Theresa Matkovits: Sure. Yes. So the ORALTO trial, as I mentioned, is 216 patients. We plan to enroll that across 65 sites in 11 countries. And we’re working with one of the world-renowned CROs who are experts in running these types of trials in invasive fungal infections. And we’re already having a lot of inbound interest in clinical sites of excellence to participate in our global trial. And we know the centers of excellence based on the track record of the CRO we’re working with. We’ll be targeting transplant centers and centers of excellence running trials in oncology patients as well since they’re a key cohort of immunocompromised patients. Based on the detailed experience of our CRO, we’re expecting enrollment to take approximately 22 to 24 months across these sites.
We expect to have topline data based on starting our first patients at the end of this year in the February 27 timeframe, which would allow us to support an NDA filing in the middle of 2027 and with our appropriate designation, fast track and such, we think that an NDA approval could be seen in the early part of 2028 in the first quarter. We believe that also given that our drug delivery of amphotericin B, the known gold standard for the treatment of invasive aspergillosis in patients with limited treatment options would be a great benefit from an enrollment perspective because that risk of not being a new chemical entity from a patient perspective, we believe will also be an important enhancement for the recruitment of patients in this trial.
Robert LeBoyer: Okay. Great. Thank you very much. And if I could just ask a second question. You had mentioned some of the primary and secondary endpoints in the trial. Are there any other things in terms of reduction in comorbidity or hospital stays or any of the other things outside of the requirements for approval that is being executed? Or is that – is it too early to expect that? You certainly have plenty of endpoints to support the NDA, anything else that might come out of the trial to justify cost or pricing or anything like that?
Theresa Matkovits: Absolutely, great question. So one of the key secondary endpoints will be pharmacoeconomic endpoints that we’ll be evaluating the health economic impact of being able to discharge a patient on oral treatment. So exactly to your point, we’ll be looking at the number of days of hospitalization, requirements for rehospitalization. For example, for the standard of care arm. We’ll be also looking at infusion days as well as the cost associated with managing a patient on an IV-administered product relative to an orally delivered amphotericin B. So all of those measures will be evaluated and collected and will support the value proposition from a commercial perspective. Additionally, we will be evaluating quality of life of patients.
So as patients are being able to be treated in the home setting, we have seen already in our compassionate use patients that they’re able to return to work, they’re able to return to daily living activities. So we expect that both on the pharmacoeconomic as well as the quality of life part of our data that we will further support the value proposition from a commercial perspective for the product.
Robert LeBoyer: Okay. Great. That sounds like a very well thought-out design. Looking forward to hearing those.
Theresa Matkovits: Thank you.
Jerome Jabbour: Thanks, Robert.
Operator: Ladies and gentlemen, there are no further questions at this time. I’d like to hand the call back to Jerry Jabbour for closing remarks.
Jerome Jabbour: Thank you, Joe. Thanks to everyone for joining us today and for your continued interest in Matinas. As I hope we conveyed during the call, we remain very excited and very optimistic about the company’s future. We look forward to reporting further progress during our first quarter conference call in May, and the second quarter is going to be a very big quarter for this company. Thank you again, and have a great evening.
Operator: This concludes today’s conference. You may now disconnect your lines at this time. Enjoy the rest of your day.
