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spk04: Greetings, and welcome to the Cinexus Third Quarter 2021 Earnings Conference Call. At this time, all participants are in a listen-only mode. A brief question and answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press star zero on your telephone keypad. As a reminder, this conference is being recorded. It is now my pleasure to introduce your host, Debbie Etchison, Executive Director of Communications. Thank you. You may begin.
spk01: Hello, everyone, and welcome to today's conference call to discuss our third quarter 2021 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 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 statements. 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, included in each case under the caption, Risk Factors, and in other documents subsequently filed or furnished to the Securities and Exchange Commission. All forward-looking statements speak only as of today, November 10th, 2021. Cenexus undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they're made. The information on today's call is not intended for promotional purposes and not sufficient for prescribing decisions. Joining us today on the call are Cenexus President and CEO, Dr. Marco Taglietti, Chief Commercial Officer, Christine Coyne, Chief Medical Officer, Dr. David Angulo, and Chief Financial Officer, Eric Francois. Following our prepared remarks, we'll open the call to your questions. Now I will return the call over to Dr. Marco Tagliati.
spk06: Thank you, Debbie. Good morning, everyone. Buongiorno a tutti. Thank you for joining us today for our third quarter 2021 Earnings Investor Call, our inaugural earnings call with investors since the FDA approval in June and after the launch of Prexafen. For all of you who have been following us in the last few years, you witness how we have been true to our word, commitments and timelines to turn our vision for Ibrexafunger into reality. Our vision for Ibrexafunger has always been to build a global antifungal franchise for both community and hospital infections. by leveraging the versatility and potency of a Brexaphone jerk and to extract the full value of this unique, systemic antifungal agent for the benefit of patients and for the reward of our shareholders. And with 14 years of exclusivity until 2035, we have the time to build a solid, long-lasting antifungal franchise to create a stream of approvals over the years to continue to expand its use. So, today you will hear about the significant progress we have made so far in achieving our vision for Edressa Fungerba. First, you will hear from Christine, our Chief Commercial Officer, who will provide an overview of the market, our commercial activities, and the promising early trend of the launch of BrexFM for the treatment of vulvovaginal candidiasis. We are very excited about bringing innovation from a new antifungal class to the millions of women suffering from this symptomatic condition who have been underserved for so long. We are so proud to bring to patients the first new antifungal class in more than 20 years. Then you will hear from David, our chief medical officer, about our significant progress in research and development. We are finishing the phase three candle study for the prevention of recurrent BBC, which, assuming positive data, may result in a second approval for a breast upon jerk in the second half of next year. David will also give you an update about our liposomal intravenous formulation. We successfully completed the phase one in healthy volunteers, opening new avenues of development for hospital invasive fungal infections on top of our ongoing hospital programs. And finally, all our commercial and R&D activities are built on a solid financial foundation. Our chief financial officer will give you a brief financial update. Now, I would like to turn the call over to Christine Coyne. Christine?
spk03: Thank you, Marco, and good morning. We have several exciting commercial updates to share with you today. Following the FDA approval of BrexFM in June, our team hastened the launch efforts of bringing this truly innovative product to market and to the millions of women who suffer daily in the U.S., Vaginal yeast infections are extremely common, with about three out of four women experiencing them at least once in their lifetime. Despite the high prevalence of DVC, there has been limited advancement in this area of women's health for decades, until now. Brexifen is a truly novel, first-in-class antifungal with a mechanism of action designed to kill the yeast causing the infection, including azole-resistant strains. BrexFM brings long-awaited innovation to the market, and physician feedback has been excellent. Healthcare providers confirm that BrexFM is meaningfully different from the outdated tools they have been left to use for the last two decades. Physicians are excited about the novel mechanism of BrexFM and its fungicidal properties. They are delighted that BrexFM is a non-asal, oral, one-day dosing alternative for patients Physicians aren't just saying great things. They are changing their long-held habits and prescribing BrexFM for their patients. From the beginning of launch, we have closely monitored physicians' motivation to prescribe. These early indicators of motivation have converted to action. These indicators are quite strong and encouraging. Now let me provide more details on the progress we've made since our launch this summer. First, We established the foundational building blocks that set the stage for commercial success. Together with AmpliTea Health, our contract commercial partner, we rapidly hired, trained, and deployed high-performing SALS representatives and regional SALS leaders post-approval. The Synexis and AmpliTea collaborative partnership has allowed us to efficiently leverage AmpliTea's deep expertise and experience to achieve our strategic vision for BrexFM. AmpliT is a great partner. They equally realize the importance of this launch and what it means to Synexis and to physicians and patients. At this time, we are continuing to execute our launch plan, which includes our SALS teams consistently promoting BrexFM to their physician targets. As we have discussed previously, The U.S. BBC prescription market is nicely concentrated and makes for a strategic and executable approach, especially this early in launch. Effectiveness of efforts is the name of the game at this juncture. My expectation is that we continue expanding our prescriber base in breadth and depth, and the team is focused on just that. All indicators confirm that our efforts are working. Just to remind everyone on the call the history of our launch process. By August, the product had been manufactured, packaged, and distributed to pharmacies. By then, our SALS force had been hired and trained, and the commercial launch was formally announced in September. SALS started to come in as soon as the drug was available in pharmacy in August, which we believe highlights the pent-up demand for an alternative to Azols, Cyprexafem. We started to achieve real significant traction now and in September, and we continue to see an upward trajectory in October. According to IQVIA data, there were 1,006 total prescriptions for Brexfem in the first partial quarter of the launch. This is in line with our expectations. As physician awareness and experience increases, so does their adoption of Brexfem. We see a very consistent week-over-week growth rate of prescriptions from early August to the end of September, with nearly 700 prescriptions in September alone. There is a similar trajectory of growing positive momentum continuing into the fourth quarter, with IQVS showing 1,100 Rexapen prescriptions in October alone. Very encouraging indeed. Prescriber feedback remains aligned with what we learned in our prelaunch research. Having a new non-nasal option with a novel mechanism of action that has shown activity against resistant strains of candida while rapidly eliminating signs and symptoms of the infection continues to be important to physicians and patients. In addition, the ability to provide a one-day therapy is also extremely compelling. healthcare providers are motivated to prescribe Brexifem, and we are starting to see repeat prescribing as physicians broaden their practical experience. As our SALS teams continue to generate awareness and utilization of Brexifem, our national account directors are busy continuing their work with commercial payers. We have presented to numerous payers, we have discussed contracts, and we are in the midst of negotiating agreements with key payers. As of today, coverage of Brexfem has grown to over 30% of commercial lives and is still growing. We are actively engaged in ongoing contract negotiations with additional payers representing the majority of commercial DBC patients. Progress with payers have yielded not only scheduled P&T pharmacy and therapeutic reviews, but also contract discussions and negotiations. I'm delighted with the efforts and results of the payer national account teams. They have strong customer relationships and deep tenure in this space. Based on all of this, we are on pace to meet our goal of Tier 3 coverage non-preferred. We will begin educating and activating patients early next year. Pre-launch research showed high patient motivation based on the strong attributes of Brexifem. Similar to the positive physician reception we have been experiencing, we expect consistent response from patients. The marketing team is working hard to deliver compelling patient education materials in 2022. It is incredibly fulfilling to bring a new product to market that addresses an unmet need where there has not been a new development in a long time and where there was high frustration about lack of scientific advancement in this area until now. Again, the response we are receiving from the medical community is encouraging and extremely satisfying. I look forward to reporting on the team's continued progress in 2022. Thank you, and I will now turn the call over to Dr. David Angulo, our Chief Medical Officer. David?
spk05: Thank you, Christine. After hearing these positive trends regarding breakfast and commercialization activities, I will be sharing with you some updates in our development programs. Please keep in mind that the programs I will be covering in this section are evaluating indications that are not approving BrexFM labeling, but potential indications for ibrexafungur and their clinical development. With a vision to maximize the potential for our novel agent to become a blockbuster antifungal addressing multiple unmet needs in the market, we have been making significant progress on several development programs for ibrexafungur. Let me start with a quick update on our vulvovaginal candidiasis, or VBC, program. After securing the approval of BrexFM for the treatment of VBC with our two pivotal VANISH trials, we continue progressing our VBC development activities with our ongoing CANDLE phase three trial. CANDLE is intended to support an indication of prevention of recurrence in patients with recurrent VBC. As you may recall, We had previously announced the completion of the study enrollment, and I'm happy to report that we are on target for last subject last visit by end of this year. We anticipate availability of top line results early in the second quarter of next year, followed by a supplemental NDA submission shortly after. And with a potential FDA approval of a new indication by the end of 2022, after an anticipated six-month expedited review by the FDA. Moving into the hospital-based indications, we are quite busy, and we have some great news to share. The first exciting update relates to the intravenous formulation of ibrexafungur. From a strategic drug development standpoint, anti-infectives benefit from having both an IV and an oral formulation for initial inpatient hospital IV treatment and the ability to shift to oral once the person is discharged from the hospital to continue therapy in the home setting. We completed dosing in our phase one study that included multiple dose panels with up to seven days of dosing. The tolerability of this new liposomal formulation was clearly better than previous formulations tested. There were no serious adverse events, and the most common adverse events were mild redness, swelling, and or pain at the site of infusion. The pharmacokinetic analysis is ongoing, and we are in the process of outlining the subsequent stages of our development plans for intravenous formulation. We believe that these study results could be game-changing for our company, as an IV formulation may significantly expand the potential opportunity for Ibrexa fungher and increase strategic interest in the product. Our FURI and CARES program aimed to provide treatment options for fungal infections for which there are limited or no other treatment options have continued to progress well. These studies will continue running during the next year, allowing us to gather additional information about the potential clinical utility of Vibrexa fungher in difficult-to-treat invasive fungal infections. As you know, Previous interim looks at the data have been supportive of the potential of ibrexafungur to be a much-needed salvage treatment alternative for invasive fungal diseases. As we expand our data and experience with the use of ibrexafungur in the hospital setting, we continue to advance our discussions with regulatory agencies regarding the optimal regulatory path and data needed to support a salvage therapy indication. Our synergist study Evaluating oral ibrexifungal in combination with voriconazole for the treatment of invasive pulmonary aspergillosis has not enrolled as rapidly as initially projected. The prioritization of hospital resources towards addressing COVID-19 pandemic has impacted the ability of many institutions to focus on screening and enrollment of patients into clinical trials, including Synergia. Our investigators are telling us that now, with a decrease in the numbers of COVID-19 hospitalizations in some regions, they anticipate having a better opportunity to focus on enrolling patients for this study. We have made a decision to extend the enrollment timelines into 2022. Lastly, I want to share with you an exciting preclinical development for ibrexafungur. As you may be aware, mucormycosis is a devastating fungal infection with a very high mortality rate. more than 50% in some situations, even with the best currently available antifungal therapy. Mucormycosis can become a public health threat when the right conditions are present. As an example, more than 47,000 cases of this infection have been associated with a COVID-19 pandemic in India. In an NIH-sponsored preclinical study conducted by Dr. Ashraf Ibrahim, a well-known expert in the field, A substantial improvement in survival was observed in a mouse model of mucormycosis when ibrexafungal was administered in combination with liposomal amphotericin, one of the key standard of care options for this infection. This finding suggests that the co-administration of these drugs may be synergistic for the treatment of this infection. This is very encouraging development. Aiming to better elucidate the significance of this potential clinical benefit, we now allow combination therapy with a brexifungal as a treatment option for mucormycosis in our FURI study. Finally, we will be hosting a hospital pipeline update investor call on December 6th to get more details about our development progress and plans for the hospital indications. Please mark your calendars. And now, let me turn the call over to Eric Francois, our Chief Financial Officer.
spk09: Thank you, David. Let me first start my presentation by highlighting a few numbers on the revenue side. This is our first quarter ever to report product sales. We are very proud of the progress and excited about it. As you heard from Christine, the launch is proceeding well. This was a partial quarter for us, and we ended the quarter strong. and already see indications of a strong positive trajectory of sales in the fourth quarter. For the third quarter of 2021, its first quarter post-launch, Brexfm generated $516,000 in net sales. As a reminder, we are recording sales as soon as we sell inventory to a wholesaler. At launch, we worked with wholesalers to stock more units at relevant pharmacy networks to ensure drug availability, and we expect to have approximately three weeks of inventory on hand at the wholesalers over time. The net sales number we will be reporting represents sales, net of all discounts to insurers, and also includes any impact from patient assistance programs like our copay card, which is the main impact on Q3 net sales given the early commercial launch. Please refer to our press release issued today for a detailed breakout of expense line items. cash and cash equivalents totaled $100.1 million on September 3, 2021, compared to $93 million cash and cash equivalents on December 31, 2020. Based upon our existing operating plan, we believe that our existing cash and cash equivalents, the sale of our New Jersey NOLs, and the anticipated sales of BrexFM will enable us to fund our operating requirements into 2023. We did not draw down additional debt from our remaining $30 million Hercules and SBB term loan facility in the third quarter, but we'll have access to additional capital in 2022, sending reporting positive phase three data in our candle, recurring VBC, and achieving certain sales thresholds. As we are still early in the commercial launch, we are not providing revenue or expense guidance. I will turn the call back over to Marco.
spk06: Thank you, Eric. Before we begin the Q&A, I want to reiterate a few key points. First, our vision for Ibrexa Funger is becoming a reality. Second, following approval in June, we've been aggressively executing our commercial launch plans with very positive trends, as you have heard. Our R&D pipeline is extremely robust with the hospital moving into the forefront now. Stay tuned on December 6th at 10 a.m. Eastern Time when we will provide our plans and timelines for the hospital program. Fourth, we are in a very strong financial position with the cash runway into 2023. And lastly, just let me take a moment to thank Eric Francois our chief financial officer, for his services over the last six years. As we announced, he's leaving the company to pursue a career opportunity in banking. Eric played a key role in transforming Synexis into a fully integrated commercial state company, and he leaves us well-positioned for success. We wish him the best in his next endeavor. Thank you, Eric. An interim CFO is in place. Larry Hoffman of Danforth Advisor for a smooth transition, and you will meet him soon, and we are actively recruiting for a new CFO. Operator, please open the floor for questions.
spk04: Thank you. We will now be conducting a question and answer session. If you would like to ask a question, please press star 1 on your telephone keypad. A confirmation tone will indicate your line is in the question queue. You may press star 2 if you would like to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys. Once again, if you would like to ask a question, press star 1 on your telephone keypad. One moment, please, while we poll for questions. Thank you. Our first question comes from the line of Louise Chen with Cantor Fitzgerald. Please proceed with your question.
spk00: Hi, this is Wayne Wu for LUIS, and congrats on all the progress, and thank you for taking our questions. We got two, if we may. So the first is, on your partnership with Henso Pharma in China, could you provide us some updates on the progress, and what is your plan on commercializing Brexfem in the other regions of the world? And then our second question is, as the VVC can be viewed as the first step for Synapse, and now you're commercialized, What are the major catalysts we should be looking out for in the next talk to 18 months? Thank you.
spk06: Thank you. Thank you for the questions. So let me start, first of all, with the partnership with Hanso. It has been a great partnership. As you know, Hanso is one of the top five largest public biotech company in China. We licensed their product at the beginning of the year. They filed the IND for bulbar vaginal candidacy in China. So they are moving very aggressively with the development of the product in order to ensure approval in China of the product. So we expect, just as you know, we expect to continue to progress very, very rapidly in the VBC indication, but also to continue to progress with the hospital, too. We are, of course, we have, as you all know, rights for the product worldwide. And, of course, it is our plans. monetize this product and to have this, our product, Idressa Funger, commercialized outside of the U.S. Therefore, as you can expect, following approval in June of the product and following the validation of the value of the product outside of the U.S. with the partnership with Hanso, as you can expect, our phone calls have been intensifying with potential partners outside of the U.S. But at this point, we cannot provide any other additional information other than saying that we certainly we are moving forward to make sure that Ibrexafunger becomes available to all the patients globally. And finally, yes, VBC is really the first step or the first indication of a series of indication that we see for the product. This product has a great versatility, the ability to be used for community type of infection that are difficult to treat like VBC but not necessarily life-threatening. but also can be used for hospital indication where there are infections of the bloodstream, of internal organs with high mortality. And so we are progressing all these indications in parallel. Future catalysts, next year we expect a second approval for the prevention of recurrence of DBC for ibrexafungitis that will allow us to bring an additional indication in the bank of our sales force and therefore to go out with a new indication to our current group of targeted doctors. But also we expect to move forward with the hospital indication, as I mentioned. Stay tuned. On December 6th, 10 a.m. Eastern Time, we will have a teleconference to share our plans and timelines for the hospital indications. Thank you. Thank you.
spk04: Our next question comes from the line of Michael Higgins with Ladenburg-Thalman. Please proceed with your question.
spk10: Thanks, guys. Appreciate the opportunity to take some questions. And let me say, Eric, thank you. You'll be missed around here. A couple questions on the launch, if I could, with Christine. How are the commercial coverage, how's that coming along versus internal expectations? What do you see happening in the next few months? I've got a handful of them here. I'll try to keep this tight so we can talk later maybe. So under related Medicaid coverage, how's that tracking along? And then finally here, are you targeting nurses and pharmacists? And if so, in what ways? Thanks.
spk03: Thank you for the questions, Michael. Commercial coverage, again, I spoke a little bit about this. I think the National Accounts Directors are doing it. a really great job in getting to the payer customers and having the necessary conversation. So they've gotten some really great traction throughout 2021. We've had a lot of meetings with important payers that are important to us. So we are tracking over 30% commercial covered lives right now. My expectation is that trend continues going in that direction and We'll bring in some important coverage by the end of 2021, and then we'll pick up the rest in 2022. As it relates to Medicaid, just participating in the state Medicaid reviews that are ongoing, we have some states reach out to us proactively, and our, again, national accounts directors and our medical science liaisons take those meetings, and we'll continue watching that as it goes. As it relates to nurses and pharmacists, yeah, we call it a total office call, and that includes the pharmacy as well. And we are having success there. I should say the representatives are having great success there with not only the physicians but their nursing staff, and then also rounding back to the pharmacies to ensure that the physician and the patient have the best experience with Brexifem that they can. And that's going very, very well. I hope that answers your question, Michael.
spk06: That's great. Thank you, and Michael, as you said, Eric, and Michael, just I wanted to say that with Eric, don't worry, he will be around. This is a small world, so I'm sure that we will continue to interact with him, and you will continue to interact with him. Please go ahead.
spk10: I'm sure. I appreciate that. No, I look forward to that. Just one quick follow-up on that. I'll jump back in the queue. I've got some other ones on the IV and the other studies, but just one here on the launch. Any feedback on the GI, the nausea? Is it being managed with food? What are you hearing from your reps? Thanks.
spk03: Yeah, no. I mean, the reaction from the physicians is exactly what we saw in research. They're really excited to have this alternative to azoles, they've just been waiting for something like this. The reception on, Michael, on the fungicidal, the ability that it can kill the yeast infection, they can take it in one day, it's a different mechanism of action. Really strong reception from our call targets.
spk06: Tolerability, as you may remember, Michael, in our clinical trials was a very mild event, short-lasting. We don't, this is why, we see these reflected in the type of experience of our patients.
spk10: Okay, so feedback is minimal on the GI then. That's correct. Okay, appreciate it. Thanks, guys. I'll jump back in the queue.
spk09: Thank you. Thanks, Michael.
spk04: As a reminder, if you would like to ask a question, press star 1 on your telephone keypad. Our next question comes from the line of Kumar Raja with Brookline Capital Markets. Please proceed with your question.
spk07: Thanks for taking my questions and congratulations on the first quarter of product sales. First, with regard to the paint-up demand, how much of that has been satisfied? Also, with regard to the positions that are being targeted, what percentage has been targeted there? And where is this prescriptions that are coming from? What percentage of positions it is coming from? And what are you seeing in terms of, like, are some positions describing more than others?
spk03: Yes, so thank you. The pent-up demand, yes. So we put stocking into the pharmacies around our call target so that our physicians, once they started prescribing BrexFM, their patients could get the product. So we did put that into the channel. I think my comment that you're questioning is sometimes you see organic sales happen before the reps actually get to, in earnest, round to their physicians, and that's what we were talking about. And that right there is an organic signal that A lot of the work that has been done previous to the SALS reps getting out there, with the awareness of Brexit then, doctors were waiting, some doctors were waiting and ready to trial, and that's exactly what happened. As it relates to the doctors being targeted, we did a lot of research in prelaunch to identify the territories that would be most advantageous and productive for us to address, and you can imagine it was high fluconazole prescription writers, and those are the doctors that we're targeting. Those doctors are in the geographies that represent around 90% of the VC prescription market, so it's a very, as I said in a prepared remark, very concentrated territory, which makes it easier for us to address, and that's what we're seeing right now. Yeah, we are seeing, it's really, I'm very, very delighted and extremely encouraged because part of it is what we do, part of it is organic. We are seeing prescribers, and it's increasing month over month, we are seeing prescribers broaden their clinical experience by using BrexFM for more patients. For me, that's the effectiveness of what we're doing in the way of bringing information and education on BrexFM to our prescribers. but it's also prescribers having a good experience and wanting to expand to their patient membership. So yes, hope that answers your question.
spk07: Thank you. And in terms of the commercial covered lives, what's happening in that front in terms of is that having an impact on the number of prescriptions and how is that expected to change over time, like, you know, what are your thinking in terms of time limits of getting these additional types on board?
spk03: Yes, you're right. You expect those lines to kind of travel together, so prescription utilization and covered lives traveling together, because obviously when a doctor chooses BrexFM for his or her patients, and you generate more coverage for those patients, you start to see increases in both of those lines. They travel together.
spk07: Thanks so much.
spk03: Of course. Thank you.
spk07: Thank you, Kumar.
spk04: A final reminder, if you would like to ask a question, press star 1 on your telephone keypad. Our next question comes from the line of Nathan Weinstein with Aegis Capital. Please proceed with your question.
spk08: Hey, good morning, Marco and Eric. Thanks for taking my question. And a big thank you to Eric for being a great CFO and a great person to work with. So maybe just anecdotally, could you speak to the role the patients themselves can play of being advocates for BrexFM, you know, via word-of-mouth marketing? And then also, are there any big communities online where the patients tend to congregate and share information?
spk03: Yes, thank you for the question. Patients are very big advocates for themselves, for their own health, and there's a sequence to how we do these things. The most important thing in early stages of launch is to get the prescriber, the one who has the prescribing ability, to understand that BrexFM exists and what it is, such that when the patient arrives into the physician's office, and they do, and ask for a product, the doctor then understands what the product is has some familiarity, they may do some research if they have yet not utilized the product, but the perfect situation is a patient walking through the doctor's office asking for Brexfem and then the doctor knowing what Brexfem is and having clinical experience, practical experience themselves. So that's kind of the sequence you like, that's the sequence you would like to follow. We do see patients having conversations with their physicians now We are, the marketing team is doing beautiful work to educate patients properly and in a good way, in a fruitful way in 2022, such that the connection between those patients going into the doctor's offices is a very productive one. Sometimes you can have a patient come into the physician's office, the physician doesn't know about the product and it really is not a fruitful endeavor. Hope that helps answer the question.
spk08: Yeah, thank you. That's a very thoughtful and helpful answer. Much appreciated.
spk03: Thank you.
spk08: Thank you.
spk04: Our next question is a follow-up question from Michael Higgins with Ladenburg-Thalman. Please proceed with your question.
spk10: Thanks, guys, for taking the second round here. Quick one here for Eric. I can't let you off the hook. Are there any inventory numbers in the Q2 results, and what should we expect as the delta on the Q4 pull through?
spk09: Thanks. Thanks, Michael. As I mentioned in my prepared remark, we had a higher number at launch to ensure that all relevant pharmacy networks had enough drug availability. Over time and as we mature into our commercial launch, you know, Christine, I think we want to keep about three weeks of inventory on hand. And so that's going to be basically our plan. Now, as we learn and as we get more historical data, we'll adjust accordingly, Michael. But for now, this is kind of the trajectory that we're taking.
spk10: I guess as a follow-up to that, of the 50,000 or 60,000 or so U.S. pharmacies, how many are you stocked in with at least one bottle?
spk09: I'll let Christine address.
spk03: Yeah, you know what? We stopped 50% of them early in the launch, and then there's reordering happening, so they're pulling those through now. So I'd have to look and see where we are at this time.
spk10: Okay, that's hopeful. And let me switch to the IV, a couple questions on that. I'm sorry if these have been asked. I'm kind of juggling calls here. Have you done any additional injection site assessments given the history here with developing an IV Brexit hunger? Thanks.
spk05: Sure. Thank you, Michael. This is David. Certainly during this study, we were addressing and assessing very carefully what was the tolerability of the intravenous formulation. And as I mentioned during my remarks initially, we did observe a substantially better tolerability of this liposomal formulation when injected in these healthy volunteers. So we did still observe some mild infusion-side reactions, typically redness, some swelling, but in no way this prevented the dosing from continuing, and that was extraordinary and encouraging. So from that point of view, this liposomal formulation is doing what we were expecting to be doing. which has really improved the tolerability of the IV administration of our product, enabled us to move it forward to the next stages of development.
spk10: Okay. Next question on IVs. It sounded like either in the press release comments or in your prepared remarks that there were next steps that you were considering for the IV. I'm not entirely sure what that means. I would expect that you're going into phase two, but are you planning to run another phase one possibly? Thanks.
spk05: At this point, as you mentioned, we are really doing the final analysis of our pharmacokinetic data, and we are going to be in a better shape to really show you or tell you exactly what are the outline of the different stages of the next stages of the development program for this product, let's say in December, once we have all the PK data analyzed and in hand. If you ask me right now, certainly the ambition is that probably phase two is the next stage, but we would like to confirm that in December.
spk10: Okay. I'll save that follow-up one here because it sounds like we'll hear this in December. Question for you on Candle. I mean, this is a question maybe for all of you, maybe for Christine. when you think about positive data here from Candle, what impact do you think that'll have on sales at different time points? For example, once the data comes out, doctors can see that and then also following its approval, is this something that you envision as kind of a 10 to 25% bump on the current trajectory of sales or something more like a 50% or higher impact on sales? Thanks.
spk06: So, Michael, we have been actually talking about this also in the past. The real need here with the treatment of VBC, but I've seen nothing coming for the last 25 years. We expect actually to have some, of course, to have the opportunity here with prevention of recurrent VBC to target another group of patients where this infection is just almost a chronic affliction. And we expect this to contribute to our bottom line, but probably will be relatively small, probably an additional 10%, 15% is what we have been... expecting because really the innovation here is bringing a product that with one day treatment can really clear the infection thanks to its fungicidal activities. And that is really where we expect the Ibrexafone GERP and Brexafam really to make a significant difference.
spk10: That's super helpful. Thank you. One here on Synergia. You mentioned that COVID delayed enrollment into 22. Any plans to adjust the enrollment criteria or execution of the trial, given what the CDC and the Emerging Infectious Disease Journal posted this month about the increasing prevalence of aspergillosis among COVID patients? Any positive that can come from that for you guys, at least? Thanks.
spk05: Sure. No, thank you for the question, Michael. This is David again. Yes, certainly the COVID-19 pandemic has impacted the ability of the institutions to really focus the resources in really enrolling or doing research. And a lot of the resources were focused in COVID-related, COVID-19-related type of research if they were still available there. And certainly that had an impact in the Synergia trial. The fact that COVID-19 also increases the risk of patients to really acquire invasive pulmonary aspergillosis. So that's an opportunity there. Our current protocol allows for patients to be enrolled, COVID-19 patients with invasive pulmonary aspergillosis to be potentially enrolled in the Synergist study. However, we need to here be careful because really it's just, we are just learning what is the actual natural progression and outcome of invasive pulmonary aspergillosis in COVID-19 afflicted subjects. And that is something that we definitely need to be careful in analyzing that information so that we can very well assess really what is the treatment effect versus what is just the underlying conditioned outcome of these patients. So the protocol allows the inclusion of these patients At the same time, I would expect that at this point we don't expect that it's going to be the majority of the patients enrolled because physicians, as you can understand, this is a new condition or a new combination of conditions, which is COVID and invasive pulmonary aspergillosis. And physicians are going to be more likely to treat them. with standard therapies rather than enroll them into clinical trials for specifically the treatment of invasive pulmonary aspergillosis, where they may be enrolled in clinical trials for the treatment of COVID-19. That is what we have seen right now, the little bit competing priorities that they prefer to enroll the patients into studies that are being assessed in treatments for COVID-19. However, I anticipate that we will have some cases.
spk10: Right. Okay. That does make sense. We don't quite know the effective standard of care here in this new patient and setting. Then one last one here on CARES and FURY. Any potential for updates before Q1 when you've historically provided updates, given the fact that there's likely an increased pace of enrollment? Maybe you can keep the 20 or so patients for FURY at least. and provide us some information by year-end, or is the plan still to wait for Q1? Thanks.
spk05: Yeah, we're always very excited to take a look at all the data. And as you know, the opportunity that these studies are open-label allows us to really do that. We have not made a decision regarding when we will be announcing the next round of results from this particular study. but certainly we are having the discussions internally here to verify when is the right timing to really focus the resources of the team in doing that analysis. We will update as we make that decision.
spk10: Okay, and then just one final one here finally for me. Any plans to adjust FURY's protocol or the execution given the mucormycosis preclinical evidence and the synergy with AMFO, AMFO-terrible? Thanks.
spk05: No, thank you, Michael, and thank you for all those very thoughtful questions. The answer is that we don't need to amend the FURY protocol. The FURY protocol, as it is right now, is adequately written in the way that allows enrollment of patients with different fungal infections, including mucor. In the past, we were not actually advocating its use in mucormycosis patients or ibrexifungal combination using mucormycosis patients in the protocol because we just didn't have enough evidence of the potential clinical benefit. Now, with this information coming from the preclinical data, we are certainly addressing it with investigators that this is a potential that they can take advantage of within the FURI protocol. So the FUTI study, as it is, allows the enrollment, and we officially notified investigators that now this is an opportunity for them to consider patients with mucormycosis to be included in the FUTI study.
spk10: Interesting. Very helpful. Thanks, guys. Appreciate the time with all the questions.
spk06: Thank you. Thank you, Michael. Thank you, Michael.
spk04: We have reached the end of the question and answer session. Dr. Tagliagadi, I would now like to turn the floor back over to you for closing comments.
spk06: Thank you very much. First of all, thank you to all, many thanks to all of you who have been listening to our conference. I will just be saying that we share the excitement of the patients and doctors for the ability of bringing in finally a new treatment for VBC, not to mention the progress in research and development in the area of hospital. The role of a Brexaphone GERP for the treatment of fungal infection will become more and more relevant as we will get new indications. And at Ascenexis, we have the expertise, the tools, the resources to make Ibrahima phone journey a success. Thank you very much for listening to us today.
spk04: Ladies and gentlemen, this does conclude today's teleconference. You may disconnect your lines at this time. Thank you for your participation, and have a wonderful day.
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