Earnings Sentiment

Sentiment Analysis of the earnings transcript to help figure out if there are any bullish or bearish sentiments that could be gathered from it. We're doing ML and AI based analysis on the earnings call to get some more insights.

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Sentiment Distribution

   

Earnings Call Transcript Word Cloud

     

Bullish Statements during Earnings call

Statement
The need for pre-filled syringes is as 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 and advance our procedures
It's just -- it really is going to make it hopefully be a anticoagulant that is easy to use in all the patients, and it's great for the nurses and they will be happy to adopt it
This serves as an advantage for us to efficiently move Niyad towards approval, since device studies typically require much lower patient exposures than drug study
Knowing that the nafamostat has been a standard of care for CRRT in South Korea and Japan with decades of use and a favourable safety profile, we're confident in the success of this study as it is evaluating the nafamostat versus saline as the placebo for activated clotting time
These new investors appreciate the value of Niyad, and have been extremely supportive of management as Niyad development progresses and with the clinical study about to begin
We recently completed our Investigators' Meeting, where the participants expressed excitement at the prospect of the near-term availability of an ultra-short acting anticoagulant for use in CRRT
At the close of the third quarter, we were pleased to receive approval for our Niyad IDE, allowing us to proceed with the registrational study for what could potentially become the first FDA-approved regional anticoagulant for the dialysis circuit
So that would certainly be upside
Our interactions with leaders in the field of nephrology have reinforced the urgent medical need for an alternative anticoagulant for use during CRRT
Our lead product candidate, Niyad is a novel anticoagulant for use during dialysis and has received Breakthrough Device Designation from the FDA
I had a question on -- again, I presume a good data and ultimate FDA approval
The feedback that we have heard from the clinical sites is that enrolment should be robust, allowing top line data mid-2024 and a PMA submission soon thereafter
To round out our transformation, the transition of DSUVIA to Alora Pharmaceuticals is still ongoing, and AcelRx continues to support Alora to facilitate their success
So that is something that would benefit from nafamostat as well
Finally, the completion of the DSUVIA early evaluation of pain or DEEP trial sponsored by the DoD at the University of Pittsburgh Medical Center will be a key milestone
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 this, combined with our recently conducted US quantitative research reaffirms the market potential for Niyad
In terms of market opportunity, we estimate Niyad to have a peak annual sales potential of over $200 million in the US
We remain focused on driving long-term shareholder value absolutely with targeted investment and our late-stage development high-value assets
And it's -- so it's really interesting how when you don't have good options, you have a very fractured approach to clinical protocols
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 next year
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
So we're really hoping with nafamostat to streamline that and finally give them a good option that they can use in many patients
Vince Angotti Thank you, operator, and thank you all for joining us today and for your continued support of AcelRx
This would enable us to potentially launch Niyad in the first half of 2025
We continue to lead the relationship with the Department of Defense or DoD to ensure continued engagement
We think that there's opportunity to get that, but that has not really been a significant or were any part of our projections to date
Citrate avoids the bleeding risk that heparin has
Good afternoon, everyone
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
       

Bearish Statements during earnings call

Statement
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
But it's got so many other risks, and it's very difficult to run for these sites
It's got the same problem that CRRT has, blood hits a foreign object and starts to clot
And so to simplify the treatment, get back something as simple as heparin, which is what a nafamostat would do with potentially much less bleeding, and some of the other problems that happened like heparin, like Heparin-induced thrombocytopenia or heparin resistance
   

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