Actinogen Medical Ltd ( ASX:ACW , OTC:ATGGF ) earlier this week highlighted progress towards the November topline readout from its pivotal XanaMIA Phase 2b/3 Alzheimer's disease trial, with the final patient visit completed and the company carrying a pro-forma cash position of around A$21.9 million.
Managing director and CEO Dr Steven Gourlay said the completion of the final patient visit in September marked an important operational milestone after a 36-week treatment programme involving 247 patients across Australia and the US.
Gourlay said the focus had now shifted to cleaning and finalising the clinical database ahead of the topline results. He noted that the study remained fully blinded, adding that "nobody knows the results" until the data is formally analysed.
The November readout represents the most immediate potential catalyst for Actinogen Medical. XanaMIA is evaluating Xanamem 10 mg once daily in patients with mild to moderate Alzheimer's disease, with the Clinical Dementia Rating Scale Sum of Boxes as the primary endpoint.
Gourlay also pointed to a recently published scientific paper exploring the rationale for targeting excess cortisol in the brain through inhibition of the 11β-HSD1 enzyme. He said elevated cortisol had been strongly associated with Alzheimer's disease and its progression, while previous company data had also shown activity in depression.
The company's financial position could provide added strategic flexibility following the clinical readout. Gourlay said earlier fundraising, the exercise of unlisted options and an expected tax credit had contributed to a pro-forma cash balance of approximately A$21.9 million.
He said this meant Actinogen Medical was "not in a hurry to do anything" and could take time to engage with potential strategic partners.
Should the XanaMIA results prove positive, Gourlay said the preferred pathway would be to engage a global pharmaceutical company with established clinical trial and commercial launch capabilities.
He described the possibility of a strong Alzheimer's result as having the "Holy Grail for Alzheimer's" in the company's hands, while outlining the potential for Actinogen Medical to delay Phase 3 expenditure as partnership discussions and future trial design progressed.
Beyond the November data, potential catalysts therefore include regulatory engagement, confirmation of the next pivotal study design and the emergence of a pharmaceutical partnership capable of supporting Xanamem's further development and potential commercialisation.
Interview highlights
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Actinogen Medical completed the final patient visit in the XanaMIA Phase 2b/3 Alzheimer's disease trial in September, keeping the study on track for topline results in November.
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The trial involved 247 patients across Australia and the US, with participants undergoing a 36-week treatment period.
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Clinical data is now being cleaned and finalised ahead of the topline readout.
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Dr Steven Gourlay stressed that the double-blind, randomised design means the trial results remain confidential until the database is finalised and analysed.
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Gourlay discussed a new scientific paper examining the rationale for targeting excess cortisol in the brain through inhibition of 11β-HSD1.
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He said elevated cortisol is associated with Alzheimer's disease and its progression, while also noting previous Xanamem data showing activity in depression.
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Actinogen Medical reported a pro-forma cash position of around A$21.9 million, supported by earlier fundraising, around A$5 million from the exercise of unlisted options and an expected tax credit.
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Gourlay said the cash position gives the company flexibility around future clinical spending and strategic discussions.
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If the November results are positive, the company intends to pursue discussions with potential global pharmaceutical partners with established clinical development and commercialisation capabilities.
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A positive XanaMIA readout could therefore become the key catalyst for the next stage of Xanamem's development, including regulatory planning, trial design and potential partnering.
Proactive: Actinogen Medical closed the September quarter with its pivotal XanaMIA Phase 2b/3 Alzheimer's disease trial on track for topline results in November and a pro-forma cash position of around A$21.9 million. With me to discuss the quarter's milestones is Managing Director and CEO Dr Steven Gourlay. Steven, good to see you again. Talk us through the key achievements for the quarter, especially as we approach the November deadline.
Dr Steven Gourlay: We're very excited to detail the progress over the last few months as we get closer to the clinical trial result, with topline results due in November.
It's no trivial exercise doing a pivotal trial. We have 247 patients across two countries, with a 36-week treatment period, many visits and a lot of data. All of that culminated in the final patient visit in September.
The data will now be cleaned and finalised so we have very high-quality data when we finally get to open the envelope, if you like, in November. Until then, the trial results are completely confidential. Nobody knows the results. This is what a double-blind, randomised trial does. So we're very excited about that.
Proactive: November is not far away now. In the meantime, there has also been a new scientific paper in Clinical and Translational Neuroscience looking at how Xanamem controls cortisol in the brain. How important is that paper to you?
Dr Steven Gourlay: There are a number of authors from the company, but also an important professor who is a real expert in 11β-HSD1 and cortisol synthesis.
The paper sets out the rationale for tackling cortisol and, in particular, the attractive approach of being able to inhibit this enzyme to reduce tissue cortisol synthesis and control excess levels of cortisol in the brain.
Those excess levels are strongly associated with Alzheimer's disease and the progression of Alzheimer's, and probably many other diseases.
We have also shown in our own depression data some activity as an antidepressant. This is the first time we have really detailed why this is such an intelligent and appropriate approach to cortisol, and why we believe the clinical trial in November has a good chance of reading out positively.
Proactive: The quarter also delivered a pro-forma cash position of A$21.9 million. Talk us through the options that gives Actinogen Medical as you approach the results and beyond.
Dr Steven Gourlay: The board and management have been striving to create as much optionality as possible. We raised some money earlier in the year and, together with the exercise of some unlisted options, we've brought in another A$5 million.
There is also a tax credit due, and that brings the pro-forma cash position to A$21.9 million, which is a great position to be in going into the results.
We're not in a hurry to do anything. We have the money to talk to relevant strategic partners who could be very important 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 would obviously be to recruit a global pharmaceutical company with established clinical trial capabilities and commercial launch capabilities as a partner.
We'll be going straight into those discussions. We also have the option to hold back on Phase 3 spending, discuss the design of the trials and the partnership with those parties, and then move forward as needed.
Proactive: There is certainly plenty to look forward to, especially with November only a few weeks away. Thanks for your time this morning, and good luck with it all.
