Q1 2025 Anavex Life Sciences Corp Earnings Call - Q&A
Speaker Change: Good morning, everyone and welcome to the NFX Life Sciences fiscal 2025 1st quarter conference call.
Speaker Change: My name is Clint Tomlinson, and I will be your host for today's call. At this time, all participants are in a listen-only mode, and later we will conduct a question and answer session. During this session, if you would like to ask a question, please use the Q&A box or raise your hand.
Note that this conference is being recorded.
Christopher Missling: With us today is Dr. Christopher Missling, President and Chief Executive Officer, and Sondra Boenisch, Principal Financial Officer.
Speaker Change: Before we begin, please note that this conference call the company will make some projections and forward-looking statements.
Speaker Change: These statements are only predictions based on current information and expectations and involve a number of risks and uncertainties.
Speaker Change: We encourage you to review the company's filings with the SEC. This includes, without limitation, the company's Forms 10-K and 10-Q, which identify the specific factors that may cause actual results or events to differ materially from those described in these forward-looking statements.
Speaker Change: These factors may include, without limitation, risks inherent in the development and or commercialization of potential products, uncertainty in the results of clinical trials or regulatory approvals, need and ability to obtain future capital, and maintenance of intellectual property rights.
Speaker Change: And with that, I'd like to turn the call over to Dr. 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.
Christopher Missling: I would like to point out that we are receiving growing support from stakeholders for the potential to advance a novel precision medicine treatment for early Alzheimer's disease with convenient oral dosing and with potential clinical meaningful benefit.
Christopher Missling: We are excited to be potentially making a difference for individuals suffering from Alzheimer's disease by presenting a scalable treatment alternative alongside the ease of oral administration.
Christopher Missling: Significantly reduced clinical decline, showing continued clinical meaningful benefit for early Alzheimer's disease patients.
Christopher Missling: Also in January, we announced that the Journal of Prevention of Alzheimer's Disease, J-PAD, published a peer-reviewed detailed results from the Phase 2b-3 study, evaluating oral blockamazine for the treatment of early Alzheimer's disease.
Christopher Missling: One stately oral black carmesine, demonstrating a safety profile with no associated neuroimaging adverse events, significantly slowed clinical progression by 36.3% at 48 weeks.
Christopher Missling: with Black Kami's gene group, as well as the pre-specified Sigma-1 wild-type gene group by 49.8% at 48 weeks on the pre-specified primary cognitive endpoint ADAS-CoG13, respectively.
Christopher Missling: The peer-reviewed publication of these data underscores the significance of the findings for both the scientific community and those focused on Alzheimer's disease.
Christopher Missling: We are grateful for the dedication from participants, the families, and the sites for taking part in this important study.
Christopher Missling: Finally, at the end of January, we announced that Anavex was issued a new composition of meta-U.S. patents expected to remain in force at least until July 2039.
Christopher Missling: entitled A2-73 Crystalline Polymorph Compositions of Matter and Methods of Use Thereof from the United States Patent and Trademark Office.
Christopher Missling: This new patent claims crystalline forms of the dihydrogen phosphate salt of anavex 273 pre-base.
Christopher Missling: as well as transdermal patches and etheric-coded oral dosage forms, including the same for neuroprotection and treatment of neurodegenerative disorders, including Alzheimer's disease, Parkinson's disease, and other disorders.
Christopher Missling: The issuance of this U.S. patent again showcases our expertise in identifying and pursuing novel therapeutic forms and formulations that are rooted in science.
Christopher Missling: With respect to Rfx371, which will now include more participants at the longer treatment duration within Part B, Rfx expects data from the ongoing Part B of the placebo-controlled Phase II study in schizophrenia in the first half of 2025.
Speaker Change: And now I would like to direct the call to Sander Boenisch, Principal Financial Officer of Onavex, for a financial summary of the recently reported quarter.
Thank you, Christopher. Good morning, everyone.
I'm pleased to share with you today
Today, our first quarter.
all for the 2025 fiscal year.
Speaker Change: Our cash position at December 31st was $120.8 million, and we had no debt. During the quarter, we utilized cash and cash equivalents of $12.1 million in operating activities after taking into account changes in non-cash working capital accounts. As of quarter end, we anticipate at the current cash utilization rate and range a runway of approximately four years.
Speaker Change: During our most recent quarter, general and administrative expenses were $3.1 million as compared to $2.7 million for the comparable first quarter.
Speaker Change: Our research and development expenses for the quarter were $10.4 million, as compared to $8.7 million for the comparable first quarter. And lastly, we reported a net loss of $12.1 million for the quarter, or $0.14 per share.
Speaker Change: Thanks and back to you Christopher. Thank you Sandra. In summary, we are receiving growing support from stakeholders for the potential to advance a novel treatment for early Alzheimer's disease with convenient oral dosing and with potential clinically meaningful benefit.
Speaker Change: We are very excited to be potentially making a difference for individuals suffering from Alzheimer's disease by presenting a scalable treatment alternative alongside the ease of all administration using precision medicine.
Speaker Change: I would now like to turn the call back to Clint for Q&A.
Clint Tomlinson: Thank you, Christopher. We will begin the Q&A session now. If you have a question, please raise your hand or enter it in the Q&A box.
Speaker Change: And it looks like the first question is coming from Tom Bishop.
Tom, can you hear us?
Speaker Change: I can hear you now, Tom. Good. With regards to the...
Speaker Change: the next few months. I guess we're hoping for some word from Europe around mid-year or
Thank you.
Speaker Change: Is that the timeline? I thought I heard six months, but then I heard maybe it could be longer.
Speaker Change: So we will expect the review to take 210 days since filing which was in November last year and it was accepted in December the following month.
Speaker Change: less than 30 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.
Speaker Change: or maybe September? We expect the feedback for the review to complete it in by the end of this year and I don't know more specifics at this time so that's what we are here for.
Speaker Change: Okay, now was there any discussion about a priority review of any sort or as that ship has sailed?
Speaker Change: 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 days.
Okay.
Speaker Change: Also, what are the upcoming events that we can look forward to? I guess we have the 371.
trial due sometime before by mid-year.
Speaker Change: That's correct. So we expect the RNAVX371 schizophrenia readout, as we mentioned, in the first half of this year.
Speaker Change: Then we also are a expecting a scientific presentation of detailed
Speaker Change: 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.
Speaker Change: And further, we will provide updates on the pipeline. We expect updates on the Parkinson's disease program and other subsequent programs as well.
We don't hear you.
You said you are receiving increasing interest?
Speaker Change: for increasing support, and I was just wondering if you could elaborate.
Elaborate on that, uh-oh.
Speaker Change: We are getting support from stakeholders that is advocacy groups across the board and that's very encouraging and because the unmet need in the current limited availability of scalable drugs for this
Speaker Change: horrible condition and that includes an advocacy group in Europe and around the globe.
Speaker Change: Okay, and how about from other pharmaceutical companies? I mean, if this was approved, you'd need to file.
I think the company's just been quiet about it.
Speaker Change: Yeah, that's not accurate because there's ongoing discussions and we initiated that last month at J.P. Morgan.
and also regarding the material for
Speaker Change: marketing the drug. We have enough supply for launching this drug. The manufacturing has been extremely productive to have marketed a product ready for the market entry.
Speaker Change: pharma company, this is deciding on the terms of those discussions and the deciding factor or guiding factor will be creating the most shareholder value for shareholders.
Speaker Change: So, 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 Rhett?
Speaker Change: Red Syndrome, we decided to, and we said it a while ago, we plan to do another study.
Speaker Change: to reconfirm 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.
Speaker Change: 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.
Speaker Change: Okay it's been a while since that last trial ended so I'm just wondering what what's the...
Speaker Change: We like resources and we also like to, you know, focus on what is most, creating most value right now. This is the Alzheimer's program and the filing of the Alzheimer's indication was the most priority for us the last few months.
Speaker Change: Okay and you mentioned the Crystalline patent and I was just wondering what...
How significant is that?
API was actually used in all prior clinical studies.
Speaker Change: So, it's not a new patent which has been suddenly, you know, identified as a patentable composition of matter, but these...
Speaker Change: trials which we ran in Alzheimer's disease, we're all utilizing these composition of matter of the patent, which expires at the earliest.
Speaker Change: and that's very important because that means our composition of matter is protected for the entire spectrum of these indications including Alzheimer's disease as well as Parkinson's disease.
Speaker Change: for the capsule or the tablets used with the respective API, which will be the case as well in the market.
That is very good news then.
Also, any update on Parkinson's?
Speaker Change: Yeah, 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 glucomacin goes?
Speaker Change: We, for Alzheimer's disease, we are planning to have a meeting, and that is what we did with EMA, with a 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 proceed, and we're looking forward to this interaction.
Speaker Change: Okay great and are the OLE patients still on the drug? They are actually and we mentioned it at the last press release when we mentioned the OLE data that
The 74 participants are still on study drug.
Speaker Change: on a Compassionate Youth Program, and we will also follow up with them for real-world evidence.
and we expect data from that as well going forward.
Speaker Change: 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,
Speaker Change: Patients still continue to take the drug and are requesting to be on study drugs.
Speaker Change: and we are able for that reason to use this additional.
Speaker Change: population for real-world evidence potentially. Insofar nobody died from the drug.
Speaker Change: So it's important to point out that there's a requirement for clinically meaningfulness and that's been recently published in a paper 2020 for which we also.
Speaker Change: Pointed out it was cited in one of the last press releases on the efficacy data on the open label as well as the paper.
Speaker Change: Publication on Jay Pat and that threshold as a two point score or more delta of others Cog.
Speaker Change: And we demonstrated in our trials a cock 13 of.
Speaker Change: 2.03 for the entire population all participants.
Speaker Change: And that means we are cleaning clearly clinically meaningful because that means that a patient a participant can identify these changes himself or herself, but also the caregiver can identify these changes as well as the physician can't identify these changes and every score less than that.
Speaker Change: That would be not a identifiable and to put this in perspective, our artist cockpit team over 48 weeks.
Speaker Change: Reached that level of two point or more and in comparison.
Keith Hula: Keith Hula, although not them up on <unk>.
Keith Hula: Lilly have reached for the <unk> T in exactly the same score.
Keith Hula: Score only of 1.35 delta to placebo and that would not meet the clinically meaningful threshold of two point.
Keith Hula: 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 black cognizant and that comes on top of the advantage of a oral once daily admin.
Keith Hula: Australia, which.
Keith Hula: Is.
Keith Hula: Mechanistically, probably closer to the complexity or origination of the disease, which is a hand or earlier than a better in tau aggregation in inflammation and other dysfunctions, which are within this disease than other drugs, including.
Keith Hula: The monoclonal antibodies, which are targeting further downstream limited pathways for example, the a better pathway, which has recently gotten.
Keith Hula: In a bit of critique because of the focus on this and support which was.
Keith Hula: Criticized in some media recently as well, but there is no doubt that we are happy to consider black cognizant is a potentially a complementary to existing <unk> that includes the antibodies, but also existing treatments, which is uh huh.
Keith Hula: Donepezil and Memantine, which was demonstrated in our trial to be on the data was on top of a block compazine on top of Donepezil and Memantine. So our effect is basically on top of standard of care available at the time of the.
After of the trial.
Keith Hula: But again the key thing is that the scalability the ecosystem of the health care would be better suited with our oral once daily and given its.
Keith Hula: Ability not to cause a serious of debts.
Speaker Change: Is that the antibodies are doing and that's 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.
Speaker Change: A very carefully and it requires a mandatory MRI every three weeks and this requires a contrast medium it's not a <unk>.
Speaker Change: Trivial tasks also defined our appointment for an MRI and MRI centers are not widely spread out in the Midwest you hardly find any and it is probably also the contribution of the slow uptake of the antibodies and the limited ability to expand this into a broader patient.
Speaker Change: <unk> with diverse background and a location that would be overcome with our oral once daily small molecule liked about common theme of course.
Speaker Change: Well, thank you for that.
Speaker Change: Mhm.
Speaker Change: Another question and I think it's the last one here is.
Speaker Change: Assuming an EMA approval.
Speaker Change: What other countries may follow and open their markets to block Amazon.
Speaker Change: So we are planning to submit to other jurisdictions among them in the U K and others, Canada and Australia have been also participating in this trial that will probably happen before the end of the year. So we are expanding this and I mentioned the plan for the U S as well.
Speaker Change: <unk> will be a dialogue with the agency as well. So we are expanding the jurisdictions of beyond E. M. A.
Speaker Change: Because of the unmet need.
Speaker Change: Excellent. Thank you.
Speaker Change: I believe that's all the questions at this time activism.
Speaker Change: Thank you so in closing wed like to continue to focus on execution and commercial readiness as we advance our therapeutic pipeline to potentially improve patient lives with these devastating conditions I'd like to thank you for your attention. Thank you.
Speaker Change: Thank you everyone for joining the call today. This concludes our conference call. We appreciate your participation you may now disconnect.
Speaker Change: Correct.
Speaker Change: Yeah.
Speaker Change: Okay.