Q1 2026 Talphera Inc Earnings Call
Operator: Welcome to the Talphera Q1 2026 Financial Results Conference Call. This call is being webcast live via the Events page of the Investors section of Talphera's website at www.talphera.com. You may listen to a replay of this webcast by going to the Investors section of Talphera's website. I would now like to turn the call over to Raffi Asadorian, Talphera's Chief Financial Officer. Please go ahead.
Speaker #2: You may listen to a replay of this webcast by going to the Investor Section of TALPHERA's website. I would now like to turn the call over to Raffi Asadorian, TALPHERA's Chief Financial Officer.
Speaker #2: Please go ahead.
Speaker #1: Thank you. And thank you for joining us on the call today. Today we announced our first quarter 2026 financial results, an associated business updates in a press release.
Raffi Asadorian: Thank you, and thank you for joining us on the call today. Today, we announced our Q1 2026 financial results and associated business updates in a press release. With me today are Vince Angotti, our Chief Executive Officer, and Dr. Shakil Aslam, Talphera's Chief Medical Officer. Before we begin, I want to remind listeners that during this call, we will likely make forward-looking statements within the meaning of the federal securities laws. These forward-looking statements involve risks and uncertainties regarding the operations and future results of Talphera. Please refer to our press release in addition to the company's periodic, current, and annual reports filed with the SEC for a discussion of the risks associated with such forward-looking statements. These documents can also be found on the website within the Investors section. I'll now hand the call over to Vince.
Raffi Asadorian: Thank you, and thank you for joining us on the call today. Today, we announced our Q1 2026 financial results and associated business updates in a press release. With me today are Vince Angotti, our Chief Executive Officer, and Dr. Shakil Aslam, Talphera's Chief Medical Officer. Before we begin, I want to remind listeners that during this call, we will likely make forward-looking statements within the meaning of the federal securities laws. These forward-looking statements involve risks and uncertainties regarding the operations and future results of Talphera. Please refer to our press release in addition to the company's periodic, current, and annual reports filed with the SEC for a discussion of the risks associated with such forward-looking statements. These documents can also be found on the website within the Investors section. I'll now hand the call over to Vince.
Speaker #1: With me today are Vincent Angotti, our Chief Executive Officer, and Dr. Shakil Aslam, TALPHERA's Chief Medical Officer. Before we begin, I want to remind listeners that during this call we will likely make forward-looking statements within the meaning of the Federal Securities Laws.
Speaker #1: These forward-looking statements involve risks and uncertainties regarding the operations and future results of TALPHERA. Please refer to our press release in addition to the company's periodic, current, and annual reports filed with the SEC.
Speaker #1: For discussion, of the risks associated with such forward-looking statements. These documents can also be found on the website within the Investor Section. I'll now hand the call over to Vince.
Speaker #2: Thanks, Raffi. Good afternoon and thank you to everyone joining our call today. It's been less than two months since our last update, and we're excited about the progress we've made this year and the NEFRO study with our ongoing enrollment at current clinical study sites activation of additional sites achievement of the 50% enrollment milestone and consequently the closure of an additional financing tranche.
Vince Angotti: Thanks, Raffi. Good afternoon, and thank you to everyone joining our call today. It's been less than 2 months since our last update, and we're excited about the progress we've made this year in the NEPHRO study with our ongoing enrollment at current clinical study sites, activation of additional sites, achievement of the 50% enrollment milestone, and consequently, the closure of an additional financing tranche. With this continued progress, we believe we are well-positioned to complete enrollment in the NEPHRO CRRT study this year and file the PMA for a targeted potential approval of Niyad in 2027. As mentioned, in early March, we announced the attainment of the 50% enrollment milestone in the NEPHRO study. With continued enrollment since that date, I'm pleased to report that we have well exceeded this level.
Vince Angotti: Thanks, Raffi. Good afternoon, and thank you to everyone joining our call today. It's been less than 2 months since our last update, and we're excited about the progress we've made this year in the NEPHRO study with our ongoing enrollment at current clinical study sites, activation of additional sites, achievement of the 50% enrollment milestone, and consequently, the closure of an additional financing tranche. With this continued progress, we believe we are well-positioned to complete enrollment in the NEPHRO CRRT study this year and file the PMA for a targeted potential approval of Niyad in 2027. As mentioned, in early March, we announced the attainment of the 50% enrollment milestone in the NEPHRO study. With continued enrollment since that date, I'm pleased to report that we have well exceeded this level.
Speaker #2: With this continued progress, we believe we are well positioned to complete enrollment in the NEFRO CRRT study this year, and file the PMA for a targeted potential approval of NIAD in 2027.
Speaker #2: As mentioned in early March, we announced the attainment of the 50% enrollment milestone in the NEFRO study. With continued enrollment since that date, I'm pleased to report that we have well exceeded this level.
Speaker #2: The protocol changes we adopted last year, supported by bringing on new target profile clinical study sites, have positioned us to achieve our goal of completing the study this year.
Vince Angotti: The protocol changes we adopted last year, supported by bringing on new target profile clinical study sites, have positioned us to achieve our goal of completing the study this year. Building on our virtual investor and analyst event in March, we continue to be genuinely excited about completing this study and submitting our PMA for potential approval of Niyad. The KOLs who participated in our March event highlighted the disadvantages with the currently available anticoagulants they're using and their belief that nefamostat will fill an unmet need in this market. These insights, as well as our ongoing discussions with other nephrologists, further reinforce our belief that Niyad could have an important role in anticoagulation for CRRT if approved by the FDA. Nine of our 12 activated sites align with the new target site profile that we set last year.
Vince Angotti: The protocol changes we adopted last year, supported by bringing on new target profile clinical study sites, have positioned us to achieve our goal of completing the study this year. Building on our virtual investor and analyst event in March, we continue to be genuinely excited about completing this study and submitting our PMA for potential approval of Niyad. The KOLs who participated in our March event highlighted the disadvantages with the currently available anticoagulants they're using and their belief that nefamostat will fill an unmet need in this market. These insights, as well as our ongoing discussions with other nephrologists, further reinforce our belief that Niyad could have an important role in anticoagulation for CRRT if approved by the FDA. Nine of our 12 activated sites align with the new target site profile that we set last year.
Speaker #2: Building on our virtual investor and analyst event in March, we continue to be genuinely excited about completing this study and submitting our PMA for potential approval of NIAD.
Speaker #2: The KOLs who participated in our March event highlighted the disadvantages with the currently available anticoagulants they're using, and their belief that Nifamistat will fill an unmet need in this market.
Speaker #2: These insights as well as our ongoing discussions with other nephrologists further reinforce our belief that NIAD could have an important role in anticoagulation for CRRT if approved by the FDA.
Speaker #2: Nine of our 12 activated sites align with the new target site profile that we set last year. And with nephrologists as the lead, these sites have enrolled over 90% of the patients in the study.
Vince Angotti: With nephrologists as the lead, these sites have enrolled over 90% of the patients in the study. The quality of our study sites and the principal investigators and their teams is excellent. Dr. Aslam and I have been actively visiting many of the sites over the past several weeks, and all of them are highly engaged and have expressed their desire to have a new CRRT anticoagulant approved for use. In addition, we look forward to welcoming a couple of additional institutions who've been enthusiastic to participate in the study, allowing us to maximize the 14 sites granted by the FDA.
Vince Angotti: With nephrologists as the lead, these sites have enrolled over 90% of the patients in the study. The quality of our study sites and the principal investigators and their teams is excellent. Dr. Aslam and I have been actively visiting many of the sites over the past several weeks, and all of them are highly engaged and have expressed their desire to have a new CRRT anticoagulant approved for use. In addition, we look forward to welcoming a couple of additional institutions who've been enthusiastic to participate in the study, allowing us to maximize the 14 sites granted by the FDA.
Speaker #2: The quality of our study sites, and the principal investigators and their teams, is excellent. Dr. Aslam and I have been actively visiting many of the sites over the past several weeks, and all of them are highly engaged and have expressed their desire to have a new CRRT anticoagulant approved for use.
Speaker #2: In addition, we look forward to welcoming a couple of additional institutions who've been enthusiastic participating in the study allowing us to maximize the 14 sites granted by the FDA.
Speaker #2: While these new sites will find us further along in enrollment, they've been drawn in the NEFRO study by a deep appreciation for nifamistat's nearly four decades of use outside the US.
Vince Angotti: While these new sites will find us further along in enrollment, they've been drawn in the NEPHRO study by a deep appreciation for nefamostat's nearly 4 decades of use outside the US and a strong interest in contributing to the US research with their peers on a potentially new approved CRRT anticoagulant. Adding these final sites helps lay the groundwork for broader clinical awareness of nefamostat, which will serve us well if the FDA approves it next year. With that, I'll now hand the call over to Raffi to update you on the financial results for Q1.
Vince Angotti: While these new sites will find us further along in enrollment, they've been drawn in the NEPHRO study by a deep appreciation for nefamostat's nearly 4 decades of use outside the US and a strong interest in contributing to the US research with their peers on a potentially new approved CRRT anticoagulant. Adding these final sites helps lay the groundwork for broader clinical awareness of nefamostat, which will serve us well if the FDA approves it next year. With that, I'll now hand the call over to Raffi to update you on the financial results for Q1.
Speaker #2: And a strong interest in contributing to the US research with their peers on a potentially new approved CRRT anticoagulant. Adding these final sites helps lay the groundwork for broader clinical awareness of nifamistat which will serve us well if the FDA approves it next year.
Speaker #2: With that, I'll now hand the call over to Raffi to update you on the financial results for the first quarter.
Speaker #1: Thank you, Vince. Our cash balance at March 31, 2026 was $21.1 million. We believe this cash combined with future conditional financing tranches will provide a sufficient capital through at least a potential NIAD PMA approval expected next year.
Raffi Asadorian: Thank you, Vince. Our cash balance at 31 March 2026 was $21.1 million. We believe this cash, combined with future conditional financing tranches, will provide us sufficient capital through at least a potential Niyad PMA approval expected next year. During the quarter, we closed a $4.1 million financing tranche from the March 2025 private placement. There are two remaining conditional financing tranches totaling approximately $16 million of additional capital, which, if the conditions are met, are expected to close around the date we release our top-line data and announce completion of the study later this year. Our cash operating expenses or combined R&D and SG&A expenses for Q1 2026 totaled $3.9 million compared to $2.9 million for Q1 2025.
Raffi Asadorian: Thank you, Vince. Our cash balance at 31 March 2026 was $21.1 million. We believe this cash, combined with future conditional financing tranches, will provide us sufficient capital through at least a potential Niyad PMA approval expected next year. During the quarter, we closed a $4.1 million financing tranche from the March 2025 private placement. There are two remaining conditional financing tranches totaling approximately $16 million of additional capital, which, if the conditions are met, are expected to close around the date we release our top-line data and announce completion of the study later this year. Our cash operating expenses or combined R&D and SG&A expenses for Q1 2026 totaled $3.9 million compared to $2.9 million for Q1 2025.
Speaker #1: During the quarter, we closed a $4.1 million financing tranche from the March 2025 private placement. There are two remaining conditional financing tranches totaling approximately $16 million of additional capital which if the conditions are met are expected to close around the date we release our top line data and announce completion of the study later this year.
Speaker #1: Our cash operating expenses, which combine R&D and SG&A expenses for the first quarter of 2026, totaled $3.9 million compared to $2.9 million for the first quarter of 2025.
Speaker #1: Excluding non-cash stock-based compensation expense, these amounts were $3.7 million for the first quarter of 2026 compared to $2.7 million for the first quarter of 2025.
Raffi Asadorian: Excluding non-cash stock-based compensation expense, these amounts were $3.7 million for Q1 2026 compared to $2.7 million for Q1 2025. The increase in cash operating expenses in Q1 2026 was primarily due to higher Niyad development expenses, reflecting increased enrollment and an increase in certain G&A expenses. I'll now turn the call back over to Vince.
Raffi Asadorian: Excluding non-cash stock-based compensation expense, these amounts were $3.7 million for Q1 2026 compared to $2.7 million for Q1 2025. The increase in cash operating expenses in Q1 2026 was primarily due to higher Niyad development expenses, reflecting increased enrollment and an increase in certain G&A expenses. I'll now turn the call back over to Vince.
Speaker #1: The increase in cash operating expenses in the first quarter of 2026 was primarily due to higher NIAD development expenses reflecting increased enrollment and an increase in certain G&A expenses.
Speaker #1: I'll now turn the call back over to Vince.
Speaker #2: Thank you, Raffi. And I'd like to open the line for any questions you might have. Operator?
Vince Angotti: Thank you, Raffi. I'd like to open the line for any questions you might have. Operator?
Vince Angotti: Thank you, Raffi. I'd like to open the line for any questions you might have. Operator?
Speaker #3: Thank you. Ladies and gentlemen, we will now begin the question-and-answer session. Should you have a question, please press star followed by the one on your touchtone phone.
Operator: Thank you. Ladies and gentlemen, we will now begin the question-and-answer session. Your first question comes from the line of James Molloy from Alliance Global Partners. Please go ahead.
Operator: Thank you. Ladies and gentlemen, we will now begin the question-and-answer session. Your first question comes from the line of James Molloy from Alliance Global Partners. Please go ahead.
Speaker #3: You will hear a prompt that your hand has been raised. Should you wish to decline from the polling process, press the star followed by the two.
Speaker #3: If you are using a speakerphone, please lift the handset before pressing any keys. One moment, please, for your first question. Your first question comes from the line of James Malloy, from Alliance Global Partners.
Speaker #3: Please go ahead.
Speaker #4: Hey guys, Matt on for Jim today. I was just wondering if you guys are going to announce enrollment at any other milestone, maybe 75%, or is the next update going to be full enrollment and then where to expect data quickly after?
Matt: Hey, guys. Matt on for Jim today. I was just wondering if you guys are going to announce enrollment and any other milestone, maybe 75%, or is the next update going to be full enrollment and then we're to expect data quickly after? Thanks.
Matt Venezia: Hey, guys. Matt on for Jim today. I was just wondering if you guys are going to announce enrollment and any other milestone, maybe 75%, or is the next update going to be full enrollment and then we're to expect data quickly after? Thanks.
Speaker #4: Thanks.
Speaker #2: Yeah, Raffi I'll start it and then you can give them an idea of kind of the data communication we're planning. So we're not planning on any additional enrollment updates in particular realizing that the balance of the study isn't tied to any tranches until the closure of the study, until the study is being completed.
Vince Angotti: Yeah, Raffi, I'll start it, and then you can give them an idea of kind of the data communication we're planning. We're not planning on any additional enrollment updates, in particular realizing that the balance of the study isn't tied to any tranches until the closure of the study, until the study is being completed. With that said, I think Raffi can communicate to you what our expectation is upon study completion or enrollment completion being last patient out and how we plan to communicate data thereafter.
Vince Angotti: Yeah, Raffi, I'll start it, and then you can give them an idea of kind of the data communication we're planning. We're not planning on any additional enrollment updates, in particular realizing that the balance of the study isn't tied to any tranches until the closure of the study, until the study is being completed. With that said, I think Raffi can communicate to you what our expectation is upon study completion or enrollment completion being last patient out and how we plan to communicate data thereafter.
Speaker #2: With that said, I think Raffi can communicate to you what our expectation is upon study completion or enrollment completion, being last patient out, and how we plan to communicate data thereafter.
Speaker #1: Yeah, sure. Yeah, I think we'll announce last patient out. But the most important is the top line data which should come within a month after that last patient out.
Raffi Asadorian: Yeah, sure. I think we'll announce last patient out. The most important is the top-line data, which should come, you know, within a month after that last patient out. Remember, it's a very, very quick study, 72 hours at the secondary endpoint, 24-hour primary endpoint. It's a quick study, and we're cleansing the data along the way. It'll be a quick announcement for that top-line data.
Raffi Asadorian: Yeah, sure. I think we'll announce last patient out. The most important is the top-line data, which should come, you know, within a month after that last patient out. Remember, it's a very, very quick study, 72 hours at the secondary endpoint, 24-hour primary endpoint. It's a quick study, and we're cleansing the data along the way. It'll be a quick announcement for that top-line data.
Speaker #1: Remember, it's a very quick study, 72 hours at the secondary endpoint, 24-hour primary endpoint. So it's a quick study and we're cleansing the data along the way.
Speaker #1: So it'll be a quick announcement for that top line data.
Speaker #4: Got it, thank you. And is there any guidance you can give as to where you might be now, or timing going forward? Second half of '26 still looking like the most likely for a top-line read?
Matt: Got it. Thank you. Is there any guidance you can give as to where you might be now or timing going forward? H2 2026 still looking like the most likely for a top-line read?
Matt Venezia: Got it. Thank you. Is there any guidance you can give as to where you might be now or timing going forward? H2 2026 still looking like the most likely for a top-line read?
Speaker #2: Yeah, the second half of 26. The study goes in ebbs and flows and so we're going to remain on our guidance for the second half of 2026 depending on the flow of those qualifying patients moving forward.
Vince Angotti: Yeah, the H2 of 2026. You know, the study goes in ebbs and flows. We're gonna remain on our guidance for the H2 of 2026, depending on the flow of those qualifying patients moving forward. We're confident in it being completed this year and announcing those results this year.
Vince Angotti: Yeah, the H2 of 2026. You know, the study goes in ebbs and flows. We're gonna remain on our guidance for the H2 of 2026, depending on the flow of those qualifying patients moving forward. We're confident in it being completed this year and announcing those results this year.
Speaker #2: But we're confident in it being completed this year. And announcing those results this year.
Speaker #4: Great. Thanks for taking my questions, guys.
Matt: Great. Thanks for taking my questions, guys.
Matt Venezia: Great. Thanks for taking my questions, guys.
Speaker #2: Thanks, Matt.
Vince Angotti: Thanks, Matt.
Vince Angotti: Thanks, Matt.
Speaker #3: Thank you. Your next question comes from the line of Ed Arce from West Capital. Please go ahead.
Operator: Thank you. Your next question comes from the line of Ed Arce from WestPark Capital. Please go ahead.
Operator: Thank you. Your next question comes from the line of Ed Arce from WestPark Capital. Please go ahead.
Speaker #5: Hi Vince, Raffi. Good to be with you. Congrats on the continued progress. Just a couple of quick questions for me. As we anxiously await full enrollment and top line data later this year, the first one is these two new sites that you expect to come online pretty soon here.
Ed Arce: Hi, Vince, Raffi. Good to be with you. Congrats on the continued progress. Just a couple of quick questions for me, as we anxiously await full enrollment and top-line data later this year. The first one is these 2 new sites that you expect to come online pretty soon here and basically cap out the full complement of sites, would you be able to disclose which sites those are or perhaps give a qualitative description of the type of site and the type of patients that they see? Then the other question is, have you received any commentary from site administrators that are treating the patients, anyone that is conducting the study?
Ed Arce: Hi, Vince, Raffi. Good to be with you. Congrats on the continued progress. Just a couple of quick questions for me, as we anxiously await full enrollment and top-line data later this year. The first one is these 2 new sites that you expect to come online pretty soon here and basically cap out the full complement of sites, would you be able to disclose which sites those are or perhaps give a qualitative description of the type of site and the type of patients that they see? Then the other question is, have you received any commentary from site administrators that are treating the patients, anyone that is conducting the study?
Speaker #5: And basically cap out the full complement of sites. Would you be able to disclose which sites those are or perhaps give a qualitative description of the type of site and the type of patients that they see?
Speaker #5: And then the other question is have you received any commentary from site administrators that are treating the patients? Anyone that is conducting the study?
Speaker #5: Any commentary that you could share with us about how things are progressing? Thanks so much.
Ed Arce: Any commentary that you could share with us about how things are progressing? Thanks so much.
Ed Arce: Any commentary that you could share with us about how things are progressing? Thanks so much.
Speaker #2: Yeah, I'll start with the new sites, Ed, and then I'll turn it over to Shakil to give a little more insight on those sites and the site administrators' feedback.
Vince Angotti: Yeah. I'll start with the new sites, Ed, and then I'll turn it over to Shakil to give a little more insight on those sites and the site administrators' feedback. The two new sites we don't expect to be significant contributors to the study, but they have significant CRRT populations. I say not to be significant contributors to the study because they're coming in so late to the study, but they wanted to be involved moving forward. These are study sites that match our new profile with nephrologists being the lead. One of the sites in particular is one of the top five as far as our data suggests CRRT administering hospitals in the country.
Vince Angotti: Yeah. I'll start with the new sites, Ed, and then I'll turn it over to Shakil to give a little more insight on those sites and the site administrators' feedback. The two new sites we don't expect to be significant contributors to the study, but they have significant CRRT populations. I say not to be significant contributors to the study because they're coming in so late to the study, but they wanted to be involved moving forward. These are study sites that match our new profile with nephrologists being the lead. One of the sites in particular is one of the top five as far as our data suggests CRRT administering hospitals in the country.
Speaker #2: The two new sites—we don't expect them to be significant contributors to the study. But they have a significant CRT population. I say not to be significant contributors to the study because they're coming in so late to the study, but they want to be involved moving forward.
Speaker #2: These are study sites that match our new profile with nephrologists being the lead. One of the sites in particular is one of the top five as far as our data suggests CRT administering hospitals in the country.
Speaker #2: And we'll end up communicating those sites when we update federal gov.com on the study sites. So you'll be able to see who those sites are specifically in conjunction with all the balance of the sites we have to round out the 14.
Vince Angotti: We'll end up communicating those sites when we update ClinicalTrials.gov on the study sites. You'll be able to see who those sites are specifically in conjunction with all the balance of the sites we have to round out the 14. As it relates to the site administrators and how it's going, I think Shakil's best positioned to communicate that while he and I have been making our rounds over the last several weeks. Remember, it's a blinded study, but I think what's important about this is the placebo and the product are treated similar in the protocol and the simplicity that comes with it. Shakil? Sure. Thanks, Ed. Absolutely.
Vince Angotti: We'll end up communicating those sites when we update ClinicalTrials.gov on the study sites. You'll be able to see who those sites are specifically in conjunction with all the balance of the sites we have to round out the 14. As it relates to the site administrators and how it's going, I think Shakil's best positioned to communicate that while he and I have been making our rounds over the last several weeks. Remember, it's a blinded study, but I think what's important about this is the placebo and the product are treated similar in the protocol and the simplicity that comes with it. Shakil?
Speaker #2: As it relates to the site administrators and how it's going, I think Shakil's best positioned to communicate that, while he and I have been making our rounds over the last several weeks.
Speaker #2: Remember, it's a blinded study, but I think what's important about this is the placebo and the product are treated similar in the protocol and the simplicity that comes with it.
Speaker #2: So Shakil?
Speaker #1: Sure. Thanks, Ed. Absolutely. So when we talk to the PIs and the investigators and then as well as the nurses who are running this study and who are doing testing and looking at some of the test results, they are all very, very impressed with the ease of administering this intervention.
Shakil Aslam: Sure. Thanks, Ed. Absolutely.
Shakil Aslam: When we talk to the PIs, and the investigators and as well as the nurses who are running this study and who are doing testing and looking at some of the test results, they are all very, very impressed with the ease of administering this intervention. As Vince said, both placebo as well as Niyad, they are administered exactly the same way. Sure, for first 24 hours, we have little bit more intense monitoring of blood tests to see how patients are responding to it. After 24 hours, you know, that intensity goes down and they basically all are very, very impressed at how little variability they are seeing in the test results.
Shakil Aslam: When we talk to the PIs, and the investigators and as well as the nurses who are running this study and who are doing testing and looking at some of the test results, they are all very, very impressed with the ease of administering this intervention. As Vince said, both placebo as well as Niyad, they are administered exactly the same way. Sure, for first 24 hours, we have little bit more intense monitoring of blood tests to see how patients are responding to it. After 24 hours, you know, that intensity goes down and they basically all are very, very impressed at how little variability they are seeing in the test results.
Speaker #1: As Vin said, both placebo as well as NIAD, they are administered exactly the same way. And sure, for first 24 hours, we have a little bit more intense monitoring of blood tests to see how patients are responding to it.
Speaker #1: But after 24 hours, that intensity goes down and they basically all are very, very impressed that how little variability they are seeing in the test results.
Speaker #1: So that's quite a pleasant surprise to them that they don't have to chase their tails trying to keep the parameters within a target range.
Shakil Aslam: That's quite a pleasant surprise to them that they don't have to chase their tails trying to keep some, you know, the parameters within a target range. Once they have somebody stable, at a parameter, lab parameter, they basically stays the same value. Overall, I think, Shakeel Everybody is Yeah. Sorry. Shakeel, can you comment on the reach or the conclusion of that stability to get to the proper dose in that first hour and why that protocol works for them, and how we're Absolutely controlling that primary endpoint on that first hour? Right.
Shakil Aslam: That's quite a pleasant surprise to them that they don't have to chase their tails trying to keep some, you know, the parameters within a target range. Once they have somebody stable, at a parameter, lab parameter, they basically stays the same value. Overall, I think, Shakeel Everybody is Yeah. Sorry. Shakeel, can you comment on the reach or the conclusion of that stability to get to the proper dose in that first hour and why that protocol works for them, and how we're Absolutely controlling that primary endpoint on that first hour? Right.
Speaker #1: Once they have somebody stable at a parameter lab parameter, they basically stay the same value. So overall, I think everybody is yeah. Yeah.
Speaker #2: Shakil, can you comment on the reach or the conclusion of that stability to get to the proper dose in that first hour? And why that protocol works for them?
Speaker #2: And how we're basically controlling that primary endpoint on that first hour.
Speaker #1: Right. So as you know, this study we start at a starting dose. Which is predefined. And 15 minutes later, we check the activated clotting time by handheld device by the bedside, which we provide and we provide the cartridges as well.
Shakil Aslam: As you know, this study, we start at a starting dose, which is predefined, and 15 minutes later, we check the activated clotting time by a handheld device by the bedside, which we provide, and we provide the cartridges as well. It's pretty standardized tests across all sites. Within 15 minutes to check the value, and we have a certain range in which we want that value to be. About 70% of the cases, you see the ACT going in that range right at the first starting dose.
Shakil Aslam: As you know, this study, we start at a starting dose, which is predefined, and 15 minutes later, we check the activated clotting time by a handheld device by the bedside, which we provide, and we provide the cartridges as well. It's pretty standardized tests across all sites. Within 15 minutes to check the value, and we have a certain range in which we want that value to be. About 70% of the cases, you see the ACT going in that range right at the first starting dose.
Speaker #1: So it's a pretty standardized test across all sites. And within 15 minutes, they check the value, and we have a certain range in which we want that value to be.
Speaker #1: So about 70% of the cases you see the ACT going in that range right at the first starting dose. Occasionally, a patient rests 25% may need one and a couple of them may have needed even more than one titration, two titrations.
Shakil Aslam: Occasionally, a patient, that's 25%, may need 1, and a couple of them may have needed even more than 1 titration, 2 titrations, which is, by the end of 1st hour, everybody is in the range in which they are expected to be. Obviously, you know, I'm not gonna disclose for different groups because there's 1 placebo in which we don't expect the value to change much, but as expected, the value doesn't change. In active treatment, the value changes, but they remain within that range. It's a very, very stable response, which is not a total surprise to us because nefamostat's metabolism is really not dependent on any specific organ.
Shakil Aslam: Occasionally, a patient, that's 25%, may need 1, and a couple of them may have needed even more than 1 titration, 2 titrations, which is, by the end of 1st hour, everybody is in the range in which they are expected to be. Obviously, you know, I'm not gonna disclose for different groups because there's 1 placebo in which we don't expect the value to change much, but as expected, the value doesn't change. In active treatment, the value changes, but they remain within that range. It's a very, very stable response, which is not a total surprise to us because nefamostat's metabolism is really not dependent on any specific organ.
Speaker #1: Which is, by the end of the first hour, everybody is in the range in which they are expected to be. Obviously, I'm not going to disclose for different groups, because there's one placebo in which we don't expect the value to change much, but as expected, their value doesn't change, and in active treatment, the value changes.
Speaker #1: But they remain within that range. So it's a very, very stable response. And which is not a total surprise to us because Nephamostat's metabolism is really not dependent on any specific organ.
Speaker #1: So there are other drugs which either depend on liver or kidneys or any other organ for metabolism. And every time the function of those organs deteriorates or changes, you can see different response.
Shakil Aslam: There are other drugs which either depend on liver or kidneys or any other organ for metabolism, and every time the function of those organs deteriorates or changes, you can see different response and then, in whatever parameter you are following. Whereas the beauty about nefamostat, it really is not dependent on any organ. The most of these patients, they can have fluctuating organ function, which can affect other medications such as heparin being one example. Citrate is another example. If you have liver failure, citrate will not be metabolized as quickly. Nefamostat doesn't have those issues, that's the reason why once you hit the target level, it essentially remains stable. Does that answer your question? Shakil, Yeah. Yeah. Sure. Yeah, that's. If you could add a little color, that answers. Thank you.
Shakil Aslam: There are other drugs which either depend on liver or kidneys or any other organ for metabolism, and every time the function of those organs deteriorates or changes, you can see different response and then, in whatever parameter you are following. Whereas the beauty about nefamostat, it really is not dependent on any organ. The most of these patients, they can have fluctuating organ function, which can affect other medications such as heparin being one example. Citrate is another example. If you have liver failure, citrate will not be metabolized as quickly. Nefamostat doesn't have those issues, that's the reason why once you hit the target level, it essentially remains stable. Does that answer your question?
Speaker #1: And then in whatever parameter you're following. Whereas the beauty about Nephamostat, it really is not dependent on any organ. And most of these patients, they can have fluctuating organ function.
Speaker #1: Which can affect other medications, such as heparin being one example. Citrate is another example—if you have liver failure, citrate will not be metabolized as quickly.
Speaker #1: Nephamostat doesn't have those issues. So that's the reason why once you hit the target level, it essentially remains stable. Does that answer your question?
Speaker #2: Shakil, can I ask you?
Speaker #1: Yeah. Sure.
Vince Angotti: Shakil,
Shakil Aslam: Yeah. Yeah. Sure.
Speaker #2: Yeah, that's fine.
Ed Arce: Yeah, that answers. Thank you.
Speaker #3: I was going to add a little follow-up. Thank you.
Speaker #2: Shakil, a little bit more color. So on the administrative side, can you comment to the people on the line, how many of the sites are typically using citrate as a primary intervention for anticoagulation and CRT?
Vince Angotti: A little bit more color. On the administrative side, can you comment to the people on the line how many of the sites are typically using citrate as a primary intervention for anticoagulation in CRRT, and/or heparin as a primary intervention, both anticoagulation and CRRT? Sure. Of the 12 sites that we have, we don't have any site that uses citrate as a standard of care. There are 2 or 3 sites that will use citrate only if a patient continues to clot. These sites do not use heparin at all. The sites that are using citrate, they don't believe in heparin.
Vince Angotti: If you could add A little bit more color. On the administrative side, can you comment to the people on the line how many of the sites are typically using citrate as a primary intervention for anticoagulation in CRRT, and/or heparin as a primary intervention, both anticoagulation and CRRT?
Speaker #2: And/or heparin as a primary intervention of anticoagulation and CRT?
Speaker #1: Right. Sure. So of the 12 sites that we have that we don't have any site that uses citrate as a standard of care. So there are two or three sites that will use citrate.
Shakil Aslam: Sure. Of the 12 sites that we have, we don't have any site that uses citrate as a standard of care. There are 2 or 3 sites that will use citrate only if a patient continues to clot. These sites do not use heparin at all. The sites that are using citrate, they don't believe in heparin.
Speaker #1: Only if a patient continues to clot. And these sites do not use heparin at all. So the sites that are using citrate, they don't believe in heparin.
Speaker #1: So, the two or three sites that have access to citrate—they are not citrate-first users. They only use citrate as a rescue, as citrate is the only rescue they have.
Shakil Aslam: They, two or three sites that have access to citrate, they are not citrate first users, only use citrate as a rescue, as citrate is the only rescue they have. We have two sites, only one site that uses heparin as standard of care of all the sites that we have. We have two or three sites that use heparin as a rescue therapy. They don't use either citrate or heparin when the CRRT started, but if they see clotting, they don't have access to citrate, so then they go back to rescue heparin. Majority of our sites right now, I would say, you know, 10 out of 12 or 13 that we have, they don't really have any first-line anticoagulant that they use for every single patient. They are really using either heparin or citrate as a rescue.
Shakil Aslam: They, two or three sites that have access to citrate, they are not citrate first users, only use citrate as a rescue, as citrate is the only rescue they have. We have two sites, only one site that uses heparin as standard of care of all the sites that we have. We have two or three sites that use heparin as a rescue therapy. They don't use either citrate or heparin when the CRRT started, but if they see clotting, they don't have access to citrate, so then they go back to rescue heparin. Majority of our sites right now, I would say, you know, 10 out of 12 or 13 that we have, they don't really have any first-line anticoagulant that they use for every single patient. They are really using either heparin or citrate as a rescue.
Speaker #1: We have about two sites, but only one site that uses heparin as standard of care out of all the sites that we have. Then we have two or three sites that use heparin as a rescue therapy.
Speaker #1: So they don't use either citrate or heparin. When the CRRT started, but if they see clotting, they don't have access to citrate. So then they go back to rescue heparin.
Speaker #1: The majority of our sites right now—I would say 10 out of 12 or 13 that we have—they don't really have any first-line anticoagulant that they use for every single patient.
Speaker #1: They are really using a rescue. And we don't have any site that uses citrate for everybody.
Shakil Aslam: We don't have any site that uses citrate for everybody.
Shakil Aslam: We don't have any site that uses citrate for everybody.
Speaker #2: And I think importantly, Ed, when they execute the protocol in the nephro study, and the titration schedule, they see the ease of use whether it's placebo or controlled doesn't matter.
Vince Angotti: I think importantly, Ed, when they execute the protocol in the NEPHRO study and the titration schedule, they see the ease of use, whether it's placebo or control doesn't matter, placebo or active doesn't matter. It's just the ease of that titration schedule compared to what their historic, challenges have been with heparin and citrate. That seems to be the additional feedback.
Vince Angotti: I think importantly, Ed, when they execute the protocol in the NEPHRO study and the titration schedule, they see the ease of use, whether it's placebo or control doesn't matter, placebo or active doesn't matter. It's just the ease of that titration schedule compared to what their historic, challenges have been with heparin and citrate. That seems to be the additional feedback.
Speaker #2: Placebo or active doesn't matter. It's just the ease of that titration schedule compared to what their historic challenges have been with heparin and citrate.
Speaker #2: And that seems to be the additional feedback. Simplicity. Is the main comment.
Vince Angotti: Right.
Ed Arce: Right.
Vince Angotti: is the main comment.
Vince Angotti: is the main comment.
Speaker #1: Right. And nurses, even we spoke, I'm visiting a site today and the nurses, they were shocked. Okay, we don't have to do anything else?
Shakil Aslam: Right. The nurses, even we spoke, visiting a site today, and the nurses, they were, like, shocked. Okay, we don't have to do anything else? No, that's it. You know, that's all the monitoring that's required. Yeah.
Shakil Aslam: Right. The nurses, even we spoke, visiting a site today, and the nurses, they were, like, shocked. Okay, we don't have to do anything else? No, that's it. You know, that's all the monitoring that's required. Yeah.
Speaker #1: No, that's it. That's all the monitoring that's required. So, yeah. Yeah.
Speaker #3: That's very helpful. Thank you both.
Ed Arce: That's very helpful. Thank you both.
Ed Arce: That's very helpful. Thank you both.
Speaker #1: Sure.
Shakil Aslam: Sure.
Shakil Aslam: Sure.
Speaker #4: Thank you. There are no further questions at this time. I will now turn the call over to Vince. Please continue.
Operator: Thank you. There are no further questions at this time. I will now turn the call over to Vince. Please continue.
Operator: Thank you. There are no further questions at this time. I will now turn the call over to Vince. Please continue.
Speaker #2: Thank you, operator. And I'll just clarify my comment. I said earlier about the site names, the additional two that will be coming on. That'll be on clean trials.gov, clinicaltrials.gov.
Vince Angotti: Thank you, operator. I'll just clarify my comment I said earlier about the site names, the additional 2 that'll be coming on. That'll be on ClinicalTrials.gov, ClinicalTrials.gov, excuse me, in our next update of those sites. Again, thank you all for joining us on our first quarter earnings call. We're really very high on what's happening at the start of 2026 and the enrollment that's continuing to move forward. The NEPHRO study progress has been excellent. Our commitment, enthusiasm to bring the potentially new regional anticoagulant for CRRT to the market next year is unwavering. We appreciate your attendance today, and we're very excited about the future for the NEPHRO study as well as Talphera moving forward. We'll provide you additional updates on our progress, and thank you for joining us on the call today.
Vince Angotti: Thank you, operator. I'll just clarify my comment I said earlier about the site names, the additional 2 that'll be coming on. That'll be on ClinicalTrials.gov, ClinicalTrials.gov, excuse me, in our next update of those sites. Again, thank you all for joining us on our first quarter earnings call. We're really very high on what's happening at the start of 2026 and the enrollment that's continuing to move forward. The NEPHRO study progress has been excellent. Our commitment, enthusiasm to bring the potentially new regional anticoagulant for CRRT to the market next year is unwavering. We appreciate your attendance today, and we're very excited about the future for the NEPHRO study as well as Talphera moving forward. We'll provide you additional updates on our progress, and thank you for joining us on the call today.
Speaker #2: Excuse me. And our next update of those sites. So again, thank you all for joining us on our first quarter earnings call. We're really very high on what's happening at the start of 2026 in the enrollment that's continuing to move forward.
Speaker #2: The nephro study progress has been excellent. Our commitment, enthusiasm to bring the potentially new regional anticoagulant for CRT to the market next year is unwavering.
Speaker #2: So, we appreciate your attendance today, and we're very excited about the future for the nephro study as well as Telfera moving forward. We'll provide you additional updates on our progress.
Speaker #2: And thank you for joining us on the call today. Operator, that concludes our call.
Vince Angotti: Operator, that concludes our call.
Vince Angotti: Operator, that concludes our call.
Operator: Thank you very much. Ladies and gentlemen, this concludes today's conference call. Thank you for your participation. You may now disconnect.
Operator: Thank you very much. Ladies and gentlemen, this concludes today's conference call. Thank you for your participation. You may now disconnect.
