Q2 2024 Talphera Inc Earnings and Business Update Call

Welcome to Talphera's second quarter 2024 financial results conference call. This call is being webcasted live via the events page of the investor section of Talphera's website at www.talphera.com.

Operator: This call is being webcasted live via the events page of the investor section of Talphera's website at www.talphera.com. This call is the property of Talphera, and any recording, reproduction or distribution of this call, without the express written consent of Talphera, is preempted.

Operator: This call is being webcasted live by the events page of the Investors section of the Ferris website at www.tulfhera.com.

Operator: This call is the property of Tulfhera, and any recording, reproduction, or transmission of this call without the express written consent of Tulfhera is prohibited. As a reminder, this webcast is being recorded. You may listen to a replay of this webcast by going to the Investors section of Tulfhera's website.

Speaker Change: This call is the property of Talphera, and any recording, reproduction, or transmission of this call without the express written consent of Talphera is prohibited.

Raffi Asadorian: As a reminder, this webcast is being broadcast, and you may listen to a replay of this webcast by going to the investor's section of Talphera's website. I would now like to turn the call over to Raffi Asadorian, Talphera's Chief Financial Officer. Thank you for joining us on the call today. This afternoon, we announced our second quarter 2024 financial results and associated business updates in a press release This press release can be found in the Investors section of our website.

As a reminder, this webcast is being recorded. You may listen to a replay of this webcast by going to the investor section of Telfera's website.

Raffi Asadorian: I would not like to turn the call over to Raffi Asadorian, but Ferris Chief Financial Officer.

Speaker Change: I would now like to turn the call over to Raffi Asadorian, Dolph Harris' Chief Financial Officer.

Vincent Angotti: Thank you for joining us on the call today. This afternoon, we announced our second quarter of 2024 financial results and associated business updates and a press release. This press release can be found within the Investors section of our website.

Raffi Asadorian: Thank you for joining us on the call today. This afternoon, we announced our second quarter 2024 financial results and associated business updates in a press release.

Speaker Change: This press release can be found within the investors section of our website. With me today are Vince Angotti, our Chief Executive Officer, and Dr. Pam Palmer, Talphera's founder and Chief Medical Officer.

Vincent Angotti: With me today, are Vince Angotti, our Chief Executive Officer, and Dr. Pam Palmer, Talphera's Founder and Chief Medical Officer. Before we begin, I want to remind listeners that during this call, we will 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 Tulfhera. 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 a discussion of the risks associated with such forward-looking statements. These documents can be found on our website within the Investors section.

Raffi Asadorian: With me today are Vince Angotti, our Chief Executive Officer, and Dr. Pam Palmer, Talphera's Founder and Chief Medical Officer. Before we begin, I want to remind listeners that during this call, we will 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 Securities and Exchange Commission for a discussion of the risks associated with such forward-looking statements. These documents can be found on our website within the Investors section.

Speaker Change: Before we begin, I want to remind listeners that during this call, we will 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.

Speaker Change: 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 a discussion of the risks associated with such forward-looking statements. These documents can be found on our website within the Investors section.

Vincent Angotti: I will now hand the call over to Vince.

Vincent Angotti: Thank you, Raffi. Good afternoon, and thank you for joining us on the call.

Vincent Angotti: I will now hand the call over to Vincent. Thank you, Raffi. Good afternoon, and thank you for joining us on the call. Before jumping into the updates for the quarter, I'd like to congratulate Dr. Palmer on her decision to retire this coming October. Pam was the co-founder and chief medical officer of the company, as well as a dedicated leader for nearly two decades.

Speaker Change: I will now hand the call over to Vince.

Vince Angotti: Thank you, Raffi. Good afternoon, and thank you for joining us on the call. Before jumping into the updates for the quarter, I'd like to congratulate Dr. Palmer on her decision to retire this coming October.

Vincent Angotti: Before jumping into the updates for the quarter, I would like to congratulate Dr. Palmer on her decision to retire this coming October. Pam was the co-founder and Chief Medical Officer of the company, as well as a dedicated leader for nearly two decades. Dr. Palmer is a renowned physician, pioneer, and long-time entrepreneur with a mission to improve care for patients in the medically supervised setting. Pam has made remarked in the World of Pharmaceuticals and Health Care and met her countless people along the way who will continue her legacy. What she may be retiring, Dr. Palmer will continue to advise Tulfhera and support Dr. Shaquille-Azlam until the Neffros study has been completed and the potential FDA approval of NIET is received.

Speaker Change: Pam was the co-founder and chief medical officer of the company, as well as a dedicated leader for nearly two decades.

Vincent Angotti: Dr. Palmer is a renowned physician, pioneer, and long-time entrepreneur with a mission to improve care for patients in the medically supervised setting. Pam has made her mark in the world of pharmaceuticals and health care and mentored countless people along the way who will continue her legacy. Well, she may be retiring, but Dr. Palmer will continue to advise Talphera and support Dr. Shaquille Aslam until the Neffro study has been completed, and the potential FDA approval of Nia is received. So please join me in wishing her all the best in her return.

Speaker Change: Dr. Palmer is a renowned physician, pioneer, and longtime entrepreneur with a mission to improve care for patients in the medically supervised setting.

Speaker Change: Pam has made her mark in the world of pharmaceuticals and healthcare and mentored countless people along the way who will continue her legacy.

Speaker Change: Well, she made me retiring, Dr. Palmer will continue to advise Telfera and support Dr. Shakil Aslem until the NEPHROS study has been completed and the potential FDA of approval of NIA is received.

Vincent Angotti: So please join me in wishing her all the best in her retirement. I'm happy to report that we now have multiple site screening patients in the study. We had a busy quarter continuing to work through the administrative processes encountered at the academic institutions where the Neffros study will be conducted. And we have finalized clinical trial agreement terms now with eight large academic institutions, including our potentially highest enrolling sites. The final four site initiation visits of these initial eight institutions are scheduled to be completed this month. While each institution is at their own unique upfront administrative activities, once enrolling, we do not expect additional delays as the protocol dictates how the study is conducted.

Speaker Change: So please join me wishing her all the best in her return.

Vincent Angotti: I'm happy to report that we now have multiple screening sites in the study. We had a busy quarter continuing to work through the administrative processes encountered at the academic institutions where the NEPRWO study will be conducted. And we have finalized clinical trial agreement terms now with eight large academic institutions, including our potentially highest enrolling site. The final four site initiation visits of these initial eight institutions are scheduled to be completed this month. Well, each institution has had its own unique upfront administrative activities.

Speaker Change: I'm happy to report that we now have multiple site screening patients in the study.

Speaker Change: We had a busy quarter, continuing to work through the administrative processes encountered at the academic institutions where the NETPRO study will be conducted.

Speaker Change: and we have finalized clinical trial agreement terms now with eight large academic institutions including our potentially highest enrolling sites.

Speaker Change: The final four site initiation visits of these initial eight institutions are scheduled to be completed this month.

Speaker Change: While each institution has had their own unique upfront administrative activities, once enrolling, we do not expect additional delays as the protocol dictates how the study is conducted.

Vincent Angotti: Once enrollment is completed, we do not expect additional delays as the protocol dictates how the study is conducted. NIAID's breakthrough designation has continued to prove valuable in our interactions with the FDA. Our ongoing real-time communications with the FDA regarding the study have been efficient, and we expect this to continue as we progress the study over the coming months. For example, we recently requested and promptly received the FDA's approval to increase the number of nephrostudy sites to a maximum of 14.

Vincent Angotti: and I as Breakthrough Designation has continued to prove valuable in our interactions with the FDA. Our ongoing real-time communications with the FDA regarding the study have been efficient, and we expect this to continue as we progress the study over the coming months. For example, we recently requested and promptly received the FDA's approval to increase the number of Neffro study sites to a maximum of 14. We sought this approval to one expedite study completion by increasing the number of high-volume CRRT institutions and to maintain access to a broad patient population to inform healthcare providers on the use of NIAD, if approved.

Speaker Change: NIAID's breakthrough designation has continued to prove valuable in our interactions with the FDA. Our ongoing real-time communications with the FDA regarding the study have been efficient and we expect this to continue as we progress the study over the coming months.

Speaker Change: For example, we recently requested and promptly received the FDA's approval to increase the number of nephrostudy sites to a maximum of 14.

Vincent Angotti: We sought this approval to expedite study completion by increasing the number of high-volume CRRT institutions and to maintain access to a broad patient population to inform healthcare providers on the use of niad if approved. Dr. Asom's nephrology expertise and established professional network have already proven invaluable in identifying this expanded base of potential clinical sites in support of the study. That's what was communicated on the last call.

Speaker Change: We sought this approval to, one, expedite study completion by increasing the number of high-volume CRRT institutions.

Speaker Change: and to maintain access to a broad patient population to inform health care providers on the use of niat if approved.

Vincent Angotti: Dr. Aslam's nephrology expertise and established professional network has already proven invaluable in identifying this expanded base of potential clinical sites in support of the study.

Speaker Change: Dr. Asim's nephrology expertise and established professional network has already proven invaluable in identifying this expanded base of potential clinical sites in support of the study.

Vincent Angotti: As communicated on the last call, Dr. Aslam joined Talphera as our new Chief Development Officer on May 20th. Dr. Aslam has over 20 years of clinical research experience specializing in nephrology. Dr. Aslam joined us from Bio-Christopharmaceuticals, where he served as vice president, clinical development, nephrology, and rare diseases. He's helped development roles at Angian, Przenius, and Angian, and was an assistant professor at Georgetown University Hospital for 12 years, focused on clinical care of acute and chronic kidney disease, hypertension, renal transplantation, and other nephrological diseases. Dr. Aslam's extensive experience across industry and academia as a renal expert, particularly in the design and conduct of both drug and device clinical trials, is impressive and a true asset to our organization.

Vincent Angotti: Dr. Aslam joined Talphera as our new chief development officer on May 20th. Dr. Aslam has over 20 years of clinical research experience specializing in nephrology. Dr. Asim joined us from BioChris Pharmaceuticals, where he served as Vice President, Clinical Development, Nephrology, and Rare Diseases. He's held development roles at Angion, Presenius, and Amgen, and was an assistant professor at Georgetown University Hospital for 12 years, focused on clinical care of acute and chronic kidney disease, hypertension, renal transplantation, and other nephrological diseases.

Speaker Change: Now, as communicated on the last call,

Dr. Aslem: Dr. Aslam joined Talphera as our new Chief Development Officer on May 20th.

Speaker Change: Dr. Asim has over 20 years of clinical research experience specializing in nephrology. Dr. Asim joined us from Biocris Pharmaceuticals where he served as vice president clinical development nephrology and rare diseases.

Speaker Change: He's held development roles at Angion, Fresenius, and Amgen, and was an assistant professor at Georgetown University Hospital for 12 years, focused on clinical care of acute and chronic kidney disease, hypertension, renal transplantation, and other nephrological diseases.

Vincent Angotti: Dr. Asam's extensive experience across industry and academia as a renal expert, particularly in the design and conduct of both drug and device clinical trials, is impressive and a true asset to our organization. Immediately upon joining Talphera, Dr. Asam immersed himself in establishing and fostering Talphera's relationships with our selected NEFRO institutions and research personnel, including personally conducting site initiation activities and training of the institutional teams. Importantly, the balance of our eight sites, including our potentially largest enrolling sites, should be enrollment ready in the coming weeks, and we're not prepared to provide guidance on expected steady completion in PMA following this timeline. Our engagement with the principal investigators remains high.

Speaker Change: Dr. Asam's extensive experience across industry and academia as a renal expert, particularly in the design and conduct of both drug and device clinical trials, is impressive in the true asset to our organization.

Vincent Angotti: Immediately upon joining Talphera, Dr. Aslam immersed himself in establishing and fostering Talphera's relationships with our selected nephro institutions and research personnel, including personally conducting site initiation activities and training of the institutional teams. Importantly, the balance of our eight sites, including our potentially largest enrolling sites, should be enrollment ready in the coming weeks. And what we're not prepared to provide guidance on expected study completion in PMA filing timelines, our engagement with the principal investigators remains high. And we believe the study will enroll efficiently at the sites. Recall that the primary endpoint of activated clotting time is measured over 24 hours, with the patient completing the study after activated clotting time is assessed at 72 hours, which is also a secondary endpoint.

Speaker Change: Immediately upon joining Talphera

Speaker Change: Dr. Asim immersed himself in establishing and fostering Talphera's relationships with our selected Nefro institutions and research personnel, including personally conducting site initiation activities and training of the institutional teams.

Speaker Change: Importantly.

Speaker Change: The balance of our eight sites, including our potentially largest enrolling sites, should be enrollment ready in the coming weeks.

Speaker Change: And while we're not prepared to provide guidance on expected study completion and PMA filing timelines, our engagement with the principal investigators remains high, and we believe the study will enroll efficiently at the sites.

Vincent Angotti: And we believe the study will enroll efficiently at the site. Recall that the primary endpoint of activated clotting time is measured over 24 hours. For the patient completing the study after activated clotting time is assessed at 72 hours, which is also a secondary endpoint. These relatively short study time points, combined with a patient population of only 166 patients.

Speaker Change: Recall that the primary endpoint of activated clotting time is measured over 24 hours, with a patient completing the study after activated clotting time is assessed at 72 hours, which is also a secondary endpoint.

Vincent Angotti: These relatively short study time points combined with a patient study population of only 166 patients and now expansion to 14 study sites should support the fishing completion of the study once fully underway.

Speaker Change: These relatively short study time points.

Speaker Change: combined with a patient study population to 14 study sites should support efficient completion of the study once fully underway.

Vincent Angotti: And now, expansion to 14 study sites should support efficient completion of the study once fully underway. We expect to provide an updated timeline for study completion. PMA filing, and anticipated PMA approval on our next quarterly call. Meanwhile, the clinical study is ongoing. We've been working on pre-launch commercial activities in preparation for the commercial launch of NIAID, again, if approved. This has included further market research for the group of nephrologists, intensivists, and pharmacy directors.

Vincent Angotti: We expect to provide an updated timeline for study completion, PMA filing, and anticipated PMA approval on our next quarterly call. While the clinical study is ongoing, we've been working on pre-launch commercial activities in preparation for the commercial launch of NIAD, again, if approved. This has included further market research for the group of nephrologists, intensivists, and pharmacy directors. The participants in our research group highlighted in a famous that strong safety profile over the last 30-plus years, particularly for patients with liver impairment or contraindications to Hepburn and Citrus. Specifically, the participants commented on the famous that safety attributes, such as its ultra-short half-life, allowing it to be rapidly cleared and potentially avoiding unwanted complications, seen with longer circulating agents such as Hepburn and Citrus.

Speaker Change: We expect to provide an updated timeline for study completion, PMA filing, and anticipated PMA approval on our next quarterly call.

Speaker Change: While the clinical study is ongoing, we've been working on pre-launch commercial activities in preparation for the commercial launch of NIAID, again, if approved.

Speaker Change: This has included further market research with a group of nephrologists, intensivists, and pharmacy directors.

Vincent Angotti: The participants in our research group highlighted the Famous Dutch Strong Safety Profile over the last 30 plus years, particularly for patients with liver impairment or contraindications to Hepburn and Citrus. Specifically, they commented on famistat's safety attributes, such as its ultra-short half-life, allowing it to be rapidly cleared and potentially avoiding unwanted complications seen with longer circulating agents, such as heparin and citrate.

Speaker Change: The participants in our research group highlighted the Femistat's strong safety profile over the last 30-plus years, particularly for patients with liver impairment or contraindications to heparin and citrate.

Speaker Change: Specifically, the participants commented on the famistat's safety attributes, such as its ultra-short half-life, allowing it to be rapidly cleared and potentially avoiding unwanted complications seen with longer circulating agents, such as heparin and citrate.

Vincent Angotti: In addition, our research continues to support the potential commercial uptake of NIAD at a competitive price as compared to the total cost of Citrus and Icoagulation, which includes the cost of calcium and the required monitoring of calcium levels. These results reinforce our belief that the peak sales estimate for NIAD in the hospital setting approximates $100 million, while a potential opportunity in outpatient dialysis settings could add at least another $100 million of peak sales. We remain focused on the hospital opportunity, as this is where our current NephroCRRT study is being conducted. In addition to the progressing clinical study and commercial preparation, we continue to make positive advancements in our manufacturing and related CMC efforts for NIAD.

Vincent Angotti: In addition, our research continues to support the potential commercial uptake of NIAD at a competitive price as compared to the total cost of surgery and I-coagulation, which includes the cost of calcium and the required monitoring of calcium levels. These results reinforce our belief that the peak sales estimate for NIAID in the hospital setting approximates $100 million, while a potential opportunity in outpatient dialysis settings could add at least another $100 million in peak sales.

Speaker Change: In addition, our research continues to support the potential commercial uptake of NIAID at a competitive price as compared to the total cost of citrate anticoagulation, which includes the cost of calcium,

Speaker Change: and the required monitoring of calcium levels.

Speaker Change: These results reinforce our belief that the peak sales estimate for NIAID in the hospital setting approximates 100 million dollars while a potential opportunity in outpatient dialysis settings could add at least another 100 million dollars of peak sales.

Vincent Angotti: We remain focused on the hospital opportunity as this is where our current nephro-CRRT study is being conducted, in addition to the progressing clinical study and commercial preparation. We continue to make positive advancements in our manufacturing and related CMC efforts for NIAC. All active ingredient and finished drug production to date have met our specifications. We're collecting extended stability data on our GMP-grade product to support shelf life for our potential commercial product.

Speaker Change: We remain focused on the hospital opportunity, as this is where our current nephro-CRRT study is being conducted.

Speaker Change: In addition to the progressing clinical study and commercial preparation,

Speaker Change: We continue to make positive advancements in our manufacturing and related CMC efforts for NIAID.

Vincent Angotti: All active ingredient and finished drug production to date have met our specifications or collecting extended stability data on our GMP grade product to support shelf life for our potential commercial product. Our manufacturing partners have done an excellent job achieving timelines, specifications, and the cost expectations we've set for them.

Speaker Change: All active ingredient and finished drug production to date have met our specifications. We're collecting extended stability data on our GMP grade product to support shelf life for our potential commercial product.

Vincent Angotti: Our manufacturing partners have done an excellent job achieving the timelines, the specifications, and the cost expectations we've set for them, and ahead of the call of a Raffi, it's important to know that our largest investor, Nakahala, remains supportive and, with continued progress in the clinical study, committed to ensuring Talphera's adequate funding to reach potential PMA approval for NIA. This continued support is highly appreciated, and as a result of the extension of the original timeline, both parties agree on the need to amend the timing of the planned second close of our financing, which was originally expected to occur by September 30th of this year. Now, I'll hand the call over to Raffi to take you through the details of our second quarter financial results. Raff?

Speaker Change: Our manufacturing partners have done an excellent job achieving timelines, specifications, and the cost expectations we've set for them.

Vincent Angotti: Before handing a call over to Rafi, it's important to know that our largest investor, Natahala, remains supportive and, with continued progress in the clinical study, committed to ensuring tougher as adequate funding to reach potential PMA approval of NIAD. This continued support is highly appreciated, and as a result of the extension of the original timeline, both parties agree on the need to amend the timing of the planned second close of our financing, which was originally expected to occur by September 30th of this year.

Speaker Change: And before handing the call over to Raffi, it's important to know that our largest investor, Nakta Hala, remains supportive and with continued progress in the clinical study, committed to ensuring Talphera has adequate funding to reach potential PMA approval of NIAID.

Raffi Asadorian: This continued support is highly appreciated, and as a result of the extension of the original timeline, both parties agree on the need to amend the timing of the planned second close of our financing, which was originally expected to occur by September 30th of this year.

Raffi Asadorian: Now, I'll hand a call over to Rafi to take you through the details of our second quarter financial results. Rafi, we continue to control operating expenses while prioritizing investments that will facilitate the timely filing of our NIAD PMA. This emphasis on expense containment has helped us close the second quarter with $14 million in cash and investments. Our cash operating expenses, or combined R&D and SG&A expenses, excluding non-cash stock-based compensation of $0.2 million in the second quarter, totaled $4 million, compared to $3.8 million last year. While we incurred certain expenses related to the Nefros CRRT study in the second quarter, we expect these costs will increase for the remaining quarters of the year as study enrollment accelerates.

Raffi Asadorian: I'll hand the call over to Raffi to take you through the details of our second quarter financial results. Raff?

Raffi Asadorian: Thanks, Vince. We continue to control operating expenses while prioritizing investments that will facilitate the timely filing of our NIAID PMA. This emphasis on expense containment has helped us close the second quarter with $14 million in cash and investments. Cash operating expenses, or combined R&D and SG&A expenses, excluding non-cash stock-based compensation of $0.2 million in the second quarter totaled $4 million, compared to $3.8 million last year.

Raffi Asadorian: We continue to control operating expenses while prioritizing investments that will facilitate the timely filing of our NIAID VMA. This emphasis on expense containment has helped us close the second quarter with $14 million in cash and investments.

Raffi Asadorian: Our cash operating expenses, or combined R&D and SG&A expenses, excluding non-cash stock-based compensation of $0.2 million in the second quarter totaled $4 million, compared to $3.8 million last year.

Raffi Asadorian: While we encourage certain expenses related to the NEFRO CRRT study in the second quarter, we expect these costs will increase for the remaining quarters of the year as study enrollment accelerates. The estimated range of cash operating expenses for the year has been reduced to $19 to $21 million from the previous range of $21 to $23 million, according. As mentioned earlier, we plan on amending the date of the planned second closing from our January 2024 financing that was contingent upon achieving the pivotal trial milestone by September 30 of this year. We expect this amendment to be completed before filing our next quarter 10. I'll now turn the call back to Vince.

Raffi Asadorian: While we encourage certain expenses related to the NEFRO-CRRT study in the second quarter, we expect these costs will increase for the remaining quarters of the year as study enrollment accelerates.

Raffi Asadorian: The estimated range of cash operating expenses for the year has been reduced to $19 to $21 million from the previous range of $21 to $23 million accordingly.

Raffi Asadorian: The estimated range of cash operating expenses for the year has been reduced to $19 to $21 million dollars from the previous range of $21 to $23 million dollars accordingly.

Raffi Asadorian: As mentioned earlier, we plan on amending the date of the planned second closing from our January 2024 financing that was contingent upon achieving the pivotal trial milestone by September 30 of this year. We expect this amendment to be completed before filing our next quarter 10-Q.

Raffi Asadorian: As mentioned earlier, we plan on amending the date of the planned second closing from our January 2024 financing that was contingent upon achieving the pivotal trial milestone by September 30 of this year. We expect this amendment to be completed before filing our next quarter 10Q.

Raffi Asadorian: I'll turn the call back to this.

Vincent Angotti: Thanks, Raffi.

Vincent Angotti: Thanks, Raff. And I'd like to open the line up for any questions you might have. Li-Wei?

Vincent Angotti: I'd like to open the line up for any questions you might have. Lee Wei? Thank you so much.

this: I'll now turn the call back to Vince. Thanks, Raffi.

Speaker Change: And I'd like to open the line up for any questions you might have. Leeway?

Operator: Thank you so much. And ladies and gentlemen, we will now begin the question and answer session. If you have a question, please press the star followed by the number one on your touch screen. You will hear a prompt that your hand has been detected. And should you wish to stop the polling process, please press the star followed by the number one, here using a speaker phone. Please lift the handset before pressing.

Operator: And ladies and gentlemen, we will now begin the question-and-answer session. Should we have a question, please press the star followed by the number one on your touchstone phone. You will hear a prompt that your hand has been raised. And should you wish to remove the client from the polling process, please press the star followed by the number two. If you're using a speaker phone, please lift the handset before pressing any keys.

Speaker Change: Thank you so much. And ladies and gentlemen, we will now begin the question and answer session. Should you have a question, please press the star followed by the number one on your touchtone phone. You will hear a prompt that your hand has been raised. And should you wish to decline from the polling process, please press the star followed by the number two.

Speaker Change: If you're using a speakerphone, please lift the handset before pressing any keys.

Ed RSA: And our first question comes from the line of Ed RSA of HBC Weinerite. Your line is now open. Hi, thanks for taking my questions, and congrats on the progress.

Ed Arce: And our first question comes from the line of Ed Arce of HBC Wainwright, Hugh Lannace Nell. Hi, thanks for taking my questions, and congrats on the part where... I have a couple of questions, but first I just wanted to add my congratulations to Pam on covering the company for 12 years. I worked with Pam from the very beginning of the video, and wanted to offer my hearty congratulations, which were very well-deserved.

Speaker Change: Hello, I'm Pamela Palmer, Raffi Asadorian, Raffi Asadorian, Raffi

Speaker Change: And our first question comes from the line of Ed Arce of H.C. Wainwright. Your line is now open.

Speaker Change: Hi, thanks for taking my questions and congrats on the progress.

Ed RSA: I have a couple of questions, but first I just wanted to add my congratulations to Pam. I've been covering the company for 12 years now, work with Pam since the very beginning and wanted to offer my hearty congratulations to a very well-deserved retirement.

Speaker Change: I have a couple of questions, but first I just wanted to add my congratulations to Pam.

Speaker Change: I've been covering the company for 12 years now, worked with Pam since the very beginning, and wanted to offer my hearty congratulations to a very well-deserved retirement.

Vincent Angotti: Thank you, Ed. You're very welcome. So I know it's coming up in the next call for the timeline update.

Vincent Angotti: Thanks, Ed. You're very welcome. So I know it's coming up on the next call for the timeline update, but I wanted to get a sense for where we are now, if possible. In terms of the number of patients that have completed the study, or perhaps and or patients that have been screened. Day to go into tout. Yeah, I can help answer that. This is Vince.

Speaker Change: Thank you, Ed. You're very welcome.

Speaker Change: So, I know it's coming up in the next call for the timeline update, but I wanted to get a sense for where we are now, if possible, in terms of the number of patients that have completed the study.

Vincent Angotti: But I wanted to get a sense for where we are now, if possible, in terms of the number of patients that have completed the study or perhaps and/or patients that have been screened to date to go into the study. Yeah, I can help answer that.

Speaker Change: Or perhaps, and or patients that have been screened to date to go into the study.

Vincent Angotti: This is Vince. So, as it relates to screening, the screening has just begun within the last several weeks. And primarily done at what I'll call our lower enrollment potential sites. These sites were selected because of the quality of the care at their particular institutions. And in particular, you might say why would you have a lower potential enrollment site vault, the quality of the PI at these sites, and the diversity of patients at these sites, which makes them by nature lower enrollment potential.

Vincent Angotti: So as it relates to screening, screening has just begun within the last several weeks and is primarily done at what I'll call our lower enrollment potential sites. These sites were selected because of the quality of the care at their particular institutions, and in particular, you might say why you would have a lower potential for rolling sites involved, the quality of the PI at these sites, and the diversity of patients at these sites, which makes them, by nature, lower in rolling potential.

Speaker Change: I can help answer that. This is Vince.

Speaker Change: So, as it relates to screening, the screening has just begun within the last several weeks and primarily done at what I'll call our lower enrollment potential sites.

Speaker Change: These sites were selected because of the quality of the care at their particular institutions.

Speaker Change: And in particular, you might say, why would you have a lower potential enrolling site vault, the quality of the PI at these sites, and the diversity of patients at these sites.

Vincent Angotti: Dr. Palmer, maybe you can comment on the characteristics of the patients at these particular sites. Yeah, they just happened to be the ones that got up and running more quickly, but yeah, these particular sites, we need to see NIAD's efficacy and safety and sort of a broad spectrum of patients, different ICUs, surgical ICUs, medical ICUs, patients with liver failure, younger patients, younger adults versus older adults, and so these two sites were put in the mix for that reason.

Pamela Palmer: Dr. Palmer, maybe you can comment on the characteristics of the patients at these particular sites. Yeah, they just happen to be the ones that got up and running more quickly. But these particular sites, we need to see NIAD's efficacy and safety in a broad spectrum of patients: different ICU, surgical ICU, medical ICU, patients with liver failure, younger patients, new younger adults versus older adults. And so these two sites were put in the mix for that reason. They just happen to get up and running more quickly than the others. But we're not expecting a lot of patients from them.

Speaker Change: which makes them.

Speaker Change: By nature, lower enrolling potential. Dr. Palmer, maybe you can comment on the characteristics of the patients at these particular sites. Yeah, they just happen to be the ones that got up and running more quickly. But these, yeah, these particular sites, I mean, we need to see NIAID's efficacy and safety in sort of a broad spectrum of.

Vincent Angotti: They just happened to get up and running more quickly than the others, but we're not expecting a lot of patients from them, so even though they have started pre-screening and screening, they were more recently, the screening site that we've gotten up and running is considered to be a much bigger heavy hitter. Yeah, I think importantly, to your point on that, while no one has completed the study, the third site that Dr. Palmer mentioned that just came up to become enrollment ready and screening over the course of, I think it's the last week and a half to two weeks, the first day after they started screening patients. So they immediately got on the PIS, highly involved and excited about the study.

Dr. Palmer: of patients, different ICU, surgical ICU, medical ICU, patients with liver failure, younger patients. You know, younger adult versus older adults.

Speaker Change: and so these two sites were put in the mix for that reason. They just happened to get up and running more quickly than the others, but we're not expecting a lot of it.

Vincent Angotti: So even though they have started prescreening and screening, they were more recently screening site that we've gotten up and running is considered to be a much bigger heavy hitter.

Speaker Change: So even though they have started pre-screening and screening.

Speaker Change: They, you know, they're, were not, the more recently,

Speaker Change: Screening site that we've gotten up and running is considered to be a much bigger heavy hitter. I think importantly to your point on that, well no one has completed the study, the third site that Dr. Palmer mentioned it just came up.

Vincent Angotti: Yeah, I think importantly to your point on that, while no one has completed the study, the third site that Dr. Palmer mentioned just came up to become enrollment ready and screening over the course of, I think, it's the last week and a half to two weeks. The first day after started screening patients. Williams. So they immediately got on to the PI as highly involved and excited about the study, and the balance of our sites are all the highest and rolling sites, and they all should complete their site initiation visits this month as scheduled and be enrollment ready as the goal by the close of this month, and then we'll start to really see the ramp in the cadence on the screening versus completions.

Speaker Change: To become enrollment ready and screening over the course of I think it's the last week and a half to two weeks. The first day after started screening patients.

Speaker Change: So, they immediately got on to the PIs, highly involved and excited about the study. And the balance of our sites.

Vincent Angotti: And the balance of our sites are all the highest enrolling sites, and they should all complete their site initiation visits this month as scheduled and be enrolling ready as the goal by the close of this month. And then we'll start to really see the ramp and the cadence on the screening versus completion. Two others, if I may, these four are for Raffi. You mentioned in your prepared remarks that the cost for the remainder of the year, operating costs, which one would expect with an enrollment phase. I'm wondering if there's any sort of... Quonetative, David Boldt, David Boldt, Fullerton, and many others.

Speaker Change: are all the highest enrolling sites and they all should complete their site initiation visits this month as scheduled and be enrollment ready as they go by the close of this month and then we'll start to really see the ramp and the cadence on the screening versus completions.

Vincent Angotti: Okay, that's helpful.

Speaker Change: Hello, I'm Pamela Palmer, Raffi Asadorian, Raffi Asadorian, Raffi

Raffi Asadorian: Two others, if I may, these four are for Raffi. I think you mentioned in your preparator marks that the cost for the remainder of the year operating costs would be expected to increase, which is as one would expect with an enrolling phase three. I'm wondering if there's any sort of quantitative color that you could provide on op-x.

Speaker Change: Okay.

Speaker Change: I think you mentioned in your prepared remarks that the cost for the remainder of the year, operating costs, would be expected to increase, which is.

Speaker Change: As one would expect with an enrolling Phase 3. Wondering if there's any sort of...

Speaker Change: quantitative

Speaker Change: And then the other question was around the financing.

Raffi Asadorian: Thank you. Thank you. And then the other question was about finance, and... I missed what exactly you said about September and what's happening there. Yeah, sure. So the new guidance, Ed, for the year we reduced it, this is for cash operating expenses, has been reduced to $19 to $21 million. So if you take that $19 million, we've had about $8 million year to date. So we can expect around $11 million for the close of the second half for cash operating expenses, given that range.

Raffi Asadorian: And then the other question was around the financing, and I missed exactly what you said about September and what's happening there in your plans to refinance that.

Speaker Change: and...

Speaker Change: I missed what exactly you said about September and what's happening there and your plans to refinance that.

Raffi Asadorian: Thanks, yeah, sure. So the new guidance for the year we reduced this is for cash operating expenses has been reduced to $19 to $21 million. So if you take that 19 million, we've had about 8 million year-to-date. So we can expect around 11 million for the close of the second half of cash operating expenses, given that range. So it increases a bit from the, we've had about $4 million of cash operating expenses in the previous for each quarter, $4 million for Q1, about $4 million for Q2. So expect that to increase, you know, if you forecast that pretty evenly, that remaining $11 million for the second half of the year.

Speaker Change: Yeah, sure.

Speaker Change: So the new guidance, Ed, for the year, we reduced. This is for cash operating expenses.

Speaker Change: has been reduced to $19 to $21 million, so if you take that $19 million, we've had about 8 million year to date, so we can expect around 11 million for the close of the second half of cash operating expenses given that range.

Raffi Asadorian: So it increases a bit from the previous, we've had about $4 million of cash operating expenses in the previous quarters, $4 million for Q1, about $4 million for Q2. So expect that to increase, you know, if you forecast that pretty evenly. That remaining $11 million for the second half of the year, that answers that question.

Ed R.C.: So it increases

Ed R.C.: that remaining 11 million for the second half of the year.

Raffi Asadorian: Does that answer that question? Yeah, that's awesome. Thanks.

Raffi Asadorian: Yeah, that's all. Yeah, and in terms of the, yeah, in terms of the Nantahala amendment, I mean, that's the focus here really is to work on amending that date. And we've already had some initial discussions, but amending that September 30th date to a new date that, you know, works for both parties in terms of the study completion and announcement to get to that pivotal trial milestone. I don't want to forecast what that date will be, but that's the real focus of our discussions with Nathahala, to get that done as kind of the first priority. I'll make a comment about Nath Tehalla just quickly. I just want to remind you that they're on our board. Avi Jain is a representative of Nath Tehalla.

Speaker Change: Did that answer that question? Yeah, that's helpful. Thanks.

Raffi Asadorian: Okay, yeah. And in terms of the, yeah, in terms of the, not the hollow of the amendment, I mean that's the focus here really is to work on amending that date. And we've already had some initial discussions, but amending that September 30th date to a new date that works for both parties in terms of the study completion and an announcement to get to that pivotal trial milestone.

Vincent Angotti: And they're highly active with the management team and in the know on how the study is being conducted and the pace. So there's very good alignment, which has been very helpful to have. Got it, thanks for all the perspective. I appreciate it. Sure. Thank you so much. And your next question comes from the line of Nazraman of Mexico. Your line is now open.

Speaker Change: In terms of the Nantahala, the amendment, the focus here really is to

Speaker Change: work on amending that date, and we've already had some initial discussions, but

Speaker Change: amending that September 30th date to a new date that works for both parties in terms of the study completion and announcement to get to that pivotal trial milestone.

Raffi Asadorian: I don't want to forecast what that date will be, but that's the real focus on our discussions with, with not the hollow to get that done as kind of the first priority. You know, make a comment about not the hollow just quickly. I just want to remind you, they're on our board. I'll be Jane as representative, not the hollow. And they're highly active with the management team. And in the know on how the studies being conducted in the pace. So there's very good alignment, which has been very helpful to have. We went down right.

Speaker Change: I don't want to forecast what that date will be, but that's the real focus on our discussions with Not The Holiday, get that done as kind of the first priority.

Speaker Change: I'll make a comment about Nath Tehala just quickly. I just want to remind you they're on our board. Avi Jain is a representative of Nath Tehala and they're highly active with the management team and in the know on how the study is being conducted in the PACE. So there's very good alignment, which has been very helpful to have.

Raffi Asadorian: Go. Thanks for all the perspective. Appreciate it.

Speaker Change: Whit Whit Down Ray.

Speaker Change: Got it. Thanks for all the perspective. Appreciate it. Sure.

Raffi Asadorian: Thank you so much.

Nazram: And your next question comes from the line of Nazram and of Maxine Group. Your line is now open. Hi, thanks for taking my questions.

Speaker Change: Vincent Angotti, Raffi Asadorian

Speaker Change: Thank you so much, and your next question comes from the line of Nazaraman of Maxine Group. Your line is now open.

Operator: This call is being webcasted live by the events page of the Investors section of the Ferris website, at www.tulfhera.com.

Nazraman: Hi, thanks for taking my questions. First, I also want to extend my congratulations to Dr. Palmer on her work and her well-earned retirement. I just have a couple of questions, if I may.

Nazram: First, I also want to extend my congratulations to Dr. Palmer on her work and her well-learned retirement. I just have a couple questions, if I may. So I think how you mentioned that you're expanding the number of study sites to 14. What gives you confidence that you could initiate the new and additional site in a timely manner? Do you think you get that done by the end of 2024 considering what happened to the prior sites and how long do you think it would take to initiate the additional sites? Yeah, I think that's a really good question.

Nazaraman: Hi, thanks for taking my questions. First, I also want to extend my congratulations to Dr. Palmer on her work and her well-earned retirement.

Vincent Angotti: So, seeing how you mentioned that you're expanding the number of study sites to 14, what gives you confidence that you could initiate the new and additional sites in a timely manner? Do you think you could get that done by the end of 2024, considering what happened to the prior sites? And how long do you think it would take to initiate the additional sites? Yeah, I think that's a really good question and a couple things, and I'm going to turn it over to Dr. Palmer.

Operator: This call is the property of Tulfhera and any recording, reproduction or transmission of this call without the express reading consent of Tulfhera is prohibited. As a reminder, this webcast is being recorded. You may listen to a replay of this webcast by going to the Investors section of Tulfhera's website.

Nazaraman: I just have a couple of questions that I may. So, thank you how you mentioned that you're expanding the number of study sites to 14. What gives you confidence that you could initiate the...

Speaker Change: new and additional sites in a timely manner? Do you think you'd get that done by the end of 2024, considering what happened to the prior sites? And how long do you think it would take to initiate the additional sites?

Raffi Asadorian: I would not like to turn the call over to Raffi Asadorian, but Ferris Chief Financial Officer. Thank you for joining us on the call today. This afternoon, we announced our second quarter of 2024 financial results and associated business updates and a press release. This press release can be found within the Investors section of our website.

Vincent Angotti: And a couple of things, and I'm going to turn it over to Dr. Palmer. So I think it's important to understand why we did that with the FDA. And while we've got eight sites now that we feel are prepared to be enrollment ready by the close of this month. And again, I want to emphasize the highest enrolling sites, the highest potentially rolling sites within that group occurring in August. We've always been sourcing sites to get up to the original 10. And so, of course, you've sourced many more sites than that. I think what we've learned along the way is that the facilitation of the contracting process and administrative process and combination with the quality of the sites is the key element moving forward.

Speaker Change: Yeah, I think that's a really good question and a couple of things that I'm going to turn over to Dr. Palmer.

Vincent Angotti: So I think it's important to understand why we did that with the FDA. And while we've got eight sites now that we feel are prepared to be enrollment ready by the close of this month, and again, I'll emphasize the highest enrolling sites, the highest potential enrolling sites within that group occurring in August, we've always been sourcing sites to get up to the original 10.

Dr. Palmer: So I think it's important to understand why we did that with the FDA and why we've got eight sites now that we feel up prepared to the enrollment ready by the close of this month and again I want to emphasize the highest and rolling sites, the highest potentially rolling sites within that group occurring in August.

Raffi Asadorian: With me today, our Vince Angotti, our Chief Executive Officer, and Dr. Pam Palmer, Talphera's Founder and Chief Medical Officer. Before we begin, I want to remind listeners that during this call, we will make forward-looking statements within the meeting of the federal securities laws. These forward-looking statements involve risks and uncertainties regarding the operations and future results of Tulfhera.

Dr. Palmer: We've always been sourcing sites to get up to the original 10.

Vincent Angotti: And so, of course, you've sourced many more sites than that. I think what we've learned along the way is that The facilitation of the contracting process and the administrative process, in combination with the quality of the site, is the key element moving forward. So Dr. Palmer, maybe you can comment on what we've learned today and how we're going to apply that to the next set of sites. And I do believe that we might not have them all up and rolling by the end of the year.

Dr. Palmer: and so of course you source many more sites than that. I think what we've learned along the way is that the facilitation of the contracting process and administrative process in combination with the quality of the sites

Raffi Asadorian: 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 a discussion of the risks associated with such forward-looking statements. These documents can be found on our website within the Investors section.

Dr. Palmer: is...

Vincent Angotti: And they likely want to affect the first half of enrollment. We certainly expect them to affect the second half of the 166 patient enrollment. Yeah, truly an insurance policy.

Pamela Palmer: So, Dr. Palmer, maybe you can comment that what we've learned today and how we're going to apply that to the next set of sites. And I do believe that we might not have them all up enrolling by the end of the year. And they likely want to affect the first half of enrollment. We certainly expect them to affect the second half of the 166 patient enrollment. Yeah, it's really an insurance policy. I mean, our site feasibility questionnaires were focused around the volume of CRT patients, the type of CRT patients at these different academic centers. And this new set of sites that were evaluating is really going to be focusing not only on that, but on the rapid ability to contract and budget.

Dr. Palmer: the key element moving forward.

Dr. Palmer: So Dr. Palmer, maybe you can comment that what we've learned today and how we're going to apply that to the next set of sites. And I do believe that we might not have a mall up and rolling by the end of the year.

Vincent Angotti: I will now hand the call over to Vince. Thank you, Raffi. Good afternoon, and thank you for joining us on the call.

Dr. Palmer: and they likely want to affect the first half of enrollment. We certainly expect them to affect the second half of the 1606 patient enrollment. Yeah, it's really an insurance policy. I mean, our site feasibility questionnaires were focused around volume of CRT patients, the type of CRT patients.

Vincent Angotti: Before jumping into the updates for the quarter, I would like to congratulate Dr. Palmer on her decision to retire this coming October. Pam was the co-founder and Chief Medical Officer of the company, as well as a dedicated leader for nearly two decades. Dr. Palmer is a renowned physician, pioneer, and long-time entrepreneur with a mission to improve care for patients in the medically supervised setting. Pam has made remarked in the World of Pharmaceuticals and Health Care and met her countless people along the way who will continue her legacy. What she may be retiring, Dr. Palmer will continue to advise Tulfhera and support Dr. Shaquille-Azlam until the Neffros study has been completed and the potential FDA of approval of NIET is received.

Pamela Palmer: I mean, our site feasibility questionnaires were focused around the volume of CRT patients, the type of CRT patients at these days in different academic centers. And this new set of sites that were evaluated is really going to be focusing not only on that but on the rapid ability to contract and budget, which is just absolutely critical for them to be able to quickly get on board and give us an insurance policy so that the last half of the enrollment will be a lot faster than the first half.

Speaker Change: at these different academic centers and this new set of sites that we're evaluating is really going to be focusing not only on that but on the rapid ability to contract and budget.

Pamela Palmer: That is just absolutely critical for them to be able to quickly get on board and give us an insurance policy so that the last half of the enrollment will be a lot faster than the first half.

Speaker Change: You know, that that is just absolutely critical for them to be able to quickly get on board and give us an insurance policy so that the last half of the enrollment will be a lot faster than the first half.

Pamela Palmer: Hi, just on that point, did you guys give more color or context around the scale of these additional sites? Are they closer to like the high enrollment sites or closer to, I guess, the lower enrollment quantity sites? No, definitely the higher, but it's not just their CRT volume and their ability to enroll, but it's also going, we're going to be selecting for rapid, you know, paperwork processing universities sites that really can streamline that. We've already started our initial contact with an additional 20 sites, so we're going out pretty large to funnel it down to get to the ultimate 14 number.

Pamela Palmer: Hi, just on that point, could you, I guess, give more color or context around the scale of these additional sites? Are they closer to, like, the high enrollment sites or closer to, I guess, the lower enrollment quantity sites? Now definitely higher, but it's not just their CRRT volume and their ability to enroll, but we're also going to be selecting, for rapid, you know, paperwork processing universities, sites that really can streamline that.

Speaker Change: Hi, just on that point, did you guys give more color or context around this scale of these additional sites? Are they closer to like the high enrollment sites or closer to, I guess, the lower enrollment client sites?

Vincent Angotti: So please join me in wishing her all the best in her retirement.

Vincent Angotti: I'm happy to report that we now have multiple site screening patients in the study. We had a busy quarter continuing to work through the administrative processes encountered at the academic institutions where the Neffros study will be conducted. And we have finalized clinical trial agreement terms now with eight large academic institutions, including our potentially highest enrolling sites.

Speaker Change: No, definitely the higher, but it's not just their CRT volume and their ability to enroll, but it's also going, we're going to be selecting for for rapid, you know, paperwork processing universities sites that really can streamline that.

Pamela Palmer: We've already started our initial contact with an additional 20 sites, so we're going out pretty large to funnel it down to get to the ultimate 14 number. Early assessment is they know fairly quickly and respond fairly quickly where the contracting process can be facilitated, in an expedited manner.

Speaker Change: We've already started our initial contact with an additional 20 sites. So we're going out pretty large to funnel it down to get to the ultimate 14 number. And again, they...

Vincent Angotti: The final four site initiation visits of these initial eight institutions are scheduled to be completed this month. While each institution is at their own unique upfront administrative activities, once enrolling, we do not expect additional delays as the protocol dictates how the study is conducted, and I as Breakthrough Designation has continued to prove valuable in our interactions with the FDA. Our ongoing real-time communications with the FDA regarding the study have been efficient and we expect this to continue as we progress the study over the coming months.

Nazram: And again, the early assessment is they know fairly quickly and respond fairly quickly where the contracting process can be facilitated in an expedited manner or not. Got it.

Speaker Change: Early assessment is, they know fairly quickly and respond fairly quickly where the contracting process can be facilitated.

Nazraman: Thanks for taking my questions. And once again, congratulations on your retirement, Dr. Palmer. Thank you. Thank you so much, and our next question comes from the line of James Molloy of Alliance Global Partners. Your line is now open.

Speaker Change: in an expedited manner or not.

Nazram: Thanks for taking my questions.

Nazram: And once again, congrats on your retirement, Dr. Palmer. Thank you.

Speaker Change: Got it, thanks for taking my questions and once again congrats on your retirement Dr. Palmer.

James Molloy: Thank you so much. And our next question comes from the line of James Molloy with Alliance Global Partners. Your line is now open. I think I thank you for taking my questions.

Speaker Change: Thank you.

Speaker Change: Thank you so much, and our next question comes from the line of James Malloy of Alliance School of Alliance School of Alliance School of Alliance School of Alliance School of

James Molloy: Thank you for taking my questions. Congratulations, Dr. Palmer, on your retirement as well. Can you walk through a little bit?

James Molloy: Congratulations, Dr. Palmer, on your retirement as well. Could you walk through a little bit? It's not off to Dr. Aslan's on the on the call. I'd love to get it. It starts views on the changes that were instituted on coming in to sort of get this thing going. Hopefully, in the near term. And then I think you highlighted the eight sites being the highest and rolling sites. What does that mean since no one's been enrolled yet? Yes, I can comment on the last part. So it's a total of eight sites. The final four site initiation visits are occurring this month, meaning August, so then they'll be enrollment ready.

James Malloy: I think I thank you for taking my questions for your questions, Dr. Palmer and your time as well. Can you walk through a little bit? I don't know if Dr. Asalans on the call. I'd love to get it as thought to be is.

James Molloy: It's Dr. Aslan on the call. I'd love to get your thoughts for you on the changes that were instituted upon coming in, so to get this thing going, hopefully, in the near term. And then I think you highlighted the eight sites being the highest enrolling sites. What does that mean, since no one's been enrolled yet? Yes, so I can comment on the last part.

Vincent Angotti: For example, we recently requested and promptly received the FDA's approval to increase the number of Neffro study sites to a maximum of 14. We sought this approval to one expedite study completion by increasing the number of high-volume CRRT institutions and to maintain access to a broad patient population to inform healthcare providers on the use of NIAD, if approved.

Speaker Change: on the changes that that were instituted on coming in so to get this thing going hopefully in the near term. And then I think you highlighted the eight sites being the highest enrolling sites. What does that mean since no one's been enrolled yet?

Vincent Angotti: So there are a total of eight sites. The final four site initiation visits are occurring this month, meaning August, so then they'll be enrollment-ready. Of these final sites, they are the highest-enrolling sites, so they'll be enrollment-ready by the end of August. Our goal is by the end of August.

Speaker Change: Yes, so I can comment on the last part.

Speaker Change: The final four.

Speaker Change: Site initiation visits are occurring this month.

Vincent Angotti: Dr. Aslam's nephrology expertise and established professional network has already proven invaluable in identifying this expanded base of potential clinical sites in support of the study.

Vincent Angotti: Of these final sites, they are the highest and rolling sites, so they'll be enrollment ready by the close. Our goal is by the close of August. The first initial site that are now what has rolling sites mean in a trial that hasn't enrolled anybody. I don't mean to pick on it, but what do you mean highest and rolling sites? Do you think there'll be the highest and rolling? Yeah, well, these are the non-specialty sites. So, as we mentioned earlier, the initial two over the three are specialty sites that are focused on maybe cardio thoracic surgery, maybe younger patients where the patient flow is going to be much lower.

Speaker Change: Meaning August, so then there'll be enrollment ready.

Speaker Change: All of these final sites, they are the highest enrolling sites, so they'll be enrollment ready by the close, our goal is by the close of August.

Vincent Angotti: The first initial sites that are now – What does the highest-enrolling sites mean in a trial that hasn't enrolled anybody? I don't mean to pick on it, but what do you mean by "highest-enrolling sites"? You think they'll be the highest-enrolling? Yeah, what these are are the non-specialty sites, so as we mentioned earlier, the initial two of the three are specialty sites that are focused on maybe cardiothoracic surgery, remember younger patients where the patient flow is going to be much lower, and the screening process in volume is going to be much lower.

Speaker Change: What do highest enrolling sites mean in a trial that hasn't enrolled anybody? I don't mean to pick on it, but what do you mean highest enrolling sites? Do you think they'll be the highest enrolling?

Vincent Angotti: As communicated on the last call, Dr. Aslam joined Talphera as our new chief development officer on May 20th. Dr. Aslam has over 20 years of clinical research experience specializing in nephrology. Dr. Aslam joined us from Bio-Christopharmaceuticals where he served as vice president, clinical development, nephrology, and rare diseases. He's helped development roles at Angian, Przenius, and Angian and was an assistant professor at Georgetown University Hospital for 12 years focused on clinical care of acute and chronic kidney disease, hypertension, renal transplantation, and other nephrological diseases.

Speaker Change: Yeah, well, these are the non-specialty sites. So, as we mentioned earlier, the initial two of the three are specialty sites that are focused on maybe cardiothoracic surgery, maybe younger patients where the patient flow is going to be much lower and the screening process and volume is going to be much lower.

Vincent Angotti: And the screening process in volumes can be much lower. The balances of these sites are unlike those two original sites where the volumes in both screening and enrollment will be higher just based off of the pure patient population that they have that fits our criteria. Also based off of the feasibility of the study parameters that they've sold out in order to be included within the study. So that's according to them and our assessment of them.

Vincent Angotti: The balances of these sites are unlike those two original sites where the volumes in both screening and enrollment will be higher just based on the pure patient population that they have that fits our criteria, and also based on the feasibility of the study parameters that they filled out in order to be included within the study.

Speaker Change: The balances of these sites are unlike those two original sites where the volumes in both screening and enrollment will be higher just based off of the pure patient population that they have that fits our criteria.

Vincent Angotti: Dr. Aslam's extensive experience across industry and academia as a renal expert, particularly in the design and conduct of both drug and device clinical trials is impressive in a true asset to our organization. Immediately upon joining Talphera, Dr. Aslam immersed himself in establishing and fostering Talphera's relationships with our selected nephro institutions and research personnel, including personally conducting site initiation activities and training of the institutional teams. Importantly, the balance of our eight sites, including our potentially largest enrolling sites, should be enrollment ready in the coming weeks.

Speaker Change: Also based off of the feasibility of the study parameters that they sold out in order to be included within the study.

Vincent Angotti: So that's according to them and our assessment of them. Beyond that, I think your question, Jim, was... What are some of the changes or modifications that might have occurred since Dr. Aslam joined the company? Dr. Palmer? He's not on the call. Yeah, and he's not on the call this time. But yeah, he's really, he knows some of these folks. You know, he comes from this world.

Speaker Change: So that's according to them and our assessment of them.

Vincent Angotti: Beyond that, I think your question, Jim, was what are some of the changes or modifications that might have occurred since Dr. Aslam has joined the company? Not on the call. Yeah, and he's not on the call. It's not on the call this time, but yeah, he's really, he knows some of these folks. You know, he comes from this world. I'm an anesthesiologist pain specialist. He is a nephrologist, knows CRRT extensively, and knows a lot of folks in Syria. So he's really handholding a lot of these sites and getting them, you know, just pushing and urging and getting them through this contacting budgeting phase so that we can get on to the more fun, you know, enrollment part of things.

Speaker Change: Beyond that, I think your question, Jim, was...

Jim: What are some of the changes or modifications that might have been occurred since Dr. Aslem has joined the company Dr. Paul. He's not on the call. He's not on the call this time.

Speaker Change: Yeah, he's really, he knows some of these folks, you know, he comes from this world, I'm an anesthesiologist, pain specialist.

Vincent Angotti: I'm an anesthesiologist and a pain specialist. He's a nephrologist, knows CRRT extensively, and knows a lot of folks in this area. So he's really hand-holding a lot of these sites and getting them, you know, just pushing and urging them and getting them through this contracting and budgeting phase so that we can get on to the more fun, you know, enrollment part of things. So, and that's just a critical part of this, his relationships and just his deep knowledge in this field.

Speaker Change: He is a nephrologist, nose CRRRT, extensively in nose a lot of folks in Syria.

Speaker Change: So he's really handholding a lot of his sights and getting them.

Speaker Change: You know, just pushing and urging and getting them through this contracting budgeting phase so that we can get on to the more fun, you know, enrollment part of things. So, and that's just a critical part of this is relationships and just his deep knowledge in this field.

Vincent Angotti: And what we're not prepared to provide guidance on expected study completion in PMA filing timelines our engagement with the principal investigators remains high. And we believe the study will enroll efficiently at the sites. Recall that the primary endpoint of activated clotting time is measured over 24 hours with the patient completing the study after activated clotting time is assessed at 72 hours, which is also a secondary endpoint. These relatively short study time points combined with a patient study population of only 166 patients and now expansion to 14 study sites should support the fishing completion of the study once fully underway.

Vincent Angotti: So, and that's just a critical part of this is relationships and just his deep knowledge in this field. Jim, did that answer your question on the first part of your question, though? And make sure we answer that in terms of highest enrolling because the highest enrolling haven't started screening yet. That's coming at the close of this month. Is that just make sure we're answering that question? Yeah, I guess, I guess the highest enrolling is sort of an aspirational name for them. I get to say they will be the highest enrolling once you start enrolling. Well, I can give you an idea based on the feasibility study.

Vincent Angotti: Jim, did that answer your question about the first part of your question, though? We'll make sure we answer that in terms of highest enrollment, because the highest enrollment hasn't started screening yet. That's coming at the close of this month.

Speaker Change: Jim, did that answer your question on the first part of your question, though, we'll make sure we answer that.

Jim: in terms of highest and rolling, because the highest and rolling haven't started screening yet. That's coming at the close of this month. Does that make sure we're answering that question? Yeah, I guess the highest and rolling is sort of an aspirational name for them. I get to say they will be the highest and rolling when you start rolling.

Vincent Angotti: Is that to make sure we're answering that question? Yeah, I guess the highest enrollment is sort of an aspirational name for them. I guess they will be the highest enrollment once you start enrolling. Well, I can give you an idea based on the feasibility study, these particular institutions are fully capable at 400% times what I'll call the low enrollment sites would be.

Vincent Angotti: These particular institutions feel the ability at 400% times what I'll call the low enrollment sites would be. Yeah, there are site questions there. Yeah, I mean all the sites had to fill out their feasibility questionnaires at the beginning of the study. And these were the ones that we asked, you know, how many CRRT patients, you know, are you seeing per week that would fit into your, you know, inclusion exclusion criteria, the protocol. So we already knew ahead of time, again just a little bit unlucky, that the two sites that we knew would be low enrolling happened just to be the ones that got up and running first.

Speaker Change: Well, I can give you an idea based on the feasibility study. These particular institutions feel the of the ability at 400 percent times what I'll call the low enrollment sites would be.

Vincent Angotti: We expect to provide an updated timeline for study completion, PMA filing, and anticipated PMA approval on our next quarterly call. While the clinical study is ongoing, we've been working on pre-launch commercial activities in preparation for the commercial launch of NIAD, again, if approved. This has included further market research for the group of nephrologists, intensivists and pharmacy directors. The participants in our research group highlighted in a famous that strong safety profile over the last 30-plus years, particularly for patients with liver impairment or contraindications to Hepburn and Citrus.

Vincent Angotti: Yeah, there are site questions there. Yeah, I mean, all the sites had to fill out their feasibility questionnaires at the beginning of the study. And these were the ones that we asked, you know, how many CRRT patients you see per week that would fit into your, you know, inclusion, exclusion criteria, the protocol? So, we already knew ahead of time, again, just a little bit unlucky that the two sites that we knew would be low enrollers happened just to be the ones that got up and running first.

Speaker Change: Yeah, their site questionnaire, I mean all the sites had to fill out their feasibility questionnaires at the beginning of the study.

Speaker Change: These were the ones that we asked, you know, how many CRRT patients...

Speaker Change: Are you seeing per week that would fit the inclusion exclusion criteria of the protocol? So we already knew how to time again, just...

Speaker Change: Little bit unlucky that the two sites that we knew would be low in rolling happened just to be the ones that got up and running first. So it's not our guest gym. This is based on their feedback to us and the questionnaires that we sent to them when we get this process started with an institution.

Vincent Angotti: Right, so it's not ours, it's not our guest gym. This is based on their feedback to us and the questionnaires that we sent to them when we got this process started with an institution. Does that make sense? Yeah. Yes, yes, I guess in that respect.

James Molloy: So it's not our, it's not our guest gym. It is based on their feedback to us and the questionnaires that we sent to them when we get this process started with an institution. Does that make sense? Yes, yes, I guess in that respect it does. I appreciate very much the clarification, General and Lady.

Vincent Angotti: Specifically, the participants commented on the famous that safety attributes, such as its ultra-short half-life, allowing it to be rapidly cleared and potentially avoiding unwanted complications, seen with longer circulating agents such as Hepburn and Citrus. In addition, our research continues to support the potential commercial uptake of NIAD at a competitive price as compared to the total cost of Citrus and Icoagulation, which includes the cost of calcium and the required monitoring of calcium levels.

Speaker Change: That makes sense?

Vincent Angotti: I appreciate very much the clarification, gentlemen and ladies. I think it's also important, Jim, that you might ask, and if I were an investor or someone evaluating, why would you, again, and we'll reiterate what we said before, include potentially some lower enrollment sites? It's again because of the quality of the PI, the influence of the PIs, their involvement with international guidelines and domestic guidelines, the fact that they are the key thought leaders in this, even though they might have a smaller patient population that is streaming into their particular facility.

Speaker Change: Yes, yes, I guess in that respect. I appreciate very much the clarification, gentlemen and lady.

Vincent Angotti: I think it's also important, Jim, that you might ask, and if I was an investor or someone of the value list of, well, why would you again, and we'll read it. Why would you include potentially some lower enrolling sites? It's again because of the quality of the PI, the influence of the PIs, their involvement with international guidelines and domestic guidelines, the fact that they are the key thought leaders in this even though they might have a smaller patient population that is streaming to their particular facility. That's one and two, with some of these, in particular these two, they give you the diversity of patients that I think would be important in the data set.

Speaker Change: I think it's also important, Jim, that you might ask, and if I was an investor or someone evaluating, I'd say, well, why would you, again, and we'll reiterate what we said before, why would you include potentially some lower enrolling sites? It's, again, because of the quality of the PI, the influence of the PIs, their involvement with international guidelines and domestic guidelines.

Speaker Change: The fact that they are the key thought leaders in this, even though they might have a smaller patient population that is streaming to their particular facility. That's one and two with some of these, in particular, these two, they give the diversity of patients that I think will be important in the day of that.

Vincent Angotti: That's one. And two, with some of these, in particular these two, they give you the diversity of patients that I think will be important in the data set. It is interesting, as Dr. Palmer mentioned, that of these two more unique sites, they were the first two up and ready to screen.

Vincent Angotti: These results reinforce our belief that the peak sales estimate for NIAD in the hospital setting approximates $100 million while a potential opportunity in outpatient dialysis settings could add at least another $100 million of peak sales. We remain focused on the hospital opportunity as this is where our current NephroCRRT study is being conducted. In addition to the progressing clinical study and commercial preparation, we continue to make positive advancements in our manufacturing and related CMC efforts for NIAD.

Pamela Palmer: It is interesting, as Dr. Palmer mentioned, that of these two more unique sites, that they're the first two up and ready to screen.

Speaker Change: It is interesting as Dr. Palmer mentioned that of these two more unique sites that there was a first-to-up and ready-to-screen.

James Molloy: Thank you very much.

Vincent Angotti: Thank you very much. Thank you, Jim. Thank you so much. And there are no further questions at this time. I would like to turn it over to Vincent Angotti for closing.

Operator: Thank you, Jim.

Operator: Thank you so much, and there are no further questions at this time.

Speaker Change: Thank you very much.

Speaker Change: Thank you, Jim. Thank you so much, and there are no further questions at this time. I would like to turn it over to Vincent Angotti for closing remarks.

Vincent Angotti: I would like to turn it over to Vincent Goldie for closing remarks. Yes, thank you, Lee Wei. Again, thank you to all of you who are joining us today and for your continued support.

Vincent Angotti: Thank you, Li-Wei. And again, thanks to all of you who are joining us today and for your continued support. We remain absolutely focused on controlling our spend and driving shareholder value through the execution of the NEFRA study and making NIAID available to healthcare providers and their patients, again, if approved. Please feel free to contact us after the call with any additional questions, and we look forward to sharing our future developments. We have high expectations moving forward.

Vincent Angotti: Thank you, Lee Wei, and again, thank all of you who are joining us today for your continued support. We may absolutely focus on controlling our spend and driving servo to the execution of the first study and to make it available to healthcare providers and their patients to get it approved.

Vincent Angotti: We made absolutely focused on controlling our spend and driving shareholder value to the execution of an effort study and to make night available to healthcare providers and their patients. Again, it's approved.

Vincent Angotti: All active ingredient and finished drug production to date have met our specifications or collecting extended stability data on our GMP grade product to support shelf life for our potential commercial product. Our manufacturing partners have done an excellent job achieving timelines, specifications, and the cost expectations we've set for them.

Vincent Angotti: Please feel free to contact us after the call if any additional questions, and we look forward to sharing our future developments. We have high expectations moving forward.

Vincent Angotti: Please feel free to contact us after the call if you have any additional questions and we look forward to sharing our future developments. We have high expectations moving forward. Thank you.

Operator: Thank you.

Operator: Thank you. Thank you, ladies and gentlemen. This concludes today's conference call. Thank you for your participation. You may now disconnect. Have a...

Operator: Thank you, ladies and gentlemen. This is Vincent Goldie's conference call. Thank you for participation.

Speaker Change: Thank you, ladies and gentlemen, this concludes today's conference call. Thank you for participation. You may now disconnect. Have a good day.

Operator: You may now disconnect. Have a good day.

Vincent Angotti: Before handing a call over to Rafi, it's important to know that our largest investor, Natahala, remains supportive and with continued progress in the clinical study committed to ensuring tougher as adequate funding to reach potential PMA approval of NIAD. This continued support is highly appreciated, and as a result of the extension of the original timeline, both parties agree on the need to amend the timing of the planned second close of our financing, which was originally expected to occur by September 30th of this year.

Raffi Asadorian: Now, I'll hand a call over to Rafi to take you through the details of our second quarter financial results. Rafi, we continue to control operating expenses while prioritizing investments that will facilitate the timely filing of our NIAD PMA. This emphasis on expense containment has helped us close the second quarter with $14 million in cash and investments. Our cash operating expenses, or combined R&D and SGNA expenses, excluding non-cash stock based compensation of $0.2 million in the second quarter, totaled $4 million, compared to $3.8 million last year.

Raffi Asadorian: While we incurred certain expenses related to the Nefros CRRT study in the second quarter, we expect these costs will increase for the remaining quarters of the year as study enrollment accelerates. The estimated range of cash operating expenses for the year has been reduced to $19 to $21 million from the previous range of $21 to $23 million accordingly.

Raffi Asadorian: As mentioned earlier, we plan on amending the date of the planned second closing from our January 2024 financing that was contingent upon achieving the pivotal trial milestone by September 30 of this year. We expect this amendment to be completed before filing our next quarter 10 queue.

Raffi Asadorian: I'll turn the call back to this.

Vincent Angotti: Thanks, Raffi. I'd like to open the line up for any questions you might have.

Lee Wei: Lee Wei? Thank you so much.

Operator: And ladies and gentlemen, we will now begin the question and answer session. Should we have a question, please press the star followed by the number one on your touchstone phone. You will hear a prompt that your hand has been raised. And should you wish the client from the polling process, please press the star followed by the number two. If you're using a speaker phone, please lift the handset before pressing any keys.

Ed RSA: And our first question comes from the line of Ed RSA of HBC Weinerite. Your line is now open. Hi, thanks for taking my questions and congrats on the progress. I have a couple of questions, but first I just wanted to add my congratulations to Pam.

Vincent Angotti: I've been covering the company for 12 years now, work with Pam since the very beginning and wanted to offer my hearty congratulations to a very well-deserved retirement. Thank you, Ed. You're very welcome. So I know it's coming up in the next call for the timeline update. But I wanted to get a sense for where we are now if possible in terms of the number of patients that have completed the study or perhaps and or patients that have been screened to date to go into the study. Yeah, I can help answer that.

Vincent Angotti: This is Vince. So as it relates to screening, the screening has just begun within the last several weeks. And primarily done at what I'll call our lower enrollment potential sites. These sites were selected because of the quality of the care at their particular institutions. And in particular, you might say why would you have a lower potential enrollment site vault, the quality of the PI at these sites, and the diversity of patients at these sites, which makes them by nature lower enrollment potential.

Pamela Palmer: Dr. Palmer, maybe you can comment on the characteristics of the patients at these particular sites. Yeah, they just happen to be the ones that got up and running more quickly.

Vincent Angotti: But these particular sites, we need to see NIAD's efficacy and safety in a broad spectrum of patients, different ICU, surgical ICU, medical ICU, patients with liver failure, younger patients, new younger adults versus older adults. And so these two sites were put in the mix for that reason. They just happen to get up and running more quickly than the others. But we're not expecting a lot of patients from them. So even though they have started prescreening and screening, they were more recently screening site that we've gotten up and running is considered to be a much bigger heavy hitter.

Vincent Angotti: Yeah, I think importantly to your point on that, while no one has completed the study, the third site that Dr. Palmer mentioned, it just came up to become enrollment ready and screening over the course of I think it's the last week and a half to two weeks. The first day after started screening patients. Williams. So they immediately got on to the PI as highly involved and excited about the study and the balance of our sites are all the highest and rolling sites and they all should complete their site initiation visits this month as scheduled and be enrollment ready as the goal by the close of this month and then we'll start to really see the ramp in the cadence on the screening versus completions. Okay, that's helpful.

Raffi Asadorian: Two others, if I may, these four are for Raffi. I think you mentioned in your preparator marks that the cost for the remainder of the year operating costs would be expected to increase, which is as one would expect with an enrolling phase three. I'm wondering if there's any sort of quantitative color that you could provide on op-x.

Raffi Asadorian: And then the other question was around the financing and I missed with exactly you said about September and what's happening there in your plans to refinance that. Thanks, yeah, sure. So the new guidance for the year we reduced this is for cash operating expenses has been reduced to 19 to $21 million. So if you take that 19 million, we've had about 8 million year to date. So we can expect around 11 million for the close of the second half of cash operating expenses given that that range.

Raffi Asadorian: So it increases a bit from the, we've had about $4 million of cash operating expenses in the previous for each quarter, $4 million for Q1, about $4 million for Q2. So expect that to increase, you know, if you forecast that pretty evenly, that remaining $11 million for the second half of the year. Does that answer that question? Yeah, that's awesome. Thanks. Okay, yeah. And in terms of the, yeah, in terms of the, not the hollow of the amendment, I mean that's the focus here really is to work on amending that date.

Raffi Asadorian: And we've already had some initial discussions, but amending that September 30th date to a new date that works for both parties in terms of the study completion and an announcement to get to that pivotal trial milestone. I don't want to forecast what that date will be, but that's the real focus on our discussions with, with not the hollow to get that done as kind of the first priority. You know, make a comment about not the hollow just quickly.

Raffi Asadorian: I just want to remind you, they're on our board. I'll be Jane as representative, not the hollow. And they're highly active with the management team. And in the know on how the studies being conducted in the pace. So there's very good alignment, which has been very helpful to have. We went down right. Go. Thanks for all the perspective. Appreciate it. Thank you so much.

Nazram: And your next question comes from the line of Nazram and of Maxine Group. Your line is now open. Hi, thanks for taking my questions.

Vincent Angotti: First, I also want to extend my congratulations to Dr. Palmer on her work and her well-learned retirement. I just have a couple questions if I may. So I think how you mentioned that you're expanding the number of study sites to 14. What gives you confidence that you could initiate the new and additional site in a timely manner? Do you think you get that done by the end of 2024 considering what happened to the prior sites and how long do you think it would take to initiate the additional sites? Yeah, I think that's a really good question.

Vincent Angotti: And a couple things and I'm going to turn it over to Dr. Palmer. So I think it's important to understand why we did that with the FDA. And while we've got eight sites now that we feel are prepared to be enrollment ready by the close of this month. And again, I want to emphasize the highest enrolling sites, the highest potentially rolling sites within that group occurring in August. We've always been sourcing sites to get up to the original 10.

Vincent Angotti: And so of course, you've sourced many more sites than that. I think what we've learned along the way is that the facilitation of the contracting process and administrative process and combination with the quality of the sites is the key element moving forward.

Pamela Palmer: So Dr. Palmer, maybe you can comment that what we've learned today and how we're going to apply that to the next set of sites. And I do believe that we might not have them all up enrolling by the end of the year. And they likely want to affect the first half of enrollment. We certainly expect them to affect the second half of the 166 patient enrollment. Yeah, it's really an insurance policy.

Pamela Palmer: I mean, our site feasibility questionnaires were focused around volume of CRT patients, the type of CRT patients at these different academic centers. And this new set of sites that were evaluating is really going to be focusing not only on that, but on the rapid ability to contract and budget. That is just absolutely critical for them to be able to quickly get on board and give us an insurance policy so that the last half of the enrollment will be a lot faster than the first half.

Nazram: Hi, just on that point, did you guys give more color or context around the scale of these additional sites? Are they closer to like the high enrollment sites or closer to, I guess, the lower enrollment quantity sites? No, definitely the higher, but it's not just their CRT volume and their ability to enroll, but it's also going, we're going to be selecting for rapid, you know, paperwork processing universities sites that really can streamline that.

Nazram: We've already started our initial contact with an additional 20 sites, so we're going out pretty large to funnel it down to get to the ultimate 14 number. And again, they Early assessment is they know fairly quickly and respond fairly quickly where the contracting process can be facilitated in an expedited manner or not. Got it. Thanks for taking my questions.

Nazram: And once again, congrats on your retirement, Dr. Palmer. Thank you. Thank you so much.

James Molloy: And our next question comes from the line of James Molloy with Alliance Global Partners. Your line is now open. I think I thank you for taking my questions.

Vincent Angotti: Congratulations, Dr. Palmer and your retirement as well. Could you walk through a little bit? It's not off to Dr. Aslan's on the on the call. I'd love to get it. It starts views on the changes that that were instituted on coming in to sort of get this thing going. Hopefully in the near term. And then I think you highlighted the eight sites being the highest and rolling sites. What does that mean since no one's been enrolled yet?

Vincent Angotti: Yes, I can comment on the last part. So it's a total of eight sites. The final four site initiation visits are occurring this month, meaning August, so then they'll be enrollment ready. Of these final sites, they are the highest and rolling sites, so they'll be enrollment ready by the close. Our goal is by the close of August. The first initial site that are now what has rolling sites mean in a in a trial that hasn't enrolled anybody.

Vincent Angotti: I don't mean to pick on it, but what do you mean highest and rolling sites? Do you think there'll be the highest and rolling? Yeah, well, these are the non specialty sites. So as we mentioned earlier, the initial two over the three are specialty sites that are focused on maybe cardio thoracic surgery, maybe younger patients where the patient flow is going to be much lower. And the screening process in volumes can be much lower.

Vincent Angotti: The balances of these sites are unlike those two original sites where the volumes in both screening and enrollment will be higher just based off of the pure patient population that they have that fits our criteria. Also based off of the feasibility of the study parameters that they've sold out in order to be included within the study. So that's according to them and our assessment of them. Beyond that, I think your question, Jim, was what are some of the changes or modifications that might have been occurred since Dr. Aslam has joined the company?

Vincent Angotti: Not on the call. Yeah, and he's not on the call. It's not on the call this time, but yeah, he's really, he knows some of these folks, you know, he comes from this world. I'm an anesthesiologist pain specialist. He is an nephrologist, knows CRRT extensively and knows a lot of folks in Syria. So he's really handholding a lot of these sites and getting them, you know, just pushing and urging and getting them through this contacting budgeting phase so that we can get on to the more fun, you know, enrollment part of things.

Vincent Angotti: So, and that's just a critical part of this is relationships and just his deep knowledge in this field. Jim, did that answer your question on the first part of your question, though, and make sure we answer that in terms of highest enrolling because the highest enrolling haven't started screening yet. That's coming at the close of this month. Is that just make sure we're answering that question? Yeah, I guess, I guess the highest enrolling is sort of an aspirational name for them.

Vincent Angotti: I get to say they will be the highest enrolling once you start enrolling. Well, I can give you an idea based on the feasibility study. These particular institutions feel the ability at 400% times what I'll call the low enrollment sites would be. Yeah, there are site questions there. Yeah, I mean all the sites had to fill out their feasibility questionnaires at the beginning of the study. And these were the ones that we asked you know how many CRRT patients you know are you seeing per week that would fit into your you know inclusion exclusion criteria the protocol.

Vincent Angotti: So we already knew ahead of time again just a little bit unlucky that the two sites that we knew would be low enrolling happened just to be the ones that got up and running first. So it's not our it's not our guest gym. It is based on their feedback to us and the questionnaires that we we sent to them when we get this process started with an institution. Does that make sense?

Vincent Angotti: Yes, yes, I guess in that respect it does. I appreciate very much the clarification general and lady. I think it's also important, Jim, that you might ask and if I was an investor or someone of the value list of well why would you again and we'll read it. Why would you include potentially some lower enrolling sites? It's again because of the the quality of the PI, the influence of the PI's, their involvement with international guidelines and domestic guidelines, the fact that they are the key thought leaders in this even though they might have a smaller patient population that is streaming to their particular facility. That's one and two with some of these in particular these two they give you the diversity of patients that I think would be important in the data set.

Vincent Angotti: It is interesting as Dr. Palmer mentioned that of these two more unique sites that they're the first two up and ready to screen. Thank you very much. Thank you, Jim.

Vincent Angotti: Thank you so much and there are no further questions at this time. I would like to turn it over to Vincent Goldie for closing remarks. Yes, thank you, Lee Wei. Again, thank to all of you who are joining us today and for your continued support. We made absolutely focused on controlling our spend and driving shareholder value to the execution of an effort study and to make night available to healthcare providers and their patients.

Vincent Angotti: Again, it's approved. Please feel free to contact us after the call if any additional questions and we look forward to sharing our future developments. We have high expectations moving forward. Thank you. Thank you, ladies and gentlemen. This is Vincent Goldie's conference call. Thank you for participation. You may now disconnect. Have a good day.