Transcription of The Stock Network Interview with Acrux (ASX:ACR), CEO and Managing Director John Warmbrunn
Lel Smits: Acrux is continuing to advance its female testosterone program with the FDA providing a clear pathway toward late-stage clinical trials and global pharmaceutical companies showing strong interest in partnering on its product. Alongside this, the company’s commercial business continues to generate cash helping to fund development of what management describes as a once-in-a-generation opportunity in women’s health. I’m joined today by CEO and Managing Director John Warmbrunn to discuss the June quarter, the female testosterone opportunity and growing commercial momentum, also key milestones ahead.
John, welcome back to the Stock Network.
John Warmbrunn: Oh great, great to be here.
Lel Smits: Great to have you on and look the FDA has provided greater clarity on the next steps for female testosterone while interest from potential partners continues to build.
Why do you think that’s such an important milestone? Also, can you run us through what it actually means for the future of the program?
John Warmbrunn: Sure, look, clearly the USA is the biggest market and the FDA is the world’s leading regulator so getting something from them really means a lot to us. It also means that when we’re talking about co-development we can get really specific now about what we’re doing. If you like, we can move from theory to reality and we can actually get on with planning the specifics in the trial, getting on with selecting clinical research partners and, of course, looking at the exact finances and how it’s going to work.
So it’s a significant moment for us.
Lel Smits: Fantastic and look, millions of women have had limited treatment options for low libido, making this a significant unmet medical need. What do you think makes female testosterone different? Also, if you could outline why you believe it has the potential to make a real impact?
John Warmbrunn: Okay, look, I think just to set the context, you know, hormone replacement therapy has changed and the way women are looking at that and what it can do for them has changed, understanding the benefits and understanding the risk.
So that means that testosterone is coming at a time where they’re actually open to thinking about it. But if you think there’s already a couple of million people, women in the US, using testosterone, using a male product, they’re prepared to take the risk. So what it tells you is that there’s real demand from this from women.
The other thing that’s important is that we’ve got patchless patch technology. So a testosterone transfer and mess are not things you want to get into. So our spray and patchless patch is ideal for women and it means we can have a controlled dose specifically for women.
So the other side of it that’s exciting for us is because we’ve been doing this for so long, you know, we had male testosterone a long time ago and we worked on female a long time ago and had to pause, we’re really well advanced and ready to go at exactly the right time. And the other thing about female testosterone is it’s not just about low libido, it’s a much broader set of benefits. So we’re not a one-trick pony and that means that women are going to be interested for more than just low libido.
Lel Smits: Okay. And John, with Phase 3 planning now underway, partnership discussions that are also progressing for you and also that additional Lenzetto milestone that are available, what do you think are really the commercial catalysts here that we should be watching for?
John Warmbrunn: Look, I think the key thing is obviously going to be getting a co-development partner. That’s the big one. But then we go through a process there. We’ve created a shortlist already. We’re talking to Big Pharma, we’re talking to Women’s Health. And we’ll go through a process and that’s been very positive. We’ve set up a data room this week. Now we’ve got the FDA guidance, that’s the last piece of the puzzle.
So we can actually get into real meeting discussions. And then we’ll choose the right partner and the right commercial terms about whether it’s upfront payments, co-development, whatever that mix is. And then there’s a whole lot of milestones around the trials themselves.
So Phase 3 recruitment, the batch trials, putting a research organisation in place, manufacturing, all those are going to be milestones along the way to getting this product to market.
Lel Smits: John, thank you for the update from Acrux. Thank you.
Ends