BioXcel Therapeutics Q2 2023 Earnings Call Transcript

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Provided by Quartr
August 14, 2023

There are 12 speakers on the call.

Operator

Good morning, and welcome to the BioXcel Therapeutics Second Quarter 2023 Financial Results Conference Call. At this time, all participants are in a listen only mode. After the presentation, there will be a question and answer session. 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.

Operator

Risk factors that may affect future results are detailed in the company's annual report on Form 10Q for the quarter ended March 31, 2023, which can be found at www.bioexceltherapeutics.comoronwww.sec .gov, and which will be updated in its quarterly report on Form 10 Q for the quarter ended June 30, 2023. As a reminder, today's conference is being recorded. Joining us on today's call are Doctor. Vimal Mehta, Chief Executive Officer Richard Steinhart, Chief Financial Officer Matt Wiley, Chief Commercial Officer Doctor. Rob Reisinger, Chief Medical Officer of Neuroscience Doctor.

Operator

Vince O'Neill, Chief R and D Officer of Oncus Accel Therapeutics and Doctor. Frank Yaka, Chief Scientific Officer. It is now my pleasure To turn the call over to Doctor. Ahmedda, the CEO and Founder of BioXcel Therapeutics. Please go ahead.

Speaker 1

Thank you, operator. Welcome, everyone, and thank you for joining our call today. Before we begin, I first want to say that the company was dismayed and frustrated by our recent discovery of certain Investigator misconduct that occurred during our Tranquility II trial. This summer has not progressed as we had anticipated, and we plan to make significant changes to our entire business structure. While I'm deeply disappointed, I'm more determined than ever to continue developing our drug candidate and put BioXcel Therapeutics back in a position to accomplish its core mission.

Speaker 1

Now I will start by covering our strategic reprioritization and how it is designed to position us for success going forward. In addition, I will share As much information as I can about the status of our Trangibility program in Alzheimer's associated agitation. 6 years ago, we founded Bioclass Therapeutics with a clear mission: to build a uniquely disruptive biopharmaceutical model using AI approaches to bring transformative medicines to patients. We believe we have fulfilled this mission with the approval and launch of IgALMII and with our program in the late stage of clinical development. We are now taking the necessary steps across the business to strengthen our ability to advance our land and expand strategy.

Speaker 1

Specifically, we are taking clear, well defined and decisive actions in 3 areas. First, let's discuss our commercial reprioritization. We landed with Agami's approval in the institution setting. We are now shifting resources to expand Aspect of our market strategy into what we believe is a potentially more promising retail pharmacy and outpatient setting. This shift is largely due to the fact that the hospital setting proved to be more difficult to penetrate than we originally anticipated, particularly in a challenging post COVID environment.

Speaker 1

Despite these challenges, However, we remain committed to making IgALMIA available to patients in the institutional setting. We began deploying a contracting effort with large hospitals, healthcare systems and integrated delivery network prior to our reprioritization and have been pleased to see it achieved some initial success with increased demand from existing hospital customers and large health systems. In fact, our Q2 revenues doubled from Q1, largely due to this contracting study. Therefore, we will now broadly adopt it. As part of this action, we plan to reduce our total workforce from approximately 190 To 80 employees over the next several months, the majority of these reductions We'll be in the commercial organization to help us build toward potential label expansions and to support Agami, we will maintain This decision to reduce our workforce was extremely difficult for the management team and abode, but was necessitated by a variety of market and business factors.

Speaker 1

I'm grateful to all of our employees Who made many contributions to our company, we are committed to providing support to those impacted as they transition from the company. The second part of our business transformation involves shifting our development high potential agitation market opportunities for BXCL501 in bipolar disorders, schizophrenia and Alzheimer's Dementia. We firmly believe this drug has the potential to have a positive impact on patients and caregivers and addresses significant unmet medical needs. For example, 23,000,000 Episodes of bipolar schizophrenia related agitation occur annually in the U. S, In the at home setting, in addition, 100,000,000 Alzheimer's related agitation episodes occur every year in the U.

Speaker 1

S. Importantly, more than 80% of these patients are in a residential setting and episode We have represented more than half of the total episode volume. We are motivated to develop 501 to address the needs of these patients. We have developed a comprehensive plan for our Tranquility program in Alzheimer's associated agitation. In June, we announced positive top line data from Tranquility 2.

Speaker 1

This was a uniquely complex trial Requiring mobilization of clinical team whenever an agitation episode occurred. We were pleased That our top line data showed that we met our primary endpoint with the 60 microgram dose with 501 demonstrating a statistically significant 39% greater reduction impact score from baseline compared to placebo at 2 hours. We also met a key 2nd, the endpoint with the statistically significant reduction in agitation symptoms versus placebo, As measured by PEC score change from baseline at 1 hour with 60 microgram dose. 501 was well tolerated with no drug related serious adverse events over trial duration. As we disclosed in an 8 ks filing, there were issues related to a principal investigator at a Tranquility 2 clinical The conduct by this PI was unacceptable and extremely unfortunate.

Speaker 1

We are investigating the issue and, for example, have already initiated an audit by an independent 3rd party of the data from the PI's clinical side. In addition, we have requested a meeting with the FDA to discuss our entire Tranquility program. This will include both Tranquility II, Tranquility III clinical trials, The data audit and the data package that may be required to support submission of an sNDA seeking approval of 501 for the acute treatment of agitation in mild to moderate dementia patient with probable Alzheimer's disease. We hope to have an update on the Tranquility program, including the audit and FDA meeting by the end of the year. Regarding TRANCLED III, we paused enrollment after early trial data showed a much higher background Frequency of agitation episode than originally expected.

Speaker 1

It appears that this patient population may be better suited for a chronic treatment of agitation, while our focus is on developing 501 as acute treatment of Alzheimer's agitation. As a reminder, we have breakthrough therapy designation for the acute treatment of agitation associated with dementia. In parallel, we are advancing our serenity program for the at home acute treatment of agitation associated with bipolar disorders or schizophrenia. In May, we reported top line results from Ceredi3 Part 1. We evaluated patients in Part BXCL501, which is half of the lowest approved dose of VEGALME using the same primary and secondary endpoints as in the CINITY While we believe the data suggests the potential for 501 to be effective in a monitored medical setting with 60 microgram dose, We did not meet the primary endpoint of Mean Change Impact Score at 2 hours.

Speaker 1

However, the 60 microgram dose was well tolerated and demonstrated favorable safety results, including proportionately fewer adverse events Compared to those observed during Serenity 1 and 2, which evaluated the approved 120 microgram or 180 microgram doses. We believe these safety results support the potential for at home use. We are now conducting serenity 3 Part 2. It is a 12 week study to evaluate the safety of a 60 microgram dose of BXCL501 with an optional 60 microgram dose. To identify a dose to potentially provide an optimal balance between the safety and efficacy in the at home population, We performed pharmacokinetic and pharmacodynamic modeling that suggested that use of an 80 microgram dose of BX-five zero one could provide this balance.

Speaker 1

We believe the evaluation of an 80 microgram dose is Further supported by our previous clinical experience with this dose during our Phase 1b trial in schizophrenia patients with agitation. We plan to meet with the FDA to discuss the 80 microgram dose and a protocol amendment to the ongoing Serenity 3 Part 2 study. The primary objective of Part 2 is to describe the incidence of treatment emergent adverse events. The primary endpoint is a comparison of serious adverse events and treatment emergent Adverse events as compared to placebo and the secondary endpoints include a number of efficacy assessments. Turning to our major depressive disorder program, we reported positive top line results from the Phase 1b Multiple ascending dose trial in May.

Speaker 1

As part of our reprioritization effort, we will pause this program. To augment our clinical development team, Doctor. Vince O'Neil, who is currently serving as Head of R and D for Onco's XL will play a broader role in our neuroscience development. Vince has been with the company since the IPO in 2018 and has extensive pharmaceutical clinical development experience. Vince played an instrumental role in CENITY-1 and two trials Along with our Chief Medical Officer, Doctor.

Speaker 1

Rob Lissinger, that resulted in the approval of Egalmi and the successful human proof of concept trials for 701 in our oncology program. Dushan Caustic, Our Head of Medical Affairs will play an important role in developing clinical and medical strategies of 501 to support commercialization of any potential indications. He has more than 2 decades of pharmaceutical industry experience In neuroscience, this includes clinical development and commercialization of leading drugs such as We have also initiated a search to expand our Board of Directors to strengthen clinical development expertise. The 3rd Part of our business transformation involves prioritizing AI driven innovation to strengthen our neuroscience clinical development. Our unique integration of data science, clinical expertise and commercialization gives us a powerful and distinct competitive advantage in building a robust R and D pipeline.

Speaker 1

We are truly excited about our clinical development Initiatives and pipeline candidates including BXL502. We look forward to highlighting these developments at an R and D event We plan to host later this year. We also plan to spotlight our next generation AI platform capability for identify and reinnovating late stage drug candidates and introduce BXCL501504. In summary, this is challenging yet transformative period for our company. We are taking swift and decisive steps with the goal of putting the company in the best possible position for future success.

Speaker 1

We have received interest from potential corporate partners. However, it is far too early to know what, if any, form such a transaction could take. We are passionate about our goals and remain committed to delivering long term value to shareholders. Now I will turn the call over to Rich, who will discuss our Q2 financial results.

Speaker 2

Thank you, Vimal. Our Q2 2023 financial results are as follows. Net revenue of Agami was approximately $457,000 for the quarter. Research and development expenses were $27,000,000 for the Q2 of 2023 compared to $17,900,000 for the same period in 2022. The increased expenses were primarily attributable to increased clinical trial expenses for Serenity 3 and Tranquility 2.

Speaker 2

Selling, general and administrative expenses were $25,900,000 for the Q2 of 2023 compared to $18,400,000 for the same period in 2022. The increased expenses were primarily attributable to an increase in personnel and related costs to support the commercialization of ILGAMI. BioXcel Therapeutics had a $53,500,000 loss for the Q2 of 2023 compared to a net loss of $37,700,000 for the same period in 2022. Loss for the quarter included approximately $6,100,000 in non cash stock based compensation. Cash and cash equivalents totaled $127,500,000 as of June 30, 2023.

Speaker 2

As noted, the company is undertaking a strategic reprioritization that includes a reduction in the workforce of more than 50%, which is expected to reduce expenses significantly. In the absence of additional capital becoming available, The company under the strategic financing agreements or otherwise, the company estimates that its current cash and cash equivalents will last through mid-twenty 24. The company's previously disclosed cash runway projection assumed a full utilization of its strategic financing agreements of $155,000,000 with Oaktree Fund Administration and Qatar Investment Authority. Based on recent events, the company is not likely to be in a position to meet the milestones required to access the additional capital under the financing agreements. The company is exploring multiple ways to extend its cash runway and is already in discussions with its strategic financing partners to amend the agreements.

Speaker 2

Successful modification of these agreements could extend the company's cash runway. Finally, with regards to Onco's XL, we are currently examining strategic alternatives, including strategic partnerships or financing. Now, I'd like to turn the call back to Vimal.

Speaker 1

Thank you, Rich. We would now like to open the call for questions. Operator?

Operator

At this time, we will be conducting a question and answer Our first question today comes from Greg Harrison of Bank of America. Please proceed with your question.

Speaker 3

Hey, good morning. Thanks for taking the question. How are you thinking about the outlook for the company with this restructuring? And how do you think investors should think about the story at this point?

Speaker 1

Good morning, Greg. This is Vimal. I'm very excited about the outlook for our business. As I shared earlier, we are laser focused On the at home opportunities for BXL-five zero one, specifically the two value drivers for 501 are serenity program for We landed with Egalmi in the institutional setting. We are now shifting resources to expand into a potentially more promising retail pharmacy and outpatient setting.

Speaker 1

We also look forward to highlighting our pipeline with BXCL502 update at R and D Day by the end of this year.

Speaker 3

Got it. That's helpful. And one more if I can. Could you give us some more color on Why you made the decision to shift focus to the at home setting and away from institutional medical setting?

Speaker 1

We are shifting our focus from the institution setting to the retailat home market due to the market and business factors we shared in our call. The hospital setting was more difficult to penetrate than originally anticipated, particularly in a challenging post COVID environment. It is important to note that we will continue to make egalmi available to our We are committed To bringing Agalmi to current and future patients and their families for current indication and for new indications.

Speaker 3

Great. Thank you for taking the question.

Operator

The next question is from Colin Bristol of UBS.

Speaker 4

I just wanted to pass on, well done on this reprioritization, you made

Speaker 5

tough decisions, But I think they had to be done.

Speaker 4

And maybe first question and just kind of picking back Could you outline how you see the market opportunity for origami now that you're shifting the focus to the at home setting? And How should we think about that specifically from a market opportunity point of view? And then secondly, and I think this is the most common question we're getting from investors is Just updates on the timing of first, the external audit. I think I heard you say by the end of the year, but any more color you can give With where you are in this process would be great. And then on the second part of that is just timing regarding feedback from FDA.

Speaker 4

I know you've requested an 18, but When do you expect this to occur? Have you had any sort of interactions or feedback around this data issue? Thank you.

Speaker 1

Good morning, Colin. Regarding your question about the Tranquility program update, as I stated in my Earlier remarks that we expect to have update or hope to have the update by the end of the year. Independent audit is in progress. We have requested a meeting. Once we have the meeting, we will have a clarity What is the data package required to file an sNDA?

Speaker 1

And that will be a good time to provide an update on the TANQUILITY program. I just would appreciate if you can come back to your first question That you had asked so that we can address that.

Speaker 6

Yes. So I think Good morning, Colin. It's Matt. How are you?

Speaker 4

Hey, I was just checking you heard it, right?

Speaker 6

I did. Yes. So, the question about market opportunity switching from the hospital setting to the at home setting. Keep in mind that there are 23,000,000 episodes In the at home setting, one of the things that we accounted for in our models as well is that we would capture many of the patients that wind up in the emergency department In the at home setting as well. And given the market research that we've conducted, we recognize the unmet need in the home setting It's quite significant.

Speaker 6

It's under recognized and under diagnosed, but the patients certainly see value here. And they indicated that both they and their caregivers would use this product profile for PXCL501 In 80% of their episodes. So we feel that the market conditions for the at home setting is Quite favorable, and we look forward to bringing the drug to those patients.

Speaker 4

Great. Thank

Operator

you. The next question is from Sumant Kulkarni of Canaccord. Please proceed with your question.

Speaker 7

Good morning. Thanks for taking my questions. So for your breakthrough therapy designation status, how exactly does the FDA define acute treatment of agitation In terms of number of episodes or instances of film usage per month, along those lines, do you think the current pricing of $105 per film is appropriate or a strategic misstep I'm asking because of 2 factors. First, even one were to hit the annual specialty tier of roughly $10,000 per year for pricing on a gross basis, That would translate to a patient using 100 films a year and makers of chronic treatments of agitation enjoyed significantly higher market caps or buyout values, but pricing assumptions there were much higher as well.

Speaker 6

So let me I'll address the price question And the number of episodes. 1st and foremost, we did conduct research when we Establish our launch price in both bipolar schizophrenia in the at home setting and also in ADA. And what we found is that For episodic treatment, there was appetite in the market for that price point. Certainly, what we see is that the volume of episodes in the mild Alzheimer's dementia patients is roughly 3 a month. And that can escalate further as they become more moderate, but we also recognize that 81% of the ADA people are either in an at home setting or an ALS setting, Which is akin to an at home setting and represent over 50% of the total volume of agitation episodes.

Speaker 6

And that doesn't preclude 501 from being used in episodic breakthrough episodes episodic breakthrough in other locations as well.

Speaker 7

Got it. And then does your new cash runway include the potential to redo Tranquility 2 in case the FDA says you will

Speaker 1

Sumant, we are not Speculating on that, we are doing an audit, and we want to meet with the FDA and get the feedback, then we will be able to comment on it.

Speaker 7

Thanks. I'll hop back

Speaker 4

in the queue.

Operator

The next question comes from Ram Selvaraju of H. C. Wainwright.

Speaker 8

I just wanted to revert back to The formulary wins that you had previously announced that you were previously engaged in pursuing in the institutional setting and wanted to ask How that is affected, if at all, by your reprioritization here into the at home setting? To what extent could we potentially expect you to be able to capitalize on the formulary wins that have already happened In the institutional setting and along what trajectory? And also if you could comment at all on how you expect Promotional activities to be different in the at home context versus the institutional context? Thank you.

Speaker 6

Sure. So, first of all, we reported out that we had over 185 formulary wins, P and T wins to date. We're still Accumulating those wins at a win rate of over 65%. In fact, we had 3 wins on Friday. And so we would expect that the 650 or so hospitals that are still scheduled to vote will continue with that process.

Speaker 6

And assuming that we continue to accrue these hospitals, we will Reach out to them through medical affairs activities, through market access activities contracting and certainly support them with Kraton distribution To ensure that they can access the drug and utilize it. The medical affairs support will obviously be really important in helping them The promotional activities for the at home market is a little bit different because you are Educating physicians and patients at the same time. As you know, patients can be motivated to ask for Prescription drugs, so that would be part of the plan as well. And then through sampling and contracting with PBMs. And these are activities that the contract So those are activities that we're planning out to get ahead of that potential approval and more to come on

Operator

The next question is from Yatin Suneva of Guggenheim Partners. Please proceed with your question.

Speaker 5

Hey, guys. Thank you for taking my question. Maybe first question is on the Alzheimer disease agitation. I understand you will meet with the FDA and try to get their feedback on TRIN quality 2 and 1. Can you just talk about what Generally, is the ICS guidelines for an indication like this?

Speaker 5

What sort of exposure, duration of exposure is needed From a regulatory perspective for a disease that affects millions of people, it seems like you are sort of stopping Tranquility 2. It's still not fair to me if TRANQUILITY 12 combined is enough for you to get an approval. So that's one. Basically just help me understand the path forward for Alzheimer disease education as you understand. The second is, it seems like on the R and D day, you're going Talked a little bit about the 502, just curious, maybe if you can highlight a little bit there.

Speaker 5

And In terms of the cash runway, maybe help us understand how should we model it going forward? Where exactly are you cutting cost? How many of the sales rep you're still going to have? So yes, these three questions. Thanks.

Speaker 1

Thank you, Yatin. First question regarding the tranquility program. Rob will answer like what our plans are.

Speaker 8

Yes. So let me be clear. We paused the trial because the early data in TRANQUELITY-three indicated that the patient population may be better suited For chronic as opposed to episodic therapy and as you know, our focus is on the episodic treatment in line with our breakthrough therapy designation by FDA for episodic treatment. We have decided to pause trial in order to discuss this issue with the FDA at an upcoming meeting, and we'll be able to provide more guidance on that once that meeting We do expect at that meeting to discuss both the auditing and The Tranquility II results and at that point, we'll be able to provide more guidance At the end of the year, with regard to what will be necessary for filing an sNDA package?

Speaker 1

Yate, regarding your second question, I will pass it on to Frank for 502.

Speaker 9

Hi, Yadi. This is Frank Yacke. I'm excited about our emerging pipeline development candidates, especially BXCL 502. We really are looking forward to an upcoming R and D Day where we'll present our progress with this molecule, Particularly its development, but also discuss some unique indications of interest. Secondly, We will discuss our next generation AI platform.

Speaker 9

This has evolved considerably from the first time we did our R and D Day 2 years ago. The capabilities are have been enhanced for identifying and reinnovating late stage opportunities and we'll also discuss some candidates for Additional pipeline entries such as BXCL501 and 504. So it will be a very interesting day.

Speaker 1

So regarding your 3rd question, Yate, related to the cash runway, Richard will address it.

Speaker 2

Sure, Yate. So the reprioritization That we're working on now. We'll extend the cash runway by reducing our burn significantly. And we're also working on various other options to extend the cash runway, which Working with our strategic partner. As we said, the goal is to get the company to about an $80,000,000 Go forward annualized burn rate and that's what we're working towards.

Speaker 2

In terms of the market, we'll reduce that the market access Team will be a core group of market access teams to work through the commercial sector.

Operator

The next question is from Greg Suvagente of Mizuho Securities. Please proceed with your question.

Speaker 5

Good morning. This is Richard on for Greg Sivanovich, RBC Hello. So just two questions from me. One, just following up from the crash one night question. How do you expect the split between R and D and SG and A going forward?

Speaker 5

And then 2, for the Gaome opportunity in sales, how should we be modeling that on a go forward basis

Speaker 2

So in terms of the commercialization, it's going to be a small core team of about a dozen people. So that will reduce our SG and A expenses pretty dramatically Moving forward, our R and D expenses should go down. Remember in the first half of the year, We had Serenity III and Tranquility II fully implemented and that's what caused the increase in expenses in the first half of twenty twenty three.

Speaker 6

And Richard regarding your second question on modeling, we've never provided guidance on Agami sales. And so I think the way to think about this is by reducing our headcount in commercial to 12, It limits our ability to go out and prospect the way that we had in targeting the 1700 hospitals. However, We will continue to support through contracting efforts and through trade and distribution on both our existing customers and those that Choose to come online and approve Agami through formulary, we will support them in the same way. So that may help you, But I can't give guidance beyond that.

Operator

The next question is from Robin Karnauskas of Truist Securities. Please proceed with your question.

Speaker 6

Hi, this is Alex on for Robin. Can you remind us what the approximate market opportunity is, the breakdown for dementia Setting between assisted living facility versus nursing home and what are the gating factors to economic uptake on the assisted living facility? So as I think we've communicated previously, with their 100,000,000 episodes total, Better than 80% of the patients with Alzheimer's dementia, I mentioned this earlier in the call, are in either the at home setting or the ALF setting. And I don't have a specific breakdown for you here, but certainly something I can communicate later as we get closer to A market entry disclosure. Better than 50% of the episodes are in those settings.

Speaker 6

And we feel that That allows us to price the drug as an episodic drug as opposed to pricing it as a chronic drug, and Certainly can be used episodically in any setting. So we think that the TAM still holds at 100,000,000 episodes.

Operator

The next question is from Corrine Jenkins of Goldman Sachs. Please proceed with your question.

Speaker 5

Hi, this is Omari on for Corrine Jenkins. So first, What do you view as your best options to further expand runway beyond mid-twenty 24? And then second question is, if the FDA requires an additional Will they have to start would you have to start including the trial with the same population in TRIM-forty two?

Speaker 1

Hi, this is Vimal. Regarding our cash runway expense, and as Richard has already outlined, Our cash runway is mid of 2024 and that's obviously dedicated on what clinical trials we will be executing on. In terms of our options to extend that cash runway, we have multiple opportunities. 1 is working with our strategic partner, which Richard has already outlined, Who are our financing partners? There is interest developing in these programs by other corporate partners.

Speaker 1

We are looking into that. And in addition, we have some core assets that we can monetize and capitalize to extend our cash runway. So Good news is that we have multiple opportunities to extend our cash runway and achieve meaningful clinical milestones.

Speaker 8

So let me handle if the FDA has to another study. At this point, It's premature to discuss whether another study is required. But in terms of whether that study would be ALF We're just at home again. We certainly make that decision upon consultation with the FDA and we'll be providing that Update later this year.

Speaker 1

I think I'd just like to add on top of what Rob said. We We are a pioneer in developing an episodic medication to treat agitation. We are learning from the data, From the time, from the clinical outcomes that we are observing, we never or FDA never expected that we will have so many Episode observed in the nursing home study. So we are taking that information back to the FDA And designing a program what makes most sense. Does it make sense to have ALF and home setting as episodic And whatever is needed to put together that package.

Speaker 1

And would it make sense to go back later on and evaluate the nursing home as a more chronic Because I'd like to remind everyone our breakthrough therapy designation is in for acute treatment of agitation And we believe mild to moderate probable Alzheimer's disease population is the relevant one so far what we have observed.

Operator

The next question is from Samir Devani of Rx Securities. Please proceed with your question.

Speaker 10

Yes. Hi, guys. Thanks for taking my questions. Most of them have been asked already, but I've got a couple. I guess the big question for me is it realistic for you guys to market directly to the Generalist Physicians for the at home setting.

Speaker 10

Isn't that really more the domain of big pharma? And have you thought about just doing A partnership deal around egalmi to address that and reduce the cash burn. And then I guess the second question is Just really out of interest, how many agitation episodes were you seeing in Tranquility 3 in the nursing home setting? Thanks very much.

Speaker 6

So, I'll take the first question. Good morning. So, when we think about the at home setting for We manage the therapeutic treatments for those patients. So we feel that we would be very well positioned to access As it relates to Alzheimer's dementia agitation, these patients are managed From a top line perspective by about 65,000 physicians in the United States, about 30,000 of those would be of interest to us. Those 30,000 are Additionally making the diagnosis and treatment evaluation for these patients.

Speaker 6

Now of those there are somewhere between 3000 to 4000 that are specialists of interest, but the primary care opportunity or the generalist opportunity as you We would either have to partner with CSO, a potential partnership with a larger pharmaceutical company we're permutations of all three of those. And so that market entry strategy is not yet that clearly defined, but we're working through those problems or those Potential opportunities,

Speaker 8

I guess, at this time.

Speaker 1

So Samir, regarding how many episodes we observed, I will let Rob answer that.

Speaker 8

So, there are patients continuing in the trial at this point and they continue to have episodes, so the number is accruing. It's hard to say it on a given day. So, I think the best way to describe it would be to say it's regular And it is greater on an individual basis than what we reported in our Tranquility 2 Results. And this is exactly why we're discussing it with the FDA, so that we have a clear path forward for episodic treatment of acute episodes and We'll have that guidance at the end of the year.

Speaker 10

Thanks very much.

Operator

The next question is from Kaviz Yazzie of Jefferies. Please proceed with your question.

Speaker 11

Good morning, team. What are the proposed features that are going to be in the protocol amendment for Serenity III Part II? What are the kind of the Key secondary efficacy assessments that would be valuable. And then maybe on your strategic financing Partnerships, what modifications to your credit agreement and RIFA would enable you to access capital earlier and be attractive to your partners? Thank you.

Speaker 8

So we are finalizing that amended protocol. The secondary measures have to do with a variety of different, we'll call them perspectives on efficacy. And once we have the meeting with the FDA, I think it will be much easier to describe the entire

Speaker 1

So, Kambe, did it answer your question because what we are saying is now we have selected a dose 80 microgram Based on our pharmacokinetic, pharmacodynamic modeling as we were expecting and now it's a matter of modifying Protocol submitting to the FDA and then we will be in a position to initiate the study. As Rob has said, The primary is safety and then efficacy trends as we measure over a 12 A week period. So that's what will be the outcome we will be looking from that trial.

Speaker 11

Yes. Thank you, Vimal.

Speaker 1

Regarding your next question, modification on the credit agreement, as Richard has mentioned that we are in active discussions. And as we make progress, we'll provide an update.

Speaker 11

Thank you very much. Appreciate it.

Operator

There are no additional questions at this time. I'd like to turn the call back over to Doctor. Mehta for closing remarks.

Speaker 1

Thank you, everyone, for joining us today. We are excited about our path forward through this strategic reprioritization and look forward to sharing updates on our progress. Thank you for your continued interest in BioXcel Therapeutics and have a great day.

Operator

This concludes today's conference. You may disconnect your lines at this time. Thank you for your participation.

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