00:00
Dr. Steven Goulay
And why we have belief that this clinical trial uh in November has a really good chance of reading out uh very positively.
00:13
Jonathan
Actinogen medical closed the September quarter with its pivotal Xanamem Alzheimer's disease trial on track for top-line results in November and a pro-forma cash position of around 21.9 million.
00:26
Jonathan
With me to discuss the quarter's milestones is managing director and CEO, Dr. Steven Goulay. Steven, good to see you again.
00:33
Dr. Steven Goulay
Uh Hi, Jonathan. Thanks for having me.
00:35
Jonathan
It's a pleasure. So, yeah, talk us through these key achievements for the quarter, especially as we come to this November deadline.
00:43
Dr. Steven Goulay
Yeah, so, uh, look, we're very excited to detail, you know, the pretty amazing progress over the last few months as we get closer to the clinical trial result. The top line results in November. It's no trivial exercise doing a pivotal trial.
01:00
Dr. Steven Goulay
247 patients across two countries, a 36 week long treatment period, many visits, a lot of data, all of which uh has culminated now in the last patient visit uh in September, and of course, the data will be cleaned and scrubbed, so we have super high quality data when we finally get to open the envelope, if you like in November. But until then, the trial results are completely confidential.
01:31
Dr. Steven Goulay
Nobody knows the results. This is what a double blind randomized trial does. So, yeah, very excited about that.
01:38
Jonathan
Yeah, we're not November's not far away now, but uh uh, in in the meantime and a new scientific paper, clinical and translational neuroscience. Um, it's looking at how Zana or Xanamem controls cortisol in the brain. How is how important is that paper to you?
01:58
Dr. Steven Goulay
Yes. So um, you know, we were uh a number of authors from the company but also a very important professor from Edinburgh, Jonathan Sele who's a real expert in 11 beta21 in ambition this is the target cortisol synthesis. high of the rational between tackling cortisol and particularly the the really attractive way of being able to inhibit this enzyme to inhibit tissue cortisol synthesis,
02:27
Dr. Steven Goulay
control uh excess levels of cortisol in the brain that are so strongly associated with Alzheimer's and the progression of Alzheimer's and probably many other diseases. And we showed in our own data, depression data as well, some activity as an anti-depressant. So it's the first time it's really detailed why Xanamem is such an intelligent and appropriate approach to cortisol.
02:45
Dr. Steven Goulay
And why we have belief that this clinical trial uh in November has a really good chance of reading out uh very positively.
02:54
Jonathan
Mhm. And the quarter also uh delivered 21.9 million uh proformer cash position. Um talk talk us through the options that gives you as as you approach the results and beyond.
03:06
Dr. Steven Goulay
Yes. So the board and the and the management have been striving to create as much optionality as possible. Uh and we raised a bit of money earlier in the year. Um and then can together with the option exercises of some unlisted options, uh which brought in another 5 million and the tax credit due at any time. You know, that's the proformer of 21.9, which is a great position to be in going into results.
03:32
Dr. Steven Goulay
We're not in a hurry to do anything. Uh we have money to talk to the relevant strategic potential strategic partners who could be very critical, of course, to the future of the company and the development of Xanamem. If we do have the holy grail for Alzheimer's in our hands in November, the right thing to do, obviously, is to recruit a global pharmaceutical company with established uh clinical trials capabilities and and commercial launch capabilities as a partner. And uh we'll be going straight into those discussions.
04:06
Dr. Steven Goulay
And we have the optionality to uh hold back on phase three spending, uh discuss the design of the trials and the partnership with those people and then um move forward as we need to.
04:16
Jonathan
Yeah, Stephen, lots to look forward to especially as November's only a few weeks away as well. Um thanks for your time this morning and uh yeah, good luck with it all.
04:24
Dr. Steven Goulay
Thanks so much.