Q4 2024 DURECT Corp Earnings Call
A question and answer session will follow the formal presentation.
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Tim: It is now my pleasure to introduce Tim <unk> Chief Financial Officer.
Tim: Good afternoon, and welcome to direct Corporation's fourth quarter 2024 earnings Conference call. This is Tim <unk>, Chief Financial Officer of Durect.
Tim: 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 direct products and development expected product benefits, our development plans future clinical trials or projected financial results.
Tim: These forward looking statements involve risks and uncertainties that can cause actual results to differ materially from those in such forward looking statements.
Greetings and welcome to the direct Corporation fourth quarter and full year 2024 earnings conference call. At this time I'll pause here all participants are in a listen only mode.
Tim: Further information regarding these and other risks can be found in our SEC filings, including our 10-K and 10-Qs under the heading risk factors.
[music].
Tim: To begin I would like to review, our fourth quarter and full year 2024 financial results.
Question and answer session will follow the formal presentation.
Greetings and welcome to the direct Corporation fourth quarter and full year 2024 earnings conference call. At this time, all participants on a listen only mode.
If anyone should require operator assistance. Please press star zero on your telephone keypad.
Tim: The following financial information relates solely to our continuing operations and therefore it does not include the operations of our <unk> product line, which we sold in the fourth quarter of 2024.
As a reminder, this conference is being recorded.
Question and answer session will follow the formal presentation.
Speaker Change: No my pleasure to introduce <unk> Chief Financial Officer.
If anyone should require operator assistance. Please press star zero on your telephone keypad.
Tim: Total revenues in 2024 were $2 million compared with $2 6 million in 2023 and half a million dollars for the fourth quarter of 2004 compared to 0.9 million for the prior year.
Tim: Good afternoon, and welcome to Durect corporations fourth quarter 2024 earnings Conference call. This is Tim <unk>, Chief financial officer of direct.
As a reminder, this conference is being recorded.
No my pleasure to introduce <unk> Chief Financial Officer.
Tim: 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 direct products and development expected product benefits, our development plans future clinical trials or projected financial results.
Tim: 2024 revenues were lower due to lower earn out revenue from <unk> lower revenue recognized from feasibility agreements with other companies and lower sales of excipient.
Good afternoon, and welcome to direct Corporation's fourth quarter 2024 earnings Conference call. This is Tim <unk>, 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 direct products and development expected product benefits, our development plans future clinical trials or projected financial results.
Tim: R&D expense was $10 4 million in 2024 as compared to $29 4 million for the prior year and $1 9 million for the fourth quarter compared with $5 6 million for the prior year 2023.
Tim: These forward looking statements involve risks and uncertainties that can cause actual results to differ materially from those in such forward looking statements.
Tim: Further information regarding these and other risks can be found in our SEC filings, including our 10-K and 10-Qs under the heading risk factors.
Tim: The decreases were primarily due to lower clinical trial related expenses following completion of the affirm trial.
These forward looking statements involve risks and uncertainties that could cause actual results to differ materially from those in such forward looking statements.
Tim: We also experienced lower contract manufacturing expenses and other external expenses as well as lower employee related costs.
Tim: To begin I would like to review, our fourth quarter and full year 2024 financial results.
Further information regarding these and other risks can be found in our SEC filings, including our 10-K and 10-Qs under the heading risk factors.
Tim: The following financial information relates solely to our continuing operations and therefore it does not include the operations of our all of that product line, which we sold in the fourth quarter of 2024.
Tim: SG&A expenses were $10 million in 2024, as compared to $12 7 million for the prior year and $2 million for the fourth quarter of 24, compared with $2 2 million for the prior year. These decreases were primarily due to lower employee expenses as well as lower consulting patent and audit related expenses.
To begin I would like to review, our fourth quarter and full year 2024 financial results.
Tim: Total revenues in 2024 were $2 million compared with $2 6 million in 2023 and half a million for the fourth quarter of 24 compared to 0.9 million for the prior year.
Following financial information relates solely to our continuing operations and therefore it does not include the operations of our all of that product line, which we sold in the fourth quarter of 2024.
Tim: As of the end of 2024, we had cash and investments of $12 million as compared to $29 8 million at December 31 2023.
Total revenues in 2024 were $2 million compared with $2 6 million in 2023 and half a million for the fourth quarter of 24 compared to 0.9 million for the prior year.
Tim: 2024 revenues were lower due to lower revenue from and Debbie you are lower revenue recognized from feasibility agreements with other companies and lower sales of excipient.
Tim: We believe our cash on hand is sufficient to fund operations through the third quarter of 2025.
Tim: R&D expense was $10 4 million in 2024 as compared to $29 4 million for the prior year and $1 9 million for the fourth quarter compared with $5 6 million for the prior year 2023.
2024 revenues were lower due to lower revenue from India. You are lower revenue recognized from feasibility agreements with other companies and lower sales of excipient.
Tim: As I previously mentioned, we completed the sale of the <unk> product line during the fourth quarter of 2024, we used a portion of the proceeds to repay the remainder of our term loan and are now debt free.
R&D expense was $10 4 million in 2024 as compared to $29 4 million for the prior year and $1 9 million for the fourth quarter compared with $5 6 million for the prior year.
Tim: This transaction both strengthened our balance sheet and was consistent with our corporate strategy of streamlining our operations to focus on developing our CECO sterile for alcohol associated hepatitis.
Tim: The decreases were primarily due to lower clinical trial related expenses following completion of the affirmed trial.
Tim: We also experienced lower contract manufacturing expenses and other external expenses as well as lower employee related costs.
23.
Tim: We are continuing to explore all options for funding the clinical development of <unk>, newco sterile, including strategic partnerships and financing through the capital markets.
The decreases were primarily due to lower clinical trial related expenses following completion of the affirmed trial.
Tim: SG&A expenses were $10 million in 2024, as compared to $12 7 million for the prior year and $2 million for the fourth quarter of 24, compared with $2 2 million for the prior year. These decreases were primarily due to lower employee expenses as well as lower consulting patent and audit related expenses.
We also experienced lower contract manufacturing expenses and other external expenses as well as lower employee related costs.
Jim: Now I would like to turn the call over to Jim for a business update.
Jim: Thank you Tim.
Jim: Hello, everyone. Thank you for joining us today for our fourth quarter 2024 update.
Speaker Change: SG&A expenses were $10 million in 2024, as compared to $12 7 million for the prior year and $2 million for the fourth quarter of 24, compared with $2 2 million for the prior year. These decreases were primarily due to lower employee expenses as well as lower consulting patent and audit related expenses.
Jim: I would like to use our call today to provide some context for the rare opportunity we have here at Durect.
Tim: As of the end of 2024, we had cash and investments of $12 million as compared to $29 8 million at December 31 2023.
Jim: Our lead asset <unk> for the treatment of alcohol associated hepatitis.
Tim: We believe our cash on hand is sufficient to fund operations through the third quarter of 2025.
Jim: Lifesaving potential for a disease with no approved therapy.
Tim: As of the end of 2024, we had cash and investments of $12 million as compared to $29 8 million at December 31 2023.
Jim: About 30% of the 164000 U S patients hospitalized due to H will die within 90 days of hospitalization.
Tim: As I previously mentioned, we completed the sale of all of that product line. During the fourth quarter of 2024, we used a portion of the proceeds to repay the remainder of our term loan and are now debt free.
Tim: We believe our cash on hand is sufficient to fund operations through the third quarter of 2025.
Jim: This means a H is responsible for greater than 40000 deaths each year in the U S.
Tim: As I previously mentioned, we completed the sale of the all that product line during the fourth quarter of 2024, we used a portion of the proceeds to repay the remainder of our term loan and are now debt free.
Tim: This transaction both strengthened our balance sheet and was consistent with our corporate strategy of streamlining our operations to focus on developing Lars it does sterile for alcohol associated hepatitis.
Jim: More than 100 people each day.
Jim: This is roughly equivalent to the number of deaths from breast cancer or car accidents.
Tim: We are continuing to explore all options for funding the clinical development of Zika sterile, including strategic partnerships and financing through the capital markets.
Tim: This transaction both strengthened our balance sheet and was consistent with our corporate strategy of streamlining our operations to focus on developing our CECO sterile for alcohol associated hepatitis.
Jim: But the awareness of this disease remains limited.
Jim: We believe we have a potential solution. They can save a large portion of these patients.
Jim: Now I would like to turn the call over to Jim for a business update.
Tim: We are continuing to explore all options for funding the clinical development of large sukkoth, Darryl, including strategic partnerships and financing through the capital markets.
Jim: Thank you Kim.
Jim: Hello, everyone. Thank you for joining us today for our fourth quarter 2024 update.
Jim: In our phase <unk> trial, we saw nearly 60% reductions in mortality with both doses of marsico sterile compared with placebo and the 232 U S patients.
Jim: Now I would like to turn the call over to Jim for a business update.
Jim: I'd like to use our call today to provide some context for the rare opportunity we have here at Durect.
Jim: Thank you Tim.
Jim: Hello, everyone. Thank you for joining us today for our fourth quarter 2024 update.
Jim: This represents approximately 75% of the total patients enrolled in this study.
Jim: Our lead asset marsico sterile for the treatment of alcohol associated hepatitis.
Jim: These strong results have garnered significant attention in the medical and scientific community.
Tim: I'd like to use our call today to provide some context for the rare opportunity we have here at Durect.
Jim: That's shown lifesaving potential for disease with no approved therapy.
Jim: Delighted by the FDA granting <unk> breakthrough therapy designation.
Jim: About 30% of the 164000 U S patients hospitalized due to a H will die within 90 days of hospitalization.
Tim: Our lead asset marsico sterile for the treatment of alcohol associated hepatitis.
Jim: New England Journal of Medicine's publication of our phase <unk> results in any JM evidence <unk>.
Tim: Lifesaving potential for a disease with no approved therapy.
Jim: And the late breaker presentation of our topline data at <unk> last year.
Jim: This means a H is responsible for greater than 40000 deaths each year in the U S.
Tim: About 30% of the 164000 U S patients hospitalized due to a H will die within 90 days of hospitalization.
Jim: We are committed to developing <unk> to provide hope for AAV patients for their families and loved ones and for the medical professionals, who have no effective treatments to offer these patients.
Jim: More than 100 people each day.
Tim: This means a H is responsible for greater than 40000 deaths each year in the U S.
Jim: This is roughly equivalent to the number of deaths from breast cancer or car accidents.
Jim: Our sole focus as a company is to secure the funding to complete our phase III trial, whether to financing or business development.
Jim: But the awareness of this disease remains limited.
Tim: More than 100 people each day.
Jim: We believe we have a potential solution. They can save a large portion of these patients.
Tim: This is roughly equivalent to the number of deaths from breast cancer or car accidents.
Jim: With such funding, we are ready to initiate a phase III trial and once underway, we expect to be able to report topline data in approximately two years.
Tim: But the awareness of this disease remains limited.
Jim: In our phase two B trial, we saw nearly 60% reductions in mortality with both doses up our so called sterile compared with placebo and the 232 U S patients.
Tim: We believe we have a potential solution. They can save a large portion of these patients.
Jim: We firmly believe that our CECO sterol represents the best hope for a breakthrough in the treatment of H and look forward to the opportunity to demonstrate this in our phase III trial.
Jim: This represents approximately 75% of the total patients enrolled in this study.
Tim: In our phase two B trial, we saw nearly 60% reductions in mortality with both doses up archducal sterile compared with placebo and the 232 U S patients.
Jim: These strong results have garnered significant attention in the medical and scientific community.
Jim: We would now like to take any questions that you may have.
Speaker Change: Highlighted by the FDA granting vasu cristero breakthrough therapy designation.
Tim: This represents approximately 75% of the total patients enrolled in this study.
Speaker Change: Ladies and gentlemen, if you would like to ask a question. Please press star one on your telephone keypad and a confirmation tone will indicate your line is in the question queue.
Speaker Change: The New England Journal of Medicine's publication of our Phase <unk> results in any J M evidence and a late breaker presentation of our topline data at <unk> last year.
Tim: These strong results have garnered significant attention in the medical and scientific community.
Tim: Delighted by the FDA granting vasu cristero breakthrough therapy designation.
Jim: You May press Star two if you would like to remove your question from the queue.
Speaker Change: We are committed to developing next shoe called sterile to provide hope for AAV patients.
Tim: New England Journal of Medicine publication of our Phase <unk> results in any J M evidence and the late breaker presentation of our topline data at <unk> last year.
Jim: For participants using speaker equipment, and David necessary to pick up your handset before pressing the star keys.
Speaker Change: Or their families and loved ones and for the medical professionals, who have no effective treatments to offer these patients.
Speaker Change: And our first question comes from the line of French law versus Aqua with Oppenheimer and company. Please proceed.
Tim: We are committed to developing next juco sterile to provide hope for AAV patients for their families and loved ones and for the medical professionals, who have no effective treatments to offer these patients.
Speaker Change: Our sole focus as a company is to secure the funding to complete our phase III trials, whether to financing or business development.
French law: Alright, Thanks, guys. Just a couple quick ones here I was just wondering if you.
Speaker Change: With such funding, we are ready to initiate a phase III trial and once underway, we expect to be able to report top line data in approximately two years.
French law: We have an idea you can share how much you think is trial.
Jim: Our sole focus as a company is to secure the funding to complete our phase III trials, whether to financing or business development.
French law: Costume.
French law: And then I'll have a follow up.
French law: Sure Yeah, I think right now we're estimating it would be about $20 million. There are some things that we are considering it might make it a little bit under that but that's approximately what it would cost.
Speaker Change: We firmly believe that Laura Chico sterol represents the best hope for a breakthrough in the treatment of BPH and look forward to the opportunity to demonstrate this in our phase III trial.
Jim: With such funding, we are ready to initiate a phase III trial and once underway, we expect to be able to report top line data in approximately two years.
Speaker Change: We would now like to take any questions that you may have.
Jim: We firmly believe that Laura Chico sterol represents the best hope for a breakthrough in the treatment of H and look forward to the opportunity to demonstrate this in our phase III trial.
French law: And two years tended to data is that is that right right yes.
Speaker Change: Ladies and gentlemen, if you would like to ask a question. Please press star one on your telephone keypad and a confirmation tone will indicate your line is in the question queue.
French law: Okay, Great and then is there any just quick chance for you to kind of elaborate a little bit more maybe on the variations in time from hospitalization to first dose. They were highlighted in kind of the recent in the article and.
Jim: We would now like to take any questions that you may have.
Speaker Change: You May press Star two if you would like to remove your question from the queue.
Jim: Ladies and gentlemen, if you would like to ask a question. Please press star one on your telephone keypad and a confirmation tone will indicate your line is in the question queue.
Speaker Change: For participants using speaker equipment, it would be necessary to pick up your handset before pressing the star keys.
French law: New England Journal evidence here, so just anything there they kind of totally makes sense, where the issue might have been ex U S. Here and that's it for me yeah. It does totally makes sense. It makes intuitive sense because this is an acute.
Jim: You May press Star two if you would like to remove your question from the queue.
French: And our first question comes from the line of French law for supply with Oppenheimer and company. Please proceed.
Jim: For participants using speaker equipment, and it would be necessary to pick up your handset before pressing the star keys.
Alright, Thanks, guys. Just a couple quick ones here I was just wondering if you.
Speaker Change: And our first question comes from the line of French law personal claw with Oppenheimer and company. Please proceed.
French law: Acute assault.
Speaker Change: We have an idea you can share how much you think is trial.
French law: Based on on chronic conditioning of the liver, so I kind of think about it.
French: Cost you.
Speaker Change: Alright, Thanks, guys just a couple quick ones here.
French law: It looks like a heart attack for the leather so its hepatitis right of acute inflammation of the liver and and so time to intervention is very important and we certainly learned that in this trial, we're fortunate out on the call to have both.
French: And then I'll have a follow up.
French: Sure Yeah, I think right now we're estimating it would be about $20 million. There are some things that we are considering it might make it a little bit under that but that's the approximately what it would cost.
Jim: Wondering if you.
Jim: I have an idea you can share how much you think is trial.
Will cost you.
Jim: And then I'll have a follow up.
French law: And wait to see it I think I'll ask both of them in their turn to to kind of speak to that and also how we're looking to address that in the phase III. So mainly normally you can start and then <unk> can follow on.
Jim: Sure Yeah, I think right now we're estimating it would be about $20 million. There are some things that we are considering it might make it a little bit under that but that's approximately what it would cost.
French: And two years tended to data is that is that right right yes.
French: Okay, Great and then is there any just quick chance for you to kind of elaborate a little bit more maybe on the variations in time from hospitalization that first dose they were highlighted in the recent in the article and.
Frank: Hi, Frank.
Speaker Change: Yeah.
Speaker Change: And two years tended to data is that is that right right yes.
Frank: So the eight.
Frank: Previously there's been no active there's been no effective therapy and so.
Speaker Change: Okay, Great and then is there any just quick chance for you to kind of elaborate a little bit more maybe on the variations in time from hospitalization. Just curious does that were highlighted in kind of the recent in the article and.
Frank: It's show time was never a factor in steroids.
French: New England Journal evidence here, so just anything there they kind of totally makes sense, where you know the issue might have been ex U S. Here and that's it for me Yeah. You know it does totally makes it I mean, it makes intuitive sense because this is an acute.
Frank: It's time to dosing didn't make any difference if you have an effective therapy in acute evolving disease.
Speaker Change: New England Journal evidence here, so just anything there they kind of totally makes sense, where you know the issue might have been ex U S. Here and that's it for me yeah.
Frank: Makes sense it would be it would be effective.
Frank: And you saw the graphs in the New England Journal article they are quite impressive as clearly appears to be an effect of early dosing or dosing with <unk> in the first.
French: You know acute assault.
French: Based on on chronic conditioning of the liver, so I kind of think about it.
Speaker Change: It does totally makes sense it makes intuitive sense because this is an acute.
Almost like a heart attack. So let me so it's it's hepatitis ride of acute inflammation of the liver and and so time change I mentioned is very important and we certainly learned that in this trial, we're fortunate that on the call. If you have both.
Speaker Change: <unk>.
Speaker Change: Acute assault.
Frank: In this case nine days.
Speaker Change: Based on on chronic conditioning of the liver, so I kind of think about it.
Frank: Okay.
Frank: Yeah, the way, we do want to add anything to that.
Speaker Change: It's almost like a heart attack or let me say its hepatitis right acute inflammation of the liver.
Speaker Change: Oh, I think Jim on the non Manhattan, [laughter] have my thoughts and said Ah.
French: And wait to see it I think I'll ask both of them in their turn to us to kind of speak to that and also how we're looking to address that in the phase III.
Speaker Change: And and so time to intervention is very important and we certainly learned that in this trial were fortunate on the calls have both preliminary and wait to see it I think I'll ask both of them in their turn to us too.
Speaker Change: The Wow about this time, because we treat our importance of that and then I think I saw it.
Speaker Change: It made me normally you can start and then wage he can follow on.
Speaker Change: Suddenly credit call for her I'm told it had to tweak in the south, particularly on the patient population.
Frank: Hi, Frank.
French: So the eight.
Speaker Change: Speak to that and also how we're looking to address that in the phase III. So maybe normally you can start and then wait you can follow on.
Speaker Change: Previously there's been no there's been no effective therapy and so.
Speaker Change: I just want to add on top of that Jim and Norman.
French: So tying was never effects.
Speaker Change: Hi, Frank.
Speaker Change: It's time to treat Ah indeed contribute a large part to the odd differences between U S and at.
Speaker Change: Zero.
Speaker Change: Eight.
Speaker Change: It's time to dosing didn't make Egypt, if you have any effective therapy in acute evolving disease. It really makes sense. It would be it would be effective and you saw the graphs in the new England Journal article they're quite impressive is clearly appears to be an effect.
French: Previously there's been there has been no effective therapy and so.
Speaker Change: <unk> patient population are what that difference we saw in that right.
French: It's show time was never a factor.
French: Zero.
Speaker Change: Without a doubt.
French: Hey.
Speaker Change: It's just a one off but also it's a very important factor, but it's not one knocked on multiple factors.
French: <unk> dosing didn't make a difference if you have any effective therapy in acute evolving disease.
Speaker Change: Really makes sense it would be it would be effective and you saw the graphs in the new England Journal article they are quite impressive.
Speaker Change: Oh.
Speaker Change: That's what I would like to ask.
Speaker Change: Early dosing dosing, which didn't.
Speaker Change: Yes, I think that's an important point and within the U S. Typically patients are treated within four days or so and in the.
Speaker Change: Fish.
Speaker Change: In this case nine days.
Speaker Change: Okay.
French: It is clearly appears to be an effect of that.
Speaker Change: Yeah. The way to you would you want to add anything to that.
Poorest performing region and Franco Belgian region. It was two weeks. So that's a substantial difference if you've got an acute circumstance to wait two weeks before you do much.
French: Early dosing dosing, which didn't.
Speaker Change: Oh, I think our agenda in the northern has [laughter], Tulsa and said Ah.
French: Fish.
French: In this case nine days.
French: Okay.
Speaker Change: Oh Wow about this heightened to retreat in part of that and then I think it's certainly.
French: Yeah. The way to you would you want to add anything to that.
Speaker Change: And so we're really excited about what.
Speaker Change: Oh, I think our agenda in the northern has [laughter] have my boxer and said Ah.
Speaker Change: What this might mean for our phase III, because we intend to dose everyone within <unk>.
Speaker Change: Suddenly credit cauliflower.
Speaker Change: According to tweet in this particular patient population.
Speaker Change: Nine days or so in the.
Speaker Change: Oh Wow about this heightened cause a treat in part of that.
Speaker Change: In the phase III trial, which will eliminate.
Speaker Change: I just want to add on top off the agenda and Norman.
Speaker Change: The longer term duration in fact, most of the patients will probably be treated very quickly based on what we've learned and.
Speaker Change: And then I think.
French: Certainly the credit card.
Speaker Change: That's time to tweak Ah indeed contribute a large part to the odd definitely between you actually I'm not at all.
French: That's hard to tweak in this particular patient population.
Speaker Change: We anticipate that.
Speaker Change: We should even possibly have a stronger signal.
French: I just want to add on top of the agenda and Norman.
Speaker Change: U S patient population are what that difference we saw in that.
Speaker Change: That certainly was the case and we looked at these data.
French: It's time to tweak Ah indeed contribute a large part to the.
Speaker Change: Thank you.
Speaker Change: Without.
Speaker Change: Thanks.
Speaker Change: But it's just a one off those although it's a very important factor that's one knocked on multiple factors.
French: Differences between U S and X.
Speaker Change: The next question comes from the line of Carl Byrnes with Northland Capital markets. Please proceed.
French: <unk> patient population.
French: It shouldn't.
French: That difference we saw in <unk>.
Speaker Change: That's what I would like to ask.
Speaker Change: Thanks for the question I'm wondering if you can share any updates on potential strategic partnerships or business development discussions that you might be having that would support the phase III study, whether it's a co development of regional licensing or other non dilutive.
French: Without a doubt.
Speaker Change: Yeah, I think that that's an important point and it is in the U S. Typically patients are treated within four days or so and.
French: It's just a one off although it's a very important factor that's one knocked on multiple factors.
Speaker Change: The poorest performing region Franco Belgian region. It was two weeks. So that's a substantial difference if you've got an acute circumstance to wait two weeks before you do much.
French: That's what I would like to ask.
French: Yes, I think that that's an important point and within the U S. Typically patients are treated within four days or so and <unk>.
Speaker Change: Opportunities. Thanks.
Speaker Change: Yes, certainly we have been.
Speaker Change: In that process and we continue in that process, but I don't think I'll, let maybe Tim since you are leading the effort.
Speaker Change: And so we're really excited about the what this might mean for our phase III, because we intend to dose everyone within.
French: Poorest performing region Franco Belgian region. It was two weeks. So that's a substantial difference if you've got an acute circumstance to wait two weeks before you do much.
Tim: Maybe you have a comment here.
Speaker Change: Yes.
Speaker Change: Nine days or so in the in the <unk>.
Speaker Change: Certainly have ongoing efforts on to explore the full range of possibilities to take this product forward.
Speaker Change: <unk> III trial, which will eliminate.
Speaker Change: And so we're really excited about what this might mean for our phase III, because we intend to dose everyone within.
Speaker Change: The longer term duration in fact, most of the patients will probably be treated very quickly based on what we've learned and we anticipate that Oh, we should even.
Speaker Change: As you can appreciate it I'm sure we can't comment on specifics or give a sense of what the timing would be but we.
Speaker Change: Nine days or so in the in the phase III trial, which will eliminate.
Speaker Change: Possibly have a stronger signal.
Speaker Change: We have been very active.
Speaker Change: The longer term duration in fact, most of the patients will probably be treated very quickly based on what we've learned and.
Speaker Change: That certainly was the case when we looked at these days.
Speaker Change: Over the past couple of quarters certainly.
Speaker Change: Thank you.
Speaker Change: Got you.
Speaker Change: Thanks.
Speaker Change: We anticipate that we should even possibly have a stronger signal.
Speaker Change: And we're optimistic that we'll be able to find a solution that despite the challenges of the capital markets. These days.
Speaker Change: The next question comes from the line of Carl Byrnes with Northland Capital markets. Please proceed.
Speaker Change: Okay Thats certainly was the case when we looked at these days.
Speaker Change: Yeah.
Speaker Change: Thank you.
Speaker Change: Thanks for the question I'm wondering if you can share any updates on potential strategic partnerships or business development discussions that you might be having it would support the phase III study, whether it's a co development of regional licensing or other non dilutive.
Speaker Change: Understood. Thanks, so much.
Speaker Change: Thanks.
Speaker Change: Yes.
Speaker Change: The next question comes from the line of Carl Byrnes with Northland Capital markets. Please proceed.
Speaker Change: And the next question comes from the line of Ed Arce.
Arce: Arce with H C. Wainwright. Please proceed.
Speaker Change: Thanks for the question I'm wondering if you can share any updates on potential strategic partnerships or business development discussions that you might be having that would support the phase III study, whether it's a co development of regional licensing or other non dilutive.
Tom: Hi, This is Tom.
Speaker Change: Opportunities. Thanks.
Tom: A couple of questions, whereas thank you so much lift in impressions.
Speaker Change: Yes, certainly we've been in that process and we continue on that process, but I don't think I'll, let maybe Tim since you are leading the efforts you've made.
Tom: So first question.
Jim: Hi, Jim.
Jim: Given the statistical significance 90 day mortality reduction observed enduro stations and the face severe firms study.
Speaker Change: You have a comment here.
Speaker Change: Opportunities. Thanks.
Tim: Yeah, you know, we certainly have ongoing efforts on to explore the full range of possibilities to take this product forward.
Speaker Change: Yes, certainly we have been.
Tim: In that process and we continue on that process, but I think I'll, let maybe Tim since you are leaving the Africa, maybe you have a comment here.
Jim: Is there a possibility to seek funding pool for a smaller but more rigorous rfps to be steady to generate new data.
Tim: As you can appreciate it I'm sure we can't comment on specifics or give a sense of what the timing would be but we we have been very active.
Speaker Change: Yes.
Speaker Change: Certainly have ongoing efforts on to explore the full range of possibilities to take this product forward.
Jim: To confirm list of this thorough.
Jim: On the tighter setting in the U S market.
Tim: Over the past couple of quarters certainly.
Speaker Change: As you can appreciate it I'm sure we can't comment on specifics or give a sense of what the timing would be but we we have been very active.
It's an interesting question, we actually what we're looking at right now with our phase III is a very.
Tim: Got you.
Tim: And we're optimistic that we'll be able to find a solution that despite the challenges of the capital markets. These days.
Jim: Tight steady.
Speaker Change: Over the past couple of quarters certainly.
Jim: We're looking at here is we're taking advantage of the fact that this trial can be conducted entirely in the U S where the health care system is more uniform than what one sees the disease is diagnosed in patients are presented in a more timely matter as they are in the U S versus ex U S. So that's the first thing that you could be U S. We then piece we're going to do is we're going to.
Tim: Yeah.
Tim: Understood. Thanks, so much.
Speaker Change: And we're optimistic that we'll be able to find a solution that despite the challenges of the capital markets. These days.
Tim: Yes.
Speaker Change: And the next question comes from the line of Ed Arce with H C. Wainwright. Please proceed.
Speaker Change: Understood. Thanks, so much.
Speaker Change: Hi, this is asking.
Speaker Change: Yes.
Speaker Change: You're asking a couple of questions, whereas thank you so much luck in their questions.
Speaker Change: And the next question comes from the line of Ed.
Jim: We're going to centralize bice or excuse me randomized by site versus central randomization and that will.
Speaker Change: So first question Hi, Jim.
Ed Arce: Arce with H C. Wainwright. Please proceed.
Speaker Change: Given the statistical significance 90 day mortality reduction observed in euro stations and the pace to be affirmed study.
Jim: Hopefully eliminate any regional biases that we certainly saw with the <unk> group.
Tom: Hi, This is Tom yes, asking.
Tom: You're asking a couple of questions, whereas thank you so much luck in their questions.
Speaker Change: So first question Hi, Jim.
Jim: And.
Jim: We didnt see nearly as much of that in the U S. When we have now randomization. So if you have a site in New York lets say youre going to receive a can't afford to will be placebo two will be active and and when you could burn through that then you get another cater for and so we'll keep the randomization balanced across the.
Speaker Change: Is there a possibility to seek funding pool for a smaller but more rigorous piece could be study to generate new data.
Speaker Change: Given the statistical significance 90 day mortality reduction observed in U S patients in the phase to be affirmed study.
Speaker Change: To confirm the simple sterile.
Speaker Change: Is there a possibility to seek funding for a smaller but more rigorous piece to be steady if you generate new data.
Speaker Change: The tightest setting in the U S market.
Speaker Change: It's an interesting question, we actually are what we're looking at right now with our phase III is a very tight.
Jim: Across the various sites and then lastly, we're going to control that time to dose that we spoke about earlier and that can be very important so everyone. Within the trial will be dosed within nine or 10 days or earlier, probably much earlier.
Speaker Change: To confirm the Super sterile.
Speaker Change: And the tighter setting in the U S market.
Speaker Change: Right.
Speaker Change: Steady.
Speaker Change: We're looking at here is we're taking advantage of the fact that this trial can be conducted entirely in the U S where the health care system is more uniform than what one sees the disease is diagnosed in patients are presented in a more timely matter as they are in U S versus ex U S. So that's the first thing that you could be U S isn't that the next piece, we're going to do is we're going to.
Speaker Change: It's an interesting question we actually.
Speaker Change: We're looking at right now with our phase III is a very.
It's based in U S, but two.
Jim: <unk>.
Speaker Change: Tight study what we're looking at here is we're taking advantage of the fact that this trial can be conducted entirely in the U S where the health care system is more uniform than what one sees the disease is diagnosed in patients are presented in a more timely manner as they are in U S versus ex U S. So that's the first thing you can be use with the next piece.
Jim: Another phase two b trial.
Jim: You know what you would have to have that.
Jim: 200 patients to show.
Jim: Reasonable a reasonable signal and by the time, you've done that you've done the phase III and so I think at this point, it's faster and more cost effective for us simply could do a.
Speaker Change: We're going to centralize bice or excuse me when randomized by site versus central randomization and that will Oh, hopefully eliminate any regional biases that we certainly saw with the <unk> group.
Jim: Our phase III trial, rather than an under powered phase <unk> might still leave you guessing.
Speaker Change: We're going to do is we're going to.
Tim: We're going to centralize bice or excuse me, we had randomized by site versus central randomization and that will.
Speaker Change: And we didnt see nearly as much of that in the U S. But when we have now with randomization. So if you have a site in New York lets say you you're going to receive a kid afford to will be placebo two will be active.
Jim: I don't know I mean normally you have have any thoughts on that.
Tim: Hopefully eliminate any regional biases that we certainly saw with the ex U S group.
Jim:
Jim: Well, what I would say is the other trial.
Jim: Schedule was again patient trial with two doses. So we really had two active arms and they gave nearly identical results. So in my mind that was the equivalent of two phase III trials.
Tim: We didnt see nearly as much of that in the U S.
Speaker Change: And when you could burn through that and you get another kid afore and so we'll keep the randomization balanced across the across the various sites and then lastly, we're going to control that time to dose that we spoke about earlier and that can be very important so everyone. Using the trial will be dosed within nine or 10 days or earlier, probably in my earlier.
Tim: We have now randomization. So if you have a site in New York lets say you youre going to receive a kid afford to will be placebo two will be active.
Tim: And when we could burn through that then you'll get another kid afore and so we'll keep the randomization balanced across the.
Jim: Also with <unk> and for the product and where they are saying if you have a good result in another trial, we would consider that sufficient.
Tim: Across the various sites and then lastly, we're going to control that time to dose that we spoke about earlier and that can be very important so everyone. Who's in the trial will be dosed within nine or 10 days or earlier, probably much earlier.
Speaker Change: And since it's based in U S but to.
Jim: I don't know why we wouldn't just move to the phase III trial. It is as Jim says, a very compact and streamline trial.
Speaker Change: To conduct another phase two b trial.
Speaker Change: You know what you'd have to have about.
Speaker Change: About 200 patients to show.
Jim: Yeah.
Speaker Change: It's based in U S but to.
Jim: Okay.
Speaker Change: Reasonable a reasonable signal and by the time, you've done that you've done the phase III.
Jim: Got it.
Speaker Change: Conducted another phase two b trial.
Jim: So the rationale there.
Jim: And then what are those opportunities.
Speaker Change: I think at this point.
Speaker Change: You know what you would have to have about 200 patients to show.
Speaker Change: Foster and more cost effective for us simply could do a.
Jim: Or is.
Jim: The therapy ultimately non diluted funding and the ex U S countries.
Speaker Change: Reasonable a reasonable signal and by the time, you've done that you've done the phase III and so I think at this point faster and more cost effective for us simply could do.
Speaker Change: Phase three trial, rather than an underpowered phase to be what might still leave you guessing.
Jim: To generate new data.
Speaker Change: I don't know I mean normally you have have any thoughts on that.
Jim: And our country.
Speaker Change: Yes.
Speaker Change:
Jim: <unk> trial comes out.
Speaker Change: Our phase three trial, rather than and then the power phase <unk> might still leave you guessing.
Speaker Change: Well, yeah, what I would say is the other trial.
Jim: In countries with the.
Jim: Rigorous.
Speaker Change: Central was it 200 patient trial with two doses. So we really had two active arms and they gave me easily identical results. So in my mind that was the equivalent of two phase III trials are also with ft agencies, yet until the product and go there where they're saying if you have a good day.
Jim: Control in place.
Speaker Change: I don't know I mean normally you have any thoughts on that.
Jim: Would that be possible.
Jim: They do some work outside the U S.
Speaker Change: Well, yeah, what I would say is the other trial.
Jim: Certainly we could there are obviously numerous other indications want to pursue as well, but what we're doing right. Now is just focusing entirely on the entirety of our effort on a H.
Speaker Change: Since we'll be patient.
Speaker Change: Patient trial with two doses. So we really had two active arms and they gave newly identical results. So in <unk>.
Jim: But the possibility of doing a regional study with an ex U S partner is certainly something that we would consider that.
Speaker Change: So in another trial, we would consider that sufficient.
Speaker Change: My mind that was the equivalent of two phase III trials.
Speaker Change: I don't know why we wouldn't just move to the phase III trial and it is as Jim said, it's a very compact and streamline trial.
Speaker Change: Also with SD agencies, yet for the product and.
Jim: That might indeed, there are certain markets that.
Speaker Change: They are saying if you have a good result in another trial, we would consider that sufficient.
Jim: I'd like to have that for sure they would like to see it in their population.
Speaker Change: Yeah.
Jim: No.
Speaker Change: Yeah.
Jim: Okay.
Speaker Change: I don't know why we wouldn't just move to the phase III trial and it is as Jim says very compact and streamline trial.
Speaker Change: Got it.
Jim: Thank you again for taking my questions.
Speaker Change: And as to the rationale there.
Jim: Sure.
Speaker Change: And then what about our opportunities are as good as the.
Speaker Change: Yeah.
Jim: Thank you.
Speaker Change: With that the opportunity for non diluted funding and your countries are.
Speaker Change: Got it.
Ladies and gentlemen, there are no further questions at this time I would like to turn the call back to Jim Brown for closing remarks.
Speaker Change: So the rationale there.
Speaker Change: And then what about our opportunities.
Speaker Change: Where you can generate in theater.
Jim Brown: Thank you and we thank you all for for your time today and look forward to catching up if you have any further questions. Please reach out thank you all and take care.
Speaker Change: Perhaps in the country.
Speaker Change: Okay.
Speaker Change: Mentioned trial comes out.
Speaker Change: But there would be absolutely non diluted funding and our ex U S countries.
Speaker Change: Hum.
Speaker Change: You know in countries with a rigorous.
Speaker Change: Control and place them with that.
Speaker Change: To generate new data.
Speaker Change: And our country.
Jim Brown: This concludes today's conference you may disconnect your lines at this time.
Speaker Change: It would be possible.
Speaker Change: They do some work outside the U S.
Speaker Change: Ah trial comes out.
Speaker Change: Certainly we could there are obviously numerous other indications want to pursue as well, but what we're doing right. Now is just focusing entirely the entirety of our efforts on a H.
Jim Brown: The rest of your day.
Speaker Change: In countries with a rigorous.
Jim Brown: Oh.
Speaker Change: Control in place.
Speaker Change: Would that be possible.
Speaker Change: They do some work outside the U S.
Speaker Change: Certainly we could there are obviously numerous other indications won't pursue as well, but what we're doing right. Now is just focusing entirely on the entirety of our effort on a H b.
Speaker Change: But the possibility of doing a regional study with an ex U S partner is certainly something that we would consider.
Speaker Change: That might indeed, there are certain markets that that like to have that for sure they like to see it in their population.
Speaker Change: But the possibility of doing a regional study with an ex U S. Partner is certainly something that we would consider something that might indeed, there are certain markets that that like to have that for sure. They like to see it in their population.
Speaker Change: So.
Speaker Change: I see that they're working with a couple of questions.
Speaker Change: Sure.
Speaker Change: So.
Speaker Change: Thank you.
Speaker Change: Oh I see.
Speaker Change: Ladies and gentlemen, there are no further questions at this time I would like to turn the call back to Jim Brown for closing remarks.
Speaker Change: They're working with a couple of questions.
Speaker Change: Sure.
Jim Brown: Thank you and we thank you all for your for your time today and look forward to catching up if you have any further questions. Please reach out thank you all and take care.
Speaker Change: Thank you.
Speaker Change: Ladies and gentlemen, there are no further questions at this time I would like to turn the call back to Jim Brown for closing remarks.
Speaker Change: Thank you and we thank you all for your for your time today and look forward to catching up if you have any further questions. Please reach out thank you all and take care.
Jim Brown: This concludes today's conference you may disconnect your lines at this time.
Jim Brown: Enjoy the rest of your day.
Jim Brown: Hum.
Jim Brown: Hum.
Speaker Change: This concludes today's conference you may disconnect your lines at this time.
Jim Brown: [music].
Speaker Change: The rest of your day.
Jim Brown: Mhm.
Speaker Change: Hum.
Jim Brown: Mhm.
Jim Brown: Hum.
Speaker Change: [music].
Jim Brown: Hum.
Jim Brown: Hum.
Speaker Change: Okay.
Jim Brown:
Speaker Change: Mhm.
Jim Brown: [music].
Speaker Change: Hum.
Speaker Change: Hum.
Speaker Change: [music].
Jim Brown: Mhm.
Speaker Change: Hum.
Speaker Change: [music].
Jim Brown: Hum.
Jim Brown: Uh huh.
Speaker Change: [music].
Jim Brown: Hum.
Speaker Change: Okay.
Speaker Change: Uh huh.
Speaker Change: [music].
Jim Brown: Uh huh.
Speaker Change: Hum.
Speaker Change: Yes.
Speaker Change: Yes.