I would suggest that, if someone is looking for a metaphor, an analog here on something like this, I would suggest that you go back and look at the case. It’s not an oncology, but the business case would be similar. Look at the business case for , which was Schering-Plough cholesterol absorption inhibitor, which was approved as Zetia. And how that product was used in combination with almost all of the then approved statins. And then ultimately, a new product was developed, which is now called Vytorin, which is actually the combination of simvastatin, Merck second generation statin, plus ezetimibe in a single product sold as Vytorin and ultimately became one of the reasons why Merck purchased Schering-Plough. But you can see the model there of how a product that can be used in combination with a variety of other products can be marketed in a variety of different ways and can achieve great commercial success.
Operator: Thank you. [Operator Instructions]. Our next question comes from the line of Kemp Dolliver with Brookline Capital Markets. Your line is now open.
David Mazzo: Hi, Kemp.
Kemp Dolliver: Thanks. And good afternoon. I have two or three questions. Just to close the loop on with WARPNINE, how long do they have to raise the adequate amount of money to run the trials before you can just contractually walk away and find another entity?
David Mazzo: There’s really–there’s nothing contractually in that about a timeline. So it’s really something again, we approach pragmatically. To the best of our knowledge, they are very close to having all the funding necessary to supply for iGoLSTA. And they’ve already, of course, fully funded iGoLSTA alone. So they’re actually pretty efficient at getting to full funding, and it’s because they tap a network of philanthropic organizations and individuals within their region of the world, mostly Australia and New Zealand, who are very interested in supporting the cause.
Kemp Dolliver: Okay, that’s helpful. Thank you. And when do you expect you will get your rebates for your Australian activity for this year? It looks like you were paid about $2 million last year in the second quarter. Is that a good ballpark, number one? And then number two, are these R&D credits included in the runway guidance?
David Mazzo: So the R&D credits are included in the runway guidance. James, if you’re still available and your connection is working, could you just jump in, please?
James Nisco: Yep. So in September, we received $600,000 from the Australian Taxation Office. That was related to the 2022 tax year. And at the end of this year, we did have $1 million recorded as an income tax receivable. So we typically file our returns in the June, July timeframe and then receive the refund around the September timeframe. And that’ll be the expectation of about $1 million in 2024, based on the 2023 tax year. And yes, that is included in our projected capital runway.
Kemp Dolliver: That’s great. Thank you. And then with regard to Qilu, it looks like you’ve had some recent communication with them because there was some verbiage added versus last quarter regarding the timing of them advancing the program once they have data. And so I think in the past, you’ve said the next milestone from them would be in 2025. Is that still the case? And I think the estimate could be that it would be as much as $10 million.
David Mazzo: So the estimate is correct. Actually, it’s not an estimate, it’s contractual. At the beginning of Phase, when they dose the first patient in Phase 3 or in a registration trial, which is typically a Phase 3 trial, in the region, they are contractually obliged to pass a milestone of USD10 million. And to the best of our knowledge, they’ll be starting Phase 2 at the end of this quarter or early next quarter. And while we don’t know the projection of a Phase 2 timeline in China, but one could guesstimate that a typical Phase 2 program takes between 18 and 24 months. So if we’re starting now, roughly two years from now, one might expect that the milestone might become due. But it’s all dependent on enrollment rate and progression of the development program by Qilu in China.
Kemp Dolliver: Okay, thank you. And I’ll just press on this a little more in case they’ve indicated anything. But the CFDA has done a pretty good job of replicating many of the accelerated pathways of US, FDA. And so, have you heard from Qilu whether or not CFDA has indicated some eligibility for an accelerated pathway if the data pulled up?
David Mazzo: To our knowledge, they have, that is Qilu, has had discussions with the Chinese regulatory authorities. And I believe that their program is designed to take maximum advantage of the possibility of an accelerated approval pathway. But we have not been privy to any written. Well, we don’t read Chinese anyway, but any translated of the written communications between them that might actually codify that. But that’s what we’ve been told that they’re developing with achieving accelerated approval in mind.
Operator: Thank you. This concludes the Q&A portion. I will now turn the call back to Dr. Mazzo for closing remarks.
David Mazzo: Thank you, operator. And again, thank you all for participating in today’s call. We look forward to speaking with you again during our next quarterly conference call and to continuing to provide updates on our achievements and progress. We remain grateful for your continued interest and support. Stay well and have a good evening.
Operator: This concludes today’s conference call. Thank you for your participation. You may now disconnect. Everyone have a wonderful day.
