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

Greetings. And welcome to the SCYNEXIS VANISH program conference call. [Operator Instructions] As a reminder, this conference is being recorded. It's now my pleasure to introduce your host, Paul Arndt with LifeSci Advisors. Please go ahead, Paul.

Thank you, operator, and good morning, everyone. And thank you for joining us as we report positive results from the VANISH program. Joining me today are Dr. Marco Taglietti, President and Chief Executive Officer; Dr. David Angulo, Chief Medical Officer; and Eric Francois, Chief Financial Officer. 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 on 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 Investors 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. Marco?

Thank you, Paul, and good morning to everyone. [Foreign Language] Welcome to today's SCYNEXIS investor call. Firstly, we hope that all of you and your families are healthy and managing well during this time of COVID-19. During this unprecedented and turbulent times, our team at SCYNEXIS continue to work diligently to close out our second pivotal trial of ibrexafungerp, VANISH-306, for the treatment of women with vulvovaginal candidiasis, commonly called vaginal yeast infection, an infection affecting millions of women worldwide, for which treatment options are limited and patients are underserved. There is currently only one antifungal class of therapies available for the treatment of vaginal yeast infections. The dose with only one oral treatment, fluconazole. For the many women, not well served by fluconazole, there are currently no available oral alternatives. So thank you for joining me today. To me, one of the most exciting and rewarding moments in our industry is when a Phase III program is successfully completed, clearing the path to an NDA submission and approval. Today, I am delighted to share with you one of these moments. With the positive results of VANISH-306, we now have, in our hands, data from 2 successful, well-controlled pivotal trials, which set us up to submit our first NDA as planned in the second half of this year for the treatment of vaginal yeast infections. In a moment, I will have Dr. David Angulo, our Chief Medical Officer, reviewing the results of the VANISH Phase III program, but let me first highlight a few key points. The VANISH program is the first large Phase III program in VVC in over 20 years. We successfully achieved highly statistical significant superiority of ibrexafungerp over placebo for all primary and secondary efficacy end points. Moreover, we confirmed the sustained effect of ibrexafungerp at day 25 that we observed in previous studies. With regard to safety, we have now a large safety database demonstrating that the dose of ibrexafungerp for the treatment of VVC, a convenient 1-day treatment of 600 milligram, was generally safe and well tolerated. Based on our internal forecast, at this time, we do not expect any material delays associated with the COVID-19 pandemic with respect to the NDA submission in the second half of this year or to the PDUFA date next year. Let me emphasize that the completion of the Phase III VANISH program is a transformational event for SCYNEXIS, transitioning SCYNEXIS from solely an R&D-focused organization to a fully integrated company with commercial U.S. capabilities. Our vision for ibrexafungerp is exciting, is doable and very commercially attractive. Ibrexafungerp will be the first and only oral non-azole agent for the treatment of VVC and prevention of recurrent VVC in over 20 years. And now I will turn the call over to Dr. David Angulo, our Chief Medical Officer, who will walk you through the data, and then we will open the call up to your questions. David?

Thank you, Marco. Good morning, everyone. It is my pleasure to present to you today the positive results of our second Phase III trial, VANISH-306, and a brief summary of prior relevant studies as well. The dating of program has been very consistent, demonstrating a clear efficacy signal and a good tolerability profile in patients with vaginal yeast infections. The VANISH program consisted of 2 pivotal, randomized, double-blind, placebo-controlled trials with identical design. The design of the studies is in line with the FDA guidance for the development of products for vulvovaginal candidiasis, or VVC. Study 303 was conducted entirely in the United States and enrolled 371 patients in 28 centers; and study 306 was conducted across 42 centers in the U.S. and Europe, enrolling 449 patients. The subjects enrolled in the study had vulvovaginal candidiasis with severities ranging from mild to severe and were randomized to receive oral ibrexafungerp or placebo in a 2:1 ratio. The dose of ibrexafungerp was a single-day administration of 600 milligrams, divided in 2 doses of 300 milligrams approximately 12 hours apart. The primary population for efficacy evaluations is the modified intent-to-treat, or mITT, that consists of patients who receive at least one dose of study drug and have confirmed positive culture for Candida at baseline. It is important to note that in the VANISH studies, consistent with the typical standard clinical practice, the treatment of a symptomatic vaginal yeast infection starts in advance of having confirmed results from a culture, and a percentage of culture results from patients suspected to have VVC may come back negative. The regulatory guidelines clearly indicate a preference for key efficacy analysis to be conducted in the population of patients with culture-confirmed vaginal yeast infections, which is the mITT in our studies. In contrast, the safety is reported in all treated subjects. The VANISH studies consisted of baseline evaluations and assessments of safety and efficacy at 2 different time points. The test-of-cure assessments were conducted at day 10 after treatment and follow-up visits at day 25. The time point for primary efficacy evaluations is the test-of-cure visit at day 10 or TOC. The assessment of sign and symptoms is conducted using a standardized scale that includes 3 symptoms evaluated by the patient and 3 signs evaluated by the physician. Each sign and symptom is a score from 0 to 3 based on the severity. The full range for the scale goes from 0, no signs of symptoms; to 18, the maximum severity for all signs and symptoms. The primary efficacy end point is clinical cure at TOC, which is defined as complete resolution of all signs and symptoms of VVC, meaning a score of 0 in the sign and symptoms scale. Other efficacy end points included mycological eradication or negative cultures for yeast; clinical improvement, which includes patients with complete or almost complete resolution of sign and symptoms, with a score not greater than 1, which is a meaningful end point for a physician to evaluate response to therapy; and complete resolution of symptoms at day 25, the follow-up visit, which assess the persistence of the clinical benefit beyond data. The demographic characteristics of the patients were similar between ibrexafungerp and the placebo subjects. The table illustrates selected baseline characteristics of patients who receive ibrexafungerp for both VANISH studies. The medium age is in the mid-30s, mostly patients of childbearing potential. Also, postmenopausal women were also enrolled. The minimum sign and symptom score required to be enrolled in the study was 4. And as you can see, the studies enrolled a wide range of severities, from 4 to 18, in the sign and symptoms scale. The medians in both studies of 9 and 10 represent a very symptomatic condition. The majority of subjects enrolled were white, but there was also a good representation of nonwhite patients included. We also had a meaningful number of patients that were overweight. In general, the characteristics of the patients enrolled reassure us that the overall population of patients seeking treatment for VVC in regular clinical practice are well represented within our Phase III program, which is ideal. The mITT population of ibrexafungerp in each study included 188 patients. Now let me cover the efficacy results. We are extraordinarily pleased to present the results of our second pivotal trial in VVC, study 306, that has confirmed the positive results observed in our first pivotal report -- trial reported previously, study 303. In study 306, clinical cure at TOC, the primary efficacy end point, was reported in 63.3% of patients, mycological eradication in 58.5% and clinical improvement in 72.3%. Complete resolution of symptoms at day 25 in study 306 was reported in 73.9% of ibrexafungerp patients. For all these end points, ibrexafungerp was highly statistically significant superior versus placebo. Study 303 also showed highly statistically significant superiority versus placebo in all these key end points. The consistent evidence of clinical benefit of ibrexafungerp treatment in patients with vaginal yeast infections in 2 large clinical trials is very reassuring and provides a very solid base of support to our NDA submission plans. As previously mentioned, the efficacy of single-day 600-milligram dose of ibrexafungerp has been consistent across all studies, including the sustained efficacy at day 25. As we can see in this slide, the proportion of patients that have their symptoms resolved at TOC are not only maintained at follow-up but consistently, a higher proportion of patients have resolution of their symptoms at the follow-up visit, day 25. We saw this phenomenon initially in our Phase II study, DOVE, which contrasted with the deterioration of efficacy at day 25 for fluconazole-treated patients in that study. And now we have been able to confirm this observation in 2 large Phase III trials. We are excited that this observation may translate into a more sustained clinical benefit to patients suffering from this condition and could also be a point of differentiation for physicians. Ibrexafungerp was well tolerated. We have [ narrow systemic ] safety concerns in our VANISH program, and there were no discontinuations due to drug-related adverse events in this study. The majority of the treatment-emergent adverse events observed at a higher frequency in the ibrexafungerp group were gastrointestinal in nature. The 3 most common events were diarrhea or loose stool reported in 9.4% of patients, nausea in 8.4% and abdominal pain in 2.7%. As you can see in the table, the great majority of these events, from 86% to 100%, were considered mild and the duration was typically short. We now have a significant data set of patients who have received oral ibrexafungerp at the intended dose for VVC. You can see here the summary, 575 patients, allowing us to estimate the overall frequency of these gastrointestinal side effects in a large population. Overall, diarrhea was observed in 16.7% of patients, nausea in 11.8% and abdominal pain in 4.5%. Consistently, the great majority of these events have been reported as mild. In summary, we now have more than 1,200 patients exposed to ibrexafungerp. Many of them at doses and treatment durations that are substantially exceeding those intended for VVC without any meaningful safety signal, supporting the favorable safety profile of the drug. We have conducted additional assessments that further give us confidence in ibrexafungerp's safety. For example, the embryo toxicity preclinical studies did not indicate the risk of toxicity, which is key considering that VVC patients are mostly of childbearing-potential age. Our QT investigations have not indicated risk for QTc prolongation, and there is very low potential for drug-drug interactions. Taken together, this data illustrates that ibrexafungerp may result in a safer option than currently available oral alternatives, the azoles, for the millions of women suffering from vaginal yeast infections. Let me turn the call back to Marco.

Thank you, David. So in conclusion, we have now demonstrated both safety and efficacy for ibrexafungerp in our Phase III program. With the 2 Phase III studies showing consistent positive results, we plan to file NDA in the second half of this year for a potential approval in mid of 2021. In parallel, we are still running our CANDLE Phase III study in recurrent vaginal yeast infection with top line data expected in the second half of 2021. And the supplemental NDA for this additional indication to be filed shortly thereafter by end of 2021. We also continue to enroll patients in hospital trials, addressing refractory invasive fungal infections, aspergillosis and Candida auris, which may potentially allow us to expand our label and continue building the ibrexafungerp franchise. Just in VVC, the vaginal yeast program, ibrexafungerp represents a significant commercial opportunity with potential peak sales of $400 million to $600 million at peak in the U.S. alone. Additionally, we have worldwide rights that we can out-license in the future outside of the U.S. As you may expect, our discussions with potential partners outside of the U.S. have been intensifying since we had the positive results of VANISH-303 study in November of last year. In brief, our company is now transforming from an R&D-focused organization into a fully integrated pharmaceutical company. Our commercial strategy is clear. Outside of the U.S., we will find commercialization partner and monetize our worldwide rights. In the U.S., VVC is a large specialty market, with most of VVC prescription written by OB/GYN doctors and nurse practitioners. We can reach the high-prescriber groups with a targeted sales force. Working in our favor is also the fact that the market is not crowded at all. There is only one oral product, fluconazole. Therefore, from a promotional perspective, our share of voice will be high. And at long last, women suffering from vaginal yeast infection will have an alternative to fluconazole. Ibrexafungerp's new mechanism of action is fungicidal against all Candida species, which differentiated it from fluconazole. For example, unlike the azoles and fluconazole, ibrexafungerp has a broad spectrum of activity and kills Candida, including azole-resistant Candida. Ibrexafungerp also appears to provide a margin of safety for patients with comorbidities, women in childbearing years, as animal models have shown no embryo-fetal toxicity. All these attributes are in a convenient 1-day oral therapy. We are excited about the opportunity to provide ibrexafungerp, a novel non-azole oral therapy, to this prescribing audience, which is in need of an alternative class of treatment for vaginal yeast infection. Recent market research indicates that clinicians who treat vaginal yeast infections are highly interested in a new oral alternative to fluconazole and find ibrexafungerp's profile very appealing. We believe that we have an excellent new treatment option for vaginal yeast infection, and we are currently working on developing the commercial infrastructure at SCYNEXIS to reach the clinicians treating women with this problematic infection. We are actively working on the prelaunch activities to successfully launch ibrexafungerp into the marketplace. Now that we have the full data set, we can conduct even more targeted positioning research with both prescribers and payers. We intend to further update investors about our commercial plans at a later time point. With regard to our finances, we are in a very strong position with cash runway past our expected PDUFA date of mid-2021. We closed the year 2019 with approximately $48 million in cash. Recently, we raised our cash balance by $10 million by expanding our convertible debt facility with one of our long-term investors, Puissance Capital. And we also implemented a $20 million equity line with Aspire Capital, providing efficient access to additional cash. Now before moving to the Q&A section, let me share some personal thoughts about the future of SCYNEXIS and of the anti-infective sector in the light of the COVID-19 pandemic. As a company dedicated to the battle against serious and often deadly infectious agents, we know that the war against infectious diseases is never over, and it is critical for industry to diligently pursue cures, not only for current pandemics like COVID-19 but also for emerging pathogens that are either new or growing resistance to current treatment. This COVID-19 pandemic is a painful and powerful reminder that our fight against infectious diseases, viral, bacterial or fungal, is a never-ending battle. SCYNEXIS is focused on and continuously fight against other deadly infections like Candida auris and refractory invasive fungal infection. I am hopeful that the entire anti-infective sector, which is currently undervalued, will be appreciated again by the public, the policy lawmakers, the investors and the pharma industry following the public health threat of the COVID-19 pandemic. In summary, let me conclude, we are thrilled with the totality of our Phase III data and we plan to submit our NDA in the second half of 2020. And as to date, we do not expect significant delays associated with COVID-19 pandemic. We also have sufficient cash on the balance sheet to comfortably get past our PDUFA date in mid-2021. We thank you for your interest in ibrexafungerp and SCYNEXIS, and we'll now open up the call to Q&A. Thank you. Operator?

[Operator Instructions] Our first question today is coming from Oren Livnat from H.C. Wainwright.

Congrats on the results. It's obviously a big moment for you guys. I have a few questions, then I can hop back in the queue. Firstly, can you give us a sense of the placebo cure rates? I don't think those were presented for either of these trials. And also, is the day 25 test-of-cure, is that the exact same criteria as day 10 with regards to both signs and symptoms? And I guess, how do you think, given you have both studies with slightly different nominal cure rates for the drug, how do you think that will shake out in the potential labeled efficacy of these drugs? And how might that compare, you think, to real-world fluconazole perception?

Thank you, Oren, and you're absolutely right. This is a great moment for us. So thank you for the kind words. So with regards to the placebo, let me first stress that the placebo response was highly statistically significant inferior to ibrexafungerp. We -- the VANISH program is the largest program that we have conducted according to the new FDA guidance to assess a product in VVC against placebo. And we will share the placebo response in the future scientific meeting. But for the time being, we prefer to keep this information confidential because it has significant competitive strategic value when planning a clinical trial in VVC. However, let me reassure you that both studies have similar magnitude of difference between active arm and placebo. And with regard to your question about day 25 and how this was done, I will actually pass now the question to David to address it. David?

Sure, Marco. Thank you. Thank you, Oren, for the question. The day 25 assessment is slightly different than the day 10 assessment. So in the day 10 assessment, every patient has an assessment of symptoms but also a vaginal exam for the assessment of signs. And in the day 25 visits, the patients who were asymptomatic, so that they were not reporting any symptoms, they were allowed not to have a vaginal exam. So it's -- for those patients that are asymptomatic at day 25, we don't have a vaginal exam and we don't have signs for them. Does that answer the question? So that means that -- that's why it has been reported as asymptomatic, which will be -- let me just clarify, which will be a real-life scenario or situation. That's why the guidance for the FDA are written in that way. The real life is that they may have to come, the patient, 1 month later and say, "How are you feeling? If you're feeling good, I'm not going to do a vaginal exam on you. I'm not going to take samples." That's real life.

And just with regard to the overall efficacy magnitude across, it's higher in 306 versus 303, how do you think that ultimately would be labeled for sort of a headline cure rate? And remind us, what do you think real-world fluconazole is at this point?

David?

Yes. The efficacy rates that we observed in both studies were very, very consistent in the sense that they're slightly higher in 306 study versus 303. However, very consistent as well with what we observed in DOVE, which -- and the important aspect is all these small variations is within what is the expected variation of clinical trials conducted in different centers in different regions. That's the reason why you do typically 2 well-controlled randomized controlled trials to really know what is the breadth of the response rate that you would expect once the product is in the market. So we are extraordinarily pleased with the results and that variation is not definitely unexpected in that sense. So that is the answer in regards to the variation of the 2. In regards to the labeling, the most common way that the most frequent labels are right now crafted is really showing the efficacy results for independent studies and that's probably the most likely scenario for our labeling. You know that fluconazole -- in regards to the comparison of the fluconazole, fluconazole was conducted or the fluconazole trials when they were conducted, at least the information that is in the public domain many, many years ago, used a different time point and potentially slightly different end points. At that time, the important time point was day 25. And as far as we know, the guidance at that time were indicating that success could be considered if the signs and symptoms were 0 or 1. So it's difficult to have an exact head-to-head comparison regarding the results that we are observing here versus what is exactly in the fluconazole label. However, probably the best indicator of how these 2 products behave when they are contrasted in exactly the same conditions, exactly the same populations, is the DOVE study, in which we exactly compared with the same assessments, the activity of ibrexa versus the activity of fluconazole. And the results for that are public there. We have very comparable response rate at day 10. However, we have numerically better response rates at day 25 in that particular study.

The next question today is coming from Alan Carr from Needham & Company.

Wondering about your speculation as to why there's different response between the 2 trials. Have you looked at the pathogens, Candida albicans or some other ones, other Candida involved? And then also what's the latest on commercial plans? Are you still aiming for relatively small sales force upfront and then expand after CANDLE? And then the third one is around MAA. Is that something that would be filed by a collaborator? Or would you do that before finding a partner?

Okay, Alan. That's a lot of questions. So let me start, first of all, with the difference. As David was pointing out, the variability we have seen in some ways what you will expect when you have 2 trials done in different centers and in different regions. In terms of distribution of pathogens, what we saw is really what we will expect in this type of indication with most of the pathogens being Candida, but we saw also some additional less common Candida strains like Candida glabrata, and we are going to share all this information at the -- at one of the next scientific meetings. Moving to your next question, the -- our commercial plans. In the U.S., yes, we plan to commercialize this on our own. In the U.S., VVC is a large specialty market. So we expect with a relatively small sales force to be able to target high prescribers who actually are craving for an alternative to fluconazole. Also, as you mentioned, yes, that is also our strategy since we have 2 approvals coming in the next -- in the future: one, in mid-2021, which will be the treatment of VVC based on the VANISH trial; and then in 2022, the approval for the recurrent VVC based on the CANDLE study, which is ongoing. So these staggered approvals will allow also us to have a staggered implementation of our sales force. And finally, with regards to MAA and discussion with potential partners, also on a worldwide scale, as I mentioned, it is -- since the positive results of 303, our first pivotal trial in VVC in November, our discussions with potential partners and in different regions have been intensifying, and we will continue with these discussions.

Do you -- well, 2 follow-ups on that. So I have in my notes that you've been contemplating maybe around 35 people for a sales force initially. And to clarify, would you do an -- would you not submit an MAA in Europe until -- or would you have a collaborator do it? Or might you submit an MAA without a collaborator?

In MAA -- in Europe, sorry, I misunderstood when you talked about M&A. So with regard to the market authorization approval in Europe, our plan is actually to do that in discussion with potential partners. However, let me stress that the program, the VANISH program, has been discussed with EMEA and is acceptable program for an approval of treatment of VVC as it is here in the U.S.

Okay. And is 35 your initial estimate? Or is that still your thinking on size of sales force? Or has that evolved over time?

Yes, that is the type of size of the sales force that we expect will be adequate to commercialize a product in specialty market like this one, targeting the high prescriber based on our marketing research.

Great. And congratulations on a second positive trial.

Thank you. Thank you, Alan.

Our next question today is coming from Michael Higgins from Ladenburg Thalmann.

Congrats on the impressive data. It looks better than what we saw with the 303 data. And in fact, we're seeing a bit more detail this morning, so we appreciate that. Hoping for a few more details here. Doesn't sound like you're providing much in the way of the placebo patient response. If you can provide us a little information on any data yet by baseline S&S score or, for that matter, any other baseline scores would be helpful.

So as we mentioned, we are planning actually in the future -- in the near future to share all this information and more detailed information on -- in a scientific meeting. One of the reasons we provide actually a relatively focused information during these sessions is because scientific meetings are actually very strict on their criteria to consider study being unpublished. So our -- we want to make sure that we present information that will not compromise our ability to present this data to a scientific meeting. However, I believe that we have shown -- we have shared adequate information to give everyone a sense of it, high efficacy of the product, of the good tolerability. And one piece of information that we were able to show also at this session is really the sustained treatment at day 25, which was one of information actually, Michael, you mentioned more than once in our past conversation that you would like to hear. So I think that this data shows really the -- how this product has a sustained effect that we believe will be very beneficial to women with these infections.

Yes. That's very helpful. The follow-up to that would be what conferences or conference might you suspect that we would see additional information given how COVID is affecting trials here this spring. Lot of companies had data that we were looking for is pushed out to August or at some time point, maybe even in the fall. Hopefully, we don't have that same scenario going into the fall, and we can see some things that will come out like this in the fall, but any details as to what or any insight as to what conferences you may present this in the fall?

Actually, Michael, you are raising a very good point. We are trying actually to figure out too what are the conferences that will happen in the near future. This past weekend would have been ECCMID in Paris. And we were actually having several presentations there, presentation that since the meeting has been completely canceled, we are now planning to present in the future. Of course, the COVID-19 has been completely disrupting the calendar of conferences. And so we are truly assessing the situation, Michael, and we would like really to make sure that in the near future, we find congresses, either in person or virtual, that we -- virtual that we can share of this data.

Just one more follow-up, if I could -- actually, a new question here is, remind us of the food effect. Does taking it with or without food have any impact on the GI symptoms or as well as the efficacy of the drug?

David, maybe you can share our experience with the food -- with regard to food.

Yes. What we anticipate in terms of the product is that it should be able to be taken with or without food. We have noticed in previous studies that when the product is taken with food, some of the gastrointestinal adverse events, particularly nausea, is less common or it's less commonly reported when it's taken with food. So recommendation in this particular study was that the drug should be taken when it is possible with food as a recommendation but not mandatory. We don't estimate that really taking with or without food will have any impact in the efficacy of the product itself.

Our next question is a follow-up from Oren Livnat from H.C. Wainwright.

I'm sorry if I missed it. Did you mention what specific gating factors there still are with regards to this second half NDA filing? And separately, you kind of reiterated the second half 2021 are VVC filing timing, which I don't think has really changed from my prior assumption. So are you not seeing much COVID impact on the CANDLE enrollment progress? Or is that one just maybe otherwise enrolling faster than expected, similarly to what we saw with the VANISH program?

So I'm not sure I understood the first question about the filing.

Yes. It's just what do you still need to do before you can file it that would take theoretically up until the end of the year to do.

Yes. Actually, we are now -- this was the last piece of information that really for us was the make or break. And of course, now we are very excited. We are working on the preparation of the NDA. At this point, all the key sections are in preparation, being the toxicology actually we presented, and we share with the investor community the results with regards to all the toxicology studies that we have done recently. The same is for the CMC working in making sure that we have our NDA batches and the commercial infrastructure in place for the supply chain. And so at this point, we don't foresee any reason for any delay in filing our NDA for treatment of VVC this year. With regards to CANDLE and the impact of COVID, at this point, we are following the situation. We -- this study is multicenter and in different regions. So something that we are seeing is that different regions may have a different point of the curve of the COVID-19. So we expect, at this point, to continue -- to be able to continue to progress the study. And we -- at this point, we are not seeing a delay that justify changing our guidance.

Our next question is a follow-up from Michael Higgins from Ladenburg Thalmann.

Just one quick extra one here. Looking at FURI, we saw 20 patients' worth of data early in '18, early in '19. So the trend would suggest maybe early -- sorry, I think I got those wrong, early '19, early '20. So would suggest maybe early '21, you may have another 20 patients or so. Given the potential for increase in enrollments, the data that we've seen, I guess it would be possible that you can enroll a bit faster but then we have COVID affecting it. So just looking for some feedback on how you think about providing more information from FURI.

FURI is actually a critical study for us and for the patients. As you know, we enroll -- just for everyone to know, FURI is the study in which we enroll refractory invasive fungal infections. In other words, infection for which the currently available treatments are not working. So it's a salvage setting type of study and our drug may be the remaining option for these patients. And as you know, in January, we presented very positive data on the first 41 patients that were enrolled, showing that 85% of these patients that did not respond actually to other treatment had a positive response. So we are continuing to enroll in these patients. And our plans, as we mentioned in January, when we showed the results of this first 41 patients, is to discuss this data with the agency, with FDA, to discuss next steps. So stay tuned, and we will continue -- we are continuing to enroll. And we plan in the future to provide an update about FURI as we have done in the past.

And Marco, is it fair to look for the feedback from the discussions with the FDA possible this summer?

Well, let me say, we will keep everyone informed as soon as we will have more feedback by the agency.

Thank you. We reached the end of our question-and-answer session. I'd like to turn the floor back over to management for any further or closing comments.

So thank you very much, Kevin, and we -- and thank you to all of you for attending the session. Let me summarize the key points that is first of all, with this positive study, now we have a clear path to the submission by the end of this year. Second, we have a significant commercial opportunity here with VVC. With this positive data, we think that we have a drug that actually will result in a significant benefit for women with vulvovaginal candidiasis, with vaginal yeast. And we have other indications that are progressing. And at this point, our expectation is that we will have this drug approved in mid of 2021. And therefore, we are transitioning the company to become a commercially integrated -- fully integrated company with commercial operations. So we are very excited about these results and we are looking forward to provide you further updates in the future. Thank you very much to everyone for attending this session. Thank you.

Thank you. That does conclude today's teleconference. You may disconnect your line at this time, and have a wonderful day. We thank you for your participation today.