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spk03: Greetings and welcome to Synexis Inc. first quarter 2022 earnings conference call. At this time, all participants are in listen-only mode. 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. Now I'd like to turn the conference over to your host, Debbie Hutchinson from Investor Relations. Please go ahead, ma'am.
spk08: Thank you. 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 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, including, in each case, under the caption, Risk Factors, and in other documents subsequently filed with or furnished to the Securities and Exchange Commission. All forward-looking statements speak only as of today May 12, 2022. Cinexus 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 Cinexus President and CEO, Dr. Marco Taglietti, Chief Commercial Officer, Christine Coyne, Chief Medical Officer, Dr. David Angulo, and Interim Chief Financial Officer, Larry Hoffman. Following our prepared remarks, we'll open the call to your questions. Now, I will turn the call over to Dr. Marco Teglietti, President and CEO.
spk06: Thank you, Debbie. Good morning, everyone. Buongiorno a tutti. Thank you for joining us today for our first quarter of 2022 earnings in Best of Corn. We are excited. to share with you updates on the progress of the launch of Brexafen and to outline our vision for the future of the iBrexafen Jerk franchise. 2022 is a pivotal year for Synaxis, and we are making great strides. Let me briefly summarize a few key recent accomplishments and near-term goals. On the R&D side, we continue our successful efforts to expand the labeling of iBrexafen Jerk. We expect to file the supplemental NDA for the recurrent BBC indication this quarter with an approval by the end of this year. We reported positive results from the new interim analysis of the Fourier and CARES trials, highlighting oral ibrexafone jerks' potency against severe fungal infections, with more than 83% of combined patients demonstrating a clinical response to oral ibrexafone jerks. Finally, the MARIO study is being initiated, and we expect the first patients to be enrolled soon. The MARIO study is expected to report results in 2024 with a 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 results to date. Our first commercial product, Brexafem, a Brexafunger tablet, 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 Cohen, will discuss the set of coordinated and integrated actions that we are taking 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've been 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 Ibrexa fungér 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 hope, 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 the resources 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 Hanso for Greater China, and for other non-dilutive ways to strengthen our cash balance. I would like to underscore that our vision to make Ibraxia Fungi Earth a successful, sustainable, and profitable antifungal franchise is becoming a reality. With BrexFM now approved and launched for the treatment of BVC, we plan to expand its labeling by end of this year, as I mentioned, to include the prevention of recurrent BVC. We are diligently and successfully following our plan to attain each key milestone along our path to build a broad, long-lasting antifungal franchise. All these indications, when taken together, We'll create a franchise with the potential to generate $700 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 a Q&A session. Now I would like to turn the call over to our chief commercial officer, Christine Coyne. Christine?
spk09: Thank you, Marco, and good morning. In August 2021, our field reps began calling on their physician targets. Physicians' interest in learning more about BrexFM was encouraging. We stocked drugs on pharmacy shelves and we began to see doctors prescribing BrexFM. We were off to a strong start, all while our insurance coverage of commercial lives continued growing and tracked 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 effort into critical success factors such as reach and frequency of visits to high-prescribing HCPs. The good news? We are now seeing a positive growth trend picking up at a good pace. Our messaging about the benefits of Brexifem 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 two quarters, we've built a base of Brexifem 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 BrexFM volumes, in the first quarter of 2022 versus 28% 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. RexFM prescriptions group 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 Brexipen. 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 commercially insured lives reported last quarter. We expect continued momentum on this front as our discussions with our payer customers are signaling justice. Our national account directors are very experienced with extensive payer relationships, and the strong coverage numbers are a demonstration of how important the non-ASIL option of BREXFM is to payers and their patient members. Now that we have built payer coverage, we are 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 out to 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 Brexafen to be more powerful and more robust. Our new patient 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. Saying no more is becoming the 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. Brexifem. It's time patients had a new option. The say no more patient advertising will activate patients and consumers seeking help to learn about Brexipim's symptom relief and to ask their doctor for Brexipim. As our field teams solidify their efforts with our key prescribers, we will monitor our augmented patient efforts and amplify those with the greatest impact. We know physicians are pleased with their experience with Brexipim, and we look forward to reporting back on our patient efforts. While our field teams do their work and we let the patient awareness programs roll out, we have also taken this opportunity to launch additional communication vehicles to create a surround sound of communications. For example, last week we implemented a satellite media tour with two of our spokespersons, Dr. Ankechi Asiye, Vice President of Medical Affairs at Synexis, and Barb Dean, also known as Nurse Barb, an expert nurse practitioner. These spokespersons talked to 26 TV and radio stations, highlighting the importance of vaginal health and the advancements made by Synexis in the field. The call to action for this successful effort was twofold. We asked viewers to go to www.yourthehealth.com for more information on the latest advancements to fight yeast infections. The URL redirects to brexfem.com in order to drive traffic to the site. And we encourage them to ask their HCPs 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 will 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 are not satisfied. it is clear that we have brought a long-needed non-asal option to yeast infection treaters. But that's not enough. We must continue to consistently remind our BrexFM 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 levers 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.
spk10: Thank you, Christine. As previously announced, we completed our Phase III study candle, evaluating ibrexafungal for the prevention of recurrent vulvovaginal candidiasis, or RBDC. The results were positive, showing significant and sustained response with ibrexafungal treatment. With these results, we are now on track for submission of a supplemental MDA by end of this quarter, with an anticipated approval by end of this year. In the study, Ibrexafungur was well-polarized. There were no serious drug-related adverse events, and no patients treated with Ibrexafungur 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 Brexafum label. In addition, we recently reported positive outcomes in patients with refractory VBC treated with oral ibrexafungal from the ongoing phase 3 study FURI. These results were presented during the annual meeting at the American College of Obstetricians and Gynecologists ACOG. Ibrexafungal showed efficacy in difficult-to-treat patients that have VBC refractory to standard antifungal therapies. 14 patients with refractory BDC were treated with ibrexafunga, 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 ibrexafunga to address critical and med needs, including invasive candidiasis, refractory fungal infections, and invasive aspergillosis. We have initiated the MARIO study, evaluating ibrexifungal as a step-down therapy in patients with invasive candidiasis. We anticipate first subject enrolled this quarter. The CARES and FURI study evaluating the ibrexifungal 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 II 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 this study. As you know, the FUTI and CARES studies are open-label and allows the opportunity to do preliminary evaluation of the outcomes of the patients enrolled with these very difficult-to-treat infections. 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 an unstable 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 multidrug-resistant candidiasis. The most common pathogens reported in this group of patients include fungal strains commonly associated with antifungal resistance. such as Candida glabrata, Candida crucii, and Candida auris. The consistency of this data with previous analysis give us continued confidence of the potential utility of iberexafunga in this salvage study. Finally, our key milestones associated with our development pipeline remain on track, and we continue developing iberexafunga for multiple indications as discussed previously. And now, let me turn the call over to Larry Hoffman. or interim chief financial officer.
spk01: Thank you, David. For the first quarter of 2022, Brexit Fund 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, not 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 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 Brexit fence. 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, Cenexus recognized non-cash gains of $10 million and $1.3 million respectively on 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 Hanso provides us with an additional potential of $112 million in future long-term development and commercial milestones. And the strength of our patent protection and ongoing business development efforts provides us with additional opportunities internationally. Thank you. Before we begin the Q&A, I will turn the call back over to Marco. Marco?
spk06: 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 the fact that a Breast Upon GERP is a unique, first-in-class systemic antifungal with great 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. We have started to build the franchise by launching Brexafim MVVC in September, and Brexafim is making great strides with HCP and patients. And this is only the first of multiple potential indications for a Brexafim GERP, 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 patients in our MARIU trial this quarter, and we anticipate regulatory approval of our first hospital indication for a Brexapunger by the end of 2024 as an oral step-down therapy for invasive candidiasis and for subsetting in refractory invasive fungal infections. Fourth, not only we can build a broad antifungal franchise, but it's a franchised 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. And now let me finish with our rallying cry. East Infection, say no more. I hope you will love our new rallying cry. And now, operator, please. Open the floor for questions.
spk03: Thank you, sir. At this time, we will be conducting our question and answer session. If you would like to ask a question, please press star 1 on your telephone keypad. 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. One moment, please, while we poll for questions. To ask a question, ladies and gentlemen, please press star one now.
spk02: We have a first question from the lineup. Michael Higgins with Leidenberg Thalmann.
spk03: Please go ahead.
spk04: Thanks, operator. Congrats, guys, on the continued progress. Thanks for taking some questions. With all the activity lately, despite the ongoing launch, I wanted to start with the Furee Care Stat, 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 project will be in the next?
spk10: Thank you Michael. This is David. Yeah, 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 more than, let's say, about 60% of patients having complete or partial response is 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 has been reported in the salvage therapy setting, we are very much on target to what we expect as a response rate for this particular population. As you can see here, the candidate out is cases. The response rate observed against Candida auris has been, I would not say surprisingly good, that has been very, very good. We are seeing really very good responses in Candida auris cases that we didn't have too much benchmark information for because those are new diseases that we were just following very closely to see how Iplexa would work on them. So we are very, very pleased with the results that we are observing in these groups. Right now, the plan is to complete, as you can see there, to really wrap up those studies by next year. The estimated enrollment for these studies has been, as you can see in clinicaltribe.gov, about 200 subjects. We're estimating to enroll in FUTI and about 30 subjects to enroll in CARES. And we believe that we are on target for completion of that enrollment within the time that we are disclosing right now.
spk04: That's great. I'll double-check my notes. We were looking earlier. It seemed like we were seeing favorable responses, how it's described in the label, of 30% and 40% for the other fungals when they had come out. So really impressive, but thanks for your feedback on that. If I can switch to, Christine, a question for you on the Brexfem Rxs. Do you have for us an update on the percent of Rxs going to women with RBVC? And has it changed much since last quarter?
spk09: Thanks You mean good morning Michael. Thanks for the question. Are you talking about the market? Are you talking about Brex FM prescriptions?
spk04: Yeah, Brex FM scripts. How many are going to refractory patients versus on label?
spk09: Yeah, so from a commercial standpoint Michael, you know, we say on label that's all we can do so the reps are talking to doctors about VVC, not RVVC. So that's really what we track are the scripts to VVC.
spk06: But I think, Michael, you, 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, you know, technically classified as recurrent VVC may just simply patients where the fungistatic effect of fluconazole doesn't just clear the infection. So the infection with a fungistatic agent like fluconazole or other azoles is just that the candida continues to stay lingering around and then over time the candida will start to regrow. So we believe that one of the great advantages of our product is really the fungicidal effect that kills the candida, clears the infection and and really becomes in a cure. So you may have patients that have been afflicted by this recurrent infection, but possibly they may be treated and cured of their infection for good. So that is one of the things that we expect that the product with our profile will be able to achieve.
spk04: Thanks. And one last one, if I could, here. Any update for us on Synergia and how that's rolling? Thanks.
spk10: Yeah. So thank you, Michael. This is David again. yeah the signature trial as we have discussed in the past really the enrollment has been lower than initially projected we we have received the feedback from the centers that during the past couple of years with the covet pandemia really the focus in that particular study was difficult for them however during this year we have seen much more activity that we saw in the past three years so we keep we really keep uh speaking with investigators and really uh continue as we disclose, we will continue enrollment during this year, really trying to wrap up all the information that we have 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 in that particular study.
spk02: Thank you, Michael.
spk03: Thank you. If there's a gentleman to ask a question, please press star followed by one on your touchstone phone now. We have next question from the lineup. Luis Chen with Cantor Fitzgerald. Please go ahead.
spk05: Hi, this is Wayne for Luis. 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 mycovias or test conical impact uptake of the brett's lemon And then how is the relationship with Templatee? Are they planning to expand the sales force? And my last question is, are there any distribution on market access challenges that are hindering the uptake of Brexlamin? Thank you.
spk06: Well, these are very good questions, Wayne. Let me start with the first one about talking about the competition and the mycovia. But the first thing I want to say is that we are happy to see that there is finally innovation in the field of VBC. If you think about it, in the last three decades, there has been nothing new coming for patients with VBC, despite the well-known limitation of ASOS. So two approvals in this field in the last 12 months is great news for all women suffering of this condition. And we wish well to our colleagues at Mycovia However, our two companies have taken different paths. We decided to develop a unique product, a new class beyond ASILs, with a very favorable safety profile without major restrictions or limitations. Moreover, we expect that when Brexit will be approved for recurrent VVC at the end of this year, it will be the only product approved for both the treatment of VVC and the prevention of 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 BreastFM to continue to remain the recognized major innovation in the field of BVC. With regards to your second question about AmpliT, our relations with AmpliT is very clear. They are a contract commercial organization, so we are hiring a sales force fully dedicated, fully dedicated to Synexis. 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 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 cost in the near term. And finally, about the distribution. Distribution, actually, I'm not sure what you 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 Synexis, that this DNA actually is a manufacturing company. This is what the company has been for probably two decades. So we know how to develop produce manufacturing product, and the supply chain has been actually quite successful in 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.
spk09: No, 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 into the chain and over into the retail pharmacies that were in the call footprint of the reps. To Wayne's second question, did 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 co-pay support program for now. I mean, those things, you put them up at 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, you know, our charge is 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. So 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. But 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 best results. So that's some helpful information.
spk06: Thank you, Christine. Of course.
spk02: Thank you. Congrats again. Thank you. Thank you, Wayne.
spk03: Thank you. To ask a question, ladies and gentlemen, please press star one. We have next question from the line of Kumar Raja with Brooklyn Capital. Please go ahead.
spk11: Hi, I'm Shubhendu for Kumar. Thank you for the update. I was just wondering if you could provide some color to the to the ongoing phase three MARIO studies? Like how many sites are you planning to activate and do you expect all the sites to come on board at the same time? Thank you.
spk10: Sure. This is David. Thank you for the question. So, answering first the second part of your question, are all the sites going to come out at the same time? No. Typically, in these very large global pastry studies, really, the different regions start coming at different times because everyone has kind of a different regulatory timeline for approval. And we are planning to conduct this study. At this point, we're wrapping up the final feasibility assessment of all the geographic regions, but it's going to be a global study that will involve European centers, centers in Asia, centers in the United States, et cetera. The initial centers have been already open, so we already have sites open for enrollment at this point. And that's why we are confident in our ability to really be able to enroll our first patient within this quarter. So we're just waiting for those 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.
spk11: Okay, thank you. Yeah, that was helpful. Thank you. So you had some preclinical data with mucormycosis. So how are you planning to take it to the clinic? Do you have any patients enrolled for... combination therapy in the ongoing flu trial? Thank you.
spk10: Yes, we do have patients enrolled with combination therapy for other fungal diseases, other rare pathogens, but not for mucor. We recently, as you pointed out, we recently conducted these preclinical investigations in which we observed that really the combination therapy of Amphotericin B with Ibrexafunga had surprisingly good results in this mice model of mucormycosis. With that information that has been recently just reached out to the scientific community, we made a confirmatory study with different strains of the mucoralis, and we observed the same trend again. Those results were recently presented at ECMID again. And we are now the investigators of the FUTI 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 the study for them. So we are looking forward to really start seeing how some of these patients may get enrolled and start seeing some clinical activity from that particular indication as well. But this is an extraordinarily exciting data for us, even if preclinical, because of the significant unmet need in that condition, the very, very high mortality. Anything that can help these patients to survive is really extraordinary good news.
spk11: Thank you. Just to be clear, so you're opening the fluid trial for these patients, for mucormycosis patients?
spk10: Yes. So mucormycosis patients can be right now enrolled immediately. We didn't need to modify the protocol. The protocol already allowed 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... The product could be a resource for them. We can allow them to enroll in the FUTI study. So the study as it is allows right now enrollment of new core patients.
spk06: And we will keep you stay tuned. We'll keep you updated in the future if we have patients enrolled.
spk10: Yep.
spk11: Okay, great. Thank you so much for taking my questions.
spk02: Thank you. Thank you. We have next question from the lineup, Oren Livnat with HC Wainwright.
spk03: Please go ahead.
spk07: Thanks for taking the questions. A couple. The first on Ibrex and then a follow-up on the FURY CARES program. So on Ibrex, it sounds like there's a change of messaging you mentioned, you know, focusing on empowerment and I'm detecting – a change or, you know, some specific focus on high prescribers you've mentioned a couple 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, you know, resource allocation and targeting perhaps, you know, are you, for now, at least coming out of COVID, backing off of some efforts to broaden the prescriber base and focus more on, you know, deepening, increasing the frequency of writing within quote unquote, high prescribers, and then I'll ask a follow up after, thanks.
spk09: Hi, Oren, good morning. It's Christine, thank you for the question. Now, you heard my words, but I want to make sure that I'm clear. The high prescribers, and I think you know this very well, are our most prolific writers. They're largely OBGYNs, and they're the first adopters. Everything we thought about in pre-launch happened after we commercialized. So they continue, those 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. we saw some inability to get in there as frequently as our call plan called for. So then when we look at, you know, as those offices open up in February and March and then beyond, you start to see our reps being able to get in there, Oren, and then you see us come back online with that prescribing rate, which is what we're looking for. So no change in strategy, continue executing the plan, and just, you know, making sure as often as we are able to to get into those high prescribers.
spk07: And as far as the messaging, is that in terms of changing or, you know, refining messaging for patients primarily, or is, you know, the pitch to doctors changing as well?
spk09: Right, yeah. So, I mean, we've been out there executing for nine months, and at the same time, so we will learn from the ground up with the field team. So we'll get the report back from our reps. So that's one thing. point of information. The other point is over that course of time, we do customer listening exercises to see how the messages that we've crafted initially are going. And so all it is is honing and refinement based on those two. It's really rounding the edges, but I think on the slide, hopefully you got to see the 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 kind of 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, you know, away from launch, nine months, 12 months, You learn a lot from what your customer is saying or doing after we give them a message. And so that's what I'm talking about here.
spk07: All right. Thanks. And if I may, for Marco and David, you know, you're putting some specific goals out there with regards to the timing of data from Furion Cares, but also an approval by end 2024. So can you clarify, is that presumably using the LPAD pathway? And if so, what is the purpose of that? Can you talk about any additional conversations you've had with the FDA on that front? Just to help us understand, you know, we don't have a lot to go on. We're precedent in LPADS. If you can help us understand what you're thinking in terms of what you need to show, what kind of indications, you know, in specific or broad use cases can you imagine? Thanks.
spk10: 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-blinded study in invasive candidiasis setting, and to align that with the data that we're going to be having from CURI and CARES. And really to try to get an indication that is broad, that may allow us to really use the Olalibrexafunga as a step down from an IV equinox candin coming from the MARIO, but also to be able to use ibrexifungal as a salvage therapy in patients that are not responding or not tolerating other antifungal agents. We believe that the most likely scenario is going to be narrow to invasive candidiasis salvage therapy because it's where the majority of our patients are right now in FUTI and exclusively candid infections, candiditis infections in CARES. You know that the FUTI study enrolls at this point a great variety of different diseases. but the majority have been candida infections. And so that is the 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, not refractory, not resistant, a step down normal patient with invasive candidiasis from an IDA kinocannin, but also salvage therapy in those patients not tolerated or not responding to other therapies with invasive candidiasis. Considering the very significant unmet need for other diseases, let's talk about mucor. If we were to have some experience with mucor, other 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 from my point of view, the number of patients there is an invasive candidiasis in both of these studies have been consistently, the data very consistently reported in these cases as favorable outcomes. That's the overall strategy, and we have discussed with the agency regarding combining these data sets and these packages. We have not come to the final agreement regarding exactly what is going to be the final analytical plan over toward the end of 2023. However, at this point, we do have a conceptual agreement of the data pieces of information that could substantiate an approval in this area.
spk07: Thank you very much. Appreciate it. Good luck.
spk02: Thank you. Thank you, Arun.
spk03: Thank you. Again, to ask a question, participants may press star followed by one on the touchtone phone now.
spk02: Thank you.
spk03: 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 Tagliati, CEO for Closing Remarks. Over to you, sir.
spk06: So thank you very much, operator, and I would like just to stress a very quick point. 2022 is a critical year. We started very well in all the three major areas, launching Breast FM with very positive trend, great data in the hospital setting, and a solid, solid financial foundation to make sure that we have the resources for support all our efforts with the cash runway into 2024. We couldn't have started 2022 in any better way. So thank you very much for your attention and for your support. Operator, thank you very much. You can close the call.
spk03: Thank you very much. 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.
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