Anavex Life Sciences Corp. Price & Performance (AVXL)

Missling.

Thank you, Clint, and good morning, everyone. Thank you for being with us today to review our most recently reported financial results. And to provide our quarterly business update. I would like to point out that we are receiving growing a novel precision medicine treatment for early Alzheimer disease. With convenient oral dosing and with potential clinical meaningful benefit, We are excited to be potentially making a difference for individuals suffering from Alzheimer disease. By presenting a scalable treatment alternative alongside the ease of oral administration. Last month, we provided top line long term data from the Phase 2bthree ATTENTION AD open label extension The data demonstrated that over three years of continuous treatment with Placarmesine significantly reduced clinical decline showing continued clinical meaningful benefit for early Alzheimer disease patients. Also in January, we announced that the Journal of Prevention of Alzheimer's Disease J PALET, published the peer reviewed detailed results from the Phase 2bthree study, evaluating oral blacamizine for treatment of early Alzheimer disease. Once daily oral glaucomaZine, demonstrating a safety profile with no associated neuroimaging adverse events, significantly slow clinical progression by thirty six point three percent at forty eight weeks with Plakamiz in group as well as the pre specified sigma one wild type gene group by forty nine point eight percent.

At forty eight weeks. On the pre specified primary cognitive endpoint, [indiscernible] The peer reviewed publication of these data underscores the significance of the findings for both the scientific community and those focused on Alzheimer disease. Alzheimer disease is a highly complex condition. And this dataset plays a crucial role in advancing our understanding of the phase 2bthree results. We are grateful for the dedication from families, and the sites for taking part in this important study. Finally, at the January, we announced that Anavex was issued a new composition of meta, U. S. Patent expected to remain in force at least until July 2039 entitled A2 slash 73 crystalline polymorph compositions of matter and method of use thereof. From the United States Patent and Trademark office, This new patent claims crystalline forms of the de hydrogene [indiscernible] Well as transdermal patches and Eteric coated oral dosage forms, including the same for including Alzheimer's disease, Parkinson's Parkinson's disease and other disorders. The issuance of this US patent again showcases our expertise in identifying and pursuing novel therapeutic forms and formulations that are rooted in science. With respect to Anavex three seventy one, which will now include more participants, at the longer treatment duration within Part B. Iuvreux expects data from the ongoing Part B of the placebo controlled Phase two study in schizophrenia in the first half of twenty twenty five.

And now I would like to direct the call to Sander Berneisch, Principal Financial Officer of Anavex, who for a financial summary of the recently reported quarter. Thank you, Christopher. Good morning, everyone. I'm pleased to share with you today our first quarter financial results for the 2025 fiscal year. Our cash position at December 31 was $120,800,000 and we had no debt. During the quarter, we utilized cash and cash equivalents of $12,100,000 dollars in operating activities, after taking into account changes in non cash working capital accounts. As of quarter end, we anticipate that the current cash utilization rate and range a runway of approximately four years. During our most recent quarter, general and administrative expenses were $3,100,000 as compared to $2,700,000 for the comparable first quarter, Our research and development expenses for the quarter $10,400,000 as compared to 8,700,000.0 for the comparable first quarter. And lastly, we reported a net loss of $4,100,000 for the quarter or $0.14 per share.

Thanks. And back to you, Christopher. Thank you, Sandra.

In summary, we are receiving growing support from stakeholders Alzheimer disease with convenient oral dosing and with potential clinically meaningful benefit We are very excited to be potentially making a difference for individuals suffering from Alzheimer disease. By presenting a scalable treatment alternative alongside the ease of all administration using precision medicine. I would now like to turn the call back to Clint for Q and A. Thank you, Christopher. And it looks like the first question is coming from Tom Bishop. [indiscernible] Tom, can you hear us? I can hear you now, Tom.

Good. With regards to the the next few months, I guess we're hoping for some word from the from Europe Around midyear or is that the timeline? I thought I heard six months, but then there's then I heard maybe it could be longer. So we will expect the review to take two ten days since filing, which was in November, and it was accepted in December following months.

Less than thirty days after the filing So we are prepared for this review, and we're looking forward to it.

So that would be like July ish? Or maybe September?

We expect the feedback for the review to completed in by the end of this year. I don't know more specifics at this time. That's why we are ready to take care for. Okay. Now was there any discussion about a priority review of any sort or that ship has sailed? The requirement for that is a prime status. And since we filed without the prime because we were encouraged to file without the prime because of the unmet need, This is a procedure which is 210 Okay. Also, what are the upcoming events that We can look forward to. I guess we have the three seventy one trial due sometime before by midyear, That's correct. So we expect the ANNEX371 schizophrenia readout as we mentioned, in the first half of this year. Then we also a presentation of detailed data of the open label extension study attention AD in April at the ADPD conference. Which we top lined last month. And the details will be presented at this conference. And further, we will provide updates on the pipeline. We Tom, we don't hear you.

You said you are receiving increasing [indiscernible] or increasing support. And I was just wondering if you could elaborate elaborate on that.

We are getting support from stakeholders that is advocacy groups across the board and that's very encouraging. Because the unmet need in the current limited availability of scalable drugs for this horrible condition and that is includes advocacy group in Europe and around the globe.

Okay. And how about from other pharmaceutical companies? I mean, if this was approved, you need to [indiscernible] you need to start to market it in Europe and produce it and all that. And I guess one thing people point to is that there's been no hint yet of any interest from a pharma company. So just wondering I think the company has just been quiet about it.

Yes, that's not accurate, of course. Ongoing discussions [indiscernible] we initiated that last month at JPMorgan. And also regarding the material for marketing the drug. We have enough supply for launching this drug. [indiscernible] Manufacturing has been extremely productive to have marketed product ready for the market entry. Regarding how to move forward in terms of a sales force, or a partnership with a pharma company This is deciding on the terms of those discussions and the deciding factor guiding factor will be creating the most shareholder value for shareholders.

Whatever is in the interest of shareholders, that path will be taken But there's no doubt if there's a drug approved for such an indication, there will be a lot of interest. Also, what is the status of RET?

Brett's syndrome, we decided to and we said it a while ago, we plan to do another study to reconfirm and a larger study given that the last study was short on number of patients and the placebo arm was small giving some volatility in the endpoints. So we are planning to do another study in Rett syndrome as well. And this is what I refer to updates will come accordingly throughout this year. Okay.

It's been a while since that last trial ended, so I I just wondering what's We are migrating resources and we also like to focus on what is most creating most value right now. This is the Alzheimer program and the filing of the Altima indication was the most priority for us last few months.

Okay. And you mentioned the crystalline patent. [indiscernible] I was just wondering what How significant is that? It was hard to tell.

It's actually very significant. And I think that should be pointed out thanks for asking the question, that this crystallized patent API was actually used in all prior clinical studies. So it's not a new patent which has been suddenly identified as a patentable composition of matter, but these trials which we ran in Alzheimer disease we're all utilizing these [indiscernible] of the patent, which expires at at the earliest. In July 2039.

And that's very important because that means composition of meta is protected for the entire spectrum of these indications, including Alzheimer disease as well as Parkinson's disease for the for the capsule or the tablets used with respective API, which will be the case as well in the market.

That is very good news then. Also any update on Parkinson Yes, as I said, we will update Parkinson's program We had interaction with regulatory bodies and we will provide an update accordingly shortly about how to proceed with Parkinson's disease program. Anything on the FDA as far as glaucomaSeq goes?

We for Alzheimer disease, we are planning to have a meeting and that is what we did with EMA with the dialogue, with a very open dialogue in a meeting to request and share the data and asking what is the recommended procedure for us to lead and we're looking forward to this interaction. Okay, great. And are the OLE patients still on the drug or They are actually and we mentioned it at the last press release when we mentioned the OLE data that the seventy four people participants are still on study drug. As on a compassionate use program. And we will also follow-up with them for real world evidence we expect data from that as well going forward. So that's very encouraging that after four years of total intake of the drug, in the placebo controlled part as well as in the open label part, patients still continue to take the drug and are requesting to be on study drug. And we are able for that reason to use this additional population for real world evidence potentially. And so far nobody died from the drug in our study and outside of the study. And that's actually preceded the Phase twothree that includes also the Phase 2a, which started over nine years ago.

So over nine years, there has been no debt in caused by the drug.

The drug is just amazing in its advantages over these infusion therapy drugs and it's just I'm very excited. Well, thank you for answering my questions.

Thank you.

There's another question here. If you wanted to expand on that, if you wanted to expand on that, a brief overview of efficacy compared to the monoclonal antibodies?

So it's important to point out that these are twenty twenty four, which we also pointed out or cited in one of the last press releases on the efficacy data on the open label as well as the paper publication. On JPEG and that threshold is a two point score or more delta of Adderskog And we demonstrated in our trials [indiscernible] all participants. That means we are clearly clinically meaningful because that means that our patient, a participant can identify these changes himself or herself also the caregiver can identify these changes as well as the physician can identify these changes. And every score less than that would be not identifiable.

And to put this in perspective, our AdascoK13 over forty eight weeks reached that level of two point or more. And in comparison, Lilly reached for the ADASK0G13, exactly the same score a score only of 1.35. Delta to placebo and that would not meet the clinically meaningful threshold of two point or more and it was also reached after a much longer period of time this 1.35 So we are better and earlier in identifying improvement compared to placebo with placamizine and that comes on top of the advantage of an oral once daily administration, which is mechanistically probably closer to the complexity or origination of the disease which is ahead or earlier than a better and tau aggregation and inflammation and other dysfunctions which are within this disease, then other drugs including the monoclonal antibodies, which are targeting further downstream limited pathways, for example, the A beta pathway, which has recently gotten in a bit of critique because of the focus on this and the support, which was criticized in some media recently as well. But there's no doubt that we are happy to consider Blacamizine as a potentially complementary to existing treatments. That includes the antibodies, but also existing treatments which is donepidcil and memantine.

Which was demonstrated in our trial to be on the data was on top of Blacamazene on top of Donnebicel and Memantine So our effect is basically on top of standard of care available at the time of the of the trial. But again, the key thing is that the scalability the ecosystem of the healthcare would be better suited with oral once daily. And given it's ability not to cause serious [indiscernible] is the antibodies are doing and that why they have a black box warning. That means you can die from this drug in case of the antibodies. And you need to have a physician which has to be very courageous to prescribe this drug and given that it has to monitor the effect on the patient very carefully and requires a mandatory MRI every three weeks and this requires contrast medium. It's not a trivial task also to find appointment for an MRI. MRI centers are not widely spread out. In the Midwest, you hardly find any and that is probably also the contribution of slow uptake of the antibodies and the limited ability to expand this into a broader patient population with diverse background in the location.

That will be overcome with oral once daily small molecule like the bacamizine of course.

Well, thank you for that.

Another question, and I think it's the last one here is, assuming an EMA approval What other countries may follow and open their markets [indiscernible] So we are planning to submit to other jurisdictions [indiscernible] Canada and Australia Anavex been also participating in this trial. That will probably happen before the end of the year.

So we're expanding this and I mentioned the plan for The U. S. As well which will be a dialogue with the agency as well. So we are expanding the jurisdictions of beyond EMA because of the unmet need. Excellent.

Thank you. Believe that's all the questions at this time, Doctor. Misson.

Thank you. So in closing, we like to continue to focus on execution and commercial readiness as we advance our therapeutic pipeline to potentially improve patients' lives with these devastating conditions. I'd like to thank you for your attention Thank you. Thank you everyone for joining the call today. This concludes our conference call. We appreciate your participation. You may now disconnect.