Q4 2024 Talphera Inc Earnings Call
Raffi Asadorian, Raffi
Raffi, Raffi, Raffi, Raffi Raffi.
Speaker Change: Welcome to the Talphera 4th quarter and clear 2024 financial results conference call. This call is being webcast live via the events page of the Investor section of Talphera's website www.talphera.com. You may listen to or apply this webcast by going to the Investor section of Talphera's website. I would now like to turn a call over to Raffi Asadorian. Talphera's Chief Financial Officer, please go ahead.
Speaker Change: Thank you for joining us on the call today. Today we announced our fourth quarter and full year 2024 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.
Speaker Change: Before we begin, I want to remind listeners that during this call, we will likely make forward-looking statements within the meeting of the federal securities laws.
Speaker Change: 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 Securities and Exchange Commission for Discussion of the Risks.
Speaker Change: Associated with such forward-looking statements. These documents can also be found on our website within the Investors section. Now, hand the call over.
Vince Angotti: Thanks, Raffi. Good afternoon, and thank you to everyone joining our call today.
Vince Angotti: We made strong progress in 2024 and anticipate furthering that progress in 2025 with the expectation that our Nefro CRRT studies should be completed by the end of the year.
Speaker Change: Rafi will provide additional details on the financing later in the call.
Speaker Change: I'll now provide key updates we've made to the Metro D. R. R. T study.
Speaker Change: As a reminder, the famous that has been approved and used for multiple indications in Japan, and South Korea, including as an anti coagulant for the extra poil circuit for well over 30 years.
Speaker Change: This extensive clinical use demonstrating its safety and efficacy in those territories as well as multiple studies performed outside the U S. We believe will be corroborated by the data being produced from the Neff row E. R. R. T clinical study.
Speaker Change: If approved <unk> would become the only FDA approved regional am I Quaggy went for use during continuous renal replacement therapy.
Speaker Change: We believe this profile would be impactful given the many disadvantages of the currently used products heparin, which is systemic in nature and citrate, which is being used off label.
Speaker Change: Importantly, we announced that the FDA approved our request for a reduction in the size of the NEF Road trial from 166 patients down to 70.
Speaker Change: And even with this significant study size reduction to 70 patients. The primary endpoint remains powered at 90%.
Speaker Change: This was a major step forward for the Tommy development of NIAD, we're staying for the FDA continues to meet or exceed the statutory timelines and responding to our requests.
Speaker Change: The Fda's responsiveness has been a key benefit of NIE adds breakthrough designation.
During the same meeting held with the FDA in January where we discussed the study size reduction.
Speaker Change: We also requested and the FDA approved two major protocol changes to the inclusion exclusion criteria.
Speaker Change: At a high level one we're now allowed to enroll patients that have been on C. R. R. T for over 48 hours.
Speaker Change: And two the inclusion criteria requiring documentation of heparin and tolerance has been removed for institutions that do not use heparin as part of their protocol.
Speaker Change: Which importantly is applicable to six of our seven current sites.
Speaker Change: All of these changes to the macro study are crucial modifications that support our projected timeline to complete the study by the end of the year.
Speaker Change: Dr. RASM will provide more details on what these changes mean and how we believe they will impact enrollment.
Speaker Change: Yeah.
Speaker Change: In parallel to our work on the regulatory front, making changes to the study protocol. We've also been focused on adding new clinical study sites.
Speaker Change: Not only is the number of sites important but also the site profile.
Specifically again won the type of intensive care unit, where the study will be performed for example, medical icu's instead of surgical or cardio thoracic icu's.
Speaker Change: To the specialty of the principle investigator specifically, a nephrologist as a primary lead for selecting patients to enroll compared to an intensivist or other specialists.
Speaker Change: And three the efficiency of the administration to initiate a new study at their institution.
Speaker Change: That drives them identified these site characteristics after its review and learnings from assessing the existing sites as critical to successful and timely enrollment.
Speaker Change: Okay.
Speaker Change: At the end of 2024, we had five enrollment ready site.
Speaker Change: Four of which were inherited relationships from our acquisition of lull therapeutics.
Speaker Change: And upon Doctor as well as review do not meet our ideal state profile moving forward.
Speaker Change: The fifth site identified by Tav Farah meets our target safe profile and has enrolled five of the six patients who have completed the study.
Speaker Change: The principal investigator at this institution as a nephrologist and is enrolling patients.
Speaker Change: From the medical ICU.
Speaker Change: We added three new sites in the first quarter two of which are just now starting to screen patients for a total of eight sites that are now enrollment ready.
Speaker Change: We expect to bring five additional sites on by mid year.
Speaker Change: Before I turn the call over to secure I want to reiterate our belief that the three critical risk elements clinical regulatory and commercial.
Speaker Change: For the net pro program are low for a number of reasons.
Speaker Change: First with over 30 years of use as an anti coagulate during CRT in Japan, and South Korea, We know in a famous stats track record of efficacy and safety minimizing the clinical risk.
The trial design has been agreed with the FDA, including broader inclusion criteria and a reduced number of patients all of which helped minimize execution risk.
Speaker Change: Second we have a clear regulatory path.
Speaker Change: Including breakthrough designation from the FDA, which has provided us with efficient access to the agency leave me to a quick review on response times.
Speaker Change: Yes.
Speaker Change: Lastly, while we know Theres always commercial risk. We believe this has mitigated given the disadvantages of the products currently being used for anti coagulation of the CRT circuit.
Speaker Change: <unk> heparin and citrate.
Speaker Change: In fact, we recently attended the 30th annual Hai and see our our team meeting in San Diego, where a number of physicians asked us if they could have accessed in the famous that to a compassionate use program, where neither heparin north citrate meet their needs.
Speaker Change: I'll now turn the call over to Dr. <unk>, who was named as tough ferrous Chief Medical Officer in October last year. He has been critical in instituting the major changes to the protocol as well as the site selection process.
Speaker Change: Dr RASM.
Speaker Change: Thank you Vince.
Speaker Change: We have been busy making changes to the study protocol.
Speaker Change: As well as evaluating effective it takes our clinical sites to improve but steady enrollment.
Speaker Change: I'm happy to say as we highlighted.
Speaker Change: We have had success on both fronts as the FDA has approved the changes with your question.
Speaker Change: We now better understand the profile of an ideal clinical site work is based on the trial.
Speaker Change: The three newest site have our targets profile with the highest thearchy volumes and grew up besides I guess beginning to screen patients.
Speaker Change: Our current total enrollment ready sites to eight seven of which are screening today.
Speaker Change: Before providing more information on the study site I would like to elaborate on the reasons. We believe the FDA agreed with our request to significantly reduce the study site.
Speaker Change: 166 patients to 70.
Speaker Change: With 156 patients. This study was overpowered with over 99% power to meet the primary endpoint.
Despite a significant tax reduction it is important to note that even with 70 patients. The study had at least 90% power to meet the primary endpoint.
Speaker Change: You are probably wondering why this study, but so overpowered in the first place.
Speaker Change: It is our understanding that lull quite a few days proposed a steady diet of 166 patients to assure the FDA that a sufficient number of patients would be exposed to <unk> from a safety perspective.
Speaker Change: And our meeting with the FDA in January we presented the safety data from the existing large safety data sets and the published literature on the real world use often the bandwidth that across multiple indications in Japan, and South Korea, but over 30 years.
Speaker Change: We were able to assure the FDA that and the bandwidth that <unk> safety and a favorable benefit risk profile based on over three decades of use across multiple indications, including CRT.
Speaker Change: Based on the screening data from our active study sites and input from Ipi.
Speaker Change: We identified two eligibility criteria, which you are responsible for several screen failures and could be modified without affecting the study outcome.
Speaker Change: The first was an exclusion criterion, which excluded patients from the study if they had been on CRT are more than 48 hours.
Speaker Change: The site's informed us that many patients who are started on CRD late Friday at over the weekend with no longer eligible by the time the study team on Monday.
Speaker Change: The FDA allowed us to remove this exclusion criterion agreeing with that rationale that time on CRT before steady enrollment had no impact on the primary endpoint.
Speaker Change: <unk> patients, but excluded from the study because of this criterion.
Speaker Change: Believe this protocol change will be impactful to the enrollment speed going forward.
Speaker Change: Okay.
Speaker Change: The second change we requested was the inclusion criterion that acquired the site to document either in progress or counter indication to happening.
Speaker Change: We found with requirement irrelevant and restrictive.
Speaker Change: As many institutions, including most of our study sites do not use happening during CRT.
Speaker Change: The FDA agreed to remove this requirement for these sites.
10 patients were excluded from the study because of this criterion.
Speaker Change: As a note only one of our current sites use it happening, but anticoagulation during CRT.
Speaker Change: And this dissatisfaction with heparin is universal amongst the physicians with Fitbit.
Speaker Change: Okay.
Speaker Change: In addition to these protocol changes, we analyze the screening data to understand the study sites profile bandwidth predict better patient enrollment.
Speaker Change: We identified an ideal type profile based on the type of ICU.
Speaker Change: Specialty of the principal investigator and the time to complete the startup paperwork. The startup activities were the main bottleneck and site activation previously.
Speaker Change: As part of our strategic review we identified.
Speaker Change: Nephrologist led sites, who are an important differentiator.
Speaker Change: <unk> followed this effectively beside on cri to use and study enrollment.
Speaker Change: The other key factor was the type of ICU.
Speaker Change: We determine that medical ICU, what the most appropriate hydro ICU, but steady enrollment.
Speaker Change: In contrast, our initial less productive sites in July on the cardio traffic and general surgical ICU.
We had most patients on CRP, we receive systemic happening, but other indications are out actively.
Speaker Change: Excluding criteria for NAPCO enrollment.
Speaker Change: The one initial site that has been done has been the most productive has the nephrologist has the pie.
Speaker Change: With all enrolled patients coming from the medical ICU.
Speaker Change: As a result, our new and future sites targeting Nephrologist has the Ti.
Speaker Change: And draw patients primarily from the medical ICU.
Speaker Change: It includes the two new sites that just began screening and six additional sites expected to be activated in the first half of 2025.
Speaker Change: All of which are similar in profile to our current highest enrolling sites, but with highest thearchy volumes.
Speaker Change: Our most productive current site has about 20 patients.
Speaker Change: Patients per month, while the three new enrollment ready sites range historically between 90 and 180 patients per months.
Speaker Change: With many of the additional sites planned by midyear, having even higher monthly ACI hockey volumes.
Speaker Change: Because of our collection of sites with a quick administrative timeline, we have experienced a much shorter time for their activation.
Speaker Change: Example, our most recent site took us less than four months to activate.
Speaker Change: <unk> over a year for some of the initial sites.
Speaker Change: In summary, we expect to have 13 sites enrollment ready for midyear and we continue to pursue additional sites after the limit up 14.
Vince Angotti: And with that I'll turn the call over to Vince.
Speaker Change: Okay.
Speaker Change: Thank you Dr. Azlon I'd like to highlight Dr. <unk> expertise in CRT and experienced both drug and device trials. During this accomplished career that have facilitated these enhancements to the program.
Speaker Change: I'll now hand, the call over to Rafi for a financial update.
Rafi: Thanks Vince.
Rafi: As mentioned, we have been highly focused on delivering a completed <unk> study by the end of this year.
Rafi: Accordingly, we have reduced our operating expenses to reflect this objective.
Rafi: Also as announced earlier today, we signed agreements with investors regarding our private placement financing with existing and new fundamental investors led by not the hull of capital and Rosalind advisors, who remain committed and supportive shareholders.
Rafi: The amount of the financing is expected to provide capital to support the targeted completion of the study by the end of 2025.
Rafi: The financing was structured in three equal tranches of $4 $9 million to $5 million.
Rafi: With the first tranche received at the initial closing.
Rafi: Expected shortly here in April.
Rafi: And the two additional tranches based on achieving an enrollment of 17 patients in 35 patients and with the stock trading above 73 per share.
Rafi: In total the $14 8 million dollar commitment is expected to be achieved later this year as we expect acceleration in enrollment rates given all the changes made to the Neff Rosie R. R. T study.
Rafi: And the new sites that are coming online.
Rafi: As mentioned this financing combined with the $8 $9 million in cash at December 31, 2024 supports the completion of this study anticipated by the end of the year.
Rafi: Our combined R&D and SG&A expenses for the fourth quarter of 2024 totaled $3 million compared to $4 $6 million for the fourth quarter of 2023.
Rafi: Okay.
Rafi: Excluding noncash stock based compensation expense. These amounts were $2 $8 million for the fourth quarter of 2024 compared to $4 3 million for the fourth quarter of 2023.
Rafi: The decrease in combined R&D and SG&A expenses in the fourth quarter of 2024 was primarily due to reductions in personnel expense and other general and administrative expenses.
Speaker Change: We expect cash operating expenses, our SG&A and R&D, excluding stock based compensation to be in the range of $18 million to $19 million in 2025, I'll now turn the call back to the events.
Rafi: Thank you Rafi.
Rafi: Before we open the line for questions I'll reiterate that we have made significant improvements in the study designed in concert with the FDA.
We now have an improved trial design with the right types of ICU is operating sites and I look forward to sharing our progress in the night Registrational trial over the course of the year.
Rafi: And I'd like to open the lineup for any questions you might have operator.
Rafi: Thank you.
Rafi: Ladies and gentlemen, we will now begin the question and answer session.
Rafi: Should you have a question. Please press the star followed by the number one on your Touchtone phone.
Rafi: You'll hear a prompt that you had has been raised.
Rafi: Should you wish to decline from the polling process. Please press the star followed by the number too.
Rafi: Fewer using a speaker phone please lift the handset before pressing any keys.
Rafi: One moment. Please for your first question.
Speaker Change: Your first question is from Ed Arce from H C. Wainwright. Please go ahead.
Speaker Change: Hi, Good afternoon, everyone. This is Thomas Yip asking a couple of questions for Eric. Thank you so much for the kind of questions.
Speaker Change: So first regarding the changes.
Speaker Change: The inclusion criteria that was formally approved by the FDA.
Speaker Change: So I think our mix of ourselves.
Speaker Change: But can you discuss.
Speaker Change: The original line of thoughts or excluding these patients in the previous political.
Speaker Change: So we'll have that over to Shaquille again. The question is changes in the inclusion criteria and what were the original thoughts on let me I just wanted to assure Thomas why that protocol was written originally as it was with law.
Speaker Change: Yes, yes, that's what I meant.
Speaker Change: So <unk> you want to answer that thats relative to the heparin and relative to the 48 hours on CRT and why they were originally included that way.
Speaker Change: So.
Speaker Change: Since I was not part of the initial protocol development. So.
Speaker Change: I can only guess.
Speaker Change: The reason that Mick.
Speaker Change: Medical sense from my point of view.
Speaker Change: So 48 hours.
Speaker Change: Restriction, perhaps was done.
Speaker Change: You were to look at some important clinical endpoint.
Speaker Change: And my thinking on this one since we are not really looking at clinical endpoint as the primary efficacy endpoint.
Speaker Change: Time on CRT.
Speaker Change: Had no impact on how somebody is going to respond to but not yet so so thats why we change it but my understanding is that because of.
Speaker Change: Impact that.
Longer duration on <unk> for example could have patients for a longer on CRP. They may take longer time to recover their kidney function or they may have higher mortality.
Speaker Change: They are not recovering the kidney quick enough. So that's my.
Speaker Change: At my I guess that was the reason.
Speaker Change: The second in terms of counter indication to use up happening fda's position has been that.
Speaker Change: Happiness, the FDA approved for this indication and it is and perhaps should be used or at least offer to every patient who starts on CRD.
Speaker Change: As we approach many of these sites and activated these sites, we did not find that to be the case, but we found that the most of the sites were not offering happening at all to their patients.
Speaker Change: So as a result, it <unk> make any sense for us to acquire these sites to document counter indication to use up happening.
Speaker Change: The FDA.
Vince Angotti: As Vince mentioned also agreed to remove that restriction.
Speaker Change: Does that answer your questions.
Speaker Change: Yes. Thank you so much for clarification.
Speaker Change: Updated endpoint.
Speaker Change: Jill can I ask you also to quickly elaborate on why.
Speaker Change: These institutions decided not to use heparin for the most part.
Speaker Change: In your clinical experience in discussion with these sites what has been their main rationale for those on the phone today to understand why they are not using the heparin, even though it's indicated for this condition.
Speaker Change: Alright. So there are many reasons I think overall most institutions do not feel that the risks from happening.
Speaker Change: Justify the use up happening routinely in all patients.
It's kind of difficult to use in this patient population number one it has a long half life approximately two to three hours and the half life can change and within the same patient. So that makes it very difficult to use and titration of happening is quite difficult.
Speaker Change: It takes a while before you titrate to their target.
Speaker Change: Our therapeutic.
Speaker Change: Activated proton beam time, which is the market that we use in the clinic.
Speaker Change: And I think the most important thing perhaps is that.
Speaker Change: Pamuk Anticoagulants. So you were trying to prevent clotting and its circuit, which is outside of the body. So there really is no justification to expose the whole patients do anticoagulation because these patients are very high risk of.
Speaker Change: Bleeding from many organs and so this increases the risk of systemic bleeding. So those out I think my.
Speaker Change: Bob few reasons, why I never liked at acting and most physicians don't.
Joe: Thanks, Joe.
Speaker Change: Got it.
Joe: Thank you so much.
Joe: Perhaps a couple of questions regarding this private placement.
Joe: That was about.
Joe: With us today.
Joe: Just wonder the second and third milestones.
Joe: The patient that Reuben 17.
Joe: <unk> respectively.
Joe: Is there any time limit to these achievements.
Milestones.
Joe: No theyre not.
Joe: Okay, So just to be clear.
Joe: From being will trigger.
Joe: So.
Joe: For the number of patients being enrolled and also the share price.
Joe: Frankly.
Joe: <unk>.
Joe: That's correct, yeah as opposed to and some normal closing conditions, but yes that is correct.
Joe: Okay. Okay and then one final question on also on the private placement just whether you have disclosed.
Joe: Which remember management team participated in it and also.
Joe: Whats the amounts.
Joe: Yes.
Joe: We didn't but it's Vince.
Joe: Okay.
Joe: That would be me Thomas.
Joe: Any member of management.
Joe: And youll see the amounts I suspect with the filing Martha.
Speaker Change: Alright, great.
Speaker Change: Thank you so much what's kind of a question for Jeff.
Speaker Change: Looking forward to hear in progress or for this study throughout the year.
Speaker Change: Thanks Thomas.
Speaker Change: Yes.
Speaker Change: The next question is from Jim Molloy from Alliance Global Partners. Please go ahead.
Speaker Change: Hey, guys, it's Matt on for Jim Congrats on the quarter and the.
Speaker Change: Private placement this morning.
Speaker Change: First question I wanted to follow up.
Speaker Change: On the private placement for those milestones in 2017, and 35 patients had <unk> guided at all to when you might see that come in 17, maybe next quarter is that fair assumption.
Speaker Change: Yes, we havent, but yeah, we're expecting kind of mid mid year for the first one in.
Speaker Change: Third third quarter or so for the for the second one.
Speaker Change: Okay Gotcha.
Speaker Change: Yeah.
Speaker Change: And then as far as the existing sites do you have any plan to shift the ti to Nephrologists and maybe make those sites look a little bit more like the highest enrolling is that a possibility.
Speaker Change: Yeah, I'm going to I'm going to turn that one over to Shaquille and just preface. It by Shaquille can you also include in your answer.
Speaker Change: As we continue to find highly productive sites that really meet our criteria with a high number of CRT patients.
Speaker Change: One would you ever consider deactivating, the unproductive sites and two especially with the demand that we're starting to see to get into the trial into for those sites that we have been very close with which is all of them. The work you're doing to potentially shift those pies over to the specialty that most fit our needs.
Speaker Change: Absolutely. So yes that is the case, we are in discussions with these.
Speaker Change: And to see it.
Speaker Change: Either they can ship the primary responsibility to a nephrologist or they can broaden their.
Ah patient population by including medical ICU.
Speaker Change: In terms of closing any of the sites that are not being productive I think thats and thats possible.
Speaker Change: Once we recognized so close to getting the 14 sites up and running and by then if any of these sites have not performed well.
Speaker Change: Wed like to swap them for a better performing sites. So right now we have a lot of interest in joining this study.
Speaker Change: And we are activating those sites as quickly as we can.
Speaker Change: I think an important additional color I'll add on that.
Speaker Change: <unk>.
Speaker Change: These sites.
Speaker Change: Or the ones that really brought to our attention the challenges they were experiencing with the protocol and the two particular exclusion criteria, so kudos to them, even though they haven't been as productive on their engagement and enthusiasm for the study.
Speaker Change: And I think you have to remember these are very prominent sites around the country related to the reputation of the institutions.
Speaker Change: And the pies are extraordinary but these are the same <unk> that worked with the founding company law and prior to that La Jolla on geopressured.
Speaker Change: Which is a vasopressor and then it starts to make a lot of sense the comfort level with these pies as intensivists.
Speaker Change: In the ICU as they were pulling from being cardio thoracic indoor surgical and I think that lull slash.
Speaker Change: Oil leaned on those relationships.
Speaker Change: Jordan Aerie talents.
Speaker Change: It might not be the best fit as Dr. RASM is explained for many reasons for this particular study.
Speaker Change: Okay.
Speaker Change: Got it okay. Thank you for the color I appreciate that and lastly.
Speaker Change: Do you have any clues yet to the enrollment rate.
Speaker Change: New revised criteria and.
Speaker Change: Or should we assume those six patients that have completed the study RMB 50 patients fully that have been enrolled.
Speaker Change: As of right now.
Speaker Change: Yes, yeah. So those are the original six again I'll reiterate we said in the script that five of those six are coming from one of the institutions that we had identified to add it to the study.
Speaker Change: Yes.
Speaker Change: That really met the criteria that Doctor Azlan has framed out moving forward.
Speaker Change: Got it and any clues to the enrollment rate going forward based on these new criteria that has been agreed upon by the FDA or is it too early to tell.
Speaker Change: No I think I think it's too early to tell again I'll reiterate what we said that we had 25 patients excluded since the enrollments started the trial for these two criteria.
Speaker Change: Turn on one in 15 on another I think it was <unk> 15 on the 48 hours 10 on the heparin exclusion. So you can see a number of patients were screened out from these original.
Speaker Change: Sites based off of those two criteria.
Speaker Change: We expect those original sites to have some production moving forward, but we really expect that change in the criteria to more heavily affect these higher potential sites remember his doctor as Lynn said, our most productive site to date is averaging about 20 C. R T patients per <unk>.
Speaker Change: Months.
Speaker Change: With the sites that Doctor Azlon, just activate it and just started screening.
Speaker Change: They're averaging historically, no there's peaks and troughs, but on average between 90 and 100 CR patients per month. So you see the magnitude of.
Speaker Change: <unk> potential penetration of that population and then the additional state stocked RASM is engage that we planned up having by mid year.
Speaker Change: Some of those are even larger than those sites that are averaging 90 to 100 CRT patients per month. So it starts exponentially rising the pool of patients we can pull from and.
Speaker Change: That should work in concert with the inclusion exclusion criteria the FDA just granted us.
Speaker Change: Alright, great. Thanks for the color guys. Congrats on the progress and thanks for taking my questions.
Speaker Change: Thanks, Matt.
Robin: The next question is from Robin <unk> from Maxim Group. Please go ahead.
Robin: Hi, everyone. Thanks for taking my question and congrats on the progress.
Robin: Contact of everyone happened, what ultimately gives you confidence that you could have the base you can see in the data by the end of the year you are saying that it still takes four months give or take two initiated therapy, which is faster than before but that still seems like it would take a while to initiate additional screening and initiate additional site.
Robin: Which.
Robin: And take us into mid year.
Robin: That considered what gives you confidence you can have the data by the end of the year.
Yeah. So I can start on the answer that question Shaquille, maybe you can add some additional color so far original.
Speaker Change: Seven sites you mentioned that we have two more we plan on adding here actually in April. So it's very early on it's not an additional four months from here.
Speaker Change: And then the balance of the sites to get us to the 13 that were currently engaged with will be by mid year. So it's not four months starting from now.
Speaker Change: We're already well into it with two of the sites.
Speaker Change: And then fairly far along with the additional sites to get us to the 13 by mid year. When you just do the math on that Nos.
Speaker Change: I mean, you're looking at 13 sites with the balance of.
Speaker Change: 64 patients left to enroll so one to one five patients per month with exponentially larger populations as I just outlined.
Speaker Change: I think from an engagement standpoint or other.
Speaker Change: There may be Shaquille you can add some color on the new sites.
Speaker Change: Engagement.
Speaker Change: The teams and the profile that we've kind of already reiterated.
Speaker Change: Okay.
Speaker Change: The <unk>.
Speaker Change: Shaquille you might be muted sir.
Speaker Change: Sure.
Speaker Change: Okay. Thank you, yes, so the biggest change that we.
We are seeing is the level of engagement.
Speaker Change: From the Nephrologist and now Nephrologist deal with this issue.
Speaker Change: Antique regulating these patients and how do antique regulate to just that.
Speaker Change: Circuit and not the patient.
Speaker Change: They deal with this issue.
Speaker Change: And every single time, they started patients on <unk>. So this is an issue, which really is very very close to them.
Speaker Change: The biggest difference that I see is.
Speaker Change: These neurologists they are helping us with the paperwork they want and the families that are available to further their patients most of them don't use happening most of them do not to use citrate and they want an option.
Speaker Change: They don't have to throw away the circa 76 to eight hours in some of these patients. So that level of engagement is what gives me a lot of confidence that they are actually going to go and look for those patients. They know that this is not a big study and if they can help us and we can actually get this product in their hand.
Speaker Change: Sure.
Speaker Change: Next year, so I think that is.
Speaker Change: The most confidence inspiring part of this.
Speaker Change: And these new sites that I'm seeing.
Vince Angotti: And Vince you've been talking to some of those people as well I don't know how you felt about the degree of involvement and how enthusiastic they are.
Vince Angotti: Yes, I think it's very similar to Dr. Dr. Roslyn, they've engaged but not that the engagement from the previous ones wasn't high.
Vince Angotti: But the Nephrologist make a big difference because this is their world everyday that they are in the hospital <unk>.
Speaker Change: Alright, Thank you it sounds very helpful.
Vince Angotti: Thanks.
Vince Angotti: Okay.
Speaker Change: There are no further questions at this time. Please proceed with closing remarks.
Okay again, thank you for joining our <unk> earnings call, but we're excited about the study modifications to address enrollment and the continued alignment with the FDA.
Speaker Change: In particular with the goal of completing the <unk> trial in 2025, and an FDA approval overnight in 2026 and will remain disciplined on our cash management and we look forward to providing additional updates on our progress.
Speaker Change: Thank you for all your interest and that concludes our call.
Speaker Change: Ladies and gentlemen, this concludes your conference call for today, we thank you for participating.
Speaker Change: These disconnect your lines.