Q1 2024 BioXcel Therapeutics Inc Earnings Call
Operator: Good morning, and welcome to the BioXcel Therapeutics First Quarter 2024 Earnings Conference Call. At this time, all participants are in a listen-only mode.
Good morning, and welcome to the Biolife cell Therapeutics first quarter 'twenty 'twenty four earnings conference call.
At this time all participants are in a listen only mode. If during the conference call you require operator assistance. Please press star zero on your telephone keypad.
Operator: If during the conference call you require the operator's assistance, please press star zero on your telephone keypad. After the formal remarks, there will be a question and answer session. If you would like to register a question, you may press the star on your telephone keypad. 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 subject to risks and uncertainties related to future events and or the future financial or business performance of the company. However, actual results could differ materially from those anticipated in these forward-looking statements.
The formal remarks, there will be a question and answer session.
You like to Register a question you May press Star one on your telephone keypad.
Just to remind everyone certain matters discussed in today's conference call and our answers that maybe given to questions.
Our forward looking statements 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.
Risk factors that may affect future results are detailed in the company's annual report on Form 10-K for the year ended December 31st 2024.
Which can be found at biologic cell therapeutics dotcom or on W. W. F E C Dot Gov.
And which will be updated in its quarterly report on Form 10-Q for the quarterly period ended March 31st 2024.
As a reminder, today's call is being recorded speaking on today's call our Doctor Venmo met our Chief Executive Officer Dr.
Doctor, Vince O'neill, Chief of product development, and medical Officer, and Richard Steinhart, Chief Financial Officer.
They will be joined in the Q&A session by Dr. Frank JAKO, Chief Scientific Officer, Matt Wiley, Chief Commercial Officer, and Doctor, Rob Risinger, Chief Medical Officer of Neuroscience. It is now my pleasure to turn the call over to the Doctor Mehta. Please go ahead.
Operator: Risk factors that may affect future results are detailed in the company's annual report on Form 10-K for the year ending December 31, 2024, which can be found at bioxceltherapeutics.com or on www.sec.gov, and which will be updated in its quarterly report on Form 10-Q for the quarterly period ending March 31, 2024. As a reminder, today's call is being recorded. Speaking on today's call are Dr. Vimal Mehta, Chief Executive Officer; Dr. Vince O'Neill, Chief of Product Development and Medical Officer; and Richard Steinhart, Chief Financial Officer.
Vimal D. Mehta: Thank you operator.
Operator: They will be joined in the Q&A session by Dr. Frank Yocca, Chief Scientific Officer, Matt Wiley, Chief Commercial Officer, and Dr. Rob Risinger, Chief Medical Officer of Neuroscience. It is now my pleasure to turn the call over to Dr. Mehta. Please go ahead.
Vimal D. Mehta: Good morning, and thank you for joining us.
Vimal D. Mehta: Thank you, operator. Good morning, and thank you for joining us. 2024 has been an important period of progress for BioXcel Therapeutics, both at the program and corporate level, starting with our Neuroscience Program. Our journey with BioXcel 501 is well underway to expand the market potential for our agitation portfolio into the retail sector. We are focused on potentially bringing this novel treatment option for bipolar and schizophrenia-related agitation into the home setting.
Vimal D. Mehta: 2024, and it hasn't been embarked on.
Vimal D. Mehta: No progress whereby it so that if you take both the program and corporate levels.
Vimal D. Mehta: Starting with our new design program.
Vimal D. Mehta: Our Germany with VX 501 is well under way to expand the market potential for our education portfolio into that it is happening.
We have a forecast on potentially bringing this novel treatment option for bipolar and schizophrenia related agitation into the home setting.
Vimal D. Mehta: We are also dedicated to expanding into a much larger indication, Alzheimer's-related agitation, both in the in-care and home sectors. We believe these two opportunities are unique with no known FDA-approved therapies and represent transformative value drivers for the company and our shareholders. We are pleased to be advancing the plans for both late-stage tranquility and serenity programs. Vince will discuss the details of these programs shortly. I want to point out that we believe Serenity at Home may provide us with a nearer-term opportunity to create shareholder value through a potential label expansion for the previously approved 120 micrograms. The TRANQUILITY-IN-CARE trial is similar in design to our positive phase 3 TRANQUILITY-2 trial.
Vimal D. Mehta: We are also dedicated to expanding into a much larger indication as I must related agitation.
Vimal D. Mehta: In the <unk> and home setting.
Vimal D. Mehta: We believe these two opportunities are unique with no known FDA approved therapies.
Vimal D. Mehta: And Zane transformative value drivers for the company and our shareholders.
Vimal D. Mehta: We are pleased to be advancing the plans for both late stage thankfully begins at any of the programs.
Vimal D. Mehta: While Vince will discuss the details of these programs shortly.
Vimal D. Mehta: I wanted to point out that we believe may provide us with any other opportunity to create shareholder value through a potential label expansion part of the previously approved unnamed joining microgram dose.
Vimal D. Mehta: The brine quality and care trial is similar in design to our positive phase <unk> two trial.
Vimal D. Mehta: We see larger long-term growth potential for this program. We believe there is a significant upside to being the first to enter this untapped market. In addition to progressing our clinical development program, we have further expanded intellectual property for our neuroscience franchise. We were recently granted two new patents in the U.S. and Japan. We believe this provides long-term protection for our assets and gives us a solid foundation from which to pursue further development of BioXcel 501 and potential partnerships in key international markets.
Vimal D. Mehta: We see a large long term growth potential with this program. We believe there is significant upside to be there for us to enter this market.
Vimal D. Mehta: In addition to progressing our clinical development program, we have part of the expanded intellectual property for our neuroscience franchise.
Vimal D. Mehta: We were recently granted two new paradigms in U S and Japan.
Vimal D. Mehta: Believe this provides long term protection for all of that assay and gives us a solid foundation from which to pursue further development of <unk> 501 and potential partnerships in key international markets.
Vimal D. Mehta: Our IP portfolio is substantial. As of April 2024, we have 30 granted or allowed patents, and more than 140 additional patent applications in prosecution. We also have eight U.S. patents for our approved drug Igalmi listed in the FDA's Orange Book, with two additional recently allowed patents eligible for listing, one issued by the U.S. Patent and Trademark Office.
Vimal D. Mehta: Our IP portfolio is substantial.
Vimal D. Mehta: As of April 2000, and joined the board, we have clarity good R&D or allowed patents and more than 540 additional patent applications and prosecution.
Vimal D. Mehta: We also have eight U S paradigms, what one approved drug you got me listed in the Fda's Orange book with two additional decently allowed paradigms eligible for listing one issued by the U S patent and trademark office.
Vimal D. Mehta: Turning to economic commercialization traction, our revised and focused strategy is yielding results as we increase net revenue in Q1 2024 by 55% over Q4 2023. This growth is being primarily driven by volume contracting.
Vimal D. Mehta: Gardening doing guardsmen commercialization traction.
Vimal D. Mehta: While device and focused strategies.
Vimal D. Mehta: As we increase net revenue in the Q1 2024 by 55% over Q4 2000 joined GTT.
Vimal D. Mehta: This growth is being primarily driven by volume contracting.
Vimal D. Mehta: New Customer Acquisitions, Increased Utilization from Existing Customers, and the recently implemented permanent J-Code for EGALS. We are seeing this momentum carrying forward into the second quarter, with cartel volume already exceeding that of the first quarter this year. We are pleased that EGALMI is reaching a greater number of patients and healthcare providers and expect this momentum to continue. Both institutional and homesteading markets for bipolar and schizophrenia-related agitation are symbiotic, and Commercially Strategic.
Vimal D. Mehta: New customer acquisitions and increase utilization from existing customers and the recently implemented <unk> J code for you got them.
Vimal D. Mehta: We are seeing this momentum carrying forward into the second quarter.
With carton volume already exceeding that of the first quarter this year.
Vimal D. Mehta: We are pleased that the economy is reaching a greater number of patients and health care providers and expect this momentum to continue.
Vimal D. Mehta: Both institutional and home setting market for bipolar and schizophrenia related agitation.
Vimal D. Mehta: Symbiotic and commercially it's strategic we.
Vimal D. Mehta: We are excited about achieving an uptick in economic utilization and having a clear development path for the home. Turning now to the corporate front, we are pleased to have completed the 25 million registered direct offering we recently announced. This transaction provides an important bridge to continue advancing our business strategy and clinical trial plans. We remain focused on further strengthening our balance sheet and exploring multiple financing options, including potential partners, to extend our cash flow.
Vimal D. Mehta: We are excited about achieving an uptick in utilization and having a clear development path for <unk>.
Vimal D. Mehta: Turning now to the corporate front, we are pleased to have completed the $25 million or just started direct offering we recently announced.
Vimal D. Mehta: This transaction provides an important bridge to continue advancing our.
Vimal D. Mehta: Business strategy and clinical trial plans.
Vimal D. Mehta: We remain focused on further strengthening our balance sheet and exploring multiple financing options, including potential partnerships to extend our cash.
Vimal D. Mehta: We also continue to optimize operational efficiency. To wrap up, we believe our business fundamentals are strong. We are advancing two late-stage clinical programs, strengthening intellectual property, and seeing progress with commercialization. These accomplishments are underpinned by a compelling value proposition for driving future growth for the company. With that, I will turn it over to Vince.
Vimal D. Mehta: We also continue to optimize operational efficiencies.
Vimal D. Mehta: To wrap up we believe our business fundamentals that is strong.
We are advancing to late stage clinical programs.
Vimal D. Mehta: The strengthening intellectual property.
Vimal D. Mehta: And seeing progress with commercialization of it.
Vimal D. Mehta: These accomplishments are underpinned by our compelling value preposition for driving future growth for the company.
Speaker Change: With that John.
Speaker Change: And it over to Vince.
Vince O'Neill: Thank you I appreciate the opportunity to review the progress we've made with our late stage clinical development programs for fiber one so since speaking with you in March we received the minutes from our meetings with FDA regarding the development plans for the tranquility and serenity programs based on that feedback we have developed and announced the designs.
Unknown Executive: late-stage clinical development programs for 5.0.1. So, since speaking with you in March, we've received the minutes from our meetings with FDA regarding the development plans for the Tranquility and Serenity programs. Based on that feedback, we have developed and announced the designs of both Pivaril Phase III trials. We're pleased to have clarity on development paths, which may lead to two potential SND submissions, both for Alzheimer's-related agitation and bipolar and schizophrenia-related agitation. It's important to note that this is the same endpoint used in previous positive Tranquility trials and in studies that supported the FDA approval of EGAL.
Vince O'Neill: Both pivotal phase III trials, we are pleased to have clarity on development paths, which may lead to two potential SNB submissions, both for Alzheimer's related agitation and bipolar and schizophrenia related agitation.
Vince O'Neill: As a reminder, in the Tranquility program, we're evaluating final one as an acute treatment for agitation associated with Alzheimer's dementia.
Vince O'Neill: <unk> N care trial.
Designed as a double blind placebo controlled multicenter study to evaluate the efficacy and safety of a 60 microgram dose a final one over a 12 week period. The primary endpoint is change in PEC score at two hours post first dose.
Important to note that this is the same endpoint used in previous positive tranquility trials and in studies that supported the FDA approval of <unk>.
Unknown Executive: In the SERENITY program, we're evaluating the potential at-home use of 501 for agitation associated with bipolar disorders or schizophrenia. Our SERENITY at-home trial is designed to be a double-blind, placebo-controlled, multi-center study to evaluate the safety and efficacy of a 120-microgram dose of 501 over a 12-week period. The primary objective is safety, with efficacy measures as exploratory endpoints. Again, we've taken a thoughtful and deliberate approach to our trial designs with the ultimate goal of accessing the retail setting in mind, and we look forward to advancing our plans.
In the Serenity program, we're evaluating the potential at home use a final one for agitation associated with bipolar disorders schizophrenia.
Vince O'Neill: <unk> at home trial is designed to be a double blind placebo controlled multicenter study to evaluate the safety and efficacy of <unk> 120, microgram dose a final one over a 12 week period. The primary objective is safety with efficacy measures as exploratory endpoints.
Vince O'Neill: Again, we've taken a thoughtful and deliberate approach to our trial designs with the ultimate goal of accessing the retail setting in mind and we look forward to advancing our plans. The trial protocols have now been finalized and are being shared with the FDA and our theater always for clinical site selection.
Unknown Executive: The trial protocols have now been finalized and are being shared with the FDA, and our CRO is for clinical site selection. In our PMR study, we recently completed the enrollment of 22 patients with frequent episodes of agitation for bipolar disorders or schizophrenia in that open-label study. It is designed to evaluate whether tolerance, tachyphylaxis, or withdrawal occur following repeat dosing of the 180-microgram dose of EGALIMI after seven days of repeated treatment. These trial results can help address the language around limitations of use and warnings and precautions in EGALIMI's current label.
Vince O'Neill: In our PMA study, we recently completed the enrollment of 22 patients with frequent episodes of agitation for bipolar disorders are schizophrenia in that open label study its design to evaluate whether tolerance tachyphylaxis or withdrawal of car following repeat dosing of the 180 microgram dose of Big Gal Me.
Vince O'Neill: After seven days of repeated treatment. These trial results can help address the language around limitations of use and warnings and precautions <unk> current label.
Unknown Executive: We're performing data cleaning currently and look forward to announcing results from this PMR study shortly. I'd like to end my remarks with a few comments about our lead immuno-oncology asset, 7.0.1. Earlier this year, we announced the completion of patient enrollment in the safety portion of the Phase 2 trial of 7.0.1 in combination with K-TRUDA in metastatic pancreatic ductal adenocarcinoma. The trial is being led by Georgetown Lombardi Comprehensive Cancer Center. We are pleased that a late-breaking abstract was selected for presentation at the 2024 ASCO annual meeting and look forward to sharing the data on June the 1st with you.
Vince O'Neill: We're performing data cleaning currently and look forward to announcing results from this PMA study shortly.
Speaker Change: I'd like to end my remarks, with a few comments about our lead immuno oncology asset 701 earlier this year, we announced the completion of patient enrollment in the safety portion of the phase II trial of 701 in combination with Keytruda in metastatic pancreatic ductal adenocarcinoma.
Speaker Change: Bill is being led by Georgetown Lombardi comprehensive cancer Center. We are pleased that our late breaking abstract was selected for presentation at the <unk> at the 2020 for <unk> annual meeting and look forward to sharing the data on June the first with you.
Unknown Executive: We have formally initiated the process for monetization of this asset. I would now like to turn the call over to Rich, who will review our financial results for the first quarter of 2024. Richard. Thank you, Vince.
Speaker Change: We are formally initiated the process for monetization of this asset.
Speaker Change: Now I would like to turn the call over to Rich, who will review our financial results for the first quarter of 'twenty for Richard.
Richard I. Steinhart: Thank you, Vince. Net revenue from Melgami was $582,000 for the first quarter of 2024, compared to $206,000 for the same period in 2023, a 182% year-over-year increase. Sequential quarterly revenue increased 55% in the first quarter of 2024 from the fourth quarter of 2023. Increased revenue for both periods was primarily attributable to increasing demand with our existing customer base, as well as the addition of new customer orders and
Speaker Change: Vince.
Rich: Net revenue from <unk> was $582000 for the first quarter of 2024 compared to 206000 for the same period in 2023% to 182% year over year increase.
Rich: Sequential quarterly revenue increased 55% in the first quarter of 2024 from the fourth quarter of 2023.
The increased revenue for both periods was primarily attributable to increasing demand with our existing customer base.
Rich: The addition of new customer orders and volume based contracting.
Richard I. Steinhart: Research and development expenses were $11.4 million for the first quarter of 2024, compared to $27.8 million for the same period in 2023. The decreased expenses were primarily attributable to the wind-downs of the Serenity 3 and Tranquility 2 and 3 trials, as well as decreased professional fees, personnel, and related costs. Selling, general, and administrative expenses were $13.3 million for the first quarter of 2024 compared to $23.6 million for the same period in 2023.
Rich: Research and development expenses were $11 $4 million for the first quarter of 2024 compared to $27 8 million for the same period in 2023.
Rich: The decrease in expenses were primarily attributable to the wind down of the serenity three and the tranquility two and three trials as well as decreased professional fees personnel and related costs.
Rich: Selling general and administrative expenses were $13 3 million for the first quarter of 2024 compared to $23 6 million for the same period in 2023.
Richard I. Steinhart: The reduced expenses were primarily attributable to a decrease in personnel and costs associated with the commercialization of El Gambi compared to the first quarter of 2023. However, these reduced expenses were partially offset by increased professional fees during the first quarter of 2024. BioXcel Therapeutics had a net loss of $26.8 million for the first quarter of 2024, compared to a net loss of $52.8 million for the same period in 2023. The company used approximately $17.7 million in operating cash during the first quarter of 2024.
Rich: The reduced expenses were primarily attributable to a decrease in personnel and costs associated with the commercialization of <unk> compared to the first quarter of 2023.
Rich: Reduced expenses were partially offset by increased professional fees during the first quarter of 2024.
Rich: <unk> Therapeutics had a net loss of $26 8 million for the first quarter of 2024 compared to a net loss of $52 8 million for the same period in 2023.
Rich: The company used approximately $17 7 million in operating cash during the first quarter of 2024.
Richard I. Steinhart: Cash and cash equivalents total $74.1 million as of March 31, 2024. This includes the $25 million from the Registered Direct Offering announced on March 25, 2024. This investment extends our cash runway beyond our previous guidance of mid-2024 into the second half of 2024. Now, I'd like to turn the call back to Vimal.
Cash and cash equivalents totaled 20, $74 1 million as of March 31, 2024. This includes the $25 million from the registered direct offering announced on March 25 2024.
Rich: This investment extends our cash runway beyond our previous guidance.
Rich: Mid 2024 into the second half of 2024.
Speaker Change: Now I'd like to turn the call back to them.
Speaker Change: Thank you rich.
Vimal D. Mehta: I would like to add that in the coming weeks, we plan to attend several upcoming Investor Healthcare Conferences and look forward to continuing our discussion. We would now like to open the call to questions. Operator.
Speaker Change: To add that in the coming weeks, we plan to attend several upcoming investor conferences and look forward to continuing our discussions.
Speaker Change: We would now like to open the call for questions operator.
Operator: Thank you. If you would like to ask a question, please press star 1 on your telephone keypad. A confirmation tone will indicate your line is in the question queue. You may press star 2 if you would like to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys.
Speaker Change: Thank you if he would like to ask a question. Please press star one on your telephone keypad, a confirmation tone will indicate your line is in the question queue.
Speaker Change: Press Star two if he would like to remove your question from the queue.
Speaker Change: And for participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys. Please ask one question and one follow up question.
Operator: Please ask one question and one follow-up question. Our first question is from Colin Bristow with UBS. Please proceed. Hey, good morning, and thanks for taking the questions. So I think the major questions investors have are
Speaker Change: Our first question is from Colin Bistro with UBS. Please proceed.
Colin Nigel Bristow: Hey, good morning, and thanks for taking the questions. So I think the major questions investors are wrestling with are, what is the timeline for data and approval in Alzheimer's agitation? And what do you expect the cost of this program to be? And then, just as a kind of follow-up on that, with regard to this path to approval in Alzheimer's agitation, can you say what FDA has specifically said regarding the need for 12-month safety data? Thanks.
Colin Nigel Bristow: Hey, good morning, and thanks for taking the questions.
Colin Nigel Bristow: So I think the major questions investors are wrestling with.
Colin Nigel Bristow: What is the timeline to data.
Colin Nigel Bristow: Oh.
Speaker Change: And outside with agitation.
Speaker Change: Do you expect the cost of this program to be in.
Speaker Change: Then just as a kind of follow up on that with regards to this path to approval in outside with agitation can you say what FDA has specifically said regarding the need for the 12 month safety data. Thank you.
Speaker Change: Hi can you please check and see if the speaker line is muted we're not able to hear you.
Operator: Hi, can you please check and see if the speaker line is muted? We're not able to hear you. Once again, we're not able to hear the speaker line.
Speaker Change: Once again, we're not able to hear the speaker line.
Speaker Change: Okay.
Operator: Hello, we can hear audio now. Are the speakers there?
Speaker Change: Yes.
Speaker Change: Sure.
Hello, We can hear audio now are the speakers there.
Speaker Change: Thank you.
Speaker Change: Okay.
Speaker Change: Okay.
Speaker Change: Can you hear US now, yes, we can.
Vimal D. Mehta: Okay, so sorry, we have a technical glitch on this site. So Colin, thanks for the question. To try and answer that, and sorry for the delay, we can't give specific dates today or this morning, but what I can say in terms of the Tranquility in Care study, look at Tranquility 2, which had very similar trials and design. So we would anticipate a timeline and a cost very similar to Tranquility 2.
Okay. So sorry, we have a technical glitch on the site. So Colin thanks for the question.
Colin Nigel Bristow: To try and answer that and sorry for the delay.
Colin Nigel Bristow: We can't give specific dates today this morning, but what I can say in terms of the tranquility and care study.
Colin Nigel Bristow: Tranquility to the very similar trials in design and so we would anticipate a timeline on our cost very similar to the tranquility to study.
Vimal D. Mehta: Okay, and on the FDA requirement for 12 months, they've Yeah, so I think, as we've said,
Colin Nigel Bristow: Okay and on the FDA requirement for 12 months safety.
Vimal D. Mehta: Yeah, so, as we've said, we will re-approach the FDA to discuss specifically the details around the long-term safety trial, but the need for that trial is clearly not in doubt. That has to be done, and that would form part of the package for Tranquility in Care.
Speaker Change: Yeah. So I think as we've said we will re approach the FDA to discuss specifically the details around the long term safety trial, but the need for that trial is clearly not an david that that has to be done and that would form part of the package for the tranquility and cure.
Colin Nigel Bristow: Sandy.
Sandy: Okay. Thank you.
Operator: Our next question is from Ram Selvaraju, with H.C. Wainwright. Please proceed.
Sandy: Our next question is from Ram <unk> with H C. Wainwright. Please proceed.
Matt Wiley: Hi. Thanks so much for taking my question. Can you offer us some additional color regarding the status of group contracting discussions and when you anticipate the impact on net revenue to manifest itself in the coming quarters? Are there any important GPO purchasing contracting decisions expected in the coming months, please?
Hi, Thanks for taking my question.
Ram: <unk> can you offer us some additional color regarding the status of our group contracting discussions and when you anticipate.
The impact to net revenue to manifest itself in the coming quarters are there any important GPO purchasing contracting decisions expected in the coming months. Please.
Ram: So yes. Good morning, this is Matt.
Matt Wiley: So yeah, good morning, this is Matt. So, the answer to the question is we continue to matriculate contracts. We had multiple contracts in Q1. We continue to execute the plan, and in Q2, we've seen, excuse me. An increase in unit volume, in fact, as Vimal said in the prepared remarks, we've already seen unit volume increase more than what we posted in Q1, so far in Q2. So the contracting strategy, the volume of the contracting strategy is working. We see that existing customers continue to order, and we also see the acquisition of new accounts, which I think is really important for continued growth throughout the year.
Matt Wiley: So yes the answer the question as we continue to matriculate contracts, we have multiple contracts in Q1, we continue to execute the plan and over Q2, we've seen excuse me.
Matt Wiley: An increase in unit volume in fact, as <unk> said in the prepared remarks, we've already seen unit volume increase more than what we posted in Q1.
Matt Wiley: So far in Q2, so the contracting strategy the volume of contracting strategy is working.
Matt Wiley: We see that existing customers continue to order and we also see the acquisition of new accounts, which I think is really important for continued growth throughout the year.
Matt Wiley: Okay.
Vimal D. Mehta: And then secondly, with respect to the earlier stage neuroscience aspect, are you exploring strategic options for these, or... and effectively continue to develop them in-house?
Speaker Change: And then secondly, with respect to the earlier stage neuroscience assets are you exploring strategic options for these or.
Speaker Change: To effectively continue to develop them in house. Thank you.
Vimal D. Mehta: Ram, this is Vimal.
Jim: This is Jim.
Jim: Yeah.
Vimal D. Mehta: The focus, as I mentioned, is primarily on the two late-stage clinical programs, Serenity at Home and Tranquility in Care. We are dedicating all our resources to those programs, but early programs certainly will be explored if there is interest in potential partnership, and that we plan to explore.
Jim: Focus as I mentioned is primarily on the two late stage clinical program, Sir entity at home and tranquility and gear.
Jim: We are dedicating all our resources to those programs, but oddly program thirdly will be explored.
Jim: If there is interest for potential partnership.
Jim: The debt that we plan to explore.
Jim: Okay.
Jim: Okay.
Operator: Our next question is from Alex Stranahan with Bank of America. Please proceed.
Jim: Our next question is from Alec Stranahan with Bank of America. Please proceed.
Alex Stranahan: Hey guys, good morning.
Alec Stranahan: Hey, guys. Good morning, Thanks for thanks for taking our questions just two from us.
Alex Stranahan: Thanks for taking our questions. Just two from us, maybe both on the metastatic PDAC data we should be expecting at ASCO. I guess maybe just high-level, walk us through how 701 is designed to treat these patients. And then, as a follow-up, what would we typically expect with Keytruda monotherapy in this line of treatment in these patients? Thanks. Good morning, Alex.
Alec Stranahan: Maybe both on the metastatic feedback data, we should be expecting in ESCO I guess, maybe just high level walk us through how 701 is designed to treat these patients and then as a follow up what would we typically expect with Keytruda monotherapy.
Alec Stranahan: In this line.
Alec Stranahan: Of treatment in these patients.
Unknown Executive: Sure. Good morning, Alex. This is Vin.
Alec Stranahan: Sure. Good morning, Alex This is Dan So I'll take your second the second part of your question first Keytruda is not active as a monotherapy I think that's generally accepted pancreatic cancer is a very very cold tumor really the definition of a cold tumor the only exception would be MSI high.
Unknown Executive: So I'll take the second part of your question first. Keytruda is not active as monotherapy. I think that's generally accepted. Pancreatic cancer is a very, very cold tumor, really the definition of a cold tumor. The only exception would be MSI-high pancreatic cancer. Keytruda has a separate label to cover tissue-agnostic MSI-high patients. So that's 1%, approximately of the pancreas. So Keytruda is not active there.
Alec Stranahan: Pancreatic cancer Keytruda has a separate label to cover our tissue agnostic MSI high patients, so thats, 1% approximately of pancreas.
Alec Stranahan: Okay. So it doesn't all active there.
Our approach is to combine with Keytruda, So 71, plus keytruda in a combination.
Unknown Executive: Our approach is to combine it with Keytruda, so 71 plus Keytruda in a combination. It's second line, refractory pancreatic cancer, approximately 40 patients in total, Simon 2 stage, stage 1, about 20 patients, followed by another 20 patients. So that's the general gist of the approach. The reason we're doing the study at all is that we have very strong and encouraging preclinical data for the combination we've presented. And just lastly, on the point that pancreas is a cold tumor, it's also surrounded, as you'll know, by a fibrous layer, which again makes it very difficult to treat. But we've now published data that show that 701 essentially makes that collagen disappear. So there are multiple reasons to anticipate encouraging results, and you'll see those results in June.
Alec Stranahan: It's second line refractory pancreatic cancer.
Alec Stranahan: Similarly, 40 patients in total Simon two stage stage, one about 20 patients followed by another 20 patients. So thats the general gist of the of the approach.
Alec Stranahan: The reason we're doing the study at all.
Because we are very strong and encouraging preclinical data for the combination of which we have presented and just lastly on the point in the pancreas is a cold tumor and it's also surrounded as youll know by a fiber.
Layer, which again makes it very difficult to treat we've now published data that showed that 701, essentially makes that college and disappear. So there's multiple reasons too.
Alec Stranahan: Dissipate encouraging results.
Alec Stranahan: And you'll see those results in June.
Speaker Change: Great. Thank you.
Operator: Our next question is from Avantika Dashi with Mizuho Securities. Please proceed.
Our next question is from Atlantica, Jesse with Mizuho Securities. Please proceed.
Avantika Dashi: Hi, can you hear me? Hi, this is Avantika for Graig. Our question is, between tranquility in care and serenity at home, which trial would you say is the priority for you guys? And would you run these studies concurrently, or would it make more sense to run them one after another? Thanks.
Jesse: Hi can you hear me yes.
Jesse: Hi.
Jesse: This is <unk> on for Greg.
Jesse: Austin is between shrink quality and Karen Serenity at homes, which trial would you say is the priority for you guys.
Jesse: And would you run these studies concurrently or would it make more sense to run them one after another thanks.
Speaker Change: Thanks, everyone.
Speaker Change: Strategically we would prefer to run both trials in Berlin.
Speaker Change: As I indicated bolt.
Speaker Change: A big value drivers for the company.
Vimal D. Mehta: There are no FDA-approved therapies, and they represent transformative value drivers. Serenity, on the one hand, is a near-term opportunity through label expansion for the 120-microgram approved dose, while Tranquility is a much larger and longer-term opportunity with a significant upside and being first to market. So, to answer your question, we prefer to run both. If we have to, then we will make the decision of prioritizing one over the other or step by step.
Speaker Change: No approved FDA therapies and presented at Astro amenity value drivers.
Sidney.
Speaker Change: On one hand is a near term opportunity.
Speaker Change: Through label expansion for the 120 microgram approved dose while tranquility is a much larger and longer term opportunity with significant upside.
Speaker Change: Being first to market. So to answer your question, we prefer to run both if.
Speaker Change: If we have to then we will take the decision of prioritizing one over the other auto stepwise approach.
Speaker Change: Thank you.
Operator: As a reminder, it is star one on your telephone keypad if you would like to ask a question. Our next question is from Sumant Kulkarni with Kanakar Genuity. Please proceed. Good morning.
Speaker Change: As a reminder, it is star one on your telephone keypad, if he would like to ask a question. Our next question is from Samantha Hoh Kearney.
Speaker Change: <unk> with Canaccord Genuity. Please proceed.
Sumant Satchidanand Kulkarni: Good morning. Thanks for taking my questions. I have three. So, how do you frame the capital needs for running Tranquility and Serenity as they stand now relative to your current cash and the additional $25 million that you'll need to raise in November to conform to your financing agreement? That's the first.
Speaker Change: Good morning, Thanks for taking my questions I have three so.
Speaker Change: On how would you frame the capital needs that you foresee.
Speaker Change: Presenting tranquility instead any D. As they stand now relative to your current cash and the additional $25 million that youll need to raise in November to conform deal financing agreement that's in place.
Vimal D. Mehta: Hi everyone, this is Vimal. As Vince indicated, the Tranquility in Care trial is very similar to the Tranquility 2 trial where we had positive data. We are trying to have another well-controlled phase 3 trial for confirmation of efficacy and safety. So we expect the trial cost to be very similar to Tranquility. So we have a very good idea about what the per patient cost will be. And in terms of timelines, it will be pretty much similar.
Vermont: Hi, Simeon this is Vermont.
Vermont:
Vermont: As Vince indicated tranquility.
Speaker Change: Trial is very similar to the Tango two trial, where we had the positive data we are trying to have another.
Vermont: Well controlled phase III trial for confirmation of efficacy and safety. So we expect the trial cost will be very similar to the tranquility. So we have very good like <unk>.
Yeah about worked upon patient cost says.
Vermont: And in terms of <unk>.
Vermont: Timelines it will be pretty much similar while when we think of that entity at home is much smaller number of patients almost 100 patients so that.
Vimal D. Mehta: While when we think of serenity at home, it's a much smaller number of patients, almost 100 patients, so its recruitment is much faster than what we have observed in our previous three trials, Serenity 1, 2, and 3, and the cost is much lower, almost 50% of what it would be in a tank already. So we are trying to look at both opportunities, and as you know, with Serenity, we could potentially be, if we can complete the trial file as an NDA in 2025.
Vermont: Is recruitment is much faster than what we have observed in our previous C trial, nearly one two and three.
Vermont: And cost is much lower almost 50% of what it would be in your tank quality. So we're trying to look at both opportunity and as you know with <unk>, we can be potentially if we can complete that well file an NDA in 2025, so it's very synergistic.
Vimal D. Mehta: So, and it's very synergistic because we already have a combination. So I would say that we have a very good handle on it, and based on our current cash, which was reported at $74 million, we are laying out what the trial cost is and what the capital requirement is and how to finance the trials. As previously answered, then we prioritize, or we use it step-by-step.
Vermont: Because we already have the commercial environment. So I would say that we have a very good handle and based on our current cash which was reported at $74 million.
Vermont: We're laying out what the trial cost is and what the capital requirement is and how to finance that rise in previously Unserved then we prioritize our we use a stepwise approach.
Sumant Satchidanand Kulkarni: And then I'll ask the second and third questions in one shot here. So, in tranquility in care, what's a general target percentage of patients you expect to enroll that might already be on Raxelti as a chronic treatment for agitation in Alzheimer's? And going back to cost, do you think that the operating expense base at the company as it stands currently is optimized relative to the things you need to execute?
Speaker Change: Got it and then I'll ask the second question in one shot here. So in tranquility incur what say jindal target percentage of patients you expect to enroll that might already be indirect Saturday as a chronic treatment for agitation in Alzheimer's and going back to cost do you think that the operating expense base at the company as it stands currently as optimized relative to the things you need to.
Vermont: Execute on.
Robert Risinger: So on Resalti, I'll ask my colleague, Dr. Risinger, to come in here.
Vermont: So on NAV.
Speaker Change: So I'll say I'll ask my colleague Dr Rising answer to come in here.
Robert Risinger: I don't think we exclude or... We do not exclude patients who are on Rexalti or any other antipsychotic, and I'll point back to the Tranquility 2 data, which demonstrated that about 50% of patients are on concomitant antipsychotics. And your last question, Sumant, I'm sorry, I can ask you to repeat it.
Robert Risinger: I don't think we exclude or we do not exclude patients who are on <unk> or any other anti psychotic and I'll point back to the.
Robert Risinger: Tranquility to data, which demonstrated about 50% of patients are on concomitant anti psychotics.
Robert Risinger: And your last question Samantha I'm, sorry can I ask you to repeat it yes sure do you think the operating expense base at the company as it stands currently as optimized as dilutive to all the things that you need to execute on in the near to midterm here.
Sumant Satchidanand Kulkarni: Yeah, sure. Do you think the operating expense base at the company as it stands currently is optimized relative to all the things that you need to execute on in the near to midterm? Yeah, thanks so much. It's Richard.
Richard I. Steinhart: Thanks so much Richard, how are you? The answer is we continue to evaluate the operating overhead, and we continue to look at ways to make it more efficient and optimize it. So that's an ongoing process.
Yes. Thanks, Richard how are you. The answer is we continually to evaluate we continue to evaluate the operating overhead and we continue to look at ways to make it more efficient and optimize it so thats an ongoing process here.
Robert Risinger: Thanks.
Operator: Our next question is from Samir Devani with RX Securities. Please proceed.
Robert Risinger: Our next question is from Sameer Giovanni with Rx Securities. Please proceed.
Samir Devani: Hi guys, thanks for taking my question. I just wanted to come back to the comment about the 12-month safety study that would be required for the Tranquility in Care Study. I just want to confirm that that would be required before you make the SNDA and also, now that you've essentially completed these discussions with the FDA, what's the trigger left now to initiate that trial? Thanks very much.
Samir Devani: Hi, guys. Thanks for taking my question I, just wanted to come back to the comment.
Samir Devani: Comment about the 12 month safety.
Samir Devani: Study that would be required.
Samir Devani: For the tranquility in Cat <unk>.
Samir Devani: Study.
Speaker Change: I just wanted to confirm that that would be required before you make the S. N D E and also now that you've essentially completed these discussions with the FDA whats the trigger left now to initiate that trial, thanks very much.
Unknown Executive: Good morning, this is Vin. So, I think, as we've said, we will go to the FDA and discuss the, not the need, of course, for long-term safety, that's clear, but the details, and that will fundamentally be around the data that we collect in the study. So it's going to be a protocol discussion, which of course is why, you know, typically why we go and discuss things with the FDA. In terms of the requirements, I think your question was maybe around the numbers and requirements. I mean, those are obviously set by ICH guidelines, so 300 at six months and 100 at one year. We would need long-term safety data to support an SNDS. And Samir, to answer your question, when...
Speaker Change: Sure. Good morning. This is Ben So I think as we've said we will go to the FDA and discuss the not the need of course for long term safety that that's clear.
Ben: But the details on that will fundamentally be around the data that we collect in the study. So it's going to be a protocol discussion which of course is why typically why we go and discuss things with the FDA.
Ben: In terms of the required I think your question was when they ran the numbers and requirements. I mean, those are obviously set by ICA ICH guidelines. So 300 at six months and 100 at one year, we would need the long term safety.
Ben: Data.
Ben: To support an NDA submission.
Vimal D. Mehta: We have reached the end of our question and answer session. I would like to turn the call back over to management for closing remarks.
Unknown Executive: And Samir, to answer your question, when do we expect to initiate the study? As Vince mentioned, now we are sharing the protocol with the FDA and giving it to the CROs for site selection. And once we have the financing in place up to the data readout, we will initiate. We are preparing for the technical readiness.
Speaker Change: For me to answer your question when do we expect to initiate this study as Vince mentioned Navios sharing the protocol with FDA and given it to the Seattle Port site selection and once we have the financing in place up to the data readout, we will initiate that study.
Speaker Change: We are getting the technical readiness.
Speaker Change: Great. Thanks very much.
Vimal D. Mehta: Thank you everyone for joining us today and for your continued interest in BioXcel Therapeutics. Have a great day. Thank you. This will conclude today's conference.
Speaker Change: We have reached the end of our question and answer session I would like to turn the call back over to management for closing remarks.
Speaker Change: Thank you everyone for joining us today and for your continued interest in box on therapeutic.
Speaker Change: Good day.
Operator: Thank you. This will conclude today's conference. You may disconnect your lines at this time, and thank you for your participation. www.youtube.com.uk
Speaker Change: Thank you. This will conclude today's conference you may disconnect. Your lines at this time and thank you for your participation.
Speaker Change: Okay.
Speaker Change: Yes.
Speaker Change: Yes.
unknown: www.youtube.com.uk www.youtube.com.uk www.youtube.com.uk www.youtube.com.uk
Speaker Change: Yeah.
Speaker Change: [music].
Speaker Change: Yes.
Speaker Change: Okay.
Speaker Change: Okay.
Speaker Change: Okay.
Speaker Change: Okay.
Speaker Change: Yeah.
Speaker Change: Yes.
Speaker Change: Yeah.
Speaker Change: Okay.
Speaker Change: Yes.
Speaker Change: Yes.
Speaker Change: Yes.
Speaker Change: Okay.
Speaker Change: Yes.
Speaker Change: Yeah.
Speaker Change: Yes.
Speaker Change: Okay.
Speaker Change: Okay.
Speaker Change: [music].