Hello, everyone. Thank you for joining the H.C. Wainwright 26th Annual Global Investment Conference. My name is Vivian Chang. I'm an Analyst on the Corporate Access team. H.C. Wainwright is a full-service investment bank dedicated to providing corporate finance, strategic advisory, and related services to public and private companies across multiple sectors and regions. If you would like more information, please visit hcwco.com. From a logistics standpoint, please make sure to reference your online conference portal. That'll provide your individual links to your meetings and all presentations. With that said, we wish you a productive and enjoyable day. Now, I will hand it off to David Angulo, the CEO of SCYNEXIS.
Thank you very much for the introduction, and thank you for the invitation to present at the conference. I'm going to be providing you a corporate update about SCYNEXIS. The presentation is available in our website, and I invite you to read the forward-looking statements in detail. I'm not going to spend too much time here. As a key highlights for this update right now at SCYNEXIS, as you know, we licensed our initial product, ibrexafungerp, that we developed up to having approval for the first indication. We licensed it then to GSK. Our first product that we developed and licensed to GSK is ibrexafungerp.
We continue to really executing in the partnership with GSK, and the partnership has a total potential deal value up to $448 million plus royalties. So far, we have received out of this agreement $150 million, and I'm going to go into a little bit further on the details of that in subsequent slides. We have already been progressing very efficiently the development of our second-generation fungerp. So we focus in the development of antifungal products, and 247 is our next-generation antifungal agent, and we have been presenting very promising preclinical data in multiple scientific meetings during this year. We are well in our way to reinitiate our first study in humans by the next quarter.
So before the end of the year, we will be in humans with this particular molecule. At the same time, we have been able to wrap up, complete all our, previous, most of our previous ongoing studies with ibrexafungerp, FURI, CARES, NATURE, SCYNERGIA, and VANQUISH. All these studies that were part of the, that were ongoing at the time of our agreement with GSK have been completed, and, we have already delivered the CSRs for FURI, CARES, and NATURE. That particular activity triggered a $10 million development milestone to SCYNEXIS And, just to remind everyone who hasn't necessarily followed us very closely, but FURI, CARES, and NATURE are studies that were designed with the intention to support an indication of ibrexafungerp for, as a salvage therapy in patients with invasive fungal diseases.
And so in patients who cannot tolerate, do not respond well to other antifungal agents, these studies were designed to really support that indication. We have the MARIO study is still ongoing. The MARIO study is with ibrexafungerp. This is a study of ibrexafungerp in invasive candidiasis patients. We needed to put this particular study on hold last year because we identified that the supplies for the study were manufactured at the facility that manufacture ezetimibe. Ezetimibe is an anti-cholesterol drug but has a beta-lactam ring into its structure, and the year prior, FDA put guidelines recommending that ezetimibe should be manufactured in a segregated facility to avoid the potential risk for cross-contamination that could result in hypersensitivity reactions.
We identified that the product that was used in the MARIO study had not followed that specific guidelines because it was manufactured even prior to those guidelines being issued. And in abundance of caution, we decided to retrieve all the clinical trial material and to remanufacture new clinical trial material. And the FDA agreed with us that this study should be placed on hold, and now we are in the process of really planning to file or request to the FDA to leave such clinical hold to be able to restart the MARIO study. We're planning to file this request to the agency next quarter.
We have a very strong balance sheet with a cash runway greater than two years, and that includes $83.7 million in cash, cash equivalents, and investments, as of the end of the second quarter. And this does not include the recently achieved $10 million development milestone that I was talking about in the first bullet, which we are expecting to be paid in Q3 of this year. Trying to make sure that we are somehow familiar with the antifungal space. So the antifungal space is an interesting one because it doesn't have too many representatives. Really, there is a limited antifungal development. There are few, really few families of antifungals. It's very different to the antibacterial space, in which you see really many families of antibacterial agents.
In this particular case, the main families that are being used to really treat invasive fungal diseases that, by the way, have a very high mortality. Just as an example, invasive candidiasis has a mortality of about 30%, invasive aspergillosis in 20%-40%. Mucormycosis may have mortality rates up to 50%. So these are very severe conditions that are typically affecting immunocompromised patients that are either receiving chemotherapy agents, that have received a transplant, organ transplant, lung, liver, heart, et cetera, and they are immunosuppressive therapy for a long period of time, or they had been spending a lot of time in the intensive care units. So these patients are highly susceptible to fungal infections, and what we have seen is that there are very few antifungal options available to treat them, not too many families.
The last family that is becoming available to treat these patients is the fungerp, which is really the ibrexafungerp, is the first representative of that family, and that is the family of compounds that we are developing. So you see these couple, the few alternative options, coupled with the emergence of resistance, particularly resistance against the azoles, and really has created a situation in which there are really few options for the patients to be treated, and then we need to keep into consideration that the vulnerable population is growing. We see more and more patients receiving immunosuppressive therapy. We see new targeted therapies, extraordinarily effective against cancer, that are allowing these patients to live longer, and for that reason, that population that gets exposed to and is at risk of developing fungal diseases, systemic fungal diseases, is growing.
There is also a significant limitation in the antifungal pipeline as a whole, that out of the groups that you see here, only the azoles and the fungerps can be administered orally. Polyenes and echinocandins can only be administered intravenously, and the treatment duration for these fungal diseases is typically several weeks to months. For that reason, having the option of a product to be administered IV and orally is really optimal to enable the best possible care to these patients. At SCYNEXIS, we are dedicating at this point in really developing our proprietary platform of fungerp, antifungal pathogens. The need for new antifungals has been clearly highlighted by many organizations worldwide, including the WHO, who has already provided a list of fungal pathogens for which they consider is absolutely needed to develop new antifungal agents.
This has been highlighted by the CDC as well, considering Candida auris a very serious and urgent threat for the United States because it's typically multi-drug resistant. About a year or so ago, BARDA, for the first time, announced that they will start having a new priority: the development of antifungals. In the past, if you are familiar with BARDA offerings in the past, it has been only focused in antibacterial developments. The fungerps, the family of products that we are developing, have a broader spectrum of activity, actually covering the majority of the fungal pathogens that the WHO has identified as a priority to develop new antifungal agents. When you see a check mark in this slide, it means that the fungerps have activity against those particular pathogens.
As I mentioned before, the first analog of this, or the first representative of this family, that we developed ibrexafungerp. Right now, GSK has global rights to this particular product, with exception of some regions in China, in which we have another partner developing the product in that particular region. And there is an estimated market opportunity of at least or greater than $500 million. We do believe that the market opportunity for this analog, and also the next-generation analog, which is 247, has a similar market opportunity. Something to highlight about the market opportunity of the antifungals, which is somehow different to antibacterial products, is that basically all of them have reached, at their maturity in the market, sales that are in the hundreds of millions of dollars.
We believe that obviously, our products have that potential as well. The focus of the organization right now to continue growing shareholder value is two-fold at this point. It's really to maximize the ibrexafungerp opportunity to ensure that we are providing to GSK all the information and data needed for them to be able to wrap up the new study for us to wrap up the new studies, and for them to continue pursuing new indications for this molecule, and at the same time, supporting in any way that we can, the commercialization of Brexafemme, which is already approved in the United States for VVC and RVVC, also not commercially available because of the same reason of the potential cross-contamination.
So that is one focus, really helping GSK and really delivering everything that we work to deliver to GSK for really maximizing the ibrexafungerp opportunity. And the other part is really to develop the new generation of the fungicide, SCY-247. Obviously, we have that internal expertise, substantial internal expertise in developing antifungal medications in this particular group of compounds, and we are focusing the development of this new compound, addressing very recognized and significant unmet needs that will represent a significant market potential. With a strong balance sheet, it also gives us the opportunity to potentially look at and deliver additional innovative therapies to patients with significant unmet needs.
To provide just an outline of really the licensing agreement with GSK, that licensing agreement provided us with a $90 million up-front payment, and subsequent to that, we have up to $72.35 million tied to the continued development of ibrexafungerp. For all the activities that were ongoing at the time of agreement, we agreed to continue executing these activities up to the point of completion. So far, out of the $72.35 million in development milestones, we have triggered already $35 million, and we are still to trigger the $37.35 million.
Those remaining $37+ million are tied to the restart of the MARIO study and the progression of the MARIO study, which is really, as I was mentioning to you, is very short in the short term. Additional to that, we will have milestone payments up to $49 million upon regulatory approvals of the new indications, $57.5 million coming out of the first commercial sale of a product in the new indications in the U.S. and EU. We have a total up to $179.5 million in sales milestones plus royalties.
It's a very significant deal, and that also shows a significant commitment by the GSK to really bring innovative therapies into the space as well, since they have told their commitment to really be supportive of the anti-infective space. So what we are focusing on our activities on, as I mentioned before, we are focusing on development in SCY-247 or next-generation fungerp. We're going to be developing this particular compound for invasive fungal diseases. We're focusing really in those significant unmet medical needs still not met by the ibrexafungerp or other products in the development, and we're anticipating to be first-in-human by the end of this year.
We are developing this product in two formulations, oral and intravenous formulation, to provide the maximum flexibility to be able to treat patients in the intensive care unit or in serious conditions. For ibrexafungerp, I think that I summarized that we have already developed the product for vulvovaginal candidiasis and recurrent VVC. We have these two approvals in the United States. The commercial name is Brexafemme. GSK is responsible for remanufacturing supplies in order to relaunch the product, so to say. And for the invasive fungal infections, we completed FURI and CARES study, which are addressing the needs in the or investigating ibrexafungerp in the salvage therapy, and the MARIO study is ongoing in invasive candidiasis. Let me talk a little bit more about our next generation fungerp.
So the fungerps is a family of compounds that are amphotericin derivatives. They have the beauty to have a validated mechanism of action. They are glucan synthase inhibitors. Glucan synthase, the enzyme, is not found in human cells, and for that reason, the off-target effects are very limited. This has been already demonstrated because echinocandins, another very successful group of antifungal agents, have the same mechanism of action, but echinocandins can only be given intravenously, and that provides some limitation. Echinocandins has shown to be very safe, and we have already demonstrated with ibrexafungerp there is a safe, kind of a platform of antifungal agents, and they have extraordinarily good activity against Candida strains. This mechanism of action is very good against Candida strains.
It also has activity against molds, Aspergillus, Pneumocystis, dimorphic fungi, which are really the biggest group of fungal diseases that are really affecting human beings. So we have a very broad spectrum of activity, potent activity against Candida strains. This particular molecule is slightly different than ibrexafungerp. We selected after a very comprehensive screening of all the fungerps that we have in our pipeline. This one is the second generation because it's a smaller molecule than ibrexafungerp. It will, in our opinion, favor or enhance tissue penetration, which is extraordinarily important in treating certain fungal diseases. It will even reduce further the potential for drug-drug interactions.
Drug-drug interactions is a big problem in treating invasive fungal diseases because we're talking about patients receiving chemotherapy agents that many of them are metabolized via CYP enzymes. You really want a product that has no interaction with CYP enzymes to really be able to play well with all the other drugs that these patients are taking at the same time. We also wanted a drug that was going to be easy to formulate intravenously and orally. We anticipate getting certain designations from regulatory bodies that really enhance the value of this asset, including QIDP designation, which is Qualified Infectious Disease Product Designation, and Orphan Drug Designation and Fast Track. These designations will allow regulatory exclusivity of at least ten years.
We were successful in obtaining these regulatory designations for ibrexafungerp, and this particular product qualifies as well, in our opinion. We will start filing for those designations upon opening of the IND. The IP is wholly owned by SCYNEXIS the IP for SCY-247. The development has been already supported by NIH with some funds in order to really further investigate the activity of this very potent compound against a particular pathogen that is called Candida auris. I'm not sure if you're familiar with this pathogen, which is multi-drug resistant and has caused outbreaks globally. As I mentioned, we are progressing well on development path to be able to initiate this first-in-human study by the end of this year. In summary, as I mentioned before, we have been presenting preclinical data in multiple congresses so far.
The stage of preclinical development is the time when you really investigate in many of your animal models, the potential efficacy in many disease conditions, and we have done that in Candida. We have done that in pathogens, multi-drug resistance, such as Candida auris, in echinocandin- and azole-resistant Candida species, as well as we have presented the data in Mucorales infections, which are very deadly and difficult to treat conditions. So far, we have seen very, very promising results in all these models that we have been testing. As a way of illustration, I'm just going to show you one here. You can see this is activity of the compound orally administered to mouse models in a mouse model of Candida glabrata. Candida glabrata is one of the strains that has the biggest concern about resistance to azoles.
You can see here the black dots are the control, the yellow, blue, and red dots are the different doses of SCY-247 administered orally. You can see there a very nice dose response. Then what you can see in orange is fluconazole, which you see in this particular pathogen, they didn't have much response. The green dots is caspofungin, which is an intravenous echinocandin that is considered a very potent antifungal agent for this model. You can see here that SCY-247 behave as well, if not better than the control caspofungin, and this is true in either kidney and lung tissues as well. So with this, we are very excited about the continued development of our next generation fungerp.
At this point, we are considered a category leader in the fight against deadly fungal pathogens. There are not so many companies developing antifungal medications, and we are very proud to be the ones who brought to the market a totally new family of compounds after more than twenty years than the next family of compounds was discovered and brought to market. There's a very well-recognized global urgency to rapidly develop potent antifungals to treat these emerging fungal infections, and we do have the internal expertise, a strong supply chain in IP protection to be able to bring the new generation of products in.
At this point, we have a strong balance sheet with a cash runway more than two years, which I think that places us perfectly to really continue moving ahead our mission to really develop these significant products for these significant unmet needs.