Q1 2022 AcelRx Pharmaceuticals Inc Earnings Call

Welcome to the accelerate further.

Operator: Welcome to the Accelerac... first quarter 2022 earnings call. This call is being webcast live on the events page of the Investors section of Accelerac's Web site at www.accelerex.com. This call is the property of Accelerex, and any recording, reproduction, or transmission of this call without the express written consent of Accelerex is strictly prohibited. If you require operator assistance, please press star then zero.

First quarter 2022 earnings call.

This call is being webcast live on the events page of the investors section of <unk>.

Website at Www Dot excel erect dot com. This call is the property of accelerates and any recording reproduction or transmission of this call without the express written consent of <unk> is strictly prohibited if you require operator assistance. Please press Star then zero.

Operator: As a reminder, this call is being recorded. You may listen to a webcast replay of this call by going to the investor section of Accelerex's website. I would now like to turn the call over to Raffi Asadorian, Chief Financial Officer. Thank you for joining us this morning.

As a reminder, this call is being recorded.

You may listen to a webcast replay of this call by going to the investors section of its celebrex as website.

Now I'd like to turn the call over to Rafi, Dorian acceleration Chief Financial Officer.

Thank you for joining us this morning.

Raffi Asadorian: Earlier this morning, we announced our first quarter 2022 financial results and some business updates in a press release. This press release and the slide presentation accompanying this call are available in the investors section of our website. With me today are Vince Angotti, our Chief Executive Officer, and Dr. Pam Palmer, our Chief Medical Officer. Before we begin, I'll remind listeners that during this call, we will make forward-looking statements within the meaning of the federal securities laws.

Earlier this morning, we announced our first quarter 2022 financial results and some business updates in a press release.

This press release and the slide presentation accompanying this call are available in the investors section of our website.

With me today are Vince and Gaudy, our Chief Executive Officer, and Dr. Pam Palmer, our Chief Medical Officer.

Before we begin I'll 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.

Raffi Asadorian: These forward-looking statements involve risks and uncertainties regarding the operations and future results of Acceleride. 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 activities.

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 I'll now hand, the call over to that.

Vince Angotti: A lot has changed in our first quarter of 2022, both in the macro market environment and also at Accelerac. We completed our acquisition of Law Therapeutics earlier in the quarter, which has provided us with a number of promising product candidates. We have also advanced preparation of the NDAs for our two prefilled syringe products, ephedrine and phenylephrine, and expect initial feedback from the FDA on our inquiries at the end of this month.

Thank you Rafi and good morning, everyone.

A lot has changed in our first quarter of 2022, both in the macro market environment, but also it accelerates.

We completed our acquisition of <unk> therapeutics earlier in the quarter, which has provided us with a number of promising product candidates.

We have also advanced preparation of the NDA for our two pre filled syringe products ephedrine and phenylephrine and.

And expect initial feedback from the FDA to our inquiries at the end of this month.

Vince Angotti: In addition, SUVIA has continued to demonstrate impressive growth in the procedural suite market, even with the limited commercial team that we've maintained. In fact, we have further aligned our cost structure to concentrate on our recently expanded development pipeline. This reorganization is expected to generate annual savings of approximately $9 million. The value of Dysuvia for patients and healthcare providers is evident based on the feedback we continue to receive from the healthcare community, as well as the numerous studies that are being published exploring the benefits of Dysuvia in various procedural environments. However,

In addition, the studios continues to demonstrate impressive growth in the procedural suite market, even with the limited commercial team we've maintained.

In fact, we are further aligned our cost structure to concentrate on our recently expanded development pipeline.

This reorganization is expected to generate annual savings of approximately $9 million.

The value of the shoot me for patients and health care providers as evidenced based on the feedback we continue to receive from the health care community as well as the numerous studies that are being published extolling the benefits of the Suvs and various procedural environments.

However.

Vince Angotti: We realize that, in this current market environment, Distribute's full potential as a unique analgesic can be maximized by an entity with broader resources. Accordingly, we're actively discussing strategic relationships with third parties with a more robust commercial presence that can help maximize CVS value for all stakeholders. Our goal is to enhance the value of this unity with an organization that is better resourced and equipped to carry out the ongoing launch of this very valuable product and even further reduce our cost structure.

We realize that in this current market environment.

Its full potential as a unique analgesic can be maximized by an entity with broader resources.

Accordingly, we're actively discussing strategic relationships with third parties with a more robust commercial presence that can help maximize distributes value for all stakeholders.

Our goal is to enhance the value of the city with an organization that is better resource and equipped to carry out the ongoing launch it is very valuable product and even further reduce our cost structure.

Now, let's move on to provide further details on the progress made this quarter.

Vince Angotti: Now, let's move on and provide further details on the progress made this quarter. As we announced in January, we closed our strategic acquisition of Lull, which has added a family of novel mefamistat products to our portfolio with diverse potential applications, including our lead asset, NIAID, which is intended for use in renal replacement therapy. Given the importance of this asset, we recently held a Key Opinion Leader webinar with two leading internationally renowned physician experts specializing in acute kidney injury.

As we announced in January we closed our strategic acquisition of law, which is a family of novel the famous debt products to our portfolio with diverse potential applications, including our lead asset <unk>, which is intended for use in renal replacement therapy.

Given the importance of this asset we recently held a key opinion leader webinar with two leading internationally pronounced physician experts specializing in acute kidney injury.

Vince Angotti: The replay of this webinar is currently posted on the investor section of our website, and we'd encourage you to listen to hear many of the outstanding attributes of famistide. The webinar detailed the scientific and clinical basis behind the use of NIAID for anticoagulation of the extracorporeal dialysis circuit in both adults and children. NIAID is a lyophilized form of nifamostat that is being regulated as a device by the FDA given that its mechanism of action takes place outside of the body of the patient. That is, within the extracorporeal circuit.

The replay of this webinar is currently posted on the investors section of our website and we encourage you to listen to hear many of the outstanding attributes and a fast start.

The webinar detailed the scientific and clinical basis behind the use of not yet for anti coagulation of the extra <unk> dialysis circuit in both adults and children.

Not yet as a lyophilize form of the famous stat that is being regulated as a device by the F. D. A given that its mechanism of action takes place outside of the body of the patient that is within the extra poil circuit.

Vince Angotti: Famistat is approved and widely used for the syndication in Japan and South Korea, but it's never been developed for such use in the United States. The FDA has assigned NIAID a breakthrough device designation, which provides us with several advantages in gaining regulatory approval. In addition, CMS has already assigned an ICD-10 procedural code for its use in extracorporeal circuits, which will facilitate reimbursement. Once we've manufactured the first CGMP lot of NIAID, which is expected to occur early next year, we intend to apply to the FDA for an Emergency Use Authorization, or EUA.

<unk> is approved and widely used for the syndication of Japan, and South Korea, but it's never been developed for such use in the United States.

The FDA has assigned NIAD with a breakthrough device designation, which provides us with several advantages and gaining regulatory approval.

Further CMS has already assigned an ICD 10 procedural code for its use in extra <unk> circuit.

Which will facilitate reimbursement.

Once we have manufactured the first cgmp lot of NIAD, which is expected to occur early next year, we intend to apply to the FDA for an emergency use authorization or EUA.

Vince Angotti: We're currently in the final stages of securing supply and manufacturing partners for NIAID. After manufacturing our initial lots, our development plan, which has been informed by the FDA, includes a single registrational study in 160 patients, which is expected to begin in 2023. And if approved, NADD would be the only regional anticoagulant for this syndication in the U.S. The Femistat portfolio is promising with the potential for NIAID. However, Femistat has other beneficial therapeutic applications.

We're currently in the final stages of securing supply and manufacturing partners for Knight.

After manufacturing of our initial lots or development plan that has been informed by the F. D. A.

Includes a single Registrational study in 160 patients, which is expected to begin in 2023.

If approved <unk> would be the only regional anti coagulant for this indication in the U S.

On a famous that portfolio is promising with the potential for not yet however in a famous that has other beneficial therapeutic applications.

Vince Angotti: Therefore, we'll be exploring other potential indications for nifamostat as an intravenous synthetic serine protease inhibitor to be developed in the future under the name LTX-608. In the near term, we intend to focus our resources on NIAID's approval for CRRT and potential emergency use authorization. Currently, 60% of the patients on continuous renal replacement therapy in the U.S. do not receive anticoagulants, often due to the risk of currently available options.

Therefore, we'll be exploring other potential indications for in a thermostat as an intravenous synthetic serine protease inhibitor to be developed in the future under the name L. T X six Oh wait.

In the near term, we intend to focus our resources on <unk> approval for CRT and potential emergency use authorization.

Currently 60% of the patients on continuous renal replacement therapy in the U S do not receive anti coagulants often due to the risk of currently available options.

Vince Angotti: We believe NIAID could address this unmet market need. In addition, we believe the potential peak sales for NYAD alone could exceed $200 million annually. And this amount is attributed to just the inpatient and outpatient dialysis markets.

We believe <unk> can address this unmet market need.

In addition, we believe the potential peak sales for NIAD alone exceed $200 million annually.

And this amount is attributed to just the inpatient and outpatient dialysis markets.

Vince Angotti: The markets for the other target indications for LTX-608 are also sizeable. Now, consistent with our priority of advancing our late-stage pipeline assets, we've made progress on the regulatory pathway for our pre-filled syringes. Pre-filled ephedrine and phenylephrine syringes were licensed from Agatant, who is also our European partner for Dasuvia or Dasuvi We anticipate feedback from the FDA by the end of this month on our plan for the first pre-filled syringe product candidate, ephedrine or PFS-01.

The markets for the other target indications for L. T X X weight are also sizable.

Now consistent with our priority of advancing our late stage pipeline assets, you've made progress on the regulatory pathway for our Prefilled syringes.

The pre filled ephedrine and phenylephrine syringes, where license from Agata Heart, who is also our European partner for the Subia or deserve a O as its named in Europe .

We anticipate feedback from the FDA by the end of this month on our plan for the first pre filled syringe product candidate vedran or PFS. So one.

Assuming agreement from the FDA, we expect to submit NDA is for these two products. These two product candidates this year.

Vince Angotti: Assuming agreement from the FDA, we expect to submit NDAs for these two products, these two product candidates, this year. With two NDAs filed in 2022, we expect to have approved products to launch next year. The market opportunity for these two assets exceeds $100 million, and we believe we'll be able to obtain a large share of this market with minimal commercial investment.

With two NDA filing in 2022, we expect to have approved products to launch next year in.

The market opportunity for these assets exceeds $100 million and we believe we'll be able to obtain a large share of this market with minimal commercial investment.

Vince Angotti: And while we're eager to concentrate resources on our pipeline, we've made very good progress focusing our commercial efforts for DeSuvia in procedural suites over the last three quarters. As a result of this continued growth and what we strongly believe are favorable prospects for Dissuvia, there's interest from other parties related to commercializing the product. Accordingly, to ensure value is maximized for our shareholders, we're in active discussions with more resourced potential commercial partners to take on Dissuvia. This would potentially provide Acceler-X the opportunity to benefit from a stronger commercial presence from a larger company.

And while we're eager to concentrate resources on our pipeline. We've made very good progress focusing our commercial efforts for the subia into procedural suites over the last three quarters.

As a result of this continued growth and what we strongly believe our favorable prospects for <unk>, there's interest from other parties related to commercializing the product.

Accordingly to ensure value is maximize for our shareholders. We're in active discussions with more resource potential commercial partners.

Understood.

This would potentially provide accelerates the opportunity to benefit from a stronger commercial presence from a larger company reduce.

Vince Angotti: reduce the investment required by Acceler-X and provide an accelerated return on investment to our shareholders as Dissuvia continues to accelerate its growth trajectory. The adoption of Dysuvia for use in procedural suites remains encouraging and is the largest driver of use. This is an important market as many painful procedures are now being performed in procedural suites which are more cost-effective than hospitals in ASD and 1Q22. D'Souza achieved historical highs in new ordering customers. Reordering customers. Total number of unique orders:

Reduce investment required by accelerates and provide an accelerated return on investment to our shareholders as the <unk> continues to accelerate its growth trajectory.

Yeah.

The adoption for <unk> for use of procedural suites remains encouraging and is the largest driver of use.

This is an important market as many painful procedures are now being performed in procedural suites, which are more cost effective than hospitals and a S sees.

And <unk> 22.

Sue the achieved historical highs and new ordering customers.

Reordering customers.

Total number of unique orders.

Vince Angotti: Doses to End Users, and New REMS Enrollment. This growth was driven by the procedure suite market as it now represents 71% of all commercial sales in 1Q22. That's up from 59% in 4Q21 and up from 28% in 1Q21.

Doses to end users and new Rems enrollments.

This growth was driven by the procedure sweet market as it now represents 71% of all commercial sales and <unk> 22.

That's up from 59% and <unk> 21, and up from 28% and <unk> 21.

Vince Angotti: Now that we have identified where Distribuya can be successful, an increased presence is required in these locations to further grow sales. This is why we're confident that working with a commercial partner and distributor is a necessary next step. In the meantime, we've restructured our commercial resources to consist of a small virtual sales team focused on procedural suites, which we believe is the most efficient approach. You are here today.

Now that we have identified where just shoot it can be successful and increased presence is required in these locations to further grow sales. This is why were confident that they are working with a commercial partner to serve you as a necessary next step.

In the meantime, we've restructured our commercial resources to consist of a small virtual sales team focused on procedural suites, which we believe is the most efficient approach.

Year to date.

Vince Angotti: We've had a number of publications about Dysuvia, specifically for its use in plastic and cosmetic surgery, providing further real-world evidence of the many benefits both to patients and the overall healthcare system that can be experienced when administering Dysuvia in a procedural suite setting, as well as in other settings. In terms of other markets for Distribuya's application, you may have seen our year-end earnings release announcing a commentary published in the Journal of Military Medicine highlighting the favorable pharmacological properties of Distribuya for use in the military setting. In addition, more recently, an editorial was published in this same journal describing the potential psychological benefits to injured soldiers by initiating timely pain management on the battlefield.

We've had a number of publications about the Serbia, specifically for its use in plastic and cosmetic surgery, providing further real world evidence of the many benefits both to patients and the overall health care system that can be experienced when administering to Serbia and the procedural suites setting as well as other settings.

In terms of other markets for distributed application may have seen our yearend earnings release announcing our commentary published in the journal of military medicine, highlighting the favorable pharmacological properties of <unk> for use in the military setting.

In addition, more recently and editorial was published in the same journal, describing disused potential psychological benefits to injured soldiers by initiating timely pain management on the battlefield.

Vince Angotti: The editorial identified dysphoria as, quote, certainly a step forward in improving acute pain management in combat settings. End quote. We're further encouraged that the DOD has finally initiated two studies that were originally planned to commence 18 to 24 months ago. We believe that the initiation of these two studies, as well as the recent military publications, further cement the DoD's commitment to distribute Dissouvier for battlefield use. However, despite the U.S. military deeming Dissouvier the preferred treatment choice for those in the battlefield, things have moved slower than anticipated to formally roll out Dissouvier in this setting.

The editorial identified SUV is quote certainly a step forward in improving acute pain management and combat settings and quote.

We're further encouraged that the Doj has finally initiated two studies that were originally planned to commence 18 to 24 months ago.

We believe that the initiation of these two studies as well as the recent military publications further cement the dod's commitment to distribute for battlefield use.

However, despite the U S military deeming distribute the preferred treatment choice for those in the battlefield things have moved slower than anticipated to formally roll out distributing the setting we continue to wait on final clearance related to the administrative and logistic prerequisites that once cleared will facilitate the U S army and purchasing distribute for their sets kits and outfits or S. Chaos.

Vince Angotti: We continue to wait on final clearance related to the administrative and logistic prerequisites that, once cleared, will facilitate the U.S. Army in purchasing Dissouvier for their sets, kits, and outfits, or FKOs. The Army continues to make purchases for its pre-positioned stockpiling program, but we expect an increase once the Army begins supplying the SKOs for deploying and deployed troops. We remain excited about the upcoming launch of DeZuvio in Europe. We expect Agaton to launch DeZuvio in the third quarter of this year and remain focused on all their pre-launch activities.

<unk>.

The army continues to make purchases for their preposition stockpiling program, but we expect an increase once the army begin supplying the S. K OS for deploying and deployed troops.

We remain excited about the upcoming launch of <unk> in Europe , We expect <unk> will launch <unk> in the third quarter of this year and remain focused on all their prelaunch activities.

Raffi Asadorian: We look forward to monitoring the uptake of this important drug in a new market and believe that Agatant will definitely benefit from our experience in launching Vesuvia in the U.S. as they further their launch plan. I'll now hand the call over to Raffi to take you through the first quarter financial results. Thank you, Vince. Our financial position remains solid with $39.3 million in cash at March 31, and $11.4 million in senior debt.

We look forward to monitoring the uptake of this important drug in a new market and believe that <unk> will definitely benefit from our experience in launching <unk> in the U S. As they further their launch plans.

I'll now hand, the call over to Rafi to take you through the first quarter financial results.

Thank you Vince are first our financial position remains solid with $39 $3 million in cash at March 31.

And $11 $4 million and senior debt.

Raffi Asadorian: The debt level continues to reduce each quarter as we reach maturity in Q2 2023. Total sales of $0.4 million in the first quarter were an increase of 17% over the fourth quarter of 2021. Souvia sales volume growth continues to accelerate with volume growth excluding DOD of 64% in the first quarter compared to the fourth quarter of 2021. This is the fourth consecutive quarter of commercial or ex- Department of Defense sales growth, which was led by procedural.

Our debt level continues to reduce each quarter as we reach maturity Q2 2023.

Total sales of zero point $4 million in the first quarter was an increase of 17% over the fourth quarter of 2021.

Subia sales volume growth continues to accelerate with volume growth excluding D. O D of 64% in the first quarter compared to the fourth quarter of 2021.

This is the fourth consecutive quarter of commercial or ex department of defense sales growth.

Sales volume growth, which was led by procedural suites.

Raffi Asadorian: All of this despite a limited commercial. Operating expenses, or combined SG&A and R&D expenses, were $8.7 million in the first quarter of 2022, compared to $8.6 million in 2021, excluding non-cash depreciation and stock-based compensation. First quarter 2022 cash operating expenses. Chillis, it's 7.7 million."

All of this despite a limited commercial infrastructure.

Operating expenses or combined SG&A and R&D expenses were $8 $7 million in the first quarter of 2022 compared to $8 6 billion in 2021.

Excluding noncash depreciation and stock based compensation first quarter 2022, cash operating expenses were $7 $7 million.

Operator: The increase in operating expenses in Q1 2022 was mainly driven by increased DeSuvia manufacturing-related costs partially offset by reductions in personnel-related expenses. And restructuring, Vince discussed earlier on this call, is expected to generate approximately $9 million in annual savings and an estimated $500,000 restructuring charge that will be recorded in our second quarter financial year. Now, I turn the call back over to Vince. Thank you, Raffi. We're excited about the many upcoming potential catalysts and value drivers, our future, and the transformation we have made over the past year with our late-stage development assets.

The increase in operating expenses in Q1, 2022 was mainly driven by increased the Soviet manufacturing related costs, partially offset by reductions in personnel related expenses.

The restructuring Vince discussed earlier on this call is expected to generate approximately $9 million in annual savings and an estimated $500000 restructuring charge that will be.

That will be recorded in our second quarter financial statements.

I'll now turn the call back over to Vince.

Thank you Rafi, we're excited about the many upcoming potential catalysts and value drivers our future and the transformation, we made over the past year with our late stage development assets.

Operator: And I'd like to open the line up for any questions you might have. Operator. We will now begin the question and answer session. To ask a question, you may press star, then 1 on your telephone keypad. If you're using a speakerphone, please pick up your handset before pressing the key.

Like to open the lineup for any questions you might have operator.

We will now begin the question and answer session to ask a question you May Press Star then one on your telephone keypad, if youre using a speakerphone. Please pick up your handset before pressing the keys if at any time. Your question has been addressed and you'd like to withdraw. Your question. Please press Star then two.

Operator: If at any time your question has been addressed and you'd like to withdraw your question, please press star then 2. At this time, we will pause momentarily to assemble our roster. The first question comes from Brandon Foulkes with Cancer Fitzgerald. Please go ahead. Hi, thanks for taking my questions and congratulations on all the progress. Just two for me this morning.

At this time, we will pause momentarily to assemble our roster.

The first question comes from Brandon Folkes with cancer Fitzgerald. Please go ahead.

Raffi Asadorian: Firstly, maybe just on the OPEX savings, how should we think about those savings being reinvested back into the new programs that you do bring on board versus, or that you have brought on board, I beg your pardon, versus dropping to the bottom line? And then, secondly, can you talk about the interest you've had in DeSuvia and what you are looking for in terms of an agreement to get it over the line here? How important is a large upfront payment? Thank you. Hey, Brandon. It's Raffi.

Hi, Thanks for taking my questions and congratulations on all the progress and just two for me. This morning, Firstly, maybe just on the Opex savings how should we think about those savings being reinvested back into the new programs that you do bring on board visit or they can have more time for what's being put.

Victor is dropping to the bottom line.

And then secondly can you talk about it.

Interest you had in this new yet and what are you looking for intensive and agreement to get it over the line yeah. How important is a large Brian. Thank you.

Hey, Brendan it's Rafi.

Raffi Asadorian: I missed that last part of it, but Vince got it. So I'll answer the first question. The savings we have this year, most of that will be dropping to, if you want to call it the bottom line, but will be additional cash savings because the development costs are not significant early on for our pipeline products. So I think for this year, most of that comes back as a cash shaver.

Missed that last part of it but you got a Vince Vince got it so I'll answer the first the first question I mean, the savings we have this year. Most most all of that that will be dropping too. If you want to call. It the bottom line, but will be additional cash savings because of the development costs are not significant early on for <unk>.

Our for our pipeline products so.

So I think for this year most of that comes back.

As I as a cash savings.

Raffi Asadorian: As relates to the second question, Brandon, the interest in Dissuvia and kind of how that looks, it actually runs the gamut, anything from licensing in particular aspects of the market, whether it be a segment and procedural suites, hospitals, others, to full divestiture of the program. And we're entertaining everyone as we move through these discussions. Great, thank you very much. You're very welcome very much. The next question comes from Ed Arce with H.C. Wainwright. Please go ahead. Hi, good morning, everyone.

As it relates to the second question brand the interest in <unk> and kind of how that looks when it actually runs the gamut and anything from licensing in particular aspects of the market whether it be a segment and procedural suites hospital. Other two full divestiture of the program.

And we're entertaining all as we move through these discussions.

Great. Thank you very much.

Youre welcome very much.

The next question comes from Ed Arce with.

H C. Wainwright. Please go ahead.

Operator: This is Thomas Yip asking a couple questions for Ed. First, can you announce today the headcount reduction? Can you provide an estimated number of positions and what are their primary work functions, in general? It's in the neighborhood. I'll give you a percentage of between 40 to 45 percent of our headcount, predominantly in the commercial arena, with other tangential positions that might affect that, that have multiple duties.

Hi, Good morning, everyone. This is Thomas Yip, asking a couple of questions for Ed.

So so so first announced today the headcount reduction.

Provide an estimated number of acquisitions.

Alright, there are primary work functions and then general area.

Yeah. It's in the neighborhood I'll give you a percentage of between 40% to 45% of our head count.

Predominantly in the commercial arena.

With other Tan general positions that might affect that that have a multiple duties.

Vince Angotti: Got it. Okay. And also, somewhat related to that, you also announced that I'm going to be talking about discussions with potential partners to support a commercial plan for sales expansion of Vesuvia, and you just talked a little bit about the general framework. Should we expect any impact on your work with the DOD, and how would that work out? No, you shouldn't expect any impact on that.

Got it okay.

And also awesome.

Somewhat related to that are you.

We'll also announce Oh.

Discussions with potential partners to support our commercial plan.

So it's expansion of Sylvia.

Can you just talk about a little bit about a general framework should we expect any impact on your work with D.

P a with that how would that work out.

No you shouldn't impact expect any impact that we've had a long standing relationship now with the D. O D. We are in frequent communication with them and it wouldn't have an impact relative to that.

Vince Angotti: We've had a longstanding relationship now with the DOD. We are in frequent communication with them, and it wouldn't have an impact relative to that. I mean, again, the functions we're looking at are anything from a full divestiture to actually keeping certain segments of it, like the DOD or some others that may have small resourcing. But again, it's the full gamut of possibilities for the product, and the DOD will not be affected. Okay, thanks. Thanks for the edit, Culler.

I mean again the the functions. We're looking at is there anything from a full divestiture actually us keeping certain segments of it like the D O D or some others that may have small resourcing, but again, it's the full gamut of possibilities for the product and the D. O D will not be affected.

Okay. Thanks, Thanks for the added color and perhaps as you just pointed out.

Vince Angotti: And then perhaps, as you just pointed out, we'll exclude DOD and... a range of possibilities. Can you give us some ideas of how you envision this new plan, either through your own effort and also through partners as well, any roadmap to kind of elevate the sous-vide sales in the U.S. from the current level? Yeah, the plan here, look, so we like the response we're getting from our communications. We made a lot of adaptations; we adapted a lot of new mechanisms to move into the procedural suite market, in particular during COVID.

And.

A range of possibilities.

Okay, and Ken can you give us some ideas of how you envision.

This new plan either through your own effort and then also through partners as well any roadmap to us too.

To kind of elevate the souvenir sales and in the U S from current levels.

Yeah, the the plan here.

We like the response, we're getting from our communications, we made a lot of adapt.

We adapted a lot of new mechanisms to move into the procedural suite market in particular during COVID-19, but not only because of COVID-19, because we see the market moving away from hospitals for many of these procedures and the selling cycle being shorter.

Vince Angotti: But not only because of COVID, because we see the market moving away from hospitals for many of these procedures and the selling cycle being shorter. With that said, we still think hospitals are an opportunity moving forward, we still believe the ASEs are an opportunity obviously moving forward, but all this requires a much larger infrastructure than we have, even in the procedural suite. So we're maintaining primarily a virtual sales team today, which is a more efficient cost structure and has been very responsive to communications and education for Dissuvia. But it's not enough.

With that said, we still think hospitals are an opportunity moving forward, we still believe the asc's or it optically obviously moving forward, but all of this requires a much larger infrastructure than we have even in the procedural suites.

So we're maintaining primarily a virtual sales team today, which is more efficient cost structure and has been very responsive to communications and educations Ford to Sylvia.

But it's not enough and that not enough factor is the point, where we believe for our shareholders for <unk> for the education of healthcare practitioners. It has to come with a larger effort and effort that we can't do.

Vince Angotti: And that isn't enough factor is the point where we believe for our shareholders, for Dysuvia, and for the education of health care practitioners, it has to come with a larger effort, an effort that we can't do well while we're also concentrating on the recently acquired late stage development pipeline. So as opposed to trying to do both, we are going to really focus on that late stage development pipeline. We'll continue the momentum on Vesuvio but hope to expand it to a much greater degree moving forward with a partner.

Well, while we're also concentrating on the recently acquired late stage development pipeline.

So as opposed to trying to do both.

We're going to really focus on that late stage development pipeline will continue the momentum on the shoe view, but hope to expand it in a much greater degree moving forward with a partner.

Okay.

Vince Angotti: I understand that that makes a lot of sense, and perhaps one final question, speakers on the FAMISTAT, can you discuss what are the next steps to move the FAMISTAT into Phase 3 and has the study protocol been agreed with the FDA? Yeah, I'll have that question relative to nephemostat moved to Dr. Palmer about the next steps on nephemostat and our plan over the course of the next year. Yeah, so Thomas, we're planning on initially making the first batch of product and, as Vince mentioned, applying for an EUA, which has already received very favorable feedback from the FDA, and we talked about that on the KOL day that we had recently.

That makes lot of sense, perhaps one final question.

Speaking of the funds that can.

Can you.

Discuss what are the next steps to move to phase III.

The study protocol agreed with the FDA.

Yeah, I'll have that question relative to the famous that moved to Dr. Palmer about the next steps on the famous statin our plan over the course of the next year.

Yeah, So Todd we're planning on basically making the first batch of product and its Vince mentioned applying for an EUA, which has already received very favorable.

Feedback from the FDA and we talked about that on the.

The Kols data we had recently.

Vince Angotti: But the protocol itself, the endpoints have been agreed upon, and they're very straightforward. Again, it's a simple study of 80 nifamicat patients versus 80 placebo patients, so that's a patient getting no anticoagulation while they're undergoing renal replacement therapy.

But the protocol itself the endpoints have been agreed upon to a very straightforward simple.

Simple study of 80 odd.

The famous that patients versus 80 proceed though patients. So that's a patient getting no anti coagulation, while they're undergoing renal replacement therapy.

Pamela Palmer: And the primary endpoint is looking at the activated clotting time. So it's straightforward, it's been approved by the FDA, and we're excited to start that phase three program after batches of the drug are made. Thank you so much, Dr. Palmer, and thank you very much, Vince. I am looking forward to your progress in the coming months. Thank you, Thomas. The next question comes from Robert LaBoyer with Noble Capital. Please go ahead. Good morning, there was a mention of Yousef and the procedural suites, and it sounds as if... Robert, just a comment. You went blank on us there at the start.

And the primary endpoint is looking at the activate the clotting time. So it's a it's straightforward it's been informed by the FDA and we're excited to start that phase three program. After a batches of the drug or me.

Got it. Thank you so much stuff the longer end. Thank you very much things.

What's your progress in coming months.

Thank you Thomas.

The next question comes from Robert Leboyer with Noble capital. Please go ahead.

Operator: Could you repeat the question at the beginning? Okay, uh, there was a mention that the sous vide is being used and growing in the procedural suites, which sounds like you're identifying procedures and settings where the drug is growing and could continue to grow. Could you just elaborate a little bit on the types of surgeries and the procedures where it's being used? Absolutely.

Good morning, there was a mention of the the use in the procedural suites and it sounds as Robert just just a comment you you went blank on US there at the start could you repeat the question at the beginning I apologize.

Okay. There was there was a mention that the that the <unk> is being used in growing in the procedural suites, which sounds like you're you're identifying.

Procedures and settings, where where the drug is growing and could continue to grow could you just elaborate a little bit on the types of surgeries and the and the procedures, where it's being used.

Pamela Palmer: I'll refer this to Dr. Palmer in a moment, but there are three main categories where physician disciplines are using them, and I think the thing you have to commonly think of are awake surgeries. Those three disciplines are primarily plastic, Oromax Lofacial, and E.N.T. And within those three disciplines, Pam, maybe you can talk about the results we've seen in the concentration of efforts on certain procedures. Sure.

Absolutely I'll refer this to Dr. Palmer, one moment, but there's three main categories where physician.

Disciplines are using it and I think the thing you have to commonly think of are awake surgeries.

Those three disciplines are primarily plastics.

Oral maxillofacial and E N T.

And within those three disciplines Pam maybe you could talk about the results we've seen in the concentration of efforts on certain procedures.

Pamela Palmer: Plastics has been the most straightforward one for years and years. Plastics have been working their way away from hospitals and ASCs into the procedural suites. It's more patient-friendly, and Frankly, it's less expensive.

Sure plastics has been the most straightforward one.

For years and years plastics had been working away from hospitals and ASC into the procedural suites. It's more patient friendly are frankly, it's less expensive and as we know a lot of plastic surgeries are self paid from the patient.

Pamela Palmer: And as we know, a lot of plastic surgeries are self-pay from the patient. So they have adopted D'Souza fairly quickly. Something like ENT, for example, that's a specialty that only recently has been focusing its painful procedures in an outpatient setting. They typically were done in hospitals and ASCs before, but because of reimbursement to physicians that has changed recently, they get actually more reimbursement for performance in an outpatient procedural suite, then we've seen a large volume of those sinuloplasty's, etc. move into that setting.

So they have to adopt it does seem to be a fairly quickly.

Something like A&P for example, that's a specialty that only recently has been focusing their painful procedures.

Outpatient setting they typically go down in hospitals and <unk>.

Our FICO score, but because of the reimbursement to the physicians that that's changed recently they get actually more.

Our reimbursement purpose for me in an outpatient procedural suite then we've seen a large volume of those tiny package et cetera move into that setting and so they have been more recently very interested in learning more about <unk> and the e&ps that have adopted it are really excited about.

Pamela Palmer: And so they've been very interested in learning more about de suvia, and the ENTs that have adopted it are really excited about what they're able to do comfortably with the patient in an office-based setting. And then oral surgeons, of course, we've been interested in that group for a while. There has been a slow and steady adoption by oral surgeons, but we really feel that it could be reaching a tipping point soon as more of them are hearing about Dysphoia. And that's just the three.

They're able to do comfortably with the patient in an office based setting.

And then oral surgeons of course, we've been interested in that group for a while there has been a slow and steady adoption with the oral surgeon, but we really feel that it could be reaching a tipping point in as more of them are hearing about it.

And that's just the three I mean, we've always believed that colonoscopy.

Pamela Palmer: I mean, we've always believed that colonoscopies, as the scopes become smaller with time and a little less painful during the actual procedure, they don't need that heavy sedation they typically had in the past with your IV propofol, IV fentanyl, et cetera. So we're really excited about Dysphooia to be going into those areas as well. So from a procedural suite standpoint, that's the movement; all procedural.

The scopes become smaller.

With time, and a little less painful on the actual procedure.

They don't need that heavy sedation. They typically had in the past with your IV Propofol IV fentanyl et cetera. So we're really excited about the season, yet to be going into those areas as well so from a procedural suite standpoint, that's the movement all procedural.

Vince Angotti: Painful Procedures are really sort of moving in that direction, and we believe Dissidia is just the perfect opportunity to create a non-invasive analgesic that can really address the unmet need in that market. Yeah, Robert, so while we've had personal exposure to the plastics for anything from liposuction to radiofrequency microneedling, which we just saw a published paper on more recently, neck lifts, awake neck lifts, And for the ENTs, as Pam mentioned, the sinoplasties for oral maxillofacial, full mouth tooth extractions, and full arch implants, really painful procedures for these patients.

Painful procedures are really sort of moving in that direction and we believe this is just the perfect opportunity to create a noninvasive analgesic that can really address the unmet need in that market.

Yeah, Robert so well, while we've had personal exposure to the plastics for anything from liposuction of Radiofrequency micro needling, which we just saw a published paper on more recently neck lifts awake neck lifts and blepharoplasty is.

And for the E&ps as Pam mentioned, the Sino Plas These four oral maxillofacial.

Mouth, a tooth extractions in full arch in plants.

Really painful procedures for these patients that's only where we've concentrated our efforts and I think that's an important point that Pam mentioned and as we moved to a strategy where others can be involved.

Vince Angotti: That's only where we've concentrated our efforts, and I think that's an important point that Pam mentioned. And as we move to a strategy where others can be involved, markets like GI, as she mentioned, OBGYN, others that we can't address just based on limited resources, I think will now become more transformational for our product within their particular practices moving forward. Okay, thank you.

Markets like G I as she mentioned obgyn and others that we can't adjust just based on limited resources I think we will now.

Become more transformational for our product within their particular practices moving forward.

Okay. Thank you that was very helpful.

Youre welcome.

This concludes our question and answer session I would like to turn the conference back over to Vince and gaudy for any closing remarks.

Operator: That was very helpful. This concludes our question and answer session. I would like to turn the conference back over to Vince Angotti for any closing remarks. Yeah, well, thank you for joining us today and for your continued support of Acceler-X. We're especially grateful to our employees for all their hard work and dedication. Again, we believe we're well positioned for the future, we're excited about the prospects of our development pipeline, maximizing the potential of Dissuvia, and we'll remain focused on driving shareholder value while controlling expenses.

Yeah.

Yeah, well, thank you for joining us today and for your continued support of accelerates, we are especially grateful to our employees for all their hard work and dedication.

We believe we're well positioned for the future. We're excited about the prospects of our development pipeline maximizing the potential for distributor and will.

Main focused on driving shareholder value while controlling expenses.

Operator: We look forward to sharing more developments in the near future. Thank you. Be safe and take care. The conference has now concluded. Thank you for attending today's presentation. You may now disconnect. Richard Ford, Alan Bellini, and Duane Reade, we will see you at the next session.

Look forward to sharing more developments in the near future.

Be safe and take care.

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

Hum.

Yes.

[music].

Yeah.