is expected in the first half of 2023 and will inform our dose selection for a fee.

Future proof of concept depression study.

Vimal Mehta: Over 300 million antidepressant prescriptions are filled annually in the U.S., and current, antidepressant treatments are limited by slow onset of action and incomplete responses.

Yeah.

Or 300 million anti depression prescriptions annually.

Annually in the U S and current treatments are limited by slow onset of action and incomplete responses.

More broadly the 60 microgram dose daily dosing over seven days in healthy volunteers is quite encouraging.

Vimal Mehta: More broadly, the 60-microgram daily dosing over seven days in healthy volunteers is quite, encouraging and supportive for our leading programs for at-home use.

And supportive for our leading program for at home use.

Vimal Mehta: Moving on to the third and final pillar for our 501 expansion strategy, growing geographic, footprint.

Moving onto the third and final pillar for our fiber expansion strategy growing Joe geographic footprint.

Vimal Mehta: Given the significant near-term U.S. market opportunities the company has available by, As an adjunctive treatment for MDD, we have made the strategic choice to prioritize resources to execute on U.S. strategy over ex-U.S. As a result, we have chosen not to file an MAA at this time.

Given the significant U S market opportunity. The company has available by developing 501 for bipolar one and two in schizophrenia patients in the home setting.

And as an adjunctive treatment for MTV, we have made the strategic choice.

To prioritize resources to execute on your strategy or what ex U S.

As a result, we have chosen not to file an MAA at this time.

Vimal Mehta: We fully intend to pursue a well-timed geographic expansion at the most, appropriate and opportune time.

We fully intend to point to you.

Jonathan <unk>.

Expansion at the most appropriate and opportunistic time.

Vimal Mehta: Moving beyond 5.0.1, we are leveraging our proven AI technology to build out a sustainable R&D pipeline.

Moving beyond 501, we are leveraging our proven <unk> technology to build out a sustainable R&D pipeline.

Vimal Mehta: As part of our efforts to build out our neuroscience franchise, we continue to advance formulation work for BXCL 5.0.2, which demonstrates a novel and differentiated mechanism of action for the chronic treatment of agitation related to dementia and other neuropsychiatric conditions.

As part of our effort to build out our neuroscience franchise, we continue to advance formulation for <unk>, which they're more states and novel and differentiated mechanism of action for the chronic treatment of agitation related to diminish.

Vimal Mehta: Shifting to our oncology franchise, we have established OncoXcel, a fully operational focus subsidiary to provide maximum strategic and financial flexibility and position us for sustained expansion and optimization of the franchise. We are actively seeking strategic options, including third-party investments to advance OncoXcel and ultimately unlock significant value for our immuno-oncology franchise.

And other neuro psychiatric conditions.

Shifting to our oncology franchise, we have established <unk> XL, if fully operational focus update that aim to provide maximum strategic and financial flexibility flexibility and position us for sustained expansion and optimization of the franchise.

We are actively seeking strategic options, including third party investments to advance <unk> XL and ultimately unlock significant value for our immuno oncology franchise.

Vimal Mehta: Under OncoXcel, we are advancing the clinical development of BXCL 7.0.1, our leading immuno-oncology clinical candidate being developed for the treatment of aggressive forms of prostate cancer. This includes progress on our metastatic castrate-resistant prostate cancer phase 2 trial of BXCL 7.0.1 plus Ketruda combination therapy in patients with either small cell neuroendocrine carcinoma or adenocarcinoma phenotype. Patient enrollment in the SCNC cohort is expected to be completed in the second half of this year.

Under <unk>, we are advancing the clinical development of <unk> 701, our leading <unk>.

No one called <unk> clinical candidate being developed for the treatment of aggressive forms of prostate cancer.

This includes progress on our metastatic castrate resistant prostate cancer phase two trial, albeit off several no one plus scheduled a combination therapy in patients with small cell neuron endocrine carcinoma, all adenocarcinoma phenotype patient enrolled.

Finally in the CMC or is expected to be completed in the second half of this year.

In addition at <unk>.

Vimal Mehta: In addition, enrollment is advancing for our adenocarcinoma randomized trial expansion, evaluating 7.0.1 monotherapy versus 7.0.1 Ketruda combination therapy.

<unk> is advancing toward our adenocarcinoma randomized trial expansion.

101, monotherapy <unk> hundred one keytruda combination therapy with <unk>.

Look forward to providing additional updates on our plans to maximize shareholder value to our oncology subsidiary later this year.

Vimal Mehta: We look forward to providing additional updates on our plans to maximize shareholder value to our oncology subsidiary later this year.

On the corporate front, we have valid gun industry veteran Michael Miller to our board of directors.

Vimal Mehta: On the corporate front, we have welcomed industry veteran Michael Miller to our board, of directors and the BioXcel family.

Vimal Mehta: We are very pleased to have his strategic leadership and commercial growth experience available during this exciting time for BioXcel.

And biodiesel family, we are very pleased to have his strategic leadership and commercial growth.

<unk> is available during this exciting time for <unk>.

Lastly, we continue to fortify our intellectual property with two new burden related to economies.

Vimal Mehta: Lastly, we continue to fortify our intellectual property with two new patents related to Igalmi's film formulations containing dexmedimedine and methods of treating agitation using the film.

Film formulation containing <unk> and methods of treating agitation using defense.

Vimal Mehta: In summary, we have made great progress across all aspects of our business this quarter and are continuing our work to transform the agitation treatment landscape, and other neuropsychiatric conditions.

In summary, we have made great progress across all aspects of our business this quarter and are continuing our work to transform the agitation diekman landscape.

And other neuropsychiatric conditions.

Vimal Mehta: We have many exciting catalysts on the horizon, and look forward to continuing our journey toward becoming the leading AI-enabled neuroscience company.

There are many exciting catalysts on the horizon and look forward to continuing our journey towards becoming the leading AI enabled neuroscience company.

Now I would like to turn the call over to Matt Wiley, who will give an update on the economy launch Matt.

Vimal Mehta: Now, I would like to turn the call over to Matt Wiley, who will give an update on the IGALMI launch.

Matthew Wiley: Matt?

Matthew Wiley: Thank you, Vimal.

Thank you Ben and good morning, everyone.

Matthew Wiley: Good morning, everyone.

Matthew Wiley: I'm pleased to report our progress, on three fronts this morning. Our early market access momentum, key learnings from our initial field force efforts, and our commercial strategy and execution. The market access activities are progressing very well, and are on schedule. While the contracting timeframe, with group purchasing organizations, or GPOs, can take six to nine months on average, we have been encouraged by our early engagement. There are three national GPOs, that represent over 90% of the beds in our 1,700 targeted hospitals. And we are in various stages of discussions, and negotiations with each.

I'm pleased to report our progress on three fronts. This morning, our early market access momentum key learnings from our initial field force efforts and our commercial strategy and execution.

The market access activities are progressing very well and are on schedule.

While the contracting timeframe with group purchasing organizations or GPS can take six to nine months on average we.

We have been encouraged by our early engagement.

There are three national GPO is it represent over 90% of beds in our <unk> hundred targeted hospitals.

And we are in various stages of discussions and negotiations with each.

We expect to finalize the contracting process over the next few months and we'll share our progress with you. When these relationships are complete.

Matthew Wiley: We expect to finalize the contracting process, over the next few months, and we'll share our progress with you when these relationships are complete.

In addition, a national GPO as we've engaged with integrated delivery network hospitals are idms to drive further downstream adoption of our gourmet.

Matthew Wiley: In addition to national GPOs, we've engaged with Integrated Delivery Network Hospitals, or IDNs, to drive further downstream adoption of IGALMI. We have also executed the CMS contract, and completed the Federal Supply Schedule submission for access to state and VA hospitals, respectively.

We have also executed the CMS contract and completed the federal supply schedule submission to unlock access to state in VA hospitals, respectively.

We've completed the first phase of our commercial build out and deployment of our sales personnel in our highest priority targets.

Matthew Wiley: We have completed the first phase, of our commercial build-out and deployment of our sales personnel in the highest priority targets. To date, our field force has successfully engaged, a majority of their target hospitals, and has made progress in P&T formulary review discussions. Multiple hospital systems and IDNs, have indicated their interest for the product and expressed an intent to review. As the P&T committees review IGALMI, in their scheduled meetings during the second half of this year, we will provide an update with more specific metrics.

Date, our field force has successfully engaged a majority of their target hospitals.

And has made progress in PMT formulary review discussions.

Multiple hospital systems, and Ibms have indicated their interest for the product and express an intent to review.

As the P&C committees review of Gourmet and Theyre scheduled meetings during the second half of this year, we will provide an update with more specific metrics.

We've learned a lot since the field launched 10 weeks ago.

Matthew Wiley: We've learned a lot since the field launched 10 weeks ago.

Matthew Wiley: The early response to our awareness activity, sales messaging, and IGALMI concept, for which there is no commercial precedent, has been starkly positive and has revealed tremendous opportunity within the bipolar and schizophrenia agitation markets. Through discussions with stakeholders in target hospitals, our understanding of the value proposition of IGALMI continues to strengthen. The challenges surrounding the administration, of intramuscular injections is a market dynamic that is becoming increasingly worrisome to institutional stakeholders, and one which creates a market environment favorable to IGALMI.

The early response to our awareness activity sales messaging and galante concept for which there is no commercial precedent has been starkly positive and has revealed tremendous opportunity within the bipolar and schizophrenia agitation markets.

Through discussions with stakeholders and target hospitals are understanding of the value proposition of Gaumy continues to strengthen.

The challenges surrounding the administration of intramuscular injections is a market dynamic that is becoming increasingly worrisome to institutional stakeholders, and one which creates a market environment favorable to <unk>.

Matthew Wiley: The use of physical restraint is often required, to inject agitated patients, and can increase both the expenses and safety risk to staff. Physical restraint can be costly, and resource-intensive for hospitals at approximately $1,500 per patient, which typically surpasses the reimbursement. Consequently, a novel treatment option like IGALMI, may offer an effective solution to address these issues while potentially limiting associated expenses.

The use of physical restraint is often required to inject agitated patients and can increase both the expenses and safety risks to staff.

Physical restraint can be costly and resource intensive for hospitals at approximately $500 per patient, which typically surpasses the reimbursement.

Consequently, a novel treatment option like a gummy may offer an effective solution to address these issues, while potentially limiting associated expenses.

Matthew Wiley: Furthermore, agitated patient outburst, may result in patient, caregiver, and staff injuries, which leads to lost work time, transfers, lawsuits, and generally unsafe work environment.

Furthermore, agitated patients.

Outburst may result in patient caregiver and staff injuries, which leads to lost work time transfers lawsuits and generally unsafe work environments.

Matthew Wiley: Covid-driven staffing pressures still exist at many of these places of care.

Covid driven staffing pressures still exist at many of these places of care.

Matthew Wiley: As institutions look for ways to decrease the use of restraints and reduce injury to staff, we are observing a desire to increase the use of oral less-invasive medications for managing agitation, consistent with consensus guidelines.

As institutions look for ways to decrease the use of restraints and reduce injury to staff. We are observing a desire to increase the use of oral less invasive medications for managing agitation consistent with consensus guidelines.

Matthew Wiley: Turning now to marketing, we are deploying tactics to support the sales efforts and amplify the awareness of IGALMI.

Turning now to marketing we are deploying tactics to support the sales efforts and amplify the awareness of our gourmet.

Matthew Wiley: To educate health care providers on the core benefits of IGALMI, we have recently deployed our promotional speaker peer-to-peer program. These programs will ramp up significantly over the next two quarters to drive interest, formulary adoption, and demand. The team has also successfully launched our IGALMI Now Available digital campaign, which has achieved over 100,000 visits to our HCP website and garnered meaningful engagement with content in just a short period of time.

To educate healthcare providers on the core benefits of our gourmet, we've recently deployed our promotional speaker peer to peer program.

These programs will ramp up significantly over the next two quarters to drive interest formulary adoption and demand. The team is also successfully launched our gourmet now available digital campaign, which has achieved over 100000 visit store HCP website, and garner meaningful engagement with content in just a short period of time.

Matthew Wiley: Based on the positive market response to IGALMI, significant process with market access, and increasingly favorable market dynamics, we are excited to begin our second phase of personal promotion and fully deploy our sales team across 70 territories over the next several months. This puts us in a strong position to take full advantage of the opportunity to treat volumes of patients.

Based on the positive market response to Gaumy significant process with market access and increasingly favorable market dynamics. We are excited to begin our second phase of personal promotion and fully deploy our sales team across 70 territories over the next several months. This puts us in a strong position to take full advantage of the.

<unk> Creek volumes of patients now I will turn the call over to Richard who will give a financial update rich. Thank you, Matt I will now review, our second quarter 2022 financial results.

Richard Steinhart: Now, I'll turn the call over to Richard, who will give a financial update.

Richard Steinhart: Rich?

Richard Steinhart: Thank you, Matt.

Richard Steinhart: I will now review our second quarter 2022 financial results. Research and development expenses were $17.9 million for the second quarter of 2022, compared to $13.9 million for the same period in 2021. The increase in R&D expenses were primarily attributable to clinical costs related to the company's Tranquility Program. Selling, general, and administrative expenses were $18.4 million for the second quarter of 2022, compared to $14.1 million for the same period in 2021.

Research and development expenses were $17 9 million for the second quarter of 2022 compared to $13 9 million for the same period in 2021 the.

The increase in R&D expenses were primarily attributable to clinical cost related to the Companys tranquility program.

Richard Steinhart: The increase in SG&A expenses were primarily due to personnel and costs related to the launch of IGALMI in the U.S. BioAccel Therapeutics reported a net loss of $37.7 million for the second quarter of 2022, compared to a net loss of $27.6 million in the same period in 2021. Cash burned for the quarter was approximately $33 million, which includes approximately $700,000 in inventory costs and $3.6 million in prepaid clinical trial fees.

Selling general and administrative expenses were $18 4 million for the second quarter of 2022 compared to $14 1 million for the same period in 2021.

The increase in SG&A expenses were primarily due to personnel and costs related to the launch of ill call me in the U S.

<unk> Therapeutics reported a net loss of $37 7 million for the second quarter of 2022 compared to a net loss of $27 6 million in the same period in 2021.

Cash burn for the quarter was approximately $33 million, which includes approximately $700000 in inventory costs, and $3 6 million and prepaid clinical trial fees.

Richard Steinhart: As of June 30, 2022, cash and cash equivalents totaled approximately $233.5 million. This excludes $30 million of contributions from the $260 million strategic financing announced in April. To date, the company has met the milestones and received $100 million from that agreement.

As of June 32022, cash and cash equivalents totaled approximately $233 $5 million.

This excludes $30 million of contributions from the $260 million strategic financing announced in April .

To date the company has met the milestones and received $100 million from that agreement.

Now I'd like to turn the call back to them all.

Vimal Mehta: Now I'd like to turn the call back to Vimal.

Vimal Mehta: Thank you, Richard.

Thank you Richard we would now like to open the call for questions operator.

Vimal Mehta: We would now like to open the call for questions.

Operator: Operator?

Thank you at this time, ladies and gentlemen, we will be conducting our question and answer session.

Operator: Thank you.

Operator: At this time, ladies and gentlemen, we will be conducting our question-and-answer session.

Operator: If you would like to ask a question, please press star 1 on your telephone keypad.

If you would like to ask a question. Please press star one on your telephone keypad.

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Information tone will indicate that your line is in the question queue you.

Operator: You may press star 2 if you would like to remove your question from the queue.

You May press Star two if you would like to remove your question from the Q.

Operator: For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star key.

For participants using speaker equipment and may be necessary to pick up your handset before pressing the star keys, one moment. Please poll for questions.

Gregory Harrison: Our first question is coming from the line of Greg Harrison with Bank of America.

Our first question is coming from the line of Greg Harrison with Bank of America. Please proceed with your question.

Gregory Harrison: Please proceed with your question.

Gregory Harrison: Hey, good morning, guys.

Hey, good morning, guys. Thanks for taking the questions.

Gregory Harrison: Thanks for taking the questions.

Vimal Mehta: Maybe to start out, could you provide some more color on the ex-US strategy?

Maybe to start out could you provide some more color on the ex U S strategy.

Maybe just talk a little bit about the drivers behind the decision and how you would characterize the discussions that you've had with potential partners.

Vimal Mehta: Maybe just talk a little bit about the drivers behind the decision and how you would characterize, the discussions that you've had with potential partners.

Regarding the tiered strategy. It has been evolving considering that our program is evolving really fast.

Vimal Mehta: Regarding the ex-US strategy, it has been evolving, considering that our program is, evolving really fast, and U.S. opportunity is so attractive in a short run with our recent announcement of the Serenity 3 program, where our drug is already approved, it can go to the home setting.

And USA, Virginia D is sort.

In a short run.

Our recent announcement of the Serenity program, where.

Our drug is already approved economy. It can go to the home setting.

Vimal Mehta: Alzheimer's program is progressing, and we will be ready to file an SNDA in that program, after completion of two pivotal trials.

As the <unk> program is progressing and we will be ready to file an NDA and that program. After completion of two pivotal trials so opportunity in the U S is really large in addition, we are putting MTB.

Vimal Mehta: So opportunity in U.S. is really large.

Vimal Mehta: In addition, we are pursuing MDD.

It's a strategic choice on resource deployment shall we focused on the U S.

Vimal Mehta: It's a strategic choice on resource deployment.

Vimal Mehta: Will we focus on U.S. or continue to focus both in U.S. and outside U.S.?

<unk> continued to focus both in U S and outside U S. So once we have captured opportunity in Europe . Then we will start deployment strategy I would say ex U S and our goal will be to look for a partner who can cover multiple geographies.

Vimal Mehta: So once we have captured opportunity in U.S., then we will start deployment of strategy, outside ex-U.S., and our goal will be to look for a partner who can cover multiple geographies rather than originally we were thinking of just like looking for a single partner in, Europe.

Rather than originally we were thinking low just like looking for a single partner in Europe now, Japan is a very attractive market considering that related agitation and we are very strong.

Vimal Mehta: Now, Japan is a very attractive market, considering the Alzheimer's-related agitation, and we, have a very strong IP position.

IP position, so we're making strategic choices just from a resource.

Vimal Mehta: So we are making strategic choices just from a resource deployment perspective.

<unk> perspective.

Vimal Mehta: Otherwise, opportunity is very attractive outside U.S. in addition to U.S.

Otherwise opportunity is very attractive outside U S.

In addition to U S.

Vimal Mehta: Okay.

Gregory Harrison: That makes sense.

Okay that makes sense and then maybe just one more.

Gregory Harrison: And then maybe just one more, maybe an update on the Agami launch.

Maybe an update on our gourmet launched.

Gregory Harrison: Have you seen any early adopters in the month or so since trade launch?

Have you seen any early adopters in a month or so since trade launch in and if not when would you expect the first to start to come on board.

Gregory Harrison: And if not, when would you expect the first to start to come on board?

Gregory Harrison: Well, the process, Greg, first of all, thanks for the question.

Well the process, Greg first of all thanks for the question. The process takes six to 12 months on average to just get the formulary approval in the hospitals and so driving adoption typically happens after that process has been completed so the steps that we're taking now that we've been taking over the last 10 weeks is to drive interest.

Gregory Harrison: The process takes six to 12 months on average to just get the formulary approval in the, hospitals.

Gregory Harrison: And so driving adoption typically happens after that process has been completed.

Gregory Harrison: So the steps that we're taking now that we've been taking over the last 10 weeks is to drive, interest, identify P&T stakeholders, and begin the process to get formulary adoption in those hospitals.

Identify PMT stakeholders and begin the process to get formulary adoption in those hospitals once that happens, we will see swift or uptake, but this is how typical hospital launches.

Gregory Harrison: Once that happens, we'll see swifter uptake, but this is how typical hospital launches, proceed.

Gregory Harrison: It's an operational fact, and we're just working within that set of facts.

<unk>, it's an operational fact, and we're just working within that set of facts.

Gregory Harrison: Got it.

Gregory Harrison: Okay.

Gregory Harrison: Well, thanks again, and congrats on the progress.

Got it okay, well, thanks, again and congrats on the progress.

Gregory Harrison: Thank you, Greg.

Thank you Greg.

Gregory Harrison: Thank you.

Robyn Karnauskas: Our next question is coming from the line of Robin Karnaskas with Truist Securities.

Thank you. Our next question is coming from the line of Robyn <unk> with <unk> Securities. Please proceed with your question.

Robyn Karnauskas: Please proceed with your question.

Robyn Karnauskas: Hi.

Robyn Karnauskas: Thanks for taking my question, and again, good work on the progress.

Hi, Thanks for taking my question and again you can work on the progress so I'm serenity three why not why just 60 milligrams.

Robyn Karnauskas: So on Serenity 3, why just 60 milligrams?

Robyn Karnauskas: Can you repeat dose?

Can you repeat dose.

Robyn Karnauskas: And what percentage of the population might that exclude that would need a higher dose?

And.

What percentage of the population might that excluded that would need a higher dose. That's my first question and then I have a follow up.

Robyn Karnauskas: That's my first question, then I have a follow-up.

Robyn Karnauskas: That's a great question Robyn, 60 micrograms as you know in our previous dose escalation, study we saw that 60, 80, 120, 180 they were all effective, we starting with 60 because that's a dose like you know most relevant in an outpatient setting and I will have Rob outline why we chose the 60 microgram dose drop.

That's a great question Robin.

<unk> as you know in our previous dose escalation study, we saw that <unk>. They were all effective.

We starting with <unk> because thats it does like.

Most relevant in an outpatient setting and I will have.

Rob outlined why we chose 60 micros nematodes drop sure. So we chose the 60 simmel pointed out because we actually have data on 60 micrograms from our.

Robyn Karnauskas: Sure, so we chose the 60 as Vimal pointed out because we actually have data on 60 micrograms, from our dose ranging study in schizophrenia, it separated from placebo at 2 hours, it has a large proportion of patients who respond to 60 so the number that might let's say need another dose is very small so the trial is designed, it's a frankly very slick design, we're demonstrating the efficacy in almost an identical population, it will be a combination of schizophrenia and bipolar disorder, it will be done at the very same sites that completed Serenity 1 and 2, so we expect identical results in terms of an improvement from baseline, and the PEC total score at 2 hours and then we're testing it for safety purposes at home which we've received agreement from the FDA that this is a pivotal trial and will allow us to expand the label for this same indication if you will agitation associated with schizophrenia or bipolar disorder but at home use.

Dose ranging study in schizophrenia.

Separated from placebo at two hours. It has a large proportion of patients who respond to 60. So the number that might let's say need another dose is very small.

So the trial is designed it's frankly very slick design, we're demonstrating the efficacy in almost an identical population it will be a combination of schizophrenia and bipolar disorder.

It will be done at the very same sites that completed serenity, one and two.

So we expect identical results in terms of an improvement from baseline in the <unk> total score at two hours and then we're testing it for safety purposes at home.

Robyn Karnauskas: So just to be clear, can you repeat those and is the first portion just in the hospital, and then the second portion at home or is it all at home and just the second portion is more for safety?

Which we've received agreement from the FDA that this is a pivotal trial and will allow us to expand the label for this.

Same indication, if you will agitation associated with schizophrenia or bipolar disorder, but at home use.

So just to be clear can you repeat dose and is the first portion just in the hospital and then second question at home or all at home and just the second question is more for safety.

Robyn Karnauskas: The first portion is identical to what we've done in Serenity 1 and 2, it will be acutely, agitated patients who present in an acutely agitated state, we will be able to demonstrate the 60 microgram dose is efficacious and then the second portion of the study is testing the safety at home. So the first portion is in a hospital setting, just to be clear.

First portion is.

Identical to what we've done in the serenity wanted to it will be acutely agitated patients who present in an acutely agitated state we will be able to demonstrate the 60 microgram dose is efficacious and then the second portion of the study is testing the safety at home.

So the first question is in a hospital setting.

That's pretty clear.

And David.

Robyn Karnauskas: And there is a reason for it because we are using PEC score and it's a lot more convenient, to have a PEC score rated by some experts rather than at home setting and that was the reason we split the two phases.

We then partly because we are using <unk> and.

<unk> more convenient to have apex court vacated by some exports rather than in a home setting and that's what that means.

It is clear that two phases ridges PEC score with what we've already demonstrated.

Robyn Karnauskas: It bridges the PEC score with what we've already demonstrated.

Robyn Karnauskas: That makes sense.

That makes sense and then the second question habits regarding the impact of the health care Reform Bill I mean, obviously, if you sell this drug significantly in Alzheimer's, it's a rather large Medicare population.

Robyn Karnauskas: And then the second question I have is regarding the impact of the healthcare reform bill.

Robyn Karnauskas: I mean obviously if you sell this drug significantly in Alzheimer's, it's a rather large Medicare, population and by nine years after launch you could be outside of that small biotech exclusion criteria, putting you within the 50 top drugs in Medicare.

Nine years after launch you could be outside of that small biotech exclusion criteria for you within the 50 top drives and Medicare have you thought about how we should think about.

Robyn Karnauskas: Have you thought about how we should think about, I guess the first question would be, what is your estimated split for Alzheimer's for Medicare in the United States and if you thought about how we should model that given that that's now going to look like it's going to be in law?

You know I guess the first question would be what is your estimated split for Alzheimer's for Medicare.

United States and have you thought about how we should model that given that that's now.

It looks like it's going to be in la.

Robyn Karnauskas: So the MedD provision in the draft bill is really focused in on those drugs that are, already costing CMS billions of dollars. So that's where the negotiations are going to happen first.

So the med D.

Provision in the draft Bill is really focused in on those drugs that are already costing CMS bill.

And so that's where the negotiations are going to happen first.

So to answer your question the Medicare portion of Alzheimers opportunity is roughly a third of the total opportunity.

Robyn Karnauskas: So to answer your question, the Medicare portion of Alzheimer's opportunity is roughly a third, of the total opportunity that we've seen in our modeling.

That we've seen in our modeling.

Robyn Karnauskas: And we would expect that we would address these potential issues down the line as we're, thinking about, for instance, pricing flexibility that we've communicated in the past and how we want to approach this particular market.

And we would expect that.

We would.

Addressed these potential issues down the line as we're.

Thinking about for instance, pricing flexibility that we've communicated in the past and how we want to approach. This this particular market.

The fact is we've got a long way to go to get to FDA approval and thinking downstream about a bill that has not yet been ratified.

Robyn Karnauskas: The fact is, we've got a long way to go to get to FDA approval, and, you know, thinking, downstream about a bill that has not yet been ratified is a little premature.

Is a little premature.

Robyn Karnauskas: Okay.

Robyn Karnauskas: Great.

Robyn Karnauskas: Thank you.

Okay, great. Thank you.

Robyn Karnauskas: Thanks, Robyn.

Robyn Karnauskas: Thank you.

Sumant Kulkarni: Our next question is coming from the line of Sumant Kulkarni with Canaccord.

Thanks Robyn.

Sumant Kulkarni: Please proceed with your question.

Sumant Kulkarni: Thanks for taking my question.

Our next question is coming from the line of Simonton Kearney with Canaccord. Please proceed with your question.

Sumant Kulkarni: I'm sorry for any background noise.

Sumant Kulkarni: I have a couple.

Sumant Kulkarni: The first one is on 73.

Thanks for taking my question and sorry for any background noise I have a couple.

The first one is on 73.

Sumant Kulkarni: On the safety aspect, what exactly do you plan to collect in terms of metrics for the, at-home use component?

On the Cps, what exactly do you plan to collect in terms of metrics.

For the at home use component.

Sumant Kulkarni: Thanks, Sumant.

Thanks, Simona, it's Rob Risinger the metrics for adverse events for example would be collected as you collect adverse events in any trial the patients will be collecting adverse events at the time of dosing.

Sumant Kulkarni: It's Rob Reisinger.

Sumant Kulkarni: The metrics for adverse events, for example, would be collected as you collect adverse, events in any trial.

Sumant Kulkarni: The patients will be collecting adverse events at the time of dosing.

Sumant Kulkarni: There will be a reliable informant, we'll say, maybe a caregiver, maybe a spouse, maybe, a family member, a son, daughter, whomever, will be there to also report adverse events and they'll report these to the investigators.

There will be.

Reliable informant will say, maybe a care giver it may be a spouse, maybe a family member a son, daughter whomever will be there to also report adverse events and they will report these two the investigators.

Sumant Kulkarni: So the adverse events are collected identically to how you might study adverse events in other, trials. As an outpatient, a patient comes into the office and says, this is what happened, this, is how I felt, and the investigator records that.

So the adverse events are collected identically to how you might.

Study adverse events in other trials as an outpatient.

Patient comes into the office and says this is what happens this is how I felt and the investigator.

Our records that okay.

Sumant Kulkarni: And then my follow-up is, given that the label currently does not restrict use of the GALMI, to a specific setting, is there anything that precludes a physician from sending a patient home with the film today as things stand?

And then my follow up is given the legal currently does not restrict us if we got them to a specialty setting is there anything that precludes a physician from sending efficient tool.

As things stand.

Sumant Kulkarni: Sumant, that's a great question.

That's a great question.

Sumant Kulkarni: As you said, label focuses on under the supervision.

As you said label focuses on under the supervision. So wherever there is no provision available.

Sumant Kulkarni: So wherever there is a supervision available, GALMI, we believe, can be used.

Hey, Gautam, we believe can be used.

Sumant Kulkarni: We're just focusing in the hospital setting because two-thirds of the patient out of 25, million episodes comes to the hospital market.

Vijay focusing in the hospital setting because two thirds of the patient out of $25 million episode comes to the market. It's a very rare defined and focused approach how physicians will use it when they develop experian.

Sumant Kulkarni: It's a very well-defined and focused approach.

Sumant Kulkarni: How physicians will use it once they develop experience, all of that will unfold in the, next six to 12 months.

All of that will unfold in next six to 12 months.

Sumant Kulkarni: Thank you.

Thank you.

Sumant Kulkarni: Thank you, Sumant.

Yes.

Sumant Kulkarni: Thank you.

Thank you Simon.

Kambiz Yazdi: Our next question is coming from the line of Kambiz Yazdi with Jeffries.

Thank you. Our next question is coming from the line of Kansas Yahtzee with Jefferies. Please proceed with your question.

Kambiz Yazdi: Please proceed with your question.

Kambiz Yazdi: Hi, team.

Hi team this is <unk> on for Chris.

What's the significance of.

<unk> for us or any three.

Kambiz Yazdi: This is Kambizan for Chris.

Do you anticipate.

That bring the outpatient.

Lately.

As a second indication.

Regarding clinical meaningfulness in Alzheimer's agitation and psychosis.

What gives you confidence.

And your endpoint and interpretation.

Clinically meaningful.

And then for us.

Lastly for your MD&A trial, what are the drivers for dose selection in that trial.

Thank you for your questions I will pass it onto Rob to answer both tranquility program as well as then followed up follow up with them duty.

Kambiz Yazdi: What's the significance of in-home use for Serenity, 3?

So.

Let me be clear, it's the <unk>.

Same indication and serenity three this is acute agitation episodes associated with schizophrenia or bipolar disorder, and so we believe that using all means for.

Kambiz Yazdi: Do you anticipate that freeing the outpatient completely as a second indication?

Episodes that aren't just in the hospital or just directly in front of a health care provider, but enabling the patient to take this when they're agitated at home could potentially even prevent the patient from requiring hospitalization or going to the emergency room or or running to a clinic.

Kambiz Yazdi: Regarding clinical meaningfulness in Alzheimer's, agitation, and psychosis, what gives you confidence in your endpoint and interpretation is clinically meaningful?

So it's exactly the same indication, but there is tremendous value to the patient and the.

People around the patient to sort of prevent.

An escalation from occurring.

And then the second piece is that why patients end up in the emergency room, because agitation is a spectrum mild moderate and severe it escalate. So if you are that preventing the agitation venues at least there is a mild stages at home.

It's very different than these patients will not need to go to the emergency room. So I think it's the dynamics between the institution. The reason patient end up there because they don't have a choice or no.

<unk> options at home. So that's why they're in two thirds of the vision and the institution and if we got me is available and then they're back scores are lower compared to when they end up in the emergency room.

Did these patients with the dose we are selected.

Kambiz Yazdi: And then, lastly, for your MDD trial, what are the drivers for dose selection in that trial?

So with respect to.

The major depression and dose selection, we are testing the tolerability and of course safety.

Of escalating doses, both escalating individual doses and dosing at more than once a day for example, dividing doses a morning and evening dose for example, and so the Tolerability is really important prior to testing this in a proof of <unk>.

Concept study for depression. So those are the sort of very simple biomarkers.

That would enable us to select the dose how well is a tolerated are there any safety issues and thus far we continue to escalate.

Kambiz Yazdi: Thank you for your questions.

Thank you we'll move onto our next question, which is coming from the line of <unk> <unk> with Guggenheim. Please proceed with your question.

Kambiz Yazdi: I will pass it on to Rob to answer both the tranquility, program as well as the follow-up with the MDD.

Hi, Good morning. This is Eddie on for Gautam, Thanks for taking our questions and congrats on all the progress for the at home expansion program in <unk> three in part one what would be a reason why a patient would not proceed at home dosing does the company or experts you've spoken to our regulators have some safety bar for what would need to happen to ensure that patients can safely move to at home.

Administration, and then would there be a limit to the number of doses of patient can taken part too.

And then for the <unk> program given the rapid onset of action you saw for agitation would do you expect to see a rapid onset of antidepressant efficacy and what are the earliest time points youre looking for.

For efficacy in this study.

So.

Kambiz Yazdi: Sure.

Thank you so.

The patience and serenity three and the first portion will be dosed with either placebo or the 60 microgram dose those patients are independent of the patients in part two part two is testing that dose at home.

It's not a gateway so I realize that you're.

Your question implies that you think are patients going to start with part one and continue to use it at home that's not what we're doing.

Kambiz Yazdi: So, let me be clear.

Kambiz Yazdi: It's the same indication in Serenity 3.

The first part of the trial is patients who are acutely agitated a present with agitation and we're treating it with the 60 microgram dose.

Kambiz Yazdi: This is acute agitation episodes, associated with schizophrenia or bipolar disorder.

So we will have very accurate feed if you will on efficacy as well as safety and tightly controlled situation, where everything can be monitored just as if you were in the emergency room.

Kambiz Yazdi: And so, we believe that using EGALMI for episodes that aren't just in the hospital or just directly in front of a healthcare provider but enabling the patient to take this when they're agitated at home could potentially even prevent the patient from requiring hospitalization or going to the emergency room or running to a clinic.

The second part of the study is entirely at home in a whole different set of patients. So again, we will have enough data. The FDA has said that they will consider this a pivotal trial for the indication at home.

Kambiz Yazdi: So, it's exactly the same indication, but there's tremendous value to the patient and the people around the patient to sort of prevent an escalation from occurring.

So there were no safety concerns or any reason that we cannot do the first boats.

Portion in.

Add on Saturday.

As I mentioned previously it's all about having the robustness of the data and using the scale that we have used incident, we run into.

And we were able to use this and at the same time demonstrate the safety at home so that it can become.

Package too for label expansion or partner that is India.

Got you that's helpful.

Kambiz Yazdi: And then, the second piece is that why a patient ends up in the emergency room because, agitation is a spectrum, mild, moderate, and severe.

And then al.

Efficacy.

So let me say that again please.

Kambiz Yazdi: It escalates.

The MVD study if you could talk about what the earliest time points are going to look at for antidepressant efficacy and whether that would be similar to what you'd see for agitation.

Kambiz Yazdi: So, if you are preventing the agitation when it's in early stages or mild stages at home, it's very different than these patients will not need to go to the emergency room.

In MTBE, we're not looking at one or two hours, we're looking at the days and weeks efficacy in <unk>, we expect to see very early but remains to be seen we'll be likely testing. This within the first week second week et cetera, and we're not just looking at the acceleration.

Kambiz Yazdi: So, I think it's a dynamics between the institution, the reason patient end up there because they don't have a choice or no treatment options at home.

Kambiz Yazdi: So, that's why they end up two-thirds of the patient in the institution.

Kambiz Yazdi: And if EGALMI is available and when their PEC scores are lower compared to when they end up in the emergency room, you could treat this patient with the dose we have selected.

<unk> of anti Depressant response, we're also looking at the proportion of patients who improved we know that ssris or not the be all and Endo for example.

Anti depressants don't work for everyone, maybe they work for a large.

Large proportion greater than 50%, but wed like to greatly improve that so we're looking at both acceleration.

And responders or response overall.

When treated with <unk> 501.

Kambiz Yazdi: So, with respect to the major depression and dose selection, we are testing the tolerability, and, of course, safety of escalating doses, both escalating individual doses and dosing at more than once a day. For example, dividing doses, a morning and an evening dose, for example.

And this study is going to have four weeks or something like that statement daily dosing over a period of four weeks.

Kambiz Yazdi: And so, the tolerability is really important prior to testing this in a proof of concept study for depression.

Thank you we'll move on to our next question, which is coming from the line of Colin Bristow with UBS. Please proceed with your question.

Kambiz Yazdi: So, those are the sort of very simple biomarkers that would enable us to select a dose.

Hey, good morning, Thanks for taking the questions.

Kambiz Yazdi: How well is it tolerated?

I guess as we think about subsequent quarters, where your eventual report revenue can you just give us any details around how revenue will be recognized when orders are made and the ship they received.

Kambiz Yazdi: Are there any safety issues?

Kambiz Yazdi: And thus far, we continue to escalate.

Kambiz Yazdi: Thank you.

Kambiz Yazdi: We'll move on to our next question, which is coming from the line of Yatin Suneja

Yatin Suneja: with Guggenheim.

Yatin Suneja: Please proceed with your question.

So that's question one question two sorry, if ive missed this tranquility to timing.

And of this yet.

Next just curious what's the rationale behind that.

And then third.

Any details so anything you can give us on the other assets.

Thanks.

This is Richard on the on the sales were going to recognize sales when it when it is sold to the final customers. So the hospital, that's where we actually work ignite sales.

Yatin Suneja: Good morning.

Yatin Suneja: This is Eddie on for Yatin.

Yatin Suneja: Thanks for taking our questions and congrats, on all the progress.

Okay great.

And regarding the tranquility program.

We are conducting this trial in <unk>.

Where the elderly.

Patients reside and residential setting and we have observed.

Over disruption, sometimes in the site and that restrict access for Seattle to go into the elderly center.

And we don't know what could happen in next several months in the fall with the Covid. So we are just being cautious in providing a guidance that there could be.

Slip on the data readout because of those reasons in terms of operational.

Aspect, we are not seeing any issues in terms of number of patients that are there.

These are the early patients. They are frail. So you do get a little bit more of a screen failure. Then you will get it in the affinity trial because those are younger patient. So I would say those are the reasons nothing very specific except global related delay or you can get more screen failures because.

These patients are frail and they may have some other associated medical complication and they can get excluded.

Okay, great. Thank you.

And you had the third question.

Was it related to MTV.

I just wanted to clarify.

Just in terms of the new when do we get more information on your other assets.

We will unveil a leading stealthy forward.

Yes.

Sure so.

That asset is now going through the formulation, we expect that work to complete and then once we have done all the.

Preclinical walks up and we are ready to take to the clinic, we will disclose what that asset is which indications. We are choosing initially we have mentioned that like no one of them India.

Indication, where it fits in very well is chronic.

Education and statement of chronic agitation in dementia, but we continue to explore additional options, where the mechanism will fit in and we will lay out the plan in 2023.

Great. Thank you guys.

Thank you Colin.

Thank you. Our next question is coming from the line of Greg <unk> with Mizuho. Please proceed with your question.

Good morning, I hope everyone is having a fantastic day. This is Richard Nguyen for Greg Jovanovich, who sends his best and it's great to be back on the name.

Yatin Suneja: For the at-home expansion program in Serenity 3, in Part 1, what would be a reason why a patient wouldn't proceed to at-home dosing?

So my first question goes on to Serenity, We plan how large do you expect the state to be what the goal of enrolling how many patients and by when you can expect from them.

And my second part of that is that what do you think is the incremental increase to revenues came on third of episodes occur.

Good of institutional settings can we assume a 30% increase the peak revenues or what would the company.

Thank you Richard.

Yatin Suneja: Does the company or experts you've spoken to or regulators have some safety bar for what would need to happen to ensure a patient can safely move to at-home administration?

Those questions around the tenant industry.

First question I will pass it onto Rob. So he can outline he is agreeing on number of patients and everything but we expect this trial to be pretty short just to remind everyone. Our board trials <unk>, one and two.

Yatin Suneja: And then would there be a limit to the number of doses a patient can take in Part 2?

<unk> had 750 patients 275, each and steady.

Steady there we were testing two doses and placebo and we completed enrollment in about five months or so so these are very fast trial in terms of the timing and in terms of the number of patient I will pass it onto Rob because he is currently doing powering studies to make sure. We powered the study et cetera. So.

Yatin Suneja: And then for the MDD program, given the rapid onset of action you saw for agitation, would you expect to see a rapid onset of antidepressant efficacy?

Yatin Suneja: And what are the earliest time points you're looking for efficacy in those studies?

Each portion of the study the first and second half will be well under the I believe it was 350 patients in serenity, one 350 and serenity II.

Yatin Suneja: Thank you.

So because they're independent patients are essentially.

Yatin Suneja: So the patients in Serenity 3 in the first portion will be dosed with either, placebo or the 60-microgram dose.

In a way independent studies, we know that these will enroll relatively quickly. In addition, this theres no exclusion. So unlike certainly one and twos for any one was patients with schizophrenia serenity II was patients with bipolar disorders.

Yatin Suneja: Those patients are independent of the patients in Part 2.

Yatin Suneja: Part 2 is testing the dose at home.

Yatin Suneja: It's not a gateway.

Yatin Suneja: So I realize that your question, implies that you think a patient is going to start with Part 1 and continue to use it at home.

Yatin Suneja: That's not what we're doing.

Mixing that and the FDA has agreed that we can test this in both patients with schizophrenia and bipolar disorder at the same time in the same study.

Because our effects are similar humans are humans rigor.

Regardless of what the underlying illnesses and thus we expect an even faster enrollment we don't anticipate any problems with recruitment.

Yatin Suneja: The first part of the trial is patients who are acutely agitated, they present with agitation, and we're treating it with the 60-microgram dose.

For this agitation is relatively common and we were able to enroll both the surrounding wanted to very rapidly even in the midst of the.

Yatin Suneja: So we'll have very accurate bead, if you will, on efficacy as well as safety and a tightly controlled situation where everything can be monitored just as if you were in the emergency room.

Yatin Suneja: The second part of the study is entirely at home in a whole different set of patients.

The major part of the Covid.

Pandemic so.

So Richard we will provide guidance when we rollout the planned pivotal plan.

That and vendor data readout is expected, but it will certainly be in 2023 and will provide more granular guidance on first half or second.

Yatin Suneja: So again, we will have enough data.

So Richard this is Matt.

Just to take your question on revenues for the community setting.

Yatin Suneja: The FDA has said that they will consider this a pivotal trial for the indication at home. So there were no safety concerns or any reasons that we could not do the first portion in, the at-home setting.

So the math that you are that you are.

We're calculating here is correct and that there are roughly a third of the agitation episodes in the community setting, but one of the things that we've learned in recent market research is that specifically in the bipolar population.

Yatin Suneja: As I mentioned previously, it's all about having the robustness of the data and using the scale that we have used in SIDINC 1 and 2, and we were able to use this and at the same time demonstrate the safety at home so that it can become a package to – for label expansion or for another SMD.

Which represents the majority of agitation, we see approximately 10 additional episodes that are not captured in the claims data. So this is roughly a 60% increase in what we previously thought community setting opportunity was.

These episodes were not seen in the schizophrenia patients.

Typically when they are compliant with their anti psychotics. It would suppress the agitation episode. So it makes sense to identical to what we saw on claims but in bipolar those 10, well call Shadow episodes are being managed through meditation exercise illicit drug use alcohol. We believe that those are opportunities for 501.

Should we get the approval for that indication.

Great. Thank you. So then and you also mentioned that gummy exceeded expectations and their value preparation proposition. What do you think the uptake curve should look like for Academy that are you comfortable with where consensus is currently or do you see that shifting.

So there is a as I said, there is an operational or mechanical process to unlock the value in uptake in hospitals, and we still have to deal with that process. However.

The early signs have been very encouraging the interest in the drug is very encouraging and we see things moving in a very positive direction. So.

I wouldn't see that impacting the uptake curves near term just because of the mechanics of getting drug on formulary in unlocking the potential for demand.

Once that is behind us I see a big opportunity in helping a lot of patients.

Okay.

We continue to see lot of face to face meeting.

Our sales teams are getting lot of face to face time, despite the colgate or any other reason.

And they are getting very positive feedback as Matt said, there is all very encouraging in fact, whatever we were thinking this potential will be now being in the marketplace for 10 weeks.

Im more excited about it.

Great. Thank you so much.

Thank you Richard.

Thank you. The next question is coming from the line of Ron Silverado with HC Wainwright. Please proceed with your question.

Yatin Suneja: Gotcha.

Yatin Suneja: That's helpful.

Yatin Suneja: And then on – efficacy?

Thanks, very much for taking my questions just.

Yatin Suneja: Sorry, say that again, please.

Here I wanted to ask if you could do some additional.

Yatin Suneja: The MDD study, if you could talk about what the earliest time points you're going to, look at for antidepressant efficacy and whether that would be similar to what you'd see for agitation.

Information regarding the regulatory process for the indication for the users.

Follow me within the context of.

What you are trying to capture with.

Great.

Yatin Suneja: In MDD, we're not looking at one or two hours. We're looking at days and weeks.

If serenity II proves to be positive what we should be thinking about with respect to regulatory.

<unk> period, and also if you could comment on any intent.

On your side with respect to doing any exploratory clinical work in generalized anxiety disorder. If any thank you.

Thank you Ron So Rob you want to take.

So Ron we would expect once the trial is complete to be able to put together a package.

For a supplemental NDA application very rapidly within a few months.

And the review timeline will depend on the FDA of course, we could request for example fast track.

On the basis of several.

Findings, which we fully anticipate should have robust efficacy and.

Similar or even better safety than what we have been approved with 120 and 180 microgram doses.

And so that regulatory process, we can certainly outline and a future discussion.

But we really need to get this data we believe we will have the data relatively quickly.

Because we're enrolling all comers, if you will with schizophrenia and bipolar disorder.

And then.

We can provide more clarity and an update.

In the future with with regard to additional indications such as generalized anxiety disorder, we are planning.

<unk> is to look at a variety of potential indications if you will putting our toes in the water for indications like generalized anxiety disorder, we could look at any anxiety disorder panic PTSD.

Excuse me acute stress disorder might even look at developmental disorders, we've had a lot of discussions with <unk>.

In fact investors who've said well why aren't you studying this in.

<unk> for example.

And so we have plans to do basket studies. These are studies, where you take small numbers of patients and sort of preliminary tend they tend to be open label studies and you just determine if there's a signal or not they are cheap there fast and they are a way for us to give a certain directionality to the next steps.

And development, but let me point out that our focus has been and continues to be primarily on the expansion to at home use too.

Yatin Suneja: Efficacy in MDD, we expect to see very early but remains to be seen.

Yatin Suneja: We'll be likely, testing this within the first week, second week, et cetera.

Yatin Suneja: And we're not just looking at the acceleration of antidepressant response. We're also looking at the proportion of patients who improve.

Yatin Suneja: We know that SSRIs are not the be-all and end-all, for example.

Yatin Suneja: Antidepressants don't work for everyone. Maybe they work for a large – a large proportion, greater than 50%, but we'd like to greatly improve that.

Demonstrating utility efficacy and safety in Alzheimers disease, and agitation associated with Alzheimers.

And <unk>.

Major depressive disorder. These will be the next if you will for <unk>.

Thank you.

Thank you. Our next question is coming from the line of Corinne Jenkins with Goldman Sachs. Please proceed with your question.

Hi, how should we think about your pricing strategy for potential indication expansion to include include as needed OXXO, Nick dosing of economy. Thank you.

Yes so.

As we think of of further downstream indications, we continue to have flexibility in how we might think about pricing in those settings. We haven't made any determinations yet will.

We will still continue to monitor the market.

Per the previous question around legislation and things of that nature, We will watch the market dynamics closely and will make decision on pricing to best.

The markets that we're going into <unk>.

Suffice to say that we have a very smart pricing strategy now in the institutional setting and that may actually fit future downstream indications. So we will continue to monitor and make that decision as if should we get approval for those indications and at the time that we.

And are those markets.

Sure. Thanks, and could you also please confirm how many doses of <unk>.

Are you expecting patients to receive in part two of this at any particular time and for how long will you be evaluating the patients.

Yes.

Patients will be using the.

<unk> 501 at home when they have an episode of acute agitation and so we're giving the film and monitoring them over a period of months.

So that we pick up the frequency and what happens when they use the film.

Patients because it's placebo controlled patients are able to take if you will a rescue medication that will be very much an individual thing.

Patients do take additional medications at home.

To attempt to treat their anchor.

Anxiety.

Obviously also take alcohol or marijuana try meditation theres a lot of things that they take but principally we are testing the effect of a single dose of <unk>.

<unk> 501 that 60 microgram dose.

And there is a possibility for an additional dose but that would.

That will have to be up to the patient.

As to whether or not they're feeling something from the initial dose and calming.

Sure. Thank you.

Yatin Suneja: So we're looking at both acceleration and responders or response overall when treated with BXCL501.

Yatin Suneja: And this study is going to have four weeks, or something like that, right? Treatment of daily dosing over a period of four weeks.

Thank you. It appears we have no additional questions at this time, so I'd like to pass the floor back over to Dr. <unk> Mehta for any additional concluding remarks.

Yatin Suneja: Thank you.

Yatin Suneja: We'll move on to our next question,

Thank you everyone for joining us today, we look forward to connecting with many of you in the coming weeks, including at the Canaccord.

Colin Bristow: which is coming from the line of Colin Bristow with UBS.

Colin Bristow: Please proceed with your question.

Colin Bristow: Hey, good morning.

Colin Bristow: Thanks for taking the questions.

Colin Bristow: I guess as we think about subsequent quarters, where you're going to report revenue, can you just give us any details around how revenue will be recognised?

Colin Bristow: Is it when orders are made?

Colin Bristow: Is it when they're shipped?

Colin Bristow: Is it when they're received?

Colin Bristow: So that's question one.

Growth conference, where Matt and I will be hosting meetings in participating in a fireside chat have a great day.

Colin Bristow: Question two, sorry if I've missed this, but it looks like Tranquility 2 timing slipped a little from end of this year to first half of next.

Colin Bristow: Just curious what's the rationale behind this.

Colin Bristow: And then third, any details or anything further, you can give us on the other assets you're moving into the Senate?

Colin Bristow: Thanks.

Richard Steinhart: This is Richard.

Richard Steinhart: On the sales, we're going to recognise sales, when it's sold to the final customers, so the hospital.

Colin Bristow: And you had the third question, was it related to MDD or our, I just want to clarify.

Richard Steinhart: That's when we actually will recognise sales.

Colin Bristow: Just in terms of the, when do we get more information on your other assets that are somewhat under moving stealthily forward?

Richard Steinhart: Okay, great.

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.

Richard Steinhart: And regarding the Tranquility programme, we are conducting this trial in ALF where the elderly patients reside and in residential setting. And we have observed COVID disruptions sometimes, in these sites, and that restricts access for CRO to go into the elderly centre.

Richard Steinhart: And we don't know what could happen, in the next several months in the fall with the COVID.

Richard Steinhart: So we are just being cautious, and providing a guidance that there could be slip on the data readout because of those reasons.

Richard Steinhart: In terms of operational aspect, we are not seeing any issues in terms of number of patients that are there. These are elderly patients, they are frail.

Richard Steinhart: So you do get a little bit more screen failure, than you will get it in the serenity trial because those are younger patients.

Richard Steinhart: So I would say those are the reasons, nothing very specific except COVID-related delay, or you can get more screen failures because these patients are frail and they may have other associated medical complications and they can get excluded.

Richard Steinhart: Okay, great, thank you.

Yeah.

[music].

Colin Bristow: Sure, so that asset is now going through the formulation.

Vimal Mehta: We expect that work to complete.

Vimal Mehta: And then once we have done all the, like preclinical workup and we are ready to take to the clinic, we will disclose what that asset is, which indications we are choosing. Initially, we have mentioned that, like, you know, one of the indication where it fits in very well is chronic agitation and treatment of chronic agitation and dementia.

Vimal Mehta: But we continue to explore additional options, where the mechanism will fit in and we will lay out the plan in 2023.

Vimal Mehta: Thank you.

Vimal Mehta: Thank you, Colin.

Graig Suvannavejh: Our next question is coming from the line of Graig Suvannavejh

Graig Suvannavejh: with Mizuho.

Operator: Copyright © 2020 Mooji Media Ltd. All Rights Reserved.

Graig Suvannavejh: Please proceed with your question.

Operator: No part of this recording may be reproduced, without Mooji Media Ltd.'s express consent.

Graig Suvannavejh: Good morning.

Graig Suvannavejh: I hope everyone's having a fantastic day.

Graig Suvannavejh: This is Richard Nguyen for Graig Suvannavejh, who sent it best, and it's great to be back on the main.

Graig Suvannavejh: So my first question goes on to Serenity 3 plan.

Graig Suvannavejh: How large do you expect the study to be, with the goal of enrolling how many patients, and by when do you expect enrollment to end?

Graig Suvannavejh: And my second part of that is that what do you think is the incremental increase to revenue since a third of episodes occur outside of institutional settings?

Graig Suvannavejh: Can we assume a 30% increase to peak revenues, or what would the company think?

Graig Suvannavejh: Thank you.

Vimal Mehta: Thank you, Richard, for those questions around the Serenity 3.

Vimal Mehta: First question, I will pass, it on to Rob so he can outline.

Vimal Mehta: He's agreeing on number of patients and everything, but we expect this trial to be pretty short.

Vimal Mehta: Just to remind everyone, our board trials, Serenity 1 and 2, had 750 patients, 375 each, and three arm study. There we were testing two doses, and a placebo, and we completed the enrollment in about five months or so. So these are very fast trials in terms of the timing.

Vimal Mehta: And in terms of the number of patients, I will pass it on to Rob because he's currently doing, powering studies to make sure we power the studies.

Vimal Mehta: Rob?

Vimal Mehta: So each portion of the study, the first and second half, will be well under the, I believe it was 350 patients in Serenity 1, 350 in Serenity 2.

Vimal Mehta: So because they're independent patients, they're essentially, in a way, independent studies, we know that these will enroll relatively quickly. In addition, there's no exclusion.

Vimal Mehta: So unlike Serenity 1 and 2, Serenity 1 was patients with schizophrenia, Serenity 2 was patients with bipolar disorders.

Vimal Mehta: We're mixing that, and the FDA has agreed that we can test this in both patients with schizophrenia and bipolar disorder at the same time in the same study because our effects are similar.

Vimal Mehta: Humans are humans, regardless of what the underlying illness is, and thus we expect an even faster enrollment.

Vimal Mehta: We don't anticipate any problems with recruitment for this. Agitation is relatively common, and we were able to enroll both the Serenity 1 and 2 very rapidly, even in the midst of the major part of the COVID pandemic.

Vimal Mehta: So Richard, we will provide a guidance once we roll out the plan, pivotal plan, then when the data readout is expected.

Vimal Mehta: But it will certainly be in 2023, and we'll provide more granular guidance on first half or second half.

Vimal Mehta: So Richard, this is Matt.

Matthew Wiley: Just to take your question on revenues for the community setting, so the math that you're calculating here is correct in that there are roughly a third of the agitation episodes in the community setting.

Matthew Wiley: But one of the things that we've which represents the majority of agitation, we see approximately 10 additional episodes that are not captured in the claims data.

Matthew Wiley: So this is roughly a 60% increase in what we previously thought the community setting opportunity was.

Matthew Wiley: These episodes were not seen in the schizophrenia patients, and typically when they're compliant with their antipsychotics, it would suppress the agitation episodes, so it makes sense.

Matthew Wiley: It was identical to what we saw in claims.

Matthew Wiley: But in bipolar, those 10 well-called shadow episodes are being managed through meditation, exercise, illicit drug use, alcohol.

Matthew Wiley: We believe that those are opportunities for 501 should we get the approval for that indication.

Matthew Wiley: Great, thank you.

Matthew Wiley: So then, and you also mentioned that eGalmi exceeded expectations in their value proposition.

Matthew Wiley: What do you think the uptake curve should look like for eGalmi then?

Matthew Wiley: Are you comfortable with where consensus is currently, or do you see that shifting?

Matthew Wiley: So there's a, as I said, there's an operational or mechanical process to unlock the value and uptake in hospitals, and we still have to deal with that process.

Matthew Wiley: However, the early signs have been very encouraging. The interest in the drug is very encouraging, and we see things moving in a very positive direction.

Matthew Wiley: So, you know, I wouldn't see that impacting the uptake curves near term just because of the mechanics of getting drug on formulary and unlocking the potential for demand.

Matthew Wiley: But once that's behind us, I see a big opportunity in helping a lot of patients.

Matthew Wiley: And we continue to see a lot of face-to-face meetings.

Matthew Wiley: Our sales teams are getting a lot of face-to-face time despite the COVID or any other reason. And they're getting very positive feedback, as Matt said. It's all very encouraging.

Matthew Wiley: In fact, whatever we were thinking this drug potential will be now being in the marketplace for 10 weeks, we are even more excited about it.

Matthew Wiley: Great.

Matthew Wiley: Thank you so much.

Matthew Wiley: Thank you, Richard.

Matthew Wiley: Thank you.

Raghuram Selvaraju: The next question is coming from the line of Ron Selvaraju with HC Wainwright.

Raghuram Selvaraju: Please proceed with your question.

Raghuram Selvaraju: Thanks very much for taking my questions.

Raghuram Selvaraju: I wanted to ask if you could provide some additional information regarding the regulatory process for the indication for the utilization of thalamine within the context of what you are trying to capture with Serenity 3.

Raghuram Selvaraju: So, if Serenity 3 proves to be positive, what we should be thinking about with respect to a regulatory situation timeline review period?

Raghuram Selvaraju: And also, if you could comment on any intent on your side with respect to doing any exploratory clinical work in generalized anxiety disorder, if any.

Raghuram Selvaraju: Thank you.

Raghuram Selvaraju: Thank you, Ron.

Raghuram Selvaraju: So, Ron, we would expect once the trial is complete to be able to put together a package for a supplemental NDA application very rapidly within a few months.

Raghuram Selvaraju: And the review timeline will depend on the FDA, of course. We could request, for example, fast track on the basis of several findings, which we fully anticipate should have robust efficacy and similar or even better safety than what we have been approved with 120 and 180 microgram doses.

Raghuram Selvaraju: And so that regulatory process we can certainly outline in a future discussion, but we really need to get this data.

Raghuram Selvaraju: We believe we will have the data relatively quickly because we are enrolling all comers, if you will, with schizophrenia and bipolar disorder.

Raghuram Selvaraju: And then we can provide more clarity and an update in the future.

Raghuram Selvaraju: With regard to additional indications such as generalized anxiety disorder, we are planning studies to look at a variety of potential indications.

Raghuram Selvaraju: If you will, putting our toes in the water for indications like generalized anxiety disorder.

Raghuram Selvaraju: We could look at any anxiety disorder, panic, PTSD, acute stress disorder, might even look at developmental disorders.

Raghuram Selvaraju: We've had a lot of discussions with, in fact, investors who have said, well, why aren't you studying this in autism, for example?

Raghuram Selvaraju: And so we have plans to do basket studies. These are studies where you take small numbers of patients and sort of preliminary. They tend to be open-label studies, and you just determine if there's a signal or not. They're cheap, they're fast, and they are a way for us to give a certain directionality to the next steps in development.

Raghuram Selvaraju: Let me point out that our focus has been and continues to be primarily on the expansion to at-home use, to demonstrate utility, efficacy, and safety in Alzheimer's disease and agitation associated with Alzheimer's, and major depressive disorder.

Raghuram Selvaraju: These will be the next, if you will, for EGALMI.

Raghuram Selvaraju: Thank you.

Raghuram Selvaraju: Thank you.

Corinne Jenkins: Our next question is coming from the line of Corinne Jenkins with Goldman Sachs.

Corinne Jenkins: Please proceed with your question.

Corinne Jenkins: Hi.

Corinne Jenkins: How should we think about your pricing strategy for potential indication expansion to include as needed or chronic dosing of economy?

Corinne Jenkins: Thank you.

Corinne Jenkins: Yes.

Corinne Jenkins: So, you know, as we think of further downstream indications, we continue to have flexibility in how we might think about pricing in those settings.

Corinne Jenkins: We haven't made any determinations yet.

Corinne Jenkins: We'll still continue to monitor the market. You know, per the previous question around legislation and things of that nature, we'll watch the market dynamics closely and we'll make a decision on pricing to best fit the markets that we're going into.

Corinne Jenkins: Suffice to say that we have a very smart pricing strategy now in the institutional setting, and that may actually fit future downstream indications.

Corinne Jenkins: So, we'll continue to monitor and make that decision as if – should we get approval for those indications and at the time that we enter those markets.

Corinne Jenkins: Sure.

Corinne Jenkins: Thanks.

Corinne Jenkins: And could you also please confirm how many doses of EGALMI are you expecting patients to receive in Part 2 of the Serenity 3 trial, and for how long will you be evaluating the patients?

Corinne Jenkins: Patients will be using the BXL501 at home when they have an episode of acute agitation, and so we're giving the film and monitoring them over a period of months so that we pick up the frequency and what happens when they use the film.

Corinne Jenkins: Patients, because it's placebo controlled, patients are able to take, if you will, a rescue medication.

Corinne Jenkins: That will be very much an individual thing.

Corinne Jenkins: Patients do take additional medications at home to attempt to treat their anxiety.

Corinne Jenkins: They obviously also take alcohol or marijuana, try meditation.

Corinne Jenkins: There's a lot of things that they take, but principally we're testing the effect of a single dose of BXL501, that 60-microgram dose, and there is a possibility for an additional dose, but that would – that will have to be up to the patient as to whether or not they're feeling something from the initial dose and calming.

Corinne Jenkins: Sure.

Corinne Jenkins: Thank you.

Corinne Jenkins: Thank you.

Vimal Mehta: It appears we have no additional questions at this time, so I'd like to pass the floor back over to Dr. Mehta for an additional concluding remarks.

Vimal Mehta: Thank you, everyone, for joining us today.

Vimal Mehta: We look forward to connecting with many of you in the coming weeks, including at the Canaccord Growth Conference, where Matt and I will be hosting meetings and participating in a fireside chat.

Vimal Mehta: Have a great day.

Operator: Ladies and gentlemen, this does conclude today's teleconference and webcast.

Operator: Once again, we thank you for your participation, and you may disconnect your lines at this time.