Q3 2023 AcelRx Pharmaceuticals Inc Earnings Call

Speaker 1: Welcome to the Acceler X 3rd quarter 2023 financial results conference call. This call is being webcasted live via the events page of the investor section of Acceler X's website at www.aceler X.com. This call is...

Welcome to the accelerate <unk> third quarter 2023 financial results Conference call. This call is being webcast live via the events page of the investors section of accelerates its website at www dot accelerates dot com.

This call is property of accelerate any and any recording reproduction or transmission of this call without the expressed written consent of accelerates is strictly 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 accelerometers website and now I would.

Speaker 1: any and any recording, reproduction or transmission of this call without the express trig concept of accelerax is strictly prohibit.

Speaker 1: As a reminder, this webcast is being reported. You may listen to a replay of this webcast by going to the Investor section of Accelerax's website. And now I would like to turn the call over to Raffi Asadorian, Accelerax's Accelerax Pharmaceuticals Chief Financial.

I'd like to turn the call over to Rafi Aciduria accelerates, just accelerates pharmaceuticals, Chief Financial Officer.

Speaker 2: Thank you for joining us on the call today. This afternoon, we announced our third quarter, 2023, financial results, and associated business updates.

Thank you for joining us on the call today. This afternoon, we announced our third quarter 2023 financial results and.

And associated business updates in our press release.

Speaker 2: This press release can be found within the Investors section of our website.

This press release can be found within the investors section of our website.

Speaker 2: With me today, our Vintan Gadi, our Chief Executive Officer and Dr. Pam Palmer, Accelerated to the Founder and Chief Medical Officer.

With me today are been saying gaudy, our chief Executive Officer and Dr. Pam Palmer.

<unk> founder and Chief Medical Officer.

Speaker 2: 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 Excel Rec.

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 accelerates.

Speaker 2: 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.

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.

Speaker 2: These documents can be found on our website with any investor's section. I will now hand to call over to Vince.

These documents can be found on our website within the investors section.

I will now hand, the call over to Vince.

Thank you Rafi and good afternoon, everyone.

Speaker 3: Today we look forward to updating you on NIAD, ExcelRex's lead and a FEMISTAT program, as well as other highlights of our business.

Today, we look forward to updating you on NIAD accelerates is leading a firm step program as well as other highlights of our business.

Speaker 3: So those of you who have followed Acceler X over time, you know that our focus on product candidates for use in the medically supervised setting has greatly evolved from acute pain.

For those of you who have followed accelerates over time.

Note that our focus on product candidates for use in a medically supervised setting has greatly evolved from acute pain.

Speaker 3: We're now at a stage where we're focusing our expertise in drug development on a very different area of on-met medical need, specifically dialysis.

We're now at a stage, where we're focusing our expertise in drug development.

On a very different area of unmet medical need specifically dialysis.

Speaker 3: Our lead product candidate, NIAD, is a novel anti-coagulant for use during dialysis and has received a breakthrough device designation from the FDA.

Our lead product candidate <unk> is a novel anti coagulant for use during dialysis and has received breakthrough device designation from the FDA.

Speaker 3: At the close of the third quarter, we were pleased to receive approval for our NIAD IDE, allowing us to proceed with the Registrational Study.

At the close of the third quarter, we were pleased to receive approval for our not yet I D E, allowing us to proceed with the Registrational study.

Speaker 3: for what could potentially become the first FDA approved regional anti-coagulant for the dialysis circuit.

For what could potentially become the first FDA approved regional anti coagulant for the dialysis circuit.

Speaker 3: We recently completed our investigators meeting with a participants expressed excitement at the prospect of the near-term availability of an ultra-short-acting anti-coagulant for use in CRRT.

We recently completed our investigator's meeting, where the participants expressed excitement at the prospect of the near term availability oven Ultra short acting anti coagulant for use in C. R. R T.

Speaker 3: We'll now proceed with our Registration Study, known as the Nefro CRRT Study.

We'll now proceed with a Registrational study known as the Neff Roe.

E R. R T study.

Speaker 3: The Nathamistat, efficacy, and Phase III Registrational Continuous Reign of Replacement Therapy Study.

The nurse Amistad efficacy in phase III registrational continuous renal replacement therapy study.

Speaker 3: This 166 patient study will evaluate NIAD versus placebo, measuring clinical endpoints that have been agreed upon with the FDA.

This 166 patient study will evaluate <unk> versus placebo.

<unk> clinical endpoints that have been agreed upon with the FDA.

Speaker 3: Based on the results from this study, we plan to submit a pre-market approval or PMA application in the second half of 2024.

Based on the results from this study we plan to submit a premarket approval or PMA application in the second half of 'twenty 'twenty four.

Speaker 3: In terms of market opportunity, we estimate NIA to have a peak annual sales potential of over $200 million in the US.

In terms of market opportunity, we estimate naya debit peak annual sales potential of over $200 million in the U S.

Speaker 3: And this is attributed to just the inpatient and outpatient dialysis markets, excluding use in any other extracorporeal circuit.

And this is attributed to just the inpatient and outpatient dialysis markets, excluding Houston any other extra poor you'll circuits.

Speaker 3: Note that our estimate and peak sales potential assumes modest penetration into these markets, specifically attaining only about a 20% share of the current in-hospital CRRT market.

Note that our estimate of peak sales potential assumes modest penetration into these markets specifically attaining only about a 20% share of the current in hospital C. R. R T market.

Speaker 3: and 6% of the dialysis market outside of the hospital.

6% of the dialysis market outside of the hospital.

Speaker 3: Our interactions with leaders in the field in the phrology have reinforced the urgent medical need for an alternative anticoagulant for use during CRRT.

Our interactions with leaders in the field of nephrology have reinforced the urgent medical need for an alternative anti coagulant for use during C. R. A T.

Speaker 3: And this combined with a recently conducted US quantitative research reaffirms the market potential for NIAID.

And this combined with a recently conducted U S. Quantitative research reaffirms the market potential for <unk>.

Speaker 3: In fact, as announced yesterday, we're hosting a key opinion leader panel discussion on December 6th, with thought leaders in the apology and critical care to discuss the use of anti-coagulation in dialysis circuits and the Nefro study protocol.

In fact as announced yesterday, we're hosting a key opinion leader panel discussion on December six with thought leaders in nephrology in critical care to discuss the use of anti coagulation in dialysis circuits and the Neff rope study protocol.

Speaker 3: At this point, I'd like to turn it over to Dr. Palmer to brief you expand on this. Thank you, Ben. Thank you.

At this point I'd like to turn it over to Dr. Palmer to briefly expand on this.

Thank you and good afternoon, everyone.

Speaker 4: As Vince mentioned, we are hosting a KOL panel discussion on Wednesday, December 6th, with experts from two prestigious institutions.

As Vince mentioned, we are hosting a K O L panel discussion on Wednesday December 6th with expert from Kim prestigious institution.

Speaker 4: Joining us for this event are Dr. Lauren Spussy of Emery University School of Medicine and Dr. David Bol of UCLA School.

Joining us for the phone.

Our Doctor Lawrence Bussey of Emory University School of Medicine, and Dr. David Bowl of UCLA School of Medicine.

Speaker 4: They are experts in continuous renal replacement therapy and are principal investigators in the NEPRO-CRRT study.

They are expert in continuous renal replacement therapy, and our principal investigators in the Nephron C. R. R. T study.

Speaker 4: The panel discussion will focus on the current approach to anticoagulation in the dialysis circuit informed by our market research study.

The panel discussion will focus on the current approach.

Anticoagulation in the dialysis.

Informed by our market research study.

Speaker 4: for which both physicians are co-authors on this study's manuscript recently submitted for publication.

For which both physicians are coauthors studies manuscript recently submitted for publication.

Speaker 4: We will also discuss the NEPRO study protocol with Drs. Bussey and Bolt at this event.

We will also discuss the NEP Route study protocol with doctors about handful at this event.

Speaker 4: A live question and answer session for analysts will follow the panel discussion.

A live question and answer session for analysts will follow the panel discussion.

Speaker 4: With NIAID's breakthrough device designation, open discussion with the FDA allowed an efficient IDE submission and agreement with respect to the protocol's patient population, key endpoints, and inclusion-exclusion criteria.

With Knight had breakthrough device designation open discussion with the FDA allowed.

I D submission and agreement with respect to the protocols patient population key endpoint and inclusion exclusion criteria.

Speaker 4: The primary endpoint of the study is assessing the activated clotting time, or ACT, resulting from the administration of NIAID to the dialysis circuit.

The primary endpoint of this study is assessing the activated clotting time or a C T, resulting from the administration of <unk> to the dialysis circuit.

Speaker 4: compared to the ACT in the placebo saline group over the first day of CRRT.

Compared to the E T in the placebo saline.

Over the first day of C. R. R. A T.

Speaker 4: We believe that this should be a straightforward primer endpoint to achieve. Since those patients on placebo will not be receiving any anticoagulant, and therefore their ATT would not be expected to induce.

We believe that this should be a straightforward primary endpoint to achieve.

Those patients on placebo will not be receiving any any client right and.

And therefore, they're acte would not be expected to increase.

Speaker 4: Secondary endpoints include duration of filter life before clotting.

Secondary endpoints include duration of centralized for clotting occurs and the number of transfusions required due to red blood cells or platelets law.

Speaker 4: and the number of transfusions required due to red blood cell or platelet loss.

Speaker 4: As a reminder, NIAID is being regulated by the FDA as a device.

As a reminder, NIAD is being regulated by the FDA hasn't declined since.

Speaker 4: since the mechanism of action of NIAID is within the dialysis circuit and not the patient.

Since the mechanism of action of <unk> is within the dialysis circuit and not the patient.

Speaker 4: This serves as an advantage for us to efficiently move NIAID towards approval. This device that is typically require much lower patient exposures than drug.

This serves as an advantage for us to efficiently.

Ed towards approval. This device that is typically require much lower patient exposures than drugs.

Speaker 4: The feedback that we have heard from the clinical sites is that enrollment should be robust, allowing top-line data mid-2024 and a PMA submission soon thereafter. I will now turn the call back.

The feedback that we've heard from the clinical site is that enrollment should be robust, allowing top line data mid 2024, and a PMA submission in thereafter.

I will now turn the call back over to Dan.

Thank you Dr Palmer.

Speaker 3: Knowing that nifamostat has been a standard of care for CRRT in South Korea and Japan with decades of use and a favorable safety profile, we're confident in the success of this study as it is evaluating nifamostat versus saline as the placebo for activated clotting time.

Knowing that the famous stat, it's been the standard of care for C. R. R. T in South Korea, and Japan with decades of use and a favorable safety profile. We're confident in the success of this study as it is evaluating the famous stat versus saline as the placebo for activated clotting time.

Speaker 3: As Dr. Palmer stated, based on study timing, we plan to prepare a PMA submission to the FDA in the second half of next year.

As Dr. Former stated based on study timing, we plan to prepare a PMA submission to the FDA in the second half of next year.

Speaker 3: This would enable us to potentially launch NIAID in the first half of 2025.

This would enable us to potentially launch not yet in the first half of 2025.

Speaker 3: We're proceeding with early-stage commercial planning after already receiving an ICD-10 CMS procedural code to facilitate reimbursement. Now, just a few words.

We're proceeding with early stage commercial planning after already receiving ICD 10, CMS procedural code to facilitate reimbursement.

Now just a few words on a pre filled syringe candidates.

Speaker 3: The need for pre-filled syringes is clear, since their availability offers a significant improvement and advantage for the overall health care system, including less waste, improved safety, and the convenience of not having to dilute and prepare the syringe in advance of procedures.

The need for pre filled syringe as is clear since their availability offers a significant improvement in advantage for the overall health care system, including less waste improved safety and convenience of not having to dilute and prepare the syringe and advance their procedures.

Speaker 3: Our FEDSERA prefilled syringe containing the antihypotensive ephedrine is the first of two prefilled syringe product candidates in our pipeline that is closest to an NDA filing.

Our fed seara pre filled syringe containing the anti hypotensive ephedrine is the first of two prefilled syringe product candidates in our pipeline that is closest to an NDA filing.

Speaker 3: Following our capital raise in the second quarter, we have continued to prioritize resources on the development of NIAC.

Following our capital raise in the second quarter, we have continued to prioritize resources on the development of not yet.

Speaker 3: and are evaluating the timing of the NDA submission for FedZero.

Evaluating the timing of the NDA submission for fed seara.

Speaker 3: Accelerex has evolved quite a bit over the past 18 months.

Accelerates has evolved quite a bit over the past 18 months.

Speaker 3: And we're now a very different company than we were just a few years ago.

And we're now a very different company than we were just a few years ago.

Speaker 3: To round out our transformation, the transition of Dysuvia to Allura Pharmaceuticals is still ongoing and AccelerX continues to support Allura to facilitate their success.

To round out our transformation the transition of the shoe to a lora pharmaceuticals is still ongoing and accelerates continues to support lora to facilitate their success.

Speaker 3: We expect their focus to turn to commercial activities early next year as the supply chain transition is completed.

We expect their focus to turn to commercial activities early next year as the supply chain transition is completed.

Speaker 3: As a reminder, AccelerX is being reimbursed by Laura for all support provided during the transition.

As a reminder, accelerates as being reimbursed by Laura for all support provided during the transition.

Speaker 3: We continue to lead the relationship with the Department of Defense or DOD to ensure continued engagement.

We continue to lead the relationship with the department of Defense or D. O D to ensure continued engagement.

Speaker 3: The DoD is the single largest Dissuvia customer and has been recently placing orders on a more regular basis.

The Dod is the single largest distributor customer.

It has been recently, placing orders on a more regular basis.

Speaker 3: Third quarter distributed demand from the DoD was comparable to the second quarter, but revenue recognition was impacted by the timing of certain shipments.

Third quarter distribute demand from a D. O D was comparable to the second quarter, but revenue recognition was impacted by the timing of certain shipments.

Speaker 3: In addition, the DoD has entered into a contingency contract with a wholesaler who must now maintain a minimum amount of inventory on hand with rapid replenishment requirements.

In addition, the D. O D has entered into a contingency contract with a wholesaler who must now maintain a minimal amount of inventory on hand with rapid replenishment requirements.

Speaker 3: Finally, the completion of the Dysuvia Early Evaluation of Pain, or DEEP trial, sponsored by the DoD at the University of Pittsburgh Medical Center, will be a key milestone.

Finally, the completion of the dispute of your early evaluation of pain or.

Or deep trial sponsored by the D O D. At the University of Pittsburgh Medical Center will be a key milestone.

Speaker 3: This study is expected to be completed in the first quarter of next year, and of note, the DoD granted UPMCA a total of $11 million including support of this Dissuvia trial, the results of which may lead to additional DoD branches adopting Dissuvia.

This study is expected to be completed in the first quarter of next year.

Of note the Doj granted U P. M C. A total of $11 million, including support of this huge trial the results of which may lead to additional D. O D branches adopting to Sue you.

Speaker 3: As a reminder, we received a 75% royalty on all sales to the DOD, a 15% royalty on non-DOD commercial sales, and up to $116.5 million in sales-based milestone payments from those commercial sales.

As a reminder, we received a 75% royalty on all sales to the D O D.

A 15% royalty on non D O D commercial sales and up to $116 $5 million and sales based milestone payments from those commercial sales.

Speaker 3: Now I'll hand the call over to Rafi to take you through the details of our third quarter financial results.

Now I'll hand, the call over to Rafi to take you through the details of our third quarter financial results.

Speaker 2: Thank you, Vince. We ended the quarter with $13.4 million in cash and short-term investment.

Thank you Vince we ended the quarter with $13 $4 million in cash and short term investments. This includes the capital raised through the financing closed in July with new and existing health care investors.

Speaker 2: This includes the capital raised through the financing closed in July with new and existing health care investments.

Speaker 2: This financing provides capital of up to $26 million upon the exercise of the milestone-based warrants, including $10 million of gross proceeds that were made immediately available.

This financing provides capital of up to $26 million upon the exercise of the milestone based warrants.

Including $10 million of gross proceeds that were made immediately available.

Speaker 2: These new investors appreciate the value of NIA and have been extremely supportive of management as NIA development progresses in what the clinical study about to begin.

These new investors appreciate the value of diet and have been extremely supportive of management as NIAD development progresses, and with the clinical study about to begin.

Speaker 2: Revenues for the third quarter of $0.1 million were generated primarily from royalties on the sales of DeSuvia, principally from sales to the Department of Dept Defense, on which we earn a 75% royalty from Alora.

Revenues for the third quarter of zero point $1 million were generated primarily from royalties on the sales of the Silvia principally from sales to the department of defense on which we are in a 75% royalty from our Lora.

Speaker 2: As Vince mentioned, the quarter was negatively impacted by timing of shipments in the quarter, which are expected to be realized in the fourth quarter of this year.

As Vince mentioned the quarter was negatively impacted by timing of shipments in the quarter, which are expected to be realized in the fourth quarter of this year.

Speaker 2: Our combined R&D and SG&A expenses in the third quarter totaled $3.4 million, compared to $4.5 million last year. And excluding non-cash related expenses was $3 million in Q3 2023.

Our combined R&D and SG&A expenses in the third quarter totaled $3 $4 million compared to $4 $5 billion last year.

And excluding noncash related expenses was $3 million in Q3, 2023.

Speaker 2: Remain on track to stay within the range of our full year 2023 combined R&D and SG&A expense guidance, excluding non-cash expenses, of $16 to $20 million.

We remain on track to stay within the range of our full year 2023, combined R&D and SG&A expense guidance, excluding noncash expenses of $16 million to $20 million.

Speaker 2: We expect fourth quarter R&D and SGNA expenses, excluding non-cash expenses, to increase from the third quarter as we begin our clinical study.

We expect fourth quarter, R&D and SG&A expenses, excluding noncash expenses to increase from the third quarter as we begin our clinical study.

Speaker 2: We anticipate top-line data of this clinical study by the middle of next year, so we expect expense levels over the next several quarters to be higher than levels we've seen over the last two quarters.

We anticipate topline data of this clinical study by the middle of next year. So we expect expense levels over the next several quarters to be higher than levels, we've seen over the last two quarters.

Speaker 3: We will provide further financial guidance for 2024 at a later date. I'll now turn the call back to Vince. Thanks, Rafi. And I'd like to open the line for any questions you might have. Operator?

We will provide further financial guidance for 2024 at a later date.

I'll now turn the call back to us Thanks Rafi.

Now I'd like to open the line for any questions you might have operator.

[noise].

Speaker 1: Thank you. We'll now begin the question-and-answer session. To join the question queue, you can press star, then 1 on your touch-tone keypad. And if you'd like to remove yourself from the queue, you can press star, then key.

Thank you we will now begin the question and answer session to join the question queue. You can press Star then one on you touched him he pad and if you'd like to remove yourself from the queue compressed star than Q if.

Speaker 1: If you're using a speakerphone, you may need to pick up your handset before pressing it.

If youre using a speakerphone you may need to pick up your handset before pressing any keys.

Speaker 1: And our first question comes from Ed Arsene with H.C. Wayne Wright. Please go ahead.

And our first question comes from Ed Arce with H C. Wainwright. Please go ahead.

Speaker 5: I'm going to ask everyone this time, is asking a couple of questions for Ed. Thank you for your kind of question.

Hi, Good afternoon, everyone. This Thomas asking a couple of questions for Ed. Thank you, let's go to questions.

Speaker 5: So first question for the NAFRO CRT study. Can you discuss what you estimated timeline to full enrollment in order for the next 2024 readout and also given the start date where as we approach the end of the year, how a beer anticipate slow pace around question of a new year at time frame?

So first question for the macro Yorkie study.

Can you discuss what's your estimated timeline you are full enrollment in order for the first.

'twenty 'twenty four readout and also given the start they are with US we have close yeah.

Ear.

Or do you anticipate slower pace around Christmas and new year's timeframe.

Speaker 4: Yeah, it's Pam here. You know, these are ICU patients. So in fact, the holidays really don't affect their enrollment whatsoever. They, you know, have acute kidney failure, unfortunately, sort of regardless of the time of year. So we don't anticipate coming into the end of the year here, your normal clinical trials slow down that you would see with many studies.

Hi, Yeah, it's Tim here.

No. These are ICU patients. So in fact, the holidays really don't affect our their enrollment whatsoever and he you know have acute kidney failure. Unfortunately sort of regardless of the time of year. So we don't anticipate them coming into the end of the year here your normal clinical trial slow down that you would see with wood.

Many studies.

Speaker 4: It's a small study. So as far as last patient out till top line data, there shouldn't be a large delay. I will be making sure we clean up the database as time goes on and so there shouldn't be a large lag. So we're expecting the study to end sort of mid next year and then also have top line data student thereafter. At the top line data student.

With its a small study so as far as last patient out till topline data there shouldn't be a large delay will be.

Making sure we clean up the database as time goes on and so there shouldn't be a large lag. So we're expecting the study to any sort of mid next year and then also to have topline data soon thereafter.

The same time.

Speaker 5: Got it. And the still that perhaps more detail around the NFO CRT study. Of the 10 ICU centers that were selected for this study. Can you describe some major attributes for this action?

Got it.

They are the perhaps what.

More detail around an apples CRP study.

Of the 10, a few centers that were selected for this study. He described some major attributes for the selection.

So the patient selection.

Speaker 4: the site flexing. The site flexing, sorry. Site flexing are actually major academic centers.

Sighful exercise flagship sorry.

Actions are actually major academic centers, they're the top names in this field in fact, many of them were our advisors are our advisors are when we took on la <unk> and.

Speaker 4: There are the top names in this field. In fact, many of them were our advisors. Our advisors when we took on Lowell and looked at this protocol and had to reach out to folks who were knowledgeable in this area to help us define inclusion, exclusion, criteria, et cetera.

And looked at this protocol and had to reach out to folks who are knowledgeable in this area to help us define inclusion exclusion criteria et cetera.

Speaker 4: Also when we did our quantitative market research to help us analyze that data, we relied on these folks. So they're also the co-authors in that manuscript that's been submitted. So that's really who we're we're weaning on for the clinical trials as well. And they're sort of, they all know each other, they're all friends. And it's a small tight knit community. And it's the major centers, Emory, UCLA, very centers.

Also when we did our quantitative market research to help us analyze that data we relied on these folks. So there also the coauthors and that manuscript that's been submitted so that's really who we're oh you know what.

Leaning on for the clinical trials as well and they're sort of they all know each other they're all friends and its the small tightening community and it's the major centers Emory UCLA.

Things like that.

Speaker 5: Got it. And then perhaps one, just one last question for us. And then we'll jump back on the queue. Assuming NEPO CRTs study data positive.

Got it.

Perhaps once this one last question from US and then well jump back on the queue.

Assuming knuckles the rfps.

The study data possible.

Speaker 5: which will expect to be a G-PART of the PMA. Can you, or what are some other major components of the PMA or NIA?

Which we would expect to be keep our PMA.

T K E L. A what are some other major components of the PMA.

Speaker 3: Maybe talk about components or endpoints of the study, you mean components of the PMA?

Maybe talk about.

Components are endpoints of the study you mean components of the PMA.

Speaker 5: Yeah, components of the P&I in addition to the rational study data.

Yes.

Oh, yes components of the PMA. In addition to the ER to the Registrational studies data.

Speaker 4: Yeah, so there's going to be just a couple of pre-clinical top studies that are very short needed to run. We'll be doing that concurrently with the trial. And of course, there's our stability date as well that we're actually generating right now.

Yeah, Yeah, so theres going to be just a couple of preclinical Tox studies that are very short and easy to run won't be doing that can concurrently with that trial and of course, there is our stability data as well that we're actually generating right now.

Speaker 3: Maybe expand on the secondary end points just quickly. I know we mentioned them, but just a reinforce. Yeah.

Maybe expand on the secondary endpoints just quickly I know, we mentioned them, but just to reinforce yes.

Speaker 4: Yeah, for the clinical end point on the trial, the primary end point is activated crowding time over the first 24 hours.

Oh, you mean for the clinical end point on the trial on the primary endpoint is activated clotting time.

And the first 24 hours.

Speaker 4: And then the secondary endpoint is looking at that same activated clouding time over the first 72 hours along with the number of transfusions, filter changes, do the clotting, et cetera, of the first 72 hours. So.

And then the secondary endpoint is looking at that same activated clotting time I'll take the first half each flowers along with.

The number of transfusions filter changes due to crowding et cetera. The first time in two hours.

Speaker 6: All the primary and secondary endpoints are over within 72 hours and therefore a completed is somebody who's gone to the study for at least those three days. They can be enrolled up to seven days per the protocol, but they will be considered a completed.

All the primary and secondary endpoints are over within 72 hours and therefore, a complete or is somebody who's gone through this study for at least at those three days they can be enrolled up to seven days.

Per the protocol, but they will be considered a complete or after just three.

Yeah.

Speaker 5: That's thank you so much for the details. So looking forward to the study start and

Okay.

Thank you so much for all the detail so looking forward to the study start in a very shortly.

Thanks Thomas.

Speaker 1: The next question comes from James Maloy with Alliance Global Partners. Please go ahead.

The next question comes from James Molloy with Alliance Global Partners. Please go ahead.

Speaker 7: Hey guys, thanks for taking my questions. I had a question on, I get a presuming good data and ultimately FDA approval. Can you walk through a little bit the opportunity to potentially be taking from Heparina's site trade? And obviously there's a third percent of the people out there, Nellanda Quaggol and site traders, where you're gonna be trying to grab from as well. Is there an opportunity to try to take from the 43% of Heparina as well?

Hey, guys. Thank you for taking my questions I had a question on AR I get up.

I'm presuming up assuming good data and an ultimate FDA approval can you walk us to walk through a little bit the opportunity to potentially be taking from heparin, a citrate and obviously theres a third set of people out there now and acquired go inside trade is where you're going with trying to trying to grab from as well is there an opportunity to try to take them a 43% of the heparin as well.

Okay.

Speaker 4: yeah so so you know that it's considered off in the standard of care one thing i was pan to do quickly is and then we'll address that question further is maybe you can comment pamm on what is considered standard care at many of these clinical sites that are involved in the trial to give them some type of flavor yeah what and i think that forty three percent that that uh... games mentioned it comes from our quantity of market research where

Yeah. So so you know that's considered often a standard of care one thing I'll ask Pam to do quickly is and then we will address that question. Even further is maybe you can comment Pam on what is considered standard of care at many of these clinical sites that are involved in the trial to give them some type of flavor, yeah, well and I think that 43% that debt.

James mentioned it comes from our quantitative market research where we.

Speaker 6: We asked 150 physicians about half were nephrologists and half were critical care specialists. What is the current state of the state of the art with anticoagulation relates to CRRT? And 43% said, 43% of the patients are getting haphrored. And the rest of it, the other 60% is split evenly between getting no anticoagulant or getting citric acid.

We asked 150 position about half for Nephrologists and half for critical care specialists. You know what is the current state of the state of the art with anticoagulation as relates to see Archie and 43% said they.

Our 43% of the patients are getting heparin and the rest of it together, 60% is split evenly between getting no anticoagulant or getting citrate.

Speaker 6: And so each of these sites that were actually enrolling the study, there is no United States sort of standard of care.

And so each of these sites that were actually enrolling in the study there is no United States sort of standard of care there.

Speaker 6: There are sort of all over the map and they'll admit that. We've got sites that don't use any anticoagulation at all. We have sites that are only using citrate. We have sites that are only using heparin.

Or is there sort of all over the map and they'll admit that we've got sites that don't use any anticoagulation and all we have sites that are only using citrate. We have sites that are only using heparin.

Speaker 6: or nothing. And it's, so it's really interesting how, when you don't have good options, you have a very sort of fractured approach to clinical protocol. So we're really hoping with an FMSAT to streamline that and finally give them a good option that they can use in many patients.

Or nothing and it's it's so it's really interesting how when you don't have good options you have a very sort of fractured approach the clinical protocols. So we're really hoping within the families that to streamline that and finally gives them a good option that they can use in many patients.

Speaker 6: So I think we'll be pulling mainly from the...

So I think we'll be pulling mainly from.

The.

Speaker 6: that commercially will be looking at folks who aren't using anything or using citrate and will break into that market. But I actually believe that there's many folks that are getting, they're using heparin and patients. The otherwise don't think it's really a good option. And I think we could also erode into that.

The commercially we'll be looking at folks who aren't using anything or using citrate and we'll break into that market, but I actually believe that there's many folks that are getting are they're using half bringing patients. The otherwise don't think it's really a good option and I think we had also a erode into that as well so when we've communicated commentary about.

Speaker 3: So when we've communicated commentary about our potential peak sales, the bulk of that is really coming from situate no anti-coagulation. So anything we generate from those patients that are,

What are potential peak sales the bulk of that is really coming from citrix no anti coagulation. So anything we generate from those patients that are.

Speaker 3: where the site is utilizing hapernet risk because they're either ill-equipped, used to treat and don't want to not anticoagulate. We think that there's opportunity to get that, but that has not really been significant or any part of our projections to date. So that would certainly be upside.

Where the site is utilizing hepburn at risk because they're either ill equipped used to treat.

And don't want to not anti coagulate, we think that there's opportunity to get that but that has not really been a significant or any part of our projections.

Our projections to date, so that would certainly be upside.

Yes.

Speaker 7: or thank you for that i think uh... you guys talk a little bit about the potential for potential uh... to go into the intermittent human eye out for smartly talk a little bit as as you're thinking of all the matter all is there an opportunity to go into but that space beyond the continuous

Alright. Thank you for that I think you guys talked a little bit about the potential for potential to grow into the intermittent hemodialysis market can you talk a little bit is is your has your thinking evolved on that at all or is there an opportunity there to go to go to that space beyond the continuous.

Speaker 4: Yeah, you know, I mean, it's next to coral circuit. It's got the same problem that CRRT has. Blood hits a foreign object and it starts to clot. And there's not any really good options for that as well. The patients with intermittent hemadialysis tend to not be as sick as the folks who require continuous re-replacement therapy. So many more of them can tolerate Heparin.

Yeah, you know I mean, it's.

It's an extracorporeal circuit, if I've got the same problem that C. R. A T hat.

I'm glad to hit a foreign object and starts to cry.

There's not any really good options for that as well for patients with intermediate hemodialysis tend to not be as sick as folks who require continuous renal replacement therapy. So many more of them can tolerate heparin.

Speaker 6: So that's why it would not as big a market as far as the percentage, but the actual denominator is much larger than CRRT. So, you know, that is something that would benefit from the family set as well. And we just got to make sure that...

So that's why it was not as big a market as far as the percentage, but the actual denominator is much larger than C. R. A T. So.

That is a.

Something that would benefit from the handset as well and we just got to make sure that.

Speaker 6: you know, we're blocking and tackling in all of this.

You know we're blocking and.

<unk> and all of us.

Speaker 8: Hey Jim, I'm going to circle back to the previous segment of that question as well, where you ask the particular CRRT, is there an opportunity potentially?

Jim I'm going to circle back to the previous segment of that question as well, where you asked in particular on C. R. R. T is there an opportunity potentially.

Speaker 8: to take any of that market your way from Hepburn. I think it's important to understand a Dr. Palmer-Yoon comment on this. When patients or I'm sorry, the sites are gonna use the Famostat. Can you clarify, is there any new training or difference relative to what they typically do with Hepburn when they utilize the Famostat?

To take any of that market share away from happened I think it's important to understand that Dr. Palmer you can comment on this.

When patients or I'm, sorry, the sites are going to use the famous stack can you clarify is there any new training or difference relative to what they typically do with heparin when they utilize the famous stat.

Speaker 6: No, and that's the beauty of Nebamastat is that it's as simple.

No and that's the beauty of it.

And with that is that it is as simple.

Speaker 6: to initiate as happenings. That's why happens the use for so long. It's very simple.

She is initiate is happening and that's why happens being used for so long it's very simple.

Speaker 6: a citrate avoids the bleeding risk that Hepburn has.

Citrate avoids the bleeding risk that heparin had.

Speaker 4: but it's got so many other risks and it's very difficult to run for these sites. And so to simplify.

But it's got so many other risks and very difficult to run any sites instead of just simplify.

Speaker 6: The treatment, get back something as simple as pepper and this is what the family in the family that would do, is potentially much less bleeding. And some of the other problems with pepper and like pepper and just tomaside apenia or pepper and grises.

The treatment get back something as simple as happened with you understand that then that would deal with potentially much less bleeding and the other problems that happen like Katherine just on the cytopenia or heparin resistance. It just it really is going to make it hopefully be a annick wagon that.

Speaker 6: It really is going to make it hopefully be an anticoagulant that is easy to use in all the patients in the straight-close to nurses and for the rapid.

The teams in all the patients straightforward for nurses and doctors.

Speaker 7: Okay, maybe that question for me then, I'll hop back in the queue. Looking down the road, is there other opportunities? Do you guys are seeing beyond obviously the pre-filled syringes to complement the methamistats and you're silting?

Okay. Maybe last question for me then I'll hop back in the queue looking down the road is there other opportunities you guys are seeing beyond obviously, the pre filled syringes.

To complement.

The famous stat and your sales team.

Speaker 8: Yeah, so first of all, you know, we'll be evaluating the potential development opportunities with LTX-608 where they've already been proven XUS, PAM, some of those disease states again are. Yeah, keep pancreatitis.

Yeah. So first of all you know we will be evaluating the potential development opportunities with L. T X six away, where they've already been proven ex U S. Pam some of those disease States again are.

Yeah acute pancreatitis disseminated each vascular coagulation or actually approved indications ex U S and there's other potential applications as well, so again I'll reiterate that else yet six away.

Speaker 8: are actually approved indications XUS and there's other potential applications as well. So again, I'll reiterate that LTX608 really is a pipeline in a product for us in our goal of course in the short term is to get it across the finish line as efficiently as we can over the course of this next year.

Really as a pipeline in a product for us and our goal of course in the short term is to get it across the finish line as efficiently.

As we can over the course of this this next year.

Speaker 8: Beyond that, we are in business development discussions. We have business development discussions in particular, XUS for some parties that are interested in NIAD. So we'll continue to evaluate those opportunities moving forward, but want to be sure that we absolutely maximize the value of this asset for our shareholders.

And that we are in business development discussions we have the business thought discussions in particular, you know ex U S. For some parties that are interested in NIAD. So we'll continue to evaluate those opportunities moving forward, but want to ensure that we absolutely maximize the value of this asset for our shareholders.

Great. Thanks for taking the questions.

Thank you Jim.

Speaker 1: This will conclude our question and answer session. I'll turn the conference back over to Vince for any closing or

This will conclude our question and answer session I'll turn the conference back over to Vince for any closing remarks.

Speaker 3: Thank you operator. And thank you all for joining us today and for your continued support of Acceler X. We remain focused on driving long-term shareholder value absolutely with targeted investment in our late-stage development high-value assets. Please feel free to contact us after the call if you have any additional questions. And we look forward to sharing our future in particular near future developments. Thank you.

Thank you operator, and thank you all for joining us today and for your continued support of accelerates we remain focused on driving long term shareholder value.

Absolutely with targeted investment in our late stage development high value assets.

Please feel free to contact us after the call. If you have any additional questions and we look forward to sharing our future in particular near future developments. Thank you.

Yeah.

The conference has now concluded. Thank you for attending today's presentation you may now disconnect.

Speaker 1: The conference is now concluded. Thank you for attending today's presentation. You may now disconnect.