NASDAQ:DRRX DURECT Q1 2024 Earnings Report $0.67 -0.03 (-4.34%) As of 04/25/2025 04:00 PM Eastern Earnings HistoryForecast DURECT EPS ResultsActual EPS-$0.25Consensus EPS -$0.21Beat/MissMissed by -$0.04One Year Ago EPSN/ADURECT Revenue ResultsActual Revenue$1.83 millionExpected Revenue$2.73 millionBeat/MissMissed by -$900.00 thousandYoY Revenue GrowthN/ADURECT Announcement DetailsQuarterQ1 2024Date5/13/2024TimeN/AConference Call DateMonday, May 13, 2024Conference Call Time4:30PM ETUpcoming EarningsDURECT's Q1 2025 earnings is scheduled for Monday, May 12, 2025, with a conference call scheduled at 4:30 PM ET. Check back for transcripts, audio, and key financial metrics as they become available.Q1 2025 Earnings ReportConference Call ResourcesConference Call AudioConference Call TranscriptPress Release (8-K)Quarterly Report (10-Q)Earnings HistoryCompany ProfilePowered by DURECT Q1 2024 Earnings Call TranscriptProvided by QuartrMay 13, 2024 ShareLink copied to clipboard.There are 6 speakers on the call. Operator00:00:00Greetings, and welcome to the DURECT Corporation First Quarter 2024 Earnings Conference Call. At this time, all participants are in a listen only mode. A brief question and answer session will follow the formal presentation. As a reminder, this conference is being recorded. It is now my pleasure to introduce your host, Tim Papp, Chief Financial Officer. Operator00:00:30Thank you, sir. You may begin. Speaker 100:00:32Good afternoon, and welcome to Direct Corporation's Q1 2024 earnings conference call. This is Tim Papp, Chief Financial Officer of Direct. Before we begin, I would like to remind you of our Safe Harbor statement. During the course of this call, we may make forward looking statements regarding DURECT's products and development, expected product benefits, our development plans, future clinical trials or projected financial results. These forward looking statements involve risks and uncertainties that can cause actual results to differ materially from those in such forward looking statements. Speaker 100:01:04Further information regarding these and other risks can be found in our SEC filings, including our 10 ks and 10 Qs under the heading Risk Factors. To begin, I would like to review our Q1 2024 financial results. Total revenues in the Q1 of 2024 were $1,800,000 compared to $2,100,000 in 2023. 2024 revenues were lower primarily due to lower revenues from feasibility agreements as well as lower revenue from product sales. R and D expense was $4,100,000 in the Q1 of 2024 compared to $8,600,000 for the prior year. Speaker 100:01:41The decrease was primarily due to lower clinical trial related expenses as we substantially completed the AFFIRM trial and lower employee related costs. SG and A expenses were $3,100,000 in the Q1 of 2024 compared to $4,100,000 for the prior year. The decrease was primarily due to lower market research expenses, lower patent expenses as well as lower employee costs. As of March 31, 2024, we had cash and investments of $21,600,000 as compared to $29,800,000 at December 31, 2023. And our cash burn for the Q1 was $8,900,000 excluding net proceeds of approximately $650,000 from ATM financing. Speaker 100:02:24We believe our cash on hand is sufficient to fund operations through the end of 2024. Now I would like to turn the call over to Jim for a business update. Speaker 200:02:34Thank you, Tim. Hello, everyone, and thank you for joining us today. We're making good progress towards initiating our Phase 3 clinical trial for larcicosterol in alcohol associated hepatitis. Through a Type C meeting with the FDA, we've received feedback that a single Phase 3 trial, if successful, could be sufficient to support an NDA filing in Ah. We are in the process of designing a pivotal trial that incorporates the FDA feedback and the key learnings from our AFFIRM Phase 2b trial. Speaker 200:03:08We are continuing to analyze the clinical data from Affirm and believe the data provide a strong foundation for the design of our registrational Phase 3 trial. We look forward to sharing additional data analysis and the details of the protocol in an update later this year. We're also excited that the AFERM data has been accepted for an oral late breaker presentation at the upcoming EASL conference in June of this year. This will be our first opportunity to share the Affirm data with the medical community at a scientific meeting. We are very encouraged by the continued enthusiasm of the hepatology thought leaders and key opinion leaders for the Afirm results and their recognition of our sequestered potential to provide a clinically meaningful survival benefit in Ah patients. Speaker 200:04:00As a brief reminder, AFFIRM was a placebo controlled, double blind, multinational study with 2 active arms of 30 milligrams 90 milligrams of larcicosterol and a placebo arm of approximately 100 patients each. In total, we randomized 307 patients with severe Ah from a global network of clinical sites. Our sites included renowned liver centers in the United States, Australia, the EU and the UK. And we have beyond our working with some of the world's preeminent thought leaders in Ah. The top line results and the key secondary endpoint of mortality at 90 days showed a 41% reduction with the 30 milligram dose of Lexucosterol and a 35% reduction with the 90 milligram dose of Lexucosterol as compared with placebo. Speaker 200:04:51We also reported a numerical improvement in the primary endpoint of reduction in mortality or liver transplant at 90 days. So neither the primary or key secondary endpoint results achieved statistical significance. Even more impressive results were observed in the U. S. Population, which comprised 3 quarters of the total enrollment in Affirm and that was 232 out of the 307 patients. Speaker 200:05:15In the U. S. Patients, we saw reductions in the 90 day mortality of 57% 58% for the 30 90 milligram arms respectively as compared with placebo. Although not part of the original statistical analysis plan, the P values for these results were both approximately 0.01. Very importantly, clarsicocereol exhibited an excellent safety profile with no serious adverse events in either arm and greater than 20% reductions in the number of treatment emergent adverse events for both active arms in these severely ill patients. Speaker 200:05:52Ultimately, these clinically meaningful reductions in mortality, coupled with reduction in adverse events in these severely ill patients reinforce the compelling risk reward proposition for larcicoasterol. We continue to believe that the AFFIRM data provide compelling evidence that larcicoasterol could represent a safe and effective therapy with life saving potential for Ah patients. There are no approved therapies for Ah today. So if varsugosterol meets our expectation in the Phase 3 and we are able to gain approval, it would likely be the 1st FDA approved treatment for this disease and establish a new standard of care. Ah is the cause of more than 160,000 hospitalizations each year in the United States and with a 90 day mortality rate of approximately 30% is responsible for tens of thousands of deaths each year. Speaker 200:06:49In addition to its high mortality rate, Ah represents a significant cost to the U. S. Healthcare system. Hospitalizations attributed to Ah incur charges between $67,000,000 to $180,000 per patient, a total charge to hospitals of approximately $10,000,000,000 annually. As a result, Larchikosteo represents a potential blockbuster opportunity in the U. Speaker 200:07:13S. Alone and could simultaneously provide overall cost savings to the healthcare system. We would now like to take any questions you may have. Operator00:07:25Thank you. We will now be conducting a question and answer Our first question comes from Frank Zisbois with Oppenheimer and Co. Please proceed with your question. Speaker 300:07:59Hi, thanks for the question. I was just wondering if you could share anything around EASL late break. Is there should we be expecting new data? Or can you share anything about kind of progress with the FDA or just any thoughts on EVO would be helpful? Thank you. Speaker 200:08:20Yes, sure, Frank. First of all, good to catch up. Yes, the late breaker is the first time we'll have an opportunity to present the data from a firm. And so we'll be focusing on a lot of what's understood today. We won't be giving additional FDA updates beyond what we've just talked about at this call. Speaker 200:08:43But it certainly is quite an honor to receive an oral late breaker opportunity here and to present the data. They're very important data. And as well, I believe we should be presenting some additional data this fall at the AASLD meeting as we continue to learn more and more about the results from this trial. Speaker 300:09:10Okay. That's helpful. And then in terms of the patient severity, maybe the MELD scores, is there I know there's moderate to severe was kind of a thought. Has there ever been a thought of the milder patient population? Or is that patient population just not necessarily going to the hospital? Speaker 300:09:28Or just any thoughts about Speaker 200:09:32the milder conditions? Thank you. Yes. We certainly we look at all and I believe this drug will have an opportunity to help all. We certainly saw that tendency in the Phase 2a as a smaller trial, but we treated both moderate and severe patients in that. Speaker 200:09:49But our focus right now has been on the severe patients, patients with a MELD score of 21 to 30. To put that in perspective, you have a MELD of 21 that means you got about 20% chance of dying in the next 90 days. And if it's now the 30, you have about a 60% chance of dying. So they're very ill. That being said, moderates still have 7% to 10% to 15% to 20% chance of dying. Speaker 200:10:12So they're not they're in a dangerous position as well. And so a lot of the patients in the hospital are moderate patients. But with the objective here and the ultimate goal is to get this product approved with the opportunity to hopefully save lives. That's what we're focusing on with this molecule. And we think the fastest way to do that is to stay in the severe patient population now with further analysis, we're seeing information that helps really understand things globally as well. Speaker 200:10:48So all that being said, we feel very good about where we're going with the severes. I think eventually if the product is approved for severe, we will roll it out for use in moderates as well with additional studies. Speaker 300:11:03Thank you. Operator00:11:07Our next question comes from Karl Brines with Northland Capital Markets. Please proceed with your question. Speaker 400:11:15Thanks for the question. Understanding that you're yet to define the pivotal study in terms of the trial design, do you have any target in terms of initiation date internally or anything that you can disclose at this juncture? Thanks. Speaker 200:11:30Yes. We'll be breaking that out as the year unfolds. But we are working on the protocol right now. The hope would be to start it, get it underway as soon as we possibly can. So I mean that's every month that goes by more patients are at risk of dying from this disease. Speaker 200:11:48And so we're doing everything we can to get the opportunity lined up from a business perspective to be able to do that. And so that's our entire focus. Great. Thanks. Sure. Operator00:12:06Our next question comes from Ed Arce with H. C. Wainwright. Please proceed with your question. Speaker 500:12:13Hi, afternoon, everyone. This is Thomas here asking a couple of questions for Ed. Thank you very much for taking your questions. So first, can you discuss some preliminary thoughts on the trial design key elements of the Phase 3 study, especially efficacy endpoint and perhaps any parallels or contrast between the Phase 3 study and the Phase 2 study? Speaker 200:12:39We absolutely look forward to doing that. We're not going to do it right now because we're still finalizing that protocol. But once we are, we'll light it all up. And we're doing it with the learnings that have come from Affirm. So we'll be able to, Speaker 500:12:51I think, quite logically layout Speaker 200:12:54what we're looking at, the number of patients, the way the trial will be designed and administered. There certainly are some key lessons learned from Affirm that I think will help make this a very efficient trial and with an opportunity to amplify the potential efficacy. And as I said, get this thing going, get it on the market as soon as we can. Speaker 500:13:22Understood. And then perhaps the other key elements with the Phase III study perhaps is the way to finance this study. Can you discuss what are some options and perhaps the timing of any such decisions to work into? Yes. Speaker 200:13:42We certainly have a number of options in front of us and there's a large effort that Tim is undertaking. So perhaps Tim, maybe I'll let you jump in on that one. Speaker 100:13:53Yes, absolutely. I don't think we're doing anything that is unexpected at this point. We obviously will need additional financing to complete a Phase 3. And that can come from a variety of sources, as Jim referred to, whether it's business development or the financial markets. So we can't give you any specifics on the details at this point around timing or what that might look like. Speaker 100:14:22But rest assured, we're undertaking the appropriate processes to find that financing. Speaker 500:14:32Understood. Thank you again for the kind of questions. We look forward to the EASL presentation and then with the Phase III trial design later this year. Speaker 200:14:41Absolutely. Thank you. Operator00:14:45It appears that there are no further questions at this time. I would now like turn the floor back over to Jim Brown for closing comments. Speaker 200:14:52Yes. With that, I just want to thank you all for your attention and your time. And as always, please feel Speaker 300:14:57free to reach out. Speaker 200:14:58We look forward to catching up with all of you. Take care. Bye. Operator00:15:03This concludes today's teleconference. You may disconnect your lines at this time. Thank you for your participation.Read morePowered by Conference Call Audio Live Call not available Earnings Conference CallDURECT Q1 202400:00 / 00:00Speed:1x1.25x1.5x2x Earnings DocumentsPress Release(8-K)Quarterly report(10-Q) DURECT Earnings HeadlinesStockNews.com Initiates Coverage on DURECT (NASDAQ:DRRX)April 20, 2025 | americanbankingnews.comOppenheimer Sticks to Its Buy Rating for Durect (DRRX)March 30, 2025 | markets.businessinsider.comDOGE officially begins retirement transformationElon Musk's Department of Government Efficiency ("DOGE") just announced the first-ever "fully digital retirement" process . This fired the starting gun on the biggest economic transformation in American history.April 26, 2025 | Altimetry (Ad)Here's Why We're A Bit Worried About DURECT's (NASDAQ:DRRX) Cash Burn SituationMarch 28, 2025 | finance.yahoo.comDURECT Corporation (NASDAQ:DRRX) Q4 2024 Earnings Call TranscriptMarch 28, 2025 | msn.comDURECT outlines $20M Phase 3 trial for larsucosterol in alcohol-associated hepatitisMarch 27, 2025 | msn.comSee More DURECT Headlines Get Earnings Announcements in your inboxWant to stay updated on the latest earnings announcements and upcoming reports for companies like DURECT? Sign up for Earnings360's daily newsletter to receive timely earnings updates on DURECT and other key companies, straight to your email. Email Address About DURECTDURECT (NASDAQ:DRRX), a biopharmaceutical company, develops medicines based on its epigenetic regulator program. The company's lead product larsucosterol (DUR-928), an endogenous, orally bioavailable small molecule that is in Phase IIb clinical trial to play a regulatory role in lipid metabolism, stress and inflammatory responses, and cell death and survival to treat alcohol-associated hepatitis, as well as completed Phase Ib clinical trial to treat patients with nonalcoholic steatohepatitis. It also offers ALZET product line that consists of osmotic pumps and accessories used for research in mice, rats, and other laboratory animals. In addition, the company offers POSIMIR, a post-surgical pain product to deliver bupivacaine over three days in adults; and Methydur to treat attention deficit hyperactivity disorder. It markets and sells its ALZET lines through direct sales force in the United States, as well as through a network of distributors in other countries. The company has strategic collaboration and other agreements with Virginia Commonwealth University Intellectual Property Foundation; Indivior UK Ltd.; and Innocoll Pharmaceuticals Limited. DURECT Corporation was incorporated in 1998 and is headquartered in Cupertino, California.View DURECT ProfileRead more More Earnings Resources from MarketBeat Earnings Tools Today's Earnings Tomorrow's Earnings Next Week's Earnings Upcoming Earnings Calls Earnings Newsletter Earnings Call Transcripts Earnings Beats & Misses Corporate Guidance Earnings Screener Earnings By Country U.S. Earnings Reports Canadian Earnings Reports U.K. Earnings Reports Latest Articles Markets Think Robinhood Earnings Could Send the Stock UpIs the Floor in for Lam Research After Bullish Earnings?Market Anticipation Builds: Joby Stock Climbs Ahead of EarningsIs Intuitive Surgical a Buy After Volatile Reaction to Earnings?Seismic Shift at Intel: Massive Layoffs Precede Crucial EarningsRocket Lab Lands New Contract, Builds Momentum Ahead of EarningsAmazon's Earnings Could Fuel a Rapid Breakout Upcoming Earnings Cadence Design Systems (4/28/2025)Welltower (4/28/2025)Waste Management (4/28/2025)AstraZeneca (4/29/2025)Mondelez International (4/29/2025)PayPal (4/29/2025)Starbucks (4/29/2025)DoorDash (4/29/2025)Honeywell International (4/29/2025)Regeneron Pharmaceuticals (4/29/2025) Get 30 Days of MarketBeat All Access for Free Sign up for MarketBeat All Access to gain access to MarketBeat's full suite of research tools. 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There are 6 speakers on the call. Operator00:00:00Greetings, and welcome to the DURECT Corporation First Quarter 2024 Earnings Conference Call. At this time, all participants are in a listen only mode. A brief question and answer session will follow the formal presentation. As a reminder, this conference is being recorded. It is now my pleasure to introduce your host, Tim Papp, Chief Financial Officer. Operator00:00:30Thank you, sir. You may begin. Speaker 100:00:32Good afternoon, and welcome to Direct Corporation's Q1 2024 earnings conference call. This is Tim Papp, Chief Financial Officer of Direct. Before we begin, I would like to remind you of our Safe Harbor statement. During the course of this call, we may make forward looking statements regarding DURECT's products and development, expected product benefits, our development plans, future clinical trials or projected financial results. These forward looking statements involve risks and uncertainties that can cause actual results to differ materially from those in such forward looking statements. Speaker 100:01:04Further information regarding these and other risks can be found in our SEC filings, including our 10 ks and 10 Qs under the heading Risk Factors. To begin, I would like to review our Q1 2024 financial results. Total revenues in the Q1 of 2024 were $1,800,000 compared to $2,100,000 in 2023. 2024 revenues were lower primarily due to lower revenues from feasibility agreements as well as lower revenue from product sales. R and D expense was $4,100,000 in the Q1 of 2024 compared to $8,600,000 for the prior year. Speaker 100:01:41The decrease was primarily due to lower clinical trial related expenses as we substantially completed the AFFIRM trial and lower employee related costs. SG and A expenses were $3,100,000 in the Q1 of 2024 compared to $4,100,000 for the prior year. The decrease was primarily due to lower market research expenses, lower patent expenses as well as lower employee costs. As of March 31, 2024, we had cash and investments of $21,600,000 as compared to $29,800,000 at December 31, 2023. And our cash burn for the Q1 was $8,900,000 excluding net proceeds of approximately $650,000 from ATM financing. Speaker 100:02:24We believe our cash on hand is sufficient to fund operations through the end of 2024. Now I would like to turn the call over to Jim for a business update. Speaker 200:02:34Thank you, Tim. Hello, everyone, and thank you for joining us today. We're making good progress towards initiating our Phase 3 clinical trial for larcicosterol in alcohol associated hepatitis. Through a Type C meeting with the FDA, we've received feedback that a single Phase 3 trial, if successful, could be sufficient to support an NDA filing in Ah. We are in the process of designing a pivotal trial that incorporates the FDA feedback and the key learnings from our AFFIRM Phase 2b trial. Speaker 200:03:08We are continuing to analyze the clinical data from Affirm and believe the data provide a strong foundation for the design of our registrational Phase 3 trial. We look forward to sharing additional data analysis and the details of the protocol in an update later this year. We're also excited that the AFERM data has been accepted for an oral late breaker presentation at the upcoming EASL conference in June of this year. This will be our first opportunity to share the Affirm data with the medical community at a scientific meeting. We are very encouraged by the continued enthusiasm of the hepatology thought leaders and key opinion leaders for the Afirm results and their recognition of our sequestered potential to provide a clinically meaningful survival benefit in Ah patients. Speaker 200:04:00As a brief reminder, AFFIRM was a placebo controlled, double blind, multinational study with 2 active arms of 30 milligrams 90 milligrams of larcicosterol and a placebo arm of approximately 100 patients each. In total, we randomized 307 patients with severe Ah from a global network of clinical sites. Our sites included renowned liver centers in the United States, Australia, the EU and the UK. And we have beyond our working with some of the world's preeminent thought leaders in Ah. The top line results and the key secondary endpoint of mortality at 90 days showed a 41% reduction with the 30 milligram dose of Lexucosterol and a 35% reduction with the 90 milligram dose of Lexucosterol as compared with placebo. Speaker 200:04:51We also reported a numerical improvement in the primary endpoint of reduction in mortality or liver transplant at 90 days. So neither the primary or key secondary endpoint results achieved statistical significance. Even more impressive results were observed in the U. S. Population, which comprised 3 quarters of the total enrollment in Affirm and that was 232 out of the 307 patients. Speaker 200:05:15In the U. S. Patients, we saw reductions in the 90 day mortality of 57% 58% for the 30 90 milligram arms respectively as compared with placebo. Although not part of the original statistical analysis plan, the P values for these results were both approximately 0.01. Very importantly, clarsicocereol exhibited an excellent safety profile with no serious adverse events in either arm and greater than 20% reductions in the number of treatment emergent adverse events for both active arms in these severely ill patients. Speaker 200:05:52Ultimately, these clinically meaningful reductions in mortality, coupled with reduction in adverse events in these severely ill patients reinforce the compelling risk reward proposition for larcicoasterol. We continue to believe that the AFFIRM data provide compelling evidence that larcicoasterol could represent a safe and effective therapy with life saving potential for Ah patients. There are no approved therapies for Ah today. So if varsugosterol meets our expectation in the Phase 3 and we are able to gain approval, it would likely be the 1st FDA approved treatment for this disease and establish a new standard of care. Ah is the cause of more than 160,000 hospitalizations each year in the United States and with a 90 day mortality rate of approximately 30% is responsible for tens of thousands of deaths each year. Speaker 200:06:49In addition to its high mortality rate, Ah represents a significant cost to the U. S. Healthcare system. Hospitalizations attributed to Ah incur charges between $67,000,000 to $180,000 per patient, a total charge to hospitals of approximately $10,000,000,000 annually. As a result, Larchikosteo represents a potential blockbuster opportunity in the U. Speaker 200:07:13S. Alone and could simultaneously provide overall cost savings to the healthcare system. We would now like to take any questions you may have. Operator00:07:25Thank you. We will now be conducting a question and answer Our first question comes from Frank Zisbois with Oppenheimer and Co. Please proceed with your question. Speaker 300:07:59Hi, thanks for the question. I was just wondering if you could share anything around EASL late break. Is there should we be expecting new data? Or can you share anything about kind of progress with the FDA or just any thoughts on EVO would be helpful? Thank you. Speaker 200:08:20Yes, sure, Frank. First of all, good to catch up. Yes, the late breaker is the first time we'll have an opportunity to present the data from a firm. And so we'll be focusing on a lot of what's understood today. We won't be giving additional FDA updates beyond what we've just talked about at this call. Speaker 200:08:43But it certainly is quite an honor to receive an oral late breaker opportunity here and to present the data. They're very important data. And as well, I believe we should be presenting some additional data this fall at the AASLD meeting as we continue to learn more and more about the results from this trial. Speaker 300:09:10Okay. That's helpful. And then in terms of the patient severity, maybe the MELD scores, is there I know there's moderate to severe was kind of a thought. Has there ever been a thought of the milder patient population? Or is that patient population just not necessarily going to the hospital? Speaker 300:09:28Or just any thoughts about Speaker 200:09:32the milder conditions? Thank you. Yes. We certainly we look at all and I believe this drug will have an opportunity to help all. We certainly saw that tendency in the Phase 2a as a smaller trial, but we treated both moderate and severe patients in that. Speaker 200:09:49But our focus right now has been on the severe patients, patients with a MELD score of 21 to 30. To put that in perspective, you have a MELD of 21 that means you got about 20% chance of dying in the next 90 days. And if it's now the 30, you have about a 60% chance of dying. So they're very ill. That being said, moderates still have 7% to 10% to 15% to 20% chance of dying. Speaker 200:10:12So they're not they're in a dangerous position as well. And so a lot of the patients in the hospital are moderate patients. But with the objective here and the ultimate goal is to get this product approved with the opportunity to hopefully save lives. That's what we're focusing on with this molecule. And we think the fastest way to do that is to stay in the severe patient population now with further analysis, we're seeing information that helps really understand things globally as well. Speaker 200:10:48So all that being said, we feel very good about where we're going with the severes. I think eventually if the product is approved for severe, we will roll it out for use in moderates as well with additional studies. Speaker 300:11:03Thank you. Operator00:11:07Our next question comes from Karl Brines with Northland Capital Markets. Please proceed with your question. Speaker 400:11:15Thanks for the question. Understanding that you're yet to define the pivotal study in terms of the trial design, do you have any target in terms of initiation date internally or anything that you can disclose at this juncture? Thanks. Speaker 200:11:30Yes. We'll be breaking that out as the year unfolds. But we are working on the protocol right now. The hope would be to start it, get it underway as soon as we possibly can. So I mean that's every month that goes by more patients are at risk of dying from this disease. Speaker 200:11:48And so we're doing everything we can to get the opportunity lined up from a business perspective to be able to do that. And so that's our entire focus. Great. Thanks. Sure. Operator00:12:06Our next question comes from Ed Arce with H. C. Wainwright. Please proceed with your question. Speaker 500:12:13Hi, afternoon, everyone. This is Thomas here asking a couple of questions for Ed. Thank you very much for taking your questions. So first, can you discuss some preliminary thoughts on the trial design key elements of the Phase 3 study, especially efficacy endpoint and perhaps any parallels or contrast between the Phase 3 study and the Phase 2 study? Speaker 200:12:39We absolutely look forward to doing that. We're not going to do it right now because we're still finalizing that protocol. But once we are, we'll light it all up. And we're doing it with the learnings that have come from Affirm. So we'll be able to, Speaker 500:12:51I think, quite logically layout Speaker 200:12:54what we're looking at, the number of patients, the way the trial will be designed and administered. There certainly are some key lessons learned from Affirm that I think will help make this a very efficient trial and with an opportunity to amplify the potential efficacy. And as I said, get this thing going, get it on the market as soon as we can. Speaker 500:13:22Understood. And then perhaps the other key elements with the Phase III study perhaps is the way to finance this study. Can you discuss what are some options and perhaps the timing of any such decisions to work into? Yes. Speaker 200:13:42We certainly have a number of options in front of us and there's a large effort that Tim is undertaking. So perhaps Tim, maybe I'll let you jump in on that one. Speaker 100:13:53Yes, absolutely. I don't think we're doing anything that is unexpected at this point. We obviously will need additional financing to complete a Phase 3. And that can come from a variety of sources, as Jim referred to, whether it's business development or the financial markets. So we can't give you any specifics on the details at this point around timing or what that might look like. Speaker 100:14:22But rest assured, we're undertaking the appropriate processes to find that financing. Speaker 500:14:32Understood. Thank you again for the kind of questions. We look forward to the EASL presentation and then with the Phase III trial design later this year. Speaker 200:14:41Absolutely. Thank you. Operator00:14:45It appears that there are no further questions at this time. I would now like turn the floor back over to Jim Brown for closing comments. Speaker 200:14:52Yes. With that, I just want to thank you all for your attention and your time. And as always, please feel Speaker 300:14:57free to reach out. Speaker 200:14:58We look forward to catching up with all of you. Take care. Bye. Operator00:15:03This concludes today's teleconference. You may disconnect your lines at this time. Thank you for your participation.Read morePowered by