SCYNEXIS, Inc. (SCYX) Q1 2022 Earnings Report, Transcript and Summary

Greetings and welcome to SCYNEXIS, Inc. First Quarter 2022 Earnings Conference Call. At this time, all participants are in listen-only mode. [Operator Instructions]. As a reminder, this conference is being recorded. Now, I'd like to turn the conference over to your host, Debbie Etchison from Investor Relations. Please go ahead, ma'am.

Thank you. Hello, everyone and welcome to today's conference call to discuss our First Quarter 2022 Financial Results and Corporate Update. Before we start, let me remind you that today's call will include forward-looking statements based on current expectations, including statements concerning our financial outlook for the future, leadership's expectations for our future financial and operational performance, as well as our business strategy. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statement. Please refer to our filings with the Securities and Exchange Commission, including our most recent Annual Report on Form 10-K and quarterly report on Form 10-Q, including in each case under the caption Risk Factors, in another document subsequently filed with or furnished to the Securities and Exchange Commission. All forward-looking statements speak only as of today, May 12th, 2022. SCYNEXIS undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made. The information on today's call is not intended for promotional purposes and not sufficient for prescribing decisions. Joining us today on our call is SCYNEXIS President and CEO, Dr. Marco Taglietti, Chief Commercial Officer, Christine Coyne, Chief Medical Officer, Dr. David Angulo, and Interim Chief Financial Officer, Lawrence Hoffman. Following our prepared remarks, we'll open the call to your questions. Now, I will turn the call over to Dr. Marco Taglietti, President and CEO.

Thank you, Debbie. Good morning, everyone. [Foreign Language]. Thank you for joining us today for our First Quarter of 2022 earnings investor call. We are excited to share with you updates on the progress of the launch of BREXAFEMME and to outline our vision for the future of the ibrexafungerp franchise. 2022 is a pivotal year for SCYNEXIS and we are making great stride. Let me briefly summarize a few key recent accomplishments in near-term goals. On the R&D side, we continue our successful efforts to expand relabeling of ibrexafungerp. We expect to file the supplemental NDA for the recurrent VVC indication this quarter, with an approval by the end of this year. We reported positive results from the new interim analysis of the FURI and CARES trials, highlighting all our ibrexafungerp's potency against severe fungal infections with more than 83% of combined patients demonstrating a clinical response to oral ibrexafungerp. Finally, the MARIO study is being initiated and we expect the first patient to be enrolled soon. The MARIO study expect to report the result in 2024 with the potential approval for hospital indications by end of 2024. Dr. David Angulo, our Chief Medical Officer, will provide you more details on this program and the positive result to date. Our first commercial product, BREXAFEMME, ibrexafungerp tablets, launched in September 2021, achieved nearly 4,000 prescriptions and reached the net revenues of $700,000 in the first quarter of 2022. We saw a promising growth trend in the first quarter of 2022, as we continue to boost our efforts to accelerate sales this year and beyond to reach our goals. Our Chief Commercial Officer, Christine Coyne will discuss the set of coordinated and the integrated actions but we're thinking to grow prescriptions from field sales force to launching a direct-to-patient campaign. On the corporate side, we closed the first quarter 2022 with more than $95 million in cash. We're being extremely fortunate and very thankful to our investors for being able recently to strengthen our available cash with $45 million public offering, which will enable us to advance our goal of building a broad antifungal franchise for ibrexafungerp across multiple indications. I say fortunate because strengthening our cash situation will allow us to navigate successfully through the current, let's call it, environmental challenges of today's world. A war in Ukraine. I mean, a war in the heart of Europe. The pandemic that we [Indiscernible] but we don't know yet if it's over. Inflation, higher interest rates and whatnot. Having secured the cash to fund our corporate activities into the first quarter of 2024 puts us in a strong position. In fact, based on our cash, we currently have better sources to support our commercial efforts in VVC, including preparing for the launch in 2023 of recurrent VVC, and we have the resources to complete our hospital programs to enable additional regulatory filings, in 2024. And by the way, we also continue to look for business development deals like the one we did with Hansoh for Greater China, and for other non - dilutive ways to strengthen our cash balance. I would like to underscore, but our vision to make ibrexafungerp is successful, sustainable, and profitable antifungal franchise is becoming reality. With BREXAFEMME now approved and launched for the treatment of VVC, we plan to expand its labeling by end of this year, as I mentioned, to include the prevention of recurrent VVC. We are diligently and successfully following our plan to obtain each key milestone along our path to build a broad, long-lasting antifungal franchise. All these indications, when taken together, will create a franchise with the potential to generate $700 million to $800 million a year in net sales in the U.S. alone. Larry, our Interim CFO will provide more details on our expenses and cash balance. And then we will open the floor for the Q&A session. Now, I would like to turn the call over to our Chief Commercial Officer, Christine Coyne. Christine.

Thank you, Marco, and good morning. In August 2021, our field reps began calling on their physician target. Physicians interest in learning more about BREXAFEMME was encouraging. We stocked drove on pharmacy shelves and we began to see doctors prescribing BREXAFEMME. We are off to a strong start all while our insurance coverage of commercial lives continued growing and track ahead of schedule. However, over the winter, we saw growth trends slowing mostly because of environmental factors like the Omicron wave that affected the commercial sales force of many other companies as well. Therefore, we have been putting even more efforts into critical success factors, such as reach and frequency of visits to high prescribing HCP. The good news, we are now seeing a positive growth trend picking up at a good pace. Our messaging about the benefits of BREXAFEMME is resonating with prescribers, which is great news. We will continue to refine our messaging as we work to broaden our prescriber base. At the same time, we are increasing our patient outreach efforts. Based on the field response to these initiatives, we are seeing these efforts having a positive impact that will help us achieve our target sales. Now let's look at some numbers. Over the last few quarters, we built a base of BREXAFEMME prescribers. Our focus is to continue broadening out this prescriber base and helping those doctors to expand their use with more patients. We grew our prescriber base about 10% in the first quarter of 2022, especially with the number of repeat writers growing to almost three times the level as of fourth quarter 2021. Repeat prescribers contribute the majority, 56% of BREXAFEMME volumes in the first quarter 2022, versus 20% in the fourth quarter of 2021. Over the last few weeks, we have generated learnings from these repeat writers, and we are applying these learnings to all prescribers. BREXAFEMME prescriptions grew continued to grow over the last quarter. We generated almost 4,000 prescriptions in the first quarter of 2022, representing growth over the last quarter of 2021. The first quarter prescription growth came from adding new prescribers and broader adoption among fourth quarter 2021 prescribers. We continue to see steady progress each month and are encouraged by the most recent growth trends. Our commercial coverage continues to steadily tick higher as payers recognize the benefits and value associated with BREXAFEMME. By the end of the first quarter of 2022, we successfully garnered coverage of more than $93 million commercially insured lives, representing 55% of the commercial universe, up from the 48% of commercial insured lives reported last quarter. We expect continued momentum on this front, as their discussions with our payer customers are signaling just this. Our national account directors are very experienced with extensive payer relationships, and the strong coverage numbers are a demonstration of how important the [Indiscernible] option of BREXAFEMME is to payers and their patient members. Now that we have built payer coverage, we're coupling it with a new campaign called Say No More. This campaign was launched with HCPs in April and prominently features relatable and iconic imagery paired with new data and messaging. Our next step is to amplify our collective outreach to patients and consumers starting this month. We will reach after patients with the Say No More campaign. We have been talking to patients, deepening our understanding of what motivates them. Based on these findings, we have changed language used to describe the key attributes of BREXAFEMME to be more powerful and more robust. Our new [Indiscernible] materials are much more about empowerment, which resonates with our target audiences. Rolling out later this month will be digital advertising, social media advertising, and much more. Say No More is becoming a rally cry for these patients who have been suffering with yeast infections and trying the same thing to help alleviate their symptoms. Say No More, BREXAFEMME. It's time patients had a new option. The Say No More patient advertising will activate patients and consumers seeking health to learn about BREXAFEMME symptom relief, and to ask their doctor for BREXAFEMME. As our field teams solidified our efforts with our key prescribers. We will monitor our all augmented patient efforts, and amplify those with the greatest impact. We know physicians are pleased with their experience with BREXAFEMME, and we look forward to reporting back on our patient efforts. While our field teams do their work and we left the patient awareness programs roll-out. We have also taken this opportunity to launch additional Communication vehicles to create a surround sound of Communication. For example, last week we implemented a satellite media tour with two of our spokes person's Dr Nkechi Azie, Vice President of medical affairs at SCYNEXIS and [Indiscernible], also known as nurse Barb, an expert nurse practitioner. These folks’ person's talked to 26 TV and radio stations highlighting the importance of natural health and the advancements made by SCYNEXIS in the field. The call to action for this successful effort was twofold. We asked viewers to go to [Indiscernible] more information in the latest advancements to fight yeast infections. The url redirects to BREXAFEMME.com in order to drive traffic to the site. And we encourage them to after. The keys about the new product that kills yeast. These are just a few of the TV stations in the key markets across the country where the segments aired. And we'll continue to air during the month of May. As you can see, we have efforts across multiple channels that will continue to expand over the next few quarters, these times are exciting indeed. However, we are pleased but we're not satisfied. It is clear that we have brought a long needed non-azole option to yeast infections traders. But that's not enough. We must continue to consistently remind our BREXAFEMME prescribers not to fall into old habits and we must continue adding new prescribers to our base. We know when we do this, we see positive impact. While our field teams focus there, we will get these patient outreach efforts out, harmonizing all these promotional leavers will help us to continue to drive growth. We look forward to reporting back to you on all these efforts. Thank you and I will now turn the call over to Dr. David Angulo, our Chief Medical Officer. Dr. Angulo.

Thank you, Christine. As previously announced, we completed our Phase 3 study CANDLE, evaluating ibrexafungerp for the prevention of recurrent vulvovaginal candidiasis or rVVC. The results were positive, showing significant and sustained response with ibrexafungerp treatment. With these results, we are now on track for submission of a supplemental NDA by end of this quarter with an anticipated approval by end of this year. In the study, ibrexafungerp was well tolerated, there were no serious drug related adverse events and no patient treated with ibrexafungerp discontinued therapy due to adverse events. The most commonly reported adverse events were headaches and gastrointestinal events, which were mostly mild and generally consistent with the current BREXAFEMME label. In addition, we recently reported positive outcomes in patients with refractory VVC treated with other ibrexafungerp from the ongoing Phase 3 study FURI. These results were presented during the annual meeting at the American College of Obstetricians and Gynecologists, ACOG. Ibrexafungerp showed efficacy in difficult to treat patients that have VVC refractory to standard antifungal therapies; 14 patients with the refractory VVC were treated with ibrexafungerp, 750 milligrams every three days for three doses, and 10, 71% of them had successful clinical outcomes as judged by the independent data review committee. In the hospital setting, as you know, we are developing ibrexafungerp to address critical unmet needs, including invasive candidiasis, refractory fungal infections, and invasive aspergillosis. We have initiated the MARIO study evaluating ibrexafungerp as a step-down therapy in patients with invasive candidiasis. We anticipate first subject enroll this quarter, the CARES and FURI study evaluating the ibrexafungerp in patients with candidiasis infections and refractory fungal diseases continue progressing well. We estimate having data available from these three studies by early 2024, supporting an NDA submission and an anticipated approval later that year. The Phase 2 study in invasive aspergillosis synergia will continue until the end of this year, and the next steps of development will be guided by the data from these studies. As you know, the FURI and CARES studies are open label and allows the opportunity to do preliminary evaluation of the outcomes of the patients enrolled with this very difficult-to-treat infection. And we recently reported the results from the last interim look at the data from these studies. With now more than 130 patients reviewed in these studies, we are very pleased to see that the response rate as evaluated by the external group of experts continues to be positive. More than 60% of the patients achieved complete or partial response, and 22% achieved a stable disease, which is a favorable outcome in cases of progressive fungal infection, resulting in more than 80% of patients experiencing a clinical benefit. The results were positive in both, the FURI study, that includes patients with different fungal infections, and in the CARES study, focused on patients with multi-drug-resistant Candida auris. The most common pathogens reported in these group of patients include fungal strength commonly associated with antifungal resistance, such as Candida glabrata, Candida krusei, and Candida auris. The consistency of this data with previous analysis gives us continued confidence of the potential utility of ibrexafungerp in this [Indiscernible] study. Finally, our key milestones associated with our development pipeline remain on track and we continue developing ibrexafungerp for multiple indications, as discussed previously. And now, let me turn the call over to Lawrence Hoffman, our Interim Chief Financial Officer.

Thank you, David. For the first quarter of 2022, BREXAFEMME generated $700,000 in net revenues. As a reminder, we are recording revenue upon the sale of inventory to the wholesaler. The net revenue amount represents sales. None of all discounts to insurers also includes any discounts from patient assistance programs like our co-pay card. We expect our net selling price to improve over the course of the year. Cost of product revenue was a 100,000 for the first quarter of 2022, R&D expense for the first quarter of 2022 decreased to $5.7 million from $6.9 million versus the comparable prior year quarter, SG&A expense for the first quarter of 2022 increased to $14.6 million from $6.7 million versus the first quarter of 2021. The increase of $7.9 million was driven by an increase in commercial expenses related to the ongoing commercialization of BREXAFEMME. Total other income was $9.6 million for the first quarter of 2022 versus total other expense of $2 million for the first quarter of 2021. During the first quarters of 2022 and 2021, SCYNEXIS recognized non-cash gains of 10 million of $1.3 million respectively when the fair value adjustment of warrant liabilities and non-cash gains of $1 million on the fair value adjustment of derivative liabilities. Net loss for the first quarter of 2022 was $5.5 million or $0.17 basic loss per share compared to a net loss of $4.7 million or $0.18 basic loss per share for the comparable prior-year quarter. As Marco mentioned at the start of the call, we have a strong cash runway into the first quarter of 2024. We have cash and cash equivalents of $95.2 million as of March 31, 2022, with an additional $45 million received in gross proceeds, which approximated $42 million net after certain costs and expenses, which we received from our common stock offering in April 2022. Our partnership with Hansoh provides us with an additional potential of $112 million in future long-term development and commercial milestones, and the strength of our patent protection ongoing business development efforts provides us with additional opportunities internationally. Thank you. And before we begin the Q&A, I will turn the call back over to Marco. Marco.

Thank you, Larry. And before we open the floor for a Q&A session, I want to reiterate a few key points. First, I cannot stress enough we thank the BREXAFEMME therapy is a unique first-in-class systematic antifungal with the right potential. A product around which we can build and we are building a long lasting franchise, helping patients in both the community and hospital settings. Second, we have started to build the franchise by launching BREXAFEMME in VVC in September. And BREXAFEMME is making great strive with HCP and patients. And this is only the first of multiple potential indication for ibrexafungerp as we anticipate expanding the labeling to include the recurrent yeast infections by the end of this year. Third, our R&D pipeline is extremely robust and we expect to enroll the first patient in our MARIO trial this quarter. And we anticipate the regulatory approval of our first hospital indication for ibrexafungerp by the end of 2024, as an oral step-down therapy for invasive candidiasis and for some intersecting in refractory invasive fungal infections. Fourth, not only we can build a broad antifungal franchise, but a franchise that will last for a long time since we have exclusivity protection until 2035. Finally, we are in a strong financial position with a cash runway into the first quarter of 2024. Now let me finish with our rallying cry. Yeast infection, Say No More. I hope you will love our new rallying cry. And now, Operator, please open the floor for questions.

Thank you, sir. At this time, we will be conducting our question-and-answer session. [Operator instructions]. Confirmation tone will indicate your line is in the question queue. [Operator instructions]. One moment please, while we pause for questions. [Operator instructions]. We have our first question from the line of Michael Higgins with Ladenburg Thalmann. Please go ahead.

Thanks, Operator. Congrats guys on the continued progress. Thanks for taking some questions. With all the activity lately, [Indiscernible] the ongoing launch. I want to start with the FURI carrier’s data if I could. What are your thoughts on the response rates when you compare them to other novel fungals? How many patients do you at this point projects to an NDA filing? Thanks.

Thank you, Michael, this is David. Yes. The response rates that we're seeing right now. This is a salvage therapy setting, so we are very, very pleased with the response rates. We have been disclosing that for the past years. And we're seeing that a more than let's say about 60% of patients having compete or partial responses, very, very positive for people who have been already failing other therapies or other therapies are not available to them. So in comparison to what have reporting the salvage therapy setting, we are very much on on-target too, but we expect that the response rate for -- for these particular population, as you can see here, that the candidiasis cases. So the response rates of served in the against candidiasis has been I would not say so [Indiscernible] good has been very good. We are seeing really very good responses to in candidiasis cases that we getting hit too much benchmark information for because those are new, nearly CCIT that we were just following very closely to see how it breaks. I will work come that. So we're very -- very -- very pleased with the results of we're offsetting these groups, right. now the plan is to complete. As you can see they had to really ramp up those studies by next year. The estimated enrollment for these studies has been, as you can see in clinical trials, that got about 200 subjects, we're estimating to enroll in [Indiscernible] and about 30 subjects to enroll in CARES. And we believe that we add on target for completion of that enrollment within -- within the time that we are disclosing right now.

That's great. I will double check my notes. We were looking earlier, seemed like we were seeing favorable responses, how it's described in the label of 30% and 40% for the other fungals when they come out. So really impressive, but thanks for your feedback on that. If I can switch to Christine, a question for you on the BREXAFEMME [Indiscernible]. Do you have for us an updating the percent of [Indiscernible] going to women with rVVC? And has that changed months since the last quarter? Thanks.

Good morning, Michael. Thanks for the question. You're talking about the market or are you talking about BREXAFEMME prescriptions?

Yes, BREXAFEMME scripts. How many are going to refractory patients versus on-label?

Yes. From a commercial standpoint, Michael, we stay on-label. That's all we can do. So the reps are talking to doctors about VVC, not rVVC. That's really what we track are the scripts of VVC.

But I think Michael; this is Marco; I think you're raising a very good point. Something that we may have noticed is the fact that some of the patients that are technically classified as the current VVC, may just simply patients where the fungistatic effect of fluconazole doesn't just clear the infection. So the infection with fungistatic agent like fluconazole or other azoles exacerbates the Candida continues to stay lingering around, and then over time, the Candida will start to regrow. So we believe that one of the big disadvantage of our product is really the fungicidal effect that kills the Candida, clears the infection, and really becomes in a cure. So you may have patients with when been afflicted by these recurrent infections, but possibly they may not maybe have treated and cure their infection for good. So that is one of the things, but we expect that the product with our profile would be able to achieve.

Thanks. And one last one if I could here, any update for us on Synergia on how that's enrolling. Thanks.

Yes. So thank you Michael, this is David again. Yes. The synergia trial, as we have disclosed in the past, really the enrollment has been lower than initially projected. We have received the feedback from the centers that during the past couple of years with the COVID pandemic, really the focus in that particularly study was difficult for them. However, during this year we have seen much more activity than we saw in the past few years. So we keep -- we really keep speaking with investigators and really continue as we disclose, we will continue enrollment during this year, really trying to wrap up the old information that we had by the end of the year, and really make a decision regarding subsequent development for invasive pulmonary aspergillosis, specifically based on that data. But we are looking forward to really reporting those results later on, but we continue enrolling that particular study.

Thank you, Michael.

Thank you. Please gentlemen, [Operator Instructions]. We have next question from the line of Louise Chen with Cantor Fitzgerald. Please go ahead.

Hi, this is Wayne Ho (ph.) for Louise. Congrats on the progress this quarter and thank you for taking our questions here. So my first question is on the competitive landscape. How will the recent approval of Mycovia's [Indiscernible] going to impact uptake of the BREXAFEMME? And then how is the relationship with [Indiscernible], are they planning to expand a sales force? And my last question is, are there any distribution on market access challenges that are hindering the uptake of BREXAFEMME? Thank you.

these are very good question Wayne, let me stuff that we've been first one I about talking about the competition and my call here, but first thing I want to say is that we are happy to see, but there is finally innovation in the field of VVC. If you think about the it in the last three decades, but has been nothing new coming for patients with be VVC, despite the well known limitation of EASL. So two approvals in this field in the last 12 months is great news for all women suffering with this condition. And the we wish well, to our colleagues like Mike Olivia, I want to two companies have taken different paths. We've decided to develop a unique product in new class beyond EASL with a very favorable safety profile, without major restrictions or limitations. Moreover, we expect that when BREXAFEMME will be approved for [Indiscernible] at the end of this year. It will be only product approved for both the treatment of VVC and the prevention of a recurrent VVC. With an easy dosing and with an indication for a broad range of patients, both in terms of age, from 12 years old and beyond, and also in terms of women of childbearing potential. So we expect BREXAFEMME to continue to remain the recognized major innovation in the field of VVC.

In regards to your second question about Amplity, our relations with Amplity is very clear, but as we -- they are a contract commercial organization. So we are hiring a sales force fully dedicated; fully dedicated to SCYNEXIS. I want to make always this very clear. And one of the reason we decided to have this type of approach instead of our own sales force, is because having an organization like Amplity give us flexibility eventually to expand when needed to be or the -- the sales organization without having to build internally a large infrastructure. So Amplity is there to help us to be successful, and as you know, this is a partnership where we have an agreement that will allow also to defer some of the costs in the near-term. And finally, about the distribution. The distribution actually, I'm not sure but what we are mentioning -- but that has been really one of the areas where our supply chain has been working extremely well. We were able to get the product in the pharmacies, actually end of August beginning of September, I would like to remind you that SCYNEXIS at its DNA actually is a manufacturing company. This is what the company has been for, probably two decades. So we know how to develop, produce, manufacture a product; and the supply chain has been actually quite successfully making sure that the product was available in all pharmacies, and we don't see any issue with the pharmacy. But let me actually have Christine confirming that aspect, just to make sure I didn't miss anything.

You did not. Thanks, Marco. Hi, Wayne, thanks for the question. You're absolutely right, Marco. We did not have any trouble getting the product in queue, the chain, and over into the retail pharmacies that were in the [Indiscernible]. To Wayne's second question, do we see any obstruction as it relates to the scripts being adjudicated for the patient when the doctor writes, we have not seen that signal. I mean, we've enjoyed really good access with the 93 million commercial lives that we opened up from last year into this quarter. So I think that's really helpful. We also have our copay support program for now, and those things you put them off that launch and they start to wind down as our commercial lives get covered. We're in a really good spot. We do not see a signal of obstruction there. We watch it very closely, Wayne. It really is our charges what Marco talked about which is ensure that the reps are in front of their high prescribing call targets. Every time we do that, Wayne, we get the intended result, which is broader utility and bringing on new prescribers. That's where we focus for now. And then, to Marco’s point, we're always looking to see where you go after that relative to expansion of your footprint. So we're always looking at that right now, coming out of the first quarter with some of those COVID office closures. We're doubling down with our high prescribers because that's where we get the results. Hope that's some helpful information.

Thank you, Christine.

Of course.

Thank you. Congrats again.

Thanks.

Thank you, Wayne.

Thank you. [Operator Instructions]. We have next question from the line of Kumar Raja with Brookline Capital, please go ahead.

Hi, am Tremendo (ph.) for Kumar. Thank you for the update. I was just wondering if you would provide some color to the ongoing Phase 3 MARIO studies. Like how many sites are you planning to activate? And do you expect all the sites will come on board at the same time? Thank you.

Sure, this is David. Thank you for the question. So entering first at the second part of your question, are all the sites going to come out that the same time, no. Typically in these very large global Phase 3 studies, really the different regions that are coming at different time because everyone has kind of a different regulatory timelines for approval. And we are planning to conduct this study. At this point we're doing -- wrapping up the final feasibility assessment of all the geographic regions, that is going to be a global study, that it will involve European centers, centers in Asia, centers in the United States, etc. And the initial centers have been already opened, so we already have sites open for enrollment at this point. And that's why we are confident in our ability to really enable to enroll our first patient within this quarter. So we're just waiting for those -- that first patients to come in, but we already have sites open for initiation of enrollment. The total number of sites that we are estimating at this point, it's going to be in the round of between 70 to 80 sites globally. And that's what we are currently planning.

That was helpful thank you. So you had some preclinical data with mucormycosis. So how're you planning to take it to the clinics? Do you have any patients enrolling for a combination therapy in the ongoing [Indiscernible]? Thank you.

Yes, we do have patients enrolling with combination therapy for other fungal diseases, rare, other rare pathogens, but not for mucor. We recently as you pointed out, do we recently conducted these step preclinical investigations in which we observed that we will have combination therapy of amphotericin B with ibrexafungerp had surprisingly good results in this mucormycosis. With that information that has been recently just reached out to the scientific community, we made a confirmatory study even with different strains of the [Indiscernible]. And we observed the same trend again, those results were recently presented at [Indiscernible] again. And we are now the investigators of the FURI study. We are notifying them that now they have the opportunity to enroll patients with mucor into the study. So in the past, we were not enrolling patients with mucor because really we have very limited information regarding the potential clinical utility of Ibrexa, and you understand these patients have a very, very high mortality. You can only allow them to participate in your trials when you have very good reasons to believe that you can benefit them. But now we are opening this study for them, so we are looking forward to where we start seeing how some of these patients may get enrolled and we've started seeing some clinical activity from that particular indication as well. But this is an extraordinary exciting data for us even if pre -clinical because of the significant unmet need in that condition, they are very, very high mortality. Anything that can help these patients to survive is really extraordinary goodness.

Thank you. Just to be clear, so you're opening the FURI trial for these patients, for mucormycosis patients?

Yes. So mucor patients can be right now enrolled immediately. We didn't need to modify the protocol. The protocol already allows that. The protocol was specific that there are certain pathogens, even they are not defined by name in the protocol, in which the product could be a resource for them. We can allow them to enroll in the FURI study. So the study, as it is, allows right now enrollment of mucor patients.

And we will keep you -- so stay tuned, we'll keep you updated in the future if we have patients enrolled.

Yes.

Okay, great. Thank you so much for taking my questions.

Thank you.

Thank you. We have next question from the line of Oren Livnat with H.C. Wainwright. Please go ahead.

Thanks for taking the questions, had a couple. The first on ibrex and then a follow-up on the FURI, CARES program. So on ibrex, it sounds like there's a change of messaging you mentioned, focusing on empowerment and I'm detecting a change your -- some specific focus on high prescribers, you mentioned a couple of times. And I'm just wondering, am I reading too much into the language or has there been some change in strategy with regards to resource allocation and targeting perhaps? Are you, for now at least, coming out of COVID, backing off of some efforts to broaden the prescriber base and focus more on deepening, increasing the frequency of writing within [Indiscernible] high prescribers? And then I'll ask a follow-up after that.

Hi Oren good morning. It's Christine thank you for the questio. Now you heard --you've heard my words, but I want to make sure that I'm clear. The high prescribers and I think you know that very well are our most prolific writers. They're largely OB-GYNs and they are the first adopters. Everything we thought about in pre -launch happened after we commercialized. So they continue the high prescribers continue to be really important to our base. So some of the offices we did experience office closures in the first quarter like many other companies did because of COVID. And so we saw some inability to get in there as frequently as our call plan called for so then when we look at, as this office open up in February and March and then beyond, you start to see our reps being able to get in there or and then you see us comes back online with that prescribing rate, which is what we're looking for. So no change in strategy. Continue executing the plan and just making sure as often as we are able to get into those high prescribers.

And as far as the messaging, that in terms of changing message or refining messaging for patients primarily or is the pitch to doctors changing as well?

Right. Yes, so I mean, we've announced they're executing for nine months and at the same time we will learn from the ground up with the field teams. So we'll get the report back from our reps. So that's one point of information. The other point is over that course of time, we do customer listening exercises to see how the message is that we've crafted initially are going. And so, all it is honing and refining based on those tips. It's really rounding the edges. But I think on the slide, hopefully, you got to see the slides. The imagery is more evocative and it's more provocative. Oren, we're trying to get higher memorability after the rep leaves the office and that's kind of what you're seeing there on that Say No More slide. So the imagery we pumped up a little bit, Oren, and then just refined the messaging based on customer feedback. So no change in strategy there, just it's rank and file as you get out away from launch nine months, 12 months. You learn a lot from what your customer is saying or doing after we give in the message, and so that's what I'm talking about here.

All right, thanks. And if I may, for Marco and David, the -- you're putting some specific goals out there with regards to the timing of data from FURI and CARES, but also an approval by end 2024. So can you clarify, that presumably using the L pad pathway and if so, can you talk about any additional conversations you've had with the FDA on that front? Just to help us understand, we don't have a lot to go on, or a precedent in L pad, you could help us understand what you're thinking in terms of what you need to show, what kind of indications in specific or broad use cases could you imagine? Thanks.

Sure, thank you Oren, this is David. Yes, the intention as you can see there in our timeline, sorry, is to really align the completion of the MARIO study that is going to be kind of a randomized double-blind study in basic candidiasis study. And to align that with the data that we're going to be having from FURI and CARES. And really to try to get an indication that is broad that may allow us to really use the oral ibrexafungerp as a step-down from an IV echinocandin coming from the MARIO, but also to be able to use ibrexafungerp as a salvage therapy in patients that are not responding or not tolerated other antifungal agent. We believe that the most likely scenario is going to be narrow to the basic candidiasis salvage therapy because it's what the majority of our patients as right now in FURI and exclusively Candida infections, Candida auris infections in CARES. You know that the FURI study enrolls at this point a great variety of different diseases, but the majority have been candida infections. So that is current thinking, that really these two pieces of information will be complementary to each other to enable a broad label. A label that allows you to use as a step-down in a patient that is, let's say, refractory networks is done to step-down normal patient with invasive candidiasis from an idea can be, but also salvage therapy in those patients not tolerated or not responding to all other therapies including basic Candidasis. Considering the very significant unmet need for all their diseases, let's talk about mucor and we were to have some experience with mucor, all their fungal diseases that we have already enrolled patients in, but for which the numbers are still limited. It's difficult for me to say with a very strong confidence if the data is going to be large enough for the agency to consider expanding potentially or considering the label expansion into those conditions. The part that I feel very confident because at least for my point of view, the number of patients there is invasive Candida. Yes, is in both of these studies have been consistently -- data very consistently reporting these cases as several outcomes, so that's the overall strategy. We have discussed with the agency regarding combining these data sets and these days’ packages, we have not onto the final at the remained regarding exactly what it's going to be the finals and analytical plan over there towards the end of 2023. However, that these point we do have a conceptual agreement of the data, pieces of information that could substantiate an approval in the [Indiscernible].

Thank you very much. Appreciate it. Good luck.

Thank you all. Thank you, Oren.

Thank you. [Operator Instructions]. Thank you, ladies and gentlemen, we have reached the end of the question-and-answer session, and I'd like to turn the call back to Marco Taglietti, CEO, for closing remarks. Over to you, Sir.

Thank you very much, Operator. And I would like just to slash some very quick point; 2022 is a critical year, we started very well in all three major areas. Launching BREXAFEMME with very positive trend, great data in the hospitals setting; and a solid financial foundation to make sure that we have the resources for support all our efforts with a cash runway into 2024. We couldn't ever start 2022 in any better way. Thank you very much for your attention and for your support. Operator, thank you very much, you can close the call.

Thank you very much, sir. Ladies and gentlemen, this concludes today's conference. You may disconnect your lines at this time. Thank you for your participation.