Jonathan Aschoff: Okay. That’s helpful. And so how many additional sales and marketing heads do you think you’ll bring on for both OLPRUVA and arimoclomol, assuming approval in the middle of the next year, by the end of ’24.
Joshua Schafer: Yes. I don’t think we’re yet prepared to give you a precise number. But we are planning to use a very — use the same team to commercialize both OLPRUVA and arimoclomol. And given the fact that both markets are very concentrated and largely these patients are treated within the same centers of excellence of which there are roughly 40 or 50 across the country, we believe that we’ll be able to reach the majority of physicians who diagnose and treat these patients with a very small team focused on those centers of excellence. And again, that team will be comprised of a sales team, marketing, account managers talking with payers and ensuring that there’s sufficient access for these patients as well as a medical team out there as well.
Jonathan Aschoff: Yes, because you had mentioned not even quantity required for arimoclomol. Do you think 30 for everything or is it still something where it’s that same number, not even 20?
Joshua Schafer: Yes. It’s probably in that range in terms of the customer-facing team, but then we’ll also have patient services and a robust hub that will provide support for those patients as they embark on their treatment journey. So I think within that range is probably a good direction.
Jonathan Aschoff: Okay. And lastly, do you have any sense of timing for OLPRUVA label expansion? How aggressively you might go into maple syrup or anything else or are you more so looking for additional orphan acquisition?
Neil McFarlane: Jonathan, this is Neil. That’s a great question. We’re going to — and what I’m doing as part of my listening tour is really understanding what are the things that we need to focus on and have clear line to execute on today. That is our Acer program, that is the arimoclomol program and that’s 1077. I think what I’m looking for the team right now to do is to evaluate the entire portfolio and find out how we’re going to be able to make those decisions based on — and prioritize those areas of development. So I think you got to stay tuned on that one. Give me another quarter and let’s have that conversation next time.
Jonathan Aschoff: Okay, thank you.
Operator: Thank you. Our next question will come from Sumant Kulkarni with Canaccord. Please go ahead.
Sumant Kulkarni: Good morning. Thanks for taking my question and again, nice to see all the updates. So you mentioned several interactions with the FDA, but could you specify how long ago was the last interaction?
Neil McFarlane: Christal?
Christal Mickle: Yes, hi Sumant, thanks for the question. Our last interaction was the FDA meeting at the beginning of August.
Sumant Kulkarni: Got it. And then assuming the company has both OLPRUVA and arimoclomol to commercialize next year, do you think the organization will be at capacity with selling 2 important products for some time? Or do you think the infrastructure could support additional acquired rare disease products? And along those lines, how would you characterize the landscape of available rare disease products today, especially given how markets have treated small and mid-cap biotech?
Neil McFarlane: Sumant, the opportunity for us to be able to accelerate our commercial platform and capabilities by bringing the talent together with Acer and OLPRUVA and then arimoclomol, really is a platform. This is a step in the direction of us becoming a leading rare disease company. How we execute on that, I think we’ll earn the right to be able to do this again and again and again. So from a standpoint of will we be at capacity, I think clearly executing on what we have to do will allow us to be able to make that decision at the time as to bring in additional assets under the umbrella. Josh, do you want to take the next one?
Joshua Schafer: Yes, absolutely. And just to add on to what Neil said. We are building the commercial capability in a way that it can be scalable for that purpose. And we’re building it today with the intention to execute against our OLPRUVA plans, but scalable to then add arimoclomol and potentially other rare disease products if that comes. But that’s the intent. And in terms of other rare disease products in the landscape, there are a number of very attractive other opportunities out there, whether they’re in late-stage clinical development or already commercializing on the market. And so we are constantly scanning the horizon for other opportunities. But our focus right now is really on building the commercial team and executing against the plans that we have in place.
Sumant Kulkarni: All right, thanks.
Operator: Thank you. Our next question will come from Oren Livnat with H.C. Wainwright. Please go ahead.
Oren Livnat: Thanks for taking my questions. I think all of them are kind of touched on already, but just to build out some more. Firstly, I don’t follow Acer already. Can you just help us understand what is the current state of OLPRUVA commercialization, so to speak, already in terms of existing support awareness. Obviously, you’re going to dramatically resource that product early next year, but where is that at now?
Neil McFarlane: Oren, I’ll ask Josh to hit on that.
Joshua Schafer: Yes, hey Oren. So OLPRUVA was approved in late 2022, but didn’t actually make it into the market and into the channels until July of this year due to some of the financial challenges that the company was faced. And so consequently, there isn’t a tremendous amount of awareness of OLPRUVA in the market today and the team at Acer is a pretty small team. They’ve been, I think, really effective given the limited resources that they have. But they don’t have a sales force out there talking with physicians. They have a very small account team talking with payers. So we see this as a real opportunity to put appropriate resources behind it and to really drive the awareness of OLPRUVA and the benefits that it confers to our patients. And we think with that concerted efforts and the combined efforts of our two companies coming together, we can really drive awareness and demand for OLPRUVA.
