SCYNEXIS, Inc. (SCYX) Earnings Call Transcript & Summary

Good morning, and welcome to the SCYNEXIS Conference Call. [Operator Instructions] As a reminder, this conference is being recorded. I would now like to turn the call over to Irina Koffler, Investor Relations. You may begin.

Good morning, and thank you for joining us as we report positive results from the third interim analysis of our ongoing oral ibrexafungerp Phase III, open-label FURI study and our first analysis of the CARES study. Joining me today from SCYNEXIS are Dr. Marco Taglietti, President and Chief Executive Officer; and Dr. David Angulo, Chief Medical Officer. And joining them today is Dr. Andrej Spec, Assistant Professor, Infectious Disease; Associate Director of the Infectious Disease Clinical Research Unit; and Director, Invasive Mycoses Clinic at Washington University School of Medicine in St. Louis. During this call, please note we will be making forward-looking statements. These statements are subject to factors, risks and uncertainties, including those that are detailed in today's presentation and our Form 10-K for the year ended December 31, 2019, as well as our subsequent SEC filings that may cause actual results to differ materially from those results expressed or advised by such statements. Please also note that this call is being webcast, and accompanying slides are available on the Investor page of the SCYNEXIS website at www.scynexis.com. With that, I would like to turn the call over to Marco for his opening remarks.

Thank you, Irina. Good morning to all. [Foreign Language] And thank you for joining us this morning. We are excited to share with you the positive results of ibrexafungerp from the third interim analysis of our ongoing Phase III FURI study in patients with difficult-to-treat mucocutaneous and invasive fungal infections and our first analysis of the CARES study in patients with infection due to the urgent threat pathogen, Candida auris. Let me give you a quick overview of today's call. We are honored to have with us today, Dr. Andrej Spec, a world-renowned infectious disease specialist and one of our investigators in our FURI study. Dr. Spec will discuss the infectious disease landscape and the emergence of new, difficult-to-treat fungal organisms. Dr. David Angulo, our Chief Medical Officer, will then review the data of ibrexafungerp from the latest interim analysis and present a few patient case studies. Then we will take your questions. But before I turn it over to Dr. Spec, next slide, let me spend a couple of minutes on why we believe that these additional FURI and CARES results further confirm our vision of the potential for ibrexafungerp to be a transformative antifungal agent in both the hospital and community settings. As we have been saying for a long time now, fungal inflations remain a major growing public health threat with a very limited treatment options. The COVID-19 pandemic over the past year has been a painful reminder for public health experts and regulatory authorities about the constant danger caused by infectious pathogens. Make no mistake about it. Infectious diseases will continue to be a menace for humankind, and we will always battle against infectious pathogens in a never-ending warfare both in the hospital and in the community settings. Fungal pathogens are evolving, and new threats are emerging. Most recently, a new Candida species, Candida auris, has spread all over the globe, reaching the U.S. around 2014 and now detected across the United States. As an infectious disease specialist, I can tell you, and as many of you know, Candida auris is a frightening pathogen, multi-drug resistant, difficult to contain because of its ability to survive and contaminate surfaces and objects; transmissible from patient to patient; and most importantly, associated with high mortality in the 40%, 50% range in immunocompromised subjects. In fact, given its aggressiveness, Candida auris is now included in the short list of urgent public health threat by the CDC. To the best of our knowledge, today's result from the CARES study represent the first clinical data of an investigational agent against Candida auris. But as I mentioned at the beginning, fungal infections are public health threat not only in the hospital setting but also in the community setting. Ibrexafungerp has the potential to be a versatile solution for fungal infections in both settings. In the community setting, we are now only 3 months away from our June 1 PDUFA date for the approval of ibrexafungerp in vulvovaginal candidiasis. We have also an FDA conditionally approved brand name for ibrexafungerp for just the specific indication in women's health, Brexafemme. We love this name. Do you realize that it will be the first new antifungal class introduced in the market in more than 20 years? Let's go back to focus on the use of ibrexafungerp in the hospital setting. I will now turn it over to Dr. Spec, who can provide even more color on the antifungal landscape in the hospital setting. Dr. Spec?

Thank you, Marco. So I'm just going to talk a little bit about fungal infections in general and where they are evolving. And so I often like to talk -- they are often discussed as rare diseases, but what I like to often say is that they're the most common rare disease you'll ever see. And that's because there are approximately 1.7 billion individuals suffering from these infections worldwide. And these are some of the most difficult diseases to manage in humans. The overall mortality of these infections can be between 30% and 50% for some of them and higher for others. Currently, unfortunately, on the market, there are only 3 main classes of antifungals that have been approved for the treatment of IFIs and that's the polyenes, azoles, echinocandins. The polyenes date back to the 1940s and the 1950s. The azoles were introduced in 1970, 1980s. And our latest new class, the youngest one in the market, are the echinocandins, which were introduced, as Marco suggested, over 20 years ago. So in 20 years, there has been a dearth of new classes that have -- that have the potential to change the marketplace. And in the meantime, in those 20 years that we've not been developing new antifungals, the fungus has been developing new arms. And what we've been seeing is a rise of resistance in both Aspergillus species, predominantly in Northern Europe but pretty much everywhere, and non-albicans Candida species that have decreased azole susceptibility or frank azole resistance are now becoming a larger portion of the Candida that we treat. And we're seeing it now -- personally, I'm seeing it in places where we didn't really see it before. We used to see it only in very sick patients with invasive disease. We're now seeing it in much less sick patients who are outpatient. And then they just -- they're becoming a larger part of the overall fungal milieu that is out there in the world right now. And because this is happening, because we have this rise of new drug-resistant anti-fungus -- sorry, drug-resistant fungi that we have not had in the past, we desperately need new antifungal therapies. And by that, I mean new novel classes, more than just [ ami-6 ] azole or [ ami-5 ] echinocandin. And we need them in order to help produce the high mortality of the invasive fungal disease and to combat the emergence of the resistance because resistance to antimicrobials will rise in any species. We just have to outpace it with our drug development. And then ultimately, the other thing that's a big issue is that of those 3 drugs that I talked about, 3 drug classes I talked about, only 1 is an oral drug class and that's the 1 that has the highest rate of resistance. So a very large portion of patients are actually spending unnecessary amount of time on IV therapy, which is both dangerous to patients because they get central lines placed, which lead to other infections because anytime you have a piece of plastic in you, it increases the risk of another infection; as well as driving up health care costs and providing significant inconvenience to the patients. So would you mind advancing to the next slide, please? The big story though that has been emerging in the fungal world is the Candida auris. The CDC has classified it as an urgent threat, and the reason for that is that it's a new fungus that we did not know of its existence until 2009. There's been no -- there was virtually no human case until 2009 that we know of. And since 2009 to now, it has emerged what looks like in parallel all across the world, as in there hasn't just been one spot and then it spread throughout. There has been multiple, separate emergences of the same species all across the world. And as you can see on the map, it is basically everywhere. And what's really interesting is I think we really don't know where all is at this point because we had our first case last year in St. Louis. And normally, that would have been met with a whole lot of fanfare and an incredible amount of dedicated work being done to make sure that it doesn't spread laterally in St. Louis. However, all the infectious disease physicians, as you may imagine, have been occupied elsewhere. And so the amount of effort that was received was much less. And what's really scary about it is that it's 90% resistant to at least 1 fungal (sic) [ antifungal ], 30% of isolates are resistant to at least 2 antifungals. And if you think it, 2 antifungals, that knocks out all of your -- it knocks out 2 of your 3 classes and it's -- and there has been several isolates in the neighborhood of 5% that are resistant to all commercially available antifungals. And so there has been nosocomial outbreaks and transmissions that have occurred in health care facilities, and these have been very, very difficult to eradicate to the point where people have had to close down whole units to get rid of them. It's associated with very high mortality in the developed world. It's as high as 50% in places like India, where it's been very prominent. There's reports of mortality as high as 75%. A lot of the normal enhanced infection prevention, things that we do to eradicate it, don't seem to work. So as a result, it's really hard to get it off of surfaces in the ICU. And it also has been historically difficult to identify using conventional molecular biology testing. And so far, it's been spreading very quickly, which has resulted in, as we have stated on this slide, 45 countries, including 23 in the United States, but it's actually increasing. That's probably more than 23 at this point. We just haven't had a chance to report at all, 9 new states in the past year, 300 cases reported in 2018, 468 in 2019, 607 in 2020. So it's increasing rapidly. And so the past 5 months represents the 5 highest numbers of reported cases on record. So this is actually suggesting rapid growth, especially for a fungal pathogen, which usually does not spread as fast as this does. So with that said, I would like to turn it over back to you guys, to Dr. David Angulo.

Thank you, Andrej. I will take it from here. I'm David Angulo. I'm the Chief Medical Officer, and I'm excited to share the results from this third interim look at the data from our ongoing FURI study and also to share the data from an analysis of 10 Candida auris patients treated in the CARES study. These trials focus on providing an alternative to patients with difficult-to-treat fungal infections that have, as we heard, very limited treatment options. Most patients enrolled in the FURI study have complex and severe underlying conditions, such as malignancies, hematopoietic or solid organ transplants, chronic immunodeficiencies, complex intra-abdominal surgeries, complicated diabetes mellitus, among many other conditions that make them more susceptible to severe fungal infections. As was mentioned before, treatment of severe fungal infections is complicated by the fact that there are only 3 main antifungal classes. So when a fungal pathogen becomes resistant to one or more of these classes, treatment options can run out very quickly. Here is an overview of the FURI study. It's a multicenter, open-label, single-arm study to evaluate the efficacy and safety of ibrexafungerp in adult patients with an invasive and/or severe mucocutaneous fungal disease that meets one of the following criteria: It's refractory to standard-of-care antifungal treatment, which means that they have a documented failure to an approved antifungal drug or patients that are intolerant to a standard-of-care antifungal treatment, either they show evidence of toxicity or they have risk for toxicity due to drug-drug interactions, for example; or fungal infections for which current available oral antifungal options are not appropriate for continuation of therapy after an initial IV antifungal, specifically patients with azole-resistant Candida strains for which a stepping down to an oral azole is not adequate. Keep in mind that the ability to step down to an effective oral therapy is key for the optimal management of most fungal infections that actually requires several weeks of therapy. And so far, only the azoles have the oral option available. However, there are several Candida strains that have shown resistant to azoles. FURI is a global study. And we currently have centers open in the United States, Germany, the U.K., Spain, Netherlands and Austria. As a reminder, we have amended the FURI protocol to allow the enrollment of patients with fungal infections for which there are very limited treatment options, including aspergillosis, both acute invasive and chronic, coccidioidomycosis, blastomycosis, histoplasmosis and recurrent VVC, among others. On the basis of favorable toxicology data, we have also extended the treatment duration up to 6 months since many of these conditions require longer treatment durations. Last year, we reported a positive outcome of the second cohort of 21 subjects reviewed by the Data Review Committee, or DRC. A new cohort of 33 subjects was recently reviewed by the DRC, providing us now with data from 74 subjects treated in the FURI study. The analysis included subjects who have completed the study as of the end of October 2020, and this data is considered interim and preliminary since the database is not locked. We are also reporting, for the first time, data on the first 10 patients who have completed treatment from the CARES trial. CARES is a Phase III, open-label, single-arm, global trial that focuses exclusively on patients with Candida auris infections. We are running this trial from sites in Southeast Asia and Africa, where infections caused by Candida auris are more common. Both studies have several features in common, including the dose regimen. The patients received an initial loading dose of oral ibrexafungerp of 750 milligrams twice a day for 2 days followed by 750 milligrams once a day. And the efficacy end point for both studies is global response at end of therapy, as adjudicated by the Data Review Committee. Both of these trials have been designed to include a population with significant unmet medical need, in line with guidance for drugs that may be approved under the limited population pathway for antibacterial and antifungal drugs, or LPAD. The data we have gathered from this third interim analysis of the FURI trial and the first interim analysis from CARES validate and support our prior findings from -- for ibrexafungerp. The consistency of the data across all 3 analyses highlights the robustness of the trial. We have confirmed a strong antifungal activity of oral ibrexafungerp in patients with difficult-to-treat, severe mucocutaneous and invasive fungal infections. The drug was generally safe and well tolerated even in extremely sick patients. These findings reinforce the potential of oral ibrexafungerp to be a valuable alternative to existing antifungals and long-term IV therapy. Lastly but very critically, our results further support the potential for a future regulatory submission under the LPAD pathway, which offers a benefit/risk assessment that more flexibly considers the severity and prevalence of the infection that the drug is intended to treat and the lack of alternatives available for the patient population. Let me now walk you through the key results of the study. The mean duration of treatment for these 84 subjects in the FURI and CARES studies was approximately 41 days. The combined results from our 3 interim analyses of FURI and the data from CARES are summarized in this table. Oral ibrexafungerp consistently demonstrated clinical benefit in the majority of the patients, with 86% of them achieving complete or partial response, clinical improvement or a stable disease. Specifically, more than 60% of the patients achieved a complete or partial response or clinical improvement with an additional 20% of patients attaining a stable disease, which is also an important positive outcome in those patients with progressive fungal infections. Of the 84 patients analyzed to date, only 7 patients did not respond to oral ibrexafungerp, and 2 of them died due to underlying conditions and their deaths were not deemed to be related to the study drug. There were also 5 patients for whom the outcome was considered indetermined. It is also important to highlight that this initial report of outcomes from the 10 cases infected with Candida auris is very encouraging, and 8 out of the 10 patients achieved complete response. Very critically, the results from FURI are consistent with the outcomes observed in salvage therapy setting even with intravenous antifungal agents. On the safety side, oral ibrexafungerp was generally safe and well tolerated, with most common related adverse events characterized as mild to moderate gastrointestinal events. No safety signals warranting changes in the study were identified. In the study -- in the studies, there were a variety of fungal diseases. Around 58% of these patients have invasive candidiasis, 38% had severe mucocutaneous candidiasis, and 4% had aspergillosis. The most common infections were candidemia, oropharyngeal candidiasis, intra-abdominal infections and esophageal candidiasis. Not surprisingly, the great majority of the patients have fungal infections caused by Candida species that are often resistant to one or multiple antifungal agents, particularly Candida glabrata and Candida krusei. Candida albicans typically accounts for half of the invasive candidiasis cases in the U.S., and it's generally considered susceptible to most antifungals. However, as we can observe here, a significant number of patients with infections due to Candida albicans were enrolled in the FURI study, which indicates an unmet medical need for infection due to this [indiscernible]. The most common fungal pathogen were Candida glabrata, Candida albicans and Candida auris. I will now provide a summary of 2 cases treated under the FURI and CARES studies to illustrate the underlying conditions that these patients typically have, the type of infections included in these studies, and share examples of successful outcomes that motivate us to keep developing ibrexafungerp for these difficult-to-treat fungal infections. In this slide, you can see 2 cases from the FURI study. I'm not going to go through all the details here, but as a summary, both have significant underlying conditions, one with bone infection and the other with an intra-abdominal Candida infection, both of them very difficult to treat fungal infections. They were refractory to standard-of-care therapies, and these were successfully treated with ibrexafungerp. The treatment duration for these conditions is typically long, as illustrated by these 2 cases, in 1 case, 12 months; and in the other, 73 days. And in the next slides, we have a couple of cases from the CARES study, both of them with bloodstream infections caused by Candida auris and very significant comorbidities, and they both achieved complete response with ibrexafungerp. Results from these ongoing studies continue to encourage us about oral ibrexafungerp potential as a powerful and well-tolerated antifungal agent capable of addressing significant unmet medical needs across a variety of infections. We will continue to enroll patients in this hospital program and to release additional details and patient cases from this interim analysis at upcoming scientific meetings. Before I turn the call back to Marco, let me take this opportunity to thank the patients that have participated in our studies, the physicians that are acting as investigators, and the Data Review Committee that analyzes the cases. Marco, back to you.

Thank you, David. Before we open the call to questions, let me finish by reminding you all the significant milestones we have achieved so far this year: first, of course, these strong and confirmatory data from FURI and CARES; second, the out-licensing of our right for Greater China to Hansoh with terms that we believe are among the best in our sector, also validating the value of ibrexafungerp in the hospital and community setting globally; third, the selection of Amplity, a well-known contract commercial organization to commercialize Brexafemme in the VVC indication in the second half of the year while deferring a portion of its fees in 2021 and 2022; and fourth are all these bringing additional non-dilutive cash, extending our cash runway into 2023. With that, let us open the call to your questions. Operator, please go ahead.

[Operator Instructions] And our first question is from Dana Flanders with Guggenheim.

Congratulations on the data and the consistency of the data. My first question, Marco, is for you. I was just wondering if you had any updated thoughts on the regulatory pathway here when you might have enough data to discuss the pathway with FDA. And then in terms of the label initially, I know you've talked about a potentially narrow label, just wondering how you're thinking about what that might encompass, potentially a pathogen-based approach or a body-part-based approach. Curious if you could maybe just give us some more color there. And then I have a follow-up.

Absolutely. Thank you, Dana, for the questions. So let me start just saying that we have an ongoing dialogue with FDA about the potential regulatory path. And actually, I will let David, who is the one actually conducting our discussions with that agency, to make some comments. David?

Sure, Marco. Thank you. So yes, you're right that with the growing evidence of really ibrexafungerp's safety and efficacy in -- as a salvage therapy in this very difficult-to-treat population, we have ongoing discussions with the regulatory agencies, and we are very much engaged with them really to define what is the optimal approach and what is the optimal data package that will enable a favorable review by the FDA. Some of the elements that you are asking are certainly relevant and are part of our discussion right now. Would this be a salvage therapy? Or what is the subsetting that we are going to be defining salvage therapy for? Will this be pathogen-driven? Will this be condition-driven? And those are the aspects that we are probably trying to outline and have comfortable terms with the agency as well. And your other relevant question that I'm -- don't have the precise answer to you as well is what is the sample size specifically for this type of salvage setting that the agency will be comfortable with and -- however, data -- we are in the process of -- we're having these discussions with them. And as soon as we have more guidance in that regard and we receive a firm -- a confirmation regarding what those numbers will be, we will be happy to really share that in our guidance.

Okay, okay. Great. And maybe just on the Candida auris data. I was wondering if you could break down those 8 patients that had response between complete, partial and clinical improvement. And then how long were the Candida auris patients on drug?

In this particular case, out of the 8 cases that we have in that bucket, all of them were complete responses. So 8 of the 8 were complete responses in this case, for the CARES study. And the treatment duration for the specific 8 subjects there, as an average, I don't have it right now on hand. The treatment duration for them included with FURI, what we outlined. However, as an example, the 2 cases that I'm presenting here, they have a treatment duration of about 2 weeks to one; 15 days and 24 days, the other. And I will say that, that is probably the -- a good parameter of the treatment duration that we are seeing under CARES. These patients have been -- the majority of them with bloodstream infection, so candidemia. And the typical duration of candidemia is 2 weeks -- at least 2 weeks after the first negative culture, depending on the underlying conditions. So I would say that, that is a good range for the treatment duration of the CARES patient, between 2 to 3 to a little bit more than 3 weeks.

And our next question is from Louise Chen with Cantor.

This is Carvey in for Louise. Congrats on the data. Just a couple of questions from us. So in the study aggregate, 84% (sic) [ 84 ] of the patients experienced CR. Can you give us a little bit more color on the characteristics on the nonresponders? Were there any notable traits that might suggest subsets of patients who work better than others? And then secondly, in the in-hospital setting, is combination treatment common for severe fungal infections? Do today's data set a baseline for the Phase II SCYNERGIA study that's going to come out, we believe, the second half of this year?

Thank you. This is David. So let me take you a little bit about the -- if we have any particular pattern that we have identified for the nonresponders. And the answer is no. So we don't -- we have not identified that there is a particular -- either pathogen or type of infection and/or any particular pattern for these patients who have not adequately responded to ibrexafungerp. We have seen, which is not uncommon, that in some of these cases, source control is not optimal. And just to explain this a little bit. Source control, which is removing all the sources for the fungal infection or removing those events or characteristics that perpetuate a fungal infection, for instance, in intra-abdominal access. If you don't remove the access or try to clean the abdomen from the access, it's extraordinarily difficult that an antifungal agent by itself is going to be able to completely eradicate infection. And this type of things, when you're not able to even remove certain catheters which could be the source of infection, are among the most common reasons for antifungal therapy failure. And we have observed that in some of our cases. There is nothing that really lead us to believe that the drug is not even working in this type of infection or in this type of pathogen that would have made us to modify the protocol to exclude that population. So we have not observed any trend towards that. And so that's a little bit of the characteristics. Most of them have been associated either with -- it's potentially difficult to eradicate due to source control issues. And sorry, your second question was regarding the SCYNERGIA study, but I couldn't catch exactly the question. Can you repeat...

Yes. So the second question was -- yes. So basically, in inpatient setting, is combination really common? And will today's data set a baseline for the Phase II data that's going to come out later this year? I just want to get a sense of how a combination treatment will turn out to be.

Okay. Yes. Combination data is -- combination treatment is already -- as well was introduced as an allowed approach for the FURI study in very, very special locations. And certainly, we do believe that combination antifungal approaches is something that has not been -- as we have mentioned before, has not been evaluated fully as it has been done with antibacterials and that there is a great opportunity to potentially start improving outcomes in these very difficult-to-treat cases or people who have already failed therapies through a combination antifungal approach, and the FURI study is tapping into that. The SCYNERGIA study, as you know, are patients who are not failing prior therapies but are kind of -- combination given from the start to them and -- but certainly, it's an area that, along with the data that we may gather from combination therapy from salvage cases from the FURI plus what we learned from the SCYNERGIA, will help us to really better understand how well the ibrexa will play in combination with other antifungal agents. And here, I would like to invite Dr. Spec that he may be able to provide us a more color regarding what are the typical reasons that you see regarding -- for instance, in antifungal therapy failures? And/or what are your views regarding the potential role in the future of combination therapy with antifungals? Andrej, would you like to comment?

Yes. So combination therapy in -- antifungal combination therapy, especially using beta glucans and TACE inhibitors, which is classically echinocandin but now includes ibrexafungerp as well, has been in the research realm for quite some time and has shown a whole lot of promise. It's the word I will use because we have seen it work pretty well in retrospective studies, and we have seen it work pretty well in in vitro studies. Now the question has always been, does it work for -- can we develop it in a prospective study? We had an underpowered trial that showed -- that didn't show a difference early -- a few years ago with anidulafungin. However, there is a -- in the subset analysis that -- of the patients who actually made sense to be in that trial, it actually appears to work. So many of us in the mycology community feel that combination therapy, especially for things like invasive pulmonary aspergillosis in these very vulnerable patients, is likely to yield positive results if we pick the right population, which I think the SCYNERGIA study does.

And now our next question is from Michael Higgins with Ladenburg Thalmann.

Congratulations on the results. Great to see the consistency in the refractory patients and great first-time evidence and CRs as well at least in this setting. A couple of questions for you on FURI, if I could. As the trials enrolled over the years, any differences in the patients that are being enrolled as the sites have gotten more experience with the drug? Have the enrollment patterns changed by study site? I assume you're having more sites involved over time. And then the last one being -- actually, I'll hold that question there.

Thank you. Thank you, Michael. So actually, I think that maybe, Andrej, who is -- Dr. Spec, who is our -- one of our investigators with actually one of the largest pool of patients enrolled in FURI, maybe Andrej, you can comment on the -- on your experience with ibrexafungerp in your hands and...

Yes. Sure.

Difference in -- some kind of difference over time in the type of patients you have been enrolling as you gain more confidence.

Yes. I think the first step that we started enrolling were patients who needed oral step-down. So this is the [ fixed pairing ] regimen, people we could avoid getting a central line to. And then as we got more comfortable with ibrexa, we started including people who are failing primary therapy as well. But that was a pretty early-on addition. But what has really changed has been, one, the increase of Candida auris because now we can include those people in the study, and that's something we did not have at the beginning of the study. And with the expansion now of -- including new species, that has kind of opened up the possibility of adding people who have other invasive fungal infections who could benefit from ibrexa. And I think we're going to start seeing in the next -- in the future some changes towards that way.

It's some kind of an expansion.

Yes.

An expansion of the patient.

And Michael, you said that you had another question.

Yes. Any change in the duration of treatment for any of the patients due to GI symptoms? Or has it been pretty steady with the dosing?

David?

Yes. The -- so the most common GI symptoms that we observed in these studies are, as we have mentioned before, the nausea, diarrhea. They are typically mild to moderate, and the most common pattern is that these symptoms are present during the loading dose, and they typically tend to get better immediately after the loading dose. That is what we have observed in this -- with this dose regimen in this population. This population also is actually pretty used to really receive multiple medications, many of them, because of all the underlying conditions. So I would say that for the invasive fungal disease, tolerability for mild GI discomfort doesn't typically really raise to any level of concern to the patient itself. And so the tolerability is pretty high. And the rate of really those being problematic to the point of requiring to either consider modifying the dose regimen or something like that has been very, very uncommon. So at this point, the -- in the great majority of the cases, the GI disturbances that we can observe has not impacted the ability to the -- to properly deliver the study medication.

If I may, one question here on CARES. Obviously, this one has not enrolled the same number of patients as FURI. And I think we can look at the number of patients with a different criteria to enter each study as the permanent main cause. But now that you have evidence, do you expect the pace of enrollment in CARES to pick up? Any other changes to the protocol that you can make as you've made with FURI along the way?

Sure. Yes. Well, we also need to remember that even -- so the CARES -- the Candida auris infections are certainly on the rise and are extraordinarily concerning. However, really, enrollment of patients with Candida, exclusively with Candida auris, is not necessarily an extraordinary, easy task. That's why we have gone to countries even though they have a greater incidence of those and when -- we see the great opportunity to enroll the -- to really enroll this type of cases. Having said that, I think that, as you mentioned, with the disclosure of this initial analysis of CARES data, would that increase confidence of all the investigators participating in the trial and motivating to enroll more and more or other sites asking or willing to participate? That is always useful to really provide this type of interim analysis to really encourage that. So that is feasible. In terms of protocol changes, we are not planning any particular protocol change. This is -- at this point for the CARES study because this is a very tailored study, which means that basically, any Candida -- any infections due to Candida auris can be -- could be enrolled in this study. So there is not too much in terms of protocol amendments that we're planning on this. However, what we are doing is that we are exploring other centers and other territories in which Candida auris his -- or has become prevalent. That, we are doing.

All right. Thank you. It appears we have no further questions. So I'd like to turn the floor back over to the doctor for any closing remarks. Thank you.

Thank you. Thank you, Omar, and thank you all again for joining us here this morning. At SCYNEXIS, we keep moving full speed ahead to stay ahead of evolving fungal pathogen. Our team remains committed to innovation and advancing the entire portfolio of ibrexafungerp development programs to create a drug with broader utilization that can help patients across a spectrum of infections in the hospital and in the community setting. We look forward to sharing additional updates with you in the future. And let me thank my entire team at SCYNEXIS for their ongoing commitment, effort and hard work. Thank you very much, and have a wonderful rest of the day. Operator, we can close the conference.

Thank you.

Yes. Thank you so much, Dr. Marco. This concludes this morning's conference. You may disconnect your lines at this time. Thank you so much for your participation, and have a great rest of your day, guys. Thank you.