SCYNEXIS, Inc. Q2 FY2022 earnings call

• FDA assigned a November 30, 2022 PDUFA date for the supplemental new drug application to expand BREXAFEMME's labeling to include the recurrent VVC indication. • Started Phase 3b VANQUISH study of oral ibrexafungerp in VVC patients not responding to fluconazole. • Enrollment started for the MARIO study in invasive candidiasis with top-line results expected in 2024. • BREXAFEMME had over 5,100 prescriptions and $1.3 million in net revenues in Q2 2022, showing 29% quarter-over-quarter growth in prescriptions. • Closed Q2 2022 with over $118 million in cash, having raised $45 million in April, with a solid cash runway into Q1 2024.

The company's only product segment, BREXAFEMME, achieved net revenues of $1.3 million in the second quarter of 2022, nearly double the amount from the first quarter. BREXAFEMME's prescription count exceeded 5,100 in Q2 2022.

• FDA PDUFA date for recurrent VVC is November 30, 2022. • Anticipated readout of synergia data by end of 2022. • Data from FURI and CARES programs expected in 2024. • Enrollment started in MARIO study with completion anticipated by end of 2024. • Aim to have consultation with FDA regarding liposomal IV formulation of ibrexafungerp by end of 2022.

Q: Good morning, everyone. This is Carvey on for Louise from Cantor. Congrats on the quarter. A couple of questions here. First, we’re looking forward to your PDUFA date in November. As we are approaching that date, can you talk a little bit about the added market opportunity that it will be enabling, post approval? Secondly, it’s almost been a year since the commercial launch of BREXAFEMME. Can you highlight additional color on physician feedback from the community? Also, what level of coverage are you targeting by the end of this year?

A: Thank you so much. Hi. This is Christine. Thank you for the question. The additional indication for recurrent VVC will give our field teams a lot of opportunity to go back into our physicians with additional data that will be helpful to them and their patients. You probably heard me say in the prepared remarks that we, after a year of working with physicians, have tightened up our call target list to the ones that are most opportunistic, and that includes this RVVC indication. New data is always helpful, both for the physicians or patients, but also for the reps to bring in fresh information and make the sales call fresh. So, that’s one thing for RVVC. As it relates to BREXAFEMME overall and doc feedback, we do continue to get very positive feedback across all, let’s say, intake areas. So, the reps, we always hear from the reps. We do third-party unbiased ATU, trial and usage panels as well as market research. And when I look across all of those pieces, we hear similar feedback, at the doc, and they report from their patient perspective too that BREXAFEMME is easy-to-use. They love the one-day dosing. They love the fungicide -- as you heard Dr. Angulo speak about that. That’s important to the doctors. And they like the fact that they see early symptom relief very, very quickly. So, those are things we hear coming back to us across all of those channels. And then, your last question was on coverage? Thank you, Marco. Yes, on coverage. And right now, we’re sitting at 109 million patient lives. It’s about 60-ish percent of the commercial universe. I believe our target going into 2023 is 65%. So, we’re in the ballpark. We may be ahead of it, but you always got to rank these things to the ground. And so, it’s not done until it’s done. Does that help?

Q: This is Farhana on behalf of Michael. Congrats on the great quarter. We have two questions. The first one is, could you provide a little bit more color on the timing of your discussions with the FDA, for the Phase 1 data for the IV formulation?

A: Sure. Thank you for the question. This is David. So, at this point, as I mentioned, we completed our Phase 1 study. The results were very positive. The drug -- the formulation was well tolerated. We were able to achieve our target exposure. And right now, we are just putting together all that information, all the pieces from that particular information, along with all -- obviously our toxicology program that enabled this first Phase 1 study. And we’re planning just to put together all that as a regular study package to really understand with the FDA what will be needed in order to get this particular formulation integrated into our development program and/or to really find a path for approval that it is fast and in our opinion should be an abbreviated path for approval for this particular formulation. So, that’s the pieces that we are aiming to have discussion with them. And certainly, we have had previous discussions with the regulatory agencies regarding how to develop our intravenous formulation. And we believe that at this point with this new data, we will be in a very good position to really have a very productive discussion with them to have a clear definition of the development path, to really try to bring this new formulation into our development program as soon as possible, and really try to progress at it very rapidly.

Q: And the second question that we had was -- when can we expect data from the FURI and CARES studies? Is it safe to say around the first top of 2023?

A: Well, we have guided that really the data and the submission, et cetera, is in 2024, actually. So, that’s what is actually there guided, and we are planning, as I mentioned with you to really wrap up the FURI study towards the -- in the remaining of this year. However, we need to remember that the treatment duration for patients in the FURI study could be long, and we obviously need to allow those patients to complete their treatment. As I mentioned before, we are aiming to really wrap up all activities so that everyone has its last visit of treatment during the first half of next year. And from that point, we’re going to be start wrapping up the data, doing data review committee -- data review committee meetings, et cetera, in order to try to have the data available. The data should be available in conjunction with, or at the same time that we have the data from MARIO, so that we can really put together a regulatory package that it is -- that enable us to have all that information together. That’s the current plan. As usual, if we can accelerate that, we will, and we will guide you in the future, if we see an opportunity to really have data sooner than at that point.

Q: Thanks. And could you also just remind me for the VANQUISH study, do you have any timing for when that is expected to read out?

A: Yes, we do. So, at this point we are in the process of reinitiating all the centers for the VANQUISH study. We are anticipating approximately about 18 months of enrollment, which means that it will take us that the data -- or anticipated the data will be sometime in 2024, probably first half of 2024 is when we’re anticipating the data from that study.

Q: Thanks for taking my questions. With regard to the liposomal formulation, how quickly will you be able to start a trial following the interaction with the FDA and how should we think about these trials?

A: How quickly, I would say just soon. I’m not going to give you that soon because the reality is that we have to -- all the manufacturing pieces, et cetera, are ready. So once we are ready with the design of the proper study, I think that we will be able to really start implementation very rapidly after that. And what we are -- what I’m anticipating, but contingent upon discussion with them is that we will need some level of potentially Phase 2 -- Phase 2/Phase 3 type of trial first. And that’s what we really want to discuss with them. So, may need to have an initial evaluation of -- the product has been evaluated so far in healthy volunteers. We will need to evaluate the product in patients to really see tolerability in patients and then to expand a little bit in a broader number of patients that are going to be receiving -- having a sufficient number of safety information associated with the drug. So, that’s what we are in the purpose of really putting together, a package for discussion with the agency. Will this be a combined Phase 2/Phase 3 approach? Does it need to be two separate studies? How big they are, to what should be the endpoints to assess? How can we breach with all the very solid package of safety information that we already have with ibrexafungerp when giving orally in a very, very large population setting, in which we have been clearly been able to define the safety of the product. So, those are the pieces that we are really aiming to discuss with them. And we are optimistic that with the information that we have on hand right now, it will be -- we will be able to reach an agreement with the agency of a very reasonable and efficient development path forward.