DURECT Q2 2023 Earnings Call Transcript

Quartr
Provided by Quartr
August 9, 2023

There are 9 speakers on the call.

Operator

Greetings, and welcome to the Dura Corporation's Second Quarter's Earnings Conference Call. At this time, all participants are in a listen only mode. A brief question and answer session will follow the formal presentation. As a reminder, this conference is being recorded. It is now my pleasure to introduce your host, Tim Papp, Chief Financial Officer.

Operator

Thank you, sir. You may begin.

Speaker 1

Good afternoon, and welcome to Direct Corporation's Q2 2023 earnings conference call. This is Tim Papp, Chief Financial Officer of Direct. Before we begin, I would like to remind you of our Safe Harbor statement. During the course of this call, we may make forward looking statements regarding the development of larsukosterol, expected product benefits, Market potential, clinical trial results, regulatory approval and the company's financial projections. These forward looking statements involve risks and uncertainties that can cause actual results to differ materially from those in such forward looking statements, including the risk that larsukosterol does not meet the endpoints in the AFFIRM trial.

Speaker 1

Further information regarding these and other risks can be found in our SEC filings, including our 10 ks and 10 Qs under the heading Risk Factors. To begin, I would like to review our Q2 2023 financial results. Our total revenue in the Q2 were $2,100,000 similar to the prior year. R and D expenses were $7,900,000 compared with $8,800,000 for the prior year. The decrease was primarily due to lower employee related costs and contract research expenses, partially offset by higher costs associated with the AFFIRM trial And higher contract manufacturing costs.

Speaker 1

SG and A expenses were $3,800,000 compared with $4,000,000 for the prior year. This decrease was primarily due to lower patent expenses and recruiting costs. As of June 30, 2023, We had cash and investments of $34,900,000 as opposed to $43,600,000 at December 31, 2022. Subsequent to the end of the quarter, in July 2023, we completed a registered direct offering, raising $13,800,000 in net proceeds. Our cash burn in the 2nd quarter was approximately $10,100,000 excluding proceeds from sales under our ATM program, and We believe our cash on hand is sufficient to fund operations through mid-twenty 24.

Speaker 1

Now, I would like to turn the call over to our CEO, Jim Brown, for an update on our programs.

Speaker 2

Thank you, Tim. Hello, everyone. Thank you for joining us today for our 2nd Quarter 2023 update. We had a productive second quarter during which we achieved a significant milestone on our journey toward completing The Affirm Phase 2b clinical trial for larsuchosterol in alcohol associated hepatitis. In June, we announced that we had completed enrollment for Affirm and we continue to be on track to report top line data in the Q4 of this year.

Speaker 2

We are eagerly anticipating this event, which we believe has the potential to be transformative for Direct and our shareholders. Our primary focus as a company remains gaining approval for lasuchosterol in Ah and bringing this Life saving therapeutic to patients with no effective treatment options today. Assuming a positive outcome from the firm, We plan to review the results with the FDA in the Q1 of 2024. If approved, larcicosterol would be the 1st FDA approved treatment for Ah and we look forward to the possibility of bringing this potentially life saving therapeutic Furthermore, during the 2nd quarter, the American Journal of Gastroenterology published clinical data from our Phase 2a trial in Ah and we held an Ah focused KOL event. Lastly, we're excited to announce the expansion of our epigenetic modulator platform into the field of oncology.

Speaker 2

By leveraging our expertise in epigenetic modulation, we have internally developed multiple new chemical entities that we think have Attractive properties for the potential treatment of both solid and liquid tumor types. I'll come back to our new oncology program in a few minutes. But first, I'd like to provide a quick refresher on our Ah program as we get closer to the upcoming data readout. As I mentioned, we completed enrollment in our FIRM trial in June of this year. We follow these patients for 90 days.

Speaker 2

So our last patient last visit will be in early September, which puts us on track to report top line data in the Q4. As a reminder, AFIRM It's a placebo controlled, double blind, multinational study with 2 active dosing arms and a placebo arm of approximately 100 patients each. In total, we randomized and dosed 301 patients with severe Ah, which are patients with MELD scores ranging from 21 to 30 and moderate discriminant functions scores greater than or equal to 32. The primary endpoint for Affirm is the difference in mortality or liver transplant at 90 days between larcicoasterial treatment And placebo. We enrolled patients in Affirm through a global network of clinical sites, including leading hospitals in the United States, Australia, the EU and the UK.

Speaker 2

Our sites include renowned liver centers We are working with some of the world's preeminent thought leaders in Ah. The FDA has granted our larcuchosterol Ah program fast track designation, And we are hopeful that a positive result in Affirm could support an NDA filing. With this in mind, larceprosterol has the potential to be the 1st FDA approved treatment for Ah where there is a substantial unmet need for patients. Our confidence That the AFFIRM trial will be successful is supported by our compelling Phase 2a study data, including the recently published comparisons The mechanism of action of lefseclosterol, which ties directly into the biology of Ah and our multiple preclinical animal studies where we observed a profound survival benefit in multiple relevant acute organ injury models. We designed AFFIRM to be a potentially pivotal trial Based on our Phase IIa data.

Speaker 2

In our open label Phase IIa trial, all 19 patients survived at 28 days, An encouraging result given that based on historical data, approximately 26% of hospitalized Ah patients are expected to die within 28 days. We also observed consistent improvements in key biochemical markers, including bilirubin level, MELD score and legal scores across patients and In the Q2, the data from our Phase 2a trial were published in the American Journal of Gastroenterology. This peer reviewed article includes cross study comparisons with well matched severe Ah patients from a contemporaneous trial conducted By the DEFEAT Alcohol Steadle Hepatitis or DASH Consortium. While the sample sizes were small and these were not part of the control study, These comparisons indicate that severe Ah patients treated with either 30 milligrams or 90 milligrams of lefseclosterol Has statistically significant lower Lille scores compared to patients treated with the standard of care, including steroids. Lille scores, as a reminder, are a predictor of mortality in liver disease.

Speaker 2

In addition, liver enzymes levels decreased rapidly in the larcico sterile treated patients, including We believe These results provide further evidence of the potential for lasuchosterol as a treatment for Ah. In May, we hosted a KOL event for investors To provide physician perspectives on this devastating disease, we were pleased to be joined by Doctor. Paul Gaglio from Columbia Presbyterian Doctor. Brett Fortune from Montiforre Agtai. They were able to draw from their wealth of experience treating Ah patients and share their views on the unmet need in Ah and the potential role our sucral sterile could play to transform the treatment of this highly lethal disease.

Speaker 2

The slides and audio from this presentation are available on our website. During our KOL event, we shared additional information on the commercial opportunity for Lussecoasterol and if we obtain approval, Our approach to building for a successful launch. In addition to its high mortality rate, Ah represents a significant cost to the U. S. Healthcare system With over 150,000 hospitalizations attributed to Ah at a cost of between $50,000 to $150,000 each.

Speaker 2

As a result, in addition to the potential saving of patients' lives, Larciecoastriol represents a potential multibillion dollar opportunity in the United States alone and could simultaneously provide overall cost savings to the healthcare system. We've begun to lay the groundwork Potentially commercializing Glashutro Sterile in the United States and believe we can launch the product effectively through a moderately sized hospital focused sales force. We also continue to build awareness around the role of epigenetic regulation in acute diseases like Ah. As one of these initiatives, we launched a new disease education website that you can find at www. Exploreahepigenetics.com to elucidate the role of the epigenome in Ah.

Speaker 2

Ah is also a global concern, allowing larsuchosterol the potential to serve ex U. S. Ah patients and their healthcare systems. These ex U. S.

Speaker 2

Markets represent additional attractive commercial opportunities. Because we enrolled patients from a global site network, We believe a positive result from Affirm may support regulatory filings in the EMA and other regions. We are also pleased to announce the expansion of our epigenetic modulation platform into the field of oncology. Our mission at Direct is to be a global leader in the emerging field of epigenetic medicine, and this latest development is a significant step towards achieving that goal. Averitt DNA methylation has been shown to play an important role in the development of tumors.

Speaker 2

As a result, We believe DNFT inhibitors have significant potential as a drug class for the treatment of cancer. Building on our knowledge of epigenetic regulation and our unique understanding of DNMTs, we have focused on a novel approach to DNMT inhibition. The inhibition of DNMTs is a well established and highly desired target in oncology. Working with teams of experienced chemists and biologists, we have created a large complement of internally developed novel small molecule dNFT inhibitors that exhibit broad spectrum activity against multiple liquid and solid tumor types. We currently have multiple new chemical entities that are in preclinical development for a variety of oncology applications.

Speaker 2

These compounds display unique and desirable physiochemical properties and pharmacokinetic profile as well as favorable tolerability. By the end of 2023, we intend to select a product candidate to advance Into clinical trials in cancer patients. Our goal for this program is to be prepared to initiate clinical trials by the end of 2024. In summary, we completed Affirm enrollment in the Q2 and are on track to report top line results in the Q4 of 2023. If Affirm is successful, we intend to review the results with the FDA in the Q1 of 2024.

Speaker 2

We are leveraging our knowledge of epigenetic regulation to the field of oncology and look forward to selecting a lead Product candidate from our NCE development program and advancing into the clinic. We would now like to take any questions you may have.

Operator

Thank you. We will now be conducting a question and answer session. Our first question is from Kristen Kuskka with Cantor Fitzgerald. Please proceed with your question.

Speaker 3

Hello, everyone. This is Rick on for Kristen. Thank you for taking our questions. Maybe first on the oncology program you Talked about today, is there any color you can give us into the screening process that you've gone through with these library of molecules in In terms of the magnitude of different molecules here?

Speaker 2

We probably won't give That kind of detail, but just sufficient to say, we screened a large number of cancers against a large number of molecules and we have actually from there Paired it down into the group that the initial class is graduating that we're taking forward. So we have we're very close in between now and the end of the year. We'll select The first cancer and first drug that we're taking forward.

Speaker 3

Excellent. You also mentioned Ex U. S. Opportunities for larsukosterol. So just as you're thinking about kind of ex U.

Speaker 3

S. Opportunities, is there any development kind And thinking about whether you'd be looking at ex U. S. Commercial partners or how are you thinking about that process?

Speaker 2

Yes. We certainly wouldn't be looking to commercialize it ourselves ex U. S. We think the opportunity is from a patient number standpoint, I think Western Europe is probably equivalent to or a bit larger than the U. S.

Speaker 2

Patient population size. And so we think it's an exciting opportunity and these patients are in as desperate need as They are here in the United States. So, the opportunity is absolutely there and we're looking to put a partnership in place, actually. And I'll let Keith, who's on the line as well, maybe Speak a little bit more to that.

Speaker 4

Yes, I would just add that given the diversity of the reimbursement pricing and various other regulatory factors In Europe and other ex U. S. Markets, it's likely that we would look for a formidable partnership there. So I agree with Jim's comments there. And there's certainly an equal, if not potentially larger marketplace outside of just the U.

Speaker 4

S, where we think larcilo could achieve prominence there. Ah is not regional to just the U. S. So it certainly is a global

Speaker 3

Okay. And maybe one more, maybe we'll swing back to the Oncology program, just to ask, given the different indications with potential for DNMT inhibitors, can you talk a little bit about the decision making Process that led to undertaking in oncology specifically and maybe also touch on Whether there could be different indications for larsuchosterol down the road as you've talked about in the past? Thanks.

Speaker 2

Yes. First, just stay with our sucrose channel because that is the main theme here at Direct. And so, yes, we obviously looking at Ah, but as We've talked about in the past, we've done about a dozen different animal models where we've shown it can protect against multi organ damage from things as broad ranging as Acute pancreatitis, sepsis, stroke, acute kidney injury, things like that. So there's a lot of opportunity there as well. As you know, We did the 1 month study in NASH, but we showed tremendous potential as well for LASUKO Sterile.

Speaker 2

As far as the oncology program, what we're doing here is we often get A question from shareholders, kind of what is next outside of Large Siguzerral. And so it's a program that Weiqi has been guiding for a number of years now and has finally gotten to the point where we're ready to bring things into development and that's why we're talking about it at this point in time. Certainly, DNMTs are important targets for various cancers in the Hematology space, currently, we think we have potential advantages over the azacitabines and decitabines of the world because of Tolerability because of dosing, because of a whole number of advantages that we see at least to date. And we think we can expand the use of DNMTs into beyond liquid tumors, but into the solid tumor space as well.

Speaker 5

Excellent. Thank you. Sure.

Operator

Our next question comes from Francois Brisebois with Oppenheimer. Please proceed with your question.

Speaker 6

Hey, can you maybe remind us the differences in

Speaker 2

That's a great question. Good to hear from you, by the way. Yes, There really aren't many. First, if you look at dosing, it's the same. We dose the patients on day 1 and then they get another dose on day 3.

Speaker 2

In the first trial, we allowed steroids to be used. In this trial, we didn't want the confusion potential of steroid side effects to be laid upon the shoulders of electrosterol. So we've set up this Double blind, double dummy arrangement, so that if I get placebo, then I get a capsule that would have active steroids. If I get one of the 2 doses of Loxubosterol, Then I would receive a placebo capsule instead. So that is one difference.

Speaker 2

The other difference is the severity of the illness of the patients. In the first study, we had 2 components. We had the moderate patients, which were MELD up to 21, and then We had the severe, which were 21 to 30. In this trial, all 301 patients that were dosed received Excuse me, had MELD scores that started at 20 MELD to 21 and could go as high as MELD was 30. And we followed for 90 days versus 28 days.

Speaker 2

So 90 days versus 28 days, all severe and Absolutely no steroids and Larcico sterile group and if the physician wanted, they could give steroids to their placebo patients in a blinded fashion.

Speaker 6

Can you just remind us the mortality rate at 28 days, what's historically known versus 90 days? Yes. And has that changed in the past?

Speaker 2

No, it really hasn't changed really in the last 40 years and it's been confirmed with this 7, what was it, 7,8000 patients publication?

Speaker 7

Yes. Yes. And 2,000.

Speaker 2

Yes. Yes. So, yes, yes. Yes. Yes.

Speaker 2

2,800. Okay. And so there was a 2,800 patient large publication that kind of spoke to it. But the mortality rate at 28 days has been historically 26% and at 90 days 30%. So you can see, you're only adding another 4% over the 2 months.

Speaker 2

So it's a the majority of the damage is done and the majority of the deaths occur early on.

Speaker 5

Thank you. Sure.

Operator

Our next question comes from Ed Arce with H. C. Wainwright. Please proceed with your question.

Speaker 8

Hi. Thanks for taking my questions. Can you hear me okay?

Speaker 2

Yes. We can.

Speaker 1

Great.

Speaker 8

Okay. So first, I wanted to ask about your commercialization plans. The focus rightly has been for Several years now on the develop and now that we're on the cusp of a readout, potentially Enabling filing, I wanted to ask if you could provide a little more details On your preparations at this stage, in particular, you mentioned moderately sized Hospital focused sales force. Are there any investments? I know you also mentioned the website.

Speaker 8

Any investments now into awareness for physicians or other things to sort of prime the market? And then I have a question.

Speaker 2

Yes, we certainly are. And I'll let Keith speak to that.

Speaker 4

Yes. Thanks, Jen. Thanks for the question, Ed. On the commercialization front, surely we've been doing We've had a number of efforts there. We have personnel that have launch experience, both on the medical affairs side and the marketing We are a small but mighty team.

Speaker 4

Jim mentioned in his remarks, we explore A HIV Genetics as a disease awareness site that we launched Late last year actually. And then, we certainly, the past couple of years, have had a live Presence at the major international liver conferences. We're just coming off of presenting a poster actually at EASL In Austria, just last month, we've been at both EASL and AASLD with boots. And last year, really the focus was on a firm awareness and recruitment. Now that that's closed, we really have shifted gears into disease education.

Speaker 4

But we've Certainly invested in various market research and market landscaping, understanding the unmet medical needs, Where a drug with larsupacero's product profile could sit, and we explained some of those Top line results, when I presented at the KOL event in New York back in May, but we continue those launch readiness efforts. Really, it's about Putting plans in place internally to ensure all of our cross functional groups are singing off the same And we certainly have a fully integrated watch readiness plan With the same expectations, because every launch is different, every launch has its own challenges and obstacles, and really it's going to take a village, Both the folks had direct, as well as our outside consultants. But right now between now and top line results, it's really about preparation And cannot over preparing, if you will, but preparing at the right pace and having plans in place after top line results and after our interactions with FDA To execute what could be a very short time launch, if everything hits.

Speaker 8

Great. That's helpful, Keith. And maybe just a little bit further, wondering if you can Discuss how you view the initial ramp of the launch. In particular, I know this is a very specific call point really dealing with Hospital ICUs and There's a lot of inertia with physicians changing therapies in general, but in particular In high stress situations like this, but on the other hand, you potentially have a therapy that is Life changing could save lives. So I'm just wondering in the mix of that, how you think about The speed of ramp in regards to not only physicians, But also payers.

Speaker 2

Yes. Marta, I'll start and then I'll certainly have Keith continue. First of all, you're right and that these are hospitalized patients, oftentimes in the ICU. But These aren't patients, who are typically going to die in the very, very near term or their outcomes It'll be determined in the next 12 hours kind of thing as you would get with stroke and sepsis and things like that. That was the reason we selected Ah As the first acute indication for lafuchosterol because one could take the time.

Speaker 2

And when you look at these other For which we've done a lot of preclinical work, there have been a history of more challenging clinical trials because of the variability one gets with patients. And here, We have the time to talk to these patients because and their families because they're on a very slow, unrelenting Train ride that leads to death in 30% of them. And just to witness on our first in our Phase 2a trial, there was A man in his 30s at the San Diego site who was at another hospital for a month and was sent home on hospice to die, enrolled in our trial. The study coordinator commented how good he looked just a week or so after dosing. And Last time I talked to Doctor.

Speaker 2

Hassaneen, he was this gentleman who's going live 2 years more than 2 years later. So Certainly, one has the time and the circumstance to be able to evaluate the patients. As far as the ramp and the like, obviously, If you want more information on some of this information that Keith presented during our KOL event, we have What he discussed from ClearView, which is off of our website, but I'll let Keith kind of give a description of thoughts with regard to that.

Speaker 4

Yes. Ed, good question. As it relates to physicians, one of the outputs that we had from our commercial assessment earlier this year, when we were looking at blinded target product profiles with data that we would assume would hit Statistical significance for Affirm, we had very high willingness in that qualitative study from physicians to that product profile A statistically significant overall survival or transplant primary endpoint, especially given that a disease area like Ah Where there are no drug approved and the de facto standard of care being steroids that are only applicable in about 50% of patients, That is suboptimal, never showing any kind of survival benefit past 28 days. So, the willingness to prescribe from the physician standpoint, particularly in the In the Affirm patient population, the severe Ah, now 20 to 30 range was very high. And so we think that The willingness to prescribe there and the ramp there could be significant, but we also cross check that with the reality of The reimbursement environment and the DRG driven reimbursement of hospital inpatient delivered drugs.

Speaker 4

So we've done quite a lot of work As it relates again to the commercialization plan, particularly on the market access, understanding the landscape, Looking at other like acute care in hospital delivered products and learning from What's worked and where the challenges have been, understanding those obstacles and internally working on Developing strategies to positively influence those factors, understanding what we have up against us for launch And what we can do now to better understand that environment and what strategies we can deploy early. And certainly after top line results, Market access will be the initial focus for our commercialization strategic efforts. We can get out now Given some of the changes in the commercialization regulatory environment that allows us to interact with hospitals and certain payers prior to the launch And building those value propositions, those health economics and outcomes research models, that will be of top of mind for our Commercial team to develop those and start those efforts even prior to our launch.

Speaker 8

That's great. Thank you for all that. If I can, I'd like to squeeze one more in And that is regarding your new expansion into oncology. I'm just wondering given this platform, there's you already produced several NCEs And you've mentioned that they could apply to both solid and liquid tumors. So I guess a couple of questions here is, What would be your preference?

Speaker 8

And how would you decide that? Sort of what criteria Are you looking at the HealthVest decide sort of what which would be your first candidate that you nominate To go into the clinic by the end of the next year. Thanks so much.

Speaker 2

Sure. I think we're going to let the science really drive it, but maybe wait till you

Speaker 7

Well, I think the criteria, it's really What we determined by many multiple aspects of the lead compounds we have generated And then the indications, including also the trial designs, including the Populations including the so it's really not a one single factor what is driving the set In the process, it is quite we also need to talk to various people with But he is in oncology and then get their input. So it's really driven by multiple, multiple factors. So I think we will be happy to talk about that and more information in the future time.

Speaker 2

Yes, I think so. I think we'll be Taking the same filter that we used when we selected indication for lysocostero, so we're looking at unmet need, Time to market, time to prove a concept in this case, obviously, but in oncology it's different, so that kind of thing.

Speaker 8

Thanks again, everyone. Sure.

Operator

Our next question comes from Sean Kim with Jones Trading. Please

Speaker 5

Hi, thank you for taking my questions. My first question is, could you Please remind us whether the statistical plan for the AFFIRM trial has been submitted And if you have provided any detail on the statistical powering for the trial?

Speaker 2

Yes, it certainly has been submitted, but we haven't really provided a great bit Of color to that, suffice to say, we've designed it such that 300 patients should the trial proceed as we hope And the placebo group performed as history has dictated and we're in the range of events That would allow for that, then we'll have a statistically significant trial, but it all remains to be seen. As always, The data will dictate at the end.

Speaker 5

Okay. Thank you. And about the physician survey that you did recently, Could you share some more color on the excitement expressed by the doctors from the survey, maybe specific around their willingness and intent to prescribe on their own? Absolutely.

Speaker 2

I'd love to, but I'll let Keith do that. Yes, that was certainly quite nice.

Speaker 4

Yes, this is Keith. So, on that market assessment that we did earlier this year, we worked with a group called ClearView, Who's well known in this space, and with the physicians that we recruited for the study, Again, they had very high willingness to prescribe. This is based off of a blinded target product profile, just a one page profile of What our drug may look like and what those statistical parameters would look like or safety and efficacy Based on a presumed positive AFFIRM trial, again, it was blinded to the company and to what the product name is, so physicians had no idea of that. But again, their affinity for the product And pleasure with something that would have a statistical significant difference versus standard of care And especially how we designed the trial where it really is physicians' discretion on whether or not steroids are used on that placebo arm Really mimicked their current standard of care. And with that kind of an improvement, with what they considered as The highest order endpoint of survival or transplant, particularly at 90 days, for an acute disease like this, would be very significant for them.

Speaker 4

And so, We did see that it was nice to see that their preference share that they assigned to this product Was quite high, particularly in that severe patient population that we're testing for that we're testing in Affirm With NELS between 20 30.

Speaker 2

Yes. I think it's exactly what one would have hoped. If you have a disease where 30% of the patients are dying and there's no therapy that's able to change that, yes, so it was both

Speaker 5

Okay.

Speaker 4

Yes. And maybe just one more point. I mentioned that the that there was high affinity for prescribing Product X or larsupersterol in that study With the Affirm patient population, but given that we're not sure what the final label would be, But there also was a willingness to prescribe this product for MELD greater than 30. There are no products approved at all, And there are certainly high in the medical need for those who are extremely severe with NELDs greater than 30. So again, reassuring to hear that Unbiased take from our key hepatologists that would be our target from a commercial standpoint.

Speaker 2

That's great. Thanks, Keith. Yes, and just as a reminder, Sean, just one other additional piece. If you have a MELD Of 30, you've got the mortality expected 90 days is 60%. So it goes up very quickly.

Speaker 5

Okay. Got you. And my last question for today is, as you look to move cancer programs into clinics by End of next year, just curious to hear your thoughts on strategic prioritization and resource allocation between These upcoming cancer programs and potential expansion into other hepatological indications for Loscoastro.

Speaker 2

Yes, it's a great question. The first and the primary focus is Ah. That's where our efforts are. Certainly, and we already discussed this one of the questions earlier to find a partnership. So if the data comes out as we hope and we have a successful trial with Affirm, We'll be looking to partner it for ex U.

Speaker 2

S. To advance to submission as quickly as possible. We here at Direct will be all hands on deck to move that forward. And then as well, we'll be looking at the next indications for listercoasterol. And then but that the oncology effort that Weichy is running It's not a very large budget item.

Speaker 2

It's as most of you who've been involved with research know it, this takes time. It doesn't take a lot of money. It doesn't cost any reasonable amount of money at all until you get into the clinic. And so as the year unfolds, we'll preparing for that and that will take its own course. But the primary focus will be a firm meeting with the FDA deciding One trial will be sufficient for submission of an NDA and commercialization partnerships and all the rest of those kinds of things.

Speaker 5

Okay. Thank you very much.

Operator

There are no further questions at this time. I would now like to turn the floor back over to Jim Brown for closing comments.

Speaker 2

Just want to thank you all for your time. And as always, we are here. So if you have Follow-up questions, just reach out. We look forward to talking to you. Thanks a lot and take care.

Operator

This concludes today's conference. You may disconnect your lines at this time. Thank you for your

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DURECT Q2 2023
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